Clovis Oncology
Annual Report 2015

Plain-text annual report

! UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.For the fiscal year ended December 31, 2015.¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.For the transition period from to .Commission file number: 001-35347 Clovis Oncology, Inc.(Exact name of Registrant as specified in its charter) Delaware 90-0475355(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.) 5500 Flatiron Parkway, Suite 100Boulder, Colorado 80301(Address of principal executive offices) (Zip Code)(303) 625-5000(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registeredCommon Stock par value $0.001 per share The NASDAQ Global Select MarketSecurities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No xIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. Yes x No ¨Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405) of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). Yes x No ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to thebest of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to thisForm 10-K. ¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. Seethe definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No xThe aggregate market value of the registrant’s common stock, par value $0.001 per share, held by non-affiliates of the registrant on June 30, 2015, the lastbusiness day of the registrant’s most recently completed second quarter, was $2,122,270,803 based on the closing price of the registrant’s common stock onthe NASDAQ Global Market on that date of $87.88 per share.The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of February 19, 2016 was 38,359,454.DOCUMENTS INCORPORATED BY REFERENCEPortions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A inconnection with the registrant’s 2016 Annual Meeting of Stockholders, which is to be filed within 120 days after the end of the registrant’s fiscal year endedDecember 31, 2015, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated therein. TABLE OF CONTENTS PagePART I ITEM 1. BUSINESS 3ITEM 1A. RISK FACTORS 25ITEM 1B. UNRESOLVED STAFF COMMENTS 43ITEM 2. PROPERTIES 44ITEM 3. LEGAL PROCEEDINGS 44ITEM 4. MINE SAFETY DISCLOSURES 45PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIES 45ITEM 6. SELECTED FINANCIAL DATA 47ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 48ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 61ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 61ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 61ITEM 9A. CONTROLS AND PROCEDURES 62ITEM 9B. OTHER INFORMATION 64PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 65ITEM 11. EXECUTIVE COMPENSATION 65ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERMATTERS 65ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 65ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 65PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 66 SIGNATURES 67 2PART IThis Annual Report filed on Form 10-K and the information incorporated herein by reference includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms“believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, theirnegative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in anumber of places throughout this Annual Report on Form 10-K and include statements regarding our intentions, beliefs, projections, outlook, analyses orcurrent expectations concerning, among other things, our ongoing and planned non-clinical studies and clinical trials, the timing of and our ability tomake regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree of clinical utility of our products,particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects,growth and strategies, the industry in which we operate and the trends that may affect the industry or us.By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change anddepend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We cautionyou that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidityand the development of the industry in which we operate may differ materially from the forward-looking statements contained herein.Any forward-looking statements that we make in this Annual Report on Form 10-K speak only as of the date of such statement, and we undertake noobligation to update such statements to reflect events or circumstances after the date of this Annual Report on Form 10-K or to reflect the occurrence ofunanticipated events.You should also read carefully the factors described in the “Risk Factors” section of this Annual Report on Form 10-K to better understand the risks anduncertainties inherent in our business and underlying any forward-looking statements. You are advised, however, to consult any further disclosures wemake on related subjects in our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and our website.Clovis Oncology® and the Clovis logo are trademarks of Clovis Oncology, Inc. in the United States and in other selected countries. All other brandnames or trademarks appearing in this report are the property of their respective holders. Unless the context requires otherwise, references in this report to“Clovis,” the “Company,” “we,” “us” and “our” refer to Clovis Oncology, Inc., together with its consolidated subsidiaries. ITEM 1.BUSINESSOverviewWe are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europeand other international markets. We generally target our development programs for the treatment of specific subsets of cancer populations and seek tosimultaneously develop, with partners, companion diagnostics that direct our product candidates to the patients that are most likely to benefit from their use.We are currently developing three product candidates: ●Rociletinib, an oral epidermal growth factor receptor (“EGFR”), mutant-selective covalent inhibitor that is currently under review with the U.S.and E.U. regulatory authorities for the treatment of advanced non-small cell lung cancer (“NSCLC”) in patients with activating EGFRmutations, as well as the dominant resistance mutation, T790M; ●Rucaparib, an oral inhibitor of poly (ADP-ribose) polymerase (“PARP”) that is currently in advanced clinical development for the treatment ofovarian cancer and for which the first U.S. regulatory application is expected to be submitted for approval during the second quarter of 2016and the first E.U. regulatory application is expected to be submitted in the second half of 2016; and ●Lucitanib, an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1-3 (“VEGFR1-3”), platelet-derivedgrowth factor receptors alpha and beta (“PDGFR a/ß”) and fibroblast growth factor receptors 1-3 (“FGFR1-3”) that is currently in Phase IIdevelopment for the treatment of breast cancer.We hold global development and commercialization rights for rociletinib and rucaparib. For lucitanib, we hold development and commercializationrights in the U.S. and Japan and have sublicensed rights to Europe and rest of world markets, excluding China, to Les Laboratoires Servier (“Servier”).3We have built our organization to support innovative oncology drug development for the treatment of specific subsets of cancer populations. Toimplement our strategy, we have assembled an experienced team with core competencies in global clinical development and regulatory operations inoncology, as well as conducting collaborative relationships with companies specializing in companion diagnostic development. We have fully establishedour U.S. commercial and medical affairs organizations in preparation for potential approvals for our New Drug Applications (“NDAs”) for rociletinib, whichwas filed in July 2015, and for rucaparib, which we expect to file in the second quarter of 2016.Product CandidatesWe are developing our product candidates for selected patient subsets and collaborating with partners for companion diagnostic development. Thefollowing table summarizes the ongoing studies for our product candidates: Rociletinib - an Oral EGFR Mutant-Selective InhibitorOverviewRociletinib is a novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC, and is thesubject of a global clinical development program.In May 2010, we in-licensed rociletinib from Avila Therapeutics, Inc. (now Celgene Avilomics Research Inc., part of Celgene Corporation). In May 2014,rociletinib received “Breakthrough Therapy” designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with EGFRmutation-positive NSCLC, whose disease has progressed on prior EGFR-directed therapy due to T790M-mediated acquired drug resistance.In July 2015, we submitted an NDA to the FDA and a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) forrociletinib as treatment for patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790Mmutation. During a regularly scheduled Mid-Cycle Communication meeting in early November 2015, the FDA requested additional clinical data for use inthe efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. We submitted these data in a Major Amendment on November16, 2015 after which the FDA extended the Prescription Drug User Fee Act goal date for the rociletinib NDA by three months to June 28, 2016 to allowadditional time for review of the new information requested by the agency. The FDA has scheduled the NDA for rociletinib for discussion by the OncologicDrugs Advisory Committee (“ODAC”) on April 12, 2016. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed andinvestigational human drug products used in the treatment of cancer and makes recommendations to the FDA.4Market Overview - Resistance to EGFR Tyrosine Kinase Inhibitors (“TKIs”) Represents an Unmet Medical NeedLung Cancer and EGFR TKIs. According to the American Cancer Society, in 2016, there will be an estimated 224,000 new cases of lung cancer in theUnited States, making it one of the most common types of cancer. In addition, according to GLOBOCAN, in 2012, there were an estimated 313,000 new casesof lung cancer in the European Union and an estimated 95,000 new cases in Japan. Lung cancer typically presents relatively late in its clinical course, whenlocally-directed therapy (surgery and radiation) is not curative.Lung cancer is typically divided into two groups based upon the histologic appearance of the tumor cells (small cell and non-small cell lung cancer), eachof which is treated with distinct chemotherapeutic approaches. According to the American Cancer Society, NSCLC accounts for approximately 85% of lungcancer cases. The standard of care for treatment of advanced or metastatic NSCLC has historically been a cytotoxic chemotherapy doublet of platinum pluspaclitaxel. In the last few years, in a subset of NSCLC patients, Avastin® (bevacizumab) has been shown to prolong survival when added to the chemotherapydoublet, and Alimta® (pemetrexed) has replaced paclitaxel on the basis of improved tolerability and ease of administration. Despite these additions, patientswith locally advanced or metastatic NSCLC have five-year survival rates of just 27% and 4%, respectively, according to the Survival Epidemiology and EndResults program of the National Cancer Institute.Small molecule inhibitors of the tyrosine kinase activity of EGFR were introduced into the treatment of lung cancer just over 10 years ago. The growth-promoting EGFR was known to be frequently expressed on lung cancer cells, often at high levels, and non-clinical work had suggested that EGFR TKIs, suchas gefitinib and erlotinib, could provide effective cancer therapy in certain patient subsets. Iressa® (gefitinib) and Tarceva® (erlotinib) were approved by theFDA in 2003 and 2004, respectively, for patients who had failed to respond to conventional chemotherapy.In 2004, it was discovered that the subset of NSCLC patients who experienced dramatic clinical responses to EGFR TKIs had activating mutations in theEGFR gene in their lung cancer tissue, typically either a point mutation in exon 21 (L858R) or a deletion mutation in exon 19 (del(19)). It became clear thatthe EGFR TKIs potently inhibited the mutant EGFR proteins, switching off their activity and causing dramatic tumor shrinkage in patients. This is anexample of “oncogene addiction,” whereby a single gene mutation (EGFR in this case) is absolutely necessary for the proliferation and/or survival of a tumorcell. A corollary of this situation is that inhibition of that single gene product (in this case with TKIs) is therapeutic and drives tumor shrinkage. It wassubsequently shown in a study conducted by Jeffrey A. Engelman, et al. published in Clinical Cancer Research in 2008 that EGFR mutations generatetumors with adenocarcinoma histology and are found in approximately 10% to 15% of Caucasian NSCLC patients and 30% to 35% of East Asian NSCLCpatients.The original approvals of the TKIs made no reference to patient selection, but these more recent data suggest that the majority, if not all, of theirtherapeutic benefit can be attributed to the subset of patients with activating EGFR mutations. During 2013, the FDA approved Gilotrif ® (afatinib) andexpanded the label for Tarceva® (erlotinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have activatingEGFR mutations, as detected by FDA-approved tests. During 2015, the FDA also approved Iressa® (gefitinib) for the same indication.Resistance to EGFR TKIs. Despite the success of TKIs in patients with mutant EGFR-related NSCLC, most patients’ disease will progress, typically afterapproximately one year of therapy. Molecular studies, including a study conducted by Helena A. Yu, et al., published in Clinical Cancer Research in 2013,have shown that approximately 60% of the resistant tumors carry a second, acquired resistance mutation in the EGFR gene. This resistance mutation is aspecific change in the type of amino acid located at position 790 in the EGFR protein, called a “T790M” mutation. As a consequence of this switch, thethree-dimensional structure of the TKI binding site changes and the EGFR becomes resistant to TKI therapy. This T790M mutation is also called the“gatekeeper” mutation because of its strategically important position in the EGFR protein. Until recently, there were no approved therapies for patientswhose disease progressed due to the emergence of the T790M mutation. Patients who developed TKI resistance received standard cytotoxic chemotherapythat carried toxicity and only modest palliative efficacy. In November 2015, the FDA approved TagrissoTM (osimertinib) for the treatment of patients withmetastatic EGFR T790M mutation-positive NSCLC as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy, representingthe first approved therapy for the treatment of EGFR mutant NSCLC patients who test positive for the T790M mutation. In February 2016, the EuropeanCommission granted conditional marketing approval to Tagrisso™ for the treatment of advanced NSCLC patients who test positive for the T790M mutation.5Design of Rociletinib - a Targeted Covalent DrugMost human diseases are rooted in the abnormal activity of certain proteins. Traditional small molecule drugs, while able to inhibit disease-causingproteins, are generally only able to form transient binding interactions with the disease targets and are thus considered reversible. A covalent drug, however,forms a strong and durable bond with its protein target, known as a covalent bond. A targeted covalent drug is designed to form its covalent bond in a highlydirected and controlled manner with a specific site on the disease target. This directed bond formation is key to achieving a distinct selectivity profile that isdifficult to achieve with traditional reversible small molecules. Rociletinib was developed using a proprietary platform to purposefully and systematicallydesign and develop targeted covalent inhibitors.Rociletinib was designed by identifying a site on the EGFR protein where a covalent bond could be formed and, using proprietary drug designtechniques, modeling chemical structures that could selectively form a bond with this site. These molecules were then synthesized and tested in assays toverify their ability to form targeted covalent bonds and to potently inhibit the mutant forms of EGFR and also to demonstrate that covalent bonds were notformed indiscriminately with other targets.Clinical DevelopmentWe are pursuing the development of rociletinib as both a second-line or later treatment for EGFR-mutated NSCLC patients who become resistant to TKIsdue to the emergence of the T790M mutation, and potentially, as a first-line treatment for EGFR-mutated NSCLC when given in combination with otheragents. We are also exploring rociletinib’s utility for progressing EGFR-mutated NSCLC patients who do not express the T790M mutation (T790M-negativepatients).In the first quarter of 2012, we initiated our first Phase I/II study of rociletinib in patients with metastatic or unresectable recurrent NSCLC and adocumented EGFR mutation. Patients were not required to be T790M positive for the Phase I portion of the study but had to have progressed on prior EGFR-directed TKI therapy (prior chemotherapy was also allowed). The Phase I portion of the study was conducted in the U.S., France and Australia. Data from thisstudy were used to determine the tolerability and pharmacokinetics of rociletinib, as well as provide initial evidence of efficacy.We recently completed enrollment of the Phase II expansion cohorts of that study, designated as TIGER-X under the TIGER (Third-generation Inhibitorof Mutant EGFR in Lung CancER) program, conducted in the U.S., Europe and Australia. These cohorts are testing the safety and efficacy of rociletinib inpatients with T790M-positive NSCLC, either immediately after progression on their first and only TKI therapy or after progression on their second or laterTKI therapy of subsequent chemotherapy.In addition to TIGER-X, three global studies are currently ongoing as part of the TIGER program: ●TIGER-1, a randomized Phase II study of rociletinib vs. erlotinib in EGFR mutation-positive patients who have not had TKI therapy, but whomay have received one type of chemotherapy. Enrollment for this study was recently discontinued, as we intend to focus our evaluation ofrociletinib as a first-line therapy only in combination with other agents. ●TIGER-2, a single-arm study in second-line patients immediately after progression on their first and only TKI therapy, which includes bothT790M-positive and T790M-negative cohorts. Enrollment in this study was recently completed. ●TIGER-3, a randomized study of rociletinib vs. chemotherapy in later-line patients progressing on second or later TKI or subsequentchemotherapy, which includes both T790M-positive and T790M-negative cohorts. TIGER-3 continues to enroll patients and is intended toserve as the confirmatory study following accelerated approval of rociletinib, which is currently under review by the FDA.Data from the interim data cuts of the TIGER-X expansion cohorts, combined with an interim data cut of TIGER-2, serve as the basis of the NDA in theU.S. and the MAA in the E.U. filed in July 2015 for the initial approvals for rociletinib for the treatment of patients with mutant EGFR NSCLC who have beenpreviously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The primary efficacy analysis for these submissions is based onpooled data from patients enrolled in the TIGER-X and TIGER-2 studies who were given rociletinib at doses of 500mg and 625mg BID, or twice daily. Thedata in the final MAA dataset will be based on a larger number of patients than in the NDA dataset. 6In the intent to treat analysis of the 79 patients in the 500mg BID dose group, the confirmed response rate by investigator was 28% and by independentreview was 23%, and the duration of response by both investigator and independent review was nine months. For the 170 patients in the 625mg BID dosegroup, the confirmed response rate by investigator was 34% and by independent review was 32%, and the duration of response by investigator was sevenmonths and by independent review was nine months. The only grade 3 or higher treatment emergent adverse reaction observed in greater than 15% ofpatients is hyperglycemia (27% for the 500mg BID dose and 28% for the 625mg BID dose, both based on lab values), with QTc prolongation also notable,though with lower frequency of grade 3 or higher events. Based on this data set, we have requested that the FDA consider 625mg BID as the dose forrociletinib approval, although this matter is still under review by the FDA. The data in the final MAA dataset, including a pre-agreed update that includes alarger number of patients, is planned to be submitted to the EMA in the second quarter of 2016. Based on our planned second quarter submission, weanticipate the Committee for Medicinal Products for Human Use (“CHMP”) to issue an opinion on the rociletinib MAA by the end of 2016.We expect that should rociletinib be approved, the primary information on response rates and duration of response included in the prescribinginformation will be based on confirmed response rate by independent review.As noted above, we are also exploring rociletinib’s utility for progressing T790M-negative, EGFR-mutated NSCLC patients. In T790M-negative patientstreated in the TIGER-X study at the 625mg BID dose, a confirmed response rate of 29% was achieved (N=24), with a median duration of response ofapproximately seven months. T790M-negative patient cohorts are being further evaluated in both the TIGER-2 and TIGER-3 studies.These studies are ongoing, so data may change over time.In January 2016, we announced our intention to explore rociletinib in Phase Ib/II combination studies with other agents in first- and later-line NSCLCpatients who possess the EGFR mutation. These include combinations with immuno-oncology agents, anti-VEGF inhibitors (e.g. bevacizumab) and EGFRmonoclonal antibodies (e.g. cetuximab). These studies will include both T790M-positive and T790M-negative patients. The first of these studies, a trialevaluating the combination of rociletinib with Genentech’s investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL-1) for thetreatment of advanced EGFR-mutant NSCLC, was initiated in January 2016.Concurrent with our drug development program, we are collaborating with QIAGEN for the development of a companion diagnostic to enableidentification of the T790M mutation in patients with mutant EGFR driven NSCLC. The PCR-based diagnostic test will build on QIAGEN’s therascreen®EGFR RGQ PCR Kit, which was approved by the FDA in July 2013 as a companion diagnostic used in the treatment of metastatic NSCLC patients whosetumors have certain EGFR mutations. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including T790M.The diagnostic is being developed in parallel with the clinical development of rociletinib, and QIAGEN submitted a Premarket Approval Application(“PMA”) with the FDA during the third quarter of 2015, in a time frame intended to allow for regulatory approval of the companion diagnostic atsubstantially the same time that rociletinib may be approved.Rucaparib - a PARP InhibitorOverviewRucaparib is a novel, oral, small molecule inhibitor of PARP-1 and PARP-2, which is currently being explored in Phase II and III clinical trials as bothtreatment and maintenance therapy for advanced ovarian cancer patients with tumor-BRCA mutations (germline and somatic mutations in genes that arelinked to breast and ovarian cancers) and with other DNA repair deficiencies, commonly referred to as “BRCA-like” mutations. We in-licensed rucaparib fromPfizer Inc. in June 2011. In April 2015, rucaparib received “Breakthrough Therapy” designation from the FDA as monotherapy treatment of advanced ovariancancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA(gBRCA) and somatic BRCA (sBRCA) mutations. We intend to submit our initial NDA for rucaparib to the FDA as treatment for advanced ovarian cancer patients with a germline or somatic BRCAmutation in the second quarter of 2016. We completed enrollment of the mutant BRCA population that will serve as the basis of the submission during thefourth quarter of 2015. In addition, a planned MAA filing in the E.U. for the same indication is expected by the end of 2016. We also intend to studyrucaparib as a treatment for BRCA mutant prostate cancer patients and plan to initiate a registration study in this patient population in the second half of2016.7DNA Repair and PARPCells in the human body are under constant attack from agents that can cause damage to DNA, including sunlight and other forms of radiation, as well asDNA-binding chemicals that can cause changes in the composition of DNA. Since DNA is the vehicle by which fundamental information is passed on when acell divides, it is critical to the integrity of cells and human health that DNA damage can be repaired. Cells have evolved multiple mechanisms to enable suchDNA repair, and these mechanisms are complementary to each other, each driving repair of specific types of DNA damage. If a cell’s DNA damage repairsystem is overwhelmed, then the cell will undergo a form of suicide called apoptosis that appears to operate as a fail-safe system to limit the ability of amutated cell to proliferate and potentially form a cancer. A fundamental principle of cancer therapy is to damage cells profoundly with radiation or DNA-binding drugs, such as alkylating agents or platinums, and induce apoptosis in those cells, thus killing the cancer cells. DNA repair mechanisms may reducethe activity of these anti-cancer therapies but, conversely, inhibition of DNA repair processes may enhance the effects of DNA-damaging anti-cancer therapy.Poly (ADP-ribose) is a part of the early warning system for DNA damage and is synthesized by PARP enzymes on regions of damaged DNA, where itsignals to the cell that DNA repair needs to take place. In the absence of PARP, as is seen in gene-knockout mice, cells are unusually sensitive to DNAdamage when exposed to radiation or DNA-alkylating agents. There are two major forms of PARP that signal DNA damage in this way, PARP-1 and PARP-2.Knockout of either PARP gene leads to enhanced DNA damage in both instances, although the mice may survive; however, the double knockout in whichboth the PARP-1 and PARP-2 genes are deleted is fatal to the mice at an embryonic stage. We believe that a drug that inhibits both PARP-1 and PARP-2,which rucaparib does, may have enhanced activity in preventing DNA repair.Synthetic LethalityAn important advance in the field of cancer treatment occurred when it was recognized that germline mutations in the BRCA genes (BRCA1 and BRCA2,two tumor suppressor genes) were associated both with high rates of breast and ovarian cancer in female mutant gene carriers and also impaired the ability ofcells to repair DNA damage. BRCA gene products were shown to be key mediators of DNA repair. The notion was that advanced treatment of BRCA-defective cells with PARP inhibitors could lead to a disabling blow against a tumor cell’s ability to repair DNA and could induce apoptosis. Thisphenomenon was termed “synthetic lethality” and was demonstrated in humans in a study conducted by Peter C. Fong, M.D. et al., published in the NewEngland Journal of Medicine in 2009, as evidenced by women with advanced breast and ovarian cancer and germline BRCA mutations experiencingobjective tumor responses when treated with monotherapy PARP inhibitors. Germline and somatic BRCA mutations are a minority subset of all breast andovarian cancers, representing approximately 20% to 25% of those cancers. BRCA-like TumorsThe hypothesis that some tumors might have defective DNA repair function for reasons other than germline (hereditary) or somatic (acquired) genemutation has also been explored. This notion has been called “BRCAness” or “BRCA-like.” Subsequent work has shown that BRCA-like alterations exist,and that these cancer patients with normal BRCA genes, but BRCA-like mutations can respond to monotherapy with PARP inhibitors. Work is underway toidentify a molecular signature for patients with tumors that are BRCA-like that could enable patient selection for therapy. If successful, this work has thepotential to increase the percentage of high-grade serous ovarian cancer patients eligible for rucaparib therapy from the approximately 20% to 25% typicallyfound to have germline or somatic BRCA mutations to an estimated 50%, which includes those patients whose tumors have certain DNA repair deficiencies,and thus may be considered a BRCA-like population.Clinical DevelopmentRucaparib is currently the subject of several clinical studies, including the ARIEL (Assessment of Rucaparib In Ovarian CancEr TriaL) program, whichincludes the Phase II ARIEL2 treatment study and the Phase III ARIEL3 maintenance study, both in advanced ovarian cancer patients.ARIEL2 is a single-arm, registration study of rucaparib treatment in relapsed patients, designed to identify tumor characteristics that predict sensitivity torucaparib using DNA sequencing to evaluate each patient’s tumor. Both archived tumor and recent biopsy samples are collected from patients and DNAsequenced. The patients’ response to rucaparib is being assessed and those clinical responses are correlated to pre-defined molecularly defined patient sub-groups, including germline BRCA mutant, somatic BRCA mutant and the BRCA-like signature identified through the genetic diagnostic testing. The firstpart of the global ARIEL2 study completed enrollment of 206 ovarian cancer patients with relapsed, platinum-sensitive disease in 2014. In early 2015,ARIEL2 was expanded (ARIEL2 extension or ARIEL2 Part 2) to include an additional 300 patients with recurrent disease after at least three prior lines ofchemotherapy. Enrollment in the ARIEL2 extension study is not limited to platinum-sensitive disease, but also includes patients with platinum-resistant orplatinum-refractory disease.8ARIEL3 is a randomized, double-blind, registration study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as amaintenance therapy to platinum-sensitive patients can extend the period of time for which the disease is controlled after a positive outcome with platinum-based chemotherapy. Patients are randomized to receive either placebo or rucaparib and the primary endpoint of the study is progression-free survival(“PFS”). The primary efficacy analysis will evaluate mutant BRCA patients, all HRD patients (including mutant BRCA and BRCA-like) and all patients.In addition to ARIEL2 and ARIEL3, the Phase II portion of rucaparib’s initial dose finding study (Study 010) continues to assess efficacy of rucaparib inadvanced ovarian cancer patients with tumors harboring a germline or somatic BRCA mutation.Data from a blended population of patients from ARIEL2, the ARIEL2 extension and the Phase II portion of Study 010 are expected to form the basis of aplanned NDA filing for the treatment of patients with tumor-BRCA-mutant advanced ovarian cancer, which includes both germline and somatic BRCApatients, expected to be submitted during the second quarter of 2016, as well as a planned MAA filing in the E.U. for the same indication, which is expectedto be submitted by the end of 2016. During 2016, we currently plan to initiate the ARIEL4 study, a Phase III study of rucaparib versus chemotherapy as atreatment for patients with tumor-BRCA-mutant and, potentially, BRCA-like relapsed ovarian cancer. We expect that ARIEL4 will serve as the confirmatorystudy required by the FDA for the potential accelerated approval of rucaparib using data from ARIEL2 and Study 010.Data from ongoing rucaparib studies presented at medical conferences during 2015 demonstrated meaningful clinical activity and safety in ovariancancer patients with tumors with BRCA mutations, as well as in those with the BRCA-like signature. Data from 204 evaluable patients in the first part of theongoing ARIEL2 study presented in September 2015 and updated in January 2016 demonstrated encouraging clinical activity and safety in two pre-specified subgroups of these patients. The most robust clinical activity was observed in platinum-sensitive patients with tumor BRCA mutations. Seventy-five percent (30/40) of BRCA-mutant patients achieved a confirmed response. The response rate was similar in both germline and somatic BRCA-mutanttumors. Six of these patients achieved a complete response by RECIST. The median duration of response was 9.5 months in this patient population, in whichpatients had received a median of two prior therapies. In addition, in platinum-sensitive patients with normal BRCA genes, rucaparib activity was differentbetween those with the prospectively-defined BRCA-like signature versus biomarker negative (normal BRCA and no BRCA-like mutations) patients. Thirtypercent (23/77) of patients with normal BRCA, but with the BRCA-like signature, achieved a confirmed response. In biomarker negative patients, fewresponses were observed. Ten percent (7/68) achieved a confirmed response. Median duration of response in both the tumor BRCA mutant and the BRCA-like populations was 9.5 months compared to 5.5 months in the biomarker negative patients.In early 2016, we also presented interim data from a blended population of tumor BRCA-mutant ovarian cancer patients who had received at least threeprior lines of therapy from Study 010 and ARIEL2. Sixty-one percent (14/23) of the platinum-sensitive patients achieved a confirmed response, including13% who achieved a complete response. The median duration of response for these patients was 12.9 months. As we expand enrollment to a larger number ofpatients, the response rate and duration of response may be different than that reported to date for the smaller set of patients. Data presented to date includeonly platinum-sensitive patients, while the NDA submission will include a blended population of platinum-sensitive, -resistant and –refractory patients fromthe ARIEL2 extension study, in addition to the platinum-sensitive patients in ARIEL2 and Study 010.Data from ARIEL2 and Study 010 have also demonstrated that rucaparib is generally well-tolerated with a manageable safety profile. The only grade 3/4treatment-related adverse reactions observed in greater than 15% of patients are anemia/decreased hemoglobin (19%) in the first part of ARIEL2 andfatigue/asthenia (21%) and anemia (26%) in the Phase II portion of Study 010. The safety profile of rucaparib is an important attribute for a drug that is alsointended to be used in a maintenance setting. These studies are ongoing, so data may change over time.We intend to explore rucaparib as a treatment for BRCA-mutant and BRCA-like patients with other solid tumors through a combination of Company-sponsored and investigator initiated studies. In particular, we plan to initiate a registration study of rucaparib in castrate-resistant BRCA mutant prostatecancer patients in the second half of 2016. We are collaborating with Foundation Medicine, Inc. for the development of a companion diagnostic to identify our BRCA-like signature, as well as bothgermline and somatic BRCA mutations. The diagnostic is being developed in parallel with the clinical development of rucaparib, with a goal of filing a PMAwith the FDA in a time frame that would allow for regulatory approval of the companion diagnostic at substantially the same time that rucaparib would beapproved.9Lucitanib – a VEGFR, PDGFR and FGFR InhibitorOverviewLucitanib is a potent, oral angiogenesis inhibitor that selectively inhibits vascular endothelial growth factor receptors 1-3 (VEGFR1-3), platelet-derivedgrowth factor receptors alpha and beta (PDGFR a/ß) and fibroblast growth factor receptors 1-3 (FGFR1-3). In a Phase I/IIa clinical study, lucitanibdemonstrated multiple tumor responses in FGFR1 gene-amplified breast cancer patients, as well as in patients with tumors often sensitive to VEGFRinhibitors, such as renal cell and thyroid cancer. In collaboration with Servier, we initiated a broad Phase II development program in advanced breast andlung cancer, where FGFR amplification is common.We obtained rights to lucitanib through our acquisition of Ethical Oncology Science S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.) inNovember 2013, which had in-licensed exclusive development and commercial rights to lucitanib on a global basis, excluding China, from AdvenchenLaboratories LLC in 2008. EOS, in turn, sublicensed lucitanib rights to markets outside of the U.S. and Japan to Servier in 2012. We hold exclusive rights forlucitanib in the U.S. and Japan, and we are collaborating with Servier on the global clinical development of lucitanib outside of China.VEGF, PDGF and FGFThe VEGFs are a family of related extracellular proteins that normally regulate blood and lymphatic vessel development in humans. They act by bindingto and activating VEGF receptors, which are cell surface proteins that transmit growth signals to specific cells that are involved in the development of newblood vessels. Certain VEGFs promote growth of multiple solid tumors by stimulating the formation of new blood vessels to feed the tumor and allow it togrow and metastasize. Tumors produce an excessive amount of VEGF. This results in excess VEGFR signaling and the formation of new blood vessels withinthe tumor. The VEGF ligands that induce angiogenesis are often present in a wide range of cancer indications, including a type of kidney cancer called renalcell carcinoma, a type of liver cancer called hepatocellular carcinoma, gastric cancer, head and neck cancers and other solid tumors.The PDGF family consists of five different isoforms of PDGF ligand that bind to and activate cellular responses through two different receptors (PDGFRa/ß). In tumors, PDGF signaling plays a diverse role in many aspects of tumor development promoting cell proliferation, invasion, migration andangiogenesis. Amplification and/or mutation of the gene encoding the PDGFR a receptor is observed in a wide range of cancers, including lung cancer, anaggressive form of brain cancer called glioblastoma and a cancer of the gastrointestinal tract known as gastrointestinal stromal tumors. Amplification of thePDGFR a gene results in excess production, or the over-expression, of PDGFR a protein on the surface of the tumor cell. The over-expression of PDGFR a onthe tumor cell surface leads to an increased receptor signaling, which stimulates uncontrolled proliferation of some types of tumor cells.The FGFs are a family of related extracellular proteins that normally regulate cell proliferation and survival in humans. The FGF family consists of 22ligands that exert their physiological effect on cells by binding to four FGFRs (FGFR1- 4). As with the PDGF family, some cancers display FGF/FGFR geneamplification/mutation resulting in continual activation of the FGFR signaling pathway leading to uncontrolled cell division. Tumors with a relatively highincidence of FGF aberrations, which include amplification of the FGFR1 gene and amplification of a region of chromosome 11q that contains several FGFligands, include breast cancer (25%) and lung cancer (15%). In addition, FGFR gene amplification/mutation is also observed at a frequency of 3% to 19% ina wide range of cancer indications including sarcoma, ovarian cancer, adenocarcinoma of the lung, bladder cancer, colorectal cancer and endometrial cancer.As an inhibitor of VEGFR1-3, PDGFR a/ß and FGFR1-3 and given the role that each of these receptor kinases plays in tumor progression and metastasisformation, lucitanib has the potential benefit of targeting three relevant pro-angiogenic growth factors in targeted patient populations identified bymolecular markers.Clinical DevelopmentThe first-in-man clinical trial of lucitanib was initiated in Europe in July 2010. This initial trial was an open-label, dose-escalation, Phase I/IIa study todetermine efficacy, pharmacokinetics and pharmacodynamics of oral lucitanib in adult patients with advanced solid tumors. A maximum tolerated dose(“MTD”) dose of 20mg QD was identified using a standard dose limiting toxicity window definition, but in the heavily pre-treated study population,toxicity-related dose reductions were frequent and, therefore, 15mg QD was adopted as a starting dose for the Phase II portion of the study. Overall, thetoxicity profile observed to date is consistent with what was expected from non-clinical studies, with hypertension, proteinuria and subclinicalhypothyroidism requiring supplementation being commonly observed. Other common treatment-related events include asthenia and gastrointestinalsymptoms (diarrhea, abdominal pain, nausea and vomiting). Subsequent to MTD identification, a dose expansion phase was initiated in patients who wereeither FGFR or 11q amplified or angiogenesis inhibitor-sensitive. Six of 12 FGF-aberrant breast cancer patients achieved partial responses, some of whichwere confirmed, with additional responses seen across other tumor types. Median PFS for these heavily pre-treated breast cancer patients (median of six priorlines of therapy) was 9.4 months.10Development StrategyBased on the initial signals of activity and safety described above, a Phase II program is underway exploring lucitanib in advanced breast cancer. AClovis-sponsored study of lucitanib monotherapy in metastatic breast cancer initiated in 2014 and is expected to complete enrollment in early 2016. Thegoal of this study is to compare two doses of lucitanib, 10mg and 15mg, with PFS as the primary endpoint. In 2015, an interim analysis was completed, whichindicated a difference in tolerability of the two doses. Based on this result, the go-forward dose for all lucitanib studies is 10mg. An ongoing Phase II study inadvanced metastatic lung cancer is being discontinued due to low enrollment.In parallel with our breast study underway in the U.S., Servier is conducting a Phase II study of lucitanib monotherapy in patients with advanced breastcancer. This ex-U.S. study, known as FINESSE, is expected to enroll approximately 100 patients into three cohorts: (1) FGFR-1 amplified, (2) 11q amplifiedand (3) neither FGFR-1 nor 11q amplified. This study seeks to determine whether the activity of lucitanib is limited to a biomarker-defined population ofbreast cancer tumors with FGF-aberrations or if a more broadly defined population may benefit.As data emerge from ongoing studies, it appears that lucitanib’s VEGF inhibition may be the primary driver of its activity. Accordingly, we believe itsfuture development will likely be focused in combination with other cancer therapies. In addition to evaluating lucitanib in breast cancer, we intend toexplore it in combination with other agents and in other solid tumors, including ovarian and hepatocellular cancers.Development costs for lucitanib incurred to date have been fully funded by Servier as part of its commitment to fund the first €80 million of developmentcosts in accordance with the sub-license agreement (see License Agreements – Les Laboratoires Servier below). Based on current cost estimates, we expectthat commitment will be fulfilled in late 2016 or early 2017, and thereafter, we will share equally in future development costs with Servier pursuant to amutually agreed upon global development plan.CompetitionThe development and commercialization of new drugs is competitive, and we face competition from major pharmaceutical and biotechnology companiesworldwide. Our competitors may develop or market products or other novel technologies that are more effective, safer or less costly than any that have beenor will be commercialized by us, or may obtain regulatory approval for their products more rapidly than we may obtain approval for ours.The acquisition or licensing of pharmaceutical products is also very competitive, and a number of more established companies, which haveacknowledged strategies to license or acquire products, may have competitive advantages over us, as may other emerging companies taking similar ordifferent approaches to product acquisitions. Many of our competitors will have substantially greater financial, technical and human resources than we have.Additional mergers and acquisitions in the pharmaceutical industry may result in even more resources being concentrated in our competitors. Competitionmay increase further as a result of advances made in the commercial applicability of technologies and greater availability of capital for investment in thesefields. Our success will be based in part on our ability to build and actively manage a portfolio of drugs that addresses unmet medical needs and creates valuein patient therapy.Rociletinib CompetitionTarceva®, Iressa® and Gilotrif® are currently approved drugs for the treatment of first-line EGFR-mutant NSCLC, and Tagrisso™ was approved inNovember 2015 for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy. Tagrisso™ is thefirst approved therapy for the treatment of EGFR mutant NSCLC who test positive for the T790M mutation. In February 2016, the European Commissiongranted conditional marketing approval to Tagrisso™ for the treatment of advanced NSCLC patients who test positive for the T790M mutation. In addition,we are aware of a number of other products in development targeting cancer-causing mutant forms of EGFR for the treatment of NSCLC patients. Theseproducts include Pfizer’s PF-06747775, currently in Phase I/II trials, Astellas Pharma’s ASP8273, currently in Phase I/II trials, Novartis’ EGF816, currently inPhase I/II trials, Hanmi Pharmaceutical’s and Boehringer Ingelheim’s BI-1482694 (HM61713), HM781-36B (Poziotinib), currently in Phase I/II trials, andAcea Bio (Hangzhou)’s avitinib and AC0010MA, currently in Phase I/II trials. Bristol Myers Squibb’s Opdivo® and Merck’s Keytruda®, both approved forsecond-line NSCLC, may also represent competition to rociletinib.11Rucaparib CompetitionIn late 2014, Lynparza™ (olaparib) was approved in the U.S. as monotherapy in patients with germline BRCA mutated advanced ovarian cancer whohave been treated with three or more prior lines of chemotherapy and in the EU for the maintenance treatment of BRCA mutated platinum-sensitive relapsedserous ovarian cancer. There are a number of other PARP inhibitors in clinical development including AbbVie’s ABT-888 (veliparib), currently in Phase IIIclinical trials, Tesaro, Inc.’s niraparib, currently in Phase III trials, Eisai’s E-7016, currently in Phase II trials and Medivation’s talazoparib (BMN-673),currently in Phase III trials.Lucitanib CompetitionThere are currently no approved drugs that specifically inhibit each of VEGFR, PDGFR and FGFR; however, there are currently a number of oralantiangiogenic drugs that target one or a subset of those markers and are approved or in development for various solid tumors, including: nintedanib(Boehringer Ingelheim), lenvatinib (Eisai), sunitinib (Pfizer), sorafenib (Bayer), pazopanib (Novartis), axitinib (Pfizer) and cabozantinib (Exelixis).License AgreementsCelgene CorporationIn May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research Inc., part ofCelgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the EGFR gene product. As a result of thecollaboration contemplated by the agreement, rociletinib was identified as the lead inhibitor candidate, which we are developing under the terms of thelicense agreement. Under the agreement, we are required to use commercially reasonable efforts to develop and commercialize rociletinib, and we areresponsible for all non-clinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib.We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 uponthe acceptance by the FDA of our Investigational New Drug (“IND”) application for rociletinib and a $5.0 million milestone payment in the first quarter of2014 upon the initiation of the Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million uponacceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquiredin-process research and development expense.When and if commercial sales of rociletinib commence, we will pay Celgene tiered royalties at percentage rates ranging from mid-single digits to lowteens based on annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and regulatory milestonepayments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved, including $15.0 million upon the first approvalof an NDA by the FDA and $15.0 million upon the first approval of an MAA by the EMA. In addition, we are required to pay up to an aggregate of $120.0million in sales milestone payments if certain annual sales targets are achieved, the majority of which relate to annual sales targets of $500.0 million andabove.We have full sublicensing rights under the license agreement, subject to our sharing equally with Celgene any upfront payments from any sub-licensingarrangements relating to Japan, or Japan and any one or more of China, South Korea and Taiwan, which we refer to herein as an Asian Partnership, and subjectto our paying royalties on sales in Asia equal to the greater of the royalty rates contained in our license agreement or 50% of the royalties we receive from ourAsian Partnership.The license agreement will remain in effect until the expiration of all of our royalty and sublicense revenue obligations to Celgene, determined on aproduct-by-product and country-by-country basis, unless we elect to terminate the license agreement earlier. If we fail to meet our obligations under theagreement and are unable to cure such failure within specified time periods, Celgene can terminate the agreement, resulting in a loss of our rights torociletinib and an obligation to assign or license to Celgene any intellectual property rights or other rights we may have in rociletinib, including ourregulatory filings, regulatory approvals, patents and trademarks for rociletinib.Pfizer Inc.In June 2011, we entered into a license agreement with Pfizer Inc. to obtain the exclusive global rights to develop and commercialize rucaparib. Theexclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Under the terms of the license agreement, we made a $7.0 millionupfront payment to Pfizer. In April 2014, the Company initiated the ARIEL3 pivotal registration study for rucaparib, which resulted in a $0.4 millionmilestone payment to Pfizer as required by the license agreement. This payment was recognized as acquired in-process research and development expense.12We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize rucaparib, and we are responsible forall remaining development and commercialization costs for rucaparib. When and if commercial sales of rucaparib begin, we will pay Pfizer tiered royalties ata mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties tocommercialize rucaparib.We are required to make regulatory milestone payments to Pfizer of up to an additional $88.5 million if specified clinical study objectives and regulatoryfilings, acceptances and approvals are achieved, including $20.75 million associated with the first approval of an NDA by the FDA. In addition, we areobligated to make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which relate to annual sales targetsof $500.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million.The license agreement with Pfizer will remain in effect until the expiration of all of our royalty and sublicense revenue obligations to Pfizer, determinedon a product-by-product and country-by-country basis, unless we elect to terminate the license agreement earlier. If we fail to meet our obligations under theagreement and are unable to cure such failure within specified time periods, Pfizer can terminate the agreement, resulting in a loss of our rights to rucapariband an obligation to assign or license to Pfizer any intellectual property rights or other rights we may have in rucaparib, including our regulatory filings,regulatory approvals, patents and trademarks for rucaparib.Advenchen Laboratories LLCIn October 2008, EOS entered into an exclusive license agreement with Advenchen Laboratories LLC (“Advenchen”) to develop and commercializelucitanib on a global basis, excluding China. If and when commercial sales commence, we are obligated to pay Advenchen tiered royalties at percentage ratesin the mid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving effect to the first and secondamendments to the license agreement, we are required to pay to Advenchen 25% of any consideration, excluding royalties, we receive from sublicensees, inlieu of the milestone obligations set forth in the agreement. We are obligated under the agreement to use commercially reasonable efforts to develop andcommercialize at least one product containing lucitanib, and we are also responsible for all remaining development and commercialization costs forlucitanib.The license agreement with Advenchen will remain in effect until the expiration of all of our royalty obligations to Advenchen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the agreement earlier. If we fail to meet our obligations under the agreement and areunable to cure such failure within specified time periods, Advenchen can terminate the agreement, resulting in a loss of our rights to lucitanib.Les Laboratoires ServierIn September 2012, EOS entered into a collaboration and license agreement with Servier, whereby EOS sublicensed to Servier exclusive rights to developand commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an upfront payment of €45.0million. We are entitled to receive additional payments on the achievement of specified development, regulatory and commercial milestones up to€100.0 million in the aggregate, €10.0 million of which was received in the first quarter of 2014. In addition, we are entitled to receive sales milestonepayments if specified annual sales targets for lucitanib are met, each of which relates to annual sales targets of €250.0 million and above, which, in theaggregate, could amount to a total of €250.0 million. We are also entitled to receive royalties at percentage rates ranging from low to mid-teens on sales oflucitanib by Servier.We, along with Servier, are obligated to use diligent efforts to develop a product containing lucitanib and to carry out the activities delegated to eachparty under a mutually-agreed global development plan. Servier is responsible for all of the development costs for lucitanib up to €80.0 million, as incurredby each party in connection with global development plan activities. Cumulative global development plan costs in excess of €80.0 million, if any, will beshared equally between the Company and Servier. Based on current estimates, we expect that Servier’s €80.0 million funding commitment will be fulfilled inlate 2016 or early 2017, and thereafter, we and Servier will share in future development costs pursuant to a mutually agreed upon global development plan.The collaboration and license agreement will remain in effect until the expiration of all of Servier’s royalty obligations to us, determined on a product-by-product and country-by-country basis, unless Servier elects to terminate the agreement earlier. If we fail to meet our obligations under the agreement and areunable to cure such failure within specified time periods, Servier can terminate the agreement, resulting in the granting of a perpetual license to Servier ofrights to lucitanib.13Government RegulationGovernment authorities in the United States (including federal, state and local authorities) and in other countries, extensively regulate, among otherthings, the manufacturing, research and clinical development, marketing, labeling and packaging, storage, distribution, post-approval monitoring andreporting, advertising and promotion, pricing and export and import of pharmaceutical products, such as those we are developing. The process of obtainingregulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure ofsubstantial time and financial resources. Moreover, failure to comply with applicable regulatory requirements may result in, among other things, warningletters, clinical holds, civil or criminal penalties, recall or seizure of products, injunction, disbarment, partial or total suspension of production or withdrawalof the product from the market. Any agency or judicial enforcement action could have a material adverse effect on us.U.S. Government RegulationIn the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (“FDCA”) and its implementing regulations. Drugs are alsosubject to other federal, state and local statutes and regulations. The process required by the FDA before product candidates may be marketed in the UnitedStates generally involves the following: ●submission to the FDA of an IND which must become effective before human clinical trials may begin and must be updated annually; ●completion of extensive non-clinical laboratory tests and non-clinical animal studies, all performed in accordance with the FDA’s GoodLaboratory Practice regulations; ●performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for eachproposed indication; ●submission to the FDA of an NDA after completion of all pivotal clinical trials; ●a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review; ●satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active pharmaceutical ingredient(“API”) and finished drug product are produced and tested to assess compliance with Current Good Manufacturing Practices (“cGMP”); and ●FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States.An IND is a request for authorization from the FDA to administer an investigational drug product to humans. The central focus of an IND submission is onthe general investigational plan and the protocol(s) for human studies. The IND also includes results of animal studies or other human studies, as appropriate,as well as manufacturing information, analytical data and any available clinical data or literature to support the use of the investigational new drug. An INDmust become effective before human clinical trials may begin. An IND will automatically become effective 30 days after receipt by the FDA, unless beforethat time the FDA raises concerns or questions related to the proposed clinical trials. In such a case, the IND may be placed on clinical hold and the INDsponsor and the FDA must resolve any outstanding concerns or questions before clinical trials can begin. Accordingly, submission of an IND may or may notresult in the FDA allowing clinical trials to commence.Clinical trials involve the administration of the investigational drug to human subjects under the supervision of qualified investigators in accordancewith Good Clinical Practices (“GCPs”), which include the requirement that all research subjects provide their informed consent for their participation in anyclinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoringsafety and the efficacy criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA aspart of the IND. Additionally, approval must also be obtained from each clinical trial site’s Institutional Review Board (“IRB”) before the trials may beinitiated, and the IRB must monitor the study until completed. There are also requirements governing the reporting of ongoing clinical trials and clinical trialresults to public registries.The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted sequentially, they may overlap orbe combined. The three phases of an investigation are as follows: ●Phase I. Phase I includes the initial introduction of an investigational new drug into humans. Phase I clinical trials are typically closelymonitored and may be conducted in patients with the target disease or condition or in healthy volunteers. These studies are designed toevaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational drug in humans, the side effects associatedwith increasing doses, and if possible, to gain early evidence on effectiveness. During Phase I clinical trials, sufficient information about theinvestigational drug’s pharmacokinetics and pharmacological effects may be obtained to permit the design of well-controlled and scientificallyvalid Phase 2 clinical trials. The total number of participants included in Phase I clinical trials varies, but is generally in the range of 20 to 80.14 ●Phase II. Phase II includes controlled clinical trials conducted to preliminarily or further evaluate the effectiveness of the investigational drugfor a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and toidentify possible adverse side effects and safety risks associated with the drug. Phase II clinical trials are typically well-controlled, closelymonitored, and conducted in a limited patient population, usually involving no more than several hundred participants. ●Phase III. Phase III clinical trials are generally controlled clinical trials conducted in an expanded patient population generally atgeographically dispersed clinical trial sites. They are performed after preliminary evidence suggesting effectiveness of the drug has beenobtained and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of theinvestigational drug product and to provide an adequate basis for product approval. Phase III clinical trials usually involve several hundred toseveral thousand participants.A pivotal study is a clinical study which adequately meets regulatory agency requirements for the evaluation of a drug candidate’s efficacy and safetysuch that it can be used to justify the approval of the product. Generally, pivotal studies are also Phase III studies but may be Phase II studies if the trialdesign provides a well-controlled and reliable assessment of clinical benefit, particularly in situations where there is an unmet medical need.The FDA, the IRB or the clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that theresearch subjects are being exposed to an unacceptable health risk. Additionally, some clinical trials are overseen by an independent group of qualifiedexperts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether or not atrial may move forward at designated check points based on access to certain data from the study. We may also suspend or terminate a clinical trial based onevolving business objectives and/or competitive climate.Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailed investigational drug productinformation is submitted to the FDA in the form of an NDA requesting approval to market the product for one or more indications.The application includes all relevant data available from pertinent non-clinical and clinical trials, including negative or ambiguous results, as well aspositive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls and proposed labeling, among other things.Data can come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product, or from a number of alternativesources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity toestablish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA.Once the NDA submission has been accepted for filing, the FDA’s goal is to review applications within 10 months of submission or, if the applicationrelates to an unmet medical need in a serious or life-threatening indication, six months from submission. The review process is often significantly extendedby FDA requests for additional information or clarification. The FDA may refer the application to an advisory committee for review, evaluation andrecommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it typicallyfollows such recommendations.After the FDA evaluates the NDA and conducts inspections of manufacturing facilities where the drug product and/or its API will be produced, it mayissue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing informationfor specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application is not ready forapproval. A Complete Response Letter may require additional clinical data and/or an additional pivotal Phase III clinical trial(s), and/or other significant,expensive and time-consuming requirements related to clinical trials, non-clinical studies or manufacturing. Even if such additional information is submitted,the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. The FDA could also approve the NDA with a Risk Evaluation andMitigation Strategies plan to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such asrestricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes toproposed labeling, development of adequate controls and specifications or a commitment to conduct one or more post-market studies or clinical trials. Suchpost-market testing may include Phase IV clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness aftercommercialization. Regulatory approval of oncology products often requires that patients in clinical trials be followed for long periods to determine theoverall survival benefit of the drug.15After regulatory approval of a drug product is obtained, we are required to comply with a number of post-approval requirements. As a holder of anapproved NDA, we would be required to report, among other things, certain adverse reactions and production problems to the FDA, to provide updated safetyand efficacy information and to comply with requirements concerning advertising and promotional labeling for any of our products. Also, quality control andmanufacturing procedures must continue to conform to cGMP after approval to ensure and preserve the long term stability of the drug product. The FDAperiodically inspects manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural, substantive and record keepingrequirements. In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require priorFDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting anddocumentation requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expendtime, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our product candidates. Future FDAand state inspections may identify compliance issues at our facilities or at the facilities of our contract manufacturers that may disrupt production ordistribution or require substantial resources to correct. In addition, discovery of previously unknown problems with a product or the failure to comply withapplicable requirements may result in restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal or recall of the productfrom the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit further marketing. Newly discovered or developed safety oreffectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications and also may requirethe implementation of other risk management measures. Also, new government requirements, including those resulting from new legislation, may beestablished or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.Europe/Rest of World Government RegulationIn addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinicaltrials and any commercial sales and distribution of our products.Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to thecommencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have a similar process thatrequires the submission of a clinical trial application much like the IND prior to the commencement of human clinical trials. In Europe, for example, a clinicaltrial application, (“CTA”) must be submitted to each country’s national health authority and an independent ethics committee, much like the FDA and IRB,respectively. Once the CTA is approved in accordance with a country’s requirements, clinical trial development may proceed.The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In allcases, the clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin inthe Declaration of Helsinki.To obtain regulatory approval of an investigational drug under European Union regulatory systems, we must submit a marketing authorizationapplication. The application used to file the NDA in the United States is similar to that required in Europe, with the exception of, among other things,country-specific document requirements.For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct ofclinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordancewith GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal ofregulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.Available Special Regulatory ProceduresFormal MeetingsWe are encouraged to engage and seek guidance from health authorities relating to the development and review of investigational drugs, as well asmarketing applications. In the United States, there are different types of official meetings that may occur between us and the FDA. Each meeting type issubject to different procedures. Conclusions and agreements from each of these meetings are captured in the official final meeting minutes issued by the FDA.The EMA also provides the opportunity for dialogue with us. This is usually done in the form of Scientific Advice, which is given by the ScientificAdvice Working Party of the CHMP. A fee is incurred with each Scientific Advice meeting.16Advice from either the FDA or EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controlstesting), nonclinical testing and clinical studies and pharmacovigilance plans and risk-management programs. Such advice is not legally binding on thesponsor. To obtain binding commitments from health authorities in the United States and the European Union, SPA or Protocol Assistance procedures areavailable. A SPA is an evaluation by the FDA of a protocol with the goal of reaching an agreement with the sponsor that the protocol design, clinicalendpoints and statistical analyses are acceptable to support regulatory approval of the product candidate with respect to effectiveness in the indicationstudied. The FDA’s agreement to a SPA is binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issueessential to determining the safety or effectiveness of the product after clinical studies begin, or if the study sponsor fails to follow the protocol that wasagreed upon with the FDA. There is no guarantee that a study will ultimately be adequate to support an approval even if the study is subject to a SPA.Orphan Drug DesignationThe FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in theUnited States, or if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and makingthe drug for this type of disease or condition will be recovered from sales in the United States. In the European Union, the EMA’s Committee for OrphanMedicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of alife-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Union Community. Additionally,designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chroniccondition and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment indeveloping the drug or biological product.In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs,tax advantages and user-fee waivers. