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Schedule 10.2.1 Existing Patents |
Schedule 10.8 Representations and Warranties for the Option Data Package Disclosure Schedule |
Schedule 13.7.3 ADR Procedures |
COLLABORATION AND OPTION TO LICENSE AGREEMENT |
This Collaboration and Option to License Agreement (this "Agreement") is made and entered into effective as of October 12, 2021 (the "Effective Date") by and between Plexium, Inc., a Delaware corporation ("Plexium"), and AbbVie Global Enterprises Ltd., a company organized under the laws of Bermuda ("AbbVie"). Plexium a... |
RECITALS |
WHEREAS, Plexium has developed and owns proprietary platform technology that identifies E3 ligase modulating small molecules; |
WHEREAS, the Parties wish to collaborate to conduct certain research programs using Plexium's proprietary platform technology; and |
WHEREAS, Plexium wishes to grant, and AbbVie wishes to take, exclusive options to take one or more Exclusive Licenses (as defined herein) under certain intellectual property rights to Exploit Licensed Compounds (as defined herein) and Licensed Products (as defined herein), if any, in each case, in accordance with the t... |
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 Agreement IP" means all Information, Patents and other intellectual property rights that are (a) conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or sublicensees) under or in connection with this Agreement, and (b) necessary or reasonably u... |
1.3 "AbbVie Background Technology" means all Information (including, to the extent applicable, Regulatory Documentation) Controlled by AbbVie or any of its Affiliates (a) prior to the Effective Date, or (b) on or after the Effective Date during the Term, outside of the scope of this Agreement, in either case (a) or (b)... |
1.4 "AbbVie Competitor" means a pharmaceutical company that has a Competitive Program. |
1.5 "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.6 "AbbVie Product Patents" mean any Product Patent that is conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or sublicensees) under or in connection with this Agreement, and that AbbVie owns in accordance with Section 8.1.1. |
1.7 "AbbVie Prosecuted Infringements" has the meaning set forth in Section 8.3.4. |
1.8 "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... |
1.9 "Acquiring Party" has the meaning set forth in Section 6.9.2. |
1.10 "ADR" has the meaning set forth in Section 13.7.1. |
1.11 "Adverse Ruling" has the meaning set forth in Section 12.2.1. |
1.12 "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 ... |
1.13 "Agreement" has the meaning set forth in the preamble hereto. |
1.14 "Alliance Manager" has the meaning set forth in Section 2.2.6. |
1.15 "Alternative Remedy Trigger" has the meaning set forth in Section 12.6.2. |
1.16 "Annual Net Sales Based Milestone Table" has the meaning set forth in Section 7.6. |
1.17 "Annual Net Sales Milestone Threshold" has the meaning set forth in Section 7.6. |
1.18 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be ... |
1.19 "Audit Arbitrator" has the meaning set forth in Section 7.15. |
1.20 "Available Target" means any target that is not, as of the date selected by AbbVie, (a) the subject of an existing agreement between Plexium or its Affiliates, on the one hand, and a Third Party, on the other hand, as evidenced by, in Plexium's sole discretion, (i) a written definitive agreement (which such agreem... |
1.21 "Bankruptcy Code" has the meaning set forth in Section 12.5.1. |
1.22 "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. |
1.23 "Board of Directors" has the meaning set forth in Section 1.31.1 |
1.24 "Breaching Party" has the meaning set forth in Section 12.2.1. |
1.25 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois are open for business. |
1.26 "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... |
1.27 "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... |
1.28 "Cancelled Research Plan Activities" has the meaning set forth in Section 3.2.1(b). |
1.29 "CDA" means that certain Bilateral Confidential Disclosure Agreement by and between the Parties dated April 21, 2020, as amended. |
1.30 "Centralized Approval Procedure" means the procedure through which an MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.31 "Change in Control," with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.31.1 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 then outstanding and normally entitled (without regard to the occurren... |
1.31.2 such Party enters into a merger, consolidation or similar transaction with another Person (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 constitu... |
1.31.3 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 total assets to which this Agreement relates; or |
1.31.4 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... |
1.32 "Clinical Program Data" means all Information with respect to any Licensed Compound or Licensed Product that is made, collected, or otherwise generated under or in connection with any Clinical Study, including any raw data, reports, and results with respect thereto. For clarity, "Clinical Program Data" includes an... |
1.33 "Clinical Study" means clinical 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 expa... |
1.34 "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 (a) is sold as a fixed dose unit at a single price, or (b) is sold in... |
1.35 "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 interacting ... |
1.36 "Commercially Reasonable Efforts" means, (a) with respect to the performance of Development, Commercialization or Manufacturing activities with respect to any Compound or Product by AbbVie, the carrying out of such activities using reasonable and diligent efforts and resources comparable to the efforts and resourc... |
1.37 "Competitive Program" has the meaning set forth in Section 6.9.2. |
