atnahspharmauklimitedlic






THE SYMBOL “[****]” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, AND (ii)  WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.      LICENSE AND SUPPLY AGREEMENT  by and between  AQUESTIVE THERAPEUTICS, INC.  and  ATNAHS PHARMA UK LIMITED   Dated as of September 26, 2022       





 






      LICENSE AND SUPPLY AGREEMENT  This LICENSE AND SUPPLY AGREEMENT (together with the Schedules hereto, this  “Agreement”) is entered into as of September 26, 2022 (the “Effective Date”) by and between  Aquestive Therapeutics, Inc., a Delaware corporation having its principal place of business at 30  Technology Drive, Warren, New Jersey 07059 (“Aquestive”), and Atnahs Pharma UK Limited, a  company registered in England and Wales  having its principal place of business at Suite 1, 3rd  Floor 11-12 St. James’ Square, London, United Kingdom, SW1Y 4LB  (“Pharmanovia”).   Aquestive and Pharmanovia are sometimes referred to hereinafter individually as a “Party” and  collectively as the “Parties.”  RECITALS:  A. Aquestive owns patented and trade secret proprietary technology related to film- based drug delivery systems using its PharmFilm® technologies, including orally soluble film  strips containing active pharmaceutical ingredients.  B. Pharmanovia desires to obtain from Aquestive, and Aquestive desires to grant to  Pharmanovia, an exclusive license to Commercialize (defined below) the Product (defined below)  in the Field (defined below) in the Territory (defined below), subject to the terms of this Agreement  and as set forth in the Product Schedule (defined below) which shall form a part of this Agreement.  C. The Parties desire that Aquestive shall act as the exclusive manufacturer and  supplier to Pharmanovia of finished drug products as specifically described in the Product  Schedule, subject to the terms of this Agreement.  D. In consideration of the foregoing and the mutual representations, warranties and  covenants contained herein, the Parties, intending to be legally bound hereby, agree as follows:  1. DEFINITIONS  As used herein, the following terms shall have the following meanings:  1.1 “Adverse Event” means any untoward medical occurrence in a patient, clinical  investigation subject, or consumer following administration of a medicine, as related to the use of  the Product which requires reporting to a Regulatory Authority.  1.2 “Affiliate” of a Person means any other Person that directly, or indirectly through  one or more intermediaries, controls, is controlled by, or is under common control with such first  Person.  As used in this definition of Affiliate, “control” and, with correlative meanings, the terms  “controlled by” and “under common control with,” shall mean to possess the power to direct the  management or policies of a Person, whether through: (a) direct or indirect beneficial ownership  of fifty percent (50%) or more of the voting interest in such entity; (b) the right to appoint fifty  percent (50%) or more of the directors of such entity; or (c) by contract or otherwise.    1.3 “Agreement” has the meaning set forth in the Preamble of this Agreement.  





 






   2    1.4 “API” means the active pharmaceutical ingredient(s) with respect to the Product as  set forth in the Product Schedule.  1.5 “Applicable Currency” means the applicable currency of a country in a Territory  for the purpose of calculating amounts recognized as Net Sales under this Agreement.   1.6 “Applicable Law” means all laws, rules and regulations, or other requirements of  Regulatory Authorities including, without limitation, the FCPA and Healthcare Laws, applicable  to the Development, Commercialization, or Supply of the Product, as the case may be, that may  be in effect from time to time during the Term.  1.7 “Aquestive” has the meaning set forth in the Preamble to this Agreement.  1.8 “Aquestive Indemnitees” has the meaning set forth in Section 11.1.  1.9 “Aquestive IP” means the Aquestive Patents, the Dossier and further any and all  Intellectual Property owned or Controlled by Aquestive or its Affiliates as of the Effective Date or  during the Term, including Improvements, which is useful or necessary to Commercialize the  Product in the Field in the Territory.  1.10 “Aquestive Know-How” means data, knowledge, techniques, inventions, designs,  drawings, health and safety information, material safety data sheets, tests (including Supply,  manufacturing and batch records), reports, procedures, processes, models, manuals, formulae,  systems, experiments, samples, specimens, results, statistics, research, tables of operating  conditions and the like and all other know-how, in each case to the extent not in the public domain  (whether proprietary or not) in connection with the Product in the Territory.  1.11 “Aquestive Marks” means, collectively, the Aquestive Housemark and the  Aquestive Product Mark(s).  1.12 “Aquestive Product Mark(s)” means the Aquestive trademark(s) with respect to the  Product, if any, set forth in the Product Schedule.  1.13 “Aquestive Patents” means those patents and patent applications owned or  Controlled by Aquestive or its Affiliates during the Term related to the formulation, manufacturing  and use of the Product in the Field in the Territory, including, without limitation, any divisionals  or any substitute applications, any patent issued with respect to any such patent applications, any  patents which remain valid subsequent to any post grant proceedings or other challenges which  result in the patent being enforceable, any amendment or extension including any supplementary  protection certificate of any such patent, and any confirmation patent or registration patent or  patent of addition based on any such patent, and all foreign counterparts of any of the foregoing,  or as applicable portions thereof or individual claims therein.  A list of the Aquestive Patents as of  the Effective Date is attached hereto as Schedule 1.13, which may be updated from time to time,  as applicable, by amendment of such Schedule or, if specific to the Product, as set forth in the  Product Schedule to this Agreement (each such Aquestive Patent specific to the Product, an  “Aquestive Product Patent”).  1.14 “Bankruptcy Code” has the meaning set forth in Section 14.18.  





 






   3    1.15 “Bankruptcy Event” means the occurrence of any of the following with respect to  a Party: (a) such Party files or has filed against it in any court or agency, pursuant to any statute or  regulation of any state or country, a petition in voluntary or involuntary bankruptcy or insolvency  or for reorganization and such filing is not withdrawn or dismissed within sixty (60) days after the  filing thereof; (b) such Party files for, or consents to be filed against it an arrangement or for the  appointment of a receiver or trustee of such Party or of its assets and such filing is not withdrawn  within sixty (60) days after the filing thereof; (c) such Party is served with an involuntary petition  against it, filed in any insolvency proceeding, and such petition is not dismissed within sixty (60)  days after the filing thereof; or (d) the dissolution or liquidation of such Party, or such Party shall  make an assignment for the benefit of its creditors or (e) such Party ceases to carry on business.   1.16 “Bankruptcy Supply Failure” means Aquestive’s inability or failure to Supply  Product manifested over a period of sixty (60) days or more following a Bankruptcy Event.  1.17 “Business Day” means any day other than a Saturday or Sunday on which banking  institutions in New York, New York, United States and London, England are open for business.  1.18 “Calendar Quarter” means the three (3) month period in any given calendar year  ending on March 31, June 30, September 30, and December 31.  1.19 “Certificate of Analysis” means the certificate evidencing the analytical tests  conducted on a specific lot of the Product reflecting that such Product and any Raw Materials used  therein conform to the relevant Specifications and setting forth, inter alia, the items tested and test  results, and accompanied by all documentation required by Applicable Law and/or a Regulatory  Authority to Commercialize such Product in the Territory.    1.20 “Certificate of Compliance” means the certificate evidencing that the Product  delivered to Pharmanovia was manufactured in accordance with Applicable Law, and the  applicable Regulatory Approval.  1.21 “Clinical Supply” has the meaning set forth in Section 4.3.1.  1.22 “CMC Data” means chemistry, manufacturing and controls data required by  Applicable Law and/or a Regulatory Authority to Develop the Product in the Territory.    1.23 “COGS” means the following costs incurred by Aquestive or its Affiliates or  subcontractors related to the Supply of the Product on a per Unit basis: (i) the landed cost of raw  materials, including invoice price, freight and duties; (ii) reasonably allocated direct and indirect  labor and overhead costs; (iii) costs in incurred in connection with quality assurance (including  testing, sampling and complaint investigation); and (iii) warehousing and shipping costs,  determined in accordance with GAAP, consistently applied.  1.24 Commercialization” means any and all activities directed to preparation for sale of,  registration, marketing, promoting, distributing, including importing, exporting, transporting,  offering for sale and selling the Product in the Field in the Territory and interacting with Regulatory  Authorities regarding any of the foregoing.  When used as a verb, “Commercialize” means to  engage in Commercialization.  





 






   4    1.25 “Commercially Reasonable Efforts” means, with respect to a Party and its  obligations under this Agreement with respect to a Product, the level of efforts and resources  (measured as of the time that such efforts and resources are required to be used under this  Agreement) that are comparable to those used by a similarly situated company in the industry of a  similar size and profile as such Party to develop, manufacture, supply or commercialize, as the  case may be, a pharmaceutical product owned by such company or to which it has rights which is  at a similar stage of research, development or commercialization (as the case may be), and with  similar market potential as the applicable Product and at a similar stage in life cycle, taking into  account, as applicable: that product’s profile of efficacy and safety; proprietary position, including  expected and actual market exclusivity (including patent and regulatory exclusivity); regulatory  status, including anticipated or approved labeling and anticipated or approved post-approval  requirements; present and future market and commercial potential, including the competitiveness  of the marketplace; any legal and regulatory issues involved, the expected and actual profitability  of that product and other relevant factors, including technical, legal, scientific, medical, sales  performance, commercial and/or marketing factors.  1.26 “Competitive Infringement” has the meaning set forth in Section 13.2.1.  1.27 “Confidential Information” has the meaning set forth in Section 10.1.  1.28 “Confidentiality Agreement” means that certain Confidentiality Agreement  between Aquestive and Pharmanovia executed and delivered as of December 13, 2021.  1.29 “Control” or “Controlled” means, with respect to any Intellectual Property, the  possession (whether by ownership, license or sublicense, other than by a license, sublicense or  other right granted (but not assignment) pursuant to this Agreement) by a Party (or its Affiliate) of  the ability to assign or grant to the other Party the licenses, sublicenses or rights to access and use  such Intellectual Property as provided for in this Agreement, without violating the terms of any  agreement or other arrangement with any Third Party in existence as of the time such Party would  be required hereunder to grant such license, sublicense, or rights of access or use.  1.30 “CPA Firm” has the meaning set forth in Section 7.11.  1.31 “Delivery Failure” has the meaning set forth in Section 5.10.1.  1.32 “Development” means all development activities conducted in connection with or  as a condition of seeking or obtaining and maintaining Regulatory Approval of the Product in the  Field in the Territory including, among other things: (a) the conduct of all research, non-clinical,  and pre-clinical activities, testing and studies of the Product; drug discovery, toxicology,  pharmacokinetic, pharmacodynamic, drug-drug interaction, safety, tolerability and  pharmacological studies, formulation, statistical analysis and report writing; (b) the conduct of all  clinical studies (including post-Marketing Authorization human studies) and the distribution of the  Product for use in clinical studies, if any; (c) preparation, filing and prosecution of any Regulatory  Approval or Regulatory Approval Application for the Product; (d) responsibility for all regulatory  filing submissions and registrations; (e) Raw Material testing; (f) all development activities  directed to label expansion (including prescribing information) or obtaining Marketing  Authorization of the Product for one or more additional indications following initial Marketing  





 






   5    Authorization; (g) all development activities conducted after receipt of Marketing Authorization  of the Product that are required or requested in writing by a Regulatory Authority as a condition  of, or in connection with, obtaining or maintaining a Marketing Authorization; (h) any  pharmacoeconomic studies required for the Marketing Authorization; (i) any investigator- or  institution-sponsored studies required for the Marketing Authorization; (j) pre-approvals, post- approval obligations and reporting relating to the Product in the Field in the Territory; and (j) all  regulatory affairs related to any of the foregoing.  When used as a verb, “Develop” means to  engage in Development.  1.33 “Disclosing Party” has the meaning set forth in Section 10.1.  1.34 “Dosage Strength” means the dosage strength with respect to the Product as set  forth in the Product Schedule.    1.35 “Dossier” means a copy of the documents submitted to the FDA in support of the  NDA for the Product including scientific and technical data relating to the Product and other  related information that may be required for Pharmanovia’s submissions for Regulatory Approvals  in the Territory; for the avoidance of doubt this includes but not limited to any raw technical data  supporting the NDA during pre-assessment and assessment phases.   1.36 “Excluded Claim” has the meaning set forth in Section 14.12.8.  1.37 “Effective Date” has the meaning set forth in the Preamble of this Agreement.  1.38 “Exchange Rate” has the meaning set forth in Section 7.2.  1.39 “Executive Officer” has the meaning set forth in Section 14.12.2.  1.40 “FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section 78dd-1,  et. seq.), as amended and as may be further amended after the Effective Date, and any equivalent  non-U.S. regulations or standards, if and as applicable during the Term.  1.41 “FDA” means the United States Food and Drug Administration, and any of its  successor agencies or departments.   1.42 “Field” means the field with respect to the Product as set forth in the Product  Schedule.  1.43 “First Commercial Sale” means with respect to a country in the Territory, the first  sale of the Product to a Third Party by Pharmanovia (or any Affiliate or subcontractor of  Pharmanovia authorized by Pharmanovia pursuant to this Agreement) within such country in the  Territory after Regulatory Approval (and where applicable, (i) pricing or reimbursement approval  in such country and (ii) labeling approval) for the Product has been obtained in such country.   1.44 “Force Majeure” has the meaning set forth in Section 14.7.  1.45 “GAAP” means generally accepted accounting principles set forth from time to  time in the opinions and pronouncements of the Accounting Principles Board and the American  





 






   6    Institute of Certified Public Accountants and statements and pronouncements of the Financial  Accounting Standards Board (or agencies with similar functions of comparable stature and  authority within the United States accounting profession), which are applicable to the  circumstances as of the date of determination, in any case consistently applied.  1.46 “Healthcare Laws” shall mean (i) the Federal Food, Drug & Cosmetic Act (FDC  Act) (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder, including but not  limited to those related to current good manufacturing practices (cGMP) and any analogous law  of any foreign country (including for the avoidance of doubt EU cGMP); (ii) any and all federal,  state and local fraud and abuse laws, including, without limitation, the federal Anti-Kickback  Statute (42 U.S.C. § 1320a-7b), the Stark Law (42 U.S.C. § 1395nn and §1395(q)), the civil False  Claims Act (31 U.S.C. § 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United  States Code, the criminal health care fraud statute (18 U.S.C. § 1347), the regulations promulgated  pursuant to such statutes, and any analogous law of any state or foreign country; (iii) any federal,  state, or local law regulating the interactions with healthcare professionals and reporting thereof  and any analogous law of any foreign country; (iv) the Controlled Substances Act and the  regulations promulgated thereunder and any analogous law of any foreign country; (v) the Health  Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) (HIPAA), the Health  Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), the  regulations promulgated under such laws, and any applicable state privacy and security laws and  any analogous law of any foreign country; (vi) Medicare (Title XVIII of the Social Security Act)  and the regulations promulgated thereunder; (vii) Medicaid (Title XIX of the Social Security Act)  and the regulations promulgated thereunder; (viii) TRICARE (f/k/a CHAMPUS); (ix) the  Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173)  and the regulations promulgated thereunder; (x) quality, safety and accreditation standards and  requirements of all applicable state, federal, and foreign laws or regulatory bodies; (xi)  requirements of law relating to the manufacturing, labeling or relabeling, packaging or  repackaging, marketing, sale, or distribution of drugs or medical devices, including laws governing  license requirements for any of the foregoing activities; (xii) laws related to the hiring of  employees or acquisition of services or supplies from those who have been excluded from  government health care programs, quality, safety, privacy, security, licensure or accreditation; and  (xiii) laws and regulations promulgated by any regulatory authority equivalent to the FDA in a  foreign country including but not limited to the European Medicines Agency (“EMA”) and the  Medicines and Healthcare Products Regulatory Agency (“MHRA”) including the applicable  regulations and guidances of the FDA and the EMA (and national implementations thereof) that  constitute good laboratory practices, good manufacturing practices and good clinical practices).     1.47 “Housemark” means the name and logo of Aquestive or any of its Affiliates as  identified in Schedule 1.47A attached hereto, and the name and logo of Pharmanovia or any of its  Affiliates as identified on Schedule 1.47B attached hereto, as each such schedule may be updated  from time to time, and made a part hereof by amendment of such Schedule.  1.48 “ICC” has the meaning set forth in Section 14.12.3.  1.49 “ICC Rules” has the meaning set forth in Section 14.12.3.  





 






   7    1.50 “Improvements” means any invention, discovery, development or modification  with respect to the Product, the technology covered by the Aquestive Patents and/or the Aquestive  Know-How and/or relating to the exploitation thereof, whether or not patented or patentable,  including any enhancement in the efficiency, operation, Supply, ingredients, preparation,  presentation, formulation, means of delivery (including the development of any delivery system  or enhancement thereto) or dosage of the Product, the technology covered by the Aquestive IP,  any discovery or development of any new or expanded indications for the Product, the technology  covered by the Aquestive IP or any discovery or development that improves the stability, safety  or efficacy of the Product, the technology covered by the Aquestive IP.   1.51 “Indemnitee” has the meaning set forth in Section 11.3.1.  1.52 “Indemnitor” has the meaning set forth in Section 11.3.1.  1.53 “Intellectual Property” means, collectively, all: (a) patents and patent applications,  including, without limitation, any divisionals or any substitute applications, any patent issued with  respect to any such patent applications, any patents which remain valid subsequent to any post  grant proceedings or other challenges which result in the patent being enforceable, any amendment  or extension including any supplementary protection certificate of any such patent, and any  confirmation patent or registration patent or patent of addition based on any such patent, and all  foreign counterparts of any of the foregoing, or as applicable portions thereof or individual claims  therein; (b) copyrightable works, copyrights in works of authorship of any type, including  computer software and industrial designs, registrations and applications for registration thereof;  (c) trade secrets, know-how, processes, specifications, product designs, descriptions of the  manufacturing process and equipment and all other manufacturing information, engineering and  other manuals and drawings, standard operating procedures, flow diagrams, chemical,  pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality assurance,  quality control and clinical data, technical information, data, research records, supplier lists and  similar data and information, and all rights in any jurisdiction, according to the Applicable Laws  of such jurisdiction, to limit the use or disclosure thereof; (d) any and all rights to extensions to  any of the foregoing; (e) any and all rights of application regarding any of the foregoing; and  (f) rights to sue and recover damages or obtain injunctive relief for infringement, or  misappropriation of any of the foregoing.   1.54 “Losses” means any and all damages, awards, deficiencies, settlement amounts,  defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses,  lost profits and expenses (including, without limitation, court costs, interest and reasonable fees of  attorneys, accountants and other experts), together with all documented out-of-pocket costs and  expenses incurred in complying with any judgments, orders, decrees, stipulations, investigations  and injunctions that arise from or relate to a Third Party Claim.  1.55 “Marketing Authorization” means authorization from the relevant Regulatory  Authority within the Territory to market, sell or otherwise Commercialize the Product in one or  more countries in the Field in the Territory.  1.56 “Marketing Expenses” means all costs and expenses incurred in connection with  the Commercialization of the Product in the Field in the Territory, including, without limitation:  





 






   8    (a) marketing, advertising, sampling, and promotional activities; (b) marketing studies;  (c) primary and secondary market research; (d) promotional materials; and (e) samples.    1.57 “Milestone Payments” has the meaning set forth in Section 7.1.  1.58 “Minimum Volume Commitment” has the meaning set forth in Section 7.4.  1.59 “[****]” has the meaning set forth in Section 2.9.  1.60 “NDA” means a new drug application submitted pursuant to the requirements  of the FDA under 21 U.S.C. § 355(b)(1) of the Act, in each case, with all additions, deletion  or supplements thereto.   1.61 “Net Sales” means, for any period of determination, the aggregate amount  invoiced for the Product by Pharmanovia (or any Affiliate, or agent of Pharmanovia) to a Third  Party during such period, less amounts for the following accruals applied on a per Unit basis:  (a) credits, refunds, allowances, charge-backs, rebates, returns, distribution and  other fees, reimbursements, bona fide price reductions, and similar payments provided  to wholesalers, chains, mass merchandisers, group purchasing organizations and other  distributors, buying groups, health care insurance carriers, pharmacy benefit  management companies, health maintenance organizations, other institutions or health  care organizations, any governmental, quasi-governmental or regulatory body, agency  or authority in respect of any governmental programs;  (b) credits or discounts related to sales promotions, trade show discounts and  stocking allowances and trade volume and cash discounts and rebates in amounts that  are usual and customary, including retroactive corrections, including shelf stock or  other pricing related adjustments (and corrections for billing errors or shipping errors);  and  (c) any tax, tariff, duty or government charge (including any sales, value added,  excise or similar tax or relevant surtax or government charge) levied on the sale,  importation, exportation, transportation or delivery of the Product and borne by the  seller thereof that is not reimbursed by any Third Party.  (d) costs incurred for such Product that is destroyed due to recall of goods; and  (e) any other similar and customary deductions that are consistent with  International Financial Reporting Standards.  The amounts recognized as Net Sales, including any deductions accrued pursuant to  clauses (a) through (d) of this Section 1.61 shall be consistent with and determined from books  and records maintained in accordance with International Financial Reporting Standards and shall  only be deducted once and only to the extent not otherwise deducted from the aggregate amount  invoiced.  





