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
 
For the Fiscal Year Ended April 30, 2014
 
Commission File No. 001-34600
 
OXYGEN BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
26-2593535
(State or other jurisdiction of Incorporation or organization)
(I.R.S. Employer Identification No.)
 
ONE Copley Parkway, Suite 490, Morrisville, NC 27560
(Address of Principal Executive Offices) (Zip Code)
 
Registrant’s Telephone Number and area code: (919) 855-2100
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class
Name of Each Exchange on Which Registered
Common Stock, $0.0001 par value per share
The NASDAQ Stock Market LLC
 
Securities registered pursuant to Section 12(g) of the Act: NONE
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No þ
 
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 o No þ
 
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 þ No o
 
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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No o
 
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 registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to the this Form 10-K.   o
 
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
o
Accelerated filer
o
Non-accelerated filer
o
Smaller reporting company
þ
       
(Do not check if a 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 o No þ
 
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: $19,682,675.
 
The number of shares outstanding of the registrant’s class of $0.0001 par value common stock as of July 24, 2014 was 28,107,206.
 
DOCUMENTS INCORPORATED BY REFERENCE:
 
Proxy Statement for the 2014 Annual Meeting of Stockholders is incorporated by reference in Part III to the extent described therein.
 


 
 
 
 
 
TABLE OF CONTENTS
 
PART I
    3  
     ITEM 1—BUSINESS
    8  
     ITEM 1A—RISK FACTORS
    21  
     ITEM 1B—UNRESOLVED STAFF COMMENTS
    21  
     ITEM 2—PROPERTIES
    22  
     ITEM 3—LEGAL PROCEEDINGS
    22  
     ITEM 4— MINE SAFETY DISCLOSURES
    23  
PART II
    23  
     ITEM 5—MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
    23  
     ITEM 6—SELECTED FINANCIAL DATA
    24  
     ITEM 7—MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
    24  
     ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
    31  
     ITEM 8—CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
    31  
     ITEM 9—CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
    65  
     ITEM 9A—CONTROLS AND PROCEDURES
    65  
   I TEM 9B— OTHER INFORMATION
    66  
PART III
    66  
     ITEM 10— DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
    66  
     ITEM 11— EXECUTIVE COMPENSATION
    66  
     ITEM 12— SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
    66  
     ITEM 13— CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
    66  
     ITEM 14— PRINCIPAL ACCOUNTANT FEES AND SERVICES
    66  
PART IV
    67  
     ITEM 15— EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
    67  
 
 
 
2

 
 
PART I
 
FORWARD-LOOKING STATEMENTS
 
All statements contained in this report, other than statements of historical fact, which address activities, actions, goals, prospects, or new developments, that we expect or anticipate will or may occur in the future, including plans for clinical tests and other such matters pertaining to testing and development products, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of such terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including, but not limited to, progress in our product development and testing activities, obtaining financing for operations, development of new technologies and other competitive pressures, legal and regulatory initiatives affecting our products, conditions in the capital markets, the risks discussed in Item 1A – “Risk Factors,” and the risks discussed elsewhere in this report that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activities, performance or achievements expressed or implied by such forward-looking statements.
 
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of such statements. We are under no duty to update any of the forward-looking statements after the date of filing of this report or to conform such statements to actual results, except as may be required by law.
 
All references in this Annual Report to “Oxygen Biotherapeutics”, “we”, “our” and “us” means Oxygen Biotherapeutics, Inc.
 
ITEM 1—BUSINESS
 
Oxygen Biotherapeutics was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc.  Effective June 30, 2008, we changed the domiciliary state of the corporation to Delaware and changed the company name to Oxygen Biotherapeutics, Inc.
 
Oxygen Biotherapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market. On November 13, 2013, through our wholly owned subsidiary, Life Newco, Inc., or Life Newco, we acquired a license granting Life Newco an exclusive, sublicenseable right in the United States and Canada to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial, for use in the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome or LCOS. We plan to start a Phase 3 trial with levosimendan in that indication during the third quarter of calendar year 2014.
 
We are also developing Oxycyte®, a systemic perfluorocarbon, or PFC, product we believe is a safe and effective oxygen carrier for use in situations of acute ischemia. In addition, we have developed a family of perfluorocarbon-based oxygen carriers for use in personal care, topical wound healing, and other topical indications. Oxycyte has been successful in two clinical trials and is currently being evaluated in a Phase II-b clinical trial for the treatment of traumatic brain injury, or TBI.
 
Business Strategy
 
Our principal business objective is to discover, develop, and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and commercial opportunity. The key elements of our business strategy are outlined below.
 
 
3

 
 
Efficiently conduct clinical development to establish clinical proof of concept with our lead product candidates. Levosimendan and Oxycyte represent novel therapeutic modalities for the treatment of LCOS, TBI and other critical care conditions. We are conducting clinical development in a variety of clinical studies with the intent to establish proof of concept in a number of important disease areas where these therapeutics would be expected to have benefit. Our focus is on conducting well-designed studies early in the clinical development process to establish a robust foundation for subsequent development, partnership and expansion into complementary areas.
 
Efficiently explore new high potential therapeutic applications, leveraging third-party research collaborations and our results from related areas .  Our product candidates have shown promise in multiple disease areas. We are committed to exploring potential clinical indications where our therapies may achieve best-in-class profile, and where we can address significant unmet medical needs. In order to achieve this goal, we have established collaborative research relationships with investigators from research and clinical institutions and the United States Army and Navy. These collaborative relationships have enabled us to cost effectively explore where our product candidates may have therapeutic relevance, and how it may be utilized to advance treatment over current clinical care. Additionally, we believe we will be able to leverage clinical safety data and preclinical results from some programs to support accelerated clinical development efforts in other areas, saving substantial development time and resources compared to traditional drug development.
 
Continue to expand our intellectual property portfolio . Our intellectual property is important to our business and we take significant steps to protect its value. We have ongoing research and development efforts, both through internal activities and through collaborative research activities with others, which aim to develop new intellectual property and enable us to file patent applications that cover new applications of our existing technologies or product candidates.
 
Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas . In addition to our internal development efforts, an important part of our product development strategy is to work with collaborators and partners to accelerate product development, reduce our development costs, and broaden our commercialization capabilities. We believe that this strategy will help us to develop a portfolio of high quality product development opportunities, enhance our clinical development and commercialization capabilities, and increase our ability to generate value from our proprietary technologies.
 
Our Current Programs
 
Levosimendan
 
Levosimendan was discovered and developed by Orion Pharma, a Finnish company. Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 50 countries for this indication and not available in the United States or Canada. It is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of LCOS. Our acquisition of levosimendan brings to Oxygen Biotherapeutics not only the exclusive rights in the United States and Canada to develop and commercialize levosimendan for the specific indication of prevention and treatment of LCOS, but also the United States Food and Drug Administration’s, or FDA’s, approval of Fast Track status for a Phase 3 trial, and the FDA’s Special Protocol Assessment or SPA which represents agreement with the Phase III clinical trial’s study protocol. The FDA has also provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. Pursuant to our license to levosimendan, we are required to use the “Simdax®” trademark to commercialize this product.
 
The effects of levosimendan are mediated through:
 
-  
increased cardiac contractility by calcium sensitization of troponin C;
 
-  
vasodilation through the opening of potassium channels; and
 
-  
cardioprotection and antiapoptopic effect through the opening of mitochondrial potassium channel.
 
The physiologic effects of levosimendan have been very well characterized in clinical trials of acutely decompensated heart failure or ADHF patients and cardiac surgery patients. The collective findings of these clinical trials form the basis for developing levosimendan in cardiac surgery patients at risk for LCOS.
 
Current data in cardiac surgery suggest that levosimendan is superior to traditional inotropes (dobutamine, phosphodiesterase [PDE]-inhibitors) as it achieves:
 
-  
sustained hemodynamic improvement;
 
 
4

 
 
-  
diminished myocardial injury;
 
-  
improved tissue perfusion;
 
-  
better outcomes and fewer hospital days;
 
-  
effects most favorable in patients with low left ventricular ejection fraction (LVEF) (< 40%); and
 
-  
opportunity to initiate therapy pre-operatively due to increased cardiac contractility without increasing intracellular calcium, without increasing oxygen consumption, or affecting cardiac rhythm and relaxation.
 
We have selected Duke University’s Duke Clinical Research Institute, or DCRI, to conduct the Phase 3 trial of levosimendan. DCRI is the world’s largest academic clinical research organization, with substantial experience in conducting cardiac surgery trials. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass graphs or CABG and/or mitral valve surgery who are at risk for developing LCOS. The trial is expected to be a double blind, randomized, placebo controlled study seeking to enroll 760 patients. It is expected that enrollment will begin in the third quarter of calendar year 2014, and will take approximately 18 months to complete. The protocol of the Phase 3 trial has been submitted to ClinicalTrials.gov.
 
Should levosimendan successfully progress in clinical testing and if it appears regulatory approval for one or more medical uses is likely, we intend to evaluate our options for commercializing the product. These options include licensing levosimendan to a third party for distribution, selling the product ourselves, or establishing some other form of strategic relationship for making and distributing levosimendan with a participant in the pharmaceutical industry. We are currently investigating and evaluating all options.
 
Oxycyte
 
Our Oxycyte oxygen carrier product is a PFC-based oil in water emulsion, which is provided to the patient intravenously. The physical-chemical properties of PFCs enable our product to concentrate oxygen from the lungs and transport it through the body releasing it along the way.  Over a period of days Oxycyte is gradually exhaled through the lungs during the normal process of respiration. Oxycyte requires no cross matching, so it is immediately available and compatible with all patients’ blood types. Oxycyte has an extended shelf life compared to blood and is provided as a sterile emulsion ready for intravenous administration.  Because it contains no biological components, there is reduced risk of transmission of blood-borne viruses from human blood products.  Further, since Oxycyte is based on readily available inert compounds, we believe it can be manufactured on a cost-effective basis in amounts sufficient to meet demand.
 
We received approval of our Investigational New Drug application, or IND, for severe TBI filed with FDA and began Phase I clinical studies in October 2003, which were completed in December 2003. We submitted a report on the results to the FDA along with a Phase II protocol in 2004. Phase II-A clinical studies began in the fourth quarter of 2004, and were completed in 2006. A further Phase II study protocol was filed with the FDA in the spring of 2008, but remained on clinical hold by the FDA due to safety concerns raised by the regulatory agency.
 
Despite the FDA’s postponement of Oxycyte trials in the United States, we filed a revised protocol as a dose-escalation study with the regulatory authorities in Switzerland and Israel. The relevant Swiss regulatory body approved the protocol in August 2009, and the Israel Ministry of Health approved the protocol in September 2009. The new study began in October 2009. In March 2010, we determined that it is feasible to simplify the trial design and also reduce the number of patients to be enrolled. We have completed the first of three cohorts and we were authorized by the Swiss and Israeli regulatory authorities to initiate the second cohort.  Despite their authorization, we stopped enrollment in order to reevaluate the protocol’s patient enrollment parameters, secure our Current Good Manufacturing Practice, or cGMP, supply of Oxycyte, review our contractor and clinical sites, and examine the possibility of opening clinical sites in other countries. In July 2013 we resumed enrollment in the second cohort. Upon completion of the Phase II trials, a Phase III trial will need to be implemented.  In that instance, we would seek a partner to either conduct the Phase III trials, or collaborate with us to conduct the trials.
 
In March 2011, we received confirmation of a $2.07 million, two-year cost reimbursement award from the U.S. Army to conduct safety related studies for Oxycyte.  PFC emulsions, as a therapeutic class, are known to interact with the reticuloendothelial system as part of the clearance mechanism, as well as affect the number of circulating platelets. The studies supported by this grant will examine the effects of Oxycyte on the immune system, platelet function and distribution, as well as the safety and efficacy of platelet transfusion, which can be necessary for patients with TBI and related polytrauma. Additional studies under this grant will be conducted to evaluate the pharmacokinetics of PFCs in relevant species. On September 12, 2013, we submitted to the FDA results from two series of animal studies designed to address Agency concerns regarding the use of Oxycyte in treating TBI patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage (ICH). We expect to complete the remaining studies over the next 12 months.
 
 
5

 
 
On February 28, 2014, we were notified that the FDA had completed its review of the September 2013 nonclinical submission and that we satisfactorily addressed all clinical hold issues identified by the agency. In connection with this notice, the FDA lifted the clinical hold on Oxycyte. Lifting of the clinical hold clears us to proceed with the clinical development program in the United States.
 
Should Oxycyte successfully progress in clinical testing and if it appears regulatory approval for one or more medical uses is likely, either in the United States or in another country, we intend to evaluate our options for commercializing the product. These options include licensing Oxycyte to a third party for manufacture and distribution, manufacturing Oxycyte ourselves for distribution through third party distributors, manufacturing and selling the product ourselves, or establishing some other form of strategic relationship for making and distributing Oxycyte with a participant in the pharmaceutical industry. We are currently investigating and evaluating all options.
 
We believe that important competitive factors in the market for oxygen carrier products will include the relative speed with which competitors can develop their respective products, complete the clinical testing and regulatory approval process, and supply commercial quantities of their products to the market. In addition to these factors, competition is expected to be based on the effectiveness of oxygen carrier products and the scope of the intended uses for which they are approved, the scope and enforceability of patent or other proprietary rights, product price, product supply, and marketing and sales capability. We believe that our competitive position will be significantly influenced by the timing of the clinical testing and regulatory filings for Oxycyte, our ability to maintain and enforce our proprietary rights covering Oxycyte and its manufacturing process, and our ability to develop capabilities for manufacturing and distributing the product ourselves or with others, should we obtain regulatory approval.
 
Other Products
 
In addition to our primary products described above, we have also developed our Dermacyte® line of topical cosmetic products, which contain our patented PFC technology and other known cosmetic ingredients to promote the appearance of skin health and other desirable cosmetic benefits, as well as Wundecyte™, a novel gel developed under a contract agreement with a lab in Virginia that is designed to be used as a wound-healing gel.  At this time, we do not expect that Dermacyte or Wundecyte constitute a material portion of our business going forward.
 
Suppliers
 
Pursuant to the terms of our license for levosimendan, Orion Corporation is our sole manufacturing source for levosimendan.
 
With respect to Oxycyte, we are actively pursuing agreements with multiple manufacturers to ensure we are able to consistently obtain our raw materials and topical products timely, within our defined specifications, and at competitive prices.
 
Our FtBu PFC currently is manufactured by Fluoromed. We have obtained exclusive manufacturing rights for our PFC, and we strengthened these rights with documentation of the manufacturer’s critical formulations and processes. This documentation is being held in escrow and will revert to us in the event the manufacturer undergoes a change-of-control or fails to remain a going concern.
 
In September 2011 we entered into a development and supply agreement with Bioserve, Inc. to manufacture our Oxycyte emulsion for clinical use under cGMP standards. In January 2012, Bioserve transferred the manufacturing process from Hospira, our previous supplier, to their cGMP facilities and demonstrated their ability to produce clinical grade Oxycyte.
 
Intellectual Property
 
We rely on a combination of patent applications, patents, trade secrets, proprietary know-how, trademarks, and contractual provisions to protect our proprietary rights. We believe that to have a competitive advantage, we must develop and maintain the proprietary aspects of our technologies. Currently, we require our officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, and other advisors to execute confidentiality agreements in connection with their employment, consulting, or advisory relationships with us, where appropriate. We also require our employees, consultants, and advisors who we expect to work on our products to agree to disclose and assign to us all inventions conceived during the work day, developed using our property, or which relate to our business.
 
To date, we own or in-license the rights to 9 U.S. and foreign patents. In addition, we have numerous U.S. patent applications pending that are complemented by the appropriate foreign patent applications related to our product candidates and proprietary processes, methods and technologies. Our issued and in-licensed patents, as well as our pending patents, expire between 2014 and 2030.
 
We have:
 
-  
three U.S. patents (5,824,703; 5,840,767; 6,167,887), three Australian patents (690,277; 722,417; 759,557), and two Canadian patents (2,239,170; 2,311,122) pertaining to the use and application of PFCs as gas transport agents in blood substitutes and liquid ventilation with an average remaining life of approximately 3 years;
 
 
6

 
 
-  
exclusive in-licenses to three fundamental gas transport patent applications that represent the core technology used in our products and product candidates (other than levosimendan) with an average remaining life of approximately 15 years; and
 
-  
one U.S. patent (8,513,309) and numerous patent applications for treatment of several medical and dermatological conditions such as TBI, acne, burns and wounds with an average remaining life of approximately 16 years.
 
Our patent and patent applications include claims covering:
 
-  
methods to treat certain diseases and conditions and for biological gas exchange;
 
-  
therapies for burn and wound victims;
 
-  
delivery of oxygenated PFC;
 
-  
various formulations containing PFC; and
 
-  
methods and compositions for controlled and sustained production and delivery of peroxide and/or oxygen for biological and industrial applications.
 
We have received U.S. trademark registrations for Oxycyte®, Dermacyte®, Defense Medicine® and Oxygen Biotherapeutics, Employing  O2, Preserving Life®. We have trademark applications pending for the following marks: Acnecyte™, Wundecyte™ and Vitavent™.  Simdax® is owned by Orion and is licensed to us for sales and marketing purposes in the United States and Canada.
 
In addition, we own numerous domain names relevant to our business, such as www.oxygenbiotherapeutics.com, www.DermacyteUS.com, www.oxybiomed.com, and others.
 
Government regulation
 
The manufacture and distribution of levosimendan and Oxycyte, as well as our other products, and the operation of our manufacturing facilities will require the approval of United States government authorities as well as those of foreign countries. In the United States, the FDA regulates medical products. The Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our medical products. In addition to FDA regulations, we are also subject to other federal and state regulations, such as the Occupational Safety and Health Act and the Environmental Protection Act. Product development and approval within this regulatory framework requires a number of years and involves the expenditure of substantial funds.
 
Preclinical tests include evaluation of product chemistry and studies to assess the safety and effectiveness of the product and its formulation. The results of the preclinical tests are submitted to the FDA as part of the application. The goal of clinical testing is the demonstration in adequate and well-controlled studies of substantial evidence of the safety and effectiveness of the product in the setting of its intended use. The results of preclinical and clinical testing are submitted to the FDA from time to time throughout the trial process. In addition, before approval for the commercial sale of a product can be obtained, results of the preclinical and clinical studies must be submitted to the FDA. The testing and approval process requires substantial time and effort and there can be no assurance that any approval will be granted on a timely basis, if at all. The approval process is affected by a number of factors, including the severity of the condition being treated, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. Additional preclinical studies or clinical trials may be requested during the FDA review process and may delay product approval. After FDA approval for its initial indications, further clinical trials may be necessary to gain approval for the use of a product for additional indications. The FDA may also require post-marketing testing, which can involve significant expense, to monitor for adverse effects.
 
 
7

 
 
Our regulatory strategy is to pursue Phase III clinical testing for levosimendan in the United States. We then intend to use the results of these tests to pursue FDA marketing approval of levosimendan in the United States. In addition, we are continuing with our Phase II clinical testing and initial regulatory approval of Oxycyte in Switzerland and Israel.
 
Research and Development
 
Our research and development efforts will be focused on the development and commercialization of levosimendan for its use in clinical indications, primarily LCOS. We are also focusing on furthering the development and manufacture of Oxycyte for its use in clinical indications, primarily TBI, spinal cord injury, and decompression sickness. We spent approximately $3.0 million and $2.5 million on research and development during each of the fiscal years ended April 30, 2014 and 2013, respectively.
 
Employees
 
We believe that our success will be based on, among other things, the quality of our clinical programs, our ability to invent and develop superior and innovative technologies and products, and our ability to attract and retain capable management and other personnel. We have assembled a high quality team of scientists, clinical development managers, and executives with significant experience in the biotechnology and pharmaceutical industries.
 
As of April 30, 2014, we had 14 full-time employees. In addition to our employees, we also use the service and support of outside consultants and advisors. None of our employees are represented by a union, and we believe relationships with our employees are good.
 
ITEM 1A—RISK FACTORS
 
Risks Related to Our Financial Position and Need for Additional Capital
 
We have a limited operating history, and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.
 
Our operations, to date, have been primarily limited to organizing and staffing our company, developing our technology and undertaking preclinical studies and clinical trials of our product candidates. We have not yet obtained regulatory approvals for any of our clinical product candidates. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
 
Specifically, our financial condition and operating results have varied significantly in the past and will continue to fluctuate from quarter-to-quarter and year-to-year in the future due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include the following factors, among others:
 
-  
our ability to obtain additional funding to develop our product candidates;
 
-  
the need to obtain regulatory approval of our most advanced product candidates;
 
-  
potential risks related to any collaborations we may enter into for our product candidates;
 
-  
delays in the commencement, enrollment and completion of clinical testing, as well as the analysis and reporting of results from such clinical testing;
 
-  
the success of clinical trials of our Oxycyte and levosimendan product candidates or future product candidates;
 
-  
any delays in regulatory review and approval of product candidates in development;
 
 
8

 
 
-  
our ability to establish an effective sales and marketing infrastructure;
 
-  
competition from existing products or new products that may emerge;
 
-  
the ability to receive regulatory approval or commercialize our products;
 
-  
potential side effects of our product candidates that could delay or prevent commercialization;
 
-  
potential product liability claims and adverse events;
 
-  
potential liabilities associated with hazardous materials;
 
-  
our ability to maintain adequate insurance policies;
 
-  
our dependency on third-party manufacturers to supply or manufacture our products;
 
-  
our ability to establish or maintain collaborations, licensing or other arrangements;
 
-  
our ability, our partners’ abilities, and third parties’ abilities to protect and assert intellectual property rights;
 
-  
costs related to and outcomes of potential litigation;
 
-  
compliance with obligations under intellectual property licenses with third parties;
 
-  
our ability to adequately support future growth; and
 
-  
our ability to attract and retain key personnel to manage our business effectively.
 
Due to the various factors mentioned above, and others, the results of any prior quarterly or annual periods should not be relied upon as indications of our future operating performance.
 
We may need additional funding and if we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our product development programs.
 
Developing biopharmaceutical products, including conducting preclinical studies and clinical trials and establishing manufacturing capabilities, is expensive. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we focus on and proceed with our Phase III and Phase II-B clinical programs and begin clinical trials for our other products. In addition, our expenses could increase beyond expectations if applicable regulatory authorities, including the FDA, require that we perform additional studies to those that we currently anticipate, in which case the timing of any potential product approval may be delayed. As of April 30, 2014, we had $58.3 million of cash and cash equivalents on hand. Based on our current operating plans, we believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements through the fiscal year ending April 30, 2017. We will need substantial additional capital in the future in order to complete the development and commercialization of levosimendan and Oxycyte and to fund the development and commercialization of future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding, if needed, may not be available on favorable terms, if at all. In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
 
If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or to grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
 
Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including, but not limited to:
 
-  
the scope, rate of progress and cost of our clinical trials and other research and development activities;
 
-  
the costs and timing of regulatory approval;
 
-  
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
 
 
9

 
 
-  
the effect of competing technological and market developments;
 
-  
the terms and timing of any collaboration, licensing or other arrangements that we may establish;
 
-  
the cost and timing of completion of clinical and commercial-scale manufacturing activities; and
 
-  
the costs of establishing sales, marketing and distribution capabilities for our cosmetic products and any product candidates for which we may receive regulatory approval.
 
Risks Related to Commercialization and Product Development
 
Orion may have the right to terminate our license for the levosimendan product, and, if the license is terminated, our business would be materially harmed.
 
The License grants Life Newco an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimedan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada.  Under the License, if we do not enroll a randomized patient in a human clinical trial using the levosimedan product by July 31, 2014, Orion will have the right to immediately terminate the License.  While we have commenced our clinical trial process, activated trial sites, and expect the enrollment of the first patient at any time, it is possible that the first patient will be enrolled by July 31, 2014.  Accordingly, we intend to seek a waiver or amendment to this condition in the License.  There can be no assurance that we will obtain such a waiver or amendment before July 31, 2014, or at all, which could potentially result in Orion’s termination of the License. If Orion terminates the License, we would not be able to develop or commercialize the levosimedan product.  The loss of our license with Orion with respect to the levosimedan product would have a material adverse effect on our business.
 
We are limited in the number of products we can simultaneously pursue and therefore our survival depends on our success with a small number of product opportunities.
 
We have limited financial resources, so at present we are primarily focusing these resources on developing levosimendan for the treatment of low cardiac output syndrome and our Oxycyte oxygen carrier product. We have delayed development on our Wundecyte topical wound product and Vitavent, our oxygen-carrying liquid, until we find a licensing partner willing to pursue development or obtain additional financing to pursue development ourselves. At present we intend to commit most of our resources to advancing levosimendan and Oxycyte to the point it receives regulatory approval for one or more medical uses, and if this effort is unsuccessful we may not have resources to pursue development of our other products and our business would terminate. Furthermore, by delaying development of Vitavent, this technology may become obsolete by the time we have sufficient capital to resume development and testing, so the funds expended on this product to date would be lost, as well as our opportunity to benefit if the product could be successfully developed.
 
Failure to integrate or realize the expected benefits of the Phyxius asset acquisition could adversely affect our business and results of operations.
 
On November 13, 2013, we completed our acquisition of certain assets of Phyxius Pharma, Inc., or Phyxius.  At the same time, three former employees of Phyxius became employees of our company. We conducted this transaction based on certain assumptions regarding our business, markets, cost structures and synergies. If we do not successfully integrate or realize the anticipated benefits of this transaction, instead of resulting in growth for and enhanced value to our company, our strategy may cause us to experience operational issues and expose us to operational and regulatory risk, each of which could have material adverse effects on our reputation, business, financial condition and results of operations.
 
We currently have no approved drug products for sale and we cannot guarantee that we will ever have marketable drug products.
 
We currently have no approved drug products for sale. The research, testing, manufacturing, labeling, approval, selling, marketing, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, with regulations differing from country to country. We are not permitted to market our product in the United States until we receive approval of a new drug application, or an NDA, from the FDA for each product candidate. We have not submitted an NDA or received marketing approval for any of our product candidates. Obtaining approval of an NDA is a lengthy, expensive and uncertain process. Markets outside of the United States also have requirements for approval of drug candidates which we must comply with prior to marketing. Accordingly, we cannot guarantee that we will ever have marketable drug products.
 
The development of levosimendan and Oxycyte is subject to a high level of technological risk.
 
We expect to devote a substantial portion of our financial and managerial resources to pursuing Phase III and Phase II clinical trials for levosimendan and Oxycyte over the next three years. The biomedical field has undergone rapid and significant technological changes. Technological developments may result in our products becoming obsolete or non-competitive before we are able to recover any portion of the research and development and other expenses we have incurred to develop and clinically test levosimendan and Oxycyte. As our opportunity to generate substantial product revenues within the next four to five years is most likely dependent on successful testing and commercialization of levosimendan and Oxycyte for surgical and oxygen delivery applications, any such occurrence would have a material adverse effect on our operations and could result in the cessation of our business.
 
 
10

 
 
We may be required to conduct additional clinical trials in the future, which are expensive and time consuming, and the outcome of the trials is uncertain.
 
We expect to commit a substantial portion of our financial and business resources over the next three years to clinical testing of levosimendan and Oxycyte and advancing these products to regulatory approval for use in one or more medical applications. All of these clinical trials and testing will be expensive and time consuming and the timing of the regulatory review process is uncertain. The applicable regulatory agencies may suspend clinical trials at any time if they believe that the subjects participating in such trials are being exposed to unacceptable health risks. We cannot ensure that we will be able to complete our clinical trials successfully or obtain FDA or other governmental or regulatory approval of our products, or that such approval, if obtained, will not include limitations on the indicated uses for which our products may be marketed. Our business, financial condition and results of operations are critically dependent on obtaining capital to advance our testing program and receiving FDA and other governmental and regulatory approvals of our products. A significant delay in or failure of our planned clinical trials or a failure to achieve these approvals would have a material adverse effect on us and could result in major setbacks or jeopardize our ability to continue as a going concern.
 
The market may not accept our products.
 
Even if regulatory approval is obtained, there is a risk that the efficacy and pricing of our products, considered in relation to our products’ expected benefits, will not be perceived by health care providers and third-party payers as cost-effective, and that the price of our products will not be competitive with other new technologies or products. Our results of operations may be adversely affected if the price of our products are not considered cost-effective or if our products do not otherwise achieve market acceptance.
 
Any collaboration we enter with third parties to develop and commercialize our product candidates may place the development of our product candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us.
 
We may enter into collaborations with third parties to develop and commercialize our product candidates, including levosimendan and Oxycyte. Our dependence on future partners for development and commercialization of our product candidates would subject us to a number of risks, including:
 
-  
we may not be able to control the amount and timing of resources that our partners may devote to the development or commercialization of our product candidates or to their marketing and distribution;
 
-  
partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
 
-  
disputes may arise between us and our partners that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
 
-  
partners may experience financial difficulties;
 
-  
partners may not properly maintain or defend our intellectual property rights, or may use our proprietary information, in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential litigation;
 
-  
business combinations or significant changes in a partner’s business strategy may adversely affect a partner’s willingness or ability to meet its obligations under any arrangement;
 
-  
a partner could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and
 
-  
the collaborations with our partners may be terminated or allowed to expire, which would delay the development and may increase the cost of developing our product candidates.
 
Delays in the commencement, enrollment and completion of clinical testing could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
 
Delays in the commencement, enrollment and completion of clinical testing could significantly affect our product development costs. We do not know whether planned clinical trials for levosimendan and Oxycyte will begin on time or be completed on schedule, if at all. The commencement and completion of clinical trials requires us to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs for the same indication as our product candidates or may be required to withdraw from our clinical trial as a result of changing standards of care or may become ineligible to participate in clinical studies. The commencement, enrollment and completion of clinical trials can be delayed for a variety of other reasons, including delays related to:
 
 
11

 
 
-  
reaching agreements on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
 
-  
obtaining regulatory approval to commence a clinical trial;
 
-  
obtaining institutional review board, or IRB, approval to conduct a clinical trial at numerous prospective sites;
 
-  
recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our product candidates;
 
-  
retaining patients who have initiated a clinical trial but may be prone to withdraw due to the treatment protocol, lack of efficacy, personal issues or side effects from the therapy or who are lost to further follow-up;
 
-  
maintaining and supplying clinical trial material on a timely basis; and
 
-  
collecting, analyzing and reporting final data from the clinical trials.
 
In addition, a clinical trial may be suspended or terminated by us, the FDA or other regulatory authorities due to a number of factors, including:
 
-  
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
 
-  
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
 
-  
unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
 
-  
lack of adequate funding to continue the clinical trial, including unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties.
 
Changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes with appropriate regulatory authorities. Amendments may require us to resubmit our clinical trial protocols to IRBs for re-examination, which may impact the costs, timing or successful completion of a clinical trial. If we experience delays in the completion of, or if we terminate, our clinical trials, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Even if we are able to ultimately commercialize our product candidates, other therapies for the same or similar indications may have been introduced to the market and established a competitive advantage.
 
Risks Relating to Regulatory Matters
 
Our activities are and will continue to be subject to extensive government regulation, which is expensive and time consuming, and we will not be able to sell our products without regulatory approval.
 
Our research, development, testing, manufacturing, marketing and distribution of levosimendan and Oxycyte are, and will continue to be, subject to extensive regulation, monitoring and approval by the FDA and other regulatory agencies. There are significant risks at each stage of the regulatory scheme.
 
Product approval stage
 
During the product approval stage we attempt to prove the safety and efficacy of our product for its indicated uses. There are numerous problems that could arise during this stage, including:
 
-  
The data obtained from laboratory testing and clinical trials are susceptible to varying interpretations, which could delay, limit or prevent FDA and other regulatory approvals;
 
-  
Adverse events could cause the FDA and other regulatory authorities to halt trials;
 
-  
At any time the FDA and other regulatory agencies could change policies and regulations that could result in delay and perhaps rejection of our products; and
 
-  
Even after extensive testing and clinical trials, there is no assurance that regulatory approval will ever be obtained for any of our products.
 
 
12

 
 
Commercialization approval stage
 
We will be required to file a BLA of an NDA with the FDA in order to obtain regulatory approval for the commercial production and sale of our product candidates in the United States and similar applications with regulatory authorities in countries where we seek to commercialize our product candidates. Under FDA guidelines, the FDA may comment upon the acceptability of the applicable application following its submission. After an application is submitted, there is an initial review to be sure that all of the required elements are included in the submission. There can be no assurance that the submission will be accepted for filing or that the FDA may not issue an RTF. If an RTF is issued, there is opportunity for dialogue between the sponsor and the FDA in an effort to resolve all concerns. There can be no assurance that such a dialogue will be successful in leading to the filing of the BLA or NDA. If the submission is filed, there can be no assurance that the full review will result in product approval.
 
Post-commercialization stage
 
Discovery of previously unknown problems with our products, or unanticipated problems with our manufacturing arrangements, even after FDA and other regulatory approvals of our products for commercial sale may result in the imposition of significant restrictions, including withdrawal of the product from the market.
 
Additional laws and regulations may also be enacted that could prevent or delay regulatory approval of our products, including laws or regulations relating to the price or cost-effectiveness of medical products. Any delay or failure to achieve regulatory approval of commercial sales of our products is likely to have a material adverse effect on our financial condition, results of operations and cash flows.
 
The FDA and other regulatory agencies continue to review products even after they receive agency approval. If and when the FDA or another regulatory agency outside the United States approves one of our products, its manufacture and marketing will be subject to ongoing regulation, which could include compliance with current good manufacturing practices, adverse event reporting requirements and general prohibitions against promoting products for unapproved or “off-label” uses. We are also subject to inspection and market surveillance by the FDA for compliance with these and other requirements. Any enforcement action resulting from failure, even by inadvertence, to comply with these requirements could affect the manufacture and marketing of Oxycyte or our other products. In addition, the FDA or other regulatory agencies could withdraw a previously approved product from the market upon receipt of newly discovered information. The FDA or another regulatory agency could also require us to conduct additional, and potentially expensive, studies in areas outside our approved indicated uses.
 
We must continually monitor the safety of our products once approved and marketed for signs that their use may elicit serious and unexpected side effects and adverse events, which could jeopardize our ability to continue marketing the products. We may also be required to conduct post-approval clinical studies as a condition to licensing a product.
 
As with all pharmaceutical products, the use of our products could sometimes produce undesirable side effects or adverse reactions or events (referred to cumulatively as adverse events). For the most part, we would expect these adverse events to be known and occur at some predicted frequency. When adverse events are reported to us, we will be required to investigate each event and circumstances surrounding it to determine whether it was caused by our product and whether it implies that a previously unrecognized safety issue exists. We will also be required to periodically report summaries of these events to the applicable regulatory authorities.
 
In addition, the use of our products could be associated with serious and unexpected adverse events, or with less serious reactions at a greater than expected frequency. This may be especially true when our products are used in critically ill or otherwise compromised patient populations. When these unexpected events are reported to us, we will be required to make a thorough investigation to determine causality and implications for product safety. These events must also be specifically reported to the applicable regulatory authorities. If our evaluation concludes, or regulatory authorities perceive, that there is an unreasonable risk associated with the product, we would be obligated to withdraw the impacted lot(s) of that product. Furthermore, an unexpected adverse event of a new product could be recognized only after extensive use of the product, which could expose us to product liability risks, enforcement action by regulatory authorities and damage to our reputation and public image.
 
A serious adverse finding concerning the risk of our products by any regulatory authority could adversely affect our reputation, business and financial results.
 
 
13

 
 
When a new product is approved, the FDA or other regulatory authorities may require post-approval clinical trials, sometimes called Phase IV clinical trials. If the results of such trials are unfavorable, this could result in the loss of the license to market the product, with a resulting loss of sales
 
After our products are commercialized, we expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties.
 
Health care providers, physicians and others will play a primary role in the recommendation and prescription of our clinical products. Our arrangements with third-party payers and customers may expose us to broadly applicable fraud and abuse and other health care laws and regulations that may constrain the business or financial arrangements and relationships through which we will market, sell and distribute our products. Applicable federal and state health care laws and regulations are expected to include, but not be limited to, the following:
 
-  
The federal anti-kickback statute is a criminal statute that makes it a felony for individuals or entities knowingly and willfully to offer or pay, or to solicit or receive, direct or indirect remuneration, in order to induce the purchase, order, lease, or recommending of items or services, or the referral of patients for services, that are reimbursed under a federal health care program, including Medicare and Medicaid;
 
-  
The federal False Claims Act imposes liability on any person who knowingly submits, or causes another person or entity to submit, a false claim for payment of government funds. Penalties include three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim. In addition, the False Claims Act permits a person with knowledge of fraud, referred to as a qui tam plaintiff, to file a lawsuit on behalf of the government against the person or business that committed the fraud, and, if the action is successful, the qui tam plaintiff is rewarded with a percentage of the recovery;
 
-  
Health Insurance Portability and Accountability Act imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
 
-  
The Social Security Act contains numerous provisions allowing the imposition of a civil money penalty, a monetary assessment, exclusion from the Medicare and Medicaid programs, or some combination of these penalties; and
 
-  
Many states have analogous state laws and regulations, such as state anti-kickback and false claims laws. In some cases, these state laws impose more strict requirements than the federal laws. Some state laws also require pharmaceutical companies to comply with certain price reporting and other compliance requirements.
 
Our failure to comply with any of these federal and state health care laws and regulations, or health care laws in foreign jurisdictions, could have a material adverse effect on our business, financial condition, result of operations and cash flows.
 
Health care reform and controls on health care spending may limit the price we can charge for our products and the amount we can sell.
 
As a result of Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “ACA”) enacted in March 2010, substantial changes have occurred and are expected to continue to occur in the system for paying for health care in the United States, including changes made in order to extend medical benefits to those who currently lack insurance coverage. This comprehensive health care reform legislation also included provisions to control health care costs and improve health care quality. Together with ongoing statutory and budgetary policy developments at a federal level, this health care reform legislation could include changes in Medicare and Medicaid payment policies and other health care delivery administrative reforms that could potentially negatively impact our business. Because not all the administrative rules implementing health care reform under the legislation have been finalized, and because of ongoing federal fiscal budgetary pressures not yet resolved for federal health programs, the full impact of the ACA and of further statutory actions to reform healthcare payment on our business is unknown, but there can be no assurances that health care reform legislation will not adversely impact either our operational results or the manner in which we operate our business. Cost of care could be reduced by reducing the level of reimbursement for medical services or products (including those biopharmaceuticals that we intend to produce and market), or by restricting coverage (and, thereby, utilization) of medical services or products. In either case, a reduction in the utilization of, or reimbursement for, our products could have a materially adverse impact on our financial performance.
 
 
 
14

 
 
Uncertainty of third-party reimbursement could affect our future results of operations.
 
Sales of medical products largely depend on the reimbursement of patients’ medical expenses by governmental health care programs and private health insurers. We will be required to report detailed pricing information, net of included discounts, rebates and other concessions, to the Centers for Medicare and Medicaid Services, or CMS, for the purpose of calculating national reimbursement levels, certain federal prices, and certain federal rebate obligations. If we report pricing information that is not accurate to the federal government, we could be subject to fines and other sanctions that could adversely affect our business. In addition, the government could change its calculation of reimbursement, federal prices, or federal rebate obligations which could negatively impact us. There is no guarantee that government health care programs or private health insurers will reimburse for the sales of our products, or permit us to sell our products at high enough prices to generate a profit.
 
Governments outside the United States tend to impose strict price controls and reimbursement approval policies, which may adversely affect our prospects for generating revenue outside the United States.
 
In some countries, particularly European Union countries, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time (6 to 12 months or longer) after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries with respect to any product candidate that achieves regulatory approval, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products upon approval, if at all, is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our prospects for generating revenue, if any, could be adversely affected which would have a material adverse effect on our business and results of operations. Further, if we achieve regulatory approval of any product, we must successfully negotiate product pricing for such product in individual countries. As a result, the pricing of our products, if approved, in different countries may vary widely, thus creating the potential for third-party trade in our products in an attempt to exploit price differences between countries. This third-party trade of our products could undermine our sales in markets with higher prices.
 
Risks Relating to Our Dependence on Third Parties
 
We depend on third parties to manufacture our products.
 
We do not own or operate any manufacturing facilities for the commercial-scale production of our products. Instead, we rely on third party manufacturers. For example, Orion produces levosimendan for us, Bioserve currently manufacturers Oxycyte for us and Fluoromed currently produces FtBu for us. Accordingly, a delay in achieving scale-up of commercial manufacturing capabilities when needed will have a material adverse effect on sales of our products. Additionally, the manufacture of our products will be subject to extensive government regulation. Among the conditions for marketing approval is that our quality control and manufacturing procedures conform to applicable good manufacturing practice regulations. There is a risk that we will not be able to obtain the necessary regulatory clearances or approvals to manufacture our products on a timely basis or at all.
 
A change in manufacturer likely would require formal approval by the FDA or other regulatory agencies before the new manufacturer could produce commercial supplies of our products. This approval process would likely take at least 12 to 18 months and, during that time, we could face a shortage of supply of our products, which could negatively affect our financial condition, results of operations and cash flows.
 
We depend on the services of a limited number of key personnel.
 
Our success is highly dependent on the continued services of a limited number of scientists and support personnel. The loss of any of these individuals, in particular, John P. Kelley, our Chief Executive Officer, could have a material adverse effect on us. In addition, our success will depend, among other factors, on the recruitment and retention of additional highly skilled and experienced management and technical personnel. There is a risk that we will not be able to retain existing employees or to attract and retain additional skilled personnel on acceptable terms given the competition for such personnel among numerous large and well-funded pharmaceutical and health care companies, universities, and non-profit research institutions, which could negatively affect our financial condition, results of operations and cash flows.
 
 
15

 
 
We have limited experience in the sale and marketing of medical products.
 
We have limited experience in the sale and marketing of approved medical products and marketing the licensing of such products before FDA or other regulatory approval. We have not decided upon a commercialization strategy in these areas. We do not know of any third party that is prepared to distribute our products should they be approved. If we decide to establish our own commercialization capability, we will need to recruit, train and retain a marketing staff and sales force with sufficient technical expertise. We do not know whether we can establish a commercialization program at a cost that is acceptable in relation to revenue or whether we can be successful in commercializing our product. Factors that may inhibit our efforts to commercialize our products directly and without strategic partners include:
 
-  
Our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
 
-  
The inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products;
 
-  
The lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
 
-  
Unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
 
Failure to successfully commercialize our products or to do so on a cost effective basis would likely result in failure of our business.
 
We may enter into distribution arrangements and marketing alliances for certain products and any failure to successfully identify and implement these arrangements on favorable terms, if at all, may impair our ability to commercialize our product candidates.
 
We do not anticipate having the resources in the foreseeable future to develop global sales and marketing capabilities for all of the products we develop, if any. We may pursue arrangements regarding the sales and marketing and distribution of one or more of our product candidates and our future revenues may depend, in part, on our ability to enter into and maintain arrangements with other companies having sales, marketing and distribution capabilities and the ability of such companies to successfully market and sell any such products. Any failure to enter into such arrangements and marketing alliances on favorable terms, if at all, could delay or impair our ability to commercialize our product candidates and could increase our costs of commercialization. Any use of distribution arrangements and marketing alliances to commercialize our product candidates will subject us to a number of risks, including the following:
 
-  
We may be required to relinquish important rights to our products or product candidates;
 
-  
We may not be able to control the amount and timing of resources that our distributors or collaborators may devote to the commercialization of our product candidates;
 
-  
Our distributors or collaborators may experience financial difficulties;
 
-  
Our distributors or collaborators may not devote sufficient time to the marketing and sales of our products; and
 
-  
Business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement.
 
We may need to enter into additional co-promotion arrangements with third parties where our own sales force is neither well situated nor large enough to achieve maximum penetration in the market. We may not be successful in entering into any co-promotion arrangements, and the terms of any co-promotion arrangements we enter into may not be favorable to us.
 
Risks Relating to Intellectual Property
 
It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.
 
Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our product candidates and the methods used to manufacture them, as well as successfully defending these patents against third-party challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our products is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.
 
 
16

 
 
We license certain intellectual property from third parties that covers our product candidates. We rely on certain of these third parties to file, prosecute and maintain patent applications and otherwise protect the intellectual property to which we have a license, and we have not had and do not have primary control over these activities for certain of these patents or patent applications and other intellectual property rights. We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights. Our enforcement of certain of these licensed patents or defense of any claims asserting the invalidity of these patents would also be subject to the cooperation of the third parties.
 
The patent positions of pharmaceutical and biopharmaceutical companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biopharmaceutical patents has emerged to date in the United States. The biopharmaceutical patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in the patents we own or to which we have a license from a third-party. Further, if any of our patents are deemed invalid and unenforceable, it could impact our ability to commercialize or license our technology.
 
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:
 
-  
others may be able to make compositions or formulations that are similar to our product candidates but that are not covered by the claims of our patents;
 
-  
we might not have been the first to make the inventions covered by our issued patents or pending patent applications;
 
-  
we might not have been the first to file patent applications for these inventions;
 
-  
others may independently develop similar or alternative technologies or duplicate any of our technologies;
 
-  
it is possible that our pending patent applications will not result in issued patents;
 
-  
our issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
 
-  
we may not develop additional proprietary technologies that are patentable; or
 
-  
the patents of others may have an adverse effect on our business.
 
We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
 
We rely on confidentiality agreements that, if breached, may be difficult to enforce and could have a material adverse effect on our business and competitive position.
 
Our policy is to enter agreements relating to the non-disclosure and non-use of confidential information with third parties, including our contractors, consultants, advisors and research collaborators, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them. However, these agreements can be difficult and costly to enforce. Moreover, to the extent that our contractors, consultants, advisors and research collaborators apply or independently develop intellectual property in connection with any of our projects, disputes may arise as to the proprietary rights to the intellectual property. If a dispute arises, a court may determine that the right belongs to a third party, and enforcement of our rights can be costly and unpredictable. In addition, we rely on trade secrets and proprietary know-how that we seek to protect in part by confidentiality agreements with our employees, contractors, consultants, advisors or others. Despite the protective measures we employ, we still face the risk that:
 
-  
These agreements may be breached;
 
-  
These agreements may not provide adequate remedies for the applicable type of breach; or
 
-  
Our trade secrets or proprietary know-how will otherwise become known.
 
 
17

 
 
Any breach of our confidentiality agreements or our failure to effectively enforce such agreements would have a material adverse effect on our business and competitive position.
 
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use, our technology.
 
If we or our partners choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company has the right to ask the court to rule that these patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources even if we were successful in stopping the infringement of these patents. In addition, there is a risk that the court will decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to these patents.
 
Furthermore, a third party may claim that we or our manufacturing or commercialization partners are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we or our commercialization partners are infringing the third party’s patents and would order us or our partners to stop the activities covered by the patents. In addition, there is a risk that a court will order us or our partners to pay the other party damages for having violated the other party’s patents. We have agreed to indemnify certain of our commercial partners against certain patent infringement claims brought by third parties. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either does not infringe the patent claims of the relevant patent and/or that the patent claims are invalid, and we may not be able to do this. Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
 
Because some patent applications in the United States may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications, or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications or patents, which could further require us to obtain rights to issued patents by others covering such technologies. If another party has filed a U.S. patent application on inventions similar to ours, we may have to participate in an interference proceeding declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful if, unbeknownst to us, the other party had independently arrived at the same or similar invention prior to our own invention, resulting in a loss of our U.S. patent position with respect to such inventions.
 
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
 
Our collaborations with outside scientists and consultants may be subject to restriction and change.
 
We work with chemists, biologists and other scientists at academic and other institutions, and consultants who assist us in our research, development, regulatory and commercial efforts, including the members of our scientific advisory board. These scientists and consultants have provided, and we expect that they will continue to provide, valuable advice on our programs. These scientists and consultants are not our employees, may have other commitments that would limit their future availability to us and typically will not enter into non-compete agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, we will be unable to prevent them from establishing competing businesses or developing competing products. For example, if a key scientist acting as a principal investigator in any of our clinical trials identifies a potential product or compound that is more scientifically interesting to his or her professional interests, his or her availability to remain involved in our clinical trials could be restricted or eliminated.
 
 
18

 
 
Under current law, we may not be able to enforce all employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
 
We have entered into non-competition agreements with certain of our employees. These agreements prohibit our employees, if they cease working for us, from competing directly with us or working for our competitors for a limited period. Under current law, we may be unable to enforce these agreements against certain of our employees and it may be difficult for us to restrict our competitors from gaining the expertise our former employees gained while working for us. If we cannot enforce our employees’ non-compete agreements, we may be unable to prevent our competitors from benefiting from the expertise of our former employees.
 
We may infringe or be alleged to infringe intellectual property rights of third parties.
 
Our products or product candidates may infringe on, or be accused of infringing on, one or more claims of an issued patent or may fall within the scope of one or more claims in a published patent application that may be subsequently issued and to which we do not hold a license or other rights. Third parties may own or control these patents or patent applications in the United States and abroad. These third parties could bring claims against us or our collaborators 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 or our collaborators, we or they 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.
 
If we are found to infringe the patent rights of a third party, or in order to avoid potential claims, we or our collaborators may choose or be required to seek a license from a third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may 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 or our collaborators are unable to enter into licenses on acceptable terms.
 
There have been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the United States Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products. Our products, after commercial launch, may become subject to Paragraph IV certification under the Hatch-Waxman Act, thus forcing us to initiate infringement proceedings against such third-party filers. 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. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.
 
Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We try to ensure that our employees do not use the proprietary information or know-how of others in their work for us. We may, however, be subject to claims that we or these employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of any such employee’s former employer. Litigation may be necessary to defend against these claims and, even if we are successful in defending ourselves, could result in substantial costs to us or be distracting to our management. If we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
 
Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop.
 
Our business exposes us to the risk of product liability claims that are inherent in the manufacturing, distribution, and sale of biotechnology products. We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and an even greater risk when we commercially sell any products. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
 
 
19

 
 
-  
Decreased demand for our products and any product candidates that we may develop;
 
-  
Injury to our reputation;
 
-  
Withdrawal of clinical trial participants;
 
-  
Costs to defend the related litigation;
 
-  
Substantial monetary awards to trial participants or patients;
 
-  
Loss of revenue; and
 
-  
The inability to commercialize any products that we may develop.
 
We currently maintain limited product liability insurance coverage for our clinical trials in the total amount of $3 million. However, our profitability will be adversely affected by a successful product liability claim in excess of our insurance coverage. There can be no assurance that product liability insurance will be available in the future or be available on reasonable terms.
 
Risks Related to Owning Our Common Stock
 
Our share price has been volatile and may continue to be volatile which may subject us to securities class action litigation in the future .
 
The market price of shares of our common stock has been, and may be in the future, subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including:
 
-  
actual or anticipated fluctuations in our financial condition and operating results;
 
-  
status and/or results of our clinical trials;
 
-  
status of ongoing litigation;
 
-  
results of clinical trials of our competitors’ products;
 
-  
regulatory actions with respect to our products or our competitors’ products;
 
-  
actions and decisions by our collaborators or partners;
 
-  
actual or anticipated changes in our growth rate relative to our competitors;
 
-  
actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate;
 
-  
competition from existing products or new products that may emerge;
 
-  
issuance of new or updated research or reports by securities analysts;
 
-  
fluctuations in the valuation of companies perceived by investors to be comparable to us;
 
-  
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
 
-  
market conditions for biopharmaceutical stocks in general;
 
-  
status of our search and selection of future management and leadership; and
 
-  
general economic and market conditions.
 
On April 30, 2014 the closing price of our common stock was $4.88 as compared with $5.00 as of April 30, 2013. During the twelve months ended April 30, 2014, the lowest closing price of our common stock was $1.23 and the highest closing price was $8.38, all as adjusted for the 1-for-20 reverse stock split effective on May 10, 2013.
 
Some companies that have had volatile market prices for their securities have had securities class action lawsuits filed against them. Such lawsuits, should they be filed against us in the future, could result in substantial costs and a diversion of management’s attention and resources. This could have a material adverse effect on our business, results of operations and financial condition.
 
We are likely to attempt to raise additional capital through issuances of debt or equity securities, which may cause our stock price to decline, dilute the ownership interests of our existing stockholders, and/or limit our financial flexibility.
 
Historically we have financed our operations through the issuance of equity securities and debt financings, and we expect to continue to do so for the foreseeable future.  As of April 30, 2014, we had $58.3 million of cash and cash equivalents on hand. Based on our current operating plans, we believe that our existing cash and cash equivalents are sufficient to continue to fund operations through our fiscal year ending April 30, 2017. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution of their ownership interests.  Debt financing, if available, may involve restrictive covenants that limit our financial flexibility or otherwise restrict our ability to pursue our business strategies. Additionally, if we issue shares of common stock, or securities convertible or exchangeable for common stock, the market price of our existing common stock may decline. There can be no assurance that we will be successful in obtaining any additional capital resources in a timely manner, on favorable terms, or at all.
 
 
20

 
 
We have issued in the past, and may issue in the future, substantial amounts of instruments that are convertible into or exercisable for common stock, and our existing stockholders may face substantial dilution if such instruments are converted or exercised.
 
As of July 24, 2014, we had outstanding warrants and options, securities purchase agreements, and other instruments that are exercisable into an aggregate of 6,267,850 shares of our common stock, which, if exercised, would represent approximately 18% of our current outstanding common stock.  These instruments carry a wide variety of different terms and prices, and there can be no assurance as to when or whether exercises of these instruments may occur.  If all or any substantial portion of these instruments are exercised, our existing stockholders may face substantial dilution of their ownership interests. 
 
Certain investors may be able to exercise significant influence over us.
 
As of July 24, 2014, SPC 1 Vatea Segregated Portfolio, or Vatea Fund, held 189,082 shares of our common stock and JP SPC 3 obo OXBT FUND, SP, or OXBT Fund, held 3,192,593 shares of our common stock, representing 12% of our outstanding common stock. As of July 24, 2014, OXBT Fund held warrants that are exercisable into an aggregate of up to 2,251,742 shares of our common stock, which, if exercised, would represent 18.6% of our current outstanding common stock. Mr. Gregory Pepin, one of our directors, is the investment manager of both Vatea Fund and OXBT Fund. In addition, as of July 24, 2014, each of John P. Kelly, Doug Randall and Douglas Hay, PhD, our Chief Executive Officer, Vice President, Business and Commercial Operations and Vice President, Regulatory Affairs, respectively, held 1,166,511 shares of our common stock, individually representing 4.2% of our outstanding common stock.  As of July 24, 2014, each of Mr. Kelley, Mr. Randall and Dr. Hay also hold options to purchase 893,220 shares of our common stock, individually representing 3.1% of our outstanding common stock. Accordingly, these parties, either individually or as part of a group, may have a strong ability to influence our business, policies and affairs.  We cannot be certain that their interests will be consistent with the interests of other holders of our common stock.
 
Risks Relating to Employee Matters and Managing Growth
 
We may need to increase the size of our company, and we may experience difficulties in managing growth.
 
As of July 24, 2014, we had 14 full-time employees. We may need to expand our managerial, operational, administrative, financial and other resources in order to manage and fund our operations and clinical trials, continue our development activities and commercialize our product candidates. To support this growth, we may hire additional employees within the next 12 months. Our management, personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively manage our operations, growth and various projects requires that we continue to improve our operational, financial and management controls, reporting systems and procedures.
 
We may not be able to attract or retain qualified management and scientific personnel in the future. If we are unable to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede our achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.
 
In addition, we have scientific and clinical advisors who assist us in our product development and clinical strategies. These advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us, or may have arrangements with other companies to assist in the development of products that may compete with ours. Because our business depends on certain key personnel and advisors, the loss of such personnel and advisors could weaken our management team and we may experience difficulty in attracting and retaining qualified personnel and advisors. 
 
ITEM 1B—UNRESOLVED STAFF COMMENTS
 
Not applicable.
 
ITEM 2—PROPERTIES
 
We own no real property. We lease our principal executive office at ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560. The current rent is approximately $9,219 per month for the facility.
 
 
21

 
 
ITEM 3—LEGAL PROCEEDINGS
 
The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s Consolidated Financial Statements.
 
ITEM 4— MINE SAFETY DISCLOSURES
 
Not applicable
 
 
22

 
 
PART II
 
 
ITEM 5—MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
 
Market Price and Number of Stockholders
 
Our common stock is listed on the NASDAQ Capital Market under the symbol “OXBT.” The following table sets forth, for the past two fiscal years, the range of high and low sales prices in each fiscal quarter for our common stock, all as adjusted for the 1-for-20 reverse stock split effective on May 10, 2013.
 
Year-Ended April 30, 2013
 
High
   
Low
 
First Quarter
  $ 45.00     $ 21.40  
Second Quarter
  $ 24.20     $ 10.40  
Third Quarter
  $ 22.00     $ 10.40  
Fourth Quarter
  $ 15.80     $ 3.60  
 
Year-Ended April 30, 2014
 
High
   
Low
 
First Quarter
  $ 5.69     $ 1.40  
Second Quarter
  $ 3.46     $ 1.19  
Third Quarter
  $ 11.40     $ 3.04  
Fourth Quarter
  $ 8.35     $ 4.46  
 
As of July 24, 2014, there were 1,360 holders of record of our common stock. In addition, we believe that a significant number of beneficial owners of our common stock hold their shares in nominee or in “street name” accounts through brokers.  On July 24, 2014, the last sale price reported on the NASDAQ Capital Market for our common stock was $3.98 per share.
 
Dividend Policy
 
Since our inception, we have not paid dividends on our common stock. We intend to retain any earnings for use in our business activities, so it is not expected that any dividends on our common stock will be declared and paid in the foreseeable future.
 
Repurchases of Common Stock
 
The following table lists all repurchases during the fourth quarter of fiscal 2014 of any of our securities registered under Section 12 of the Exchange Act by or on behalf of us or any affiliated purchaser.
 
Issuer Purchases of Equity Securities
 
Issuer Purchases of Equity Securities
 
Total Number of Shares Purchased (1)
   
Average Price Paid per Share (2)
   
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
   
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs
 
Period
                       
February 1, 2014 - February 28, 2014
    20     $ 6.18       -     $ -  
March 1, 2014 - March 31, 2014
    20       6.47       -       -  
April 1, 2014 - April 30, 2014
    19       5.55       -       -  
Total
    59     $ 6.08       -     $ -  
 
(1)  
Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
(2)   
Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
 
23

 
 
Unregistered Sales of Equity Securities
 
On March 31, 2014 we issued 250 shares of unregistered common stock as payment of $11,275 of interest due on our outstanding convertible notes.
 
All of the securities described above were issued in reliance on the exemption from registration set forth in Section 4(a)(2) of the Securities Act.
 
ITEM 6—SELECTED FINANCIAL DATA
 
Not Applicable.
 
ITEM 7—MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
You should read the following discussion and analysis together with the Consolidated Financial Statements and the related notes to those statements included in “Item 8 – Consolidated Financial Statements and Supplementary Data.” This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements.
 
Results of operations- Comparison of the year ended April 30, 2014 and 2013
 
Revenue
 
Product Revenue and Gross Profit
 
We generate revenue through the sale of Dermacyte® through distribution agreements, on-line retailers and direct sales to physician and medical spa facilities.  Product revenue, cost of sales and gross profit, as well as corresponding percentage changes, for the years ended April 30, 2014 and 2013 are as follows:
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Product revenue
  $ 25,731     $ 92,683     $ (66,952 )     (72 ) %
Cost of sales
    129,800       43,111       86,689       201 %
Gross profit
  $ (104,069 )   $ 49,572     $ (153,641 )     (310 ) %
 
The decrease in product revenue for the year ended April 30, 2014 was primarily due to license fees earned in accordance with our distribution agreement for Dermacyte for the year ended April 30, 2013.
 
Gross profit as a percentage of revenue was (404) % and 53% for year ended April 30, 2014 and 2013, respectively. The decrease for the year ended April 30, 2014, as compared to the same period in the prior year, was due to the write-down of Dermacyte product in the current year that is no longer being marketed for sale.
 
Government Grant Revenue
 
Grant Revenue is recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party CROs.
 
 
24

 
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Government grant revenue
  $ 262,995     $ 1,141,356     $ (878,361 )     (77 ) %
 
For the year ended April 30, 2014, we recorded approximately $263,000 in revenue under the grant program as compared to approximately $1.1 million in revenue during the same period in the prior year. In addition to the revenue earned, we have recorded approximately $124,000 in deferred revenue associated with the grant. Deferred revenue under the grant represents pass-through costs that have been reimbursed in advance of performing the studies underlying the subcontracts. The decrease in revenue earned under the grant is due primarily to our completion of multiple studies in the prior year.
 
Marketing and Sales Expenses
 
Marketing and sales expenses consisted primarily of personnel-related costs, including salaries, commissions, and the costs of marketing programs aimed at increasing revenue, such as advertising, trade shows, public relations and other market development programs. Marketing and sales expenses and percentage changes for the year ended April 30, 2014 and 2013, respectively, are as follows:
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Marketing and sales expense
  $ 102     $ 108,165     $ (108,063 )     (100 ) %
 
The decrease in marketing and sales expenses for the year ended April 30, 2014 was driven by the elimination of costs incurred for compensation and direct advertising following the execution of the Dermacyte distribution agreement in the prior year.
 