1.38 "Compound" means an Option Compound or Licensed Compound, as applicable. For the purpose of clarity, Compound does not include any Rejected Compound. |
1.39 "Confidential Information" means any Information provided orally, visually, in writing, electronically or in any 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, w... |
1.40 "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... |
1.41 "Convicted Entity" has the meaning set forth in Section 10.5.4. |
1.42 "Convicted Individual" has the meaning set forth in Section 10.5.4. |
1.43 "Cost-Sharing Option" has the meaning set forth in Section 5.3.2. |
1.44 "Cost-Sharing Option Data Package" means, with respect to an applicable Licensed Product, copies of (a) the Investigator's Brochure, (b) all available interim Clinical Study reports and all regulatory filings and communications in AbbVie's possession, and (c) any other information or documentation in AbbVie's cont... |
1.45 "Cost-Sharing Option Exercise Notice" means Plexium's written notice to AbbVie exercising the Cost-Sharing Option. |
1.46 "Cost-Sharing Option Package" means, with respect to an applicable Licensed Product, (a) a Cost-Sharing Option Data Package, and (b) a Non-Binding Budget, and (c) a complete and accurate description, together with reasonable documentation, of the costs incurred by AbbVie in connection with Development activities c... |
1.47 "Cost-Sharing Option Period" means, with respect to each Licensed Product, the period beginning on the License Option Effective Date and ending ninety (90) days after Plexium's receipt of the complete Cost-Sharing Option Package for such Licensed Product. |
1.48 "Cost-Sharing Period" means, with respect to the Cost-Sharing Product, the period beginning upon the date of delivery of Plexium's Cost-Sharing Option Exercise Notice and continuing through the date of First Commercial Sale of the Cost-Sharing Product; provided that, in the event the Cost-Sharing Product is being ... |
1.49 "Cost-Sharing Product" has the meaning set forth in Section 5.3.2. |
1.50 "Cost-Sharing Royalty" has the meaning set forth in Section 7.7.1(b). |
1.51 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, data protection, integrity, Processing and security of Personal Data, including but not limited to: (a) federal and state Applicable Laws, including the Health Insurance Portability and Accountability Act of 1996, as amended and al... |
1.52 "Debarred Entity" has the meaning set forth in Section 10.5.2. |
1.53 "Debarred Individual" has the meaning set forth in Section 10.5.1. |
1.54 "Default Notice" has the meaning set forth in Section 12.2.1. |
1.55 "Deferral Notice" has the meaning set forth in Section 5.3.6. |
1.56 "Deferred Excess Shared Costs" has the meaning set forth in Section 5.3.7. |
1.57 "Dependent Research Plan Activities" has the meaning set forth in Section 3.2.1(a). |
1.58 "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, pre-clinical studies (including ... |
1.59 "Development Costs" means, with respect to the Cost-Sharing Product (or a potential Cost-Sharing Product), the fully-burdened internal and out-of-pocket costs and expenses incurred by or on behalf of AbbVie or any of its Affiliates (including FTE Costs) in accordance with Accounting Standards, this Agreement, the ... |
1.60 "Dispute" has the meaning set forth in Section 13.7. |
1.61 "Distributor" has the meaning set forth in Section 6.5. |
1.62 "DOJ" means the United States Department of Justice, or any successor department or body thereto. |
1.63 "Dollars" or "$" means United States Dollars. |
1.64 "Drug Approval Application" means a New Drug Application 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 Procedure or with the a... |
1.65 "Effective Date" means the effective date of this Agreement as set forth in the preamble hereto. |
1.66 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.67 "European Major Markets" means the United Kingdom, France, Germany, Italy and Spain. |
1.68 "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. |
1.69 "Excess Shared Costs" has the meaning set forth in Section 5.3.6. |
1.70 "Excluded Entity" has the meaning set forth in Section 10.5.3. |
1.71 "Excluded Individual" has the meaning set forth in Section 10.5.3. |
1.72 "Exclusive License" has the meaning set forth in Section 6.2.1. |
1.73 "Exclusive Rejected Compound" means any Rejected Compound that satisfies the Preliminary Hit Criteria (including, for clarity, any compounds in the same chemical series that did not satisfy the Preliminary Hit Criteria) for an applicable Research Plan. |
1.74 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.75 "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, optimize, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, transport, or ot... |
1.76 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.77 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.5.5. |
1.78 "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). |
1.79 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.80 "First Commercial Sale" means, with respect to a Licensed Product and a country or other jurisdiction, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country or other jurisdiction after all Regulatory Approvals for such Licensed Product has been obtained i... |
1.81 "FTC" means the United States Federal Trade Commission, or any successor agency thereto. |
1.82 "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 activities pursuant to this Agreement. Any person who devotes less than eighteen hundred (1800) hours per Calendar Ye... |
1.83 "FTE Costs" means, with respect to AbbVie or its Affiliates for any period, the FTE Rate multiplied by the applicable number of FTEs of such Party or its Affiliates performing Development activities related to the Cost-Sharing Product (or a potential Cost-Sharing Product). |
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