Palatin
Annual Report 2016

Plain-text annual report

SECURITIES & EXCHANGE COMMISSION EDGAR FILING PALATIN TECHNOLOGIES INC Form: 10-K Date Filed: 2016-09-19 Corporate Issuer CIK: 911216 © Copyright 2016, Issuer Direct Corporation. All Right Reserved. Distribution of this document is strictly prohibited, subject to the terms of use. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10 - K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2016 or For the transition period from ___________ to __________ Commission file number: 001-15543 PALATIN TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 95-4078884 (I.R.S. Employer Identification No.) 4B Cedar Brook Drive Cranbury, New Jersey (Address of principal executive offices) 08512 (Zip Code) (609) 495-2200 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Common Stock, par value $.01 per share Name of Each Exchange on Which Registered NYSE MKT Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ 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 ☑ Securities registered pursuant to Section 12(g) of the Act: None Indicate 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 1934 during 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 filing requirements for the past 90 days. Yes ☑ No ☐ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ 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 the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 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. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer Non-accelerated filer (Do not check if a smaller reporting company) ☐ ☐ Accelerated filer 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 ☑ State the aggregate market value of the voting and non-voting common equity held by non-affiliates, computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter (December 31, 2015): $44,069,665. Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date (September 16, 2016): 85,934,037. EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. Table of Contents PART I Item 1. Item 1A. Item 1B. Item 2. Item 3. Item 4. Item 5. Item 6. Item 7. Business Risk Factors Unresolved Staff Comments Properties Legal Proceedings Mine Safety Disclosures Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Selected Financial Data Management’s Discussion and Analysis of Financial Condition and Results of Operations PART II Item 7A. Quantitative and Qualitative Disclosures About Market Risk Item 8. Item 9. Item 9A. Item 9B. Item 10. Item 11. Item 12. Item 13. Item 14. Financial Statements and Supplementary Data Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Controls and Procedures Other Information Directors, Executive Officers and Corporate Governance Executive Compensation PART III Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Certain Relationships and Related Transactions, and Director Independence Principal Accountant Fees and Services PART IV Item 15. Exhibits, Financial Statement Schedules Forward-Looking Statements Page 1 18 38 38 38 38 39 39 39 43 44 67 67 67 68 72 78 81 81 82 Statements in this Annual Report on Form 10-K (this Annual Report), as well as oral statements that may be made by us or by our officers, directors, or employees acting on our behalf, that are not historical facts constitute “forward-looking statements,” which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. The forward-looking statements in this Annual Report do not constitute guarantees of future performance. Investors are cautioned that statements that are not strictly historical facts contained in this Annual Report, including, without limitation, those relating to our current or future financial performance, management’s plans and objectives for future operations, ability to raise capital or repay debt, if required, clinical trials and results, uncertainties associated with product research and development, product plans and performance, management’s assessment of market factors, as well as statements regarding our strategy and plans and those of our strategic partners, constitute forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “believe,” will,” “may,” “estimate,” “continue,” “anticipated,” “intend,” “should,” “plan,” “expect,” “predict,” “could,” “potentially,” or the negative of these terms or other similar expressions. Such forward-looking statements involve substantial risks, uncertainties and other factors that could cause our actual results to be materially different from our historical results or from any results expressed or implied by such forward-looking statements. Our future operating results are subject to risks and uncertainties and are dependent upon many factors, including, without limitation, the risks identified under the caption “Risk Factors” and elsewhere in this Annual Report, and any of those made in our other reports filed with the Securities and Exchange Commission, or the SEC. Except as required by law, we do not intend, and undertake no obligation, to publicly update forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events. In this Annual Report, references to “we,” “our,” “us,” the “Company” or “Palatin” means Palatin Technologies, Inc. and its subsidiary. EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 1. Business. Overview PART I We are a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Our programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. Our primary product in clinical development is bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder, or HSDD, which is a type of female sexual dysfunction, or FSD, defined as low desire with associated distress. In addition, we have drug candidates or development programs for obesity, erectile dysfunction, cardiovascular diseases, pulmonary diseases, inflammatory diseases and dermatologic diseases. The following drug development programs are actively under development: ● Bremelanotide, an as needed subcutaneous injectable peptide melanocortin receptor agonist, for treatment of HSDD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual response. Bremelanotide has completed the efficacy portion of patient studies in the primary Phase 3 clinical studies; ● Melanocortin receptor-4, or MC4r, compounds for treatment of obesity and diabetes. Results of our studies involving MC4r peptides suggest that certain of these peptides may have significant commercial potential for treatment of conditions responsive to MC4r activation, including FSD, HSDD, erectile dysfunction or ED, obesity and diabetes; ● PL-3994, a natriuretic peptide receptor-A, or NPR-A, agonist, for treatment of cardiovascular and pulmonary indications. PL-3994 is our lead natriuretic peptide receptor product candidate, and is a synthetic mimetic of the neuropeptide hormone atrial natriuretic peptide, or ANP. PL-3994 is in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension; and ● Melanocortin receptor-1, or MC1r, agonist peptides for treatment of inflammatory and dermatologic disease indications. Our MC1r peptide drug candidates are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. We have selected one of our MC1r peptide drug candidates, designated PL-8177, as a clinical trial candidate. The following chart illustrates the status of our drug development programs. 1 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Our Strategy Key elements of our business strategy include: ● Using our technology and expertise to develop and commercialize products in our active drug development programs; ● Entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that we are developing; ● Partially funding our product development programs with the cash flow generated from research collaboration and license agreements and any potential future agreements with third parties; and ● Completing development and seeking regulatory approval of bremelanotide for HSDD and our other product candidates. Our Melanocortin Receptor-Specific Programs The melanocortin system is involved in a large and diverse number of physiologic functions. Therapeutic agents modulating this system may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, pigmentation disorders and inflammation-related diseases. Bremelanotide for HSDD. We are developing subcutaneously administered bremelanotide for the treatment of HSDD in premenopausal women. HSDD is characterized by a decrease in sexual desire with significant personal distress or interpersonal difficulty as a result of the lack of desire. Bremelanotide is a melanocortin agonist with a mechanism of action involving activation of endogenous neuronal pathways regulating sexual arousal and desire responses. We initiated patient screening in our Phase 3 clinical study program of bremelanotide for the treatment of HSDD in premenopausal women, called the RECONNECT STUDY, in the fourth quarter of calendar 2014, completed patient enrollment in the fourth quarter of calendar 2015, and completed the last patient visits in the double blind, or efficacy, portion of the studies in the third quarter of calendar 2016. Topline results are projected early fourth quarter of calendar 2016. The open-label safety extension portion of the RECONNECT STUDY is continuing. We cannot assure you that the Phase 3 efficacy data will support approval of bremelanotide for HSDD or that the U.S. Food and Drug Administration, or FDA, will approve a new drug application, or NDA, for bremelanotide. Phase 3 Clinical Program. Prior to initiating our Phase 3 RECONNECT STUDY clinical program, we reached preliminary agreement with the FDA on key aspects of the bremelanotide efficacy Phase 3 pivotal registration studies, including HSDD patient population, primary and key secondary efficacy endpoints, general study design, dose selection and safety monitoring. In addition, the FDA agreed that the Phase 2 data adequately characterized blood pressure and heart rate signals of bremelanotide. The FDA also agreed that the intranasal Definitive QTc study (an electrocardiographic evaluation), the carcinogenicity studies and the reproductive toxicity studies we conducted were acceptable for NDA submission. The RECONNECT STUDY is being conducted in premenopausal women diagnosed with HSDD, either with or without arousal difficulties. HSDD is the single largest specific diagnosis in FSD. We enrolled a combined total of approximately 1,250 randomized subjects in the two pivotal efficacy studies, which are double blind placebo-controlled, randomized parallel group studies. Each study had two arms, one a 1.75 mg bremelanotide dose and one a placebo. The double blind or efficacy portion of each study consisted of a 24-week treatment evaluation period, with primary and key secondary endpoints of satisfying sexual events, or SSEs, the Female Sexual Function Index, or FSFI, desire subdomain (a 28 day recall), and question 13 of the Female Sexual Distress Scale-Desire/Arousal/Orgasm, or FSDS-DAO, questionnaire. The last patient visits for efficacy portion of the RECONNECT STUDY were completed in the third quarter of calendar 2016. Patients in the efficacy portion of the RECONNECT STUDY had the option, after completion of the randomized portion of the study, to continue in an open-label safety extension study, in which all patients receive the 1.75 mg bremelanotide dose. The open-label safety extension study has enrolled approximately 680 patients. The open-label safety extension study will continue through the third quarter of calendar 2017, and the purpose of the extension study is to gather additional data on the safety of long-term and repeated use of bremelanotide. The analysis of Phase 3 efficacy data is anticipated to be completed in the fourth quarter of calendar 2016. Assuming we believe that the Phase 3 data will support approval of bremelanotide for HSDD by FDA, we will conduct drug interaction and other ancillary studies, and certain chemistry, manufacturing and controls activities, required for FDA approval in the fourth quarter of calendar 2016 and first half of calendar 2017. We anticipate submitting an NDA to FDA for approval of bremelanotide for HSDD in mid-calendar 2017. We cannot assure you that the Phase 3 data will support approval of bremelanotide for HSDD or that the FDA will approve an NDA for bremelanotide. In the RECONNECT STUDY patients self-administer bremelanotide with a single-use autoinjector pen. The bremelanotide single-use autoinjector pen, intended to be the commercial drug product, does not have a visible needle, is stored at room temperature and is easy to use. Women administer bremelanotide by pressing the autoinjector pen collar against either their thigh or abdomen, and the autoinjector pen automatically introduces the needle, administers the dose of bremelanotide under the skin and audibly signals when the drug has been delivered and the needle is retracted. 2 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Phase 2B Clinical Study Results. The bremelanotide RECONNECT STUDY was predicated on the results of a Phase 2B clinical study of bremelanotide. The Phase 2B clinical study was a multicenter, placebo-controlled, randomized, parallel group, dose- finding trial testing three dose levels, 0.75 mg, 1.25 mg and 1.75 mg, of subcutaneously administered bremelanotide against placebo in premenopausal women diagnosed with hypoactive sexual desire disorder, female sexual arousal disorder or both. The 1.75 mg dose demonstrated clinically meaningful and statistically significant results for all predefined endpoints and was well-tolerated. Full data on the Phase 2B clinical study was presented at the March 2013 annual meeting of the International Society for the Study of Women’s Sexual Health, and was published in Women’s Health, 12:3425-337 (2016). The Phase 2B clinical study enrolled 395 premenopausal women across 66 sites within the United States and Canada, with patients randomized to one of three bremelanotide treatment arms and a placebo arm for 16 weeks of treatment. The objective of the Phase 2B study was to measure safety and efficacy in premenopausal women with hypoactive sexual desire disorder, female sexual arousal disorder or both of bremelanotide compared to placebo. In the Phase 2B study, subcutaneous doses of bremelanotide and placebo were self-administered by the patient prior to a sexual encounter. The primary efficacy endpoint was change from baseline to end of study in the number of SSEs, with pre-specified analysis of pooled 1.25 and 1.75 mg doses compared to placebo. In the Phase 2B clinical study, the primary endpoint data analysis of 327 premenopausal women with hypoactive sexual desire disorder, female sexual arousal disorder or both showed statistically significant and clinically meaningful increases in the number of SSEs, and statistically significant and clinically meaningful improvement in secondary endpoint measures of overall sexual functioning and distress related to sexual dysfunction, for women taking bremelanotide compared to placebo. Satisfying sexual events were measured with an event log and overall sexual functioning and distress related to sexual dysfunction were measured using validated patient reported outcome measurement tools. Bremelanotide showed a statistically significant increase from baseline in the number of SSEs compared against placebo at both the 1.75 mg dose and pooled results of the 1.75 and 1.25 mg doses. The mean increase in SSEs at 1.75 mg dose levels was 0.8 SSEs per month, from 1.8 to 2.6, with a p value of 0.021 against placebo. For the pooled doses, the mean increase in SSEs was 0.7 SSEs per month, from 1.6 to 2.4 (a 50% increase), with a p value of 0.018 against placebo. By contrast, with placebo, the mean change from baseline was from 1.7 to 1.9 (a 12% increase) in SSEs. The 0.75 mg dose demonstrated a response that was not significant different from placebo. The mean change from baseline in a validated measurement tool of overall sexual functioning, the FSFI total score, was 4.4 at the 1.75 mg dose level, compared to 1.88 for placebo, with a p value of 0.0021 against placebo. For the pooled doses, the FSFI total score mean change from baseline was 3.55, compared to 1.88 for placebo, with a p value of 0.0017 against placebo. The FSFI is a 19-item questionnaire measuring improvement in arousal, desire and overall sexual function. The mean change from baseline in a validated measurement tool of distress related to sexual dysfunction, the FSDS-DAO total score, was -13.1 at the 1.75 mg dose level, compared to -6.8 for placebo, with a p value of 0.0005 against placebo. For the pooled doses, the FSDS-DAO total score mean change from baseline was -11.1, compared to -6.8 for placebo, with a p value of 0.036 against placebo. The FSDS-DAO is a 15-item questionnaire that measures personal distress associated with HSDD. A significantly higher percentage of women receiving the 1.75 mg bremelanotide dose – 55% – achieved a clinically meaningful change from baseline of at least one satisfying sexual event, compared to 37% of women receiving placebo. In addition, compared against placebo a significantly higher percentage of women also achieved a clinically meaningful improvement in sexual function, as measured by the FSFI (53% vs. 29%), and a clinically meaningful decrease in distress associated with sexual dysfunction as measured by the FSDS-DAO (69% vs. 45%). Using a validated self-assessment questionnaire of treatment benefit, 79.5% of blinded patients receiving the 1.75 mg dose of bremelanotide reported they benefited from taking the drug, compared to 48.4% of blinded patients receiving placebo. Bremelanotide was well-tolerated during the Phase 2B clinical study. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea, emesis and headache, which were mainly mild-to-moderate in severity. Adverse events that most commonly led to discontinuation were nausea and emesis, with less than 3% discontinuation due to an adverse event. Twenty-six patients, evenly distributed among placebo and active arms of the Phase 2B clinical study, met the predefined blood pressure withdrawal criteria. Drug treated patients had approximately a 2 mm Hg change in blood pressure, predominately during the first four hours following dosing. No serious adverse events were attributable to bremelanotide during the trial. 3 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Medical Need — HSDD. Hypoactive sexual desire disorder, either with or without arousal difficulties, is the largest single category of FSD. Female sexual dysfunction is a multifactorial condition that has anatomical, physiological, medical, psychological and social components, and is defined as persistent or recurring problems during one or more of the stages of sexual response with associated distress. HSDD has a significant impact on a patient’s self-image, relationships and general well-being. The 2006 PRESIDE (Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking) study, a cross-sectional, population-based survey of 31,581 female adult respondents in the United States published in 2008 in the journal Obstetrics & Gynecology , found that approximately 22% of women reported a sexual problem and 11% were women with HSDD. Based on the number of premenopausal women in the United States according to the U.S. Census, the presenting market size of premenopausal women with primary HSDD is at least 5.1 million women. Subcutaneous Bremelanotide. Bremelanotide, which is believed to act through activation of melanocortin receptors in the central nervous system, is a first-in-class pharmaceutical agent in development as a treatment of HSDD. Bremelanotide is intended for as needed use and is self-administered by the patient thirty minutes to one hour prior to anticipated sexual activity. We selected a simple and patient-friendly single-use autoinjector pen used in the RECONNECT STUDY and intended for commercialization of the bremelanotide drug product. Partnering. In August 2014, we entered into a license agreement with Gedeon Richter to co-develop and commercialize bremelanotide for FSD in the European Union, other European countries and additional selected countries. We received €7.5 million ($9.8 million) in total upfront payments from Gedeon Richter, and a milestone payment of €2.5 million ($3.1 million) upon the initiation of our Phase 3 clinical trial program in the United States. On September 16, 2015, we entered into a termination agreement pursuant to which we and Gedeon Richter agreed to mutually and amicably terminate the license agreement. In connection with this termination, all rights and licenses to co-develop and commercialize bremelanotide for FSD indications held by Gedeon Richter terminated and reverted back to us. Neither we nor Gedeon Richter have any future material obligations under the license agreement. We have worldwide rights for bremelanotide for FSD, HSDD and all other indications. We are in active discussions with potential partners for U.S. marketing and commercialization rights for bremelanotide for HSDD. We may not be able to enter into suitable agreements with potential partners on acceptable terms, if at all. Prior Clinical Trials. We have completed several Phase 1 clinical studies in which various safety parameters, including blood pressure effects of subcutaneously administered bremelanotide, were studied. Based in part on these studies, our Phase 2B clinical trial assessed the magnitude and duration of blood pressure effect, and determined that subcutaneous administration of selected doses of bremelanotide for treatment of HSDD in premenopausal women provides acceptable control of blood pressure effects. We have also completed clinical studies involving an alternative route of administration. Bremelanotide has been administered in 34 clinical studies involving about 3,000 subjects, including studies of premenopausal and postmenopausal women with HSDD and other forms of FSD and men with ED. MC1r Peptide Agonists. We have conducted preclinical animal studies with MC1r peptide drug candidates for inflammatory disease and autoimmune indications. The MC1r is upregulated in a number of diseases, including inflammatory bowel disease, nephritis, which is inflammation of the kidneys, and rheumatoid arthritis, and ocular indications such as uveitis and dry eye. We believe that MC1r peptides have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of pro-inflammatory responses. MC1r peptides also have potential application in a number of dermatologic indications, including vitiligo and erythropoietic protoporphyria. Our MC1r peptide drug candidates are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. In vitro safety studies have shown that our MC1r peptide drug candidates have no activity in a wide range of various receptors, ion channels and kinases. We have selected one of our MC1r peptide drug candidates, designated PL-8177, as a clinical trial candidate. Animal studies that we have conducted with our MC1r peptide drug candidates have shown positive results in experimental models of inflammatory bowel disease, uveitis and nephritis. We are continuing to conduct studies on a number of different indications. We have completed preclinical toxicology testing on PL-8177 and chemistry, controls and manufacturing activities to support Phase 1 studies, and anticipate filing an IND application on PL-8177. Next Generation MC4r Peptide and Small Molecule Agonists. We have developed a series of highly selective MC4r peptides and are developing orally active small molecules. In developing these compounds, we examined effectiveness in animal models of sexual response, obesity and related metabolic signals, and also determined cardiovascular effects, primarily looking at changes in blood pressure. Results of these studies suggest that certain of these compounds may have significant commercial potential for treatment of conditions responsive to MC4r activation, including HSDD, FSD, ED, obesity and diabetes. We are engaged in preclinical activities with these compounds, and are evaluating potential pharmaceutical applications. 4 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. We have selected an internal lead compound for obesity, designated PL-8905, which has over 100-fold functional selectivity for MC4r over MC1r with minimal effect on blood pressure and limited central nervous system penetration. PL-8905 exhibits significant chemical and metabolic stability. Obesity. Obesity is a multifactorial condition with numerous biochemical components relating to satiety (feeling full), energy utilization and homeostasis. A number of different metabolic and hormonal pathways are being evaluated by companies around the world in efforts to develop better treatments for obesity. Scientific research has established that melanocortin receptors have a role in eating behavior and energy homeostasis, and that melanocortin receptor agonists can decrease food intake and induce weight loss. With a previous partner, we completed clinical proof-of-concept studies for the MC4r mechanism in obesity, which met the primary objectives of significant decrease in food intake and weight loss. Other Melanocortin Receptor-Specific Programs. We are continuing drug discovery efforts in the melanocortin receptor field, primarily developing peptide compounds, including highly selective MC1r agonists and peptides specific for MC4r, including both agonists and antagonists. Our Natriuretic Peptide Receptor-Specific Programs The natriuretic peptide receptor system has numerous cardiovascular functions, and therapeutic agents modulating this system may be useful in treatment of heart failure, acute asthma, other pulmonary diseases and hypertension. While the therapeutic potential of modulating this system is well appreciated, development of therapeutic agents has been difficult due, in part, to the short biological half-life of native peptide agonists. We have designed and are developing candidate drugs that are selective for different natriuretic peptide receptors, including NPR-A, natriuretic peptide receptor B, or NPR-B, natriuretic peptide receptor C, or NPRC, and both NPR-A and NPR-B. We are in active discussions with potential partners for marketing and commercialization rights in the United States and the rest of the world for PL-3994 and our related candidate drugs. We may not be able to enter into suitable agreements on acceptable terms with potential partners, if at all. PL-3994. PL-3994 is our lead natriuretic peptide receptor product candidate, and is a synthetic mimetic of the neuropeptide hormone ANP and an NPR-A agonist. PL-3994 is in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension. PL-3994 activates NPR-A, a receptor known to play a role in cardiovascular homeostasis. Consistent with being an NPR-A agonist, PL-3994 increases plasma cyclic guanosine monophosphate, or cGMP, levels, a pharmacological response consistent with the effects of endogenous (naturally produced) natriuretic peptides on cardiovascular function and smooth muscle relaxation. PL-3994 also decreases activity of the renin-angiotensin-aldosterone system, or RAAS, a hormone system that regulates blood pressure and fluid balance. The RAAS system is frequently over-activated in heart failure patients, leading to worsening of cardiovascular function. PL-3994, our lead product development candidate which is ready for Phase 2 safety and efficacy studies, is one of a number of natriuretic peptide receptor agonist compounds we have developed. PL-3994 is a synthetic molecule incorporating a novel and proprietary amino acid mimetic structure, and has an extended circulation half-life and metabolic stability compared to endogenous ANP. Based on the half-life and pharmacokinetics, we believe that PL-3994 is amenable to once daily chronic use subcutaneous administration. PL-3994 for Heart Failure. Heart failure is an illness in which the heart is unable to pump blood efficiently, and includes acutely decompensated heart failure with dyspnea (shortness of breath) at rest or with minimal activity. Endogenous natriuretic peptides have a number of beneficial effects, including vasodilation (relaxation of blood vessels), natriuresis (excretion of sodium) and diuresis (excretion of fluids). Patients who have been admitted to the hospital with an episode of worsening heart failure have an increased risk of either death or hospital readmission in the three months following discharge. Up to 15% of patients die in this period and as many as 30% need to be readmitted to the hospital. We believe that decreasing mortality and hospital readmission in patients discharged following hospitalization for worsening heart failure is a large unmet medical need for which PL-3994 may be effective. PL-3994 could potentially be utilized as an adjunct to existing heart failure medications, and may, if successfully developed, be self-administered by patients as a subcutaneous injection following hospital discharge. We believe that PL-3994, through activation of NPR-A, may, if successful, reduce cardiac hypertrophy (increase in heart size due to disease), which is an independent risk factor for cardiovascular morbidity and mortality. 5 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. According to a report from the American Heart Association published in 2014 in the journal Circulation, an estimated 5.7 million Americans suffer from heart failure, with 870,000 new cases of heart failure diagnosed each year, with disease incidence expected to increase with the aging of the American population. Heart failure has tremendous human and financial costs. The same report estimated that the 2012 total costs in the United States for heart failure were $30.7 billion, with heart failure constituting the leading cause of hospitalization in people over 65 years of age and with over 1 million hospital discharges for heart failure in 2010. Heart failure is a high mortality disease, with approximately one-half of heart failure patients dying within five years of initial diagnosis. Patient populations have been identified which have reduced levels of endogenous active natriuretic peptides, including endogenous active ANP. The reduced levels have a variety of causes, including mutations in endogenous natriuretic peptides and in enzymes necessary to convert natriuretic peptide sequences to their active form. Patients with reduced levels of endogenous active natriuretic peptides are reported to have a poor response to current drug therapies and to have increased rates of cardiac remodeling and cardiac events. We believe that PL-3994 has the potential to treat heart failure with preserved ejection fraction, or HFpEF, which is a high unmet medical need with no approved treatment options, heart failure with reduced ejection fraction, or HFrEF, and patients with reduced levels of endogenous active natriuretic peptides, such as corin deficiencies, which is a high unmet medical need in patients with a poor response to current therapies, with the objective to restore normal natriuretic peptide function. We have planned a repeat dose Phase 2 clinical trial in patients with HFpEF, HFrEF and corin deficiency to evaluate safety profiles and symptom relief as well as pharmacokinetic (period to metabolize or excrete the drug) and pharmacodynamic (period of action or effect of the drug) endpoints. Analysis will include cardiac imaging and measurement of left ventricular ejection fraction. Contingent on adequate available funds, we intend to initiate this trial in the first half of calendar 2017. Assuming favorable results from this trial, we have planned a repeat dose Phase 2 proof-of-principle clinical trial in patients with heart failure, which would involve treatment for a three- to six-month period, and would evaluate safety, cardiac function, effects on remodeling, symptom improvement and hospitalization admission rates. Contingent on adequate available funds, the proof-of-principle Phase 2 trial will be initiated following completion of the first repeat dose Phase 2 clinical trial. PL-3994 for Acute Exacerbations of Asthma. Research over the past two decades has demonstrated potent bronchodilator effects with both systemic and inhalation administration of natriuretic peptides. NPR-A agonism is known to relax smooth muscles in airways and works through a pathway independent of the beta-2 adrenergic receptor. Preclinical testing demonstrated potent airway smooth muscle relaxation in guinea pig and human tissues using PL-3994, and animal studies in sensitized guinea pigs have demonstrated a bronchodilator effect with PL-3994 using both subcutaneous and inhalation administration. Acute exacerbations of asthma, also called acute severe asthma, is an ongoing, unremitting asthma episode in which asthma symptoms do not adequately respond to initial bronchodilator therapy. Inhaled beta-2 adrenergic receptor agonists, such as albuterol, inhaled anticholinergic drugs, such as ipratropium, and systemic corticosteroids are primary treatments for episodes of acute exacerbations of asthma. Some patients with acute exacerbations of asthma become unresponsive to beta-2 adrenergic receptor agonists, significantly limiting treatment options and increasing risk. Patients who do not respond to initial therapy are at risk of severe complications. We intend to initially target PL-3994 as a treatment for those at-risk unresponsive patients. According to a 2014 report from the National Center for Environmental Health, Asthma Prevalence in the United States, in 2010 there were 1.8 million emergency room visits and 439,000 hospitalizations attributed to asthma. Approximately 25.7 million Americans have asthma. Endogenous natriuretic peptides have a very short half-life, due primarily to degradation by neutral endopeptidase and clearance through the natriuretic peptide clearance receptor. PL-3994 is resistant to neutral endopeptidase and clears from the body much more slowly than endogenous natriuretic peptides. PL-3994 has a blood-plasma half-life of at least three hours in humans when administered by subcutaneous injection, with biological effects seen for over eight hours post-administration. Clinical Studies with PL-3994. Human clinical studies of PL-3994 commenced with a Phase 1 trial, which concluded in 2008. This was a randomized, double-blind, placebo-controlled study in 26 healthy volunteers who received either PL-3994 or a placebo subcutaneously. The evaluations included safety, tolerability, pharmacokinetics and several pharmacodynamic endpoints, including levels of cGMP. Dosing concluded with the successful achievement of the primary endpoint of the study, a pre-specified reduction in systemic blood pressure. No volunteer experienced a serious or severe adverse event. Elevations in plasma cGMP levels, increased diuresis and increased natriuresis were all observed for several hours after single subcutaneous doses. 6 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Later in 2008, we conducted a Phase 2A trial in volunteers with controlled hypertension who were receiving one or more conventional antihypertensive medications. In this trial, which was a randomized, double-blind, placebo-controlled, single ascending dose study in 21 volunteers, the objective was to demonstrate that PL-3994 can be given safely to patients taking antihypertensive medications commonly used in heart failure and hypertension patients. Dosing concluded with the successful achievement of the primary endpoint of the study, a pre-specified reduction in systemic blood pressure. No volunteer experienced a serious or severe adverse event. Elevations in plasma cGMP levels were observed for several hours after single subcutaneous doses. Based on the studies to date, PL-3994 is ready for Phase 2 safety and efficacy studies. Administration of PL-3994. For heart failure and refractory hypertension indications we believe that subcutaneous administration of PL-3994 may be preferable. PL-3994 is well absorbed through the subcutaneous route of administration. In human studies, the pharmacokinetic and pharmacodynamic half-lives were on the order of hours, significantly longer than the comparable half-lives of endogenous natriuretic peptides. We believe that subcutaneous PL-3994, if successful, will be appropriate for self-administration by patients, similar to insulin and other self-administered drugs. For asthma indications we believe that inhalation administration of PL-3994 may be preferable to subcutaneous or other systemic administration. Technologies We Use We used a rational drug design approach to discover and develop proprietary peptide, peptide mimetic and small molecule agonist compounds, focusing on melanocortin and natriuretic peptide receptor systems. Computer-aided drug design models of receptors are optimized based on experimental results obtained with peptides and small molecules that we develop. With our approach, we believe we are developing an advanced understanding of the factors which drive agonism. We have developed a series of proprietary technologies used in our drug development programs. One technology employs novel amino acid mimetics in place of selected amino acids. These mimetics provide the receptor-binding functions of conventional amino acids while providing structural, functional and physiochemical advantages. The amino acid mimetic technology is employed in PL-3994, our compound in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension. Some compound series have been derived using our proprietary and patented platform technology, called MIDAS™, or Metal Ion-induced Distinctive Array of Structures. This technology employs metal ions to fix the three-dimensional configuration of peptides, forming conformationally rigid molecules that remain folded specifically in their active state. These MIDAS molecules are generally simple to synthesize, are chemically and proteolytically stable, and have the potential to be orally bioavailable. In addition, MIDAS molecules are information-rich and provide data on structure-activity relationships that may be used to design small molecule, non-peptide drugs. Amount Spent on Research and Development Activities Research and development expenses were approximately $43.1 million for the fiscal year ended June 30, 2016, or fiscal 2016, $24.6 million for the fiscal year ended June 30, 2015, or fiscal 2015, and $10.8 million for the fiscal year ended June 30, 2014, or fiscal 2014. Competition General. Our products under development will compete on the basis of quality, performance, cost effectiveness and application suitability with numerous established products and technologies. We have many competitors, including pharmaceutical, biopharmaceutical and biotechnology companies. Furthermore, there are several well-established products in our target markets that we will have to compete against. Products using new technologies which may be competitive with our proposed products may also be introduced by others. Most of the companies selling or developing competitive products have financial, technological, manufacturing and distribution resources significantly greater than ours and may represent significant competition for us. In addition, if any of our product candidates are approved by FDA, they will eventually face competition from generic versions that will sell at significantly reduced prices, be preferred by managed care and health insurance payers, and be eligible for automatic pharmacy substitution even when a prescriber writes a prescription for our product. The timing and extent of future generic competition is dependent upon both our intellectual property rights and the FDA regulatory process, but cannot be accurately predicted. The pharmaceutical and biotechnology industries are characterized by extensive research efforts and rapid technological change. Many biopharmaceutical companies have developed or are working to develop products similar to ours or that address the same markets. Such companies may succeed in developing technologies and products that are more effective or less costly than any of those that we may develop. Such companies may be more successful than us in developing, manufacturing and marketing products. 7 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. We cannot guarantee that we will be able to compete successfully in the future or that developments by others will not render our proposed products under development or any future product candidates obsolete or noncompetitive or that our collaborators or customers will not choose to use competing technologies or products. Bremelanotide for Treatment of HSDD. There is competition and financial incentive to develop, market and sell drugs for the treatment of HSDD and other forms of FSD. Flibanserin, sold under the trade name Addyi®, is the only drug currently approved in the United States for treatment of HSDD. Flibanserin, a non-hormonal oral serotonin 5-HT1A agonist, 5-HT2A antagonist, which requires chronic dosing, was approved by the FDA on August 18, 2015 for treatment of premenopausal women with HSDD. The FDA approval included a risk evaluation and mitigation strategy, or REMS, because of the increased risk of severe hypotension and syncope due to the interaction between flibanserin and alcohol, and a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with flibanserin, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Approval by the FDA followed a positive FDA advisory committee recommendation in June 2015. We are aware of several other drugs at various stages of development, most of which are taken on a chronic, typically once-daily, basis. An oral fixed-dose combination of two antidepressants, bupropion and trazodone, is reported to be entering Phase 2 studies in premenopausal women with HSDD. Another company is developing two different oral fixed-dose combination drugs, one a combination of sildenafil and testosterone and the other a combination of testosterone and buspirone hydrochloride, and has conducted Phase 2 studies. Libigel®, a testosterone gel, completed two Phase 3 efficacy trials for treatment of FSD in surgically post-menopausal women, but did not show statistical separation from placebo in those trials. Intrinsa, a transdermal testosterone patch, successfully completed a Phase 3 clinical program, but was not approved in the United States based on potential long-term use safety risks of cancer and cardiovascular adverse events. There are other companies reported to be developing new drugs for FSD indications, some of which may be in clinical trials in the United States or elsewhere. We are not aware of any company actively developing a melanocortin receptor agonist drug for HSDD. PL-3994 for Heart Failure Indications. Nesiritide (sold under the trade name Natrecor®), a recombinant human B-type natriuretic peptide drug, is marketed in the United States by Scios Inc., a Johnson & Johnson company. Nesiritide is approved for treatment of acutely decompensated congestive heart failure patients who have dyspnea at rest or with minimal activity. Other peptide drugs, including carperitide, a recombinant human atrial natriuretic peptide drug, and ularitide, a synthetic form of urodilatin, a naturally occurring human natriuretic peptide related to atrial natriuretic peptide, have been investigated for treatment of congestive heart failure, but we are not aware of any active development in the United States. We are aware of other companies developing intravenously administered natriuretic peptide drugs, with at least one reported to have completed Phase 2 clinical trials for acute heart failure. A combination drug comprised of sacubitril and valsartan developed by Novartis AG, sold under the trade name Entresto®, inhibits both the angiotensin II receptor and neprilysin (an enzyme which inactivates endogenous active natriuretic peptides). This combination drug, which was approved by the FDA in July 2015, results in increases of endogenous active ANP levels, and thus has a mechanism of action with similarities to PL-3994. In a Phase 3 trial, the combination drug was compared to an angiotensin-converting-enzyme inhibitor, enalapril, in heart failure patients with reduced ejection fraction. It significantly improved the rate of death from cardiovascular causes, significantly reduced hospitalization for heart failure and significantly improved heart failure symptoms. This combination drug demonstrated that upregulation of the natriuretic peptide system in combination with angiotensin-converting-enzyme inhibition is superior to angiotensin-converting-enzyme inhibition alone, and thus provides validation of the natriuretic peptide system as a target for improving outcomes in treating heart failure patients. In addition, there are a number of approved drugs and drugs in development for treatment of heart failure through mechanisms or pathways other than agonism of NPR-A. PL-3994 for Acute Exacerbations of Asthma Indications. The asthma market is intensively competitive, with substantial competition and financial incentive to develop, market and sell drugs for treatment of asthma, with projected costs of prescription drugs of $5.9 billion in the United States in 2010. We are aware of companies developing drugs for the specific indications of either acute exacerbations of asthma or acute severe asthma, including at least one company with a drug reported to be currently in clinical trials. Certain of these drugs under development work by mechanisms of action different from the mechanisms of action of currently approved products. In addition, a number of clinical trials are conducted by hospitals, research institutes and others exploring various methods and combinations of drugs to treat acute exacerbations of asthma. There are a number of drugs and therapies currently used to treat acute exacerbations of asthma, including administration of oral or intravenous systemic steroids, use of oxygen or heliox, a mixture of helium and oxygen, nebulized short-acting beta-2 adrenergic receptor agonists, intravenous or nebulized anticholinergic agents and, for patients in or approaching respiratory arrest, intubation and mechanical ventilation. However, each of these drugs or therapies has recognized limitations or liabilities, and we believe that there remains an unmet medical need for a safe and effective treatment for acute exacerbations of asthma. We are not aware of any other company actively developing a drug to treat asthma using a natriuretic peptide receptor pathway. 8 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. MC4r Peptides for Erectile Dysfunction. Leading drugs approved for erectile dysfunction, or ED, indications are PDE-5 inhibitors which target the vascular system, such as sildenafil (sold under the trade name Viagra®), vardenafil (sold under the trade name Levitra®) and tadalafil (sold under the trade name Cialis®). Other drugs approved for ED indications include alprostadil for injection (sold under the trade name Caverject Impulse® among others), which is injected directly into the penis, and alprostadil in urethral suppository format (sold under the trade name MUSE®). In addition, a variety of devices, including vacuum devices and surgical penile implants, have been approved for ED indications. We are aware of a number of companies developing new drugs for ED indications, some of which are in clinical trials in the United States and elsewhere. We are not aware of any company actively developing a melanocortin receptor agonist drug for ED. Obesity. There are a number of FDA-approved drugs and medical devices for the treatment of obesity, and a large number of products in clinical development by other companies, including products which target melanocortin receptors. At least one Phase 2 study has been reported on use of an MC4r agonist for obesity indications. MC1r Peptides for Dermatologic and Inflammatory Disease-Related Indications. Many dermatologic and inflammatory disease-related indications are treated using systemic steroids or immunosuppressant drugs, both of which have side effects which can be dose limiting. There are a large number of approved biological drugs and biological drugs under development for treatment of dermatologic and inflammatory disease-related indications. Patents and Proprietary Information Patent Protection. Our success will depend in substantial part on our ability to obtain, defend and enforce patents, maintain trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad. We own a number of issued United States patents and have pending United States patent applications, many with issued or pending counterpart patents in selected foreign countries. We seek patent protection for our technologies and products in the United States and those foreign countries where we believe patent protection is commercially important. We own two issued United States patents claiming the bremelanotide substance and an issued patent claiming the bremelanotide substance in each of Australia, Austria, Belgium, Brazil, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, Monaco, Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. The issued United States patents have a term until 2020, which term may be subject to extension for a maximum period of up to five years as compensation for patent term lost during drug development and the FDA regulatory review process, pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments. Whether we will be able to obtain patent term extensions under the Hatch-Waxman Amendments and the length of any such extension cannot be determined until the FDA approves for marketing, if ever, a product in which bremelanotide is the active ingredient. In addition, the claims of issued patents covering bremelanotide may not provide meaningful protection. Further, third parties may challenge the validity or scope of any issued patent, and under the Hatch-Waxman Amendments, potentially receive approval of a competing generic version of our product or products even before a court rules on the validity or infringement of our patents. We own an issued United States patent and pending patent applications in the United States for methods of treating FSD with bremelanotide, and related patent applications are pending in Australia, Brazil, Canada, China, Colombia, Georgia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Africa, Ukraine, Vietnam and before the European and Eurasian patent offices. The issued United States patent has a term until 2033. Whether we will be able to obtain a patent term extension in the United States under the Hatch-Waxman Amendments, assuming that a relevant patent issues in the United States, and the length of any such extension, cannot be determined until the FDA approves for marketing, if ever, a product utilizing bremelanotide by methods claimed in the patent. Pending applications in the United States and elsewhere in the world have a presumptive term, if a patent is issued, until 2033. We have patents and patent applications on an alternative class of melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications, including obesity, consisting of two issued patents in the United States, an issued patent in each of Australia, Canada, China, Israel, Mexico, New Zealand, Japan and Russia, and pending patent applications on the same class in Brazil, India, Korea, and South Africa and before the European patent office. The presumptive term of the issued patents and pending patent applications is until 2029. We also have patents and pending patent applications for a second class of alternative melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications, including obesity, consisting of issued patents in the United States, Australia, China, Japan, Mexico, New Zealand, Russia, and South Africa and pending patent applications on the same class in Brazil, Canada, China, India, Israel, Korea, and before the European patent office. The presumptive term of the issued patents and pending patent applications is until 2030. Until one or more product candidates covered by a claim of one of these patents and patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments. 9 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. We own issued patents in the United States, Mexico, New Zealand, South Africa and Russia claiming highly selective MC1r agonist peptides for treatment of inflammation-related diseases and disorders and related indications, and pending patent applications on two broad classes of highly selective MC1r agonist peptides in the United States, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, and Mexico and before the European patent office. The presumptive term of the issued patents and pending patent applications is until 2030. Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments. We own two issued United States patents claiming the PL-3994 substance and other natriuretic peptide receptor agonist compounds that we have developed and an issued United States patent claiming a precursor molecule to the PL-3994 substance, both of which expire in 2027. Corresponding patents on the PL-3994 substance and other natriuretic peptide receptor agonist compounds were issued in Australia, Austria, Belgium, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Russia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom, with terms until 2027. Patent applications on the PL-3994 substance and other natriuretic peptide receptor agonist compounds are pending in Brazil and Canada, with presumptive terms until 2027. Applications claiming precursor molecules for the PL-3994 substance and other compounds have issued in the United States, Australia, China, France, Germany, Hong Kong, India, Ireland, Israel, Japan, Mexico, Netherlands, Philippines, Korea, South Africa, Sweden, Switzerland and the United Kingdom, and expire in 2027. Patent applications on the precursor molecules are pending in Brazil, Canada, and before the Eurasian Patent Office, with presumptive terms until 2027. We also own an issued United States patent claiming use of the PL-3994 substance for treatment of acute asthma and chronic obstructive pulmonary disease, which expires in 2031. We do not know the full scope of patent coverage we will obtain, or whether any patents will issue other than the patents already issued. Until one or more product candidates covered by a claim of the issued patents or one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments. We additionally have 31 issued United States patents on melanocortin receptor specific peptides and small molecules, and three issued United States patents on natriuretic peptide receptor agonist compounds, but we are not actively developing any product candidate covered by a claim of any of these patents. In the event that a third party has also filed a patent application relating to an invention we claimed in a patent application, we may be required to participate in an interference proceeding adjudicated by the United States Patent and Trademark Office to determine priority of invention. The possibility of an interference proceeding could result in substantial uncertainties and cost, even if the eventual outcome is favorable to us. An adverse outcome could result in the loss of patent protection for the subject of the interference, subjecting us to significant liabilities to third parties, the need to obtain licenses from third parties at undetermined cost, or requiring us to cease using the technology. Future Patent Infringement. We do not know for certain that our commercial activities will not infringe upon patents or patent applications of third parties, some of which may not even have been issued. Although we are not aware of any valid United States patents which are infringed by bremelanotide or PL-3994, we cannot exclude the possibility that such patents might exist or arise in the future. We may be unable to avoid infringement of any such patents and may have to seek a license, defend an infringement action, or challenge the validity of such patents in court. Patent litigation is costly and time consuming. If such patents are valid and we do not obtain a license under any such patents, or we are found liable for infringement, we may be liable for significant monetary damages, may encounter significant delays in bringing products to market, or may be precluded from participating in the manufacture, use or sale of products or methods of treatment covered by such patents. Proprietary Information. We rely on proprietary information, such as trade secrets and know-how, which is not patented. We have taken steps to protect our unpatented trade secrets and know-how, in part through the use of confidentiality and intellectual property agreements with our employees, consultants and certain contractors. If our employees, scientific consultants, collaborators or licensees develop inventions or processes independently that may be applicable to our product candidates, disputes may arise about the ownership of proprietary rights to those inventions and processes. Such inventions and processes will not necessarily become our property, but may remain the property of those persons or their employers. Protracted and costly litigation could be necessary to enforce and determine the scope of our proprietary rights. 10 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. If trade secrets are breached, our recourse will be solely against the person who caused the secrecy breach. This might not be an adequate remedy to us because third parties other than the person who causes the breach will be free to use the information without accountability to us. This is an inherent limitation of the law of trade secret protection. U.S. Governmental Regulation of Pharmaceutical Products General Regulation by governmental authorities in the United States and other countries will continue to significantly impact our research, product development, manufacturing and marketing of any pharmaceutical products. The nature and the extent to which regulations apply to us will vary depending on the nature of any such products. Our potential pharmaceutical products will require regulatory approval by governmental agencies prior to commercialization. The products we are developing are subject to federal regulation in the United States, principally by the FDA under the Federal Food, Drug, and Cosmetic Act, or FFDCA, and by state and local governments, as well as regulatory and other authorities in foreign governments that include rigorous preclinical and clinical testing and other approval procedures. Such regulations govern or influence, among other things, the research, development, testing, manufacture, safety and efficacy requirements, labeling, storage, recordkeeping, licensing, advertising, promotion, distribution and export of products, manufacturing and the manufacturing process. In many foreign countries, such regulations also govern the prices charged for products under their respective national social security systems and availability to consumers. All drugs intended for human use are subject to rigorous regulation by the FDA in the United States and similar regulatory bodies in other countries. The steps ordinarily required by the FDA before an innovative new drug product may be marketed in the United States are similar to steps required in most other countries and include, but are not limited to: ● completion of preclinical laboratory tests, preclinical animal testing and formulation studies; ● submission to the FDA of an IND, which must be in effect before clinical trials may commence; ● submission to the FDA of an NDA that includes preclinical data, clinical trial data and manufacturing information; ● payment of substantial user fees for filing the NDA and other recurring user fees; ● FDA review of the NDA; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities; and ● FDA approval of the NDA, including approval of all product labeling. For combination products deemed to have a ‘‘drug’’ primary mode of action, primary review of the product will be conducted by the appropriate division within the Center for Drug Evaluation and Research, or CDER, but CDER will consult with the Center for Devices and Radiological Health, or CDRH, to ensure that the device components of the product meet all applicable device requirements. The research, development and approval process requires substantial time, effort and financial resources, and approvals may not be granted on a timely or commercially viable basis, if at all. Preclinical testing includes laboratory evaluations to characterize the product’s composition, impurities, stability, and mechanism of its pharmacologic effect, as well as animal studies to assess the potential safety and efficacy of each product. Preclinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practices, or GLP, and the U.S. Department of Agriculture’s Animal Welfare Act. Violations of these laws and regulations can, in some cases, lead to invalidation of the tests, requiring such tests to be repeated and delaying approval of the NDA. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND and are reviewed by the FDA before the commencement of human clinical trials. Unless the FDA objects to an IND by placing the study on clinical hold, the IND will go into effect 30 days following its receipt by the FDA. The FDA may authorize trials only on specified terms and may suspend ongoing clinical trials at any time on various grounds, including a finding that patients are being exposed to unacceptable health risks. If the FDA places a study on clinical hold, the sponsor must resolve all of the FDA’s concerns before the study may begin or continue. The IND application process may become extremely costly and substantially delay development of products. Similar restrictive requirements also apply in other countries. Additionally, positive results of preclinical tests will not necessarily indicate positive results in clinical trials. Clinical trials involve the administration of the investigational product to humans under the supervision of qualified principal investigators. Our clinical trials must be conducted in accordance with Good Clinical Practice, or GCP, regulations under protocols submitted to the FDA as part of an IND. In addition, each clinical trial is approved and conducted under the auspices of an institutional review board, or IRB, and requires the patients’ informed consent. An IRB considers, among other things, ethical factors, the safety of human subjects, and the possibility of liability of the institutions conducting the trial. The IRB at each institution at which a clinical trial is being performed may suspend a clinical trial at any time for a variety of reasons, including a belief that the test subjects are being exposed to an unacceptable health risk. As the sponsor, we can also suspend or terminate a clinical trial at any time. 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Clinical trials are typically conducted in three sequential phases, Phases 1, 2, and 3, involving an increasing number of human subjects. These phases may sometimes overlap or be combined. Phase 1 trials are performed in a small number of healthy human subjects or subjects with the targeted condition, and involve testing for safety, dosage tolerance, absorption, distribution, metabolism and excretion. Phase 2 studies, which may involve up to hundreds of subjects, seek to identify possible adverse effects and safety risks, preliminary information related to the efficacy of the product for specific targeted diseases, dosage tolerance, and optimal dosage. Finally, Phase 3 trials may involve up to thousands of individuals often at geographically dispersed clinical trial sites, and are intended to provide the documentation of effectiveness and important additional safety data required for approval. Prior to commencing Phase 3 clinical trials many sponsors elect to meet with FDA officials to discuss the conduct and design of the proposed trial or trials. In addition, federal law requires the listing, on a publicly-available website, of detailed information on clinical trials for investigational drugs. Some states have similar or supplemental clinical trial reporting laws. Success in early-stage animal studies and clinical trials does not necessarily assure success in later-stage clinical trials. Data obtained from animal studies and clinical activities are not always conclusive and may be subject to alternative interpretations that could delay, limit or even prevent regulatory approval. All data obtained from the preclinical studies and clinical trials, in addition to detailed information on the manufacture and composition of the product, would be submitted in an NDA to the FDA for review and approval for the manufacture, marketing and commercial shipments of any of our products. FDA approval of the NDA is required before commercial marketing or non-investigational interstate shipment may begin in the United States. The FDA may also conduct an audit of the clinical trial data used to support the NDA. The FDA may deny or delay approval of an NDA that does not meet applicable regulatory criteria. For example the FDA may determine that the preclinical or clinical data or the manufacturing information does not adequately establish the safety and efficacy of the drug. The FDA has substantial discretion in the approval process and may disagree with an applicant’s interpretation of the data submitted in its NDA. The FDA can request additional information, seek clarification regarding information already provided in the submission or ask that new additional clinical trials be conducted, all of which can delay approval. Similar types of regulatory processes will be encountered as efforts are made to market any drug internationally. We will be required to assure product performance and manufacturing processes from one country to another. Even if the FDA approves a product, it may limit the approved uses for the product as described in the product labeling, require that contraindications, warning statements or precautions be included in the product labeling, require that additional studies be conducted following approval as a condition of the approval, impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a REMS, or otherwise limit the scope of any approval or limit labeling. Once it approves an NDA, the FDA may revoke or suspend the product approval if compliance with post-market regulatory standards is not maintained or if problems occur after the product reaches the marketplace. In addition, the FDA may require post-marketing studies to monitor the effect of approved products, and may limit further marketing of the product based on the results of these post-market studies. The FDA and other government agencies have broad post-market regulatory and enforcement powers, including the ability to levy civil and criminal penalties, suspend or delay issuance of approvals, seize or recall products and revoke approvals. Pharmaceutical manufacturers, distributors and their subcontractors are required to register their facilities with the FDA and state agencies. Manufacturers are required to list their marketed drugs with the FDA, are subject to periodic inspection by the FDA and other authorities, where applicable, and must comply with the FDA’s current Good Manufacturing Practices, or GMP, regulations, and the product specifications set forth in the approved NDA. The GMP requirements for pharmaceutical products are extensive and compliance with them requires considerable time, resources and ongoing investment. The regulations require manufacturers and suppliers of raw materials and components to establish validated systems and to employ and train qualified employees to ensure that products meet high standards of safety, efficacy, stability, sterility (where applicable), purity, and potency. The requirements apply to all stages of the manufacturing process, including the synthesis, processing, sterilization, packaging, labeling, storage and shipment of the drug product. For all drug products, the regulations require investigation and correction of any deviations from GMP requirements and impose documentation requirements upon us and any third-party manufacturers that we may decide to use. Manufacturing establishments are subject to mandatory user fees, and to periodic unannounced inspections by the FDA and state agencies for compliance with all GMP requirements. The FDA is authorized to inspect manufacturing facilities without a warrant at reasonable times and in a reasonable manner. 12 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. We or our present or future suppliers may not be able to comply with GMP and other FDA regulatory requirements. Failure to comply with the statutory and regulatory requirements subjects the manufacturer and/or the NDA sponsor or distributor to possible legal or regulatory action, such as a delay or refusal to approve an NDA, suspension of manufacturing, seizure or recall of a product, or civil or criminal prosecution of the company or individual officers or employees. Post-Marketing Regulation Any drug products manufactured or distributed by us pursuant to FDA approvals, as well as the materials and components used in our products, are subject to pervasive and continuing regulation by the FDA, including: ● recordkeeping requirements; ● periodic reporting requirements; ● GMP requirements related to all stages of manufacturing, testing, storage, packaging, labeling and distribution of finished dosage forms of the product; ● monitoring and reporting of adverse experiences with the product; and ● advertising and promotional reporting requirements and restrictions. Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or product removal. Product approvals may be revoked if compliance with regulatory requirements is not maintained or if problems concerning safety or effectiveness of the product occur following approval. The FDA is developing a national electronic drug safety tracking system known as SENTINEL that may impose additional safety monitoring burdens, and enhanced FDA enforcement authority, beyond the extensive requirements already in effect. As a condition of NDA approval, the FDA may require post-approval testing and surveillance to monitor a product’s safety or efficacy. The FDA also may impose other conditions, including labeling restrictions which can materially impact the potential market and profitability of a product. With respect to post-market product advertising and promotion, the FDA and other government agencies including the Department of Health and Human Services and the Department of Justice, and individual States, impose a number of complex regulations on entities that advertise and promote pharmaceuticals, including, among others, standards and restrictions on direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. The FDA has very broad enforcement authority under the FFDCA, and failure to abide by these regulations can result in administrative and judicial enforcement actions, including the issuance of a Warning Letter directing correction of deviations from FDA standards, a requirement that future advertising and promotional materials be pre-cleared by the FDA, False Claims Act prosecution based on alleged off-label marketing seeking monetary and other penalties, including potential exclusion of the drug and/or the company from participation in government health care programs, and state and federal civil and criminal investigations and prosecutions. Foreign regulatory bodies also strictly enforce these and other regulatory requirements and drug marketing may be prohibited in whole or in part in other countries. We, our collaborators or our third-party contract manufacturers may not be able to comply with the applicable regulations. After regulatory approvals are obtained, the subsequent discovery of previously unknown problems, or the failure to maintain compliance with existing or new regulatory requirements, may result in: ● restrictions on the marketing or manufacturing of a product; ● Warning Letters or Untitled Letters from the FDA asking us, our collaborators or third-party contractors to take or refrain from taking certain actions; ● withdrawal of the product from the market; ● the FDA’s refusal to approve pending applications or supplements to approved applications; ● voluntary or mandatory product recall; ● fines or disgorgement of profits or revenue; ● suspension or withdrawal of regulatory approvals; ● refusals to permit the import or export of products; ● product seizure; and 13 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ● injunctions or the imposition of civil or criminal penalties. We may also be subject to healthcare laws, regulations and enforcement and our failure to comply with any such laws, regulations or enforcement could adversely affect our business, operations and financial condition. Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We are subject to regulation by both the federal government and the states in which we or our partners conduct our business. The laws and regulations that may affect our ability to operate include: ● the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or Affordable Care Act, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; 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 services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. 14 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Achieving and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Generic Competition Orange Book Listing. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product. Upon approval of a drug, the applicant identifies all patents that claim the approved product’s active ingredient(s), the drug product’s approved formulation, or an approved method of use of the drug. Each of the identified patents are then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application, or ANDA. An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown through bioequivalence testing, unless such testing is waived by the FDA, as is the case with some injectable drug products, to be therapeutically equivalent to the listed drug. Other than bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as ‘‘generic equivalents’’ to the listed drug, and can usually be substituted by pharmacists under prescriptions written for the original listed drug. The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book. Specifically, the applicant must certify either that: (1) the required patent information has not been filed (a Paragraph I Certification); (2) the listed patent has expired (a Paragraph II Certification); (3) the listed patent has not expired, but will expire on a particular date and the generic approval is being sought only after patent expiration (a Paragraph III Certification); or (4) the listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product (a Paragraph IV Certification). In certain circumstances, the ANDA applicant may also elect to submit a ‘‘section (viii)’’ statement instead of a Paragraph IV Certification, certifying that its proposed ANDA label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. If the application contains only Paragraph I or Paragraph II Certifications, the ANDA may be approved as soon as FDA completes its review and concludes that all approval requirements have been met. If the ANDA contains one or more Paragraph III Certifications, the ANDA cannot not be approved until each listed patent for which a Paragraph III Certification was filed have expired. If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA holder and patent owner once the ANDA has been accepted for filing by the FDA. The patent owner or NDA holder may then commence a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months (the ‘‘30-month stay’’), expiration of the patent, settlement of the lawsuit in which the patent owner admits that the patent is invalid or not infringed by the ANDA product, or a decision in the infringement case that holds the patent to be invalid or not infringed, or an order by the court shortening the 30-month stay due to actions by the patent holder to delay the litigation. In most circumstances, NDA holder is only eligible for one 30-month stay against an ANDA. If a patent infringement action is filed against an ANDA applicant, any settlement of the litigation must be submitted to the Federal Trade Commission, or the FTC. If the FTC believes the terms or effects of the settlement are anticompetitive, FTC may bring an antitrust enforcement action against the parties. Private parties may also bring antitrust lawsuits against drug companies based on such patent litigation settlements. The ANDA also will not be approved until any applicable non-patent regulatory exclusivity listed in the Orange Book for the referenced product has expired. Regulatory Exclusivity. Upon NDA approval of a new chemical entity or NCE, which is a drug that contains no active moiety that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which the FDA cannot receive for review any ANDA seeking approval of a generic version of that drug. An ANDA containing a Paragraph IV Certification may be received by FDA 4 years after the NCE drug’s approval, but any 30-month stay that ensues would be extended so that it expires seven and one half years after the NCE approval date, subject to early termination by reason of a court decision or settlement as described above. 15 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Certain changes to an NDA drug, such as the addition of a new indication to the package insert, for which new clinical trials, conducted or sponsored by the applicant are deemed by FDA to be essential to the approval of the change, can be eligible for a three- year period of exclusivity during which the FDA cannot approve an ANDA for a generic drug that includes the change. An ANDA that contains a section (viii) statement to a method of use patent may be approved with labeling that omits the patented use before the use patent expires. Generic drugs approved with such a labeling carve out may be substituted by pharmacists for the original branded drug before the method of use patent expires. Section 505(b)(2) New Drug Applications. Most drug products obtain FDA marketing approval pursuant to an NDA or an ANDA. A third alternative is a special type of NDA, commonly referred to as a 505(b)(2) NDA, which enables the applicant to rely, in part, on the FDA’s previous approval of a similar product, or published literature, in support of its application. 505(b)(2) NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products. A 505(b)(2) NDA may be used where at least some of the information required for approval comes from studies not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference. If the 505(b)(2) applicant can establish that reliance on the FDA’s previous approval is scientifically appropriate, it may eliminate the need to conduct certain preclinical or clinical studies of the new product. The FDA may also require companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product candidate for all, or some, of the label indications for which the referenced product has been approved, as well as for any new indication or conditions of use sought by the Section 505(b)(2) applicant. To the extent that the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would. As a result, approval of a 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired, and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the expiration of any 30-month stay, subject to early termination of the stay as described above. Changing Legal and Regulatory Landscape Periodically, legislation is introduced in the U.S. Congress that could change the statutory and regulatory provisions governing the approval, manufacturing and marketing of our drugs. In addition, the FDCA, FDA regulations and guidance are often revised or reinterpreted by the FDA or the courts in ways that may significantly affect our business and products. We cannot predict whether or when legislation or court decisions impacting our business will be enacted or issued, what FDA regulations, guidance or interpretations may change, or what the impact of such changes, if any, may be in the future. Third-Party Reimbursements Successful sales of our proposed products in the United States and other countries depend, in large part, on the availability of adequate reimbursement from third-party payers such as governmental entities, managed care organizations, health maintenance organizations, or HMOs, and private insurance plans. Reimbursement by a third-party payer depends on a number of factors, including the payer’s determination that the product has been approved by the FDA for the indication for which the claim is being made, that it is neither experimental nor investigational, and that the use of the product is safe and efficacious, medically necessary, appropriate for the specific patient and cost effective. Since reimbursement by one payer does not guarantee reimbursement by another, we or our licensees may be required to seek approval from each payer individually. Seeking such approvals is a time-consuming and costly process. Third-party payers routinely limit the products that they will cover and the amount of money that they will pay and, in many instances, are exerting significant pressure on medical suppliers to lower their prices. Payers frequently employ a tiered system in reimbursing end users for pharmaceutical products, with tier designation affecting copay or deductible amounts. The only approved product for treating HSDD is flibanserin, sold under the trade name Addyi®. There is significant uncertainty concerning the extent and scope of third-party reimbursement for products treating HSDD. Based on third-party reimbursement for approved products treating ED, we believe bremelanotide will be classified as a Tier 3 drug, so that reimbursement will be limited for bremelanotide for treatment of premenopausal women with HSDD, assuming the product is approved by the FDA. Less than full reimbursement by governmental and other third-party payers may adversely affect the market acceptance of bremelanotide. Further, healthcare reimbursement systems vary from country to country, and third-party reimbursement might not be made available for bremelanotide for HSDD under any other reimbursement system. 16 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Manufacturing and Marketing To be successful, our proposed products will need to be manufactured in commercial quantities under GMP prescribed by the FDA and at acceptable costs. We do not have the facilities to manufacture any of our proposed products under GMP. We intend to rely on collaborators, licensees or contract manufacturers for the commercial manufacture of our proposed products. Our bremelanotide product candidate is a synthetic peptide. While the production process involves well-established technology, there are few manufacturers capable of scaling up to commercial quantities under GMP at acceptable costs. We have identified one third-party manufacturer for the production of bremelanotide, Lonza Ltd., and have validated manufacturing of the bremelanotide drug substance under GMP with that manufacturer. We are in the process of negotiating a long-term supply agreement with Lonza, and may not be able to enter into a supply agreement on acceptable terms, if at all. Our bremelanotide product candidate will be a combination product, incorporating both the bremelanotide drug substance and a delivery device. We will rely on a third-party manufacturer, Ypsomed AG, to make the delivery device and to ensure its and the device’s continued compliance with all FDA medical device regulations. We have selected an autoinjector pen delivery device, and are negotiating a long-term supply and manufacturing agreement, but may not be able to enter into such an agreement on acceptable terms, if at all. A third-party contract manufacturer, Catalent Belgium S.A., performs fill, finish and packaging of our bremelanotide product candidate. We have negotiated a long-term commercial supply agreement with Catalent Belgium S.A. Our PL-3994 product candidate is a peptide mimetic molecule, incorporating a proprietary amino acid mimetic structure and amino acids. We identified a manufacturer that made the product in quantities sufficient for Phase 1, and are evaluating commercial- scale manufacturers. Scaling up to commercial quantities may involve production, purification, formulation and other problems not present in the scale of manufacturing done to date. Our MC1r and MC4r agonist product candidates are synthetic peptides, which we have manufactured only at laboratory scale. We have not contracted with a third-party manufacturer to produce these synthetic peptides for either clinical trials or commercial purposes. While the production process involves well-established technology, there are few manufacturers capable of scaling up to commercial quantities under GMP at acceptable costs. Additionally, scaling up to commercial quantities may involve production, purification, formulation and other problems not present in the scale of manufacturing done to date. The failure of any manufacturer or supplier to comply with FDA regulations, including GMP or medical device quality systems regulations, or QSR, or to supply the device component or drug substance and services as agreed, would force us to seek alternative sources of supply and could interfere with our ability to deliver product on a timely and cost effective basis or at all. Establishing relationships with new manufacturers or suppliers, any of whom must be FDA-approved, is a time-consuming and costly process. Product Liability and Insurance Our business may be affected by potential product liability risks that are inherent in the testing, manufacturing, marketing and use of our proposed products. We have liability insurance providing $10 million coverage in the aggregate as to certain clinical trial risks. Employees As of September 16, 2016, we employed 22 people full time, of whom 16 are engaged in research and development activities and 6 are engaged in administration and management, and had no part-time employees. While we have been successful in attracting skilled and experienced scientific personnel, competition for personnel in our industry is intense. None of our employees are covered by a collective bargaining agreement. All of our employees have executed confidentiality and intellectual property agreements. We consider relations with our employees to be good. We rely on contractors and scientific consultants to work on specific research and development programs. We also rely on independent organizations, advisors and consultants to provide services, including aspects of manufacturing, testing, preclinical evaluation, clinical management, regulatory strategy and market research. Our independent advisors, contractors and consultants sign agreements that provide for confidentiality of our proprietary information and that we have the rights to any intellectual property developed while working for us. Corporate Information We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996. Our corporate offices are located at 4B Cedar Brook Drive, Cranbury, New Jersey 08512 and our telephone number is (609) 495-2200. We maintain an Internet site at www.palatin.com, where among other things, we make available free of charge on and through this website our Forms 3, 4 and 5, annual reports on Form 10-K, quarterly reports on Form 10- Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) and Section 16 of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our website and the information contained in it or connected to it are not incorporated into this prospectus. The reference to our website is an inactive textual reference only. 17 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 1A. Risk Factors. Risks Related to Our Financial Results and Need for Financing Our auditors have expressed substantial doubt about our ability to continue as a going concern. If we do not have sufficient funding, we may have to suspend or cease operations within twelve months. Our audited financial statements for the year ended June 30, 2016 were prepared using the assumption that we will continue our operations as a going concern. As of June 30, 2016, we had an accumulated deficit of $343,412,252 and stockholders’ deficiency of $17,585,967. As a result, our independent registered public accounting firm, in their audit report, has expressed substantial doubt about our ability to continue as a going concern. Continued operations are dependent on our ability to complete equity or debt financing activities or collaboration arrangements or to generate positive cash flow from operations, neither of which is certain. We believe that if we do not have sufficient funding, we may have to curtail or cease certain programs or operations within twelve months. Therefore, we may be unable to continue operations in the future as a going concern. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in the Company. Investors in our securities should review carefully the report of our independent registered public accounting firm included in this Annual Report. We have a history of substantial net losses and expect to continue to incur substantial net losses over the next few years; we may never achieve or maintain profitability. We have never been profitable and we may never become profitable. As of June 30, 2016, we had an accumulated deficit of $343,412,252. We expect to incur additional losses as we continue our development of bremelanotide, PL-3994 and other product candidates. These losses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity, total assets and working capital. Since 2005 we have not had any products available for commercial sale and have received no revenues from the sale of our product candidates. For the foreseeable future, we will have to fund all of our operations and capital expenditures from license and contract revenue under collaborative development agreements, existing cash balances and outside sources of financing, which may not be available on acceptable terms, if at all. Unless and until we receive approval from the FDA or other equivalent regulatory authorities outside the United States, we cannot sell our products and will not have product revenues from them. We have devoted substantially all of our efforts to research and development, including preclinical and clinical trials. Because of the numerous risks associated with developing drugs, we are unable to predict the extent of future losses, whether or when any of our product candidates will become commercially available, or when we will become profitable, if at all. We will need additional financing, including financing to submit required regulatory applications to the FDA for bremelanotide for HSDD and to complete clinical trials for our other product candidates, which may be difficult to obtain. As of June 30, 2016, we had cash, cash equivalents and investments of $9,383,224, with current liabilities of $13,994,439. On August 4, 2016, we closed on an equity private placement, with net proceeds of approximately $8,500,000. We believe we currently have sufficient existing capital resources to fund our planned operations through the anticipated release date of topline data from the double blind efficacy portion of our Phase 3 trial and through the quarter ending December 31, 2016. We will need additional funding to complete development of our bremelanotide for HSDD program, including completing ancillary studies and clinical trials, completing certain chemistry, manufacturing and controls activities, preparing and submitting regulatory filings for product approval, and launch readiness commercialization efforts. We will also need additional funding to conduct and complete required clinical trials for our other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required regulatory applications to the FDA. We have completed the last patient visits in the double blind portion of our Phase 3 clinical trial of bremelanotide for HSDD, and have adequate funds to analyze the efficacy data and disclose results. However, we do not have adequate funds to complete the open-label safety extension study, all ancillary studies and clinical trials required for submission of an NDA to FDA for approval of bremelanotide for HSDD, or to prepare and submit the NDA to FDA. We may be required to curtail or delay our bremelanotide for HSDD program unless we have adequate funds to complete the program. We estimate that the bremelanotide for HSDD program, including regulatory filings for product approval, will cost at least $87,000,000, of which approximately $57,000,000 has been expensed to date. We will seek funds to support the program through collaborative arrangements on bremelanotide, including marketing and distribution partnering agreements, public or private equity or debt financings, and other sources, but such additional funding may not be available on acceptable terms, or at all. 18 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. We do not have any source of significant recurring revenue and must depend on financing or partnering to sustain our operations. We may raise additional funds through public or private equity or debt financings, collaborative arrangements on our product candidates, or other sources. However, additional funding may not be available on acceptable terms, or at all. To obtain additional funding, we may need to enter into arrangements that require us to develop only certain of our product candidates or relinquish rights to certain technologies, product candidates and/or potential markets. If we are unable to raise sufficient additional funds when needed, we may be required to curtail operations significantly, cease clinical trials and decrease staffing levels. We may seek to license, sell or otherwise dispose of our product candidates, technologies and contractual rights on the best possible terms available. Even if we are able to license, sell or otherwise dispose of our product candidates, technologies and contractual rights, it is likely to be on unfavorable terms and for less value than if we had the financial resources to develop or otherwise advance our product candidates, technologies and contractual rights ourselves. Our future capital requirements depend on many factors, including: ● the results of our Phase 3 clinical trials for bremelanotide for HSDD; ● the timing of, and the costs involved in, obtaining regulatory approvals for bremelanotide for HSDD and our other product candidates; ● the number and characteristics of any additional product candidates we develop or acquire; ● the scope, progress, results and costs of researching and developing bremelanotide for HSDD, PL-3994 or any future product candidates, and conducting preclinical and clinical trials; ● the cost of commercialization activities if bremelanotide for HSDD, PL-3994 or any future product candidates are approved for sale, including marketing, sales and distribution costs; ● the cost of manufacturing bremelanotide for HSDD, PL-3994 or any future product candidates and any products we successfully commercialize and maintaining our related facilities; ● our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms and timing of such arrangements; ● the degree and rate of market acceptance of any future approved products; ● the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments; ● any product liability or other lawsuits related to our products; ● the expenses needed to attract and retain skilled personnel; ● the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and ● the timing, receipt and amount of sales of, or royalties on, future approved products, if any. We have a limited operating history upon which to base an investment decision. Our operations are primarily focused on acquiring, developing and securing our proprietary technology, conducting preclinical and clinical studies and formulating and manufacturing on a small-scale basis our principal product candidates. These operations provide a limited basis for stockholders to assess our ability to commercialize our product candidates. We have not yet demonstrated our ability to perform the functions necessary for the successful commercialization of any of our current product candidates. The successful commercialization of our product candidates will require us to perform a variety of functions, including: ● continuing to conduct preclinical development and clinical trials; ● participating in regulatory approval processes; ● formulating and manufacturing products, or having third parties formulate and manufacture products; ● post-approval monitoring and surveillance of our products; ● conducting sales and marketing activities, either alone or with a partner; and ● obtaining additional capital. If we are unable to obtain regulatory approval of any of our product candidates, to successfully commercialize any products for which we receive regulatory approval or to obtain additional capital, we may not be able to recover our investment in our development efforts. 19 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The clinical and commercial success of our product candidates will depend on a number of factors, including the following: ● the ability to raise additional capital on acceptable terms, or at all; ● timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; ● acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; ● our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product candidates or any future product candidates; ● the prevalence, duration and severity of potential side effects experienced with our product candidates or future approved products, if any; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any; ● the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with GMP; ● a continued acceptable safety profile and efficacy during clinical development and following approval of our product candidates or any future product candidates; ● our ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others; ● acceptance by physicians and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments; ● our and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates; ● our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and ● our ability to in-license or acquire additional product candidates or commercial-stage products that we believe can be successfully developed and commercialized. If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to obtain regulatory approvals or commercialize our product candidates. Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly, we cannot assure you that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue our business. Raising additional capital may cause dilution to existing shareholders, restrict our operations or require us to relinquish rights. We may seek the additional capital necessary to fund our operations through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing shareholders’ ownership interests will be diluted and the terms may include liquidation or other preferences that adversely affect their rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. 20 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Risks Related to Our Business, Strategy and Industry We are substantially dependent on the clinical and commercial success of our product candidates, primarily our lead product candidate, bremelanotide for HSDD, which is in Phase 3 clinical development. We cannot be certain that we will be able to obtain regulatory approval for or successfully commercialize any of our product candidates. To date, we have invested most of our efforts and financial resources in the research and development of bremelanotide for HSDD, which is currently our lead product candidate. We have completed the last patient visit in the double blind efficacy portion of our Phase 3 RECONNECT STUDY for bremelanotide for HSDD. Our near-term prospects, including our ability to finance our company and generate revenue, will depend heavily on the successful development, regulatory approval and commercialization of bremelanotide for HSDD, as well as any future product candidates. The clinical and commercial success of our product candidates will depend on a number of factors, including the following: ● timely completion of, or need to conduct additional, clinical trials, including for bremelanotide for HSDD, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the accurate and satisfactory performance of third-party contractors; ● our ability to demonstrate to the satisfaction of the FDA the safety and efficacy of bremelanotide for HSDD or any future product candidates through clinical trials; ● whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of bremelanotide for HSDD or any future product candidates; ● the acceptance of parameters for regulatory approval, including our proposed indication, primary endpoint assessment and primary endpoint measurement, relating to our lead indications of bremelanotide for HSDD; ● our success in educating physicians and patients about the benefits, administration and use of bremelanotide for HSDD or any future product candidates, if approved; ● the prevalence and severity of adverse events experienced with bremelanotide for HSDD or any future product candidates or approved products; ● the adequacy and regulatory compliance of the autoinjector device, supplied by an unaffiliated third party, to be used as part of our bremelanotide combination product; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● our ability to raise additional capital on acceptable terms to achieve our goals; ● achieving and maintaining compliance with all regulatory requirements applicable to bremelanotide for HSDD or any future product candidates or approved products; ● the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments; ● the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations; ● our ability to manufacture clinical trial supplies of bremelanotide for HSDD or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current GMP; ● our ability to successfully commercialize bremelanotide for HSDD or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others; ● our ability to enforce our intellectual property rights in and to bremelanotide for HSDD or any future product candidates; ● our ability to avoid third-party patent interference or intellectual property infringement claims; ● acceptance of bremelanotide for HSDD or any future product candidates, if approved, as safe and effective by patients and the medical community; and ● a continued acceptable safety profile and efficacy of bremelanotide for HSDD or any future product candidates following approval. If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates. Accordingly, we cannot assure you that we will be able to generate sufficient revenue through the sale of bremelanotide for HSDD or any future product candidate to continue our business. In addition to preventing us from executing our current business plan, any delays in our clinical trials, or inability to successfully commercialize our products could impair our reputation in the industry and the investment community, and could hinder our ability to fulfill our existing contractual commitments. As a result, our share price would likely decline significantly, and we would have difficulty raising necessary capital for future projects. 21 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Most of our product candidates are still in the early stages of development, and all of our product candidates remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our product candidates, we will not be successful. Our product candidates are at various stages of research and development, will require regulatory approval, and may never be successfully developed or commercialized. Our product candidates will require significant further research, development and testing before we can seek regulatory approval to market and sell them. We must demonstrate that our product candidates are safe and effective for use in patients in order to receive regulatory approval for commercial sale. Preclinical studies in animals, using various doses and formulations, must be performed before we can begin human clinical trials. Even if we obtain favorable results in the preclinical studies, the results in humans may be different. Numerous small-scale human clinical trials may be necessary to obtain initial data on a product candidate’s safety and efficacy in humans before advancing to large scale human clinical trials. We face the risk that the results of our trials in later phases of clinical trials may be inconsistent with those obtained in earlier phases. Adverse or inconclusive results could delay the progress of our development programs and may prevent us from filing for regulatory approval of our product candidates. Additional factors that could inhibit the successful development of our product candidates include: ● lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints; ● failure to design appropriate clinical trial protocols; ● uncertainty regarding proper dosing; ● inability to develop or obtain a supplier for an autoinjector device that meets the FDA’s medical device requirements; ● insufficient data to support regulatory approval; ● inability or unwillingness of medical investigators to follow our clinical protocols; ● inability to add a sufficient number of clinical trial sites; or ● the availability of sufficient capital to sustain operations and clinical trials. You should evaluate us in light of these uncertainties, difficulties and expenses commonly experienced by early stage biopharmaceutical companies, as well as unanticipated problems and additional costs relating to: ● product approval or clearance; ● regulatory compliance; ● good manufacturing practices; ● intellectual property rights; ● product introduction; and ● marketing and competition. If clinical trials for our product candidates are prolonged or delayed, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales. We may be unable to commercialize our product candidates on a timely basis due to unexpected delays in our human clinical trials. Potential delaying events include: ● discovery of serious or unexpected toxicities or side effects experienced by study participants or other safety issues; ● slower than expected rates of subject recruitment and enrollment rates in clinical trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment; ● difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason; ● difficulty in obtaining institutional review board, or IRB, approval for studies to be conducted at each site; ● delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials; ● inadequacy of or changes in our manufacturing process or the product formulation or method of delivery; ● changes in applicable laws, regulations and regulatory policies; 22 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ● delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research organizations, or CROs, clinical trial sites and other third-party contractors; ● failure of our CROs or other third-party contractors to comply with contractual and regulatory requirements or to perform their services in a timely or acceptable manner; ● failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug, medical device and biologic products; ● delays in the scheduling and performance by the FDA of required inspections of us, our CROs, our suppliers, or our clinical trial sites, and violations of law or regulations by discovered in the course of FDA inspections; ● scheduling conflicts with participating clinicians and clinical institutions; or ● difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data. Any of these events or other delaying events, individually or in the aggregate, could delay the commercialization of our product candidates and have a material adverse effect on our business, results of operations and financial condition. We may not be able to secure and maintain research institutions to conduct our clinical trials. We rely on research institutions to conduct our clinical trials, and we therefore have limited control over the timing and cost of clinical trials and our ability to recruit subjects. If we are unable to reach agreements with suitable research institutions on acceptable terms, or if any such agreement is terminated, we may be unable to quickly replace the research institution with another qualified institution on acceptable terms. We may not be able to secure and maintain suitable research institutions to conduct our clinical trials. Even if our product candidates receive regulatory approval, they may never achieve market acceptance, in which case our business, financial condition and results of operation will be materially adversely affected. Regulatory approval for the marketing and sale of any of our product candidates does not assure the product’s commercial success. Any approved product will compete with other products manufactured and marketed by major pharmaceutical and other biotechnology companies. If any of our product candidates are approved by the FDA and do not achieve adequate market acceptance, our business, financial condition and results of operations will be materially adversely affected. The degree of market acceptance of any such product will depend on a number of factors, including: ● perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of any such product; ● cost-effectiveness relative to competing products and technologies; ● availability of reimbursement for our products from third-party payers such as health insurers, health maintenance organizations and government programs such as Medicare and Medicaid; and ● advantages over alternative treatment methods. There is one FDA approved product for treatment of HSDD, flibanserin, which is sold under the trade name Addyi®, and started marketing in October 2015. The actual market size and market dynamics for HSDD are unknown, and there is significant uncertainty concerning the extent and scope of third-party reimbursement for products treating HSDD. While we believe that an on-demand drug for HSDD has competitive advantages compared to chronic or daily use hormones and other drugs, we may not be able to realize this perceived advantage in the market. Bremelanotide is administered by subcutaneous injection. While the single-use, disposable autoinjector pen format is designed to maximize market acceptability, bremelanotide as a subcutaneous injectable drug for HSDD may never achieve significant market acceptance. In addition, we believe reimbursement of bremelanotide from third-party payers such as health insurers, HMOs or other third-party payers of healthcare costs will be similar to reimbursement for ED drugs, and that the ultimate user may pay a substantial part of the cost of bremelanotide for HSDD. If the market opportunity for bremelanotide is smaller than we anticipate, it may also be difficult for us to find marketing partners and, as a result, we may be unable to generate revenue and business from bremelanotide. If bremelanotide for HSDD does not achieve adequate market acceptance at an acceptable price point, our business, financial condition and results of operations will be materially adversely affected. 