EX-10.51 17 exhibit10-51.htm EXHIBIT 10.51 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. LICENSE AGREEMENT between LIGHTLAKE THERAPEUTICS INC. and ADAPT PHARMA OPERATIONS LIMITED Dated as of December 15, 2014 LICENSE AGREEMENT This License Agreement (the “ Agreement ”) is made and entered into effective as of December 15, 2014 (the “ Effective Date ”) by and between Lightlake Therapeutics Inc., a Nevada corporation (“ Lightlake ”), and Adapt Pharma Operations Limited, an Irish limited company (“ Adapt ”). Lightlake and Adapt are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”. RECITALS WHEREAS , Lightlake owns or Controls certain intellectual property relating to the use of intranasal naloxone for a treatment to reverse opioid overdoses; and WHEREAS , Lightlake wishes to license to Adapt, and Adapt wishes to license from Lightlake, through the license grants contemplated herein, such intellectual property rights to develop and commercialize Products (as defined below) in accordance with the terms and conditions set forth below. NOW, THEREFORE , in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: ARTICLE I DEFINITIONS Unless otherwise specifically provided herein, the following terms shall have the following meanings: 1.1 “ Adapt ” has the meaning set forth in the preamble hereto. 1.2 “ Adapt Applied Know-How ” means all Information Controlled by Adapt or any of its Affiliates as of the Effective Date or during the Term (other than as a result of the licenses granted by Lightlake to Adapt under this Agreement) and incorporated by Adapt in any Product prior to any termination of this Agreement (provided, however, that such Information is necessary or reasonably useful for the Development, manufacture or Commercialization of any Product). 1.3 “ Adapt Applied Patents ” means all of the Patents Controlled by Adapt or any of its Affiliates as of the Effective Date or during the Term (other than as a result of the licenses granted by Lightlake to Adapt under this Agreement) that claim any Adapt Applied Know-How or claim or cover a Product. 1.4 “ Affiliate ” means, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with”, means (i) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. 1.5 “ Applicable Law ” means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity. 1.6 “ [**] Unit Dose Device ” means that certain nasal unit-dose spray device sold by [**] Inc. or its Affiliates. 1.7 “ Business Day ” means a day other than a Saturday or Sunday on which banking institutions in New York, New York and Ireland are open for business. 1.8 “ Calendar Quarter ” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. 1.9 “ Calendar Year ” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. 1.10 “ Change in Control ” means with respect to a Party: (1) the sale of all or substantially all of such Party’s assets or business relating to this Agreement; (2) a merger, reorganization or consolidation involving such Party in which the holders of voting securities of such Party outstanding immediately prior thereto cease to hold voting securities that represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (3) a person or entity, or group of persons or entities, acting in concert acquire more than fifty percent (50%) of the voting equity securities or management control of such Party. 1.11 “ Commercial Sublicensee ” means a Sublicensee to whom Adapt has granted a right to offer for sale, have sold or sell one or more Products in all or a portion of the Territory including exclusive distributors, but excluding (i) Persons who Manufacture Product(s) or any element thereof and sell such Product(s) only to or at the direction of Adapt, Sublicensees or any of their respective Affiliates, (ii) wholesalers, (iii) pharmacies, (iv) Persons comprising the First Responder Market, (v) any Person performing third party logistics or warehousing services on behalf of Adapt or its Affiliates or Sublicensees, and (v) any other Person to whom Adapt has not relinquished material control over commercial decision-making in respect of the applicable Products and where such Person does not have any obligation to make an upfront, milestone or royalty payment with respect to the applicable Products. 1.12 “ Commercialization ” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “ to Commercialize ” and “ Commercializing ” means to engage in Commercialization, and “ Commercialized ” has a corresponding meaning. 1.13 “ Commercialization Costs ” means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation. 