 






   9    A “sale” shall not include transfers or dispositions of Product for pre-clinical or clinical  purposes or as samples, in each case, without charge.  For the purposes of this definition the transfer of Product by Pharmanovia to any Affiliate  shall not be considered a sale unless such Affiliate is the last entity in the distribution chain that  directly sells and dispenses Product to patients, health care providers, and/or health institutions.   1.62 “Party” or “Parties” has the meaning set forth in the Preamble to this Agreement.  1.63 “Payment Period” means each Calendar Quarter period during the Term;  commencing in the year in which the First Commercial Sale of the Product occurs.  1.64 “Person” means an individual, sole proprietorship, partnership, limited partnership,  limited liability partnership, corporation, limited liability company, business trust, joint stock  company, trust, unincorporated association, joint venture or other legal entity or organization,  including a government or political subdivision, department, or agency of a government.  1.65 “Pharmanovia” has the meaning set forth in the Preamble to this Agreement.  1.66 “Pharmanovia Indemnitees” has the meaning set forth in Section 11.2.  1.67 “Pharmanovia Marks” means the Pharmanovia Housemark and such trade dress  and trademarks as are notified to Aquestive by Pharmanovia in writing from time to time.   1.68 “Primary Packaging” means the foil pouch that individually wraps and touches each  Unit.  1.69 “Primary Packaging Design” means artwork associated with the Primary Packaging  for the Product in the Field in the Territory.  1.70 “Product” means the Product set forth in the Product Schedule.    1.71 “Product Label” means labels and other written material pertaining to the core label  for the Product including, but not limited to, safety information, prescribing information,  medication guides, and instructions for use.  1.72 “Product Requirements” has the meaning set forth in Section 5.1.  1.73  “Product Schedule” means with respect to the Product, the Product specific details  concerning the Product including the Product description, the API, specific Aquestive Product  Patents (if any) covering the Product, specific Aquestive Product Mark(s) (if any) covering the  Product, Dosage Strength, Milestone Fees, Minimum Volume Commitment, Royalty Fees,  Territory, Product Transfer Price and any other Product or Territory-specific information required  for the performance of the obligations contemplated under this Agreement.    1.74 “Product Transfer Price” has the meaning set forth in Section 5.2.  





 






   10    1.75 “Profit” means, for any period of determination, Net Sales, less Product Transfer  Price on a per Unit basis, less the following accruals applied on a per Unit basis: quality release,  distribution and logistics fees, freight and insurance.  1.76 “Profit Share” has the meaning set forth in Section 5.2.  1.77  “Purchase Orders” has the meaning set forth in Section 5.1.  1.78 “Quarterly Payment Reports” has the meaning set forth in Section 7.5.  1.79 “Quality Agreement” has the meaning set forth in Section 5.11.  1.80 “Raw Materials” means raw materials, chemicals, work-in-process, and other  materials used to Supply Product under this Agreement.  1.81 “Raw Materials Safety Stock” has the meaning set forth in Section 5.9.  1.82 “Recall” has the meaning set forth in Section 4.8.1.  1.83 “Recall Expenses” has the meaning set forth in Section 4.8.1.  1.84 “Recall Objection Notice” has the meaning set forth in Section 4.8.3.  1.85 “Receiving Party” has the meaning set forth in Section 10.1.  1.86 “Regulatory Approval” means authorization from the relevant Regulatory  Authorities within the Territory for approval to Commercialize the Product in the Field in the  Territory, including the Marketing Authorization for the Product.  1.87 “Regulatory Approval Application” means any filings submitted to a Regulatory  Authority in the Territory, in each case, with all additions, deletion or supplements thereto, for  Regulatory Approval of the Product in the Field in the Territory.  1.88 “Regulatory Authority” means any national, international, federal, regional, state,  provincial or local government, or political subdivision thereof, or any multinational  organization or any authority, regulatory agency, department, bureau, commission, council or  other regulatory or taxing authority entitled to exercise any administrative, executive, judicial,  legislative, police, regulatory or taxing authority or power, including with respect to the granting  of approvals (including pricing and reimbursement approvals), licenses, registrations, or  authorizations for the marketing, sale, manufacturing, testing, labeling, storage, handling,  packaging, shipping or supply of the Product or granting Regulatory Approval for the Product,  including the FDA, any other regulatory authority(ies) equivalent to the FDA including the EMA  and the MHRA, and any successor(s) thereto having substantially the same functions, or any court  or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral  body).  1.89 “Regulatory Notification” shall have the meaning given to it in Section 4.6.2.  





 






   11    1.90 “Rescheduled Delivery Date” has the meaning set forth in Section 5.10.1.  1.91 “[****]” has the meaning set forth in Section 2.9.  1.92 “[****]” has the meaning set forth in Section 2.9.  1.93 “[****]” has the meaning set forth in Section 2.9.  1.94 “Royalty Fees” has the meaning set forth in Section 7.2.  1.95 “Safety Data Exchange Agreement” has the meaning set forth in Section 5.12.  1.96 “Secondary Packaging” means the packaging that contains the Primary Packaging  and which does not come in contact with the single dosage strips of the Product.   1.97 “Secondary Packaging Design” means artwork associated with the Secondary  Packaging for the Product in the Field in the Territory.  1.98 “Specifications” means the written specifications for the Product and Raw  Materials including, without limitation, the shelf life of the Product and Raw Materials for such  Product and the specifications as set forth in the applicable Regulatory Approval for the Product.   The Specifications, and any modifications or supplements thereto from time to time during the  Term, shall be mutually approved in a specific written agreement by the Parties and, upon such  mutual written agreement, shall be deemed to be incorporated by reference in this Agreement.  1.99 “Statement of Work” means a written document executed and delivered by the  Parties that defines, as applicable, the work activities, requirements, deliverables, timeline,  associated pricing and any other terms and conditions to govern given work project to be conducted  by Aquestive under this Agreement.  1.100 “Steering Committee” has the meaning set forth in Section 6.  1.101 “Supply” means all activities related to the manufacture, supply, processing,  storing, labeling, and packaging (as specified in this Agreement) quality control, storage release  by Aquestive for sale and delivery of the Product including quality control and release.  1.102 “Technology Transfer Plan” has the meaning set forth in Section 9.2.  1.103 “Technology Transfer Partner” has the meaning set forth in Section 9.2.  1.104 “Term” has the meaning set forth in Section 12.1.  1.105 “Territory” means the territory with respect to the Product as set forth in the Product  Schedule.    1.106 “Third Party” means any Person other than Aquestive and Pharmanovia and their  respective Affiliates.  1.107 “Third Party Claim” has the meaning set forth in Section 11.1.   





 






   12    1.108 “Unit” shall mean a single dosage strip of the Product, in an individual foil pouch,  for sample or sale.   2. CERTAIN RIGHTS AND OBLIGATIONS  2.1 Licenses Granted to Pharmanovia.  Subject to the terms and conditions of this  Agreement, Aquestive hereby grants to Pharmanovia, and Pharmanovia hereby accepts, during the  Term, as to the Product in the Field in the Territory, an exclusive (including as to Aquestive and  its Affiliates), royalty-bearing license under and to the Aquestive Product Patents and as to the  Product in the Field in the Territory, an exclusive, royalty-bearing, license under and to the  Aquestive IP to: (i) register the Product with the applicable Regulatory Authorities within the Field  in the Territory and (ii) Commercialize the Product in the Field in the Territory (including but not  limited to the right to sublicense to distributors the right to distribute and promote the Product in  the Territory in accordance with the terms of this Agreement.  2.2 Exclusivity.    2.2.1 Aquestive hereby covenants and agrees with Pharmanovia that during the  Term, other than as expressly provided in this Agreement, neither Aquestive or its Affiliates, nor  any Person acting on behalf of Aquestive or its Affiliates, shall grant any license or right with  respect to the Aquestive IP to any Affiliate or Third Party to, research, make, have made, Develop  or Commercialize the Product in the Field in the Territory.  Notwithstanding anything to the  contrary contained in this Agreement, Aquestive shall have the sole and exclusive right to be the  exclusive Developer (except for the limited Development rights of Pharmanovia set forth in  Section 4.3, manufacturer and supplier of all Product Commercialized under this Agreement.  2.2.2 Pharmanovia hereby covenants and agrees that neither Pharmanovia, nor  any of its Affiliates shall, directly or indirectly (whether through an Affiliate, Third Party, or by  any transfer or license rights to an Affiliate or Third Party), during the Term, make, use, Develop  (except for the limited Development rights of Pharmanovia set forth in Section 4.3), import/export,  seek Regulatory Approval for, manufacture, supply, distribute, offer to sell, sell, market, promote,  detail, or otherwise commercialize any products that contains the API as the active pharmaceutical  ingredient and that is delivered in a buccal, sublingual or nasal form, in the Field in the Territory  other than pursuant to this Agreement and other than to the extent such products are being  commercialized by Pharmanovia as of the Effective Date.  2.3 No Implied Licenses; Negative Covenant.  Except as set forth in this Agreement,  neither Party shall acquire any license or other Intellectual Property interest, by implication or  otherwise, under any Intellectual Property Controlled by the other Party or its Affiliates.  Neither  Party shall, nor shall it permit any of its Affiliates or subcontractors to, practice any Intellectual  Property licensed to it by the other Party outside the scope of the licenses granted to it under this  Agreement.  2.4 Use of Subcontractors.   2.4.1 Aquestive Use of Subcontractors.  Subject to the terms of the Agreement,  Pharmanovia acknowledges and agrees that Aquestive may exercise its rights or perform its  obligations, including Development, clinical and Supply activities, under this Agreement through  





 






   13    one or more subcontracts with Third Parties selected by Aquestive; provided that, Aquestive will  remain fully responsible to Pharmanovia for the performance of all obligations delegated to the  subcontractor including responsibility for the work allocated to, and payment to, such Third Parties  to the same extent it would if it had done such work itself.  Aquestive shall notify Pharmanovia in  writing of all activities sub-contracted to Third Parties and the names thereof.  2.4.2 Pharmanovia Use of Subcontractors.  Subject to the terms of the Agreement,  Aquestive acknowledges and agrees that Pharmanovia may exercise its rights or perform its  obligations including the right to Develop (as set forth in Section 4.3), Commercialize, to hold  Regulatory Approvals and distribute the Product in the Territory under this Agreement through  one or more subcontracts for distribution with Third Parties selected by Pharmanovia; provided  that, except as set forth in this Agreement, Pharmanovia will remain fully responsible for the  performance of all obligations delegated to the subcontractor including responsibility for the work  allocated to, and payment to, such Third Parties to the same extent it would if it had done such  work itself.   2.5 Trademarks.  2.5.1 Subject to the terms and conditions of this Agreement, Aquestive hereby  grants to Pharmanovia, and Pharmanovia hereby accepts as to the Product in the Field in the  Territory: (a) a non-exclusive, non-transferable, non-sublicensable license to use the Aquestive  Marks (excluding the Aquestive Product Mark(s)); and (b) an exclusive, non-transferable, non- sublicensable license to use the Aquestive Product Mark(s), in each case, solely in conjunction  with the Commercialization of the Product in the Field in the Territory and solely for such uses as  are specifically approved in writing by Aquestive (which uses Aquestive hereby confirms includes  use of the Aquestive Marks to identify Aquestive as the manufacturer of the Product if so required  by Applicable Laws).  For the avoidance of doubt there is no obligation on Pharmanovia to apply  the Aquestive Marks to the Product packaging, except as required by Applicable Law.  2.5.2 Aquestive hereby confirms that Pharmanovia may apply the Pharmanovia  Marks to the Product. Subject to the terms and conditions of this Agreement, Pharmanovia hereby  grants to Aquestive, and Aquestive hereby accepts, a non-exclusive, non-transferable, non- sublicensable license to use the Pharmanovia Marks solely in conjunction with the labeling and  specified packaging of Product for Supply in the Field in the Territory and solely as such are  approved in writing by Pharmanovia.  2.5.3 Without prejudice to Section 2.5.2, Aquestive shall:   2.5.3.1 only use the Pharmanovia Marks in accordance with all written  instructions (including any brand guidelines) which Pharmanovia may provide to Aquestive from  time to time;    2.5.3.2  not apply to register or otherwise attempt to register  (whether in its own name, or in the name of any third party), any Pharmanovia Mark or any  confusingly similar trade mark as a trade mark with any governmental authority, in any  jurisdiction, at any time.  





 






   14    2.5.4 All use of the Pharmanovia Marks by Aquestive and its Affiliates, and all  goodwill generated in connection therewith, shall inure solely for and to the benefit of  Pharmanovia.  2.6 Packaging and Labeling.    2.6.1 Packaging and Labeling.  Aquestive shall label and package Product in  accordance with the Primary Packaging Design Specifications and Secondary Packaging  specifications that are provided by Pharmanovia from time to time.  Pharmanovia shall be  responsible, at its cost and expense, for developing and providing Aquestive with a copy of all  graphics and artwork to be used with the Product, including the Primary Packaging Design, which  shall be delivered to Aquestive as an electronic file in Adobe Illustrator format.  Pharmanovia shall  be responsible, at its cost and expense, for any required submissions to the applicable Regulatory  Authorities in the Territory regarding the labeling and packaging configurations for the Product,  including any permitted changes in labeling or packaging configurations, and shall be responsible,  at its cost and expense, for ensuring that labeling, packaging configurations, and the Primary  Packaging Design Specifications complies with Applicable Law.  Pharmanovia shall be  responsible for ensuring that all Primary Packaging and Secondary Packaging complies with  Applicable Law.  The packaging for the Product, including the Primary Packaging and Secondary  Packaging, shall, if required by Applicable Law indicate that the Product is manufactured by  Aquestive.    2.6.2 Changes.  2.6.2.1 Changes to Packaging of Product. Pharmanovia shall have the  right, upon prior written notice to Aquestive, to change the Primary Packaging and Secondary  Packaging of the Product consistent with Applicable Law and the terms and conditions of this  Agreement.  Upon delivery of such written notice, the Parties will mutually agree in good faith  upon a written Statement of Work that shall include a reasonable timeframe for implementation of  such changes, including without limitation, giving effect to the use of the remaining work-in- process and any Raw Materials and packaging materials in-process or held in inventory by  Aquestive prior to effecting such change and a reasonable estimate of the additional costs and  expenses to be reimbursed to Aquestive by Pharmanovia as a result of the implementation of such  changes; provided that any such costs and expenses arising from a change of Manufacturing Site  by Aquestive shall be borne by Aquestive. Subject to the foregoing, such changes shall be at  Pharmanovia’s sole cost and expense (including documented cost of any inventory, work-in- process, Raw Materials, documentation updates and packaging materials of Aquestive which  become obsolete or unusable as a result of such request) provided that Aquestive shall use  Commercially Reasonable Efforts to reallocate such inventory, work in process, Raw Materials  and packaging materials.  Aquestive shall not be required to make any such change if: (a) it  requires any material capital investment by Aquestive; or (b) it results in any cost increases  (including manpower allocations or resources) to Aquestive that is not reimbursed by  Pharmanovia. For the avoidance of doubt the initial implementation of a new SKU of the Product  in the Territory shall not constitute a change pursuant to this Section 2.6.2.1.  2.6.2.2 Changes to Product Specifications. Either Party shall have the  right to request that a change be made to the Specifications for the Product upon prior written  





 






   15    notice to, and (except for changes required by Applicable Law) subject to the approval of, the other  Party and, if approved, the Parties shall agree on a reasonable timeframe for implementation of  such changes.  If either Party proposes making any material changes to the Specifications, such  Party shall give the other Party at least sixty (60) days prior written notice of the proposed change  unless such change is required because of Applicable Law, regulatory requirements or product  performance concerns, or the availability or quality of the Product components, in which case such  notice shall be provided as soon as reasonably possible.  The other Party shall promptly, but no  later than within thirty (30) days after receiving such written notice, inform the notifying Party in  writing of any objections to the proposed change, including any changed validation requirements  necessary to accept such proposed change.  In no event may any change in the Specifications of  the Product be implemented except in compliance with Applicable Law.  Neither Pharmanovia nor  Aquestive shall refuse without good and reasonable cause implementation of a proposed change  in the Specifications that is or would be otherwise allowed by Regulatory Authorities and that does  not affect the Product Transfer Price or the performance of the Product and Aquestive shall not  refuse the implementation of a proposed change requested by Pharmanovia subject to Aquestive  and Pharmanovia agreeing in good faith in writing to such change.  If a change is made under this  Section 2.6.2.2, the Party requesting the change shall be liable for the costs and expenses of  implementing such change (with the exception of if a change is required to comply with Applicable  Law or regulatory requirements in the Territory in which case Pharmanovia shall be liable for such  costs and expenses).   2.7 Aquestive Retained Rights.  Any rights of Aquestive not expressly granted to  Pharmanovia under the provisions of this Agreement shall be retained by Aquestive.  In  furtherance of the foregoing and not in limitation thereof, Aquestive, except as expressly set forth  in Section 2.1, shall retain the right: (a) to carry-out its obligations under this Agreement; and (b)  to exploit the Aquestive IP for purposes outside of the scope of the licenses granted in Section 2.1  for any and all purposes anywhere in the world, without any duty to account to Pharmanovia or  obtain Pharmanovia’s consent for such exploitation.   2.8 Confirmatory Licenses. Aquestive shall if requested to do so by Pharmanovia,  enter into one or more confirmatory license agreements in such form as may be agreed by the  Parties for purposes of recording the licenses granted under this Agreement with the applicable  patent offices in the Territory.  The Parties shall use best efforts to ensure that, subject to  Applicable Law, neither this Agreement, nor the contents thereof (excepts as required by  Applicable Law) shall form part of any public record.  2.9 [****]  3. COMMERCIALIZATION  3.1 Pharmanovia Responsibility and Control.  Except as otherwise expressly set  forth in this Agreement, Pharmanovia shall have sole responsibility for all Commercialization  activities for the Product in the Field in the Territory, including developing strategies and tactics  related to the advertising, promotion, pricing, marketing, and selling the Product in the Field in the  Territory. Pharmanovia shall comply, and shall use Commercially Reasonable Efforts to procure  that all of its Third Party agents and subcontractors, if any, to comply, with all Applicable Law in  Commercializing the Product in accordance with this Agreement.  





