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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 Ente... |
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 u... |
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 usefu... |
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 ... |
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 Sta... |
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 ... |
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 f... |
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 Oc... |
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... |
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 ... |
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 constitut... |
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 t... |
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 t... |
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 Pr... |
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) produc... |
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 purpose... |
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 su... |
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 generat... |
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 ... |
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... |
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... |
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... |
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; HG... |
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... |
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 Recepto... |
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 Phas... |
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