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1.7 "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 c... |
1.8 "Agreement" has the meaning set forth in the preamble hereto. |
1.9 "Alliance Manager" has the meaning set forth in Section 2.2.8. |
1.10 "Annual Net Sales Milestone Threshold" has the meaning set forth in Section 6.4. |
1.11 "Annual Net Sales-Based Milestone Payment" has the meaning set forth in Section 6.4. |
1.12 "Annual Net Sales-Based Milestone Payment Date" has the meaning set forth in Section 6.4. |
1.13 "Annual Net Sales-Based Milestone Table" has the meaning set forth in Section 6.4. |
1.14 "Antibody(ies)" means: |
1.14.1 an immunoglobulin (Ig) molecule, generally comprising four (4) polypeptide chains, two (2) heavy (H) chains and two (2) light (L) chains, or an equivalent Ig homologue thereof (e.g., a camelid nanobody, which comprises only a heavy chain, single domain antibodies (dAbs) which can be either heavy or light chain);... |
1.14.2 a molecule comprising at least one (1) polypeptide chain that is not full length, including (a) a Fab fragment, which is a monovalent fragment consisting of the variable light (VL), variable heavy (VH), constant light (CL) and constant heavy 1 (CH1) domains; (b) a F(ab')2 fragment, which is a bivalent fragment c... |
1.15 "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, which may be in effect ... |
1.16 "Audit Arbitrator" has the meaning set forth in Section 6.16. |
1.17 "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. |
1.18 "Biosimilar Application" has the meaning set forth in Section 7.3.2. |
1.19 "Biosimilar Product" means, on a country-by-country basis, with respect to a Licensed Product, a biologic product (a) whose licensing, approval, or marketing authorization relies in whole or in part on (i) a prior Regulatory Approval granted for such Licensed Product or (ii) any data generated in support of a prio... |
1.20 "BLA" has the meaning set forth in the definition of "Drug Approval Application." |
1.21 "Board of Directors" has the meaning set forth in the definition of "Change in Control." |
1.22 "Breaching Party" has the meaning set forth in Section 12.3.1. |
1.23 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois and Paris, France are open for business. |
1.24 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1, or 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 O... |
1.25 "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... |
1.26 "Centralized Approval Procedure" means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.27 "Change in Control," with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.27.1 any "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 (or any controlling Affiliate) then outstanding and normally entitled ... |
1.27.2 such Party (or any controlling Affiliate) enters into a merger, consolidation or similar transaction with another Person (whether or not such Party (or any controlling Affiliate) is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Director... |
1.27.3 such Party (or any controlling Affiliate) 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 (or any controlling Affiliate's) total assets to which this Agreement relates; or |
1.27.4 the holders of capital stock of such Party (or any controlling Affiliate) approve a plan or proposal for the liquidation or dissolution of such Party (or any controlling Affiliate). |
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... |
1.28 "Clinical Studies" means any tests and studies in human subjects that are required or permitted by Applicable Law to obtain or maintain any Regulatory Approval for, or to support the pricing, reimbursement or use of, a Licensed Product, including tests or studies that are intended to expand the Product Labeling fo... |
1.29 "CMO Supply Agreements" means the manufacturing supply contracts between OSE and Third Party manufacturer for the supply of Licensed Antibody and Licensed Product, all of which are set forth in Schedule 1.29. |
1.30 "Combination Product" means a Licensed Product containing one (1) or more Licensed Antibodies and one (1) or more Other Active Ingredients. By way of example, and not meant to limit the foregoing definition, a Combination Product includes: |
(a) a Licensed Product that contains (i) one (1) or more Licensed Antibodies and (ii) one (1) or more Other Active Ingredients, such as a conventional Antibody, each of which are in the same formulation; and |
(b) a Licensed Product that is one (1) molecule (e.g., dual specific, bispecific, multispecific or dual variable domain immunoglobulins) whereby (i) a component of such Antibody is the binding portion of the Licensed Antibody and (ii) another component of such an Antibody is the binding portion of a different Antibody,... |
1.31 "Commercialization" means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Antibody or Licensed Product, including activities related to marketing, promoting, distributing, importing, and exporting such Licensed Antibody or Licensed Product, including cond... |
1.32 "Commercially Reasonable Efforts" means with respect to the performance of activities with respect to a Licensed Antibody or Licensed Product by AbbVie, the carrying out of such activities using efforts and resources comparable to the efforts and resources that AbbVie and its Affiliates would typically devote to a... |
1.33 "Competing Product" has the meaning set forth in Section 13.2.2. |
1.34 "Confidential Information" means any Information 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... |
1.35 "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 i... |
1.36 "Convicted Entity" has the meaning set forth in Section 10.2.20(d). |
1.37 "Convicted Individual" has the meaning set forth in Section 10.2.20(d). |
1.38 "CREATE Act" has the meaning set forth in Section 7.2.5. |
1.39 "Data" means any and all Information, in any form (including data, reports and results), that is made, collected, or otherwise generated with respect to any Licensed Antibody or Licensed Product (raw, analyzed, etc.), including from Clinical Studies. |
1.40 "Data Breach" has the meaning set forth in Section 8.1.3. |
1.41 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.42 "Debarred Entity" has the meaning set forth in Section 10.2.20(b). |