 






   16    3.2 Specific Commercialization Rights and Obligations of Pharmanovia.  Subject  to any conditions or limitations set forth in this Agreement, it shall be Pharmanovia’s sole right  and responsibility as to the Product in the Field in the Territory to: (a) develop advertising and  promotional materials related to the Product; (b) book sales for the Product; (c) handle all returns  of the Product; (d) handle all aspects of order processing, Product distribution, invoicing and  collection of receivables for the Product; (e) collect data regarding sales to end users of the Product;  (f) monitor inventory levels of the Product; (g) provide first line customer support; (h) conduct  pharmacovigilance; (i) warehouse the Product; and (j) determine the price for the Product and any  discounts and rebates that may be offered thereto, including decisions relating to customer  allowances and credits.   3.3 Product Launch and Market Coverage.  Pharmanovia shall use its Commercially  Reasonable Efforts to launch the Product in the applicable country in the Territory within sixty  (60) days of receiving the first delivery of saleable, Product following the later of pricing  reimbursement and receipt of the Regulatory Approval of such Product in such country in the  Territory. Aquestive acknowledges that it shall be consistent with Commercially Reasonable  Efforts for Pharmanovia to prioritize Commercialization of the Product in certain countries of the  Territory and not to proceed with Commercialization of a Product in all countries of the Territory  at the same planned timetable.  3.4 Commercialization and Marketing Expenses.  Pharmanovia shall be responsible  for and pay one hundred percent (100%) of all costs and expenses incurred in connection with the  Commercialization of a Product in the Territory including, without limitation, all Marketing  Expenses.  4. DEVELOPMENT AND REGULATORY MATTERS  4.1 Transfer of Regulatory Documentation and Other Information.    4.1.1 At no cost to Pharmanovia except as set out in the Product Schedule,  Aquestive will provide Pharmanovia with the applicable Dossier (including associated CMC Data  and clinical and other data referenced in the Dossier to the upon Pharmanovia’s payment of the  first milestone payment to Aquestive as set forth in the Product Schedule and, subject to the terms  of this Agreement, will use Commercially Reasonable Efforts to provide, on an ongoing basis  during the Term:  4.1.1.1 copies of all (i) applications (including all INDs), registrations,  licenses, authorizations and approvals including ANDA in relation to the Product; and (ii) material  correspondence and reports submitted to or received from Regulatory Authorities related to the  Product and all supporting documents with respect thereto and referenced therein, including all  adverse event files and complaint files;   4.1.1.2 necessary technical consultation and clinical study support by  Aquestive personnel;  





 






   17    4.1.1.3 to the extent in Aquestive’s possession or control, such further  documentation related to a Regulatory Approval for the Product requested by a Regulatory  Authority;  in each case in a timely manner to support Pharmanovia’s efforts to obtain Regulatory Approvals  for the Product in the Field in the Territory.  4.1.2 At no cost to Aquestive, Pharmanovia shall provide Aquestive with copies  of: (a) data and documents submitted to Regulatory Authorities in connection with obtaining  Regulatory Approvals and post-approval maintenance of the Regulatory Approvals for the Product  on a quarterly basis during the Term; (b) its annual report for safety and Adverse Events filed with  applicable Regulatory Authorities in English; and (c) in English other safety data received by  Pharmanovia with respect to the Product on an annual basis or more frequently as required to  ensure expedited safety reporting in accordance with Applicable Law or as reasonably requested  by Aquestive in writing from time to time during the Term and in accordance with the Safety Data  Exchange Agreement.    4.1.3 At no cost to Pharmanovia, Aquestive shall provide Pharmanovia a  summary of Adverse Events reported by Aquestive to the FDA on an annual basis or more  frequently as required to ensure expedited safety reporting in accordance with Applicable Law in  the relevant country in the Territory or as reasonably requested by Pharmanovia in writing from  time to time during the Term and in accordance with the Safety Data Exchange Agreement.  4.1.4 Aquestive will provide Pharmanovia with such documentation (including  clinical trial data) in Aquestive’s possession or control, and technical assistance, as is necessary or  desirable for Pharmanovia to maintain the Regulatory Approvals in the Territory.   4.1.5 The documentation and support and consultation to be provided pursuant to  Section 4.1.2 and Section 4.1.4 by Aquestive to Pharmanovia shall be provided at no charge except  the extent that Aquestive is not in possession or control of the relevant documentation and/or  further work is required to generate the documentation and/or provide the support; in these  circumstances Aquestive will provide Pharmanovia with cost estimates to provide the relevant  documentation and/or support and the Parties mutually agree in writing to execute a Statement of  Work for these activities prior to the commencement of such work.  4.2 Development Rights and Responsibilities of Aquestive.  Aquestive shall provide  Pharmanovia, at no cost, with regulatory materials and other regulatory data and information in its  possession or control related to the Product (in English), to the extent necessary to support the  Development activities to be conducted by Pharmanovia under this Agreement with respect to the  Product in the Field in the Territory to the extent required by a Regulatory Authority in connection  with the Regulatory Approvals including to achieve Marketing Authorization for the Product in  the Field in the Territory or maintenance thereof. Aquestive shall use Commercially Reasonable  Efforts to cause the relevant Third Parties to provide Pharmanovia with regulatory materials and  other regulatory data and information related to each Product in English to the extent required by  a Regulatory Authority in connection with a Regulatory Approval including the Marketing  Authorization for the Product in the Field in the Territory; in connection with this Third Party  support Aquestive will provide Pharmanovia with cost estimates from these Third Parties to  





 






   18    provide the relevant support and the Parties mutually agree in writing to execute a Statement of  Work for these activities prior to the commencement of such work. At Pharmanovia’s written  request in connection with a Regulatory Approval or Regulatory Approval Application or  maintenance thereof for the Product in the Field in the Territory, Aquestive shall use Commercially  Reasonable Efforts to provide reasonable assistance to Pharmanovia with its preparation and  submission of such Regulatory Approval Application or maintenance for the Product in Field in  the Territory.  4.3 Development Rights and Responsibilities of Pharmanovia.  Subject to the  general oversight of the Steering Committee, Pharmanovia shall have sole responsibility for and  have sole right to carry out, the performance of, and unless otherwise expressly set forth in this  Agreement, shall be responsible for the sole cost of, the Development activities described in this  Section 4.3.    4.3.1 Approval and Post-Approval Activities.  Pharmanovia shall be solely  responsible for, and have sole right to perform, the Development activities required to obtain the  Regulatory Approvals and any post-approval maintenance of Regulatory Approvals for the  Product in the Field in the Territory including, without limitation, any Phase III or Phase IV  commitments, periodic safety reviews, annual reports, regulatory submissions, and the  development, stability testing, implementation, and maintenance of a pharmacovigilance program.   Pharmanovia shall provide Aquestive data and documents relating to such Development activities  and post-approval maintenance of the Regulatory Approvals: (i) as requested by Aquestive and (ii)  at least thirty (30) days prior to submitting any such data or document to any Regulatory Authority.   Aquestive shall Supply Pharmanovia quantities of Product required for clinical studies (“Clinical  Supply”), registration purposes, and validation purposes at the Product Transfer Price, in each  case, if necessary for Development of the Product in the Field in the Territory and to the extent  included in a Statement of Work.  Aquestive shall provide Clinical Supply with blank packaging,  and Pharmanovia shall be solely responsible for the labeling of Clinical Supply.  4.3.2 No Right to Develop Product Formulation.  Notwithstanding anything to  the contrary contained in this Agreement or otherwise, Pharmanovia acknowledges and agrees that  neither it nor any of its Affiliates, agents or subcontractors shall have any right to Develop the  Product formulation itself.  In the event that any Regulatory Authority requires any modification  to the Product formulation, Aquestive shall, at Pharmanovia’s sole cost and expense: (i) assess in  good faith the feasibility of such modifications to the Product formulation and (ii) if feasible,  engage in Development of the Product formulation and shall deliver the necessary information and  documents to Pharmanovia in accordance with the requirements of such Regulatory Authority.   4.4 Regulatory Activities.  Pharmanovia shall be responsible for preparing and filing  all Regulatory Approval Applications and other documents in the Field in the Territory, and each  Regulatory Approval relating to the Product in the Field in the Territory shall, during the Term, be  owned by and held in the name of Pharmanovia or its Affiliate or nominee.  Pharmanovia shall file  each Regulatory Approval Application in accordance with Applicable Law.  Pharmanovia shall be  solely responsible for the conduct of, have sole right to conduct, and shall use Commercially  Reasonable Efforts to, promptly conduct: all Development activities in connection with or as a  condition of seeking or obtaining and maintaining Regulatory Approval of each Product in the  Field in the Territory, including, without limitation, preparing and filing all regulatory applications  





 






   19    and documents in the Territory, meetings with Regulatory Authorities in the Territory, submissions  and maintenance of each Regulatory Approval Application and preparation and submission of all  supplements thereto, conducting periodic safety reviews, all submissions to the Regulatory  Authorities in the Territory, all post-marketing obligations required by the Regulatory Authorities,  and the development and implementation of a pharmacovigilance program specific to the Product  in the Field in the Territory, all in compliance with all Applicable Law.  Pharmanovia shall be  responsible and pay for one hundred percent (100%) of the costs and expenses incurred in  connection with the foregoing activities unless otherwise specifically provided for in this  Agreement.  Pharmanovia shall designate a regulatory liaison to report to the Steering Committee  on the status of regulatory activities, including material communications with all Regulatory  Authorities in the Territory, on an as-needed basis as determined by the Steering Committee.   Pharmanovia shall provide the Steering Committee with reasonable advance notice, but not less  than thirty (30) days’ notice, of Pharmanovia’s intent to file any Regulatory Approvals for the  Product.   4.5 Annual Stability Testing.  If any annual stability testing on the Product is required  by any Regulatory Authority in the Territory (which is outside the scope of any annual stability  testing that has already been completed by Aquestive, or if Aquestive does not already have the  data required by the Regulatory Authority to prevent the need for any further annual stability  testing) where the Product is commercially sold, Aquestive shall perform such stability testing  pursuant to a Statement of Work, and Pharmanovia shall be responsible for all costs and expenses  associated with the performance and maintenance of such stability testing.  For the avoidance of  doubt, at no cost to Pharmanovia, Aquestive shall share with Pharmanovia stability data in its  possession or control generated from any stability data testing on the Product required by any  Regulatory Authority outside the Territory.   4.6 Communications and Meetings with Regulatory Authorities.    4.6.1 Communications with Regulatory Authorities.  Pharmanovia shall have sole  control, and have authority and responsibility for, interfacing, corresponding, and meeting with all  Regulatory Authorities for Regulatory Approvals in the Territory.  At all times during the Term,  Pharmanovia shall be responsible, at its cost and expense, for pharmacovigilance reporting to the  applicable Regulatory Authorities in compliance with Applicable Law in the Territory, including,  but not limited to, reporting any and all Adverse Events to the applicable Regulatory Authorities.   4.6.2 Notification by the Parties of Regulatory Actions.  Each Party shall as soon  as reasonably possible after receipt of any notices of inspections, proposed regulatory actions,  investigations or material official written requests by any Regulatory Authority with respect to the  Supply or Commercialization of Product, as well as any corrective or other actions with Regulatory  Authorities initiated by a Party with respect thereto within or outside the Territory (“Regulatory  Notification”) so far as they relate to the Territory, provide written notice to the other Party in  reasonable detail with respect thereto and will provide the other Party with copies of all related  documentation.  





 






   20    4.7 Regulatory Notifications.   4.7.1 Notice.  Each Party or its respective authorized representative shall provide  the other Party with written notice, in a sufficiently timely basis to enable the other Party to comply  in all material respects with Applicable Law in the relevant country in the Territory and in any  event within three (3) Business Days of receipt of a Regulatory Notification that: (a) raises any  material concerns regarding the safety or efficacy of the Product; (b) indicates or suggests a Third  Party Claim arising in connection with the Product; or (c) is reasonably likely to lead to a Recall,  market withdrawal or field correction of, field alert report or comparable report with respect to the  Product.  Examples of Regulatory Notifications shall include, but not be limited to correspondence  from a Regulatory Authority relating to:  4.7.1.1 inspections by a Regulatory Authority of manufacturing,  distribution or other related facilities concerning  safety or efficacy issues with the Product;  4.7.1.2 inquiries by a Regulatory Authority concerning clinical  investigation activities (including, without limitation, inquiries regarding investigators, clinical  monitoring organizations and other related Third Parties) with respect to the Product;  4.7.1.3 any receipt of a warning letter from a Regulatory Authority  relating to the Product;  4.7.1.4 any initiation of any Regulatory Authority investigation,  detention, seizure, or injunction concerning the Product.  4.8 Recalls or Other Corrective Action.    4.8.1 Notice of Action.  Aquestive shall maintain traceability records in  accordance with Applicable Law, necessary to permit a recall, field correction or other notification  to the field, of the Product.  Pharmanovia shall have the exclusive right to institute a recall, market  withdrawal, field correction or field report of the Product and shall be responsible for managing  the recall and communications with customers and Regulatory Authorities.  As soon as reasonably  possible, Pharmanovia shall notify Aquestive of any actions to be taken by Pharmanovia or its  Affiliates, subcontractors or agents with respect to any recall or market withdrawal or field  correction, field alert report or comparable report or any matter which is suspected or likely to be  the subject of a complaint which may require a recall, market correction or similar action relating  to the Product in the Territory (a “Recall”) if possible this shall be prior to any such action being  taken so as to permit Aquestive a reasonable opportunity to consult with Pharmanovia with respect  thereto.  At Pharmanovia’s written request and cost, Aquestive shall use Commercially Reasonable  Efforts to provide reasonable assistance to Pharmanovia in conducting such Recall; the costs of  such assistance shall be borne in the same manner as other Recall Expenses.  The cost of any  Recall, including, the costs of notifying customers and the costs associated with the shipment of  such Product from customers and all reasonable credits extended to customers as a result thereof,  and the costs of replacing the Product (collectively, “Recall Expenses”), occasioned or required as  part of a general Recall of Product, shall be borne as provided in the following sentences:   4.8.1.1 Any Recall Expenses, to the extent solely caused by Aquestive its  Affiliates or subcontractors, or the failure of Aquestive to Supply the Product conforming to the  





 






   21    Specifications or applicable Regulatory Approvals, as determined by a final non-appealable order  of a Regulatory Authority or as mutually agreed in writing by the Parties, shall be borne by  Aquestive.   4.8.2 Any Recall Expenses to the extent caused by Pharmanovia or any Third  Party (other than Aquestive’s subcontractors) or the failure of Pharmanovia or its subcontractors  to Commercialize the Product conforming to the applicable Regulatory Approvals or other breach  of this Agreement by Pharmanovia, as determined by a final non-appealable order of a Regulatory  Authority or as mutually agreed in writing by the Parties, shall be borne by Pharmanovia.  4.8.3 Recall Objection Notice. In the event that there is no determination by a  Regulatory Authority or the Parties dispute which Party is the cause of a Recall, either Party may  send a written notice of objection regarding such Recall to the other Party (the “Recall Objection  Notice”).  The Parties agree to attempt to resolve such dispute within ten (10) days after receipt of  the Recall Objection Notice.  If Pharmanovia and Aquestive fail within ten (10) days after receipt  of the Recall Objection Notice to agree as to the Party that is the cause of such Recall, the issue,  and as applicable, any representative samples of the Product, shall be submitted to a mutually and  reasonably acceptable independent Third Party laboratory of national reputation, or consultant (if  not a laboratory analysis issue), as evidenced by written agreement of the Parties, for analysis or  review.  The results of such evaluation by such independent Third Party laboratory or consultant,  as the case may be, must be in writing and shall be binding upon the Parties.  If Aquestive, its  Affiliates or subcontractors is determined to have been the sole cause of such Recall, Aquestive  shall pay one hundred percent (100%) of the Recall Expenses including the cost of any such  evaluation, or, if it is determined that both Parties are partially at fault, then the Parties shall share  in the Recall Expenses in proportion to each Party’s relative fault.  Otherwise, Pharmanovia shall  pay the Recall Expenses relating to such Recall including the cost of any such evaluation and  destruction of any recalled Product.  If the fees of the independent laboratory or consultant are due  in advance, Pharmanovia and Aquestive shall each pay fifty percent (50%) of such fees; provided,  however, that promptly after the independent Third Party laboratory or consultant completes its  evaluation, the Party that is responsible for the Recall Expenses shall reimburse the other Party for  its fifty percent (50%) share of such fees; and if the Parties are found to be proportionately at fault,  each Party shall reimburse the other Party for such Party’s proportion of such fees.    4.8.4 Recall Information Received.  Each Party shall, as soon as reasonably  practicable, notify the other Party in writing of any Recall, market withdrawal or field correction  of, field alert report or comparable report as detailed in the Quality Agreement with respect to the  Product and supply all information received by it relating thereto in sufficient detail to allow the  Parties to comply with Applicable Law in the relevant country in the Territory.  5. SUPPLY   5.1 Commercial Supply Obligations.    5.1.1 Subject to the terms and conditions of this Agreement, during the Term,  Aquestive shall exclusively Supply Pharmanovia and Pharmanovia’s Affiliates and subcontractors  with, and Pharmanovia shall, subject to Section 5.2, exclusively purchase from Aquestive, all of  Pharmanovia’s requirements of Pharmanovia and Pharmanovia’s Affiliates and subcontractors of  





 






   22    the Product for commercial sale in the Field in the Territory during the Term, pursuant to binding  purchase orders delivered by Pharmanovia to Aquestive in accordance with Section 5.3 (“Purchase  Orders”).  Aquestive shall Supply Product to Pharmanovia in Units in accordance with the terms  and conditions of this Agreement, Applicable Law, the Purchase Order the Specifications and the  shelf-life requirements set out in the Product Schedule (“Product Requirements”).  5.1.2 Without prejudice to any other rights that Pharmanovia may have under this  Agreement, in equity or at law the restriction in Section 5.1.1 shall not apply if and to the extent a  Bankruptcy Supply Failure occurs. In such an event and without prejudice to any other any other  rights that Pharmanovia may have under this Agreement, in equity or at law:  5.1.2.1 Pharmanovia may immediately terminate the exclusivity of the  appointment of Aquestive pursuant to Section 5.1 by written notice to Aquestive and with effect  from such notification the exclusive purchase obligation pursuant to Section 5.1 shall cease to  apply for the remainder of the Term; and  5.1.2.2 Aquestive shall grant to Pharmanovia, a perpetual irrevocable,  non-exclusive sub-licensable license to the Aquestive Know-How and a license to Supply and/or  have Supplied the Product; and  5.1.2.3 The provisions of Section 9 relating to technology transfer shall  apply.  5.1.2.4 For the avoidance of doubt, Aquestive shall not be relieved of its  Supply obligations by virtue of such loss of exclusivity. Following such loss of exclusivity, nothing  in this Agreement shall prevent Pharmanovia or any Affiliate of Pharmanovia from purchasing  and/or having manufactured the Product from or by any other manufacturer or supplier, or from  manufacturing the Product itself.  5.2 Product Transfer Price.    5.2.1 Aquestive shall Supply quantities of each Unit of the Product to  Pharmanovia at each of the initial transfer prices set forth in the Product Schedule (each a “Product  Transfer Price”). The Parties agree that upon the earlier of (a) the end of Commercialization Year  3 (as defined in the Product Schedule) and (b) each time an adjustment to the Minimum Volume  Commitment, if any, is made pursuant to Section 7.4, the Parties shall discuss and agree upon in  good faith a revision to the Product Transfer Price.  Thereafter, Aquestive may, after notification  to Pharmanovia, increase the Product Transfer Price providing Pharmanovia not less than [****]  days written notice of any such proposed increase no more than [****] to the extent necessary to  cover actual increases in COGS, as evidenced by relevant supporting documents provided,  however, any such price increase shall apply prospectively only and shall not apply to Product  subject to binding Purchase Orders. The Parties acknowledge that cost reductions and Product  Transfer Price may be possible by improvements in manufacturing processes and increased  purchasing resulting from an increase in purchasing volume by Pharmanovia, among other  reasons.  In the event that Aquestive’s COGS are reduced the Parties shall have a good faith  discussion about a proportion reduction in the Product Transfer Price. Thereafter, Aquestive shall,  after notification to Pharmanovia, reduce the Product Transfer Price providing Pharmanovia  