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, theproduct is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indicationfor a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity.In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and 10 years of marketexclusivity is granted following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are nolonger met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation does not convey anyadvantage in, or shorten the duration of, the regulatory review and approval process.Pediatric DevelopmentIn the United States, the FDCA provides for an additional six months of marketing exclusivity for a drug if reports are filed of investigations studying theuse of the drug product in a pediatric population in response to a written request from the FDA. Separate from this potential exclusivity benefit, NDAs mustcontain data (or a proposal for post-marketing activity) to assess the safety and effectiveness of an investigational drug product for the claimed indications inall relevant pediatric populations in order to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. TheFDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the productfor use in adults or full or partial waivers if certain criteria are met. Discussions about pediatric development plans can be discussed with the FDA at any time,but usually occur any time between the end-of-Phase II meeting and submission of the NDA.For the EMA, a Pediatric Investigation Plan, and/or a request for waiver or deferral, is required for submission prior to submitting a marketingauthorization application.Authorization Procedures in the European UnionMedicines can be authorized in the European Union by using either the centralized authorization procedure or national authorization procedures. ●Centralized procedure. The EMA implemented the centralized procedure for the approval of human medicines to facilitate marketingauthorizations that are valid throughout the European Union. This procedure results in a single marketing authorization issued by the EMAthat is valid across the European Union, as well as Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for humanmedicines that are: derived from biotechnology processes, such as genetic engineering, contain a new active substance indicated for thetreatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immunedysfunctions, and officially designated orphan medicines.17For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketingauthorization to the EMA, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation, or if itsauthorization would be in the interest of public health. ●National authorization procedures. There are also two other possible routes to authorize medicinal products in several countries, which areavailable for investigational drug products that fall outside the scope of the centralized procedure: §Decentralized procedure. Using the decentralized procedure, an applicant may apply for simultaneous authorization in more thanone European Union country of medicinal products that have not yet been authorized in any European Union country and that donot fall within the mandatory scope of the centralized procedure. §Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one European Union MemberState, in accordance with the national procedures of that country. Following this, further marketing authorizations can be soughtfrom other European Union countries in a procedure whereby the countries concerned agree to recognize the validity of the original,national marketing authorization.Breakthrough Therapy Designation in the United StatesThe U.S. Congress created the Breakthrough Therapy designation program as a result of the passage of the Food and Drug Administration Safety Act of2012. FDA may grant Breakthrough Therapy status to a drug intended for the treatment of a serious condition when preliminary clinical evidence indicatesthat the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapydesignation, which may be requested by a sponsor when filing or amending an IND, is intended to facilitate and expedite the development and FDA review ofa product candidate. Specifically, the Breakthrough Therapy designation may entitle the sponsor to more frequent meetings with FDA during drugdevelopment, intensive guidance on clinical trial design and expedited FDA review by a cross-disciplinary team comprised of senior managers. Thedesignation does not guarantee a faster development or review time as compared to other drugs, however, nor does it assure that the drug will obtain ultimatemarketing approval by the FDA. Once granted, the FDA may withdraw this designation at any time.We have received Breakthrough Therapy designation for rociletinib for the treatment of second-line EGFR mutant NSCLC in patients with the T790Mmutation and for rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA and somatic BRCA. Because the Breakthrough Therapy designationprogram is relatively new, it is difficult for us to predict the effect that this designation will have on the development and FDA review of rociletinib orrucaparib.Expedited Review and Approval in the United StatesThe FDA has various programs, including Fast Track, priority review and accelerated approval, which are intended to expedite or simplify the process forreviewing drugs and biologics, and/or provide for the approval of a drug or biologic on the basis of a surrogate endpoint. Even if a drug qualifies for one ormore of these programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review orapproval will be shortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions, those with the potential toaddress unmet medical needs and those that offer meaningful benefits over existing treatments. For example, based on results of the Phase III clinical trial(s)submitted in an NDA, upon the request of an applicant, the FDA may grant the NDA a priority review designation, which sets the target date for FDA actionon the application at six months, rather than to the standard FDA review period of 10 months. Priority review is granted where preliminary estimates indicatethat a product, if approved, has the potential to provide a safe and effective therapy where no satisfactory alternative therapy exists, or a significantimprovement compared to marketed products is possible. Priority review designation does not change the scientific/medical standard for approval or thequality of evidence necessary to support approval.Accelerated approval provides for an earlier approval for a new drug that is intended to treat a serious or life-threatening disease or condition upon adetermination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit and is better than available therapy. Asurrogate endpoint is a laboratory measurement or physical sign used as an indirect or substitute measurement representing a clinically meaningful outcome.The FDA will also take into account the severity, rarity or prevalence of the condition. As a condition of approval for drugs granted accelerated approval, oneor more post-marketing confirmatory studies are required to confirm as predicted by the surrogate marker trial an effect on clinical benefit, which is defined ashaving a positive effect on how a patient feels, functions or survives.18Accelerated Review in the European UnionUnder the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application is 210 days(excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP).Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest,defined by three cumulative criteria: the seriousness of the disease (e.g. heavy disabling or life-threatening diseases) to be treated; the absence orinsufficiency of an appropriate alternative therapeutic approach; and anticipation of high therapeutic benefit. In this circumstance, EMA ensures that theopinion of the CHMP is given within 150 days of submission of the MAA, excluding clock stops.Pharmaceutical Coverage, Pricing and ReimbursementSignificant uncertainty exists as to the coverage and reimbursement status of any drug products for which we obtain regulatory approval. In the UnitedStates and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on theavailability of reimbursement from third-party payors. Third-party payors include government health administrative authorities, managed care providers,private health insurers and other organizations. The process for determining whether a payor will provide coverage for a drug product may be separate fromthe process for setting the price or reimbursement rate that the payor will pay for the drug product. Third-party payors may limit coverage to specific drugproducts on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication. Third-party payors areincreasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safetyand efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of ourproducts, in addition to the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. Apayor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be established. Adequate third-partyreimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in productdevelopment.There have been a number of federal and state proposals in recent years regarding the pricing of pharmaceutical products, government control and otherchanges to the healthcare system of the United States. The U.S. government enacted legislation providing a partial prescription drug benefit for Medicarebeneficiaries. Government payment for some of the costs of prescription drugs may increase demand for any products for which we receive marketingapproval; however, to obtain payments under this program, we would be required to sell products to Medicare recipients through prescription drug plansoperating pursuant to this legislation. These plans will likely negotiate discounted prices for our products. Additionally, the Patient Protection andAffordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Affordable Care Act”) was enacted in 2010 with agoal of reducing the cost of healthcare and substantially changing the way healthcare is financed by both government and private insurers. Among other costcontainment measures, the Affordable Care Act established: ●An annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; ●A Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have their drugs covered under Part Dmust offer discounts to eligible beneficiaries during their coverage gap period (the “donut hole”); and ●A formula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program.We expect that federal, state and local governments in the United States will continue to consider legislation to limit the growth of healthcare costs,including the cost of prescription drugs. Future legislation could limit payments for pharmaceuticals such as the drug candidates that we are developing.Different pricing and reimbursement schemes exist in other countries. In the European Community, governments influence the price of pharmaceuticalproducts through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products toconsumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has beenagreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectivenessof a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor andcontrol company profits. The downward pressure on health care costs in general, particularly prescription drugs, has become very intense. As a result,increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert acommercial pressure on pricing within a country.19The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors failto provide adequate coverage and reimbursement. In addition, emphasis on reducing the rate of healthcare spending in the United States has increased, andwe expect will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time.Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coveragepolicies and reimbursement rates may be implemented in the future. The implementation of cost containment measures or other healthcare reforms mayprevent us from being able to generate revenue, attain profitability or commercialize our products.Advertising and PromotionThe FDA and other U.S. federal regulatory agencies closely regulate the marketing and promotion of drugs through, among other things, the FDCA andthe FDA’s implementing regulations and standards. The FDA’s review of marketing and promotional activities encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directed advertising and promotion, sales representative communications to healthcare professionals,communications regarding unapproved or “off-label” uses, industry-sponsored scientific and educational activities and promotional activities involving theinternet. A product cannot be commercially promoted before it is approved. After approval, product promotion can include only those claims relating tosafety and effectiveness that are consistent with the labeling approved by the FDA. FDA regulations impose stringent restrictions on manufacturers’communications regarding off-label uses. Failure to comply with applicable FDA requirements and restrictions regarding unapproved uses of a drug or forother violations of its advertising and labeling laws and regulations, may result in adverse publicity and enforcement action by the FDA, the Department ofJustice or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities. A range of penalties are possiblethat could have a significant commercial consequences, including product seizures, injunctions, civil and/or criminal fines and agreements that materiallyrestrict the manner in which a company promotes or distributes its products or regulatory letters, which may require corrective advertising or other correctivecommunications to healthcare professionals.Other Healthcare Laws and Compliance RequirementsIf we obtain regulatory approval for any of our product candidates, we may be subject to various federal and state laws targeting fraud and abuse in thehealthcare industry. For example, in the United States, there are federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribesor other remuneration intended to induce the purchase or recommendation of healthcare products and services or reward past purchases or recommendations.Violations of these laws can lead to civil and criminal penalties, including fines, imprisonment and exclusion from participation in federal healthcareprograms.The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly orindirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be madeunder a federal healthcare program, such as the Medicare and Medicaid programs. The reach of the Anti-Kickback Statute was broadened by the AffordableCare Act, which, among other things, amended the intent requirement of the federal Anti-Kickback Statute and the applicable criminal healthcare fraudstatutes contained within 42 U.S.C. § 1320a-7b. Pursuant to the statutory amendment, a person or entity no longer needs to have actual knowledge of thisstatute or specific intent to violate it in order to have committed a violation. In addition, the Affordable Care Act provides that the government may assertthat a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes ofthe civil False Claims Act (discussed below) or the civil monetary penalties statute. Many states have adopted laws similar to the federal Anti-KickbackStatute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaidprograms.The federal False Claims Act imposes liability on any person who, among other things, knowingly presents, or causes to be presented, a false or fraudulentclaim for payment by a federal program, including federal healthcare programs. The “qui tam” provisions of the False Claims Act allow a private individualto bring civil actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share inany monetary recovery. In addition, various states have enacted false claims laws analogous to the False Claims Act. Many of these state laws apply where aclaim is submitted to any third-party payer and not merely a federal healthcare program. When an entity is determined to have violated the False Claims Act,it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties.In addition to the laws described above, the Affordable Care Act also imposed new reporting requirements on drug manufacturers for payments made tophysicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submitrequired information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate of $1.0 million per year for“knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in anannual submission. Applicable drug manufacturers are required to collect data for each calendar year and submit reports to CMS by March 31st of eachsubsequent calendar year.20Also, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created several new federal crimes, including health care fraud and falsestatements relating to health care matters. The health care fraud statute prohibits knowingly and willfully executing a scheme to defraud any health carebenefit program, including private third-party payers. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up amaterial fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items orservices. In addition, we may be subject to, or our marketing activities may be limited by, HIPAA, as amended by the Health Information Technology forEconomic and Clinical Health Act (“HITECH”) and its implementing regulations, which established uniform standards for certain “covered entities”(healthcare providers, health plans and healthcare clearinghouses) and their business associates governing the conduct of certain electronic healthcaretransactions and protecting the security and privacy of protected health information.Regulation of Diagnostic TestsIn the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medicaldevice design and development, non-clinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage,advertising and promotion, sales and distribution, export and import, and post-market surveillance. Diagnostic tests are classified as medical devices underthe FDCA. Unless an exemption applies, diagnostic tests require marketing clearance or approval from the FDA prior to commercial distribution. The twoprimary types of FDA marketing authorization applicable to a medical device are premarket notification, also called 510(k) clearance, and premarketapproval, or PMA approval. Because the diagnostic tests being developed by our third-party collaborators are of substantial importance in preventingimpairment of human health, they are subject to the PMA approval process.PMA applications must be supported by valid scientific evidence, which typically requires extensive data, including technical, non-clinical, clinical andmanufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device. For diagnostic tests, a PMA application typicallyincludes data regarding analytical and clinical validation studies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of themanufacturing facility or facilities to ensure compliance with the Quality System Regulation, or QSR, which requires manufacturers to follow design, testing,control, documentation and other quality assurance procedures. FDA review of an initial PMA application is required by statute to take between six to tenmonths, although the process typically takes longer, and may require several years to complete. If the FDA evaluations of both the PMA application and themanufacturing facilities are favorable, the FDA will either issue an approval letter or an approvable letter, which usually contains a number of conditions thatmust be met in order to secure the final approval of the PMA. If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable, the FDA willdeny approval of the PMA or issue a not approvable letter. A not approvable letter will outline the deficiencies in the application and, where practical, willidentify what is necessary to make the PMA approvable. The FDA may also determine that additional clinical trials are necessary, in which case the PMAapproval may be delayed for several months or years while the trials are conducted and then the data submitted in an amendment to the PMA. Once granted,PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards is notmaintained or problems are identified following initial marketing.We and our third-party collaborators who are developing the companion diagnostics will work cooperatively to generate the data required for submissionwith the PMA application, and will remain in close contact with the Center for Devices and Radiological Health (“CDRH”) at the FDA to ensure that anychanges in requirements are incorporated into the development plans. We anticipate that meetings with the FDA with regard to our drug product candidates,as well as companion diagnostic product candidates, will include representatives from the Center for Drug Evaluation and Research and CDRH to ensure thatthe NDA and PMA submissions are coordinated to enable FDA to conduct a parallel review of both submissions. On July 14, 2011, the FDA issued its finalguidance document addressing the development and approval process for “In Vitro Companion Diagnostic Devices.” According to the guidance, for noveltherapeutic products such as our product candidates, the PMA for a companion diagnostic device should be developed and approved or clearedcontemporaneously with the therapeutic. We believe our programs for the development of our companion diagnostics are consistent with this guidance.In the European Economic Area (“EEA”), in vitro medical devices are required to conform with the essential requirements of the E.U. Directive on in vitrodiagnostic medical devices (Directive No 98/79/EC, as amended). To demonstrate compliance with the essential requirements, the manufacturer mustundergo a conformity assessment procedure. The conformity assessment varies according to the type of medical device and its classification. For low-riskdevices, the conformity assessment can be carried out internally, but for higher risk devices it requires the intervention of an accredited EEA Notified Body. Ifsuccessful, the conformity assessment concludes with the drawing up by the manufacturer of an EC Declaration of Conformity entitling the manufacturer toaffix the CE mark to its products and to sell them throughout the EEA. The data generated for the U.S. registration will be sufficient to satisfy the regulatoryrequirements for the European Union and other countries.21Patents and Proprietary RightsThe proprietary nature of, and protection for, our product candidates, processes and know-how are important to our business. Our success depends in parton our ability to protect the proprietary nature of our product candidates, technology, and know-how, to operate without infringing on the proprietary rightsof others, and to prevent others from infringing our proprietary rights. We seek patent protection in the United States and internationally for our productcandidates and other technology. Our policy is to patent or in-license the technology, inventions and improvements that we consider important to thedevelopment of our business. We also rely on trade secrets, know-how and continuing innovation to develop and maintain our competitive position. Wecannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in thefuture, nor can we be sure that any of our existing patents or any patents granted to us in the future will be commercially useful in protecting our technology.In May 2010, we acquired an exclusive, worldwide license to rociletinib from Avila Therapeutics, Inc. (now Celgene Avilomics Research Inc., part ofCelgene Corporation). U.S. Patent 8,975,927, directed to rociletinib composition of matter, expires in 2032 and U.S. Patent 9,108,927, directed to rociletinibHBr salts and polymorphs, expires in 2033. Other patent applications are pending that claim rociletinib generically that, if issued, would have expirationdates in 2029. In January 2013, we acquired from Gatekeeper Pharmaceuticals, Inc. an exclusive worldwide sub-license to a Dana Farber patent family havingclaims directed to wild-type sparing irreversible EGFR inhibitors, such as rociletinib. We or our licensors have filed additional patent applications related torociletinib methods of use, metabolites, combinations, diagnostic methods and dosing regimens.In June 2011, we obtained an exclusive, worldwide license from Pfizer to develop and commercialize rucaparib. U.S. Patent 6,495,541, and its equivalentcounterparts issued or pending in dozens of countries, directed to the rucaparib composition of matter, expire in 2020 and are potentially eligible for up tofive years patent term extension in various jurisdictions. We believe that patent term extension under the Hatch-Waxman Act could be available to extendour patent exclusivity for rucaparib to at least 2024 in the United States depending on timing of our first approval. In Europe, we believe that patent termextension under a supplementary protection certificate could be available for an additional five years to at least 2025. In April 2012, we obtained anexclusive license from AstraZeneca under a family of patents and patent applications which will permit the development and commercialization of rucaparibfor certain methods of treating patients with PARP inhibitors. Additionally, other patents and patent applications are directed to methods of making, methodsof using, dosing regimens, various salt and polymorphic forms and formulations and have expiration dates ranging from 2020 through 2035.We obtained rights to lucitanib by acquiring EOS in November 2013, along with its license agreements with Advenchen and Servier. In October 2008,EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excluding China. In September2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop andcommercialize lucitanib in all countries outside of the U.S., Japan and China. Composition of matter and method of use patent protection for lucitanib and agroup of structurally-related compounds is issued in the U.S., Europe and Japan and is issued or pending in other jurisdictions. In the U.S., the composition ofmatter patent will expire in 2030, and in other jurisdictions, it expires in 2028. We believe that patent term extension could be available to extend ourcomposition of matter patent up to five years beyond the scheduled expiration under the Hatch-Waxman Act. Additionally, patents or patent applicationsdirected to methods of manufacturing lucitanib are issued or pending in the United States, Europe, Japan, and China.In addition, we intend to seek patent protection whenever available for any products or product candidates and related technology we acquire in thefuture.The patent positions of pharmaceutical firms like us are generally uncertain and involve complex legal, scientific and factual questions. In addition, thecoverage claimed in a patent application can be significantly reduced before the patent is issued. Consequently, we do not know whether any of the productcandidates we acquire or license will gain patent protection or, if any patents are issued, whether they will provide significant proprietary protection or willbe challenged, circumvented or invalidated. Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for 18months, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, until that time we cannot be certain thatwe were the first to file any patent application related to our product candidates. Moreover, we may have to participate in interference proceedings declaredby the U.S. PTO to determine priority of invention or in opposition or other third-party proceedings in the U.S. or a foreign patent office, either of whichcould result in substantial cost to us, even if the eventual outcome is favorable to us. There can be no assurance that the patents, if issued, would be held validby a court of competent jurisdiction. An adverse outcome in a third-party patent dispute could subject us to significant liabilities to third parties, requiredisputed rights to be licensed from third parties or require us to cease using specific compounds or technology.22The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file,the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, a patent’s term may be lengthened bypatent term adjustment, which compensates a patentee for administrative delays by the U.S. PTO in granting a patent, or may be shortened if a patent isterminally disclaimed over another patent.The patent term of a patent that covers a FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration ascompensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984(“Hatch-Waxman Act”) permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension isrelated to the length of time the drug is under regulatory review. Patent extension cannot extend the remaining term of a patent beyond a total of 14 yearsfrom the date of product approval and only one patent applicable to an approved drug may be extended. Similar provisions are available in Europe and othernon-U.S. jurisdictions to extend the term of a patent that covers an approved drug. In the future, if and when our pharmaceutical products receive FDAapproval, we expect to apply for patent term extensions on patents covering those products.To protect our rights to any of our issued patents and proprietary information, we may need to litigate against infringing third parties, or avail ourselves ofthe courts or participate in hearings to determine the scope and validity of those patents or other proprietary rights. These types of proceedings are oftencostly and could be very time-consuming to us, and we cannot assure you that the deciding authorities will rule in our favor. An unfavorable decision couldallow third parties to use our technology without being required to pay us licensing fees or may compel us to license needed technologies to a third-party.Such a decision could even result in the invalidation or a limitation in the scope of our patents or forfeiture of the rights associated with our patents orpending patent applications. To the extent prudent, we intend to bring litigation against third parties that we believe are infringing one or more of ourpatents.In addition we have sought and intend to continue seeking orphan drug status whenever it is available. If a product which has an orphan drug designationsubsequently receives the first regulatory approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, meaningthat the applicable regulatory authority may not approve any other applications to market the same drug for the same indication, except in certain verylimited circumstances, for a period of seven years in the United States and ten years in the European Union. Orphan drug designation does not preventcompetitors from developing or marketing different drugs for an indication.We also rely on trade secret protection for our confidential and proprietary information. No assurance can be given that others will not independentlydevelop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technology, or that wecan meaningfully protect our trade secrets. However, we believe that the substantial costs and resources required to develop technological innovations willhelp us to protect the competitive advantage of our products.It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentialityagreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential informationdeveloped or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to thirdparties except in specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual shall be ourexclusive property. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for our trade secretsin the event of unauthorized use or disclosure of such information.ManufacturingWe currently contract with third parties for the manufacture of our product candidates for non-clinical studies and clinical trials and intend to do so in thefuture. We currently have a long-term agreement with a third-party contract manufacturing organization (“CMO”) for the production of the active ingredientfor rucaparib. For contract manufacturers not under long-term agreements, we currently obtain our supplies of active ingredients and finished drug productthrough individual purchase orders. We do not own or operate manufacturing facilities for the production of clinical quantities of our product candidates. Wecurrently have no plans to build our own clinical or commercial scale manufacturing capabilities. To meet our projected needs for commercial manufacturing,third parties with whom we currently work will need to increase their scale of production or we will need to secure alternate suppliers. Although we rely oncontract manufacturers, we have personnel with extensive manufacturing experience to oversee the relationships with our contract manufacturers.23The active pharmaceutical ingredient for rociletinib is currently being manufactured by two CMOs, each at a single site. The current drug substanceproduction process has already been sufficiently developed to satisfy immediate clinical demands. Additional scale-up work and/or additional productioncapacity is in process to support larger clinical development or commercialization requirements. We have engaged a single CMO capable of both formulationdevelopment and drug product manufacturing. The current drug product production process has already been sufficiently developed to satisfy immediateclinical demands. Additional scale-up work and/or additional production capacity may be necessary to support larger clinical development orcommercialization requirements.We have developed the process for manufacturing rucaparib’s active pharmaceutical ingredient to a degree sufficient to meet clinical demands andprojected commercial requirements. Manufacturing of rucaparib drug substance is being performed at a single CMO. The rucaparib drug product formulationand manufacturing process to produce that formulation have been developed to a degree sufficient to meet clinical demands. Additional development work isbeing performed to optimize the drug product formulation and manufacturing process to meet projected commercial requirements. A single third-partycontract manufacturer capable of both formulation development and drug product manufacturing is currently producing rucaparib drug product. To date, ourthird-party manufacturers have met our manufacturing requirements. We expect third-party manufacturers to be capable of providing sufficient quantities ofour product candidates to meet anticipated full scale commercial demands.The active pharmaceutical ingredient for lucitanib is currently being produced by a third-party supplier. To date, the current production process has beensufficient to satisfy immediate clinical demands. We may undertake additional development work to further optimize the active pharmaceutical ingredientmanufacturing process. The finished drug product for lucitanib is currently being manufactured at a CMO. The current product and process are sufficientlydeveloped to meet immediate clinical demands. Additional development work is being performed to optimize the drug product formulation andmanufacturing process to meet projected clinical and commercial requirements. Additional scale-up work and/or additional production capacity will benecessary to support larger clinical development or commercialization requirements.Sales and MarketingWe have built the commercial infrastructure in the U.S. necessary to effectively support the commercialization of our product candidates, if and when theyreceive regulatory approval. The commercial infrastructure for oncology products typically consists of a targeted, specialty sales force that calls on a limitedand focused group of physicians supported by sales management, internal sales support, an internal marketing group and distribution support. Additionalcapabilities important to the oncology marketplace include the management of key accounts such as managed care organizations, group-purchasingorganizations, specialty pharmacies, oncology group networks and government accounts. To develop the appropriate commercial infrastructure, we haveinvested significant amounts of financial and management resources, some of which have been committed prior to any confirmation that rociletinib,rucaparib or lucitanib will be approved. We have also begun to establish a commercial presence in the major European markets with the hiring of certaincountry managers and market access professionals.We may also elect in the future to utilize strategic partners, distributors or contract sales forces to assist in the commercialization of our products.EmployeesAs of February 22, 2016, we had 309 full-time employees. None of our employees is represented by labor unions, and a small number of internationalemployees are covered by collective bargaining agreements. We consider our relationship with our employees to be good.Research and DevelopmentWe invested $269.3 million, $137.7 million and $66.5 million in research and development during the years ended December 31, 2015, 2014 and 2013,respectively.About ClovisWe were incorporated under the laws of the State of Delaware in April 2009 and completed our initial public offering of our common stock in November2011. Our common stock is listed on the NASDAQ Global Select Market under the symbol “CLVS.” Our principal executive offices are located at 5500Flatiron Parkway, Suite 100, Boulder, Colorado 80301, and our telephone number is (303) 625-5000. We maintain additional offices in San Francisco,California, Cambridge, UK, and Milan, Italy. Our website address is www.clovisoncology.com. Our website and the information contained on, or that can beaccessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this report.24Available InformationAs a public company, we file reports and proxy statements with the Securities and Exchange Commission (“SEC”). These filings include our annualreports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and proxy statements on Schedule 14A, as well as any amendments tothose reports and proxy statements, and are available free of charge through our website as soon as reasonably practicable after we file them with, or furnishthem to, the SEC. Once at www.clovisoncology.com, go to Investors & News/SEC Filings to locate copies of such reports. You may also read and copymaterials that we file with SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You may obtain information on theoperation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains a website at www.sec.gov that contains reports,proxy statements and other information regarding us and other issuers that file electronically with the SEC. ITEM 1A.RISK FACTORSOur business faces significant risks and uncertainties. Certain factors may have a material adverse effect on our business prospects, financial conditionand results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the followingdiscussion of risk factors, in its entirety, in addition to other information contained in or incorporated by reference into this Annual Report on Form 10-Kand our other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect ourbusiness, prospects, financial condition and results of operations.Risks Related to Our Financial Position and Capital RequirementsWe have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We are a clinical-stage company with no approved products, and no historical revenues, which makes it difficult to assess our future viability.We are a clinical-stage biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a highly speculativeundertaking and involves a substantial degree of risk. We have focused primarily on in-licensing and developing our product candidates. We are notprofitable and have incurred losses in each year since our inception in April 2009. We have only a limited operating history upon which you can evaluate ourbusiness and prospects. In addition, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequentlyencountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical area. We have not generated any revenue from productsales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. For the years endedDecember 31, 2015, 2014 and 2013, we had net losses of $352.9 million, $160.0 million and $84.5 million, respectively. As of December 31, 2015, we hadan accumulated deficit of $781.9 million. We expect to continue to incur losses for the foreseeable future, as we continue our development of, and seekregulatory approvals for, our product candidates, and begin to commercialize any approved products. As such, we are subject to all of the risks incident to thedevelopment of new biopharmaceutical products and related companion diagnostics, and we may encounter unforeseen expenses, difficulties, complications,delays and other unknown factors that may adversely affect our business. If any of our product candidates fail in clinical trials or do not gain regulatoryapproval, or if any of our product candidates, if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieveprofitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses, combined with expected future losses, have hadand will continue to have an adverse effect on our stockholders’ equity and working capital.We will require substantial additional funding which may not be available to us on acceptable terms, or at all. If we fail to obtain additional financing, wemay be unable to complete the development and commercialization of our product candidates or continue our development programs.Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts to advance the clinicaldevelopment of our product candidates and launch and commercialize any product candidates for which we receive regulatory approval, including buildingour own commercial organizations to address certain markets.Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allow us to fund our operating planthrough the next 12 months. As of December 31, 2015, we had cash, cash equivalents and available-for-sale securities totaling $528.6 million. We expect thatwe will need to raise additional capital during 2016 in order to fully implement our business plan to further the development and commercialization of ourproduct candidates, as well as to fund our other operating expenses and capital expenditures, including milestone payments to our licensors. We do not haveany material committed external source of funds or other support for our development efforts other than that portion of the costs associated with globaldevelopment activities for lucitanib for which Servier is responsible pursuant to our collaboration and license agreement. Based on current cost estimates, weexpect that commitment will be fulfilled in late 2016 or early 2017, and thereafter, we will share equally in future development costs with Servier pursuant toa mutually agreed upon global development plan.25Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cashneeds through a combination of public or private equity offerings, collaborations, strategic alliances and other similar licensing arrangements. We cannot becertain that additional funding will be available on acceptable terms, or at all. Furthermore, it may be difficult for us to raise additional funds while we aresubject to uncertainty related to litigation described under “Part I, Item 3-Legal Proceedings” in this report. If we are unable to raise additional capital insufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of oneor more of our product candidates. We may also seek collaborators for one or more of our current or future product candidates on terms that are less favorablethan might otherwise be available. Any of these events could significantly harm our business, financial condition and prospects.Servicing our long-term debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.In September 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the“Notes”), resulting in net proceeds to the Company of $278.3 million after deducting offering expenses. The Notes are governed by the terms of the indenturebetween the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. Interest is payable on the Notes semi-annually, and theNotes mature on September 15, 2021, unless redeemed, repurchased or converted prior to that date. In addition, if, as defined by the terms of the indenture, afundamental change occurs, holders of the Notes may require us to repurchase for cash all or any portion of their Notes at a purchase price equal to 100% ofthe principal amount of the Notes to be repurchased plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. As ofDecember 31, 2015, all $287.5 million principal amount of the Notes remained outstanding.Our ability to make scheduled payments of interest and principal on the Notes, or to pay the repurchase price for the Notes on a fundamental change,depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We may not have sufficientcash in the future to service our debt. If we are unable to generate such cash flow or secure additional sources of funding, we may be required to adopt one ormore alternatives, such as restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinanceour indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities orengage in these activities on desirable terms, which could result in a default on our debt obligations.We and certain of our officers and directors have been named as defendants in several lawsuits that could result in substantial costs and divertmanagement’s attention.We and certain of our officers were named as defendants in four separate purported class action lawsuits initiated in 2015 that generally allege that we andcertain of our officers violated federal securities laws by making allegedly false and misleading statements regarding the progress toward FDA approval andthe potential for market success of rociletinib. The complaints seek unspecified damages. Additionally, in December 2015, a plaintiff filed a derivativecomplaint allegedly on our behalf, naming certain of our officers and directors as defendants and alleging breach of fiduciary duty, abuse of control, grossmismanagement and unjust enrichment. The derivative complaint seeks, among other relief, an award of money damages and declaratory and injunctive reliefconcerning the alleged fiduciary breaches. Moreover, in January 2016, we and certain of our officers, directors, investors and underwriters were named asdefendants in a purported class action lawsuit that alleges that the defendants violated the Securities Act because the offering documents for our July 2015follow-on offering contained allegedly false and misleading statements regarding the progress toward FDA approval and the potential for market success ofrociletinib. A second derivative complaint was filed in February 2016. This derivative complaint also alleges breach of fiduciary duty, abuse of control andgross mismanagement and seeks, among other relief, an award of money damages.We intend to engage in a vigorous defense of these lawsuits; however, we are unable to predict the outcome of these matters at this time. If we are notsuccessful in our defense of the class action litigation, we could be forced to make significant payments to, or enter into other settlements with, ourshareholders and their lawyers (and in certain circumstances reimburse costs and expenses incurred by the underwriters), and such payments or settlementarrangements could have a material adverse effect on our business, operating results and financial condition. For example, we could incur substantial costsnot covered by our directors’ and officers’ liability insurance, suffer a significant adverse impact on our reputation and divert management’s attention andresources from other priorities, any of which could have a material adverse effect on our business. In addition, any of these matters could require paymentsthat are not covered by, or exceed the limits of, our available directors’ and officers’ liability insurance, which could have a material adverse effect on ouroperating results or financial condition.Additional lawsuits with similar claims may be filed by other parties against us and our officers and directors. Even if such claims are not successful, theselawsuits or other future similar actions, or other regulatory inquiries or investigations, may result in substantial costs and have a significant adverse impact onour reputation and divert management’s attention and resources, which could have a material adverse effect on our business, operating results or financialcondition.26Risks Related to Our Business and IndustryWe are heavily dependent on the success of our product candidates, and we cannot give any assurance that any of our product candidates will receiveregulatory approval, which is necessary before they can be commercialized.To date, we have invested a significant portion of our efforts and financial resources in the acquisition and development of our product candidates.Rociletinib is currently under review with the U.S. and E.U regulatory authorities and rucaparib and lucitanib are currently in clinical trials. Our businessdepends entirely on the successful development and commercialization of our product candidates, which may never occur. We currently generate norevenues from sales of any drugs, and we may never be able to develop or commercialize a marketable drug.Each of our product candidates requires clinical development, management of clinical, non-clinical and manufacturing activities, regulatory approval inmultiple jurisdictions, obtaining manufacturing supply, building of a commercial organization and significant marketing efforts in order to generate anyrevenues from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA orcomparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates. In addition, our productdevelopment programs contemplate the development of companion diagnostics by third-party collaborators. Companion diagnostics are subject toregulation as medical devices and must themselves be approved for marketing by the FDA or certain other foreign regulatory agencies before our productcandidates may be commercialized.We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidatesmay not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we maynot be able to continue our operations. Even if we successfully obtain regulatory approvals to market one or more of our product candidates, our revenueswill be dependent, in part, upon our diagnostic collaborators’ ability to obtain regulatory approval of the companion diagnostics to be used with our productcandidates, as well as the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets for patientsubsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved.We plan to seek regulatory approval to commercialize our product candidates in the United States, the European Union and in additional foreigncountries. While the scope of regulatory approval is similar in other countries, obtaining separate regulatory approval in many other countries requirescompliance with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinicaltrials and commercial sales, pricing and distribution of our product candidates, and we cannot predict success in these jurisdictions.Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not bepredictive of future trial results.Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during theclinical trial process. The results of non-clinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stageclinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed throughnon-clinical studies and initial clinical trials. It is not uncommon for companies in the biopharmaceutical industry to suffer significant setbacks in advancedclinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Indeed, based on the negative results of apivotal study, we ceased further development of our previous product candidate CO-101. Our future clinical trial results may not be successful.Although we have clinical trials ongoing, we may experience delays in our ongoing clinical trials, and we do not know whether planned clinical trialswill begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons,including delays related to: ●obtaining regulatory approval to commence a trial; ●reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of whichcan be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ●obtaining institutional review board (“IRB”) approval at each site; ●recruiting suitable patients to participate in a trial; ●developing and validating companion diagnostics on a timely basis; ●having patients complete a trial or return for post-treatment follow-up; ●clinical sites deviating from trial protocol or dropping out of a trial; ●adding new clinical trial sites; or ●manufacturing sufficient quantities of product candidate for use in clinical trials.27Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population,the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ andpatients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may beapproved for the indications we are investigating. Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinicaltrials, and while we have agreements governing their committed activities, we have limited influence over their actual performance.We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, bythe Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities. Such authorities may impose a suspension or termination due toa number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of theclinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues oradverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequatefunding to continue the clinical trial. If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, thecommercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will bedelayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval processand jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition andprospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may alsoultimately lead to the denial of regulatory approval of our product candidates.The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if weare ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, but typically takes many years following thecommencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approvalpolicies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinicaldevelopment and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that none of ourexisting product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval. Although our productcandidates rociletinib and rucaparib have been granted Breakthrough Therapy designation by the FDA, which allows for greater interaction with, andexpedited review by, the FDA, the designation does not guarantee a faster development or review time as compared to other drugs, nor does it ensure that thedrugs will obtain ultimate marketing approval by the FDA. In addition, the FDA may withdraw this designation at any time.Our product candidates could fail to receive regulatory approval or approval may be delayed for many reasons, including the following: ●the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ●we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safeand effective for its proposed indication; ●the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authoritiesfor approval; ●the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from non-clinical studies or clinical trials; ●the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submissionor to obtain regulatory approval in the United States or elsewhere; ●the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturerswith which we contract for clinical and commercial supplies; ●the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing withpartners; and ●the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner renderingour clinical data insufficient for approval.28For example, in early November 2015, during the regularly scheduled Mid-Cycle Communication meeting with the FDA held in connection with itsreview of the rociletinib NDA, the agency requested additional clinical efficacy data. We submitted these data in a Major Amendment on November 16, 2015after which the FDA extended the Prescription Drug User Fee Act goal date for the rociletinib NDA to June 28, 2016 to allow additional time for review of thenew information. The FDA has scheduled the rociletinib NDA for discussion by the Oncologic Drugs Advisory Committee (“ODAC”) on April 12, 2016. TheODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products used in the treatment ofcancer and makes recommendations to the FDA.This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval tomarket our product candidates, which would significantly harm our business, results of operations and prospects.Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review,which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictionsand market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems withour products.Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which theproduct may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing and clinical trials andsurveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA or comparable foreign regulatory authority approves any ofour product candidates, the manufacturing processes, pricing, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion andrecordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and otherpost-marketing information and reports, registration, as well as continued compliance with current good manufacturing practices and good clinical practicesfor any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with a product, including adverse events ofunanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes or failure to comply with regulatory requirements, mayresult in, among other things: ·restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory productrecalls; ·fines, warning letters or holds on clinical trials; ·refusal by the FDA and comparable foreign authorities to approve pending applications or supplements to approved applications filed by us, orsuspension or revocation of product license approvals; ·product seizure or detention, or refusal to permit the import or export of products; and ·injunctions or the imposition of civil or criminal penalties. The FDA’s and comparable foreign authorities’ policies may change and additional government regulations may be enacted that could prevent, limit ordelay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from futurelegislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or theadoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may haveobtained, and we may not achieve or sustain profitability, which would adversely affect our business. Any of the foregoing scenarios could materially harmthe commercial prospects for our product candidates.Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit thecommercial profile of an approved label or result in significant negative consequences following marketing approval, if any.Adverse events (“AEs”) attributable to our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and couldresult in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Clinical studies conductedto date have generated AEs related to our product candidates, some of which have been serious. The most notable AEs experienced by patients treated withrociletinib include hyperglycemia and QTc prolongation, while patients treated with rucaparib have commonly experienced anemia/decreased hemoglobinand fatigue/asthenia. In studies of lucitanib, hypertension, proteinuria and subclinical hypothyroidism requiring supplementation are the most common AEsobserved. As is the case with all oncology drugs, it is possible that there may be other potentially harmful characteristics associated with their use in futuretrials, including larger and lengthier Phase III clinical trials. As we evaluate the use of our product candidates in combination with other active agents, wemay encounter safety issues as a result of the combined safety profiles of each agent, which could pose a substantial challenge to that development strategy.29Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our trials could besuspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of ourproduct candidates for any or all targeted indications. The drug-related AEs could affect patient recruitment or the ability of enrolled patients to complete thetrial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by suchproducts, a number of potentially significant negative consequences could result, including: ●regulatory authorities may withdraw approvals of such product; ●regulatory authorities may require additional warnings on the label; ●we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; ●we could be sued and held liable for harm caused to patients; and ●our reputation may suffer.Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and couldsignificantly harm our business, results of operations and prospects.Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our drug development strategy.As one of the key elements of our clinical development strategy, we seek to identify patient subsets within a disease category who may derive selectiveand meaningful benefit from the product candidates we are developing. In collaboration with partners, we plan to develop companion diagnostics to help usto more accurately identify patients within a particular subset, both during our clinical trials and in connection with the commercialization of our productcandidates. Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and requireseparate regulatory approval prior to commercialization. We do not develop companion diagnostics internally and thus we are dependent on the sustainedcooperation and effort of our third-party collaborators in developing and obtaining approval for these companion diagnostics. We and our collaborators mayencounter difficulties in developing and obtaining approval for the companion diagnostics, including issues relating to selectivity/specificity, analyticalvalidation, reproducibility, or clinical validation. Any delay or failure by our collaborators to develop or obtain regulatory approval of the companiondiagnostics could delay or prevent approval of our product candidates. In addition, our collaborators may encounter production difficulties that couldconstrain the supply of the companion diagnostics, and both they and we may have difficulties gaining acceptance of the use of the companion diagnosticsin the clinical community. If such companion diagnostics fail to gain market acceptance, it would have an adverse effect on our ability to derive revenuesfrom sales of our products. In addition, the diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companiondiagnostic that we anticipate using in connection with development and commercialization of our product candidates or our relationship with suchdiagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of analternative diagnostic test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonableterms, which could adversely affect and/or delay the development or commercialization of our product candidates.The failure to maintain our collaboration with Servier, or the failure of Servier to perform its obligations under the collaboration, could negatively affectour business.Pursuant to the terms of our collaboration and license agreement with Servier, Servier was granted exclusive rights to develop and commercializelucitanib in markets outside of the United States and Japan (excluding China). Consequently, our ability to realize any revenues from lucitanib in the Servierterritory depends on our success in maintaining our collaboration with Servier and Servier’s ability to obtain regulatory approvals for, and to successfullycommercialize, lucitanib in its licensed territory. Although we collaborate with Servier to carry out a global development plan for lucitanib, we have limitedcontrol over the amount and timing of resources that Servier will dedicate to these efforts.We are subject to a number of other risks associated with our collaboration and license agreement with Servier, including: ●Servier may not comply with applicable regulatory requirements with respect to developing or commercializing lucitanib, which couldadversely affect future development or sales of lucitanib in Servier’s licensed territory and elsewhere; ●Servier is responsible for the first €80.0 million of development costs in support of the lucitanib program; however we have limited controlover the costs Servier may incur with respect to its development activities for the compound, and therefore our obligation to share additionalcosts could be triggered sooner than planned;30 ●If Servier does not agree to include within the global development plan new studies that we propose to conduct for lucitanib, we may beresponsible for all costs associated with carrying out such activities; ●We and Servier could disagree as to current or future development plans for lucitanib, and Servier may delay clinical trials or stop a clinicaltrial for which it is the sponsor; ●There may be disputes between us and Servier, including disagreements regarding the collaboration and license agreement, that may result in(1) the delay of or failure to achieve regulatory and commercial objectives that would result in milestone or royalty payments, (2) the delay ortermination of any future development or commercialization of lucitanib, and/or (3) costly litigation or arbitration that diverts ourmanagement’s attention and resources; ●Business combinations or significant changes in Servier’s business strategy may adversely affect Servier’s ability or willingness to perform itsobligations under our collaboration and license agreement; and ●The royalties we are eligible to receive from Servier may be reduced or eliminated based upon Servier’s and our ability to maintain or defendour intellectual property rights and the presence of generic competitors in Servier’s licensed territory.Based on current cost estimates, we expect Servier’s funding commitment will be fulfilled in late 2016 or early 2017, and thereafter, we will share equallywith Servier in future development costs pursuant to a mutually agreed upon global development plan.The collaboration and license agreement is subject to early termination, including through Servier’s right to terminate the agreement without cause uponadvance notice to us. If the agreement is terminated early, we may not be able to find another collaborator for the further development and commercializationof lucitanib outside of the United States and Japan on acceptable terms, or at all, and we could incur significant additional costs by pursuing continueddevelopment and commercialization of lucitanib in those territories on our own.We rely on third parties to conduct our non-clinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meetexpected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantiallyharmed.We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data for our ongoing non-clinical and clinical programs.We rely on these parties for execution of our non-clinical and clinical trials, and control only certain aspects of their activities. Nevertheless, we areresponsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and ourreliance on the CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCP, which are regulations andguidelines enforced by the FDA, the EEA and comparable foreign regulatory authorities for all of our products in clinical development. Regulatoryauthorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs fail to complywith applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or comparable foreign regulatoryauthorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by agiven regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trialsmust be conducted with product produced under current GMP regulations. Our failure to comply with these regulations may require us to repeat clinicaltrials, which would delay the regulatory approval process.Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs have an abilityto terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrantssuch termination, if we make a general assignment for the benefit of our creditors or if we are liquidated.If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so oncommercially reasonable terms. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such CROs,we cannot control whether or not they devote sufficient time and resources to our on-going clinical and non-clinical programs. If CROs do not successfullycarry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data theyobtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended,delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our resultsof operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues couldbe delayed.31Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition periodwhen a new CRO commences work. As a result, delays occur, which can materially influence our ability to meet our desired clinical development timelines.Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the futureor that these delays or challenges will not have a material adverse effect on our business, financial condition and prospects.We rely completely on third parties to manufacture our clinical drug supplies and we intend to rely on third parties to produce commercial supplies of anyapproved product candidate, and our commercialization of any of our product candidates could be stopped, delayed or made less profitable if those thirdparties fail to obtain approval of the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of drug product or failto do so at acceptable quality levels or prices.We do not currently have nor do we plan to acquire the infrastructure or capability internally to manufacture our clinical drug supplies for use in theconduct of our clinical trials, and we lack the resources and the capability to manufacture any of our product candidates on a clinical or commercial scale. Wedo not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the GMP regulatoryrequirements for manufacture of both active drug substances and finished drug products. If our contract manufacturers cannot successfully manufacturematerial that conforms to the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for theirmanufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, qualityassurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of ourproduct candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantlyaffect our ability to develop, obtain regulatory approval for or market our product candidates, if approved.We rely on our manufacturers to purchase from third-party suppliers the materials necessary to produce our product candidates for our clinical trials. Thereare a limited number of suppliers of raw materials that we use to manufacture our drugs and there may be a need to assess alternate suppliers to prevent apossible disruption of the manufacture of the materials necessary to produce our product candidates for our clinical trials, and if approved, ultimately forcommercial sale. We do not have any control over the process or timing of the acquisition of these raw materials by our manufacturers. Moreover, wecurrently do not have any agreements for the commercial production of these raw materials. Any significant delay in the supply of a product candidate, or theraw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay completion ofour clinical trials, product testing and potential regulatory approval of our product candidates. If our manufacturers or we are unable to purchase these rawmaterials after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed or therewould be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.We are dependent on our third party manufacturers to conduct process development and scale-up work necessary to support greater clinical developmentand commercialization requirements for our product candidates. Carrying out these activities in a timely manner, and on commercially reasonable terms, iscritical to the successful development and commercialization of our product candidates. We expect that our third-party manufacturers are capable ofproviding sufficient quantities of our product candidates to meet anticipated clinical and full-scale commercial demands, however if third parties with whomwe currently work are unable to meet our supply requirements, we will need to secure alternate suppliers. While we believe that there are other contractmanufacturers having the technical capabilities to manufacture our product candidates, we cannot be certain that identifying and establishing relationshipswith such sources would not result in significant delay or material additional costs.We expect to continue to depend on third-party contract manufacturers for the foreseeable future. We have not entered into long-term agreements with allof our current contract manufacturers or with any alternate fill/finish suppliers, and though we intend to do so prior to commercial launch in order to ensurethat we maintain adequate supplies of finished drug product, we may be unable to enter into such an agreement or do so on commercially reasonable terms,which could have a material adverse effect upon our business. We currently obtain our supplies of finished drug product through individual purchase orders.Although we have begun to build our marketing and sales organization, if we are unable to establish sufficient internal marketing, sales and distributioncapabilities, or enter into agreements with third parties to market and sell our product candidates, we may not be able to successfully commercialize ourproducts.We have no history as a company in the sales and distribution of pharmaceutical products. In order to successfully commercialize any of our productcandidates, if approved, we must establish and maintain our marketing, sales, distribution, managerial and other non-technical capabilities, or makearrangements with third parties to perform these services. Our commercial and medical affairs organizations in the U.S. are in place, but we are only beginningto build those capabilities in Europe to support the marketing, sales and distribution of our pharmaceutical products. Establishing our sales and marketingorganization with technical expertise and supporting distribution capabilities to commercialize our product candidates will continue to be expensive andtime consuming. 