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13.19 Schedules ..................................................................................................................... 119
13.20 Construction ................................................................................................................. 119
SCHEDULES
Schedule 1.54 Corporate Names
Schedule 1.56 D3 Receptor Compound
Schedule 1.59 D3 Receptor Discovery Program Plan
Schedule 1.106 Identified Indications
Schedule 1.134 Manufacturing Cost
Schedule 1.164 Pro-metabolite Compounds
Schedule 1.167 Pro-metabolite Discovery Program Plan
Schedule 1.197 Richter Territory
Schedule 3.6.1 Draft Development Manufacturing Plan
Schedule 3.9.5 FTE Rates
Schedule 4.9.1(a) Principal Terms of Richter Supply Agreement
Schedule 4.9.2(a) Principal Terms of AbbVie Supply Agreement
Schedule 9.5 Form of Press Release
Schedule 10.2.1 Existing Patents
Schedule 12.9.1 Reversion Royalties Dispute Resolution
Schedule 13.7.3 ADR Procedures
CO-DEVELOPMENT AND LICENSE AGREEMENT
This Co-Development and License Agreement (the "Agreement") is made and entered into effective as of March 10, 2022 (the "Execution Date") by and between Gedeon Richter Plc., a public limited company organized under the laws of Hungary located at Gyömrői út 19-21, Budapest, 1103, Hungary ("Richter"), AbbVie Global Enterprises Ltd., a Bermuda company located at 16 Church Street, Hamilton HM 11 Bermuda ("AbbVie"), and, for purposes of Section 5.10 only, (a) Gedeon Richter USA, Inc. a wholly owned subsidiary of Richter, organized under the laws of the State of Delaware, USA and having its principal offices at 119 Cherry Hill Road, Suite 325 Parsippany, New Jersey 07054, USA and (b) Allergan Pharmaceuticals International Limited, a company incorporated and registered in Ireland, with a business address of Clonshaugh Business & Technology Park, Dublin 17, Ireland and with company number 334821. Richter and AbbVie are sometimes referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, The Parties wish to collaborate with respect to the discovery and development of Licensed Compounds (as defined herein) and Licensed Products (as defined herein);
WHEREAS, Richter Controls (as defined herein) certain intellectual property rights with respect to the Licensed Compounds; and
WHEREAS, Richter wishes to grant, and AbbVie wishes to take, a license under such intellectual property rights to develop and commercialize Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1 DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 "AbbVie" has the meaning set forth in the preamble hereto.
1.2 "AbbVie Formulation Manufacturing Process" has the meaning set forth in Section 4.9.3(b).
1.3 "AbbVie Formulation Manufacturing Technology Transfer" has the meaning set forth in Section 4.9.3(b).
1.4 "AbbVie Grantback License" has the meaning set forth in Section 12.12.1.
1.5 "AbbVie Grantback Technology" has the meaning set forth in Section 12.7.1(c).
1.6 "AbbVie Indemnitees" has the meaning set forth in Section 11.2.
1.7 "AbbVie Know-How" means all Information that is (a) Controlled by AbbVie or any of its Affiliates during the Term, (b) developed or acquired under this Agreement by AbbVie or any of its Affiliates or Sublicensees after the Effective Date and during the Term, (c) not generally known and (d) reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Licensed Compound or a Licensed Product, but excluding any Joint Know-How or any Information published in AbbVie Patents or Joint Patents.
1.8 "AbbVie Patents" means all of the Patents that (a) are Controlled by AbbVie or any of its Affiliates during the Term, (b) claim inventions made or conceived under this Agreement by or on behalf of AbbVie or any of its Affiliates after the Effective Date and during the Term, and (c) are reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture, or Commercialization of a Licensed Compound or a Licensed Product, but excluding any Joint Patents.
1.9 "AbbVie Product Trademarks" means (a) the Trademark(s) to be owned and used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the AbbVie Territory and (b) any registrations thereof or any pending applications relating thereto in the AbbVie Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).
1.10 "AbbVie Proprietary Manufacturing Information" has the meaning set forth in Section 4.9.3(c).
1.11 "AbbVie Prosecuted Infringements" has the meaning set forth in Section 7.3.1(b).
1.12 "AbbVie Supply Agreement" has the meaning set forth in Section 4.9.2(a).
1.13 "AbbVie Territory" means worldwide, except for the Richter Territory.
1.14 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles or (b) to the extent applicable International Financial Reporting Standards as issued by the International Accounting Standards Board, in each case, consistently applied.
1.15 "ADR" has the meaning set forth in Section 13.7.1.
1.16 "Adverse Ruling" has the meaning set forth in Section 12.3.1.
1.17 "Affiliate" means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common control with" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that solely in such cases, such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity.
1.18 "Agreement" has the meaning set forth in the preamble hereto.
1.19 "Alliance Manager" has the meaning set forth in Section 2.2.5.
1.20 "ANDA Act" has the meaning set forth in Section 7.3.3.
1.21 "Annual Net Sales Milestone Threshold" has the meaning set forth in Section 6.3.1.
1.22 "Annual Net Sales-Based Milestone Payment" has the meaning set forth in Section 6.3.1.