 






   23    written notice to the COGS have been reduced. In connection with the foregoing, the Parties agree  to discuss in good faith potential actions to be taken to develop cost reductions, but the foregoing  does not constitute a guarantee of any cost reductions.  5.2.2 Notwithstanding the foregoing, if, at any time after the end of the [****] year  of this Agreement, Pharmanovia can establish by competent evidence that its Profit/Net Sales in  respect of the Product on a [****] month basis has fallen below [****]% for all countries in the  Territory, then at Pharmanovia’s request, the Parties agree that for future Purchase Orders:  5.2.2.1 the Product Transfer Price shall be equal to COGS plus [****]%;  and   5.2.2.2 no further Royalty payments shall be made by Pharmanovia and  Pharmanovia shall instead pay to Aquestive a Profit Share as further set out in Section 7.3.  5.3 Forecasts, Order and Delivery of Product.    5.3.1 In order to assist Aquestive in planning production, Pharmanovia shall  deliver to Aquestive in advance of each Calendar Quarter a supply forecast that includes the  quantities of each Product and Primary Packaging (including samples) required by Pharmanovia  by month for the next twelve (12) months.  The first such forecast for the Product shall be delivered  within a mutually agreed timeframe in writing in advance of the First Commercial Sale of such  Product in the relevant country in the Territory, and thereafter on the first Business Day of each  February, May, August, and November of each calendar year during the Term for the immediately  succeeding Calendar Quarter.  Aquestive shall, no later than [****] Business Days after receipt of  each such forecast, notify Pharmanovia in writing of any objections or prospective problems in  meeting Pharmavovia’s forecasted requirements; provided however, that such objections or  prospective problems can be raised only if and to the extent the forecasted requirements with  regard to the applicable month exceeds [****]% of forecasted requirements with regard to the  same month set forth in the immediately preceding supply forecast.   5.3.2 Pharmanovia shall furnish to Aquestive binding Purchase Orders on a  monthly basis corresponding to the first three (3) months of the most recent supply forecast.  Each  such Purchase Order shall designate the quantity of the Product ordered and the requested date of  delivery of such Product to Pharmanovia. Aquestive shall confirm receipt and acceptance of each  conforming Purchase Order in writing within five (5) Business Days after its receipt of each  Purchase Order.  Pharmanovia shall furnish Purchase Orders by the fifth (5th) Business Day of  each month and a minimum of ninety (90) days prior to the requested delivery date.  Each Purchase  Order shall be in whole batch increments of Units and corresponding Primary Packaging based on  the batch sizes and minimum orders set forth in the Product Schedule or as may otherwise be  agreed in writing by the Parties.  The Parties agree that no provision of any Purchase Order, invoice  or of any confirmation or acknowledgement or any other documentation or forms submitted by  either Party to the other Party shall be controlling to the extent it sets forth any terms or conditions  that are additional to, or in conflict or inconsistent with, the terms or conditions of this Agreement.  5.3.3 In the event that any Purchase Order is more than [****]% of the amounts  set forth in the most recent supply forecast, Aquestive shall use Commercially Reasonable Efforts  





 






   24    to Supply such excess amounts but shall not be liable for its inability to do so. If there is a shortage  of any Product and/or Raw Materials, components or other materials, or capacity at the  Manufacturing Facility, Aquestive shall use Commercially Reasonable Efforts to equitably  apportion such Products or materials or capacity between the affected Products for supply and sale  to Pharmanovia under this Agreement and those corresponding products (or other products  requiring the same Raw Materials) manufactured by or on behalf of Aquestive and/or its Affiliates  (whether for themselves or Third Parties) for sale in or outside the Territory. Aquestive shall  inform Pharmanovia without delay of any actual or suspected capacity issues at the Manufacturing  Facility and/or any supply difficulties in relation to the Products.  5.3.4 Aquestive and Pharmanovia will consider each individual Purchase Order  filled as long as no less than [****]% and no more than [****]% of the quantities are delivered  against the individual Purchase Order.  Pharmanovia agrees to accept delivery of up to [****]%  of the requested Purchase Order.   5.3.5 Aquestive shall deliver Products set forth in each Purchase Order Ex Works  (Incoterms 2020 edition, published by the International Chamber of Commerce and any successor  thereto) at the Manufacturing Facility to Pharmanovia’s designated carrier as specified by  Pharmanovia in the applicable Purchase Order or otherwise notified in writing to Aquestive by  Pharmanovia at least thirty (30) days prior to the applicable delivery date set forth in such Purchase  Order.  Title to the Products shall pass to Pharmanovia on delivery free of any security, charge,  interest, lien or other encumbrance.  5.3.6 Each batch of Product Delivered to Pharmanovia (or its nominee) under this  Agreement will have a remaining shelf life at the time of delivery of no less than the minimum  shelf life for such Product set out in the Product Schedule.  5.3.7  Aquestive shall not change the Manufacturing Facility for the Supply of  the Product or the process, plant or equipment used in the manufacture (including packaging) of  the Product, without twelve (12) months’ prior written notice to Pharmanovia. Aquestive shall be  responsible for all costs or expenses incurred by Pharmanovia and its Affiliates incurred as a result  of any request by Aquestive to change the Manufacturing Facility.  5.4 Invoice.  Aquestive shall invoice Pharmanovia at the Product Transfer Price for all  quantities of the Product delivered in accordance herewith.  Each invoice shall be delivered  concurrently with each shipment of such Product and be accompanied by a Certificate of Analysis,  Certificate of Compliance, customs invoice, packing list and at the cost and expense of  Pharmanovia, any other documentation required by the applicable Regulatory Authorities or by  Applicable Law to Commercialize such Product in the Field in the Territory.  Payments shall be  made in accordance with Section 7.7, and shall be due within [****] days after receipt of the  invoice with respect thereto, subject to the procedure for rejected shipments set forth in  Section 5.6.  In the event that any invoice is disputed in writing by Pharmanovia, the Parties shall  meet within ten (10) Business Days after Aquestive’s receipt of such written dispute to discuss and  submit any relevant document necessary for clarifications.  5.5 Suspension of Services.  Subject to any invoice being disputed by either Party in  good faith, if the payment of any sum exceeding $[****] due under this Agreement to Aquestive  





 






   25    is not paid or is delayed, in addition to any other rights and remedies available to Aquestive under  this Agreement (including, without limitation, interest due under Section 7.77), at law or in equity,  Aquestive shall have the right, with forty-five (45) days prior written notice during which time  Pharmanovia may cure any default, to suspend or delay the performance of the services by  Aquestive under this Agreement, provided that Aquestive shall have given Pharmanovia at least  two written notices of intention to suspend or delay performance pursuant to this Section 5.5 during  such forty-five (45) day notice period.  In the event of suspension or discontinuation of the services  due to delayed or non-payment in circumstances where Aquestive is entitled to do so pursuant to  the terms hereof, Aquestive shall not be liable for any Losses (whether direct or indirect) incurred  by Pharmanovia as a result of the suspension or discontinuation of services.   5.6 Product Not in Compliance with Purchase Order.  If Pharmanovia does not submit  written notice that the Product does not meet the Product Requirements, including the reasons  therefore, within ten (10) Business Days of:  5.6.1.1 delivery of the Product if such failure to meet the Product  Requirements is reasonably discoverable by visual inspection at the delivery date; and  5.6.1.2 discovery of the failure, if such failure to meet the Product  Requirements is not reasonably discoverable by visual inspection at the delivery date and which  renders such Product unsuitable for distribution to subjects or patients,  such Product shall be deemed accepted by Pharmanovia provided, however, that such acceptance  or deemed acceptance shall not adversely affect any claim for indemnification provided in  Section 11.  If Pharmanovia and Aquestive do not agree on the rejection of the Product, then either  Party may refer the matter for final analysis to an independent Third Party laboratory of national  reputation pursuant to Section 5.7 for the purpose of determining the results thereof.  5.7 Independent Testing.  If Aquestive disagrees with Pharmanovia’s rejection of any  shipment of the Product, then such Product shall be submitted to an independent Third Party  laboratory (or other professional Third Party independent assessor) of national reputation,  mutually and reasonably acceptable to both Parties in writing, for analytical testing to determine  the extent of such Product’s compliance or non-compliance with the Product Requirements.  Any  determination by such Third Party shall be in writing and shall be final and binding upon the  Parties.  The fees and expenses of such laboratory testing and all other related expenditure incurred  as a result of the dispute shall be borne entirely by the Party against whom such Third Party’s  findings are made.  5.8 Return of Non-Conforming Product.  Notwithstanding any other provisions of this  Agreement to the contrary, Pharmanovia agrees to return to Aquestive (or at Aquestive’s written  direction, to its contractors) or dispose of such Product as Aquestive may direct in writing to  Pharmanovia any Product, in any such case at Aquestive’s sole cost, that: (a) does not conform  with the Product Requirements at the time of Ex Works delivery to Pharmanovia; (b) to the extent  is not in compliance with the Purchase Order as set forth in Section 5.6; or (c) if Pharmanovia and  Aquestive mutually agree in writing.  Aquestive shall be responsible for the costs associated with  the return and proper disposal of all such Product to the extent not in conformance with the Product  Requirements and Purchase Order at the time of shipment and Pharmanovia’s sole remedy for such  





 






   26    shipment of non-conforming Product is replacement thereof by Aquestive with Product  conforming to Product Requirements (at Aquestive’s sole cost including shipping costs incurred  by Pharmanovia).  Notwithstanding the foregoing, Aquestive shall not be responsible for any costs  associated with the return and proper disposal of any such Product that is in conformance with the  Specifications and Purchase Order at the time of shipment including but not limited to where such  non-conformance arose after the time of shipment due to any act or omission of Pharmanovia or a  Third Party.   5.9 Raw Materials Safety Stock. Within sixty (60) days after the First Commercial  Sale, Aquestive will establish and at all times during the term of this Agreement maintain a safety  stock of Raw Materials in quantities sufficient to satisfy Pharmanovia’s requirements for Products  for the succeeding ninety (90) days based on Pharmanovia’s most recent quarterly forecast  delivered pursuant to Section 5.3.1 (“Raw Materials Safety Stock”). Deliveries by Aquestive to  Pharmanovia of Product may use the Raw Materials Safety Stock. Aquestive shall keep  Pharmanovia reasonably informed of the level of Raw Materials safety stock. If the Raw Materials  Safety Stock drops below a ninety (90) day supply, Aquestive shall replenish the Raw Materials  Safety Stock as quickly as practicable.  5.10 Delivery Failure.  5.10.1 Where the quantity of conforming Product delivered is less than [****]%  of the amount required by the relevant binding Purchase Order, the Parties shall enter into good  faith discussions regarding the cure of such delivery shortfall, and, unless otherwise agreed in  writing by Pharmanovia, in the event of any such Product shortfall resulting in delivery of less  than [****]% of the amount of Product required by a binding Purchase Order or the Product is not  delivered on the delivery date set forth in such binding Purchase Order (“Delivery Failure”),  Aquestive shall cure such Product shortfall as soon as reasonably practicable after the original  delivery date in accordance with such delivery schedule as may be mutually agreed between the  Parties and in any event no later than with the next delivery of Product as set forth in the relevant  binding Purchase Order (each, a “Rescheduled Delivery Date”).  5.10.2 In the event a Delivery Failure continues after a Rescheduled Delivery Date,  provided that the reason for the Delivery Failure is not due in whole or in part to any delay, fault  or failure attributable to Pharmanovia or a dispute covered by Section 5.7, by written notice to  Aquestive, the Parties shall discuss a resolution in good faith  and Pharmanovia shall be entitled  to (i) require Aquestive to prioritize its manufacturing capacity (if the Delivery Failure is a result  of a deficiency in Aquestive’s manufacturing capacity) to ensure the Delivery Failure is cured no  later than sixty (60) days after receipt of such written notice by Aquestive; (ii) cancel such binding  Purchase Order (or the relevant portions thereof) without penalty to Pharmanovia; and (iii) recover  any expedited shipping fees actually incurred by Pharmanovia as a direct result of such Delivery  Failure, in each case only if Pharmanovia can establish that it will have insufficient inventory of  Product to satisfy forecasted customer orders for the succeeding sixty (60) days as a result of such  Delivery Failure.  5.10.3 In the event of Delivery Failure continues after a Rescheduled Delivery  Date on [****] or more occasions in any [****] month period Pharmanovia shall be entitled to a  





 






   27    [****]% percent discount per calendar month for each month a Purchase Order subject to such  Delivery Failure is delivered beyond the delivery date.  5.10.4 Notwithstanding anything in this Section 5.10 or elsewhere in this  Agreement to the contrary, any delay in delivery to the extent due to Force Majeure,  Pharmanovia’s requested change of a binding Purchase Order, or any negligence on the part of  Pharmanovia shall not be regarded as Delivery Failure.  5.11 Aquestive Quality Agreement.  In connection with the Supply activities of the  Product under this Agreement, within ninety (90) days of the Effective Date, Pharmanovia and  Aquestive will enter into a written quality assurance agreement, reasonably acceptable to both  Parties, which details the obligations of each Party with respect to the Supply of the Product by  Aquestive (the “Quality Agreement”).  The definitive terms and conditions for such detailed  quality assurance obligations shall be discussed in good faith and agreed upon between  Pharmanovia and Aquestive separately in the Quality Agreement, which shall thereupon be  incorporated by reference into and made a part of this Agreement.  In the event of conflict between  terms of the Quality Agreement and the terms of this Agreement, the terms of this Agreement will  govern.  5.12 Adverse Event and Safety Reporting.  Within thirty (30) days of the Effective Date,  the Parties will enter into a written Safety Data Exchange Agreement with respect to the Product  which shall thereupon be incorporated by reference into and made part of this Agreement (the  “Safety Data Exchange Agreement”).  In the event of conflict between terms of the Safety Data  Exchange Agreement and the terms of this Agreement, the terms of this Agreement will govern.  Notwithstanding anything to the contrary contained in this Agreement, Pharmanovia shall be  responsible for making all reports of Adverse Events to the applicable Regulatory Authority.  6. STEERING COMMITTEE.    No later than one (1) month following the Effective Date, the Parties will establish a committee  consisting of the appropriate business and/or technical leaders to provide a forum for  communication between the Parties regarding Development, Supply and Commercialization  activities under this Agreement (the “Steering Committee”).  Each Party shall assign an alliance  manager (who shall serve on the Steering Committee) to oversee the implementation of this  Agreement and to organize each Steering Committee meeting and provide updates for the Product  to the Steering Committee.  The Steering Committee shall discuss key activities deemed critical to  Regulatory Approvals and Commercialization of the Product.  The Steering Committee shall meet  at least two (2) times per Calendar Year, on a schedule and at a location to be agreed by the Parties.   Notwithstanding the foregoing, the Steering Committee shall be solely advisory and not have any  decision-making authority.  For the avoidance of doubt, Pharmanovia shall have the sole decision- making authority regarding the Commercialization for the Product in the Field in the Territory and  all other activities for which Pharmanovia has responsibility under this Agreement.  7. PAYMENTS AND REPORTS   7.1 Milestone Payments. Milestone payments shall be due from Pharmanovia to  Aquestive in respect of a Product as set forth in the Product Schedule (“Milestone Payments”).  





 






   28    Each Milestone Payment shall be payable only once on the first attainment of the corresponding  milestone event irrespective of (i) the number of times each milestone event is achieved; and (ii)  the number of Products that achieve the milestone event or countries of the Territory in which the  milestone event is achieved.   7.2 Royalties.  During the Term, subject to the provisions of Section 5.3 and Section  7.3, Pharmanovia shall pay to Aquestive a royalty payment in each Payment Period through the  termination or expiration of this Agreement as set forth the Product Schedule (“Royalty Fees”).  Royalty Fees shall be paid in US Dollars (as per Section 7.7) and shall be calculated by applying  a weighted average exchange rate based on monthly Net Sales.  This calculation shall be based on  [****].  7.3 Profit Share. If the conditions set out in Section 5.2.2 are met, Pharmanovia shall  pay to Aquestive a Profit share in each Payment Period through the termination or expiration of  this Agreement as set forth the Product Schedule (“Profit Share”).  7.4 Minimum Volume Commitment.  In the event in any year during which the  exclusivity of the Supply arrangement described at Section 5.1.1 is in operation, the quantity of  Product purchased by Pharmanovia from Aquestive under this Agreement is less than the  minimum amount set forth for such year in the Product Schedule (the “Minimum Volume  Commitment”), then unless such failure is attributable to the failure of Aquestive to supply  conforming Product to Pharmanovia under this Agreement within 60 days of its due date, or due  to matters outside of the control of Pharmanovia that impacts Pharmanovia’s ability to sell Product,  in which case the Parties shall have a good faith discussion regarding adjustment of the Minimum  Volume Commitment, and unless otherwise set forth in the Product Schedule, Pharmanovia shall  pay to Aquestive the price of the quantity of Product that Pharmanovia would have to purchase to  meet the Minimum Volume Commitment in such year within thirty (30) days of the end of such  year.  For any part year during which the Minimum Volume Commitment applies, the amount of  the Minimum Volume Commitment shall be pro-rated.   7.5 Pharmanovia Reports and Payments.  During the Term, Pharmanovia shall  submit Quarterly Payment Reports or quarterly Profit Share reports (as applicable) (“Quarterly  Payment Reports”) to Aquestive within [****] days following the end of each Calendar Quarter.   Each Quarterly Payment Report shall cover the most recently completed Calendar Quarter and  shall show: (a) the aggregate gross and Net Sales of each Product during the most recently  completed Calendar Quarter including reasonable detail with respect to the calculation of Net  Sales, Units sold, discounts, credits and other components in the calculation of Net Sales; and  (b) the Royalty Fees or Profit Share (as applicable), in U.S. dollars, payable with respect to such  Net Sales; and (c) in relation to the Profit Share, further deductions made to Net Sales in relation  to the Profit Share calculation.   7.6 Invoicing and Payment. Aquestive shall invoice Pharmanovia for the Royalty  Fees or Profit Share (as applicable) within [****] Business Days of receipt of each Quarterly  Payment Report.  Pharmanovia shall pay the Royalty Fees or Profit Share (as applicable) within  [****] days of receipt of the invoice.  