32With respect to our product candidates, we may elect to collaborate with third parties that have direct sales forces and established distribution systems,either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems in certain territories. To the extentthat we enter into licensing or co-promotion arrangements for any of our product candidates, our product revenue may be lower than if we directly marketedor sold our approved products. In addition, any revenue we receive as a result of such arrangements would depend in whole or in part upon the efforts of suchthird parties, which may not be successful and are generally not within our control. If we are unable to enter into such arrangements on acceptable terms or atall, we may not be able to successfully commercialize our product candidates that receive regulatory approval. If we are not successful in commercializingour product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incursignificant additional losses.Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients,healthcare payors and major operators of cancer clinics.Even if we obtain regulatory approval for our product candidates, the product may not gain market acceptance among physicians, health care payors,patients and the medical community, which are critical to commercial success. Market acceptance of any product candidate for which we receive approvaldepends on a number of factors, including: ●the efficacy and safety as demonstrated in clinical trials; ●the timing of market introduction of such product candidate as well as competitive products; ●the clinical indications for which the drug is approved and the product label approved by regulatory authorities, including any warnings thatmay be required on the label; ●the approval, availability, market acceptance and reimbursement for the companion diagnostic; ●acceptance by physicians, major operators of cancer clinics and patients of the drug as a safe and effective treatment; ●the potential and perceived advantages of such product candidate over alternative treatments, especially with respect to patient subsets that weare targeting with such product candidate; ●the safety of such product candidate seen in a broader patient group, including its use outside the approved indications; ●the cost, safety and efficacy of the product in relation to alternative treatments; ●the availability of adequate reimbursement and pricing by third-party payors and government authorities; ●relative convenience and ease of administration; ●the prevalence and severity of adverse side effects; and ●the effectiveness of our sales and marketing efforts.If our product candidates are approved but fail to achieve an adequate level of acceptance by physicians, healthcare payors and patients, we will not beable to generate significant revenues, and we may not become or remain profitable.We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to competeeffectively.The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. In addition, thecompetition in the oncology market is intense. We have competitors both in the United States and internationally, including major multinationalpharmaceutical companies, biotechnology companies and universities and other research institutions. For example, in November 2015, the FDA approvedTagrisso™ (osimertinib) for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy. Thisrepresents the first approved therapy for the treatment of EGFR mutant NSCLC patients who test positive for the T790M mutation. In February 2016, theEuropean Commission granted conditional marketing approval to Tagrisso™ for the treatment of advanced NSCLC patients who test positive for the T790Mmutation. In addition, we are aware of a number of other products in development targeting cancer-causing mutant forms of EGFR for the treatment of NSCLCpatients. These products include Pfizer’s PF-06747775, currently in Phase I/II trials, Astellas Pharma’s ASP8273, currently in Phase I/II trials, Novartis’EGF816, currently in Phase I/II trials, Hanmi Pharmaceutical’s and Boehringer Ingelheim’s BI-1482694 (HM61713), HM781-36B (Poziotinib), currently inPhase I/II trials and Acea Bio (Hangzhou)’s avitinib and AC0010MA, currently in Phase I/II trials. Bristol Myers Squibb’s Opdivo® and Merck’s Keytruda®,both approved for second-line NSCLC, may also represent competition to rociletinib.In late 2014, Lynparza™ (olaparib) was approved in the U.S. as monotherapy in patients with germline BRCA mutated advanced ovarian cancer whohave been treated with three or more prior lines of chemotherapy and in the EU for the maintenance treatment of BRCA mutated platinum-sensitive relapsedserous ovarian cancer. There are a number of other PARP inhibitors in clinical development including AbbVie’s ABT-888 (veliparib), currently in Phase IIIclinical trials, Tesaro, Inc.’s niraparib, currently in Phase III trials, Eisai’s E-7016, currently in Phase II trials and Medivation’s talazoparib (BMN-673),currently in Phase III trials.33There are currently no approved drugs that specifically inhibit each of VEGFR, PDGFR and FGFR, as does lucitanib; however, there are currently anumber of oral antiangiogenic drugs that target one or a subset of those markers and are approved or in development for various solid tumors, including:nintedanib (Boehringer Ingelheim), lenvatinib (Eisai), sunitinib (Pfizer), sorafenib (Bayer), pazopanib (Novartis), axitinib (Pfizer) and cabozantinib(Exelixis).Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experiencedmarketing and manufacturing organizations. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in evenmore resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval more rapidly than we are able and may bemore effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularlythrough collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercialapplicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring orlicensing on an exclusive basis drug products that are more effective or less costly than any drug candidate that we are currently developing or that we maydevelop. If approved, our product candidates will face competition from commercially available drugs, as well as drugs that are in the development pipelinesof our competitors and later enter the market.Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novelcompounds that could make our product candidates less competitive. In addition, any new product that competes with an approved product mustdemonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commerciallysuccessful. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA, EMA or other regulatory approval or discovering,developing and commercializing medicines before we do, which would have a material adverse effect on our business.Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell ourproducts profitably.There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. We intend to seek approval to market ourproduct candidates in the United States, Europe and other selected foreign jurisdictions. Market acceptance and sales of our product candidates in bothdomestic and international markets will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any ofour product candidates and may be affected by existing and future healthcare reform measures. Government and other third-party payors are increasinglyattempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new drugs and, as a result, they may not cover or provideadequate payment for our product candidates. These payors may conclude that our product candidates are less safe, less effective or less cost-effective thanexisting or later introduced products, and third-party payors may not approve our product candidates for coverage and reimbursement or may cease providingcoverage and reimbursement for these product candidates.Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process thatcould require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. We may not be able to providedata sufficient to gain acceptance with respect to coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be availablefor any of our product candidates. Even if we obtain coverage for our product candidates, third-party payors may not establish adequate reimbursementamounts, which may reduce the demand for, or the price of, our products. If reimbursement of our future products is unavailable or limited in scope or amount,or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.In both the United States and certain foreign jurisdictions, there have been and we expect there will continue to be a number of legislative and regulatorychanges to the health care system that could affect our ability to sell our products profitably. The U.S. government and other governments have shownsignificant interest in pursuing healthcare reform. In particular, the Medicare Modernization Act of 2003 revised the payment methodology for manyproducts under the Medicare program in the United States. This has resulted in lower rates of reimbursement. In 2010, the Patient Protection and AffordableCare Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Affordable Care Act”), was enacted. The Affordable Care Actsubstantially changed the way healthcare is financed by both governmental and private insurers. Such government-adopted reform measures may adverselyaffect the pricing of healthcare products and services in the United States or internationally and the amount of reimbursement available from governmentalagencies or other third-party payors.There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availabilityof healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts ofthe government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare mayadversely affect the demand for any drug products for which we may obtain regulatory approval, as well as our ability to set satisfactory prices for ourproducts, to generate revenues, and to achieve and maintain profitability.34In some foreign countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In thesecountries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. Toobtain reimbursement or pricing approval in some countries, we may be required to conduct additional clinical trials that compare the cost-effectiveness ofour product candidates to other available therapies. If reimbursement of our product candidates is unavailable or limited in scope or amount in a particularcountry, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability of our products in such country.If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Further,we will need to grow our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.Our industry has experienced a high rate of turnover of management personnel in recent years. Our ability to compete in the highly competitivebiotechnology and pharmaceuticals industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel.We are highly dependent on our management, scientific and medical personnel, especially Patrick J. Mahaffy, our President and Chief Executive Officer, ErleT. Mast, our Executive Vice President and Chief Financial Officer, Lindsey Rolfe, our Executive Vice President of Clinical and Preclinical Development andPharmacovigilance and Chief Medical Officer, Dale Hooks, our Senior Vice President and Chief Commercial Officer and Gillian C. Ivers-Read, our ExecutiveVice President, Technical Operations and Chief Regulatory Officer, whose services are critical to the successful implementation of our product candidateacquisition, development and regulatory strategies. As previously announced, Erle T. Mast intends to resign as Executive Vice President and Chief FinancialOfficer effective as of March 31, 2016. We are currently searching for a successor CFO; however, we have not yet identified his replacement.Despite our efforts to retain valuable employees, members of our management, scientific, development and commercial teams may terminate theiremployment with us on short notice. Pursuant to their employment arrangements, each of our executive officers may voluntarily terminate their employmentat any time by providing as little as thirty days advance notice. Our employment arrangements with all of our employees provide for at-will employment,which means that any of our employees (other than our executive officers) could leave our employment at any time, with or without notice. For example,Andrew R. Allen, our former Executive Vice President of Clinical and Pre-Clinical Development and Chief Medical Officer, resigned in July 2015, andSteven L. Hoerter, our former Executive Vice President and Chief Commercial Officer, resigned in January 2016. The loss of the services of any of ourexecutive officers or other key employees and our inability to find suitable replacements could potentially harm our business, financial condition andprospects. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well asjunior, mid-level and senior scientific and medical personnel.As of February 22, 2016, we employed 309 full-time employees. As our development plans and strategies develop, we expect to expand our employeebase for managerial, operational, financial and other resources. Future growth will impose significant added responsibilities on members of management,including the need to identify, recruit, maintain, motivate and integrate additional employees. Also, our management may need to divert a disproportionateamount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be ableto effectively manage the expansion of our operations which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of businessopportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expendituresand may divert financial resources from other projects. If our management is unable to effectively manage our expected growth, our expenses may increasemore than expected, our ability to generate revenues could be reduced and we may not be able to implement our business strategy.We may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for a limited number ofqualified personnel among biopharmaceutical, biotechnology, pharmaceutical and other businesses. Many of the other pharmaceutical companies that wecompete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. Theyalso may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high qualitycandidates than what we have to offer. In order to induce valuable employees to continue their employment with us, we have provided stock options that vestover time. The value to employees of stock options that vest over time is significantly affected by movements in our stock price that are beyond our control,and may at any time be insufficient to counteract more lucrative offers from other companies. If we are unable to continue to attract and retain high qualitypersonnel, the rate and success at which we can develop and commercialize product candidates will be limited.35Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which couldhave a material adverse effect on our business.We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDAregulations, provide accurate information to the FDA, comply with manufacturing standards we have established, comply with federal and state health-carefraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketingand business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing andother abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission,customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in thecourse of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Business Ethics, but it isnot always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective incontrolling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failureto be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or assertingour rights, those actions could have a significant effect on our business and results of operations, including the imposition of significant fines or othersanctions.We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy andsecurity laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may bedirectly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws may affect, among other things, our proposed sales, marketing and education programs. Inaddition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that mayaffect our ability to operate include: ●the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering orpaying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable undera federal healthcare program, such as the Medicare and Medicaid programs; ●federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities fromknowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false orfraudulent; ●HIPAA which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and makingfalse statements relating to healthcare matters; ●HIPAA, as amended by HITECH and its implementing regulations, which imposes certain requirements relating to the privacy, security andtransmission of individually identifiable health information; and ●state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or servicesreimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information incertain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicatingcompliance efforts.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subjectto penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations, any of which could adversely affectour ability to operate our business and our results of operations.If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our productcandidates.We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if wecommercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable duringproduct testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, afailure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumerprotection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limitcommercialization of our product candidates, if approved. Even successful defense would require significant financial and management resources. Regardlessof the merits or eventual outcome, liability claims may result in: ●decreased demand for our product candidates or products that we may develop;36 ●injury to our reputation; ●withdrawal of clinical trial participants; ●initiation of investigations by regulators; ●costs to defend the related litigation; ●a diversion of management’s time and our resources; ●substantial monetary awards to trial participants or patients; ●increase in insurance premiums; ●product recalls, withdrawals or labeling, marketing or promotional restrictions; ●loss of revenues from product sales; ●the inability to commercialize our product candidates; and ●a decline in our stock price.Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims couldprevent or inhibit the commercialization of products we develop. We have a program of product liability insurance covering our ongoing clinical trials;however, the amount of insurance we maintain may not be adequate to cover all liabilities that we may incur. Although we maintain such insurance, anyclaim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance orthat is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liabilityclaim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitationsor that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches.We and our business partners maintain sensitive company data on our computer networks, including our intellectual property and proprietary businessinformation, as well as certain clinical trial information. Cybersecurity attacks are becoming more commonplace and include, but are not limited to,malicious software, attempts to gain unauthorized access to data and other electronic security breaches that could lead to disruptions in systems,misappropriation of information and corruption of data. Despite the implementation of security measures, our internal computer systems and those of ourCROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war andtelecommunication and electrical failures. While we have not experienced any such material system failure, accident or security breach to date, if such anevent were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and business operations.For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts andsignificantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage toour data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of ourproduct candidates could be delayed.Risks Related to Our Intellectual PropertyIf our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to competeeffectively in our market.We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to ourtechnologies. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quicklyduplicate or surpass our technological achievements, thus eroding our competitive position in our market.37The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patentapplications that we own or license may fail to result in issued patents in the United States or in other foreign countries. Even if the patents do successfullyissue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or heldunenforceable. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property orprevent others from designing around our claims. If the breadth or strength of protection provided by the patent applications we hold or pursue with respectto our product candidates is threatened, it could threaten our ability to commercialize our product candidates. Further, if we encounter delays in our clinicaltrials, the period of time during which we could market our product candidates under patent protection would be reduced. Since patent applications in theUnited States and most other countries are confidential for a period of time after filing, we cannot be certain that we were the first to file any patentapplication related to our product candidates. Furthermore, an interference proceeding can be provoked by a third-party or instituted by the United StatesPatent and Trademark Office (“U.S. PTO”) to determine who was the first to invent any of the subject matter covered by the patent claims of our applications.In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our drug development processes that involveproprietary know-how, information or technology that is not covered by patents. Although we require all of our employees to assign their inventions to us,and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter intoconfidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitorswill not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Further, the laws of someforeign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encountersignificant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent materialdisclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or maintain a competitive advantage in ourmarket, which could materially adversely affect our business, results of operations and financial condition.Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amountof litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including interference, inter partiesreview and reexamination proceedings before the U.S. PTO or oppositions and other comparable proceedings in foreign jurisdictions. Numerous UnitedStates and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing productcandidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may giverise to claims of infringement of the patent rights of others.Third parties may assert that we are employing their proprietary technology without authorization. There are or may be third-party patents with claims tomaterials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Because patentapplications can take many years to issue, there may be currently pending patent applications, which may later result in issued patents that our productcandidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If anythird-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formedduring the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such productcandidate unless we obtain a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid orunenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes formanufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our abilityto develop and commercialize the applicable product candidate unless we obtain a license, limit our uses, or until such patent expires or is finally determinedto be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all.Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop andcommercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense andwould be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to paysubstantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, limit our uses, payroyalties or redesign our infringing product candidates, which may be impossible or require substantial time and monetary expenditure. We cannot predictwhether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence oflitigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail toobtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize oneor more of our product candidates, which could harm our business significantly.38The patent protection and patent prosecution for some of our product candidates is dependent on third parties.While we normally seek and gain the right to fully prosecute the patents relating to our product candidates, there may be times when platform technologypatents that relate to our product candidates are controlled by our licensors. This is the case with our license to rociletinib, under which Celgene holds theright to prosecute and maintain the patents and patent applications covering its core discovery technology, including molecular backbones, building blocksand classes of compounds generated by that technology, aspects of which relate to rociletinib. While we have the right to jointly prosecute and maintain thepatent rights for the composition of matter for rociletinib, if Celgene or any of our future licensing partners fail to appropriately prosecute and maintainpatent protection for patents covering any of our product candidates, our ability to develop and commercialize those product candidates may be adverselyaffected and we may not be able to prevent competitors from making, using and selling competing products.We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming andunsuccessful.Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringementclaims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors isnot valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover thetechnology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, heldunenforceable or interpreted narrowly and could put our patent applications at risk of not issuing.Interference proceedings provoked by third parties or brought by the U.S. PTO may be necessary to determine the priority of inventions with respect toour patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt tolicense rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonableterms. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and otheremployees.We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countrieswhere the laws may not protect those rights as fully as in the United States. Furthermore, because of the substantial amount of discovery required inconnection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this typeof litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securitiesanalysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.We may not be able to protect our intellectual property rights throughout the world.Filing, prosecuting and defending patents on all of our product candidates throughout the world would be prohibitively expensive. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringingproducts to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with ourproducts in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficientto prevent them from so competing.Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legalsystems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection,particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competingproducts in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost anddivert our efforts and attention from other aspects of our business.If we breach any of the agreements under which we license commercialization rights to our product candidates from third parties, we could lose licenserights that are important to our business.We license the use, development and commercialization rights for all of our product candidates, and may enter into similar licenses in the future. Undereach of our existing license agreements we are subject to commercialization and development, diligence obligations, milestone payment obligations, royaltypayments and other obligations. If we fail to comply with any of these obligations or otherwise breach our license agreements, our licensing partners mayhave the right to terminate the license in whole or in part. Generally, the loss of any one of our three current licenses or other licenses in the future couldmaterially harm our business, prospects, financial condition and results of operations.39Intellectual property rights do not necessarily address all potential threats to our competitive advantage.The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may notadequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative: ●Others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of the patents that weown or have exclusively licensed. ●We or our licensors or strategic partners might not have been the first to make the inventions covered by the issued patent or pending patentapplication that we own or have exclusively licensed. ●We or our licensors or strategic partners might not have been the first to file patent applications covering certain of our inventions. ●Others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectualproperty rights. ●It is possible that our pending patent applications will not lead to issued patents. ●Issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid orunenforceable, as a result of legal challenges by our competitors. ●Our competitors might conduct research and development activities in countries where we do not have patent rights and then use theinformation learned from such activities to develop competitive products for sale in our major commercial markets. ●We may not develop additional proprietary technologies that are patentable. ●The patents of others may have an adverse effect on our business.Should any of these events occur, they could significantly harm our business, results of operations and prospects.Risks Related to Ownership of our Common Stock and Convertible Senior NotesThere may not be a viable public market for our common stock and as a result it may be difficult for you to sell your shares of our common stock.Our common stock had not been publicly traded prior to our initial public offering in November 2011. The trading market for our common stock on TheNASDAQ Global Select Market has been limited and an active trading market for our shares may not be sustained. As a result of these and other factors, youmay be unable to resell your shares at a price that is attractive to you or at all. Further, an inactive market may also impair our ability to raise capital byselling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using our shares ofcommon stock as consideration.The price of our stock has been, and may continue to be, volatile, and you could lose all or part of your investment.The trading price of our common stock has been, and may continue to be, volatile and could be subject to wide fluctuations in response to various factors,some of which are beyond our control. During calendar year 2015, the price of our common stock on the NASDAQ Global Select Market ranged from $24.50per share to $116.75 per share. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factors include: ●adverse results of regulatory actions or decisions; ●our failure to successfully commercialize our product candidates, if approved; ●actual or anticipated adverse results or delays in our clinical trials; ●unanticipated serious safety concerns related to the use of any of our product candidates; ●changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals; ●disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection forour product candidates; ●our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial; ●inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices; ●our dependence on third parties, including CMOS and CROs, as well as our partners that provide us with companion diagnostic products;40 ●additions or departures of key scientific or management personnel; ●failure to meet or exceed any financial guidance or expectations regarding development milestones that we may provide to the public; ●actual or anticipated variations in quarterly operating results; ●failure to meet or exceed the estimates and projections of the investment community; ●overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance ofour competitors, including changes in market valuations of similar companies; ●conditions or trends in the biotechnology and biopharmaceutical industries; ●introduction of new products offered by us or our competitors; ●announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; ●issuances of debt or equity securities; ●significant lawsuits, including patent or stockholder litigation; ●sales of our common stock by us or our stockholders in the future; ●trading volume of our common stock; ●publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage bysecurities analysts; ●ineffectiveness of our internal controls; ●general political and economic conditions; ●effects of natural or man-made catastrophic events; and ●other events or factors, many of which are beyond our control.In addition, the stock market in general, and the NASDAQ Global Select Market and biotechnology companies in particular, have experienced extremeprice and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market andindustry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. The realization of any of theabove risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse effect on themarket price of our common stock.Because our outstanding Notes are convertible into shares of our common stock, volatility or depressed prices of our common stock could have a similareffect on the trading price of our Notes. In addition, the existence of the Notes may encourage short selling in our common stock by market participantsbecause the conversion of the Notes could depress the price of our common stock.The conversion of some or all of the Notes may dilute the ownership interest of existing stockholders. Holders of the outstanding Notes will be able toconvert them at any time prior to the close of business on the business day immediately preceding September 15, 2021. Upon conversion, holders of theNotes will receive shares of common stock. Any sales in the public market of shares of common stock issued upon conversion of such Notes could adverselyaffect the trading price of our common stock. We cannot predict the size of future issuances or the effect, if any, that they may have on the market price of ourcommon stock. The issuance and sale of substantial amounts of common stock, or the perception that such issuances and sales may occur, could adverselyaffect the market price of our common stock and impair our ability to raise capital through the sale of additional equity or convertible debt securities.Following periods of volatility in a company’s stock price, litigation has often been initiated against companies. Following the decline in our stock pricerelated to the rociletinib regulatory update in November 2015, a number of lawsuits have been filed against us (see “Part I, Item 3-Legal Proceedings”). Theseproceedings and other similar litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources,which could materially and adversely affect our business and financial condition.41Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject tostockholder approval.Our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates known to us beneficially owned approximately36.9% of our voting stock as of December 31, 2015. These stockholders have the ability to influence us through this ownership position. These stockholdersmay be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors,amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourageunsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.Persons who were our stockholders prior to our initial public offering continue to hold a substantial number of shares of our common stock. If suchpersons sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock coulddecline.In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our equity incentive plans willbecome eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under theSecurities Act, and, in any event, we have filed a registration statement permitting shares of common stock issued on exercise of options to be freely sold inthe public market. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of ourcommon stock could decline.Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result inadditional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell common stock,convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock,convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may alsoresult in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to those of holders of ourcommon stock.Pursuant to our equity incentive plan(s), our compensation committee (or its designee) is authorized to grant equity-based incentive awards to ouremployees, directors and consultants. As of December 31, 2015, the number of shares of our common stock available for future grant under our 2011 StockIncentive Plan (“2011 Plan”) is 1,181,722. The number of shares of our common stock reserved for issuance under our 2011 Plan will be increased (i) fromtime to time by the number of shares of our common stock forfeited upon the expiration, cancellation, forfeiture, cash settlement or other termination ofawards under our 2009 Equity Incentive Plan, and (ii) at the discretion of our board of directors, on the date of each annual meeting of our stockholders, byup to the lesser of (x) a number of additional shares of our common stock representing 4% of our then-outstanding shares of common stock on such date and(y) 2,758,621 shares of our common stock. Future option grants and issuances of common stock under our 2011 Plan may have an adverse effect on themarket price of our common stock. In addition, a substantial number of shares of our common stock are reserved for issuance upon conversion of the Notes.Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if anacquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for athird-party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management. Theseprovisions include: ●authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued withoutstockholder approval; ●limiting the removal of directors by the stockholders; ●creating a staggered board of directors; ●prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; ●eliminating the ability of stockholders to call a special meeting of stockholders;42 ●permitting our board of directors to accelerate the vesting of outstanding option grants upon certain transactions that result in a change ofcontrol; and ●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted uponat stockholder meetings.These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult forstockholders to replace members of our board of directors, which is responsible for appointing the members of our management. Because we are incorporatedin Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may discourage, delay or prevent someonefrom acquiring us or merging with us whether or not it is desired by or beneficial to our stockholders. Under Delaware law, a corporation may not, in general,engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among otherthings, the board of directors has approved the transaction. Any provision of our certificate of incorporation or bylaws or Delaware law that has the effect ofdelaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, andcould also affect the price that some investors are willing to pay for our common stock. Additionally, certain provisions of our outstanding Notes could makeit more difficult or more expensive for a third party to acquire us. The repurchase price of the Notes must be paid in cash, and this obligation may have theeffect of discouraging, delaying or preventing an acquisition of the Company that would otherwise be beneficial to our security holders.If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and tradingvolume could decline.The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business.If one or more of the analysts who cover us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price wouldlikely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock coulddecrease, which might cause our stock price and trading volume to decline.We may not be able to raise the funds necessary to repurchase the Notes upon a fundamental change, and our future debt may contain limitations on ourability to repurchase the Notes.If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may require us to repurchase for cash allor any portion of the Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued andunpaid interest to, but excluding, the fundamental change repurchase date. We may not have or be able to borrow the funds required to repurchase the Noteson the fundamental change repurchase date. In addition, our ability to repurchase the Notes may otherwise be limited by law, regulatory authority oragreements governing our future indebtedness. Our failure to repurchase the Notes at a time when the repurchase is required by the indenture wouldconstitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under agreementsgoverning our future indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we maynot have sufficient funds to repay the indebtedness and repurchase the Notes when required.We may incur substantially more debt or take other actions which would intensify the risks discussed above; and we may not generate cash flow fromoperations in the future sufficient to satisfy our obligations under the Notes and any future indebtedness we may incur.We may incur substantial additional debt in the future, subject to the restrictions contained in any debt instruments that we enter into in the future, someof which may be secured debt. We are not restricted under the terms of the indenture governing the Notes from incurring additional debt, securing existing orfuture debt, recapitalizing our debt or taking a number of other actions that are not limited by the terms of the indenture governing the Notes that could havethe effect of diminishing our ability to make payments on the Notes when due. Our ability to refinance the Notes or future indebtedness will depend on thecapital markets and our financial condition at such time. In addition, agreements that govern any future indebtedness that we may incur may containfinancial and other restrictive covenants that will limit our ability to engage in activities that may be in our long-term best interests. Our failure to complywith those covenants could result in an event of default that, if not cured or waived, could result in the acceleration of some or all of our debt. ITEM 1B.UNRESOLVED STAFF COMMENTSNot applicable. 43ITEM 2.PROPERTIESOur principal offices are located at four leased facilities, a 29,177 square foot facility in Boulder, Colorado used primarily for corporate functions, a24,877 square foot facility in San Francisco, California used for clinical development operations and research laboratory space, a 4,411 square foot facility inCambridge, United Kingdom used for our European regulatory and clinical operations and a 416 square foot facility in Milan, Italy used for clinicaloperations. These leases expire in January 2023, December 2021, May 2016 and March 2017, respectively. We believe that our existing facilities aresufficient for our needs for the foreseeable future. ITEM 3.LEGAL PROCEEDINGSOn November 19, 2015, Steve Kimbro, a purported shareholder of Clovis, filed a purported class action complaint (the “Kimbro Complaint”) againstClovis and certain of its officers in the United States District Court for the District of Colorado. The Kimbro Complaint purports to be asserted on behalf of aclass of persons who purchased Clovis stock between October 31, 2013 and November 15, 2015. The Kimbro Complaint generally alleges that Clovis andcertain of its officers violated federal securities laws by making allegedly false and misleading statements regarding the progress toward FDA approval andthe potential for market success of rociletinib. The Kimbro Complaint seeks unspecified damages.Also on November 19, 2015, a second purported shareholder class action complaint was filed by Sonny P. Medina, another purported Clovis shareholder,containing similar allegations to those set forth in the Kimbro Complaint, also in the United States District Court for the District of Colorado (the “MedinaComplaint”). The Medina Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock between May 20, 2014 andNovember 13, 2015.On November 20, 2015, a third complaint was filed by John Moran in the United States District Court for the Northern District of California (the “MoranComplaint”). The Moran Complaint contains similar allegations to those asserted in the Kimbro and Medina Complaints and purports to be asserted onbehalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 13, 2015.On December 14, 2015, Ralph P. Rocco, a fourth purported shareholder of Clovis, filed a complaint in the United States District Court for the District ofColorado (the “Rocco Complaint”). The Rocco Complaint contains similar allegations to those set forth in the previous complaints and purports to beasserted on behalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 15, 2015.On January 19, 2016, a number of motions were filed in both the District of Colorado and the Northern District of California seeking to consolidate theshareholder class actions into one matter and for appointment of a lead plaintiff. All lead plaintiff movants other than M.Arkin (1999) LTD and ArkinCommunications LTD (the “Arkin Plaintiffs”) subsequently filed notices of non-opposition to the Arkin Plaintiffs’ application.On February 2, 2016, the Arkin Plaintiffs filed a motion to transfer the Moran Complaint to the District of Colorado (the “Motion to Transfer”). Also onFebruary 2, 2016, the defendants filed a statement in the Northern District of California supporting the consolidation of all actions in a single court, theDistrict of Colorado. On February 3, 2016, the Northern District of California court denied without prejudice the lead plaintiff motions filed in that courtpending a decision on the Motion to Transfer.On February 16, 2016, the defendants filed a memorandum in support of the Motion to Transfer, and plaintiff Moran filed a notice of non-opposition tothe Motion to Transfer. On February 17, 2016, the Northern District of California court granted the Motion to Transfer.On February 18, 2016, the Medina court issued an opinion and order addressing the various motions for consolidation and appointment of lead plaintiffand lead counsel in the District of Colorado actions. By this ruling, the court consolidated the Medina, Kimbro and Rocco actions into a single proceeding.The court also appointed the Arkin Plaintiffs as the lead plaintiffs and Bernstein Litowitz Berger & Grossman as lead counsel for the putative class. TheCompany intends to vigorously defend against the allegations contained in the Kimbro, Medina, Moran and Rocco Complaints, but there can be noassurance that the defense will be successful. If the lawsuits were to result in a loss, the amount of any such loss cannot reasonably be estimated.On December 30, 2015, Jamie McCall, a purported shareholder of Clovis, filed a shareholder derivative complaint (the “McCall Complaint”) againstcertain officers and directors of Clovis in the Colorado District Court, County of Boulder. The McCall Complaint generally alleges that the defendantsbreached their fiduciary duties owed to Clovis by participating in misrepresentation of the Company’s business operations and prospects. The McCallComplaint also alleges claims for abuse of control, gross mismanagement and unjust enrichment. The McCall Complaint seeks, among other things, an awardof money damages, declaratory and injunctive relief concerning the alleged fiduciary breaches and other forms of equitable relief. The Company intends tovigorously defend against the allegations contained in the McCall Complaint, but there can be no assurance that the defense will be successful. If the lawsuitwere to result in a loss, the amount of any such loss cannot reasonably be estimated.44On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder of Clovis, filed a purported classaction complaint (the “Electrical Workers Complaint”) against Clovis and certain of its officers, directors, investors and underwriters in the Superior Court ofthe State of California, County of San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased stock inClovis’ July 8, 2015 follow-on offering. The Electrical Workers Complaint generally alleges that the defendants violated the Securities Act because theoffering documents for the July 8, 2015 follow-on offering contained allegedly false and misleading statements regarding the progress toward FDA approvaland the potential for market success of rociletinib. The Electrical Workers Complaint seeks unspecified damages. On February 25, 2016, the defendantsremoved the case to the United States District Court for the Northern District of California and thereafter moved to transfer the case to the District ofColorado. The Company intends to vigorously defend against the allegations contained in the Electrical Workers Complaint, but there can be no assurancethat the defense will be successful. If the lawsuit were to result in a loss, the amount of any such loss cannot reasonably be estimated.On February 19, 2016, Maris Sanchez, a purported shareholder of Clovis, filed a shareholder derivative complaint (the “Sanchez Complaint”) againstcertain officers and directors of Clovis in the United States District Court for the District of Colorado. The Sanchez Complaint generally alleges that thedefendants breached their fiduciary duties owed to Clovis by participating in misrepresentation of the Company’s business operations and prospects. TheSanchez Complaint also alleges claims for abuse of control and gross mismanagement. The Sanchez Complaint seeks, among other things, an award of moneydamages. The Company intends to vigorously defend against the allegations contained in the Sanchez Complaint, but there can be no assurance that thedefense will be successful. If the lawsuit were to result in a loss, the amount of any such loss cannot reasonably be estimated. ITEM 4.MINE SAFETY DISCLOSURESNot applicable.PART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIESMarket Information and HoldersOur common stock trades on the NASDAQ Global Select Market under the symbol “CLVS.” The following table sets forth, for the periods indicated, thehigh and low sales prices for our common stock as reported on the NASDAQ Global Select Market: HIGH LOW Year Ended December 31, 2015 First Quarter $83.46 $54.88 Second Quarter $102.28 $68.40 Third Quarter $116.75 $65.00 Fourth Quarter $109.18 $24.50 Year Ended December 31, 2014 First Quarter $93.33 $58.18 Second Quarter $72.48 $36.11 Third Quarter $50.87 $35.33 Fourth Quarter $62.20 $40.66 On February 19, 2016, there were approximately 27 holders of record of our common stock.DividendsWe have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings tosupport our operations and finance the growth and development of our business. We do not intend to pay cash dividends on our common stock for theforeseeable future. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend upon,among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects and other factors ourboard of directors may deem relevant.45Securities Authorized for Issuance Under Equity Compensation PlansEquity Compensation Plan InformationAs of December 31, 2015 Number of securities tobe issued upon exerciseof outstanding optionsand rights Weighted-averageexercise priceof outstandingoptions and rights Number ofsecuritiesremainingavailablefor issuanceunder equitycompensationplans (excludingsecuritiesreflectedin column (a)) Plan Category (a) (b) (c) Equity compensation plans approved by security holders (1) (2) 5,360,257 $51.53 1,557,953 Equity compensation plans not approved by security holders — — — Total 5,360,257 $51.53 1,557,953 (1)As of December 31, 2015, 6,262,641 shares were authorized for issuance under our 2011 Stock Incentive Plan (“2011 Plan”), which becameeffective upon closing of the Company’s initial public offering in November 2011, including 191,496 remaining shares available for futureissuance under the 2009 Equity Incentive Plan (“2009 Plan”), which were transferred to the 2011 Plan. The number of shares of our common stockreserved for issuance under the 2011 Plan will be increased (i) from time to time by the number of shares of our common stock forfeited upon theexpiration, cancellation, forfeiture, cash settlement or other termination of awards under the 2009 Plan and (ii) at the discretion of our board ofdirectors, on the date of each annual meeting of our stockholders, by up to the lesser of (x) a number of additional shares of our common stockrepresenting 4% of our then-outstanding shares of common stock on such date and (y) 2,758,621 shares of our common stock. (2)As of December 31, 2015, 376,231 shares were reserved for issuance under our 2011 Employee Stock Purchase Plan (“ESPP”), which becameeffective upon closing of the Company’s initial public offering in November 2011. The number of shares of our common stock reserved forissuance under the ESPP will be increased at the discretion of our board of directors, on the date of each annual meeting of our stockholders, by upto the lesser of (x) a number of additional shares of our common stock representing 1% of our then-outstanding shares of common stock on suchdate and (y) 344,828 shares of our common stock.46Performance Graph (1)The following graph shows a comparison from November 16, 2011 through December 31, 2015 of the cumulative total return on an assumed investmentof $100 in cash in our common stock, the NASDAQ Composite Index and the NASDAQ Biotechnology Index. Such returns are based on historical results andare not intended to suggest future performance. Data for the NASDAQ Composite Index and the NASDAQ Biotechnology Index assume reinvestment ofdividends. (1) This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of Section 18 of the Securities andExchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section, and shall not be deemed incorporated by referenceinto any filing of Clovis Oncology, Inc. under the Securities Act of 1933, as amended. ITEM 6.SELECTED FINANCIAL DATAThe following table sets forth certain of our selected historical financial data at the dates and for the periods indicated. The selected historical statement ofoperations data presented below for the years ended December 31, 2015, 2014 and 2013 and the historical balance sheet data as of December 31, 2015 and2014 have been derived from our audited financial statements, which are included elsewhere in this Annual Report on Form 10-K. The historical statement ofoperations data presented below for the years ended December 31, 2012 and 2011 and the historical balance sheet data as of December 31, 2013, 2012 and2011 have been derived from our audited financial statements that do not appear in this report.Our historical results are not necessarily indicative of results expected in any future period.The selected historical financial data presented below should be read in conjunction with “Management’s Discussion and Analysis of FinancialCondition and Results of Operations” and our financial statements and the related notes thereto, which are included elsewhere in this Annual Report on Form10-K. The selected historical financial information in this section is not intended to replace our financial statements and the related notes thereto.47Statement of Operations Data: Year Ended December 31, 2015 2014 2013 2012 2011 (in thousands, except per share amounts) Revenues: License and milestone revenue $— $13,625 $— $— $— Operating expenses: Research and development 269,251 137,705 66,545 58,894 40,726 General and administrative 30,524 21,457 16,567 10,638 6,860 Acquired in-process research and development 12,000 8,806 250 4,250 7,000 Impairment of intangible asset 89,557 3,409 — — — Change in fair value of contingent purchase consideration (24,611) 707 405 — — Total expenses 376,721 172,084 83,767 73,782 54,586 Operating loss (376,721) (158,459) (83,767) (73,782) (54,586)Other income (expense): Interest expense (8,372) (2,604) — — (949)Foreign currency gains (losses) 2,740 3,580 (535) (65) 49 Other income (expense) 416 (240) (178) (163) (57)Other income (expense), net (5,216) 736 (713) (228) (957)Loss before income taxes (381,937) (157,723) (84,480) (74,010) (55,543)Income tax benefit (expense) 29,076 (2,308) (52) 27 (27)Net loss $(352,861) $(160,031) $(84,532) $(73,983) $(55,570)Basic and diluted net loss per common share $(9.79) $(4.72) $(2.95) $(2.97) $(14.42)Basic and diluted weighted average common shares outstanding 36,026 33,889 28,672 24,915 3,854 Balance Sheet Data: As of December 31, 2015 2014 2013 2012 2011 (in thousands) Cash, cash equivalents and available-for-sale securities $528,588 $482,677 $323,228 $144,097 $140,248 Working capital 464,125 443,400 307,644 132,712 130,519 Total assets 713,386 786,206 649,635 145,994 143,445 Convertible senior notes 279,885 278,680 — — — Common stock and additional paid-in capital 1,130,016 785,123 762,204 317,925 242,243 Total stockholders’ equity 300,650 331,630 497,886 133,496 131,793 ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following discussion and analysis of our financial condition and results of operations together with our financial statements andrelated notes appearing at the end of this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forthelsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing,includes forward-looking statements that involve risks and uncertainties. You should read the “Risk Factors” section of this report for a discussion ofimportant factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained inthe following discussion and analysis.48OverviewWe are a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europeand other international markets. We generally target our development programs for the treatment of specific subsets of cancer populations and seek tosimultaneously develop, with partners, companion diagnostics that direct our product candidates to the patients that are most likely to benefit from their use.We are currently developing three product candidates: ·Rociletinib, an oral epidermal growth factor receptor (“EGFR”), mutant-selective covalent inhibitor that is currently under review with the U.S.and E.U. regulatory authorities for the treatment of advanced non-small cell lung cancer (“NSCLC”) in patients with activating EGFRmutations, as well as the dominant resistance mutation, T790M; ·Rucaparib, an oral inhibitor of poly (ADP-ribose) polymerase (“PARP”) that is currently in advanced clinical development for the treatment ofovarian cancer and for which the first U.S. regulatory application is expected to be submitted for approval during the second quarter of 2016and the first E.U. regulatory application is expected to be submitted in the second half of 2016; and ·Lucitanib, an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1-3 (“VEGFR1-3”), platelet-derivedgrowth factor receptors alpha and beta (“PDGFR a/ß”) and fibroblast growth factor receptors 1-3 (“FGFR1-3”) that is currently in Phase IIdevelopment for the treatment of breast cancer.We hold global development and commercialization rights for rociletinib and rucaparib. For lucitanib, we hold development and commercializationrights in the U.S. and Japan and have sublicensed rights to Europe and rest of world markets, excluding China, to Les Laboratoires (“Servier”).We commenced operations in April 2009. To date, we have devoted substantially all of our resources to identifying and in-licensing product candidates,performing development activities with respect to those product candidates and the general and administrative support of these operations. ThroughDecember 31, 2015, we have generated $13.6 million in license and milestone revenue related to our collaboration and license agreement with Servier, buthave generated no product revenues. We have principally funded our operations using the net proceeds from the sale of convertible preferred stock, theissuance of convertible promissory notes, public offerings of our common stock and our convertible senior notes offering.We have never been profitable and, as of December 31, 2015, we had an accumulated deficit of $781.9 million. We incurred net losses of $352.9 million,$160.0 million and $84.5 million for the years ended December 31, 2015, 2014 and 2013, respectively, and had cash, cash equivalents and available-for-salesecurities totaling $528.6 million at December 31, 2015.We expect to incur significant losses for the foreseeable future, as we advance our product candidates through clinical development to seek regulatoryapproval and, if approved, commercialize such product candidates. Based on our current estimates, we believe that our cash, cash equivalents and available-for-sale securities will allow us to fund activities through the next 12 months; however, we expect that we will need to raise capital during 2016 in order tofully implement our business plan to further the development and commercialization of our product candidates, as well as to fund our other operatingexpenses, milestone payments to licensors and capital expenditures. We expect to finance future cash needs through a combination of public or privateequity or debt offerings, collaborations, strategic alliances or other similar licensing arrangements. Adequate additional financing may not be available to uson acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability topursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.In July 2015, the Company sold 4,054,487 shares of its common stock in a public offering at $78.00 per share. The net proceeds to the Company from theoffering were $298.5 million, after deducting underwriting discounts and commissions and offering expenses.In July 2015, the Company submitted a New Drug Application (“NDA”) regulatory filing and a Marketing Authorization Application (“MAA”) forrociletinib to the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”), respectively. Both the FDA and EMAsubsequently accepted the respective filings, and they are currently under active review. In December 2015, the FDA extended the Prescription Drug User FeeAct goal date for the rociletinib NDA by three months to June 28, 2016 to allow additional time for review of additional clinical data submitted by theCompany in a Major Amendment in November 2015. The FDA has scheduled the NDA for rociletinib for discussion by the Oncologic Drugs AdvisoryCommittee (“ODAC”) on April 12, 2016. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigationalhuman drug products used in the treatment of cancer and makes recommendations to the FDA.49Product License AgreementsRociletinibIn May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research Inc., part ofCelgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the EGFR gene product. As a result of thecollaboration contemplated by the agreement, rociletinib was identified as the lead inhibitor candidate, which we are developing under the terms of thelicense agreement. Under the agreement, we are required to use commercially reasonable efforts to develop and commercialize rociletinib, and we areresponsible for all non-clinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib.We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 uponthe acceptance by the FDA of our Investigational New Drug (“IND”) application for rociletinib and a $5.0 million milestone payment in the first quarter of2014 upon the initiation of the Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million uponacceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquiredin-process research and development expense.When and if commercial sales of rociletinib commence, we will pay Celgene tiered royalties at percentage rates ranging from mid-single digits to lowteens based on annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and regulatory milestonepayments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved, including $15.0 million upon the first approvalof an NDA by the FDA and $15.0 million upon the first approval of an MAA by the EMA. In addition, we are required to pay up to an aggregate of $120.0million in sales milestone payments if certain annual sales targets are achieved, the majority of which relate to annual sales targets of $500.0 million andabove.In January 2013, the Company entered into an exclusive license agreement with Gatekeeper Pharmaceuticals, Inc. (“Gatekeeper”) to acquire exclusiverights under patent applications associated with mutant EGFR inhibitors and methods of treatment. Pursuant to the terms of the license agreement, theCompany made an upfront payment of $0.25 million upon execution of the agreement, which was recognized as acquired in-process research anddevelopment expense. If rociletinib is approved for commercial sale, the Company will pay royalties to Gatekeeper on future net sales.RucaparibIn June 2011, we entered into a license agreement with Pfizer Inc. to obtain the exclusive global rights to develop and commercialize rucaparib. Theexclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Under the terms of the license agreement, we made a $7.0 millionupfront payment to Pfizer. In April 2014, the Company initiated a pivotal registration study for rucaparib, which resulted in a $0.4 million milestone paymentto Pfizer as required by the license agreement. This payment was recognized as acquired in-process research and development expense.We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize rucaparib, and we are responsible forall remaining development and commercialization costs for rucaparib. When and if commercial sales of rucaparib begin, we will pay Pfizer tiered royalties ata mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties tocommercialize rucaparib.We are required to make regulatory milestone payments to Pfizer of up to an additional $88.5 million if specified clinical study objectives and regulatoryfilings, acceptances and approvals are achieved, including $20.75 million associated with the first approval of an NDA by the FDA. In addition, we areobligated to make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which relate to annual sales targetsof $500.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million.In April 2012, the Company entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights associated with rucaparib under afamily of patents and patent applications that claim methods of treating patients with PARP inhibitors in certain indications. The license enables thedevelopment and commercialization of rucaparib for the uses claimed by these patents. Pursuant to the terms of the license agreement, the Company made anupfront payment of $0.25 million upon execution of the agreement, which was recognized as acquired in-process research and development expense. TheCompany may be required to pay up to an aggregate of $0.7 million in milestone payments if certain regulatory filings, acceptances and approvals areachieved. If approved, AstraZeneca will also receive royalties on any net sales of rucaparib.50LucitanibOn November 19, 2013, the Company acquired all of the issued and outstanding capital stock of Ethical Oncology Science, S.p.A. (“EOS”) (now knownas Clovis Oncology Italy S.r.l.) and gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further describedbelow, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”).Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Servier in exchange forupfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments.In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excludingChina. If and when commercial sales commence, we are obligated to pay Advenchen tiered royalties at percentage rates in the mid-single digits on net salesof lucitanib, based on the volume of annual net sales achieved. In addition, after giving effect to the first and second amendments to the license agreement,we are required to pay to Advenchen 25% of any consideration, excluding royalties, received by the Company from sublicensees, in lieu of the milestoneobligations set forth in the agreement.We are obligated under the agreement to use commercially reasonable efforts to develop and commercialize at least one product containing lucitanib, andwe are also responsible for all remaining development and commercialization costs for lucitanib. In the first quarter of 2014, the Company recognizedacquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense agreement consideration of $13.6 millionreceived from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office.In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to developand commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an upfront payment of €45.0million. We are entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to anadditional €90.0 million in the aggregate. In addition, we are entitled to receive sales milestone payments if specified annual sales targets for lucitanib aremet, which, in the aggregate, could total €250.0 million. We are also entitled to receive royalties at percentage rates ranging from low to mid-teens on sales oflucitanib by Servier.We, along with Servier, are obligated to use diligent efforts to develop a product containing lucitanib and to carry out the activities delegated to eachparty under a mutually-agreed global development plan. Servier is responsible for all of the development costs for lucitanib up to €80.0 million, as incurredby each party in connection with global development plan activities. Cumulative global development plan costs in excess of €80.0 million, if any, will beshared equally between the Company and Servier. Based on current estimates, we expect that Servier’s €80.0 million funding commitment will be fulfilled inlate 2016 or early 2017, and thereafter, we will share with Servier in future development costs pursuant to a mutually agreed upon global development plan.Financial Operations OverviewRevenueTo date, we have generated $13.6 million in license and milestone revenue related to our collaboration and license agreement with Servier. In the future,we may generate revenue from the sales of product candidates that are currently under review with the U.S. and E.U. regulatory authorities and underdevelopment by the Company, as well as from milestone payments or royalties pursuant to our sublicense agreement with Servier. If we fail to successfullycomplete the regulatory review and development of our product candidates and, together with our partners, companion diagnostics or obtain regulatoryapproval for them, our ability to generate future revenue, and our results of operations and financial position, will be adversely affected.Research and Development ExpensesResearch and development expenses consist of costs incurred for the development of our product candidates and companion diagnostics, which include: ·license fees and milestone payments related to the acquisition of in-licensed products, which are reported on our Consolidated Statements ofOperations as acquired in-process research and development; ·employee-related expenses, including salaries, benefits, travel and share-based compensation expense; ·expenses incurred under agreements with contract research organizations (“CROs”) and investigative sites that conduct our clinical trials; ·the cost of acquiring, developing and manufacturing clinical trial materials; ·costs associated with non-clinical activities and regulatory operations; 51 ·market research, disease education and other commercial product planning activities, including the hiring of a U.S. sales and marketing andmedical affairs organization in preparation for potential commercial launch; and ·activities associated with the development of companion diagnostics for our product candidates.Research and development costs are expensed as incurred. License fees and milestone payments related to in-licensed products and technology areexpensed if it is determined that they have no alternative future use. Costs for certain development activities, such as clinical trials and manufacturing ofclinical supply, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical siteactivations or information provided to us by our vendors.Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development,primarily due to the increased size and duration of later stage clinical trials. We plan to increase our research and development expenses for the foreseeablefuture as we seek to expand our clinical and companion diagnostic development activities for our product candidates.The following table identifies research and development and acquired in-process research and development costs on a program-specific basis for ourproducts under development. Personnel-related costs, depreciation and share-based compensation are not allocated to specific programs, as they are deployedacross multiple projects under development and, as such, are separately classified as personnel and other expenses in the table below. Year Ended December 31, 2015 2014 2013 (in thousands) Rociletinib Expenses Research and development $122,912 $69,920 $17,020 Acquired in-process R&D 12,000 5,000 250 Rociletinib Total 134,912 74,920 17,270 Rucaparib Expenses Research and development 58,922 35,010 24,625 Acquired in-process R&D — 400 — Rucaparib Total 58,922 35,410 24,625 Lucitanib Expenses Research and development (a) 1,923 (491) 110 Acquired in-process R&D — 3,406 — Lucitanib Total 1,923 2,915 110 CO-101 Expenses Research and development (b) — — 795 CO-101 Total — — 795 cKIT Inhibitor Expenses Research and development (c) — — 4,373 cKIT Inhibitor Total — — 4,373 Personnel and other expenses 85,494 33,266 19,622 Total $281,251 $146,511 $66,795 (a)This amount reflects actual costs incurred less amounts due from Servier for reimbursable development expenses pursuant to the collaboration andlicense agreement described in Note 12 to our audited consolidated financial statements included in this Annual Report on Form 10-K. (b)In November 2009, the Company entered into a license agreement with Clavis Pharma ASA to develop and commercialize CO-101. In November2012, the Company ceased development of CO-101 due to negative results from a pivotal study and terminated the license agreement. (c)In July 2012, the Company entered into a drug discovery collaboration agreement with Array BioPharma Inc. for the discovery of a novel cKITinhibitor targeting resistance mutations for the treatment of GIST, a gastrointestinal cancer. Under the terms of the agreement, the Company wasresponsible for funding all costs of the discovery program, as well as costs to develop and commercialize any clinical candidates discovered. Thisdrug discovery program did not identify a compound to be used in further development activities, and the program was terminated in the fourthquarter of 2013.52Research and development expenses increased significantly from 2013 through 2015 due to the expansion of our clinical development activities forrociletinib and rucaparib. In addition, during 2015, we increased commercial product planning activities in anticipation of the potential regulatory approvaland commercial launch in the U.S. of rociletinib. These activities included the hiring of our U.S. sales and marketing and medical affairs organizations. For2016, we do not expect research and development expenses to increase over 2015 as they have for the previous two years, but we expect such costs to remainconsistent with 2015 expenses.General and Administrative ExpensesGeneral and administrative expenses consist principally of salaries, share-based compensation expense and other personnel-related costs for employees inexecutive, finance, legal, investor relations, human resources and information technology functions. Other general and administrative expenses includefacilities expenses, communication expenses, information technology costs, corporate insurance and professional fees for legal, consulting and accountingservices.Acquired In-Process Research and Development ExpensesAcquired in-process research and development expenses consist of upfront payments to acquire a new drug compound, as well as subsequent milestonepayments. Acquired in-process research and development payments are immediately expensed provided that the drug has not achieved regulatory approvalfor marketing and, absent obtaining such, approval, has no alternative future use.Impairment of Intangible AssetIn connection with the acquisition of EOS, we recorded intangible assets to reflect the fair value of acquired in-process research and development(“IPR&D”) as of the acquisition date. The fair value was established based upon discounted cash flow models using assumptions related to the timing ofdevelopment, probability of development and regulatory success, sales and commercialization factors and estimated product life.The IPR&D intangible assets are treated as indefinite-lived intangible assets and are not amortized. Amortization of these assets will commence uponcompletion of the related research and development activities. IPR&D intangible assets are evaluated for impairment at least annually or more frequently ifimpairment indicators exist and any reduction in fair value would be recorded as impairment of intangible asset on the Consolidated Statements ofOperations. During the fourth quarter of 2015, the Company recorded an $89.6 million impairment charge to the IPR&D intangible asset as the result of theCompany’s and our development partner’s decision to terminate the development of lucitanib for lung cancer, as well as updates to the probability-weighteddiscounted cash flow assumptions for the breast cancer indication.Change in Fair Value of Contingent Purchase ConsiderationIn connection with the acquisition of EOS, we also recorded a purchase consideration liability equal to the estimated fair value of future payments that arecontingent upon the achievement of various regulatory and sales milestones. Subsequent to the acquisition date, we re-measure contingent considerationarrangements at fair value each reporting period and record changes in fair value to change in fair value of contingent purchase consideration and foreigncurrency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations. Changes in fair value are primarilyattributed to new information about the likelihood of achieving such milestones and the passage of time. In the absence of new information, changes to fairvalue reflect only the passage of time as we progress towards the achievement of future milestones. During the fourth quarter of 2015, the Company recordeda $26.9 million reduction in the fair value of the contingent purchase consideration liability due to a change in the estimated probability-weighted futuremilestone payments, as well as the timing of such payments, for the lucitanib program.Other Income and ExpenseOther income and expense is primarily comprised of foreign currency gains and losses resulting from transactions with CROs, investigational sites andcontract manufacturers where payments are made in currencies other than the U.S. dollar. In addition, a significant portion of the contingent purchaseconsideration liability will be settled in Euro-denominated payments if certain future milestones are achieved and is subject to fluctuations in foreigncurrency rates. Other expense also includes interest expense recognized related to the Company’s convertible senior notes.53Critical Accounting Policies and Significant Judgments and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared inaccordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgmentsthat affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates andjudgments, including those related to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment, clinical trialaccruals and share-based compensation. We base our estimates on historical experience, known trends and events and various other factors that are believedto be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that arenot readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.Our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this AnnualReport on Form 10-K. We believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of ourfinancial statements.Accrued Research and Development ExpensesAs part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing opencontracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level ofservice performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority ofour service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expensesas of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy ofour estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include: ·fees paid to CROs in connection with clinical studies; ·fees paid to investigative sites in connection with clinical studies; ·fees paid to vendors in connection with non-clinical development activities; ·fees paid to vendors associated with the development of companion diagnostics; and ·fees paid to vendors related to product manufacturing, development and distribution of clinical supplies.We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROsthat conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract andmay result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result ina prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and thecompletion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed, enrollment of patients,number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort variesfrom our estimate, we adjust the accrual or prepaid accordingly. Although we do not expect our estimates to be materially different from amounts actuallyincurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and mayresult in us reporting amounts that are too high or too low in any particular period. Based on the amount of accrued research and development expenses as ofDecember 31, 2015, if our estimates of our net accrued liabilities are too high or too low by 5%, this could increase or decrease our research and developmentexpenses by approximately $2.7 million.Share-Based CompensationDetermining the amount of share-based compensation to be recorded requires us to develop estimates of the fair value of stock options as of their grantdate. Compensation expense is recognized over the vesting period of the award. Calculating the fair value of share-based awards requires that we make highlysubjective assumptions. We use the Black-Scholes option pricing model to value our stock option awards. Use of this valuation methodology requires thatwe make assumptions as to the expected dividend yield, price volatility of our common stock, the risk-free interest rate for a period that approximates theexpected term of our stock options and the expected term of our stock options. We utilize a dividend yield of zero based on the fact that we have never paidcash dividends and have no current intention to pay cash dividends.54The fair value of stock options for the years ended December 31, 2015, 2014 and 2013 was estimated at the grant date using the following weightedaverage assumptions for the respective periods: Year Ended December 31, 2015 2014 2013 Dividend yield — — — Volatility (a) 72% 70% 69%Risk-free interest rate (b) 1.77% 1.92% 1.16%Expected term (years) (c) 6.1 6.2 6.2 (a)Volatility: The expected volatility was estimated using peer data of companies in the biopharmaceutical industry with similar equity plans. (b)Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose maturity period approximatesthe option’s expected term. (c)Expected term: The expected term of the award was estimated using peer data of companies in the biopharmaceutical industry with similar equityplans. We recognized share-based compensation expense of approximately $40.4 million, $21.5 million and $9.5 million for the years ended December 31,2015, 2014 and 2013, respectively. As of December 31, 2015, we had $88.6 million in total unrecognized share-based compensation expense, net of relatedforfeiture estimates, which is expected to be recognized over a weighted-average remaining vesting period of 2.7 years. We expect our share-basedcompensation to continue to grow in future periods due to the potential increases in the value of our common stock and headcount.We are required to estimate the level of forfeitures expected to occur and record compensation expense only for those awards that we ultimately expectwill vest. Due to the lack of historical forfeiture activity of our plan, we estimated our forfeiture rate based on peer company data with characteristics similarto our company.Valuation of Contingent Consideration Resulting from a Business CombinationContingent consideration resulting from a business combination is reported at its fair value on the acquisition date. Each subsequent reporting period, thecontingent consideration obligations are revalued and changes in fair value are recorded to change in fair value of contingent purchase consideration andforeign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations.Changes to contingent consideration obligations can result from adjustments to discount rates and time periods, updates in the assumed achievement ortiming of any development milestone or changes in the probability of certain clinical events and regulatory approvals. The assumptions related todetermining the value of contingent consideration require significant judgment and changes to the assumptions may have a material impact on the amount ofexpense recorded in any given period. The acquisition of EOS resulted in the recognition of a contingent consideration liability, based on assumptionsrelated to potential future payout amounts, estimated discount rate, probability of success for each milestone achievement and the estimated timing of themilestone payments to the former EOS shareholders.Intangible AssetsThe IPR&D intangible assets are treated as indefinite-lived intangible assets and are not amortized. Amortization of these assets will commence uponcompletion of the related research and development activities. IPR&D intangible assets are evaluated for impairment at least annually in the fourth quarter ormore frequently if impairment indicators exist and any reduction in fair value would be recorded as impairment of intangible asset on the ConsolidatedStatements of Operations.Revenue RecognitionRevenue is recognized from milestone payments when the following criteria have been met: (1) persuasive evidence of an arrangement exists; (2) deliveryhas occurred or services have been rendered; (3) the price is fixed or determinable; and (4) collectability is reasonably assured. We exercise judgment indetermining that collectability is reasonably assured or that services have been delivered in accordance with the arrangement. We assess whether the fee isfixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assesscollectability based primarily on the customer’s payment history and creditworthiness of the customer. Payments that are contingent upon the achievement ofa milestone will be recognized in the period in which the milestone is achieved.55Results of OperationsComparison of Years Ended December 31, 2015, 2014 and 2013:License and Milestone Revenue. License and milestone revenue for the year ended December 31, 2014 was due to the recognition of $13.6 million ofmilestone revenue from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office in the first quarter of 2014. Wedid not recognize any revenue in 2015 and 2013.Research and Development Expenses. Research and development expenses for the years ended December 31, 2015, 2014 and 2013 were as follows: Year Ended December 31, 2015 2014 2013 (in thousands) Research and development expenses $269,251 $137,705 $66,545 Increase from prior year $131,546 $71,160 $7,651 % Change from prior year 95.5% 106.9% 13.0% The increase in research and development expenses for the year ended December 31, 2015 compared to 2014 was primarily due to increased developmentactivities for the rociletinib and rucaparib programs. Costs associated with non-clinical and clinical development activities for rociletinib were $35.6 millionhigher than 2014 driven by increased patient enrollment in the TIGER program of studies in NSCLC. In addition, market research, disease education andother commercial product planning activities for rociletinib were $18.2 million higher in 2015 due to the preparation for the potential commercial launch ofrociletinib. Clinical trial costs for rucaparib were $10.3 million higher than the prior year primarily due to higher enrollment in the ARIEL2 and ARIEL3 studies inovarian cancer, as well as the expansion of Study 010 in 2015. Development costs for rucaparib were $5.9 million higher than 2014 due to the advancementof our collaboration with Foundation Medicine, Inc. to develop a novel companion diagnostic test to identify patients most likely to respond to rucaparib. Clinical supply and related manufacturing development costs for both programs were $3.2 million higher than 2014, as we increased production tosupport the expanded clinical studies. Salaries, share-based compensation expense and other personnel-related costs were $49.4 million higher in 2015, including a $15.8 million increase inshare-based compensation expense, driven by increased headcount to support our expanded development and commercial planning activities. During 2015,we completed the hiring of our U.S. sales and marketing and medical affairs organizations in preparation for the potential commercial launch of rociletinib. The increase in research and development expenses for the year ended December 31, 2014 compared to 2013 was primarily due to expanded developmentactivities for the rociletinib and rucaparib programs. Costs associated with non-clinical and clinical development activities for rociletinib were $29.4 millionhigher than 2013 driven by higher enrollment in the ongoing Phase I/II study in NSCLC, as well as the initiation of the TIGER-1, TIGER-2 and JapanesePhase I studies in 2014. Clinical trial costs for rucaparib were $11.8 million higher than the prior year primarily due to the initiation of the ARIEL2 andARIEL3 studies in ovarian cancer. Development costs for rucaparib were $3.4 million higher than 2013 due to the expansion of our collaboration with Foundation Medicine, Inc. toincorporate a coordinated regulatory strategy for the development of a novel companion diagnostic test. Clinical supply and related manufacturing development costs for both programs were $13.8 million higher than 2013, as we increased production tosupport expanded clinical studies. In addition, salaries, share-based compensation expense and other personnel related costs were $13.2 million higher in2014 driven by higher headcount to support our expanded development activities. These increases were partially offset by $4.4 million lower costs due to thetermination of the cKIT program in late 2013. General and Administrative Expenses. General and administrative expenses for the years ended December 31, 2015, 2014 and 2013 were as follows: Year Ended December 31, 2015 2014 2013 (in thousands) General and administrative expenses $30,524 $21,457 $16,567 Increase from prior year $9,067 $4,890 $5,929 % Change from prior year 42.3% 29.5% 55.7% 56The increase in general and administrative expenses for the year ended December 31, 2015 over 2014 was primarily due to $3.0 million higher share-based compensation expense, $1.4 million higher facilities expense, $1.2 million higher personnel costs, $1.1 million higher legal expense and $1.0 millionhigher consulting fees. The increase in general and administrative expenses for the year ended December 31, 2014 over 2013 was primarily due to $4.8 million higher share-based compensation expense.Acquired In-Process Research and Development Expenses. Acquired in-process research and development expenses for the years ended December 31,2015, 2014 and 2013 were as follows: Year Ended December 31, 2015 2014 2013 (in thousands) Acquired in-process research and development $12,000 $8,806 $250 Increase (decrease) from prior year $3,194 $8,556 $(4,000)% Change from prior year 36.3% 3,422.4% (94.1)%The increase in acquired in-process research and development expenses for the year ended December 31, 2015 compared to 2014 was due to higherpayments made to partners related to in-licensing agreements. During the third quarter of 2015, we made milestone payments totaling $12.0 million toCelgene upon acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. During the first quarter of 2014, we made a $5.0 millionmilestone payment to Celgene upon initiation of the Phase II study for rociletinib, and we recorded a $3.4 million charge for a milestone payment toAdvenchen, representing 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of thelucitanib patent by the European Patent Office. During the second quarter of 2014, we also made a $0.4 million milestone payment to Pfizer upon initiationof a pivotal registration study for rucaparib.The increase in acquired in-process research and development expenses for the year ended December 31, 2014 compared to 2013 was also due to higherpayments made to partners related to in-licensing agreements. During the year ended December 31, 2014, we made $8.8 million in milestone payments, asdetailed above. In January 2013, we made a $0.25 million upfront payment to Gatekeeper upon execution of the license agreement. Impairment of Intangible Asset. During the fourth quarter of 2015, the Company recorded an $89.6 million impairment charge to the IPR&D intangibleasset relating to our lucitanib product candidate. This reduction in the estimated fair value of lucitanib was the result of the Company’s and its developmentpartner’s decision to terminate the development of lucitanib for lung cancer, as well as updates to the probability-weighted discounted cash flow assumptionsfor the breast cancer indication. During the first quarter of 2014, the Company recorded a $3.4 million reduction to the intangible asset’s expected future cashflows resulting from the receipt of a lucitanib milestone payment from Servier.Change in Fair Value of Contingent Purchase Consideration. Change in fair value of contingent purchase consideration totaled ($24.6) million for theyear ended December 31, 2015 compared to $0.7 million in 2014. During the fourth quarter of 2015, the Company recorded a $26.9 million reduction in thefair value of the contingent purchase consideration liability due to a change in the estimated probability-weighted future milestone payments, as well as thetiming of such payments, for the lucitanib program.Other Income (Expense), Net. Other income (expense), net for the years ended December 31, 2015, 2014 and 2013 was as follows: Year Ended December 31, 2015 2014 2013 (in thousands) Other income (expense), net $(5,216) $736 $(713)(Decrease) increase from prior year $(5,952) $1,449 $485 % Change from prior year (808.7%) (203.2%) 212.7% Other expense increased for the year ended December 31, 2015 compared to 2014 primarily due to higher interest expense related to the Company’sconvertible senior notes issued in September 2014. Other income increased for the year ended December 31, 2014 compared to 2013 driven by $4.1 million net currency gains primarily due to fluctuationsin the foreign currency rate utilized to translate our Euro-denominated contingent purchase consideration liability into U.S. dollars. The net currency gainswere partially offset by $2.6 million interest expense related to the Company’s convertible senior notes issued in September 2014.57Income Tax Benefit (Expense). For the year ended December 31, 2015, the Company recognized a $29.1 million deferred tax benefit primarily associatedwith the impairment of the IPR&D intangible assets recorded in the fourth quarter of 2015. For the year ended 2014, the Company recognized income taxexpense primarily due to recording foreign tax provisions during the first quarter of 2014 related to milestone revenue recognized under the Servier licenseagreement, partially offset by a deferred tax benefit recognized upon the reduction of the carrying value of the IPR&D intangible assets in the first quarter of2014.Liquidity and Capital ResourcesTo date, we have funded our operations through the public offering of our common stock and the private placement of convertible debt securities andpreferred stock. As of December 31, 2015, we had cash, cash equivalents and available-for-sale securities totaling $528.6 million.The following table sets forth the primary sources and uses of cash for each of the periods set forth below: Year Ended December 31, 2015 2014 2013 (in thousands) Net cash used in operating activities $(253,066) $(117,051) $(71,712)Net cash used in investing activities (254,578) (2,286) (10,034)Net cash provided by financing activities 304,480 279,476 260,842 Effect of exchange rate changes on cash and cash equivalents (757) (690) 35 Net (decrease) increase in cash and cash equivalents $(203,921) $159,449 $179,131 Operating ActivitiesNet cash used in operating activities for all periods resulted primarily from our net losses adjusted for non-cash charges and changes in components ofworking capital. Net cash used in operating activities increased $136.0 million for the year ended December 31, 2015 compared to 2014 driven by higherrociletinib and rucaparib research and development costs associated with the expansion of the clinical trials, as well as the preparation for the potentialcommercial launch of rociletinib, and higher salaries, benefits and personnel-related costs resulting from increased headcount to support the expandeddevelopment activities and commercial planning for our product candidates. During the third quarter of 2015, we made milestone payments totaling $12.0million to Celgene upon acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. During the year ended December 31, 2015, wealso paid $7.3 million in interest related to the convertible senior notes. The net loss for the year ended December 31, 2014 was partially offset by a $13.6million milestone revenue payment received from Servier.Net cash used in operating activities increased $45.3 million for the year ended December 31, 2014 compared to 2013 driven by higher rociletinib andrucaparib research and development costs associated with the expansion of the clinical trials, drug formulation and manufacturing costs and higher salaries,benefits and personnel-related costs resulting from higher headcount to support the expanded development activities of our product candidates, partiallyoffset by the milestone revenue payment received from Servier.Investing ActivitiesNet cash used in investing activities increased $252.3 million for the year ended December 31, 2015 compared to 2014 primarily due to net purchases ofavailable-for-sale securities.Net cash used in investing activities decreased $7.7 million for the year ended December 31, 2014 compared to 2013 primarily due to the cash portion ofthe EOS acquisition price paid in November 2013, partially offset by higher purchases of property and equipment in 2014.Financing ActivitiesNet cash provided by financing activities for the year ended December 31, 2015 includes $298.5 million in net proceeds received from our common stockoffering in July 2015 and $6.0 million received from employee stock option exercises and stock purchases under the employee stock purchase plan.Net cash provided by financing activities for the year ended December 31, 2014 includes $278.3 million in net proceeds received from our convertiblesenior notes offering in September 2014 and $1.2 million received from employee stock option exercises and stock purchases under the employee stockpurchase plan.Net cash provided by financing activities for the year ended December 31, 2013 includes $259.1 million in net proceeds received from our common stockoffering in June 2013 and $1.8 million received from employee stock option exercises and stock purchases under the employee stock purchase plan.58Operating Capital RequirementsAssuming we successfully complete clinical trials and obtain requisite regulatory approvals, we do not anticipate commercializing any of our productcandidates until at least the second half of 2016. As such, we anticipate that we will continue to generate significant losses for the foreseeable future as weincur expenses to complete our development activities for each of our programs, prepare for the potential commercial launch of our products and expand ourgeneral and administrative functions to support the growth in our research and development and commercial organizations.As of December 31, 2015, we had cash, cash equivalents and available-for-sale securities totaling $528.6 million and total current liabilities of $75.6million. Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allow us to fund our operatingplan through the next 12 months. We expect that we will need to raise additional capital during 2016 in order to fully implement our business plan to furtherthe development and commercialization of our product candidates, as well as to fund our other operating expenses, milestone payments to licensors andcapital expenditures. We expect to finance future cash flow needs through the public or private sale of equity or debt securities, collaborations, strategicalliances or other similar licensing arrangements. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we areunable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue thedevelopment or commercialization of one or more of our product candidates.The sale of additional equity and debt securities may result in additional dilution to our shareholders. In addition, if we raise additional funds through theissuance of debt securities or preferred stock, these securities may have rights senior to those of our common stock and could contain covenants that wouldrestrict our operations. Furthermore, any such required additional capital may not be available on reasonable terms, if at all. If we were unable to obtainadditional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned development and commercialization activities,which could harm our business.Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unableto estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors, including but not limitedto: ·the number and characteristics of the product candidates, companion diagnostics and indications we pursue; ·the achievement of various development, regulatory and commercial milestones resulting in required payments to partners pursuant to theterms of our license agreements; ·the scope, progress, results and costs of researching and developing our product candidates and related companion diagnostics and conductingclinical and non-clinical trials; ·the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates and companion diagnostics; ·the cost of commercialization activities, if any, assuming our product candidates are approved for sale, including marketing and distributioncosts; ·the cost of manufacturing any of our product candidates we successfully commercialize; ·the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs andoutcome of such litigation; and ·the timing, receipt and amount of sales, if any, of our product candidates.Contractual Obligations and CommitmentsThe following table summarizes our contractual obligations at December 31, 2015 (in thousands): Less than 1Year 1 to 3 Years 3 to 5 Years More Than 5Years Total Convertible senior notes $— $— $— $287,500 $287,500 Interest on convertible senior notes 7,187 14,375 14,376 5,091 41,029 Operating lease commitments 1,795 3,529 3,728 2,547 11,599 Purchase obligations (a) 6,455 9,682 — — 16,137 Total $15,437 $27,586 $18,104 $295,138 $356,265 (a)In February 2013, the Company entered into a development and manufacturing agreement with a third-party supplier for the production of the activeingredient for rucaparib. Under this agreement, the Company will provide the third-party supplier a rolling 24-month forecast that will be updated bythe Company on a quarterly basis. The Company is obligated to order the quantity specified in the first 12 months of any forecast.59Royalty and License Fee CommitmentsWe have certain obligations under licensing agreements with third parties contingent upon achieving various development, regulatory and commercialmilestones. Pursuant to our license agreement for the development and commercialization of rociletinib, we may be required to pay up to an additionalaggregate of $98.0 million in regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptance and approvals areachieved. Further, we may be required to pay up to an aggregate of $120.0 million in sales milestone payments if certain annual sales targets are met forrociletinib.Pursuant to our license agreements for the development of rucaparib, we may be required to pay up to an aggregate $258.5 million in milestone paymentsupon the successful attainment of development, regulatory and sales milestones. We are also obligated to pay to Advenchen 25% of any consideration,excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. The Company is obligated to pay additional consideration to the former EOS shareholders if certain future regulatory and lucitanib-related salesmilestones are achieved. The estimated fair value of these payments was recorded as contingent purchase consideration on our Consolidated Balance Sheets.The potential contingent milestone payments range from a zero payment, which assumes lucitanib fails to achieve any of the regulatory milestones, to $190.5million ($65.0 million and €115.0 million) if all regulatory and sales milestones are met, utilizing the translation rate at December 31, 2015. The estimatedfair value of the liability was $24.7 million at December 31, 2015.Finally, pursuant to terms of each of our product license agreements, we will pay royalties to our licensors on sales, if any, of the respective products.Off-Balance Sheet ArrangementsWe did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under the rules promulgatedby the U.S. Securities and Exchange Commission.Tax Loss CarryforwardsAs of December 31, 2015, we have net operating loss (“NOL”) carryforwards of approximately $504.8 million to offset future federal income taxes. Wealso have research and development and orphan drug tax credit carryforwards of $177.7 million to offset future federal income taxes. The federal netoperating loss carryforwards and research and development and orphan drug tax credit carryforwards expire at various times through 2035.We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of the Company’s publicoffering of common stock completed in April 2012. Future utilization of the federal net operating losses and tax credit carryforwards accumulated frominception to the change in ownership date will be subject to annual limitations to offset future taxable income. We do not, however, believe this limitationprevents utilization prior to expiration. It is possible that a change in ownership will occur in the future, which will limit the NOL amounts generated sincethe last estimated change in ownership against future taxable income. At December 31, 2015, we recorded a 100% valuation allowance against our netdeferred tax assets in the U.S. of approximately $446.9 million and a $2.2 million valuation allowance against tax assets in foreign jurisdictions, as webelieve it is more likely than not that the tax benefits will not be fully realized. In the future, if we determine that a portion or all of the tax benefits associatedwith our tax carryforwards will be realized, net income would increase in the period of determination.Recently Adopted Accounting StandardsIn April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-03, “Interest – Imputation ofInterest (Subtopic 835-30) – Simplifying the Presentation of Debt Issuance Costs.” ASU No. 2015-03 requires debt issuance costs to be presented as adeduction from the corresponding debt liability rather than as an asset. This update is effective for fiscal years beginning after December 15, 2015, includinginterim periods within those years. Early adoption is permitted. Upon adoption, the guidance must be applied retrospectively to all periods presented in thefinancial statements. The Company elected to early adopt this standard effective December 31, 2015. Adoption of the standard resulted in the reclassificationof the Company’s debt issuance costs from other assets to convertible senior notes on its Consolidated Balance Sheets. As of December 2014, thereclassification resulted in a decrease of $8.8 million to other assets with a corresponding decrease to convertible senior notes.60In November 2015, the FASB issued ASU No. 2015-17, “Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes.” ASU No. 2015-17requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet. This update iseffective for fiscal years beginning after December 15, 2016, including interim periods within those years. Early adoption is permitted. Upon adoption, theguidance may be applied either prospectively, for all deferred tax assets and liabilities, or retrospectively to all periods presented in the financial statements.The Company elected to early adopt the standard effective December 31, 2015. Adoption of the standard was applied retrospectively and resulted in nochange to the Company’s Consolidated Balance Sheets.Recently Issued Accounting StandardsIn May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 specifies the accounting forrevenue from contracts with customers and establishes disclosure requirements relating to the nature, timing and uncertainty of revenue and cash flowsarising from an entity’s contracts with customers. In August 2015, the FASB issued ASU 2015-14, “Revenue from Contracts with Customers (Topic606): Deferral of the Effective Date,” which delayed the effective date of the standard to annual and interim periods beginning after December 15, 2017.Early application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods. ASU 2014-09allows for either full retrospective or modified retrospective adoption. The Company is currently evaluating its planned method of adoption and the impactthe standard may have on its consolidated financial statements and related disclosures.In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern,” whichrequires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concernand to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning in 2016 and interim reporting periods startingin the first quarter of 2017. Early application is permitted. The Company is currently evaluating the impact the standard may have on its disclosures.In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets and liabilities for the rights andobligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interimperiods within those fiscal years. Early application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or enteredinto after, the date of initial application, with an option to use certain transition relief. The Company is currently evaluating the impact the standard mayhave on its consolidated financial statements and related disclosures. ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKWe are exposed to market risk related to changes in interest rates. As of December 31, 2015, we had cash, cash equivalents and available-for-sale securitiesof $528.6 million, consisting of bank demand deposits, money market funds and U.S. treasury securities. The primary objectives of our investment policy areto preserve principal and maintain proper liquidity to meet operating needs. Our investment policy specifies credit quality standards for our investments andlimits the amount of credit exposure to any single issue, issuer or type of investment. Our primary exposure to market risk is interest rate sensitivity, which isaffected by changes in the general level of U.S. interest rates, particularly because our investments are in short-term securities. Our available-for-sale securitiesare subject to interest rate risk and will decline in value if market interest rates increase. Due to the short-term duration of our investment portfolio and thelow risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair value of our portfolio.We contract with contract research organizations, investigational sites and contract manufacturers globally where payments are made in currencies otherthan the U.S. dollar. In addition, a significant portion of the contingent purchase consideration liability will be settled with Euro-denominated payments ifcertain future milestones are achieved. We may be subject to fluctuations in foreign currency rates in connection with these agreements and future contingentpayments. While we periodically hold foreign currencies, primarily Euro and Pound Sterling, we do not use other financial instruments to hedge our foreignexchange risk. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactionsarise. As of December 31, 2015 and 2014, approximately 3% and 7%, respectively, of our total liabilities were denominated in currencies other than thefunctional currency. ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAThe financial statements required by this Item are included in Item 15 of this report and are presented beginning on page F-1. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone. 61ITEM 9A.CONTROLS AND PROCEDURESConclusion Regarding the Effectiveness of Disclosure Controls and ProceduresOur disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under theSecurities Exchange Act of 1934, as amended (“Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in theSecurities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including theChief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures. Any controls and procedures, no matter howwell designed and operated, can provide only reasonable assurance of achieving the desired control objective.As of December 31, 2015, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation ofthe effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act.Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2015, the design and operation of ourdisclosure controls and procedures were effective at the reasonable assurance level.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining effective internal control over financial reporting and for the assessment of theeffectiveness of internal control over financial reporting. Internal control over financial reporting is a process designed by, or under the supervision of, acompany’s principal executive officer and principal financial officer and effected by our board of directors, management and other personnel, to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that: ·pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; ·provide reasonable assurance that transactions are recorded as necessary to permit preparation of the consolidated financial statements inaccordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance withauthorizations of our management and directors; and ·provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that couldhave a material effect on the consolidated financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluationof effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or the degree of compliancewith the policies or procedures may deteriorate.As of December 31, 2015, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, assessed the effectiveness ofour internal control over financial reporting as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act. In making its assessment, management used thecriteria established in Internal Control—Integrated Framework (2013 framework) issued by the Committee of Sponsoring Organizations of the TreadwayCommission. Based on its assessment, our management determined that, as of December 31, 2015, we maintained effective internal control over financialreporting based on those criteria.In addition, the effectiveness of our internal control over financial reporting as of December 31, 2015 has been audited by Ernst & Young, LLP, anindependent registered public accounting firm.Changes in Internal Control Over Financial ReportingThere were no changes in our internal controls over financial reporting during the quarter ended December 31, 2015 that have materially affected, or arereasonably likely to materially affect, our internal controls over financial reporting.62Report of Independent Registered Public Accounting FirmThe Stockholders and Board of Directors of Clovis Oncology, Inc.:We have audited Clovis Oncology, Inc.’s internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). ClovisOncology, Inc.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness ofinternal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Ourresponsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all materialrespects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testingand evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considerednecessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal controlover financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairlyreflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are beingmade only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention ortimely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate.In our opinion, Clovis Oncology, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, basedon the COSO criteria.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheetsof Clovis Oncology, Inc. as of December 31, 2015 and 2014 and the related consolidated statements of operations, comprehensive loss, stockholders’ equityand cash flows for each of the three years in the period ended December 31, 2015 and our report dated February 29, 2016 expressed an unqualified opinionthereon./s/ Ernst & Young LLPDenver, ColoradoFebruary 29, 2016 63ITEM 9B.OTHER INFORMATIONNone. 64PART IIICertain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated herein by reference from our definitiveproxy statement relating to our 2016 annual meeting of stockholders, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, alsoreferred to in this Form 10-K as our 2016 Proxy Statement, which we expect to file with the SEC no later than April 30, 2016. ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEInformation regarding our directors, including the audit committee and audit committee financial experts, and executive officers and compliance withSection 16(a) of the Exchange Act will be included in our 2016 Proxy Statement and is incorporated herein by reference.We have adopted a Code of Business Ethics for all of our directors, officers and employees as required by NASDAQ governance rules and as defined byapplicable SEC rules. Stockholders may locate a copy of our Code of Business Ethics on our website at www.clovisoncology.com or request a copy withoutcharge from:Clovis Oncology, Inc.Attention: Investor Relations5500 Flatiron Parkway, Suite 100Boulder, CO 80301We will post to our website any amendments to the Code of Business Ethics and any waivers that are required to be disclosed by the rules of either theSEC or NASDAQ. ITEM 11.EXECUTIVE COMPENSATIONThe information required by this item regarding executive compensation will be included in our 2016 Proxy Statement and is incorporated herein byreference. ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERMATTERSThe information required by this item regarding security ownership of certain beneficial owners and management will be included in the 2016 ProxyStatement and is incorporated herein by reference. ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item regarding certain relationships and related transactions and director independence will be included in the 2016Proxy Statement and is incorporated herein by reference. ITEM 14.PRINCIPAL ACCOUNTING FEES AND SERVICESThe information required by this item regarding principal accounting fees and services will be included in the 2016 Proxy Statement and is incorporatedherein by reference. 65PART IV ITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES(a)The following documents are being filed as part of this report:(1) Financial Statements.Reference is made to the Index to Financial Statements of Clovis Oncology, Inc. appearing on page F-1 of this report.(2) Financial Statement Schedules.All financial statement schedules have been omitted because they are not applicable or not required or because the information is included elsewherein the Financial Statements or the Notes thereto.(3) Exhibits.Reference is made to the Index to Exhibits filed as a part of this Annual Report on Form 10-K. 66SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized. CLOVIS ONCOLOGY, INC. By: /S/ PATRICK J. MAHAFFY Patrick J. MahaffyDate: February 29, 2016 President and Chief Executive OfficerPursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed by the following persons on behalf of theregistrant and in the capacities and on the dates indicated: Name Title Date/S/ PATRICK J. MAHAFFY Patrick J. Mahaffy President and Chief Executive Officer; Director(Principal Executive Officer) February 29, 2016 /S/ ERLE T. MAST Erle T. Mast Executive Vice President and Chief Financial Officer(Principal Financial Officer and Principal Accounting Officer) February 29, 2016 /S/ BRIAN G. ATWOOD Brian G. Atwood Director February 29, 2016 /S/ M. JAMES BARRETT M. James Barrett Director February 29, 2016 /S/ JAMES C. BLAIR James C. Blair Director February 29, 2016 /S/ KEITH FLAHERTY Keith Flaherty Director February 29, 2016 /S/ GINGER L. GRAHAM Ginger L. Graham Director February 29, 2016 /S/ PAUL KLINGENSTEIN Paul Klingenstein Director February 29, 2016 /S/ EDWARD J. MCKINLEY Edward J. McKinley Director February 29, 2016 /S/ THORLEF SPICKSCHEN Thorlef Spickschen Director February 29, 2016 67INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Index to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm F-2 Consolidated Statements of Operations F-3 Consolidated Statements of Comprehensive Loss F-4 Consolidated Balance Sheets F-5 Consolidated Statements of Stockholders’ Equity F-6 Consolidated Statements of Cash Flows F-7 Notes to Consolidated Financial Statements F-8 F-1Report of Independent Registered Public Accounting FirmThe Stockholders and Board of DirectorsClovis Oncology, Inc.We have audited the accompanying consolidated balance sheets of Clovis Oncology, Inc. as of December 31, 2015 and 2014, and the related consolidatedstatements of operations, comprehensive loss, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2015. Thesefinancial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based onour audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includesexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accountingprinciples used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our auditsprovide a reasonable basis for our opinion.In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Clovis Oncology, Inc.at December 31, 2015 and 2014, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31,2015 in conformity with U.S. generally accepted accounting principles.As discussed in Note 2 to the consolidated financial statements, the Company changed its classification of debt issuance costs.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Clovis Oncology, Inc.’s internalcontrol over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committee ofSponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 29, 2016 expressed an unqualified opinion thereon./s/ Ernst & Young LLPDenver, ColoradoFebruary 29, 2016 F-2CLOVIS ONCOLOGY, INC.Consolidated Statements of Operations For the Year Ended December 31, 2015 2014 2013 (in thousands, except per share amounts) Revenues: License and milestone revenue $— $13,625 $— Operating expenses: Research and development 269,251 137,705 66,545 General and administrative 30,524 21,457 16,567 Acquired in-process research and development 12,000 8,806 250 Impairment of intangible asset 89,557 3,409 — Change in fair value of contingent purchase consideration (24,611) 707 405 Total expenses 376,721 172,084 83,767 Operating loss (376,721) (158,459) (83,767)Other income (expense): Interest expense (8,372) (2,604) — Foreign currency gains (losses) 2,740 3,580 (535)Other income (expense) 416 (240) (178)Other income (expense), net (5,216) 736 (713)Loss before income taxes (381,937) (157,723) (84,480)Income tax benefit (expense) 29,076 (2,308) (52)Net loss $(352,861) $(160,031) $(84,532)Basic and diluted net loss per common share $(9.79) $(4.72) $(2.95)Basic and diluted weighted average common shares outstanding 36,026 33,889 28,672 See accompanying Notes to Consolidated Financial Statements. F-3CLOVIS ONCOLOGY, INC.Consolidated Statements of Comprehensive Loss For the Year Ended December 31, 2015 2014 2013 (in thousands) Net loss $(352,861) $(160,031) $(84,532)Other comprehensive (loss) income Foreign currency translation adjustments (22,629) (29,144) 4,643 Net unrealized loss on available-for-sale securities (383) — — Other comprehensive (loss) income (23,012) (29,144) 4,643 Comprehensive loss $(375,873) $(189,175) $(79,889) See accompanying Notes to Consolidated Financial Statements. F-4CLOVIS ONCOLOGY, INC.Consolidated Balance Sheets December 31, 2015 2014 (in thousands, except for share amounts) ASSETS Current assets: Cash and cash equivalents $278,756 $482,677 Available-for-sale securities 249,832 — Prepaid research and development expenses 3,377 3,765 Other current assets 7,736 4,730 Total current assets 539,701 491,172 Property and equipment, net 4,946 2,718 Intangible assets 101,500 212,900 Goodwill 59,327 66,055 Other assets 7,912 4,541 Total assets $713,386 $777,386 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $11,260 $2,917 Accrued research and development expenses 53,011 37,257 Other accrued expenses 11,305 7,598 Total current liabilities 75,576 47,772 Contingent purchase consideration 24,661 52,453 Deferred income taxes, net 31,133 66,851 Convertible senior notes 279,885 278,680 Deferred rent, long-term 1,481 — Total liabilities 412,736 445,756 Commitments and contingencies (Note 11) Stockholders' equity: Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2015 and 2014 — — Common stock, $0.001 par value per share, 100,000,000 shares authorized at December 31, 2015 and 2014; 38,359,454 and 33,977,187 shares issued and outstanding at December 31, 2015 and 2014, respectively 38 34 Additional paid-in capital 1,129,978 785,089 Accumulated other comprehensive loss (47,460) (24,448)Accumulated deficit (781,906) (429,045)Total stockholders' equity 300,650 331,630 Total liabilities and stockholders' equity $713,386 $777,386 See accompanying Notes to Consolidated Financial Statements. F-5CLOVIS ONCOLOGY, INC.Consolidated Statements of Stockholders’ Equity Accumulated Additional Other Common Stock Paid-In Comprehensive Accumulated Shares Amount Capital Income (Loss) Deficit Total (in thousands, except for share amounts) Balance at January 1, 2013 26,207,190 $26 $317,899 $53 $(184,482) $133,496 Issuance of common stock, net of issuance costs of $15,929 3,819,444 4 259,067 — — 259,071 Issuance of common stock related to EOS acquisition 3,713,731 4 173,650 — — 173,654 Issuance of common stock under employee stock purchaseplan 16,324 — 378 — — 378 Exercise of stock options 140,632 — 1,671 — — 1,671 Share-based compensation expense — — 9,505 — — 9,505 Foreign currency translation adjustments — — — 4,643 — 4,643 Net loss — — — — (84,532) (84,532)Balance at December 31, 2013 33,897,321 34 762,170 4,696 (269,014) 497,886 Issuance of common stock under employee stock purchaseplan 13,633 — 481 — — 481 Exercise of stock options 66,233 — 921 — — 921 Share-based compensation expense — — 21,517 — — 21,517 Foreign currency translation adjustments — — — (29,144) — (29,144)Net loss — — — — (160,031) (160,031)Balance at December 31, 2014 33,977,187 34 785,089 (24,448) (429,045) 331,630 Issuance of common stock, net of issuance costs of $17,741 4,054,487 4 298,505 — — 298,509 Issuance of common stock under employee stock purchaseplan 32,021 — 493 — — 493 Exercise of stock options 295,759 — 5,534 — — 5,534 Share-based compensation expense — — 40,357 — — 40,357 Net unrealized loss on available-for-sale securities — — — (383) — (383)Foreign currency translation adjustments — — — (22,629) — (22,629)Net loss — — — — (352,861) (352,861)Balance at December 31, 2015 38,359,454 $38 $1,129,978 $(47,460) $(781,906) $300,650 See accompanying Notes to Consolidated Financial Statements. F-6CLOVIS ONCOLOGY, INC.Consolidated Statements of Cash Flows Year ended December 31, 2015 2014 2013 (in thousands) Operating activities Net loss $(352,861) $(160,031) $(84,532)Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation expense 40,357 21,517 9,505 Depreciation and amortization 761 444 250 Amortization of premiums and discounts on available-for-sale securities 1,400 — — Amortization of debt issuance costs 1,205 368 — Impairment of intangible asset 89,557 3,409 — Change in fair value of contingent purchase consideration (27,792) (3,301) 1,028 Loss on disposal of equipment 39 67 — Deferred income taxes (28,874) 761 — Changes in operating assets and liabilities, net of acquisition of a business: Prepaid and accrued research and development expenses 14,122 18,112 3,276 Other operating assets (4,380) (910) (995)Accounts payable 8,105 (1,369) 958 Other accrued expenses 5,295 3,882 (1,202)Net cash used in operating activities (253,066) (117,051) (71,712)Investing activities Purchases of property and equipment (3,035) (2,286) (121)Purchases of available-for-sale securities (392,540) — — Sales of available-for-sale securities 140,997 — — Acquisition of business, net of cash acquired — — (9,913)Net cash used in investing activities (254,578) (2,286) (10,034)Financing activities Proceeds from the sale of common stock, net of issuance costs 298,509 — 259,071 Proceeds from the issuance of convertible senior notes, net of issuance costs — 278,313 — Proceeds from the exercise of stock options and employee stock purchases 5,971 1,163 1,771 Net cash provided by financing activities 304,480 279,476 260,842 Effect of exchange rate changes on cash and cash equivalents (757) (690) 35 (Decrease) increase in cash and cash equivalents (203,921) 159,449 179,131 Cash and cash equivalents at beginning of period 482,677 323,228 144,097 Cash and cash equivalents at end of period $278,756 $482,677 $323,228 Supplemental disclosure of cash flow information: Cash paid for interest $7,307 $— $— Non-cash investing and financing activities: Issuance of shares for acquisition of business $— $— $173,654 Contingent consideration for acquisition of business $— $— $55,754 See accompanying Notes to Consolidated Financial Statements. F-7CLOVIS ONCOLOGY, INC.NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Nature of BusinessClovis Oncology, Inc. (the “Company”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-canceragents in the United States, Europe and other international markets. The Company has and intends to continue to license or acquire rights to oncologycompounds in all stages of clinical development. In exchange for the right to develop and commercialize these compounds, the Company generally expectsto provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, the Company generallyexpects to assume the responsibility for future drug development and commercialization costs. The Company currently operates in one segment. Sinceinception, the Company’s operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates andgeneral corporate activities.In July 2015, the Company submitted a New Drug Application (“NDA”) regulatory filing and a Marketing Authorization Application (“MAA”) forrociletinib to the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”), respectively. Both the FDA and EMAsubsequently accepted the respective filings, and they are currently under active review. In December 2015, the FDA extended the Prescription Drug User FeeAct goal date for the rociletinib NDA by three months to June 28, 2016 to allow additional time for review of additional clinical data submitted by theCompany in a Major Amendment in November 2015. The FDA has scheduled the NDA for rociletinib for discussion by the Oncologic Drugs AdvisoryCommittee (“ODAC”) on April 12, 2016. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigationalhuman drug products used in the treatment of cancer and makes recommendations to the FDA.LiquidityThe Company has incurred significant net losses since inception and has relied on its ability to fund its operations through debt and equity financings.Management expects operating losses and negative cash flows to continue for the foreseeable future. As the Company continues to incur losses, transition toprofitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenuesadequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue toneed to raise additional cash.Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital througharrangements with strategic partners or from other sources. Based on current estimates, management believes that existing working capital at December 31,2015 is sufficient to meet the cash requirements to fund planned operations through the next 12 months, although there can be no assurance that this can, infact, be accomplished. 2. Summary of Significant Accounting PoliciesBasis of PresentationThe accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Theconsolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances andtransactions have been eliminated in consolidation.ReclassificationsCertain reclassifications have been made to prior year amounts to conform to the current year presentation. These reclassifications had no effect on theCompany’s previously reported results of operations, financial position or cash flows.Use of EstimatesThe preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reportedamounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, management evaluates its estimates, including estimatesrelated to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment, clinical trial accruals and share-basedcompensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes tobe reasonable under the circumstances. Actual results may differ from those estimates or assumptions.F-8Fair Value of Financial InstrumentsCash, cash equivalents, available-for-sale securities and contingent purchase consideration are carried at fair value (see Note 5). Financial instruments,including other current assets and accounts payable, are carried at cost, which approximates fair value given their short-term nature. Cash, Cash Equivalents and Available-for-Sale SecuritiesThe Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cashand cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper andU.S. government and U.S. government agency obligations.Marketable securities are considered to be available-for-sale securities and consist of U.S. treasury securities. Available-for-sale securities are reported atfair value on the Consolidated Balance Sheets and unrealized gains and losses are included in accumulated other comprehensive income (loss) on theConsolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in otherincome (expense) on the Consolidated Statements of Operations. The cost of investments for purposes of computing realized and unrealized gains and lossesis based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fundcurrent operations with these securities or to make them available for current operations.A decline in the market value of a security below its cost that is deemed to be other than temporary is charged to earnings and results in the establishmentof a new cost basis for the security. Factors evaluated to determine if an investment is other-than-temporarily impaired include significant deterioration inearnings performance, credit rating, asset quality or business prospects of the issuer; adverse changes in the general market conditions in which the issueroperates; and the Company’s intent and ability to hold the security until an anticipated recovery in value occurs.Property and EquipmentProperty and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over theestimated useful lives of the assets. Equipment purchased for use in manufacturing and clinical trials is evaluated to determine whether the equipment issolely beneficial for a drug candidate in the development stage or whether it has an alternative use. Equipment with an alternative use is capitalized.Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed asincurred. The estimated useful lives of our capitalized assets are as follows: Estimated Useful LifeComputer hardware and software 3 to 5 yearsLeasehold improvements 6 yearsLaboratory, manufacturing and office equipment 5 to 7 yearsFurniture and fixtures 10 years Long-Lived AssetsThe Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not berecoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected togenerate. If the carrying value of the assets exceed their future net undiscounted cash flows, an impairment charge is recognized for the amount by which thecarrying value of the assets exceeds the fair value of the assets.Intangible AssetsIntangible acquired in-process research and development (“IPR&D”) assets were established as part of the acquisition of Ethical Oncology Science, S.p.A.(“EOS”) (see Note 3) and are not amortized. Amortization of these assets will commence upon completion of the related research and development activities.IPR&D intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment indicators exist and anyreduction in fair value would be recorded as impairment of intangible asset on the Consolidated Statements of Operations. During the fourth quarter of 2015,the Company recorded an $89.6 million impairment charge to the IPR&D intangible assets (see Note 7).F-9GoodwillGoodwill represents the excess of the purchase price over the fair value of net assets acquired in a business combination accounted for under theacquisition method of accounting and is not amortized, but is subject to impairment testing at least annually in the fourth quarter or when a triggering eventis identified that could indicate a potential impairment. We are organized as a single reporting unit and perform impairment testing by comparing thecarrying value of the reporting unit to the fair value of the Company.Other Current AssetsOther current assets are comprised of the following (in thousands): December 31, 2015 2014 Receivable from partners $3,241 $1,991 Prepaid insurance 1,231 1,190 Receivable from landlord 1,153 — Prepaid expenses - other 1,023 1,168 Receivable - other 889 281 Other 199 100 Total $7,736 $4,730 Other Accrued ExpensesOther accrued expenses are comprised of the following (in thousands): December 31, 2015 2014 Accrued personnel costs $8,250 $4,726 Accrued interest payable 2,096 2,236 Accrued expenses - other 959 636 Total $11,305 $7,598 Valuation of Contingent Consideration Resulting from a Business CombinationSubsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value each reporting period and record changes in fairvalue to change in fair value of contingent purchase consideration and foreign currency gains (losses) for changes in the foreign currency translation rate onthe Consolidated Statements of Operations. Changes in fair value are primarily attributed to new information about the IPR&D assets, including changes intimeline and likelihood of success, and the passage of time. In the absence of new information, changes in fair value reflect only the passage of time. Duringthe fourth quarter of 2015, the Company recorded a $26.9 million reduction in the fair value of the contingent purchase consideration liability (see Note 5).Research and Development ExpenseResearch and development costs are charged to expense as incurred and include, but are not limited to, salary and benefits, share-based compensation,clinical trial activities, drug development and manufacturing, companion diagnostic development and third-party service fees, including clinical researchorganizations and investigative sites. During 2015, we completed the hiring of our U.S. sales and marketing and medical affairs organizations in preparationfor the potential commercial launch of rociletinib. These costs are also included in research and development expense.Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks usingdata such as patient enrollment, clinical site activations or information provided to us by our vendors on their actual costs incurred. Payments for theseactivities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred and are reflected on the ConsolidatedBalance Sheets as prepaid or accrued research and development expenses.F-10Acquired In-Process Research and Development ExpenseThe Company has acquired and expects to continue to acquire the rights to develop and commercialize new drug candidates. The upfront payments toacquire a new drug compound, as well as subsequent milestone payments, are immediately expensed as acquired in-process research and developmentprovided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.Share-Based Compensation ExpenseShare-based compensation is recognized as expense for all share-based awards made to employees and directors and is based on estimated fair values. TheCompany determines equity-based compensation at the grant date using the Black-Scholes option pricing model. The value of the award that is ultimatelyexpected to vest is recognized as expense on a straight-line basis over the requisite service period. Any changes to the estimated forfeiture rates are accountedfor prospectively.Concentration of Credit RiskFinancial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and available-for-salesecurities. The Company maintains its cash and cash equivalent balances in the form of money market accounts with financial institutions that managementbelieves are creditworthy. Available-for-sale securities are invested in accordance with the Company’s investment policy. The investment policy includesguidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposureto concentration of credit risk. The Company has no financial instruments with off-balance sheet risk of accounting loss.Foreign CurrencyThe assets and liabilities of the Company’s foreign operations are translated into U.S. dollars at current exchange rates and the results of operations aretranslated at the average exchange rates for the reported periods. The resulting translation adjustments are included in accumulated other comprehensive losson the Consolidated Balance Sheets. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at thetime such transactions arise. Transaction gains and losses are recorded to foreign currency gains (losses) on the Consolidated Statements of Operations. As ofDecember 31, 2015 and 2014, approximately 3% and 7%, respectively, of the Company’s total liabilities were denominated in currencies other than thefunctional currency.Income TaxesThe Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future taxconsequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basesusing enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likelythan not that a tax position will be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that it isconsidered more likely than not that these benefits will not be realized.Revenue RecognitionRevenue is recognized from license milestone payments when the following criteria have been met: (1) persuasive evidence of an arrangementexists; (2) delivery has occurred or services have been rendered; (3) the price is fixed or determinable; and (4) collectability is reasonably assured.We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in accordance with thearrangement. We assess whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether thesales price is subject to refund or adjustment. We assess collectability based primarily on the customer's payment history and creditworthiness ofthe customer. Payments that are contingent upon the achievement of a substantive milestone will be recognized in the period in which themilestone is achieved.F-11Recently Adopted Accounting StandardsIn April 2015, the FASB issued ASU No. 2015-03, “Interest – Imputation of Interest (Subtopic 835-30) – Simplifying the Presentation of Debt IssuanceCosts.” ASU No. 2015-03 requires debt issuance costs to be presented as a deduction from the corresponding debt liability rather than as an asset. This updateis effective for fiscal years beginning after December 15, 2015, including interim periods within those years. Early adoption is permitted. Upon adoption, theguidance must be applied retrospectively to all periods presented in the financial statements. The Company elected to early adopt this standard effectiveDecember 31, 2015. Adoption of the standard resulted in the reclassification of the Company’s debt issuance costs from other assets to convertible seniornotes on its Consolidated Balance Sheets. As of December 31, 2014, the reclassification resulted in a decrease of $8.8 million to other assets with acorresponding decrease to convertible senior notes.In November 2015, the FASB issued ASU No. 2015-17, “Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes.” ASU No. 2015-17requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet. This update iseffective for fiscal years beginning after December 15, 2016, including interim periods within those years. Early adoption is permitted. Upon adoption, theguidance may be applied either prospectively, for all deferred tax assets and liabilities, or retrospectively to all periods presented in the financial statements.The Company elected to early adopt this standard effective December 31, 2015. Adoption of this standard was applied retrospectively and resulted in nochange to the Company’s Consolidated Balance Sheets.Recently Issued Accounting StandardsIn May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 specifies the accounting forrevenue from contracts with customers and establishes disclosure requirements relating to the nature, timing and uncertainty of revenue and cash flowsarising from an entity’s contracts with customers. In August 2015, the FASB issued ASU 2015-14, “Revenue from Contracts with Customers (Topic606): Deferral of the Effective Date,” which delayed the effective date of the standard to annual and interim periods beginning after December 15, 2017.Early application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods. ASU 2014-09allows for either full retrospective or modified retrospective adoption. The Company is currently evaluating its planned method of adoption and the impactthe standard may have on its consolidated financial statements and related disclosures.In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern,” whichrequires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concernand to provide disclosures when certain criteria are met. The guidance is effective for annual periods beginning in 2016 and interim reporting periods startingin the first quarter of 2017. Early application is permitted. The Company is currently evaluating the impact the standard may have on its disclosures.In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets and liabilities for the rights andobligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interimperiods within those fiscal years. Early application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or enteredinto after, the date of initial application, with an option to use certain transition relief. The Company is currently evaluating the impact the standard mayhave on its consolidated financial statements and related disclosures. 3. EOS AcquisitionOn November 19, 2013, the Company acquired all of the outstanding common and preferred stock of EOS (now known as Clovis Oncology Italy S.r.l.).EOS was a biopharmaceutical company located in Italy that focused on the development of novel medicines for the treatment of cancer. The primary reasonfor the business acquisition was to obtain development and commercialization rights to lucitanib, an oral, selective tyrosine kinase inhibitor.The Company paid $11.8 million in cash and issued $173.7 million of common stock at the acquisition date and may make additional future cashpayments if certain regulatory and sales milestones are achieved. The results of operations for EOS were included in our consolidated financial statementsfrom the acquisition date, and the assets acquired and liabilities assumed of EOS were recorded as of the acquisition date at their respective fair values andconsolidated with those of the Company.As part of the acquisition of EOS, the Company recorded intangible assets on the Consolidated Balance Sheets to reflect the fair value of IPR&D, whichwas based on two components. The first was the estimated fair value of lucitanib development and commercialization rights sublicensed by EOS to Servier(see Note 12 – Lucitanib). The estimated fair value of these rights was $56.1 million at the date of the acquisition based on probability-weighted cash flowpayments due from Servier upon the achievement of certain development, regulatory and commercial milestones, as well as future royalty payments resultingfrom the sale of lucitanib in the sublicensed territories.F-12The second component was based on the fair value of the expected net cash flows for the development and commercialization rights of lucitanib in theUnited States and Japan held by EOS at acquisition. The estimated fair value of $183.8 million for these rights was based on probability-weighted net cashflows of the anticipated lucitanib development and sales activities.Key assumptions used in the discounted cash flow models include estimates related to the timing of development, probability of development andregulatory success, sales and commercialization factors and estimated product life. Net cash flows were discounted at a risk-adjusted rate of 18.9%.The excess purchase price over the fair value of amounts assigned to the assets acquired and liabilities assumed was recorded as goodwill on theConsolidated Balance Sheets.The Company is obligated to pay additional consideration to the former EOS shareholders if certain future regulatory and lucitanib-related salesmilestones are achieved. The estimated fair value of these payments was recorded as contingent purchase consideration on the Consolidated BalanceSheets. The initial estimated fair value of the contingent purchase consideration was $54.7 million at the acquisition date, which was determined based onthe assumptions described below. Pursuant to the sublicense agreement with Servier, the Company is eligible to receive future milestone payments based on the achievement ofdevelopment, regulatory and sales milestones. Certain of the contingent consideration payments owed from the Company to the former EOS shareholders aretied to the receipt of milestone payments from Servier.A summary of the contingent payment obligations is as follows (in thousands and payment currency): Amount Initial approval of an NDA for lucitanib in the U.S. $65,000 Obligations associated with the receipt of milestone payments from Servier: Initial filing of a MAA for lucitanib in the E.U. €15,000 Initial approval of a MAA for lucitanib in the E.U. €45,000 Initial achievement of lucitanib net sales in Servier licensed territory of €500 million in any four consecutive quarters €55,000 Total €115,000 The fair value of the MAA filing and approval obligations of $52.5 million was based on the discounting of the probability-weighted future milestonepayments using an estimated borrowing rate ranging from 5.2% to 5.8%, which represented our estimated borrowing rate for the various terms the paymentobligations were expected to be outstanding. The sales milestone fair value of $2.2 million was based on the probability-weighted future milestone paymentsusing the risk-adjusted discount rate of 18.7%. The potential contingent milestone payments range from a zero payment, which assumes lucitanib fails toachieve any of the regulatory milestones, to $190.5 million ($65.0 million and €115.0 million) if all regulatory and sales milestones are met, utilizing thetranslation rate at December 31, 2015.During the fourth quarter of 2015, the Company recorded an $89.6 million impairment charge to the IPR&D intangible assets and a $26.9 millionreduction in the fair value of the contingent purchase consideration liability (see Note 5 and Note 7). 4. Property and EquipmentProperty and equipment consisted of the following (in thousands): December 31, 2015 2014 Laboratory, manufacturing and office equipment $2,556 $2,452 Leasehold improvements 1,861 260 Furniture and fixtures 1,487 667 Computer hardware and software 833 414 Total property and equipment 6,737 3,793 Less: accumulated depreciation (1,791) (1,075)Total property and equipment, net $4,946 $2,718 Depreciation expense related to property and equipment was approximately $761 thousand, $444 thousand and $250 thousand for the years endedDecember 31, 2015, 2014 and 2013, respectively. F-13 5. Fair Value MeasurementsFair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or mostadvantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs thatmay be used to measure fair value include: Level 1: Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. TheCompany does not have Level 1 liabilities. Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that areobservable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2assets consist of U.S. treasury securities. The Company does not have Level 2 liabilities. Level 3: Unobservable inputs that are supported by little or no market activity. The Company does not have Level 3 assets. The contingent purchaseconsideration related to the undeveloped lucitanib product rights acquired with the purchase of EOS is a Level 3 liability. The fair value of thisliability is based on unobservable inputs and includes valuations for which there is little, if any, market activity. See Note 3 for further discussionof the valuation methodology.The following table identifies the Company’s assets and liabilities that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2015 Assets: Money market $251,037 $251,037 $— $— U.S. treasury securities 249,832 — 249,832 — Total assets at fair value $500,869 $251,037 $249,832 $— Liabilities: Contingent purchase consideration $24,661 $— $— $24,661 Total liabilities at fair value $24,661 $— $— $24,661 December 31, 2014 Assets: Money market $447,994 $447,994 $— $— Total assets at fair value $447,994 $447,994 $— $— Liabilities: Contingent purchase consideration $52,453 $— $— $52,453 Total liabilities at fair value $52,453 $— $— $52,453There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the year ended December 31, 2015.The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) (in thousands): Year Ended December 31, 2015 Liabilities: Balance at beginning of period $52,453 Change in fair value (a) (24,611)Change in foreign currency gains and losses (3,181)Balance at end of period $24,661 (a)The decrease in the fair value of the contingent purchase consideration was due to a change in the estimated probability-weighted future milestonepayments discounted using an estimated borrowing rate ranging from 8.5% to 8.6%, as well as the timing of such payments, for the lucitanibprogram.F-14The change in the fair value of Level 3 instruments is included in change in fair value of contingent purchase consideration and foreign currency gains(losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations.Financial instruments not recorded at fair value include the Company’s convertible senior notes. At December 31, 2015, the carrying amount of theconvertible senior notes was $287.5 million, which represents the aggregate principal amount, and the fair value was $248.7 million. The fair value wasdetermined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the convertible senior notes,which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 8 for discussion of the convertible seniornotes.6. Available-for-Sale SecuritiesAs of December 31, 2015, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $250,215 $— $(383) $249,832As of December 31, 2015, the fair value and gross unrealized losses of available-for-sale securities that have been in a continuous unrealized loss positionfor less than 12 months were as follows (in thousands): Aggregate Gross Fair Unrealized Value Losses U.S. treasury securities $249,832 $(383)The Company’s investments have been in an unrealized loss position for between two to three months. Based upon our evaluation of all relevant factors,we believe that the decline in fair value of securities held at December 31, 2015 below cost is temporary, and we intend to retain our investment in thesesecurities for a sufficient period of time to allow for recovery of the fair value.As of December 31, 2015, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands): Amortized Fair Cost Value Due in one year or less $200,147 $199,912 Due in one year to two years 50,068 49,920 Total $250,215 $249,832 7. Intangible Assets and GoodwillIPR&D assets and goodwill were established as part of the purchase accounting of EOS (see Note 3) and consisted of the following (in thousands): December 31, 2015 2014 IPR&D assets: Balance at beginning of period $212,900 $244,518 Impairment of intangible asset (a) (89,557) (3,409)Change in foreign currency gains and losses (21,843) (28,209)Balance at end of period $101,500 $212,900 Goodwill: Balance at beginning of period $66,055 $74,811 Change in foreign currency gains and losses (6,728) (8,756)Balance at end of period $59,327 $66,055 (a)During the fourth quarter of 2015, the Company recorded an $89.6 million impairment charge due to the Company’s and its development partner’sdecision to terminate the development of lucitanib for lung cancer, as well as updates to the probability-weighted discounted cash flowassumptions for the breast cancer indication.F-15 During the first quarter of 2014, the Company recorded a $3.4 million reduction in the intangible assets driven by lower expected future milestonerevenue from the lucitanib development activities due to the receipt of a lucitanib milestone payment from Servier (see Note 12 - Lucitanib).These reductions were included in impairment of intangible asset on the Consolidated Statements of Operations.As of December 31, 2015, no impairment to the carrying value of the goodwill was identified. 8. Convertible Senior NotesOn September 9, 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the“Notes”) resulting in net proceeds to the Company of $278.3 million after deducting offering expenses. In accordance with the accounting guidance, theconversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated BalanceSheets.The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., astrustee. The Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on March 15 andSeptember 15 of each year. The Notes will mature on September 15, 2021, unless earlier converted, redeemed or repurchased.Holders may convert all or any portion of the Notes at any time prior to the close of business on the business day immediately preceding the maturitydate. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 16.1616 shares per $1,000 in principal amount ofNotes, equivalent to a conversion price of approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain eventsdescribed in the indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to thematurity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the Notes in connectionwith such a corporate event or during the related redemption period in certain circumstances.On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been atleast 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day periodending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of theprincipal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for theNotes.If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may require us to repurchase for cash allor any portion of the Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued andunpaid interest to, but excluding, the fundamental change repurchase date.The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the Notes; equal in right ofpayment to all of our liabilities that are not so subordinated; effectively junior in right of payment to any secured indebtedness to the extent of the value ofthe assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries.In connection with the issuance of the Notes, the Company incurred $9.2 million of debt issuance costs, which was included in other assets on theConsolidated Balance Sheets. Pursuant to its adoption of ASU No. 2015-03 on December 31, 2015, the Company reclassified the debt issuance costs fromother assets to convertible senior notes (see Note 2 – Recently Adopted Accounting Standards).The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Companydetermined the expected life of the debt was equal to the seven-year term of the Notes. As of December 31, 2015 and 2014, the balance of unamortized debtissuance costs was $7.6 million and $8.8 million, respectively.The following table sets forth total interest expense recognized related to the Notes during the years ended December 31, 2015 and 2014 (in thousands): Year Ended December 31, 2015 2014 Contractual interest expense $7,167 $2,236 Amortization of debt issuance costs 1,205 368 Total interest expense $8,372 $2,604F-16 9. Stockholders’ EquityCommon StockIn June 2013, the Company sold 3,819,444 shares of its common stock in a public offering at $72.00 per share. The net offering proceeds realized afterdeducting offering expenses and underwriters’ discounts and commissions were $259.1 million.In November 2013, the Company issued 3,713,731 shares of its common stock at a value of $173.7 million to acquire all of the outstanding common andpreferred stock of EOS.In July 2015, the Company sold 4,054,487 shares of its common stock in a public offering at $78.00 per share. The net proceeds to the Company from theoffering were $298.5 million, after deducting underwriting discounts and commissions and offering expenses.The holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders of the Company. Subject to thepreferences that may be applicable to any outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably such dividends, ifany, as may be declared by the Company’s Board of Directors.Accumulated Other Comprehensive LossAccumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’sfunctional currency, and unrealized gains and losses on available-for-sale securities.The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): Total Foreign Accumulated Currency Other Translation Unrealized Comprehensive Adjustments Losses Income (Loss) Balance December 31, 2013 $4,696 $— $4,696 Period change (29,144) — (29,144)Balance December 31, 2014 (24,448) — (24,448)Period change (22,629) (383) (23,012)Balance December 31, 2015 $(47,077) $(383) $(47,460) The period change between December 31, 2015 and 2014 was primarily due to the currency translation of the IPR&D intangible assets, goodwill anddeferred income taxes associated with the acquisition of EOS (see Note 3 and Note 7). 10. Share-Based CompensationStock OptionsIn May 2009, the Company’s Board of Directors approved the 2009 Equity Incentive Plan (the “2009 Plan”). The 2009 Plan provided for the granting ofstock options and other share-based awards, including restricted stock, stock appreciation rights and restricted stock units to its employees, directors andconsultants. Common shares authorized for issuance under the 2009 Plan were 1,317,125 at December 31, 2015. Options to purchase common stock underthe 2009 Plan were designated as incentive stock options or non-statutory stock options. Stock options granted under the 2009 Plan vest over either a one-year period or three-year period for Board of Director grants and over a four-year period for employee grants and expire 10 years from the date of grant. Uponthe closing of the Company’s initial public offering in November 2011, the 2009 Plan was closed, resulting in the termination of new grants from this planand the transfer of all shares available for future issuance to the 2011 Stock Incentive Plan. Future forfeitures and cancellations of options previously grantedunder the 2009 Plan were transferred to the 2011 Stock Incentive Plan and are available for grant under the 2011 Plan.F-17In August 2011, the Company’s Board of Directors approved the 2011 Stock Incentive Plan (the “2011 Plan”), which became effective upon the closingof the Company’s initial public offering in November 2011. The 2011 Plan provides for the granting of incentive and nonqualified stock options, stockappreciation rights, restricted stock, restricted stock units, performance awards and other share-based awards to its employees, directors and consultants.Common shares authorized for issuance under the 2011 Plan were 6,262,641 at December 31, 2015, which represents the initial reserve of 1,250,000 shares ofcommon stock plus 191,496 shares of common stock remaining for future grant from the 2009 Equity Incentive Plan and 4,821,145 new shares authorized bythe Board of Directors at the annual meetings of stockholders. Stock options granted vest over either a one-year period or three-year period for Board ofDirector grants or over a four-year period for employee grants and expire 10 years from the date of grant.Share-based compensation expense for the years ended December 31, 2015, 2014 and 2013, respectively, was recognized in the accompanyingConsolidated Statements of Operations as follows (in thousands): Year Ended December 31, 2015 2014 2013 Research and development (a) $27,321 $11,474 $4,289 General and administrative 13,036 10,043 5,216 Total share-based compensation expense $40,357 $21,517 $9,505 (a)During the third quarter of 2015, the Company recognized $2.9 million in share-based compensation expense associated with a modification to theterms of a former executive’s stock option agreement.The Company did not recognize a tax benefit related to share-based compensation expense during the years ended December 31, 2015, 2014 and 2013,respectively, as the Company maintains net operating loss carryforwards and has established a valuation allowance against the entire net deferred tax asset asof December 31, 2015. The following table summarizes the activity relating to the Company’s options to purchase common stock: Number ofOptions WeightedAverageExercisePrice WeightedAverageRemainingContractualTerm (Years) AggregateIntrinsicValue(Thousands) Outstanding at December 31, 2014 4,159,362 $37.69 Granted (a) 1,600,593 80.04 Exercised (295,759) 18.52 Forfeited (103,939) 56.93 Outstanding at December 31, 2015 5,360,257 $51.53 7.1 $33,927 Vested and expected to vest at December 31, 2015 5,030,757 $50.22 7.0 $33,678 Exercisable at December 31, 2015 2,608,239 $34.56 6.0 $29,607 (a)Includes 120,000 performance-based stock options granted to executives of the Company in the first quarter of 2015. Fifty percent of the grantvests contingent on approval by the FDA to commercially distribute, sell or market rociletinib and 50% of the grant vests contingent on approvalby the FDA to commercially distribute, sell or market rucaparib. Stock compensation expense will be recognized when the condition for vesting isprobable of being met. The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $35.00 as of December 31, 2015,which would have been received by the option holders had all option holders with in-the-money options exercised their options as of that date. The following table summarizes information about our stock options as of and for the years ended December 31, 2015, 2014 and 2013: Year Ended December 31, 2015 2014 2013 Weighted-average grant date fair value per share $52.70 $38.47 $18.59 Intrinsic value of options exercised $19,976,769 $2,906,304 $6,114,436 Cash received from stock option exercises $5,478,211 $682,678 $1,393,053 F-18The fair value of each share-based award is estimated on the grant date using the Black-Scholes option pricing model based upon the weighted-average assumptions provided in the following table: Year Ended December 31, 2015 2014 2013 Dividend yield — — — Volatility (a) 72% 70% 69%Risk-free interest rate (b) 1.77% 1.92% 1.16%Expected term (years) (c) 6.1 6.2 6.2 (a)Volatility: The expected volatility was estimated using peer data of companies in the biopharmaceutical industry with similar equity plans. (b)Risk-free interest rate: The rate is based on the yield on the grant date of a zero-coupon U.S. Treasury bond whose maturity period approximatesthe option’s expected term. (c)Expected term: The expected term of the award was estimated using peer data of companies in the biopharmaceutical industry with similar equityplans.Unrecognized share-based compensation expense related to non-vested options, adjusted for expected forfeitures, was $88.6 million as of December 31,2015. The unrecognized share-based compensation expense is expected to be recognized over the weighted-average remaining vesting period of 2.7 years.Common Stock Reserved for IssuanceAs of December 31, 2015, the Company reserved shares of common stock for future issuance as follows: OptionsOutstanding Available forGrantor FutureIssuance Total Shares ofCommon StockReserved 2009 Equity Incentive Plan 494,031 — 494,031 2011 Stock Incentive Plan 4,866,226 1,181,722 6,047,948 2011 Employee Stock Purchase Plan — 376,231 376,231 Total 5,360,257 1,557,953 6,918,210 Employee Stock Purchase PlanIn August 2011, our Board of Directors approved the Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan (the “Purchase Plan”). Each year, on thedate of our annual meeting of stockholders and at the discretion of our board of directors, the amount of shares reserved for issuance under the Purchase Planmay be increased by up to the lesser of (1) a number of additional shares of our common stock representing 1% of our then-outstanding shares of commonstock, (2) 344,828 shares of our common stock and (3) a lesser number of shares as approved by the Board. The Purchase Plan provides for consecutive six-month offering periods, during which participating employees may elect to have up to 10% of their compensation withheld and applied to the purchase ofcommon stock at the end of each offering period. The purchase price of the common stock is 85% of the lower of the fair value of a share of common stock onthe first trading date of each offering period or the fair value of a share of common stock on the last trading day of the offering period. The Purchase Plan willterminate on August 24, 2021, the tenth anniversary of the date of initial adoption of the Purchase Plan. We sold 32,021 and 13,633 shares to employees in2015 and 2014, respectively. There were 376,231 shares available for sale under the Purchase Plan as of December 31, 2015. The weighted-average estimatedgrant date fair value of purchase awards under the Purchase Plan during the years ended December 31, 2015 and 2014 was $26.80 and $17.31 per share,respectively. The total share-based compensation expense recorded as a result of the Purchase Plan was approximately $858 thousand, $236 thousand and$169 thousand during the years ended December 31, 2015, 2014 and 2013, respectively.F-19The fair value of purchase awards granted to our employees during the years ended December 31, 2015, 2014 and 2013, respectively, was estimated usingthe Black-Scholes option pricing model based upon the weighted-average assumptions provided in the following table: Year Ended December 31, 2015 2014 2013 Dividend yield — — — Volatility (a) 71% 71% 72%Risk-free interest rate (b) 0.11% 0.07% 0.09%Expected term (years) (c) 0.5 0.5 0.5 (a)Volatility: The expected volatility was estimated using peer data of companies in the biopharmaceutical industry with similar equity plans. (b)Risk-free interest rate: The rate is based on the U.S. Treasury yield in effect at the time of grant with terms similar to the contractual term of thepurchase right. (c)Expected term: The expected life of the award represents the six-month offering period for the Purchase Plan. 11. Commitments and ContingenciesThe Company leases office space in Boulder, Colorado, San Francisco, California, Cambridge, UK and Milan, Italy under non-cancelable operating leaseagreements that expire through 2023.The lease agreements contain periodic rent increases that result in the Company recording deferred rent over the terms of certain leases. In June 2015, theCompany entered into a seven-year lease agreement for new office space in Boulder, Colorado. Pursuant to the terms of the lease, the landlord will reimbursethe Company for $1.1 million of leasehold improvement expenditures (the “Tenant Improvement Allowance”). In December 2015, upon completion ofconstruction, the Company recorded the Tenant Improvement Allowance as deferred rent, which is being amortized as a reduction to rental expense over thelease term.Rental expense under these leases was $2.4 million, $1.4 million and $1.1 million for the years ended December 31, 2015, 2014 and 2013, respectively.Future minimum rental commitments, by fiscal year and in the aggregate, for the Company’s operating leases are provided below (in thousands): December 31,2015 2016 $1,795 2017 1,746 2018 1,783 2019 1,837 2020 1,891 Thereafter 2,547 Total future minimum lease payments $11,599 Development and Manufacturing Agreement CommitmentsIn February 2013, the Company entered into a development and manufacturing agreement with a third-party supplier for the production of the activeingredient for rucaparib. Under the Development and Manufacturing Agreement, the Company will provide the third-party supplier a rolling 24-monthforecast that will be updated by the Company on a quarterly basis. The Company is obligated to order the quantity specified in the first 12 months of anyforecast. During the years ended December 31, 2015, 2014 and 2013, $6.0 million, $3.3 million and $6.4 million, respectively, of purchases were performedunder this agreement. As of December 31, 2015, $16.1 million of purchase commitments exist under this agreement.Legal ProceedingsThe Company and certain of its officers were named as defendants in several lawsuits, as described below. We cannot reasonably predict the outcome ofthese legal proceedings, nor can we estimate the amount of loss or range of loss, if any, that may result. An adverse outcome in these proceedings could havea material adverse effect on our results of operations, cash flows or financial condition.F-20On November 19, 2015, Steve Kimbro, a purported shareholder of Clovis, filed a purported class action complaint (the “Kimbro Complaint”) againstClovis and certain of its officers in the United States District Court for the District of Colorado. The Kimbro Complaint purports to be asserted on behalf of aclass of persons who purchased Clovis stock between October 31, 2013 and November 15, 2015. The Kimbro Complaint generally alleges that Clovis andcertain of its officers violated federal securities laws by making allegedly false and misleading statements regarding the progress toward FDA approval andthe potential for market success of rociletinib. The Kimbro Complaint seeks unspecified damages.Also on November 19, 2015, a second purported shareholder class action complaint was filed by Sonny P. Medina, another purported Clovis shareholder,containing similar allegations to those set forth in the Kimbro Complaint, also in the United States District Court for the District of Colorado (the “MedinaComplaint”). The Medina Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock between May 20, 2014 andNovember 13, 2015. On November 20, 2015, a third complaint was filed by John Moran in the United States District Court for the Northern District ofCalifornia (the “Moran Complaint”). The Moran Complaint contains similar allegations to those asserted in the Kimbro and Medina Complaints and purportsto be asserted on behalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 13, 2015.On December 14, 2015, Ralph P. Rocco, a fourth purported shareholder of Clovis, filed a complaint in the United States District Court for the District ofColorado (the “Rocco Complaint”). The Rocco Complaint contains similar allegations to those set forth in the previous complaints and purports to beasserted on behalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 15, 2015.On January 19, 2016, a number of motions were filed in both the District of Colorado and the Northern District of California seeking to consolidate theshareholder class actions into one matter and for appointment of a lead plaintiff. All lead plaintiff movants other than M.Arkin (1999) LTD and ArkinCommunications LTD (the “Arkin Plaintiffs”) subsequently filed notices of non-opposition to the Arkin Plaintiffs’ application.On February 2, 2016, the Arkin Plaintiffs filed a motion to transfer the Moran Complaint to the District of Colorado (the “Motion to Transfer”). Also onFebruary 2, 2016, the defendants filed a statement in the Northern District of California supporting the consolidation of all actions in a single court, theDistrict of Colorado. On February 3, 2016, the Northern District of California court denied without prejudice the lead plaintiff motions filed in that courtpending a decision on the Motion to Transfer.On February 16, 2016, the defendants filed a memorandum in support of the Motion to Transfer, and plaintiff Moran filed a notice of non-opposition tothe Motion to Transfer. On February 17, 2016, the Northern District of California court granted the Motion to Transfer.On February 18, 2016, the Medina court issued an opinion and order addressing the various motions for consolidation and appointment of lead plaintiffand lead counsel in the District of Colorado actions. By this ruling, the court consolidated the Medina, Kimbro and Rocco actions into a single proceeding.The court also appointed the Arkin Plaintiffs as the lead plaintiffs and Bernstein Litowitz Berger & Grossman as lead counsel for the putative class. TheCompany intends to vigorously defend against the allegations contained in the Kimbro, Medina, Moran and Rocco Complaints, but there can be noassurance that the defense will be successful.On December 30, 2015, Jamie McCall, a purported shareholder of Clovis, filed a shareholder derivative complaint (the “McCall Complaint”) againstcertain officers and directors of Clovis in the Colorado District Court, County of Boulder. The McCall Complaint generally alleges that the defendantsbreached their fiduciary duties owed to Clovis by participating in misrepresentation of the Company’s business operations and prospects. The McCallComplaint also alleges claims for abuse of control, gross mismanagement and unjust enrichment. The McCall Complaint seeks, among other things, an awardof money damages, declaratory and injunctive relief concerning the alleged fiduciary breaches and other forms of equitable relief. The Company intends tovigorously defend against the allegations contained in the McCall Complaint, but there can be no assurance that the defense will be successful.On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder of Clovis, filed a purported classaction complaint (the “Electrical Workers Complaint”) against Clovis and certain of its officers, directors, investors and underwriters in the Superior Court ofthe State of California, County of San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased stock inClovis’ July 8, 2015 follow-on offering. The Electrical Workers Complaint generally alleges that the defendants violated the Securities Act because theoffering documents for the July 8, 2015 follow-on offering contained allegedly false and misleading statements regarding the progress toward FDA approvaland the potential for market success of rociletinib. The Electrical Workers Complaint seeks unspecified damages. On February 25, 2016, the defendantsremoved the case to the United States District Court for the Northern District of California and thereafter moved to transfer the case to the District ofColorado. The Company intends to vigorously defend against the allegations contained in the Electrical Workers Complaint, but there can be no assurancethat the defense will be successful.F-21On February 19, 2016, Maris Sanchez, a purported shareholder of Clovis, filed a shareholder derivative complaint (the “Sanchez Complaint”) againstcertain officers and directors of Clovis in the United States District Court for the District of Colorado. The Sanchez Complaint generally alleges that thedefendants breached their fiduciary duties owed to Clovis by participating in misrepresentation of the Company’s business operations and prospects. TheSanchez Complaint also alleges claims for abuse of control and gross mismanagement. The Sanchez Complaint seeks, among other things, an award of moneydamages. The Company intends to vigorously defend against the allegations contained in the Sanchez Complaint, but there can be no assurance that thedefense will be successful.12. License AgreementsRociletinibIn May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research Inc., part ofCelgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor(“EGFR”) gene product. As a result of the collaboration contemplated by the agreement, rociletinib was identified as the lead inhibitor candidate, which weare developing under the terms of the license agreement. We are responsible for all non-clinical, clinical, regulatory and other activities necessary to developand commercialize rociletinib.We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 uponthe acceptance by the FDA of our Investigational New Drug application for rociletinib and a $5.0 million milestone payment in the first quarter of 2014 uponinitiation of the Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDAand MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquired in-process research anddevelopment expense.When and if commercial sales of rociletinib commence, we will pay Celgene tiered royalties at percentage rates ranging from mid-single digits to lowteens based on annual net sales achieved. We are required to pay up to an additional aggregate of $98.0 million in development and regulatory milestonepayments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved, including $15.0 million upon the first approvalof an NDA by the FDA and $15.0 million upon the first approval of an MAA by the EMA. In addition, we are required to pay up to an aggregate of $120.0million in sales milestone payments if certain annual sales targets are achieved, the majority of which relate to annual sales targets of $500.0 million andabove.In January 2013, the Company entered into an exclusive license agreement with Gatekeeper Pharmaceuticals, Inc. (“Gatekeeper”) to acquire exclusiverights under patent applications associated with mutant EGFR inhibitors and methods of treatment. Pursuant to the terms of the license agreement, theCompany made an upfront payment of $0.25 million upon execution of the agreement, which was recognized as acquired in-process research anddevelopment expense. If rociletinib is approved for commercial sale, the Company will pay royalties to Gatekeeper on future net sales.RucaparibIn June 2011, the Company entered into a worldwide license agreement with Pfizer Inc. to acquire exclusive development and commercialization rights torucaparib. This drug candidate is a small molecule inhibitor of poly (ADP-ribose) polymerase (“PARP”), which the Company is developing for the treatmentof selected solid tumors. Under the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer. In April 2014, the Company initiated apivotal registration study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer as required by the license agreement. This payment wasrecognized as acquired in-process research and development expense.We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize rucaparib, and we are responsible forall remaining development and commercialization costs of rucaparib. When and if commercial sales of rucaparib begin, we will pay Pfizer tiered royalties at amid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties tocommercialize rucaparib. In addition, Pfizer is eligible to receive up to $258.5 million of further payments, in aggregate, if certain development, regulatoryand sales milestones are achieved, including $20.75 million associated with the first approval of an NDA by the FDA.In April 2012, the Company entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights associated with rucaparib under afamily of patents and patent applications that claim methods of treating patients with PARP inhibitors in certain indications. The license enables thedevelopment and commercialization of rucaparib for the uses claimed by these patents. Pursuant to the terms of the license agreement, the Company made anupfront payment of $0.25 million upon execution of the agreement, which was recognized as acquired in-process research and development expense. TheCompany may be required to pay up to an aggregate of $0.7 million in milestone payments if certain regulatory filings, acceptances and approvals areachieved. If approved, AstraZeneca will also receive royalties on any net sales of rucaparib.F-22LucitanibIn connection with its acquisition of EOS (see Note 3), the Company gained rights to develop and commercialize lucitanib, an oral, selective tyrosinekinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from AdvenchenLaboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed byEOS to Servier in exchange for upfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development fundingcommitments.In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excludingChina. If and when commercial sales commence, we are obligated to pay Advenchen tiered royalties at percentage rates in the mid-single digits on net salesof lucitanib, based on the volume of annual net sales achieved. In addition, we are required to pay to Advenchen 25% of any consideration, excludingroyalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. We are obligated under the agreement to usecommercially reasonable efforts to develop and commercialize at least one product candidate containing lucitanib, and we are also responsible for allremaining development and commercialization costs for lucitanib.In the first quarter of 2014, the Company recognized acquired in-process research and development expense of $3.4 million, which represents 25% of thesublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib patent by the EuropeanPatent Office.In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to developand commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an upfront payment of €45.0million. We are entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to€90.0 million in the aggregate. In addition, we are entitled to receive sales milestone payments if specified annual sales targets for lucitanib are met, which, inthe aggregate, could total €250.0 million. We are also entitled to receive royalties at percentage rates ranging from low to mid-teens on sales of lucitanib byServier.The development, regulatory and commercial milestones represent non-refundable amounts that would be paid by Servier to the Company if certainmilestones are achieved in the future. These milestones, if achieved, are substantive as they relate solely to past performance, are commensurate withestimated enhancement of value associated with the achievement of each milestone as a result of the Company’s performance, which are reasonable relativeto the other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement.The Company and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is responsible for all of theinitial global development costs under the agreed upon plan up to €80.0 million. Cumulative global development costs, if any, in excess of €80.0 millionwill be shared equally between the Company and Servier. Based on current estimates, we expect that Servier’s €80.0 million funding commitment will befulfilled in late 2016 or early 2017, and thereafter, we will share with Servier in future development costs pursuant to a mutually agreed upon globaldevelopment plan. Reimbursements are recorded as a reduction to research and development expense on the Consolidated Statements of Operations.The Company recorded a $3.2 million and $2.0 million receivable at December 31, 2015 and 2014, respectively, for the reimbursable development costsincurred under the global development plan, which is included in other current assets on the Consolidated Balance Sheets. During the years endingDecember 31, 2015, 2014 and 2013, we incurred $13.7 million, $9.5 million and $1.4 million, respectively, in research and development costs and recordedreductions in research and development expense of $11.8 million, $10.0 million and $1.3 million, respectively, for reimbursable development costs due fromServier. 13. Net Loss Per Common ShareBasic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted netloss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock methodfor the stock options and the if-converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common shareequivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share.F-23The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per sharedue to their anti-dilutive effect (in thousands): Year ended December 31, 2015 2014 2013 Common shares under option 2,031 2,973 2,344 Convertible senior notes 4,646 4,646 — Total potential dilutive shares 6,677 7,619 2,344 14. Income TaxesThe geographical components of income (loss) before income taxes consisted of the following (in thousands): Year ended December 31, 2015 2014 2013 Domestic $(290,342) $(165,220) $(84,534)Foreign (91,595) 7,497 54 Total loss before income taxes $(381,937) $(157,723) $(84,480) The income tax provision consists of the following current and deferred foreign tax expenses (in thousands). No U.S. tax expense was recognized in the2015 and 2014 and the 2013 tax provisions are not significant. Year ended December 31, 2015 2014 Foreign: Current expense $— $1,547 Deferred (benefit) expense (29,076) 761 Total income tax (benefit) expense $(29,076) $2,308 A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2015 2014 2013 Federal income tax benefit at statutory rate (34.0)% (34.0)% (34.0)%State income tax benefit, net of federal benefit (3.0) (3.5) (3.0)Tax credits (13.6) (20.5) (15.5)Change in tax status of foreign subsidiary — (13.5) — Limitation on future foreign tax credits (5.0) — — Other 0.4 1.0 2.1 Change in valuation allowance 47.6 72.0 50.5 Effective income tax rate (7.6)% 1.5% 0.1% F-24The components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carryforward $189,663 $111,309 Tax credit carryforwards 179,865 101,469 Intangible assets 26,766 — Deductible foreign taxes 10,836 22,729 Share-based compensation expense 23,844 10,777 Foreign currency translation 17,471 9,092 Product acquisition costs 10,470 6,866 Accrued liabilities and other 4,147 2,051 Total deferred tax assets 463,062 264,293 Valuation allowance (449,080) (259,004)Deferred tax assets, net of valuation allowance 13,982 5,289 Deferred tax liabilities: Intangible assets (31,871) (70,084)Contingent purchase consideration (11,142) (843)Prepaid expenses and other (2,102) (1,213)Total deferred tax liabilities (45,115) (72,140)Net deferred tax liability $(31,133) $(66,851)The realization of deferred tax assets is dependent upon a number of factors including future earnings, the timing and amount of which is uncertain. Avaluation allowance was established for the net deferred tax asset balance due to management’s belief that the realization of these assets is not likely to occurin the foreseeable future. The Company recorded an increase to the valuation allowance of $190.1 million and $122.7 million during the years endedDecember 31, 2015 and 2014, respectively, primarily due to an increase in net operating loss and tax credit carryforwards and future tax deductionsassociated with EOS acquisition intangible assets.As of December 31, 2015, the Company had approximately $504.8 million, $728.1 million and $2.7 million of U.S. federal, state and foreign netoperating loss carryforwards, respectively. The U.S. net operating losses will expire from 2029 to 2035 if not utilized. Included in the U.S. net operating losswas approximately $16.7 million of stock compensation expense, the benefit of which, if realized, will be an increase to additional paid-in-capital and areduction to taxes payable. In addition, the Company has research and development and orphan drug tax credit carryforwards of $177.7 million that willexpire from 2029 through 2035 if not utilized.We believe that a change in ownership as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of the Company’s publicoffering of common stock completed in April 2012. Future utilization of the federal net operating losses (“NOL”) and tax credit carryforwards accumulatedfrom inception to the change in ownership date will be subject to annual limitations to offset future taxable income. At this time, we do not believe, however,this limitation will prevent the utilization of the federal NOL or credit carryforward prior to expiration. It is possible that a change in ownership will occur inthe future, which will limit the NOL amounts generated since the last estimated change. The Company’s federal and state income taxes for the period frominception to December 31, 2015 remain open to an audit. Our foreign subsidiaries are also subject to tax audits by tax authorities in the jurisdictions wherethey operate for the periods from December 31, 2010 to December 31, 2015.Tax positions are initially recognized in the financial statements when it is more likely than not that the position will be sustained upon examination bythe tax authorities. Such tax positions must initially and subsequently be measured at the largest amount of tax benefit that has a greater than 50% likelihoodof being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts. The Company has not identifiedany significant uncertain tax positions that require recognition in our financial statements. Our evaluation was performed from inception throughDecember 31, 2015.In December 2014, the Company converted a non-U.S. entity into a U.S. entity for U.S. income tax purposes. As a result of this election, the subsidiary wastreated as a flow through entity for U.S. federal tax purposes. The election generated deferred tax assets, calculated as the difference between the subsidiary’stax basis and the underlying financial statement basis of the assets.The Company may be assessed interest and penalties related to the settlement of tax positions and such amounts will be recognized within income taxexpense when assessed. To date, no interest and penalties have been recognized by the Company. F-2515. Employee Benefit PlanWe maintain a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code for its U.S. employees. The plan allows eligibleemployees to defer, at the employee’s discretion, pretax compensation up to the IRS annual limits. The Company matches contributions up to 4% of theeligible employee’s compensation or the maximum amount permitted by law. Total expense for contributions made to U.S. employees was approximately$824 thousand, $425 thousand and $368 thousand for the years ended December 31, 2015, 2014 and 2013, respectively. The Company’s internationalemployees participate in retirement plans governed by the local laws in effect for the country in which they reside. The Company made matchingcontributions to international employees of approximately $171 thousand, $106 thousand and $81 thousand for the years ended December 31, 2015, 2014and 2013, respectively. 16. Quarterly Information (Unaudited)The results of operations on a quarterly basis for the years ended December 31, 2015 and 2014 were as follows (in thousands): March 31, June 30, Sept. 30, Dec. 31, March 31, June 30, Sept. 30, Dec. 31, 2015 2015 2015 (1) 2015 2014 2014 2014 2014 Revenues: License and milestone revenue $— $— $— $— $13,625 $— $— $— Operating expenses: Research and development 56,750 60,368 76,138 75,995 24,151 28,440 34,965 50,149 General and administrative 6,751 7,204 8,331 8,238 5,320 5,265 5,267 5,605 Acquired in-process research and development — — 12,000 — 8,406 400 — — Impairment of intangible asset — — — 89,557 3,409 — — — Change in fair value of contingent purchaseconsideration 724 764 783 (26,882) 822 861 888 (1,864) Total expenses 64,225 68,336 97,252 146,908 42,108 34,966 41,120 53,890 Operating loss (64,225) (68,336) (97,252) (146,908) (28,483) (34,966) (41,120) (53,890)Other income (expense): Interest expense (2,075) (2,097) (2,099) (2,101) — — (511) (2,093)Foreign currency gains (losses) 3,247 (1,142) (101) 736 (60) 316 2,323 1,001 Other income (expense) 11 62 179 164 (46) (46) (42) (106)Other income (expense), net 1,183 (3,177) (2,021) (1,201) (106) 270 1,770 (1,198)Loss before income taxes (63,042) (71,513) (99,273) (148,109) (28,589) (34,696) (39,350) (55,088)Income tax (expense) benefit (102) (18) 628 28,568 (2,129) (68) (292) 181 Net loss $(63,144) $(71,531) $(98,645) $(119,541) $(30,718) $(34,764) $(39,642) $(54,907)Basic and diluted net loss per common share $(1.86) $(2.10) $(2.62) $(3.12) $(0.91) $(1.03) $(1.17) $(1.62)Basic and diluted weighted average common sharesoutstanding 34,011 34,088 37,613 38,321 33,820 33,872 33,921 33,941 (1)In July 2015, the Company sold 4,054,487 shares of its common stock in a public offering at $78.00 per share. The net proceeds to the Companyfrom the offering were $298.5 million after deducting underwriting discounts and commissions and offering expenses. 17. Subsequent EventsThe Company evaluated events after the balance sheet date of December 31, 2015 and up to the date the Company filed this Annual Report anddetermined that no subsequent activity required disclosure. F-26INDEX TO EXHIBITS ExhibitNumber Exhibit Description 3.1(5) Amended and Restated Certificate of Incorporation of Clovis Oncology, Inc. 3.2(5) Amended and Restated Bylaws of Clovis Oncology, Inc. 4.1(3) Form of Common Stock Certificate of Clovis Oncology, Inc. 4.2(8) Indenture, dated as of September 9, 2014, by and between the Company and The Bank of New York Mellon Trust Company, N.A. 10.1*(4) Amended and Restated Strategic License Agreement, dated as of June 16, 2011, by and between Clovis Oncology, Inc. and Avila Therapeutics,Inc. 10.2*(4) License Agreement, dated as of June 2, 2011, by and between Clovis Oncology, Inc. and Pfizer Inc. 10.3+(1) Clovis Oncology, Inc. 2009 Equity Incentive Plan. 10.4+(4) Clovis Oncology, Inc. 2011 Stock Incentive Plan. 10.5+(1) Form of Clovis Oncology, Inc. 2009 Equity Incentive Plan Stock Option Agreement. 10.6+(4) Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan Stock Option Agreement. 10.7+(3) Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Patrick J. Mahaffy. 10.8+(3) Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Erle T. Mast. 10.9+(3) Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Gillian C. Ivers-Read. 10.10+(3) Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Andrew R. Allen. 10.11+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Paul Klingenstein. 10.12+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and James C. Blair. 10.13+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Edward J. McKinley. 10.14+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Thorlef Spickschen. 10.15+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and M. James Barrett. 10.16+(1) Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Brian G. Atwood. 10.17+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Patrick J. Mahaffy. 10.18+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Erle T. Mast. 10.19+(1) Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Gillian C. Ivers-Read. 10.20+(1) Indemnification Agreement, dated as of May 13, 2009, between Clovis Oncology, Inc. and Andrew R. Allen. 10.25+(4) Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan. 10.26+(4) Clovis Oncology, Inc. 2011 Cash Bonus Plan. 10.27+(6) Employment Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L. Hoerter. 10.28+(6) Indemnification Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L. Hoerter. 10.29+(2) Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Ginger L. Graham. 10.30+(2) Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Keith Flaherty. 10.31(9) Consulting Agreement, dated August 6, 2015, by and between Andrew Allen and Clovis Oncology, Inc. 10.32(7) Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers listed on Exhibit A thereto andSofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative.E-1ExhibitNumber Exhibit Description 10.33(7) Registration Rights Agreement, dated as of November 19, 2013, by and between the Company and the Sellers signatory thereto. 10.34*(7) Development and Commercialization Agreement, dated as of October 24, 2008, by and between Advenchen Laboratories LLC and EthicalOncology Science S.p.A., as amended by the First Amendment, dated as of April 13, 2010 and the Second Amendment, dated as of July 30, 2012. 10.35*(7) Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical Oncology Science S.p.A. and Les LaboratoiresServier and Institut de Recherches Internationales Servier. 10.36+ Indemnification Agreement, dated as of January 29, 2016, by and between Clovis Oncology, Inc. and Lindsey Rolfe. 10.37+ Employment Agreement, dated as of February 25, 2016, by and between Clovis Oncology, Inc. and Lindsey Rolfe. 10.38+ Indemnification Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale Hooks. 10.39+ Employment Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale Hooks. 21.1 List of Subsidiaries of Clovis Oncology, Inc. 23.1 Consent of Independent Registered Public Accounting Firm 31.1 Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. 31.2 Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. 32.1 Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2 Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.LAB XBRL Taxonomy Extension Label Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase Document (1)Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on June 23, 2011.(2)Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on June 14, 2013.(3)Filed as an exhibit with Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on August 31, 2011.(4)Filed as an exhibit with Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on October 31, 2011.(5)Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on March 15, 2012.(6)Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-180293) on March 23, 2012.(7)Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on November 19, 2013.(8)Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on September 9, 2014.(9)Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on August 12, 2015.+Indicates management contract or compensatory plan.*Confidential treatment has been granted with respect to portions of this exhibit, which portions have been omitted and filed separately with theSecurities and Exchange Commission.E-2 Exhibit 10.36CLOVIS ONCOLOGY, INC.INDEMNIFICATION AGREEMENTThis Indemnification Agreement (this “Agreement”) is made effective as of August 3, 2015, and is between Clovis Oncology, Inc., a Delawarecorporation (the “Company”), and Lindsey Rolfe (“Indemnitee”).RECITALSA.Indemnitee’s service to the Company substantially benefits the Company.B.Individuals are reluctant to serve as directors or officers of corporations or in certain other capacities unless they are provided withadequate protection through insurance or indemnification against the risks of claims and actions against them arising out of such service.C.Indemnitee does not regard the protection currently provided by applicable law, the Company’s governing documents and anyinsurance as adequate under the present circumstances, and Indemnitee may not be willing to serve as a director or officer without additional protection.D.In order to induce Indemnitee to continue to provide services to the Company, it is reasonable, prudent and necessary for the Companyto contractually obligate itself to indemnify, and to advance expenses on behalf of, Indemnitee as permitted by applicable law.E.This Agreement is a supplement to and in furtherance of the indemnification provided in the Company’s certificate of incorporation andbylaws, and any resolutions adopted pursuant thereto, and this Agreement shall not be deemed a substitute therefor, nor shall this Agreement be deemed tolimit, diminish or abrogate any rights of Indemnitee thereunder.The parties therefore agree as follows:1.Definitions.(a)“Corporate Status” describes the status of a person who is or was a director, trustee, general partner, managing member,officer, employee, agent or fiduciary of the Company or any other Enterprise.(b)“DGCL” means the General Corporation Law of the State of Delaware.(c)“Disinterested Director” means a director of the Company who is not and was not a party to the Proceeding in respect ofwhich indemnification is sought by Indemnitee.(d)“Enterprise” means the Company and any other corporation, partnership, limited liability company, joint venture, trust,employee benefit plan or other enterprise of which Indemnitee is or was serving at the request of the Company as a director, trustee, general partner, managingmember, officer, employee, agent or fiduciary.(e)“Expenses” include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees and costs of experts, witnessfees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other disbursements or expensesof the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be awitness in, or otherwise participating in, a Proceeding. Expenses also include (i) Expenses incurred in connection with any appeal resulting from anyProceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersedeas bond or other appeal bond or theirequivalent, and (ii) for purposes of Section 12(b), Expenses incurred by Indemnitee in connection with the interpretation, enforcement or defense ofIndemnitee’s rights under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company. Expenses, however,shall not include amounts paid in settlement by Indemnitee or the amount of judgments, penalties or fines against Indemnitee.(f)“Independent Counsel” means a law firm, or a partner or member of a law firm, that is experienced in matters of corporationlaw and neither presently is, nor in the past five years has been, retained to represent (i) the Company or Indemnitee in any matter material to either such party(other than as Independent Counsel with respect to matters concerning  Indemnitee under this Agreement, or other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to aclaim for indemnification hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicablestandards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action todetermine Indemnitee’s rights under this Agreement. (g)“Proceeding” means any threatened, pending or completed action, suit, arbitration, mediation, alternate dispute resolutionmechanism, investigation, inquiry, administrative hearing or proceeding, whether brought in the right of the Company or otherwise and whether of a civil,criminal, administrative or investigative nature, including any appeal therefrom and including without limitation any such Proceeding pending as of the dateof this Agreement, in which Indemnitee was, is or will be involved as a party, a potential party, a non-party witness or otherwise by reason of (i) the fact thatIndemnitee is or was a director or officer of the Company, (ii) any action taken by Indemnitee or any action or inaction on Indemnitee’s part while acting as adirector or officer of the Company, or (iii) the fact that he or she is or was serving at the request of the Company as a director, trustee, general partner,managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, in each case whether or not serving in such capacity at thetime any liability or Expense is incurred for which indemnification or advancement of expenses can be provided under this Agreement.(h)Reference to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxesassessed on a person with respect to any employee benefit plan; references to “serving at the request of the Company” shall include any service as a director,officer, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, employee or agent with respect to anemployee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner he or she reasonably believed to be in the bestinterests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of theCompany” as referred to in this Agreement.2.Indemnity in Third-Party Proceedings. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 2if, by reason of his or her Corporate Status, Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding, other than a Proceeding byor in the right of the Company to procure a judgment in its favor. Pursuant to this Section 2, Indemnitee shall be indemnified to the fullest extent permittedby applicable law against all Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred by Indemnitee or on his or herbehalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonablybelieved to be in or not opposed to the best interests of the Company and, with respect to any criminal Proceeding, had no reasonable cause to believe thathis or her conduct was unlawful.3.Indemnity in Proceedings by or in the Right of the Company. The Company shall indemnify Indemnitee in accordance with theprovisions of this Section 3 if, by reason of his or her Corporate Status, Indemnitee is, or is threatened to be made, a party to or a participant in any Proceedingby or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified to the fullest extentpermitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with suchProceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonably believed to be in or not opposed tothe best interests of the Company. No indemnification for Expenses shall be made under this Section 3 in respect of any claim, issue or matter in suchProceeding as to which Indemnitee shall have been adjudged by a court of competent jurisdiction to be liable to the Company, unless and only to the extentthat the Delaware Court of Chancery or any court in which the Proceeding was brought shall determine upon application that, despite the adjudication ofliability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnification for such expenses as the DelawareCourt of Chancery or such other court shall deem proper. Anything in this Agreement to the contrary notwithstanding, if the Indemnitee, by reason of theIndemnitee’s Corporate Status, is or was, or is or was threatened to be made, a party to any Proceeding by or in the right of the Company to procure ajudgment in its favor, then the Company shall not indemnify the Indemnitee for any judgment, fines, or amounts paid in settlement to the Company inconnection with such Proceeding.4.Indemnification for Expenses of a Party Who is Wholly or Partly Successful. To the extent that Indemnitee, by reason of his or herCorporate Status, is a party to or a participant in and is successful (on the merits or otherwise) in defense of any Proceeding or any claim, issue or mattertherein, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf inconnection therewith. To the extent permitted by applicable law, if Indemnitee is not wholly successful in such Proceeding but is successful, on the merits orotherwise, in defense of one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against allExpenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. Forpurposes of this section, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be asuccessful result as to such claim, issue or matter.-2-  5.Indemnification for Expenses of a Witness. To the extent that Indemnitee is, by reason of his or her Corporate Status, a witness, or is orwas made (or asked) to respond to discovery requests, in any Proceeding to which Indemnitee is not a party, Indemnitee shall be indemnified to the fullestextent permitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. 6.Additional Indemnification.(a)Notwithstanding any limitation in Sections 2, 3 or 4, the Company shall indemnify Indemnitee to the fullest extent permittedby applicable law if Indemnitee, by reason of his or her Corporate Status, is, or is threatened to be made, a party to or a participant in any Proceeding(including a Proceeding by or in the right of the Company to procure a judgment in its favor) against all Expenses, judgments, fines and amounts paid insettlement actually and reasonably incurred by Indemnitee or on his or her behalf in connection with the Proceeding or any claim, issue or matter therein.(b)For purposes of Section 6(a), the meaning of the phrase “to the fullest extent permitted by applicable law” shall include, butnot be limited to:(i)the fullest extent permitted by the provision of the DGCL that authorizes orcontemplates additional indemnification by agreement, or the corresponding provision of any amendment to or replacement of the DGCL; and(ii)the fullest extent authorized or permitted by any amendments to or replacementsof the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its officers and directors.7.Exclusions. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make anyindemnity in connection with any Proceeding (or any part of any Proceeding):(a)for which payment has actually been made to or on behalf of Indemnitee under any statute, insurance policy, indemnityprovision, vote or otherwise, except with respect to any excess beyond the amount paid, and except as may otherwise be agreed between the Company, on theone hand, and Indemnitee or another indemnitor of Indemnitee, on the other;(b)for an accounting or disgorgement of profits pursuant to Section 16(b) of the Securities Exchange Act of 1934, as amended,or similar provisions of federal, state or local statutory law or common law, if Indemnitee is held liable therefor (including pursuant to any settlementarrangements);(c)for any reimbursement of the Company by Indemnitee of any bonus or other incentive-based or equity-based compensationor of any profits realized by Indemnitee from the sale of securities of the Company, as required in each case under the Securities Exchange Act of 1934, asamended (including any such reimbursements that arise from an accounting restatement of the Company pursuant to Section 304 of the Sarbanes-Oxley Actof 2002 (the “Sarbanes-Oxley Act”), or the payment to the Company of profits arising from the purchase and sale by Indemnitee of securities in violation ofSection 306 of the Sarbanes-Oxley Act), if Indemnitee is held liable therefor (including pursuant to any settlement arrangements);(d)initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against theCompany or its directors, officers, employees, agents or other indemnitees, unless (i) the Company’s board of directors authorized the Proceeding (or therelevant part of the Proceeding) prior to its initiation, (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested inthe Company under applicable law, (iii) otherwise authorized in Section 12(b) or (iv) otherwise required by applicable law; or(e)if prohibited by applicable law.8.Advances of Expenses. The Company shall advance the Expenses incurred by Indemnitee in connection with any Proceeding in whichIndemnitee is, or is threatened to be made, a party to or a participant in by reason of Indemnitee’s Corporate Status, and such advancement shall be made assoon as reasonably practicable, but in any event no later than 60 days, after the receipt by the Company of a written statement or statements from Indemniteerequesting such advances from time to time (which shall include invoices received by Indemnitee in connection with such Expenses or otherwise reasonablyevidence the Expenses incurred by Indemnitee, but, in the case of invoices in connection with legal services, any references to legal work performed or toexpenditure made that would cause Indemnitee to waive any privilege accorded by applicable law shall not be included with the invoice). Advances shall beunsecured and interest free and made without regard to Indemnitee’s ability to repay such advances. Indemnitee hereby undertakes to repay any advance tothe extent that it is ultimately determined that Indemnitee is not entitled to be indemnified-3-  by the Company. This Section 8 shall not apply to the extent advancement is prohibited by law and shall not apply to any Proceeding for which indemnity isnot permitted under this Agreement, but shall apply to any Proceeding referenced in Section 7(b) or 7(c) prior to a determination that Indemnitee is notentitled to be indemnified by the Company. 9.Procedures for Notification and Defense of Claim.(a)Indemnitee shall notify the Company in writing upon being served with or otherwise receiving any summons, citation,subpoena, complaint, indictment or other document relating to any Proceeding or any matter which may be subject to indemnification covered hereunderwith respect to which Indemnitee intends to seek indemnification or advancement of Expenses as soon as reasonably practicable following the receipt byIndemnitee thereof. The written notification to the Company shall include, in reasonable detail, a description of the nature of the Proceeding and the factsunderlying the Proceeding. The failure by Indemnitee to notify the Company will not relieve the Company from any liability which it may have toIndemnitee hereunder or otherwise than under this Agreement, and any delay in so notifying the Company shall not constitute a waiver by Indemnitee of anyrights, except to the extent that such failure or delay materially prejudices the Company.(b)If, at the time of the receipt of a notice of a Proceeding pursuant to the terms hereof, the Company has directors’ and officers’liability insurance in effect, the Company shall give prompt notice of the commencement of the Proceeding to the insurers in accordance with the proceduresset forth in the applicable policies. The Company shall thereafter take all reasonably necessary or desirable action to cause such insurers to pay, on behalf ofIndemnitee, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.(c)In the event the Company may be obligated to make any indemnity in connection with a Proceeding, the Company shall beentitled to assume the defense of such Proceeding with counsel approved by Indemnitee, which approval shall not be unreasonably withheld, upon thedelivery to Indemnitee of written notice of its election to do so. After delivery of such notice, approval of such counsel by Indemnitee and the retention ofsuch counsel by the Company, the Company will not be liable to Indemnitee for any fees or expenses of counsel subsequently incurred by Indemnitee withrespect to the same Proceeding. Notwithstanding the Company’s assumption of the defense of any such Proceeding, the Company shall be obligated to paythe fees and expenses of Indemnitee’s counsel to the extent (i) the employment of counsel by Indemnitee is authorized by the Company, (ii) counsel for theCompany or Indemnitee shall have reasonably concluded that there is a conflict of interest between the Company and Indemnitee in the conduct of any suchdefense such that Indemnitee needs to be separately represented, (iii) the Company is not financially or legally able to perform its indemnificationobligations or (iv) the Company shall not have retained, or shall not continue to retain, such counsel to defend such Proceeding. The Company shall have theright to conduct such defense as it sees fit in its sole discretion. Regardless of any provision in this Agreement, Indemnitee shall have the right to employcounsel in any Proceeding at Indemnitee’s personal expense. The Company shall not be entitled, without the consent of Indemnitee, to assume the defense ofany claim brought by or in the right of the Company.(d)Indemnitee shall give the Company such information and cooperation in connection with the Proceeding as may bereasonably appropriate.(e)The Company shall not be liable to indemnify Indemnitee for any settlement of any Proceeding (or any part thereof) withoutthe Company’s prior written consent, which shall not be unreasonably withheld.10.Procedures upon Application for Indemnification.(a)To obtain indemnification, Indemnitee shall submit to the Company a written request, including therein or therewith suchdocumentation and information as is reasonably available to Indemnitee and as is reasonably necessary to determine whether and to what extent Indemniteeis entitled to indemnification following the final disposition of the Proceeding. The Company shall, promptly after receipt of such a request forindemnification, advise the board of directors that Indemnitee has requested indemnification. Any delay in providing the request will not relieve theCompany from its obligations under this Agreement, except to the extent such failure is prejudicial.(b)Upon written request by Indemnitee for indemnification pursuant to Section 10(a), a determination with respect toIndemnitee’s entitlement thereto shall be made in the specific case (A) by a majority vote of the Disinterested Directors, even though less than a quorum ofthe Company’s board of directors, (B) by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though lessthan a quorum of the Company’s board of directors, (C) if there are no such Disinterested Directors or, if such Disinterested Directors so direct, byIndependent Counsel in a written opinion to the Company’s board of directors, a copy of which shall be delivered to Indemnitee or (D) if so directed by theCompany’s board of-4-  directors, by the stockholders of the Company. If the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to thisSection 10(b), the Independent Counsel shall be selected by the Board of Directors and approved by Indemnitee. Upon failure of the Board of Directors to soselect, or upon the failure of Indemnitee to so approve, such Independent Counsel shall be selected by the Court of Chancery of the State of Delaware or suchother person or body as the Indemnitee and the Company may agree in writing. If the person making such determination shall determine that Indemnitee isentitled to indemnification as to part (but not all) of the application for indemnification, such person shall reasonably pro-rate such part of indemnificationamong such claims, issues or matters. If it is so determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made within tendays after such determination. Indemnitee shall cooperate with the person, persons or entity making the determination with respect to Indemnitee’sentitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or informationthat is not privileged or otherwise protected from disclosure and that is reasonably available to Indemnitee and reasonably necessary to such determination.Any costs or expenses (including attorneys’ fees and disbursements) reasonably incurred by Indemnitee in so cooperating with the person, persons or entitymaking such determination shall be borne by the Company, to the fullest extent permitted by applicable law. 11.Presumptions and Effect of Certain Proceedings.(a)The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, orupon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself create a presumption thatIndemnitee did not act in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the Company or,with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his or her conduct was unlawful.(b)For purposes of any determination of good faith, Indemnitee shall be deemed to have acted in good faith to the extentIndemnitee relied in good faith on (i) the records or books of account of the Enterprise, including financial statements, (ii) information supplied toIndemnitee by the officers of the Enterprise in the course of their duties, (iii) the advice of legal counsel for the Enterprise or its board of directors or counselselected by any committee of the board of directors or (iv) information or records given or reports made to the Enterprise by an independent certified publicaccountant, an appraiser, investment banker or other expert selected with reasonable care by the Enterprise or its board of directors or any committee of theboard of directors. The provisions of this Section 11(b) shall not be deemed to be exclusive or to limit in any way the other circumstances in whichIndemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement.(c)Neither the knowledge, actions nor failure to act of any other director, officer, agent or employee of the Enterprise shall beimputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.(d)Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’sentitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or informationwhich is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to suchdetermination. Any Independent Counsel or member of the Board of Directors shall act reasonably and in good faith in making a determination regarding theIndemnitee’s entitlement to indemnification under this Agreement. Any costs or expenses (including attorneys’ fees and disbursements) incurred byIndemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determinationas to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.(e)The Company acknowledges that a settlement or other disposition short of final judgment may besuccessful if it permits a party to avoid expense, delay, distraction, disruption and uncertainty. In the event that any Proceeding to which Indemnitee is aparty is resolved in any manner other than by adverse judgment against Indemnitee (including, without limitation, settlement of such action, claim orproceeding with or without payment of money or other consideration) it shall be presumed that Indemnitee has been successful on the merits or otherwise insuch Proceeding. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincingevidence.12.Remedies of Indemnitee.(a)Subject to Section 12(d), in the event that (i) a determination is made pursuant to Section 10 of this Agreement thatIndemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 8 or 12(b) of thisAgreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 10 of this Agreement within 90 days after thelater of the receipt by the Company of the request for indemnification or the final disposition of the Proceeding, (iv) payment of indemnification pursuant tothis Agreement is not made-5-  (A) within ten days after a determination has been made that Indemnitee is entitled to indemnification or (B) with respect to indemnification pursuant toSections 4, 5 and 12(b) of this Agreement, within 30 days after receipt by the Company of a written request therefor, or (v) the Company or any other personor entity takes or threatens to take any action to declare this Agreement void or unenforceable, or institutes any litigation or other action or proceedingdesigned to deny, or to recover from, Indemnitee the benefits provided or intended to be provided to Indemnitee hereunder, Indemnitee shall be entitled to anadjudication by a court of competent jurisdiction of his or her entitlement to such indemnification or advancement of Expenses. Alternatively, Indemnitee, athis or her option, may seek an award in arbitration with respect to his or her entitlement to such indemnification or advancement of Expenses, to beconducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration Association. Indemnitee shall commence suchproceeding seeking an adjudication or an award in arbitration within 180 days following the date on which Indemnitee first has the right to commence suchproceeding pursuant to this Section 12(a); provided, however, that the foregoing clause shall not apply in respect of a proceeding brought by Indemnitee toenforce his or her rights under Section 4 of this Agreement. The Company shall not oppose Indemnitee’s right to seek any such adjudication or award inarbitration in accordance with this Agreement. (b)Neither (i) the failure of the Company, its board of directors, any committee or subgroup of the board of directors,Independent Counsel or stockholders to have made a determination that indemnification of Indemnitee is proper in the circumstances because Indemniteehas met the applicable standard of conduct, nor (ii) an actual determination by the Company, its board of directors, any committee or subgroup of the boardof directors, Independent Counsel or stockholders that Indemnitee has not met the applicable standard of conduct, shall be a defense to the action or create apresumption that Indemnitee has or has not met the applicable standard of conduct. In the event that a determination shall have been made pursuant toSection 10 of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to thisSection 12 shall be conducted in all respects as a de novo trial, or arbitration, on the merits, and Indemnitee shall not be prejudiced by reason of that adversedetermination. In connection with any determination (including a determination by the Court of Chancery of the State of Delaware (or other court ofcompetent jurisdiction)) with respect to entitlement to indemnification hereunder, the Company shall, to the fullest extent not prohibited by law, have theburden of proving Indemnitee is not entitled to indemnification or advancement of Expenses, as the case may be, and any decision that Indemnitee is notentitled to indemnification or advancement of Expenses must be supported by clear and convincing evidence.(c)To the fullest extent permissible under applicable law, the Company shall indemnify Indemnitee against all Expenses thatare incurred by Indemnitee in connection with any action for indemnification or advancement of Expenses from the Company under this Agreement or underany directors’ and officers’ liability insurance policies maintained by the Company to the extent Indemnitee is successful in such action, and, if requested byIndemnitee, shall (as soon as reasonably practicable, but in any event no later than 60 days, after receipt by the Company of a written request therefor)advance such Expenses to Indemnitee, subject to the provisions of Section 8.(d)Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification shall berequired to be made prior to the final disposition of the Proceeding.13.Contribution.(a)To the fullest extent permissible under applicable law, whether or not the indemnification provided in Sections 2, 3, 4, or 6hereof is available, in respect of any threatened, pending or completed Proceeding in which the Company is jointly liable with Indemnitee (or would be ifjoined in such Proceeding), the Company shall pay, in the first instance, the entire amount of any judgment or settlement of such Proceeding withoutrequiring Indemnitee to contribute to such payment, and the Company hereby waives and relinquishes any right of contribution it may have againstIndemnitee. The Company shall not enter into any settlement of any Proceeding in which the Company is jointly liable with Indemnitee (or would be ifjoined in such Proceeding) unless such settlement provides for a full and final release of all claims asserted against Indemnitee.(b)To the fullest extent permissible under applicable law, without diminishing or impairing the obligations of the Company setforth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required to pay all or any portion of any judgment or settlement in anythreatened, pending or completed Proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such Proceeding), theCompany shall contribute to the amount of Expenses, judgments, fines, liabilities and amounts paid in settlement actually incurred and paid or payable byIndemnitee in proportion to the relative benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee,who are jointly liable with Indemnitee (or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, from the transactionfrom which such Proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the extent necessary to conformto law, be further adjusted by reference to the relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee,who are jointly liable with Indemnitee (or would be if joined in such Proceeding),-6-  on the one hand, and Indemnitee, on the other hand, in connection with the events that resulted in such expenses, judgments, fines, liabilities or settlementamounts, as well as any other equitable considerations which the law may require to be considered. The relative fault of the Company and all officers,directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such Proceeding), on the onehand, and Indemnitee, on the other hand, shall be determined by reference to, among other things, the degree to which their actions were motivated by intentto gain personal profit or advantage, the degree to which their liability is primary or secondary and the degree to which their conduct is active or passive. (c)The Company hereby agrees to fully indemnify and hold Indemnitee harmless from any claim of contribution brought byofficers, directors or employees of the Company, other than Indemnitee, who may be jointly liable with Indemnitee.(d)To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailableto Indemnitee, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amounts incurred by Indemnitee, whether for Expenses, judgments,fines or amounts paid or to be paid in settlement, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion asis deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company andIndemnitee as a result of the events and transactions giving rise to such Proceeding; and (ii) the relative fault of Indemnitee and the Company (and its otherdirectors, officers, employees and agents) in connection with such events and transactions.14.Non-exclusivity. The rights of indemnification and to receive advancement of Expenses as provided by this Agreement shall not bedeemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Company’s certificate of incorporation orbylaws, any agreement, a vote of stockholders or a resolution of directors, or otherwise. To the extent that a change in Delaware law, whether by statute orjudicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Company’s certificate ofincorporation and bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits soafforded by such change, subject to the restrictions expressly set forth herein or therein. Except as expressly set forth herein, no right or remedy hereinconferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other rightand remedy given hereunder or now or hereafter existing at law or in equity or otherwise. Except as expressly set forth herein, the assertion or employment ofany right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy. Notwithstandinganything in this Agreement to the contrary, the indemnification and contribution provided for in this Agreement will remain in full force and effect regardlessof any investigation made by or on behalf of Indemnitee or Indemnitee’s agents.15.Primary Responsibility. The Company acknowledges that Indemnitee may have certain rights to indemnification and advancementof expenses provided by the fund and/or certain affiliates thereof with whom Indemnitee may be affiliated (collectively, the “Secondary Indemnitors”). TheCompany agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnifiedor advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provideindemnification or advancement for the same amounts is secondary to those Company obligations. The Company waives any right of contribution orsubrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In theevent of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’scertificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights ofrecovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, tothe extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to theamounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.16.No Duplication of Payments. Subject to the provisions of Section 15 above, the Company shall not be liable under this Agreement tomake any payment of amounts otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the extent that Indemnitee hasotherwise actually received payment for such amounts under any insurance policy, contract, agreement or otherwise.17.Insurance. To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors,trustees, general partners, managing members, officers, employees, agents or fiduciaries of the Company or any other Enterprise, Indemnitee shall be coveredby such policy or policies to the same extent as the most favorably-insured persons under such policy or policies in a comparable position.-7-  18.Subrogation. In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to allof the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of suchdocuments as are necessary to enable the Company to bring suit to enforce such rights. 19.Services to the Company. Indemnitee agrees to serve as a director or officer of the Company or, at the request of theCompany, as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of another Enterprise, for so long as Indemnitee isduly elected or appointed or until Indemnitee tenders his or her resignation or is removed from such position. Indemnitee may at any time and for any reasonresign from such position (subject to any other contractual obligation or any obligation imposed by operation of law), in which event the Company shallhave no obligation under this Agreement to continue Indemnitee in such position. This Agreement shall not be deemed an employment contract between theCompany (or any of its subsidiaries or any Enterprise) and Indemnitee. Indemnitee specifically acknowledges that any employment with the Company (orany of its subsidiaries or any Enterprise) is at will, and Indemnitee may be discharged at any time for any reason, with or without cause, with or withoutnotice, except as may be otherwise expressly provided in any executed, written employment contract between Indemnitee and the Company (or any of itssubsidiaries or any Enterprise), any existing formal severance policies adopted by the Company’s board of directors or, with respect to service as a director orofficer of the Company, the Company’s certificate of incorporation or bylaws or the DGCL. No such document shall be subject to any oral modificationthereof.20.Duration. This Agreement shall continue until and terminate upon the later of (a) ten years after the date that Indemnitee shall haveceased to serve as a director or officer of the Company or as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of anyother Enterprise, as applicable; or (b) one year after the final termination of any Proceeding, including any appeal, then pending in respect of whichIndemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by Indemnitee pursuant toSection 12 of this Agreement relating thereto.21.Successors. This Agreement shall be binding upon the Company and its successors and assigns, including any direct or indirectsuccessor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company, and shall inure to the benefit ofIndemnitee and Indemnitee’s heirs, executors and administrators.22.Severability. Nothing in this Agreement is intended to require or shall be construed as requiring the Company to do or fail to do anyact in violation of applicable law. The Company’s inability, pursuant to court order or other applicable law, to perform its obligations under this Agreementshall not constitute a breach of this Agreement. If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for anyreason whatsoever: (i) the validity, legality and enforceability of the remaining provisions of this Agreement (including without limitation, each portion ofany section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable)shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (ii) such provision or provisions shallbe deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (iii) to thefullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any section of this Agreement containing any suchprovision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intentmanifested thereby.23.Enforcement. The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligationsimposed on it hereby in order to induce Indemnitee to serve as a director or officer of the Company, and the Company acknowledges that Indemnitee isrelying upon this Agreement in serving as a director or officer of the Company.24.Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matterhereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof;provided, however, that this Agreement is a supplement to and in furtherance of the indemnification provided in the Company’s certificate of incorporationand bylaws and applicable law.25.Modification and Waiver. No supplement, modification or amendment to this Agreement shall be binding unless executed in writingby the parties hereto. No amendment, alteration or repeal of this Agreement shall adversely affect any right of Indemnitee under this Agreement in respect ofany action taken or omitted by such Indemnitee in his or her Corporate Status prior to such amendment, alteration or repeal. No waiver of any of theprovisions of this Agreement shall constitute or be deemed a waiver of any other provision of this Agreement nor shall any waiver constitute a continuingwaiver.26.Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered orcertified mail, postage prepaid, sent by facsimile or electronic mail or otherwise delivered by hand, messenger or courier service addressed:-8-  (a)if to Indemnitee, to Indemnitee’s address, facsimile number or electronic mail address as shown on the signature page of thisAgreement or in the Company’s records, as may be updated in accordance with the provisions hereof; or (b)if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at c/o ThomasMark, Willkie Farr & Gallagher LLP, 787 Seventh Ave., New York, NY 10019 or at such other current address as the Company shall have furnished to theIndemnitee.Each such notice or other communication shall for all purposes of this Agreement be treated as effective or having been given (i) if delivered byhand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), (ii) if sent via mail, at the earlier of its receipt or five days after the same has been deposited in aregularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation offacsimile transfer or, if sent via electronic mail, when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, orif not sent during normal business hours of the recipient, then on the recipient’s next business day.27.Applicable Law and Consent to Jurisdiction. This Agreement and the legal relations among the parties shall be governed by, andconstrued and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. Except with respect to anyarbitration commenced by Indemnitee pursuant to Section 12(a) of this Agreement, the Company and Indemnitee hereby irrevocably and unconditionally(i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Delaware Court of Chancery, and notin any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of theDelaware Court of Chancery for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent suchparty is not otherwise subject to service of process in the State of Delaware, The Corporation Trust Company, Wilmington, Delaware as its agent in the Stateof Delaware as such party’s agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legalforce and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action orproceeding in the Delaware Court of Chancery, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in theDelaware Court of Chancery has been brought in an improper or inconvenient forum.28.Counterparts. This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be anoriginal but all of which together shall constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signatureand in counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement.Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.29.Captions. The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitutepart of this Agreement or to affect the construction thereof.(signature page follows) -9-  The parties are signing this Indemnification Agreement on January 29, 2016. COMPANY CLOVIS ONCOLOGY, INC. /s/ ERLE T. MAST (Signature) Erle T. Mast (Print name) Executive Vice President and Chief Financial Officer (Title) INDEMNITEE /s/ LINDSEY ROLFE (Signature) Lindsey Rolfe (Print name) (Street address) (City, State and ZIP) Exhibit 10.37EXECUTION COPYEMPLOYMENT AGREEMENTThis EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into as of this 25th day of February 2016, by and betweenClovis Oncology, Inc., a Delaware corporation (the “Company”), and Dr. Lindsey Rolfe (the “Employee”).W I T N E S S E T H :WHEREAS, Employee is currently employed by the Company as its Senior Vice President of Global Clinical Development; andWHEREAS, the Company desires to continue to employ Employee and to enter into this Agreement embodying the terms of suchemployment, and Employee desires to enter into this Agreement and to accept such continued employment, subject to the terms and provisions of thisAgreement.NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for other good and valuableconsideration, the receipt and sufficiency of which are mutually acknowledged, the Company and Employee hereby agree as follows:Section 1.Definitions.(a)“Accounting Firm” shall have the meaning set forth in Section 13(b) hereof.(b)“Accrued Obligations” shall mean (i) all accrued but unpaid Base Salary through the date of termination of Employee’semployment, (ii) any unpaid or unreimbursed expenses incurred prior to the date of termination in accordance with Section 7 hereof, and (iii) any benefitsprovided under the Company’s employee benefit plans upon a termination of employment (excluding any employee benefit plan providing for severance orsimilar benefits), in accordance with the terms contained therein.(c)“Agreement” shall have the meaning set forth in the preamble hereto.(d)“Annual Bonus” shall have the meaning set forth in Section 4(b) hereof.(e)“Base Salary” shall mean the salary provided for in Section 4(a) hereof or any increased salary granted to Employee pursuantto Section 4(a) hereof.(f)“Board” shall mean the Board of Directors of the Company.(g)“Change in Control” shall have the meaning ascribed to such term in the Stock Incentive Plan.(h)“Code” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(i)“Company” shall have the meaning set forth in the preamble hereto.(j)“Company Group” shall mean the Company together with any direct or indirect subsidiaries of the Company.(k)“Compensation Committee” shall mean the committee of the Board designated to make compensation decisions relating tosenior executive officers of the Company Group. Prior to any time that such a committee has been designated, the Board shall be deemed the CompensationCommittee for purposes of this Agreement.(l)“Delay Period” shall have the meaning set forth in Section 13 hereof.(m)“Disability” shall mean any physical or mental disability or infirmity of Employee that prevents the performance ofEmployee’s duties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) monthperiod. Any question as to the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall bedetermined by a qualified, independent physician selected by the Company and approved by Employee (which approval shall not be unreasonablywithheld). The determination of any such physician shall be final and conclusive for all purposes of this Agreement. (n)“Employee” shall have the meaning set forth in the preamble hereto. (o)“Excess Payment” shall have the meaning ascribed to such term in Section 13(b) below.(p)“Excise Tax” shall have the meaning set forth in Section 13(b) hereof.(q)“Good Reason” shall mean, without Employee’s consent, (i) a material diminution in Employee’s title, duties, orresponsibilities as set forth in Section 3 hereof such that Employee is no longer serving in a senior executive capacity for the Company, (ii) a materialreduction in Base Salary set forth in Section 4(a) hereof or Annual Bonus opportunity set forth in Section 4(b) hereof (other than pursuant to an across-the-board reduction applicable to all similarly situated executives), (iii) the relocation of Employee’s principal place of employment (as provided in Section 3(c)hereof) more than fifty (50) miles from its current location, or (iv) any other material breach of a provision of this Agreement by the Company (other than aprovision that is covered by clause (i), (ii), or (iii) above). Employee acknowledges and agrees that her exclusive remedy in the event of any breach of thisAgreement shall be to assert Good Reason pursuant to the terms and conditions of Section 8(e) hereof. Notwithstanding the foregoing, during the Term, in theevent that the Company reasonably believes that Employee may have engaged in conduct that could constitute Just Cause hereunder, the Company may, inits sole and absolute discretion, suspend Employee for up to sixty (60) days from performing her duties hereunder, and in no event shall any such suspensionconstitute an event pursuant to which Employee may terminate employment with Good Reason or otherwise constitute a breach hereunder; provided, that nosuch suspension shall alter the Company’s obligations under this Agreement during such period of suspension.(r)“Gross-Up Payment” shall have the meaning ascribed to such term in Section 13(b) below.(s)“Just Cause” shall mean that the Company, acting in good faith based upon the information then known to it, determines that(i) Employee has committed or engaged in negligent or willful conduct that is likely to be detrimental to the Company or any member of the CompanyGroup; (ii) Employee has engaged in acts which constitute theft, fraud, or other illegal or dishonest conduct which are considered to be harmful to theCompany or any member of the Company Group as determined by the majority vote of its Board; (iii) Employee has willfully disobeyed the reasonable andlawful directives of any superior officer or the Board; (iv) Employee has refused or is unwilling to perform her job duties; (v) Employee has failed adequatelyto perform her job duties; (vi) Employee has demonstrated habitual absenteeism; (vii) Employee is substantially dependent on alcohol or any controlledsubstance or violates any general Company policy with regard to alcohol or controlled substances; (viii) Employee has engaged in acts which constitutesexual or other forms of illegal harassment or discrimination; (ix) Employee makes public remarks that disparage the Company, the Board, or its officers,directors, advisors, employees, affiliates or subsidiaries; (x) Employee violates her fiduciary duty to the Company, or her duty of loyalty to the Company;(xi) Employee materially breaches any term of this Agreement or the Non-Interference Agreement. The Parties acknowledge that this definition of “JustCause” in not intended and does not apply to any aspect of the relationship between the Company and Employee beyond determining Employee’s eligibilityfor severance pay pursuant to Section 8 below.(t)“Non-Interference Agreement” shall mean the Confidentiality, Non-Interference, and Invention Assignment Agreementattached hereto as Exhibit A.(u)“Parachute Payments” shall have the meaning set forth in Section 13(b) hereof.(v)“Parachute Tax” shall have the meaning ascribed to such term in Section 13(b) below.(w)“Person” shall mean any individual, corporation, partnership, limited liability company, joint venture, association, joint-stock company, trust (charitable or non-charitable), unincorporated organization, or other form of business entity.(x)“Release of Claims” shall mean the Release of Claims in substantially the same form attached hereto as Exhibit B (as thesame may be revised from time to time by the Company upon the advice of counsel to reflect changes in law).(y)“Severance Benefits” shall have the meaning set forth in Section 8(g) hereof.(z)“Severance Term” shall mean the six (6) month period following Employee’s termination by the Company without JustCause (other than by reason of death or Disability) or by Employee for Good Reason; provided, that if such termination occurs within twelve (12) monthsfollowing a Change in Control, the Severance Term shall be the twelve (12) month period following such termination.-2- (aa)“Stock Incentive Plan” shall mean the Clovis Oncology, Inc. 2011 Stock Incentive Plan, as the same may be amendedand/or restated from time to time. (bb)“Target Bonus” shall have the meaning set forth in Section 4(b) hereof.(cc)“Term” shall mean the period specified in Section 2 hereof.(dd)“Underpayment” shall have the meaning ascribed to such term in Section 13(b) below.Section 2.Acceptance and Term.The Company agrees to employ Employee, and Employee agrees to serve the Company, on the terms and conditions set forthherein. The Term shall commence on August 3, 2015 and shall continue until terminated in accordance with Section 8 hereof.Section 3.Position, Duties, and Responsibilities; Place of Performance.(a)Position, Duties, and Responsibilities. During the Term, Employee shall be employed and serve as the Chief Medical Officerand Executive Vice President of Clinical and Pre-Clinical Development and Pharmacovigilance of the Company (together with such other position orpositions consistent with Employee’s title as the Board shall specify from time to time) and shall have such duties and responsibilities commensurate withsuch title. Employee also agrees to serve as an officer and/or director of any other member of the Company Group, in each case without additionalcompensation. During the Term, Employee shall report to the Chief Executive Officer.(b)Performance. Employee shall devote her full business time, attention, skill, and best efforts to the performance of her dutiesunder this Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that (x) conflictswith the interests of the Company or any other member of the Company Group, (y) interferes with the proper and efficient performance of Employee’s dutiesfor the Company, or (z) interferes with Employee’s exercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing hereinshall preclude Employee from (i) serving, with the prior written consent of the Board, as a member of the boards of directors or advisory boards (or theirequivalents in the case of a non-corporate entity) of non-competing businesses and charitable organizations, (ii) engaging in charitable activities andcommunity affairs, and (iii) managing her personal investments and affairs; provided, however, that the activities set out in clauses (i), (ii), and (iii) shall belimited by Employee so as not to materially interfere, individually or in the aggregate, with the performance of her duties and responsibilities hereunder.(c)Principal Place of Employment. Employee’s principal place of employment shall be in San Francisco, California althoughEmployee understands and agrees that she may be required to travel from time to time for business reasons.Section 4.Compensation.During the Term, Employee shall be entitled to the following compensation:(a)Base Salary. Employee shall be paid an annualized Base Salary, payable in accordance with the regular payroll practices ofthe Company, of not less than $390,000, with increases, if any, as may be approved in writing by the Compensation Committee.(b)Annual Bonus. Employee shall be eligible for an annual incentive bonus award determined by the CompensationCommittee in respect of each fiscal year during the Term (the “Annual Bonus”). The target Annual Bonus for each fiscal year shall be 45% of Base Salary(the “Target Bonus”), with the actual Annual Bonus payable being based upon the level of achievement of annual Company and individual performanceobjectives for such fiscal year, as determined by the Compensation Committee and communicated to Employee. The Annual Bonus shall be paid toEmployee at the same time as annual bonuses are generally payable to other senior executives of the Company subject to Employee’s continuousemployment through the payment date.Section 5.Employee Benefits.During the Term, Employee shall be entitled to participate in health, insurance, retirement, and other benefits provided generally tosimilarly situated employees of the Company. Employee shall also be entitled to the same number of holidays, vacation days, and sick days, as well as anyother benefits, in each case as are generally allowed to similarly situated employees of the-3- Company in accordance with the Company policy as in effect from time to time. Nothing contained herein shall be construed to limit the Company’s abilityto amend, suspend, or terminate any employee benefit plan or policy at any time without providing Employee notice, and the right to do so is expresslyreserved.Section 6.Key-Man Insurance.At any time during the Term, the Company shall have the right to insure the life of Employee for the sole benefit of the Company, insuch amounts, and with such terms, as it may determine. All premiums payable thereon shall be the obligation of the Company. Employee shall have nointerest in any such policy, but agrees to cooperate with the Company in procuring such insurance by submitting to physical examinations, supplying allinformation required by the insurance company, and executing all necessary documents, provided that no financial obligation is imposed on Employee byany such documents.Section 7.Reimbursement of Business Expenses.During the Term, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing her duties and responsibilities hereunder, which are consistent with the Company’s policies in effect fromtime to time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses.Section 8.Termination of Employment.(a)General. The Term shall terminate upon the earliest to occur of (i) Employee’s death, (ii) a termination by reason of aDisability, (iii) a termination by the Company with or without Just Cause, and (iv) a termination by Employee with or without Good Reason. Upon anytermination of Employee’s employment for any reason, except as may otherwise be requested by the Company in writing and agreed upon in writing byEmployee, Employee shall be deemed to have resigned from any and all directorships, committee memberships, and any other positions Employee holds withthe Company or any other member of the Company Group and hereby agrees to execute any documents that the Company (or any member of the CompanyGroup) determines necessary to effectuate such resignations. Notwithstanding anything herein to the contrary, the payment (or commencement of a series ofpayments) hereunder of any nonqualified deferred compensation (within the meaning of Section 409A of the Code) upon a termination of employment shallbe delayed until such time as Employee has also undergone a “separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time suchnonqualified deferred compensation (calculated as of the date of Employee’s termination of employment hereunder) shall be paid (or commence to be paid)to Employee on the schedule set forth in this Section 8 as if Employee had undergone such termination of employment (under the same circumstances) on thedate of her ultimate “separation from service.”(b)Termination Due to Death or Disability. Employee’s employment shall terminate automatically upon her death. TheCompany may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effective upon Employee’s receiptof written notice of such termination. Upon Employee’s death or in the event that Employee’s employment is terminated due to her Disability, Employee orher estate or her beneficiaries, as the case may be, shall be entitled to:(i)The Accrued Obligations; and(ii)Any unpaid Annual Bonus in respect of any completed fiscal year that has ended prior to the date of suchtermination, which amount shall be paid at such time annual bonuses are paid to other senior executives of the Company, but in no event later than the datethat is 2½ months following the last day of the fiscal year in which such termination occurred.Following Employee’s death or a termination of Employee’s employment by reason of a Disability, except as set forth in this Section 8(b), Employee shallhave no further rights to any compensation or any other benefits under this Agreement.(c)Termination by the Company with Just Cause.(i)The Company may terminate Employee’s employment at any time with Just Cause, effective upon Employee’sreceipt of written notice of such termination; provided, however, that with respect to any Just Cause termination relying on clause (iv) or (v) of the definitionof Just Cause set forth in Section 1(r) hereof, to the extent that such act or acts or failure or failures to act are curable, Employee shall be given not less thanten (10) days’ written notice by the Board of the Company’s intention to terminate her for Just Cause, such notice to state in detail the particular act or acts orfailure or failures to act that constitute the grounds on which the proposed termination for Just Cause is based, and such termination shall be effective at theexpiration of such-4- ten (10) day notice period unless Employee has fully cured such act or acts or failure or failures to act that give rise to Just Cause during such period. (ii)In the event that the Company terminates Employee’s employment with Just Cause, she shall be entitled only tothe Accrued Obligations. Following such termination of Employee’s employment with Just Cause, except as set forth in this Section 8(c)(ii), Employee shallhave no further rights to any compensation or any other benefits under this Agreement.(d)Termination by the Company without Just Cause. The Company may terminate Employee’s employment at any timewithout Just Cause, effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by theCompany without Just Cause (other than due to death or Disability), Employee shall be entitled to:(i)The Accrued Obligations;(ii)Any unpaid Annual Bonus in respect of any completed fiscal year that has ended prior to the date of suchtermination, which amount shall be paid at such time annual bonuses are paid to other senior executives of the Company, but in no event later than the datethat is 2½ months following the last day of the fiscal year in which such termination occurred;(iii)Continued payment of Base Salary during the Severance Term, payable in accordance with the Company’sregular payroll practices;(iv)Subject to Employee’s election of COBRA continuation coverage under the Company’s group health plan, onthe first regularly scheduled payroll date of each month of the Severance Term, the Company will pay Employee an amount equal to the “applicablepercentage” of the monthly COBRA premium cost (which, for purposes hereof, shall be the percentage of Employee’s health care premium costs covered bythe Company as of the date of termination); provided, that the payments pursuant to this clause (iv) shall cease earlier than the expiration of the SeveranceTerm in the event that Employee becomes eligible to receive any health benefits, including through a spouse’s employer, during the Severance Term; and(v)In the event that such termination occurs within twelve (12) months following a Change in Control:(A)accelerated vesting of all of Employee’s stock options and other equity-based awards and continuedexercisability of Employee’s stock options in accordance with the terms of the plan document governing such awards; and(B)an amount equal to the Target Bonus, payable in substantially equal monthly installments during theSeverance Term.Notwithstanding the foregoing, the payments and benefits described in clauses (ii), (iii), (iv), and (v) above shall immediately terminate, and the Companyshall have no further obligations to Employee with respect thereto, in the event that Employee breaches any provision of the Non-InterferenceAgreement. Following such termination of Employee’s employment by the Company without Just Cause, except as set forth in this Section 8(d), Employeeshall have no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusiveremedy upon a termination of employment by the Company without Just Cause shall be receipt of the Severance Benefits.(e)Termination by Employee with Good Reason. Employee may terminate her employment with Good Reason by providingthe Company ten (10) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to be effective,must be provided to the Company within sixty (60) days of the occurrence of such event. During such ten (10) day notice period, the Company shall have acure right (if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of such cure period, and Employeeshall be entitled to the same payments and benefits as provided in Section 8(d) hereof for a termination by the Company without Just Cause, subject to thesame conditions on payment and benefits as described in Section 8(d) hereof. Following such termination of Employee’s employment by Employee withGood Reason, except as set forth in this Section 8(e), Employee shall have no further rights to any compensation or any other benefits under thisAgreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of theSeverance Benefits.(f)Termination by Employee without Good Reason. Employee may terminate her employment without Good Reason byproviding the Company thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section8(f), Employee shall be entitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 8(f), theCompany may, in its sole and absolute discretion, by written notice accelerate-5- such date of termination without changing the characterization of such termination as a termination by Employee without Good Reason. Following suchtermination of Employee’s employment by Employee without Good Reason, except as set forth in this Section 8(f), Employee shall have no further rights toany compensation or any other benefits under this Agreement. (g)Release. Notwithstanding any provision herein to the contrary, the payment of any amount or provision of any benefitpursuant to subsection (b), (d), or (e) of this Section 8 (other than the Accrued Obligations) (collectively, the “Severance Benefits”) shall be conditioned uponEmployee’s execution, delivery to the Company, and non-revocation of the Release of Claims (and the expiration of any revocation period contained in suchRelease of Claims) within sixty (60) days following the date of Employee’s termination of employment hereunder. If Employee fails to execute the Releaseof Claims in such a timely manner so as to permit any revocation period to expire prior to the end of such sixty (60) day period, or timely revokes heracceptance of such release following its execution, Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of theSeverance Benefits constitutes “nonqualified deferred compensation” for purposes of Section 409A of the Code, any payment of any amount or provision ofany benefit otherwise scheduled to occur prior to the sixtieth (60th) day following the date of Employee’s termination of employment hereunder, but for thecondition on executing the Release of Claims as set forth herein, shall not be made until the first regularly scheduled payroll date following such sixtieth(60th) day, after which any remaining Severance Benefits shall thereafter be provided to Employee according to the applicable schedule set forth herein. Forthe avoidance of doubt, in the event of a termination due to Employee’s death or Disability, Employee’s obligations herein to execute and not revoke theRelease of Claims may be satisfied on her behalf by her estate or a person having legal power of attorney over her affairs.Section 9.Non-Interference Agreement.As a condition of, and prior to commencement of, Employee’s employment with the Company, Employee shall have executed anddelivered to the Company the Non-Interference Agreement. The parties hereto acknowledge and agree that this Agreement and the Non-InterferenceAgreement shall be considered separate contracts, and the Non-Interference Agreement will survive the termination of this Agreement for any reason.Section 10.Representations and Warranties of Employee.Employee represents and warrants to the Company that —(a)Employee is entering into this Agreement voluntarily and that her employment hereunder and compliance with the terms andconditions hereof will not conflict with or result in the breach by her of any agreement to which she is a party or by which she may be bound;(b)Employee has not violated, and in connection with her employment with the Company will not violate, any non-solicitation, non-competition, or other similar covenant or agreement of a prior employer by which she is or may be bound; and(c)in connection with her employment with the Company, Employee will not use any confidential or proprietary informationshe may have obtained in connection with employment with any prior employer.Section 11.Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any taxadvice to her in connection with this Agreement and that she has been advised by the Company to seek tax advice from her own tax advisors regarding thisAgreement and payments that may be made to her pursuant to this Agreement, including specifically, the application of the provisions of Section 409A of theCode to such payments.Section 12.Set Off; Mitigation. The Company’s obligation to pay Employee the amounts provided and to make the arrangements provided hereunder shall be subject toset-off, counterclaim, or recoupment of amounts owed by Employee to the Company or its affiliates; provided, however, that to the extent any amount sosubject to set-off, counterclaim, or recoupment is payable in installments hereunder, such set-off, counterclaim, or recoupment shall not modify the applicablepayment date of any installment, and to the extent an obligation cannot be satisfied by reduction of a single installment payment, any portion not satisfiedshall remain an outstanding obligation of Employee and shall be applied to the next installment only at such time the installment is otherwise payablepursuant to the specified payment schedule. Employee shall not be required to mitigate the amount of any payment provided pursuant to this Agreement byseeking other employment or otherwise, and except as provided in Section 8(d)(iv) hereof, the amount of any-6- payment provided for pursuant to this Agreement shall not be reduced by any compensation earned as a result of Employee’s other employment or otherwise.Section 13.Additional Tax Provisions. (a)Section 409A Provisions. Notwithstanding any provision in this Agreement to the contrary —(i)Any payment otherwise required to be made hereunder to Employee at any date as a result of the termination ofEmployee’s employment shall be delayed for such period of time as may be necessary to meet the requirements of Section 409A(a)(2)(B)(i) of the Code (the“Delay Period”). On the first business day following the expiration of the Delay Period, Employee shall be paid, in a single cash lump sum, an amount equalto the aggregate amount of all payments delayed pursuant to the preceding sentence, and any remaining payments not so delayed shall continue to be paidpursuant to the payment schedule set forth herein. (ii)Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes ofSection 409A of the Code.(iii)To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under thisAgreement constitutes nonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement shall bemade by the Company no later than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the rightto reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible forreimbursement or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to beprovided in any other taxable year; provided, that the foregoing clause shall not be violated with regard to expenses reimbursed under any arrangementcovered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect.(iv)While the payments and benefits provided hereunder are intended to be structured in a manner to avoid theimplication of any penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for anyadditional tax, interest, or penalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply withSection 409A of the Code (other than for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).(b)Parachute Payment Gross-Up. If any payment, benefit, or distribution of any type to or for the benefit of Employee, whetherpaid or payable, provided or to be provided, or distributed or distributable pursuant to the terms of this Agreement or otherwise (collectively, the “ParachutePayments”) would subject Employee to the excise tax imposed under Section 4999 of the Code (the “Excise Tax”), the Company will make an additionalpayment to Employee in an amount (the “Gross-Up Payment”) such that, after payment all taxes and any interest or penalties imposed with respect to suchtaxes (including, without limitation, federal, state, local income, employment, excise and other similar taxes, but excluding any taxes imposed under Section409A of the Code) (the “Parachute Tax”) on both the Parachute Payments and the Gross-Up Payment, Employee will be in the same position as if noParachute Tax had been imposed; provided, that in no event may the Gross-Up Payment exceed $2,000,000. Any Gross-Up Payment shall be timely paid bythe Company on Employee’s behalf directly to the appropriate taxing authorities when due, but in all events no later than the last day of the calendar yearafter the calendar year in which the Parachute Tax shall be paid. The determinations with respect to this Section 13(b) shall be made by an independentaccounting firm selected by the Company and reasonably acceptable to Employee (the “Accounting Firm”) paid by the Company.(i)It is possible that, after the determinations and selections made pursuant to Section 13(b), Employee will receiveParachute Payments and Gross-Up Payments that are, in the aggregate, either more or less than the limitations provided in Section 13(b) above (hereafterreferred to as an “Excess Payment” or “Underpayment”, respectively). If it is established, pursuant to a final determination of a court or an Internal RevenueService proceeding that has been finally and conclusively resolved, that an Excess Payment has been made, then Employee shall refund the Excess Paymentto the Company promptly on demand, together with an additional payment in an amount equal to the product obtained by multiplying the Excess Paymenttimes the applicable annual federal rate (as determined in and under Section 1274(d) of the Code) times a fraction whose numerator is the number of dayselapsed from the date of Employee’s receipt of such Excess Payment through the date of such refund and whose denominator is 365. In the event that it isdetermined (y) by a court of competent jurisdiction, or (z) by the Accounting Firm upon request by Employee or the Company, that an Underpayment hasoccurred, the Company shall pay an amount equal to the Underpayment to Employee within ten (10) days of such determination together with an additionalpayment in an amount equal to the product obtained by multiplying the Underpayment times the applicable annual federal rate (as determined in and underSection 1274(d) of the Code) times a fraction whose numerator is the number of days elapsed from the date of the Underpayment through the-7- date of such payment and whose denominator is 365; provided, that in no event shall the sum of (i) the Gross-Up Payment, and (ii) the additional paymentpursuant to this sentence, exceed $2,000,000. (ii)Any Gross-Up Payment, as determined pursuant to this Section 13(b), shall be paid by the Company and remittedto the relevant tax authorities when such payment is due, provided that in no event shall such payment be made later than the end of your taxable year nextfollowing Employee’s taxable year in which the Parachute Tax on a Parachute Payment are remitted to the Internal Revenue Service or any other applicabletaxing authority or, in the case of amounts relating to a claim described in Section 13(b)(i) that does not result in the remittance of any federal, state, local andforeign income, excise, social security and other taxes, the calendar year in which the claim is finally settled or otherwise resolved.Section 14.Successors and Assigns; No Third-Party Beneficiaries.(a)The Company. This Agreement shall inure to the benefit of the Company and its respective successors and assigns. Neitherthis Agreement nor any of the rights, obligations, or interests arising hereunder may be assigned by the Company to a Person (other than another member ofthe Company Group, or its or their respective successors) without Employee’s prior written consent (which shall not be unreasonably withheld, delayed, orconditioned); provided, however, that in the event of a sale of all or substantially all of the assets of the Company or any direct or indirect division orsubsidiary thereof to which the Employee’s employment primarily relates, the Company may provide that this Agreement will be assigned to, and assumedby, the acquiror of such assets, it being agreed that in such circumstances, Employee’s consent will not be required in connection therewith.(b)Employee. Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided, however, that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.(c)No Third-Party Beneficiaries. Except as otherwise set forth in Section 8(b) or Section 14(b) hereof, nothing expressed orreferred to in this Agreement will be construed to give any Person other than the Company, the other members of the Company Group, and Employee anylegal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement.Section 15.Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing andsigned by each of the parties hereto; provided, however, that any such waiver, alteration, amendment, or modification must be consented to on theCompany’s behalf by the Board. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to anysubsequent occurrences or transactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 16.Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a courtof competent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereofshall be deemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid orunenforceable term or provision hereof.Section 17.Governing Law and Jurisdiction.EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY, INTERPRETATION, CONSTRUCTION, AND PERFORMANCEOF THIS AGREEMENT IS GOVERNED BY AND IS TO BE CONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TOAGREEMENTS MADE AND TO BE PERFORMED IN THAT STATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. ANY DISPUTE OR CLAIMARISING OUT OF OR RELATING TO THIS AGREEMENT OR CLAIM OF BREACH HEREOF SHALL BE BROUGHT EXCLUSIVELY IN THE UNITEDSTATES DISTRICT COURT FOR THE 20th JUDICIAL DISTRICT OF COLORADO, TO THE EXTENT FEDERAL JURISDICTION EXISTS, AND IN ANYCOURT SITTING IN COLORADO, BUT ONLY IN THE EVENT FEDERAL JURISDICTION DOES NOT EXIST, AND ANY APPLICABLE APPELLATECOURTS. BY EXECUTION OF THIS AGREEMENT, THE PARTIES HERETO, AND THEIR RESPECTIVE AFFILIATES, CONSENT TO THE EXCLUSIVEJURISDICTION OF SUCH COURTS, AND WAIVE ANY RIGHT TO CHALLENGE JURISDICTION OR VENUE IN SUCH COURT WITH REGARD TO ANYSUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THIS-8- AGREEMENT. EACH PARTY TO THIS AGREEMENT ALSO HEREBY WAIVES ANY RIGHT TO TRIAL BY JURY IN CONNECTION WITH ANY SUIT,ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THIS AGREEMENT.Section 18.Notices.(a)Place of Delivery. Every notice or other communication relating to this Agreement shall be in writing, and shall be mailedto or delivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or delivered to theother party as herein provided; provided, that unless and until some other address be so designated, all notices and communications by Employee to theCompany shall be mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company to Employeemay be given to Employee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b)Date of Delivery. Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date ofsuch delivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered orcertified mail, on the third business day after the date of such mailing.Section 19.Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitutea part thereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 20.Entire Agreement.This Agreement, together with any exhibits attached hereto, constitutes the entire understanding and agreement of the parties heretoregarding the employment of Employee. This Agreement supersedes all prior negotiations, discussions, correspondence, communications, understandings,and agreements between the parties relating to the subject matter of this Agreement.Section 21.Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 8 through Section 22 of this Agreement (together with anyrelated definitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 22.Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which togethershall constitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.***[Signatures to appear on the following page.] -9- IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written. CLOVIS ONCOLOGY, INC. /s/ PATRICK J. MAHAFFY By: Patrick J. Mahaffy Title: President and CEO EMPLOYEE /s/ LINDSEY ROLFE Lindsey Rolfe  EXHIBIT ACONFIDENTIALITY, NON-INTERFERENCE, AND INVENTION ASSIGNMENT AGREEMENTAs a condition of my becoming employed by, or continuing employment with, Clovis Oncology, Inc., a Delaware corporation (the“Company”), and in consideration of my employment with the Company and my receipt of the compensation now and hereafter paid to me by the Company,I agree to the following:Section 23.Confidential Information.(a)Company Group Information. I acknowledge that, during the course of my employment, I will have access toinformation about the Company and its direct and indirect subsidiaries and affiliates (collectively, the “Company Group”) and that my employment with theCompany shall bring me into close contact with confidential and proprietary information of the Company Group. In recognition of the foregoing, I agree, atall times during the term of my employment with the Company and for the ten (10) year period following my termination of my employment for any reason,to hold in confidence, and not to use, except for the benefit of the Company Group, or to disclose to any person, firm, corporation, or other entity withoutwritten authorization of the Company, any Confidential Information that I obtain or create. I further agree not to make copies of such ConfidentialInformation except as authorized by the Company. I understand that “Confidential Information” means information that the Company Group has developed,acquired, created, compiled, discovered, or owned or will develop, acquire, create, compile, discover, or own, that has value in or to the business of theCompany Group that is not generally known and that the Company wishes to maintain as confidential. I understand that Confidential Information includes,but is not limited to, any and all non-public information that relates to the actual or anticipated business and/or products, research, or development of theCompany, or to the Company’s technical data, trade secrets, or know-how, including, but not limited to, research, product plans, or other informationregarding the Company’s products or services and markets, customer lists, and customers (including, but not limited to, customers of the Company on whom Icalled or with whom I may become acquainted during the term of my employment), software, developments, inventions, processes, formulas, technology,designs, drawings, engineering, hardware configuration information, marketing, finances, and other business information disclosed by the Company eitherdirectly or indirectly in writing, orally, or by drawings or inspection of premises, parts, equipment, or other Company property. Notwithstanding theforegoing, Confidential Information shall not include (i) any of the foregoing items that have become publicly and widely known through no unauthorizeddisclosure by me or others who were under confidentiality obligations as to the item or items involved or (ii) any information that I am required to disclose to,or by, any governmental or judicial authority; provided, however, that in such event I will give the Company prompt written notice thereof so that theCompany Group may seek an appropriate protective order and/or waive in writing compliance with the confidentiality provisions of this Confidentiality,Non-Interference, and Invention Assignment Agreement (the “Non-Interference Agreement”).