1.14 “ Commercially Reasonable Efforts ” means, with respect to the objective that is the subject of such efforts, such reasonable, good faith efforts and resources as a similarly-situated (including in relation to size and personnel and other resources) company within the pharmaceutical industry would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that, with respect to the Development and Commercialization of a Product by Adapt, such efforts shall take into account the Product’s safety and efficacy, its cost to Develop, the competitiveness of alternative products marketed by or being developed by Third Parties and the nature and extent of market exclusivity (including Patent coverage and regulatory exclusivity), the likelihood of obtaining Regulatory Approval, the expected or actual pricing, reimbursement and formulary status, the Product’s expected or actual profitability, including the amounts of marketing and promotional expenditures with respect to such Product and all other relevant factors with respect to the market for the Product, on a country-by-country basis. 1.15 “ Confidential Information ” means any technical, business, or other information or data provided orally, visually, in writing or other form by or on behalf of one Party to the other Party in connection with this Agreement (including any information provided under either that certain Mutual Non-Disclosure Agreement between the Parties dated May 1, 2014 or that certain Three-Way Confidential Disclosure Agreement among Lightlake, Adapt Pharma Operations Limited and [**] dated August 13, 2014 collectively, (“ Existing CDAs ”), including information relating to the terms of this Agreement, any Product (including the Regulatory Documentation), any Exploitation of any Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including Lightlake Know-How and Adapt Applied Know-How, as applicable), or the scientific, regulatory or business affairs or other activities of either Party. Notwithstanding the foregoing, (i) all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, and results of test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control activities and statistical analysis, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other Information relating to or resulting from the conduct of Development of Products after the Effective Date, or relating to or resulting from the pharmacokinetics study in respect of a Product commenced or commissioned by or at the direction of Lightlake prior to the Effective Date (the “ Pharmacokinetic Data ”), shall be Confidential Information of Adapt and (ii) subject to the foregoing clause (i), Joint Know-How shall be deemed to be the Confidential Information of both Parties. 1.16 “ Control” means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other property right existing on or after the Effective Date and during the Term, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 4.1 or 4.2) , to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. 1.17 “ Development ” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “ Develop ” means to engage in Development. 1.18 “ Development Costs ” means the out-of-pocket costs and expenses incurred by a Party or its Affiliates directly attributable to, or reasonably allocable to, the Development of a Product, including costs and expenses associated with obtaining and/or Manufacturing product and materials utilized in clinical trials, submission batches or in connection with process validation, scale-up or otherwise required for purposes of obtaining Regulatory Approval. 1.19 “ Development Data ” means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products, to the extent that the same are Controlled by or in Adapt’s or its Affiliates’ or Adapt’s Commercial Sublicensees’ possession, and may be disclosed to Lightlake without violating any obligation under Applicable Law. 1.20 “ Dollars ” or “ $ ” means United States Dollars. 1.21 “ Drug Approval Application ” means a New Drug Application (an “ NDA ”) as defined in the FFDCA, or any corresponding foreign application, including, with respect to the European Union, a Marketing Authorization Application (a “ MAA ”) filed with the EMA or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure. 1.22 “ Effective Date ” means the effective date of this Agreement as set forth in the preamble hereto. 1.23 “ EMA ” means the European Medicines Agency and any successor agency or authority having substantially the same function. 1.24 “ Existing Inventory Supply ” means Lightlake’s existing inventory of naloxone, excipients, devices and packaging set forth on Schedule 1.24 to be transferred to Adapt in accordance with Section 3.6.1 and the Initial Development Plan. 1.25 “ Exploit ” means to make, have made, import, use, sell, or offer for sale, including to research, Develop, Commercialize, Manufacture, have Manufactured, obtain Regulatory Approval for, hold, or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market, or have sold or otherwise dispose of on a worldwide basis. “ Exploitation ” shall mean the act of Exploiting. 