 






   29    7.7 Manner of Payment.  All sums due under this Agreement shall be payable in U.S.  dollars by ACH in immediately available funds to such bank account(s) as Aquestive shall  designate in writing.  All overdue amounts due to Aquestive hereunder shall bear interest at the  rate equal to one and one half percent (1.5%) per month or at the highest rate permitted by  Applicable Law, whichever is less.  7.8 Bartering Prohibited.  Pharmanovia and its Affiliates and subcontractors shall not  solicit or accept any bartered goods or services in exchange for the sale or transfer of the Product.  7.9 Taxes and Withholding.  All payments under this Agreement will be made without  any deduction or withholding for or on account of any taxes, duties, levies, or other charges.   Pharmanovia will: (a) pay to the relevant authorities the full amount otherwise required to be  deducted or withheld under Applicable Law promptly upon determining that such deduction or  withholding is required; and (b) forward to Aquestive an official receipt (or certified copy) or other  documentation reasonably acceptable to Aquestive evidencing such payment to such authorities.  The Parties shall use Commercially Reasonable Efforts to cooperate and coordinate with each  other in completing and filing documents required under the provisions of any applicable tax laws  (including tax treaties) in connection with the making of any required tax or withholding payment,  in connection with a claim of exemption from, or entitlement to, a reduced or zero rate of  withholding or in connection with any claim to a refund of or credit for any such payment.  The  Party receiving a payment pursuant to this Agreement shall provide the remitting Party appropriate  certification from relevant revenue authorities that such Party is a tax resident of that jurisdiction  or reduction or exemption from tax withholding, if such receiving Party wishes to claim the  benefits of an income tax treaty to which that jurisdiction is a party.  Upon the receipt thereof, any  deduction and withholding of taxes shall be made at the appropriate treaty tax rate.  7.10 Accounting.  Except as otherwise defined in this Agreement, all financial terms  and standards defined or used in this Agreement for sales or activities occurring in the Territory  shall be governed by and determined in accordance with GAAP, including the calculation of Net  Sales and royalties due Aquestive hereunder; provided that when the actual results become known  in accordance with GAAP relative to any accrued amount, any difference between the actual  results and the accrual shall be reported and accounted for in the next payment due hereunder  (subject to customary processing periods).  To the extent that the difference between such accruals  and the actual results has led to an underpayment, Pharmanovia shall pay Aquestive the amount  of such underpayment on the next date payment is due to Aquestive hereunder.    7.11 Record Keeping; Audits.  The Parties and their Affiliates shall keep books and  accounts of record in connection with Net Sales and Profit with respect to the Product (in the case  of Pharmanovia) in sufficient detail to permit accurate determination of all figures necessary for  verification of Royalty Fees and Profit Share to be paid hereunder and COGS (in the case of  Aquestive, solely to the extent the Profit Share is in effect).  The Parties and its Affiliates shall  retain such records for a period of at least three (3) years after the end of the Calendar Quarter in  which they were generated; provided, however, that if any records are in dispute and one Party has  received written notice from the other of the records which are in dispute, then that Party and its  Affiliates shall keep such records until such dispute is resolved.  No more than once every calendar  year, upon reasonable advance written notice to the other Party, a Party will have the right to  engage a nationally recognized public accounting firm of its choice and reasonably acceptable to  





 






   30    the other Party (which accounting firm will not be the external auditor of the selecting Party, will  not have been hired or paid on a contingency basis and will have experience auditing  pharmaceutical companies) (a “CPA Firm”) to conduct an audit of such books and records of the  other Party and its Affiliates to determine the correctness of the amount of royalties paid to  Aquestive or COGS (as applicable) under the terms of this Agreement.  The CPA Firm will be  given access to and will be permitted to examine such books and records of the audited Party as it  will reasonably request, upon thirty (30) days’ prior written notice having been given by the other  Party, during regular business hours, for the sole purpose of determining compliance with the Net  Sales royalty provisions, Profit Share provisions, or COGs calculations set out in this Agreement.   Prior to any such examination taking place, the CPA Firm will enter into a confidentiality  agreement reasonably acceptable to Pharmanovia and Aquestive with respect to the Confidential  Information to which they are given access and will not contain in its report or otherwise disclose  to the other Party or any Third Party any information labeled by the audited Party as being  confidential customer information regarding pricing or other competitively sensitive proprietary  information.  Aquestive and Pharmanovia will be entitled to receive a full written report of the  CPA Firm with respect to its findings and the requesting Party will provide, without condition or  qualification, the audited Party with a copy of the report, or other summary of findings, prepared  by such CPA Firm promptly following its receipt of same.  In the event of any dispute between  Aquestive and Pharmanovia regarding the findings of any such inspection or audit, the Parties will  initially attempt in good faith to resolve the dispute amicably between themselves, and if the Parties  are unable to resolve such dispute within thirty (30) days after delivery to both Parties of the CPA  firm’s report, each Party will select an internationally recognized independent certified public  accounting firm (other than the CPA Firm), and the two firms chosen by the Parties will choose a  third internationally recognized independent certified public accounting firm which accounting  firm will not be the external auditor of either Party, will not have been hired or paid on a  contingency basis and will have experience auditing pharmaceutical companies) which selected  accounting firm will resolve the dispute, and such selected accounting firm’s determination will  be binding on both Parties absent manifest error by such selected accounting firm.  All costs and  expenses of such auditor incurred in connection with performing any such audit shall be paid by  the requesting Party unless such audit discloses an underpayment or miscalculation of at least  [****]%, in which case the audited Party shall bear such costs and expenses.  In the event of the  engagement of other accounting firms relating to a dispute between the Parties as referred to in  this Section 7.11, all costs and expenses of such other accounting firms shall be paid by the Party  found to be at fault by the final determination of the selected accounting firm.   7.12 Underpayments and Overpayments.  If an audit conducted pursuant to Section  7.11 reveals that additional royalties were due to Aquestive under this Agreement, then  Pharmanovia shall pay to Aquestive the additional royalties within [****] days of the date  Pharmanovia receives written notice of such underpayment.  If an audit conducted pursuant to  Section 7.11 reveals that Aquestive was paid royalties in excess of those Royalty Fees or Profit  Share payments, as applicable, due to Aquestive under this Agreement, or an overpayment of the  Product Transfer Price by Pharmanovia  then Pharmanovia shall, at its election, be entitled to: (a)  a refund of such amount within [****] days of the date Aquestive receives written notice of such  overpayment; or (b) deduct such amount from the next royalty or other payment due Aquestive  under this Agreement.  





 






   31    8. REPRESENTATIONS, WARRANTIES AND COVENANTS  8.1 Representations, Warranties and Covenants of Each Party.  Each Party hereby  represents and warrants as of the Effective Date to the other Party as follows:  8.1.1 Corporate Existence, Power, and Authority.  Such Party: (a) is duly formed  and in good standing under the laws of the jurisdiction of its formation; (b) has the power and  authority and the legal right to enter into this Agreement and perform its obligations hereunder;  and (c) has taken all necessary action on its part required to authorize the execution and delivery  of this Agreement and the performance of its obligations hereunder.  8.1.2 Binding Agreement.  This Agreement has been duly executed and delivered  on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is  enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency  or other laws of general application affecting the enforcement of creditor rights and judicial  principles affecting the availability of specific performance and general principles of equity,  whether enforceability is considered a proceeding at law or equity.  8.1.3 Compliance with Applicable Law.  All necessary consents, approvals and  authorizations of all Regulatory Authorities and other Persons required to be obtained by such  Party in connection with the execution and delivery of this Agreement and the performance of its  obligations as of the Effective Date hereunder have been obtained.  8.1.4 No Conflict with Applicable Law.  The execution and delivery of this  Agreement, the performance of such Party’s obligations hereunder, and any actions or omissions  of such Party related to the activities contemplated hereunder and the circumstances surrounding  this Agreement: (a) do not and will not conflict with or violate any Applicable Law or any  provision of the articles of incorporation, bylaws or other governing charter documents of such  Party; and (b) do not and will not conflict with, violate, or breach, or constitute a default or require  any consent under, any contractual obligation or court or administrative order by which such Party  is bound.  8.1.5 Bankruptcy; Insolvency.  Neither Party is aware of any Bankruptcy Event  affecting such Party or of any action or petition, pending or otherwise, for bankruptcy or  insolvency of such Party or its Affiliates or subsidiaries in any state, country, or other jurisdiction,  and it is not aware of any facts or circumstances that could result in such Party becoming or being  declared insolvent, bankrupt or otherwise incapable of meeting its obligations under this  Agreement as they become due in the ordinary course of business.  8.2 Additional Aquestive Representations, Warranties and Covenants.  Aquestive  represents, warrants, and covenants to Pharmanovia as follows:  8.2.1 Right to Grant Licenses.  Aquestive and its Affiliates owns the rights, title,  and interest in and to the Aquestive Patents, the Aquestive IP and the Aquestive Marks free from  encumbrances, charges or liens of any kind (except such encumbrances, charges or liens granted  in connection with commercial lending arrangements in the ordinary course of business) and have  the right to grant the licenses granted to Pharmanovia herein.  





 






   32    8.2.2 Intellectual Property.    8.2.2.1 To Aquestive’s knowledge, as of the Effective Date, no Third  Party is infringing or making unauthorized use of any registered Aquestive IP.  8.2.2.2 No outstanding written claim or threat of action has been received  by Aquestive or its Affiliates (and to Aquestive’s knowledge, there are no allegations or  proceedings, pending or threatened), claiming that the grant of the licenses pursuant to this  Agreement, or the exploitation of the Aquestive IP  or the Product (including any activities relating  to the Development of the Product by Aquestive) has infringed, is infringing or would be likely to  infringe, any valid and subsisting intellectual property rights of any Third Party.  8.2.2.3 Except as disclosed to Pharmanovia in writing prior to the  Effective Date, , as of the Effective Date, there are no proceedings, pending or threatened in  writing, or to Aquestive’s knowledge, pending, which challenge Aquestive’s exclusive ownership,  the validity or the enforceability of the Aquestive IP.  8.2.2.4 As of the Effective Date, all registrations and filings necessary to  preserve the rights in the Aquestive Patents have been made and are in good standing and all  applicable fees have been paid on or before the due date for payment.  8.2.2.5 Within the three (3) years preceding the Effective Date, Aquestive  has not received written notice of any claim or threatened claim from any Person (including any  employee of Aquestive or any of its Affiliates) claiming compensation in respect of Aquestive’s  or its Affiliates’ ownership, use or exploitation of any Aquestive IP.  8.2.3 Aquestive Patents.  To Aquestive’s knowledge, the Aquestive Patents  represent all patents relating to the Supply and Commercialization of the Product in the Field in  the Territory, as of the Effective Date.  8.2.4 Third Party Agreements.  Except in connection with commercial lending  arrangements, neither Aquestive nor any of its Affiliates is a party to or otherwise bound by any  oral or written contract or agreement that conflicts with, or limits the scope of, any of the rights or  licenses granted to Pharmanovia hereunder or that will result in any Third Party obtaining any  interest in, or that would give to any Third Party any right to assert any claim in or with respect to,  any of Pharmanovia’s rights under this Agreement.  8.2.5 Product Development.   8.2.5.1 In respect of the Product, Aquestive, its  Affiliates and their  contractors have gathered, generated, prepared, processed, maintained and retained all data and  information that is required to be generated, maintained or retained pursuant to and in accordance  with (and have conducted all development activities accordance with) with good laboratory  practice and Applicable Laws; and  8.2.5.2 Aquestive has not withheld from Pharmanovia or any Regulatory  Authority any material adverse information relating to the safety or efficacy of the Product, and  





 






   33    Aquestive is not aware of any scientific or technical facts or circumstances that would adversely  affect the safety or efficacy of the Product.  8.2.6 Supply of Product.  8.2.6.1 Aquestive has the capacity and resources to Supply the Product in  accordance with this Agreement.  8.2.6.2 Aquestive has and shall maintain the necessary facilities,  equipment, know-how, procedures and personnel to manufacture and Supply the Product in  accordance with the terms of this Agreement.  8.2.6.3 All activities required to validate Aquestive’s equipment, plant,  Manufacturing Facilities, and production processes necessary for the manufacture and Supply the  Product have been completed.  8.2.7 Compliance with Applicable Law.  Aquestive shall comply with and  maintain in force all licenses, consents, permits and authorizations necessary to perform its  obligations under this Agreement and shall perform its obligations under this Agreement in  compliance with Applicable Law, in each case in all material respects.   8.2.8 Compliance with Anti-Bribery, Anti-Corruption, and Ethics Policies.   Aquestive shall have and maintain in place through the Term its own policies and procedures to  ensure compliance with Applicable Law relating to anti-bribery and anti-corruption in the  Territory.  Aquestive will immediately report to Pharmanovia any request or demand for any undue  or suspicious financial or other advantage of any kind received by Aquestive or any of its Affiliates  in connection with the performance of this Agreement.  8.2.9 No Debarment.  None of Aquestive or its Affiliates have employed or  otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services  of any Person debarred under United States law, including Section 21 U.S.C. 335a, or any foreign  equivalent thereof.   8.3 Additional Pharmanovia Representations, Warranties and Covenants.   Pharmanovia further represents, warrants, and covenants to Aquestive that:  8.3.1 Right to Grant Licenses.  Pharmanovia and its Affiliates have the right to  grant the licenses granted to Aquestive herein.  8.3.2 Third Party Agreements.  As of the Effective Date, neither Pharmanovia nor  any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement  that will result in any Third Party obtaining any interest in, or that would give to any Third Party  any right to assert any claim in or with respect to, any of Aquestive’s rights under this Agreement.  8.3.3 Compliance with Applicable Law.  Pharmanovia shall comply with and  maintain in force all licenses, consents, permits and authorizations necessary to perform its  obligations under this Agreement and shall perform its obligations under this Agreement in  compliance with Applicable Law in the Territory.    





 






   34    8.3.4 Compliance with Anti-Bribery, Anti-Corruption, and Ethics Policies.   Pharmanovia shall have and maintain in place through the Term its own policies and procedures  to ensure compliance with Applicable Law relating to anti-bribery and anti-corruption in the  Territory.  Pharmanovia will immediately report to Aquestive: (a) any request or demand for any  undue or suspicious financial or other advantage of any kind received by Pharmanovia in  connection with the performance of this Agreement.   8.3.5 No Debarment.  None of Pharmanovia or its Affiliates have employed or  otherwise used in any capacity, and will not employ or otherwise use in any capacity, the services  of any Person debarred under United States law, including Section 21 U.S.C. 335a, or any foreign  equivalent thereof.  8.4 Disclaimer.  AQUESTIVE HEREBY DISCLAIMS ANY AND ALL  REPRESENTATIONS AND WARRANTIES IN CONNECTION WITH THE  TRANSACTIONS CONTEMPLATED HEREIN NOT EXPRESSLY MADE IN THIS  AGREEMENT TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAWS,  INCLUDING WITH RESPECT TO THE PRODUCT OR ANY PATENT OR OTHER  INTELLECTUAL PROPERTY LICENSED OR GRANTED UNDER THIS AGREEMENT,  INCLUDING ANY WARRANTY OF NON-INFRINGEMENT, QUALITY, PERFORMANCE,  IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR  PURPOSE OR ANY  WARRANTIES ARISING FROM COURSE OF PERFORMANCE,  COURSE OF DEALING OR USAGE OR TRADE.   9. TECHNOLOGY TRANSFER  9.1 Upon the occurrence of a Bankruptcy Supply Failure, Pharmanovia shall be entitled  to request that a program for transitioning the Supply of the relevant Product to Pharmanovia or  its nominee is carried out by submitting a request to Aquestive. Pending such transition, Aquestive  agrees to introduce Pharmanovia or its designee to, and or assist Pharmanovia or its designee to  enter into agreements with, any of Aquestive’s Third Party manufacturers, including, if so  requested by Pharmanovia, by assigning or novating Aquestive’s or its Affiliate’s relevant  contracts (in whole or in part as applicable) to Pharmanovia or its designee.   9.2 As soon as reasonably practicable following Aquestive’s receipt of any request  pursuant to Section 9.1, but in any event no later than thirty (30) days after such receipt, the Parties  shall negotiate in good faith and agree a formal plan (“Technology Transfer Plan”) for the  transitioning of Supply of the Product to Pharmanovia or to any Affiliate of Pharmanovia or third  party contract manufacturer as Pharmanovia may direct (following consultation with Aquestive)  (“Technology Transfer Partner”).   9.3 Aquestive shall carry out the activities allocated to it in the Technology Transfer  Plan in accordance with any timelines set out therein. The methods that will be used to effect the  Technology Transfer Plan will include:  9.3.1 the provision of copies of all such documentation and materials in the  possession of Aquestive and/or its Affiliates which record Aquestive Know-How related to the  





 






   35    Supply of Products including the then-current process for the Supply of the Products, as well as  any improvements or enhancements to such processes;   9.3.2 the provision of technical assistance to Pharmanovia and/or the Technology  Transfer Partner to ensure timely transfer of Supply of the Product; and  9.3.3 access to employees of Aquestive and its Affiliates (and/or their third party  contract manufacturer) who have knowledge of the Products and the Manufacturing process at  Aquestive’s (and/or its Affiliates’ and/or their third party contract manufacturer’s) premises  and/or, where reasonably required, at Pharmanovia’s or Technology Transfer Partner’s premises.   10. CONFIDENTIAL INFORMATION  10.1 General.  Pursuant to the terms of this Agreement, each of Aquestive and  Pharmanovia (in such capacity, the “Disclosing Party”) has disclosed and will be disclosing to the  other Party, and to the Affiliates, officers, directors, employees, agents and/or representatives of  each (in such capacity, the “Receiving Party”) certain secret, confidential or proprietary data,  Intellectual Property and related information, including, without limitation, technical, scientific,  business and other information, data, materials and the like relating to drug applications, patent  applications, products, processes, formulations, manufacturing technology, samples, operating  methods and procedures, marketing, manufacturing, distribution and sales methods and systems,  sales figures, pricing policies and price lists and other business information (“Confidential  Information”).  The terms and conditions of this Agreement shall be considered Confidential  Information.  Without limiting the foregoing, it is acknowledged that the Aquestive IP (other than  any published Aquestive Patents) shall constitute the Confidential Information of Aquestive  (subject to Section 10.3) for purposes of this Agreement.  The Receiving Party shall make no use  of any Confidential Information of the Disclosing Party except in the exercise of its rights and the  performance of its obligations set forth in this Agreement.  The Receiving Party: (a) shall keep and  hold as confidential, and shall cause its officers, directors, employees, agents, and representatives  to keep and hold as confidential, all Confidential Information of the Disclosing Party; and (b) shall  not disclose, and shall cause its Affiliates, officers, directors, employees, agents, and  representatives not to disclose, any Confidential Information of the Disclosing Party.  Confidential  Information disclosed by the Disclosing Party shall remain the sole and absolute property of the  Disclosing Party, subject to the rights granted in this Agreement or Applicable Law.  10.2 Prior Confidentiality Agreement.  As of the Effective Date, the terms of this  Section 10 shall supersede any prior non-disclosure, secrecy, or confidentiality agreement between  the Parties (or their Affiliates) relating to the subject of this Agreement, including the  Confidentiality Agreement, which is hereby terminated.  Any information disclosed pursuant to  any such prior agreement shall be deemed Confidential Information for purposes of this  Agreement.  10.3 Exceptions.  The above restrictions set forth in Section 10.1 on the use and  disclosure of Confidential Information shall not apply to any information which: (a) is already  known to the Receiving Party at the time of disclosure by the Disclosing Party, as demonstrated  by competent proof (other than as a result of prior disclosure under any agreement between the  Parties with respect to confidentiality); (b) is or becomes generally known or available to the public  