(b)Former Employer Information. I represent that my performance of all of the terms of this Non-InterferenceAgreement as an employee of the Company has not breached and will not breach any agreement to keep in confidence proprietary information, knowledge,or data acquired by me in confidence or trust prior or subsequent to the commencement of my employment with the Company, and I will not disclose to anymember of the Company Group, or induce any member of the Company Group to use, any developments, or confidential or proprietary information ormaterial I may have obtained in connection with employment with any prior employer in violation of a confidentiality agreement, nondisclosure agreement,or similar agreement with such prior employer.Section 24.Developments.(a)Developments Retained and Licensed. I have attached hereto, as Schedule A, a list describing with particularityall developments, original works of authorship, developments, improvements, and trade secrets that I can demonstrate were created or owned by me prior tothe commencement of my employment (collectively referred to as “Prior Developments”), which belong solely to me or belong to me jointly with another,that relate in any way to any of the actual or proposed businesses, products, or research and development of any member of the Company Group, and that arenot assigned to the Company hereunder, or if no such list is attached, I represent that there are no such Prior Developments. If, during any period duringwhich I perform or performed services for the Company Group both before or after the date hereof (the “Assignment Period”), whether as an officer, employee,director, independent contractor, consultant, or agent, or in any other capacity, I incorporate (or have incorporated) into a Company Group product or processa Prior Development owned by me or in which I have an interest, I hereby grant the Company, and the Company Group shall have, a non-exclusive, royalty-free, irrevocable, perpetual, transferable worldwide license (with the right to sublicense) to make, have made, copy, modify, make derivative works of, use,sell, and otherwise distribute such Prior Development as part of or in connection with such product or process.  (b)Assignment of Developments. I agree that I will, without additional compensation, promptly make full written disclosure to theCompany, and will hold in trust for the sole right and benefit of the Company all developments, original works of authorship, inventions, concepts, know-how, improvements, trade secrets, and similar proprietary rights, whether or not patentable or registrable under copyright or similar laws, which I may solelyor jointly conceive or develop or reduce to practice, or have solely or jointly conceived or developed or reduced to practice, or have caused or may cause tobe conceived or developed or reduced to practice, during the Assignment Period, whether or not during regular working hours, provided they either (i) relateat the time of conception, development or reduction to practice to the business of any member of the Company Group, or the actual or anticipated researchor development of any member of the Company Group; (ii) result from or relate to any work performed for any member of the Company Group; or (iii) aredeveloped through the use of equipment, supplies, or facilities of any member of the Company Group, or any Confidential Information, or in consultationwith personnel of any member of the Company Group (collectively referred to as “Developments”). I further acknowledge that all Developments made byme (solely or jointly with others) within the scope of and during the Assignment Period are “works made for hire” (to the greatest extent permitted byapplicable law) for which I am, in part, compensated by my salary, unless regulated otherwise by law, but that, in the event any such Development is deemednot to be a work made for hire, I hereby assign to the Company, or its designee, all my right, title, and interest throughout the world in and to any suchDevelopment. If any Developments cannot be assigned, I hereby grant to each member of the Company Group an exclusive, assignable, irrevocable,perpetual, worldwide, sublicenseable (through one or multiple tiers), royalty-free, unlimited license to use, make, modify, sell, offer for sale, reproduce,distribute, create derivative works of, publicly perform, publicly display and digitally perform and display such work in any media now known or hereafterknown. Outside the scope of my service, whether during or after my employment with any member of the Company Group, I agree not to (i) modify, adapt,alter, translate, or create derivative works from any such work of authorship or (ii) merge any such work of authorship with other Developments. To theextent rights related to paternity, integrity, disclosure and withdrawal (collectively, “Moral Rights”) may not be assignable under applicable law and to theextent the following is allowed by the laws in the various countries where Moral Rights exist, I hereby irrevocably waive such Moral Rights and consent toany action of any member of the Company Group that would violate such Moral Rights in the absence of such consent. I understand that the provisions ofthis Non-Interference Agreement requiring assignment of Developments to the Company do not apply to any invention which qualifies fully under theprovisions of Section 2870 of the California Labor Code (attached hereto as Schedule B). I will advise the Company promptly in writing of any inventionsthat I believe meet the criteria in Section 2870 of the California Labor Code and I bear the full burden of proving to any member of the Company Group thatan invention qualifies fully under Section 2870 of the California Labor Code. I acknowledge receipt of this Non-Interference Agreement and of writtennotification of the provisions of Section 2870 of the California Labor Code. (c)Maintenance of Records. I agree to keep and maintain adequate and current written records of all Developmentsmade by me (solely or jointly with others) during the Assignment Period. The records may be in the form of notes, sketches, drawings, flow charts, electronicdata or recordings, and any other format. The records will be available to and remain the sole property of the Company Group at all times. I agree not toremove such records from the Company’s place of business except as expressly permitted by Company Group policy, which may, from time to time, berevised at the sole election of the Company Group for the purpose of furthering the business of the Company Group.(d)Intellectual Property Rights. I agree to assist the Company, or its designee, at the Company’s expense, in everyway to secure the rights of the Company Group in the Developments and any copyrights, patents, trademarks, service marks, database rights, domain names,mask work rights, moral rights, and other intellectual property rights relating thereto in any and all countries, including the disclosure to the Company of allpertinent information and data with respect thereto, the execution of all applications, specifications, oaths, assignments, recordations, and all otherinstruments that the Company shall deem necessary in order to apply for, obtain, maintain, and transfer such rights and in order to assign and convey to theCompany Group the sole and exclusive right, title, and interest in and to such Developments, and any intellectual property and other proprietary rightsrelating thereto. I further agree that my obligation to execute or cause to be executed, when it is in my power to do so, any such instrument or papers shallcontinue after the Assignment Period until the expiration of the last such intellectual property right to expire in any country of the world; provided, however,the Company shall reimburse me for my reasonable expenses incurred in connection with carrying out the foregoing obligation. If the Company is unablebecause of my mental or physical incapacity or unavailability for any other reason to secure my signature to apply for or to pursue any application for anyUnited States or foreign patents or copyright registrations covering Developments or original works of authorship assigned to the Company as above, then Ihereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact to act for and in mybehalf and stead to execute and file any such applications or records and to do all other lawfully permitted acts to further the application for, prosecution,issuance, maintenance, and transfer of letters patent or registrations thereon with the same legal force and effect as if originally executed by me. I herebywaive and irrevocably quitclaim to the Company any and all claims, of any nature whatsoever, that I now or hereafter have for past, present, or futureinfringement of any and all proprietary rights assigned to the Company.  Section 25.Returning Company Group Documents. I agree that, at the time of termination of my employment with the Company for any reason, I will deliver to the Company (and will notkeep in my possession, recreate, or deliver to anyone else) any and all Confidential Information and all other documents, materials, information, and propertydeveloped by me pursuant to my employment or otherwise belonging to the Company. I agree further that any property situated on the Company’s premisesand owned by the Company (or any other member of the Company Group), including disks and other storage media, filing cabinets, and other work areas, issubject to inspection by personnel of any member of the Company Group at any time with or without notice. Section 26.Disclosure of Agreement.As long as it remains in effect, I will disclose the existence of this Non-Interference Agreement to any prospective employer, partner, co-venturer, investor, or lender prior to entering into an employment, partnership, or other business relationship with such person or entity.Section 27.Restrictions on Interfering.(a)Non-Competition. During the period of my employment with the Company (the “Employment Period”), I shallnot, directly or indirectly, individually or on behalf of any person, company, enterprise, or entity, or as a sole proprietor, partner, stockholder, director, officer,principal, agent, or executive, or in any other capacity or relationship, (i) engage in any Competitive Activities, (ii) own any securities (debt or equity) in anyperson, company, enterprise, or entity that is engaged in Competitive Activities (other than a completely passive ownership interest of no more than twopercent (2%) of the equity securities of a publicly-traded company), within the United States or any other jurisdiction in which the Company Group isactively engaged in business, or (iii) engage in any Interfering Activities.(b)Non-Interference. During the Restricted Period, I shall not, directly or indirectly for my own account or for theaccount of any other individual or entity, engage in Soliciting Activities.(c)Definitions. For purposes of this Non-Interference Agreement :(i)“Business Relation” shall mean any current or prospective client, customer, licensee, or other businessrelation of the Company Group, or any such relation that was a client, customer, licensee, supplier, or other business relation within the six (6)month period prior to the expiration of the Employment Period, in each case, to whom I provided services, or with whom I transacted business, orwhose identity became known to me in connection with my relationship with or employment by the Company Group.(ii)“Competitive Activities” shall mean any business activities in which any member of the CompanyGroup is engaged (or has committed plans to engage) during the Employment Period.(iii)“Interfering Activities” shall mean encouraging, soliciting, or inducing, or in any manner attemptingto encourage, solicit, or induce, any Business Relation to cease doing business with or reduce the amount of business conducted with any memberof the Company Group.(iv)“Person” shall mean any individual, corporation, partnership, limited liability company, joint venture,association, joint‑stock company, trust (charitable or non-charitable), unincorporated organization, or other form of business entity.(v)“Restricted Period” shall mean the period commencing on the date hereof and ending on the twelve(12) month anniversary of the date of the termination of the Employment Period for any reason.(vi)“Soliciting Activities” shall mean encouraging, soliciting, or inducing, or in any manner attempting toencourage, solicit, or induce, any Person employed by, or providing consulting services to, any member of the Company Group to terminate suchPerson’s employment or services (or in the case of a consultant, materially reducing such services) with any member of the Company Group.(d)Non-Disparagement. I agree that during the Employment Period, and at all times thereafter, I will not make anydisparaging or defamatory comments regarding any member of the Company Group or its respective current or former  directors, officers, or employees in any respect or make any comments concerning any aspect of my relationship with any member of the Company Group orany conduct or events which precipitated any termination of my employment from any member of the Company Group. However, my obligations under thissubparagraph (d) shall not apply to disclosures required by applicable law, regulation, or order of a court or governmental agency. Section 28.Reasonableness of Restrictions.I acknowledge and recognize the highly competitive nature of the Company’s business, that access to Confidential Information rendersme special and unique within the Company’s industry, and that I will have the opportunity to develop substantial relationships with existing and prospectiveclients, accounts, customers, consultants, contractors, investors, and strategic partners of the Company Group during the course of and as a result of myemployment with the Company. In light of the foregoing, I recognize and acknowledge that the restrictions and limitations set forth in this Non-InterferenceAgreement are reasonable and valid in geographical and temporal scope and in all other respects and are essential to protect the value of the business andassets of the Company Group. I acknowledge further that the restrictions and limitations set forth in this Non-Interference Agreement will not materiallyinterfere with my ability to earn a living following the termination of my employment with the Company and that my ability to earn a livelihood withoutviolating such restrictions is a material condition to my employment with the Company.Section 29.Independence; Severability; Blue Pencil.Each of the rights enumerated in this Non-Interference Agreement shall be independent of the others and shall be in addition to and notin lieu of any other rights and remedies available to the Company Group at law or in equity. If any of the provisions of this Non-Interference Agreement orany part of any of them is hereafter construed or adjudicated to be invalid or unenforceable, the same shall not affect the remainder of this Non-InterferenceAgreement, which shall be given full effect without regard to the invalid portions. If any of the covenants contained herein are held to be invalid orunenforceable because of the duration of such provisions or the area or scope covered thereby, I agree that the court making such determination shall havethe power to reduce the duration, scope, and/or area of such provision to the maximum and/or broadest duration, scope, and/or area permissible by law, and inits reduced form said provision shall then be enforceable.Section 30.Injunctive Relief.I expressly acknowledge that any breach or threatened breach of any of the terms and/or conditions set forth in this Non-InterferenceAgreement may result in substantial, continuing, and irreparable injury to the members of the Company Group. Therefore, I hereby agree that, in addition toany other remedy that may be available to the Company, any member of the Company Group shall be entitled to seek injunctive relief, specific performance,or other equitable relief by a court of appropriate jurisdiction in the event of any breach or threatened breach of the terms of this Non-Interference Agreementwithout the necessity of proving irreparable harm or injury as a result of such breach or threatened breach. Notwithstanding any other provision to thecontrary, I acknowledge and agree that the Restricted Period shall be tolled during any period of violation of any of the covenants in Section 5 hereof andduring any other period required for litigation during which the Company or any other member of the Company Group seeks to enforce such covenantsagainst me if it is ultimately determined that I was in breach of such covenants.Section 31.Cooperation.I agree that, following any termination of my employment, I will continue to provide reasonable cooperation to the Company and/or anyother member of the Company Group and its or their respective counsel in connection with any investigation, administrative proceeding, or litigationrelating to any matter that occurred during my employment in which I was involved or of which I have knowledge. As a condition of such cooperation, theCompany shall reimburse me for reasonable out-of-pocket expenses incurred at the request of the Company with respect to my compliance with thisparagraph. I also agree that, in the event that I am subpoenaed by any person or entity (including, but not limited to, any government agency) to givetestimony or provide documents (in a deposition, court proceeding, or otherwise) that in any way relates to my employment by the Company and/or anyother member of the Company Group, I will give prompt notice of such request to the Company and will make no disclosure until the Company and/or theother member of the Company Group has had a reasonable opportunity to contest the right of the requesting person or entity to such disclosure.Section 32.General Provisions. (a)Governing Law and Jurisdiction. EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY,INTERPRETATION, CONSTRUCTION, AND PERFORMANCE OF THIS NON-INTERFERENCE AGREEMENT IS  GOVERNED BY AND IS TO BE CONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TO AGREEMENTS MADE AND TOBE PERFORMED IN THAT STATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. FURTHER, I HEREBY WAIVE ANY RIGHT TO TRIAL BYJURY IN CONNECTION WITH ANY SUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THIS NON-INTERFERENCE AGREEMENT. (b)Entire Agreement. This Non-Interference Agreement sets forth the entire agreement and understanding betweenthe Company and me relating to the subject matter herein and merges all prior discussions between us. No modification or amendment to this Non-Interference Agreement, nor any waiver of any rights under this Non-Interference Agreement, will be effective unless in writing signed by the party to becharged. Any subsequent change or changes in my duties, obligations, rights, or compensation will not affect the validity or scope of this Non-InterferenceAgreement.(c)No Right of Continued Employment. I acknowledge and agree that nothing contained herein shall be construedas granting me any right to continued employment by the Company, and the right of the Company to terminate my employment at any time and for anyreason, with or without cause, is specifically reserved.(d)Successors and Assigns. This Non-Interference Agreement will be binding upon my heirs, executors,administrators, and other legal representatives and will be for the benefit of the Company, its successors, and its assigns. I expressly acknowledge and agreethat this Non-Interference Agreement may be assigned by the Company without my consent to any other member of the Company Group as well as anypurchaser of all or substantially all of the assets or stock of the Company, whether by purchase, merger, or other similar corporate transaction, provided thatthe license granted pursuant to Section 2(a) may be assigned to any third party by the Company without my consent.(e)Survival. The provisions of this Non-Interference Agreement shall survive the termination of my employmentwith the Company and/or the assignment of this Non-Interference Agreement by the Company to any successor in interest or other assignee.***I, Dr. Lindsey Rolfe, have executed this Confidentiality, Non-Interference, and Invention Assignment Agreement on the respective dateset forth below:Date:February 25, 2016 /s/ DR. LINDSEY ROLFE (Signature) Dr. Lindsey Rolfe (Type/Print Name)  SCHEDULE ALIST OF PRIOR DEVELOPMENTSAND ORIGINAL WORKS OF AUTHORSHIPEXCLUDED FROM SECTION 2TitleDateIdentifying Number orBrief Description X No Developments or improvements_____Additional Sheets Attached Signature of Employee:/s/ DR. LINDSEY ROLFE Print Name of Employee:Dr. Lindsey RolfeDate: February 25, 2016  EXHIBIT BRELEASE OF CLAIMSAs used in this Release of Claims (this “Release”), the term “claims” will include all claims, covenants, warranties, promises,undertakings, actions, suits, causes of action, obligations, debts, accounts, attorneys’ fees, judgments, losses, and liabilities, of whatsoever kind or nature, inlaw, in equity, or otherwise.For and in consideration of the Severance Benefits (as defined in my Employment Agreement, dated January ___, 2016, with ClovisOncology, Inc. (my “Employment Agreement”)), and other good and valuable consideration, I, Dr. Lindsey Rolfe, for and on behalf of myself and my heirs,administrators, executors, and assigns, effective as of the date on which this release becomes effective pursuant to its terms, do fully and forever release,remise, and discharge the Company and each of its direct and indirect subsidiaries and affiliates, and its successors and assigns, together with its officers,directors, partners, shareholders, employees, and agents (collectively, the “Group”), from any and all claims whatsoever up to the date hereof that I had, mayhave had, or now have against the Group, whether known or unknown, for or by reason of any matter, cause, or thing whatsoever, including any claim arisingout of or attributable to my employment or the termination of my employment with the Company, whether for tort, breach of express or implied employmentcontract, intentional infliction of emotional distress, wrongful termination, unjust dismissal, defamation, libel, or slander, or under any federal, state, or locallaw dealing with discrimination based on age, race, sex, national origin, handicap, religion, disability, or sexual orientation. The release of claims in thisRelease includes, but is not limited to, all claims arising under the Age Discrimination in Employment Act (“ADEA”), Title VII of the Civil Rights Act, theAmericans with Disabilities Act, the Civil Rights Act of 1991, the Family Medical Leave Act, and the Equal Pay Act, each as may be amended from time totime, and all other federal, state, and local laws, the common law, and any other purported restriction on an employer’s right to terminate the employment ofemployees. The release contained herein is intended to be a general release of any and all claims to the fullest extent permissible by law.I acknowledge and agree that as of the date I execute this Release, I have no knowledge of any facts or circumstances that give rise orcould give rise to any claims under any of the laws listed in the preceding paragraph.By executing this Release, I specifically release all claims relating to my employment and its termination under ADEA, a United Statesfederal statute that, among other things, prohibits discrimination on the basis of age in employment and employee benefit plans.Notwithstanding any provision of this Release to the contrary, by executing this Release, I am not releasing (i) any claims relating to myrights under Section 8 of my Employment Agreement, (ii) any claims that cannot be waived by law, or (iii) my right of indemnification as provided by, and inaccordance with the terms of, the Company’s by-laws or a Company insurance policy providing such coverage, as any of such may be amended from time totime.I hereby expressly and knowingly waive application of Section 1542 of the California Civil Code and all comparable, equivalent or similarprovisions of state or federal law. I further certify that I have read and understand the provisions of Section 1542 of the California Civil Code, which reads asfollows:“A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS ORHER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS ORHER SETTLEMENT WITH THE DEBTOR.”]I expressly acknowledge and agree that I –§Am able to read the language, and understand the meaning and effect, of this Release;§Have no physical or mental impairment of any kind that has interfered with my ability to read and understand themeaning of this Release or its terms, and that I am not acting under the influence of any medication, drug, or chemical of any type in entering intothis Release;§Am specifically agreeing to the terms of the release contained in this Release because the Company has agreed to payme the Severance Benefits in consideration for my agreement to accept it in full settlement of all possible claims I might have or ever have had, andbecause of my execution of this Release;  §Acknowledge that, but for my execution of this Release, I would not be entitled to the Severance Benefits; §Understand that, by entering into this Release, I do not waive rights or claims under ADEA that may arise after thedate I execute this Release;§Had or could have had [twenty-one (21)][forty-five (45)]1 days from the date of my termination of employment (the“Release Expiration Date”) in which to review and consider this Release, and that if I execute this Release prior to the Release Expiration Date, Ihave voluntarily and knowingly waived the remainder of the review period;§Have not relied upon any representation or statement not set forth in this Release or my Employment Agreementmade by the Company or any of its representatives;§Was advised to consult with my attorney regarding the terms and effect of this Release; and§Have signed this Release knowingly and voluntarily.I represent and warrant that I have not previously filed, and to the maximum extent permitted by law agree that I will not file, acomplaint, charge, or lawsuit against any member of the Group regarding any of the claims released herein. If, notwithstanding this representation andwarranty, I have filed or file such a complaint, charge, or lawsuit, I agree that I shall cause such complaint, charge, or lawsuit to be dismissed with prejudiceand shall pay any and all costs required in obtaining dismissal of such complaint, charge, or lawsuit, including without limitation the attorneys’ fees of anymember of the Group against whom I have filed such a complaint, charge, or lawsuit. This paragraph shall not apply, however, to a claim of agediscrimination under ADEA or to any non-waivable right to file a charge with the United States Equal Employment Opportunity Commission (the “EEOC”);provided, however, that if the EEOC were to pursue any claims relating to my employment with Company, I agree that I shall not be entitled to recover anymonetary damages or any other remedies or benefits as a result and that this Release and Section 8 of my Employment Agreement will control as theexclusive remedy and full settlement of all such claims by me.I hereby agree to waive any and all claims to re-employment with the Company or any other member of the Group and affirmativelyagree not to seek further employment with the Company or any other member of the Group.Notwithstanding anything contained herein to the contrary, this Release will not become effective or enforceable prior to the expirationof the period of seven (7) calendar days immediately following the date of its execution by me (the “Revocation Period”), during which time I may revoke myacceptance of this Release by notifying the Company and the Board of Directors of the Company, in writing, delivered to the Company at its principalexecutive office, marked for the attention of its Chief Executive Officer. To be effective, such revocation must be received by the Company no later than11:59 p.m. on the seventh (7th) calendar day following the execution of this Release. Provided that the Release is executed and I do not revoke it during theRevocation Period, the eighth (8th) calendar day following the date on which this Release is executed shall be its effective date. I acknowledge and agreethat if I revoke this Release during the Revocation Period, this Release will be null and void and of no effect, and neither the Company nor any other memberof the Group will have any obligations to pay me the Severance Benefits.The provisions of this Release shall be binding upon my heirs, executors, administrators, legal personal representatives, and assigns. Ifany provision of this Release shall be held by any court of competent jurisdiction to be illegal, void, or unenforceable, such provision shall be of no force oreffect. The illegality or unenforceability of such provision, however, shall have no effect upon and shall not impair the enforceability of any other provisionof this Release. 1 To be selected based on whether applicable termination was “in connection with an exit incentive or other employment termination program” (as suchphrase is defined in the Age Discrimination in Employment Act of 1967).  EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY, INTERPRETATION, CONSTRUCTION, AND PERFORMANCEOF THIS RELEASE IS GOVERNED BY AND IS TO BE CONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TOAGREEMENTS MADE AND TO BE PERFORMED IN THAT STATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. ANY DISPUTE OR CLAIMARISING OUT OF OR RELATING TO THIS RELEASE OR CLAIM OF BREACH HEREOF SHALL BE BROUGHT EXCLUSIVELY IN THE UNITEDSTATES DISTRICT COURT FOR THE 20th JUDICIAL DISTRICT OF COLORADO, TO THE EXTENT FEDERAL JURISDICTION EXISTS, AND IN ANYCOURT SITTING IN COLORADO, BUT ONLY IN THE EVENT FEDERAL JURISDICTION DOES NOT EXIST, AND ANY APPLICABLE APPELLATECOURTS. BY EXECUTION OF THIS RELEASE, I CONSENT TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS, AND WAIVE ANY RIGHT TOCHALLENGE JURISDICTION OR VENUE IN SUCH COURT WITH REGARD TO ANY SUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTIONWITH THIS RELEASE. FURTHER, I HEREBY WAIVE ANY RIGHT TO TRIAL BY JURY IN CONNECTION WITH ANY SUIT, ACTION, ORPROCEEDING UNDER OR IN CONNECTION WITH THIS RELEASE.Capitalized terms used, but not defined herein, shall have the meanings ascribed to such terms in my Employment Agreement.***I, Lindsey Rolfe, have executed this Release of Claims on the respective date set forth below: /s/ LINDSEY ROLFELindsey Rolfe Date: February 25, 2016 Exhibit 10.38CLOVIS ONCOLOGY, INC.INDEMNIFICATION AGREEMENTThis Indemnification Agreement (this “Agreement”) is dated as of February 1, 2016, and is between Clovis Oncology, Inc., a Delaware corporation(the “Company”), and Dale Hooks (“Indemnitee”).RECITALSA.Indemnitee’s service to the Company substantially benefits the Company.B.Individuals are reluctant to serve as directors or officers of corporations or in certain other capacities unless they are provided withadequate protection through insurance or indemnification against the risks of claims and actions against them arising out of such service.C.Indemnitee does not regard the protection currently provided by applicable law, the Company’s governing documents and anyinsurance as adequate under the present circumstances, and Indemnitee may not be willing to serve as a director or officer without additional protection.D.In order to induce Indemnitee to continue to provide services to the Company, it is reasonable, prudent and necessary for the Companyto contractually obligate itself to indemnify, and to advance expenses on behalf of, Indemnitee as permitted by applicable law.E.This Agreement is a supplement to and in furtherance of the indemnification provided in the Company’s certificate of incorporation andbylaws, and any resolutions adopted pursuant thereto, and this Agreement shall not be deemed a substitute therefor, nor shall this Agreement be deemed tolimit, diminish or abrogate any rights of Indemnitee thereunder.The parties therefore agree as follows:1.Definitions.(a)“Corporate Status” describes the status of a person who is or was a director, trustee, general partner, managing member,officer, employee, agent or fiduciary of the Company or any other Enterprise.(b)“DGCL” means the General Corporation Law of the State of Delaware.(c)“Disinterested Director” means a director of the Company who is not and was not a party to the Proceeding in respect ofwhich indemnification is sought by Indemnitee.(d)“Enterprise” means the Company and any other corporation, partnership, limited liability company, joint venture, trust,employee benefit plan or other enterprise of which Indemnitee is or was serving at the request of the Company as a director, trustee, general partner, managingmember, officer, employee, agent or fiduciary.(e)“Expenses” include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees and costs of experts, witnessfees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other disbursements or expensesof the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be awitness in, or otherwise participating in, a Proceeding. Expenses also include (i) Expenses incurred in connection with any appeal resulting from anyProceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersedeas bond or other appeal bond or theirequivalent, and (ii) for purposes of Section 12(b), Expenses incurred by Indemnitee in connection with the interpretation, enforcement or defense ofIndemnitee’s rights under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company. Expenses, however,shall not include amounts paid in settlement by Indemnitee or the amount of judgments, penalties or fines against Indemnitee.(f)“Independent Counsel” means a law firm, or a partner or member of a law firm, that is experienced in matters of corporationlaw and neither presently is, nor in the past five years has been, retained to represent (i) the Company or Indemnitee in any matter material to either such party(other than as Independent Counsel with respect to matters concerning Indemnitee under this Agreement, or other indemnitees under similar indemnificationagreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term“Independent Counsel”shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representingeither the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement.(g)“Proceeding” means any threatened, pending or completed action, suit, arbitration, mediation, alternate dispute resolutionmechanism, investigation, inquiry, administrative hearing or proceeding, whether brought in the right of the Company or otherwise and whether of a civil,criminal, administrative or investigative nature, including any appeal therefrom and including without limitation any such Proceeding pending as of the dateof this Agreement, in which Indemnitee was, is or will be involved as a party, a potential party, a non-party witness or otherwise by reason of (i) the fact thatIndemnitee is or was a director or officer of the Company, (ii) any action taken by Indemnitee or any action or inaction on Indemnitee’s part while acting as adirector or officer of the Company, or (iii) the fact that he or she is or was serving at the request of the Company as a director, trustee, general partner,managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, in each case whether or not serving in such capacity at thetime any liability or Expense is incurred for which indemnification or advancement of expenses can be provided under this Agreement.(h)Reference to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxesassessed on a person with respect to any employee benefit plan; references to “serving at the request of the Company” shall include any service as a director,officer, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, employee or agent with respect to anemployee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner he or she reasonably believed to be in the bestinterests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of theCompany” as referred to in this Agreement.2.Indemnity in Third-Party Proceedings. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 2if, by reason of his or her Corporate Status, Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding, other than a Proceeding byor in the right of the Company to procure a judgment in its favor. Pursuant to this Section 2, Indemnitee shall be indemnified to the fullest extent permittedby applicable law against all Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred by Indemnitee or on his or herbehalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonablybelieved to be in or not opposed to the best interests of the Company and, with respect to any criminal Proceeding, had no reasonable cause to believe thathis or her conduct was unlawful.3.Indemnity in Proceedings by or in the Right of the Company. The Company shall indemnify Indemnitee in accordance with theprovisions of this Section 3 if, by reason of his or her Corporate Status, Indemnitee is, or is threatened to be made, a party to or a participant in any Proceedingby or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified to the fullest extentpermitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with suchProceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonably believed to be in or not opposed tothe best interests of the Company. No indemnification for Expenses shall be made under this Section 3 in respect of any claim, issue or matter in suchProceeding as to which Indemnitee shall have been adjudged by a court of competent jurisdiction to be liable to the Company, unless and only to the extentthat the Delaware Court of Chancery or any court in which the Proceeding was brought shall determine upon application that, despite the adjudication ofliability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnification for such expenses as the DelawareCourt of Chancery or such other court shall deem proper. Anything in this Agreement to the contrary notwithstanding, if the Indemnitee, by reason of theIndemnitee’s Corporate Status, is or was, or is or was threatened to be made, a party to any Proceeding by or in the right of the Company to procure ajudgment in its favor, then the Company shall not indemnify the Indemnitee for any judgment, fines, or amounts paid in settlement to the Company inconnection with such Proceeding.4.Indemnification for Expenses of a Party Who is Wholly or Partly Successful. To the extent that Indemnitee, by reason of his or herCorporate Status, is a party to or a participant in and is successful (on the merits or otherwise) in defense of any Proceeding or any claim, issue or mattertherein, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf inconnection therewith. To the extent permitted by applicable law, if Indemnitee is not wholly successful in such Proceeding but is successful, on the merits orotherwise, in defense of one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against allExpenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. Forpurposes of this section, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be asuccessful result as to such claim, issue or matter.5.Indemnification for Expenses of a Witness. To the extent that Indemnitee is, by reason of his or her Corporate Status, a witness, or is orwas made (or asked) to respond to discovery requests, in any Proceeding to which Indemnitee is not a party,-2- Indemnitee shall be indemnified to the fullest extent permitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or onIndemnitee’s behalf in connection therewith. 6.Additional Indemnification.(a)Notwithstanding any limitation in Sections 2, 3 or 4, the Company shall indemnify Indemnitee to the fullest extent permittedby applicable law if Indemnitee, by reason of his or her Corporate Status, is, or is threatened to be made, a party to or a participant in any Proceeding(including a Proceeding by or in the right of the Company to procure a judgment in its favor) against all Expenses, judgments, fines and amounts paid insettlement actually and reasonably incurred by Indemnitee or on his or her behalf in connection with the Proceeding or any claim, issue or matter therein.(b)For purposes of Section 6(a), the meaning of the phrase “to the fullest extent permitted by applicable law” shall include, butnot be limited to:(i)the fullest extent permitted by the provision of the DGCL that authorizes orcontemplates additional indemnification by agreement, or the corresponding provision of any amendment to or replacement of the DGCL; and(ii)the fullest extent authorized or permitted by any amendments to or replacementsof the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its officers and directors.7.Exclusions. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make anyindemnity in connection with any Proceeding (or any part of any Proceeding):(a)for which payment has actually been made to or on behalf of Indemnitee under any statute, insurance policy, indemnityprovision, vote or otherwise, except with respect to any excess beyond the amount paid, and except as may otherwise be agreed between the Company, on theone hand, and Indemnitee or another indemnitor of Indemnitee, on the other;(b)for an accounting or disgorgement of profits pursuant to Section 16(b) of the Securities Exchange Act of 1934, as amended,or similar provisions of federal, state or local statutory law or common law, if Indemnitee is held liable therefor (including pursuant to any settlementarrangements);(c)for any reimbursement of the Company by Indemnitee of any bonus or other incentive-based or equity-based compensationor of any profits realized by Indemnitee from the sale of securities of the Company, as required in each case under the Securities Exchange Act of 1934, asamended (including any such reimbursements that arise from an accounting restatement of the Company pursuant to Section 304 of the Sarbanes-Oxley Actof 2002 (the “Sarbanes-Oxley Act”), or the payment to the Company of profits arising from the purchase and sale by Indemnitee of securities in violation ofSection 306 of the Sarbanes-Oxley Act), if Indemnitee is held liable therefor (including pursuant to any settlement arrangements);(d)initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against theCompany or its directors, officers, employees, agents or other indemnitees, unless (i) the Company’s board of directors authorized the Proceeding (or therelevant part of the Proceeding) prior to its initiation, (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested inthe Company under applicable law, (iii) otherwise authorized in Section 12(b) or (iv) otherwise required by applicable law; or(e)if prohibited by applicable law.8.Advances of Expenses. The Company shall advance the Expenses incurred by Indemnitee in connection with any Proceeding in whichIndemnitee is, or is threatened to be made, a party to or a participant in by reason of Indemnitee’s Corporate Status, and such advancement shall be made assoon as reasonably practicable, but in any event no later than 60 days, after the receipt by the Company of a written statement or statements from Indemniteerequesting such advances from time to time (which shall include invoices received by Indemnitee in connection with such Expenses or otherwise reasonablyevidence the Expenses incurred by Indemnitee, but, in the case of invoices in connection with legal services, any references to legal work performed or toexpenditure made that would cause Indemnitee to waive any privilege accorded by applicable law shall not be included with the invoice). Advances shall beunsecured and interest free and made without regard to Indemnitee’s ability to repay such advances. Indemnitee hereby undertakes to repay any advance tothe extent that it is ultimately determined that Indemnitee is not entitled to be indemnified by the Company. This Section 8 shall not apply to the extentadvancement is prohibited by law and shall not apply to any Proceeding for which indemnity is not permitted under this Agreement, but shall apply to anyProceeding referenced in Section 7(b) or 7(c) prior to a determination that Indemnitee is not entitled to be indemnified by the Company.-3- 9.Procedures for Notification and Defense of Claim. (a)Indemnitee shall notify the Company in writing upon being served with or otherwise receiving any summons, citation,subpoena, complaint, indictment or other document relating to any Proceeding or any matter which may be subject to indemnification covered hereunderwith respect to which Indemnitee intends to seek indemnification or advancement of Expenses as soon as reasonably practicable following the receipt byIndemnitee thereof. The written notification to the Company shall include, in reasonable detail, a description of the nature of the Proceeding and the factsunderlying the Proceeding. The failure by Indemnitee to notify the Company will not relieve the Company from any liability which it may have toIndemnitee hereunder or otherwise than under this Agreement, and any delay in so notifying the Company shall not constitute a waiver by Indemnitee of anyrights, except to the extent that such failure or delay materially prejudices the Company.(b)If, at the time of the receipt of a notice of a Proceeding pursuant to the terms hereof, the Company has directors’ and officers’liability insurance in effect, the Company shall give prompt notice of the commencement of the Proceeding to the insurers in accordance with the proceduresset forth in the applicable policies. The Company shall thereafter take all reasonably necessary or desirable action to cause such insurers to pay, on behalf ofIndemnitee, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.(c)In the event the Company may be obligated to make any indemnity in connection with a Proceeding, the Company shall beentitled to assume the defense of such Proceeding with counsel approved by Indemnitee, which approval shall not be unreasonably withheld, upon thedelivery to Indemnitee of written notice of its election to do so. After delivery of such notice, approval of such counsel by Indemnitee and the retention ofsuch counsel by the Company, the Company will not be liable to Indemnitee for any fees or expenses of counsel subsequently incurred by Indemnitee withrespect to the same Proceeding. Notwithstanding the Company’s assumption of the defense of any such Proceeding, the Company shall be obligated to paythe fees and expenses of Indemnitee’s counsel to the extent (i) the employment of counsel by Indemnitee is authorized by the Company, (ii) counsel for theCompany or Indemnitee shall have reasonably concluded that there is a conflict of interest between the Company and Indemnitee in the conduct of any suchdefense such that Indemnitee needs to be separately represented, (iii) the Company is not financially or legally able to perform its indemnificationobligations or (iv) the Company shall not have retained, or shall not continue to retain, such counsel to defend such Proceeding. The Company shall have theright to conduct such defense as it sees fit in its sole discretion. Regardless of any provision in this Agreement, Indemnitee shall have the right to employcounsel in any Proceeding at Indemnitee’s personal expense. The Company shall not be entitled, without the consent of Indemnitee, to assume the defense ofany claim brought by or in the right of the Company.(d)Indemnitee shall give the Company such information and cooperation in connection with the Proceeding as may bereasonably appropriate.(e)The Company shall not be liable to indemnify Indemnitee for any settlement of any Proceeding (or any part thereof) withoutthe Company’s prior written consent, which shall not be unreasonably withheld.10.Procedures upon Application for Indemnification.(a)To obtain indemnification, Indemnitee shall submit to the Company a written request, including therein or therewith suchdocumentation and information as is reasonably available to Indemnitee and as is reasonably necessary to determine whether and to what extent Indemniteeis entitled to indemnification following the final disposition of the Proceeding. The Company shall, promptly after receipt of such a request forindemnification, advise the board of directors that Indemnitee has requested indemnification. Any delay in providing the request will not relieve theCompany from its obligations under this Agreement, except to the extent such failure is prejudicial.(b)Upon written request by Indemnitee for indemnification pursuant to Section 10(a), a determination with respect toIndemnitee’s entitlement thereto shall be made in the specific case (A) by a majority vote of the Disinterested Directors, even though less than a quorum ofthe Company’s board of directors, (B) by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though lessthan a quorum of the Company’s board of directors, (C) if there are no such Disinterested Directors or, if such Disinterested Directors so direct, byIndependent Counsel in a written opinion to the Company’s board of directors, a copy of which shall be delivered to Indemnitee or (D) if so directed by theCompany’s board of directors, by the stockholders of the Company. If the determination of entitlement to indemnification is to be made by IndependentCounsel pursuant to this Section 10(b), the Independent Counsel shall be selected by the Board of Directors and approved by Indemnitee. Upon failure of theBoard of Directors to so select, or upon the failure of Indemnitee to so approve, such Independent Counsel shall be selected by the Court of Chancery of theState of Delaware or such other person or body as the Indemnitee and the Company may agree in writing. If the person making such determination shalldetermine that Indemnitee is entitled to indemnification as to part (but not all) of the application for indemnification, such person shall reasonably pro-ratesuch part of-4- indemnification among such claims, issues or matters. If it is so determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall bemade within ten days after such determination. Indemnitee shall cooperate with the person, persons or entity making the determination with respect toIndemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation orinformation that is not privileged or otherwise protected from disclosure and that is reasonably available to Indemnitee and reasonably necessary to suchdetermination. Any costs or expenses (including attorneys’ fees and disbursements) reasonably incurred by Indemnitee in so cooperating with the person,persons or entity making such determination shall be borne by the Company, to the fullest extent permitted by applicable law. 11.Presumptions and Effect of Certain Proceedings.(a)The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, orupon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself create a presumption thatIndemnitee did not act in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the Company or,with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his or her conduct was unlawful.(b)For purposes of any determination of good faith, Indemnitee shall be deemed to have acted in good faith to the extentIndemnitee relied in good faith on (i) the records or books of account of the Enterprise, including financial statements, (ii) information supplied toIndemnitee by the officers of the Enterprise in the course of their duties, (iii) the advice of legal counsel for the Enterprise or its board of directors or counselselected by any committee of the board of directors or (iv) information or records given or reports made to the Enterprise by an independent certified publicaccountant, an appraiser, investment banker or other expert selected with reasonable care by the Enterprise or its board of directors or any committee of theboard of directors. The provisions of this Section 11(b) shall not be deemed to be exclusive or to limit in any way the other circumstances in whichIndemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement.(c)Neither the knowledge, actions nor failure to act of any other director, officer, agent or employee of the Enterprise shall beimputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.(d)Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’sentitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or informationwhich is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to suchdetermination. Any Independent Counsel or member of the Board of Directors shall act reasonably and in good faith in making a determination regarding theIndemnitee’s entitlement to indemnification under this Agreement. Any costs or expenses (including attorneys’ fees and disbursements) incurred byIndemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determinationas to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.(e)The Company acknowledges that a settlement or other disposition short of final judgment may besuccessful if it permits a party to avoid expense, delay, distraction, disruption and uncertainty. In the event that any Proceeding to which Indemnitee is aparty is resolved in any manner other than by adverse judgment against Indemnitee (including, without limitation, settlement of such action, claim orproceeding with or without payment of money or other consideration) it shall be presumed that Indemnitee has been successful on the merits or otherwise insuch Proceeding. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincingevidence.12.Remedies of Indemnitee.(a)Subject to Section 12(d), in the event that (i) a determination is made pursuant to Section 10 of this Agreement thatIndemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 8 or 12(b) of thisAgreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 10 of this Agreement within 90 days after thelater of the receipt by the Company of the request for indemnification or the final disposition of the Proceeding, (iv) payment of indemnification pursuant tothis Agreement is not made (A) within ten days after a determination has been made that Indemnitee is entitled to indemnification or (B) with respect toindemnification pursuant to Sections 4, 5 and 12(b) of this Agreement, within 30 days after receipt by the Company of a written request therefor, or (v) theCompany or any other person or entity takes or threatens to take any action to declare this Agreement void or unenforceable, or institutes any litigation orother action or proceeding designed to deny, or to recover from, Indemnitee the benefits provided or intended to be provided to Indemnitee hereunder,Indemnitee shall be entitled to an adjudication by a court of competent jurisdiction of his or her entitlement to such indemnification or advancement ofExpenses. Alternatively, Indemnitee, at his or her option, may seek an award in arbitration with respect to his or her entitlement to such indemnification oradvancement of Expenses, to be conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration-5- Association. Indemnitee shall commence such proceeding seeking an adjudication or an award in arbitration within 180 days following the date on whichIndemnitee first has the right to commence such proceeding pursuant to this Section 12(a); provided, however, that the foregoing clause shall not apply inrespect of a proceeding brought by Indemnitee to enforce his or her rights under Section 4 of this Agreement. The Company shall not oppose Indemnitee’sright to seek any such adjudication or award in arbitration in accordance with this Agreement. (b)Neither (i) the failure of the Company, its board of directors, any committee or subgroup of the board of directors,Independent Counsel or stockholders to have made a determination that indemnification of Indemnitee is proper in the circumstances because Indemniteehas met the applicable standard of conduct, nor (ii) an actual determination by the Company, its board of directors, any committee or subgroup of the boardof directors, Independent Counsel or stockholders that Indemnitee has not met the applicable standard of conduct, shall be a defense to the action or create apresumption that Indemnitee has or has not met the applicable standard of conduct. In the event that a determination shall have been made pursuant toSection 10 of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to thisSection 12 shall be conducted in all respects as a de novo trial, or arbitration, on the merits, and Indemnitee shall not be prejudiced by reason of that adversedetermination. In connection with any determination (including a determination by the Court of Chancery of the State of Delaware (or other court ofcompetent jurisdiction)) with respect to entitlement to indemnification hereunder, the Company shall, to the fullest extent not prohibited by law, have theburden of proving Indemnitee is not entitled to indemnification or advancement of Expenses, as the case may be, and any decision that Indemnitee is notentitled to indemnification or advancement of Expenses must be supported by clear and convincing evidence.(c)To the fullest extent permissible under applicable law, the Company shall indemnify Indemnitee against all Expenses thatare incurred by Indemnitee in connection with any action for indemnification or advancement of Expenses from the Company under this Agreement or underany directors’ and officers’ liability insurance policies maintained by the Company to the extent Indemnitee is successful in such action, and, if requested byIndemnitee, shall (as soon as reasonably practicable, but in any event no later than 60 days, after receipt by the Company of a written request therefor)advance such Expenses to Indemnitee, subject to the provisions of Section 8.(d)Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification shall berequired to be made prior to the final disposition of the Proceeding.13.Contribution.(a)To the fullest extent permissible under applicable law, whether or not the indemnification provided in Sections 2, 3, 4, or 6hereof is available, in respect of any threatened, pending or completed Proceeding in which the Company is jointly liable with Indemnitee (or would be ifjoined in such Proceeding), the Company shall pay, in the first instance, the entire amount of any judgment or settlement of such Proceeding withoutrequiring Indemnitee to contribute to such payment, and the Company hereby waives and relinquishes any right of contribution it may have againstIndemnitee. The Company shall not enter into any settlement of any Proceeding in which the Company is jointly liable with Indemnitee (or would be ifjoined in such Proceeding) unless such settlement provides for a full and final release of all claims asserted against Indemnitee.(b)To the fullest extent permissible under applicable law, without diminishing or impairing the obligations of the Company setforth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required to pay all or any portion of any judgment or settlement in anythreatened, pending or completed Proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such Proceeding), theCompany shall contribute to the amount of Expenses, judgments, fines, liabilities and amounts paid in settlement actually incurred and paid or payable byIndemnitee in proportion to the relative benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee,who are jointly liable with Indemnitee (or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, from the transactionfrom which such Proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the extent necessary to conformto law, be further adjusted by reference to the relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee,who are jointly liable with Indemnitee (or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, in connection with theevents that resulted in such expenses, judgments, fines, liabilities or settlement amounts, as well as any other equitable considerations which the law mayrequire to be considered. The relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointlyliable with Indemnitee (or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, shall be determined by reference to,among other things, the degree to which their actions were motivated by intent to gain personal profit or advantage, the degree to which their liability isprimary or secondary and the degree to which their conduct is active or passive.-6- (c)The Company hereby agrees to fully indemnify and hold Indemnitee harmless from any claim of contribution brought byofficers, directors or employees of the Company, other than Indemnitee, who may be jointly liable with Indemnitee. (d)To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailableto Indemnitee, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amounts incurred by Indemnitee, whether for Expenses, judgments,fines or amounts paid or to be paid in settlement, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion asis deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company andIndemnitee as a result of the events and transactions giving rise to such Proceeding; and (ii) the relative fault of Indemnitee and the Company (and its otherdirectors, officers, employees and agents) in connection with such events and transactions.14.Non-exclusivity. The rights of indemnification and to receive advancement of Expenses as provided by this Agreement shall not bedeemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Company’s certificate of incorporation orbylaws, any agreement, a vote of stockholders or a resolution of directors, or otherwise. To the extent that a change in Delaware law, whether by statute orjudicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Company’s certificate ofincorporation and bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits soafforded by such change, subject to the restrictions expressly set forth herein or therein. Except as expressly set forth herein, no right or remedy hereinconferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other rightand remedy given hereunder or now or hereafter existing at law or in equity or otherwise. Except as expressly set forth herein, the assertion or employment ofany right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy. Notwithstandinganything in this Agreement to the contrary, the indemnification and contribution provided for in this Agreement will remain in full force and effect regardlessof any investigation made by or on behalf of Indemnitee or Indemnitee’s agents.15.Primary Responsibility. The Company acknowledges that Indemnitee may have certain rights to indemnification and advancementof expenses provided by the fund and/or certain affiliates thereof with whom Indemnitee may be affiliated (collectively, the “Secondary Indemnitors”). TheCompany agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnifiedor advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provideindemnification or advancement for the same amounts is secondary to those Company obligations. The Company waives any right of contribution orsubrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In theevent of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’scertificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights ofrecovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, tothe extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to theamounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.16.No Duplication of Payments. Subject to the provisions of Section 15 above, the Company shall not be liable under this Agreement tomake any payment of amounts otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the extent that Indemnitee hasotherwise actually received payment for such amounts under any insurance policy, contract, agreement or otherwise.17.Insurance. To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors,trustees, general partners, managing members, officers, employees, agents or fiduciaries of the Company or any other Enterprise, Indemnitee shall be coveredby such policy or policies to the same extent as the most favorably-insured persons under such policy or policies in a comparable position.18.Subrogation. In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to allof the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of suchdocuments as are necessary to enable the Company to bring suit to enforce such rights.19.Services to the Company. Indemnitee agrees to serve as a director or officer of the Company or, at the request of theCompany, as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of another Enterprise, for so long as Indemnitee isduly elected or appointed or until Indemnitee tenders his or her resignation or is removed from such position. Indemnitee may at any time and for any reasonresign from such position (subject to any other contractual obligation or any obligation imposed by operation of law), in which event the Company shallhave no obligation under this Agreement to continue Indemnitee in-7- such position. This Agreement shall not be deemed an employment contract between the Company (or any of its subsidiaries or any Enterprise) andIndemnitee. Indemnitee specifically acknowledges that any employment with the Company (or any of its subsidiaries or any Enterprise) is at will, andIndemnitee may be discharged at any time for any reason, with or without cause, with or without notice, except as may be otherwise expressly provided inany executed, written employment contract between Indemnitee and the Company (or any of its subsidiaries or any Enterprise), any existing formal severancepolicies adopted by the Company’s board of directors or, with respect to service as a director or officer of the Company, the Company’s certificate ofincorporation or bylaws or the DGCL. No such document shall be subject to any oral modification thereof. 20.Duration. This Agreement shall continue until and terminate upon the later of (a) ten years after the date that Indemnitee shall haveceased to serve as a director or officer of the Company or as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of anyother Enterprise, as applicable; or (b) one year after the final termination of any Proceeding, including any appeal, then pending in respect of whichIndemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by Indemnitee pursuant toSection 12 of this Agreement relating thereto.21.Successors. This Agreement shall be binding upon the Company and its successors and assigns, including any direct or indirectsuccessor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company, and shall inure to the benefit ofIndemnitee and Indemnitee’s heirs, executors and administrators.22.Severability. Nothing in this Agreement is intended to require or shall be construed as requiring the Company to do or fail to do anyact in violation of applicable law. The Company’s inability, pursuant to court order or other applicable law, to perform its obligations under this Agreementshall not constitute a breach of this Agreement. If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for anyreason whatsoever: (i) the validity, legality and enforceability of the remaining provisions of this Agreement (including without limitation, each portion ofany section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable)shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (ii) such provision or provisions shallbe deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (iii) to thefullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any section of this Agreement containing any suchprovision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intentmanifested thereby.23.Enforcement. The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligationsimposed on it hereby in order to induce Indemnitee to serve as a director or officer of the Company, and the Company acknowledges that Indemnitee isrelying upon this Agreement in serving as a director or officer of the Company.24.Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matterhereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof;provided, however, that this Agreement is a supplement to and in furtherance of the indemnification provided in the Company’s certificate of incorporationand bylaws and applicable law.25.Modification and Waiver. No supplement, modification or amendment to this Agreement shall be binding unless executed in writingby the parties hereto. No amendment, alteration or repeal of this Agreement shall adversely affect any right of Indemnitee under this Agreement in respect ofany action taken or omitted by such Indemnitee in his or her Corporate Status prior to such amendment, alteration or repeal. No waiver of any of theprovisions of this Agreement shall constitute or be deemed a waiver of any other provision of this Agreement nor shall any waiver constitute a continuingwaiver.26.Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered orcertified mail, postage prepaid, sent by facsimile or electronic mail or otherwise delivered by hand, messenger or courier service addressed:(a)if to Indemnitee, to Indemnitee’s address, facsimile number or electronic mail address as shown on the signature page of thisAgreement or in the Company’s records, as may be updated in accordance with the provisions hereof; or(b)if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at c/o ThomasMark, Willkie Farr & Gallagher LLP, 787 Seventh Ave., New York, NY 10019 or at such other current address as the Company shall have furnished to theIndemnitee.Each such notice or other communication shall for all purposes of this Agreement be treated as effective or having been given (i) if delivered byhand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), (ii) if sent via mail, at the-8- earlier of its receipt or five days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed andmailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, when directed to the relevant electronicmail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s nextbusiness day. 27.Applicable Law and Consent to Jurisdiction. This Agreement and the legal relations among the parties shall be governed by, andconstrued and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. Except with respect to anyarbitration commenced by Indemnitee pursuant to Section 12(a) of this Agreement, the Company and Indemnitee hereby irrevocably and unconditionally(i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Delaware Court of Chancery, and notin any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of theDelaware Court of Chancery for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent suchparty is not otherwise subject to service of process in the State of Delaware, The Corporation Trust Company, Wilmington, Delaware as its agent in the Stateof Delaware as such party’s agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legalforce and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action orproceeding in the Delaware Court of Chancery, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in theDelaware Court of Chancery has been brought in an improper or inconvenient forum.28.Counterparts. This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be anoriginal but all of which together shall constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signatureand in counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement.Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.29.Captions. The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitutepart of this Agreement or to affect the construction thereof.