1.26 “ FDA ” means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. 1.27 “ FFDCA ” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq. , as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). 1.28 “ First Commercial Sale ” means, with respect to a Product and a country, the first sale by Adapt, its Affiliate or its Commercial Sublicensee to a Third Party for monetary value of such Product in such country after Regulatory Approval for such Product has been obtained in such country; provided, however, no sale comprising the Limited Purdue Sales shall be deemed a “First Commercial Sale” for purposes hereof. 1.29 “ First Responder Market ” means governmental agencies, non-profit institutions and medical directors that prescribe on behalf of an organization for use by fire, police, emergency medical personnel, military or similar personnel that act as first responders, but excluding hospitals and clinics and any Person acquiring Products through retail channels. 1.30 “ Generic Product ” means, with respect to a Product, any intranasal product in an intranasal device that (i) is sold by a Third Party that is not a licensee or a Commercial Sublicensee of Adapt or its Affiliates, under an Abbreviated New Drug Application (ANDA), or any of such Third Party’s direct or indirect licensees or sublicensees; (ii) contains naloxone as the primary active ingredient; and (iii) is approved in reliance, in whole or in part, on the prior approval of such Product. A Product licensed or produced by Adapt or its Affiliates or Commercial Sublicensees (i.e., an authorized generic product) will not constitute a Generic Product. 1.31 “ IND ” means an application filed with a Regulatory Authority for authorization to commence human clinical studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing. 1.32 “ Information ” means all technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays, biological methodology, other data relating to Development, all data, information and materials relating to Commercialization, including customer lists (both actual and target customers), any market studies and competitive data; in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed. 1.33 “ Initial Development Plan ” means the initial Development Plan (including the Development budget) attached hereto as Schedule 1.33 covering the initial Development activities, as the same may be amended from time to time in accordance with the terms hereof. 1.34 “ Invention ” means any writing, invention, discovery, improvement, technology, Information or other Know-How (in each case, whether patented or not) that is not existing as of the Effective Date and is invented under this Agreement during the Term. 1.35 “ LIBOR ” means the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one month published by the British Bankers’ Association, as adjusted from time to time on the first London business day of each month. 1.36 “ Liens ” means any and all liens, encumbrances, charges, security interests, options, claims, mortgages, pledges, or agreements, obligations, understandings or arrangements or other restrictions on title or transfer of any nature whatsoever. 1.37 “ Lightlake ” has the meaning set forth in the preamble hereto. 1.38 “ Lightlake Know-How ” means all Information Controlled by Lightlake or any of its Affiliates as of the Effective Date or at any time during the Term (subject to Section 11.3.2) that is not generally known and is necessary or reasonably useful for the Development, manufacture, or Commercialization of a Product, but excluding any Information to the extent covered or claimed by published Lightlake Patents or Joint Patents or any Joint Know-How. 1.39 “ Lightlake Patents ” means all of the Patents Controlled by Lightlake or any of its Affiliates as of the Effective Date or at any time during the Term (subject to Section 11.3.2) that claim or disclose the Development, Manufacture, or Commercialization of a Product, but excluding any Joint Patents, and excluding the Product Specific Patents. 1.40 “ Limited Purdue Sales ” means the sale of such number of units of Product(s) that Adapt is obligated to sell to or at the direction of Purdue pursuant to the Purdue Agreement, up to either (i) such number of units having an aggregate fair market value of fifty thousand dollars or (ii) an aggregate of 2,500 units (of two doses each), which ever is greater. For clarity, sales of Products to Purdue in excess of the foregoing number of units shall not be included in Limited Purdue Sales. 1.41 “ MAA ” has the meaning set forth in the definition of “Drug Approval Application.” 1.42 “ Major Market ” means each of France, Germany, Italy, Spain or United Kingdom. 