1.23 "Annual Net Sales-Based Milestone Payment Date" has the meaning set forth in Section 6.3.1.
1.24 "Annual Net Sales-Based Milestone Table" has the meaning set forth in Section 6.3.1.
1.25 "API" means, in respect of a Licensed Compound or Licensed Product, the active pharmaceutical ingredient for that Licensed Compound or Licensed Product.
1.26 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.
1.27 "Applicable Territory" means (a) with respect to AbbVie, the AbbVie Territory and (b) with respect to Richter, the Richter Territory.
1.28 "Audit Arbitrator" has the meaning set forth in Section 6.13.
1.29 "Backup Compound" has the meaning set forth in Section 3.1.1(c).
1.30 "Bankruptcy Code" has the meaning set forth in Section 12.6.1.
1.31 "Bayh-Dole Act" means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.
1.32 "Bioequivalence Study" means a Clinical Study to establish the bioequivalence of (a) a new formulation of a Licensed Product to (b) an existing formulation of such Licensed Product, which Clinical Study meets the requirements of Title 21 CFR Part 320 or foreign equivalent thereof.
1.33 "Board of Directors" has the meaning set forth in the definition of "Change in Control."
1.34 "Breaching Party" has the meaning set forth in Section 12.3.1.
1.35 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois and Budapest, Hungary are open for business.
1.36 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
1.37 "Calendar Year" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.38 "Change in Control" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:
1.38.1 any Third Party "person" or "group" (as such terms are defined below) acquires or becomes the "beneficial owner" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions ("Voting Stock") of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party or (b) the power to elect a majority of the members of the Party's board of directors, or similar governing body ("Board of Directors"); the Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that, solely in such cases, such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity; or
1.38.2 such Party enters into a merger, consolidation or similar transaction with a Third Party (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction; or
1.38.3 such Party sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party's consolidated total assets to which this Agreement relates; or
1.38.4 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.
For the purpose of this definition of Change in Control, (a) "person" and "group" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term "group" includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the said Act; (b) a "beneficial owner" shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (c) the terms "beneficially owned" and "beneficially own" shall have meanings correlative to that of "beneficial owner."
1.39 "Clinical Data" means all Information with respect to any Licensed Compound or Licensed Product and made, collected, or otherwise generated under or in connection with the Clinical Studies, Clinical Development Activities, or PAC Studies, including any data (including raw data), reports, and results with respect thereto.
1.40 "Clinical Development Activities" has the meaning set forth in Section 3.3.1.
1.41 "Clinical Development Plan" means a development plan setting forth in reasonable detail specific Clinical Studies and other Party Development Activities to be performed by AbbVie with respect to any Licensed Product.
1.42 "Clinical Studies" means Phase 0 Studies, Phase I Studies, Phase II Studies, Phase III Studies, PAC Studies and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain any Regulatory Approval for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.
1.43 "Combination Product" means a Licensed Product that is comprised of or contains one (1) or more Licensed Compounds as an active ingredient together with one (1) or more other active ingredients, whether in the same or different formulations, and is sold either as a fixed dose or as separate doses as one (1) product.
1.44 "Commercialization" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Compound or Licensed Product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Medical Affairs Activities, and interacting with Regulatory Authorities or other Governmental Authorities regarding any of the foregoing. When used as a verb, "to Commercialize" and "Commercializing" means to engage in Commercialization, and "Commercialized" has a corresponding meaning.
1.45 "Commercially Reasonable Efforts" means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to a Licensed Compound or Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that such Party would typically devote to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the Party would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative products (including generic or biosimilar products), the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. "Commercially Reasonable Efforts" shall be determined on a country-by-country (or region-by-region, where applicable) and Indication-by-Indication basis, except that the Party may consider the impact of its efforts and resources expended with respect to any country (or region) on any other country (or region). To the extent that the performance of a Party's obligations hereunder is adversely affected by the other Party's failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such Party has used its Commercially Reasonable Efforts to perform any such affected obligation.
1.46 "Competing Generic Product" means, with respect to a Competing Product that is sold by a Third Party under a Drug Approval Application granted to such Third Party by a Regulatory Authority in a country or jurisdiction, any product that; (a) contains a compound, molecule or other therapeutic that is or that generates a D3 Receptor Modulator, other than cariprazine, as an active ingredient; and (b) is approved for sale in such country or jurisdiction in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Competing Product as determined by such Regulatory Authority, including any product authorized for sale (i) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (ii) in any other country or jurisdiction, pursuant to all equivalents of such provisions or of Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j)), including any amendments and successor statutes with respect to the subsections (i) through (ii) thereto.
1.47 "Competing Product" means any D3 Receptor Modulator Competing Product or Pro-Metabolite Competing Product.
1.48 "Competitive Acquisition" means a transaction in which a Party acquires a Third Party (whether such acquisition occurs by way of a purchase of assets, merger, consolidation, change of control, or otherwise), other than by way of a Change in Control of such Party, where such Third Party, as of immediately prior to the consummation of such acquisition, is researching, developing or commercializing any product in the anti-psychotic field (other than a Competing Generic Product or other generic product acquired by Richter for research, development or commercialization in the Richter Territory).