General and Administrative Expenses
 
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the year ended April 30, 2014 and 2013, respectively, are as follows:
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Personnel costs
  $ 10,593,234     $ 1,490,752     $ 9,102,482       611 %
Legal and professional fees
    2,556,643       2,005,311       551,332       27 %
Other costs
    350,855       (206,788 )     557,643       270 %
Facilities
    157,449       167,693       (10,244 )     (6 ) %
Depreciation and amortization
    115,042       111,012       4,030       4 %
 
Personnel costs:
 
Personnel costs increased approximately $9.1 million for the year ended April 30, 2014 compared to the prior year. The increase was due primarily to the expense recognition of approximately $8.3 million for the granting and vesting of stock options and restricted stock, an increase of approximately $350,000 in salaries paid due to the addition of our new Chief Executive Officer and two other management positions and approximately $550,000 in performance bonuses paid and accrued for in the current year that were not paid in the prior year. The personnel costs attributable to Mr. Kelley, Mr. Jebsen, Mr. Randall and Dr. Hay reflect option grants made pursuant to their respective employment agreements, which were negotiated in connection with our acquisition of a license for levosimendan. In addition, Mr. Jebsen was paid a discretionary bonus consisting of $225,000 in cash and 32,143 shares of restricted common stock in recognition of his service as interim Chief Executive Officer from August 2011 through November 2013.
 
 
25

 
 
Legal and professional fees:
 
Legal and professional fees consist of the costs incurred for legal fees, accounting fees, recruiting costs and investor relations services, as well as fees paid to our Board of Directors. Legal and professional fees increased approximately $550,000 for the year ended April 30, 2014 compared to the prior year. This increase was primarily due to costs incurred for investor relations services and audit fees, partially offset by a decrease in legal and recruiting fees.
 
-  
Audit and accounting fees increased approximately $55,000 due to the costs incurred for valuation services related to the Phyxius acquisition and the filing of registration statements in the current year.
 
-  
Investor relation fees increased approximately $560,000 for the costs of outsourced corporate communications firms, road shows and attending investor conferences.
 
-  
Legal fees decreased approximately $40,000 due primarily to approximately $285,000 in fees incurred in the prior year for litigation defense costs, partially offset by an increase of approximately $245,000 in fees related to the Phyxius acquisition and the filing of registration statements in the current year.
 
-  
Recruiting fees decreased approximately $25,000 due to headcount additions in the prior year.
 
Other costs:
 
Other costs include costs incurred for travel, supplies, insurance and other miscellaneous charges. The approximately $558,000 increase in other costs was due primarily to the reversal of a contingent liability in the prior year related to potential liabilities in connection with non-compliance with Section 409A of the Internal Revenue Code.
 
Facilities:
 
Facilities include costs paid for rent and utilities at our corporate headquarters in North Carolina. The approximately $10,000 reduction compared to the prior year was the result of the elimination of allocated costs from the closure of the California lab facility in the prior year.
 
Depreciation and Amortization:
 
Depreciation and amortization costs remained relatively consistent for the years ended April 30, 2014 and 2013.
 
Research and Development Expenses
 
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the years ended April 30, 2014 and 2013, respectively, are as follows:
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Clinical and preclinical development
  $ 1,947,461     $ 1,569,594     $ 377,867       24 %
Personnel costs
    818,264       637,685       180,579       28 %
Consulting
    153,506       117,211       36,295       31 %
Depreciation
    41,199       42,968       (1,769 )     (4 ) %
Other costs
    26,028       32,652       (6,624 )     (20 ) %
Facilities
    10,263       55,706       (45,443 )     (82 ) %
 
Clinical and preclinical development:
 
Clinical and preclinical development costs include the costs associated with our Phase III and Phase II clinical trials for levosimendan and Oxycyte and development costs for Dermacyte. The increase of approximately $378,000 in clinical and preclinical development costs for the year ended April 30, 2014 compared to the prior year was primarily due to increases of $634,000 associated with the Phase II-b trials for Oxycyte and $214,000 in clinical development costs of levosimendan, partially offset by a decrease of $477,000 in costs incurred for preclinical safety studies for Oxycyte.
 
 
26

 
 
Personnel costs:
 
Personnel costs increased approximately $181,000 for the year ended April 30, 2014 compared to the prior year primarily due to headcount increases and employee bonuses paid in the current year.
 
Consulting fees:
 
Consulting fees increased approximately $36,000 for the year ended April 30, 2014 compared to the same period in the prior year primarily due to approximately $131,000 of fees incurred to plan and prepare for regulatory submissions, clinical trial expansions and other clinical support activities, partially offset by a reduction of approximately $95,000 of consulting fees associated with Oxycyte development.
 
Depreciation:
 
Depreciation expense remained relatively consistent for the year ended April 30, 2014 and 2013.
 
Other costs:
 
Other costs decreased approximately $7,000 for the year ended April 30, 2014 compared to the prior year primarily due to a decrease in expenses associated with travel and supplies.
 
Facilities:
 
Facilities expense decreased approximately $45,000 for the year ended April 30, 2014 compared to the same period in the prior year primarily due to the closure of our California facility.
 
Restructuring expense
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Restructuring expense
  $ -     $ 220,715     $ (220,715 )     %
 
During the year ended April 30, 2013, the Company recorded one-time charges of approximately $54,000 for severance and benefits related charges, $135,000 for net future lease obligations and $31,000 for other exit costs related to the closure of our California facility that were not incurred in the year ended April 30, 2014
 
Interest expense
 
Interest expense includes the interest payments due under our long-term debt, amortization of debt issuance costs and accretion of discounts recorded against our outstanding convertible notes, and noncash interest charges related to our Series A Stock. Interest expense and percentage changes for the year ended April 30, 2014 and 2013, respectively, are as follows:
 
   
Year ended April 30,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2014
   
2013
             
Interest expense
  $ 2,212,283     $ 4,238,456     $ (2,026,173 )     (48 ) %
 
During the year ended April 30, 2014, interest expense decreased approximately $2.0 million compared to the prior year. The decrease was due primarily to approximately $1.7 million of noncash interest charges recorded in the prior year related to our previously outstanding Series A Stock, and a decrease of approximately $326,000 in interest charges incurred on our convertible notes in the current year.
 
Other income and expense
 
Other income and expense includes non-operating income and expense items not otherwise recorded in our consolidated statement of operations. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, changes in the fair value of financial assets and liabilities, interest income earned and fixed asset disposals. Other expense for the year ended April 30, 2014 and 2013, respectively, is as follows:
 
 
27

 
 
   
Year ended April 30,
   
Increase/ (Decrease)
 
   
2014
   
2013
       
Other expense (income), net
  $ 718,436     $ (11,683 )   $ 730,119  
 
Other expense increased approximately $730,000 for the year ended April 30, 2014 compared to the prior year primarily due to the change in the recognized fair value of our warrant liability in the current year.
 
Liquidity, capital resources and plan of operation
 
We have incurred losses since our inception and as of April 30, 2014 we had an accumulated deficit of approximately $137 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur increased expenses related to our development and potential commercialization of levosimendan, Oxycyte and other product candidates and, as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
 
Liquidity
 
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had $58,966,033 and $1,842,251 total current assets and working capital (deficit) of $56,394,986 and $(67,326) as of April 30, 2014 and April 30, 2013, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments.
 
Clinical and Preclinical Product Development
 
We are in the preclinical and clinical trial stages in the development of our product candidates. We are currently initiating a Phase III clinical trial for levosimendan and we are conducting Phase II-b clinical trials for the use of Oxycyte in the treatment of severe traumatic brain injury. We expect our primary focus will be on initiating the Phase III clinical trials for levosimendan and funding the continued testing of Oxycyte, since these products are the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond April 30, 2017 may depend on obtaining license income or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.
 
Financings
 
On July 23, 2013, we sold 5,369 shares of Series C 8% convertible preferred stock and warrants for net proceeds of approximately $4.9 million. Additionally, on August 22, 2013 we issued 4,600 shares of Series D convertible preferred stock and warrants in exchange for $4.6 million of convertible notes that were scheduled to mature in June 2014.
 
On March 21, 2014, we sold 9,285,714 shares of common stock for net proceeds of approximately $55 million.
 
During the year ended April 30, 2014, we received approximately $7.1 million and issued 3,161,145 shares of common stock upon the exercise of our outstanding warrants.
   
Cash Flows
 
The following table shows a summary of our cash flows for the periods indicated:
 
 
28

 
 
   
Year ended April 30,
 
   
2014
   
2013
 
Net cash used in operating activities
  $ (9,261,571 )   $ (4,921,283 )
Net cash used in investing activities
    (147,038 )     (147,987 )
Net cash provided by financing activities
    66,945,636       3,972,926  
 
Net cash used in operating activities.  Net cash used in operating activities was $9.26 million for the year ended April 30, 2014 compared to net cash used in operating activities of $4.92 million for the year ended April 30, 2013. The increase in cash used for operating activities was due primarily to an increase in our costs incurred for the Phase II-b TBI clinical trials, the costs incurred to initiate the Phase III clinical trials for LCOS, the payment of approximately $1.25 million in assumed liabilities during the year, the increase in personnel costs, and the costs associated with the Phyxius asset acquisition.
 
Net cash used in investing activities . Net cash used in investing activities was $147,038 for the year ended April 30, 2014 compared to net cash used in investing activities of $147,987 for the year ended April 30, 2013. The cash used for investing activities, primarily capitalized legal fees incurred for filing and maintaining our patent portfolio, remained relatively consistent compared to the same period in the prior year.
 
Net cash provided by financing activities . Net cash provided by financing activities was $66.9 million for the year ended April 30, 2014 compared to net cash provided by financing activities of $4.0 million for the year ended April 30, 2013. The increase of net cash provided by financing activities was due primarily to net proceeds of $55 million received from the issuance of common stock on March 21, 2014, $4.9 million received from the issuance of Series C 8% Convertible Preferred Stock on July 23, 2013 and proceeds of $7 million received from the exercise of certain warrants as compared to the $2.5 million received from the issuance Series A Preferred Stock and $1.9 million received from the issuance of Series B Preferred Stock in the prior year.
 
Operating Capital and Capital Expenditure Requirements
 
Our future capital requirements will depend on many factors that include, but are not limited to the following:
 
-
The initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
-
The outcome, timing and cost of regulatory approvals and the regulatory approval process;
-
Delays that may be caused by changing regulatory requirements;
-
The number of product candidates that we pursue;
-
The costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
-
The timing and terms of future in-licensing and out-licensing transactions;
-
The cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
-
The cost of procuring clinical and commercial supplies of our product candidates;
-
The extent to which we acquire or invest in businesses, products or technologies; and
-
The possible costs of litigation.
 
Based on our working capital at April 30, 2014 we believe we have sufficient capital on hand to continue to fund operations through our fiscal year ending April 30, 2017.
 
We will need substantial additional capital in the future in order to complete the development and commercialization of levosimendan and Oxycyte, as well as to fund the development and commercialization of our future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements.  Such funding, if needed, may not be available on favorable terms, if at all.  In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
 
 
29

 
 
To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
 
Off-Balance Sheet Arrangements
 
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.
 
Summary of Significant Accounting Policies
 
Use of Estimates The preparation of the accompanying Consolidated Financial Statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires management to make certain 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 reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
 
Preclinical Study and Clinical Accruals —We estimate our preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and CROs that conduct and manage preclinical and clinical trials on our behalf. The financial terms of the agreements vary from contract to contract and may result in uneven expenses and payment flows. Preclinical study and clinical trial expenses include the following:
 
-
Fees paid to CROs in connection with clinical trials,
-
Fees paid to research institutions in conjunction with preclinical research studies, and
-
Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
 
Revenue Recognition —Revenues from merchandise sales are recognized upon transfer of ownership, including passage of title to the customer and transfer of the risk of loss related to those goods.  Revenues are reported on a net sales basis, which is computed by deducting from gross sales the amount of actual product returns received, discounts, incentive arrangements with retailers and an amount established for anticipated product returns.
 
Revenues from a cost-reimbursement grant sponsored by the United States Army, or Grant Revenue, are recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party CROs.
 
Stock-Based Compensation —Effective May 1, 2005, we adopted Accounting Standards Codification, or ASC, 718 Compensation — Stock Compensation, using the prospective transition method, which requires the measurement and recognition of compensation expense for all stock-based payment awards granted, modified and settled to our employees and directors after May 1, 2005. Our Consolidated Financial Statements reflect the impact of ASC 718. We chose the “straight-line” attribution method for allocating compensation costs and recognized the fair value of each stock option on a straight-line basis over the requisite service period.
 
We account for equity instruments issued to non-employees in accordance with ASC 505-50 Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Equity instruments issued to non-employees are recorded at their fair value on the measurement date and are subject to periodic adjustment as the underlying equity instruments vest.
 
Recent Accounting Pronouncements
 
In June 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-10, Development Stage Entities (Topic 915) . The objective of the amendments in this update is to improve financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities. Users of financial statements of development stage entities told the Board that the development stage entity distinction, the inception-to-date information, and certain other disclosures currently required under U.S. GAAP in the financial statements of development stage entities provide information that has limited relevance and is generally not decision useful. As a result, the amendments in this update remove all incremental financial reporting requirements from US GAAP for development stage entities, thereby improving financial reporting by eliminating the cost and complexity associated with providing that information. The amendments are effective for annual reporting periods beginning after December 15, 2014, and interim reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company has elected to early adopt this guidance, and therefore is no longer presenting the financial statements in accordance with ASU 915, with inception to date disclosures.
 
 
30

 
 
In May 2014, the FASB issued Accounting Standard Update 2014-09, Revenue from Contracts with Customers (ASU 2014-09) providing a comprehensive new revenue recognition standard. ASU 2014-09 provides revised standards of recognition predicated on when an entity transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective for us in our first quarter of fiscal 2018. ASU 2014-09 can be applied retrospectively with a modified retrospective application permitted. We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements.
 
In July 2013, the FASB issued ASU No. 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists . ASU No. 2013-11 requires entities to present in the consolidated financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward except to the extent such items are not available or not intended to be used at the reporting date to settle any additional income taxes that would result from the disallowance of a tax position. In such instances, the unrecognized tax benefit is required to be presented in the consolidated financial statements as a liability and not be combined with deferred tax assets. This guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013. The adoption of ASU 2013-11 did not have a material impact on our Consolidated Financial Statements.
 
ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Not applicable.
 
ITEM 8—CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
 
CONSOLIDATED BALANCE SHEETS
33
CONSOLIDATED STATEMENTS OF OPERATIONS
34
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
35
CONSOLIDATED STATEMENTS OF CASH FLOWS
36
CONSOLIDATED STATEMENTS OF CASH FLOWS, continued
37
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
38
 
 
31

 

OXYGEN BIOTHERAPEUTICS, INC.
 
Report of Independent Registered Public Accounting Firm
 
To the Board of Directors and Stockholders
Oxygen Biotherapeutics, Inc.
Morrisville, North Carolina
 
We have audited the accompanying consolidated balance sheets of Oxygen Biotherapeutics, Inc. and Subsidiary, formerly, Synthetic Blood International, Inc. (the Company), as of April 30, 2014 and 2013, and the related consolidated statements of operations, stockholders equity (deficit), and cash flows for each of the years in the two-year period ended April 30, 2014. The Companys management is responsible for these consolidated financial statements. 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 audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements, 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 the Company as of April 30, 2014 and 2013, and the results of its operations and its cash flows for each of the years in the two-year period ended April 30, 2014, in conformity with accounting principles generally accepted in the United States of America.
 
For the period ended April 30, 2014, the Company recognized a net loss of approximately $19.5 million and, as of April 30, 2014, the Company had incurred cumulative net losses of approximately $136.6 million. Managements plans with regard to liquidity and capital resources are described in Note B.
 
As discussed in Note B to the consolidated financial statements, the Company has elected to early adopt Accounting Standards Update 2014-10, Development Stage Enterprises. Accordingly, the Company has eliminated inception-to-date information and certain other incremental development stage entity disclosures in the consolidated financial statements referred to above.
 
/s/ CHERRY BEKAERT LLP
 
Raleigh, North Carolina
July 29, 2014
 
 
32

 
OXYGEN BIOTHERAPEUTICS, INC.
 
CONSOLIDATED BALANCE SHEETS
 
   
April 30,
2014
   
April 30,
2013
 
             
ASSETS
           
Current assets
           
Cash and cash equivalents
  $ 58,320,555     $ 783,528  
Accounts receivable
    36,358       445,237  
Government grant receivable
    29,750       96,226  
Inventory
    -       99,204  
Prepaid expenses
    401,964       247,646  
Other current assets
    177,406       170,410  
Total current assets
    58,966,033       1,842,251  
Property and equipment, net
    124,374       205,389  
Debt issuance costs, net
    21,427       150,043  
Intangible assets, net
    22,999,744       924,698  
Goodwill
    11,265,100       -  
Other assets
    52,762       58,262  
Total assets
  $ 93,429,440     $ 3,180,643  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
               
Current liabilities
               
Accounts payable
  $ 411,145     $ 977,162  
Accrued liabilities
    858,136       874,876  
Warrant liabilities
    954,876       -  
Current portion of notes payable, net
    346,890       57,539  
Total current liabilities
    2,571,047       1,909,577  
Other liabilities
    10,932       54,660  
Deferred tax liability
    7,962,100       -  
Long-term portion of notes payable, net
    -       2,994,442  
Total liabilities
    10,544,079       4,958,679  
                 
                 
Commitments and contingencies; see Note I.
               
Stockholders' equity (deficit)
               
Preferred stock, undesignated, authorized 9,947,439 and 9,990,400 shares; respectively. See Note G.
               
Series B Preferred stock, par value $.0001, issued 2,100 shares; outstanding 0 and 987, respectively.
    -       1  
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 27,858,000 and 1,930,078,  respectively
    2,786       193  
Additional paid-in capital
    219,468,498       115,265,854  
Accumulated deficit
    (136,585,923 )     (117,044,084 )
Total stockholders’ equity (deficit)
    82,885,361       (1,778,036 )
Total liabilities and stockholders' equity (deficit)
  $ 93,429,440     $ 3,180,643  
 
The accompanying notes are an integral part of these Consolidated Financial Statements.
 
 
33

 
OXYGEN BIOTHERAPEUTICS, INC.
 
CONSOLIDATED STATEMENTS OF OPERATIONS
 
   
Year ended April 30,
 
   
2014
   
2013
 
Product revenue
  $ 25,731     $ 92,683  
Cost of sales
    129,800       43,111  
Net product revenue
    (104,069 )     49,572  
Government grant revenue
    262,995       1,141,356  
Total net revenue
    158,926       1,190,928  
                 
Operating expenses
               
Selling, general, and administrative
    13,773,325       3,676,145  
Research and development
    2,996,721       2,455,816  
Restructuring expense
    -       220,715  
Loss on impairment of long-lived assets
    -       27,279  
Total operating expenses
    16,770,046       6,379,955  
                 
Net operating loss
    16,611,120       5,189,027  
                 
Interest expense
    2,212,283       4,238,456  
Other expense (income)
    718,436       (11,683 )
Net loss
  $ 19,541,839     $ 9,415,800  
                 
Preferred stock dividend
    5,803,362       958,071  
Net loss attributable to common stockholders
  $ 25,345,201     $ 10,373,871  
                 
                 
Net loss per share, basic
  $ (2.71 )   $ (6.29 )
Weighted average number of common shares outstanding, basic
    9,362,031       1,650,280  
Net loss per share,  diluted
  $ (2.71 )   $ (6.68 )
Weighted average number of common shares outstanding,  diluted
    9,362,031       1,759,025  
 
The accompanying notes are an integral part of these Consolidated Financial Statements.
 
 
34

 
OXYGEN BIOTHERAPEUTICS, INC.
 
CONOSLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
 
   
Preferred Stock
   
Common Stock
                   
   
Number of Shares
   
Amount
   
Number of Shares
   
Amount
   
Additional paid-in capital
      Accumulated deficit    
Total stockholders' equity (deficit)
 
Balance at April 30, 2012
    -     $ -       1,470,890     $ 2,942     $ 107,279,296     $ (107,628,284 )   $ (346,046 )
Preferred stock sold, net of offering costs
    2,100       1                       1,851,149               1,851,150  
Common stock sold, net of offering costs
                                                    -  
Common stock issued for convertible preferred stock
    (1,113 )             400,708       804       4,509,184               4,509,988  
Common stock issued as interest on convertible debt
                    16,524       33       745,175               745,208  
Common stock issued as dividend on convertible preferred stock
                    17,409       32       331,366               331,398  
Compensation on options and restricted stock issued
                    4,465       9       269,522               269,531  
Issuance of warrants
                                    656,535               656,535  
Exchange of warrants
                    20,000       40       (380,040 )             (380,000 )
Beneficial conversion feature of convertible debt
                                                    -  
Fractional shares of common stock due to reverse stock split
                    82       (3,667 )     3,667               -  
Net loss
                                            (9,415,800 )     (9,415,800 )
                                                         
Balance at April 30, 2013
    987     $ 1       1,930,078     $ 193     $ 115,265,854     $ (117,044,084 )   $ (1,778,036 )
Preferred stock sold, net of offering costs
    5,369       1                       4,895,187               4,895,188  
Preferred stock issued for convertible debt
    4,600       3                       4,599,997               4,600,000  
Common and preferred stock issued for asset purchase
    32,992       3       1,366,844       137       24,046,860               24,047,000  
Common stock sold, net of offering costs
                    10,678,571       1,068       54,907,282               54,908,350  
Common stock issued for convertible preferred stock
    (43,948 )     (8 )     9,056,415       906       (898 )             -  
Common stock issued as interest on convertible debt
                    4,881       1       220,040               220,041  
Common stock issued as dividend on convertible preferred stock
                    1,407,485       140       (140 )             -  
Compensation on options and restricted stock issued
                    50,144       5       8,131,619               8,131,624  
Common stock issued for services rendered
                    198,668       20       499,980               500,000  
Exercise of warrants
                    3,161,145       316       7,135,753               7,136,069  
Reclassification of warrants from equity to derivative liability
                                    (233,036 )             (233,036 )
Fractional shares of common stock due to reverse stock split
                    3,769                               -  
Net loss
                                            (19,541,839 )     (19,541,839 )
Balance at April 30, 2014
    -     $ -       27,858,000     $ 2,786     $ 219,468,498     $ (136,585,923 )   $ 82,885,361  
 
The accompanying notes are an integral part of these Consolidated Financial Statements.
 
 
35

 
OXYGEN BIOTHERAPEUTICS, INC.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
   
Year ended April 30,
 
   
2014
   
2013
 
CASH FLOWS FROM OPERATING ACTIVITIES
           
Net Loss
  $ (19,541,839 )   $ (9,415,800 )
Adjustments to reconcile net loss to net cash used in operating activities
               
Depreciation and amortization
    150,489       148,804  
Interest on debt instruments
    2,181,955       4,236,332  
Loss on impairment, disposal and write down of long-lived assets
    2,519       35,673  
Issuance and vesting of compensatory stock options and warrants
    8,042,662       84,267  
Issuance of common stock as compensation
    651,460       185,264  
Change in the fair value of warrants
    721,840       -  
Changes in operating assets and liabilities
               
Accounts receivable, prepaid expenses and other assets
    519,255       (245,747 )
Inventory
    99,204       (20,228 )
Accounts payable and accrued liabilities
    (2,089,116 )     70,152  
Net cash used in operating activities
    (9,261,571 )     (4,921,283 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES
               
Purchase of property and equipment
    (9,804 )     (17,199 )
Proceeds from the sale of property and equipment
    -       4,064  
Capitalization of patent costs and license rights
    (137,234 )     (134,852 )
Net cash used in investing activities
    (147,038 )     (147,987 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES
               
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
    62,044,419       -  
Repurchase of outstanding warrants
    -       (380,000 )
Proceeds from issuance of notes payable, net of issuance costs
    141,320       102,671  
Proceeds for issuance of convertible preferred stock, net of issuance costs
    4,895,188       4,351,150  
Payments on notes - short-term
    (135,291 )     (100,895 )
Net cash provided by financing activities
    66,945,636       3,972,926  
                 
Net change in cash and cash equivalents
    57,537,027       (1,096,344 )
Cash and cash equivalents, beginning of period
    783,528       1,879,872  
Cash and cash equivalents, end of period
  $ 58,320,555     $ 783,528  
                 
Cash paid for:
               
Interest
  $ 30,328     $ 2,123  
Income taxes
  $ -     $ -  
 
The accompanying notes are an integral part of these Consolidated Financial Statements.
 
 
36

 
OXYGEN BIOTHERAPEUTICS, INC.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS, continued
 
Non-cash financing activities during the year ended April 30, 2014:
 
-   The Company issued 4,881 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.10 for the payment of $220,041 interest payable on convertible notes with a gross carrying value of $4,900,000.
 
-   The Company issued 831,401 shares of its common stock for the payment of $ 1,300,204 as dividends on the Series C 8% Convertible Preferred stock.
 
-   The Company issued 4,600 shares of Series D 8% Convertible Preferred Stock as consideration for cancellation of $4.6 million in outstanding principal amount of a convertible promissory note issued by the Company on July 1, 2011.
 
-   The Company issued 576,084 shares of its common stock for the payment of $1,104,000 as dividends on the Series D 8% Convertible Preferred stock.
 
-   The Company issued 1,366,844 shares of its common stock that had a fair value of approximately $8.7 million and 32,992 shares of its Series E Convertible Preferred Stock, which are convertible into an aggregate of 3,299,200 shares of common stock, that had a fair value of approximately $15.3 million in exchange for the assets of Phyxius Pharma, Inc., as further discussed in Note D to these consolidated financial statements. The Company recorded Goodwill of $11,265,100 as a result of this issuance.
 
Non-cash financing activities during the year ended April 30, 2013:
 
-   The Company issued 16,524 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.11 for the payment of $745,208 interest payable on convertible notes with a gross carrying value of $4,900,000.
 
-   The Company issued 191,934 shares of its common stock upon the conversion of 3,668 shares of Series A convertible preferred stock with a fair value of $4,509,987.
 
The accompanying notes are an integral part of these Consolidated Financial Statements.
 
 
37

 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of April 30, 2014 and 2013, and for the years then ended.
 
NOTE A—DESCRIPTION OF BUSINESS
 
Description of Business—Oxygen Biotherapeutics (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008, by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware, and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics is the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted to one share of Oxygen Biotherapeutics common stock.
 
On October 18, 2013, the Company created a wholly owned subsidiary, Life Newco, Inc., a Delaware corporation (“Life Newco”), to acquire certain assets of Phyxius Pharma, Inc., a Delaware corporation (“Phyxius”) pursuant to an Asset Purchase Agreement, dated October 21, 2013 (the “Asset Purchase Agreement”), by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius (the “Phyxius Stockholders”).  As further discussed in Note D below, on November 13, 2013, under the terms and subject to the conditions of the Asset Purchase Agreement, Life Newco acquired certain assets, including a license granting Life Newco an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing Levosimedan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada.
 
Reverse Stock Split
 
The Company initiated a 1-for-20 reverse stock split effective May 10, 2013. All shares and per share amounts in these Consolidated Financial Statements and notes thereto have been retroactively adjusted to give effect to the reverse stock split.
 
NOTE B—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Use of Estimates
 
The preparation of the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain 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 reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
 
On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.
 
Principles of Consolidation
 
The accompanying consolidated financial statements include the accounts and transactions of Oxygen Biotherapeutics, Inc. and Life Newco, Inc. All material intercompany transactions and balances have been eliminated in consolidation.
 
Goodwill
 
Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired, including identifiable intangible assets, and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized.
 
 
38

 
 
Goodwill is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate potential impairment. The Company’s goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company assesses qualitative factors to determine if its sole reporting unit’s fair value is more likely than not to exceed its carrying value, including goodwill. In the event the Company determines that it is more likely than not that its reporting unit’s fair value is less than its carrying amount, quantitative testing is performed comparing recorded values to estimated fair values. If the fair value exceeds the carrying value, goodwill is not impaired. If the carrying value exceeds the fair value, an impairment charge is recognized through a charge to operations based upon the excess of the carrying value of goodwill over the implied fair value.  There was no impairment to goodwill recognized during 2014.
 
Cash and Cash Equivalents
 
The Company considers all highly liquid instruments with a maturity date of three months or less, when acquired, to be cash equivalents.
 
Cash Concentration Risk
 
On July 21, 2010, the Wall Street Reform and Consumer Protection Act permanently increased the FDIC insurance limits to $250,000 per depositor per insured bank. At April 30, 2014, the Company had $58,038,597 of cash balances uninsured by the FDIC.
 
Liquidity and Capital Resources
 
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had $58,966,033 and $1,842,251 total current assets and working capital (deficit) of $56,394,986 and $(67,326) as of April 30, 2014 and April 30, 2013, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments.
 
Cash resources as of April 30, 2014 were approximately $58.3 million, compared to approximately $784,000 as of April 30, 2013. Based on its resources at April 30, 2014, and the current plan of expenditure on continuing development of the Company’s current product candidates, the Company believes that it has sufficient capital to fund its operations through the fiscal year ending April 30, 2017. However, the Company will need substantial additional financing in order to fund its operations beyond such period and thereafter until it can achieve profitability, if ever. The Company depends on its ability to raise additional funds through various potential sources, such as equity and debt financing, or to license its product candidates to another pharmaceutical company. The Company will continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot assure that it will be able to secure such additional financing, or if available, that it will be sufficient to meet its needs.
 
To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates, or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.
 
Deferred financing costs
 
Deferred financing costs represent legal, due diligence and other direct costs incurred to raise capital or obtain debt. Direct costs include only “out-of-pocket” or incremental costs directly related to the effort, such as a finder’s fee and accounting and legal fees. These costs will be capitalized if the efforts are successful, or expensed when unsuccessful. Indirect costs are expensed as incurred. Deferred financing costs related to debt are amortized over the life of the debt. Deferred financing costs related to issuing equity are charged to Additional Paid-in Capital.
 
Derivative financial instruments
 
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risk. Terms of convertible promissory note instruments and other convertible equity instruments are reviewed to determine whether or not they contain embedded derivative instruments that are required under FASB ASC 815, Derivatives and Hedging (“ASC 815”) to be accounted for separately from the host contract, and recorded on the balance sheet at fair value. The fair value of derivative liabilities, if any, is required to be revalued at each reporting date, with corresponding changes in fair value recorded in current period operating results.
 