1.43 "Debarred Individual" has the meaning set forth in Section 10.2.20(a). |
1.44 "Default Notice" has the meaning set forth in Section 12.3.1. |
1.45 "Defense Proceeding" has the meaning set forth in Section 7.2.1. |
1.46 "Derived" means in whole or in part obtained, developed, created, designed, derived or resulting from, based upon, containing, incorporating or otherwise generated from. |
1.47 "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, including Manu... |
1.48 "Dispute" has the meaning set forth in Section 13.8. |
1.49 "Distributor" has the meaning set forth in Section 5.3. |
1.50 "Dollars" or "$" means United States Dollars. |
1.51 "Drug Approval Application" means a Biologics License Application (a "BLA") as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a "MAA") filed with the EMA pursuant to the Centralized Approval Proc... |
1.52 "EEA" means the European Economic Area. |
1.53 "Effective Date" has the meaning set forth in Section 12.2.1. |
1.54 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.55 "European Major Market" means each of the following: the United Kingdom, Germany, France, Italy, and Spain. |
1.56 "European Union" or "E.U." means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. |
1.57 "Excluded Entity" has the meaning set forth in Section 10.2.20(c). |
1.58 "Excluded Individual" has the meaning set forth in Section 10.2.20(c). |
1.59 "Execution Date" has the meaning set forth in the preamble hereto. |
1.60 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.61 "Exploit" or "Exploitation" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of. |
1.62 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.63 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.2.20(e). |
1.64 "Federally Funded Invention" means any invention or discovery that (a) was conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof; (b) is a "subject invention" as that term is de... |
1.65 "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.66 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.67 "First Commercial Sale" means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country, including any sale to a wholesaler or Distributor, after all Regulatory Approvals (but excluding any post-approval mark... |
1.68 "FTE" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of eighteen hundred (1800) hours per Calendar Year) of work performing Development, Commercialization or Manufacturing activities for a Licensed Antibody or Licensed Product. No additional... |
1.69 "Good Manufacturing Practice" or "GMP" means the current good manufacturing practices applicable from time to time to the Manufacturing of a Licensed Antibody or Licensed Product or any intermediate thereof pursuant to Applicable Law. |
1.70 "Grantback Option" has the meaning set forth in Section 12.6.1. |
1.71 "Grantback Transition Agreement" has the meaning set forth in Section 12.8.1. |
1.72 "HSR Act" means the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended. |
1.73 "HSR Filing" has the meaning set forth in Section 12.2.1. |
1.74 "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or re... |
1.75 "Indemnification Claim Notice" has the meaning set forth in Section 11.3. |
1.76 "Indemnified Party" has the meaning set forth in Section 11.3. |
1.77 "Indication" means, with respect to a Licensed Product, a use to which such Licensed Product is intended to be put for the treatment, prevention or cure of a distinct recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recogni... |
1.78 "Indirect Taxes" has the meaning set forth in Section 6.13. |
1.79 "Inflation Reduction Act" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as it may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, e... |
1.80 "Information" means all information and data of a technical, scientific, business or other nature, including technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs,... |
1.81 "Interim Period" has the meaning set forth in Section 10.2.30. |
1.82 "JGC" has the meaning set forth in Section 2.1.1 |
1.83 "Joint Intellectual Property Rights" has the meaning set forth in Section 7.1.2. |
1.84 "Joint Know-How" has the meaning set forth in Section 7.1.2. |
1.85 "Joint Patents" has the meaning set forth in Section 7.1.2. |
1.86 "Know-How" means all knowledge, materials, and Information, including inventions (whether patentable or not), in each case in written, electronic or any other form now known or hereafter developed. |
1.87 "Knowledge" means the knowledge of the CEO, the Chief of Development and Strategy and the Chief Business Officer of OSE after conducting reasonable (i) internal inquiries and (ii) external inquiries of OSE's outside intellectual property counsel as they relate to representations and warranties concerning the Licen... |
1.88 "Licensed Antibody" means (a) OSE-230, an Antibody directed against chemerin chemokine-like receptor 1 (referred to as "ChemR23" or "CMKLR1"), and (b) any other Antibody that binds to, inhibits or otherwise modulates ChemR23 that is owned, Controlled or invented by or on behalf of OSE before, on or after the Effec... |
1.89 "Licensed IP" means the OSE Know-How, OSE Patents and OSE's interest in any Joint Know-How and Joint Patents. |
1.90 "Licensed Product" means any product, or portion thereof, containing a Licensed Antibody, alone or in combination with one (1) or more other active substances, in any and all forms, presentations, delivery systems, dosage form, dosage strength and formulations. |
1.91 "Losses" has the meaning set forth in Section 11.1. |
1.92 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.93 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Licensed Antibody, any Licensed Product, or any intermediate thereof, including process development, process... |
1.94 "Manufacturing Process" has the meaning set forth in Section 3.4.1. |
1.95 "Manufacturing Technology Transfer" has the meaning set forth in Section 3.4.1. |
1.96 "Maximum Fair Price" has the meaning set forth in Section 1191(c)(3) of the Social Security Act. |
1.97 "Medical Affairs Activities" means, with respect to a Licensed Antibody or Licensed Product with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Antibodies or Licensed Products, incl... |
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