1.49 "Conduct" means, with respect to any Clinical Study or PAC Study, to (a) sponsor, support or perform, directly or indirectly through a Third Party, such Clinical Study or PAC Study; or (b) provide to a Third Party funding for, or clinical supplies (including placebos) for use in, such Clinical Study or PAC Study.
1.50 "Confidential Information" means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including Information relating to the terms of this Agreement, any Licensed Compound or Licensed Product (including the Regulatory Documentation and Regulatory Data), any Exploitation of any Licensed Compound or Licensed Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including AbbVie Know-How and Richter Know-How, as applicable), or the scientific, regulatory or business affairs or other activities of either Party. In addition, each Party's "Confidential Information," as such term is defined under the Existing Confidentiality Agreement will be deemed to be such Party's Confidential Information under this Agreement. Notwithstanding the foregoing, (a) Joint Know-How shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto, and (b) all Regulatory Documentation owned by AbbVie pursuant to Section 3.10.1 shall be deemed to be the Confidential Information of AbbVie, and AbbVie shall be deemed to be the disclosing Party and Richter shall be deemed to be the receiving Party with respect thereto.
1.51 "Control" means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Section 5.1 or Section 5.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.
1.52 "Convicted Entity" has the meaning set forth in Section 10.2.21(d).
1.53 "Convicted Individual" has the meaning set forth in Section 10.2.21(d).
1.54 "Corporate Names" means (a) with respect to Richter, the Trademarks and logos identified on Schedule 1.54(a) and such other names and logos as Richter may designate in writing from time to time and (b) with respect to AbbVie, the Trademarks and logos identified on Schedule 1.54(b) and such other names and logos as AbbVie may designate in writing from time to time.
1.55 "D3 Receptor" means all forms of the polypeptide designated as dopamine receptor 3, corresponding to the human dopamine 3 receptor protein (as exemplified in National Center for Biotechnology Information also identified as UniProtKB:P35462, X5D2G4, E9PCM4, A1A4V4, Q13167, Q9BXX6, X5DP70, Q9NY31, A8K8E4, Q16045; HGNC: HGNC:3024; Entrez Gene: Gene ID: 1814; Ensembl: ENSG00000151577 etc.), and all forms of the protein (including isoforms, mutations, conformations, post-translational modifications or other forms thereof) in human and other species, encoded by the dopamine receptor 3 gene (as exemplified by Entrez gene ID Mus musculus: 13490; Rattus norvegicus: 29238, Ensembl Transcript ID Homo sapiens: DRD3-202: ENST00000383673.5, DRD3-203: ENST00000460779.5, DRD3-204: ENST00000467632.5, DRD3-201: ENST00000295881.9) including all transcript variants.
1.56 "D3 Receptor Compound" means any D3 Receptor Modulator Controlled by Richter or any of its Affiliates as of the Effective Date or at any time during the Discovery Program Term, including (a) the compounds set forth on Schedule 1.56 and (b) any compounds identified by Richter during the Discovery Program Term under the D3 Receptor Discovery Program that meet the D3 Receptor Compound Criteria set forth in the D3 Receptor Discovery Program Plan, that is not (i) a compound generated from a Pro-metabolite Compound or (ii) cariprazine, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.
1.57 "D3 Receptor Compound Criteria" means the criteria agreed upon by the Parties for the compound, molecule or other therapeutic identified during the conduct of the D3 Receptor Discovery Program, as set forth in the D3 Receptor Discovery Program Plan.
1.58 "D3 Receptor Discovery Program" means the program of discovery and pre-clinical activities for novel D3 Receptor Modulators undertaken as set forth in Section 3.1 and the D3 Receptor Discovery Program Plan.
1.59 "D3 Receptor Discovery Program Plan" means the written summary attached hereto as Schedule 1.59 including any amendments thereto, of the specific research activities to be conducted by Richter under the D3 Receptor Discovery Program, the timelines for completion of such activities, and the corresponding D3 Receptor Compound Criteria.
1.60 "D3 Receptor Modulator" means any compound, molecule or other therapeutic that binds, agonizes, antagonizes or otherwise modulates the D3 Receptor with a Ki/EC50/IC50/KB value less than 1 micromolar.
1.61 "D3 Receptor Modulator Competing Product" means any product that is or contains a compound, molecule or other therapeutic that is a D3 Receptor Modulator, other than cariprazine as exploited pursuant to the Existing Collaboration Agreement.
1.62 "D3 Receptor Product" any product containing a D3 Receptor Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, presentations, delivery systems, dosages, and formulations.
1.63 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, Processing and security of Personal Data.
1.64 "Debarred Entity" has the meaning set forth in Section 10.2.21(d).
1.65 "Debarred Individual" has the meaning set forth in Section 10.2.21(a).
1.66 "Default Notice" has the meaning set forth in Section 12.3.1.
1.67 "Development" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies (excluding Phase IV Studies), Bioequivalence Study, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, "Develop" means to engage in Development. Development shall include PAC Studies. For purposes of clarity, Development shall include any submissions and activities required in support thereof, including as required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved Licensed Product.