Freestanding warrants issued by the Company in connection with the issuance or sale of debt and equity instruments are considered to be derivative instruments, and are evaluated and accounted for in accordance with the provisions of ASC 815. Pursuant to ASC 815, an evaluation of specifically identified conditions is made to determine whether the fair value of warrants issued is required to be classified as equity or as a derivative liability.
 
 
39

 
 
Beneficial conversion and warrant valuation
 
In accordance with FASB ASC 470-20, Debt with Conversion and Other Options, the Company records a beneficial conversion feature (“BCF”) related to the issuance of convertible debt that have conversion features at fixed rates that are in-the-money when issued and the fair value of warrants issued in connection with those instruments. The BCF for the convertible instruments is recognized and measured by allocating a portion of the proceeds to warrants, based on their relative fair value, and as a reduction to the carrying amount of the convertible debt equal to the intrinsic value of the conversion feature. As described in Note F, the discount recorded in connection with the BCF and warrant valuation is recognized as non-cash interest expense and is amortized over the life of the convertible note.
 
Preclinical Study and Clinical Accruals
 
The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that conduct and manage preclinical and clinical trials on its behalf. The financial terms of the agreements vary from contract to contract and may result in uneven expenses and payment flows. Preclinical study and clinical trial expenses include the following:
 
-
Fees paid to CROs in connection with clinical trials,
-
Fees paid to research institutions in conjunction with preclinical research studies, and
-
Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
 
Property and Equipment, Net
 
Property and equipment are stated at cost, subject to adjustments for impairment, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives:
 
Laboratory equipment
3 – 5 years
Office equipment
5 years
Office furniture and fixtures
7 years
Computer equipment and software
3 years
Leasehold improvements
Shorter of useful life or remaining lease term
 
Maintenance and repairs are charged to expense as incurred, improvements to leased facilities and equipment 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 an asset may not be recoverable.
 
Revenue Recognition
 
Revenues from merchandise sales are recognized upon transfer of ownership, including passage of title to the customer and transfer of the risk of loss related to those goods.  Revenues are reported on a net sales basis, which is computed by deducting from gross sales the amount of actual product returns received, discounts, incentive arrangements with retailers and an amount established for anticipated product returns.  The Company's practice is to accept product returns from retailers only if properly requested, authorized and approved.  As a percentage of gross sales, returns were less than 5% in fiscal years 2014 and 2013.
 
 
40

 
 
Revenues from a cost-reimbursement grant sponsored by the United States Army, or Grant Revenue, are recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party CROs.
 
Research and Development Costs
 
Research and development costs include, but are not limited to, (i) expenses incurred under agreements with contract research organizations and investigative sites, which conduct our clinical trials and a substantial portion of our preclinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements and equipment and laboratory and other supplies.  All research and development expenses are expensed as incurred.
 
Income Taxes
 
Deferred tax assets and liabilities are recorded for differences between the financial statement and tax bases of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is recorded for the amount of income tax payable or refundable for the period increased or decreased by the change in deferred tax assets and liabilities during the period.
 
Stock-Based Compensation
 
The Company accounts for stock based compensation in accordance with ASC 718 Compensation — Stock Compensation, which requires the measurement and recognition of compensation expense for all stock-based payment awards granted, modified and settled to our employees and directors. The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option on a straight-line basis over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.
 
Loss Per Share
 
Basic loss per share, which excludes antidilutive securities, is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, warrants and convertible debentures. A reconciliation of the numerator and denominator used in the calculation of basic and diluted net loss per share follows.
 
 
41

 
 
   
Year ended April 30,
 
   
2014
   
2013
 
Historical net loss per share:
           
Numerator
           
Net loss, attributable to common stockholders
  $ (25,345,201 )   $ (10,373,871 )
Less: Effect of amortization of interest expense on convertible notes
    -       (1,382,537 )
Net loss attributable to common stockholders (diluted)
    (25,345,201 )     (11,756,408 )
Denominator
               
Weighted-average common shares outstanding
    9,362,031       1,650,280  
 Effect of dilutive securities
    -       108,745  
Denominator for diluted net loss per share
    9,362,031       1,759,025  
                 
Basic net loss per share
  $ (2.71 )   $ (6.29 )
Diluted net loss per share
  $ (2.71 )   $ (6.68 )
 
The following outstanding options, convertible note shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.
 
   
Year ended April 30,
 
   
2014
   
2013
 
             
Options to purchase common stock
    3,647,858       11,336  
Warrants to purchase common stock
    2,762,466       759,410  
Restricted stock grants
    42,478       1,917  
Convertible note shares outstanding
    6,652       98  
Convertible preferred shares outstanding
    -       97,400  
 
Operating Leases
 
The Company maintains operating leases for its office and laboratory facilities. The lease agreements may include rent escalation clauses and tenant improvement allowances. The Company recognizes scheduled rent increases on a straight-line basis over the lease term beginning with the date the company takes possession of the leased space. Differences between rental expense and actual rental payments are recorded as deferred rent liabilities and are included in “Other liabilities” on the consolidated balance sheets.
 
Fair Value
 
The Company records its financial assets and liabilities in accordance with ASC 820 Fair Value Measurements.  The Company's consolidated balance sheet includes the following financial instruments: cash and cash equivalents, short-term notes payable, convertible preferred stock and convertible notes. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. The Company did not elect the fair value option and records the carrying value of its convertible notes at amortized cost in accordance with ASC 470-20.
 
Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as "the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date." The fair value measurement hierarchy consists of three levels:
 
Level one
Quoted market prices in active markets for identical assets or liabilities;
Level two
Inputs other than level one inputs that are either directly or indirectly observable, and
Level three
Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.
 
 
42

 
 
The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in its Consolidated Financial Statements.
 
The following tables show information regarding assets and liabilities measured at fair value on a recurring basis as of April 30, 2014 and 2013 :
 
         
Fair Value Measurements at Reporting Date Using
 
   
Balance as of April 30, 2014
   
Quoted prices in Active Markets for Identical Securities (Level 1)
   
Significant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Current Assets
                       
Cash and cash equivalents
  $ 58,320,555     $ 58,320,555     $ -     $ -  
                                 
Current Liabilities
                               
Warrant liabilities
  $ 954,876     $ -     $ -     $ 954,876  
 
         
Fair Value Measurements at Reporting Date Using
 
   
Balance as of April 30, 2013
   
Quoted prices in Active Markets for Identical Securities (Level 1)
   
Significant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Current Assets
                       
Cash and cash equivalents
  $ 783,528     $ 783,528     $ -     $ -  
                                 
Current Liabilities
                               
Warrant liabilities
  $ -     $ -     $ -     $ -  
 
There were no significant transfers between levels in the years ended April 30 2014 and 2013. The Warrant liabilities are recorded at fair value with changes in fair value recorded as gains or losses within other expense (income).
 
Financial assets or liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.
 
As further discussed in Note G below, on July 23, 2013, the Company issued common stock warrants (the “Series C Warrants”) in connection with the issuance of Series C 8% Convertible Preferred Stock (the “Series C Stock”).  The Series C warrants are measured using the Monte Carlo valuation model which is based, in part, upon inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions.  The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment.  As a result, if factors change and different assumptions are used, the warrant liabilities and the change in estimated fair value of the warrants could be materially different.
 
Inherent in the Monte Carlo valuation model are assumptions related to expected stock-price volatility, expected life, risk-free interest rate and dividend yield.  The Company estimates the volatility of its common stock based on historical volatility that matches the expected remaining life of the warrants.  The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants.  The expected life of the warrants is assumed to be equivalent to their remaining contractual term.  The dividend rate is based on the historical rate, which the Company anticipates to remain at zero.
 
 
43

 
 
The Monte Carlo model is used for the Series C warrants to appropriately value the potential future exercise price adjustments triggered by the anti-dilution provisions. This requires Level 3 inputs which are based on the Company’s estimates of the probability and timing of potential future financings and fundamental transactions.  The other assumptions used by the Company are summarized in the following table for the Series C warrants that were outstanding as of April 30, 2014; no Series C warrants were outstanding as of April 30, 2013:
 
Series C Warrants
 
April 30,
2014
   
April 30,
2013
 
Closing stock price
  $ 4.88     $ -  
Expected dividend rate
    0 %     - %
Expected stock price volatility
    90.32 %     - %
Risk-free interest rate
    1.75 %     - %
Expected life (years)
    5.23       -  
 
Recent Accounting Pronouncements
 
In June 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-10, Development Stage Entities (Topic 915) . The objective of the amendments in this update is to improve financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities. Users of financial statements of development stage entities told the Board that the development stage entity distinction, the inception-to-date information, and certain other disclosures currently required under U.S. GAAP in the financial statements of development stage entities provide information that has limited relevance and is generally not decision useful. As a result, the amendments in this update remove all incremental financial reporting requirements from US GAAP for development stage entities, thereby improving financial reporting by eliminating the cost and complexity associated with providing that information. The amendments are effective for annual reporting periods beginning after December 15, 2014, and interim reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company has elected to early adopt this guidance, and therefore is no longer presenting the financial statements in accordance with ASU 915, with inception to date disclosures.
 
In May 2014, the FASB issued Accounting Standard Update 2014-09, Revenue from Contracts with Customers (ASU 2014-09) providing a comprehensive new revenue recognition standard. ASU 2014-09 provides revised standards of recognition predicated on when an entity transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 is effective for us in our first quarter of fiscal 2018. ASU 2014-09 can be applied retrospectively with a modified retrospective application permitted. We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements.
 
In July 2013, the FASB issued ASU No. 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists . ASU No. 2013-11 requires entities to present in the consolidated financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward except to the extent such items are not available or not intended to be used at the reporting date to settle any additional income taxes that would result from the disallowance of a tax position. In such instances, the unrecognized tax benefit is required to be presented in the consolidated financial statements as a liability and not be combined with deferred tax assets. This guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013. The adoption of ASU 2013-11 did not have a material impact on the Company’s consolidated financial statements.
 
NOTE C—BALANCE SHEET COMPONENTS
 
Inventory
 
The Company operates in an industry characterized by rapid improvements and changes to its technology and products. The introduction of new products by the Company or its competitors can result in its inventory being rendered obsolete or requiring it to sell items at a discount. The Company evaluates the recoverability of its inventory by reference to its internal estimates of future demands and product life cycles. As of April 30, 2014, due to development delays by the Company’s licensee, the Company does not believe the existing inventory will be sold prior to the expiration of its stability life and has recorded a charge of approximately $97,000 to cost of sales for the year ended April 30, 2014 equal to the carrying value of cosmetics inventory. The Company's future estimates are subjective and actual results may vary.
 
 
44

 
 
Inventories are recorded at cost using the First-In-First-Out (“FIFO”) method. Ending inventories are comprised of raw materials and direct costs of manufacturing and valued at the lower of cost or market. Inventories consisted of the following as of April 30, 2014 and 2013:
 
   
April 30,
2014
   
April 30,
2013
 
Raw materials
  $ -     $ 28,779  
Finished goods
    -       70,425  
    $ -     $ 99,204  
 
Other current assets
 
Other current assets consist of the following:
 
   
April 30,
2014
   
April 30,
2013
 
R&D materials
  $ 177,406     $ 159,892  
Other
    -       7,090  
Dermacyte samples
    -       3,428  
    $ 177,406     $ 170,410  
 
Property and equipment, net
 
Property and equipment consist of the following:
 
   
April 30,
2014
   
April 30,
2013
 
Laboratory equipment
  $ 683,632     $ 768,252  
Computer equipment and software
    142,380       135,697  
Office furniture and fixtures
    130,192       130,192  
      956,204       1,034,141  
Less: Accumulated depreciation and amortization
    (831,830 )     (828,752 )
    $ 124,374     $ 205,389  
 
Depreciation and amortization expense was $88,300 and $92,959 for the years ended April 30, 2014 and 2013, respectively.
 
Accrued liabilities
 
Accrued liabilities consist of the following:
 
   
April 30,
2014
   
April 30,
2013
 
Employee related
  $ 609,130     $ 66,632  
Deferred revenue
    124,521       185,068  
Operating costs
    76,632       19,865  
Restructuring liability
    43,728       43,728  
Convertible note interest payable
    4,125       59,583  
Accrued settlement costs
    -       500,000  
    $ 858,136     $ 874,876  
 
 
45

 
 
Other liabilities
 
As further discussed in Note H below, following the closing of the Company’s research and development facility in California, the Company entered into a long-term sublease agreement with an unrelated third party covering the vacated space which extends through the termination date. The Company recorded a liability for the remaining lease payments due under its long-term, non-cancelable operating lease for this facility, net of sublease payments, which expires in July 2015. The table below summarizes the net future minimum payments due under this lease agreement.
 
   
April 30,
2014
   
April 30,
2013
 
Net non-cancelable operating lease obligation
  $ 54,660     $ 98,388  
Less: current portion
    (43,728 )     (43,728 )
Long-term portion of net non-cancelable operating lease obligation
  $ 10,932     $ 54,660  
 
NOTE D—ACQUISITION
 
On November 13, 2013, the Company, through its wholly owned subsidiary, Life Newco, acquired certain assets of Phyxius pursuant to the Asset Purchase Agreement. The acquisition was accounted for under the acquisition method of accounting for business combinations in accordance with FASB ASC 805,   Business Combinations, which requires, among other things that the assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date.  Acquisition-related costs are not included as a component of the acquisition accounting, but are recognized as expenses in the periods in which the costs are incurred.  Any changes within the measurement period resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recorded at the acquisition date.
 
Under the terms and subject to the conditions of the Asset Purchase Agreement, Life Newco acquired (the “Acquisition”) certain assets, including that certain License Agreement (the “License”), dated September 20, 2013 by and between Phyxius and Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”), and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion.  The License grants Life Newco an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing Levosimedan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial (the “Product”) in the United States and Canada (the “Territory”).  Pursuant to the License, Life Newco must use Orion’s “Simdax®” trademark to commercialize the Product.  The License also grants to Life Newco a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication.  Orion’s ongoing role under the License includes sublicense approval, serving as the sole source of manufacture, holding a first right to enforce intellectual property rights in the Territory, and certain regulatory participation rights.  Additionally, Life Newco must grant back to Orion a broad non-exclusive license to any patents or clinical trial data related to the Product developed by Life Newco under the License.  The License has a fifteen (15) year term, provided, however, that the License will continue after the end of the fifteen year term in each country in the Territory until the expiration of Orion’s patent rights in the Product in such country (the “Term”).  Orion may terminate the License if the human clinical trial using the Product and studying reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS) as described in the US Food and Drug Administration (the “FDA”) agreed upon clinical study protocol (the “Study”) is not started by July 31, 2014. As of July 24, 2014 the Company is in negotiations with multiple clinical sites.
 
The following table summarizes the consideration transferred to acquire Phyxius and the amounts of identified assets acquired and liabilities assumed at the acquisition date.
 
Fair Value of Consideration Transferred:
 
Common stock
    8,747,802  
Series E convertible preferred stock
    15,299,198  
   Total
    24,047,000  
 
The Company issued 1,366,844 shares of its common stock that had a total fair value of approximately $8.7 million based on the closing market price on November 13, 2013, the acquisition date. The Company also issued 32,992 shares of its Series E Convertible Preferred Stock (the “Series E Stock”), which are convertible into an aggregate of 3,299,200 shares of common stock that had a total fair value of approximately $15.3 million.
 
 
46

 
 
 
The rights, preferences and privileges of the Series E Stock are set forth in the Certificate of Designation of Series E Convertible Preferred Stock that the Company filed with the Secretary of State of the State of Delaware on November 13, 2013.  Each share of Series E Stock automatically converted into 100 shares of common stock following receipt of stockholder approval for the transaction at the special meeting of stockholders held on March 13, 2014.  Approximately 11% of the shares of converted common stock vested immediately upon receipt of stockholder approval for the transaction, while the remainder vested upon the closing of the Company’s underwritten offering of 9,285,714 shares of common stock on March 21, 2014, which resulted in net proceeds of approximately $55 million.  
 
The Series E Stock was convertible into restricted common shares using a 100-for-one ratio at any time and in accordance with a vesting schedule contingent upon achievement of Company-specific non-financial conditions. As a result, the fair value of the Preferred Shares was inferred based on their common stock equivalent value given the conversion terms. The conditional vesting of the Series E Stock was accounted for by subtracting the fair value of an equal number of put options that would effectively protect the common stock equivalent stock value as of the closing date. The terms of the put options were as follows:
 
-  
Exercise price equal to the common stock price as of the Valuation Date.
 
-  
Term based on management’s risk-adjusted expected time to meeting the vesting condition, which was further increased by 6 months to reflect the marketability restriction of the unregistered stock, consistent with SEC Rule 144 of the Securities Act.
 
-  
Volatility was consistent with the term for the individual milestone payments derived from the median historical asset volatility for a set of comparable guideline companies. The volatility was then relevered to estimate the equity volatility of the Company.
 
In accordance with the provisions of FASB ASC 805, the following table presents the preliminary allocation of the total fair value of consideration transferred, as discussed above, to the acquired tangible and intangible assets and assumed liabilities of Phyxius based on their estimated fair values as of the closing date of the transaction, measurement period adjustments recorded since the acquisition date and the adjusted allocation of the total fair value:
 
   
November 13,
2013
   
Measurement
   
November 13,
2013
 
   
(As initially reported)
   
Period Adjustments (1)
   
(As adjusted)
 
IPR&D
  $ 22,000,000     $ -     $ 22,000,000  
Trade and other payables
    (256,000 )     -       (256,000 )
Liabilities arising from a contingency
    (1,000,000 )     -       (1,000,000 )
Deferred tax liability related to intangibles acquired
    -       (7,962,100 )     (7,962,100 )
Total identifiable net assets
    20,744,000       (7,962,100 )     12,781,900  
Goodwill
    3,303,000       7,962,100       11,265,100  
Total fair value of consideration
  $ 24,047,000     $ -     $ 24,047,000  
 
(1)
The measurement period adjustments primarily reflect the recording of a deferred tax liability and resulting goodwill.  The measurement period adjustments were made to reflect facts and circumstances existing as of the acquisition date and did not result from intervening events subsequent to the acquisition date.
 
 
47

 
 
The fair value of the acquired in-process research and development, (“IPR&D”), intangible asset of approximately $22.0 million was determined using the multi-period excess earnings method. The Company did not acquire any other class of assets as a result of the acquisition.
 
Pursuant to the terms of the License, the Company paid to Orion a non-refundable up-front payment in the amount of $1 million.
 
The License also includes the following development milestones for which the Company shall make non-refundable payments to Orion no later than twenty-eight (28) days after the occurrence of the applicable milestone event: (i) $2.0 million upon the grant of FDA approval, including all registrations, licenses, authorizations and necessary approvals, to develop and/or commercialize the Product in the United States; and (ii) $1.0 million upon the grant of regulatory approval for the Product in Canada. Once commercialized, the Company is obligated to make certain non-refundable commercialization milestone payments to Orion, aggregating up to $13.0 million, contingent upon achievement of certain cumulative net sales amounts in the Territory. The Company must also pay Orion tiered royalties based on net sales of the Product in the Territory made by the Company and its sublicensees. After the end of the Term, the Company must pay Orion a royalty based on net sales of the Product in the Territory for as long as the Company sells the Product in the Territory.
 
In connection with the closing of the Acquisition, Phyxius’ co-founder, Chief Executive Officer and stockholder, John Kelley, became the Company’s Chief Executive Officer and two other Phyxius employees and stockholders, Doug Randall and Douglas Hay, PhD became employees of the Company as Vice President, Business and Commercial Operations and Vice President, Regulatory Affairs, respectively.  Michael Jebsen, the Company’s prior Interim Chief Executive Officer and current Chief Financial Officer, continued serving as the Company’s Chief Financial Officer.  In addition, Mr. Kelley was subsequently appointed to the Company’s Board of Directors, and Gerald T. Proehl, a designee of the Phyxius Stockholders, was appointed to the Board of Directors on April 3, 2014 following receipt of stockholder approval for the transaction.  Pursuant to the Asset Purchase Agreement, the Company agreed to propose that its stockholders approve an amendment to the Company’s 1999 Stock Plan to increase the amount of stock options authorized for issuance under the 1999 Stock Plan to not less than 4,000,000 shares of common stock. On March 13, 2014, the Company received stockholder approval to increase the option plan. In accordance with terms of the Acquisition, the Company issued an aggregate of 3,572,880 stock options with a grant date fair value of $15,818,512, to the individuals described above. See Note G for additional details
 
The common stock and Series E Stock issued as the consideration in the Acquisition were issued and sold without registration under the Securities Act of 1933 (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws.  Accordingly, the Phyxius Stockholders may sell the shares of common stock and Series E Stock only pursuant to an effective registration statement under the Securities Act covering the resale of those securities, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act.
 
The table below presents unaudited pro forma information as if the Company’s acquisition of Phyxius had occurred at the beginning of the earliest period presented, which was May 1, 2012. The pro forma financial information is not indicative of the results of operations that would have occurred had the transaction been effected on the assumed date or of the results that may occur in the future:
   
 
48

 
 
   
Year ended April 30,
 
   
2014
   
2013
 
Total net revenue
    158,926       1,190,928  
Net loss
  $ 19,560,030     $ 9,418,395  
                 
Net loss attributable to common stockholders
  $ 25,363,392     $ 10,376,466  
                 
                 
Net loss per share, basic
  $ (2.37 )   $ (3.44 )
Weighted average number of common shares outstanding, basic
    10,717,037       3,017,124  
Net loss per share,  diluted
  $ (2.37 )   $ (3.76 )
Weighted average number of common shares outstanding,  diluted
    10,717,037       3,125,869  
 
NOTE E—INTANGIBLE ASSETS
 
The following table summarizes our intangible assets as of April 30, 2014:
 
Asset Category
 
Value Assigned
   
Weighted Average Amortization Period (in Years)
   
Impairments
   
Accumulated Amortization
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
IPR&D
  $ 22,000,000     N/A     $ -     $ -     $ 22,000,000  
Patents
    724,067     10.8       -       (289,943 )     434,124  
License Rights
    607,947     14.6       -       (148,713 )     459,234  
Trademarks
    106,386     N/A       -       -       106,386  
Total
  $ 23,438,400           $ -     $ (438,656 )   $ 22,999,744  
 
The following table summarizes our intangible assets as of April 30, 2013:
 
Asset Category
 
Value Assigned
   
Weighted Average Amortization Period (in Years)
   
Impairments
   
Accumulated Amortization
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
Patents
  $ 645,918     11.2     $ (27,279 )   $ (258,499 )   $ 360,140  
License Rights
    572,370     15.6       -       (117,969 )     454,401  
Trademarks
    110,157     N/A       -       -       110,157  
Total
  $ 1,328,445           $ (27,279 )   $ (376,468 )   $ 924,698  
 
For the years ended April 30, 2014 and 2013, the aggregate amortization expense on the above intangibles was approximately $62,189 and $55,845, respectively. The following table summarizes the aggregate amortization expense over the remaining life of the patents and license rights as of April 30, 2014:
 
 
49

 
 
Year ending April 30,
 
Amount
 
       
2015
  $ 66,525  
2016
    65,949  
2017
    62,032  
2018
    61,239  
2019
    61,111  
Therafter
    576,502  
    $ 893,358  
 
 
In Process Research and Development The levosimendan product in Phase III clinical trial represents an IPR&D asset. The IPR&D asset is a research and development project rather than a product or processes already in service or being sold. Research and development intangible assets are considered indefinite-lived until the abandonment or completion of the associated research and development efforts. If abandoned, the assets would be impaired. Research and development expenditures that are incurred after the acquisition, including those for completing the research and development activities related to the acquired intangible research and development assets, are generally expensed as incurred.
 
Patents and License Rights The Company currently holds, has filed for, or owns exclusive rights to, U.S. and worldwide patents covering 13 various methods and uses of its perfluorocarbon (“PFC”) technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its patent applications. These capitalized costs are amortized on a straight-line method over their useful life or legal life, whichever is shorter.
 
The Company completed its annual impairment test of its patents and license rights during the fourth quarter of fiscal years 2014 and 2013. The Company wrote-off approximately $0 and $27,000 of capitalized costs for patent applications that were withdrawn or abandoned during the years ended April 30, 2014 and 2013, respectively. These asset impairment charges primarily related to the Company’s topical formulations using alternative PFCs which were determined not to be a core component of the Company’s development strategy. The Company capitalized patent costs of approximately $137,000 and $135,000 for the year ended April 30, 2014 and 2013, respectively.
 
Trademarks —The Company currently holds, or has filed for, trademarks to protect the use of names and descriptions of its products and technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its trademark applications. These trademarks are evaluated annually for impairment in accordance with ASC 350, Intangibles – Goodwill and other. The Company evaluates (i) its expected use of the underlying asset, (ii) any laws, regulations, or contracts that may limit the useful life, (iii) the effects of obsolescence, demand, competition, and stability of the industry, and (iv) the level of costs to be incurred to commercialize the underlying asset. The Company capitalized trademark costs of approximately $0 and $1,100, for the year ended April 30, 2014 and 2013, respectively.
 
NOTE F—NOTES PAYABLE
 
The following table summarizes the Company’s outstanding notes payable as of April 30, 2014 and 2013:
 
   
April 30,
2014
   
April 30,
2013
 
Current portion of notes payable, net
  $ 63,568     $ 57,539  
Current portion of convertible notes payable
    300,000       -  
Less: Unamortized discount
    (16,678 )        
Current portion of notes payable, net
  $ 346,890     $ 57,539  
                 
Long-term portion of convertible notes payable
  $ -     $ 4,900,001  
Less: Unamortized discount
    -       (1,905,559 )
Long-term portion of notes payable, net
  $ -     $ 2,994,442  
 
Convertible Note
 
On June 29, 2011, the Company issued a note (the “June Note”) with a principal amount of approximately $300,000 and Warrants to purchase 6,652 shares of common stock. On July 1, 2011, the Company issued a separate note (together with the June Note, the “Notes”) with a principal amount of $4,600,000 and warrants to purchase 101,996 shares of common stock. The aggregate gross proceeds to the Company from the offering were approximately $4.9 million, excluding any proceeds from the exercise of any warrants. The aggregate placement agent fees were $297,000 and legal fees associated with the offering were $88,839. These costs have been capitalized as debt issue costs and will be amortized as interest expense over the life of the Notes. The Company recorded amortization of debt issue costs of $128,616 for each of the years ended April 30, 2014 and 2013.
 
 
50

 
 
The total value allocated to the warrants was $1,960,497 and was recorded as a debt discount against the proceeds of the notes.  In addition, the beneficial conversion features related to the notes were determined to be $2,939,504.  As a result, the aggregate discount on the notes totaled $4,900,001, and is being amortized over term of the notes.  The Company recorded interest expense for the amortization of debt discount $483,330 and $1,633,332 for the year ended April 30, 2014 and 2013, respectively.
 
Interest on the Notes accrues at a rate of 15% annually and will be paid in quarterly installments commencing on the third month anniversary of issuance. The Notes will mature 36 months from the date of issuance. The Notes may be converted into shares of common stock at a conversion price of $45.10 per share (subject to adjustment for stock splits, dividends and combinations, recapitalizations and the like) (the "Conversion Price") in whole or in part, at any time at the option of the holders of the Notes. The Notes also will automatically convert into shares of common stock at the Conversion Price at the election of a majority-in-interest of the holders of notes issued under the purchase agreement or upon the acquisition or sale of all or substantially all of the assets of the Company. The Company may make each applicable interest payment or payment of principal in cash, shares of common stock at the Conversion Price, or any combination thereof. The Company may elect to prepay all or any portion of the Notes without prepayment penalties only with the approval of a majority-in-interest of the note holders under the purchase agreement at the time of the election.   The Notes contain various events of default such as failing to timely make any payment under the Note when due, which may result in all outstanding obligations under the Note becoming immediately due and payable.
 
As further discussed in Note G below, on August 22, 2013 holders of $4.6 million of the Notes received 4,600 shares of the Company’s Series D 8% Convertible Preferred Stock (the “Series D Stock”) as consideration for cancelling their outstanding Note. On that date, the Company recognized non-cash interest expense of $1,311,847 for the remaining unamortized debt discount associated with this Note.
 
NOTE G—STOCKHOLDERS’ EQUITY
 
Preferred Stock
 
Under the Company’s Certificate of Incorporation, the Board of Directors is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. As of April 30, 2014, 9,947,439 shares of preferred stock are undesignated.
 
On November 13, 2013, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 32,992 shares of its authorized but unissued shares of preferred stock as Series E Stock.
 
On August 22, 2013, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 4,600 shares of its authorized but unissued shares of preferred stock as Series D Stock.
 
On July 22, 2013, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 5,369 shares of its authorized but unissued shares of preferred stock as Series C Stock.
 
On February 25, 2013, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 1,600 shares and 500 shares of its authorized but unissued shares of preferred stock as Series B-1 Convertible Preferred Stock (the “Series B-1 Stock”) and Series B-2 Convertible Preferred Stock (the “Series B-2 Stock” and together with the Series B-1 Stock, the “Series B Stock”), respectively.
 
On December 8, 2011, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 7,500 shares of its authorized but unissued shares of preferred stock as Series A Stock.
 
 
51

 
 
Series E Stock
 
As further discussed in Note D above, on November 13, 2013 the Company issued 32,992 shares of its Series E Stock, which are convertible into an aggregate of 3,299,200 shares of common stock, as partial consideration to acquire certain assets of Phyxius Pharma, Inc. pursuant to the Asset Purchase Agreement.
 
The rights, preferences and privileges of the Series E Stock are set forth in the Certificate of Designation of Series E Convertible Preferred Stock (the “Certificate of Designation”) that the Company filed with the Secretary of State of the State of Delaware on November 13, 2013.  Each share of Series E Stock will automatically convert into 100 shares of common stock following receipt of stockholder approval for the transaction.  Approximately 11% of the shares of converted common stock will vest immediately upon receipt of stockholder approval for the transaction, while the remainder will vest upon achievement of certain performance milestones related to the development and commercialization of the levosimendan product in North America.   In addition, all unvested converted common stock will vest if certain change of control transactions or significant equity financings occur within 24 months of the closing of the Acquisition.  The number of shares of common stock into which the Series E Stock converts is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.  The Series E Stock does not carry dividend or a liquidation preference.  The Series E Stock carries voting rights aggregating 4.99% of the Company’s common stock voting power immediately prior to the closing of the Acquisition.
 
During the year ended April 30, 2014, 32,992 shares of Series E Stock were converted into 3,299,200 shares of Common Stock. As of April 30, 2014 there were no shares of Series E Stock outstanding.
 
