text stringlengths 1 5.46k |
|---|
13.4 Assignment. ..................................................................................................... 68 |
13.5 Severability ..................................................................................................... 69 |
13.6 Governing Law, Jurisdiction and Service. .......................................................... 69 |
13.7 Dispute Resolution ........................................................................................... 70 |
13.8 Notices. ........................................................................................................... 70 |
13.9 Entire Agreement; Amendments ....................................................................... 71 |
13.10 English Language ............................................................................................ 72 |
13.11 Equitable Relief ............................................................................................... 72 |
13.12 Waiver and Non-Exclusion of Remedies ............................................................ 72 |
13.13 No Benefit to Third Parties ............................................................................... 72 |
13.14 Further Assurance ........................................................................................... 72 |
13.15 Relationship of the Parties ................................................................................ 72 |
13.16 Performance by Affiliates ................................................................................. 72 |
13.17 Counterparts; Facsimile Execution.................................................................... 73 |
13.18 References ....................................................................................................... 73 |
13.19 Schedules ........................................................................................................ 73 |
13.20 Construction.................................................................................................... 73 |
SCHEDULES |
Schedule 1.63 Humanized 5H10 Antibody |
Schedule 1.72 Initial Development Plan and Budget |
Schedule 1.107 Operational Plan and Budget |
Schedule 1.150 University Patent Rights |
Schedule 3.6 Third Party Providers |
Schedule 6.3.1 Phase I/IA Milestone Criteria |
Schedule 6.3.2 Biomarker Milestone Criteria |
Schedule 6.3.3 Phase I/IB Milestone Criteria |
Schedule 10.1.4 No Inconsistent Obligation |
Schedule 10.2 Disclosure Schedule |
Schedule 13.7.3 ADR Procedures |
OPTION AGREEMENT |
This Option Agreement (the "Agreement") is made and entered into effective as of December 14, 2020 (the "Effective Date") by and between Opsidio, LLC, a Delaware limited liability company ("Licensor"), and AbbVie Global Enterprises Ltd., a Bermuda company ("AbbVie"). Licensor and AbbVie are sometimes referred to herein... |
RECITALS |
WHEREAS, Licensor Controls (as defined herein) certain intellectual property rights with respect to the Licensed Antibodies (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and |
WHEREAS, Licensor wishes to grant an option to a license to AbbVie, and AbbVie wishes to take, such option to 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 Grantback IP" means, as used in connection with a Licensed Product (as such Licensed Product exists as of the effective date of a termination (whether in whole or in part) of this Agreement) and any related grant back license provided in Section 12.7.1(c) or 12.8.2, (a) all Information that is (i) Controlle... |
1.3 "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.4 "AbbVie Patents" means all of the Patents that (a) are Controlled by AbbVie or any of its Affiliates during the Term, (b) claim inventions conceived, reduced to practice, discovered, developed or made by or on behalf of AbbVie or any of its Affiliates after the Effective Date and during the Term as a result of perf... |
1.5 "Abzena Agreement" means, that Research and License Agreement between Licensor and Antitope Limited (d/b/a Abzena), effective as of November 9, 2017, as amended on November 18, 2020. |
1.6 "Acceptance" means, with respect to a Drug Approval Application, receipt of written notice from the applicable Regulatory Authority indicating that such Drug Approval Application has been accepted for filing and further review. |
1.7 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with United States Generally Accepted Accounting Principles. |
1.8 "ADR" has the meaning set forth in Section 13.7.1. |
1.9 "Adverse Ruling" has the meaning set forth in Section 12.2.1. |
1.10 "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... |
1.11 "Agreement" has the meaning set forth in the preamble hereto. |
1.12 "Alliance Manager" has the meaning set forth in Section 2.2.5. |
1.13 "Antibody(ies)" means any molecule including an immunoglobulin domain or immunoglobulin-like domain, and any derivative, variant, mutant or functional equivalent thereof, that binds to a target of interest, where such molecules include, but are not limited to, full-length antibodies, camelid nanobodies, single dom... |
1.14 "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 ... |
1.15 "Audit Arbitrator" has the meaning set forth in Section 6.14. |
1.16 "Bankruptcy Code" has the meaning set forth in Section 12.6.1. |
1.17 "Biosimilar Application" has the meaning set forth in Section 7.3.3. |
1.18 "Biosimilar Competition" has the meaning set forth in Section 6.6.3(a). |