1.43 “ Manufacture ” or “ Manufacturing ” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of a Product or any intermediate thereof, including clinical and commercial manufacture. 1.44 “ NDA ” has the meaning set forth in the definition of “Drug Approval Application.” 1.45 “ Net Sales ” means, with respect to a Product for any period, the total amount billed or invoiced on sales of such Product during such period by Adapt, its Affiliates, or Sublicensees to Third Parties, less the following normal and customary bona-fide deductions and allowances actually taken: 1.45.1 trade, cash and quantity discounts; 1.45.2 price reductions, refunds or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid (whether in cash or trade) to governmental authorities or third party payors; 1.45.3 taxes on sales (such as sales, value added, or use taxes) and customs and excise duties and other duties related to sale, in each case, to the extent such taxes are included in the gross amount invoiced; 1.45.4 wholesale and distribution fees, deductions and prompt pay discounts; 1.45.5 bad debts not exceeding five percent (5%) of the value of the sales of Product during the then-current Calendar Year, provided that any recovery of bad debts shall be deemed a sale for purposes of this definition of “Net Sales”; 1.45.6 amounts repaid, deducted or credited by reason of rejections, defects, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; and 1.45.7 freight, insurance, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced. Notwithstanding the foregoing, Net Sales shall not include (i) transfers or dispositions for charitable, pre-clinical, clinical, regulatory, or governmental purposes or (ii) sales or transfers comprising the Limited Purdue Sales. To the extent that Adapt, its Affiliate or any Commercial Sublicensee sells a Product, on an arms-length basis, to any Sublicensee who is not an Affiliate of such selling Person for resale, only the initial sale of such Product by Adapt, its Affiliate, or its Commercial Sublicensee shall constitute a sale for purposes of determining Net Sales. Except as contemplated by the immediately foregoing sentence, Net sales shall not include sales between or among Adapt, its Affiliates, or Sublicensees. Net Sales shall be calculated in accordance with the standard internal policies and procedures of Adapt, its Affiliates, or Sublicensees, which must be in accordance with United States Generally Accepted Accounting Principles or International Financial Reporting Standards as applicable. If Adapt (or any of its Affiliates or Sublicensees) for a given Product sells such Product to a Third Party (including distributors) who also purchases other products or services from any such entity, then Adapt agrees not to, and shall require its Affiliates and Sublicensees not to, (a) bundle or include the Product as part of any multiple product offering or (b) discount or price the Product, in the case of either of the foregoing clauses (a) or (b), in a manner that is reasonably likely to disadvantage such Product in order to benefit sales or prices of other products offered for sale by Adapt or its Affiliates or Sublicensees to such customer. 1.46 “NIDA” means The Division of Pharmacotherapies and Medical Consequences of Drug Abuse of the National Institute on Drug Abuse. 1.47 “NIDA Agreement” means that certain Clinical Trial Agreement, dated January 31, 2013, between Lightlake and NIDA. 1.48 “ Party ” and “ Parties ” has the meaning set forth in the preamble hereto. 1.49 “ Patents ” means (i) all national, regional and international patents and patent applications, including provisional patent applications; (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models, petty patents and design patents and certificates of invention; (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii), and (iii)); and (v) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents. 1.50 “ Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, foundation, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. 1.51 “ Product ” means any pharmaceutical product or medical device, whether prescription or over-the-counter, marketed for a treatment of opioid overdose containing naloxone, alone or in combination with one or more other active or inactive ingredients, in any intranasal form, presentation, strength or delivery systems; provided, however, that “Product” shall not refer to any product Controlled, developed, manufactured, marketed, sold, offered for sale, exported, or imported directly or indirectly by a Sublicensee if such Sublicensee’s rights in respect of such product were obtained or developed independently of any sublicense or right granted by Adapt hereunder. 