23 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Even if our product candidates receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States. In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setbacks in obtaining such approval would impair our ability to develop foreign markets for our product candidates and may have a material adverse effect on our results of operations and financial condition. If side effects emerge that can be linked to our product candidates (either while they are in development or after they are approved and on the market), we may be required to perform lengthy additional clinical trials, change the labeling of any such products, or withdraw such products from the market, any of which would hinder or preclude our ability to generate revenues. If we identify side effects or other problems occur in future clinical trials, we may be required to terminate or delay clinical development of the product candidate. Furthermore, even if any of our product candidates receive marketing approval, as greater numbers of patients use a drug following its approval, if the incidence of side effects increases or if other problems are observed after approval that were not seen or anticipated during pre-approval clinical trials, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw their approval of the product; ● we may be required to reformulate such products or change the way the product is manufactured; ● we may become the target of lawsuits, including class action suits; and ● our reputation in the market place may suffer resulting in a significant drop in the sales of such products. Any of these events could substantially increase the costs and expenses of developing, commercializing and marketing any such product candidates or could harm or prevent sales of any approved products. The number of subjects in our study pools in our clinical trials may be deemed by regulators to be too small, which could cause unanticipated delays or higher than anticipated costs. Our clinical trials have been conducted on a pool of subjects that is structured for such research. Nevertheless, there is the possibility that for statistical reasons, the pool of subjects may be determined by the FDA or another regulatory body to be too small to verify statistical significance. In such a case, the conclusions from the previous trials will need to be established with at least another set of clinical trials testing the relevant issue. Due to the need to find new subjects for any additional clinical trials and the limited pool from which such subjects can be selected, any such determination by the FDA could result in a delay in obtaining FDA approval or require additional financial expenditures. We may not be able to keep up with the rapid technological change in the biotechnology and pharmaceutical industries, which could make any future approved products obsolete and reduce our revenue. Biotechnology and related pharmaceutical technologies have undergone and continue to be subject to rapid and significant change. Our future will depend in large part on our ability to maintain a competitive position with respect to these technologies. Our competitors may render our technologies obsolete by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages in our drug discovery process that we believe we derive from our research approach and proprietary technologies. In addition, any future products that we develop, including our clinical product candidates, may become obsolete before we recover expenses incurred in developing those products, which may require that we raise additional funds to continue our operations. Competing products and technologies may make our proposed products noncompetitive. Flibanserin, a daily-use oral drug sold under the trade name Addyi®, has been approved by the FDA for HSDD in premenopausal women. There are other products being developed for HSDD and other FSD indications, including a number of oral combination drugs, some of which incorporate testosterone, antidepressants or PDE-5 inhibitors. There is competition to develop drugs for treatment of HSDD and FSD in both premenopausal and postmenopausal patients. Our bremelanotide drug product is intended to be administered by subcutaneous injection, and an as needed drug product for the same indication which utilizes another route of administration, such as a conventional oral drug product, may make subcutaneous bremelanotide noncompetitive. 24 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. There are three oral FDA-approved PDE-5 inhibitor drugs for the treatment of ED, other approved products and devices for ED, and other products in development for treatment of ED, including products in clinical trials. There is competition to develop drugs for ED in patients non-responsive to PDE-5 inhibitor drugs. There are several products approved for use in treatment of obesity and related indications, and a number of other products being developed for treatment of obesity, including products in clinical trials. There is intense competition to develop drugs for treatment of obesity and related indications. There are a number of products approved for use in treating inflammatory diseases and dermatologic indication, and other products being developed, including products in clinical trials. We are aware of one recombinant natriuretic peptide product for acutely decompensated congestive heart failure approved and marketed in the United States, and another recombinant natriuretic peptide product approved and marketed in Japan. Clinical trials on other natriuretic peptide products are being conducted in the United States. In addition, other products for treatment of heart failure are either currently being marketed or in development, including a combination drug which increases active levels of ANP. There are numerous products approved for use in treatment of asthma, and a number of other products being developed for treatment of acute exacerbations of asthma, including products in clinical trials. There is intense competition to develop drugs for treatment of acute exacerbations of asthma. As discussed above, the biopharmaceutical industry is highly competitive. We are likely to encounter significant competition with respect to bremelanotide, other melanocortin receptor agonist compounds and PL-3994. Most of our competitors have substantially greater financial and technological resources than we do. Many of them also have significantly greater experience in research and development, marketing, distribution and sales than we do. Accordingly, our competitors may succeed in developing, marketing, distributing and selling products and underlying technologies more rapidly than we can. These competitive products or technologies may be more effective and useful or less costly than bremelanotide, other melanocortin receptor agonist compounds or PL-3994. In addition, academic institutions, hospitals, governmental agencies and other public and private research organizations are also conducting research and may develop competing products or technologies on their own or through strategic alliances or collaborative arrangements. We rely on third parties over whom we have no control to conduct preclinical studies, clinical trials and other research for our product candidates and their failure to timely perform their obligations could significantly harm our product development. We have limited research and development staff and do not have dedicated research or development facilities. We rely on third parties and independent contractors, such as researchers at CROs and universities, in certain areas that are particularly relevant to our research and product development plans. We engage such researchers to conduct our preclinical studies, clinical trials and associated tests. These outside contractors are not our employees and may terminate their engagements with us at any time. In addition, we have limited control over the resources that these contractors devote to our programs and they may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. There is also competition for these relationships, and we may not be able to maintain our relationships with our contractors on acceptable terms. If our third-party contractors do not carry out their duties under their agreements with us, fail to meet expected deadlines or fail to comply with appropriate standards for preclinical or clinical research, our ability to develop our product candidates and obtain regulatory approval on a timely basis, if at all, may be materially adversely affected. Production and supply of our product candidates depend on contract manufacturers over whom we have no control, with the risk that we may not have adequate supplies of our product candidates or products. We do not have the facilities to manufacture the bremelanotide active drug ingredient, the autoinjector pen component of our bremelanotide combination product, or to fill, assemble and package our bremelanotide combination product, or to manufacture any of our other potential products such as PL-3994, PL-8177 and other melanocortin receptor agonist compounds. Our contract manufacturers must perform these manufacturing activities in a manner that complies with FDA regulations. Our ability to control third- party compliance with FDA requirements is limited to contractual remedies and rights of inspection. The manufacturers of approved products and their manufacturing facilities will be subject to continual review and periodic inspections by the FDA and other authorities where applicable, and must comply with ongoing regulatory requirements, including FDA regulations concerning GMP. Failure of third-party manufacturers to comply with GMP, medical device QSR, or other FDA requirements may result in enforcement action by the FDA. Failure to conduct their activities in compliance with FDA regulations could delay our development programs or negatively impact our ability to receive FDA approval of our potential products or continue marketing if they are approved. Establishing relationships with new suppliers, who must be FDA-approved, is a time-consuming and costly process. 25 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Reliance on third-party manufacturers entails risk, to which we would not be subject if we manufactured product candidates or products ourselves, including: ● reliance on the third party for regulatory compliance and quality assurance; ● the possible breach of the manufacturing agreement by the third party because of factors beyond our control; ● the possible termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us; and ● drug product supplies not meeting the requisite requirements for clinical trial use. If we are not able to obtain adequate supplies of our product candidates, it will be more difficult for us to develop our product candidates and compete effectively. Our product candidates and any products that we and/or our potential future collaborators may develop may compete with other product candidates and products for access to manufacturing facilities. If we are unable to establish sales and marketing capabilities within our organization or enter into and maintain agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue. We do not currently have any experience in sales, marketing and distribution of pharmaceutical products. We will need to establish sales and marketing capabilities within our organization or establish and maintain agreements with third parties to market and sell our product candidates. We do not have marketing partners for any of our products, including bremelanotide and PL-3994. If any of these products are approved by the FDA or other regulatory authorities, we must either develop marketing, distribution and selling capacity and expertise, which will be costly and time consuming, or enter into agreements with other companies to provide these capabilities. We may not be able to enter into suitable agreements on acceptable terms, if at all. Engaging a third party to perform these services could delay the commercialization of any of our product candidates, if approved for commercial sale. If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and our business would suffer. In addition, if we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenues are likely to be lower than if we could market and sell any products that we develop ourselves. We will need to hire additional employees in order to commercialize our product candidates in the future. Any inability to manage future growth could harm our ability to commercialize our product candidates, increase our costs and adversely impact our ability to compete effectively. In order to commercialize our product candidates, we will need to hire experienced sales and marketing personnel to sell and market those product candidates we decide to commercialize, and we will need to expand the number of our managerial, operational, financial and other employees to support commercialization. Competition exists for qualified personnel in the biopharmaceutical field. Future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. Our future financial performance and our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively. Our ability to achieve revenues from the sale of our products in development will depend, in part, on our ability to obtain adequate reimbursement from Medicare, Medicaid, private insurers and other healthcare payers. Our ability to successfully commercialize our products in development will depend, in significant part, on the extent to which we or our marketing partners can obtain reimbursement for our products and also reimbursement at appropriate levels for the cost of our products. Obtaining reimbursement from governmental payers, insurance companies, HMOs and other third-party payers of healthcare costs is a time-consuming and expensive process. There is no guarantee that our products will ultimately be reimbursed. There is significant uncertainty concerning third-party reimbursement for the use of any pharmaceutical product incorporating new technology and third-party reimbursement might not be available for our proposed products once approved, or if obtained, might not be adequate. There is significant uncertainty concerning the extent and scope of third-party reimbursement for products treating HSDD and other forms of FSD. Based on third-party reimbursement for approved products treating ED, we believe bremelanotide for HSDD will be classified as a Tier 3 drug, so that reimbursement will be limited for bremelanotide for treatment of premenopausal women with HSDD, assuming the product is approved by the FDA. If we are able to obtain reimbursement, continuing efforts by governmental and third-party payers to contain or reduce costs of healthcare may adversely affect our future revenues and ability to achieve profitability. Third-party payers are increasingly challenging the prices charged for diagnostic and therapeutic products and related services. Reimbursement from governmental payers is subject to statutory and regulatory changes, retroactive rate adjustments, administrative rulings and other policy changes, all of which could materially decrease the range of products for which we are reimbursed or the rates of reimbursement by government payers. In addition, recent legislation reforming the healthcare system may result in lower prices or the actual inability of prospective customers to purchase our products in development. The cost containment measures that healthcare payers and providers are instituting and the effect of any healthcare reform could materially and adversely affect our ability to operate profitably. Furthermore, even if reimbursement is available, it may not be available at price levels sufficient for us to realize a positive return on our investment, which would have a material adverse effect on our business, financial condition and results of operations. 26 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Even if we receive regulatory approval for our products in Europe, we may not be able to secure adequate pricing and reimbursement in Europe for us or any strategic partner to achieve profitability. Even if one or more of our products are approved in Europe, we may be unable to obtain appropriate pricing and reimbursement for such products. In most European markets, demand levels for healthcare in general and for pharmaceuticals in particular are principally regulated by national governments. Therefore, pricing and reimbursement for our products will have to be negotiated on a “Member State by Member State” basis according to national rules, as there does not exist a centralized European process. As each Member State has its own national rules governing pricing control and reimbursement policy for pharmaceuticals, there are likely to be uncertainties attaching to the review process, and the level of reimbursement that national governments are prepared to accept. In the current economic environment, governments and private payers or insurers are increasingly looking to contain healthcare costs, including costs on drug therapies. If we are unable to obtain adequate pricing and reimbursement for our products in Europe, we or a potential strategic partner or collaborator may not be able to cover the costs necessary to manufacture, market and sell the product, limiting or preventing our ability to achieve profitability. We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits. The testing and marketing of medical products entails an inherent risk of product liability. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products or cease clinical trials. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators. We currently carry $10 million liability insurance in the aggregate as to certain clinical trial risks, but we do not have and have not obtained quotations for commercial product liability insurance. We, or any corporate collaborators, may not in the future be able to obtain insurance at a reasonable cost or in sufficient amounts, if at all. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise. Our internal computer systems, or those of our third-party contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs. Despite the implementation of security measures, our internal computer systems and those of our third-party contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. We rely on industry accepted measures and technology to secure confidential and proprietary information maintained on our computer systems. However, these measures and technology may not adequately prevent security breaches. While we do not believe that we have experienced any such system failure, accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a loss of clinical trial data for our product candidates which could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology, intellectual property, research and development or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be delayed. We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. If we begin commercializing any of our products in the United States, our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations. These laws may impact, among other things, our proposed sales, marketing, and education programs. In addition, 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 may affect our ability to operate include: 27 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ● the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care 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 from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third- party payors that are false or fraudulent; ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPPA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; ● The federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members and applicable group purchasing organizations; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. Moreover, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the False Claims Act. 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 subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations We are highly dependent on our management team, senior staff professionals and third-party contractors and consultants, and the loss of their services could materially adversely affect our business. We rely on our relatively small management team and staff as well as various contractors and consultants to provide critical services. Our ability to execute our clinical programs for bremelanotide and PL-3994 and our preclinical programs for MC1r and MC4r peptide drug candidates depends on our continued retention and motivation of our management and senior staff professionals, including executive officers and senior members of product development and management, including commercialization, who possess significant technical expertise and experience and oversee our development and commercialization programs. If we lose the services of existing key personnel, our development programs could be adversely affected if suitable replacement personnel are not recruited quickly. Our success also depends on our ability to develop and maintain relationships with contractors, consultants and scientific advisors. There is competition for qualified personnel, contractors and consultants in the pharmaceutical industry, which makes it difficult to attract and retain the qualified personnel, contractors and consultants necessary for the development and growth of our business. Our failure to attract and retain such personnel, contractors and consultants could have a material adverse effect on our business, results of operations and financial condition. 28 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Because we expect bremelanotide for the treatment of HSDD to be classified as a Tier 3 drug with reimbursement by third-party payers similar to approved products for treating ED, demand for this product will be tied to discretionary spending levels of our targeted patient population and particularly affected by unfavorable economic conditions. The market for HSDD may be particularly vulnerable to unfavorable economic conditions. We expect bremelanotide for the treatment of HSDD to have significant copay or deductible requirements and to be only partially reimbursed by third-party payers and, as a result, demand for this product may be tied to discretionary spending levels of our targeted patient population. The recent global financial crisis caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for bremelanotide for HSDD or any future product candidates, if approved, and our ability to raise additional capital when needed on acceptable terms, if at all. This is particularly true in Europe, which is undergoing a continued severe economic crisis. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our services. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which future economic climates and financial market conditions could adversely impact our business. Risks Related to Government Regulation Both before and after marketing approval, our product candidates are subject to ongoing regulatory requirements and, if we fail to comply with these continuing requirements, we could be subject to a variety of sanctions and the sale of any approved commercial products could be suspended. Both before and after regulatory approval to market a particular product candidate, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising and promotion and record keeping related to the product candidates are subject to extensive regulatory requirements. If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including: ● restrictions on the products or manufacturing process; ● warning letters; ● civil or criminal penalties; ● fines; ● injunctions; ● imposition of a Corporate Integrity Agreement requiring heightened monitoring of our compliance functions, overseen by outside monitors, and enhanced reporting requirements to, and oversight by, the FDA and other government agencies; ● product seizures or detentions and related publicity requirements; ● suspension or withdrawal of regulatory approvals; ● regulators or IRBs may not authorize us or any potential future collaborators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● total or partial suspension of production; and ● refusal to approve pending applications for marketing approval of new product candidates. Changes in the regulatory approval policy during the development period, changes in or the enactment of additional regulations or statutes, or changes in the regulatory review for each submitted product application may cause delays in the approval or rejection of an application. Even if the FDA approves a product candidate, the approval may impose significant restrictions on the indicated uses, conditions for use, labeling, advertising, promotion, marketing and/or production of such product, and may impose ongoing requirements for post-approval studies, including additional research and development and clinical trials. The approval may also impose risk evaluation mitigation strategies, or REMS, on a product if the FDA believes there is a reason to monitor the safety of the drug in the marketplace. REMS may include requirements for additional training for health care professionals, safety communication efforts and limits on channels of distribution, among other things. The sponsor would be required to evaluate and monitor the various REMS activities and adjust them if need be. The FDA also may impose various civil or criminal sanctions for failure to comply with regulatory requirements, including withdrawal of product approval. Furthermore, the approval procedure and the time required to obtain approval varies among countries and can involve additional testing beyond that required by the FDA. Approval by one regulatory authority does not ensure approval by regulatory authorities in other jurisdictions. The FDA has substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. 29 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. In addition, varying interpretations of the data obtained for preclinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate. Even if we submit an application to the FDA for marketing approval of a product candidate, it may not result in marketing approval from the FDA. We do not expect to receive regulatory approval for the commercial sale of any of our product candidates that are in development in the near future, if at all. The inability to obtain FDA approval or approval from comparable authorities in other countries for our product candidates would prevent us or any potential future collaborators from commercializing these product candidates in the United States or other countries. We may not be able to obtain regulatory approval of bremelanotide for HSDD even if the product is effective in treating HSDD. Clinical drug development programs for our product candidates are very expensive, time-consuming, difficult to design and implement and their outcome is inherently uncertain. Approval of bremelanotide for treatment of HSDD in premenopausal women requires a determination by the FDA that the product is both safe and effective. Our Phase 2B clinical trials for HSDD demonstrated an acceptable safety profile and, at selected doses, statistically significant efficacy. However, the FDA may ultimately disagree with our definition of efficacy in HSDD, our clinical trial designs, or our interpretation of our clinical trial results. Moreover, results obtained in Phase 3 clinical trials may be inconsistent with results obtained in our Phase 2B trials, and may demonstrate either an unacceptable safety profile or insufficient efficacy. It is also possible that safety or efficacy results obtained in Phase 3 clinical trials will be inconclusive. It is not possible to predict, with any assurance, whether the FDA will approve bremelanotide for any indications. The FDA may deny or delay approval of any application for bremelanotide if the FDA determines that the clinical data do not adequately establish the safety of the drug even if efficacy is established. If FDA approves bremelanotide, the approved labeling of the product may be limited or restricted in such ways as to inhibit or prevent the successful market acceptance and profitability of the product. Bremelanotide could take a significantly longer time to obtain approval than we expect and it may never gain approval. If regulatory approval of bremelanotide is delayed, limited or never obtained, our business, financial condition and results of operations would be materially adversely affected. The regulatory approval process is lengthy, expensive and uncertain, and may prevent us from obtaining the approvals that we require. Government authorities in the United States and other countries extensively regulate the advertising, labeling, storage, record-keeping, safety, efficacy, research, development, testing, manufacture, promotion, marketing and distribution of drug products. Drugs are subject to rigorous regulation in the United States by the FDA and similar regulatory bodies in other countries. The steps ordinarily required by the FDA before a new drug may be marketed in the United States include: ● completion of non-clinical tests including preclinical laboratory and formulation studies and animal testing and toxicology; ● submission to the FDA of an investigational new drug, or IND, application, which must become effective before clinical trials may begin, and which may be placed on “clinical hold” by the FDA, meaning the trial may not commence, or must be suspended or terminated prior to completion; ● performance of adequate and well-controlled Phase 1, 2 and 3 human clinical trials to establish the safety and efficacy of the drug for each proposed indication, and potentially post-approval or Phase 4 studies to further define the drug’s efficacy and safety, generally or in specific patient populations; ● submission to the FDA of a new drug application, or NDA, that must be accompanied by a substantial “user fee” payment; ● FDA review and approval of the NDA before any commercial marketing or sale; and ● compliance with post-approval commitments and requirements. Satisfaction of FDA pre-market approval requirements for new drugs typically takes a number of years and the actual time required for approval may vary substantially based upon the type, complexity and novelty of the product or disease to be treated by the drug. The results of product development, preclinical studies and clinical trials are submitted to the FDA as part of an NDA. The NDA also must contain extensive manufacturing information, demonstrating compliance with applicable GMP requirements. Once the submission has been accepted for filing, the FDA generally has twelve months to review the application and respond to the applicant. Such response may be an approval, or may be a “complete response letter” outlining additional data or steps that must be completed prior to further FDA review of the NDA. The review process is often significantly extended by FDA requests for additional information or clarification. Success in early stage clinical trials does not assure success in later stage clinical trials. Data obtained from clinical trials is not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved, but the FDA is not bound by the recommendation of the advisory committee. The FDA may deny or delay approval of applications that do not meet applicable regulatory criteria or if the FDA determines that the clinical data do not adequately establish the safety and efficacy of the drug. Therefore, our proposed products could take a significantly longer time than we expect or may never gain approval. If regulatory approval is delayed or never obtained, our business, financial condition and results of operations would be materially adversely affected. 30 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Some of our products or product candidates, including bremelanotide, may be used in combination with a drug delivery device, such as an injector or other delivery system. Medical products containing a combination of new drugs, biological products or medical devices are regulated as “combination products” in the United States. A combination product generally is defined as a product comprised of components from two or more regulatory categories (e.g., drug/device, device/biologic, drug/biologic). Each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a new drug, biologic or device. In order to facilitate pre-market review of combination products, the FDA designates one of its centers to have primary jurisdiction for the pre-market review and regulation of the overall product based upon a determination by the FDA of the primary mode of action of the combination product. The determination whether a product is a combination product or two separate products is made by the FDA on a case-by-case basis. Our product candidates intended for use with such devices, or expanded indications that we may seek for our products used with such devices, may not be approved or may be substantially delayed in receiving approval if the devices do not gain and/or maintain their own regulatory approvals or clearances. Where approval of the drug product and device is sought under a single application, the increased complexity of the review process may delay approval. In addition, because these drug delivery devices are provided by single source unaffiliated third-party companies, we are dependent on the sustained cooperation and effort of those third-party companies both to supply the devices, maintain their own regulatory compliance, and, in some cases, to conduct the studies required for approval or other regulatory clearance of the devices. We are also dependent on those third-party companies continuing to maintain such approvals or clearances once they have been received. Failure of third-party companies to supply the devices, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required approvals or clearances of the devices, and maintain compliance with all regulatory requirements, could result in increased development costs, delays in or failure to obtain regulatory approval and delays in product candidates reaching the market or in gaining approval or clearance for expanded labels for new indications. Upon approval, a product candidate may be marketed only in those dosage forms and for those indications approved by the FDA. Once approved, the FDA may withdraw the product approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the marketplace. In addition, the FDA may require post-marketing studies, referred to as Phase 4 studies, to monitor the approved products in a specific subset of patients or a larger number of patients than were required for product approval and may limit further marketing of the product based on the results of these post-market studies. The FDA has broad post-market regulatory and enforcement powers, including the ability to seek injunctions, levy fines and civil penalties, criminal prosecution, withdraw approvals and seize products or request recalls. If regulatory approval of any of our product candidates is granted, it will be limited to certain disease states or conditions, patient populations, duration or frequency of use, and will be subject to other conditions as set forth in the FDA-approved labeling. Adverse experiences with the product must be reported to the FDA and could result in the imposition of market restriction through labeling changes or in product removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval. Outside the United States, our ability to market our product candidates will also depend on receiving marketing authorizations from the appropriate regulatory authorities. The foreign regulatory approval process generally includes all of the risks associated with FDA approval described above. The requirements governing the conduct of clinical trials and marketing authorization vary widely from country to country. At present, foreign marketing authorizations are applied for at a national level, although within the European Community, or EC, registration procedures are available to companies wishing to market a product to more than one EC member state. If the regulatory authority is satisfied that adequate evidence of safety, quality and efficiency has been presented, a marketing authorization will be granted. If we do not obtain, or experience difficulties in obtaining, such marketing authorizations, our business, financial condition and results of operations may be materially adversely affected. 31 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us to obtain regulatory clearance or approval of bremelanotide for HSDD or any future product candidates and to produce, market and distribute our products after clearance or approval is obtained. From time to time, legislation is drafted and introduced in Congress, and court decisions are issued, that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of bremelanotide for HSDD or any future product candidates. We cannot determine what effect changes in regulations, statutes, court decisions, legal interpretation or policies, when and if promulgated, enacted, issued or adopted may have on our business in the future. Such changes could, among other things: ● require changes to manufacturing methods; ● require recall, replacement or discontinuance of one or more of our products; ● require additional recordkeeping; ● limit or restrict our ability to engage in certain types of marketing or promotional activities; ● alter or eliminate the scope or terms of any currently available regulatory exclusivities; and ● restrict or eliminate our ability to settle any patent litigation we may bring against potential generic competitors. Each of these would likely entail substantial time and cost and could materially harm our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any future products would harm our business, financial condition and results of operations. Changes in healthcare policy could adversely affect our business. U.S. and foreign governments continue to propose and pass legislation designed to reduce the cost of healthcare. For example, the Medicare Prescription Drug Improvement and Modernization Act of 2003, or MMA, expanded Medicare coverage for drugs purchased by Medicare beneficiaries and introduced new reimbursement methodologies. In addition, this law provided authority for limiting the number of drugs that will be covered in any therapeutic class. We do not know what impact the MMA and similar laws will have on the availability of coverage for and the price that we receive for any approved products. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare policies in setting their own reimbursement policies, and any reduction in reimbursement that results from the MMA may result in similar reductions by private payers. In March 2010, the President signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, together the ACA. This law has resulted in an increase in the number of people who are covered by both public and private insurance and has changed the way health care is financed by both government health program and private insurers, with significant impacts on the pharmaceutical industry. The ACA contains a number of provisions that may impact our business and operations in ways that may negatively affect our potential revenues in the future. For example, the ACA imposes a non-deductible excise tax on pharmaceutical manufacturers or importers that sell branded prescription drugs to U.S. government programs which we believe will increase the cost of any products that we develop. Moreover, the ACA established a 2.3% medical device excise tax on certain transactions, including many United States sales of medical devices, which currently includes, and we expect will continue to include, United States sales of drug/device combination products. While the 2.3% medical device excise tax has been suspended for two years, until September 2017, unless legislative action is taken it will go back into effect after the suspension period. In addition, as part of the ACA’s provisions closing a funding gap that currently exists in the Medicare Part D prescription drug program (commonly known as the “donut hole”), we will be required to provide a 50% discount on any branded prescription drugs that we develop sold to beneficiaries who fall within the donut hole. While it is too early to predict all of the specific effects the ACA or any future healthcare reform legislation will have on our business, they could have a material adverse effect on our business and financial condition. The availability of government reimbursement for prescription drugs will be impacted by the Budget Control Act of 2011, which was signed into law on August 2, 2011. This law is expected to result in federal spending cuts totaling between $1.2 trillion and $1.5 trillion over the next decade, over half of which will include cuts in Medicare and other health-related spending. Risks Related to Our Intellectual Property If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. Our success, competitive position and future revenues will depend in part on our ability and the abilities of our licensors to obtain and maintain patent protection for our products, methods, processes and other technologies, to preserve our trade secrets, to prevent third parties from infringing on our proprietary rights and to operate without infringing the proprietary rights of third parties. We cannot predict: 32 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ● the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents; ● if and when patents will be issued; ● whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; and ● whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose. If our products, methods, processes and other technologies infringe the proprietary rights of other parties we could incur substantial costs and we may have to: ● obtain licenses, which may not be available on commercially reasonable terms, if at all; ● redesign our products or processes to avoid infringement; ● stop using the subject matter claimed in the patents held by others; ● pay damages; or ● defend litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion of our management resources. We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time consuming. Competitors may infringe our intellectual property, including our patents or the patents of our licensors. As a result, we may be required to file infringement claims to stop third-party infringement or unauthorized use. This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover its technology or that the factors necessary to grant an injunction against an infringer are not satisfied. An adverse determination of any litigation or other proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. Interference, derivation or other proceedings brought at the United States Patent and Trademark Office, or USPTO, may be necessary to determine the priority or patentability of inventions with respect to our patent applications or those of our licensors or collaborators. Litigation or USPTO proceedings brought by us may fail or may be invoked against us by third parties. Even if we are successful, domestic or foreign litigation or USPTO or foreign patent office proceedings may result in substantial costs and distraction to our management. We may not be able, alone or with our licensors or collaborators, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other proceedings, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or proceedings. In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents. If investors perceive these results to be negative, the market price for our common stock could be significantly harmed. If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Our research, development and commercialization activities may infringe or otherwise violate or be claimed to infringe or otherwise violate patents owned or controlled by other parties. There may also be patent applications that have been filed but not published that, when issued as patents, could be asserted against us. These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit. As a result of patent infringement claims, or to avoid potential claims, we may choose or be required to seek licenses from third parties. These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms, if at all. 33 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference, derivation or post-grant proceedings declared or granted by the USPTO and similar proceedings in foreign countries, regarding intellectual property rights with respect to our current or future products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition or results of operations. We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States and in some cases may even force us to grant a compulsory license to competitors or other third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems 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 competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. In addition, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in domestic and foreign intellectual property laws. If we are unable to keep our trade secrets confidential, our technologies and other proprietary information may be used by others to compete against us. In addition to our reliance on patents, we attempt to protect our proprietary technologies and processes by relying on trade secret laws and agreements with our employees and other persons who have access to our proprietary information. These agreements and arrangements may not provide meaningful protection for our proprietary technologies and processes in the event of unauthorized use or disclosure of such information, and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, our competitors may independently develop substantially equivalent technologies and processes or gain access to our trade secrets or technology, either of which could materially and adversely affect our competitive position. Risks Related to Obligations in Our 2012, 2014 and 2015 Private Placements Under agreements relating to our 2012, 2014 and 2015 private placements, we are required to allow purchasers in the 2012, 2014 and 2015 private placements to participate in certain future equity and debt financings, which may restrict our ability to raise funds on acceptable terms, or at all. For six years after our 2012 private placement, unless the purchasers own less than 20% of our outstanding common stock calculated as if the warrants were exercised, and for four years after our 2014 and 2015 private placements, unless the FDA earlier approves bremelanotide for HSDD, the purchasers have the right of first negotiation on any subsequent equity or debt financing. Under our 2012 private placement, if we do not agree to terms of a financing with the purchasers, and negotiate with a third party on a financing, we must offer to sell to the purchasers at least 55% of the financing, and the purchasers may elect to purchase all or a portion of the financing. Under our 2014 and 2015 private placements, if we do not agree to terms of a financing with the purchasers, depending on pricing of the financing, the purchasers have the right to purchase between 83.5% and all of the financing. We will require significant additional resources and capital for our bremelanotide development program, including completing safety and ancillary studies, preparing and submitting an NDA, and implementing commercial scale manufacturing, as well as for our other clinical trial programs. The right of first negotiation and right of participation granted to the purchasers in our 2012, 2014 and 2015 private placements may make it more difficult to raise additional funding through public or private equity or debt financings or other sources. If we are able to obtain additional funding, such funding may not be available on acceptable terms 34 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Under agreements relating to our 2012, 2014 and 2015 private placements, so long as any Series A 2012, Series B 2012, Series C 2014 and Series E 2015 warrants are outstanding, we are required to redeem such warrants at the option of the holders in the event of any takeover, change of control or other fundamental transaction which we permit. Under the purchase agreements and forms of our Series A, Series B, Series C and Series E warrants for our 2012, 2014 and 2015 private placements, if we permit, make or allow a takeover, change of control or other fundamental transaction, including any transfer of all or substantially all of our properties or assets, then so long as any warrants remain outstanding we are required, as elected by such warrant holders, to pay such holders a warrant early termination price tied to the greater of the then market price of our common stock or the amount per share paid to any other person. The application of these provisions could adversely affect our financial position and have the effect of delaying or preventing a change of control or other fundamental transaction, which could adversely affect the market price of our common stock, and could make any potential acquisition or change of control more costly. Under agreements relating to our 2012, 2014 and 2015 private placements, so long as any Series A 2012, Series B 2012, Series C 2014 and Series E 2015 warrants are outstanding, we are required to oppose any takeover or change of control that does not provide specified rights to holders of such warrants. Under the purchase agreements and forms of our Series A, Series B, Series C and Series E warrants for our 2012, 2014 and 2015 private placements, so long as any such warrants remain outstanding we are required to (i) not permit, (ii) take necessary action to prevent both the occurrence or consummation of, and (iii) not be a party to any fundamental transaction, change of control or similar event unless contractually-specified rights are provided with respect to payment of any such warrant early termination price tied to the greater of the then market price of our common stock or the amount per share paid to any other person. We are also required, subject to the exercise by our board of its fiduciary duties, to take all reasonable efforts to adopt a poison pill or any other anti-takeover provision or method necessary to prevent the fundamental transaction, change of control or similar event. The application of these provisions could have the effect of delaying or preventing a change of control or other fundamental transaction, which could adversely affect the market price of our common stock, and could make any potential acquisition or change of control more costly. Risks Related to the Ownership of Our Common Stock Our stock price is volatile and may fluctuate in a way that is disproportionate to our operating performance and we expect it to remain volatile, which could limit investors’ ability to sell stock at a profit. The volatile price of our stock makes it difficult for investors to predict the value of their investment, to sell shares at a profit at any given time or to plan purchases and sales in advance. A variety of factors may affect the market price of our common stock. These include, but are not limited to: ● publicity regarding actual or potential clinical results relating to products under development by our competitors or us; ● delay or failure in initiating, completing or analyzing preclinical or clinical trials or unsatisfactory designs or results of these trials; ● interim decisions by regulatory agencies, including the FDA, as to clinical trial designs, acceptable safety profiles and the benefit/risk ratio of products under development; ● achievement or rejection of regulatory approvals by our competitors or by us; ● announcements of technological innovations or new commercial products by our competitors or by us; ● developments concerning proprietary rights, including patents; ● developments concerning our collaborations; ● regulatory developments in the United States and foreign countries; ● economic or other crises and other external factors; 35 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ● period-to-period fluctuations in our revenue and other results of operations; ● changes in the structure of healthcare payment systems or other actions that affect the effective reimbursement rates for treatment regimens containing our products; ● changes in financial estimates and recommendations by securities analysts following our business or our industry; ● sales of our common stock (or the perception that such sales could occur); and ● the other factors described in this “Risk Factors” section. We will not be able to control many of these factors, and we believe that period-to-period comparisons of our financial results will not necessarily be indicative of our future performance. If our revenues, if any, in any particular period do not meet expectations, we may not be able to adjust our expenditures in that period, which could cause our operating results to suffer further. If our operating results in any future period fall below the expectations of securities analysts or investors, our stock price may fall by a significant amount. For the 12-month period ended June 30, 2016, the price of our stock has been volatile, ranging from a high of $1.18 per share to a low of $0.36 per share. In addition, the stock market in general, and the market for biotechnology companies in particular, has experienced extreme price and volume fluctuations that may have been unrelated or disproportionate to the operating performance of individual companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. As a public company in the United States, we are subject to the Sarbanes-Oxley Act of 2002, or Sarbanes-Oxley. We can provide no assurance that we will, at all times, in the future be able to report that our internal controls over financial reporting are effective. Companies that file reports with the SEC, including us, are subject to the requirements of Section 404 of Sarbanes-Oxley. Section 404 requires management to establish and maintain a system of internal control over financial reporting, and annual reports on Form 10-K filed under the Exchange Act, must contain a report from management assessing the effectiveness of a company’s internal control over financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis will be a costly and time-consuming effort that needs to be re-evaluated frequently. Failure on our part to have effective internal financial and accounting controls would cause our financial reporting to be unreliable, could have a material adverse effect on our business, operating results, and financial condition, and could cause the trading price of our common stock to fall dramatically. If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline. As a smaller company, it may be difficult for us to attract or retain the interest of equity research analysts. A lack of research coverage may adversely affect the liquidity of and market price of our common stock. We do not have any control of the equity research analysts or the content and opinions included in their reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of our company, or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline. Holders of our preferred stock may have interests different from our common stockholders. We are permitted under our certificate of incorporation to issue up to 10,000,000 shares of preferred stock. We can issue shares of our preferred stock in one or more series and can set the terms of the preferred stock without seeking any further approval from our common stockholders. 