(signature page follows) -9-  The parties are signing this Indemnification Agreement as of the date stated in the introductory sentence. COMPANY CLOVIS ONCOLOGY, INC. /s/ ERLE T. MAST (Signature) Erle T. Mast (Print name) Executive Vice President and Chief Financial Officer (Title) INDEMNITEE /s/ DALE HOOKS (Signature) Dale Hooks (Print name) (Street address) (City, State and ZIP) Exhibit 10.39EXECUTION COPYEMPLOYMENT AGREEMENTThis EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into as of this 1st day of February 2016, by and betweenClovis Oncology, Inc., a Delaware corporation (the “Company”), and Dale Hooks (the “Employee”).W I T N E S S E T H :WHEREAS, Employee is currently employed by the Company as its Senior Vice President and Chief Commercial Officer; andWHEREAS, the Company desires to continue to employ Employee and to enter into this Agreement embodying the terms of suchemployment, and Employee desires to enter into this Agreement and to accept such continued employment, subject to the terms and provisions of thisAgreement.NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for other good and valuableconsideration, the receipt and sufficiency of which are mutually acknowledged, the Company and Employee hereby agree as follows:Section 1.Definitions.(a)“Accounting Firm” shall have the meaning set forth in Section 13(b) hereof.(b)“Accrued Obligations” shall mean (i) all accrued but unpaid Base Salary through the date of termination of Employee’semployment, (ii) any unpaid or unreimbursed expenses incurred prior to the date of termination in accordance with Section 7 hereof, and (iii) any benefitsprovided under the Company’s employee benefit plans upon a termination of employment (excluding any employee benefit plan providing for severance orsimilar benefits), in accordance with the terms contained therein.(c)“Agreement” shall have the meaning set forth in the preamble hereto.(d)“Annual Bonus” shall have the meaning set forth in Section 4(b) hereof.(e)“Base Salary” shall mean the salary provided for in Section 4(a) hereof or any increased salary granted to Employee pursuantto Section 4(a) hereof.(f)“Board” shall mean the Board of Directors of the Company.(g)“Change in Control” shall have the meaning ascribed to such term in the Stock Incentive Plan.(h)“Code” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(i)“Company” shall have the meaning set forth in the preamble hereto.(j)“Company Group” shall mean the Company together with any direct or indirect subsidiaries of the Company.(k)“Compensation Committee” shall mean the committee of the Board designated to make compensation decisions relating tosenior executive officers of the Company Group. Prior to any time that such a committee has been designated, the Board shall be deemed the CompensationCommittee for purposes of this Agreement.(l)“Delay Period” shall have the meaning set forth in Section 13 hereof.(m)“Disability” shall mean any physical or mental disability or infirmity of Employee that prevents the performance ofEmployee’s duties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) monthperiod. Any question as to the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall bedetermined by a qualified, independent physician selected by the Company and approved by Employee (which approval shall not be unreasonablywithheld). The determination of any such physician shall be final and conclusive for all purposes of this Agreement. (n)“Employee” shall have the meaning set forth in the preamble hereto. (o)“Excess Payment” shall have the meaning ascribed to such term in Section 13(b) below.(p)“Excise Tax” shall have the meaning set forth in Section 13(b) hereof.(q)“Good Reason” shall mean, without Employee’s consent, (i) a material diminution in Employee’s title, duties, orresponsibilities as set forth in Section 3 hereof such that Employee is no longer serving in a senior executive capacity for the Company, (ii) a materialreduction in Base Salary set forth in Section 4(a) hereof or Annual Bonus opportunity set forth in Section 4(b) hereof (other than pursuant to an across-the-board reduction applicable to all similarly situated executives), (iii) the relocation of Employee’s principal place of employment (as provided in Section 3(c)hereof) more than fifty (50) miles from its current location, or (iv) any other material breach of a provision of this Agreement by the Company (other than aprovision that is covered by clause (i), (ii), or (iii) above). Employee acknowledges and agrees that his exclusive remedy in the event of any breach of thisAgreement shall be to assert Good Reason pursuant to the terms and conditions of Section 8(e) hereof. Notwithstanding the foregoing, during the Term, in theevent that the Company reasonably believes that Employee may have engaged in conduct that could constitute Just Cause hereunder, the Company may, inits sole and absolute discretion, suspend Employee for up to sixty (60) days from performing his duties hereunder, and in no event shall any such suspensionconstitute an event pursuant to which Employee may terminate employment with Good Reason or otherwise constitute a breach hereunder; provided, that nosuch suspension shall alter the Company’s obligations under this Agreement during such period of suspension.(r)“Gross-Up Payment” shall have the meaning ascribed to such term in Section 13(b) below.(s)“Just Cause” shall mean that the Company, acting in good faith based upon the information then known to it, determines that(i) Employee has committed or engaged in negligent or willful conduct that is likely to be detrimental to the Company or any member of the CompanyGroup; (ii) Employee has engaged in acts which constitute theft, fraud, or other illegal or dishonest conduct which are considered to be harmful to theCompany or any member of the Company Group as determined by the majority vote of its Board; (iii) Employee has willfully disobeyed the reasonable andlawful directives of any superior officer or the Board; (iv) Employee has refused or is unwilling to perform his job duties; (v) Employee has failed adequatelyto perform his job duties; (vi) Employee has demonstrated habitual absenteeism; (vii) Employee is substantially dependent on alcohol or any controlledsubstance or violates any general Company policy with regard to alcohol or controlled substances; (viii) Employee has engaged in acts which constitutesexual or other forms of illegal harassment or discrimination; (ix) Employee makes public remarks that disparage the Company, the Board, or its officers,directors, advisors, employees, affiliates or subsidiaries; (x) Employee violates his fiduciary duty to the Company, or his duty of loyalty to the Company;(xi) Employee materially breaches any term of this Agreement or the Non-Interference Agreement. The Parties acknowledge that this definition of “JustCause” in not intended and does not apply to any aspect of the relationship between the Company and Employee beyond determining Employee’s eligibilityfor severance pay pursuant to Section 8 below.(t)“Non-Interference Agreement” shall mean the Confidentiality, Non-Interference, and Invention Assignment Agreementattached hereto as Exhibit A.(u)“Parachute Payments” shall have the meaning set forth in Section 13(b) hereof.(v)“Parachute Tax” shall have the meaning ascribed to such term in Section 13(b) below.(w)“Person” shall mean any individual, corporation, partnership, limited liability company, joint venture, association, joint-stock company, trust (charitable or non-charitable), unincorporated organization, or other form of business entity.(x)“Release of Claims” shall mean the Release of Claims in substantially the same form attached hereto as Exhibit B (as thesame may be revised from time to time by the Company upon the advice of counsel to reflect changes in law).(y)“Severance Benefits” shall have the meaning set forth in Section 8(g) hereof.(z)“Severance Term” shall mean the six (6) month period following Employee’s termination by the Company without JustCause (other than by reason of death or Disability) or by Employee for Good Reason; provided, that if such termination occurs within twelve (12) monthsfollowing a Change in Control, the Severance Term shall be the twelve (12) month period following such termination.-2- (aa)“Stock Incentive Plan” shall mean the Clovis Oncology, Inc. 2011 Stock Incentive Plan, as the same may be amendedand/or restated from time to time. (bb)“Target Bonus” shall have the meaning set forth in Section 4(b) hereof.(cc)“Term” shall mean the period specified in Section 2 hereof.(dd)“Underpayment” shall have the meaning ascribed to such term in Section 13(b) below.Section 2.Acceptance and Term.The Company agrees to employ Employee, and Employee agrees to serve the Company, on the terms and conditions set forthherein. The Term shall commence on February 1, 2016 and shall continue until terminated in accordance with Section 8 hereof.Section 3.Position, Duties, and Responsibilities; Place of Performance.(a)Position, Duties, and Responsibilities. During the Term, Employee shall be employed and serve as the Senior Vice Presidentand Chief Commercial Officer of the Company (together with such other position or positions consistent with Employee’s title as the Board shall specifyfrom time to time) and shall have such duties and responsibilities commensurate with such title. Employee also agrees to serve as an officer and/or director ofany other member of the Company Group, in each case without additional compensation. During the Term, Employee shall report to the Chief ExecutiveOfficer.(b)Performance. Employee shall devote his full business time, attention, skill, and best efforts to the performance of his dutiesunder this Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that (x) conflictswith the interests of the Company or any other member of the Company Group, (y) interferes with the proper and efficient performance of Employee’s dutiesfor the Company, or (z) interferes with Employee’s exercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing hereinshall preclude Employee from (i) serving, with the prior written consent of the Board, as a member of the boards of directors or advisory boards (or theirequivalents in the case of a non-corporate entity) of non-competing businesses and charitable organizations, (ii) engaging in charitable activities andcommunity affairs, and (iii) managing his personal investments and affairs; provided, however, that the activities set out in clauses (i), (ii), and (iii) shall belimited by Employee so as not to materially interfere, individually or in the aggregate, with the performance of his duties and responsibilities hereunder.(c)Principal Place of Employment. Employee’s principal place of employment shall be in Boulder, Colorado althoughEmployee understands and agrees that he may be required to travel from time to time for business reasons.Section 4.Compensation.During the Term, Employee shall be entitled to the following compensation:(a)Base Salary. Employee shall be paid an annualized Base Salary, payable in accordance with the regular payroll practices ofthe Company, of not less than $350,000, with increases, if any, as may be approved in writing by the Compensation Committee.(b)Annual Bonus. Employee shall be eligible for an annual incentive bonus award determined by the CompensationCommittee in respect of each fiscal year during the Term (the “Annual Bonus”). The target Annual Bonus for each fiscal year shall be 40% of Base Salary(the “Target Bonus”), with the actual Annual Bonus payable being based upon the level of achievement of annual Company and individual performanceobjectives for such fiscal year, as determined by the Compensation Committee and communicated to Employee. The Annual Bonus shall be paid toEmployee at the same time as annual bonuses are generally payable to other senior executives of the Company subject to Employee’s continuousemployment through the payment date.Section 5.Employee Benefits.During the Term, Employee shall be entitled to participate in health, insurance, retirement, and other benefits provided generally tosimilarly situated employees of the Company. Employee shall also be entitled to the same number of holidays, vacation days, and sick days, as well as anyother benefits, in each case as are generally allowed to similarly situated employees of the Company in accordance with the Company policy as in effect fromtime to time. Nothing contained herein shall be construed to limit-3- the Company’s ability to amend, suspend, or terminate any employee benefit plan or policy at any time without providing Employee notice, and the right todo so is expressly reserved.Section 6.Key-Man Insurance.At any time during the Term, the Company shall have the right to insure the life of Employee for the sole benefit of the Company, insuch amounts, and with such terms, as it may determine. All premiums payable thereon shall be the obligation of the Company. Employee shall have nointerest in any such policy, but agrees to cooperate with the Company in procuring such insurance by submitting to physical examinations, supplying allinformation required by the insurance company, and executing all necessary documents, provided that no financial obligation is imposed on Employee byany such documents.Section 7.Reimbursement of Business Expenses.During the Term, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing his duties and responsibilities hereunder, which are consistent with the Company’s policies in effect fromtime to time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses.Section 8.Termination of Employment.(a)General. The Term shall terminate upon the earliest to occur of (i) Employee’s death, (ii) a termination by reason of aDisability, (iii) a termination by the Company with or without Just Cause, and (iv) a termination by Employee with or without Good Reason. Upon anytermination of Employee’s employment for any reason, except as may otherwise be requested by the Company in writing and agreed upon in writing byEmployee, Employee shall be deemed to have resigned from any and all directorships, committee memberships, and any other positions Employee holds withthe Company or any other member of the Company Group and hereby agrees to execute any documents that the Company (or any member of the CompanyGroup) determines necessary to effectuate such resignations. Notwithstanding anything herein to the contrary, the payment (or commencement of a series ofpayments) hereunder of any nonqualified deferred compensation (within the meaning of Section 409A of the Code) upon a termination of employment shallbe delayed until such time as Employee has also undergone a “separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time suchnonqualified deferred compensation (calculated as of the date of Employee’s termination of employment hereunder) shall be paid (or commence to be paid)to Employee on the schedule set forth in this Section 8 as if Employee had undergone such termination of employment (under the same circumstances) on thedate of his ultimate “separation from service.”(b)Termination Due to Death or Disability. Employee’s employment shall terminate automatically upon his death. TheCompany may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effective upon Employee’s receiptof written notice of such termination. Upon Employee’s death or in the event that Employee’s employment is terminated due to his Disability, Employee orhis estate or his beneficiaries, as the case may be, shall be entitled to:(i)The Accrued Obligations; and(ii)Any unpaid Annual Bonus in respect of any completed fiscal year that has ended prior to the date of suchtermination, which amount shall be paid at such time annual bonuses are paid to other senior executives of the Company, but in no event later than the datethat is 2½ months following the last day of the fiscal year in which such termination occurred.Following Employee’s death or a termination of Employee’s employment by reason of a Disability, except as set forth in this Section 8(b), Employee shallhave no further rights to any compensation or any other benefits under this Agreement.(c)Termination by the Company with Just Cause.(i)The Company may terminate Employee’s employment at any time with Just Cause, effective upon Employee’sreceipt of written notice of such termination; provided, however, that with respect to any Just Cause termination relying on clause (iv) or (v) of the definitionof Just Cause set forth in Section 1(r) hereof, to the extent that such act or acts or failure or failures to act are curable, Employee shall be given not less thanten (10) days’ written notice by the Board of the Company’s intention to terminate him for Just Cause, such notice to state in detail the particular act or actsor failure or failures to act that constitute the grounds on which the proposed termination for Just Cause is based, and such termination shall be effective atthe expiration of such ten (10) day notice period unless Employee has fully cured such act or acts or failure or failures to act that give rise to Just Causeduring such period.-4- (ii)In the event that the Company terminates Employee’s employment with Just Cause, he shall be entitled only tothe Accrued Obligations. Following such termination of Employee’s employment with Just Cause, except as set forth in this Section 8(c)(ii), Employee shallhave no further rights to any compensation or any other benefits under this Agreement. (d)Termination by the Company without Just Cause. The Company may terminate Employee’s employment at any timewithout Just Cause, effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by theCompany without Just Cause (other than due to death or Disability), Employee shall be entitled to:(i)The Accrued Obligations;(ii)Any unpaid Annual Bonus in respect of any completed fiscal year that has ended prior to the date of suchtermination, which amount shall be paid at such time annual bonuses are paid to other senior executives of the Company, but in no event later than the datethat is 2½ months following the last day of the fiscal year in which such termination occurred;(iii)Continued payment of Base Salary during the Severance Term, payable in accordance with the Company’sregular payroll practices;(iv)Subject to Employee’s election of COBRA continuation coverage under the Company’s group health plan, onthe first regularly scheduled payroll date of each month of the Severance Term, the Company will pay Employee an amount equal to the “applicablepercentage” of the monthly COBRA premium cost (which, for purposes hereof, shall be the percentage of Employee’s health care premium costs covered bythe Company as of the date of termination); provided, that the payments pursuant to this clause (iv) shall cease earlier than the expiration of the SeveranceTerm in the event that Employee becomes eligible to receive any health benefits, including through a spouse’s employer, during the Severance Term; and(v)In the event that such termination occurs within twelve (12) months following a Change in Control:(A)accelerated vesting of all of Employee’s stock options and other equity-based awards and continuedexercisability of Employee’s stock options in accordance with the terms of the plan document governing such awards; and(B)an amount equal to the Target Bonus, payable in substantially equal monthly installments during theSeverance Term.Notwithstanding the foregoing, the payments and benefits described in clauses (ii), (iii), (iv), and (v) above shall immediately terminate, and the Companyshall have no further obligations to Employee with respect thereto, in the event that Employee breaches any provision of the Non-InterferenceAgreement. Following such termination of Employee’s employment by the Company without Just Cause, except as set forth in this Section 8(d), Employeeshall have no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusiveremedy upon a termination of employment by the Company without Just Cause shall be receipt of the Severance Benefits.(e)Termination by Employee with Good Reason. Employee may terminate his employment with Good Reason by providingthe Company ten (10) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to be effective,must be provided to the Company within sixty (60) days of the occurrence of such event. During such ten (10) day notice period, the Company shall have acure right (if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of such cure period, and Employeeshall be entitled to the same payments and benefits as provided in Section 8(d) hereof for a termination by the Company without Just Cause, subject to thesame conditions on payment and benefits as described in Section 8(d) hereof. Following such termination of Employee’s employment by Employee withGood Reason, except as set forth in this Section 8(e), Employee shall have no further rights to any compensation or any other benefits under thisAgreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of theSeverance Benefits.(f)Termination by Employee without Good Reason. Employee may terminate his employment without Good Reason byproviding the Company thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section8(f), Employee shall be entitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 8(f), theCompany may, in its sole and absolute discretion, by written notice accelerate such date of termination without changing the characterization of suchtermination as a termination by Employee without Good Reason. Following such termination of Employee’s employment by Employee without GoodReason, except as set forth in this Section 8(f), Employee shall have no further rights to any compensation or any other benefits under this Agreement.-5- (g)Release. Notwithstanding any provision herein to the contrary, the payment of any amount or provision of any benefitpursuant to subsection (b), (d), or (e) of this Section 8 (other than the Accrued Obligations) (collectively, the “Severance Benefits”) shall be conditioned uponEmployee’s execution, delivery to the Company, and non-revocation of the Release of Claims (and the expiration of any revocation period contained in suchRelease of Claims) within sixty (60) days following the date of Employee’s termination of employment hereunder. If Employee fails to execute the Releaseof Claims in such a timely manner so as to permit any revocation period to expire prior to the end of such sixty (60) day period, or timely revokes hisacceptance of such release following its execution, Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of theSeverance Benefits constitutes “nonqualified deferred compensation” for purposes of Section 409A of the Code, any payment of any amount or provision ofany benefit otherwise scheduled to occur prior to the sixtieth (60th) day following the date of Employee’s termination of employment hereunder, but for thecondition on executing the Release of Claims as set forth herein, shall not be made until the first regularly scheduled payroll date following such sixtieth(60th) day, after which any remaining Severance Benefits shall thereafter be provided to Employee according to the applicable schedule set forth herein. Forthe avoidance of doubt, in the event of a termination due to Employee’s death or Disability, Employee’s obligations herein to execute and not revoke theRelease of Claims may be satisfied on his behalf by his estate or a person having legal power of attorney over his affairs. Section 9.Non-Interference Agreement.As a condition of, and prior to commencement of, Employee’s employment with the Company, Employee shall have executed anddelivered to the Company the Non-Interference Agreement. The parties hereto acknowledge and agree that this Agreement and the Non-InterferenceAgreement shall be considered separate contracts, and the Non-Interference Agreement will survive the termination of this Agreement for any reason.Section 10.Representations and Warranties of Employee.Employee represents and warrants to the Company that —(a)Employee is entering into this Agreement voluntarily and that his employment hereunder and compliance with the terms andconditions hereof will not conflict with or result in the breach by him of any agreement to which he is a party or by which he may be bound;(b)Employee has not violated, and in connection with his employment with the Company will not violate, any non-solicitation,non-competition, or other similar covenant or agreement of a prior employer by which he is or may be bound; and(c)in connection with his employment with the Company, Employee will not use any confidential or proprietary information hemay have obtained in connection with employment with any prior employer.Section 11.Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any taxadvice to him in connection with this Agreement and that he has been advised by the Company to seek tax advice from his own tax advisors regarding thisAgreement and payments that may be made to him pursuant to this Agreement, including specifically, the application of the provisions of Section 409A ofthe Code to such payments.Section 12.Set Off; Mitigation. The Company’s obligation to pay Employee the amounts provided and to make the arrangements provided hereunder shall be subject toset-off, counterclaim, or recoupment of amounts owed by Employee to the Company or its affiliates; provided, however, that to the extent any amount sosubject to set-off, counterclaim, or recoupment is payable in installments hereunder, such set-off, counterclaim, or recoupment shall not modify the applicablepayment date of any installment, and to the extent an obligation cannot be satisfied by reduction of a single installment payment, any portion not satisfiedshall remain an outstanding obligation of Employee and shall be applied to the next installment only at such time the installment is otherwise payablepursuant to the specified payment schedule. Employee shall not be required to mitigate the amount of any payment provided pursuant to this Agreement byseeking other employment or otherwise, and except as provided in Section 8(d)(iv) hereof, the amount of any payment provided for pursuant to thisAgreement shall not be reduced by any compensation earned as a result of Employee’s other employment or otherwise.-6- Section 13.Additional Tax Provisions. (a)Section 409A Provisions. Notwithstanding any provision in this Agreement to the contrary —(i)Any payment otherwise required to be made hereunder to Employee at any date as a result of the termination ofEmployee’s employment shall be delayed for such period of time as may be necessary to meet the requirements of Section 409A(a)(2)(B)(i) of the Code (the“Delay Period”). On the first business day following the expiration of the Delay Period, Employee shall be paid, in a single cash lump sum, an amount equalto the aggregate amount of all payments delayed pursuant to the preceding sentence, and any remaining payments not so delayed shall continue to be paidpursuant to the payment schedule set forth herein. (ii)Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes ofSection 409A of the Code.(iii)To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under thisAgreement constitutes nonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement shall bemade by the Company no later than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the rightto reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible forreimbursement or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to beprovided in any other taxable year; provided, that the foregoing clause shall not be violated with regard to expenses reimbursed under any arrangementcovered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect.(iv)While the payments and benefits provided hereunder are intended to be structured in a manner to avoid theimplication of any penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for anyadditional tax, interest, or penalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply withSection 409A of the Code (other than for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).(b)Parachute Payment Gross-Up. If any payment, benefit, or distribution of any type to or for the benefit of Employee, whetherpaid or payable, provided or to be provided, or distributed or distributable pursuant to the terms of this Agreement or otherwise (collectively, the “ParachutePayments”) would subject Employee to the excise tax imposed under Section 4999 of the Code (the “Excise Tax”), the Company will make an additionalpayment to Employee in an amount (the “Gross-Up Payment”) such that, after payment all taxes and any interest or penalties imposed with respect to suchtaxes (including, without limitation, federal, state, local income, employment, excise and other similar taxes, but excluding any taxes imposed under Section409A of the Code) (the “Parachute Tax”) on both the Parachute Payments and the Gross-Up Payment, Employee will be in the same position as if noParachute Tax had been imposed; provided, that in no event may the Gross-Up Payment exceed $2,000,000. Any Gross-Up Payment shall be timely paid bythe Company on Employee’s behalf directly to the appropriate taxing authorities when due, but in all events no later than the last day of the calendar yearafter the calendar year in which the Parachute Tax shall be paid. The determinations with respect to this Section 13(b) shall be made by an independentaccounting firm selected by the Company and reasonably acceptable to Employee (the “Accounting Firm”) paid by the Company.(i)It is possible that, after the determinations and selections made pursuant to Section 13(b), Employee will receiveParachute Payments and Gross-Up Payments that are, in the aggregate, either more or less than the limitations provided in Section 13(b) above (hereafterreferred to as an “Excess Payment” or “Underpayment”, respectively). If it is established, pursuant to a final determination of a court or an Internal RevenueService proceeding that has been finally and conclusively resolved, that an Excess Payment has been made, then Employee shall refund the Excess Paymentto the Company promptly on demand, together with an additional payment in an amount equal to the product obtained by multiplying the Excess Paymenttimes the applicable annual federal rate (as determined in and under Section 1274(d) of the Code) times a fraction whose numerator is the number of dayselapsed from the date of Employee’s receipt of such Excess Payment through the date of such refund and whose denominator is 365. In the event that it isdetermined (y) by a court of competent jurisdiction, or (z) by the Accounting Firm upon request by Employee or the Company, that an Underpayment hasoccurred, the Company shall pay an amount equal to the Underpayment to Employee within ten (10) days of such determination together with an additionalpayment in an amount equal to the product obtained by multiplying the Underpayment times the applicable annual federal rate (as determined in and underSection 1274(d) of the Code) times a fraction whose numerator is the number of days elapsed from the date of the Underpayment through the date of suchpayment and whose denominator is 365; provided, that in no event shall the sum of (i) the Gross-Up Payment, and (ii) the additional payment pursuant to thissentence, exceed $2,000,000.-7- (ii)Any Gross-Up Payment, as determined pursuant to this Section 13(b), shall be paid by the Company and remittedto the relevant tax authorities when such payment is due, provided that in no event shall such payment be made later than the end of your taxable year nextfollowing Employee’s taxable year in which the Parachute Tax on a Parachute Payment are remitted to the Internal Revenue Service or any other applicabletaxing authority or, in the case of amounts relating to a claim described in Section 13(b)(i) that does not result in the remittance of any federal, state, local andforeign income, excise, social security and other taxes, the calendar year in which the claim is finally settled or otherwise resolved. Section 14.Successors and Assigns; No Third-Party Beneficiaries.(a)The Company. This Agreement shall inure to the benefit of the Company and its respective successors and assigns. Neitherthis Agreement nor any of the rights, obligations, or interests arising hereunder may be assigned by the Company to a Person (other than another member ofthe Company Group, or its or their respective successors) without Employee’s prior written consent (which shall not be unreasonably withheld, delayed, orconditioned); provided, however, that in the event of a sale of all or substantially all of the assets of the Company or any direct or indirect division orsubsidiary thereof to which the Employee’s employment primarily relates, the Company may provide that this Agreement will be assigned to, and assumedby, the acquiror of such assets, it being agreed that in such circumstances, Employee’s consent will not be required in connection therewith.(b)Employee. Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided, however, that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.(c)No Third-Party Beneficiaries. Except as otherwise set forth in Section 8(b) or Section 14(b) hereof, nothing expressed orreferred to in this Agreement will be construed to give any Person other than the Company, the other members of the Company Group, and Employee anylegal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement.Section 15.Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing andsigned by each of the parties hereto; provided, however, that any such waiver, alteration, amendment, or modification must be consented to on theCompany’s behalf by the Board. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to anysubsequent occurrences or transactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 16.Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a courtof competent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereofshall be deemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid orunenforceable term or provision hereof.Section 17.Governing Law and Jurisdiction.EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY, INTERPRETATION, CONSTRUCTION, AND PERFORMANCEOF THIS AGREEMENT IS GOVERNED BY AND IS TO BE CONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TOAGREEMENTS MADE AND TO BE PERFORMED IN THAT STATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. ANY DISPUTE OR CLAIMARISING OUT OF OR RELATING TO THIS AGREEMENT OR CLAIM OF BREACH HEREOF SHALL BE BROUGHT EXCLUSIVELY IN THE UNITEDSTATES DISTRICT COURT FOR THE 20th JUDICIAL DISTRICT OF COLORADO, TO THE EXTENT FEDERAL JURISDICTION EXISTS, AND IN ANYCOURT SITTING IN COLORADO, BUT ONLY IN THE EVENT FEDERAL JURISDICTION DOES NOT EXIST, AND ANY APPLICABLE APPELLATECOURTS. BY EXECUTION OF THIS AGREEMENT, THE PARTIES HERETO, AND THEIR RESPECTIVE AFFILIATES, CONSENT TO THE EXCLUSIVEJURISDICTION OF SUCH COURTS, AND WAIVE ANY RIGHT TO CHALLENGE JURISDICTION OR VENUE IN SUCH COURT WITH REGARD TO ANYSUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THIS AGREEMENT. EACH PARTY TO THIS AGREEMENT ALSO HEREBYWAIVES ANY RIGHT TO TRIAL BY JURY IN CONNECTION WITH ANY SUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THISAGREEMENT.-8- Section 18.Notices. (a)Place of Delivery. Every notice or other communication relating to this Agreement shall be in writing, and shall be mailedto or delivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or delivered to theother party as herein provided; provided, that unless and until some other address be so designated, all notices and communications by Employee to theCompany shall be mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company to Employeemay be given to Employee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b)Date of Delivery. Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date ofsuch delivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered orcertified mail, on the third business day after the date of such mailing.Section 19.Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitutea part thereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 20.Entire Agreement.This Agreement, together with any exhibits attached hereto, constitutes the entire understanding and agreement of the parties heretoregarding the employment of Employee. This Agreement supersedes all prior negotiations, discussions, correspondence, communications, understandings,and agreements between the parties relating to the subject matter of this Agreement.Section 21.Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 8 through Section 22 of this Agreement (together with anyrelated definitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 22.Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which togethershall constitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.***[Signatures to appear on the following page.] -9- IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written. CLOVIS ONCOLOGY, INC. /s/ PATRICK J. MAHAFFY By: Patrick J. Mahaffy Title: President and CEO EMPLOYEE /s/ DALE HOOKS Dale Hooks  EXHIBIT ACONFIDENTIALITY, NON-INTERFERENCE, AND INVENTION ASSIGNMENT AGREEMENTAs a condition of my becoming employed by, or continuing employment with, Clovis Oncology, Inc., a Delaware corporation (the“Company”), and in consideration of my employment with the Company and my receipt of the compensation now and hereafter paid to me by the Company,I agree to the following:Section 23.Confidential Information.(a)Company Group Information. I acknowledge that, during the course of my employment, I will have access to informationabout the Company and its direct and indirect subsidiaries and affiliates (collectively, the “Company Group”) and that my employment with the Companyshall bring me into close contact with confidential and proprietary information of the Company Group. In recognition of the foregoing, I agree, at all timesduring the term of my employment with the Company and for the ten (10) year period following my termination of my employment for any reason, to hold inconfidence, and not to use, except for the benefit of the Company Group, or to disclose to any person, firm, corporation, or other entity without writtenauthorization of the Company, any Confidential Information that I obtain or create. I further agree not to make copies of such Confidential Informationexcept as authorized by the Company. I understand that “Confidential Information” means information that the Company Group has developed, acquired,created, compiled, discovered, or owned or will develop, acquire, create, compile, discover, or own, that has value in or to the business of the Company Groupthat is not generally known and that the Company wishes to maintain as confidential. I understand that Confidential Information includes, but is not limitedto, any and all non-public information that relates to the actual or anticipated business and/or products, research, or development of the Company, or to theCompany’s technical data, trade secrets, or know-how, including, but not limited to, research, product plans, or other information regarding the Company’sproducts or services and markets, customer lists, and customers (including, but not limited to, customers of the Company on whom I called or with whom Imay become acquainted during the term of my employment), software, developments, inventions, processes, formulas, technology, designs, drawings,engineering, hardware configuration information, marketing, finances, and other business information disclosed by the Company either directly or indirectlyin writing, orally, or by drawings or inspection of premises, parts, equipment, or other Company property. Notwithstanding the foregoing, ConfidentialInformation shall not include (i) any of the foregoing items that have become publicly and widely known through no unauthorized disclosure by me or otherswho were under confidentiality obligations as to the item or items involved or (ii) any information that I am required to disclose to, or by, any governmentalor judicial authority; provided, however, that in such event I will give the Company prompt written notice thereof so that the Company Group may seek anappropriate protective order and/or waive in writing compliance with the confidentiality provisions of this Confidentiality, Non-Interference, and InventionAssignment Agreement (the “Non-Interference Agreement”).(b)Former Employer Information. I represent that my performance of all of the terms of this Non-Interference Agreement as anemployee of the Company has not breached and will not breach any agreement to keep in confidence proprietary information, knowledge, or data acquiredby me in confidence or trust prior or subsequent to the commencement of my employment with the Company, and I will not disclose to any member of theCompany Group, or induce any member of the Company Group to use, any developments, or confidential or proprietary information or material I may haveobtained in connection with employment with any prior employer in violation of a confidentiality agreement, nondisclosure agreement, or similar agreementwith such prior employer.Section 24.Developments.(a)Developments Retained and Licensed. I have attached hereto, as Schedule A, a list describing with particularity alldevelopments, original works of authorship, developments, improvements, and trade secrets that I can demonstrate were created or owned by me prior to thecommencement of my employment (collectively referred to as “Prior Developments”), which belong solely to me or belong to me jointly with another, thatrelate in any way to any of the actual or proposed businesses, products, or research and development of any member of the Company Group, and that are notassigned to the Company hereunder, or if no such list is attached, I represent that there are no such Prior Developments. If, during any period during which Iperform or performed services for the Company Group both before or after the date hereof (the “Assignment Period”), whether as an officer, employee,director, independent contractor, consultant, or agent, or in any other capacity, I incorporate (or have incorporated) into a Company Group product or processa Prior Development owned by me or in which I have an interest, I hereby grant the Company, and the Company Group shall have, a non-exclusive, royalty-free, irrevocable, perpetual, transferable worldwide license (with the right to sublicense) to make, have made, copy, modify, make derivative works of, use,sell, and otherwise distribute such Prior Development as part of or in connection with such product or process.  (b)Assignment of Developments. I agree that I will, without additional compensation, promptly make full written disclosure tothe Company, and will hold in trust for the sole right and benefit of the Company all developments, original works of authorship, inventions, concepts,know-how, improvements, trade secrets, and similar proprietary rights, whether or not patentable or registrable under copyright or similar laws, which I maysolely or jointly conceive or develop or reduce to practice, or have solely or jointly conceived or developed or reduced to practice, or have caused or maycause to be conceived or developed or reduced to practice, during the Assignment Period, whether or not during regular working hours, provided they either(i) relate at the time of conception, development or reduction to practice to the business of any member of the Company Group, or the actual or anticipatedresearch or development of any member of the Company Group; (ii) result from or relate to any work performed for any member of the Company Group; or(iii) are developed through the use of equipment, supplies, or facilities of any member of the Company Group, or any Confidential Information, or inconsultation with personnel of any member of the Company Group (collectively referred to as “Developments”). I further acknowledge that allDevelopments made by me (solely or jointly with others) within the scope of and during the Assignment Period are “works made for hire” (to the greatestextent permitted by applicable law) for which I am, in part, compensated by my salary, unless regulated otherwise by law, but that, in the event any suchDevelopment is deemed not to be a work made for hire, I hereby assign to the Company, or its designee, all my right, title, and interest throughout the worldin and to any such Development. (c)Maintenance of Records. I agree to keep and maintain adequate and current written records of all Developments made by me(solely or jointly with others) during the Assignment Period. The records may be in the form of notes, sketches, drawings, flow charts, electronic data orrecordings, and any other format. The records will be available to and remain the sole property of the Company Group at all times. I agree not to removesuch records from the Company’s place of business except as expressly permitted by Company Group policy, which may, from time to time, be revised at thesole election of the Company Group for the purpose of furthering the business of the Company Group.(d)Intellectual Property Rights. I agree to assist the Company, or its designee, at the Company’s expense, in every way tosecure the rights of the Company Group in the Developments and any copyrights, patents, trademarks, service marks, database rights, domain names, maskwork rights, moral rights, and other intellectual property rights relating thereto in any and all countries, including the disclosure to the Company of allpertinent information and data with respect thereto, the execution of all applications, specifications, oaths, assignments, recordations, and all otherinstruments that the Company shall deem necessary in order to apply for, obtain, maintain, and transfer such rights and in order to assign and convey to theCompany Group the sole and exclusive right, title, and interest in and to such Developments, and any intellectual property and other proprietary rightsrelating thereto. I further agree that my obligation to execute or cause to be executed, when it is in my power to do so, any such instrument or papers shallcontinue after the Assignment Period until the expiration of the last such intellectual property right to expire in any country of the world; provided, however,the Company shall reimburse me for my reasonable expenses incurred in connection with carrying out the foregoing obligation. If the Company is unablebecause of my mental or physical incapacity or unavailability for any other reason to secure my signature to apply for or to pursue any application for anyUnited States or foreign patents or copyright registrations covering Developments or original works of authorship assigned to the Company as above, then Ihereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact to act for and in mybehalf and stead to execute and file any such applications or records and to do all other lawfully permitted acts to further the application for, prosecution,issuance, maintenance, and transfer of letters patent or registrations thereon with the same legal force and effect as if originally executed by me. I herebywaive and irrevocably quitclaim to the Company any and all claims, of any nature whatsoever, that I now or hereafter have for past, present, or futureinfringement of any and all proprietary rights assigned to the Company.Section 25.Returning Company Group Documents.I agree that, at the time of termination of my employment with the Company for any reason, I will deliver to the Company (and will notkeep in my possession, recreate, or deliver to anyone else) any and all Confidential Information and all other documents, materials, information, and propertydeveloped by me pursuant to my employment or otherwise belonging to the Company. I agree further that any property situated on the Company’s premisesand owned by the Company (or any other member of the Company Group), including disks and other storage media, filing cabinets, and other work areas, issubject to inspection by personnel of any member of the Company Group at any time with or without notice. Section 26.Disclosure of Agreement.As long as it remains in effect, I will disclose the existence of this Non-Interference Agreement to any prospective employer, partner, co-venturer, investor, or lender prior to entering into an employment, partnership, or other business relationship with such person or entity.  Section 27.Restrictions on Interfering. (a)Non-Competition. During the period of my employment with the Company (the “Employment Period”) and the Post-Termination Non-Compete Period, I shall not, directly or indirectly, individually or on behalf of any person, company, enterprise, or entity, or as a soleproprietor, partner, stockholder, director, officer, principal, agent, or executive, or in any other capacity or relationship, engage in any Competitive Activitiesin any jurisdiction in which the Company Group is engaged in (or has demonstrable plans to commence) business activities..(b)Non-Interference. During the Employment Period and the Post-Termination Non-Interference Period, I shall not, directly orindirectly for my own account or for the account of any other individual or entity, engage in Interfering Activities.(c)Definitions. For purposes of this Non-Interference Agreement :(i)“Business Relation” shall mean any current or prospective client, customer, licensee, or other business relation ofthe Company Group, or any such relation that was a client, customer, licensee, supplier, or other business relation within the six (6) month period prior to theexpiration of the Employment Period, in each case, to whom I provided services, or with whom I transacted business, or whose identity became known to mein connection with my relationship with or employment by the Company.(ii)“Competitive Activities” shall mean any business activity that is competitive with the then-current ordemonstrably planned business activities of the Company Group.(iii)“Interfering Activities” shall mean (A) encouraging, soliciting, or inducing, or in any manner attempting toencourage, solicit, or induce, any Person employed by, or providing consulting services to, any member of the Company Group to terminate such Person’semployment or services (or in the case of a consultant, materially reducing such services) with the Company Group; (B) hiring any individual who wasemployed by the Company Group within the six (6) month period prior to the date of such hiring and with whom I had contact with during the EmploymentPeriod within the six (6) month period prior to the date of such hiring; or (C) encouraging, soliciting, or inducing, or in any manner attempting to encourage,solicit, or induce, any Business Relation to cease doing business with or reduce the amount of business conducted with the Company Group, or in any wayinterfering with the relationship between any such Business Relation and the Company Group.(iv)“Person” shall mean any individual, corporation, partnership, limited liability company, joint venture,association, joint‑stock company, trust (charitable or non-charitable), unincorporated organization, or other form of business entity.(v)“Post-Termination Non-Compete Period” shall mean the period commencing on the date of the termination of theEmployment Period for any reason and ending on the six (6) month anniversary of such date of termination.(vi)“Post-Termination Non-Interference Period” shall mean the period commencing on the date of the termination ofthe Employment Period for any reason and ending on the twelve (12) month anniversary of such date of termination.(d)Non-Disparagement. I agree that during the Employment Period, and at all times thereafter, I will not make any disparagingor defamatory comments regarding any member of the Company Group or its respective current or former directors, officers, or employees in any respect ormake any comments concerning any aspect of my relationship with any member of the Company Group or any conduct or events which precipitated anytermination of my employment from any member of the Company Group. However, my obligations under this subparagraph (d) shall not apply to disclosuresrequired by applicable law, regulation, or order of a court or governmental agency.Section 28.Reasonableness of Restrictions.I acknowledge and recognize the highly competitive nature of the Company’s business, that access to Confidential Information rendersme special and unique within the Company’s industry, and that I will have the opportunity to develop substantial relationships with existing and prospectiveclients, accounts, customers, consultants, contractors, investors, and strategic partners of the Company Group during the course of and as a result of myemployment with the Company. In light of the foregoing, I recognize and acknowledge that the restrictions and limitations set forth in this Non-InterferenceAgreement are reasonable and valid in geographical and temporal scope and in all other respects and are essential to protect the value of the business andassets of the  Company Group. I acknowledge further that the restrictions and limitations set forth in this Non-Interference Agreement will not materially interfere with myability to earn a living following the termination of my employment with the Company and that my ability to earn a livelihood without violating suchrestrictions is a material condition to my employment with the Company.Section 29.Independence; Severability; Blue Pencil.Each of the rights enumerated in this Non-Interference Agreement shall be independent of the others and shall be in addition to and notin lieu of any other rights and remedies available to the Company Group at law or in equity. If any of the provisions of this Non-Interference Agreement orany part of any of them is hereafter construed or adjudicated to be invalid or unenforceable, the same shall not affect the remainder of this Non-InterferenceAgreement, which shall be given full effect without regard to the invalid portions. If any of the covenants contained herein are held to be invalid orunenforceable because of the duration of such provisions or the area or scope covered thereby, I agree that the court making such determination shall havethe power to reduce the duration, scope, and/or area of such provision to the maximum and/or broadest duration, scope, and/or area permissible by law, and inits reduced form said provision shall then be enforceable.Section 30.Injunctive Relief.I expressly acknowledge that any breach or threatened breach of any of the terms and/or conditions set forth in this Non-InterferenceAgreement may result in substantial, continuing, and irreparable injury to the members of the Company Group. Therefore, I hereby agree that, in addition toany other remedy that may be available to the Company, any member of the Company Group shall be entitled to seek injunctive relief, specific performance,or other equitable relief by a court of appropriate jurisdiction in the event of any breach or threatened breach of the terms of this Non-Interference Agreementwithout the necessity of proving irreparable harm or injury as a result of such breach or threatened breach. Notwithstanding any other provision to thecontrary, I acknowledge and agree that the Post-Termination Non-Compete Period, or Post-Termination Non-Interference Period, as applicable, shall be tolledduring any period of violation of any of the covenants in Section 5 hereof and during any other period required for litigation during which the Company orany other member of the Company Group seeks to enforce such covenants against me if it is ultimately determined that I was in breach of such covenants.Section 31.Cooperation.I agree that, following any termination of my employment, I will continue to provide reasonable cooperation to the Company and/or anyother member of the Company Group and its or their respective counsel in connection with any investigation, administrative proceeding, or litigationrelating to any matter that occurred during my employment in which I was involved or of which I have knowledge. As a condition of such cooperation, theCompany shall reimburse me for reasonable out-of-pocket expenses incurred at the request of the Company with respect to my compliance with thisparagraph. I also agree that, in the event that I am subpoenaed by any person or entity (including, but not limited to, any government agency) to givetestimony or provide documents (in a deposition, court proceeding, or otherwise) that in any way relates to my employment by the Company and/or anyother member of the Company Group, I will give prompt notice of such request to the Company and will make no disclosure until the Company and/or theother member of the Company Group has had a reasonable opportunity to contest the right of the requesting person or entity to such disclosure.Section 32.General Provisions. (a)Governing Law and Jurisdiction. EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY,INTERPRETATION, CONSTRUCTION, AND PERFORMANCE OF THIS NON-INTERFERENCE AGREEMENT IS GOVERNED BY AND IS TO BECONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED IN THATSTATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. FURTHER, I HEREBY WAIVE ANY RIGHT TO TRIAL BY JURY IN CONNECTIONWITH ANY SUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTION WITH THIS NON-INTERFERENCE AGREEMENT.(b)Entire Agreement. This Non-Interference Agreement sets forth the entire agreement and understanding between theCompany and me relating to the subject matter herein and merges all prior discussions between us. No modification or amendment to this Non-InterferenceAgreement, nor any waiver of any rights under this Non-Interference Agreement, will be effective unless in writing signed by the party to be charged. Anysubsequent change or changes in my duties, obligations, rights, or compensation will not affect the validity or scope of this Non-Interference Agreement.  (c)No Right of Continued Employment. I acknowledge and agree that nothing contained herein shall be construed as grantingme any right to continued employment by the Company, and the right of the Company to terminate my employment at any time and for any reason, with orwithout cause, is specifically reserved. (d)Successors and Assigns. This Non-Interference Agreement will be binding upon my heirs, executors, administrators, andother legal representatives and will be for the benefit of the Company, its successors, and its assigns. I expressly acknowledge and agree that this Non-Interference Agreement may be assigned by the Company without my consent to any other member of the Company Group as well as any purchaser of all orsubstantially all of the assets or stock of the Company, whether by purchase, merger, or other similar corporate transaction, provided that the license grantedpursuant to Section 2(a) may be assigned to any third party by the Company without my consent.(e)Survival. The provisions of this Non-Interference Agreement shall survive the termination of my employment with theCompany and/or the assignment of this Non-Interference Agreement by the Company to any successor in interest or other assignee.***  I, Dale Hooks, have executed this Confidentiality, Non-Interference, and Invention Assignment Agreement on the respective date setforth below: Date: January 26, 2016 /s/ DALE HOOKS (Signature) Dale Hooks (Type/Print Name)  SCHEDULE ALIST OF PRIOR DEVELOPMENTSAND ORIGINAL WORKS OF AUTHORSHIPEXCLUDED FROM SECTION 2TitleDateIdentifying Number orBrief Description X No Developments or improvements Additional Sheets Attached Signature of Employee: /s/ DALE HOOKSPrint Name of Employee: Dale HooksDate: January 26, 2016  EXHIBIT BRELEASE OF CLAIMSAs used in this Release of Claims (this “Release”), the term “claims” will include all claims, covenants, warranties, promises,undertakings, actions, suits, causes of action, obligations, debts, accounts, attorneys’ fees, judgments, losses, and liabilities, of whatsoever kind or nature, inlaw, in equity, or otherwise.For and in consideration of the Severance Benefits (as defined in my Employment Agreement, dated February 1, 2016, with ClovisOncology, Inc. (my “Employment Agreement”)), and other good and valuable consideration, I, Dale Hooks, for and on behalf of myself and my heirs,administrators, executors, and assigns, effective as of the date on which this release becomes effective pursuant to its terms, do fully and forever release,remise, and discharge the Company and each of its direct and indirect subsidiaries and affiliates, and its successors and assigns, together with its officers,directors, partners, shareholders, employees, and agents (collectively, the “Group”), from any and all claims whatsoever up to the date hereof that I had, mayhave had, or now have against the Group, whether known or unknown, for or by reason of any matter, cause, or thing whatsoever, including any claim arisingout of or attributable to my employment or the termination of my employment with the Company, whether for tort, breach of express or implied employmentcontract, intentional infliction of emotional distress, wrongful termination, unjust dismissal, defamation, libel, or slander, or under any federal, state, or locallaw dealing with discrimination based on age, race, sex, national origin, handicap, religion, disability, or sexual orientation. The release of claims in thisRelease includes, but is not limited to, all claims arising under the Age Discrimination in Employment Act (“ADEA”), Title VII of the Civil Rights Act, theAmericans with Disabilities Act, the Civil Rights Act of 1991, the Family Medical Leave Act, and the Equal Pay Act, each as may be amended from time totime, and all other federal, state, and local laws, the common law, and any other purported restriction on an employer’s right to terminate the employment ofemployees. The release contained herein is intended to be a general release of any and all claims to the fullest extent permissible by law.I acknowledge and agree that as of the date I execute this Release, I have no knowledge of any facts or circumstances that give rise orcould give rise to any claims under any of the laws listed in the preceding paragraph.By executing this Release, I specifically release all claims relating to my employment and its termination under ADEA, a United Statesfederal statute that, among other things, prohibits discrimination on the basis of age in employment and employee benefit plans.Notwithstanding any provision of this Release to the contrary, by executing this Release, I am not releasing (i) any claims relating to myrights under Section 8 of my Employment Agreement, (ii) any claims that cannot be waived by law, or (iii) my right of indemnification as provided by, and inaccordance with the terms of, the Company’s by-laws or a Company insurance policy providing such coverage, as any of such may be amended from time totime.I expressly acknowledge and agree that I –§Am able to read the language, and understand the meaning and effect, of this Release;§Have no physical or mental impairment of any kind that has interfered with my ability to read and understand themeaning of this Release or its terms, and that I am not acting under the influence of any medication, drug, or chemical of any type in entering intothis Release;§Am specifically agreeing to the terms of the release contained in this Release because the Company has agreed to payme the Severance Benefits in consideration for my agreement to accept it in full settlement of all possible claims I might have or ever have had, andbecause of my execution of this Release;§Acknowledge that, but for my execution of this Release, I would not be entitled to the Severance Benefits;§Understand that, by entering into this Release, I do not waive rights or claims under ADEA that may arise after thedate I execute this Release;  §Had or could have had [twenty-one (21)][forty-five (45)]1 days from the date of my termination of employment (the“Release Expiration Date”) in which to review and consider this Release, and that if I execute this Release prior to the Release Expiration Date, Ihave voluntarily and knowingly waived the remainder of the review period; §Have not relied upon any representation or statement not set forth in this Release or my Employment Agreementmade by the Company or any of its representatives;§Was advised to consult with my attorney regarding the terms and effect of this Release; and§Have signed this Release knowingly and voluntarily.I represent and warrant that I have not previously filed, and to the maximum extent permitted by law agree that I will not file, acomplaint, charge, or lawsuit against any member of the Group regarding any of the claims released herein. If, notwithstanding this representation andwarranty, I have filed or file such a complaint, charge, or lawsuit, I agree that I shall cause such complaint, charge, or lawsuit to be dismissed with prejudiceand shall pay any and all costs required in obtaining dismissal of such complaint, charge, or lawsuit, including without limitation the attorneys’ fees of anymember of the Group against whom I have filed such a complaint, charge, or lawsuit. This paragraph shall not apply, however, to a claim of agediscrimination under ADEA or to any non-waivable right to file a charge with the United States Equal Employment Opportunity Commission (the “EEOC”);provided, however, that if the EEOC were to pursue any claims relating to my employment with Company, I agree that I shall not be entitled to recover anymonetary damages or any other remedies or benefits as a result and that this Release and Section 8 of my Employment Agreement will control as theexclusive remedy and full settlement of all such claims by me.I hereby agree to waive any and all claims to re-employment with the Company or any other member of the Group and affirmativelyagree not to seek further employment with the Company or any other member of the Group.Notwithstanding anything contained herein to the contrary, this Release will not become effective or enforceable prior to the expirationof the period of seven (7) calendar days immediately following the date of its execution by me (the “Revocation Period”), during which time I may revoke myacceptance of this Release by notifying the Company and the Board of Directors of the Company, in writing, delivered to the Company at its principalexecutive office, marked for the attention of its Chief Executive Officer. To be effective, such revocation must be received by the Company no later than11:59 p.m. on the seventh (7th) calendar day following the execution of this Release. Provided that the Release is executed and I do not revoke it during theRevocation Period, the eighth (8th) calendar day following the date on which this Release is executed shall be its effective date. I acknowledge and agreethat if I revoke this Release during the Revocation Period, this Release will be null and void and of no effect, and neither the Company nor any other memberof the Group will have any obligations to pay me the Severance Benefits.The provisions of this Release shall be binding upon my heirs, executors, administrators, legal personal representatives, and assigns. Ifany provision of this Release shall be held by any court of competent jurisdiction to be illegal, void, or unenforceable, such provision shall be of no force oreffect. The illegality or unenforceability of such provision, however, shall have no effect upon and shall not impair the enforceability of any other provisionof this Release.EXCEPT WHERE PREEMPTED BY FEDERAL LAW, THE VALIDITY, INTERPRETATION, CONSTRUCTION, AND PERFORMANCEOF THIS RELEASE IS GOVERNED BY AND IS TO BE CONSTRUED UNDER THE LAWS OF THE STATE OF COLORADO APPLICABLE TOAGREEMENTS MADE AND TO BE PERFORMED IN THAT STATE, WITHOUT REGARD TO CONFLICT OF LAWS RULES. ANY DISPUTE OR CLAIMARISING OUT OF OR RELATING TO THIS RELEASE OR CLAIM OF BREACH HEREOF SHALL BE BROUGHT EXCLUSIVELY IN THE UNITEDSTATES DISTRICT COURT FOR THE 20th JUDICIAL DISTRICT OF COLORADO, TO THE EXTENT FEDERAL JURISDICTION EXISTS, AND IN ANYCOURT SITTING IN COLORADO, BUT ONLY IN THE EVENT FEDERAL JURISDICTION DOES NOT EXIST, AND ANY APPLICABLE APPELLATECOURTS. BY EXECUTION OF THIS RELEASE, I CONSENT TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS, AND WAIVE ANY RIGHT TOCHALLENGE JURISDICTION OR VENUE IN SUCH COURT WITH REGARD TO ANY SUIT, ACTION, OR PROCEEDING UNDER OR IN CONNECTIONWITH THIS RELEASE. FURTHER, I HEREBY WAIVE ANY RIGHT TO TRIAL BY JURY IN CONNECTION WITH ANY SUIT, ACTION, ORPROCEEDING UNDER OR IN CONNECTION WITH THIS RELEASE. 11 To be selected based on whether applicable termination was “in connection with an exit incentive or other employment termination program” (as suchphrase is defined in the Age Discrimination in Employment Act of 1967).  Capitalized terms used, but not defined herein, shall have the meanings ascribed to such terms in my Employment Agreement.***I, Dale Hooks, have executed this Release of Claims on the respective date set forth below: /s/ DALE HOOKS Dale Hooks Date: January 26, 2016 Exhibit 21.1List of Subsidiaries of Clovis Oncology, Inc. Name: Jurisdiction ofOrganization: Clovis Oncology UK Limited United Kingdom Clovis Oncology Italy S.r.l. Italy Clovis Oncology Switzerland GmbH Switzerland Clovis Oncology France SAS France Clovis Oncology Germany GmbH Germany Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1)Registration Statements (Form S-3 Nos. 333-188063 and 333-189234) of Clovis Oncology, Inc., and(2)Registration Statements (Form S-8 Nos. 333-178283, 333-182278, 333-190565, 333-198022 and 333-206193) pertaining to the 2011 Stock IncentivePlan and 2011 Employee Stock Purchase Plan of Clovis Oncology, Inc.of our reports dated February 29, 2016, with respect to the consolidated financial statements of Clovis Oncology, Inc., and the effectiveness of internalcontrol over financial reporting of Clovis Oncology, Inc., included in this Annual Report (Form 10-K) for the year ended December 31, 2015./s/ Ernst & Young LLPDenver, ColoradoFebruary 29, 2016 Exhibit 31.1I, Patrick J. Mahaffy, certify that: 1.I have reviewed this annual report on Form 10-K of Clovis Oncology, Inc. for the year ended December 31, 2015; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this report is being prepared; b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likelyto materially affect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: February 29, 2016 /s/ PATRICK J. MAHAFFY Patrick J. MahaffyPresident and Chief Executive Officer Exhibit 31.2I, Erle T. Mast, certify that: 1.I have reviewed this annual report on Form 10-K of Clovis Oncology, Inc. for the year ended December 31, 2015; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this report is being prepared; b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likelyto materially affect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: February 29, 2016 /s/ ERLE T. MASTErle T. MastExecutive Vice President and Chief Financial Officer Exhibit 32.1CERTIFICATIONS PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002(18 U.S.C. SECTION 1350)In connection with the Annual Report of Clovis Oncology, Inc., a Delaware corporation (the “Company”), on Form 10-K for the year ended December 31,2015, as filed with the Securities and Exchange Commission (the “Report”), Patrick J. Mahaffy, as Chief Executive Officer of the Company, does herebycertify, pursuant to §906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350), that to his knowledge:(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.Date: February 29, 2016 /s/ PATRICK J. MAHAFFYPatrick J. MahaffyPresident and Chief Executive Officer Exhibit 32.2CERTIFICATIONS PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002(18 U.S.C. SECTION 1350)In connection with the Annual Report of Clovis Oncology, Inc., a Delaware corporation (the “Company”), on Form 10-K for the year ended December 31,2015, as filed with the Securities and Exchange Commission (the “Report”), Erle T. Mast, as Chief Financial Officer of the Company, does hereby certify,pursuant to §906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350), that to his knowledge:(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.Date: February 29, 2016 /s/ ERLE T. MASTErle T. MastExecutive Vice President and Chief Financial Officer 

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