1.52 “ Product Specific Patents ” means those Patents set forth on Schedule 1.52 . 1.53 “ Product Trademarks ” means the Trademark(s) to be used by Adapt or its Affiliates or its or their respective Sublicensees for the Commercialization of Products and any registrations thereof or any pending applications relating thereto (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates). 1.54 “Purdue” means Purdue Pharma LP or such Affiliate of Purdue Pharma LP that is the initial party to the Purdue Agreement, or any assignee or successor to such Person’s rights or obligations under the Purdue Agreement. 1.55 “Purdue Agreement” means the license agreement to be entered into by Lightlake or Adapt or one of their Affiliates with Purdue Pharma LP based upon the term sheet between Lightlake and Purdue Pharma LP dated September 24, 2014. 1.56 “ Regulatory Approval ” means, with respect to a country or other jurisdiction, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially distribute, sell, offer for sale, market, import or use a Product in such country or other jurisdiction, including, where applicable, (i) pricing or reimbursement approval in such country or other jurisdiction, (ii) pre-and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (iii)labeling approval. 1.57 “ Regulatory Authority ” means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory agencies, departments, bureaus, commissions, councils, or other government entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of Products. 1.58 “ Regulatory Costs ” means the out-of-pocket costs and expenses incurred by a Party or its Affiliates in connection with the preparation, obtaining or maintaining of Regulatory Documentation and Regulatory Approvals for the Product, including any filing fees that are consistent, if applicable, with the Development Plan. 1.59 “ Regulatory Documentation ” means all (i) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files; and (iii) clinical and other data contained or relied upon in any of the foregoing, in each case ((i), (ii), and (iii)) relating to a Product. 1.60 “ Senior Officer ” means, with respect to Lightlake, its Chief Executive Officer or his/her designee or his/her designee, and with respect to Adapt, its Chief Executive Officer or Chief Operating Officer or his/her designee. 1.61 “ Sublicensee ” means a Person, other than an Affiliate, that is granted a sublicense by Adapt under a license granted in Section 4.1 or a right by Adapt, its Affiliates or Commercial Sublicensees to sell a Product, offer a Product for sale, or have a Product sold (each such sublicense or right, a “ Sublicense ”). 1.62 “ Third Party ” means any Person other than Lightlake, Adapt and their respective Affiliates. 1.63 “ Trademark ” means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered. 1.64 “ United States ” or “ U . S .” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). Additional Definitions . The following terms have the meanings set forth in the corresponding Sections of this Agreement: Term Section “Adapt Indemnitees” 9.2 “Annual Net Sales Milestone Threshold” 5.3.1 “Annual Net Sales-Based Milestone Table” 5.3.1 “Annual Net Sales-Based Milestone Payment” 5.3.1 “Annual Net Sales-Based Milestone Payment Date” 5.3.1 “Audit Arbitrator” 5.13.2 “Breaching Party” 10.3 “Competing Product” 4.6 “Core IP” 5.5 “Default Notice” 10.3 “Development Plan” 3.1 “Follow-On Product” 5.2.5 “Force Majeure” 11.1 “First Product” 5.2.6 “Generic Competition” 5.4.2 “Indemnification Claim Notice” 9.3 “Indemnified Party” 9.3 “Initial First Responder Sales” 5.4.1 “Joint Development Committee” or “JDC” 2.1 “Joint Know-How” 6.1.2 “Joint Patents” 6.1.2 “Joint Intellectual Property Rights” 6.1.2 “Lightlake Cost Cap” 3.8.1 “Lightlake Indemnitees” 9.1 “Losses” 9.1 “Non-Breaching Party” 10.3 “Payment” 5.8 “Pharmacokinetic Data” 1.15 “Reconciliation Development Payment” 5.11.2 “Recovery” 6.4.3(d) “ROFN” 4.3.3 “Sublicense” 1.61 “Target Filing Date” 3.2.3 “Term” 10.1 “Third Party Claims” 9.1 ARTICLE II JOINT DEVELOPMENT COMMITTEE 2.1 Formation . Within fifteen (15) days after the Effective Date, the Parties shall establish a joint development committee (the “ Joint Development Committee ” or “ JDC ”). The JDC shall consist of relevant representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JDC. Each Party shall be entitled to appoint up to two (2) representatives to the JDC. From time to time, each Party may substitute one (1) or more of its representatives to the JDC on written notice to the other Party. Adapt shall designate from its representatives the chairperson for the JDC. From time to time, Adapt may change the representative who will serve as chairperson on written notice to Lightlake. 