4,030 shares of our Series A Preferred Stock remain outstanding as of September 16, 2016. Each share of Series A Preferred Stock is convertible at any time, at the option of the holder, and such conversion could dilute the value of our common stock to current stockholders and could adversely affect the market price of our common stock. The conversion price decreases if we sell common stock (or equivalents) for a price per share less than the conversion price or less than the market price of the common stock and is also subject to adjustment upon the occurrence of a merger, reorganization, consolidation, reclassification, stock dividend or stock split which results in an increase or decrease in the number of shares of common stock outstanding. Upon (i) liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, (ii) sale or other disposition of all or substantially all of the assets of the Company, or (iii) any consolidation, merger, combination, reorganization or other transaction in which the Company is not the surviving entity or in which the shares of common stock constituting in excess of 50% of the voting power of the Company are exchanged for or changed into other stock or securities, cash and/or any other property, after payment or provision for payment of the debts and other liabilities of the Company, the holders of Series A Preferred Stock will be entitled to receive, pro rata and in preference to the holders of any other capital stock, an amount per share equal to $100 plus accrued but unpaid dividends, if any. Any preferred stock that we issue may rank ahead of our common stock in terms of dividend priority or liquidation premiums and may have greater voting rights than our common stock. 36 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains. We do not anticipate paying any cash dividends in the foreseeable future and intend to retain future earnings, if any, for the development and expansion of our business. Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 16, 2016, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock. In addition, the terms of existing or future agreements may limit our ability to pay dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Anti-takeover provisions of Delaware law and our charter documents may make potential acquisitions more difficult and could result in the entrenchment of management. We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our charter documents may make a change in control or efforts to remove management more difficult. Also, under Delaware law, our board of directors may adopt additional anti- takeover measures. Under Section 203 of the Delaware General Corporation Law, a corporation may not engage in a business combination with an “interested stockholder” for a period of three years after the date of the transaction in which the person first becomes an “interested stockholder,” unless the business combination is approved in a prescribed manner. We are authorized to issue up to 300,000,000 shares of common stock. To the extent that we sell or otherwise issue authorized but currently unissued shares, this could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock. Our charter authorizes us to issue up to 10,000,000 shares of preferred stock and to determine the terms of those shares of stock without any further action by our stockholders. If we exercise this right, it could be more difficult for a third party to acquire a majority of our outstanding voting stock. In addition, our equity incentive plans generally permit us to accelerate the vesting of options and other stock rights granted under these plans in the event of a change of control. If we accelerate the vesting of options or other stock rights, this action could make an acquisition more costly. The application of these provisions could have the effect of delaying or preventing a change of control, which could adversely affect the market price of our common stock. We are a smaller reporting company and the reduced disclosure requirements applicable to smaller reporting companies may make our Common Stock less attractive to investors. We are currently a “smaller reporting company” as defined in the Exchange Act. Smaller reporting companies are able to provide simplified executive compensation disclosures in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes- Oxley Act requiring that an independent registered public accounting firm provide an attestation report on the effectiveness of internal control over financial reporting, and have certain other decreased disclosure obligations in their SEC filings. We cannot predict whether investors will find our common stock less attractive because of our reliance on any of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. As of September 16, 2016 there were 129,030,427 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants. Stockholders may experience dilution from the conversion of preferred stock, exercise of outstanding options and warrants and vesting of restricted stock units. As of September 16, 2016, holders of our outstanding dilutive securities had the right to acquire the following amounts of underlying common stock: ● 60,592 shares issuable on the conversion of immediately convertible Series A Convertible preferred stock, subject to adjustment, for no further consideration; ● 6,409,020 shares issuable on the exercise of stock options, at exercise prices ranging from $0.49 to $24.90 per share; ● 3,559,768 shares issuable under restricted stock units which vest on dates between December 8, 2016 and January 11, 2020, subject to the fulfillment of service conditions; and ● 119,001,047 shares issuable on the exercise of warrants at exercise prices ranging from $0.01 to $1.00 per share, of which 84,546,764 are prefunded warrants with an exercise price of $0.01. If the holders convert, exercise or receive these securities, or similar dilutive securities we may issue in the future, stockholders may experience dilution in the net book value of their common stock. In addition, the sale or availability for sale of the underlying shares in the marketplace could depress our stock price. We have registered or agreed to register for resale substantially all of the underlying shares listed above. Holders of registered underlying shares could resell the shares immediately upon issuance, which could result in significant downward pressure on our stock price. 37 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Our failure to meet the continued listing requirements of the NYSE MKT could result in a de-listing of our common stock. Our common shares are listed on the NYSE MKT, a national securities exchange, under the symbol “PTN”. Although we currently meet the NYSE MKT’s listing standards, which generally mandate that we meet certain requirements relating to stockholders’ equity, market capitalization, aggregate market value of publicly held shares and distribution requirements, we cannot assure you that we will be able to continue to meet the NYSE MKT’s listing requirements. If we fail to satisfy the continued listing requirements of the NYSE MKT, such as the corporate governance requirements or the minimum closing bid price requirement, the NYSE MKT may take steps to de-list our common stock. If the NYSE MKT delists our securities for trading on its exchange, we could face significant material adverse consequences, including: ● a limited availability of market quotations for our securities; ● reduced liquidity with respect to our securities; ● a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock; ● a limited amount of news and analyst coverage for our company; and ● a decreased ability to issue additional securities or obtain additional financing in the future. Such a de-listing would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we may take actions to restore our compliance with the NYSE MKT’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the NYSE MKT minimum bid price requirement or prevent future non-compliance with the NYSE MKT’s listing requirements. The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Our common shares are considered to be covered securities because they are listed on the NYSE MKT. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Further, if we were no longer listed on the NYSE MKT, our common stock would not be covered securities and we would be subject to regulation in each state in which we offer our securities. Item 1B. Unresolved Staff Comments None. Item 2. Properties Our corporate offices are located at 4B Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury, NJ 08512, where we lease approximately 10,000 square feet of office space under a lease that expires in June 2020. We also lease approximately 1,000 square feet of laboratory space in the Township of South Brunswick, NJ, under a lease that expires in July 2017. We believe our present facilities are adequate for our current needs. We do not own any real property. Item 3. Legal Proceedings We are involved, from time to time, in various claims and legal proceedings arising in the ordinary course of our business. We are not currently a party to any claim or legal proceeding. Item 4. Mine Safety Disclosures Not applicable. 38 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. The table below provides, for the fiscal quarters indicated, the reported high and low sales prices for our common stock on the NYSE MKT since July 1, 2014. PART II FISCAL YEAR ENDED JUNE 30, 2016 Fourth Quarter Third Quarter Second Quarter First Quarter FISCAL YEAR ENDED JUNE 30, 2015 Fourth Quarter Third Quarter Second Quarter First Quarter HIGH LOW $ $ HIGH $ $ 0.74 0.69 0.90 1.18 1.58 1.34 0.93 1.28 LOW 0.40 0.36 0.62 0.80 0.85 0.65 0.59 0.82 Our common stock has been listed on NYSE MKT under the symbol “PTN” since December 21, 1999. It previously traded on The Nasdaq SmallCap Market under the symbol “PLTN.” On September 16, 2016, we had approximately 105 record holders of common stock and the closing sales price of our common stock as reported on the NYSE MKT was $0.50 per share. Issuer purchases of equity securities. We have not and do not currently intend to retire or repurchase any of our capital securities other than providing our employees with the option to withhold shares to satisfy tax withholding amounts due from employees upon the vesting of restricted stock units in connection with our 2011 Stock Incentive Plan. The following 123,127 shares were withheld during the quarter ended June 30, 2016 at the direction of the employees as permitted under the 2011 Stock Incentive Plan in order to pay the minimum amount of tax liability owed by the employee from the vesting of those units: April 1-30, 2016 May 1-31, 2016 June 1-30, 2016 Total Period Total Number of Shares Purchased (1) Weighted Average Price Paid per Share - - 123,127 123,127 $ $ - - 0.47 0.47 Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Maximum Number of Shares that May Yet be Purchased Under Announced Plans or Programs - - - - - - - - (1) Consists solely of 123,127 shares that were withheld to satisfy tax withholding amounts due from employees upon the vesting of previously issued restricted stock units. Dividends and dividend policy . We have never declared or paid any dividends. We currently intend to retain earnings, if any, for use in our business. We do not anticipate paying dividends in the foreseeable future. Dividend restrictions. Our outstanding Series A Preferred Stock, consisting of 4,030 shares on September 16, 2016, provides that we may not pay a dividend or make any distribution to holders of any class of stock unless we first pay a special dividend or distribution of $100 per share to the holders of the Series A Preferred Stock. Equity Compensation Plan Information. Reference is made to the information contained in the Equity Compensation Plan table contained in Item 12 of this Annual Report. Item 6. Selected Financial Data. Not Applicable. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis should be read in conjunction with the consolidated financial statements and notes to the consolidated financial statements filed as part of this Annual Report. 39 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Forward-Looking Statements The following discussion and analysis contains forward-looking statements within the meaning of the federal securities laws. You are urged to carefully review our description and examples of forward-looking statements included earlier in this Annual Report on Form 10-K immediately prior to Part I, under the heading “Forward-Looking Statements.” Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. You are urged to carefully review the disclosures we make concerning risks and other factors that may affect our business and operating results, including those made in Part I, Item 1A of this Annual Report on Form 10-K, and any of those made in our other reports filed with the SEC. You are cautioned not to place undue reliance on the forward-looking statements included herein, which speak only as of the date of this document. We do not intend, and undertake no obligation, to publish revised forward- looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events. Critical Accounting Policies and Estimates Our significant accounting policies are described in Note 2 to the consolidated financial statements included in this Annual Report. We believe that our accounting policies and estimates relating to revenue recognition, accrued expenses and stock-based compensation charges are the most critical. Revenue Recognition. Revenue resulting from license fees is recognized upon delivery of the license for the portion of the license fee payment that is non-contingent and non-refundable, if the license has standalone value. Revenue resulting from the achievement of development milestones is recorded in accordance with the accounting guidance for the milestone method of revenue recognition. Revenue resulting from the achievement of sales milestone events is recognized when the milestone is achieved. Revenue from royalties is recorded when earned. Accrued Expenses. Third parties perform a significant portion of our development activities. We review the activities performed under significant contracts each quarter and accrue expenses and the amount of any reimbursement to be received from our collaborators based upon the estimated amount of work completed. Estimating the value or stage of completion of certain services requires judgment based on available information. If we do not identify services performed for us but not billed by the service-provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated. Stock-based Compensation. The fair value of stock options granted has been calculated using the Black-Scholes option pricing model, which requires us to make estimates of expected volatility and expected option lives. We estimate these factors at the time of grant based on our own prior experience, public sources of information and information for comparable companies. The amount of recorded compensation related to an option grant is not adjusted for subsequent changes in these estimates or for actual experience. The amount of our recorded compensation is also dependent on our estimates of future option forfeitures. If we initially over-estimate future forfeitures, our reported expenses will be understated until such time as we adjust our estimate. Changes in estimated forfeitures will affect our reported expenses in the period of change and future periods. In addition, awards containing a market condition are valued using a multifactor Monte Carlo simulation. The amount and timing of compensation expense to be recorded in future periods related to grants of restricted stock units may be affected by employment terminations. As a result, stock-based compensation charges may vary significantly from period to period. Results of Operations Year Ended June 30, 2016 Compared to the Year Ended June 30, 2015: Revenue – For the fiscal year ended June 30, 2016 (fiscal 2016), we did not recognize any revenue. For the fiscal year ended June 30, 2015 (fiscal 2015), we recognized $12,951,730 in revenue pursuant to our license, co-development and commercialization agreement with Gedeon Richter. In August 2014, we entered into a license, co-development and commercialization agreement with Gedeon Richter, which provided for $9,763,347 in upfront payments. The non-refundable portion of the upfront payment, $4,932,315, was recorded as revenue in the three months ended September 30, 2014 and the remaining balance was recorded as revenue in the three months ended December 31, 2014, which became non-refundable upon initiation of our Phase 3 clinical trial program in the United States. We also recognized $3,188,383 in the three months ended December 31, 2014 relating to the milestone payment due upon initiation of our Phase 3 clinical trial program in the United States, which was initiated in December 2014. On September 16, 2015, we entered into a termination agreement pursuant to which we and Gedeon Richter agreed to mutually and amicably terminate the license agreement. 40 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Research and Development – Research and development expenses were $43,071,051 for fiscal 2016 compared to $24,560,233 for fiscal 2015. These costs primarily relate to our bremelanotide Phase 3 clinical trial program. Research and development expenses related to our bremelanotide, PL-3994, MC1r, MC4r and other preclinical programs were $39,371,908 and $21,879,136 in fiscal years 2016 and 2015, respectively. Spending to date has been primarily related to our bremelanotide for the treatment of HSDD program. The increase in research and development expenses is mainly attributable to the continued progress of Phase 3 clinical trial and development of bremelanotide for HSDD. The amount of such spending and the nature of future development activities are dependent on a number of factors, including primarily the availability of funds to support future development activities, success of our clinical trials and preclinical and discovery programs, and our ability to progress compounds in addition to bremelanotide and PL-3994 into human clinical trials. The amounts of project spending above exclude general research and development spending, which were $3,699,143 and $2,681,097 in fiscal years 2016 and 2015, respectively. The increase in general research and development spending is primarily attributable to additional staffing and secondarily to the recognition of stock-based compensation primarily related to the restricted stock units granted in December 2015. Cumulative spending from inception to June 30, 2016 is approximately $234,800,000 on our bremelanotide program and approximately $123,900,000 on all our other programs (which include PL-3994, PL-8177, other melanocortin receptor agonists, obesity, other discovery programs and terminated programs). Due to various risk factors described herein under “Risk Factors,” including the difficulty in currently estimating the costs and timing of future Phase 1 clinical trials and larger-scale Phase 2 and Phase 3 clinical trials for any product under development, we cannot predict with reasonable certainty when, if ever, a program will advance to the next stage of development or be successfully completed, or when, if ever, related net cash inflows will be generated. General and Administrative – General and administrative expenses, which consist mainly of compensation and related costs, were $6,179,084 for fiscal 2016 compared to $5,677,654 for fiscal 2015. The increase in general and administrative expenses is primarily attributable to the recognition of stock-based compensation primarily related to the restricted stock units granted in December 2015. Other Income (Expense) – Other income (expense) was $(2,462,801) and $(910,914) for fiscal 2016 and fiscal 2015, respectively. For fiscal 2016, we recognized $50,226 of investment income offset by $(2,513,027) of interest expense primarily related to our venture debt. For fiscal 2015, we recognized $35,439 of investment income offset by a $(284,656) foreign exchange transaction loss and $(661,697) of interest expense primarily related to our venture debt. Income Tax Benefit – We did not record any income tax benefits in fiscal 2016. For fiscal 2015, income tax benefits recorded of $531,508 related to the sale of New Jersey state net operating loss carryforwards and tax credits. The amount of such losses and tax credits that we were able to sell depended on annual pools and allocations established by the state of New Jersey. This program enables approved, unprofitable biotechnology businesses to sell their unused Net Operating Loss Carryovers, or NOLs, and unused Research and Development, or R&D, Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. Year Ended June 30, 2015 Compared to the Year Ended June 30, 2014: Revenue – For the fiscal year ended June 30, 2015 (fiscal 2015), we recognized $12,951,730 in revenue pursuant to our license, co-development and commercialization agreement with Gedeon Richter. We did not recognize any revenue for the fiscal year ended June 30, 2014 (fiscal 2014). Research and Development – Research and development expenses were $24,560,233 for fiscal 2015 compared to $10,826,921 for fiscal 2014. These costs primarily relate to our bremelanotide Phase 3 clinical trial program. Research and development expenses related to our bremelanotide, PL-3994, MC1r, MC4r and other preclinical programs were $21,879,136 and $7,918,537 in fiscal years 2015 and 2014, respectively. Spending to date has been primarily related our bremelanotide for the treatment of HSDD program. The increase in research and development expenses is mainly attributable to the initiation of Phase 3 clinical studies of bremelanotide for HSDD. The amounts of project spending above exclude general research and development spending, which were $2,681,097 and $2,908,384 in fiscal years 2015 and 2014, respectively. 41 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. General and Administrative – General and administrative expenses, which consist mainly of compensation and related costs, were $5,677,654 for fiscal 2015 compared to $4,960,731 for fiscal 2014. The increase was attributable to the fair value of stock-based compensation related to restricted stock units granted in June 2014 and amortized to expense through fiscal 2015 and increases in accounting and other professional services. Other Income (Expense) – Other income (expense) was $(910,914) and $12,712 for fiscal 2015 and fiscal 2014, respectively. For fiscal 2015, we recognized $35,439 of investment income offset by a $(284,656) foreign exchange transaction loss and $(661,697) of interest expense primarily related to our venture debt. For fiscal 2014, we recognized $18,923 of investment income offset by $(6,211) of interest expense. Income Tax Benefit – Income tax benefits of $531,508 in fiscal 2015 and $1,846,646 in fiscal 2014 relate to the sale of New Jersey state net operating loss carryforwards and tax credits. Effects of Inflation We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented. Liquidity and Capital Resources Since inception, we have incurred net operating losses, primarily related to spending on our research and development programs. We have financed our net operating losses primarily through debt and equity financings and amounts received under collaborative agreements. Our product candidates are at various stages of development and will require significant further research, development and testing and some may never be successfully developed or commercialized. We may experience uncertainties, delays, difficulties and expenses commonly experienced by early stage biopharmaceutical companies, which may include unanticipated problems and additional costs relating to: ● the development and testing of products in animals and humans; ● product approval or clearance; ● regulatory compliance; ● GMP compliance; ● intellectual property rights; ● product introduction; ● marketing, sales and competition; and ● obtaining sufficient capital. Failure to enter into or successfully perform under collaboration agreements and obtain timely regulatory approval for our product candidates and indications would impact our ability to increase revenues and could make it more difficult to attract investment capital for funding our operations. Any of these possibilities could materially and adversely affect our operations and require us to curtail or cease certain programs. During fiscal 2016, net cash used in operating activities was $47,363,814, compared to $13,358,042 in fiscal 2015 and $12,207,656 in fiscal 2014. Higher net cash outflows from operations in fiscal 2016 compared to fiscal 2015 were primarily the result of spending on our bremelanotide for the treatment of HSDD program. Higher net cash outflows from operation in fiscal 2015 compared to fiscal 2014 were primarily the result of spending on our bremelanotide for the treatment of HSDD program offset by the receipt of the upfront and milestone payments, relating to the license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for the treatment of HSDD in Europe and selected other countries. Our periodic prepaid expenses, accounts payable and accrued expenses balances will continue to be highly dependent on the timing of our operating costs. During fiscal 2016, net cash used in investing activities was $1,404,717 consisting primarily of the purchase of investments. We did not engage in any investing activities in fiscal 2015. During fiscal 2014, net cash provided by investing activities was $5,243,415, which consisted of $5,249,654 of proceeds from the maturity of short-term investments offset by $6,239 used for capital expenditures. During fiscal 2016, net cash provided by financing activities was $29,471,931, which consisted of a private placement with net proceeds of $19,834,278, a loan of $9,853,885, net of related debt issuance costs offset by $216,232 for the payment of withholding taxes related to restricted stock units and capital lease payments. During fiscal 2015, net cash provided by financing activities was $28,472,705, which consisted of a private placement with net proceeds of $18,556,111, a loan of $9,790,634, net of related issuance costs and $254,148 of proceeds from the exercise of common stock warrants offset by $128,188 for the payment of withholding taxes related restricted stock units and capital lease payments. During fiscal 2014, cash used in financing activities of $18,786 consisted of the payment of withholding taxes related to restricted stock units of $36,377 and payments on capital lease obligation of $19,909 offset by $37,500 of proceeds from the exercise of common stock warrants. We have incurred cumulative negative cash flows from operations since our inception, and have expended, and expect to continue to expend in the future, substantial funds to complete our planned product development efforts. As a result, there is substantial doubt about our ability to continue as a going concern. Continued operations are dependent upon our ability to complete equity or debt financing activities or collaboration arrangements. We believe that if we do not have sufficient funding, we may have to curtail or cease certain programs or operations within twelve months. As of June 30, 2016, our cash, cash equivalents and investments were $9,383,224 and our current liabilities were $13,994,439. On August 4, 2016, we completed an underwritten offering of units, with each unit consisting of a share of common stock and a Series H warrant to purchase 0.75 of a share of common stock. Investors whose purchase of units in the offering would result in them beneficially owning more than 9.99% of our outstanding common stock following the completion of the offering had the opportunity to acquire units with Series I prefunded warrants substituted for any common stock they would have otherwise acquired. Gross proceeds were $9,225,000, with net proceeds to us, after deducting estimated offering expenses, of approximately $8,500,000. We issued 11,481,481 shares of common stock and ten year prefunded Series I warrants to purchase 2,218,045 shares of common stock at an exercise price of $0.01, together with Series H warrants to purchase 10,274,646 shares of common stock at an exercise price of $0.70 per share. 42 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The Series I warrants are exercisable at an initial exercise price of $0.01 per share, exercisable immediately upon issuance and expire on the tenth anniversary of the date of issuance. The Series I warrants are subject to limitation on exercise if the holder and its affiliates would beneficially own more than 9.99% of the total number of Palatin’s shares of common stock following such exercise. The Series H warrants are exercisable at an initial exercise price of $0.70 per share, are exercisable commencing six months following the date of issuance and expire on the fifth anniversary of the date of issuance. The Series H warrants are subject to the same beneficial ownership limitation as the Series I warrants. We intend to utilize existing capital resources, including the proceeds from the financing, for general corporate purposes and working capital, including our bremelanotide clinical development program for HSDD, preclinical and clinical development of our MC1r and MC4r peptide programs and PL-3994 natriuretic peptide, and development of other portfolio products. Based on our current plan, we believe that the Phase 3 clinical trial program with bremelanotide, including submission of an NDA to the FDA, will cost at least $87,000,000. We intend to seek additional capital to support the Phase 3 program through collaborative arrangements on bremelanotide, public or private equity or debt financings, or other sources. We believe that our existing capital resources, together with approximately $8,500,000 received from the August 2016 financing, will be adequate to fund our planned operations through the quarter ending December 31, 2016. Assuming the double blind efficacy portion of the Phase 3 clinical trial of bremelanotide for HSDD is successful, as to which there can be no assurance, we will need additional funding to complete required ancillary studies and clinical trials, prepare and submit regulatory filings for product approval, and establish commercial scale manufacturing capability. We will also need additional funding to complete required clinical trials for our other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required regulatory applications to the FDA. We anticipate incurring additional losses over at least the next few years. To achieve profitability, if ever, we, alone or with others, must successfully develop and commercialize our technologies and proposed products, conduct preclinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market such technologies and proposed products. The time required to reach profitability is highly uncertain, and we do not know whether we will be able to achieve profitability on a sustained basis, if at all. Off-Balance Sheet Arrangements None. Contractual Obligations We have entered into various contractual obligations and commercial commitments. The following table summarizes our most significant contractual obligations as of June 30, 2016: Facility operating leases Capital lease obligations Notes payable Other Agreements Total contractual obligations Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not applicable. Total Less than 1 Year 1 - 3 Years 3 - 5 Years More than 5 Years Payments due by Period $ $ 923,166 43,707 23,893,001 2,524,033 $ 255,985 29,138 7,299,750 2,524,033 $ 445,837 14,569 15,757,334 - $ 221,344 - 835,917 - $ 27,383,907 $ 10,108,906 $ 16,217,740 $ 1,057,261 $ - - - - - 43 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 8. Financial Statements and Supplementary Data. The following consolidated financial statements are filed as part of this annual report: Table of Contents Consolidated Financial Statements Report of Independent Registered Public Accounting Firm Consolidated Balance Sheets Consolidated Statements of Operations Consolidated Statements of Comprehensive Loss Consolidated Statements of Stockholders’ (Deficiency) Equity Consolidated Statements of Cash Flows Notes to Consolidated Financial Statements 44 Page 45 46 47 48 49 50 51 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The Board of Directors and Stockholders Palatin Technologies, Inc.: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We have audited the accompanying consolidated balance sheets of Palatin Technologies, Inc. and subsidiary as of June 30, 2016 and 2015, and the related consolidated statements of operations, stockholders’ (deficiency) equity, comprehensive loss, and cash flows for each of the years in the three-year period ended June 30, 2016. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Palatin Technologies, Inc. and subsidiary as of June 30, 2016 and 2015, and the results of their operations and their cash flows for each of the years in the three-year period ended June 30, 2016, in conformity with U.S. generally accepted accounting principles. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring net losses and negative cash flows from operations and will require substantial additional financing to continue to fund its planned developmental activities. These conditions raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters also are discussed in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. /s/ KPMG LLP Philadelphia, Pennsylvania September 19, 2016 45 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Balance Sheets ASSETS Current assets: Cash and cash equivalents Available-for-sale investments Prepaid expenses and other current assets Total current assets Property and equipment, net Other assets Total assets LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable Accrued expenses Notes payable, net of discount Capital lease obligations Total current liabilities Notes payable, net of discount Capital lease obligations Other non-current liabilities Total liabilities Commitments and contengencies (Note 11) Stockholders’ (deficiency) equity: Preferred stock of $0.01 par value – authorized 10,000,000 shares; Series A Convertible; issued and outstanding 4,030 shares as of June 30, 2016 and 4,697 shares as of June 30, 2015, respectively Common stock of $0.01 par value – authorized 300,000,000 shares; issued and outstanding 68,568,055 shares as of June 30, 2016 and 57,128,433 as of June 30, 2015, respectively Additional paid-in capital Accumulated other comprehensive loss Accumulated deficit Total stockholders’ (deficiency) equity Total liabilities and stockholders’ equity The accompanying notes are an integral part of these consolidated financial statements 46 June 30, 2016 June 30, 2015 $ $ $ 8,002,668 1,380,556 1,424,282 10,807,506 97,801 146,428 11,051,735 713,890 7,767,733 5,485,392 27,424 13,994,439 14,189,809 14,324 439,130 28,637,702 27,299,268 - 1,896,747 29,196,015 123,158 155,279 29,474,452 1,106,484 6,223,483 - 25,871 7,355,838 9,781,086 41,749 91,304 17,269,977 40 47 685,680 325,142,509 (1,944) (343,412,252) (17,585,967) 11,051,735 $ 571,284 303,332,460 - (291,699,316) 12,204,475 29,474,452 $ $ $ $ EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. REVENUES: License and contract OPERATING EXPENSES: Research and development General and administrative Total operating expenses Loss from operations OTHER INCOME (EXPENSE): Investment income Interest expense Foreign exchange transaction loss Total other income (expense), net Loss before income taxes Income tax benefit NET LOSS Basic and diluted net loss per common share PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Operations 2016 Year Ended June 30, 2015 2014 $ - $ 12,951,730 $ - 43,071,051 6,179,084 49,250,135 24,560,233 5,677,654 30,237,887 10,826,921 4,960,731 15,787,652 (49,250,135) (17,286,157) (15,787,652) 50,226 (2,513,027) - (2,462,801) (51,712,936) - 35,439 (661,697) (284,656) (910,914) (18,197,071) 531,508 18,923 (6,211) - 12,712 (15,774,940) 1,846,646 $ $ (51,712,936) $ (17,665,563) $ (13,928,294) (0.33) $ (0.15) $ (0.13) Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share 156,553,534 121,014,506 106,679,476 The accompanying notes are an integral part of these consolidated financial statements 47 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Net loss Other comprehensive loss: Unrealized loss on available-for-sale investments Total comprehensive loss PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Comprehensive Loss 2016 Year Ended June 30, 2015 2014 $ (51,712,936) $ (17,665,563) $ (13,928,294) (1,944) - - $ (51,714,880) $ (17,665,563) $ (13,928,294) The accompanying notes are an integral part of these consolidated financial statements 48 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Stockholders’ (Deficiency) Equity Preferred Stock Common Stock Shares Amount Shares Amount 4,697 - - - - 4,697 - - - - - - 4,697 - - - - (667) - - 4,030 $ 47 - - - - 47 - - - - - - 47 - - - - (7) - - 40 39,116,948 378,750 (129,103) 50,000 - 39,416,595 705,833 2,050,000 - (174,568) 15,130,573 - 57,128,433 662,186 - - (123,483) 10,890,889 10,030 - - 68,568,055 $ 391,169 3,788 (1,291) 500 - 394,166 7,058 20,500 - (1,746) 151,306 - 571,284 6,622 - - (1,235) 108,909 100 - - 685,680 $ Additional Paid-in Capital 282,692,520 817,552 (118,716) 37,000 - 283,428,356 1,160,221 18,535,611 267,820 (162,390) 102,842 - 303,332,460 1,836,743 19,834,278 305,196 (57,166) (108,909) (93) - - 325,142,509 $ Accumulated Other Comprehensive Loss - - - - - - - - - - - - - - - - - - - (1,944) - (1,944) $ Accumulated Deficit (260,105,459) - - - (13,928,294) (274,033,753) - - - - - (17,665,563) (291,699,316) - - - - - - - (51,712,936) (343,412,252) $ Total 22,978,277 821,340 (120,007) 37,500 (13,928,294) 9,788,816 1,167,279 18,556,111 267,820 (164,136) 254,148 (17,665,563) 12,204,475 1,843,365 19,834,278 305,196 (58,401) - - (1,944) (51,712,936) (17,585,967) Balance, July 1, 2013 Stock-based compensation Withholding taxes related to restricted stock units Warrant exercises Net loss Balance, June 30, 2014 Stock-based compensation Sale of common stock units, net of costs Issuance of warrants on debt Withholding taxes related to restricted stock units Warrant exercises Net loss Balance, June 30, 2015 Stock-based compensation Sale of common stock units, net of costs Issuance of warrants on debt Withholding taxes related to restricted stock units Warrant exercises Series A Conversion Unrealized loss on investments Net loss Balance, June 30, 2016 The accompanying notes are an integral part of these consolidated financial statements 49 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. CASH FLOWS FROM OPERATING ACTIVITIES: Net loss Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization Non-cash interest expense Stock-based compensation Changes in operating assets and liabilities: Prepaid expenses and other assets Accounts payable Accrued expenses Unearned revenue Other non-current liabilities Net cash used in operating activities CASH FLOWS FROM INVESTING ACTIVITIES: Proceeds from sale/maturity of investments Purchases of investments Purchases of property and equipment Net cash (used in) provided by investing activities CASH FLOWS FROM FINANCING ACTIVITIES: Payments on capital lease obligations Payment of withholding taxes related to restricted stock units Proceeds from exercise of common stock warrants Proceeds from the sale of common stock and warrants, net of costs Proceeds from the issuance of notes payable and warrants Payment of debt issuance costs Net cash provided by (used in) financing activities NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS CASH AND CASH EQUIVALENTS, beginning of year CASH AND CASH EQUIVALENTS, end of year SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest Equipment acquired under capital lease Issuance of warrants in connection with debt financing PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Cash Flows 2016 Year Ended June 30, 2015 2014 $ (51,712,936) $ (17,665,563) $ (13,928,294) 43,052 327,479 1,843,365 503,785 (392,594) 1,676,209 - 347,826 (47,363,814) - (1,387,022) (17,695) (1,404,717) (25,872) (190,360) - 19,834,278 10,000,000 (146,115) 29,471,931 117,590 87,087 1,167,279 (1,667,139) 845,204 4,666,196 (1,000,000) 91,304 (13,358,042) - - - - (12,380) (115,808) 254,148 18,556,111 10,000,000 (209,366) 28,472,705 111,906 - 821,340 176,697 (77,446) (311,859) 1,000,000 - (12,207,656) 5,249,654 - (6,239) 5,243,415 (19,909) (36,377) 37,500 - - - (18,786) (19,296,600) 15,114,663 (6,983,027) 27,299,268 12,184,605 19,167,632 $ 8,002,668 $ 27,299,268 $ 12,184,605 $ $ 1,836,743 - 305,196 $ 483,306 80,000 267,820 6,211 - - The accompanying notes are an integral part of these consolidated financial statements 50 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements (1) ORGANIZATION Nature of Business – Palatin Technologies, Inc. (Palatin or the Company) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. The melanocortin system is involved in a large and diverse number of physiologic functions, and therapeutic agents modulating this system may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, cachexia (wasting syndrome) and inflammation-related diseases. The natriuretic peptide receptor system has numerous cardiovascular functions, and therapeutic agents modulating this system may be useful in treatment of acute asthma, heart failure, hypertension and other cardiovascular diseases. The Company’s primary product in development is bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD), which is a type of female sexual dysfunction (FSD). The Company also has drug candidates or development programs for obesity, erectile dysfunction, cardiovascular diseases, pulmonary diseases, inflammatory diseases and dermatologic diseases. Key elements of the Company’s business strategy include using its technology and expertise to develop and commercialize therapeutic products; entering into alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the Company is developing; and partially funding its product candidate development programs with the cash flow generated from third parties. Going Concern – There is substantial doubt about the Company’s ability to continue as a going concern. Since inception, the Company has incurred negative cash flows from operations, and has expended, and expects to continue to expend in the future, substantial funds to complete its planned product development efforts. As shown in the accompanying consolidated financial statements, the Company had an accumulated deficit as of June 30, 2016 of $343,412,252 and incurred a net loss for fiscal 2016 of $51,712,936. The Company anticipates incurring additional losses in the future as a result of spending on its development programs and will require substantial additional financing to continue to fund its planned developmental activities. To achieve profitability, if ever, the Company, alone or with others, must successfully develop and commercialize its technologies and proposed products, conduct successful preclinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market such technologies and proposed products. The time required to reach profitability is highly uncertain, and there can be no assurance that the Company will be able to achieve profitability on a sustained basis, if at all. The accompanying consolidated financial statements have been prepared assuming that the Company continues as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amount or classification of liabilities that might result from the outcome of this uncertainty. As discussed in Note 15, on August 4, 2016, the Company closed on an underwritten offering of units resulting in gross proceeds of $9,225,000, with net proceeds, after deducting estimated offering expenses, of approximately $8,500,000. As of June 30, 2016, the Company’s cash, cash equivalents and investments were $9,383,224 and current liabilities were $13,994,439. The Company intends to utilize existing capital resources, including the proceeds from the financing for general corporate purposes and working capital, including the Phase 3 clinical trial program with bremelanotide for HSDD and preclinical and clinical development of our other product candidates and programs, including PL-3994 and melanocortin recetptor-1 and melanocortin receptor-4 programs. Management believes that the Phase 3 clinical trial program with bremelanotide, including regulatory filings for product approval, will cost at least $87,000,000. Management believes that the Company’s existing capital resources, together with approximately $8,500,000 received from the August 2016 financing, will be adequate to fund its planned operations through the quarter ending December 31, 2016. Assuming the double blind efficacy portion of the Phase 3 clinical trial of bremelanotide for HSDD is successful, as to which there can be no assurance, we will need additional funding to complete required ancillary studies and clinical trials, prepare and submit regulatory filings for product approval, and establish commercial scale manufacturing capability. 51 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary The Company will need to raise additional capital to complete required ancillary studies and clinical trials, prepare and submit regulatory filings for product approval, and establish commercial scale manufacturing capability. The Company will also need additional funding to complete required clinical trials for its other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required applications to the FDA. If the Company is unable to obtain approval or otherwise advance in the FDA approval process, the Company’s ability to sustain its operations would be materially adversely affected. The Company may seek the additional capital necessary to fund its operations through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. Additional capital that is required by the Company may not be available on reasonable terms, or at all. Concentrations – Concentrations in the Company’s assets and operations subject it to certain related risks. Financial instruments that subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents and available-for-sale investments. The Company’s cash and cash equivalents are primarily invested in one money market account sponsored by a large financial institution. For the years ended June 30, 2016 and 2014, the Company had no revenues reported. For the year ended June 30, 2015, 100% of revenues were from Gedeon Richter. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation – The consolidated financial statements include the accounts of Palatin and its wholly-owned inactive subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates – The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents – Cash and cash equivalents include cash on hand, cash in banks and all highly liquid investments with a purchased maturity of less than three months. Cash equivalents consist of $7,782,243 and $26,946,378 in a money market account at June 30, 2016 and 2015, respectively. Investments – The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held-to-maturity when the Company has the intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available-for-sale. Held-to-maturity securities are recorded as either short-term or long-term on the balance sheet, based on the contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held-to-maturity or as trading are classified as available-for-sale and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of other comprehensive (loss) income. The fair value of substantially all securities is determined by quoted market prices. The estimated fair value of securities for which there are no quoted market prices is based on similar types of securities that are traded in the market. Fair Value of Financial Instruments – The Company’s financial instruments consist primarily of cash equivalents, accounts payable and notes payable. Management believes that the carrying values of cash equivalents, available-for-sale investments and accounts payable are representative of their respective fair values based on the short-term nature of these instruments. Management believes that the carrying amount of its notes payable approximates fair value based on terms of the notes. Credit Risk – Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash and cash equivalent balances have exceeded insured balances by the Federal Depository Insurance Company (FDIC). 