Series D Stock
 
On August 22, 2013, the Company closed its private placement of an aggregate of $4.6 million of shares of the Company’s Series D Stock to JP SPC 3 obo OXBT FUND, SP (“OXBT Fund”).  In connection with the purchase of shares of Series D Stock, OXBT Fund received a warrant to purchase 2,358,975 shares of common stock at an exercise price equal to $2.60 (the “Series D Warrant”).  As consideration for the sale of the Series D Stock and Series D Warrant, $4.6 million in outstanding principal amount of a Note issued by the Company on July 1, 2011 and held by OXBT Fund was cancelled.  The Note carried interest at a rate of 15% per annum and matured on July 1, 2014.  Mr. Gregory Pepin, one of the Company’s directors, is the investment manager of OXBT Fund.  Pursuant to the terms of a lock-up agreement (the “Lock-Up Agreement”) executed prior to the closing, OXBT Fund and its affiliates are prohibited from engaging in certain transactions with respect to shares of the Company’s common stock and common stock equivalents until such time as the lead investor in the Company’s offering of Series C Stock ceases to own at least 25% of the shares of Series C Stock originally issued to such investor.
 
The table below sets forth a summary of the designation, powers, preferences and rights of the Series D Stock.
 
Conversion
 
Subject to certain ownership limitations, the Series D Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series C Stock (or $1,000) by a conversion price of $1.95 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
Until such time that for at least 25 trading days during any 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 250% of the initial conversion price, if the Company sells or grants any option to purchase or sell any common stock or common stock equivalents entitling any person to acquire shares of common stock at an effective price per share that is lower than the then conversion price, or the Base Conversion Price, then the conversion price shall be reduced to equal the Base Conversion Price
     
Dividends and Make-Whole Payment
 
 
Until the third anniversary of the date of issuance of the Series D Stock, the holder of the Series D Stock is entitled to receive dividends at the rate of 8% per annum of the stated value for each share of Series D Stock held by such holder payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the original issue date, and on each dividend payment date.  The Company can elect to pay the dividends in cash or in duly authorized, validly issued, fully paid and non-assessable shares of common stock, or a combination thereof.  If the Company pays the dividends in shares of common stock, the shares used to pay the dividends will be valued at 90% of the average volume weighted average price for the 20 consecutive trading days ending on the trading day immediately prior to the applicable dividend payment date.  From and after the third anniversary of the date of issuance of the Series D Stock, the holder of Series D Stock will be entitled to receive dividends equal, on an as-if-converted to common stock basis, to and in the same form as dividends actually paid on shares of common stock when, as, and if such dividends are paid on shares of common stock.  The Company has never paid dividends on its common stock and the Company does not intend to do so for the foreseeable future.
In the event OXBT Fund converts its Series D Stock prior to the third anniversary of the date of issuance of the Series D Stock, the Company must also pay to OXBT Fund in cash, or at the Company’s option in common stock valued as described above, or a combination of cash and shares of common stock, with respect to the Series D Stock so converted, an amount equal to $240 per $1,000 of the stated value of the Series D Stock, less the amount of any dividends paid in cash or in common stock on such Series D Stock on or before the date of conversion.
 
 
52

 
 
Liquidation
 
Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, but before any distribution or payment is made to the holders of any junior securities, the holder of Series D Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to $1,000 per share, after which any remaining assets of the Company shall be distributed among the holders of the other class or series of stock in accordance with the Company’s Certificate of Incorporation.
     
Voting rights
 
Shares of Series D Stock will generally have no voting rights, except as required by law and except that the consent of the holder of the outstanding Series D Stock will, among other things, be required to amend the terms of the Series D Stock.

During the year ended April 30, 2014, 4,600 shares of Series D Stock were converted into 2,358,974 shares of Common Stock and the Company issued 576,084 shares of its common stock in the form of Series D Stock dividends. As of April 30, 2014 there were no shares of Series D Stock outstanding.
 
Series C Stock
 
 On July 21, 2013, the Company entered into a Securities Purchase Agreement with certain investors providing for the issuance and sale by the Company (the “Series C Offering”) of an aggregate of approximately $5.4 million of shares of the Company’s Series C Stock, which are convertible into a combined total of 2,753,348 shares of common stock (the “Conversion Shares”).  In connection with the purchase of shares of Series C Stock in the Series C Offering, each investor will receive a warrant to purchase a number of shares of common stock equal to 100% of the number of Conversion Shares at an exercise price equal to $2.60 (the “Warrants”).  On July 23, 2013, the Company sold 5,369 units for net proceeds of approximately $4.9 million.
 
The table below sets forth a summary of the designation, powers, preferences and rights of the Series C Stock.
 
 Conversion
 
Subject to certain ownership limitations, the Series C Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series C Stock (or $1,000) by a conversion price of $1.95 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
Until such time that for at least 25 trading days during any 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 250% of the initial conversion price, if the Company sells or grants any option to purchase or sell any common stock or common stock equivalents entitling any person to acquire shares of common stock at an effective price per share that is lower than the then conversion price, or the Base Conversion Price, then the conversion price shall be reduced to equal the Base Conversion Price
 
 
53

 
 
Dividends and Make-Whole Payment
 
 
Until the third anniversary of the date of issuance of the Series C Stock, each holder of the Series C Stock is entitled to receive dividends at the rate of 8% per annum of the stated value for each share of Series C Stock held by such holder payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the original issue date, and on each dividend payment date.  The Company can elect to pay the dividends in cash or in duly authorized, validly issued, fully paid and non-assessable shares of common stock, or a combination thereof.  If the Company pays the dividends in shares of common stock, the shares used to pay the dividends will be valued at 90% of the average volume weighted average price for the 20 consecutive trading days ending on the trading day immediately prior to the applicable dividend payment date.  From and after the third anniversary of the date of issuance of the Series C Stock, each holder of Series C Stock will be entitled to receive dividends equal, on an as-if-converted to common stock basis, to and in the same form as dividends actually paid on shares of common stock when, as, and if such dividends are paid on shares of common stock.  The Company has never paid dividends on its common stock and the Company does not intend to do so for the foreseeable future.
In the event a holder converts his, her or its Series C Stock prior to the third anniversary of the date of issuance of the Series C Stock, the Company must also pay to the holder in cash, or at the Company’s option in common stock valued as described above, or a combination of cash and shares of common stock, with respect to the Series C Stock so converted, an amount equal to $240 per $1,000 of the stated value of the Series C Stock, less the amount of any dividends paid in cash or in common stock on such Series C Stock on or before the date of conversion.
     
Liquidation
 
Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, but before any distribution or payment is made to the holders of any junior securities, the holders of Series C Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to $1,000 per share, after which any remaining assets of the Company shall be distributed among the holders of the other class or series of stock in accordance with the Company’s Certificate of Incorporation.
     
Voting rights
 
Shares of Series C Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series C Stock will, among other things, be required to amend the terms of the Series C Stock.

The Company will not affect any conversion of the Series C Stock, nor shall a holder convert its shares of Series C Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Series C Stock or otherwise, beneficial ownership of a number shares of common stock in excess of 4.99% of the common stock outstanding immediately preceding the conversion.
 
During the year ended April 30, 2014, 5,369 shares of Series C Stock were converted into 2,753,327 shares of common stock and the Company issued 831,401 shares of its common stock for the payment of $1,288,560 as dividends on the Series C Stock. As of April 30, 2014 there were no shares of Series C Stock outstanding.
 
Series B Stock
 
On February 22, 2013, the Company entered into a Securities Purchase Agreement with an institutional investor providing for the issuance and sale by the Company of $1.6 million of shares of the Company’s Series B-1 Stock and $0.5 million of shares of the Company's Series B-2 Stock which are convertible into a combined total of 420,000 shares of common stock, subject to adjustment for subsequent equity sales.
 
On February 27, 2013, the Company sold 2,100 units for net proceeds of approximately $1.9 million. Each unit sold consisted of (i) one share of the Company’s Series B Stock and (ii) a Warrant representing the right to purchase 300 shares of common stock at a price of $1,000 per unit, less issuance costs. The shares of Series B Stock were immediately convertible upon issuance.
 
 
54

 
 
The table below sets forth a summary of the designation, powers, preferences and rights of the Series B Stock.
 
Dividends
 
No dividends shall be paid on shares of Preferred Stock.
 
     
Conversion
 
Holders may elect to convert shares of Series B Stock into shares of common stock at the then-existing conversion price at any time.  The initial conversion price is $5.00 per share of common stock, and is subject to certain adjustments, including an anti-dilution provision that reduces the conversion price upon the issuance of any common stock or securities convertible into common stock at an effective price per share less than the conversion price and a one-time price reset following the effectiveness of a reverse split of the Company’s outstanding common stock.
 
     
Liquidation preference
 
In the event of the Company’s voluntary or involuntary dissolution, liquidation or winding up, each holder of Series B Stock will be entitled to be paid a liquidation preference equal to the initial stated value of such holder’s Series B Stock of $1,000 per share, plus accrued and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Series B Stock.
 
     
Voting rights
 
Shares of Series B Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series B Stock will among other things, be required to amend the terms of the Series B Stock.
 
 
The Company will not affect any conversion of the Series B Stock, nor shall a holder convert its shares of Series B Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Series B Stock or otherwise, beneficial ownership of a number shares of common stock in excess of 4.99% of the common stock outstanding immediately preceding the conversion.
 
During the year ended April 30, 2014, 987 shares of Series B Stock were converted into 644,915 shares of common stock.  As of April 30, 2014 there were no shares of Series B Stock outstanding.
 
Series A Stock
 
On December 12, 2011, the Company sold 3,500 units for net proceeds of approximately $3.2 million. Each unit sold consisted of (i) one share of the Company’s Series A Stock and (ii) a warrant representing the right to purchase 11.275 shares of common stock (the “2011 Warrants”), at a price of $1,000 per unit, less issuance costs. The shares of Series A Stock were immediately convertible and the 2011 Warrants are exercisable on the one-year anniversary of the closing date.
 
On June 15, 2012, the Company sold an additional 2,500 units for net proceeds of approximately $2.3 million. Each unit sold consisted of (i) one share of the Company’s Series A Stock and (ii) a 2011 Warrant, at a price of $1,000 per unit, less issuance costs. The shares of Series A Stock were immediately convertible and the 2011 Warrants are exercisable beginning on the one-year anniversary of the closing date.
 
Interest expense on the outstanding Series A Stock was approximately $0 and $1.7 million for the year ended April 30, 2014 and 2013, respectively. The recorded interest for the prior period was comprised of approximately $657,000 for the calculated fair value of the warrants issued with the Series A Stock and $763,000 for the excess of the fair-value of the shares issued upon conversion over the fair value of the Series A Stock.
 
 
55

 
 
Interest expense recorded for the payment of dividends on the Series A Stock was approximately $0 and $310,000 for the year ended April 30, 2014 and 2013, respectively.
 
No Series A Stock was outstanding during the years ended April 30, 2014 or April 30, 2013.
 
Common Stock
 
The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of April 30, 2014 and 2013, there were 27,858,000 and 1,930,078 shares of common stock issued and outstanding.
 
Warrants
 
Series D Warrants
 
On August 22, 2013, the Company closed its previously announced private placement of an aggregate of $4.6 million shares of the Company’s Series D Stock to OXBT Fund.  In connection with the purchase of shares of Series D Stock, OXBT Fund received the Series D Warrant to purchase 2,358,975 shares of common stock at an exercise price equal to $2.60 and contractual term of 6 years. In accordance with ASC 815, these warrants are classified as equity and their relative fair-value of $1,531,167 was recognized as a deemed dividend on the Series D Stock during the year ended April 30, 2014. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.  
 
The Series D Warrant is exercisable beginning on the date of issuance and expires on August 22, 2019.  The exercise price and the number of shares issuable upon exercise of Series D Warrant is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock, and also upon any distributions of assets, including cash, stock or other property to the Company’s stockholders.  In addition, if stockholder approval for the transaction is obtained, the Series D Warrant will be subject to anti-dilution provisions until such time that for 25 trading days during any 30 consecutive trading day period, the volume weighted average price of the Company’s common stock exceeds $6.50 and the daily dollar trading volume exceeds $350,000 per trading day.
 
On January 30, 2014, the Company entered into an agreement with the OXBT Fund to amend the terms of the outstanding Series D Warrants. The amendment replaced the price protection anti-dilution provision of each warrant with a covenant that the Company will not issue common stock or common stock equivalents at an effective price per share below the exercise price of such warrant without prior written consent, subject to certain exceptions.
 
The Series D Stock and the Series D Warrant were issued and sold without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws.  Accordingly, OXBT Fund may exercise the Warrant and sell the Series D Stock and underlying shares only pursuant to an effective registration statement under the Securities Act covering the resale of those securities, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act.
 
Series C Warrants
 
As part of the offering of Series C Stock, the Company issued 2,753,348 Series C Warrants at an exercise price of $2.60 per share and contractual term of 6 years. In accordance with ASC 815, these warrants are classified as equity and their relative fair-value of $1,867,991 was recognized as a deemed dividend on the Series C Stock during the year ended April 30, 2014. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.
 
In connection with the Series C Offering described above, the Company entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Placement Agent”) pursuant to which the Placement Agent agreed to act as the Company’s exclusive placement agent for the Series C Offering. In accordance with the Placement Agency Agreement, on July 23, 2013 the Company issued to the Placement Agent warrants to purchase 53,539 shares of common stock at an exercise price of $2.4375 per share and a contractual term of 3 years. In accordance with ASC 815, these warrants are classified as equity and their relative fair-value of $51,231 was recognized as additional paid in capital during the year ended April 30, 2014. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.
 
 
56

 
 
On August 23, 2013, the Company entered into agreements with certain institutional investors to amend the terms of certain outstanding warrants to purchase an aggregate of 2,681,283 shares of the Company’s common stock issued by the Company on February 27, 2013 and July 27, 2013 (collectively, the “Warrant Amendments”).  The Warrant Amendments replace the price protection anti-dilution provision of each warrant with a covenant that the Company will not issue common stock or common stock equivalents at an effective price per share below the exercise price of such warrant without prior written consent, subject to certain exceptions. As of April 30, 2014, none of these amended warrants remain outstanding.
 
During the year ended April 30, 2014, the Company received cash of approximately $6.5 million and issued 2,512,825 shares of common stock upon the exercise of outstanding Series C Warrants. As of April 30, 2014, 240,523 Series C Warrants are outstanding.
 
In accordance with ASC 815-40-35-8, the company reassessed the classification of the remaining Series C Warrants. On November 11, 2013, the Company satisfied certain contractual obligations pursuant to the Series C offering which caused certain “down-round” price protection clauses in the outstanding warrants to become effective on that date. In accordance with ASC 815-40-35-9, On November 11, 2013, the Company reclassified these warrants as a current liability and recorded a warrant liability of $1,082,941 which represents the fair market value of the warrants at that date. The initial fair value recorded as warrants within stockholders’ equity of $233,036 was reversed and the change in fair value was recorded as a component of other expense.
 
The estimated fair value is determined using the Monte Carlo Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends, expected volatility of the price of the underlying common stock as well as other estimates and assumptions.
 
As of April 30, 2014, the fair value of the warrant liability was $954,876. The Company recorded a loss of $721,840 for the change in fair value on the consolidated statement of operations for the year ended April 30, 2014.
 
Series B Warrants
 
In connection with the issuance of 2,100 shares of Series B Preferred Stock described above, on February 27, 2013 the Company issued Class A and Class B warrants to purchase an aggregate of 630,000 shares of common stock. The warrants were issued at an initial exercise price equal to $10.00 and were immediately exercisable. The Class A warrants were issued with a six-year term and the Class B warrants were issued with a two-year term.
 
During the year ended April 30, 2014, the Company received proceeds of $567,000 and issued 630,000 shares of common stock upon the exercise of the Series B warrants. As of April 30, 2014, there were no Series B warrants outstanding.
 
Series A Warrants
 
On December 12, 2011, the Company issued warrants to purchase 39,415 shares of common stock as part of the Series A Stock Offering. The warrants were issued at an initial exercise price of $44.40. The Warrants were issued with a six-year term and are exercisable beginning December 12, 2012. In June 2012, the Company issued warrants to purchase 28,154 shares of Common Stock as part of the Series A Stock subsequent closing. The Warrants were issued with a six-year term and are exercisable beginning June 17, 2013. On February 21, 2013, the Company entered into an agreement with the holders of these warrants (the “Warrant Exchange Agreements”) under which all of the outstanding warrants were cancelled in exchange for an aggregate of 20,000 shares of the Company’s common stock and $380,000 in cash pursuant to Section 3(a)(9) under the Securities Act.
 
The following table summarizes the Company’s warrant activity for the year ended April 30, 2014 :
 
 
57

 
 
   
Warrants
   
Weighted Average Exercise Price
 
Outstanding at April 30, 2012
    261,999     $ 41.60  
Issued
    658,154       6.69  
Cancelled
    (67,568 )     44.40  
Forfeited
    (93,175 )     38.40  
Outstanding at April 30, 2013
    759,410     $ 11.00  
Issued
    5,165,862       2.60  
Exercised
    (3,161,145 )     2.26  
Forfeited
    (1,661 )     126.00  
Outstanding at April 30, 2014
    2,762,466     $ 4.28  
 
During the year ended April 30, 2014, the Company received approximately $7.1 million and issued 3,161,145 shares of common stock upon the exercise of outstanding warrants .
 
1999 Amended Stock Plan
 
In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “Plan”). Under the Plan, with the approval of the Compensation Committee of the Board of Directors, the Company may grant stock options, restricted stock, stock appreciation rights and new shares of common stock upon exercise of stock options. On September 30, 2011, the Company’s stockholders approved an amendment to the Plan which increased the amount of shares authorized for issuance under the Plan to 300,000, up from 40,000 previously authorized.
 
Pursuant to the Asset Purchase Agreement described in Note D above, the Company agreed to propose that its stockholders approve an amendment to the Company’s 1999 Stock Plan to increase the amount of stock options authorized for issuance under the 1999 Stock Plan to not less than 4,000,000 shares of common stock. On March 13, 2014, at the special meeting of stockholders, the Company’s stockholders approved an amendment to the Plan to increase the number of shares of common stock authorized for issuance under the Plan to 4,000,000 shares of common stock. In accordance with terms of the Acquisition, the Company issued an aggregate of 3,572,880 stock options with a grant date fair value of $15,818,512, to the Chief Executive Officer, the Chief Financial Officer, the Executive Vice President, Business and Commercial Operations and the Executive Vice President, Regulatory Affairs. During the year ended April 30, 2014, the Company recorded approximately $7.9 million of compensation expense for the vested options in its consolidated statements of operations. An additional $7.9 million of compensation expense related to these grants will be recognized as performance vesting conditions are achieved.
 
As of April 30, 2014 the Company had 155,408 shares of common stock available for grant under the Plan.
 
The following table summarizes the shares available for grant under the Plan for the year ended April 30, 2014 and 2013:
 
 
58

 
 
   
Shares Available for Grant
 
Balances, at April 30, 2012
    276,582  
Options granted
    (1,595 )
Options cancelled/forfeited
    7,851  
Restricted stock granted
    (5,318 )
Restricted stock cancelled/forfeited
    5,206  
Balances, at April 30, 2013
    282,726  
additional shares reserved
    3,600,000  
Options granted
    (3,637,822 )
Options cancelled/forfeited
    1,300  
Restricted stock granted
    (135,662 )
Restricted stock cancelled/forfeited
    44,866  
Balances, at April 30, 2014
    155,408  
 
Plan Stock Options
 
Stock options granted under the Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the Plan may be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.
 
The following table summarizes the outstanding stock options under the Plan for the years ended April 30, 2014 and 2013:
 
   
Outstanding Options
       
   
Number of Shares
   
Weighted Average Exercise Price
   
Aggregate Intrinsic Value
 
Balances, at April 30, 2012
    17,592     $ 81.20          
Options granted
    1,595     $ 32.60          
Options cancelled
    (7,851 )   $ 106.40          
Balances, at April 30, 2013
    11,336     $ 57.00          
Options granted
    3,637,822     $ 5.64          
Options cancelled
    (1,300 )   $ 43.90          
Balances, at April 30, 2014
    3,647,858     $ 5.79     $ 8,736 ( 1)
 
(1)
Amount represents the difference between the exercise price and $4.88, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2014, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
 
 
59

 
 
The following table summarizes all options outstanding as of April 30, 2014:
 
     
Options Outstanding at April 30, 2014
   
Options Exercisable and Vested at April 30, 2014
 
Exercise Price
   
Number of Options
   
Weighted Average Remaining Contractual Life (Years)
   
Number of Options
   
Weighted Average Exercise Price
 
$ 1.61 to $5.65       3,637,843       9.9       1,826,145     $ 5.63  
$ 14.80 to $59.80       6,455       7.0       5,979     $ 39.82  
$ 60.80 to $102.00       2,351       4.4       2,351     $ 80.65  
$ 111.60 to $138.00       1,209       5.4       1,209     $ 121.81  
                                     
          3,647,858       9.9       1,835,684     $ 5.91  
 
The following table summarizes options outstanding that have vested and are expected to vest based on options outstanding as of April 30, 2014:
 
   
Number of Option Shares
   
Weighted Average Exercise Price
   
Aggregate Intrinsic Value (1)
   
Weighted Average Remaining Contractual Life (Years)
 
Vested
    1,835,684     $ 5.91     $ 8,736       9.9  
Vested and expected to vest
    3,645,025     $ 5.79     $ 9,237       9.9  
 
(1)
Amount represents the difference between the exercise price and $4.88, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2014, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
 
The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.
 
The Company used the following assumptions to estimate the fair value of options granted under its stock option plans for the years ended April 30, 2014 and 2013:
   
   
For the year ended April 30
 
   
2014
   
2013
 
Risk-free interest rate (weighted average)
    1.80 %     1.29 %
Expected volatility (weighted average)
    98.20 %     79.62 %
Expected term (in years)
    6       7  
Expected dividend yield
    0.00 %     0.00 %
 
Risk-Free Interest Rate
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
   
Expected Volatility
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
   
Expected Term
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the historical experience that the Company has had with its stock option grants.
   
Expected Dividend Yield
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and do not anticipate paying any dividends in the near future.
   
Forfeitures
As stock-based compensation expense recognized in the statement of operations for the years ended April 30, 2014 and 2013 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
 
The weighted-average grant-date fair value of options granted during the years ended April 30, 2014 and 2013 was $5.64 and $32.60, respectively
 
 
60

 
 
As of April 30, 2014, there were unrecognized compensation costs of approximately $8 million related to non-vested stock option awards granted after May 1, 2004 that will be recognized on a straight-line basis over the weighted average remaining vesting period of 2 years.
 
Restricted Stock Grants
 
The following table summarizes the restricted stock grants under the Plan for the year ended April 30, 2014:
 
   
Outstanding Restricted Stock Grants
 
   
Number of Shares
   
Weighted Average Grant Date Fair Value
 
Balances, at April 30, 2012
    1,805     $ 43.80  
Restricted stock granted
    5,318     $ 35.00  
Restricted stock vested
    (4,465 )   $ 32.60  
Restricted stock cancelled
    (741 )   $ 36.20  
Balances, at April 30, 2013
    1,917     $ 48.40  
Restricted stock granted
    135,662     $ 3.00  
Restricted stock vested
    (50,235 )   $ 2.30  
Restricted stock cancelled
    (31,503 )   $ 1.67  
Restricted stock forfeited
    (13,363 )   $ 4.49  
Balances, at April 30, 2014
    42,478     $ 6.39  
 
The Company recorded compensation expense for these restricted stock grants of $356,639 and $162,991 for the year ended April 30, 2014 and April 30, 2013, respectively.
 
As of April 30, 2014, there were unrecognized compensation costs of approximately $6,000 related to the non-vested restricted stock grants that will be recognized on a straight-line basis over the remaining vesting period.
 
NOTE H—RESTRUCTURING EXPENSE
 
In May 2012, the Company decided to consolidate its operations and relocate its research and development function to North Carolina from Costa Mesa, California. To allow for this transition period, all existing development work had been completed and all of the manufacturing of the Company’s PFC-based products had been transferred to contract manufacturers. As part of these initiatives, the Company terminated all related research and development activities and a workforce reduction was implemented.  In September 2012, the Company entered into a sublease agreement with an unrelated third party that extends throughout the remaining term of the existing lease for the vacated facility.
 
The following table summarizes the impact of the work force reductions and other associated costs on operating expenses and payments for the year ended April 30, 2014, and the liability remaining on the balance sheet as of April 30, 2014.
 
 
61

 
 
   
Charges Incurred During the Year Ended April 30, 2014
 
Amounts Paid Through April 30, 2014
 
Amounts Accrued at April 30, 2014
 
Future lease obligations, net of sublease revenue
  $ -     $ 87,224     $ 54,660  
 
The Company recorded all restructuring expenses as operating expenses on the consolidated statement of operations. All restructuring costs were paid by April 30, 2014, with the exception of approximately $55,000 of future lease obligations, net of sublease revenue.
 
NOTE I—COMMITMENTS AND CONTINGENCIES
 
Operating Leases
 
The Company leases its office space under an operating lease that includes fixed annual increases and expires in February 2016. Total rent expense was $107,946 and $151,125 for the years ended April 30, 2014 and 2013, respectively.
 
The future minimum payments for the long-term, non-cancelable lease are as follows:
 
Year ending April 30,
     
2015
    111,171  
2016
    94,917  
         
    $ 206,088  
 
Simdax license agreement
 
As further discussed in Note D above, on November 13, 2013 the Company acquired the License which granted it an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing Levosimedan in the United States and Canada.  Pursuant to the License, the Company must use Orion’s “Simdax®” trademark to commercialize the Product.  The License also grants to the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication.  Orion’s ongoing role under the License includes sublicense approval, serving as the sole source of manufacture, holding a first right to enforce intellectual property rights in the Territory, and certain regulatory participation rights.  Additionally, the Company must grant back to Orion a broad non-exclusive license to any patents or clinical trial data related to the Product developed by the Company under the License.  The License has a fifteen (15) year term, provided, however, that the License will continue after the end of the fifteen year term in each country in the Territory until the expiration of Orion’s patent rights in the Product in such country.  Orion may terminate the License if the Study is not started by July 31, 2014.
 
The License includes the following development milestones for which the Company shall make non-refundable payments to Orion no later than twenty-eight (28) days after the occurrence of the applicable milestone event: (i) $2.0 million upon the grant of FDA approval, including all registrations, licenses, authorizations and necessary approvals, to develop and/or commercialize the Product in the United States; and (ii) $1.0 million upon the grant of regulatory approval for the Product in Canada. Once commercialized, the Company is obligated to make certain non-refundable commercialization milestone payments to Orion, aggregating up to $13.0 million, contingent upon achievement of certain cumulative net sales amounts in the Territory.  The Company must also pay Orion tiered royalties based on net sales of the Product in the Territory made by the Company and its sublicensees. After the end of the Term, the Company must pay Orion a royalty based on net sales of the Product in the Territory for as long as Life Newco sells the Product in the Territory.
 
As of April 30, 2014, the Company has not met any of the developmental milestones and, accordingly, has not recorded any liability for the contingent payments due to Orion.
 
Agreement with Virginia Commonwealth University
 
In May 2008 the Company entered into a license agreement with Virginia Commonwealth University (“Licensor”, “VCU”) whereby it obtained a worldwide, exclusive license to valid claims under three of the Licensor's patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license includes the right to sub-license to third parties. The term of the agreement is the life of the patents covered by the patent applications unless the Company elects to terminate the agreement prior to patent expiration.  Under the agreement the Company has an obligation to diligently pursue product development and pursue, at its own expense, prosecution of the patent applications covered by the agreement. As part of the agreement, the Company is required to pay to VCU nonrefundable payments upon achieving development and regulatory milestones. As of April 30, 2014, the Company has not met any of the developmental milestones.
 
The agreement with VCU also requires the Company to pay royalties to VCU at specified rates based on annual net sales derived from the licensed technology. Pursuant to the agreement, the Company must make minimum annual royalty payments to VCU totaling $70,000 as long as the agreement is in force. These payments are fully creditable against royalty payments due for sales and sublicense revenue earned during the fiscal year as described above. This fee is recorded as an other current asset and is amortized over the fiscal year.  Amortization expense was $70,000 for each of the years ended April 30, 2014 and 2013.
 
 
62

 
 
Litigation
 
The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s Consolidated Financial Statements.
 
NOTE J—401(k) BENEFIT PLAN
 
The Company sponsors a 401(k) Retirement Savings Plan (the “401(k) Plan”) for all eligible employees. Full-time employees over the age of 18 are eligible to participate in the 401(k) Plan after 90 days of continuous employment. Participants may elect to defer earnings into the 401(k) Plan up to the annual IRS limits and the Company provides a matching contribution up to 5% of the participants’ annual salary in accordance with the 401(k) Plan documents. The 401(k) Plan is managed by a third-party trustee. For the periods ended April 30, 2014 and 2013, the Company recorded $47,087 and $46,847 respectively, for matching contributions expense.
 
NOTE K—INCOME TAXES
 
The Company has not recorded any income tax expense or benefit for the periods ended April 30, 2014 and 2013 due to its history of net operating losses.
 
The reconciliations of income tax expenses (benefit) at the statutory federal income tax rate of 34% for the periods ended April 30, 2014 and 2013 are as follows:
 
   
2014
   
2013
 
U.S. federal taxes (benefit) at statutory rate
  $ (6,644,225 )   $ (3,201,372 )
State income tax benefit, net of federal benefit
    (765,026 )     (356,452 )
Stock compensation
    3,099,270          
Nondeductible interest
    827,284       1,592,027  
Other nondeductible
    292,355       47,652  
Other, including effect of tax rate brackets
    53,621       132,806  
Change in state tax rate
    (8,377 )     -  
Change in valuation allowance
    3,145,098       1,785,339  
    $ -     $ -  
 
 
63

 
 
The tax effects of temporary differences and carry forwards that give rise to significant portions of the deferred tax assets are as follows:
 
Deferred Tax Assets
 
2014
   
2013
 
Net operating Loss Carryforwards
  $ 30,748,100     $ 27,446,605  
Accruals and other
    230,900       336,631  
Depreciation and amortization
    -       16,766  
Net deferred tax assets
    30,979,000       27,800,002  
Deferred Tax Liabilities
               
IPR&D
    (7,962,100 )     -  
Other liabilities
    (33,900 )     -  
Valuation allowance
    (30,945,100 )     (27,800,002 )
Net Deferred Tax Liabilities
  $ (7,962,100 )   $ -  
 
 The Company has established a valuation allowance against net deferred tax assets due to the uncertainty that such assets will be realized. The Company periodically evaluates the recoverability of the deferred tax assets. At such time that it is determined that it is more likely than not that deferred tax assets will be realizable, the valuation allowance will be reduced.
 
