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1.43 "Board of Directors" has the meaning set forth in the definition of "Change in Control." |
1.44 "Breaching Party" has the meaning set forth in Section 12.2. |
1.45 "Bundle" means a Licensed Product sold together with one or more Other Products at a single price. |
1.46 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois are open for business. |
1.47 "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... |
1.48 "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... |
1.49 "CD33" means that certain transmembrane receptor protein expressed on cells of myeloid lineage known as "myeloid cell surface antigen CD33" (CD33) (and also known as "sialic acid-binding Ig-like lectin 3" (Siglec-3) or "gp67") described in UniProtKB-P20138 (CD33_Human). In addition to the amino acid sequence descr... |
1.50 "CDR" means the complementarity-determining region of an antigen binding region of an antibody as defined by the Kabat numbering scheme (Kabat et al., Sequences of Proteins of Immunological Interest (1991)). |
1.51 "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. |
1.52 "Change in Control," with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Execution Date: |
1.52.1 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 ... |
1.52.2 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... |
1.52.3 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 |
1.52.4 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... |
1.53 "Clinical Data" means the original human subject data and case report forms (CRFs) collected or generated with respect to Clinical Studies or Phase IV Studies of any Licensed Antibody or Licensed Product, together with all analysis, reports, and results with respect thereto. |
1.54 "Clinical Studies" means Phase 0, Phase I, Phase II, Phase III, 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 Regulatory Approvals for a Licensed Product for one (1) or more Indications, includin... |
1.55 "Close Homolog" has the meaning set forth in Section 12.8.1(c). |
1.56 "COGS + Royalty" has the meaning set forth in Section 6.5.2(c). |
1.57 "Collaboration Program" means a program of research, Development and Commercialization activities with respect to Licensed Antibodies and Licensed Products directed to a particular Collaboration Target (i.e., either CD33 or Trem2) conducted pursuant to this Agreement. |
1.58 "Collaboration Target" means Trem2 or CD33, as applicable. |
1.59 "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, and, for purpos... |
1.60 "Commercialization Plan and Budget" has the meaning set forth in Section 4.2. |
1.61 "Commercialization Wind-down Period" has the meaning set forth in Section 12.9.2. |
1.62 "Commercially Reasonable Efforts" means with respect to the efforts to be expended by a Party with respect to any objective, reasonable, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances for such Party's benefit. Without l... |
1.63 "Conduct" means, with respect to any Clinical Study, to (a) sponsor, support or perform, directly or indirectly through a Third Party, such Clinical Study; or (b) provide to a Third Party funding for, or clinical supplies (including placebos) for use in, such Clinical Study. |
1.64 "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... |
1.65 "Continuing Phase III Readiness Activities" means those CMC activities described in the CMC section of the Pre Exercise Development Plan and Budget that are marked with a double asterisk and that are intended to be commenced by Licensor prior to Option exercise and continued by AbbVie after Option exercise. |
1.66 "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... |
1.67 "Controlling Party" has the meaning set forth in Section 7.2.2. |
1.68 "Core Development Costs" means Development Costs incurred in connection with Development activities reasonably directed to obtaining Regulatory Approval of a Licensed Antibody or Licensed Product for the Major Markets, including without limitation the costs of generating the core dossier used as the basis for the ... |
1.69 "Corporate Names" means the Trademarks and logos identified on Schedule 1.69 and such other names and logos as Licensor may designate in writing from time to time. |
1.70 "Country-Specific Development Activities" means (a) Development activities directed to obtaining Regulatory Approvals for the Licensed Product outside of the Major Markets and (b) Phase IV Study and other Development activities for a country or region in the ROW after Regulatory Approval in such country or region. |
1.71 "Country-Specific Development Costs" means: (a) the Development Costs for obtaining Regulatory Approval of a Licensed Antibody or Licensed Product for countries other than the Major Markets that is additional or incremental to the costs of generating the core dossier or any other Development activities performed i... |
1.72 "Default Notice" has the meaning set forth in Section 12.2. |
1.73 "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... |
1.74 "Development Costs" means the FTE Costs (charged in accordance with Section 6.4.4) incurred, and the Out-of-Pocket Costs recorded as an expense in accordance with Accounting Standards, by or on behalf of a Party or any of its Affiliates that, except in the case of Development Costs incurred in accordance with clau... |
(a) pre-clinical and non-clinical activities such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development, and statistical analysis; |
(b) Clinical Studies for a Licensed Antibody or Licensed Product, including (i) the preparation for and Conduct of clinical trials; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in direct connection with such studies, including adverse event recordation... |
(c) the preparation of a regulatory dossier to the extent necessary to obtain any Regulatory Approval for a Licensed Product in the Territory and filing fees in connection with the filing of applications for such Regulatory Approvals; |