52 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Property and Equipment – Property and equipment consists of office and laboratory equipment, office furniture and leasehold improvements and includes assets acquired under capital leases. Property and equipment are recorded at cost. Depreciation is recognized using the straight-line method over the estimated useful lives of the related assets, generally five years for laboratory and computer equipment, seven years for office furniture and equipment and the lesser of the term of the lease or the useful life for leasehold improvements. Amortization of assets acquired under capital leases is included in depreciation expense. Maintenance and repairs are expensed as incurred while expenditures that extend the useful life of an asset are capitalized. Impairment of Long-Lived Assets – The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine recoverability of a long- lived asset, management evaluates whether the estimated future undiscounted net cash flows from the asset are less than its carrying amount. If impairment is indicated, the long-lived asset would be written down to fair value. Fair value is determined by an evaluation of available price information at which assets could be bought or sold, including quoted market prices, if available, or the present value of the estimated future cash flows based on reasonable and supportable assumptions. Revenue Recognition – Under our license, co-development and commercialization agreement with Gedeon Richter (Note 4), we received consideration in the form of a license fee and development milestone payment. Revenue resulting from license fees is recognized upon delivery of the license for the portion of the license fee payment that is non-contingent and non-refundable, if the license has standalone value. Revenue resulting from the achievement of development milestones is recorded in accordance with the accounting guidance for the milestone method of revenue recognition. Research and Development Costs – The costs of research and development activities are charged to expense as incurred, including the cost of equipment for which there is no alternative future use. Accrued Expenses – Third parties perform a significant portion of our development activities. We review the activities performed under significant contracts each quarter and accrue expenses and the amount of any reimbursement to be received from our collaborators based upon the estimated amount of work completed. Estimating the value or stage of completion of certain services requires judgment based on available information. If we do not identify services performed for us but not billed by the service- provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated. Stock-Based Compensation – The Company charges to expense the fair value of stock options and other equity awards granted. The Company determines the value of stock options utilizing the Black-Scholes option pricing model. Compensation costs for share-based awards with pro-rata vesting are determined using the quoted market price of the Company’s common stock on the date of grant and allocated to periods on a straight-line basis, while awards containing a market condition are valued using multifactor Monte Carlo simulations. Income Taxes – The Company and its subsidiary file consolidated federal and separate-company state income tax returns. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences or operating loss and tax credit carryforwards are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The Company has recorded a valuation allowance against its deferred tax assets based on the history of losses incurred. The Company did not have a sale of New Jersey state net operating loss (NJ NOL) carryforwards during the year ended June 30, 2016 and therefore did not record a tax benefit. During the years ended June 30, 2015 and 2014, the Company sold New Jersey state net operating loss carryforwards, which resulted in the recognition of $531,508 and $1,846,646, respectively, in tax benefits. Net Loss per Common Share – Basic and diluted earnings per common share (EPS) are calculated in accordance with the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 260, “Earnings per Share,” which includes guidance pertaining to the warrants, issued in connection with the July 3, 2012, December 23, 2014, and July 2, 2015 private placement offerings, that are exercisable for nominal consideration and, therefore, are to be considered in the computation of basic and diluted net loss per common share. The Series A 2012 warrants issued on July 3, 2012 to purchase up to 31,988,151 shares of common stock are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share for all periods presented in the consolidated statements of operations. 53 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary The Series B 2012 warrants issued on July 3, 2012 to purchase up to 35,488,380 shares of common stock are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share for all periods presented in the consolidated statements of operations. The Series C 2014 warrants to purchase up to 24,949,325 shares of common stock were exercisable starting at December 23, 2014 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on December 23, 2014. The Series E 2015 warrants to purchase up to 21,917,808 shares of common stock were exercisable starting at July 2, 2015 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on July 2, 2015. As of June 30, 2016, 2015 and 2014, there were 32,167,737, 30,212,446, and 29,358,926 common shares issuable upon conversion of Series A Convertible Preferred Stock, the exercise of outstanding options and warrants (excluding the Series A 2012, Series B 2012, Series C 2014, and Series E 2015 warrants issued in connection with the July 3, 2012, December 23, 2014, and July 2, 2015 private placement offerings), and the vesting of restricted stock units, respectively. These share amounts have been excluded from the calculation of net loss per share as the impact would be anti-dilutive. (3) NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments which requires measurement and recognition of expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This is different from the current guidance as this will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets. The new guidance will be effective for the Company on July 1, 2020. Early adoption will be available on July 1, 2019. The Company is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Improvement to Employee Share-Based Payment Accounting, which amends the current guidance related to stock compensation. The updated guidance changes how companies account for certain aspects of share-based payment awards to employees, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The update to the standard is effective for the Company on July 1, 2017, with early application permitted. We are evaluating the effect that the new guidance will have on its consolidated financial statements and related disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases, related to the recognition of lease assets and lease liabilities. The new guidance requires lessees to recognize almost all leases on their balance sheet as a right-of-use asset and a lease liability, other than leases that meet the definition of a short- term lease, and requires expanded disclosures about leasing arrangements. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from the current guidance. Lessor accounting is similar to the current guidance, but updated to align with certain changes to the lessee model and the new revenue recognition standard. The new guidance is effective for the Company on July 1, 2019, with early adoption permitted. The Company is evaluating the impact that the new guidance will have on its consolidated financial statements and related disclosures. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments: Recognition and Measurement of Financial Assets and Financial Liabilities . The new guidance relates to the recognition and measurement of financial assets and liabilities. The new guidance makes targeted improvements to GAAP impacting equity investments (other than those accounted for under the equity method or consolidated), financial liabilities accounted for under the fair value election, and presentation and disclosure requirements for financial instruments, among other changes. The new guidance is effective for the Company on July 1, 2018, with early adoption prohibited other than for certain provisions. The Company is evaluating the impact that the new guidance will have on its consolidated financial statements and related disclosures. 54 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary In November 2015, the FASB issued ASU No. 2015-17 , Income Taxes: Balance Sheet Classification of Deferred Taxes which simplifies the balance sheet classification of deferred taxes. The new guidance requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the new guidance. The new guidance is effective for the Company on July 1, 2017, with early adoption permitted as of the beginning of an interim or annual reporting period. The new guidance may be applied either prospectively to all deferred tax liabilities and assets or retrospectively to all periods presented. The Company is evaluating the impact that the new guidance will have on its consolidated financial statements and related disclosures; however, at the present time the Company has recorded a valuation allowance against its deferred tax assets based on the history of losses incurred. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs , which requires debt issuance costs related to a recognized debt liability to be presented on the balance sheet as a direct deduction from the debt liability, similar to the presentation of debt discounts. In August 2015, the FASB issued a clarification that debt issuance costs related to line-of-credit arrangements were not within the scope of the new guidance and therefore should continue to be accounted for as deferred assets in the balance sheet, consistent with existing GAAP. The new standard is effective for the Company for its fiscal year ending June 30, 2017. The Company is evaluating the effect of the standard on its consolidated financial statements. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern: Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern . The amendments in this update provide guidance in U.S. GAAP about management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. In doing so, the amendments should reduce diversity in the timing and content of footnote disclosures. The new standard is effective for the Company for its fiscal year ending June 30, 2017. Early adoption is permitted. The Company is evaluating the effect of the standard, if any, on its consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers , which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In July 2015, the FASB voted to defer the effective date of the new standard until fiscal years beginning after December 15, 2017 with early application permitted for fiscal years beginning after December 15, 2016. With the deferral, the new standard is effective for the Company on July 1, 2018, with early adoption permitted one year prior. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. (4) AGREEMENT WITH GEDEON RICHTER In August 2014, the Company entered into a license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for FSD in Europe and selected countries. On September 16, 2015, the Company and Gedeon Richter mutually and amicably agreed to terminate the license, co-development and commercialization agreement. In connection with the termination of the license agreement, all rights and licenses to co-develop and commercialize bremelanotide for FSD indications granted by the Company under the license agreement to Gedeon Richter terminated and reverted to the Company, and neither party has any future material obligations under the license agreement. Neither the Company nor Gedeon Richter incurred any early termination penalties or other payment or reimbursement obligations as a result of the termination of the license agreement. The Company viewed the delivery of the license for bremelanotide as a revenue generating activity that is part of its ongoing and central operations. The other elements of the agreement with Gedeon Richter were considered non-revenue activities associated with the collaborative arrangement. The Company believes the license had standalone value from the other elements of the collaborative arrangement because it conveyed all of the rights necessary to develop and commercialize bremelanotide in the licensed territory. 55 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. In August 2013, the Company received an initial payment of $1,000,000 from Gedeon Richter as a non-refundable option fee on the license, co-development and commercialization agreement, and in September 2014, the Company received €6,700,000 ($8,763,347) on execution of the definitive agreement. During the year ended June 30, 2015, the upfront payment of €7,500,000 ($9,763,347) was recorded as license revenue in the consolidated statements of operations. During the year ended June 30, 2015, the Company recorded revenue related to a milestone payment of €2,500,000 ($3,188,383) upon the initiation of the Company’s Phase 3 clinical trial program in the United States. As a result of fluctuations in the conversion rates between the Euro and the U.S. Dollar between the transaction dates and the settlement dates, the Company recorded a foreign exchange loss of $284,656 for the year ended June 30, 2015. PALATIN TECHNOLOGIES, INC. and Subsidiary (5) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consist of the following: Clinical study costs Insurance premiums Other (6) INVESTMENTS The following summarizes the carrying value of our available-for-sale investments at June 30, 2016, which consist of corporate debt securities: Cost Amortization of premium Gross unrealized loss Fair value There were no available-for-sale investments at June 30, 2015. (7) FAIR VALUE MEASUREMENTS June 30, 2016 June 30, 2015 $ $ 1,146,975 23,010 254,297 1,424,282 $ $ 1,641,605 30,039 225,103 1,896,747 June 30, 2016 1,387,022 (4,522) (1,944) 1,380,556 $ $ The fair value of cash equivalents is classified using a hierarchy prioritized based on inputs. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on management’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. 56 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The following table provides the assets carried at fair value: June 30, 2016: Money Market Account June 30, 2015: Money Market Account (8) PROPERTY AND EQUIPMENT, NET Property and equipment, net, consists of the following: Office equipment Laboratory equipment Leasehold improvements Less: Accumulated depreciation and amortization PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Carrying Value Quoted prices in active markets (Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs (Level 3) $ $ 7,782,243 $ 7,782,243 $ 26,946,378 $ 26,946,378 $ - - $ $ - - June 30, 2016 June 30, 2015 $ $ 1,180,210 415,303 751,226 2,346,739 (2,248,938) 97,801 $ $ 1,180,210 397,608 751,226 2,329,044 (2,205,886) 123,158 The aggregate cost of assets acquired under capital leases was $146,115 as of June 30, 2016 and June 30, 2015. Accumulated amortization associated with assets acquired under capital leases was $90,115 as of June 30, 2016 and $61,994 as of June 30, 2015. (9) ACCRUED EXPENSES Accrued expenses consist of the following: Clinical study costs Other research related expenses Professional services Other June 30, 2016 June 30, 2015 $ $ 6,983,581 69,609 231,482 483,061 7,767,733 $ $ 5,594,839 176,105 201,831 250,708 6,223,483 57 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.  (10) NOTES PAYABLE: Notes payable consist of the following: Notes payable under venture loan Unamortized related debt discount Notes payable Less: current portion Long-term portion PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements June 30, 2016 $ $ 20,000,000 (324,799) 19,675,201 $ $ June 30, 2015 10,000,000 (218,914) 9,781,086 5,485,392 - $ 14,189,809 $ 9,781,086 On July 2, 2015, the Company closed on a $10,000,000 venture loan led by Horizon Technology Finance Corporation (Horizon). The debt facility is a four-year senior secured term loan that bears interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50% and provides for interest-only payments for the first eighteen months followed by monthly payments of principal payments of $333,333 plus accrued interest through August 1, 2019. The lenders also received five-year immediately exercisable Series G warrants to purchase 549,450 shares of Palatin common stock exercisable at an exercise price of $0.91 per share. The Company has recorded a debt discount of $305,196 equal to the fair value of these warrants at issuance, which is being amortized to interest expense over the term of the related debt. This debt discount is offset against the note payable balance and included in additional paid-in capital on the Company’s balance sheet at June 30, 2016. In addition, a final incremental payment of $500,000 is due on August 1, 2019, or upon early repayment of the loan. This final incremental payment is being accreted to interest expense over the term of the related debt. The Company incurred approximately $146,000 of costs in connection with the loan agreement. These costs were capitalized as deferred financing costs and are being amortized to interest expense over the term of the related debt. In addition, if the Company repays all or a portion of the loan prior to the applicable maturity date, it will pay the lenders a prepayment penalty fee, based on a percentage of the then outstanding principal balance, equal to 3% if the prepayment occurs on or before 18 months after the funding date thereof or 1% if the prepayment occurs more than 18 months after, but on or before 30 months after, the funding date. On December 23, 2014, the Company closed on a $10,000,000 venture loan which was led by Horizon. The debt facility is a four-year senior secured term loan that bears interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50%, and provides for interest-only payments for the first eighteen months followed by monthly payments of principal payments of $333,333 plus accrued interest through January 1, 2019. The lenders also received five-year immediately exercisable Series D 2014 warrants to purchase 666,666 shares of common stock exercisable at an exercise price of $0.75 per share. The Company recorded a debt discount of $267,820 equal to the fair value of these warrants at issuance, which is being amortized to interest expense over the term of the related debt. This debt discount is offset against the note payable balance and included in additional paid-in capital on the Company’s balance sheet at June 30, 2016 and June 30, 2015. In addition, a final incremental payment equal to $500,000 is due on January 1, 2019, or upon early repayment of the loan. This final incremental payment is being accreted to interest expense over the term of the related debt. The Company incurred approximately $209,000 of costs in connection with the loan agreement. These costs were capitalized as deferred financing costs and are being amortized to interest expense over the term of the related debt. In addition, if the Company repays all or a portion of the loan prior to the applicable maturity date, it will pay the lenders a prepayment penalty fee, based on a percentage of the then outstanding principal balance, equal to 3% if the prepayment occurs on or before 18 months after the funding date thereof or 1% if the prepayment occurs more than 18 months after, but on or before 30 months after, the funding date. The Company’s obligations under these loan agreements are secured by a first priority security interest in substantially all of its assets other than its intellectual property. The Company also has agreed to specified limitations on pledging or otherwise encumbering its intellectual property assets. These loan agreements include customary affirmative and restrictive covenants, but do not include any covenants to attain or maintain specified financial metrics. These loan agreements include customary events of default, including payment defaults, breaches of covenants, change of control and a material adverse change default. Upon the occurrence of an event of default and following any applicable cure periods, a default interest rate of an additional 5% may be applied to the outstanding loan balances, and the lenders may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the loan agreements. As of June 30, 2016, the Company was in compliance with all its loan covenants 58 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Scheduled future principal payments related to notes payable as of June 30, 2016 are as follows: PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Year Ending June 30, 2017 2018 2019 2020 Less: debt discount Net $ $ 5,666,667 8,000,000 6,000,000 333,333 20,000,000 (324,799) 19,675,201 (11) COMMITMENTS AND CONTINGENCIES Operating Leases – The Company currently leases facilities under two non-cancelable operating leases. The lease on our corporate offices was renewed effective July 1, 2015 and expires on June 30, 2020 and in June 2015 we entered into a lease for approximately 1,000 square feet of laboratory space which currently expires in July 2017. Future minimum lease payments under these leases are as follows: Year Ending June 30, 2017 2018 2019 2020 For the years ended June 30, 2016, 2015 and 2014, rent expense was $256,642, $222,215, and $219,686, respectively. Capital Leases – The Company has acquired certain of its equipment under leases classified as capital leases. Scheduled future payments related to capital leases as of June 30, 2016 are as follows: Year Ending June 30, 2017 2018 Amount representing interest Net $ $ $ $ 255,985 224,493 221,344 221,344 923,166 29,138 14,568 43,706 (1,958) 41,748 Other agreements – In connection with its agreement with the Company’s third-party contract manufacturer, Catalent Belgium S.A., the Company is obligated to pay a space reservation fee over the next four quarters of approximately € 2,300,000 ($2,524,033) in the aggregate. Employment Agreements – The Company has employment agreements with two executive officers which provide a stated annual compensation amount, subject to annual increases, and annual bonus compensation in an amount to be approved by the Company’s Board of Directors. Each agreement allows the Company or the employee to terminate the agreement in certain circumstances. In some circumstances, early termination by the Company may result in severance pay to the employee for a period of 18 to 24 months at the salary then in effect, continuation of health insurance premiums over the severance period and immediate vesting of all stock options and restricted stock units. Termination following a change in control will result in a lump sum payment of one and one-half to two times the salary then in effect and immediate vesting of all stock options and restricted stock units. 59 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Employee Retirement Savings Plan – The Company maintains a defined contribution 401(k) plan for the benefit of its employees. The Company currently matches a portion of employee contributions to the plan. For the years ended June 30, 2016, 2015 and 2014, Company contributions were $138,184, $147,203, and $140,870, respectively. Contingencies – The Company accounts for litigation losses in accordance with ASC 450-20, “Loss Contingencies.” Under ASC 450-20, loss contingency provisions are recorded for probable losses when management is able to reasonably estimate the loss. Any outcome upon settlement that deviates from the Company’s best estimate may result in additional expense or in a reduction in expense in a future accounting period. The Company records legal expenses associated with such contingencies as incurred. The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. The Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. (12) STOCKHOLDERS’ (DEFICIENCY) EQUITY Series A Convertible Preferred Stock – As of June 30, 2016, 4,030 shares of Series A Convertible Preferred Stock were outstanding. Each share of Series A Convertible Preferred Stock is convertible at any time, at the option of the holder, into the number of shares of common stock equal to $100 divided by the Series A Conversion Price. As of June 30, 2016, the Series A Conversion Price was $6.65, so each share of Series A Convertible Preferred Stock is currently convertible into approximately 15.0 shares of common stock. The Series A Conversion Price is subject to adjustment, under certain circumstances, upon the sale or issuance of common stock for consideration per share less than either (i) the Series A Conversion Price in effect on the date of such sale or issuance, or (ii) the market price of the common stock as of the date of such sale or issuance. The Series A Conversion Price is also subject to adjustment upon the occurrence of a merger, reorganization, consolidation, reclassification, stock dividend or stock split which will result in an increase or decrease in the number of shares of common stock outstanding. Shares of Series A Convertible Preferred Stock have a preference in liquidation, including certain merger transactions, of $100 per share, or $403,000 in the aggregate as of June 30, 2016. Additionally, the Company may not pay a dividend or make any distribution to holders of any class of stock unless the Company first pays a special dividend or distribution of $100 per share to holders of the Series A Convertible Preferred Stock. Financing Transactions – On July 2, 2015, the Company closed on a private placement of Series E warrants to purchase 21,917,808 shares of Palatin common stock and Series F warrants to purchase 2,191,781 shares of Palatin common stock. Certain funds managed by QVT Financial LP invested $5,000,000 and another accredited investment fund invested $15,000,000. The funds paid $0.90 for each Series E warrant and $0.125 for each Series F warrant, resulting in gross proceeds to the Company of $20,000,000, with net proceeds, after deducting estimated offering expenses, of approximately $19,834,278. The Series E warrants, which may be exercised on a cashless basis, are exercisable immediately upon issuance at an initial exercise price of $0.01 per share and expire on the tenth anniversary of the date of issuance. The Series E warrants are subject to limitation on exercise if QVT and its affiliates would beneficially own more than 9.99% (4.99% for the other accredited investment fund holder) of the total number of Palatin's shares of common stock following such exercise. The Series F warrants are exercisable at an initial exercise price of $0.91 per share, exercisable immediately upon issuance and expire on the fifth anniversary of the date of issuance. The Series F warrants are subject to the same beneficial ownership limitation as the Series E warrants. The purchase agreement for the private placement provides that the purchasers have certain rights until the earlier of approval of bremelanotide for FSD by the U.S. Food and Drug Administration and July 3, 2018, including rights of first refusal and participation in any subsequent equity or debt financing. The purchase agreement also contains certain restrictive covenants so long as the funds continue to hold specified amounts of warrants or beneficially own specified amounts of the outstanding shares of common stock. Common Stock Transactions – On December 23, 2014, the Company closed on a private placement offering in which the Company sold 2,050,000 shares of its common stock and Series C 2014 warrants to purchase up to 24,949,325 shares of common stock. Funds under the management of QVT Financial LP (QVT) invested $10,000,000 and an unrelated accredited investment fund invested $10,000,000. The funds paid $0.75 for each share of common stock and $0.74 for each Series C 2014 warrant, resulting in gross proceeds to Palatin of $20,000,000, with net proceeds, after deducting estimated offering expenses, of $18,556,111. The Series C 2014 warrants, which may be exercised on a cashless basis, are exercisable immediately upon issuance at an initial exercise price of $0.01 per share and expire on the tenth anniversary of the date of issuance. The Series C 2014 warrants are subject to limitation on exercise if QVT and its affiliates would beneficially own more than 9.99% (4.99% for the other accredited investment fund holder) of the total number of Palatin’s shares of common stock following such exercise. 60 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The purchase agreement for the private placement provides that the purchasers have certain rights until the earlier of approval of bremelanotide for FSD by the U.S. Food and Drug Administration and December 23, 2018, including rights of first refusal and participation in any subsequent equity or debt financing. The purchase agreement also contains certain restrictive covenants so long as the funds continue to hold specified amounts of warrants or beneficially own specified amounts of the outstanding shares of common stock. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Outstanding Stock Purchase Warrants – As of June 30, 2016, the Company had outstanding warrants exercisable for shares of common stock as follows: Shares of Common Stock Exercise Price per Share 20,771,740 6,117,245 35,344,341 666,666 24,949,325 2,191,781 549,450 21,917,808 112,508,356 1.00 0.01 0.01 0.75 0.01 0.91 0.91 0.01 Latest Termination Date March 2, 2017 July 3, 2022 September 27, 2022 December 23, 2019 December 23, 2024 July 2, 2020 July 2, 2020 July 2, 2025 During the year ended June 30, 2016, the Company issued 10,890,889 shares of common stock pursuant to the cashless exercise provisions of warrants at an exercise price of $0.01. During the year ended June 30, 2015, the Company received $254,148 and issued 15,130,573 shares of common stock pursuant to the exercise of warrants at exercise prices of $0.01 and $1.00, including warrants exercised pursuant to cashless exercise provisions. During the year ended June 30, 2014, the Company received $37,500 and issued 50,000 shares of common stock pursuant to the exercise of warrants at an exercise price of $0.75 per share. Stock Plan – The Company’s 2011 Stock Incentive Plan was approved by the Company’s stockholders at the annual meeting of stockholders held in May 2011 and amended at the annual meeting of stockholders held on June 9, 2016. The 2011 Stock Incentive Plan provides for incentive and nonqualified stock option grants and other stock-based awards to employees, non-employee directors and consultants for up to 12,500,000 shares of common stock. The 2011 Stock Incentive Plan is administered under the direction of the Board of Directors, which may specify grant terms and recipients. Options granted by the Company generally expire ten years from the date of grant and generally vest over three to four years. The 2005 Stock Plan was terminated and replaced by the 2011 Stock Incentive Plan, and shares of common stock that were available for grant under the 2005 Stock Plan became available for grant under the 2011 Stock Incentive Plan. No new awards can be granted under the 2005 Stock Plan, but awards granted under the 2005 Stock Plan remain outstanding in accordance with their terms. As of June 30, 2016, 3,314,419 shares were available for grant under the 2011 Stock Incentive Plan. The Company also has outstanding options that were granted under the 2005 Stock Plan. The Company expects to settle option exercises under any of its plans with authorized but currently unissued shares. 61 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The following table summarizes option activity and related information for the years ended June 30, 2016, 2015 and 2014: Number of Shares Weighted Average Exercise Price PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Outstanding - July 1, 2013 Granted Forfeited Expired Outstanding - June 30, 2014 Granted Forfeited Expired Outstanding - June 30, 2015 Granted Forfeited Expired Outstanding - June 30, 2016 Exercisable at June 30, 2016 Expected to vest at June 30, 2016 3,851,448 $ 603,400 (161,900) (50,975) 4,241,973 975,800 (78,810) (8,733) 5,130,230 355,000 (170,550) (52,940) 5,261,740 $ 3,769,402 $ 1,209,630 $ 1.99 1.02 0.68 24.95 1.63 1.06 1.92 36.47 1.46 0.54 0.80 22.53 1.21 1.35 0.83 Weighted Average Remaining Term in Years 8.2 Agregate Instrinsic Value 7.7 7.3 6.2 $ 5.4 $ 8.5 $ - - - For the years ended June 30, 2016, 2015 and 2014, the fair value of option grants is estimated at the grant date using the Black-Scholes model. The Company’s weighted average assumptions for the years ended June 30, 2016, 2015 and 2014 were as follows: Risk-free interest rate Volatility factor Dividend yield Expected option life (years) Weighted average grant date fair value 2016 2015 2014 1.4% 73.5% 0% 5.7 0.35 $ 1.9% 83.4% 0% 6.1 0.76 $ 1.9% 97.1% 0% 6.1 0.80 $ Expected volatilities are based on the Company’s historical volatility. The expected term of options is based upon the simplified method, which represents the average of the vesting term and the contractual term. The risk-free interest rate is based on U.S. Treasury yields for securities with terms approximating the expected term of the option. For the years ended June 30, 2016, 2015 and 2014 the Company recorded stock-based compensation related to stock options of $529,454, $572,609 and $520,855, respectively. As of June 30, 2016, there was $674,007 of unrecognized compensation cost related to unvested options, which is expected to be recognized over a weighted-average period of 2.31 years. In June 2016, the Company granted 262,500 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company will amortize the fair value of these options of $81,435, over the vesting period. During the year ended June 30, 2016, the Company granted an aggregate 92,500 options to certain employees under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $41,470, over the vesting period. 62 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements In June 2015, the Company granted 570,000 options to its executive officers, 185,800 options to its employees and 160,000 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $446,748, $145,439 and $111,876, respectively, over the vesting period. In June 2014, the Company granted 325,000 options to its executive officers, 143,400 options to its employees and 135,000 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $265,726, $117,247 and $97,530, respectively, over the vesting period. Stock options granted to the Company’s executive officers and employees vest over a 48 month period, while stock options granted to its non-employee directors vest over a 12 month period. In June 2016, the Company made the following modifications to certain stock options that were granted to a former non-employee director in recognition of their prior services; i) accelerated the vesting, and ii) extended the date to exercise vested stock options to 24 months from the date of termination. An incremental $16,187 of stock-based compensation expense was recognized during the year ended June 30, 2016 and included in general and administrative expense in connection with these activities. During the year ended June 30, 2015, the Company made the following modifications to certain stock options that were granted to a terminated employee and former non-employee directors in recognition of their prior services; i) accelerated the vesting, and ii) extended the date to exercise vested stock options to 24 months from the date of termination. An incremental $73,664 of stock-based compensation expense was recognized during the year ended June 30, 2015 and included in general and administrative expense in connection with these activities. During the year ended June 30, 2014, the Company made the following modifications to certain stock options that were granted to certain terminated employees in recognition of their prior services; i) accelerated the vesting, and ii) extended the date to exercise vested stock options to 24 months from the date of termination. An incremental $22,000 of stock-based compensation expense was recognized during the year ended June 30, 2014 and included in research and development expense in connection with these activities. Restricted Stock Units – The following table summarizes restricted stock award activity for the years ended June 30, 2016, 2015 and 2014: Outstanding at beginning of year Granted Forfeited Vested Outstanding at end of year 2016 2015 2014 1,028,017 2,302,500 (2,563) (662,186) 2,665,768 957,150 785,800 (9,100) (705,833) 1,028,017 757,500 603,400 (25,000) (378,750) 957,150 For the years ended June 30, 2016, 2015 and 2014 the Company recorded stock-based compensation related to restricted stock units of $1,297,724, $594,670 and $300,485, respectively. In June 2016, the Company granted 262,500 restricted stock units to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $131,250, over the vesting period. In January 2016, the Company granted 50,000 restricted stock units to an employee and is amortizing the fair value of these restricted stock units of $30,000 over a 48 month vesting period. In December 2015, the Company granted 625,000 performance-based restricted stock units to its executive officers and 200,000 performance-based restricted stock units to its employees under the Company’s 2011 Stock Incentive Plan, which vest during the performance period, ending December 31, 2017, if and upon the earlier of: i) achievement of a closing price for the Company’s common stock equal to or greater than $1.20 per share for 20 consecutive trading days, which is considered a market condition, or ii) entering into a collaboration agreement (U.S. or global) of bremelanotide for FSD, which is considered a performance condition. The Company determined that the performance condition was not probable of achievement on the date of grant since such condition is outside the control of the Company. The fair value of these awards, as calculated under a multifactor Monte Carlo simulation, was $338,250. The Company is amortizing the fair value over the derived service period of 0.96 years. 63 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Also, in December 2015, the Company granted 625,000 restricted stock units to its executive officers, 340,000 restricted stock units to its non-employee directors and 200,000 restricted stock units to its employees under the Company’s 2011 Stock Incentive Plan. For executive officers and employees, the restricted stock units vest 25% on the date of grant and 25% on the first, second and third anniversary dates from the date of grant. For non-employee directors, the restricted stock units vest 50% on the first and second anniversary dates from the date of grant. The Company is amortizing the fair value of these restricted stock units of $425,000, $231,200 and $136,000, respectively, over the vesting period. In June 2015, the Company granted 400,000 restricted stock units to its executive officers, 185,800 restricted stock units to its employees and 160,000 restricted stock units to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these restricted stock units of $432,000, $200,664, and $172,800, respectively, over the vesting period. In addition, in June 2015, the Company granted 20,000 restricted stock units to former non-employee directors in recognition of their prior services. These restricted stock units vested upon issuance and the Company recognized the fair value of these restricted stock units of $21,600 as stock-based compensation expense which was included in general and administrative expense at June 30, 2015. In January 2015, the Company granted 20,000 restricted stock units to an employee and is amortizing the fair value of these restricted stock units of $16,000 over a 24 month vesting period. In June 2014, the Company granted 325,000 restricted stock units to its executive officers, 143,400 restricted stock units to its employees and 135,000 restricted stock units to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these restricted stock units of $331,500, $146,268 and $137,700, respectively, over the vesting period. Generally, restricted stock units granted to the Company’s executive officers, employees and non-employee directors in 2015 and 2014 vest over 24 months, 48 months and 12 months, respectively. In June 2013, the Company granted 420,000 restricted stock units to its executive officers and 115,000 restricted stock units to employees under the Company’s 2011 Stock Incentive Plan. The Company amortized the fair value of these restricted stock units of $260,000 and $71,000, respectively, over the 24 month vesting period ended June 30, 2015. In July 2012, the Company granted 222,500 restricted stock units to its executive officers under the Company’s 2011 Stock Incentive Plan. The Company amortized the fair value of these restricted stock units of $160,000 over the 24 months ending July 2014. During the year ended June 30, 2014, the Company accelerated the vesting of certain restricted stock units that were granted to a terminated employee in recognition of prior services. An incremental $12,000 of stock-based compensation expense was recognized during the year ended June 30, 2014 and included in research and development expense in connection with these activities. In connection with the vesting of restricted share units during the years ended June 30, 2016, 2015 and 2014, the Company withheld 123,483, 174,568 and 129,103 shares with aggregate values of $58,401, $164,136 and $120,007, respectively, in satisfaction of minimum tax withholding obligations. (13) INCOME TAXES The Company has had no income tax expense or benefit since inception because of operating losses, except for amounts recognized for sales of New Jersey state net operating loss carryforwards and tax credits. Deferred tax assets and liabilities are determined based on the estimated future tax effect of differences between the financial statement and tax reporting basis of assets and liabilities, as well as for net operating loss carryforwards and research and development credit carryforwards, given the provisions of existing tax laws. As of June 30, 2016, the Company had federal and state net operating loss carryforwards of approximately $302,600,000 and $139,400,000, respectively, which expire, if not utilized, between 2019 and 2036 for federal tax purposes and between 2016 and 2036 for state tax purposes. As of June 30, 2016, the Company had federal research and development credits of approximately $10,000,000 that will begin to expire in 2019, if not utilized. 64 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The Tax Reform Act of 1986 (the Act) provides for limitation on the use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined by the Act) that could limit the Company’s ability to utilize these carryforwards. The Company may have experienced various ownership changes, as defined by the Act, as a result of past financings. Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes; therefore, the Company may not be able to take full advantage of these carryforwards for federal income tax purposes. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements The Company’s net deferred tax assets are as follows: Net operating loss carryforwards Research and development tax credits Basis differences in fixed assets and other Valuation allowance Net deferred tax assets June 30, 2016 June 30, 2015 $ $ 114,081,000 9,965,000 1,491,000 125,537,000 (125,537,000) - $ $ 94,332,000 7,357,000 1,208,000 102,897,000 (102,897,000) - In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the application of loss limitation provisions related to ownership changes. Due to the Company’s history of losses, the deferred tax assets are fully offset by a valuation allowance as of June 30, 2016 and 2015. The Company did not have a sale of New Jersey state net operating loss (NJ NOL) carryforwards during the year ended June 30, 2016 and therefore did not record a tax benefit. During the years ended June 30, 2015 and 2014, the Company sold New Jersey state net operating loss carryforwards, which resulted in the recognition of $531,508 and $1,846,646, respectively, in tax benefits. 65 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. (14) CONSOLIDATED QUARTERLY FINANCIAL DATA - UNAUDITED The following tables provide quarterly data for the years ended June 30, 2016 and 2015. PALATIN TECHNOLOGIES, INC. and Subsidiary Notes to Consolidated Financial Statements Revenues Operating expenses Other income (expense), net Loss before income taxes Income tax benefit Net loss Basic and diluted net loss per common share Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share Revenues Operating expenses Other income (expense), net (Loss) income before income taxes Income tax benefit Net (loss) income Basic net (loss) income per common share Diluted net (loss) income per common share Weighted average number of common shares outstanding used in computing basic net (loss) income per common share Weighted average number of common shares outstanding used in computing diluted net (loss) income per common share (15) SUBSEQUENT EVENTS June 30, 2016 March 31, 2016 December 31, 2015 September 30, 2015 (amounts in thousands, except per share data) Three Months Ended - 12,738 (618) (13,356) - (13,356) (0.09) $ $ $ - 12,086 (611) (12,697) - (12,697) (0.08) $ $ $ - 12,628 (622) (13,250) - (13,250) (0.08) $ $ $ - 11,798 (612) (12,410) - (12,410) (0.08) 156,841,053 156,744,867 156,456,801 156,176,618 June 30, 2015 March 31, 2015 December 31, 2014 September 30, 2014 (amounts in thousands, except per share data) Three Months Ended - 11,782 (306) (12,088) - (12,088) (0.09) (0.09) $ $ $ $ - 8,722 (428) (9,150) - (9,150) (0.07) (0.07) $ $ $ $ 8,020 5,697 (78) 2,245 532 2,777 0.03 0.03 $ $ $ $ 4,932 4,038 (99) 795 - 795 0.01 0.01 $ $ $ $ $ $ $ 134,207,300 134,008,239 109,314,460 106,953,898 134,207,300 134,008,239 109,815,718 107,946,021 Financing Transactions – On August 4, 2016, the Company closed on an underwritten offering of units, with each unit consisting of a share of common stock and a Series H warrant to purchase 0.75 of a share of common stock. Investors whose purchase of units in the offering would result in them beneficially owning more than 9.99% of our outstanding common stock following the completion of the offering had the opportunity to acquire units with Series I prefunded warrants substituted for any common stock they would have otherwise acquired. Gross proceeds were $9,225,000, with net proceeds to us, after deducting estimated offering expenses, of approximately $8,500,000. We issued 11,481,481 shares of common stock and ten year prefunded Series I warrants to purchase 2,218,045 shares of common stock at an exercise price of $0.01, together with Series H warrants to purchase 10,274,646 shares of common stock at an exercise price of $0.70 per share. The Series I warrants are exercisable at an initial exercise price of $0.01 per share, exercisable immediately upon issuance and expire on the tenth anniversary of the date of issuance. The Series I warrants are subject to limitation on exercise if the holder and its affiliates would beneficially own more than 9.99% of the total number of Palatin’s shares of common stock following such exercise. The Series H warrants are exercisable at an initial exercise price of $0.70 per share, are exercisable commencing six months following the date of issuance and expire on the fifth anniversary of the date of issuance. The Series H warrants are subject to the same beneficial ownership limitation as the Series I warrants. 66 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. Item 9A. Controls and Procedures. Our management carried out an evaluation, with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) of the Exchange Act) as of the end of the period covered by this report. Based upon this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that, as of June 30, 2016, our disclosure controls and procedures were effective. A control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management’s Report on Internal Control Over Financial Reporting Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) or 15d-15(f) of the Exchange Act. Our internal control system was designed to provide reasonable assurance to management and the board of directors regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. There was no change in our internal control over financial reporting during the fourth quarter of the period covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Management assessed the effectiveness of our internal control over financial reporting as of June 30, 2016. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework as adopted in 2013 . Based on its assessment, management believes that, as of June 30, 2016, our internal control over financial reporting is effective based on those criteria. Item 9B. Other Information. None. 67 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 10. Directors, Executive Officers and Corporate Governance. Identification of Directors PART III The following table sets forth the names, ages, positions and committee memberships of our current directors. All directors hold office until the next annual meeting of stockholders or until their successors have been elected and qualified. All current directors were elected at our annual stockholders’ meeting on June 9, 2016. Name Carl Spana, Ph.D. John K. A. Prendergast, Ph.D. (3) Robert K. deVeer, Jr. (1) (2) J. Stanley Hull (1) (2) Alan W. Dunton, M.D. (1) (2) Angela Rossetti (1) (3) Arlene M. Morris (2) (3) (1) Member of the audit committee. (2) Member of the compensation committee. (3) Member of the nominating and corporate governance committee. Age Position with Palatin Chief Executive Officer, President and a Director Director, Chairman of the board of directors Director Director Director Director Director 54 62 70 64 62 63 64 CARL SPANA, Ph.D., co-founder of Palatin, has been our Chief Executive Officer and President since June 14, 2000. He has been a director of Palatin since June 1996 and has been a director of our wholly-owned subsidiary, RhoMed Incorporated, since July 1995. From June 1996 through June 14, 2000, Dr. Spana served as an executive vice president and our chief technical officer. From June 1993 to June 1996, Dr. Spana was vice president of Paramount Capital Investments, LLC, a biotechnology and biopharmaceutical merchant banking firm, and of The Castle Group Ltd., a medical venture capital firm. Through his work at Paramount Capital Investments and The Castle Group, Dr. Spana co-founded and acquired several private biotechnology firms. From July 1991 to June 1993, Dr. Spana was a Research Associate at Bristol-Myers Squibb, a publicly-held pharmaceutical company, where he was involved in scientific research in the field of immunology. He was previously a member of the board of the life science company AVAX Technologies, Inc. Dr. Spana received his Ph.D. in molecular biology from the Johns Hopkins University and his B.S. in biochemistry from Rutgers University. Dr. Spana’s qualifications for our board include his leadership experience, business judgment and industry experience. As a senior executive of Palatin for over nineteen years, he provides in-depth knowledge of our company, our drug products under development and the competitive and corporate partnering landscape. JOHN K. A. PRENDERGAST, Ph.D., co-founder of Palatin, has served as the non-executive Chairman of the board since June 14, 2000, and as a director since August 1996. While Mr. Prendergast has served as a member of the board, he does not, and has not, served in a management or operational role with the company. Dr. Prendergast has been president and sole stockholder of Summercloud Bay, Inc., an independent consulting firm providing services to the biotechnology industry, since 1993. Dr. Prendergast is a director and executive chairman of the board of directors of Antyra, Inc., a privately-held biopharmaceutical firm, and a director of Heat Biologics, Inc., a publicly traded clinical-stage immunotherapy company. He was previously a member of the board of the life science companies AVAX Technologies, Inc., Avigen, Inc. and MediciNova, Inc. From October 1991 through December 1997, Dr. Prendergast was a managing director of The Castle Group Ltd., a medical venture capital firm. Dr. Prendergast received his M.Sc. and Ph.D. from the University of New South Wales, Sydney, Australia and a C.S.S. in administration and management from Harvard University. 