 






   36    other than through any act or omission of the Receiving Party in breach of this Agreement (or any  other agreement between the Parties with respect to confidentiality); (c) is acquired by the  Receiving Party from a Third Party who is not directly or indirectly under an obligation of  confidentiality to the Disclosing Party with respect to same, or (d) is developed independently by  the Receiving Party without the use, direct or indirect, of the Disclosing Party’s  Confidential  Information.  In addition, nothing in this Section 10 shall be interpreted to limit the ability of either  Party to disclose its own Confidential Information to any other Person on such terms and subject  to such conditions as it deems advisable or appropriate.  10.4 Permitted Disclosures.  It shall not be a breach of Section 10.1 if a Receiving Party  discloses Confidential Information of a Disclosing Party: (a) pursuant to Applicable Law,  including securities laws applicable to a public company, to any Regulatory Authority or the listing  standards or agreements of any national or international securities exchange or The NASDAQ  Stock Market, the New York Stock Exchange, or other Regulatory Authority; (b) in order to  comply with its obligations under the listing standards or agreements of any national or  international securities exchange or The NASDAQ Stock Market or the New York Stock  Exchange; or (c) in a judicial, administrative or arbitration proceeding to enforce such Party’s  rights under this Agreement; provided, however, that the Receiving Party: (i) provides the  Disclosing Party with as much advance written notice as possible of the required disclosure;  (ii) reasonably cooperates with the Disclosing Party in any attempt to prevent, limit or seek  confidential treatment for the disclosure; and (iii) discloses only the minimum amount of  Confidential Information necessary for compliance.  The Parties may also disclose the existence  of this Agreement and terms thereof to their directors, investors, officers, employees, attorneys,  accountants and other advisers on a need to know basis and may, upon obtaining a written  confidentiality agreement, further disclose the existence and terms of this Agreement to third  Parties to whom it may be relevant in connection with financings, acquisitions, licenses and similar  transactions to the extent such Third Parties are under confidentiality obligations at least as  restrictive as those set forth herein.  10.5 Equitable Remedies.  Each Party specifically recognizes that any breach by it of  this Section 10 may cause irreparable injury to the other Party and that actual damages may be  difficult to ascertain, and in any event, may be inadequate.  Accordingly (and without limiting the  availability of legal or equitable, including injunctive, remedies under any other provisions of this  Agreement), each Party agrees that in the event of any such breach, the other Party shall be entitled  to seek injunctive relief and such other legal and equitable remedies as may be available, without  the necessity of securing or posting of any bond or proving actual damages.    11. INDEMNIFICATION; LIMITATION OF LIABILITY  11.1 Indemnification by Pharmanovia.  Pharmanovia shall defend, indemnify and  hold harmless Aquestive and its Affiliates and each of their respective successors and assigns, and  each of their respective officers, directors, shareholders, employees, subcontractors, agents, and  representatives (“Aquestive Indemnitees”) from and against all claims, allegations, suits, actions  or proceedings asserted against any Aquestive Indemnitee by any Third Parties, whether  governmental or private (“Third Party Claims”), and all associated Losses, to the extent arising  out of or resulting from: (a) the performance or failure to perform by Pharmanovia (or any of its  Affiliates, subcontractors or agents) of any of Pharmanovia’s obligations under this Agreement;  





 






   37    (b) a breach by Pharmanovia or any of its Affiliates, subcontractors or agents of any of  Pharmanovia’s obligations, representations, warranties, covenants or agreements under this  Agreement; (c) the Commercialization by or on behalf of Pharmanovia of any Products in the  Territory; or (d) violation of Applicable Law by any Pharmanovia Indemnitee; provided, that, in  all cases referred to in this Section 11.1, Pharmanovia shall not be liable to indemnify any  Aquestive Indemnitee for any Losses of such Aquestive Indemnitee to the extent that such Losses  were caused by or arise out of: (i) the negligence or willful misconduct or intentional wrongdoing  of Aquestive or any of its Affiliates, subcontractors or agents in the performance of Aquestive’s  obligations under this Agreement; (ii) any breach by Aquestive or any of its Affiliates,  subcontractors or agents of Aquestive’s obligations, representations, warranties, covenants or  agreements under this Agreement; or (iii) matters for which Aquestive has an obligation to  indemnify any Pharmanovia Indemnitee pursuant to Section 11.2.  11.2 Indemnification by Aquestive.  Aquestive shall defend, indemnify and hold  harmless Pharmanovia and its Affiliates and each of their successors and assigns, and each of their  respective officers, directors, shareholders, employees, subcontractors, agents, and representatives  (“Pharmanovia Indemnitees”) from and against all Third Party Claims, and all associated Losses,  to the extent arising out of or resulting from: (a) the performance or failure to perform by Aquestive  (or any its Affiliates, subcontractors or agents) any of Aquestive’s obligations under this  Agreement; (b) a breach by Aquestive or any of its Affiliates, subcontractors or agents of any of  Aquestive’s obligations, representations, warranties, covenants or agreements under this  Agreement; or (c) any claim or allegation that the Aquestive Patents infringe upon the Intellectual  Property Rights of a Third Party; other than any claim or demand that is directed solely to the API  and the alleged infringement would have occurred from the use of the API alone; or (d) violation  of Applicable Law by any Aquestive Indemnitee; provided, that, in all cases referred to in this  Section 11.2, Aquestive shall not be liable to indemnify any Pharmanovia Indemnitee for any  Losses of such Pharmanovia Indemnitee to the extent that such Losses were caused by or arise out  of: (i) the negligence or willful misconduct or intentional wrongdoing of Pharmanovia or any of  its Affiliates, subcontractors or agents in the performance of Pharmanovia’s obligations under this  Agreement; (ii) any breach by Pharmanovia or any of its Affiliates, subcontractors or agents of  Pharmanovia’s representations, warranties, covenants or agreements under this Agreement; or  (iii) matters for which Pharmanovia has an obligation to indemnify any Aquestive Indemnitee  pursuant to Section 11.1.  11.3 Procedure for Indemnification.    11.3.1 Notice.  In the case of a Third Party Claim or demand made by any Person  who is not a Party of this Agreement (or an Affiliate thereof) as to which a Party (the “Indemnitor”)  may be obligated to provide indemnification pursuant to this Agreement, such Party seeking  indemnification hereunder (“Indemnitee”) will notify the Indemnitor in writing of the Third Party  Claim (and specifying in reasonable detail the factual basis for the Third Party Claim and, to the  extent known, the amount of the Third Party Claim) reasonably promptly after becoming aware of  such Third Party Claim; provided, however, that failure to give such notification will not affect  the indemnification provided hereunder except to the extent the Indemnitor shall have been  actually materially prejudiced as a result of such failure.  





 






   38    11.3.2 Defense of Claim.  If a Third Party Claim is made against an Indemnitee,  then the Indemnitor will be entitled, within thirty (30) days after receipt of written notice from the  Indemnitee of the commencement or assertion of any such Third Party Claim, to assume the  defense thereof by providing written notice to Indemnitee of its intention to assume the defense of  such Third Party Claims within such thirty (30) day period (at the expense of the Indemnitor) with  counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee for so long as the  Indemnitor is conducting a good faith and diligent defense.  Should the Indemnitor so elect to  assume the defense of such Third Party Claim, the Indemnitor will not be liable to the Indemnitee  for any legal or other expenses subsequently incurred by the Indemnitee in connection with the  defense thereof; provided, however, that if under applicable standards of professional conduct a  conflict of interest exists between the Indemnitor and the Indemnitee in respect of such claim, such  Indemnitee shall have the right to employ separate counsel to represent such Indemnitee with  respect to the matters as to which a conflict of interest exists and in that event the reasonable fees  and expenses of such separate counsel shall be paid by such Indemnitor; provided, further, that the  Indemnitor shall only be responsible for the reasonable fees and expenses of one separate counsel  for all Indemnitees, provided that where a conflict of interest is found to exist each Indemnitee  with a conflict will be entitled to separate counsel at such Indemnitees’ expense.  If the Indemnitor  assumes the defense of any Third Party Claim, the Indemnitee shall have the right to participate in  the defense thereof and to employ counsel, at its own expense, separate from the counsel employed  by the Indemnitor.  If the Indemnitor assumes the defense of any Third Party Claim, the Indemnitor  will promptly supply to the Indemnitee copies of all material correspondence and documents  relating to or in connection with such Third Party Claim and keep the Indemnitee reasonably  informed of developments relating to or in connection with such Third Party Claim, as may be  reasonably requested in writing by the Indemnitee (including, without limitation, providing to the  Indemnitee on reasonable request updates and summaries as to the status thereof).  If the  Indemnitor chooses to defend a Third Party Claim, all Indemnitees shall reasonably cooperate with  the Indemnitor in the defense thereof (such cooperation to be at the expense, including reasonable  legal fees and expenses, of the Indemnitor).  If the Indemnitor does not elect to assume control by  written acknowledgement of the defense of any Third Party Claim within the thirty (30) day period  set forth above, or if such good faith and diligent defense is not being or ceases to be conducted  by the Indemnitor, the Indemnitee shall have the right, at the expense of the Indemnitor (but limited  to the reasonable legal fees and expenses of one counsel for all Indemnitees), after five (5) Business  Days’ written notice to the Indemnitor of its intent to do so, to undertake the defense of the Third  Party Claim for the account of the Indemnitor (with counsel selected by the Indemnitee), and to  compromise or settle such Third Party Claim, exercising reasonable business judgment.  11.3.3 Settlement of Claims.  In no event may the Indemnitor compromise or settle  any Third Party Claim without the prior written consent of the Indemnitee such consent not to be  unreasonably withheld or delayed.  Without limiting the foregoing, if the Indemnitor  acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the  Indemnitee will agree to any settlement, compromise or discharge of such Third Party Claim that  the Indemnitor may recommend that by its terms obligates the Indemnitor to pay the full amount  of Losses (whether through settlement or otherwise) in connection with such Third Party Claim  and unconditionally and irrevocably releases the Indemnitee completely from all Losses in  connection with such Third Party Claim; provided, however, that, without the Indemnitee’s prior  written consent, the Indemnitor shall not consent to any settlement, compromise or discharge  (including, without limitation, the consent to entry of any judgment), that provides for injunctive  





 






   39    or other nonmonetary relief affecting the Indemnitee or which admits fault or negligence on the  part of the Indemnitee.  11.3.4 Assumption of Defense.  Notwithstanding anything to the contrary  contained herein, an Indemnitee shall be entitled to assume the defense of any Third Party Claim  with respect to the Indemnitee upon written notice to the Indemnitor pursuant to this Section  11.3.4, in which case, the Indemnitor shall be relieved of liability under Section 11.1 or 11.2, as  applicable, solely for such Third Party Claim and related Losses.  11.4 Insurance.  During the Term and for a period of five (5) years after the termination  or expiration of this Agreement, each Party shall obtain and/or maintain, respectively, at its sole  cost and expense, comprehensive general liability insurance, products liability insurance and  clinical trials insurance (including any self-insured arrangements), each in amounts, respectively,  which are reasonable and customary in the pharmaceutical industry for companies of comparable  size and activities at the respective place of business of each Party but in no event less than Ten  Million Dollars ($10,000,000) per occurrence and Ten Million Dollars ($10,000,000) annual  aggregate.  Each Party shall also maintain any mandatory insurance, including but not limited to  workers compensation coverage, in accordance with all Applicable Law.  All insurance policies  reflecting such insurance shall be written on a “per occurrence” or “claims made” basis with an  insurance company rated at least A-3 by Best’s rating guide.  Each of the Parties and their  designees who have an insurable interest shall be added as an additional insured on the other  Party’s product liability insurance policy.  If requested, each Party shall provide the other with a  certificate of insurance and shall keep such policy current.  Each Party shall provide at least thirty  (30) calendar days’ prior written notice to the other Party of the cancellation or any substantial  modification of the terms of coverage.  Such product liability insurance (or self-insured  arrangements) shall insure against all liability, including without limitation personal injury,  physical injury, or property damage arising out of the manufacture, sale, distribution, or marketing  of the Products.  Each Party shall require its insurers to waive all rights of subrogation against the  other Party, and its directors, officers, employees, and agents on all the foregoing coverages.  Each  Party shall provide written proof of the existence of such insurance to the other Party upon written  request.  Each Party acknowledges and agrees that its liabilities under this Agreement will not be  limited by the amount of such Party’s insurance.  11.5 Limitation of Liability.  EXCEPT AS EXPRESSLY SET FORTH IN THIS  AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER  PARTY OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL,  INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES OR LOSSES (INCLUDING,  WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR  INCURRED BY THE OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS  AGREEMENT, THE TRANSACTIONS CONTEMPLATED HEREIN OR A BREACH OR  ALLEGED BREACH OF THIS AGREEMENT, HOWEVER ARISING WHETHER FOR  BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE.  THE  FOREGOING SENTENCE SHALL NOT APPLY IN CASES OF A PARTY’S GROSS  NEGLIGENCE, OR INTENTIONAL MISCONDUCT, FRAUD OR DEATH OR PERSONAL  INJURY CAUSED BY NEGLIGENCE.  12. TERM AND TERMINATION  





 






   40    12.1 Term.  The initial term shall commence as of the Effective Date and shall run unless  terminated in accordance with the terms of this Agreement, on a country by country basis in the  Territory, for a period of [****] years from the First Commercial Sale (together with any renewal  term, the “Term”).  Pharmanovia shall have the option to renew this Agreement for successive  [****] renewal terms by providing [****] days written notice to Aquestive prior to the expiration  of the then current term.   12.2 Termination.    12.2.1 Termination of this Agreement.  In addition to any other provision of this  Agreement expressly providing for termination of this Agreement, this Agreement may be  terminated as follows:   12.2.1.1 By either Party immediately upon written notice: (a) upon the  occurrence of a Bankruptcy Event with respect to the other Party; or (b) in addition to and not in  limitation of the termination rights set forth below in this Section 12.2, if the other Party commits  any material misrepresentation or breach of any of its covenants, obligations, representations or  warranties under this Agreement and, in the case of a breach which is capable of remedy, such  Party fails to remedy the same within sixty (60) days after receipt of a written notice describing  the breach and requiring it to be so remedied.   12.2.1.2 By Aquestive upon thirty (30) days’ prior written notice if  Pharmanovia has violated Section 2.2.2.   12.2.1.3 By Pharmanovia on thirty (30) days’ prior written notice if  Aquestive has violated Section 2.2.1.  12.2.1.4 By Aquestive upon written notice to Pharmanovia in the event that  Pharmanovia fails to pay as and when due: (a) any Milestone Payment;(b) any Royalty Fee; or (c)  any amount required to be paid with respect to a Minimum Volume Commitment; and in the case  of (a) fails to remedy same within thirty (30) days of receipt and in the case of (b) and (c) within  forty five (45) days of a written notice describing the failure and requiring it to be so remedied  provided that Pharmanovia’s failure to pay is not due to an invoice being disputed in writing by  Pharmanovia in good faith.   12.2.1.5 By either Party on no less than three (3) months’ written notice of  termination if Pharmanovia does not file for the first Regulatory Approval in a country in the  Territory within three (3) years of the Effective Date provided that the Parties shall have had good  faith discussions for at least three (3) months to discuss a resolution of this issue prior to any such  notice being served.  12.2.1.6 By Pharmanovia upon written notice to Aquestive if Aquestive  does not use Commercially Reasonable Efforts to execute its Supply responsibilities for the  Product and Aquestive fails to remedy the same within [****] days after receipt of a written notice  from Pharmanovia describing failure and requiring it to be so remedied.   12.2.1.7 By Aquestive, after the third anniversary of the Effective Date,  upon written notice in respect to a specific country in the Territory if Pharmanovia does not use  





 






   41    Commercially Reasonable Efforts to execute its Commercialization and Development  responsibilities for the Product in that specific country in the Territory and Pharmanovia fails to  demonstrate in good faith an intention to Commercialize the Product in such country in the  Territory  within [****] days after receipt of a written notice from Aquestive describing failure  and requiring it to be so remedied. For the purposes of this section, the EEA shall be considered a  single country.  12.2.1.8 By Aquestive upon [****] days’ prior written notice if the  quantities of Units purchased by Pharmanovia from Aquestive under the Product Schedule do not  meet the Minimum Volume Commitment (to the extent applicable) in any [****] consecutive  [****], unless such failure is attributable to the failure of Aquestive to supply a conforming  Product to Pharmanovia under this Agreement, or due to matters outside of the control of  Pharmanovia that impacts Pharmanovia’s ability to sell Product.  12.3 Effects of Termination.    12.3.1 Effect of Termination Generally.  On the expiration or earlier termination  of this Agreement for any reason, except as otherwise expressly provided herein, all rights and  obligations of each Party hereunder or thereunder, as the case may be, shall cease.  12.3.2 Disposition and Transfer of Inventory upon Termination; Royalty Fees Due  Thereon Not Affected By Termination.  On the expiration or earlier termination of this Agreement:  (a) all unpaid Royalty Fees for the Product sold as of the effective date of termination shall remain  due and payable as scheduled; (b) on the agreement of both Parties, Aquestive shall complete all  work-in-process, and Pharmanovia shall purchase at the Product Transfer Price under this  Agreement, all remaining inventory of Product and, at cost, all Raw Materials relating thereto in  Aquestive’s possession or control but not to exceed a supply of the affected Product corresponding  to the last [****] of the most recent supply forecast delivered by Pharmanovia in accordance with  Section 5.3 and Aquestive shall use all Commercially Reasonable Efforts to mitigate the cost  thereof to Pharmanovia and to consult with Pharmanovia in connection with such attempts to  mitigate; (c) Pharmanovia shall have the right to sell out such remaining inventory of the affected  Products for a period of up to [****] months; and (d) Pharmanovia shall pay to Aquestive the  Royalty Fees on each sale of remaining inventory of the Product by Pharmanovia and/or its  Affiliates when and as such Product is sold.   12.3.3 Accrued Rights. Termination, relinquishment, or expiration of this  Agreement for any reason shall be without prejudice to any right which shall have accrued to the  benefit of either Party prior to such termination, relinquishment or expiration including damages  arising from any breach under this Agreement.  Termination, relinquishment, or expiration of this  Agreement shall not relieve either Party from any obligation which is expressly or by implication  intended to survive such termination, relinquishment or expiration of this Agreement and shall not  affect or prejudice any provision of this Agreement which is expressly or by implication provided  to come into effect on, or continue in effect after, such termination, relinquishment, or expiration.   Remedies for breaches under this Agreement shall also survive any termination, relinquishment,  or expiration of this Agreement.  12.3.4 Intellectual Property Rights.   