As of April 30, 2014, the Company had Federal and State net operating loss carryforwards of approximately $82.8 million and $65.9 million available to offset future federal and state taxable income, respectively. The federal net operating loss carryforwards began to expire in 2012 and the state net operating loss carryforwards begin to expire in 2023 respectively and valuation allowances have been provided.
 
Utilization of the net operating loss carryforwards may be subject to an annual limitation due to the ownership percentage change limitations provided by the Internal Revenue Code of 1986 and similar state provisions. The annual limitations may result in the expiration of the net operating losses before utilization.
 
Management has evaluated all other tax positions that could have a significant effect on the Consolidated Financial Statements and determined the Company had no uncertain income tax positions at April 30, 2014.
 
The Company files U.S. and state income tax returns with varying statutes of limitations. The tax years 1999 and forward remain open to examination due to the carryover of unused net operating losses or tax credits.
 
NOTE L—SUBSEQUENT EVENTS
 
On June 25, 2014, the Company made a payment of $300,000 to the holder of the Convertible Note for the principal balance due June 29, 2014. In addition, the Company issued 255 shares of unregistered common stock for payment of $11,500 for accrued interest payable.
 
 
64

 
 
ITEM 9—CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
 
None.
 
ITEM 9A—CONTROLS AND PROCEDURES
 
Disclosure Controls and Procedures
 
Our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in rules and forms adopted by the Securities and Exchange Commission, or SEC, and that such information is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.
 
Management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Form 10-K.  Based on such evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that, as of April 30, 2014, our disclosure controls and procedures were effective at the reasonable assurance level.
 
Changes in Internal Controls over Financial Reporting
 
From time to time, we may review and make changes to our internal control over financial reporting that are intended to enhance the effectiveness of our internal control over financial reporting and which do not have a material effect on our overall internal control over financial reporting.  During the three months ended April 30, 2014, we made no changes to our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that we believe materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
 
Management’s Annual Report on Internal Control over Financial Reporting
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.  Internal control over financial reporting, as defined in rules promulgated under the Exchange Act, is a process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer and affected by our Board of Directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of Consolidated Financial Statements for external purposes in accordance with GAAP.  Internal control over financial reporting includes those policies and procedures that:
 
-
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
   
-
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of Consolidated Financial Statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and our Board of Directors; and
   
-
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our Consolidated Financial Statements.
 
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations.  Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures.  Internal control over financial reporting also can be circumvented by collusion or improper override.  Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting.  However, these inherent limitations are known features of the financial reporting process, and it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
 
 
65

 
 
Our management assessed the effectiveness of our internal control over financial reporting as of April 30, 2014.  In making its assessment, management used the criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO.  Based on its assessment, management has concluded that our internal control over financial reporting was effective as of April 30, 2014.
 
ITEM 9B—OTHER INFORMATION
 
There is no information to report under this item for the quarter ended April 30, 2014.
 
PART III
 
ITEM 10—DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
 
The information required by this item is incorporated by reference to our Proxy Statement for our 2014 Annual Meeting of Stockholders.
 
ITEM 11—EXECUTIVE COMPENSATION
 
The information required by this item is incorporated by reference to our Proxy Statement for our 2014 Annual Meeting of Stockholders.
 
ITEM 12—SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
 
The information required by this item is incorporated by reference to our Proxy Statement for our 2014 Annual Meeting of Stockholders.
 
ITEM 13—CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
 
The information required by this item is incorporated by reference to our Proxy Statement for our 2014 Annual Meeting of Stockholders.
 
ITEM 14—PRINCIPAL ACCOUNTANT FEES AND SERVICES
 
The information required by this item is incorporated by reference to our Proxy Statement for our 2014 Annual Meeting of Stockholders.
 
 
66

 

PART IV
 
ITEM 15—EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
 
(A)(1) The Consolidated Financial Statements and information listed below are included in this report in Part II, Item 8.
 
-
Reports of Independent Registered Public Accounting Firm.
   
-
Consolidated Balance Sheets as of April 30, 2014 and 2013.
   
-
Consolidated Statements of Operations for each of the two years ended April 30, 2014 and April 30, 2013.
   
-
Consolidated Statements of Stockholders’ Equity (Deficit) for each of the two years ended April 30, 2014 and April 30, 2013.
   
-
Consolidated Statements of Cash Flows for each of the two years ended April 30, 2014 and April 30, 2013.
   
-
Notes to the Consolidated Financial Statements.
 
(A)(2) No schedules have been included because they are not applicable or the required information is shown in our Consolidated Financial Statements or our notes thereto.
 
(A)(3) The exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index immediately following the signature pages to this report.
 
 
67

 

SIGNATURES
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
  OXYGEN BIOTHERAPEUTICS, INC.
 
       
Date: July 29, 2014
By:
/s/ John P. Kelley  
   
John P. Kelley
 
   
Chief Executive Officer
(Principal Executive Officer)
 
       
 
 
 
68

 
 
POWER OF ATTORNEY
 
KNOW ALL MEN BY THESE PRESENTS that each individual whose signature appears below constitutes and appoints John P. Kelley and Michael B. Jebsen, and each of them, his true and lawful attorneys-in-fact and agents with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments to this report, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their substitutes, may lawfully do or cause to be done by virtue hereof.
 
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.
 
Name
 
Title
 
Date
         
/s/ John P. Kelley  
Chief Executive Officer
 
July 29, 2014
John P. Kelley
  (Principal Executive Officer)    
         
         
/s/ Michael B. Jebsen
 
Chief Financial Officer
 
July 29, 2014
Michael B. Jebsen   (Principal Financial Officer and Principal Accounting Officer)    
         
         
/s/ Ronald R. Blanck
 
Director
 
July 29, 2014
Ronald R. Blanck, DO        
         
/s/ Gregory Pepin
 
Director
 
July 29, 2014
Gregory Pepin        
         
/s/ William A. Chatfield
 
Director
 
July 29, 2014
William A. Chatfield        
         
/s/ Chris A. Rallis
 
Director
 
July 29, 2014
Chris A. Rallis        
         
/s/ Anthony DiTonno
 
Director
 
July 29, 2014
Anthony DiTonno        
         
/s/ Gerald Proehl
 
Director
 
July 29, 2014
Gerald Proehl        
 
 
69

 

EXHIBIT INDEX
 
Exhibit No.
  
Exhibits Required by Item 601 of Regulation S-K
     
2.1
  
Agreement and Plan of Merger dated April 28, 2008 (1)
     
2.2
  
Asset Purchase Agreement by and between Oxygen Biotherapeutics, Inc., Life Newco, Inc., Phyxius Pharma, Inc., and the stockholders of Phyxius Pharma, Inc. dated October 21, 2013 (34)
     
3.1
  
Certificate of Incorporation (1)
     
3.2
 
Certificate of Amendment of the Certificate of Incorporation (14)
     
3.3
 
Certificate of Amendment of the Certificate of Incorporation (30)
     
3.4
 
Certificate of Designations of Series A Convertible Preferred Stock (28)
     
3.5
 
Certificate of Designations of Series B-1 Convertible Preferred Stock (31)
     
3.6
 
Certificate of Designations of Series B-2 Convertible Preferred Stock (31)
     
3.7
 
Certificate of Designations of Series C 8% Convertible Preferred Stock (32)
     
3.8
 
Certificate of Designations of Series D 8% Convertible Preferred Stock (33)
     
3.9
 
Certificate of Designations of Series E Convertible Preferred Stock (34)
     
3.10
  
Amended and Restated Bylaws (22)
     
4.1
  
Specimen Stock Certificate (19)
     
10.1
  
Agreement with Leland C. Clark, Jr., Ph.D. dated November 20, 1992 with amendments, Assignment of Intellectual Property/ Employment (2)
     
10.2
  
Agreement between the Registrant and Keith R. Watson, Ph.D. Assignment of Invention (2)
     
10.3
  
Children’s Hospital Research Foundation License Agreement dated February 28, 2001 (2)
     
10.4
 
Exclusive License Agreement with Virginia Commonwealth University dated May 22, 2008 (9)
     
10.5
 
Amendment no. 1 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
     
10.6
 
Amendment no. 2 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
     
10.7
  
Form of Option issued to Executive Officers and Directors (2)
     
10.8
  
Form of Option issued to Employees (2)
 
 
70

 
 
     
10.9
  
Restricted Stock Award Agreement (22)
     
10.10
  
Form of Warrant issued to Unsecured Note Holders 2006-2007 (3)
     
10.11
  
Form of Convertible Note – 2008 (4)
     
10.12
  
Form of Warrant issued to Convertible Note Holders (4)
     
10.13
  
Form of Purchase Agreement – US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
     
10.14
  
Form of Purchase Agreement – Non-US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
     
10.15
  
Form of Purchase Agreement – US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
     
10.16
  
Form of Purchase Agreement – Non-US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
     
10.17
  
Form of Warrant issued to Financing Consultants (5)
     
10.18
  
1999 Amended Stock Plan (amended 2008) (5)
     
  
Amendment No. 1 to Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan*
     
  
Amendment No. 2 to Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan*
     
10.21
  
Employment Agreement with Richard Kiral, restated February 1, 2009 (8)
     
10.22
 
Resignation of Employment and Consulting Agreement with Richard Kiral (20)
     
10.23
 
Employment Agreement with John Kelley dated November 13, 2013 (35)
     
10.24
 
Employment Agreement with Michael B. Jebsen dated December 1, 2010 (16)
     
10.25
 
Amended and Restated Employment Agreement with Michael B. Jebsen dated May 19, 2011 (20)
     
10.26
 
Second Amended and Restated Employment Agreement with Michael Jebsen dated November 13, 2013 (35)
     
10.27
 
Form of Indemnification Agreement (20)
     
10.28
  
Description of Non-Employee Director Compensation (25)
     
10.29
  
Securities Purchase Agreement (including exhibits) between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio dated June 8, 2009 (6)
     
10.30
  
Amendment no. 1 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (11)
 
 
71

 
 
     
10.31
  
Amendment no. 2 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (12)
     
10.32
  
Amendment no. 3 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (23)
     
10.33
 
Form of Exchange Agreement dated July 20, 2009 (7)
     
10.34
 
Waiver—Convertible Note (10)
     
10.35
 
Amendment—Common Stock Purchase Warrant (10)
     
10.36
 
Form of Warrant for May 2010 offering (13)
     
10.37
 
Form of Subscription Agreement for May 2010 offering (13)
     
10.38
 
Warrant issued to Blaise Group International, Inc. (14)
     
10.39
 
Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
     
10.40
 
Form of Promissory Note under Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
     
10.41
 
First Amendment to Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (17)
     
10.42
 
Lease Agreement for North Carolina corporate office (18)
     
10.43
 
Standard Industrial Lease relating to OBI’s California facility (12)
     
10.44
 
Task Order between the Company and NextPharma, dated November 15, 2011 (23)
     
10.45
 
Form of Convertible Note for July 2011 offering (included in exhibit 10.56)
     
10.46
 
Form of Warrant for July 2011 offering (included in exhibit 10.56)
     
10.47
 
Form of Convertible Note and Warrant Purchase Agreement for July 2011 offering (21)
     
10.48
 
Placement Agency Agreement, dated December 8, 2011, between Oxygen Biotherapeutics, Inc. and William Blair & Company, L.L.C., as placement agent (24)
     
10.49
 
Form of Warrant for December 2011 offering (24)
     
10.50
 
Form of Securities Purchase Agreement for December 2011 offering (24)
     
10.51
 
Form of Amendment Agreement for December 2011 offering (26)
     
10.52
 
Form of Lock-up Agreement for December 2011 offering (24)
 
 
72

 
 
     
10.53
 
Form of Amendment Agreement for December 2011 offering (27)
     
10.54
 
Fluoromed Supply Agreement (28)
     
10.55
 
Form of Warrant for February 2013 offering (29)
     
10.56
 
Placement Agency Agreement, dated February 22, 2013, between Oxygen Biotherapeutics, Inc. and Ladenburg Thalmann & Co. Inc., as placement agent (29)
     
10.57
 
Form of Securities Purchase Agreement for February 2013 offering (29)
     
10.58
 
Form of Registration Rights Agreement for February 2013 offering (29)
     
10.59
 
Form of Warrant Exchange Agreement, dated February 21, 2013, between Oxygen Biotherapeutics, Inc. and certain institutional investors party to the Securities Purchase Agreement for December 2011 Offering (29)
     
10.60
 
License and Supply Agreement dated February 5, 2013, between Oxygen Biotherapeutics, Inc. and Valor SA*
     
10.61
 
Settlement Agreement, dated March 14, 2013, among Oxygen Biotherapeutics, Inc., Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund, Ltd., and Parsoon Opportunity Fund, Ltd.*
     
10.62
 
Form of Warrant for Series C 8% Convertible Preferred Stock Offering (32)
     
10.63
 
Placement Agency Agreement, dated July 21, 2013, between Oxygen Biotherapeutics, Inc. and Ladenburg Thalmann & Co. Inc., as placement agent (32)
     
10.64
 
Form of Securities Purchase Agreement for Series C 8% Convertible Preferred Stock Offering (32)
     
10.65
 
Lock-Up Agreement, dated August 16, 2013, between Oxygen Biotherapeutics, Inc. and JPS SPC 3 obo OXBT Fund, SP (33)
     
10.66
 
Warrant for Series D 8% Convertible Preferred Stock Offering (33)
     
10.67
 
Form of February Warrant Amendment (33)
     
10.68
 
Form of July Warrant Amendment (33)
     
10.69
 
Form of Securities Purchase Agreement for Series D 8% Convertible Preferred Stock Offering (34)
     
10.70
 
License Agreement dated September 20, 2013 by and between Phyxius Pharma, Inc. and Orion Corporation (36)
     
10.71
 
Amendment to Common Stock Purchase Agreement (36)
     
 
Consent of Independent Registered Accounting Firm*
     
  
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
 
 
73

 
 
     
  
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
     
  
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350*
     
  
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350*
     
101.INS
  
XBRL Instance Document
     
101.SCH
  
XBRL Taxonomy Extension Schema Document
     
101.CAL
  
XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF
  
XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB
  
XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE
  
 XBRL Taxonomy Extension Presentation Linkbase Document
 

 (1)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 30, 2008, and are incorporated herein by this reference.
(2)
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2004, and are incorporated herein by this reference.
(3)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 6, 2006, and are incorporated herein by this reference.
(4)
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2008, and are incorporated herein by this reference.
(5)
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2008, and are incorporated herein by this reference.
(6)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 8, 2009, and is incorporated herein by this reference.
(7)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on July 21, 2009, and is incorporated herein by this reference.
(8)
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 12, 2009, and are incorporated herein by this reference.
(9)
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on September 22, 2008, and is incorporated herein by this reference.
(10)
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 19, 2010, and are incorporated herein by this reference.
(11)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 2, 2009, and is incorporated herein by this reference.
(12)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on April 28, 2010, and are incorporated herein by this reference.
 
 
74

 
 
(13)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on May 4, 2010, and are incorporated herein by this reference.
(14)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 13, 2009, and are incorporated herein by reference.
(15)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on October 13, 2010, and are incorporated herein by this reference.
(16)
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 9, 2010, and are incorporated herein by this reference.
(17)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 30, 2010, and is incorporated herein by this reference.
(18)
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2011, and are incorporated herein by this reference.
(19)
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 23, 2010, and are incorporated herein by this reference.
(20)
This document was filed as an exhibit to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 15, 2011, and is incorporated herein by this reference.
(21)
This document was filed as an exhibit to the current report on Form 8-K/A filed by Oxygen Biotherapeutics with the SEC on July 1, 2011, and is incorporated herein by this reference.
(22)
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 15, 2011, and is incorporated herein by this reference.
(23)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 16, 2011, and are incorporated herein by this reference.
(24)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 9, 2011, and are incorporated herein by this reference.
(25)
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 15, 2012, and is incorporated herein by this reference.
(26)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 15, 2012, and is incorporated herein by this reference.
(27)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 15, 2012, and is incorporated herein by reference.
(28)
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 25, 2012, and are incorporated herein by this reference.
(29)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on February 25, 2013, and are incorporated herein by this reference.
(30)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on May 15, 2013, and is incorporated herein by this reference.
(31)
These documents were filed as exhibits to the registration statement on Form S-1 filed by Oxygen Biotherapeutics with the SEC on March 22, 2013, and are incorporated herein by this reference.
(32)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on July 25, 2013, and are incorporated herein by reference.
 
 
75

 
 
(33)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on August 26, 2013, and are incorporated herein by reference.
(34)
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on October 25, 2013, and is incorporated herein by reference.
(35)
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 19, 2013, and are incorporated herein by reference
(36)
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 17, 2014, and are incorporated herein by this reference.
 *
Filed herewith.
 
 
 
76

 
Exhibit 10.19
 
AMENDMENT TO
OXYGEN BIOTHERAPEUTICS, INC.
1999 AMENDED STOCK PLAN

This Amendment to the Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan (the “Amendment”) is made on August 18, 2011, effective as of the time provided below.

WHEREAS , Oxygen Biotherapeutics, Inc. (the “Company”) has heretofore adopted the Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan (the “Plan”); and

WHEREAS , the Board of Directors of the Company has approved the Amendment contingent upon the approval of the Amendment by the stockholders of the Company.

NOW, THEREFORE , BE IT RESOLVED , that, pursuant to Section 13(a) of the Plan, the Plan is hereby amended as follows, effective as of such time as the Amendment is approved by the stockholders of the Company:

Section 4(a) of the Plan is amended by deleting “12,000,000 shares” in the first sentence thereof and replacing it with “6,000,000 shares (after giving effect to the Company’s 1-for-15 reverse stock split of its Common Stock on November 9, 2009)”

Except as expressly amended hereby, all provisions of the Plan shall remain unamended and shall continue to be, and shall remain, in full force and effect in accordance with their respective terms.

The Amendment shall have no effect until such time as it is approved by the stockholders of the Company.

The provisions of the Amendment shall be governed by and interpreted in accordance with the laws of the State of Delaware.


 
Exhibit 10.20
 
AMENDMENT NO. 2 TO
OXYGEN BIOTHERAPEUTICS, INC.
1999 AMENDED STOCK PLAN

This Amendment No. 2 to the Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan (the “Amendment”) is made on November 13,   2013, effective as of the time provided below.

WHEREAS , Oxygen Biotherapeutics, Inc. (the “Company”) has heretofore adopted the Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan, as subsequently amended (the “Plan”); and

WHEREAS , the Board of Directors of the Company has approved the Amendment contingent upon the approval of the Amendment by the stockholders of the Company.

NOW, THEREFORE , BE IT RESOLVED , that, pursuant to Section 13(a) of the Plan, the Plan is hereby amended as follows, effective as of such time as the Amendment is approved by the stockholders of the Company:

Section 4(a) of the Plan is amended by deleting “6,000,000 shares (after giving effect to the Company’s 1-for-15 reverse stock split of its Common Stock on November 9, 2009)” in the first sentence thereof and replacing it with “4,000,000 (after giving effect to the Company’s 1-for-20 reverse stock split of its Common Stock on May 10, 2013).”

Except as expressly amended hereby, all provisions of the Plan shall remain unamended and shall continue to be, and shall remain, in full force and effect in accordance with their respective terms.

The Amendment shall have no effect until such time as it is approved by the stockholders of the Company.

The provisions of the Amendment shall be governed by and interpreted in accordance with the laws of the State of Delaware.


Exhibit 10.60
 
LICENSE AND SUPPLY AGREEMENT
 
THIS LICENSE AND SUPPLY AGREEMENT ("Agreement") is   by and between Oxygen Biotherapeutics, Inc., with a place of business at ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560 ("OBI" or "Licensor"), and Valor SA (Cosmetics Division), with a place of business at Boulevard de Grancy 1 – CH1006 Lausanne - Switzerland, ("VCD" or "Licensee"), (each individually referred to herein as a “Party” and collectively referred to as the “Parties”) .
 
WITNESSETH
 
WHEREAS , OBI is the owner of a perfluorocarbon (“PFC”) based Cosmetic Product as that term is defined below, marketed under the trademark Dermacyte®; and
 
WHEREAS , OBI possesses the expertise and resources to manufacture Dermacyte; and
 
WHEREAS , VCD desires to enter into an agreement with OBI for the exclusive right to purchase from OBI bulk Dermacyte to package and sell throughout all the world; and
 
WHEREAS , the Parties desire to set forth the terms and conditions pursuant to which  OBI will supply bulk Dermacyte to VCD and license all commercial rights in the Field, as that term is defined below, exclusively to Licensee.
 
NOW, THEREFORE , in consideration of the premises and promises in this Agreement, the Parties agree as follows:
 
1.0  
CONDITIONS PRECEDENT
 
This Agreement shall become effective upon OBI’s receipt from VCD of the payment of seventy-five percent (75%) of the estimated costs to complete Product Formulation and Safety Studies on Product VCD has requested in Section 12.1(b) herein (“Effective Date”).  Notwithstanding the foregoing, OBI shall have sixty (60) days from the Effective Date to discontinue its sales of Product, including the fulfillment of any orders and termination of advertising and promotional campaigns.  The parties acknowledge OBI may be unable to terminate some advertisements previously contracted for and such advertising shall not be deemed a breach of this Agreement by OBI.
 
2.0  
DEFINITIONS
 
The following defined terms are used in this Agreement. The use of the singular form includes the plural form, and vice versa, as the context requires.
 
2.1  
"Affiliate" of a Party means a Person that, directly or indirectly, through one or more intermediaries, Controls, is Controlled by or is under common Control with the first mentioned Person. A Person shall be deemed to control another Person if such first Person possesses, directly or indirectly, the power to direct, or cause the direction of, the management and policies of the second Person, whether through the ownership of voting securities, by contract or otherwise.
 
 
 
1

 
 
2.2  
"Control” means, with respect to any Person, the possession, directly or indirectly, of the power to direct or cause the direction of management of a Person, whether through ownership of voting securities, by contract or otherwise.
 
2.3  
“Cosmetic Product” means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, expressly excluding any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
 
2.4  
“Dermacyte” means the Cosmetic Product containing PFCs manufactured and distributed by OBI.
 
2.5  
"FDA" shall   mean the U.S. Food and Drug Administration and any successor agency.
 
2.6  
"Field" mean s, and is limited to, applications involving the use of Cosmetic Products and expressly excluding dermatological products or claims.
 
2.7  
"Licensor Patent Rights" means those domestic and foreign Patent Rights that are owned or Controlled by Licensor as of January 1, 2013 as set forth on Schedule A, attached hereto and incorporated herein by reference, and which are subject to change without VCD prior approval, any such change to be automatically incorporated into this agreement upon receipt of written notification of such changes to VCD.
 
2.8  
"Licensed Products" means any Cosmetic Product the packaging, labeling, use or sale of which relies in whole or in part on some or all of the Licensor Patent Rights or OBI Know-How. For clarification, any Product purchased by VCD from OBI is Licensed Product, and includes Product in any package and under any label which VCD may utilize for commercialization.
 
2.9  
"Net Sales" means the gross amount invoiced by Licensee (and/or any sublicensees) for sales of Licensed Products less:
 
(a)  
Transportation charges or allowances actually paid or granted;
 
(b)  
Trade, quantity, cash or other discounts, if any, allowed and paid by Licensee independent parties in arms-length transactions;
 
(c)  
Credits or allowances made or given on account of rejec ts, returns, recalls or retroactive price reductions for any amount not collected;
 
(d)  
Any tax or governmental charge directly on sale or transportation, use or delivery or services paid by Licensee and not recovered from the purchaser.
 
2.10  
"OBI Know-How" means all information, data, or materials, whether in hard copy or electronic form, that are necessary or useful for the sale, packaging, labeling or other commercialization of Licensed Product(s), which OBI controls as of the Effective Date.
 
 
 
2

 
 
2.11  
"Patent Rights" means any and all patent applications and any patents issuing therefrom, worldwide, together with any extensions, registrations, confirmations, supplemental protection certificates and other like forms of patent term extensions, reissues, continuations, divisions, continuations-in-part, reexaminations, corrections, substitutions or renewals thereof, and all foreign counterparts thereof. Where applicable, it shall also mean Trademarks and copyrights.
 
2.12  
"Person" means any natural person, entity, corporation, partnership, firm, organization, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, any government or agency or political subdivision thereof, or any other entity.
 
2.13  
“Product” means a specific formulation of Cosmetic Product containing one or more PFCs, manufactured in bulk quantities by OBI, for purchase by VCD.
 
2.14  
“Territory ” means worldwide.
 
2.15  
"Third Party" means any Person other than OBI or Licensee.
 
3.0  
LICENSES
 
3.1  
Licenses:
 
Subject to the terms and conditions of this Ag reement, OBI grants to Licensee, and Licensee accepts an exclusive right and license in the Territory to use, sell, offer to sell, import, export, distribute, package, label and otherwise commercialize in the Field the Product manufactured by OBI or its subcontractors, including the right to sublicense (subject to the terms of this Agreement) under (1) the Licensor Patent Rights and (2) OBI Know-How, provided that such sublicense is granted concurrently with the grant of a sublicense to the Licensor Patent Rights.
 
3.2  
Sublicenses:
 
Subject to the terms and conditions of this Agreement, Licensee shall have the right to grant sublicenses of the license granted hereunder, provided that such sublicenses are consistent with the terms of this Agreement. Licensee shall provide a copy of all sublicense agreements to OBI no later than thirty (30) days of executing the same. All such sublicense agreements shall be deemed Confidential Information of Licensee. No sublicense shall relieve Licensee of any of its obligations under this Agreement.
 
4.0  
CONSIDERATION
 
4.1  
Annual License Fee
 
As consideration for the licenses granted to Licensee in Section 3.1, Licensee shall issue directly to OBI (or its designee), a non-refundable Annual License Fee equal to US$140,000. Twenty-five percent (25%) of the Year 1 Annual License Fee is due within 30 days of the effective date. All Annual License Fees thereafter are due according to the following schedule: US$35,000 on each March 30, June 30, September 30, and December 30. The Year 1 Annual License Fees ($140,000) will be creditable against Product purchased in the first 12 months following the effective date of this Agreement.
 
 
3

 

 
4.2  
Royalties
 
As additional consideration for the licenses granted, Licensee shall pay royalties on the Licensed Products in the amount of five percent (5%) of Net Sales, such royalty payments to begin after Licensee has attained ten million dollars (US$10,000,000) in aggregate Net Sales.  In support thereof,
 
(a)  
Licensee agrees to make quarterly written reports to OBI within thirty (30) days after the first days of each January, April, July, and October during the life of this Agreement and as of such dates, stating in each such report the number, description, and aggregate selling prices of Licensed Products sold or otherwise disposed of during the preceding three calendar months and upon which royalty is payable as provided in Section 4.2 hereof. The first such report shall include all such Licensed Products so sold or otherwise disposed of prior to the date of such report.
 
(b)  
With each such report, Licensee shall remit to OBI the total amount of royalty payments due. All amounts payable to OBI hereunder shall be payable in United States funds, subject to deduction for any taxes, assessments, fees or charges of any kind withheld or imposed by any country on any royalty or other payment payable to OBI hereunder. Payments of royalties that are not made when due shall accrue interest at the rate of one percent (1 %) over the prime rate in effect at the Chase Manhattan Bank (N.A.) on the due date.
 
(c)  
Licensee will keep complete, true and accurate books of account and records for the purpose of showing the derivation of all amounts payable to OBI under this Agreement. Such books and records will be kept at Licensee's principal place of business for at least three (3) years following the end of the calendar quarter to which they pertain, and will be available no more than once during any calendar year, during normal business hours, upon seven (7) days prior written notice, for inspection by a representative of OBI for the purpose of verifying Licensee's royalty statements or Licensee's compliance in other respects with this Agreement. The representative will be obliged to treat such books and records as Confidential Information.
 
(d)  
Inspections made under this section shall be at the expense of OBI, unless a variation or error in any amount payable to OBI under this Agreement is identified, in which case the expenses of the Inspection shall be paid by Licensee.
 

5.0  
TECHNOLOGY TRANSFER AND DILIGENCE
 
Failure to meet any requirements in this section shall be deemed a material breach of this Agreement.
 
5.1  
Technology Transfers .
 
Promptly following the Effective Date, OBI and Licensee shall cooperate to define the scope and content of the transfer of OBI Know-How from OBI to Licensee as necessary or useful for the further packaging and commercialization of the Licensed Products (the "Tech Transfer Scope"). Promptly thereafter, OBI shall disclose and provide Licensee with any and all OBI Know-How then existing which falls within the Tech Transfer Scope and shall provide to Licensee competent and knowledgeable assistance to reasonably facilitate the transfer of such OBI Know-How to and for the use of Licensee in accordance with the terms of this Agreement.
 
 
4

 
 
5.2  
Diligence Requirements .
 
Licensee shall use its reasonable best efforts to earnestly and assiduously commercialize, including the packaging, marketing and sale of, the Licensed Products during the Term. Within sixty (60) days of the Effective Date, Licensee shall submit to OBI, for OBI's review and approval (which approval shall not be unreasonably denied) a business plan for the commercialization of Licensed Products which includes: time planned for each phase of commercialization and other items as appropriate of the Licensed Products ("Business Plan"). During such sixty (60) day period, Licensee shall solicit and OBI shall provide input with regard to the Business Plan and, thereafter, Licensee shall provide OBI with quarterly reports including Product purchase forecasts for the next quarter .
 
6.0  
WARRANTIES; ASSUMPTION OF RISK; INDEMNIFICATION; AND INSURANCE
 
6.1  
OBI's Warranties .
 
OBI represents and warrants that, as of the Effective Date:
 
(a)  
it is the good faith belief that it holds all rights necessary to grant to Licensee the licenses granted under this Agreement with respect to the Licensor Patent Rights;
 
(b)  
it has received no notification that the Licensor Patent Rights are invalid and has not received written notification from a Third Party claiming that the rights granted hereunder will infringe on any patent or other proprietary right of such Third Party;
 
(c)  
it has not assigned or conveyed, and has not promised to assign or convey, any interest in any Patent Rights inconsistent with the rights granted under this Agreement;
 
(d)  
it has the good faith belief that it holds all rights necessary to grant to Licensee the licenses granted under this Agreement with respect to the OBI Know-How; and
 
(e)  
it has not assigned or conveyed, and has not promised to assign or convey, any interest in any OBI Know-How inconsistent with the rights granted under this Agreement.
 
6.2  
Licensee's Warranties .
 
Licensee represents and warrants that, as of the Effective Date:
 
(a)  
to its knowledge, the execution, delivery and performance by Licensee of this Agreement do not contravene or constitute a default under any provision of applicable law or any agreement, judgment, injunction, order, decree or other instrument binding upon Licensee; and
 
(b)  
Licensee has no agreement with any Third Party that, by its terms and without a material breach of the terms of such agreement, materially and adversely affects the rights of Licensor or the obligations of Licensee under this Agreement.
 