2.2 Specific Responsibilities . The JDC shall meet monthly in person or by phone for the purpose of facilitating the transition of Development of the Product from Lightlake to Adapt. At least seven (7) days prior to each meeting, each Party shall circulate an agenda of items that such Party wishes to cover in such meeting. In particular, the JDC shall: 2.2.1 review and serve as a forum for discussing the Initial Development Plan, and review amendments thereto; 2.2.2 oversee any transition activities under the Initial Development Plan; 2.2.3 serve as a forum for discussing strategies for obtaining Regulatory Approvals for Products; and 2.2.4 perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. 2.3 Disbandment . Upon the [**] anniversary of the Effective Date, the JDC shall have no further responsibilities or authority under this Agreement and will be considered dissolved by the Parties. 2.4 Decision Making . If the JDC cannot, or does not, reach consensus on an issue at a particular meeting, Adapt shall make the decision; provided; however, that Adapt may not exercise its decision making authority in a manner that would increase Lightlake’s full-time employee obligations under the Initial Development Plan, significantly modify the types of activities that Lightlake would have to perform under the Initial Development Plan, extend Lightlake’s period of performance more than [**] months after the Effective Date or increase the Lightlake Cost Cap. 2.5 Limitations on JDC Authority . Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JDC shall not have the power to amend, modify, or waive compliance with this Agreement, which may only be amended or modified as provided in Section 11.9 or compliance with which may only be waived as provided in Section 11.11 . ARTICLE III DEVELOPMENT, REGULATORY AND COMMERCIALIZATION ACTIVITIES 3.1 Development Plan. 3.1.1 Development Plan Delivery . By no later than November 1st of each Calendar Year during the Term after the Calendar Year in which the Initial Development Plan was delivered until First Commercial Sale of a Product in the United States, Adapt shall prepare a written development plan that describes generally the material Development activities to be undertaken by or on behalf of Adapt with respect to Products in the next Calendar Year (each, a “ Development Plan ”), and each such Development Plan shall be provided to Lightlake and Adapt shall consider any comments of Lightlake in good faith. The Initial Development Plan shall serve as the Development Plan for the first full Calendar Year of this Agreement and the period from the Effective Date through the end of the initial partial Calendar Year. Without limiting the generality of the foregoing, each Development Plan shall set forth, among other things and to the extent relevant based on the stage of Development, the following with respect to the Products then under Development: (a) any preclinical studies, toxicology studies and other clinical studies with respect to Products; (b) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals for Products; (c) the plans and timeline for preparing the necessary Regulatory Documentation and for obtaining Regulatory Approval for Products. 3.1.2 Development Plan Amendments . Adapt may amend any Development Plan at any time, subject to providing Lightlake an opportunity to discuss any proposed revisions prior to making such amendment and, during the first twelve (12) months following the Effective Date, by submitting such amendment to the JDC prior to such amendment becoming effective; provided, however, that no such amendment to any Development Plan may provide for an increase in Lightlake’s full-time employee obligations under the Initial Development Plan, significantly modify the types of activities that Lightlake would have to perform under the Initial Development Plan, extend Lightlake’s period of performance more than twelve (12) months after the Effective Date or increase the Lightlake Cost Cap. 3.2 Development. 3.2.1 Ongoing Development . The Parties acknowledge and agree that additional Development will be required to obtain Regulatory Approvals for Products. After the Effective Date, as between the Parties, except as set forth in the Initial Development Plan (as the same may be amended in accordance with Section 3.1.2) and Section 3.8.1, Adapt shall be solely responsible for Development of the Products. 3.2.2 General Diligence . Adapt shall use Commercially Reasonable Efforts to complete the activities associated with the Development of the initial Product for the United States that are contemplated by the Development Plan then in effect (other than any such activities to be undertaken by Lightlake). Adapt shall, and shall cause its Affiliates to, comply with all Applicable Law with respect to Products