68 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Dr. Prendergast brings a historical perspective to our board coupled with extensive industry experience in corporate development and finance in the life sciences field. His prior service on other publicly traded company boards provides experience relevant to good corporate governance practices. ROBERT K. deVEER, Jr. has been a director of Palatin since November 1998. Since January 1997, Mr. deVeer has been the president of deVeer Capital LLC, a private investment company. He was a director of Solutia Inc., a publicly-held chemical-based materials company, until its merger with Eastman Chemical Company in July 2012. From 1995 until his retirement in 1996, Mr. deVeer served as Managing Director, Head of Industrial Group, at New York-based Lehman Brothers. From 1973 to 1995, he held increasingly responsible positions at New York-based CS First Boston, including Head of Project Finance, Head of Industrials and Head of Natural Resources. He was a managing director, member of the investment banking committee and a trustee of the First Boston Foundation. He received a B.A. in economics from Yale University and an M.B.A. in finance from Stanford Graduate School of Business. Mr. deVeer has extensive experience in investment banking and corporate finance, including the financing of life sciences companies, and serves as the audit committee’s financial expert. J. STANLEY HULL has been a director of Palatin since September 2005. Mr. Hull has over three decades of experience in the field of sales and marketing. Mr. Hull joined GlaxoSmithKline, a research-based pharmaceutical company, in October 1987 and retired as Senior Vice President, Pharmaceuticals in May 2010, having previously served in the R&D organization of Glaxo Wellcome as Vice President and Worldwide Director of Therapeutic Development and Product Strategy – Neurology and Psychiatry. Prior to that, he was Vice President of Marketing – Infectious Diseases and Gastroenterology for Glaxo Wellcome. Mr. Hull started his career in the pharmaceutical industry with SmithKline and French Laboratories in 1978. Mr. Hull received his B.S. in business administration from the University of North Carolina at Greensboro. Mr. Hull has extensive experience in commercial operations, development and marketing of pharmaceutical drugs and corporate alliances between pharmaceutical companies and biotechnology companies. ALAN W. DUNTON, M.D. has been a director of Palatin since June 2011. Since November 2015, he has been senior vice president of research and development for Purdue Pharma L.P., with responsibilities for overall research strategy and development programs. Previously he was president of Danerius, LLC, a biotechnology consulting company, which he founded in 2006. From January 2007 to March 2009, Dr. Dunton served as president and chief executive officer of Panacos Pharmaceuticals Inc. and he served as a managing director of Panacos from March 2009 to January 2011. Dr. Dunton is currently a member of the board of directors of the publicly traded company Oragenics, Inc. He previously served on the board of directors of the publicly traded companies Targacept, Inc., EpiCept Corporation (as Non-Executive Chairman), Adams Respiratory Therapeutics, Inc. (acquired by Reckitt Benckiser Group plc), MediciNova, Inc. and Panacos Pharmaceuticals, Inc. Dr. Dunton has served as a director or executive officer of various pharmaceutical companies, and from 1994 to 2001, Dr. Dunton was a senior executive in various capacities in the Pharmaceuticals Group of Johnson & Johnson. Dr. Dunton received his M.D. degree from New York University School of Medicine, where he completed his residency in internal medicine. He also was a Fellow in Clinical Pharmacology at the New York Hospital/Cornell University Medical Center. Dr. Dunton has extensive drug development and clinical research experience, having played a key role in the development of more than 20 products to regulatory approval, and also has extensive experience as an executive and officer for both large pharmaceutical companies and smaller biotechnology and biopharmaceutical companies. ANGELA ROSSETTI has been a director of Palatin since June 2013. In June 2015 she became Executive Vice President of Cell Machines, Inc., an early stage biopharmaceutical company developing transformational biosimilars and novel protein therapies. Previously, Ms. Rossetti served in pharmaceutical marketing, communications and financial roles, including as Vice President at Pfizer Inc., where she led a global commercial medicine team for smoking cessation, and as an Assistant Vice President at Wyeth, managing a global hemophilia business. Previously, she was President of Ogilvy Healthworld, an advertising business in the pharmaceutical and biotechnology sectors, and served on the Biotech and Pharmaceutical Advisory Board of Danske Capital for six years. Ms. Rossetti is a director of Viramal Limited, a privately held specialty pharmaceutical company focused on women’s health therapeutics located in the United Kingdom. Ms. Rossetti graduated from a joint program of the Albert Einstein College of Medicine and Benjamin N. Cardozo School of Law with an M.S.in Bioethics in 2014, has an M.B.A. in Finance from Columbia University Graduate School of Business and a B.A. in Biology from the University of Pennsylvania, and is an adjunct Assistant Professor at New York Medical College. 69 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Ms. Rossetti has extensive experience in worldwide development and marketing of specialty pharmaceuticals, including prefilled syringe products, in communications and development of commercialization plans and in pharmaceutical and biotechnology finance. ARLENE M. MORRIS has been a director of Palatin since June 2015. From March 2012 until May 2015 she was Chief Executive Officer of Syndax Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development and commercialization of an epigenetic therapy for treatment-resistant cancers, and was President of Syndax Pharmaceuticals from September 2013 until May 2015 and a member of the board of directors from May 2011 until May 2015. From 2003 to January 2011, Ms. Morris served as the President, Chief Executive Officer and a member of the board of directors of Affymax, Inc., a publicly traded biotechnology company. Ms. Morris has also held various management and executive positions at Clearview Projects, Inc., a corporate advisory firm, Coulter Pharmaceutical, Inc., a publicly traded pharmaceutical company, Scios Inc., a publicly traded biopharmaceutical company, and Johnson & Johnson, a publicly traded healthcare company. She is currently a member of the board of directors of Viveve Medical, Inc., a publicly traded medical technology company focused on women’s health, Biodel Inc., a publicly traded specialty pharmaceutical company, Dimension Therapeutics, Inc., a publicly traded gene therapy company, and Neovacs, SA, a French publicly traded biotechnology company. Ms. Morris received a B.A. in Biology and Chemistry from Carlow College. Ms. Morris has extensive experience in the biotechnology industry, including prior leadership positions, current senior management and board service, and experience as chief executive officer of companies with product candidates in phase 3 clinical trials. The Board and Its Committees Committees and meetings . The board has an audit committee, a compensation committee and a nominating and corporate governance committee. During fiscal 2016, the board met five times, the audit committee met four times, the compensation committee met twice and the nominating and corporate governance committee met twice. Each director attended at least 75% of the total number of meetings of the board and committees of the board on which he served. The independent directors meet in executive sessions at least annually, following the annual board meeting. We do not have a policy requiring our directors to attend stockholder meetings. With the exception of Drs. Prendergast and Spana, the directors did not attend the annual meeting of stockholders held on June 9, 2016. Audit committee. The audit committee reviews the engagement of the independent registered public accounting firm and reviews the independence of the independent registered public accounting firm. The audit committee also reviews the audit and non-audit fees of the independent registered public accounting firm and the adequacy of our internal control procedures. The audit committee is currently composed of four independent directors, Mr. deVeer (chair), and Dr. Dunton, Ms. Rossetti and Mr. Hull. The board has determined that the members of the audit committee are independent, as defined in the listing standards of the NYSE MKT, and satisfy the requirements of the NYSE MKT as to financial literacy and expertise. The board has determined that at least one member of the committee, Mr. deVeer, is the audit committee financial expert as defined by Item 407 of Regulation S-K. The responsibilities of the audit committee are set forth in a written charter adopted by the board and updated as of October 1, 2013, a copy of which is available on our web site at www.palatin.com. Compensation committee. The compensation committee reviews and recommends to the board on an annual basis employment agreements and compensation for our officers, directors and some employees, and administers our 2011 Plan and the options still outstanding which were granted under previous stock option plans. The compensation committee is composed of Dr. Dunton (chair), Ms. Morris and Messrs. deVeer and Hull. The board has determined that the members of the compensation committee are independent, as defined in the listing standards of the NYSE MKT. Our Chief Executive Officer aids the compensation committee by providing annual recommendations regarding the compensation of all executive officers, other than himself. Our Chief Financial Officer supports the committee in its work by gathering, analyzing and presenting data on our compensation arrangements and compensation in the marketplace. The responsibilities of the compensation committee are set forth in a written charter adopted by the board effective October 1, 2013, a copy of which is available on our web site at www.palatin.com. The committee administers our 2011 Plan, under which it has delegated to an officer its authority to grant stock options to employees and to a single-member committee of the board its authority to grant restricted stock units to officers and to grant options and restricted stock units to our consultants, but in either instance not to grant options or restricted stock units to themselves, any member of the board or officer, or any person subject to Section 16 of the Securities Exchange Act of 1934. 70 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Nominating and corporate governance committee. The nominating and corporate governance committee assists the board in recommending nominees for directors, and in determining the composition of committees. It also reviews, assesses and makes recommendations to the board concerning policies and guidelines for corporate governance, including relationships of the board, the stockholders and management in determining our direction and performance. The responsibilities of the nominating and corporate governance committee are set forth in a written charter adopted by the board and updated as of October 1, 2013, a copy of which is available on our web site at www.palatin.com. The nominating and corporate governance committee is composed of Dr. Prendergast (chair) and Mss. Rossetti and Morris, each of whom meets the independence requirements established by the NYSE MKT. Duration of Office. Unless a director resigns, all directors hold office until the next annual meeting of stockholders or until their successors have been elected and qualified. Directors serve as members of committees as the board determines from time to time. Communicating With Directors Generally, stockholders or other interested parties who have questions or concerns should contact Stephen T. Wills, Secretary, Palatin Technologies, Inc., 4B Cedar Brook Drive, Cranbury, NJ 08512. However, any stockholder or other interest party who wishes to address questions regarding our business directly to the board of directors, or any individual director, can direct questions to the board members or a director by regular mail to the Secretary at the address above or by e-mail at boardofdirectors@palatin.com. Stockholders or other interested parties may also submit their concerns anonymously or confidentially by postal mail. Communications are distributed to the board, or to any individual directors as appropriate, depending on the facts and circumstances outlined in the communication, unless the Secretary determines that the communication is unrelated to the duties and responsibilities of the board, such as product inquiries, resumes, advertisements or other promotional material. Communications that are unduly hostile, threatening, illegal or similarly unsuitable will also not be distributed to the board or any director. All communications excluded from distribution will be retained and made available to any non-management director upon request. Board Role in Risk Oversight Our board, as part of its overall responsibility to oversee the management of our business, considers risks generally when reviewing our strategic plan, financial results, business development activities, legal and regulatory matters. The board satisfies this responsibility through regular reports directly from our officers responsible for oversight of particular risks. The board’s risk management oversight also includes full and open communications with management to review the adequacy and functionality of the risk management processes used by management. The board’s role in risk oversight has no effect on the board’s leadership structure. In addition, committees of the board assist in its risk oversight responsibility, including: ● ● The audit committee assists the board in its oversight of the integrity of the financial reporting and our compliance with applicable legal and regulatory requirements. It also oversees our internal controls and compliance activities, and meets privately with representatives from our independent registered public accounting firm. The compensation committee assists the board in its oversight of risk relating to compensation policies and practices. The compensation committee annually reviews our compensation policies, programs and procedures, including the incentives they create and mitigating factors that may reduce the likelihood of excessive risk taking, to determine whether they present a significant risk to our company. Board Leadership Structure Since 2000, the roles of chairman of the board and chief executive officer have been held by separate persons. John K.A. Prendergast, Ph.D., a non-employee director, has served as Chairman of the board since June 2000. Carl Spana, Ph.D., has been our Chief Executive Officer and President since June 2000. Generally, the chairman is responsible for advising the chief executive officer, assisting in long-term strategic planning, and presiding over meetings of the board, and the chief executive officer is responsible for leading our day-to-day performance. While we do not have a written policy with respect to separation of the roles of chairman of the board and chief executive officer, the board believes that the existing leadership structure, with the separation of these roles, provides several important advantages, including: enhancing the accountability of the chief executive officer to the board; strengthening the board’s independence from management; assisting the board in reaching consensus on particular strategies and policies; and facilitating robust director, board, and executive officer evaluation processes. 71 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Code of Corporate Conduct and Ethics We have adopted a code of corporate conduct and ethics, updated as of March 11, 2016, that applies to all of our directors, officers and employees, including our Chief Executive Officer and Chief Financial Officer. You can view the code of corporate conduct and ethics at our website, www.palatin.com. We will disclose any amendments to, or waivers from, provisions of the code of corporate conduct and ethics that apply to our directors, principal executive and financial officers in a current report on Form 8-K, unless the rules of the NYSE MKT permit website posting of any such amendments or waivers. Executive Officers Executive officers are appointed by the board and serve at the discretion of the board. Each officer holds his position until his successor is appointed and qualified. The current executive officers hold office under employment agreements. Name Carl Spana, Ph.D. Stephen T. Wills, MST, CPA Age Position with Palatin Chief Executive Officer, President and Director Chief Financial Officer, Chief Operating Officer, Executive Vice President, Secretary and Treasurer 54 59 Additional information about Dr. Spana is included above under the heading “Identification of Directors.” STEPHEN T. WILLS, MST, CPA, has been Executive Vice President, Secretary, Treasurer and Chief Financial Officer since 1997 and was Executive Vice President of Operations from 2005 until June 2011, when he was appointed Chief Operating Officer and Executive Vice President. Since December 2015, Mr. Wills has also served as interim executive chairman and principal executive officer of Derma Sciences, Inc., or Derma, a publicly-held company which provides wound and skin care products, and from July 1997 to July 2000, Mr. Wills was also a vice president and the chief financial officer of Derma. He is also currently a director of Derma, and was previously lead director and chair of the audit committee. Mr. Wills is a trustee of The Hun School of Princeton and is chair of its finance committee. From 1991 to August 2000, he was the president and chief operating officer of Golomb, Wills & Company, P.C., a public accounting firm. Mr. Wills, a certified public accountant, received his B.S. in accounting from West Chester University, and an M.S. in taxation from Temple University. Section 16(A) Beneficial Ownership Reporting Compliance The rules of the SEC require us to disclose failures to file or late filings of reports of stock ownership and changes in stock ownership required to be filed by our directors, officers and holders of more than 10% of our common stock. To the best of our knowledge, all of the filings for our directors, officers and holders of more than 10% of our common stock were made on a timely basis in fiscal 2016, except that a report on Form 4 relating to an acquisition of our common stock by a director was inadvertently filed late on behalf of J. Stanley Hull on December 3, 2015. Item 11. Executive Compensation. Fiscal 2016 Summary Compensation Table The following table summarizes the compensation earned by or paid to our principal executive officer and our principal financial officer, who constitute all of our executive officers, for our fiscal years ended June 30, 2016 and 2015. We have no defined benefit or actuarial pension plan, and no deferred compensation plan. 72 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Name and Principal Position Carl Spana, Ph.D., Chief Executive Officer and President Stephen T. Wills, MST, CPA, Chief Financial Officer, Chief Operating Officer and Executive Vice President Fiscal Year 2016 2015 2016 2015 Salary ($) Stock awards (1) ($) Option awards (1) ($) Nonequity incentive plan compensation (2) ($) All other compensation (3)($) 476,400 462,500 435,200 422,500 354,250 226,800 327,000 205,200 - 234,832 101,000(4) 195,000 - 92,000(4) 211,916 203,000 13,598 18,937 13,568 18,438 Total ($) 945,248 1,138,069 867,768 1,061,054 (1) Amounts in these columns represent the aggregate grant date fair value for stock awards and option awards computed using either the Black-Scholes model or a multifactor Monte Carlo simulation. For a description of the assumptions we used to calculate these amounts, see Note 12 to the consolidated financial statements included in this Annual Report. (2) Bonus amounts. (3) Consists of matching contributions to 401(k) plan. (4) Bonus amount for fiscal year 2016 paid after fiscal year end but accrued as of June 30, 2016. Employment Agreements Effective July 1, 2016, we entered into employment agreements with Dr. Spana and Mr. Wills which continue through June 30, 2019 unless terminated earlier. Under these agreements, which replaced substantially similar agreements that expired on June 30, 2016, Dr. Spana is serving as Chief Executive Officer and President at a base salary of $476,400 per year and Mr. Wills is serving as Chief Financial Officer and Chief Operating Officer at a base salary of $435,200 per year. Each agreement also provides for: ● annual discretionary bonus compensation, in an amount to be decided by the compensation committee and approved by the board, based on achievement of yearly performance objectives; and ● participation in all benefit programs that we establish, to the extent the executive’s position, tenure, salary, age, health and other qualifications make him eligible to participate. Each agreement allows us or the executive to terminate the agreement upon written notice, and contains other provisions for termination by us for “cause,” or by the employee for “good reason” or due to a “change in control” (as these terms are defined in the employment agreements and set forth below). Early termination may, in some circumstances, result in severance pay at the salary then in effect, plus continuation of medical and dental benefits then in effect for a period of two years (Dr. Spana) or 18 months (Mr. Wills). In addition, the agreements provide that options and restricted stock units granted to these officers accelerate upon termination of employment except for voluntary resignation by the officer or termination for cause. In the event of retirement, termination by the officer for good reason, or termination by us other than for “cause”, options may be exercised until the earlier of twenty-four months following termination or expiration of the option term. Arrangements with our named executive officers in connection with a termination following a change in control are described below. Each agreement includes non-competition, non-solicitation and confidentiality covenants. 73 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The compensation committee awarded performance-based bonuses to our named executive officers for fiscal 2016 and fiscal 2015, which were paid in September 2016 and June 2015, respectively, based on results of operations, including clinical trial operations and our financial condition. Stock Option and Restricted Stock Unit Grants The compensation committee determined that additional equity grants were necessary in order to reward, motivate and retain our executive officers. On December 8, 2015, we granted 325,000 performance-based restricted stock units and 325,000 non- performance-based restricted stock units to Dr. Spana and 300,000 performance-based restricted stock units and 300,000 restricted stock units to Mr. Wills. The performance-based restricted stock units vest during the performance period, ending December 31, 2017, if and upon the earlier of: (i) achievement of a closing price for the Company’s common stock equal to or greater than $1.20 per share for 20 consecutive trading days, which is considered a market condition, or (ii) entering into a collaboration agreement (U.S. or global) of bremelanotide for FSD, which is considered a performance condition. The non-performance-based restricted stock units vest 25% on the date of grant and 25% on the first, second and third anniversary dates from the date of grant. On June 11, 2015, we granted 210,000 restricted stock units to Dr. Spana and 190,000 restricted stock units to Mr. Wills, which vest as to 50% on each anniversary of the grant date. We also granted 300,000 stock options to Dr. Spana and 270,000 stock options to Mr. Wills, which vest as to 25% on each anniversary of the grant date. These options have an exercise price of $1.08, the fair market value of the common stock on the date of grant, and they expire on June 11, 2025. Outstanding Equity Awards at 2016 Fiscal Year-End The following table summarizes all of the outstanding equity-based awards granted to our named executive officers as of June 30, 2016, the end of our fiscal year. Option awards (1) Stock awards (2) Carl Spana Name Total Stock Awards Option or stock award grant date 10/06/06 03/26/08 03/26/08 03/26/08 07/01/08 07/01/09 06/22/11 07/17/12 06/27/13 06/25/14 06/11/15 06/11/15 12/08/15 12/08/15 Number of securities underlying unexercised options (#) exercisable Number of securities underlying unexercised options (#) unexercisable Option exercise price ($) - - - - - - - 37,500 68,750 87,500 225,000 12,500 28,125 4,687 4,688 25,000 25,000 300,000 112,500 206,250 87,500 75,000 74 Option expiration date 10/06/16 03/26/18 03/26/18 03/26/18 07/01/18 07/01/19 06/22/21 07/17/22 06/27/23 06/25/24 06/11/25 24.90 2.80 5.00 6.60 1.80 2.80 1.00 0.72 0.62 1.02 1.08 Number of shares or units of stock that have not vested (#) Market value of shares or units of stock that have not vested ($) (3) 105,000 243,750 325,000 673,750 $ 46,200 107,250 143,000 296,450 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.  Stephen T. Wills Name Total Stock Awards Option awards (1) Stock awards (2) Number of securities underlying unexercised options (#) exercisable Number of securities underlying unexercised options (#) unexercisable Option exercise price ($) 10,000 22,500 3,750 3,750 20,000 20,000 250,000 101,250 187,500 75,000 67,500 - - - - - - - 33,750 62,500 75,000 202,500 Option expiration date 10/06/16 03/26/18 03/26/18 03/26/18 07/01/18 07/01/19 06/22/21 07/17/22 06/27/23 06/25/24 06/11/25 24.90 2.80 5.00 6.60 1.80 2.80 1.00 0.72 0.62 1.02 1.08 Option or stock award grant date 10/06/06 03/26/08 03/26/08 03/26/08 07/01/08 07/01/09 06/22/11 07/17/12 06/27/13 06/25/14 06/11/15 06/11/15 12/08/15 12/08/15 Number of shares or units of stock that have not vested (#) Market value of shares or units of stock that have not vested ($) (3) 95,000 225,000 300,000 620,000 $ 41,800 99,000 132,000 272,800 (1) Stock option vesting schedules: all options granted on or before June 22, 2011 have fully vested. Options granted after June 22, 2011 vest over four years with 1/4 of the shares vesting per year starting on the first anniversary of the grant date, provided that the named executive officer remains an employee. See “Termination and Change-In-Control Arrangements” below. (2) Stock award vesting schedule: stock awards consist of restricted stock units granted on June 11, 2015, which will vest on June 11, 2017, provided that the named executive officer remains an employee; restricted stock units granted on December 8, 2015, as to 243,750 shares for Dr. Spana and 225,000 shares for Mr. Wills, which will vest in equal amounts over a three year period, provided that the named executive officer remains an employee; and performance-based restricted stock units granted on December 8, 2015 as to 325,000 shares as to Dr. Spana and 300,000 shares as to Mr. Wills, which expire December 31, 2017 unless the specified performance criteria is met. See “Stock Options and Restricted Stock Unit Awards” above and “Termination and Change-In-Control Arrangements” below. (3) Calculated by multiplying the number of restricted stock units by $0.44, the closing market price of our common stock on June 30, 2016, the last trading day of our most recently completed fiscal year. Termination and Change-In-Control Arrangements The employment agreements, stock option agreements and restricted stock unit agreements with Dr. Spana and Mr. Wills contain the following provisions concerning severance compensation and the vesting of stock options and restricted stock units upon termination of employment or upon a change in control. The executive’s entitlement to severance, payment of health benefits and accelerated vesting of options is contingent on the executive executing a general release of claims against us. Termination Without Severance Compensation . Regardless of whether there has been a change in control, if we terminate employment for cause or the executive terminates employment without good reason (as those terms are defined in the employment agreement and set forth below), then the executive will receive only his accrued salary and vacation benefits through the date of termination. He may also elect to receive medical and dental benefits pursuant to COBRA for up to two years (Dr. Spana) or 18 months (Mr. Wills), but must remit the cost of coverage to us. Under the terms of our outstanding options and restricted stock units, all unvested options and restricted stock units would terminate immediately, and vested options would be exercisable for three months after termination. 75 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Severance Compensation Without a Change in Control . If we terminate or fail to extend the employment agreement without cause, or the executive terminates employment with good reason, then the executive will receive as severance pay his salary then in effect, paid in a lump sum, plus medical and dental benefits at our expense, for a period of two years (Dr. Spana) or 18 months (Mr. Wills) after the termination date. In addition, upon such event all unvested options would immediately vest and be exercisable for two years after the termination date or, if earlier, the expiration of the option term, and all unvested restricted stock units would accelerate and become fully vested. Severance Compensation After a Change in Control . If, within one year after a change in control, we terminate employment or the executive terminates employment with good reason, then the executive will receive as severance pay 200% (Dr. Spana) or 150% (Mr. Wills) of his salary then in effect, paid in a lump sum, plus medical and dental benefits at our expense, for a period of two years (Dr. Spana) or 18 months (Mr. Wills) after the termination date. We would also reimburse the executive for up to $25,000 in fees and expenses during the six months following termination, for locating employment. We would also reimburse the executive for any excise tax he might incur on “excess parachute payments” (as defined in Section 280G(b) of the Internal Revenue Code). All unvested options would immediately vest and be exercisable for two years after the termination date or, if earlier, the expiration of the option term. All unvested restricted stock units would vest upon a change in control, without regard to whether the executive’s employment is terminated. Option and Restricted Stock Unit Vesting Upon a Change in Control . Options and restricted stock units granted under the 2011 Stock Incentive Plan vest upon a change in control. If any options granted under the 2005 Stock Plan are to be terminated in connection with a change in control, those options will vest in full immediately before the change in control. Definitions. Under the employment agreements, a “change in control,” “cause” and “good reason” are defined as follows: A “change in control” occurs when: (a) some person or entity acquires more than 50% of the voting power of our outstanding securities; (b) the individuals who, during any twelve month period, constitute our board of directors cease to constitute at least a majority of the board of directors; (c) we enter into a merger or consolidation; or (d) we sell substantially all our assets. The term “cause” means: (a) the occurrence of (i) the executive’s material breach of, or habitual neglect or failure to perform the material duties which he is required to perform under, the terms of his employment agreement; (ii) the executive’s material failure to follow the reasonable directives or policies established by or at the direction of our board of directors; or (iii) the executive’s engaging in conduct that is materially detrimental to our interests such that we sustain a material loss or injury as a result thereof, provided that the breach or failure of performance is not cured, to the extent cure is possible, within ten days of the delivery to the executive of written notice thereof; (b) the willful breach by the executive of his obligations to us with respect to confidentiality, invention and non-disclosure, non-competition or non-solicitation; or (c) the conviction of the executive of, or the entry of a pleading of guilty or nolo contendere by the executive to, any crime involving moral turpitude or any felony. The term “good reason” means the occurrence of any of the following, with our failure to cure such circumstances within 30 days of the delivery to us of written notice by the executive of such circumstances: (a) any material adverse change in the executive’s duties, authority or responsibilities, which causes the executive’s position with us to become of significantly less responsibility, or assignment of duties and responsibilities inconsistent with the executive’s position; (b) a material reduction in the executive’s salary; (c) our failure to continue in effect any material compensation or benefit plan in which the executive participates, unless an equitable arrangement has been made with respect to such plan, or our failure to continue the executive’s participation therein (or in a substitute or alternative plan) on a basis not materially less favorable, both in terms of the amount of benefits provided and the level of the executive’s participation relative to other participants; 76 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. (d) our failure to continue to provide the executive with benefits substantially similar to those enjoyed by the executive under any of our health and welfare insurance, retirement and other fringe-benefit plans, the taking of any action by us which would directly or indirectly materially reduce any of such benefits, or our failure to provide the executive with the number of paid vacation days to which he is entitled; or (e) the relocation of the executive to a location which is a material distance from Cranbury, New Jersey. Director Compensation The following table sets forth the compensation we paid to all directors during fiscal 2016, except for Dr. Spana, whose compensation is set forth above in the Summary Compensation Table and related disclosure. Dr. Spana did not receive any separate compensation for his services as a director. Name Fees earned or paid in cash ($) Stock awards ($) (2) Option awards ($) (1) (2) Total ($) John K.A. Prendergast, Ph.D. Robert K. deVeer, Jr. Zola P. Horovitz, Ph.D. (3) J. Stanley Hull Alan W. Dunton, M.D. Angela Rossetti Arlene Morris (1) The aggregate number of shares underlying option awards and stock awards outstanding at June 30, 2016 for each director was: Dr. Prendergast Mr. deVeer Mr. Hull Dr. Dunton Ms. Rossetti Ms. Morris 95,000 58,750 43,750 52,500 58,750 50,000 50,000 105,500 52,750 25,000 52,750 45,950 39,150 32,350 23,267 11,634 - 11,634 11,634 11,634 11,634 223,767 123,134 68,750 116,884 116,334 100,784 93,984 Option awards Stock awards 388,750 224,500 221,000 150,000 102,500 57,500 175,000 87,500 87,500 77,500 67,500 57,500 (2) Amounts in these columns represent the aggregate grant date fair value for stock awards and option awards computed using the Black-Scholes model. For a description of the assumptions we used to calculate these amounts, see Note 12 to the consolidated financial statements included in this Annual Report. Amounts in this column include options granted on June 9, 2016 for our current fiscal year ending June 30, 2017. (3) Dr. Horovitz ceased serving as a director effective June 9, 2016. Non-Employee Directors’ Equity Grants. Our non-employee directors receive an annual equity grant at the board meeting closest to the beginning of each fiscal year, or such other date as may be determined by the board. On June 9, 2016, as the annual equity grant for our current fiscal year ending June 30, 2017, the Chairman of the board received 75,000 restricted stock units which vest on June 9, 2017, and an option to purchase 75,000 shares of common stock, and each other serving non-employee director received 37,500 restricted stock units which vest on June 9, 2017, and an option to purchase 37,500 shares of common stock. All of the options have an exercise price of $0.50 per share, the closing price of our common stock on the date of grant, vest in twelve monthly installments beginning on July 31, 2016, expire ten years from the date of grant and provide for accelerated vesting in the event of involuntarily termination as a director following a change in control, with exercise permitted following accelerated vesting for up to the earlier of one year after termination or the expiration date of the option. 77 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. On December 8, 2015, the compensation committee determined that additional equity grants were necessary in order to reward, motivate and retain the non-employee directors, and we granted the Chairman of the board 100,000 restricted stock units and the other serving non-employee directors a total of 240,000 restricted stock units, consisting of 50,000 to each of Mr. deVeer, Mr. Hull and Dr. Horovitz, 40,000 to Dr. Dunton, 30,000 to Ms. Rossetti and 20,000 to Ms. Morris. The restricted stock units vest as to 50% on the first and second anniversary of the grant date, conditioned on continued service as a director through the applicable vesting dates. On June 11, 2015, as the annual equity grant for our fiscal year ending June 30, 2016, the Chairman of the board received 40,000 restricted stock units which vest on June 11, 2016, and an option to purchase 40,000 shares of common stock, and each other serving non-employee director received 20,000 restricted stock units which vest on June 11, 2016, and an option to purchase 20,000 shares of common stock. All of the options have an exercise price of $1.08 per share, the closing price of our common stock on the date of grant, vest in twelve monthly installments beginning on July 31, 2015, expire ten years from the date of grant and provide for accelerated vesting in the event of involuntarily termination as a director following a change in control, with exercise permitted following accelerated vesting for up to the earlier of one year after termination or the expiration date of the option. Non-Employee Directors’ Cash Compensation. Dr. Prendergast serves as Chairman of the board and for our fiscal year ended June 30, 2016 received an annual retainer of $87,500, payable quarterly. Other non-employee directors received an annual base retainer of $40,000, payable on a quarterly basis. The chairperson of the audit committee received an additional annual retainer of $12,500, the chairperson of the compensation committee received an additional annual retainer of $12,500 and the chairperson of the corporate governance committee received an additional annual retainer of $7,500. Members of the foregoing committees, other than the non-employee Chairman, received an additional retainer of one-half the retainer payable to the committee chairperson. For the fiscal year ending June 30, 2017, cash compensation is unchanged. Non-Employee Directors’ Expenses. Non-employee directors are reimbursed for expenses incurred in performing their duties as directors, including attending all meetings of the board and any committees on which they serve. Employee Directors. Employee directors are not separately compensated for services as directors, but are reimbursed for expenses incurred in performing their duties as directors, including attending all meetings of the board and any committees on which they serve. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. Securities Authorized for Issuance Under Equity Compensation Plans. The table below provides information on our equity compensation plans as of June 30, 2016: Equity Compensation Plan Information as of June 30, 2016 Plan category Equity compensation plans approved by security holders Equity compensation plans not approved by security holders Total Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted-average exercise price of outstanding options, warrants and rights (b) 7,927,508(1) $ - 7,927,508 1.21(2) - Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) 3,314,419 - 3,314,419 (1) Consists of 4,825,550 options and 2,665,768 restricted stock units granted under our 2011 Stock Incentive Plan and 436,190 options granted under our 2005 Stock Plan. Our 2005 Stock Plan has terminated, but termination does not affect awards that are currently outstanding under this plan. The shares subject to outstanding awards under the 2005 Stock Plan, if forfeited prior to exercise, will become available for issuance under the 2011 Stock Incentive Plan. 78 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. (2) The amount in column (a) for equity compensation plans approved by security holders includes 2,665,768 shares reserved for issuance on vesting of outstanding restricted stock units, granted under our 2011 Stock Incentive Plan, which vest on various dates through January 11, 2020, subject to the fulfillment of service conditions. Because no exercise price is required for issuance of shares on vesting of the restricted stock units, the weighted-average exercise price in column (b) does not take the restricted stock units into account. Beneficial Ownership Tables. The tables below show the beneficial stock ownership and voting power, as of September 16, 2016, of: ● each director, each of the named executive officers, and all current directors and officers as a group; and ● all persons who, to our knowledge, beneficially own more than five percent of the common stock or Series A preferred stock. “Beneficial ownership” here means direct or indirect voting or investment power over outstanding stock and stock which a person has the right to acquire now or within 60 days after September 16, 2016. See the footnotes for more detailed explanations of the holdings. Except as noted, to our knowledge, the persons named in the tables beneficially own and have sole voting and investment power over all shares listed. The common stock has one vote per share and the Series A preferred stock has approximately 15 votes per share of Series A preferred stock. Voting power is calculated on the basis of the aggregate of common stock and Series A preferred stock outstanding as of September 16, 2016, on which date 85,934,037 shares of common stock and 4,030 shares of Series A preferred stock, convertible into 60,592 shares of common stock, were outstanding. The address for all members of our management and directors is c/o Palatin Technologies, Inc., 4B Cedar Brook Drive, Cranbury, NJ 08512. Addresses of other beneficial owners are in the table. MANAGEMENT: Class Name of beneficial owner Common Common Common Common Common Common Common Common Carl Spana, Ph.D. Stephen T. Wills John K.A. Prendergast, Ph.D. Robert K. deVeer, Jr. J. Stanley Hull Alan W. Dunton, M.D. Angela Rossetti Arlene M. Morris *Less than one percent. All current directors and executive officers as a group (eight persons) Amount and nature of beneficial ownership Percent of class Percent of total voting power 1,721,079(1) 1,574,041(2) 410,517(3) 264,560(4) 235,500(5) 167,520(6) 112,500(7) 52,500(8) 4,538,217(9) 2.0% 1.8% * * * * * * 5.1% * * * * * * * * 1.9% (1) Includes 918,750 shares of common stock underlying outstanding options, 45,653 shares of common stock underlying outstanding warrants and 81,250 shares of common stock underlying restricted stock units but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (2) Includes 795,000 shares of common stock underlying outstanding options, 45,653 shares of common stock underlying outstanding warrants and 75,000 shares of common stock underlying restricted stock units but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (3) Includes 338,750 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (4) Includes 197,500 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (5) Includes 194,000 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (6) Includes 125,000 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (7) Includes 77,500 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (8) Consists of 32,500 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days. (9) Includes 2,926,556 shares of common stock underlying outstanding options, warrants and restricted stock units. 79 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Class Name and address of beneficial owner Amount and nature of beneficial ownership (1) MORE THAN 5% BENEFICIAL OWNERS: 9,089,296 (2) Percent of class 9.9% Percent of total voting power 4.7% 500 12.4% 500 12.4% 500 12.4% 250 6.2% 250 6.2% 250 6.2% 250 6.2% 250 6.2% 250 6.2% 250 6.2% 230 5.7% * * * * * * * * * * * Common Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred Series A Preferred QVT Financial LP 1177 Avenue of the Americas, 9th Floor New York, New York 10036 Steven N. Ostrovsky 43 Nikki Ct. Morganville, NJ 07751 Thomas L. Cassidy IRA Rollover 38 Canaan Close New Canaan, CT 06840 Jonathan E. Rothschild 300 Mercer St., #28F New York, NY 10003 Arthur J. Nagle 19 Garden Avenue Bronxville, NY 10708 Thomas P. and Mary E. Heiser, JTWROS 10 Ridge Road Hopkinton, MA 01748 Carl F. Schwartz 31 West 87th St. New York, NY 10016 Michael J. Wrubel 3650 N. 36 Avenue, #39 Hollywood, FL 33021 Myron M. Teitelbaum, M.D. 175 Burton Lane Lawrence, NY 11559 Laura Gold Galleries Ltd. Profit Sharing Trust Park South Gallery at Carnegie Hall 154 West 57th Street, Suite 114 New York, NY 10019 Laura Gold 180 W. 58th Street New York, NY 10019 Nadji T. Richmond 20 E. Wedgewood Glen The Woodlands, TX 77381 *Less than one percent. 80 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. (1) Unless otherwise indicated by footnote, all share amounts represent outstanding shares of the class indicated, and all beneficial owners listed have, to our knowledge, sole voting and dispositive power over the shares listed. (2) QVT Financial LP (QVT Financial) is the investment manager for QVT Fund V LP (Fund V) and other private investment funds (collectively, the Funds). The information contained herein with respect to the Funds is based on information included in filings by QVT Financial and the Funds with the SEC. Based on a Form 13F filed by QVT Financial on August 15, 2016 for the period ending June 30, 2016, the Funds beneficially own in the aggregate 9,089,296 shares of common stock, including 5,049,922 shares of common stock underlying outstanding warrants. QVT Financial has the power to direct the vote and disposition of the common stock held by the Funds, and accordingly QVT Financial may be deemed to be the beneficial owner of an aggregate amount of 9,089,296 shares of common stock, consisting of the shares beneficially owned by the Funds. QVT Financial GP LLC, as General Partner of QVT Financial, may be deemed to beneficially own the same number of shares of common stock reported by QVT Financial. QVT Associates GP LLC, as General Partner of the Funds may be deemed to beneficially own the aggregate number of shares of common stock beneficially owned by the Funds, and accordingly, QVT Associates GP LLC may be deemed to be the beneficial owner of an aggregate amount of 9,089,296 shares of common stock. Exercise of warrants held by the Funds is restricted if, as a result of an exercise, the beneficial ownership of the holder and its affiliates and any other party or person that could be deemed to be a group would exceed 9.99% of the outstanding common stock. Beneficial ownership as listed in the table above excludes warrants which are not exercisable because of that restriction, but includes warrants which are exercisable based on the common shares outstanding. Item 13. Certain Relationships and Related Transactions, and Director Independence. The board of directors has determined that all of the directors except for Dr. Spana (our Chief Executive Officer and President) are independent directors, as defined in the listing standards of the NYSE MKT. As a condition of employment, we require all employees to disclose in writing actual or potential conflicts of interest, including related party transactions. Our code of corporate conduct and ethics, which applies to employees, officers and directors, requires that the audit committee review and approve related party transactions. Since July 1, 2015, there have been no transactions or proposed transactions in which we were or are to be a participant, in which any related person had or will have a direct or indirect material interest. Item 14. Principal Accountant Fees and Services. KPMG LLP, or KPMG, served as our independent registered public accounting firm for fiscal 2016 and fiscal 2015. Audit Fees. For fiscal 2016, KPMG billed us a total of $235,500 for professional services rendered for the audit of our annual consolidated financial statements, review of our consolidated financial statements in our Forms 10-Q and services provided in connection with regulatory filings. For fiscal 2015, the total billed for the same services was $419,200. Audit-Related Fees. For fiscal 2016 and 2015, KPMG did not perform or bill us for any audit-related services. Tax Fees. For fiscal 2016, KPMG billed us a total of $16,000 for professional services rendered for tax compliance. For fiscal 2015, KPMG billed us $15,500 for professional services rendered for tax compliance. All Other Fees. KPMG did not perform or bill us for any services other than those described above for fiscal 2015 and 2016. Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors . Consistent with SEC policies regarding auditor independence, the audit committee has responsibility for appointing, setting compensation for and overseeing the work of the independent registered public accounting firm. In recognition of this responsibility, the audit committee has established a policy to pre-approve all audit and permissible non-audit services provided by the independent registered public accounting firm. The audit committee pre-approves fees for each category of service. The fees are budgeted and the audit committee requires the independent registered public accounting firm and management to report actual fees versus the budget periodically throughout the year by category of service. During the year, circumstances may arise when it may become necessary to engage the independent registered public accounting firm for additional services not contemplated in the original pre-approval. In those instances, the audit committee requires specific pre-approval before engaging the independent registered public accounting firm. The audit committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is delegated must report, for informational purposes only, any pre-approval decisions to the audit committee at its next scheduled meeting. 81 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Item 15. Exhibits, Financial Statement Schedules. (a) Documents filed as part of the report: PART IV 1. Financial statements: The following consolidated financial statements are filed as a part of this report under Item 8 – Financial Statements and Supplementary Data: — Report of Independent Registered Public Accounting Firm — Consolidated Balance Sheets — Consolidated Statements of Operations — Consolidated Statements of Comprehensive Loss — Consolidated Statements of Stockholders’ (Deficiency) Equity — Consolidated Statements of Cash Flows — Notes to Consolidated Financial Statements 2. Financial statement schedules: None. 3. Exhibits: The exhibits, listed on the accompanying exhibit index that is set forth after the signature page, are filed or incorporated by reference (as stated thereon) as part of this Annual Report on Form 10-K. 82 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Pursuant 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 its behalf by the undersigned, thereunto duly authorized. SIGNATURES PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Carl Spana, Ph.D. President and Chief Executive Officer (principal executive officer) Date: September 19, 2016 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ Carl Spana Carl Spana /s/ Stephen T. Wills Stephen T. Wills /s/ John K. A. Prendergast John K. A. Prendergast /s/ Robert K. deVeer, Jr, Robert K. deVeer, Jr. /s/ J. Stanley Hull J. Stanley Hull /s/ Alan W. Dunton Alan W. Dunton /s/ Angela Rossetti Angela Rossetti /s/ Arlene M. Morris Arlene M. Morris President, Chief Executive Officer and Director (principal executive officer) Executive Vice President, Chief Financial Officer and Chief Operating Officer (principal financial and accounting officer) Chairman and Director Director Director Director Director Director 83 September 19, 2016 September 19, 2016 September 19, 2016 September 19, 2016 September 19, 2016 September 19, 2016 September 19, 2016 September 19, 2016 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Exhibit Number Description Filed Herewith Exhibit Index 3.1 3.2 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 10.1† 10.2† 10.3† 10.4† 10.5† 10.6† 10.7† 10.8† 10.9† 10.10† 10.11† Restated Certificate of Incorporation of Palatin Technologies, Inc., as amended. Bylaws of Palatin Technologies, Inc. Warrant Agreement, dated March 1, 2011, between American Stock Transfer& Trust Company and Palatin Technologies, Inc. Form of Series B Warrant Certificate. Form of Series A 2012 Warrant. Form of Series B 2012 Warrant. Form of Series C 2014 Common Stock Purchase Warrant. Form of Series D 2014 Common Stock Purchase Warrant. Form of Series E 2015 Common Stock Purchase Warrant. Form of Series F 2015 Common Stock Purchase Warrant. Form of Series G 2015 Common Stock Purchase Warrant. Form of Series H 2016 Common Stock Purchase Warrant. Form of Series I 2016 Common Stock Purchase Warrant. 