 
 
5

 
 
6.3  
Injunctive Relief:
 
The Parties recognize and agree that remedies at law for breach by the other Party of its obligations hereunder with respect to confidentiality, indemnification, and use of trade names and trademarks may be inadequate and each Party shall, in addition to any other rights which it may have, be entitled to injunctive relief.
 
LICENSEE ACKNOWLEDGES AND AGREES FOR THE EXPRESS WARRANTIES AND COVENANTS SET FORTH IN THIS SECTION 6, OBI PATENT RIGHTS AND THE OBI KNOW­HOW IS PROVIDED *AS IS.* EACH PARTY DISCLAIMS ALL OTHER EXPRESS AND ALL IMPLIED WARRANTIES OF ANY TYPE REGARDING SUCH RIGHTS, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, INFRINGEMENT OR TITLE, VALIDITY OR SCOPE OF ANY PATENT RIGHTS, OR ANY WARRANTY OF THE EFFICACY, QUALITY, FUNCTIONALITY, OPERABILITY, USE OR PERFORMANCE OF THE LICENSED PRODUCT (INCLUDING WITHOUT LIMITATION, THE ISSUANCE OF ANY PATENT CONTAINED THEREIN OR THAT THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS WILL NOT INFRINGE ANY PATENT OR ANY OTHER RIGHT OF ANY THIRD PARTY).
 
6.4  
Assumption of Risk .
 
(a)  
Except as otherwise noted below, as between Licensee and OBI, Licensee assumes all responsibility for and all risk of damage or injury that may occur as a result of its, or its sublicensees',  storing, filling and finishing, using, marketing, selling, offering to sell, importing, exporting or distributing Licensed Products. Licensee shall indemnify, defend, and hold OBI and its directors, officers, equityholders, agents, employees, Affiliates and representatives (each, an "Licensor Indemnified Party," and collectively, "Licensor Indemnified Parties") harmless for any and all Third Party claims, suits, demands, proceedings, actions, damages, judgments, costs, liabilities, settlement costs or losses, including, without limitation, attorneys' fees, legal expenses, and costs arising from the actions of Licensee with respect to any Licensed Product used, sold, offered for sale, imported, exported, distributed, received or provided as a result of its licensing the OBI Patent Rights or the OBI Know-How under this Agreement, including without limitation (i) any products liability or similar claim for personal injury or property damage; (ii) claims or actions arising from or based on a breach of Licensee's representations and warranties set forth in this Agreement; (iii) claims or actions by Licensee's sublicensees arising from or based on a breach of Licensee's obligations under a sublicense agreement; and (iv) claims arising from clinical trial studies conducted by or on behalf of Licensee related to the Licensed Products, insofar as any such claims do not arise out of the negligence or willful misconduct of Licensor or Licensor Indemnified Party, as applicable. The foregoing right of indemnity for claims shall not be subject to the limitations of liability described in Article 7
 
 
 
6

 
 
6.5  
Indemnification .
 
Subject to Section 6. 5 , Licensor shall indemnify, defend, and hold Licensee, its directors, officers, and employees, agents, Affiliates, and representatives (each, a "Licensee Indemnified Party," and collectively, "Licensee Indemnified Parties," and together with Licensor Indemnified Party or Licensor Indemnified Parties, the "Indemnified Party" and the "Indemnified Parties," respectively) harmless for any and all Third Party claims, suits, demands, proceedings, actions, damages, judgments, costs, liabilities, settlement costs or losses, including, without limitation, attorneys' fees, legal expenses, and costs arising from Licensor's gross negligence, willful misconduct, or breach of the representations and warranties made hereunder insofar as any such claims do not arise out of the negligence or willful misconduct of Licensee or Licensee Indemnified Party, as applicable. The foregoing right of indemnity for claims shall not be subject to the limitations of liability described in Article 7.
 
6.6  
Notice and Cooperation Requirements.
 
Subject to Section 6.7 below, any claim to which indemnification applies under Section 6.5 shall be referred to herein as an "Indemnification Claim". If any Indemnified Party intends to claim indemnification under this Article 6, the Indemnified Party shall notify the Party from whom it seeks indemnification (the "Indemnifying Party") in writing promptly upon becoming aware of any claim that is an Indemnification Claim (it being understood and agreed, however, that the failure by an Indemnified Party to give such notice shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that Indemnifying Party is actually prejudiced as a result of such failure to give notice). The Indemnifying Party shall have the right to assume and control the defense of the Indemnification Claim at its own expense with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party, provided, however, that the Indemnified Party shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnifying Party, if representation of such Indemnified Party by the counsel retained by the Indemnifying Party would be inappropriate due to actual or potential differing interests between the Indemnified Party and any other party represented by such counsel in such proceedings. If the Indemnifying Party does not assume the defense of the Indemnification Claim as aforesaid, the Indemnified Party may defend the Indemnification Claim but shall have no obligation to do so. The Indemnifying Party shall not settle or compromise the Indemnification Claim in any manner which would have an adverse effect on the Indemnified Party's interests, without the prior written consent of the Indemnified Party, which consent, in each case, shall not be unreasonably withheld or delayed. The Indemnified Party shall reasonably cooperate with the Indemnifying Party at the Indemnifying Party's expense and shall make reasonably available to the Indemnifying Party all pertinent information under the control of the Indemnified Party, which information shall be subject to Section 8.  The indemnification rights of the Indemnified Party contained herein are in addition to all other rights which such Indemnified Party may have at law or in equity or otherwise.
 
 
7

 
6.7  
Infringement Claims
 
Notwithstanding anything in this Section 6 to the contrary, in the event that a Third Party asserts a claim challenging the validity or scope of any Licensor Patent Rights and/or the OBI Know-How, Licensor shall have the right to control the defense of such claim, at its sole expense, and none of Licensee or Licensee Indemnified Parties shall offer to settle, settle or otherwise compromise any such claim within the Field without such other Licensee’s prior written consent, which consent shall not be unreasonably withheld or delayed.
 
Notwithstanding the foregoing, Licensor shall have no obligation to defend, or reimburse Licensee hereunder for any defense, to the extent that any such Third Party claim is brought forth in response to an enforcement action brought under Section 10 which Licensor does not approve, in writing, as provided in Section 10.2.1.
 
6.8  
Insurance
 
(a)  
Licensee shall maintain at all times during the Term of the Agreement, and until the date that all statutes of limitation covering claims, actions or suits that may be brought for personal injury based on the packaging, labeling, sale, distribution or use of such Licensed Product have expired in all countries in the Territory., commercial general liability insurance from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and product liability, and with coverage limits of not less than $5,000,000 per occurrence, and which shall name Licensor as an "additional insured" thereunder. The minimum level of insurance set forth herein shall not be construed to create a limit on Licensee's liability hereunder.
 
(b)  
Notwithstanding the obligation set forth in Section 6.8(a) above, each Party shall at all times maintain in force at its sole cost and expense, with reputable insurance companies, general liability insurance and products liability insurance coverage in an amount reasonably sufficient to insure against liability. Within 10 days following written request of a Party, the other Party shall furnish a certificate of insurance evidencing such coverage as of such date, and, in the case of a modification or cancellation of such coverage, a new certificate of insurance evidencing coverage that meets the requirements in the first sentence of this Section 6.8.
 
7.0  
LIMITATION OF LIABILITY
 
EXCEPT WITH RESPECT TO: (i) CLAIMS ARISING FROM A PARTY'S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT AND (ii) BREACHES OF A PARTY'S CONFIDENTIALITY OBLIGATIONS, NO PARTY SHALL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, LOST PROFITS OR LOST DATA, REGARDLESS OF ANY FAILURE OF ESSENTIAL PURPOSE OF ANY REMEDY AVAILABLE UNDER THIS AGREEMENT.
 
 
8

 
 
8.0  
CONFIDENTIALITY
 
8.1  
Obligations Regarding Confidential Information
 
(a)  
The Parties have entered into a Confidential Disclosure Agreement (“CDA”) effective October 15, 2012 which is hereby incorporated by reference.  The maintenance of confidential treatment to disclosed information shall continue for at least five (5) years after termination of this Agreement.
 
(b)  
Licensee and Licensor (as applicable, each a "Receiver") shall each use all reasonable steps to keep confidential, for the term of this Agreement and for five (5) years thereafter, and with respect to trade secrets, for so long as such trade secrets are protected, any Licensee know-how and Licensor know-how, as the case may be, and any other proprietary or business information provided or made available by the other Party (as applicable, each a "Discloser") hereunder ("Confidential Information"), which steps shall include, without limitation, steps no less stringent than the Receiver employs to protect its own Confidential Information. Without the prior written consent of Discloser, Receiver shall not use (except as contemplated by this Agreement), or disclose to any Third Party, any Confidential Information of Discloser; provided, however, that the foregoing shall not apply to Confidential Information that Receiver can establish by written documentation:
 
(i)  
was publicly known at the time of disclosure by Receiver;
 
(ii)  
becomes publicly known, without Receiver's breach of this confidentiality restriction subsequent to such disclosure to Receiver hereunder;
 
(iii)  
was otherwise known by Receiver from a source (other than Discloser) lawfully having the right to possess and disclose such information without restriction;
 
(iv)  
was developed by Receiver independently of the disclosure by Discloser; or
 
(v)  
was known by Receiver without obligation to Discloser prior to receiving such information from Discloser.
 
8.2  
Permitted Disclosures of Confidential Information
 
The foregoing shall not preclude the disclosure of Confidential Information by Receiver:
 
(a)  
to its legal representatives, Affiliates, agents, consultants, directors, outside subcontractors, sublicensees, development partners, and prospective investors under like confidentiality obligations on the part of the recipients and solely for the purposes of the Receiver fulfilling its obligations under this Agreement;
 
(b)  
to the extent required by law or regulation, provided that to the extent reasonably possible, Receiver shall give prompt written notice of the proposed disclosure to Discloser so as to allow Discloser an opportunity, at its own cost and expense, to object to such requirement and, if applicable, assure that confidential treatment will be accorded to such Confidential Information;
 
 
 
9

 
 
 
(c)  
to Regulatory Authorities, to the extent that such Confidential Information is reasonably required to be disclosed for the purpose of securing necessary governmental authorization for the clinical testing or marketing of Licensed Products or for the purpose of conducting clinical testing; or
 
(d)  
to the extent that such Confidential Information is reasonably required to be disclosed for the purpose of prosecuting or defending litigation; provided, however, the Receiver shall promptly notify the Discloser of such request and cooperate with the Discloser to obtain any and all possible protection for such Confidential Information prior to providing same to requestor, if such is ultimately required.
 
8.3  
Confidentiality of This Agreement .
 
Except as otherwise provided in this Agreement or as may be required under federal securities laws, the terms of this Agreement shall not be disclosed by either Party to any Third Party or be published unless both Parties expressly agree in writing. The Parties acknowledge this may be a material contract as that term is defined by the Securities and Exchange Commission (“SEC”) and as such may be subject to disclosure for that purpose.
 
8.4  
Extension of Obligation s.
 
Licensee shall require each of its sublicensees to agree in writing to be bound by all confidentiality obligations as set forth in this Section 8.
 
9.0  
PATENTS
 
9.1  
Patent Prosecution and Maintenance .
 
OBI shall maintain, be responsible for, and shall control all of the Licensor Patent Rights. The fees incurred for any new patents or trademarks not listed under Schedule A as of January 1, 2013 shall be borne by Licensee, who shall within thirty (30) days following receipt of invoices, reimburse Licensor one hundred percent (l00%) of all costs of prosecuting and maintaining such OBI Patent Rights incurred.
 
9.2  
Further Assurances .
 
The Parties agree to execute, acknowledge and deliver all such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the intent and purposes of this Agreement.
 
9.3  
Patent Marking .
 
Licensee shall, and shall require each of its sublicensees to, comply with all applicable laws with respect to patent marking, including without limitation patent marking for Licensed Products covered by composition claims in the OBI Patent Rights that Licensee and/or any of its sublicensees sells.   Licensee shall provide copies of the patent mark to OBI for review and comment prior to commercial sale thereof.
 
 
 
10

 
 
10.0  
ENFORCEMENT OF INTELLECUAL PROPERTY RIGHTS
 
10.1  
Infringement Notice.
 
(a)  
If OBI becomes aware of any infringement or threatened infringement of any Licensor Patent Rights in the Field, then OBI shall give notice to Licensee within ten (10) business days of becoming aware of such infringement or threat.
 
(b)  
If Licensee becomes aware of any infringement or threatened infringement of any OBI Patent Rights in the Field, then Licensee shall give notice to OBI within ten (10) business days of becoming aware of such infringement or threat.
 
10.2  
Enforcement Actions .
 
(a)  
In the case of any infringement of any OBI Patent Right by any Third Party (an "Infringer") in the Field during the Term, Licensee shall have the right and the obligation, at Licensee's expense, to cause such Third Party to cease such infringement and to otherwise enforce such Licensor Patent Right. Licensor shall assist Licensee as reasonably requested, at Licensee's expense, in taking any such action against any such Infringer. Any amount recovered as a result of any action taken by Licensee hereunder shall be retained by Licensee. If, following reasonable notice from the OBI, Licensee shall fail to take any action against any Infringer which Licensor may reasonably deem necessary or desirable to prevent such infringement or violation, or to recover damages therefore, in addition to any other remedy available to it, Licensor may, upon notice to Licensee, take any steps OBI may deem appropriate against such Infringer at OBI's own expense. Licensee shall assist OBI, at OBI's expense, as reasonably requested in taking any such action against any such Infringer.  Any amount recovered as a result of any such action taken by OBI shall be retained solely by OBI. This paragraph shall survive the termination or expiration of this Agreement.
 
(b)  
No settlement, compromise, consent judgment or any voluntary final disposition of the suit may be entered into by Licensee without the prior written consent of OBI, which consent shall not be unreasonably withheld or delayed.
 
10.3  
Patent Actions .
 
(a)  
In the event that Licensee files an action for a declaratory judgment of patent invalidity, initiates a re-examination or opposition proceeding, interference, or otherwise challenges the validity or enforceability of any of OBI’s Patent Rights (each a "Patent Action"):
 
(b)  
Such Patent Action will be resolved, upon written notice of its demand for arbitration ("Demand") to OBI, by arbitration under 35 U.S.C. 294 (and, in the event of an interference action, under 35 U.S.C. l35) and the United States Arbitration Act 9 U.S.C. ss. 1 et seq., to the extent not inconsistent with 35 U.S.C. 294 or 35 U.S.C. 135. The arbitration shall be administered by the American Arbitration Association ("AAA") under its Supplementary Rules for the Resolution of Patent Disputes and judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof. The arbitrator shall be appointed within thirty (30) days of the filing of a Demand and discovery shall be limited to a period of sixty (60) days. The written decision and award shall be rendered within six (6) months of the filing of the Demand. All arbitrator(s) eligible to conduct the arbitration must undertake in writing as a condition of service to render their opinion(s) promptly after the final arbitration hearing and to provide a reasoned written opinion setting forth the findings of fact and conclusions of law. Except to the extent entry of judgment and any subsequent enforcement may require disclosure, or except as required by law, all matters relating to the arbitration, including the award, shall be held in confidence by the parties.
 
 
 
11

 
 
 
(c)  
Licensee shall continue to pay all Annual Licensing Fees and other payment obligations due under this Agreement during the pendency of any Patent Action, without the right to recoup any amounts paid under this Agreement in the event that the Patent Action is upheld.
 
(d)  
In the event there is no judgment of invalidity or infringement with respect to the Licensor Patent Rights, Licensee shall reimburse all of Licensor's costs and expenses (including without limitation, attorneys' and experts' fees) arising from its defense of such action.
 
11.0  
TERM & TERMINATION
 
11.1  
Term.
 
(a)  
Unless terminated earlier, according to the provisions of sections 11.2 or 11.3, the premises and promises and this Agreement are in effect for five (5) years from the Effective Date.
 
(b)  
Either Party may terminate this Agreement in the event of breach of a material obligation of the other Party if such breach remains uncured thirty (30) days after written notice of such breach is delivered to such breaching Party.
 
(c)  
OBI may cancel this Agreement with ten (10) business days notice in the event of a failure to pay Annual License Fees or Royalty Fees when due.
 
11.2  
Termination for Cause
 
(a)  
OBI shall have the right to terminate this Agreement immediately upon notice in the event VCD ceases to conduct its operations in the normal course of business, including inability to meet its obligations as they mature, or if any proceeding under the bankruptcy or insolvency laws is brought by or against VCD, or a receiver is appointed for VCD.
 
(b)  
OBI may terminate this Agreement without penalty immediately following written notice if Licensee (i) is the subject of any proceeding related to its liquidation or insolvency (whether voluntary or involuntary) which is not dismissed within ninety (90) calendar days or (ii) makes or attempts to make an assignment for the benefit of its creditors.
 
 
 
12

 
 
 
11.3  
Effect of Termination
 
(a)  
Except as expressly set forth herein, all licenses, rights and obligations under this Agreement shall immediately end upon termination of this Agreement for any reason; provided, however, that termination of this Agreement shall not release any Party from any payment obligation that has accrued as of the effective date of the termination. Without limiting the foregoing, Licensee shall pay OBI, within thirty (30) days after such termination, amounts equal to all reimbursable expenses payments and all other payments which were owed by Licensee. In addition, for a termination other than expiration as set forth in Section 12.1, Licensee, its Affiliates, and sublicensees, as applicable, shall return to OBI within sixty (60) days of termination all tangible OBI Know-How and Confidential Information provided to Licensee by Licensor pursuant to this Agreement.
 
(b)  
Upon termination of this Agreement VCD shall pay to OBI all undisputed amounts then due and payable, including any due but unpaid Annual License Fees and Development Costs.  VCD shall be responsible for the purchase of Product which constitute Firm Orders as of the effective date of termination; and OBI shall not otherwise be responsible for any material ordered by VCD in anticipation of forecasts or future orders or for costs or profits on Products not supplied.
 
(c)  
The respective rights and obligations of the Parties hereunder shall survive the termination or expiration of this Agreement to the extent necessary for the intended preservation of such rights and obligations including, but not limited to, insurance, indemnification, confidentiality, regulatory compliance, records retention, audit rights, and recall responsibilities.
 
(d)  
VCD shall pay Royalty Fees as they become due on any Product purchased prior to termination.
 
12.0  
PRODUCT DEVELOPMENT
 
12.1  
Product Development
 
(a)  
At the request of VCD, OBI shall use reasonable efforts to develop Product to meet VCD’s needs.
 
(b)  
VCD has requested OBI to develop the following Products:
 
(i)  
Dermacyte Concentrate with a PFC content of fifty percent (50%) or greater
 
(ii)  
Dermacyte Eye Complex with a PFC content of twenty-five percent (25%) or greater
 
(iii)  
 Dermacyte Day cream with a PFC content of one percent (1%) or greater
 
(iv)  
Dermacyte Night cream with a PFC content of  percent (3%) or greater
 
 
 
13

 
 
 
12.2  
Product Development Costs
 
(a)  
VCD shall be responsible for the payment of all costs for Product development (“Product Development Costs”).
 
(b)  
OBI shall provide VCD with estimates for costs to be incurred and no costs shall be incurred by OBI until they have received seventy-five percent (75%) of the estimated costs.
 
(c)  
VCD shall reimburse OBI for the actual costs incurred within thirty (30) days of VCD’s receipt of a final expense report from OBI,which will include a 10% markup for administrative overhead..
 
(d)  
All intellectual property and Know-How generated from or in connection with Product Development shall be owned exclusively by OBI and shall be incorporated as part of the License granted to Licensee hereunder.
 
12.3  
Product Formulation
 
(a)  
OBI shall develop formulations for each Product requested by VCD.  VCD shall have no right to independently develop formulations for Product. VCD shall approve all formulations prior to OBI’s manufacture of Product.
 
(b)  
Product formulation costs will be considered Product Development Costs.
 
12.4  
Safety Testing
 
(a)  
OBI shall conduct toxicology, stability and other safety tests (“Safety Testing”) on all Product(s) prior to making such Product(s) available for purchase by VCD.
 
(b)  
All Safety Testing shall be considered Product Development Costs.
 
12.5  
Cosmetic Clinical Trials
 
(a)  
Upon mutual agreement of the Parties, OBI shall conduct cosmetic clinical trials on Product(s).
 
(b)  
Such cosmetic clinical trials will be considered Product Development Costs.
 
(c)  
VCD shall have the right to review and approve all study protocols prior to implementation.
 
12.6  
Packaging and Labeling
 
(a)  
OBI’s obligations for packaging and labeling are limited to the packaging of bulk Product in a container that is appropriately labeled for shipment to VCD or VCD’s designee.
 
(b)  
VCD shall be solely responsible for, and shall bear all costs of, the final packaging and labeling of all Licensed Product.
 
(c)  
OBI packaging, labeling and shipping shall be considered manufacturing costs.
 
 
 
14

 
 
 
13.0  
PRODUCT SUPPLY
 
13.1  
Delivery .
 
(a)  
VCD shall provide forecasts of the quantity of Product required for the next quarter  (“Forecasted Orders”) as part of their quarterly reports in accordance with section 5.2(b) above.
 
(b)  
VCD shall provide a Purchase Order for each Product sixty (60) days prior to delivery date (“Firm Order”).  OBI shall furnish Products within the timeframe established at the time VCD requests the shipment.  OBI agrees to use its best efforts to meet any request by VCD for delivery of Products prior to a delivery date stated in the applicable Purchase Order. OBI shall notify VCD of any Late Delivery and specify the estimated delivery date and the circumstances causing the delay, keeping VCD informed about the status of the Late Delivery.
 
(c)  
VCD shall be solely responsible for all transportation expenses and risk of loss or damage to Products. OBI shall ship Products in compliance with all Applicable Laws.
 
(d)  
OBI shall pack and ship all Products in accordance with the VCD shipping specifications given at the time the shipping request is made to ensure that no damage shall result during shipping.
 
(e)  
All shipments of Product delivered by OBI shall be accompanied by the appropriate Material Safety Data Sheet (“MSDS”).
 
13.2  
Pricing/Payment .
 
(a)  
Purchase price of Product will be OBI’s actual manufacturing costs plus twenty-five percent (25%) for administrative overhead.
 
(b)  
Upon receipt of a Purchase Order signed by both parties, VCD will issue a payment equal to fifty percent (50%) of the total Purchase Order amount.  All payments will be issued as follows, or in accordance with such other written instructions as OBI shall provide:
 
Oxygen Biotherapeutics, Inc.
Attention: Accounts Payable
ONE Copley Parkway, Suite 490
Morrisville, North Carolina  27560
 
(c)  
OBI shall prepare and deliver to VCD an invoice for each lot of released Product purchased hereunder. All invoices shall be submitted in writing issued as follows, or in accordance with such other written instructions as VCD shall provide:
 
Valor SA (Cosmetics Division)
Attention:  Stéphane Ledermann
Boulevard de Grancy, 1
CH-1006 Lausanne
Switzerland
 
 
 
15

 
 
 
(d)  
All invoices shall be submitted contemporaneously with or subsequent to the release of Product under the Purchase Order.  The invoices shall specify the price of the Product, the Purchase Order number, the quantity of Product actually released, and any prior amount paid by VCD to OBI against the applicable Purchase Order as provided for in section 12.2(a).  In no event shall any invoice be dated prior to the date of release.
 
(e)  
Payment terms for each undisputed shipment of Products shall be net thirty (30) days from the date of invoice, provided that no invoice shall be dated prior to the delivery and acceptance of corresponding Products.
 
13.3  
Specifications; Quality :
 
(a)  
OBI shall label and package Product in accordance with the provisions of all Laws, Product Specifications and Purchase Order specifications, as applicable.
 
(b)  
Product released pursuant to this Agreement shall comply with the Product Specifications. A Certificate of Analysis showing the Product name, lot or batch number, date of manufacture, release date, and the specifications and results of the analysis of all Product properties requested by VCD, will be provided by OBI with each lot of manufactured Product.
 
(c)  
Subject to Applicable Laws, neither the Product Specifications, nor any change in any Product that may alter its properties, impurities, or any other characteristic of the Products, may be changed without VCD’s prior written consent. OBI shall not unreasonably withhold its agreement to any change in the Product Specifications requested by VCD. OBI shall not make any substitutions for Products ordered without the prior written approval of VCD.
 
(d)  
OBI is responsible for retaining samples of each lot of Product.
 
13.4  
Notice of Claim or Rejection.
 
(a)  
In the event that VCD learns, or should reasonably learn, of any claim with respect to Product, VCD will inform OBI in writing of the claim. OBI’s sole responsibility shall be replacement of Product.  OBI will not be responsible for replacing or reimbursing the cost of the packaging, labeling, or other processing costs incurred by VCD.
 
(b)  
Should the Product fail to meet specifications during its labeled shelf life, VCD is responsible for the recall and disposition of Product
 
(c)  
In the event that a shipment of Product fails to conform to Purchase Order or to meet any warranty hereunder, VCD shall notify OBI within ten (10) days of receipt of Product.  Notification of non-conformity must (1) be in writing, and (2) contain specific details regarding the nature of the defects, and (3) specify the specific Product(s) and Purchase Order the affected product was purchased under. Upon receipt of such notice, OBI shall advise VCD on whether to return such Product(s) to OBI or store them pending instructions from OBI as to their disposal.  Issuance of the notice of non-conformity shall be deemed a rejection of that portion of the shipment which was non-conforming and payments made in advance of rejected Product shall be credited to the next Purchase Order or replacement Product will be immediately shipped, at OBIs sole discretion.
 
 
 
16

 
 
 
 
13.5  
Audits.
 
VCD shall have the right to audit and inspect all inventory of the Products contained at OBI facility. Such audits or inspections shall occur not more than once per year (unless for cause), shall occur during business hours and shall be scheduled by VCD at least ten (10) days in advance. Purposes for such inspections may include compliance with Product Specifications, Purchase Orders, and/or investigations of complaints and/or compliance with any Laws or the terms of this Agreement.  VCD’s audit and inspection rights hereunder shall not extend to any portions of such facility, documents, records or other information: (i) which do not relate to the Products, or (ii) to the extent they relate or pertain to third parties or their products or materials.
 
13.6  
Regulatory and Environmental Compliance :
 
(a)  
To the extent an Adverse Event of which a Party becomes aware implicates supply of the Product, such Party shall promptly inform the other Party of such Adverse Event and shall disclose to the other Party any information it has regarding that Adverse Event.
 
(b)  
If any Governmental Authority shall take any action which shall require a response or action by either Party with respect to Products, Product Specifications, or any operating procedure affecting the Products, the Parties shall immediately notify each other of the required response or action. This specifically includes receiving and responding to 483s and/or Warning Letters or items of a similar nature issued by an inspecting authority.
 
(c)  
In carrying out its obligations under this Agreement, the Parties shall comply in all respects with Applicable Laws in effect.
 
14.0  
MISCELLANEOUS
 
14.1  
Information Exchange .
 
During the Term of this Agreement, the parties shall promptly notify each other of any report of an adverse event associated with the use of any Licensed Product. Licensee shall have sole discretion in determining what action, if any, is to be taken in connection with any such adverse event report relating to a Licensed Product.  Licensor shall have sole discretion in determining what action, if any, is to be taken in connection with such adverse event report relating to any other products.
 
14.2  
Subcontracting .
 
The Parties acknowledge that each has the right to enter into subcontracts as they shall deem necessary in order to carry out their obligations under this Agreement.  The use of such subcontractors  shall not relieve either Party from any of its obligations or liabilities hereunder.  Nothing herein shall constitute any contractual relationship between the non-subcontracting Party and any subcontractor of the subcontracting Party or any obligation on the part of the non-subcontracting Party to pay, or be responsible for the payment of, any sums to any such subcontractors.  The subcontracting Party shall be responsible for all work performed by, and for acts, omissions, or negligence of its subcontractors and for compliance of its subcontractors with the requirements of this Agreement, and all Laws to the same extent that the subcontracting Party would be responsible if they were doing such work directly.
 
 
 
17

 
 
14.3  
Force Majeure .
 
Subject to the provisions hereof, if supervening events, including, but limited to, natural disasters, acts of government after the Effective Date of this Agreement, power failure, acts of God, labor disputes, riots, acts of war, or epidemics, (each, a “Force Majeure Event”), beyond the reasonable control of a party hereto occur that render performance by such party of its obligations under this Agreement impossible, then such party is excused from whatever performance is rendered impossible by the Force Majeure Event (“Suspension of Performance”); provided that (i) such Force Majeure Event is unforeseeable, (ii) such party is without fault in causing such Force Majeure Event, (iii) such party informs the other party immediately of such Force Majeure Event, (iv) such party promptly informs the other party of the length of the expected delay, (v) such party takes all reasonable actions to avoid or overcome such Force Majeure Event, to mitigate damages hereunder, and to mitigate the length of any such Suspension of Performance, and (vi) such party, to the extent it is able, continue to perform its obligations under this Agreement, unless otherwise directed by the other party.  A party’s performance of covenants (i) to (iv) herein are conditions precedent to its Suspension of Performance and covenants (v) and (vi) herein are conditions precedent to its continued Suspension of Performance.  If the Suspension of Performance continues, or is expected to continue, for more than sixty (60) days, then the other party is entitled to terminate this Agreement upon giving notice thereof to the party which is excused by the Suspension of Performance.  Force Majeure Event includes the unavailability of materials, equipment or transportation that is caused by a Force Majeure Event.  Force Majeure Event does not include economic hardship, changes in market conditions, unavailability of materials, equipment or transportation that is caused by an event other than a Force Majeure Event, or insufficiency of funds.
 
14.4  
Independent Contractor .
 
In all matters relating to this Agreement, the Parties shall be acting as independent contractors. Neither Party shall have any authority to and shall not assume or create any obligation, express or implied, on behalf of the other Party and shall have no authority to and shall not represent itself as an agent, employee, or in any other capacity of such other Party.
 
14.5  
No Third Party Beneficiaries :
 
No provision of this Agreement shall in any way inure to the benefit of any third person so as to constitute to any such person a third-party beneficiary of this Agreement or otherwise give rise to any cause of action in any person not a party hereto.
 
 
 
18

 
 
14.6  
Assignment .
 
Licensee may not assign any of its rights or delegate any performance under this Agreement without OBI's prior written consent, which consent shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, Licensee may freely assign all of its rights and delegate its entire performance under this Agreement: (i) in connection with the acquisition of all, or substantially all, of its assets, or any merger, acquisition or reorganization of or by Licensee. Any purported assignment or delegation of this Agreement in violation of this Section shall be null and void and of no effect. Subject to the foregoing provisions, this Agreement shall be binding upon and inure to the benefit of all successors and permitted assigns of Licensee and Licensor.
 