 






   42    12.3.4.1 Upon expiration of this Agreement or termination by Pharmanovia  pursuant to Sections 12.2.1.1 , 12.2.1.3, 12.2.1.5 or 12.2.1.6, all right, title and interest, in and to,  with respect to each Regulatory Approval and all data generated in support of such Regulatory  Approval for the Product in the Territory shall remain with Pharmanovia or its Affiliates and  nominees, including without limitation, from all associated pre-clinical and clinical studies. For  the avoidance of doubt, in these circumstances Pharmanovia shall have no further obligation,  notwithstanding Section 12.3.2, to pay any Royalty Payments or payments associated with failure  to meet the Minimum Volume Commitments pursuant to this Agreement, relating to the period  after the expiry or termination date.  12.3.4.2 Upon termination of this Agreement or part thereof by Aquestive  pursuant to Sections 12.2.1.1, 12.2.1.2, 12.2.1.4, 12.2.1.5, 12.2.1.7 or 12.2.1.8,  Aquestive shall  have the right, to be exercised at Aquestive’s sole option, to receive an assignment in whole or in  part, directly or to a designated sublicensee, of all of Pharmanovia’s right, title and interest, in and  to, with respect to the Product in the affected country in the Territory if it is a partial termination,  (i) each Regulatory Approval and (ii) all data generated in support of such Regulatory Approval,  including without limitation, from all associated pre-clinical and clinical studies, if a partial  termination in relation to the Product in the affected country in the Territory; for the avoidance of  doubt this shall not include the Pharmanovia Marks.  Such assignment shall be made for  consideration equaling Pharmanovia’s out-of-pocket costs incurred (excluding payments made by  Pharmanovia to Aquestive in respect of same under this Agreement).  In connection with any  assignment contemplated by this Section 12.3.4.2, Pharmanovia shall cooperate with Aquestive  and execute and deliver to Aquestive any and all documents reasonably necessary to perfect its or  its sublicensee’s rights to the foregoing and, to the extent applicable, Pharmanovia shall ensure  that the all Product-related Intellectual Property and Regulatory Approvals, if a partial termination  in relation to the Product in the affected country in the Territory to be assigned remain in good  standing until such assignment to Aquestive is complete. Aquestive undertakes, in these  circumstances, within 3 months, to carry out the necessary variations to the Regulatory Approvals  and artwork related thereto, to ensure that the Pharmanovia Marks and any other reference to  Pharmanovia or its Affiliates or nominees is removed therefrom.  12.3.5 Survival.  The following Sections of this Agreement, as well as any other  provisions in this Agreement which specifically state they will survive termination or expiration  of this Agreement or any terms of this Agreement that would reasonably be expected in the  contemplation of both Parties to survive termination, shall survive expiration or termination of this  Agreement for any reason:  Section 1, Section 2.1 (provided that the license granted in Section 2.1  shall be non-exclusive and all such sections shall survive for the sole purpose of selling out  remaining inventory of Product as set forth in Section 12.3.2 , Section 4.8, Sections 5.4,  5.46, 5.6,  5.7, 5.11 and 5.12, Section 8.1 (with respect to unpaid milestone payments which have accrued as  of such termination), Section 7.2 through Section 7.12 inclusive (with respect to Royalty Fee  payments  and Profit Share payments due after such termination or expiration for sales prior to  such termination or expiration or otherwise in respect of sales permitted pursuant to Section  12.3.2), Sections 8.4, 9, 10, 11, 12.3, 13.5.2, and 14.   





 






   43    12.3.6 Return of Confidential Information.    12.3.6.1 Within thirty (30) days of any expiration or termination of this  Agreement: (a) Pharmanovia shall cease to use and shall deliver to Aquestive, upon written request  of Aquestive, all Confidential Information of Aquestive, except for any documents or records that  Pharmanovia is required to retain by Applicable Law or reasonably necessary for Pharmanovia to  exercise its rights under Section 12.3.2; and (b) Aquestive shall cease to use and shall deliver to  Pharmanovia, upon written request, all Confidential Information of Pharmanovia except for any  documents or records that Aquestive is required to retain by Applicable Law or that are reasonable  necessary for Aquestive to exercise its rights under Section 12.3.2; provided, however, that all  such retained documents or records shall continue to be subject to the confidentiality obligations  under this Agreement.  13. INTELLECTUAL PROPERTY  13.1 Patent Prosecution and Maintenance.    13.1.1 Aquestive shall be responsible for the preparation, filing, prosecution and  maintenance (including payment of renewal fees when due) of the Aquestive Patents. The cost of  such preparation, filing, prosecution and maintenance of the Aquestive Patents shall be borne by  Aquestive.     13.1.2 Aquestive shall use Commercially Reasonable Efforts to procure the grant  of any of the Aquestive Patents that are patent applications in each country of the Territory.  Aquestive shall provide updates on the status of the Aquestive Patents to the Steering Committee  on a regular basis and, if reasonably practicable, consult with Atnahs on material decisions in  relation thereto.  13.1.3 In the event that Aquestive desires to abandon or cease prosecution or  maintenance of any Aquestive Patent, Aquestive shall provide reasonable prior written notice to  Pharmanovia of such intention to abandon (which notice shall, to the extent possible, be given no  later than sixty (60) days prior to the next deadline for any action that must be taken with respect  to any such Aquestive Patent in the relevant patent office).  In such case, upon Pharmanovia’s  written election provided no later than thirty (30) days after such notice from Aquestive,  Pharmanovia shall have the right to assume prosecution and maintenance of such Aquestive Patent  at Pharmanovia’s expense.  If Pharmanovia does not provide such election within thirty (30) days  after such notice from Aquestive, Aquestive may, in its sole discretion, continue prosecution and  maintenance of such Aquestive Patent or discontinue prosecution and maintenance of such  Aquestive Patent.  13.2 IP Enforcement Against Third Parties.    13.2.1 Each Party shall promptly notify the other Party in writing of any alleged or  threatened infringement of any Aquestive Patent of which they become aware (a “Competitive  Infringement”).  13.2.2 In each such instance of Competitive Infringement of any Aquestive Patent,  Aquestive shall have the right, but not the obligation, in its own name and under its own direction  





 






   44    and control, to institute litigation against such alleged or threatened Competitive Infringement at  its cost and expense.  If Aquestive does not, within ninety (90) days after its receipt or delivery of  notice under Section 13.2.1 relating to infringement of any Aquestive Patent, commence a suit to  enforce the applicable patent, take other action to terminate such Competitive Infringement or  initiate a defense against such Competitive Infringement, then: (i) Pharmanovia will have the right,  but not the obligation, including conducting infringement proceedings and settlement negotiations  in its own and Aquestive’s name,  to commence such a suit or take such an action or defend against  such Competitive Infringement in the Territory at Pharmanovia’s cost and expense, to be  represented in any such suit by counsel of its own choice and (ii) if Pharmanovia exercises its right  under the foregoing clause (i), Aquestive will take all reasonable and appropriate actions in order  to permit Pharmanovia to commence a suit or take the actions with respect to the Competitive  Infringement.  Neither Party will enter into any settlement, consent judgment or other voluntary  final disposition of any action under this Section 13.2 without the other Party’s prior written  consent, which consent will not be unreasonably withheld, delayed, or conditioned unless the  settlement includes any express or implied admission of liability or wrongdoing on either Party’s  part, in which case the right to grant or deny consent is absolute and at its sole discretion.  13.2.3 Each Party shall reasonably assist the Party enforcing any such rights under  this Section 13.2 in any such action or proceeding if so requested by the enforcing Party, and will  be named in or join such action or proceeding if requested by the enforcing Party, and will  reasonably cooperate with the enforcing Party in such participation (including providing copies of  all prior claim construction submissions and supporting documents subject to confidentiality  provisions as required); provided, that if Aquestive is the enforcing Party, the reasonable, out-of- pocket costs and expenses of Pharmanovia in connection therewith, including any Aquestive- approved investigation and analysis thereof, is to be reimbursed to Pharmanovia on an as-incurred  basis.  The enforcing Party shall keep such other Party and/or its designated legal counsel  reasonably informed as to the progress in connection with the foregoing Competitive Infringement  (including any settlement discussions), and will reasonably consider the other Party’s comments  on any such efforts.  13.2.4 If the enforcing Party recovers monetary damages in such claim, suit or  action, such recovery will be allocated first to the reimbursement of any expenses incurred by the  Parties in such litigation the remaining amounts will be retained by Pharmanovia, however,  Pharmanovia will calculate Net Sales under this Agreement based on the remaining amounts  attributed to lost sales as if Pharmanovia had made the infringing sales directly, and will pay to  Aquestive the Royalty Fees owed by Pharmanovia to Aquestive pursuant to Section 7.2 or any  Profit Share owed by Pharmanovia to Aquestive pursuant to Section 7.3.  13.3 Action by Third Party.  In the event that any Third Party initiates a declaratory  judgment action alleging the noninfringement, invalidity or unenforceability of the Aquestive  Patents, or if any Third Party brings an infringement action against Pharmanovia or its Affiliates  or subcontractors because of the exercise of the rights granted to Pharmanovia under this  Agreement with respect to the Aquestive Patents, and Aquestive or Pharmanovia has not  commenced any action to enforce Aquestive Patents against such Third Party under the terms of  Section 13.2 above, each Party will give prompt notice to the other Party of any such action of  which it becomes aware.  Aquestive shall have the right, but not the obligation, to take any  necessary actions (including the filing of pleadings required by the Applicable Law or any local  





 






   45    rules of court) and defend against such action under its own control and at its own expense.  If  Aquestive fails to defend such action, Pharmanovia will have the right, but not the obligation to  defend against such action under its own control and at its own cost and expense; Aquestive will  take all reasonable and appropriate actions in order to permit Pharmanovia to initiate and continue  such defense and will provided all assistance reasonably requested by Pharmanovia in connection  with such defense.  Neither Party will enter into any settlement, consent judgment or other  voluntary final disposition of any action under this Section 13.3 without the other Party’s prior  written consent, which consent will not be unreasonably withheld, conditioned or delayed, unless  the settlement includes any express or implied admission of liability or wrongdoing on either  Party’s part, in which case the right to grant or deny consent is absolute and at its sole discretion.   Notwithstanding the above, if Aquestive or Pharmanovia has commenced any action to enforce  Aquestive Patents against such Third Party under the terms of Section 13.2 above, then the terms  of Section 13.2 will supersede the terms of this Section 13.3.  13.4 Ownership of Pharmanovia Housemarks; Termination of Right to Use.    13.4.1 Pharmanovia shall own all right, title, and interest in the Pharmanovia  Housemarks and Pharmanovia Marks in all forms of use or display in which they may appear, and  any goodwill associated therewith.  Notwithstanding any provision of this Agreement, Aquestive  agrees that it shall not, by virtue of this Agreement, acquire any right, title, and interest in or to the  Pharmanovia Housemarks or Pharmanovia Marks or any goodwill associated therewith.  13.4.2 Upon and following the termination of this Agreement, except in  connection with any Supply of Product to Pharmanovia after termination or expiration of this  Agreement, Aquestive shall not use the Pharmanovia Housemarks, the Pharmanovia Marks, or any  other name or mark of Pharmanovia.  13.5 Ownership of Aquestive Marks; Termination of Right to Use.    13.5.1 Aquestive shall own all right, title, and interest in the Aquestive Marks in  all forms of use or display in which they may appear, and any goodwill associated therewith.   Notwithstanding any provision of this Agreement, Pharmanovia agrees that it shall not, by virtue  of this Agreement, acquire any right, title, and interest in or to the Aquestive Marks or any goodwill  associated therewith.  13.5.2 Upon and following the termination of this Agreement, except in  connection with any Supply of Product to Pharmanovia after termination or expiration of this  Agreement, Pharmanovia shall not use the Aquestive Marks or any other name or mark of  Aquestive.  14. MISCELLANEOUS  14.1 Independent Contractor.  Neither Aquestive nor Pharmanovia, together in each  case with their respective employees and representatives, are under any circumstances to be  considered as employees, partners, joint venturers, agents, or representatives of the other by virtue  of this Agreement, and neither shall have the authority or power to bind the other or contract in  the other’s name.  





 






   46    14.2 Registration and Filing of this Agreement.  To the extent, if any, that either Party  concludes in good faith that it or is required to file or register this Agreement or a notification  thereof with any Regulatory Authority including, without limitation, the U.S. Securities and  Exchange Commission or the U.S. Federal Trade Commission, in accordance with Applicable  Law, such Party shall (a) inform the other Party thereof, (b) provide copies of the proposed  disclosure to the other Party reasonably in advance of such filing or other disclosure under the  circumstances, (c) promptly notify the other Party in writing of such requirement and any  respective timing constraints, and (d) give the other Party a reasonable time under the  circumstances from the date of notice by such Party of the required disclosure to comment upon  and request confidential treatment for such disclosure; provided, that, the other Party shall  promptly review and provide comments regarding the proposed disclosure and the disclosing Party  will in good faith consider incorporating such comments.  14.3 Notices.  All notices or other communications required or permitted to be given  under any of the provisions of this Agreement shall be in writing in the English language, and shall  be deemed to have been duly given: (a) when personally received by the intended recipient; (b)  when delivered by messenger or internationally recognized delivery service (with confirmation of  receipt); (c) when delivered via e-mail or facsimile (and promptly confirmed by mail); or (d) three  (3) Business Days after having been mailed by first class registered or certified mail, return receipt  requested, postage prepaid, addressed to the applicable party at the address indicated below, or to  any other address or addressee as any Party may in the future specify by notice to the other Party  (with notice of change of address or addressee not being valid until actually received):  If to  Pharmanovia:  Atnahs Pharma UK Limited  Sovereign House, Miles Gray Road, Basildon, Essex  SS14 3FR  Telephone: +44 1268 820 870  Attention: Dr James Burt, CEO  With a copy to: Atnahs Pharma UK Limited  Sovereign House, Miles Gray Road, Basildon, Essex  SS14 3FR  Telephone: +44 1268 820 870  Attention: General Counsel  If to Aquestive: Aquestive Therapeutics, Inc.  30 Technology Drive  Warren, New Jersey 07059  Attn:  Daniel Barber, Chief Executive Officer  E-mail:  dbarber@aquestive.com  With a copy to: Aquestive Therapeutics, Inc.  30 Technology Drive  Warren, New Jersey 07059  Attention:  General Counsel  E-mail:  lbraender@aquestive.com  





 






   47    14.4 Binding Effect; No Assignment.  This Agreement shall be binding upon and inure  to the benefit of the Parties and their respective successors and permitted assigns.  Except as  expressly set forth in this Agreement, neither Aquestive nor Pharmanovia may assign any of its  rights or delegate any of its liabilities or obligations hereunder without the prior written consent of  the other Party, provided, however, that, without the prior written consent of the other Party: (a)  either Party may assign this Agreement to any purchaser of all or substantially all of its assets or  business to which this Agreement relates; and (b) either Party may assign this Agreement and/or  its rights and obligations under this Agreement to any of its Affiliates.  No assignment hereunder  shall relieve the assigning Party of its responsibilities or obligations hereunder; provided, further  that any assignee shall agree in writing to be bound by all of the obligations of the assigning Party  hereunder.  Any purported assignment or transfer in violation of this Section 13.4 will be void  ab initio and of no force or effect. Aquestive shall not assign or otherwise transfer any right, title  or interest in any of the Aquestive IP to any third party unless provision is made to ensure that the  assignee’s rights to such Aquestive IP remain subject to the license rights granted to Pharmanovia  under this Agreement and further obligations are not imposed on Pharmanovia thereby.  14.5 No Implied Waivers; Rights Cumulative.  No failure on the part of Aquestive or  Pharmanovia to exercise and no delay in exercising any right, power, remedy or privilege under  this Agreement, or provided by statute or at law or in equity or otherwise, including the right or  power to terminate this Agreement, shall impair, prejudice or constitute a waiver of any such right,  power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an  acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or  privilege preclude any other or further exercise thereof or the exercise of any other right, power,  remedy or privilege.  14.6 Severability.  If any provision of this Agreement is held invalid or unenforceable  by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full  force and effect.  Any provision of this Agreement held invalid or unenforceable only in part or  degree shall remain in full force and effect to the extent not held invalid or unenforceable.  The  Parties further agree to replace such invalid or unenforceable provision of this Agreement with a  valid and enforceable provision that shall achieve, to the extent possible, the economic, business,  and other purposes of such invalid or unenforceable provision.  14.7 Force Majeure.  Neither Party shall be liable for delay in delivery or  nonperformance (except for any obligation for the payment of money), in whole or in part, nor  shall the other Party have the right to terminate this Agreement except as otherwise specifically  provided in  this Section 14.7, to the extent that such delay in delivery or nonperformance is caused  by any of the following events that are reasonably beyond the control of such Party and without  the fault or negligence of such Party: (i) strikes, lockouts or other labor disturbances; (ii) any  change or effect resulting from or associated with acts of war or terrorism or changes imposed by  a Regulatory Authority to address concerns associated with war or terrorism; (iii) any change or  effect resulting from any acts of God, force majeure events, armed hostilities or sabotage, riots,  civil commotion, insurrections, or any other weather developments or natural or man-made  disasters; (iv) any change or effect resulting from any epidemics, pandemics or other public health  emergencies, including COVID-19 or any worsening or variant thereof, or (vii) any change or  effect resulting from conflict in the territory of Ukraine or any sanctions or restrictions related  thereto, (a “Force Majeure”); provided, however, that the Party affected by such a condition shall,  





 






   48    as soon as it becomes aware of same (but in any event within ten (10) days of its occurrence), give  written notice to the other Party stating the nature of the condition, its anticipated duration and any  action being taken to avoid or minimize its effect.  The suspension of performance shall be of no  greater scope and no longer duration than is reasonably required and the nonperforming Party shall  use its Commercially Reasonable Efforts to remedy its inability to perform; provided, however,  that in the event the suspension of performance continues for a period of ninety (90) consecutive  calendar days after the date of the occurrence, and such failure to perform would constitute a  material breach of this Agreement in the absence of such force majeure event, the non-affected  Party may terminate this Agreement immediately by written notice to the other Party.  14.8 Amendment.  This Agreement may not be amended, and no provision hereof may  be modified or waived, except by an instrument in writing duly executed by each of the Parties  hereto.  14.9 Rules of Construction.  The Parties hereto agree that they have been represented  by counsel during the negotiation and execution of this Agreement and, therefore, waive the  application of any law, regulation, holding or ruling of construction providing that ambiguities in  an agreement or other document shall be construed against the Party drafting such agreement or  document.  14.10 Publicity.    14.10.1 Press Releases.  The Parties acknowledge that each of Pharmanovia  and Aquestive intends to issue press releases and other public statement disclosing the existence  of or relating to this Agreement, and each agrees to provide the other Party a copy of such release  and statement and to obtain the express prior written consent of the other Party, which consent  shall not be unreasonably withheld, conditioned or delayed; provided, however, that neither Party  shall be prevented from complying with any duty of disclosure it may have pursuant to Applicable  Law, including securities laws applicable to a public company.  14.10.2 Use of Marks.  During the Term, Aquestive will have the right to  display the Pharmanovia Housemark on the partnership page of its corporate website, and  Pharmanovia will have the right to display the Aquestive Marks on its corporate website.  14.11 Expenses.  Except as expressly set forth herein, each Party shall bear all fees and  expenses incurred by such Party in connection with, relating to or arising out of the execution,  delivery and performance of this Agreement and the consummation of the transactions  contemplated hereby, including attorneys’, accountants’ and other professional fees and expenses.  14.12 Governing Law; Dispute Resolution.    14.12.1 This Agreement shall be governed by and construed in accordance  with the laws (substantive and procedural) of the state of New York, United States without  regarding to its conflict of laws principles.  The Parties expressly exclude application of the United  Nations Convention for the International Sale of Goods.  14.12.2 In the event of any dispute, claim, or controversy between the Parties  under this Agreement, the Parties will first attempt in good faith to resolve such dispute by  