1996 Stock Option Plan, as amended. Form of Option Certificate (Incentive Option) Under the 2005 Stock Plan. Form of Incentive Stock Option Under the 2005 Stock Plan. Form of Opinion Certificate (Non-Qualified Opinion) Under the 2005 Stock Plan. Form of Non-Qualified Stock Option Agreement Under the 2005 Stock Plan. 2007 Change in Control Severance Plan. 2005 Stock Plan, as amended. Form of Executive Officer Option Certificate. Form of Amended Restricted Stock Unit Agreement. Form of Amended Option Certificate (Incentive Option) Under the 2005 Stock Plan. Employment Agreement, effective as of July 1, 2016, between Carl Spana and Palatin Technologies, Inc. 84 Form 10-K 10-Q 10-Q 10-Q 8-K 8-K 8-K 8-K 8-K 8-K 8-K 8-K 8-K 10-K 8-K 8-K 8-K 8-K 10-Q 10-Q 10-Q 10-Q 10-Q 8-K Filing Date September 27, 2013 February 8, 2008 May 13, 2011 May 13, 2011 July 6, 2012 July 6, 2012 December 30, 2014 December 30, 2014 July 7, 2015 July 7, 2015 July 7, 2015 August 2, 2016 August 2, 2016 September 28, 2009 September 21, 2011 September 21, 2011 September 21, 2011 September 21, 2011 February 8, 2008 May 15, 2009 May 14, 2008 May 14, 2008 May 14, 2008 June 13, 2016 SEC File No. 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 10.12† 10.13 10.14† 10.15† 10.16† 10.17† 10.18† 10.19† 10.20† 10.21† 10.22† 10.23† 10.24 10.25 10.26 10.27 10.28 Employment Agreement, effective as of July 1, 2016, between Stephen T. Wills and Palatin Technologies, Inc. Underwriting Agreement, datedFebruary 24, 2011, by and between Roth Capital Partners, LLC and Palatin Technologies, Inc. 2011 Stock Incentive Plan, as amended. Form of Restricted Share Unit Agreement Under the 2011 Stock Incentive Plan. Form of Nonqualified Stock Option Agreement under the 2011 Stock Incentive Plan. Form of Incentive Stock Option Agreement under the 2011 Stock Incentive Plan. Form of Restricted Share Unit Agreement under the 2011 Stock Incentive Plan. Form of Performance-Based Restricted Share Unit Agreement under the 2011 Stock Incentive Plan. Form of Restricted Share Unit Agreement for Non-Employee Directors under the 2011 Stock Incentive Plan. Amended form of Restricted Share Unit Agreement under the 2011 Stock Incentive Plan. Amended form of Performance-Based Restricted Share Unit Agreement under the 2011 Stock Incentive Plan. Amended form of Restricted Share Unit Agreement for Non-Employee Directors under the 2011 Stock Incentive Plan. Form of Indenture. Letter Agreement, dated October 7, 2011, between Biotechnology Value Fund, L.P. and Palatin Technologies, Inc. Purchase Agreement, dated July 2, 2012, by and between QVT Fund IV LP, QVT Fund V LP and Quintessence Fund L.P. and Palatin Technologies, Inc. Registration Rights Agreement, dated July 2, 2012, by and between QVT Fund IV LP, QVT Fund V LP and Quintessence Fund L.P. and Palatin Technologies, Inc. Securities Purchase Agreement, dated December 23, 2014, by and between Palatin Technologies, Inc. and the investors named therein. 85 8-K 8-K 8-K 10-Q 10-Q 10-Q 8-K 8-K 8-K 10-Q 10-Q 10-Q S-3 8-K 8-K 8-K 8-K June 13, 2016 001-15543 February 24, 2011 001-15543 June 13, 2016 May 13, 2011 May 13, 2011 May 13, 2011 December 11, 2015 December 11, 2015 December 11, 2015 February 12, 2016 February 12, 2016 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 001-15543 February 12, 2016 001-15543 August 3, 2015 October 7, 2011 333-206047 001-15543 July 6, 2012 001-15543 July 6, 2012 001-15543 December 30, 2014 001-15543 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 10.29 10.30 10.31 10.32 10.33 10.34 10.35†† 10.36 10.37†† 10.38†† 21 23 31.1 Registration Rights Agreement, dated December 23, 2014, by and between Palatin Technologies, Inc. and the investors named therein. Placement Engagement Letter, dated December 22, 2014, by and between Palatin Technologies, Inc. and Piper Jaffray & Co. Amended and Restated Venture Loan and Security Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and Horizon Technology Finance Corporation, Fortress Credit Co LLC, Horizon Credit II LLC and Fortress Credit Opportunities V CLO Limited. Securities Purchase Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and the investors named therein. Registration Rights Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and the investors named therein. Underwriting Agreement, dated August 1, 2016, by and between Palatin Technologies, Inc. and Canaccord Genuity Inc., on behalf of itself and as representative of the underwriters named therein. License, Co-Development and Commercialization Agreement, dated August 29, 2014, by and between Chemical Works of Gedeon Richter Plc. and Palatin Technologies, Inc. Termination Agreement, dated September 16, 2015, by and between Chemical Works of Gedeon Richter Plc. and Palatin Technologies, Inc. Commercial Supply Agreement dated June 20, 2016, by and between Catalent Belgium S.A. and Palatin Technologies, Inc. Manufacturing Preparation and Services Agreement dated June 20, 2016, by and between Catalent Belgium S.A. and Palatin Technologies, Inc. Subsidiaries of Palatin Technologies, Inc. Consent of KPMG LLP. Certification of Chief Executive Officer. X X X X X 86 8-K 8-K 8-K 8-K 8-K 8-K 10-K/A 10-K December 30, 2014 December 30, 2014 July 7, 2015 001-15543 001-15543 001-15543 July 7, 2015 001-15543 July 7, 2015 001-15543 August 2, 2016 001-15543 October 9, 2014 001-15543 September 18, 2015 001-15543 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 31.2 32.1 32.2 101.INS 101.SCH 101.CAL 101.LAB 101.PRE 101.DEF Certification of Chief Financial Officer. Certification of principal executive officer pursuant to U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Certification of principal financial officer pursuant to U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. XBRL Instance Document. XBRL Taxonomy Extension Schema Document. XBRL Taxonomy Extension Calculation Linkbase Document. XBRL Taxonomy Extension Label Linkbase Document. XBRL Taxonomy Extension Presentation Linkbase Document. XBRL Taxonomy Extension Definition Linkbase Document. X X X X X X X X X † Management contract or compensatory plan or arrangement. †† Confidential treatment granted or requested as to certain portions, which portions are omitted and filed separately with the SEC. 87 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTION 240.24b-2 COMMERCIAL SUPPLY AGREEMENT (Bremelanotide—Pre-filled syringe in auto-injector) Exhibit 10.37 THIS COMMERCIAL SUPPLY AGREEMENT (“Agreement”) is made as of this 10 TH day of June, 2016 (“Effective Date ”) BETWEEN (1) (2) A. B. C. D. Palatin Technologies, Inc., a New Jersey corporation, with a place of business at 4-B Cedar Brook Drive, Cranbury, New Jersey, USA 08512 (“ Palatin”); and Catalent Belgium S.A., a Belgian company, with a place of business at Rue Font St. Landry, 10 Parc Mercator B-1120, Neder over Heembeek, Belgium (“ Catalent”). RECITALS Palatin is a biopharmaceutical company that develops, tests and commercializes, directly or through third parties, pharmaceutical products. Catalent is a leading provider of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies. Palatin desires to engage Catalent to provide certain services to Palatin in connection with the processing of Palatin’s Product, and Catalent desires to provide such services, all pursuant to the terms and conditions set out in this Agreement. Catalent and Palatin have entered into that certain Binding Terms for Incorporation into a Capital and a Commercial Supply Agreement, dated April 1, 2016 (the “ Binding Terms”), which Binding Terms shall be superseded in its entirety by this Agreement and the Manufacturing Preparation and Services Agreement (as defined hereafter). THEREFORE, the parties agree as follows: 1. DEFINITIONS The following terms have the following meanings in this Agreement: 1.1 “Acknowledgement” has the meaning set out in Clause 4.3. EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1.2 “Affiliate” means (a) with respect to Palatin, any corporation or other business entity that, directly or indirectly, is controlled by, controls, or is under common control with Palatin; and (b) with respect to Catalent, Catalent, Inc., Catalent Pharma Solutions, Inc. and any corporation or other business entity controlled, directly or indirectly, by Catalent Pharma Solutions, Inc. For such purposes, “control” means the direct or indirect ownership of at least fifty percent (50%) of the voting interest in such corporation or other entity or the power in fact to control the management directions of such entity. 1.3 “Agreement” has the meaning set out in the introductory paragraph, and includes all its Attachments and other appendices (all of which are incorporated herein by reference). 1.4 “ANDA” has the meaning set out in Clause 9.2.1. 1.5 “Annual Product Maintenance Fee” has the meaning set forth in Clause 7.1C. 1.6 “API” means the compound bremelanotide, as further described in the Specifications. 1.7 “API Inventions” has the meaning set out in Section 11. 1.8 “Applicable Laws” means, with respect to Palatin, all laws, statutes, statutory provisions or subordinate legislation, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which API or Product is produced, marketed, distributed, used or sold; and with respect to Catalent, cGMP and all other laws, statutes, statutory provisions and subordinate legislation, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Catalent Processes Product. 1.9 “Auto Injector Assembly Line ” has the meaning set forth in Clause 3.5. 1.10 “Batch” means a defined quantity of Product that has been or is being Processed in accordance with the Specifications. 1.11 “Binding Terms” has the meaning set forth in the Recitals. 1.12 “Catalent Defective Processing” has the meaning set out in Clause 5.2. 1.13 “Catalent” has the meaning set out in the introductory paragraph. Catalent shall have the right to cause any of its Affiliates to perform any of its obligations hereunder, and Palatin shall accept such performance as if it were performance by Catalent.; provided, however, that Catalent shall remain fully liable for the performance by its Affiliate of Catalent’s obligations under this Agreement to the same extent as if Catalent had performed or failed to perform its obligations under this Agreement. 1.14 “Catalent CAPEX Expenditures” has the meaning set forth in the Manufacturing Preparation and Services Agreement. 1.15 “Catalent Indemnitees” has the meaning set out in Clause 13.2. 1.16 “Catalent IP” has the meaning set out in Section 11. 1.17 “cGMP” means current Good Manufacturing Practices promulgated by the Regulatory Authorities in the jurisdictions included in Applicable Laws. This includes 2003/94/EEC Directive (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended, if and as implemented in the relevant constituent country; and in the United States, this includes 21 C.F.R. Parts 210 and 211, as amended. 2 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1.18 “Change of Control” means, with respect to a party: (a) any merger, reorganization, consolidation, or other business combination of such party with a third party that results in the voting securities of such party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation, or other business combination; (b) a third party becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of such party in a single transaction or series of related transactions; or (c) the sale, transfer, exchange or other disposition to a third party of all or substantially all of a party’s assets or business relating to this Agreement (whether alone or in connection with a sale, transfer, exchange or other disposition of other assets or businesses of such party). 1.19 “Commencement Date” means 60 days from the first date on which the FDA gives market Regulatory Approval with respect to the Product. 1.20 “Confidential Information” has the meaning set out in Clause 10.1. 1.21 “Contract Year” means each consecutive 12 month period beginning on the Commencement Date or anniversary thereof, as applicable. 1.22 “CPR” has the meaning set out in Clause 18.10. 1.23 “Defective Product” has the meaning set out in Clause 5.2. 1.24 “Discloser” has the meaning set out in Clause 10.1. 1.25 “Effective Date ” has the meaning set out in the introductory paragraph. 1.26 “Equipment” means any equipment to be supplied by Catalent to use in the Processing. 1.27 “Exception Notice ” has the meaning set out in Clause 5.2. 1.28 “Facility” means Catalent’s facility in Brussels, Belgium or such other Catalent facility as mutually agreed by the parties. 1.29 “FDA” means the United States Food and Drug Administration or any successor thereto. 1.30 “Firm Commitment” has the meaning set out in Clause 4.2. 1.31 “GDUFA Fees” has the meaning set out in Clause 9.2.1. 1.32 “Invention” has the meaning set out in Section 11. 1.33 “Losses” has the meaning set out in Clause 13.1. 1.34 “Manufacturing Preparation and Services Agreement” means that certain agreement of even date herewith between Catalent and Palatin pursuant to which Catalent (itself or through its Affiliates) has agreed to upgrade its manufacturing capacity and infrastructure to provide certain services in relation to the manufacture of the Product and to reserve certain manufacturing capacity on its upgraded facilities. 3 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1.35 “Minimum Requirement” has the meaning set out in Clause 4.1. 1.36 “Palatin” has the meaning set out in the introductory paragraph, or any successor or permitted assign. 1.37 “Palatin Indemnitees” has the meaning set out in Clause 13.1. 1.38 “Palatin IP” has the meaning set out in Section 11. 1.39 “Palatin-supplied Materials” means any materials to be supplied by or on behalf of Palatin to Catalent for Processing, as provided in Attachment C, including API, Ypsomed auto injector components and parts, and reference standards. 1.40 “Price” shall have the meaning set forth in Attachment D hereto. 1.41 “Process” or “Processing” means the compounding, filling, producing, manufacturing, assembling and packaging (clinical, secondary or retail packaging) of Palatin-supplied Materials and Raw Materials into Product by Catalent, in accordance with the Specifications and under the terms of this Agreement. 1.42 “Processing Date” means the day on which the first step of physical Processing is scheduled to occur, as identified in an Acknowledgement. 1.43 “Process Inventions” has the meaning set out in Section 11. 1.44 “Product” means the pharmaceutical product containing the API, as more specifically described in the Specifications. 1.45 “Product Maintenance Services” has the meaning set out in Clause 2.3. 1.46 “Purchase Order” has the meaning set out in Clause 4.3. 1.47 “Quality Agreement” has the meaning set out in Clause 9.6. 1.48 “Raw Materials” means all raw materials, supplies, components, syringes, and packaging necessary to manufacture and ship Product in accordance with the Specifications, as provided in Attachment C, but excluding Palatin-supplied Materials. 1.49 “Recall” has the meaning set out in Clause 9.5. 1.50 “Recipient” has the meaning set out in Clause 10.1. 1.51 “Regulatory Approval” means any approvals, permits, product and/or establishment licenses, registrations or authorizations, including European marketing authorizations and applications and US Investigational New Drug applications, New Drug Applications and Abbreviated New Drug Applications, as applicable, of any Regulatory Authorities that are necessary or advisable in connection with the development, manufacture, testing, use, storage, exportation, importation, transport, promotion, marketing, distribution or sale of API or Product in the Territory. 1.52 “Regulatory Authority” means the regulatory bodies or agencies in the Territory that are responsible for (A) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use or (B) health, safety or environmental matters generally. This includes the European Medicines Agency; and in the United States, this includes the United States Food and Drug Administration. 4 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1.53 “Representatives” of an entity means such entity’s duly-authorized officers, directors, employees, agents, accountants, attorneys or other professional advisors. 1.54 ”Required Disclosure” has the meaning set out in Clause 10.5. 1.55 “Review Period” has the meaning set out in Clause 5.2. 1.56 “Rolling Forecast” has the meaning set out in Clause 4.2. 1.57 “Specifications” means the procedures, requirements, standards, quality control testing and other data and the scope of services as set out in Attachment C, as modified from time to time in accordance with Section 8. 1.58 “Supply Failure” has the meaning set forth in Clause 4.7. 1.59 “Term” has the meaning set out in Clause 16.1. 1.60 “Territory” means the European Union and the United States and its territories and possessions, those countries that are listed in Attachment E, and any other country that the parties agree in writing to add to this definition of Territory in an amendment to this Agreement; provided, however, that Territory shall not be amended to include countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States. Catalent shall not be obliged to Process Products for sale in any of such countries if it is prevented from doing so, or would be required to obtain or apply for special permission to do so, due to any restrictions (such as embargoes) imposed on it by any governmental authorities, including without limitation, those imposed by the US Office of Foreign Asset Control. 1.61 “Uncured Supply Failure” has the meaning set out in Clause 4.7. 1.62 “Unit Pricing” has the meaning set out in Clause 7.1B. 1.63 “Validation Services” has the meaning set out in Clause 2.1. 1.64 “Vendor” has the meaning set out in Clause 3.2B. 2. VALIDATION, PROCESSING & RELATED SERVICES 2.1 Validation Services. Catalent shall perform the Product qualification, validation and stability services set out in Attachment A (the “Validation Services”). 2.2 Supply and Purchase of Product. Catalent shall Process Product in accordance with the Specifications, Applicable Laws and this Agreement. Except as set forth in Clause 4.7, Palatin and its Affiliates shall purchase *** from Catalent no less than *** of Palatin’s and its Affiliates’ requirements of Product in the Territory in accordance with this Agreement. 2.3 Product Maintenance Services. Palatin will receive the product maintenance services set out in Attachment B (the “Product Maintenance Services”). 5 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 2.4 Other Related Services. Catalent shall provide any other Product-related services as the parties may agree in writing. Such writing shall include the scope and fees for any such services and shall be appended to this Agreement. The terms and conditions of this Agreement shall govern such services unless otherwise agreed by the parties. 3. MATERIALS, EQUIPMENT AND AUTO INJECTOR ASSEMBLY LINES 3.1 Palatin-supplied Materials. A. Palatin shall supply to Catalent for Processing, at *** cost, all Palatin-supplied Materials, in quantities sufficient to meet Palatin’s requirements for Product. Palatin shall deliver DDP (Incoterms 2010) such items and associated certificates of analysis to the Facility no later than *** (but not earlier than *** unless otherwise agreed by Catalent) before the Processing Date. Palatin shall be responsible at its cost for securing necessary export or import, or similar clearances, permits or certifications required in respect of such supply. Catalent shall use Palatin-supplied Materials solely for Processing. To the extent not previously provided, Palatin shall provide to Catalent, prior to delivery of any Palatin-supplied Materials, a copy of all associated material safety data sheets, safe handling instructions, health and environmental information, and any regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto. B. Within *** following receipt of Palatin-supplied Materials, Catalent shall inspect such items to verify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with Specifications, Catalent shall give Palatin prompt notice of such nonconformity. Catalent shall not be liable for any defects in Palatin- supplied Materials, or in Product as a result of defective Palatin-supplied Materials unless Catalent failed to properly perform the foregoing obligations. Catalent shall follow Palatin’s reasonable written instructions in respect of return or disposal of defective Palatin-supplied Materials. C. Palatin shall retain title to Palatin-supplied Materials at all times, and Palatin shall bear the risk of loss thereof, except in the event of losses related to Catalent’s gross negligence or willful misconduct, in which case Catalent’s liability shall be limited pursuant to Section 14 below. 3.2 Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring Raw Materials as necessary to meet the Firm Commitment. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Palatin’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2. B. In certain instances, Palatin may require a specific supplier, manufacturer or vendor (“ Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent. 6 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other products. 3.3 Artwork and Labeling . Palatin shall provide, or approve prior to Catalent’s procurement of applicable Raw Material, all artwork, advertising and labeling information necessary for Processing, if any. Such artwork, advertising and labeling information is and shall remain the exclusive property of Palatin, and Palatin shall be solely responsible for the content thereof. Such artwork, advertising and labeling information or any reproduction thereof may not be used by Catalent, during or after the Term, in any manner other than performing its obligations hereunder. 3.4 *** 3.5 Auto Injector Assembly Line . Catalent and Palatin agree that in order to scale up Processing of the Product, pursuant to the terms of the Manufacturing Preparation and Services Agreement Catalent shall undertake a Processing line expansion for auto injector assembly (such expanded Processing line, the “Auto Injector Assembly Line ”). With respect to all equipment and components of the Auto Injector Assembly Line, notwithstanding any amounts that Palatin contributes to the purchase of equipment and components in connection with the establishment of such Auto Injector Assembly Line, Catalent shall solely own all right, title and interest in and to such line, and all equipment and components relating thereto, and shall bear the risk of loss thereof. *** The parties shall work together in good faith to plan and schedule such Palatin priority access based on a combination of Palatin’s (i) Rolling Forecasts and Firm Commitment and (ii) Minimum Requirements for the applicable Contract Year(s). In the event that during a Contract Year(s), Catalent uses the Auto Injector Assembly Line for another Catalent customer in keeping with the priority access requirements set forth in this Clause 3.5, then ***. 4. MINIMUM REQUIREMENT, FORECASTS & PURCHASE ORDERS 4.1 Minimum Requirement. During each Contract Year, Palatin (or its Affiliates or licensees) shall purchase the minimum number of units of Product set out on Attachment D (“Minimum Requirement”). If during any Contract Year Palatin purchases a number of units of Product that is less than the Minimum Requirement (the difference, a “Purchase Shortfall”), then within *** after the end of such Contract Year, Palatin shall pay Catalent an amount equal to ***. 4.2 Forecast. On or before the ***, and thereafter on a *** basis on or before the *** of each succeeding ***, Palatin shall furnish to Catalent a written *** rolling forecast of the quantities of Product that Palatin intends to order from Catalent during such period (“Rolling Forecast”); provided that to the extent feasible at least *** of the total number of units purchased in the relevant Contract Year shall be purchased in each of the first and second six months of such relevant Contact Year. The *** of such Rolling Forecast shall constitute a binding commitment to purchase the quantities of Product specified therein (“Firm Commitment”) and *** of the Rolling Forecast shall be non-binding, good faith estimates. 7 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 4.3 Purchase Orders. A. Concurrently with the submission of each Rolling Forecast, Palatin shall submit to Catalent a binding, non-cancelable purchase order for Product, specifying the Batch size (to the extent the Specifications permit Batches of different sizes) and the requested delivery date for each Batch (“Purchase Order”); provided, that each Purchase Order shall be for not less than the Firm Commitment (but only to the extent the Firm Commitment was not covered in a previous Purchase Order). Purchase Orders for quantities of Product in excess of the Firm Commitment shall be submitted by Palatin at least *** in advance of the delivery date requested in the Purchase Order. B. Within *** after receipt of a Purchase Order, Catalent shall issue a written acknowledgement (“ Acknowledgement”) that it accepts or rejects such Purchase Order. Each acceptance Acknowledgement shall either confirm the delivery date set out in the Purchase Order or provide a reasonable alternative delivery date (which, in any event, shall be ***), and shall include the Processing Date. Catalent may reject any Purchase Order in excess of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that Catalent shall use its commercially reasonable efforts to supply Palatin with quantities of Product which are up to *** in excess of the quantities specified in the Firm Commitment, subject to Catalent’s other supply commitments and manufacturing, packaging and equipment capacity. A properly submitted Purchase Order shall be *** within *** after receipt of such Purchase Order. C. In the event of a conflict between the terms of any Purchase Order or Acknowledgement and this Agreement, the terms of this Agreement shall control unless the terms of the Purchase Order expressly override the terms set forth herein. 4.4 Catalent’s Cancellation of Purchase Orders. Notwithstanding Clause 4.5, Catalent reserves the right to cancel all, or any part of, a Purchase Order upon written notice to Palatin, and Catalent shall have no further obligations or liability with respect to such Purchase Order, if Palatin refuses or fails to timely supply conforming Palatin-supplied Materials in accordance with Clause 3.1 and such failure is not cured within *** after the giving of written notice of such failure. Any such cancellation of Purchase Orders shall not constitute a breach of this Agreement by Catalent nor shall it absolve Palatin of its obligation in respect of the Minimum Requirement. 4.5 Palatin’s Modification or Cancellation of Purchase Orders . A. Palatin may modify the delivery date or quantity of Product in a Purchase Order only by submitting a written change order to Catalent at least *** in advance of the earliest Processing Date covered by such change order. To the extent the change order modifies the delivery date or modifies the quantity of Product in a Purchase Order, such change order shall be effective and binding against Catalent only upon the written approval of Catalent, and notwithstanding the foregoing, Palatin shall remain responsible for the Firm Commitment. 8 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. B. Changes to or postponement of any Batch of Product by Palatin will not reduce or in any way affect Palatin’s Minimum Requirement obligations set out in Clause 4.1. 4.6 Unplanned Delay or Elimination of Processing . Catalent shall use commercially reasonable efforts to meet the Purchase Orders, subject to the terms and conditions of this Agreement. Catalent shall provide Palatin with as much advance notice as practicable, and shall provide at least *** advance notice where possible, if Catalent determines that any Processing will be delayed or eliminated for any reason. 4.7 Supply Failure . For purposes of this Agreement, a “ Supply Failure” shall mean a failure by Catalent to supply Product meeting the Specifications, subject to Clauses 5.2, 5.3 and 5.4, in the quantities ordered by Palatin (subject to the limitations and terms set forth in Clauses 4.3 and 4.4) for ***, where such failure is ***. In the event of *** (such event, an “Uncured Supply Failure”), Palatin shall have the right to ***. In the event of such Uncured Supply Failure,*** the parties shall meet to discuss in good faith how to equitably manage any Minimum Requirement for the then current Contract Year, ***. 4.8 Observation of Processing. In addition to Palatin’s audit right pursuant to Clause 9.4, Palatin may send *** Representatives to the Facility to observe Processing for a maximum of *** (unless otherwise agreed by Catalent in writing), upon at least *** prior notice, at reasonable times during regular business hours. Such Palatin Representatives shall abide by all Catalent safety rules and other applicable policies and procedures, and Palatin shall be responsible for such compliance. Palatin shall defend, indemnify and hold harmless Catalent for any action, omission or other activity of such Palatin Representatives while on Catalent’s premises. Palatin’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. 5. TESTING; SAMPLES; RELEASE 5.1 Batch Records and Data; Release . A. Subject to Clause 5.1B, unless otherwise agreed to by the parties in writing, within *** after Catalent completes Processing of a Batch, Catalent shall provide Palatin with copies of executed Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records within *** after resolution of the out-of-Specification result. After Catalent completes Processing of a Batch, Catalent shall also provide Palatin or its designee with a certificate of analysis for such Batch. Issuance of a certificate of conformance/analysis constitutes release of the Batch by Catalent to Palatin. Palatin shall be responsible for final release of Product (including testing), at its cost, to the market. B. If testing reveals an out-of-Specification result with respect to a Batch, Catalent shall report such result to Palatin as soon as practicable, and in any event within *** after obtaining such result. Within *** after resolution of the out-of-Specification result, Catalent shall provide Palatin a written report detailing the cause of such out-of-Specification result and the manner in which it was resolved. Catalent shall provide Palatin with such further information as Palatin reasonably requests with respect to such out-of-Specification result. 5.2 Testing; Rejection . Following Palatin’s receipt of a shipment of a Batch, Palatin or Palatin’s designee may test samples of such Batch to confirm that the Specifications have been met. Unless within *** after Palatin’s receipt of a Batch (“ Review Period”), Palatin or its designee notifies Catalent in writing (an “Exception Notice ”) that such Batch is not in compliance with Clause 12.1A (“ Defective Product”), and provides a sample of the alleged Defective Product, the Batch shall be deemed accepted by Palatin and Palatin shall have no right to reject such Batch. Upon timely receipt of an Exception Notice from Palatin, Catalent shall in its sole discretion conduct an appropriate investigation to determine whether or not it agrees with Palatin that Product is Defective Product and to determine the cause of any nonconformity. If Catalent agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to Catalent’s negligence or willful misconduct (“Catalent Defective Processing”), then Clause 5.4 shall apply. 9 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 5.3 Discrepant Results. If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, without regard to whether Catalent conducts an appropriate investigation as provided in Clause 5.2, and this is not resolved within *** of the Exception Notice date, the parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Product and its components, including Palatin-supplied Materials. The independent party’s results as to whether or not Product is Defective Product and the cause of any nonconformity shall be final and binding. Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by Catalent if Product is Defective Product attributable to Catalent Defective Processing, and by Palatin in all other circumstances. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing. 5.4 Defective Processing. Catalent shall, ***, either (A) *** or (B) ***. This shall be Palatin’s sole and exclusive remedy under this Agreement for Defective Product attributable to Catalent Defective Processing, other than as provided in Clause 4.7, 9.5 and 13.1 of this Agreement. 6. DELIVERY 6.1 Delivery. Catalent shall deliver Product Ex Works (Incoterms 2010) the Facility promptly following Catalent’s release of Product. Catalent shall segregate and store all Product until tender of delivery. Title to Product shall transfer to Palatin upon Catalent’s tender of delivery. Palatin shall qualify or validate at least three carriers to ship Product and then designate the priority of such qualified carriers to Catalent, and Catalent shall not, without Palatin’s prior written consent, utilize any other carrier for purposes of delivering Product to Palatin or its designees. Catalent shall include with each shipment of Product the applicable Purchase Order number, the Batch number and the quantity of Product. 6.2 Storage Fees. If Catalent performs in accordance with the Purchase Order, and Palatin fails to take delivery of any Product on any agreed delivery date, Catalent shall store such Product and Palatin shall be invoiced on the first day of each month following such scheduled delivery for reasonable storage costs. All such storage shall be under conditions set forth in the Specifications. For each such Batch of stored Product, risk of loss shall transfer to Palatin upon placement into storage and Catalent shall have the right to ship such Product to Palatin within two months after billing. 6.3 Bill and Hold . From time to time, at Palatin’s request, the agreed delivery date of the Purchase Order may be extended under a bill and hold arrangement as more fully set forth below. For each such Batch of stored Product, Palatin agrees that: (A) Palatin has made a fixed commitment to purchase the Product, (B) risk of loss for such Product passes to Palatin upon placement into storage, (C) such Product shall be on a bill and hold basis for legitimate business purposes, (D) Palatin shall identify a fixed delivery date for the Product and (E) Palatin shall agree to be invoiced and to pay such invoice in accordance with the payment terms set forth in Clause 7.3 of this Agreement. Upon making a request for a bill and hold arrangement, Palatin shall provide Catalent with a letter confirming items (A) through (E) of this Clause 6.3 for each Batch of stored Product. 10 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 7. PAYMENTS; LICENSING; CHANGE OF CONTROL 7.1 Fees. In consideration for Catalent performing services hereunder: A. Palatin shall pay to Catalent the fees for Validation Services set out on Attachment A. Catalent shall submit an invoice to Palatin for such fees upon the completion of the relevant phase of the Validation Services. B. Palatin shall pay Catalent the unit pricing for Product set out on Attachment D (“Unit Pricing”). Catalent shall submit an invoice to Palatin for such fees upon tender of delivery of Product as provided in Clause 6.1. C. Except as provided in Clause 3.5, Palatin shall pay Catalent the annual fees for Product Maintenance Services set out on Attachment D (the “Annual Product Maintenance Fee”). Catalent shall submit an invoice to Palatin for such Annual Product Maintenance Fee payable upon *** and upon each anniversary of such date thereafter during the Term. D. Other Fees. Palatin shall pay Catalent for all other fees and expenses of Catalent owing in accordance with the terms of this Agreement, including pursuant to Clauses 2.4, 4.1, 6.2, 9.2.1 and 16.4. Catalent shall submit an invoice to Palatin for such fees as and when appropriate. 7.2 Unit Pricing Adjustment . From and after ***, the Unit Pricing shall be adjusted ***, effective as of ***. Catalent shall give Palatin written notice of such adjustment by ***. The written notice shall specify the basis for each adjustment in the Price, including increases or decreases in the cost of Raw Materials, continuous improvement benefits and any increase or decrease of any other component of Unit Pricing. The amount of any increase in the cost of components of Unit Pricing other than Raw Materials shall not exceed ***. The cost of Raw Materials shall be passed through to Palatin ***. To manage the cost of Raw Materials, Palatin, at its option, may negotiate the terms of a supply agreement with any supplier of Raw Materials, including but not limited to *** with respect to the supply of ***. 7.3 Payment Terms. Payment of all Catalent invoices shall be due *** after the later of (A) the date of the invoice and (B) the date of delivery. Palatin shall make payment in euros. Unless an invoice is disputed by Palatin in good faith, if any payment is not received by Catalent by its due date, then Catalent may charge interest on the outstanding sum from the due date (both before and after any judgment) at *** per month until paid in full (or, if less, the maximum amount permitted by Applicable Laws). Further, if Palatin shall fail to make any payment when due other than for an invoice disputed by Palatin in good faith, and shall not have cured such non-payment within *** after receiving from Catalent written notice of non-payment, then Catalent shall have the right, at its option, to suspend any further performance hereunder until such default is corrected, without thereby releasing Palatin from its obligations under this Agreement. 7.4 Taxes. All taxes, duties and other levies assessed (excluding tax based on net income) on or in connection with Palatin-supplied Materials, services or Product in connection with provision or sale to Catalent or Palatin, shall be reimbursed by Palatin to Catalent (and shall be included in invoices) and all charges are exclusive of any applicable taxes, duties and levies which shall be added to invoices directed at Palatin. 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 7.5 Palatin and Third Party Expenses . Except as may be expressly covered by Product Maintenance Service fees, Palatin shall be responsible for 100% of its own and all third-party expenses associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies. 7.6 Development Batches. Each Batch produced under this Agreement pursuant to a Purchase Order or Palatin’s written request, including those necessary to support the validation portion of Palatin’s submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Processing has been validated. Palatin shall be responsible for the cost of each such development Batch, even if such development Batch fails to meet the Specifications, unless the cause of nonconformity is attributable to Catalent’s gross negligence or willful misconduct. Catalent and Palatin shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch. 7.7 Licensing Transaction by Palatin . In the event that Palatin enters into a marketing and/or licensing agreement with a third party pursuant to which agreement such third party acquires the right to market, sell and have sold the Product (i) within North America (comprising at least the United States of America) or (ii) worldwide, then the terms of Clause 3.3 of the Manufacturing Preparation and Services Agreement shall apply. For the avoidance of doubt, neither this Agreement nor the Manufacturing Preparation and Services Agreement shall terminate upon such event. 7.8 Palatin Change of Control. In the event of a Change of Control of Palatin, then the terms of Clause 3.4 of the Manufacturing Preparation and Services Agreement shall apply. For the avoidance of doubt, neither this Agreement nor the Manufacturing Preparation and Services Agreement shall terminate upon such event. 8. CHANGES TO SPECIFICATIONS All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Palatin or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees directly resulting from such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Palatin for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as reasonably practicable after a request is made for any change in Specifications, Catalent shall notify Palatin of the costs associated with such change and shall provide such supporting documentation as Palatin may reasonably require. Palatin shall pay all direct costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control unless the parties mutually agree that the terms of the Specifications expressly override the terms set forth herein. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment. 12 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 9. RECORDS; REGULATORY MATTERS 9.1 Record Keeping. Catalent shall maintain materially complete and accurate Batch, laboratory data, reports and other technical records relating to Processing in accordance with Catalent standard operating procedures and all Applicable Laws. Such information shall be maintained for a period of at least *** from the relevant finished Product expiry date or longer if required under Applicable Laws or the Quality Agreement. 9.2 Regulatory Compliance. Catalent shall obtain and maintain all permits and licenses with respect to general Facility operations required by any Regulatory Authority in the jurisdiction in which Catalent Processes Product. Palatin shall obtain and maintain all other Regulatory Approvals and other authorizations and certificates, including those necessary for Catalent to commence Processing. During the Term, Catalent will assist Palatin with all regulatory matters relating to Processing, at Palatin’s request and sole expense. Catalent reserves the right to assess Palatin for any regulatory fees that may be established by any Regulatory Authority subsequent to the Effective Date of this Agreement, which fees result directly from Catalent’s formulation, development, manufacturing, processing, filling, packaging, storing or testing of the Product or Palatin-supplied Materials. Except as required under Applicable Laws or by any governmental agency, Palatin shall not identify Catalent in any regulatory filing or submission with a Regulatory Authority without Catalent’s prior written consent. Such consent shall not be unreasonably withheld and shall be memorialized in a writing signed by authorized representatives of both parties. Upon Catalent’s written request, Palatin shall provide Catalent with a copy of any Regulatory Approvals required to distribute, market and sell Product in one or more countries within the Territory. If Palatin is unable to provide such information, Catalent shall have no obligation to deliver Product to Palatin, notwithstanding anything to the contrary in this Agreement. The parties intend and commit to cooperate to allow each party to satisfy its obligations under Applicable Laws relating to Processing under this Agreement. 9.2.1 GDUFA Fees. Palatin shall reimburse Catalent for any fees Catalent may be required to pay pursuant to the US Generic Drug User Fee Amendments of 2012 (“GDUFA Fees”), *** GDUFA Fees are assessed on Catalent when an Abbreviated New Drug Application (“ANDA”) applicant identifies Catalent in an ANDA application filed with FDA. GDUFA Fees are assessed by the FDA annually and shall be paid by Palatin annually, where applicable. Prior to October 1st of each year, and where applicable, Catalent will invoice Palatin for *** for each Catalent manufacturing or packaging facility identified in any Palatin ANDA(s) pursuant to FDA regulations (this includes but is not limited to any Catalent facility which manufactured or packaged Palatin’s registration batches). 9.3 Governmental Inspections and Requests. Catalent shall promptly advise Palatin if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action with respect to the Product or the Processing. Catalent shall promptly provide to Palatin a report of the result of any such inspection by any Regulatory Authority to the extent directly related to the Processing of the Product and furnish to Palatin a copy of all written information provided by such Regulatory Authority to the extent specifically and directly related to the Processing of the Product, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action taken. 13 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 9.4 Palatin Facility Audits . During the Term, Palatin’s Representatives shall be granted access upon *** prior notice, at reasonable times during regular business hours, to (A) the portion of the Facilities where Catalent performs Processing, (B) relevant personnel involved in Processing and (C) Processing records described in Clause 9.1, in each case solely for the purpose of verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch records. Palatin may not conduct an audit under this Clause 9.4 more than ***; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing. Palatin’s Quality Assurance Manager will arrange Palatin audits with Catalent Quality Management. Audits shall be designed to minimize, to the extent reasonably possible, disruption of operations at the applicable Facility. Palatin’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Such Representatives shall comply with the Facility’s rules and regulations. Palatin shall defend, indemnify and hold harmless Catalent for any action or activity of such Representatives while on Catalent’s premises. 9.5 Recall. If Catalent believes a recall, field alert, Product withdrawal or field correction (“ Recall”) may be necessary with respect to any Product supplied under this Agreement, Catalent shall promptly notify Palatin. Catalent will not act to initiate a Recall without the express prior written approval of Palatin, unless otherwise required by Applicable Laws. If Palatin believes a Recall may be necessary with respect to any Product supplied under this Agreement, Palatin shall promptly notify Catalent and Catalent shall provide all necessary cooperation and assistance to Palatin. Palatin shall provide Catalent with an advance copy of any proposed submission to a Regulatory Authority in respect of any Recall, and shall consider in good faith any comments from Catalent. The cost of any Recall shall be borne by Palatin, and Palatin shall reimburse Catalent for expenses incurred in connection with any Recall, in each case unless such Recall is caused solely by Catalent’s breach of its obligations under this Agreement with respect to Processing, violation of Applicable Laws or its negligence or willful misconduct, then such cost shall be borne by Catalent; provided, however, that for purposes hereof, such Catalent cost shall be limited to reasonable, actual and documented administrative costs incurred by Palatin (or its Affiliates, licensees or distributors) for such Recall and, subject to Section 14, replacement of the Product subject to Recall in accordance with Section 5. 9.6 Quality Agreement. Within six months after the Effective Date, and in any event prior to the first Processing of Product hereunder, the parties shall negotiate in good faith and enter into a quality or technical agreement (the “ Quality Agreement”). The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set out therein. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality- related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern. 14 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 9.7 Quality Assurance/Quality Control Standards. Upon Palatin’s written request, Catalent shall deliver to Palatin copies of Catalent’s quality assurance/quality control investigations, deviations, out-of-Specification notifications and change controls relevant to the Processing of Product. Catalent shall notify Palatin of any material changes made to any of the foregoing or any Specification during the Term. 10. CONFIDENTIALITY AND NON-USE 10.1 Definition. As used in this Agreement, the term “ Confidential Information” includes all information furnished by or on behalf of Catalent or Palatin (the “ Discloser”), its Affiliates or any of its or their respective Representatives, to the other party (the “Recipient”), its Affiliates or any of its or their respective Representatives, whether furnished before, on or after the Effective Date and furnished in any form, including written, verbal, visual, electronic or in any other media or manner and information acquired by observation or otherwise during any site visit at the other party’s facility. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other intellectual property (whether or not patented), analyses, compilations, business or technical information and other materials prepared by either party, their respective Affiliates, or any of its or their respective Representatives, containing or based in whole or in part on any information furnished by the Discloser, its Affiliates or any of its or their respective Representatives. Confidential Information also includes the existence of this Agreement and its terms. 10.2 Exclusions. Notwithstanding Clause 10.1, Confidential Information does not include information that (A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, (B) is already known by the Recipient at the time of disclosure as evidenced by the Recipient’s written records, (C) becomes available to the Recipient on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis or (D) was or is independently developed by or for the Recipient without reference to the Confidential Information of the Discloser as evidenced by the Recipient’s written records. 10.3 Mutual Obligation. The Recipient agrees that it will not use the Discloser’s Confidential Information except in connection with the performance of its obligations hereunder and will not disclose, without the prior written consent of the Discloser, Confidential Information of the Discloser to any third party, except that the Recipient may disclose the Discloser’s Confidential Information to any of its Affiliates and its or their respective Representatives that (A) need to know such Confidential Information for the purpose of performing under this Agreement, (B) are advised of the contents of this Clause and (C) are bound to the Recipient by obligations of confidentiality at least as restrictive as the terms of this Clause. Each party shall be responsible for any breach of this Clause by its Affiliates or any of its or their respective Representatives. 10.4 Permitted Disclosure. The Recipient may disclose the Discloser’s Confidential Information to the extent required under Applicable Laws or by the rules of any stock exchange on which the securities of the Discloser are listed in each case upon the reasonable advice of Recipient’s legal counsel; provided, that prior to making any such legally required disclosure, the Recipient shall give the Discloser as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances and use reasonable efforts to limit the scope of any such disclosure and to obtain confidential treatment of all Confidential Information of Discloser disclosed pursuant to such requirement. Any such disclosure, however, shall not relieve the Recipient of its confidentiality obligations as set forth in this Section 10. 15 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 10.5 Disclosure of this Agreement . A public disclosure of this Agreement or the Manufacturing Preparation and Services Agreement is permitted if, upon the reasonable advice of legal counsel of the party making the public disclosure, it is required by law (a “Required Disclosure”), including without limitation in a filing with the US Securities and Exchange Commission or the NYSE MKT, provided that the party making the public disclosure shall provide copies of the Required Disclosure to the non-disclosing party reasonably in advance of such filing or other disclosure for the non-disclosing party’s review and comment (but not approval). Each party shall consider in good faith any comments provided by the other party with respect to the content of the Required Disclosure, including with respect to the redaction of this Agreement and any other agreement that is to be filed or otherwise publicly disclosed in connection with the Required Disclosure, and shall incorporate such comments or redactions in the Required Disclosure if doing so does not interfere with the disclosing party’s ability to comply with any requirements under applicable law or any request or requirement of the US Securities and Exchange Commission or the NYSE MKT. 10.6 No Implied License. Except as expressly set out in Clause 10.1, the Recipient will obtain no right of any kind or license under any Confidential Information of the Discloser, including any patent application or patent, by reason of this Agreement. All Confidential Information will remain the sole property of the Discloser, subject to Section 11. 10.7 Return of Confidential Information. Upon expiry or termination of this Agreement, the Recipient will (and will cause its Affiliates and its and their respective Representatives to) cease its use and, upon written request, within *** either return or destroy (and certify as to such destruction) all Confidential Information of the Discloser, including any copies thereof, except for a single copy which may be retained for the sole purpose of ascertaining compliance with its obligations under this Agreement and any copies remaining on the Recipient’s standard computer back-up devices. 