14.7  
Severability .
 
Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity of enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If the final judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the Parties agree that the court making the determination of invalidity or unenforceability shall have the power to reduce the scope, duration, or area of the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable, and this Agreement shall be enforceable as so modified after the expiration of the time within which the judgment may be appealed.
 
14.8  
Waiver .
 
It is agreed that no delay or omission to exercise any right, power, or remedy accruing to any Party, upon any breach, default or noncompliance under this Agreement shall impair any such right, power, or remedy, nor shall it be construed to be a waiver of any such breach, default or noncompliance, or any acquiescence therein, or of any similar breach, default or noncompliance thereafter occurring. It is further agreed that any waiver, permit, consent, or approval or on part or noncompliance under this Agreement or any waiver by a Party of any provisions or conditions of this Agreement must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement, by law, or otherwise afforded to the Parties, shall be cumulative and not alternative.
 
14.9  
Dispute Resolution .
 
(a)  
Except as set forth in Section 10.3, all disputes, claims, or controversies arising out of or relating to this Agreement or the negotiation, validity or performance hereof that are not resolved by mutual agreement shall be finally and exclusively settled by binding arbitration to be conducted under the Rules of Arbitration of the International Chamber of Commerce ("ICC Rules") or its successor in accordance with the procedure set forth in this Section.
 
(b)  
The arbitration shall be held in Raleigh, North Carolina before a single arbitrator appointed in accordance with the ICC Rules.
 
 
 
19

 
 
 
(c)  
The Parties covenant and agree that the arbitration shall commence within ninety (90) days of the date on which a written demand for arbitration is filed by any Party hereto and shall proceed and be completed expeditiously thereafter. Each Party agrees to select one arbitrator within thirty (30) days of the commencement of the arbitration and the arbitrators selected by the Parties will select the arbitrator who will preside over the dispute. The arbitrator shall have the power to order the production of documents by each Party and any Third-Party witness that the arbitrator deems to be relevant to the issues in dispute. The arbitrator's decision and award shall be made and delivered within ninety (90) days of the conclusion of the arbitration proceeding. The arbitrator's decision shall set forth in writing a reasoned basis for any award of damages or finding of liability. It is the intent of the Parties that the arbitration proceed in a manner that is efficient and cost-effective.
 
(d)  
The Parties covenant and agree that they will participate in the arbitration in good faith and that they will share equally its costs, except as otherwise provided herein. The arbitrator may in his or her discretion assess costs and expenses (including the reasonable legal fees and expenses of the prevailing Party) against any Party to a proceeding. Any Party unsuccessfully refusing to comply with an order of the arbitrator shall be liable for costs and expenses, including attorneys' fees, incurred by the other Party in enforcing the award. This Section applies equally to requests for temporary, preliminary or permanent injunctive relief, except that in the case of temporary or preliminary injunctive relief any Party may proceed in court without prior arbitration for the limited purpose of avoiding immediate and irreparable harm.  The provisions of this Section shall be enforceable in any court of competent jurisdiction.
 
14.10  
Consent to Jurisdiction .
 
Each of the Parties hereto irrevocably and unconditionally consents to the exclusive jurisdiction of the ICC Rules to resolve all disputes, claims or controversies arising out of or relating to this Agreement or the negotiation, validity or performance hereof, and further consents to the jurisdiction of any state court of North Carolina for the purpose of enforcing the arbitration provisions of this Agreement and enforcing any arbitrator's award; provided, however, that to the extent necessary to avoid irreparable harm, either Party may seek temporary or preliminary injunctive relief in accordance with Section 14.9 above. Each Party further irrevocably waives any objection to proceeding before the arbitrator based upon lack of personal jurisdiction or to the laying of venue and further irrevocably and unconditionally waives and agrees not to make a claim in any court that arbitration hereunder has been brought in an inconvenient forum. Each of the Parties hereto hereby consents to service of process by registered mail at the address to which notices are to be given. Each of the Parties hereto agrees that its submission to jurisdiction and its consent to service of process by mail is made for the express benefit of the other Parties hereto.
 
14.11  
Joint Drafting .
 
The Parties have participated jointly in the negotiation and drafting of this Agreement with counsel sophisticated in licensing transactions. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any provisions of this Agreement.
 
14.12  
Governing Law .
 
This Agreement shall be construed, and the respective rights and obligations of the Parties determined, according to the substantive laws of the State of North Carolina, notwithstanding any contrary conflict of laws provisions thereof; provided that matters of intellectual property law shall be determined in accordance with the national intellectual property laws relevant to the intellectual property in question.
 
14.13  
Bankruptcy/Insolvency.
 
(a)  
All licenses granted under this Agreement by either Party to the other Party including, without limitation, licenses of any interests in the (i) the Licensor Patent Rights, (ii) the OBI Know-How, (iii) the Licensed Products, and any embodiments of any such intellectual property and all other intellectual property in which Licensor has any interest (collectively, the "Intellectual Property"), for all purposes of Section 365 of Title 11 of the United States Code ("Title 11"), constitute "intellectual property" as defined in Title 11. During the term of this Agreement, each Party shall create and maintain current copies to the extent practicable of all such Intellectual Property. If a bankruptcy proceeding is commenced by or against OBI under Title 11 (a “Bankrupcy Proceeding”), the Licensee shall be entitled to obtain and retain a copy of any and all such Intellectual Property, and the same, if not already in the possession of Licensee at the commencement of the Bankruptcy Proceeding, shall be promptly delivered by the Party which commenced the Bankruptcy Proceeding or its duly appointed Trustee in the Bankruptcy Proceeding (the "Trustee") to Licensee upon the written request of Licensee. If Licensor or OBI commences a Bankruptcy Proceeding and that Party or its Trustee rejects this Agreement pursuant to Section 365 of Title 11, Licensee may, in its sole and absolute discretion, elect pursuant to Section 365(n) of Title 11 to either (i) retain all rights granted to Licensee under this Agreement to the extent permitted by law, including, without limitation, all rights to enforce all exclusivity provisions with respect to the Intellectual Property and any agreements supplementary to this Agreement to the Intellectual Property and any embodiments of the Intellectual Property or (ii) treat this Agreement as terminated.
 
(b)  
In the event that (i) a Bankruptcy Proceeding is commenced by OBI or (ii) this Agreement is rejected in a Bankruptcy Proceeding of OBI pursuant to Section 365 of Title 11, Licensee retains all rights, in its sole and absolute discretion, to enforce its exclusive license, in the Territory to all of the Intellectual Property as set forth in this Agreement, with the right to sublicense (subject to the terms of this Agreement) under the Licensor Patent Rights, to develop, make, have made, use, sell, offer to sell, import, export, distribute, manufacture and otherwise commercialize the Licensed Products in the Field; provided, however, that Licensee shall continue to fulfill its royalty obligations under this Agreement. Licensee agrees to pay Licensor, or any Trustee in such Bankruptcy Proceeding of Licensor, a royalty for such a license equivalent to the license royalty provision provided in this Agreement and these rights shall survive termination or expiration of this Agreement pursuant to a Bankruptcy Proceeding.
 
 
 
20

 
 
 
14.14  
Remedies .
 
Unless otherwise set forth herein, the rights and remedies set forth in this Agreement are cumulative with and not exclusive of any other remedy. The exercise by either Party of any right or remedy conferred by this Agreement does not preclude the exercise of any other rights or remedies that may now or subsequently exist in law or in equity or by statute or otherwise.  It is specifically understood and agreed that any breach of the provisions of this Agreement will result in irreparable injury to the other Party hereto, that the remedy at law alone will be an inadequate remedy for such breach, and that, in addition to any other legal or equitable remedies which such Party may have, such other Party may enforce their respective rights by actions for specific performance (to the extent permitted by law)
 
14.15  
Export Law .
 
Notwithstanding anything to the contrary contained herein, all obligations of Licensee and Licensor are subject to prior compliance with the export regulations and such other laws and regulations of the countries in which they reside or perform any activities under this Agreement and to obtaining all necessary approvals required by the applicable agencies of the governments of those countries.
 
14.16  
Ownership of Enhancements.
 
Any changes, modifications, refinements, improvements or other enhancements to the Licensor Patent Rights and/or the OBI Know How developed by Licensee shall be owned exclusively by Licensor.
 
14.17  
Entire Agreement .
 
This Agreement, the recitals and any attachments, schedules or exhibits appended hereto, embody the entire understanding between the Parties relating to the subject matter hereof and supersede all prior understandings and agreements, whether written or oral. None of the terms of this Agreement can be modified, amended or waived except by an instrument in writing executed by authorized representatives of each Party.
 
14.18  
Headings .
 
Headings in this Agreement are included for ease of reference only and have no legal effect.
 
14.19  
Counterparts .
 
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. One or more counterparts of this Agreement or any exhibit or schedule hereto may be delivered via FAX or e-mail, with the intention that they shall have the same effect as an original counterpart hereof.
 
14.20  
Survival .
 
The respective rights and obligations of the Parties hereunder shall survive the termination or expiration of this Agreement to the extent necessary for the intended preservation of such rights and obligations related to insurance, indemnification, confidentiality, regulatory compliance, records retention, audit rights, and recall responsibilities and specifically sections 4.2, 6.4, 6.5, 6.6, 6.7, 6.8(a), 7.8, 13.4, 14.7, 14.9, 14.10, 14.12, 14.13(b) and 14.14.
 
 
21

 
 
IN WITNESS WHEREOF, the parties have executed this License And Supply Agreement and acknowledge they have the authority to enter into this agreement.
 
 
OXYGEN BIOTHERAPEUTICS, INC.
 
VALOR SA
 
By/Signature: /s/ Michael Jebsen
Name: Michael Jebsen
Title: President, Chief Financial Officer
 
 
By/Signature: /s/ Andre Valentin
Name: Andre Valentin
Title: Administrator
Date: 2/5/2013
 
Date: 2/5/2013

 
Exhibit 10.61
 
SETTLEMENT AGREEMENT

This Settlement Agreement and Mutual Release (hereinafter "Settlement Agreement") is entered into effective as of March 14, 2013 (“Effective Date”) by and between Oxygen Biotherapeutics, Inc. (“OBI”) and Tenor Opportunity Master Fund, Ltd., Aria Opportunity Fund, Ltd. and Parsoon Opportunity Fund, Ltd. (collectively "Tenor"), both of which are sometimes collectively referred to as the "Parties" and is made with reference to the following:

1.  
RECITALS

a.  
Tenor is a Plaintiff and OBI is the Defendant in the following litigation (the "Litigation") pending in the United States District Court for the Southern District of New York:   Tenor Opportunity Master Fund, Ltd., Aria Opportunity Fund, Ltd. and Parsoon Opportunity Fund, Ltd. v. Oxygen Biotherapeutics, Inc. , Case No. 11 Cv 6067( KBF).

b.  
Tenor and OBI were Parties to a Subscription Agreement dated May 4, 2010, which was the subject of the Litigation (the “Subscription Agreement”).

c.  
Each of the Parties to this Settlement Agreement desire to permanently settle and resolve any and all claims, disputes, issues or matters that exist between them as of the date of this Settlement Agreement and to dismiss with prejudice the Litigation.

NOW, THEREFORE , in consideration of the mutual promises, covenants and agreements set forth herein and subject to the terms and conditions set forth below, the Parties hereby resolve their differences and agree as follows:

2.  
SETTLEMENT TERMS

In consideration hereof, concurrently with the execution and filing of the Dismissal as described in section 4(d) below, OBI will pay Tenor the sum of one hundred thousand dollars ($100,000) (“Initial Payment”) by wire transfer on the day after Tenor delivers to OBI a fully executed copy of this Settlement Agreement pursuant to wire transfer instructions to be furnished by Tenor in conjunction with its execution and delivery of this Settlement Agreement.
 
a.  
Beginning on the first day of each calendar quarter following the Initial Payment, OBI will pay to Tenor by wire transfer five additional payments in the amount of one hundred thousand dollars ($100,000) plus interest accrued thereon from the date of this Settlement Agreement to the date of payment at the rate of fifteen percent (15%) per year (“Quarterly Payments”).  For the sake of clarity, the first such Quarterly Payment shall be due on July 1, 2013.
 
b.  
Should OBI enter into a transaction whereby cash proceeds are paid to OBI (“Financing”) or OBI receives assets of value or the aggregate sum of cash proceeds and assets received from a series of transactions during a trailing  twelve (12) month period exceeds one million dollars ($1,000,000) prior to the last Quarterly Payment being made, OBI shall pay to Tenor an Escalated Payment on a pro-rata basis as follows, with the Quarterly Payments thereafter adjusted so that the aggregate of sums paid to Tenor under this Settlement Agreement equals six hundred thousand dollars ($600,000) in aggregate plus any interest accrued thereon as provided for in this Settlement Agreement (“Total Settlement Amount”) :
 
 
1

 
i.  
Financing of five million dollars ($5,000,000) or greater:  the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing.

ii.  
Financing of four million dollars ($4,000,000) or greater:  eighty percent (80%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing.  Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.

iii.  
Financing of three million dollars ($3,000,000) or greater:  sixty percent (60%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of  proceeds from the Financing.  Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.

iv.  
Financing of two million dollars ($2,000,000) or greater:  forty percent (40%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of  proceeds from the Financing.  Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.

v.  
Financing of one million dollars ($1,000,000) or greater:  twenty percent (20%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing.  Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(b) above.

c.  
If a scheduled payment date falls on a non-business day, the payment shall be made on the first business day following the payment due date.  Such delay shall not be deemed a breach of this Settlement Agreement.  For purposes of this provision, a non-business day shall be Saturday, Sunday or any day which OBI has designated as a company closure in Exhibit A attached hereto and incorporated herein by reference, or when a state of emergency has been declared for any portion of North Carolina within a fifty (50) mile radius of OBI’s Corporate Headquarters.
 
 
 
2

 
 
3.  
NOTICE AND BREACH

a.  
In the event of any breach of any obligation under this Settlement Agreement, the non-breaching Party shall provide the breaching Party three (3) business days written notice of breach and opportunity to cure, which may be delivered via electronic mail, overnight courier, facsimile or hand delivery service, delivered in accordance with the Notice provision of this Settlement Agreement.  If and to the extent any breach is not curable, no such notice shall be required.

b.  
In the event OBI breaches its obligation to make any payment under this Settlement Agreement and such breach is not cured after notice within the period provided for in this section, all amount remaining payable or to come due under this Settlement Agreement shall immediately be accelerated and become due and payable, including interest thereon at the rate provided for in paragraph b of this section from the date of this Settlement Agreement to the date of payment.

c.  
It shall be a breach of this Settlement Agreement and constitute a default of payment obligations in the event that OBI shall (i) have entered involuntarily against it an order for relief under the Bankruptcy Code, as amended; (ii) not pay, or admit in writing its inability to pay, its debts generally as they become due; (iii) make an assignment for the benefit of creditors; (iv) apply for, seek, consent to or acquiesce in, the appointment of a receiver, custodian, trustee, examiner, liquidator or similar official for it or any substantial part of its Property; (v) institute any proceeding seeking to have entered against it an order for relief under the Bankruptcy Code, as amended, to adjudicate it insolvent, or seeking dissolution, winding up, liquidation, reorganization, arrangement, adjustment or composition of it or its debts under any law relating to bankruptcy, insolvency or reorganization or relief of debtors or fail to file an answer or other pleading denying the material allegations of any such proceeding filed against it; (vi) take any action in furtherance of any matter described in parts (i) through (v) above; and (vii) fail to contest in good faith any involuntary bankruptcy proceeding or other attempt of creditors to seek relief for failure of OBI to pay its debts when due.

d.  
If OBI shall default on any payment due under this Settlement Agreement or is in breach pursuant to paragraphc. of this section, in addition to amounts otherwise due and payable, Tenor shall be entitled to recover and receive from OBI its reasonable costs and expenses of collection of such amounts, or enforcement of its rights under this Settlement Agreement, which costs and expenses shall include, but not be limited to reasonable attorneys’ fees.
 
 
 
3

 
 
4.  RELEASES AND DISMISSAL OF THE LITIGATION

a.  
Tenor Release . Tenor, on behalf of its constituent entities and each of their agents, employees, representatives, partners,  officers, parents, shareholders, directors, subsidiaries, attorneys, predecessors, successors and assigns does hereby irrevocably release, acquit and forever discharge OBI and each of its respective  agents, employees, representatives, parents, shareholders, directors,   subsidiaries, officers, directors, attorneys, jointly and severally (the "OBI Releasees"), of and from any and all debts, suits, claims, actions, causes of action, controversies, demands, rights, damages, losses, expenses, costs, attorneys' fees, compensation, liabilities and obligations whatsoever (hereinafter referred to collectively as "Claims"), suspected or unsuspected, known or unknown, foreseen or unforeseen, arising at any time up to and including the date of this Settlement Agreement, which Tenor may now have or at any time heretofore may have had, or which at any time hereafter may have or claim to have against the OBI Releasees, relating to, arising from, or concerning any claim asserted in the Litigation, or any other claim relating to or otherwise arising from the sale of convertible debt securities of OBI consummated on June 30, 2011 and July 1, 2011 (hereinafter "Released Claims").  For avoidance of doubt, except as expressly provided herein, Tenor does not release OBI from any obligations remaining or existing under the Subscription Agreement.

b.  
OBI Release . OBI, on behalf of itself and its constituent entities and each of their agents, employees, representatives, partners, officers, parents, shareholders, directors, subsidiaries, attorneys, predecessors, successors and assigns does hereby irrevocably release, acquit and forever discharge Tenor and each of its respective agents, employees, representatives, parents, shareholders, directors,  subsidiaries,  officers, directors, attorneys, jointly and severally (the "Tenor Releasees"), of and from any and all debts, suits, claims, actions, causes of action, controversies, demands, rights, damages, losses, expenses, costs, attorneys' fees, compensation, liabilities and obligations whatsoever (hereinafter referred to collectively as "Claims"), suspected or unsuspected, known or unknown, foreseen or unforeseen, arising at any time up to and including the date of this Settlement Agreement, which OBI may now have or at any time heretofore may have had, or which at any time hereafter may have or claim to have against the Tenor Releasees, relating to, arising from, or concerning the Subscription Agreement, the Litigation or the subject matter thereof (hereinafter "Released Claims") .   For avoidance of doubt, except as expressly provided herein, OBI does not release Tenor from any obligations remaining or existing under the Subscription Agreement.

c.  
If and to the extent applicable the Parties and their representatives, heirs and assigns expressly waive and release any right or benefit which they have or may have under Section 1542 of the Civil Code of the State of California and any other statute or common law doctrine of like effect, to the fullest extent that they may waive all such rights and benefits pertaining to the matters released herein. It is the intention of the Parties, through this Settlement Agreement and with the advice of counsel, to fully, finally and forever settle and release all such matters and all claims relative thereto, in furtherance of this intention.

d.  
Dismissal With Prejudice . Tenor, upon execution and delivery of this Settlement Agreement and receipt of the Initial Payment as provided for in section 2(a) above, shall execute and deliver to OBI a Stipulation Of Voluntary Dismissal (“Dismissal”), in the form attached hereto and incorporated herein by reference as Exhibit B.

 
 
4

 
 
5.  NOTICES

a.  
 Any notice, demand, request, consent, approval, or communication that either party desires or is required to give to the other Party shall be addressed to the other Party at the address set forth below.  Any Party may change his/his/its address by notifying the other Parties of their change of address(es) in writing.  Any such notice shall be effective three (3) days after dispatch if mailed via First Class Mail, on the day after dispatch if delivered via pre-paid overnight courier and when dispatched if delivered via electronic mail or on the date of delivery if otherwise delivered via hand delivery service to the below addresses.

Oxygen Biotherapeutics, Inc.
Attn:  General Counsel
One Copley Parkway, Suite 490
Morrisville, NC  27560
 
Tenor Capital Management Company LP
Attn:  Waqas Khatri / Dan Kochav
1180 Avenue of the Americas, Suite 1940
New York, NY 10036
wkhatri@tenorcapital.com
dkochav@tenorcapital.com
 
Also, forwarding a copy of same to:
 
David Dunn, Esq.
Hogan Lovells US LLP
875 Third Avenue
New York, NY 10022
david.dunn@hoganlovells.com

 
5

 
 
6.  MISCELLANEOUS PROVISIONS

a.  
In order to carry out the terms and conditions of this Settlement Agreement, the Parties agree to promptly execute upon reasonable request any and all documents and instruments necessary to effectuate the terms of this Settlement Agreement.

b.  
By entering into this Settlement Agreement, no party admits or acknowledges that they committed any wrongdoing on their part or where a court of competent jurisdiction has held or might have held that a wrongdoing was committed, that such wrongdoing damaged the other Party in any manner.  The Parties acknowledge and agree that amounts paid by OBI under this Settlement Agreement are being made solely to avoid the costs of defense of further litigation.

c.  
This Settlement Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference to its rules regarding choice or conflict of laws. Any action brought by OBI or Tenor for breach of this Settlement Agreement shall be filed in the United States District Court for the Southern District of New York.  Subsequent changes in New York law or federal law through legislation or judicial interpretation that creates or finds additional or different rights and obligations of the Parties shall not affect this Settlement Agreement.

d.  
This Settlement Agreement, along with the Dismissal, is the entire agreement between the Parties with respect to the Released Claims or subject matter of this Settlement Agreement and supersedes all prior and contemporaneous oral and written agreements and discussions pertaining to the Released Claims or subject matter of this Settlement Agreement.  Any representations, promise or condition in connection herewith not specifically incorporated herein shall not be binding upon any Party. This Settlement Agreement may not be modified except in a writing signed by authorized representative of all Parties.

e.  
No breach of any provision of this Settlement Agreement can be waived unless in writing signed by the Party to be charged with such a waiver.  Waiver of any one breach of any provision hereof, in whole or in part, shall not be deemed to be a waiver of any other breach of the same or any other provision hereof.

f.  
This Settlement Agreement shall be binding upon and inure to the benefit of the successors and assigns of each Party; provided, however, that a Party may not assign this Settlement Agreement in whole or in part without obtaining the prior written approval of the other Party, except that a Party shall have the right to assign this Agreement without the consent of the other Party to any affiliate or to any purchaser of that Party's entire business or of substantially all of that Party's assets relating to the subject matter of this Settlement Agreement.

 
 
6

 
g.  
The Parties each represent and warrant they have not assigned all or any portion of any claim pertaining to the Released Claims to any person or entity.  In the event any claims are made by any third persons or entities based upon any purported assignment or any such liens or claims are asserted in connection with the Released Claims or proceeds of the Settlement Agreement, then the Party who has breached his representation or warranty contained herein agrees to indemnify and hold harmless the other Party from any said claims being made.

h.  
If any one or more of the provisions of this Settlement Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Settlement Agreement shall not in any way be affected or impaired thereby.  If such condition, covenant or other provisions shall be deemed invalid due to its scope or breadth, such covenant, condition or other provision shall be deemed valid to the extent of the scope or breadth permitted by law.

i.  
Each of the Parties represent and declare that in executing this Settlement Agreement, they relied solely upon their own judgment, belief and knowledge and on the advice and recommendations of their own independently selected counsel, concerning the nature, extent and duration of their rights and claims and that they have not been influenced to any extent whatsoever in executing the same by any representations or statements covering any matters made by any of the Parties hereto or by any person representing them.  The Parties each acknowledge that neither they nor any of their representatives have made any promise, representation or warranty whatsoever, written or oral to any other Party, as any inducement to enter into this Settlement Agreement, except as expressly set forth in this Settlement Agreement.

j.  
This Settlement Agreement is the result of negotiation and compromise among the Parties and no Party shall be prejudiced as having been the drafter of the Settlement Agreement or any related exhibits incorporated therein.  Ambiguities shall not be construed against the interest of either Party solely by reason of it having drafted all or any part of this Settlement Agreement.  Headings of sections and paragraphs are for convenience of the parties only and are not a part of this Settlement Agreement and shall not be considered in the interpretation or construction of this Settlement Agreement.

k.  
Each Party further represents and warrants that it has carefully read this Settlement Agreement and knows and understands the contents and that it executed this Settlement Agreement freely and voluntarily and having had the benefit of the advice of legal counsel of its choosing.

l.  
This Settlement Agreement may be executed in any number of identical counterparts, each of which shall be an original, which together constitute one and the same instrument, which shall be binding and effective as to all Parties. This Settlement Agreement may be executed via facsimile or other form of electronically transmitted signature, which shall have the same force and effect as if they were original signatures.
 
 
 
7

 

 
m.  
Each Party warrants and represents that it has all necessary right, title and authority to enter into this Settlement Agreement, to grant the rights and interests herein granted and to perform all of its obligations under this Settlement Agreement and that any person executing this Agreement on its behalf is duly authorized to do so.

n.  
The provisions and existence of this Settlement Agreement may not be cited by any Party as an admission of any issue of fact or law, except in an action to enforce or for breach of this Settlement Agreement.  It is understood and agreed that if the foregoing provision is breached by either Party, the non-breaching Party may be entitled to injunctive or other equitable relief to prevent such a breach.  Any non-breaching Party seeking such injunctive relief will not be obligated to secure any bond or give any security in connection with the   application for such relief.  The right to seek injunctive relief is in addition to all other rights, remedies and forms of relief which may be available.  In furtherance of the foregoing, any and all press releases relating to the subject matter hereof shall be mutually agreed upon.

IN WITNESS WHEREOF , the Parties have caused this Settlement Agreement to be duly executed as of the date first written above and each signatory affirms they have the authority to enter into this agreement on behalf of the Party they represent and each Party covenants that this instrument and the execution of the exhibits is a voluntary act of each Party and the manner of execution is sufficient to constitute a binding agreement on its behalf.

OXYGEN BIOTHERAPEUTICS, INC.
 
TENOR OPPORTUNITY MASTER FUND, LTD., ARIA OPPORTUNITY FUND, LTD. AND PARSOON OPPORTUNITY FUND, LTD.
 
By:   /s/ Michael Jebsen
 
Name: Michael Jebsen
 
Title President
 
By:    /s/ Daniel H. Koehar
 
Name: Daniel H. Koehar
 
Title: Director
 
 
 

 
 
8

 
 
EXHIBIT A

OBI COMPANY CLOSURE SCHEDULE

Martin Luther King Day:  January 21, 2013 (Monday)
 
Presidents’ Day:  February 18, 2013 (Monday)
 
Memorial Day:  May 27, 2013 (Monday)
 
Independence Day:  July 4, 2013 and July 5, 2013 (Thursday and Friday)
 
Labor Day:  September 2, 2013 (Monday)
 
Thanksgiving:  November 28, 2013 and November 29, 2013 (Thursday and Friday)
 
Christmas through New Years:  December 23, 2013 through January 1, 2014
  (reopen January 2, 2014)
 
 
9

 
 
EXHIBIT B

Stipulation Of Voluntary Dismissal
 
 
 
10

 
 
 
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
---------------------------------------------------------------
TENOR OPPORTUNITY MASTER FUND,
LTD., ARIA OPPORTUNITY FUND, LTD. &
PARSOON OPPORTUNITY FUND, LTD.,
 
Plaintiffs,                                           11-cv-06067 (KBF)
 
v.
 
OXYGEN BIOTHERAPEUTICS, INC.,
 
Defendant.
---------------------------------------------------------------

STIPULATION OF VOLUNTARY DISMISSAL PURSUANT TO F.R.C.P. 41(a)(1)(A)(ii)

IT IS HEREBY STIPULATED AND AGREED, by and between the parties and/or their respective counsel that the above-captioned action is voluntarily dismissed, with prejudice, against the defendant Oxygen Biotherapeutics, Inc. pursuant to the Federal Rules of Civil Procedure 41(a)(1)(A)(ii).
 
Dated:                      New York, New York
March __, 2013


 
 GUSRAE KAPLAN NUSBAUM PLLC

By:  /s/ Martin P. Russo   
Martin P. Russo, Esq. (MR-4130)  
mrusso@gkblaw.com
120 Wall Street 
New York, NY 10005
Phone: 212-269-1400
Fax: 212-804-5449   
 
Attorney for Defendant 
 HOGAN  LOVELLS US LLP
 
By: /s/ David Dunn 
David Dunn, Esq. (DD-1823)   
david.dunn@hoganlovells.com
875 Third Avenue    
New York, NY 10022
Phone: 212-918-3000
Fax: 212-918-3100
 
Attorney for Plaintiffs
 

11


Exhibit 23.1
 
Consent of Independent Registered Public Accounting Firm
 
We hereby consent to the incorporation by reference in the Registration Statement of Oxygen Biotherapeutics, Inc. (the “Company”) on Form S-8 (No. 333-196464) , on Form S-3 (No. 333-196468) and on Form S-3 (No. 333-191579) of our report , dated July 29, 2014, relating to the consolidated financial statements of the Company which appear in this Form 10-K as of April 30, 2014 .

/s/ CHERRY BEKAERT LLP

Raleigh, North Carolina
July 29, 2014

 
Exhibit 31.1
 
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

I, John P. Kelley, certify that:

1. I have reviewed this Annual Report on Form 10-K of Oxygen Biotherapeutics, Inc.;

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 subsidiaries, 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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which 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: July 29, 2014
OXYGEN BIOTHERAPEUTICS, INC.
 
       
 
By:
/s/ John P. Kelley
 
   
John P. Kelley
 
   
Chief Executive Officer
(Principal Executive Officer)
 

 
Exhibit 31.2
 
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, Michael B. Jebsen, certify that:

1. I have reviewed this Annual Report on Form 10-K of Oxygen Biotherapeutics, Inc.;

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 subsidiaries, 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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which 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: July 29, 2014
OXYGEN BIOTHERAPEUTICS, INC.
 
       
 
By:
/s/ Michael B. Jebsen
 
   
Michael B. Jebsen
 
   
Chief Financial Officer
(Principal Financial Officer)
 

 
Exhibit 32.1
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Annual Report of Oxygen Biotherapeutics, Inc. (the “Company”) on Form 10-K for the year ended April 30, 2014 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John P. Kelley, Chief Executive Officer (Principal Executive Officer) of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: July 29, 2014
 
/s/ John P. Kelley
 
   
John P. Kelley
 
   
Chief Executive Officer
(Principal Executive Officer)
 
       
 
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 

 

 
Exhibit 32.2
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Annual Report of Oxygen Biotherapeutics, Inc. (the “Company”) on Form 10-K for the period year April 30, 2014 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael B. Jebsen, Chief Financial Officer (Principal Financial Officer) of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: July 29, 2014
 
/s/ Michael B. Jebsen
 
   
Michael B. Jebsen
 
   
Chief Financial Officer
(Principal Financial Officer)
 
       
 
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request