1.19 "Biosimilar Product" means with respect to a Licensed Product and, on a country-by-country basis, a biologic product (a) whose licensing, approval, or marketing authorization, or whose application for such licensing, approval or marketing authorization, relies in whole or in part on a prior approval, licensing or ... |
1.20 "BLA" has the meaning set forth in Section 1.46. |
1.21 "Board of Directors" has the meaning set forth in Section 1.27. |
1.22 "Breaching Party" has the meaning set forth in Section 12.2.1. |
1.23 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois 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 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... |
1.25 "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 "Capable Biotech Company" has the meaning set forth in Section 1.32.2. |
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) (a) is or becomes the "beneficial owner" (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of ... |
1.27.2 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... |
1.27.3 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 assets to which this Agreement relates; or |
1.27.4 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... |
1.28 "Clinical Data" means all Information with respect to any Licensed Antibody or Licensed Product and made, collected, or otherwise generated under or in connection with Clinical Studies for a given Licensed Antibody or Licensed Product, including any data (including raw data), reports, and results with respect ther... |
1.29 "Clinical Studies" means studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more Indications, including tests or studies in human subjects that are intended to expand... |
1.30 "Combination Product" means a Licensed Product that is: (a) sold in the form of a combination product containing both a Licensed Antibody and one (1) or more other therapeutically active pharmaceutical or biologic products; or (b) sold in a form that contains (or is sold bundled with) any (i) diagnostic product or... |
1.31 "Commercialization" means any and all activities related to the preparation for sale of, offering for sale of, or sale of the Licensed Antibody or Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Antibody or Licensed Product, and interactin... |
1.32 "Commercially Reasonable Efforts" means: |
1.32.1 with respect to the efforts and resources to be expended, or considerations to be undertaken, by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Development, Manufacture or Commercialization of a Licensed Antibody or Licensed Product, the use of such efforts and re... |
1.32.2 with respect to the efforts and resources to be expended, or considerations to be undertaken, by Licensor with respect to any objective, activity or decision to be undertaken with respect to a Licensed Antibody or Licensed Product, the level of effort required to carry out an obligation in a sustained, active ma... |
1.33 "Competing Product" means any product that (a) contains any molecule or other therapeutic that binds to SCF248, or (b) contains a Licensed Antibody. |
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 other Party) in connection with this Agreement, whether prior to, ... |
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 in... |
1.36 "CSR Notification Date" has the meaning set forth in Section 12.7.2(e). |
1.37 "Data Breach" has the meaning set forth in Section 8.4. |
1.38 "Data Package" means the final written data package delivered by Licensor to AbbVie promptly, and in any case within thirty (30) days after the completion of all activities under the Initial Development Plan and Budget containing all data, findings, results and information either described in the Initial Developme... |
1.39 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.40 "Default Notice" has the meaning set forth in Section 12.2.1. |
1.41 "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... |
1.42 "Disclosure Schedule" has the meaning set forth in Section 10.2. |
1.43 "Dispute" has the meaning set forth in Section 13.7. |
1.44 "Distributor" has the meaning set forth in Section 5.3. |
1.45 "Dollars" or "$" means United States Dollars. |
1.46 "Drug Approval Application" means a Biologics License Application (a "BLA") as defined in the PHSA, 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 or with the applicable Regulatory Authorit... |
1.47 "Early Exercise Data Package" means the written data package delivered by Licensor to AbbVie promptly, and in any case within sixty (60) days of Licensor's receipt of written notice from AbbVie pursuant to Section 3.2.2 prior to the date of AbbVie's receipt of the Data Package, comprised of all data, information a... |
1.48 "Effective Date" means the effective date of this Agreement as set forth in the preamble hereto. |
1.49 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.50 "European Union" 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. |
1.51 "Excluded Intellectual Property" has the meaning set forth in Section 13.4.2. |
1.52 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.53 "Existing Third Party Royalty Obligations" means the lesser of (a) the amount equal to the Licensor's aggregate royalty obligations payable under (i) that certain draft Scope of Work between Selexis SA and Licensor dated July, 7 2020, (Proposal Number: 20/YO/003: Generation Of Stable Cell Pools And Research Cell B... |
1.54 "Exploit" or "Exploitation" means to make, have made, import, export, use, sell, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribu... |
1.55 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.56 "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). |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.