10.8 Survival. The obligations of confidentiality and non-use contained in this Section 10 will terminate *** after the expiry or termination of this Agreement, except with respect to trade secrets, for which the obligations of confidentiality and non-use contained in this Section 10 will continue for so long as such information remains a trade secret under applicable law. 11. INTELLECTUAL PROPERTY For purposes hereof, “Palatin IP” means all intellectual property and embodiments thereof owned by or licensed to Palatin as of the Effective Date or developed by Palatin other than in connection with this Agreement; “ Catalent IP” means all intellectual property and embodiments thereof owned by or licensed to Catalent as of the Effective Date or developed by Catalent other than in connection with this Agreement; “Invention” means any intellectual property developed by either party or jointly by the parties in connection with this Agreement; *** The parties shall cooperate to achieve the allocation of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection of its intellectual property. 12. REPRESENTATIONS AND WARRANTIES 12.1 Catalent. Catalent represents, warrants and undertakes to Palatin that: 16 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. A. at the time of delivery by Catalent as provided in Clause 6.1, all Product shall have been Processed in accordance with Applicable Laws and in conformance with the Specifications and the Quality Agreement and will not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Palatin-supplied Materials (including artwork, advertising and labeling); B. Catalent will comply with all Applicable Laws applicable to Catalent’s performance under this Agreement and its use of any Palatin-supplied Materials; C. To Catalent’s knowledge, there are no patents owned by others, or trade secrets or other proprietary rights of others, that would be infringed by the Catalent IP in Catalent’s performance of the Agreement; D. Catalent and its employees, affiliates, contractors, and agents have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 335(a) or 335(b) of the Federal Food, Drug, and Cosmetic Act; and E. Catalent will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications. 12.2 Palatin. Palatin represents, warrants and undertakes to Catalent that: A. all Palatin-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications, shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws, and shall have been provided in accordance with the terms and conditions of this Agreement; B. the content of all artwork provided to Catalent shall comply with all Applicable Laws; C. all Product delivered to Palatin by Catalent will be held, used and disposed of by or on behalf of Palatin in accordance with all Applicable Laws, and Palatin will otherwise comply with all laws, rules, regulations and guidelines applicable to Palatin’s performance under this Agreement; D. Palatin will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications and if Palatin does not hold all necessary Regulatory Approvals to market and sell the Product; E. Palatin has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Palatin-supplied Materials (including artwork), and the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; to Palatin’s knowledge, there are no patents owned by others related to the Palatin IP utilized with the Product that would be infringed or misused by Palatin’s performance of the Agreement; and, to Palatin’s knowledge, no trade secrets or other proprietary rights of others related to the Palatin IP utilized with the Product would be infringed or misused by Palatin’s performance of this Agreement; and F. to Palatin’s knowledge, the work to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity. 17 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 12.3 Mutual: No transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States. 12.4 Limitations. Save as expressly set out in this Agreement, neither party gives any representation or warranty in respect of the subject matter of this Agreement, and all representations and warranties that may be implied (by statute or otherwise) are hereby excluded to the maximum extent permitted by law. 13. INDEMNIFICATION 13.1 Indemnification by Catalent. Catalent shall defend, indemnify and hold harmless Palatin, its Affiliates, and their respective directors, officers and employees (“ Palatin Indemnitees”) from and against any and all claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees and reasonable investigative costs) in connection with any claim or action by any third party (“Losses”) arising out of or resulting from (A) any breach of its representations, warranties or obligations set out in this Agreement, (B) any negligence or willful misconduct by Catalent or (C) any actual or alleged infringement or violation of any patent, trade secret, copyright, trademark or other proprietary rights of a third party by the Catalent IP used in Catalent’s performance of its obligations under this Agreement, but for the avoidance of doubt not with respect to any such infringement or violation due to Palatin IP, API Inventions or Palatin-supplied Materials; in each case except to the extent that any of the foregoing arises out of or results from any Palatin Indemnitee’s negligence, willful misconduct or breach of this Agreement. 13.2 Indemnification by Palatin . Palatin shall defend, indemnify and hold harmless Catalent, its Affiliates, and their respective directors, officers and employees (“ Catalent Indemnitees”) from and against any and all Losses arising out of or resulting from (A) any breach of its representations, warranties or obligations set out in this Agreement, (B) any manufacture, packaging, sale, promotion, distribution or use of or exposure to Product or Palatin-supplied Materials, including product liability or strict liability, (C) Palatin’s exercise of control over the Processing, to the extent that Palatin’s instructions or directions violate Applicable Laws, (D) the conduct of any clinical trials utilizing Product or API, (E) any actual or alleged infringement or violation of any third party patent, trade secret, copyright, trademark or other proprietary rights by intellectual property or other information provided by Palatin, including Palatin-supplied Materials, or (F) any negligence or willful misconduct by Palatin; in each case except to the extent that any of the foregoing arises out of or results from any Catalent Indemnitee’s negligence, willful misconduct or breach of this Agreement. 13.3 Indemnification Procedures. All indemnification obligations in this Agreement are conditioned upon the indemnified party (A) promptly notifying the indemnifying party of any claim or liability of which the indemnified party becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying party of any of its obligations hereunder except to the extent the indemnifying party is prejudiced by such failure, (B) cooperating with the indemnifying party in the defense of any such claim or liability and any related settlement negotiations (at the indemnifying party’s expense) and (C) not compromising or settling any claim or liability without prior written consent of the indemnifying party. 18 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 14. LIMITATIONS OF LIABILITY 14.1 TOTAL LIABILITY. CATALENT’S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED *** 14.2 INDIRECT DAMAGES. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL LOSS OR DAMAGES, OR FOR LOSS OF REVENUES, PROFITS OR DATA, ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 15. INSURANCE Each party shall, at its own cost and expense, obtain and maintain in full force and effect during the Term the following in US dollars or foreign currency equivalent: (A) Commercial General Liability Insurance with a per-occurrence limit of not less than ***; (B) Products and Completed Operations Liability Insurance with a per-occurrence limit of not less than ***; and (C) All Risk Property Insurance, including transit coverage, in an amount equal to the full replacement value of its property while in, or in transit to, a Catalent facility as required under this Agreement. Each party may self-insure all or any portion of the required insurance as long as, together with its Affiliates, its US GAAP or foreign currency equivalent net worth is greater than *** or its annual EBITDA (earnings before interest, taxes, depreciation and amortization) is greater than ***. Each required insurance policy, other than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII. If any of the required policies of insurance are written on a claims made basis, such policies shall be maintained throughout the Term and for a period of at least *** thereafter. Each party shall obtain a waiver of subrogation clause from its property insurance carriers in favor of the other party, and such waivers will operate the same whether insurance is carried through third parties or self-insured. Upon the other party’s written request from time to time, each party shall promptly furnish to the other party a certificate of insurance or other evidence of the required insurance. 16. TERM AND TERMINATION 16.1 Term. This Agreement shall commence on the Effective Date and shall continue until the end of the fifth Contract Year (the “ Initial Term”), unless earlier terminated in accordance with Clause 16.3 or Clause 16.4 (the Initial Term as may be extended in accordance with Clause 16.2, the “Term”). 16.2 Renewal. The Initial Term shall automatically be extended for one 24-month period unless at least *** prior to the end of the Initial Term one party gives the other party written notice of its desire to terminate as of the end of the Initial Term. 16.3 Regulatory Approval. A. In the event that Palatin fails to obtain Regulatory Approval from the FDA prior to ***, then the parties shall meet to discuss in good faith such situation and shall agree upon an appropriate rental fee that Palatin shall pay to Catalent for the Auto Injector Assembly Line on a monthly basis until such time as Regulatory Approval is obtained or the Agreement is terminated hereunder, which payment shall in no event be less than***. The parties shall negotiate in good faith the minimum monthly rental payment to be made in the event that Catalent is using the Auto Injector Assembly Line on its own behalf or on behalf of a third party customer during such period.. 19 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. B. In the event that Palatin fails to obtain Regulatory Approval from the FDA prior to ***, then the parties shall meet to discuss in good faith such situation; provided, however, that notwithstanding such discussions, on or after such date, (i) Palatin shall pay to Catalent an amount equal to *** and (ii) Catalent shall have the right to terminate the Agreement after such date pursuant to the terms of this Section 16. 16.4 Termination. This Agreement may be terminated: A. by either party if steps are taken by or against the other party for the appointment of a liquidator, an administrator, a receiver, administrative receiver, manager, interim receiver, trustee, trustee in bankruptcy, nominee or supervisor or the other party proposes or enters into an agreement or arrangement with its creditors generally or makes an assignment for the benefit of its creditors generally, or otherwise suffers or permits the taking of any steps for adjudicating it to be bankrupt or insolvent and any such process, if reasonably shown to be warranted, frivolous or vexatious, is not withdrawn, dismissed or discharges within ***, or any equivalent or similar action to the above in consequence of the insolvency of that party is taken in any jurisdiction and is not withdrawn, dismissed or discharged in the circumstances described above; B. by either party if the other party materially breaches any of the provisions of this Agreement and such breach is not cured within *** after the giving of written notice requiring the breach to be remedied; provided, that in the case of a failure of Palatin to make payments in accordance with the terms of this Agreement, Catalent may terminate this Agreement if such payment breach is not cured within *** of receipt of notice of non-payment from Catalent; C. by Palatin pursuant to Clause 4.7; D. by Palatin upon notice and payment of the termination penalty provided in Clause 16.5D; and E. by Catalent pursuant to Clause 16.3B. 16.5 Effect of Termination. Expiry or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiry or termination. In the event of a termination of this Agreement: A. Catalent shall promptly return to Palatin, at Palatin’s expense and direction, all remaining inventory of Product and Palatin-supplied Materials; provided, that all outstanding undisputed invoices have been paid in full; B. Palatin shall pay Catalent all undisputed invoiced amounts outstanding, plus, upon receipt of an undisputed invoice(s), amounts for any (i) Product that has been shipped pursuant to Purchase Orders but not yet invoiced, (ii) Product Processed pursuant to Purchase Orders that has been completed but not yet shipped, and (iii) in the event that this Agreement is terminated for any reason other than by Palatin pursuant to Clause 16.3A, 16.3B or 16.3C, all Product in process of being Processed pursuant to Purchase Orders (or, alternatively, Palatin may instruct Catalent to complete such work in process, and the resulting completed Product shall be governed by clause (ii)); and 20 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. C. In the event that this Agreement is terminated for any reason other than by Palatin pursuant to Clause 16.3A, 16.3B or 16.3C, Palatin shall pay Catalent for all out-of-pocket costs and expenses incurred, and all noncancellable commitments made, in connection with Catalent’s performance of this Agreement, so long as such costs, expenses or commitments were made by Catalent consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor; provided, however, that notwithstanding the foregoing, Palatin shall have no obligation to pay Catalent for costs, expenses or commitments made with respect to Product in process of being Processed pursuant to Purchase Orders (it being understood that the amounts payable pursuant to Clause 16.4B(ii) shall fully compensate Catalent with respect to such Product in process). D. If this Agreement is terminated by Palatin pursuant to Clause 16.4D or for any reason other than pursuant to Clause 16.4B or 16. 4C, then Palatin shall pay Catalent a termination penalty in accordance with the following schedule: Date of Termination On or before the last day of Contract Year 1 During Contract Year 2 During Contract Year 3 During Contract Year 4 Amount of Termination Penalty *** *** *** *** E. Survival. The rights and obligations of the parties shall continue under Sections 11 (Intellectual Property), 13 (Indemnification), 14 (Limitations of Liability), 17 (Notice), 18 (Miscellaneous); under Clauses 10 (Confidentiality and Non-Use) and 15 (Insurance), in each case to the extent expressly stated therein; and under Clauses 7.3 (Payment Terms), 7.4 (Taxes), 7.5 (Palatin and Third Party Expenses), 9.1 (Record Keeping), 9.5 (Recall), 12.4 (Limitations on Warranties), 16.4 (Effect of Termination) and 16.5 (Survival), in each case in accordance with their respective terms if applicable, notwithstanding expiry or termination of this Agreement. 17. NOTICE All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally or by hand; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if sent by registered or certified or recorded post (return receipt requested), postage prepaid; or (D) when delivered by courier service; in each case, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof): To Palatin: Palatin Technologies, Inc. 4-B Cedar Brook Drive Cranbury, New Jersey 08512 USA Attn: Chief Financial Officer Facsimile: (609) 495-2202 21 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. With a copy to: Thompson Hine LLP To Catalent: Catalent Belgium S.A. 335 Madison Avenue, 12 th Floor New York, New York 10017 USA Attn: Faith Charles, Esq. Facsimile: (212) 344-6101 Rue Font St. Landry 10 Parc Mercator B-1120 Neder over Heembeek, Belgium Attn: General Manager Facsimile: 32-2-788-39-59 With a copy to: Catalent Pharma Solutions 14 Schoolhouse Road Somerset, NJ 08873 USA Attn: General Counsel (Legal Department) Facsimile: +1 (732) 537-6491 18. MISCELLANEOUS 18.1 Entire Agreement; Amendments . This Agreement, together with the Manufacturing Preparation and Services Agreement, the Quality Agreement and each Purchase Order, constitutes the entire understanding between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties, with respect to the subject matter hereof, including, for avoidance of doubt, that certain quotation letter (QTE- BRU 2012 059J) signed 12th October 2012 and the Binding Terms. For the avoidance of doubt, this Agreement does not supersede any existing generally applicable confidentiality agreement between the parties as it relates to time periods prior to the date hereof or to business dealings not covered by this Agreement. No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise expressly provided in this Agreement. 18.2 Captions; Certain Conventions. The headings used in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (A) words of any gender include each other gender, (B) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (C) words using the singular shall include the plural, and vice versa, (D) the words “include(s)” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import, (E) the word “or” shall be deemed to include the word “and” (e.g., “and/or”) and (F) references to “Clause” or other subdivision, or to an Attachment or other appendix, without reference to a document are to the specified provision or Attachment of this Agreement. This Agreement shall be construed as if it were drafted jointly by the parties. 18.3 Further Assurances. The parties agree to execute such further instruments and to undertake such other acts as may be reasonably necessary or appropriate to give full effect to the terms of this Agreement. 18.4 No Waiver. In no event shall any delay, failure or omission (in whole or in part) in enforcing, exercising or pursuing any right, power, privilege, claim or remedy conferred by or arising under this Agreement or by law, be deemed to be or construed as a waiver of that or any other right, power, privilege, claim or remedy in respect of the circumstances in question, or operate so as to bar the enforcement of that, or any other right, power, privilege, claim or remedy, in any other instance at any time or times subsequently. 22 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 18.5 Severability. If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect. 18.6 Independent Contractors. The relationship of the parties is that of independent contractors, and nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint venture, co-partners, employer/employee or principal/agent. 18.7 Successors and Assigns . Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party; provided, however, that either party may, without the other party’s consent, assign this Agreement in its entirety to an Affiliate or to a successor to substantially all of the business or assets of the assigning party or the assigning party’s business unit responsible for performance under this Agreement. 18.8 Third Party Rights. This Agreement shall not confer any rights or remedies upon any person or entity other than the parties to this Agreement and their respective successors and permitted assigns, and a person or entity who is not a party to this Agreement has no rights to enforce any term of this Agreement. 18.9 Governing Law. This Agreement and the legal relations between the parties in connection herewith shall be governed by, and construed in accordance with, the laws of the State of New Jersey, USA, without regard to the conflict of law principles thereof. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. 18.10 Alternative Dispute Resolution. Any dispute that arises between the parties in connection with this Agreement shall first be presented to the senior executives of the parties for consideration and resolution. If such executives cannot reach a resolution of the dispute within a reasonable time, not to exceed 30 days unless otherwise agreed by the parties in writing, then such dispute shall be submitted to arbitration by the International Institute for Conflict Prevention and Resolution, 575 Lexington Avenue, 21st Floor, New York, NY 10022 (“CPR”) by one arbitrator mutually agreed upon by the Parties. If no agreement can be reached within 30 days after names of potential arbitrators have been proposed by the CPR, then the CPR will choose one arbitrator having reasonable experience in commercial transactions of the type provided for in this Agreement. The arbitration shall take place in the English language in New York City, New York, in accordance with the CPR administered arbitration rules then in effect, and judgment upon any award rendered in such arbitration will be binding and may be entered in any court having jurisdiction thereof. Unless otherwise agreed to by the parties in writing, the arbitration shall commence within 60 days of the date on which a written demand for arbitration is filed. The arbitrator’s decision shall set forth a reasoned basis for any award of damages or finding of liability. The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages.. 18.11 Prevailing Party. In any dispute resolution proceeding between the parties in connection with this Agreement, the prevailing party will be entitled to recover its reasonable attorney’s fees and costs in such proceeding from the other party. 23 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 18.12 Publicity. Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under Applicable Laws, by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure. Notwithstanding the foregoing, the parties hereto intend to make a jointly agreed press release with respect to the Agreement within 60 days after the Effective Date or at such other time as mutually agreed by the parties. 18.13 Right to Dispose. If Catalent requests in writing from Palatin direction with respect to disposal of any inventories of Product, Palatin-supplied Materials, Palatin Equipment, other equipment, samples or other items belonging to Palatin and is unable to obtain a response from Palatin within 90 days after making such request, Catalent shall be entitled in its sole discretion to dispose of all such items. 18.14 Force Majeure. Except as to payments required under this Agreement, neither party shall be liable in damages for, nor shall this Agreement be capable of termination by reason of, any delay in such party’s performance, or breach of its obligations, hereunder if such delay or breach is caused by events beyond such party’s reasonable control, including acts of God, law or regulation or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire, flood or weather, labor disturbances, epidemic or failure of suppliers, public utilities or common carriers. If the events shall continue unabated for 90 days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from such events. 18.15 Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Delivery of an executed counterpart of this Agreement by fax or e-mail in an image format (e.g., .pdf file) shall be as effective as delivery of a manually executed counterpart of this Agreement. (signature page follows) 24 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. IN WITNESS WHEREOF, the parties have caused their respective duly authorized representatives to execute this Agreement effective as of the Effective Date. CATALENT BELGIUM S.A. /s/ Eric Kummer Name: Eric Kummer Title: General Manager June 14, 2016 PALATIN TECHNOLOGIES, INC. /s/ Stephen T. Wills Name: Stephen T. Wills Title: CFO/CO 25 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ATTACHMENT A VALIDATION SERVICES [To be agreed by the parties within ninety (90) days following the Effective Date and, when agreed to, to form a part of this Agreement. Attachment to reflect standard Catalent quotation format, including pricing. If no validation services are desired, state “N/A” on this page.] EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** ATTACHMENT B PRODUCT MAINTENANCE SERVICES EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** ATTACHMENT C SPECIFICATIONS EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** ATTACHMENT D UNIT PRICING, FEES AND MINIMUM REQUIREMENT EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. ATTACHMENT E COUNTRIES INCLUDED IN TERRITORY Canada Kosovo Former Yugoslav Republic of Macedonia Turkey Albania Andorra Bosnia and Herzegovina Iceland Liechtenstein Monaco Montenegro Norway San Marino Serbia Switzerland Vatican City State Armenia Azerbaijan Belarus Georgia Kazakhstan Kyrgyzstan Moldova Russia Tajikistan Ukraine Uzbekistan Turkmenistan Mongolia Vietnam EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTION 240.24b-2 MANUFACTURING PREPARATION AND SERVICES AGREEMENT (“Agreement”) effective as of this 10 th day of June 2016 (the “Effective Date ”), by and between Exhibit 10.38 PALATIN TECHNOLOGIES, INC. 4-B Cedar Brook Drive Cranbury, New Jersey 08512 U.S.A. (“Palatin”) and CATALENT BELGIUM S.A. Rue Font. St. Landry 10 Parc Mercator B-1120 Neder over Heembeek Belgium (“Catalent”) WHEREAS, Palatin is engaged in the development, marketing and sales of pharmaceutical products; WHEREAS, Catalent is a company engaged in the processing and supply of pharmaceutical products holding the necessary manufacturing licenses and permits in this respect; WHEREAS, it is necessary for Catalent (itself or through its Affiliates) to upgrade its manufacturing capacity and infrastructure to provide certain services in relation to the manufacture of the Product (as further defined herein) subject to this Agreement and to reserve certain manufacturing capacity on its upgraded facilities; WHEREAS, Palatin also wishes to entrust Catalent (itself or through its Affiliates) to perform certain Services (as further defined herein) in relation to the Product and Catalent agrees to perform such Services in accordance with the terms of this Agreement; WHEREAS, Catalent and Palatin have entered into that certain Binding Terms for Incorporation into a Capital and a Commercial Supply Agreement, dated April 1, 2016 (the “ Binding Terms”), which Binding Terms shall be superseded in its entirety by this Agreement and the Supply Agreement (as defined hereafter). NOW THEREFORE, in consideration of the foregoing premises and the following mutual covenants and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows: Page 1 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1. DEFINITIONS AND GENERAL 1.1 The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings: “Affiliate” means (a) with respect to Palatin, any corporation or other business entity that, directly or indirectly, is controlled by, controls, or is under common control with Palatin; and (b) with respect to Catalent, Catalent, Inc. and any corporation or other business entity controlled, directly or indirectly, by Catalent Pharma Solutions, Inc. For such purposes, “control” means the direct or indirect ownership of at least fifty percent (50%) of the voting interest in such corporation or other entity or the power in fact to control the management directions of such entity. “Catalent CAPEX Expenditures” has the meaning set forth in Section 3.1. “Change of Control” means, with respect to a party: (a) any merger, reorganization, consolidation, or other business combination of such party with a third party that results in the voting securities of such party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation, or other business combination; (b) a third party becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of such party in a single transaction or series of related transactions; or (c) the sale, transfer, exchange or other disposition to a third party of all or substantially all of a party’s assets or business relating to this Agreement (whether alone or in connection with a sale, transfer, exchange or other disposition of other assets or businesses of such party). “Facility” means Catalent’s facility in Brussels, Belgium or such other Catalent facility as mutually agreed by the parties. “GMP Space Reservation Fee” means the amount owed by Palatin to Catalent for access to Catalent’s *** resources *** and for reservation of the applicable part of the Facility space pursuant to the terms of this Agreement, which amount shall total ***. “Manufacturing Preparation” has the meaning given in Section 2.1. “Manufacturing Preparation Plan” means the plan as detailed in ANNEX 1. “Product” means the proprietary Palatin product containing the active pharmaceutical ingredient, bremelanotide. “Supply Agreement” means that certain agreement covering the commercial manufacturing and supply of the Product between Catalent and Palatin of even date herewith. “Services” has the meaning given in Section 2.2. “Term” has the meaning given in Section 4.1. 1.2 1.3 All monetary amounts are expressed in this Agreement in Euros (EUR), the official currency of the euro area with the exception of the amount set forth in Section 3.4(iii), which amount is expressed in United States Dollars. The division of this Agreement into sections, subsections and Annexes and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a section or an annex refers to the specified Section or ANNEX to this Agreement. In this Agreement, the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement. Page 2 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 1.4 1.5 1.6 2. 2.1 2.2 Except as otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa. Any reference herein to a “day” (including “week”) shall be references to a business day, excluding any Saturday, Sunday or public holiday (in the country or countries in which Palatin or Catalent or the Facility are physically located). Catalent may delegate certain activities hereunder to its Affiliates and Palatin hereby agrees to such delegation subject to the following sentence: Catalent hereby agrees that regardless of such delegation, Catalent shall remain fully liable for the performance of its obligations under this Agreement by its Affiliate(s) to the same extent as if Catalent had performed or failed to perform its obligations under this Agreement. MANUFACTURING PREPARATION AND SERVICES Catalent shall have available all necessary manufacturing equipment and infrastructure at the Facility (collectively, “ Manufacturing Preparation”) in accordance with the Manufacturing Preparation Plan as set out in ANNEX 1 to manufacture and supply the Product to Palatin pursuant to the terms of the Supply Agreement. Catalent shall take all actions necessary to make available the Manufacturing Preparation for the Products at the Facility in accordance with the Manufacturing Preparation Plan (the “ Services”). Catalent shall provide the Services in a timely manner in accordance with the estimated timelines set forth in ANNEX 1 or such other timelines as the parties agree upon in writing. If either party anticipates that certain timelines of the Manufacturing Preparation Plan may not be met, then it shall notify the other party as soon as reasonably practicable. Within *** of receipt of such notice, the parties shall meet to discuss in good faith and find an appropriate course of action to remedy the situation. Catalent shall provide the Services in conformance with that level of care and skill ordinarily exercised by other professionals in similar circumstances and in compliance with all applicable laws and regulations. 2.3 2.4 2.5 Catalent shall have sole legal title to the Facility and any improvements thereto and the Manufacturing Preparation and the right to use it for any other purposes and customers at its own discretion, subject to the right of Palatin and its Affiliates to have priority for the use of the Manufacturing Preparation pursuant to the terms of the Supply Agreement, and provided that Catalent supplies Palatin with Product as set out in the Supply Agreement. Catalent shall be solely responsible for maintenance and repair of the Manufacturing Preparation, if and as needed. Catalent shall send to Palatin a written *** report describing the progress of each event of the Manufacturing Preparation Plan set forth in ANNEX 1. Catalent shall inform Palatin about significant accomplished phases and completed equipment and infrastructure build-outs of the Manufacturing Preparation Plan. Catalent shall at all times use its commercially reasonable efforts to minimize the costs associated with the implementation of the Manufacturing Preparation. Catalent will provide an initial cost overview as set forth in ANNEX 1. In case such cost overview shows significant variations (more than ***) from the cost anticipated by both parties for the implementation of the Manufacturing Preparation as set forth in the initial cost overview in ANNEX 1, the parties shall agree in good faith on the allocation of such cost variation. Page 3 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 2.6 2.7 3. 3.1 3.2 3.3 3.4 3.5 4. 4.1 Catalent shall perform the Services in a transparent manner and provide Palatin such information regarding the Services and the Manufacturing Preparation as Palatin may reasonably request from time to time, including providing copies of relevant documentation with respect to the Manufacturing Preparation set up and the fees and costs associated therewith. Palatin shall have the right to inspect the Facility, subject to any confidentiality obligations that Catalent has in relation to other customers, and the activities being performed in connection with the Services and/or the Manufacturing Preparation Plan upon giving reasonable prior written notice and during normal business hours. If this Agreement expires or is terminated for any reason in accordance with Article 4, Catalent shall, to the extent possible and as soon as reasonably feasible, cancel any purchase orders placed in relation to any equipment or costs incurred in connection with the infrastructure upgrade that Catalent agreed to implement as part of the Manufacturing Preparation under this Agreement. Catalent shall also use its reasonable efforts to minimize the costs incurred associated with any such equipment or infrastructure upgrade including mitigating any commitments towards its suppliers, and shall not enter into any applicable further purchasing commitments. PAYMENTS; LIMITATION OF LIABILITY Catalent shall make all payments to any vendors and suppliers with respect to the Manufacturing Preparation (the total amount of such payments by Catalent, the “ Catalent CAPEX Expenditures”). Catalent shall provide written reports to Palatin on a *** basis, by ***, reflecting up-to-date Catalent CAPEX Expenditures (each, a “CAPEX Report”), and Palatin shall have the right, upon giving reasonable prior written notice and during normal business hours, to review the actual costs and supporting documents with respect thereto. Catalent shall reserve GMP space within the Facility for the period beginning *** and continuing throughout the Term of this Agreement. Palatin shall pay to Catalent the GMP Space Reservation Fee in *** installments. ***. The *** last installment ***. Catalent shall issue to Palatin an invoice for the first installment of the GMP Space Reservation Fee ***. Catalent shall issue to Palatin an invoice for each succeeding installment *** thereafter until the GMP Space Reservation Fee has been paid in full. Each payment shall be due *** after the date of the applicable invoice. Palatin shall promptly notify Catalent if Palatin enters into a marketing and/or licensing agreement with a third party pursuant to which agreement such third party acquires the right to market, sell and have sold the Product (i) within North America (comprising at least the United States of America) or (ii) worldwide. Upon receiving such notice, ***. For the avoidance of doubt, neither this Agreement nor the Supply Agreement shall terminate upon such event. In the event of a Change of Control of Palatin, then within *** after the actual effective date of such Change of Control, ***. For the avoidance of doubt, neither this Agreement nor the Supply Agreement shall terminate upon such event. The limitation of liability of Catalent and Palatin under this Agreement shall be as set forth in Article 14 of the Supply Agreement. TERM AND TERMINATION This Agreement shall come into force on the Effective Date and continue in full force and effect until completion of each party’s obligations hereunder or until such other date as the parties may mutually agree upon in writing (“ Term”). In the case of Catalent, such obligations shall be completed upon such date as the Manufacturing Preparation has been built, installed and qualified. 4.2 Either party may terminate this Agreement immediately at any time by written notice to the other party if: (a) (b) an event where the other party materially breaches a provision of this Agreement and fails or is unable to remedy such breach within *** of receipt of notice in writing specifying the breach and requiring it to be remedied; or steps are taken by or against the other party for the appointment of a liquidator, an administrator, a receiver, administrative receiver, manager, interim receiver, trustee, trustee in bankruptcy, nominee or supervisor or the other party proposes or enters into an agreement or arrangement with its creditors generally or makes an assignment for the benefit of its creditors generally, or otherwise suffers or permits the taking of any steps for adjudicating it to be bankrupt or insolvent and any such process, if reasonably shown to be warranted, frivolous or vexatious, is not withdrawn, dismissed or discharges within ***, or any equivalent or similar action to the above in consequence of the insolvency of that party is taken in any jurisdiction and is not withdrawn, dismissed or discharged in the circumstances described above. Page 4 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 4.3 4.4 4.5 Palatin shall have the right to terminate this Agreement in whole or in part at its own convenience at any time upon *** prior written notice. In the event of such termination, within *** after the effective date of such termination Palatin shall pay to Catalent ***. Termination of this Agreement shall be without prejudice to any claim or right of action of either party against the other party for any prior breach of this Agreement. Upon termination of this Agreement by either party or expiration of this Agreement, each party shall return to the other party or such party’s designee (as such party shall in its sole discretion direct) any materials or documents that have been supplied by such party to the other party under this Agreement. 4.6 Any termination or expiry of the Supply Agreement shall be without prejudice to the validity of this Agreement or any claim or right of action of either party against the other party arising out of this Agreement. 5. 5.1 CONFIDENTIALITY Neither party shall disclose to any third party nor use for any purpose outside of the scope of this Agreement any information which is not in the public domain (“ Confidential Information”) and which was disclosed in connection with this Agreement by: (a) a party or any of its Affiliates; or (b) any unaffiliated third party at the request of a party ((a) and/or (b) the “Disclosing Party”). The party receiving the Confidential Information (the “ Receiving Party”) may only provide the Disclosing Party’s Confidential Information to its and its Affiliates’ directors, officers, employees, advisors, and consultants (“Representatives”) who are informed of the confidential nature of the Confidential Information and who are bound by obligations of confidentiality and non-use no less restrictive than those contained herein and provided that the Receiving Party shall be responsible for any breach of this Agreement by its Representatives, which shall be considered a breach by the Receiving Party. The obligations of confidentiality and non-use shall expire for Confidential Information which: (a) (b) (c) is or becomes part of the public domain without a violation of this Agreement; was already in the possession of the Receiving Party at the time of receipt from the Disclosing Party, as shown by documentary evidence; or after the date of this Agreement is received by the Receiving Party, without a confidentiality obligation, from a third party whose direct or indirect source is not the Disclosing Party. 5.2 The Receiving Party may disclose the Disclosing Party’s Confidential Information to the extent required under applicable laws or by the rules of any stock exchange on which the securities of the Disclosing Party are listed in each case upon the reasonable advice of the Receiving Party’s legal counsel; provided, that prior to making any such legally required disclosure, the Receiving Party shall give the Disclosing Party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances and shall use reasonable efforts to limit the scope of any such disclosure and to obtain confidential treatment of all Confidential Information disclosed pursuant to such requirement. Any such disclosure, however, shall not relieve the Receiving Party of its confidentiality obligations as set forth in Section 5.1. Page 5 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 5.3 5.4 6. 6.1 6.2 6.3 7. 7.1 7.2 The obligations of confidentiality and non-use contained in this Section 5 will terminate *** after the expiry or termination of this Agreement, except with respect to trade secrets, for which the obligations of confidentiality and non-use contained in this Clause will continue for so long as such information remains a trade secret under applicable law. Upon expiration or termination of this Agreement, the Receiving Party will (and will cause its Affiliates and its and their respective Representatives to) cease its use and, upon written request, within *** either return or destroy (and certify as to such destruction) all Confidential Information of the Disclosing Party, including any copies thereof, except for a single copy which may be retained for the sole purpose of ascertaining compliance with its obligations under this Agreement and any copies remaining on the Receiving Party’s standard computer back-up devices. DISPUTE RESOLUTION Governing Law. This Agreement and the legal relations between the parties in connection herewith shall be governed by, and construed in accordance with, the laws of the State of New Jersey, USA, without regard to the conflict of law principles thereof. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. Alternative Dispute Resolution . Any dispute that arises between the parties in connection with this Agreement shall first be presented to the senior executives of the parties for consideration and resolution. If such executives cannot reach a resolution of the dispute within a reasonable time, not to exceed thirty (30) days unless otherwise agreed by the parties in writing, then such dispute shall be submitted to arbitration by the International Institute for Conflict Prevention and Resolution, 575 Lexington Avenue, 21st Floor, New York, NY 10022 (“CPR”) by one arbitrator mutually agreed upon by the Parties. If no agreement can be reached within thirty (30) days after names of potential arbitrators have been proposed by the CPR, then the CPR will choose one arbitrator having reasonable experience in commercial transactions of the type provided for in this Agreement. The arbitration shall take place in the English language in New York City, New York, in accordance with the CPR administered arbitration rules then in effect, and judgment upon any award rendered in such arbitration will be binding and may be entered in any court having jurisdiction thereof. Unless otherwise agreed to by the parties in writing, the arbitration shall commence within sixty (60) days of the date on which a written demand for arbitration is filed. The arbitrator’s decision shall set forth a reasoned basis for any award of damages or finding of liability. The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages. Remedy for Breach. The parties understand and agree that monetary damages may not be sufficient remedy for breach of this Agreement and that the injured party will be entitled to seek equitable relief, including injunction and specific performance, for any such breach. MISCELLANEOUS Relationship of the Parties. For the purposes of this Agreement, each party shall be an independent contractor and not an agent or employee of the other party. Neither party shall have authority or power to make any statements, representations or commitments of any kind, or to take any action which is binding on the other party, unless expressly so authorized to do so by an instrument in writing signed by authorized representatives of such other party. Notices. All notices and other communications hereunder shall be in writing and shall be deemed given: (a) when delivered personally or by hand; (b) when delivered by facsimile transmission (receipt verified); (c) when received or refused, if sent by registered or certified or recorded post (return receipt requested), postage prepaid; or (d) when delivered by courier service; in each case, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof): Page 6 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. Catalent Catalent Belgium S.A. Rue Font. St. Landry 10 Parc Mercator B-1120 Neder over Heembeek Belgium Attn: General Manager Fax: 32-2-788-39-59 With a copy to: Catalent Pharma Solutions 14 Schoolhouse Road Somerset, NJ 08873 USA Attn: General Counsel (Legal Department) Email : GenCouns@catalent.com Palatin Technologies, Inc. 4-B Cedar Brook Drive Cranbury, New Jersey 08512 U.S.A. Attn: Chief Financial Officer Fax: (609) 495-2202 With a copy to: Thompson Hine LLP 335 Madison Avenue, 12th Floor New York, New York 10017 USA Attn: Faith Charles, Esq. Facsimile: (212) 344-6101 7.3 7.4 Annexes. All Annexes (and any amendments to such Annexes) and their enclosures form an integral part of this Agreement and are incorporated herein by reference. This Agreement shall govern if there is any conflict between the terms of such Annexes and the terms of this Agreement. Entire Agreement. This Agreement (including the Annexes hereto) and the Supply Agreement constitute the entire agreement between the parties related to the subject matter covered by this Agreement, shall supersede and prevail over any other prior or contemporaneous arrangements regarding this subject matter, whether written or oral, including without limitation the Binding Terms (as defined in the Recitals hereto), and is binding upon the parties hereto and their successors and permitted assigns. For the avoidance of doubt, this Agreement does not supersede any existing generally applicable confidentiality agreement between the parties as it relates to time periods prior to the date hereof or to business dealings not covered by this Agreement. No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise expressly provided in this Agreement. 7.5 Assignment. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party; provided, however, that either party may, without the other party’s consent, assign this Agreement in its entirety to an Affiliate or to a successor to substantially all of the business or assets of the assigning party or the assigning party’s business unit responsible for performance under this Agreement. 7.6 Severability. If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect. Page 7 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 7.7 7.8 No Waiver. In no event shall any delay, failure or omission (in whole or in part) in enforcing, exercising or pursuing any right, power, privilege, claim or remedy conferred by or arising under this Agreement or by law, be deemed to be or construed as a waiver of that or any other right, power, privilege, claim or remedy in respect of the circumstances in question, or operate so as to bar the enforcement of that, or any other right, power, privilege, claim or remedy, in any other instance at any time or times subsequently. Counterparts. This Agreement (and any Annexes and amendments hereto) may be executed in two or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Delivery of an executed counterpart of this Agreement by fax or e-mail in an image format (e.g., .pdf file) shall be as effective as delivery of a manually executed counterpart of this Agreement. (signature page follows) Page 8 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The parties have caused their respective duly authorized representatives to execute this Agreement effective as of the Effective Date. Palatin Technologies, Inc. /s/ Stephen T. Wills Name: Stephen T. Wills Title: CFO/COO Date: June 20, 2016 Catalent Belgium S.A. /s/ Eric Kummer Name: Eric Kummer Title: General Manager Date: June 14, 2016 Page 9 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** ANNEX 1 MANUFACTURING PREPARATION PLAN Page 10 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. *** INITIAL COST OVERVIEW FOR THE MANUFACTURING PREPARATION Page 11 of 11 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. SUBSIDIARIES OF THE REGISTRANT EXHIBIT 21 Name of Subsidiary RhoMed Incorporated State of Incorporation New Mexico Name Under Which Subsidiary Does Business RhoMed Incorporated EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. The Board of Directors Palatin Technologies, Inc.: Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements (Nos. 333-33569, 333-56605, 333-64951, 333-72873, 333-84421, 333-52024, 333-54918, 333-74990, 333-100469, 333-101764, 333-104370, 333-112908, 333-128585, 333-132369, 333-140648, 333-146392, 333-170227, 333-174251, 333-183837, 333-185113, 333-201821, 333-206003, and 333-206047) on Form S-3 and in the registration statements (Nos. 333-57079, 333-83876, 333-128854, 333-149093, 333-163158, 333-174257, 333-191467, and 333-206009) on Form S-8 of Palatin Technologies, Inc. of our report dated September 19, 2016, with respect to the consolidated balance sheets of Palatin Technologies, Inc. and subsidiary as of June 30, 2016 and 2015, and the related consolidated statements of operations, stockholders’ (deficiency) equity, comprehensive loss and cash flows for each of the years in the three-year period ended June 30, 2016, which report appears in the June 30, 2016 annual report on Form 10-K of Palatin Technologies, Inc. Our report dated September 19, 2016 contains an explanatory paragraph that states that the Company has incurred recurring net losses and negative cash flows from operations and will require substantial additional financing to continue to fund its planned developmental activities. These conditions raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. Exhibit 23 /s/ KPMG LLP Philadelphia, Pennsylvania September 19, 2016 EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. EXHIBIT 31.1 I, Carl Spana, certify that: 1. I have reviewed this Annual Report on Form 10-K of Palatin Technologies, Inc.; Certification of Chief Executive Officer 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange 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 subsidiary, is made known to us by others within those 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness 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 most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors: (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably 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 internal control over financial reporting. Date: September 19, 2016 /s/ Carl Spana Carl Spana, President and Chief Executive Officer EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. EXHIBIT 31.2 I, Stephen T. Wills, certify that: 1. I have reviewed this Annual Report on Form 10-K of Palatin Technologies, Inc.; Certification of Chief Financial Officer 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange 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 subsidiary, is made known to us by others within those 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness 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 most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors: (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably 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 internal control over financial reporting. Date: September 19, 2016 /s/ Stephen T. Wills Stephen T. Wills, Executive Vice President, Chief Financial Officer and Chief Operating Officer EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. I, Carl Spana, President and Chief Executive Officer of Palatin Technologies, Inc., hereby certify, to my knowledge, that the Annual Report on Form 10-K for the year ended June 30, 2016 of Palatin Technologies, Inc. (the “Form 10-K”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of Palatin Technologies, Inc. Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350 As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 EXHIBIT 32.1 Dated: September 19, 2016 /s/ Carl Spana Carl Spana, President and Chief Executive Officer (Principal Executive Officer) EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. I, Stephen T. Wills, Executive Vice President, Chief Financial Officer and Chief Operating Officer of Palatin Technologies, Inc., hereby certify, to my knowledge, that the Annual Report on Form 10-K for the year ended June 30, 2016 of Palatin Technologies, Inc. (the “Form 10-K”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of Palatin Technologies, Inc. Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 EXHIBIT 32.2 Dated: September 19, 2016 /s/ Stephen T. Wills Stephen T. Wills, Executive Vice President, Chief Financial Officer and Chief Operating Officer (Principal Financial Officer) EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved. 

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