 






   49    negotiation and consultation between themselves.  In the event that such dispute is not resolved on  an informal basis within ten (10) days, either Party may refer the matter to the Parties’ Executive  Officers for attempted resolution.  Each Party shall designate an “Executive Officer” of its  company as the designee in the event of any dispute that has not been resolved in accordance with  this Section 14.12.2.  The Executive Officer shall be the President of the respective Party or his or  her designee.  The Executive Officers of the Parties will attempt in good faith to resolve such  dispute by negotiation and consultation for a thirty (30) day period following such referral.  14.12.3 If the Executive Officers cannot reach consensus on a given matter  within thirty (30) days, then, such dispute, controversy, or claim that is not an “Excluded Claim”  shall be resolved by binding arbitration by the International Court of Arbitration of the  International Chamber of Commerce (“ICC”) in accordance with the rules of the ICC as in force  on the date on which the request for arbitration is filed (“ICC Rules”).  The place of arbitration  shall be New York, New York, United States.  Such arbitration shall be conducted by a sole  arbitrator mutually selected by written agreement of the Parties.  In the event that the Parties are  not able to mutually select the sole arbitrator, the arbitration shall be conducted by a panel of three  arbitrators, consisting of one arbitrator to be selected by the Party referring such matter to  arbitration and one arbitrator to be selected by the other Party, and the third to be selected jointly  by the two arbitrators selected by the Parties in accordance with the ICC Rules.  The arbitration  shall be conducted in English.    14.12.4 It is the intention of the Parties that discovery procedures, although  permitted as described herein, will be limited except in exceptional circumstances.  The  arbitrator(s) will permit such limited discovery procedures necessary for an understanding of any  legitimate issue raised in the arbitration, including the production of documents.  No later than  thirty (30) days after selection of the arbitrator(s), the Parties and their representatives shall hold a  preliminary meeting with the arbitrator(s), to mutually agree upon and thereafter follow procedures  seeking to assure that the arbitration will be concluded within six (6) months from such meeting.   Failing any such mutual agreement, the arbitrator(s) will design and the Parties shall follow  procedures to such effect.  The arbitrator(s) will, in rendering its decision, apply the governing law  (procedural and substantive) of the State of New York, United States without giving effect to any  rules or laws relating to arbitration.  Any award rendered by the arbitrator(s) will be final and  binding, and judgment may be entered upon it in any court of competent jurisdiction.  14.12.5 Either Party may apply to the arbitrator(s) for interim injunctive relief  until the arbitration award is rendered or the controversy is otherwise resolved.  Either Party also  may, without waiving any remedy under this Agreement, seek from any court having jurisdiction  any injunctive or provisional relief necessary to protect the rights or property of that Party pending  the arbitration award.  The arbitrator(s) shall have no authority to award punitive or any other non- compensatory damages.  The prevailing Party shall be entitled to recover its reasonable attorneys’  fees, costs and disbursements.  The costs of the arbitration including without limitation, the fees  of the arbitrator (but excluding each party’s attorney’s fees) shall be initially shared equally by the  parties but may be awarded by the arbitrator as additional damages in favor of the prevailing party.  14.12.6 Except to the extent necessary to confirm or enforce an award or as may  be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results  of an arbitration without the prior written consent of both Parties.  In no event shall an arbitration  





 






   50    be initiated after the date when commencement of a legal or equitable proceeding based on the  dispute, controversy or claim would be barred by the applicable New York statute of limitations.  14.12.7 Notwithstanding anything to the contrary contained in this  Agreement, each of the Parties shall have the right to bring an action or claim for interim measures,  including specific performance or injunctive relief, in order to preserve its rights or enforce the  obligations of the other Party under this Agreement, in any court of competent jurisdiction or  having jurisdiction over any of the Parties or their respective assets, without the need to first submit  such matter to arbitration under this Section 14.12.   14.12.8 As used in this Section 14.12, the term “Excluded Claim” shall  mean a dispute, controversy or claim that concerns (i) the inventorship, validity, enforceability or  infringement of a patent, trademark or copyright; or (ii) any antitrust, anti-monopoly, anti- corruption or competition law or regulation, whether or not statutory.  14.13 Entire Agreement.  This Agreement, the Quality Agreement, the Safety Data  Exchange Agreement and the Product Schedule contains the entire agreement between the Parties  with respect to the subject matter hereof and supersede all prior agreements, written or oral,  between the Parties.  14.14 Third Party Beneficiaries.  None of the provisions of this Agreement, express or  implied, is intended to be or shall be for the benefit of or enforceable by any Person (including,  without limitation, any creditor of either Party hereto) other than Pharmanovia and Aquestive and  their respective successors and permitted assigns.  No such Person shall obtain any right under any  provision of this Agreement or shall by reasons of any such provision make any claim in respect  of any debt, liability, or obligation (or otherwise) against either Party hereto.  14.15 Non-Recourse.  No past, present or future director, officer, employee, incorporator,  member, partner, stockholder, Affiliate, agent, attorney or representative of either Party or any of  their respective Affiliates shall have any liability (whether in contract or in tort) for any obligations  or liabilities of such Party or applicable Affiliate arising under, in connection with or related to  this Agreement or any of the transactions contemplated hereunder including for any Third Party  Claim relating thereto.  14.16 Interpretation and Construction.  The headings of Sections in this Agreement  are provided for convenience only and shall not affect its construction or interpretation.  All  references to “Section” or “Sections” refer to the corresponding Section or Sections of this  Agreement.  All words used in this Agreement shall be construed to be of such gender or number  as the circumstances require.  Unless otherwise expressly provided in this Agreement, the word  “including” does not limit the preceding words or terms and shall be deemed to be followed by the  words “without limitation.” Unless otherwise expressly provided in this Agreement, the terms  “shall have responsibility for”, “shall be responsible for” or the like, shall be deemed to be followed  by “and shall be obligated to duly carry out such responsibility.”  14.17 Controlling Language.  This Agreement and the Schedules hereto are prepared  and executed in the English language only, which language shall control and prevail in all respects.   The English language shall be used in the interpretation and performance of this Agreement.  Any  





 






   51    translations of this Agreement into any other language are for reference only and shall have no  legal or other effect.  Any notice which is required or permitted to be given by one Party to the  other under this Agreement shall be in the English language and shall be in writing.  All other  correspondence and documentation required to be delivered to a Party under this Agreement,  arising out of or connected with this Agreement, and any related purchase order(s) shall be in the  English language; provided that if a document to be delivered under this Agreement is in a  language other than English in its original form, it shall be delivered in its original language and  at Aquestive’s written request, Pharmanovia will provide Aquestive with a copy of English  translation of such document the cost of which shall be borne by Aquestive.  All proceedings  related to this Agreement shall be conducted in the English language.  14.18 Rights in Bankruptcy.  The Parties acknowledge that all rights and licenses  granted under or pursuant to any Section of this Agreement are, and shall otherwise be deemed to  be, for purposes of Section 365(n) of Title 11 of the United States Code and other similar foreign  laws (collectively, the “Bankruptcy Code”), licenses of rights to be “intellectual property” as  defined under the Bankruptcy Code or such foreign laws.  Pharmanovia shall have all rights,  elections, and protections under the Code and all other applicable bankruptcy, insolvency, and  similar laws with respect to this Agreement and the subject matter hereof. If a case is commenced  during the Term by or against Aquestive or its Affiliates or their respective assets under a  Bankruptcy Code  or a similar proceeding then, then subject to Pharmanovia’s rights of election  under Section 365(n), all rights, licenses, and privileges granted to Pharmanovia under this  Agreement will continue subject to the respective terms and conditions hereof, and will not be  affected, even by Aquestive’s rejection of this Agreement and Aquestive (in any capacity,  including debtor-in-possession) and its successors and assigns (including, without limitation, a  trustee) shall perform all of the obligations provided in this Agreement to be performed by such  Party.   14.19 Product Schedule.  To the extent any terms and provisions of the Product Schedule  conflict with the terms and provisions of this Agreement, the terms and provisions of this  Agreement shall control, except to the extent that the Product Schedule expressly and specifically  states an intent to supersede a certain provision of this Agreement on a specific matter.  The  Product Schedule and any amendments thereto shall be deemed to be incorporated herein by  reference.  14.20 Counterparts; Signatures.  This Agreement may be executed in multiple  counterparts, all of which, when executed, shall be deemed to be an original and all of which  together shall constitute one and the same document.  Signatures provided by facsimile or e-mail  transmission shall be deemed to be original signatures.  [Signature page follows]    





 






  [Signature Page to License, Development and Supply Agreement]      IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by  their duly authorized representatives, effective as of the Effective Date.  AQUESTIVE THERAPEUTICS, INC.    By:    Name:   Title:     ATNAHS PHARMA UK LIMITED     By:    Name:  Title:      





 






     PRODUCT SCHEDULE 1  Product Schedule to the License and Supply Agreement (the “Agreement”) dated as of  September 26, 2022 by and between Aquestive Therapeutics, Inc. (“Aquestive”) and Atnahs  Pharma UK Limited (“Pharmanovia”).    Capitalized terms used herein and not otherwise defined shall have the meanings given them in  the Agreement.     1. PRODUCT, API, DOSAGE STRENGTH, FIELD, TERRITORY  1.1  “API” means the active pharmaceutical ingredient diazepam.  1.2 “Commercialization Year” shall mean the one year period from the First Commercial  Sale, and each annual period thereafter.  1.3 “Dosage Strength” means the 5mg, 7.5mg, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg  dosage strengths of the Product.  1.4  “Field” means the treatment of prolonged or acute, convulsive seizures in all ages, or such  other definition that is consistent with the foregoing and agreed upon in good faith by the  Parties in writing).   1.5 “Product” means diazepam buccal film.  1.6  “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site  located at 6465 Ameriplex Drive, Portage, Indiana (IN) 46368, United States (USA), FDA  Establishment Number 3004395604.  1.7 “Territory” means: (i) the countries of the European Union (as of the Effective Date),  Sweden, Switzerland and Norway; (ii) the United  Kingdom (England, Scotland, Wales  and Northern Ireland); and (iii) the Middle East and North Africa (Algeria, Bahrain, Egypt,  Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia,  Syria, Tunisia, United Arab Emirates and Yemen).  2. PRODUCT TRANSFER PRICE  Aquestive shall Supply quantities of each Unit of the Product to Pharmanovia at the initial  Product Transfer Prices below, further to adjustment pursuant to Section 5.2 of the Agreement:  Dosage Strength Product Transfer Price   Low Dose (5mg, 7.5mg, 10mg) $[****]/per Carton*  Medium Dose (12.5mg, 15mg) $[****]/per Carton  High Dose (17.5mg, 20mg) $[****]/per Carton    





 






     *each Carton contains two Units.    3. AQUESTIVE PRODUCT MARKS  The Aquestive Product Marks are set forth below:  LibervantTM  4. PHARMANVOIA  MARKS  ValiumTM  5. PRODUCT SHELF LIFE  [****]% of approved shelf life  6. AQUESTIVE PRODUCT PATENTS  The Aquestive Product Patents are set forth below:    None.  7. PAYMENTS  6.1 Milestone Payments  Non-refundable payments will be due from Pharmanovia to Aquestive as set forth in the  table below:  Milestone  Milestone Payment  (U.S. Dollars) Milestone Payment Due Date  1.    Agreement Execution $3,500,000 September 30, 2022  2. Receipt of First Ex-US  Marketing Authorization  $[****] Within [****] Business Days of receipt  of the first Marketing Authorization for  the Product within the Territory.    3. Pricing and Reimbursement  Milestone  $[****] Within [****] Business Days of pricing  and reimbursement approval being  obtained for the Product from the  applicable Regulatory Authority in the  first country in the Territory.     Pharmanovia shall give Aquestive written notice of the achievement of each milestone event in  respect of which a milestone payment is due (with the exception of the first milestone event).  Following receipt of such notice, Aquestive shall submit an invoice to Pharmanovia, and  Pharmanovia and shall pay the corresponding Milestone Payment no later than five (5) Business  Days after receipt of such invoice.  





 






     5.1 Royalty Fees    Subject to Section 5.3 of the Agreement, Pharmanovia shall pay to Aquestive for each  Payment Period a Royalty Fee during the Term with respect to the Product in the Territory  in an amount equal to [****] of Net Sales on a quarterly basis.    5.2 Profit Share    In the event that the Profit Share is payable by Pharmanovia, Pharmanovia shall pay to  Aquestive for each Payment Period [****]% of Profits on all Products sold in the  Territory on a quarterly basis.    5.3 Minimum Volume Commitments     The Minimum Volume Commitment with respect to the Product is as set forth in the table  below:    Time Period Minimum Volume Commitment    1. Commercialization Year 1 None  2. Commercialization Year 2  [****] Units  3. Commercialization Year 3 [****] Units  4. Commercialization  Year 4 [****] Units  5.  Commercialization  Year 5 and beyond To be discussed in good faith by  the Parties. The Parties agree if the  Minimum Volume Commitment in  Commercialization Year [****] is  less than in Commercialization  Year [****], to discuss the  Product Transfer Price in good  faith.    In the event Pharmanovia fails to meet the Minimum Volume Commitment set forth above for a  given time period, Pharmanovia shall have the option to make up the shortfall in the number of  Units purchased by no later than June 30 following the end of the time period.   8. ADDITIONAL TERMS   Pharmanovia shall issue purchase orders in whole batch increments of the following number of  Units:  Dosage Strength Number of Units  5mg [****]  7.5mg [****]  10mg [****]  12.5mg [****]  15mg [****]  17.5mg [****]  





 






     20mg [****]    If required by Pharmanovia, Aquestive can carton up to [****] different printed cartons, or SKUs,  per manufacturing film batch, for a $[****] charge for the first [****] SKUs and another $[****]  for any additional SKUs and up to a maximum of [****] SKUs. The minimum secondary quantity  per SKU is [****] cartons.  





 






  1.13-1  Schedule 1.13  Aquestive Patents    Docket No. Country Status Title Appln No.  Appln Date Publn.  No. Publn. Date  1199-4 PCT/EPO/DIV (2)  European  Patent  Convention -  (EP)  Filed - (F)  THIN FILM WITH NON-SELF- AGGREGATING UNIFORM  HETEROGENEITY  19169349.8 10/11/2002 3542793 9/25/2019  1199-26 PCT/EPO/DIV II  European  Patent  Convention -  (EP)  Filed - (F)  POLYETHYLENE OXIDE-BASED FILMS  AND DRUG DELIVERY SYSTEMS  MADE THEREFROM   17151005.0 5/28/2004 3210601 8/30/2017  [****] [****] [****] [****] [****] [****]      AQU-013WOEP  European  Patent  Convention -  (EP)  Filed - (F) PHARMACEUTICAL COMPOSITIONS  WITH ENHANCED PERMEATION 17723617.1 12/05/2018 3452024 03/13/2019  [****] [****] [****] [****] [****] [****]      AQU-023WOEP  European  Patent  Convention -  (EP)  Filed - (F) PHARMACEUTICAL COMPOSITIONS  WITH ENHANCED PERMEATION 18786591.0 4/16/2020 3687509 08/05/2020  [****] [****] [****] [****] [****] [****]      





 






  1.13-2    Docket No. Country Status Exp. Date Title Appln. No. Appln.  Date  Publn.  No.  Publn.  Date Pat. No. Issue Date  1199-4  B/PCT/EPO/Denm ark  Denmark -  (DK)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/Franc e  France -  (FR)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/Germ any  Germany -  (DE)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 6020040 37401.6 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/Hung ary  Hungary -  (HU)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/Irelan d  Ireland -  (IE)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/Switz erland  Switzerland  - (CH)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  B/PCT/EPO/UK  Great  Britain -  (GB)  Granted  - (G) 1/30/2024  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Systems Made  Therefrom  04707004.0 1/30/2004 1587504 10/26/2005 1587504 4/18/2012  1199-4  PCT/EPO/DIV/DE  Germany -  (DE)  Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  60249871.6 10/11/2002 2351557 8/3/2011 2351557 4/17/2019  





 






  1.13-3  Docket No. Country Status Exp. Date Title Appln. No. Appln.  Date  Publn.  No.  Publn.  Date Pat. No. Issue Date  1199-4  PCT/EPO/DIV/ES  Spain -  (ES)  Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  10182204.7 10/11/2002 2735512 12/19/2019 2351557 4/17/2019  1199-4  PCT/EPO/DIV/FR  France -  (FR)  Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  10182204.7 10/11/2002 2351557 8/3/2011 2351557 4/17/2019  1199-4  PCT/EPO/DIV/IE  Ireland -  (IE)  Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  10182204.7 10/11/2002 2351557 8/3/2011 2351557 4/17/2019  1199-4  PCT/EPO/DIV/IT Italy - (IT) Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  50201900004 4094 10/11/2002 2351557 8/3/2011 2351557 4/17/2019  1199-4  PCT/EPO/DIV/U K  Great  Britain -  (GB)  Granted  - (G) 10/11/2022  Thin Film With Non-Self  Aggregating Uniform  Heterogeneity And Drug  Delivery Made Therefrom  10182204.7 10/11/2002 2351557 8/3/2011 2351557 4/17/2019  1199-15  PCT/EPO/DIV/CH  Switzerland  - (CH)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/DIV/De nmark  Denmark -  (DK)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  





 






  1.13-4  Docket No. Country Status Exp. Date Title Appln. No. Appln.  Date  Publn.  No.  Publn.  Date Pat. No. Issue Date  1199-15  PCT/EPO/DIV/Fra nce  France -  (FR)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/DIV/Ge rmany  Germany -  (DE)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 6024553 3.2 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/DIV/Ital y  Italy - (IT) Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  50201390221 3865 10/11/2002 1115781 9.1 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/DIV/Sp ain  Spain -  (ES)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/DIV/Sw eden  Sweden -  (SE)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  





 






  1.13-5  Docket No. Country Status Exp. Date Title Appln. No. Appln.  Date  Publn.  No.  Publn.  Date Pat. No. Issue Date  1199-15  PCT/EPO/DIV/U. K.  Great  Britain -  (GB)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  11157819.1 10/11/2002 2332523 6/15/2011 2332523 9/11/2013  1199-15  PCT/EPO/France  France -  (FR)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  02801042.9 10/11/2002 1458367 4/17/2003 1458367 12/14/2011  1199-15  PCT/EPO/German y  Germany -  (DE)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  02801042.9 10/11/2002 6024176 7.8 4/17/2003 1458367 12/14/2011  1199-15  PCT/EPO/Ireland  Ireland -  (IE)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  02801042.9 10/11/2002 1458367 4/17/2003 1458367 12/14/2011  1199-15  PCT/EPO/Switzerl and  Switzerland  - (CH)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  02801042.9 10/11/2002 1458367 4/17/2003 1458367 12/14/2011  





 






  1.13-6  Docket No. Country Status Exp. Date Title Appln. No. Appln.  Date  Publn.  No.  Publn.  Date Pat. No. Issue Date  1199-15  PCT/EPO/UK  Great  Britain -  (GB)  Granted  - (G) 10/11/2022  Uniform Films For Rapid  Dissolve Dosage Form  Incorporating Taste- Masking Compositions  02801042.9 10/11/2002 1458367 4/17/2003 1458367 12/14/2011      





 






    Schedule 1.47A  Aquestive Housemark        





 






    Schedule 1.47B  Pharmanovia Housemark