(d) Manufacturing Costs for (i) a Licensed Antibody or Licensed Product for use in Clinical Studies or other Development activities for such Licensed Antibody or Licensed Product; (ii) the manufacture, purchase or packaging of comparators or placebo for use in Clinical Studies for a Licensed Antibody or Licensed Produc... |
(e) Losses incurred in connection with Third Party Claims described in Section 11.3 to the extent such Losses are to be included in Development Costs in accordance with Section 11.3; and |
(f) Costs for the development of the manufacturing process for a Licensed Antibody or Licensed Product, manufacturing process validation, including validation batches, and qualification and validation of Third Party contract manufacturers. |
Notwithstanding Section 1.30 above, any expense with respect to a Licensed Product that would otherwise be included as an Allowable Expense, but which is incurred prior to the first Regulatory Approval of such Licensed Product in the United States shall be deemed a Development Cost rather than an Allowable Expense. |
1.75 "Development Plan and Budget" means, a development plan with respect to a Collaboration Program setting forth in reasonable detail specific Clinical Studies and other Party Development Activities to be performed with respect to the Licensed Antibody or a Licensed Product and the budget for such Development activit... |
1.76 "Development Wind-down Period" has the meaning set forth in Section 12.9.1. |
1.77 "Dispute" has the meaning set forth in Section 13.7. |
1.78 "Distribution Costs" means, to the extent not included in a Party's Manufacturing Costs, the FTE Costs (charged in accordance with Section 6.4.4) incurred, and the Out-of-Pocket Costs recorded as an expense by a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreem... |
(a) handling and transportation to fulfill orders (excluding such costs, if any, treated as a deduction in the definition of Net Sales); |
(b) customer services, including order entry, billing and adjustments, inquiry and credit and collection; and |
(c) cost of storage and distribution of such Licensed Product. The Parties may, if appropriate, agree that Distribution Costs be determined on the basis of a specified annual charge or as a percentage of Net Sales. |
1.79 "Distributor" has the meaning set forth in Section 5.5. |
1.80 "Divestiture" means (a) the divestiture of an AbbVie Competing Product within twelve (12) months after the relevant Acquisition through (i) an outright sale or assignment of all material rights in such AbbVie Competing Product to a Third Party or (ii) an exclusive out-license of all Development and commercializati... |
1.81 "Dollars" or "$" means United States Dollars. |
1.82 "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... |
1.83 "Effective Date" has the meaning set forth in Section 12.1.2. |
1.84 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.85 "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. |
1.86 "Excess Costs" has the meaning set forth in Section 3.7.1(b). |
1.87 "Excess Cost Reimbursement" has the meaning set forth in Section 3.7.1(b). |
1.88 "Excluded Indication" has the meaning set forth in Section 6.5.2(b)(iii)(B). |
1.89 "Execution Date" has the meaning set forth in the preamble hereto. |
1.90 "Existing In-License Agreements" means the agreements set forth on Schedule 1.90 between Licensor and a Third Party under which AbbVie is granted a sublicense under this Agreement. |
1.91 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.92 "Existing Regulatory Documentation" means the Regulatory Documentation Controlled by Licensor or any of its Affiliates as of the Execution Date. |
1.93 "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. |
1.94 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.95 "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). |
1.96 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.97 "First Additional Repayment Amount" has the meaning set forth in Section 3.7.1(e)(i). |
1.98 "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 after Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of Regulat... |
1.99 "First Repayment Amount" has the meaning set forth in Section 3.7.1(b). |
1.100 "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. Any person w... |
1.101 "FTE Costs" means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing Development, Commercialization or Manufacturing activities during such period in accordance with the applicable Development Plan and Budget or Commercialization P... |
1.102 "FTE Rate" means the rates set forth in Schedule 6.4.4, as adjusted pursuant to Section 6.4.4. |
1.103 "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. |
1.104 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.105 "HSR Filing" has the meaning set forth in Section 12.1.1. |
1.106 "Human Samples" has the meaning set forth in Section 3.11. |
1.107 "IMS" has the meaning set forth in Section 6.5.4(a). |
1.108 "Incremental Royalty" has the meaning set forth in Section 6.5.2(a). |
1.109 "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 r... |
1.110 "Indemnification Claim Notice" has the meaning set forth in Section 11.4. |
1.111 "Indemnified Party" has the meaning set forth in Section 11.4. |
1.112 "Indication" means each disease or condition separately categorized in the World Health Organization's International Classification of Diseases 10 coding system at the level defined two places to the right of the decimal point. For clarity, any patient population within such a disease or condition shall be deemed... |
1.113 "Indirect Taxes" has the meaning set forth in Section 6.10. |
1.114 "Information" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs... |
1.115 "Interim Analysis Readout Date" means, on a Collaboration Program-by-Collaboration Program basis, the date of commencement of the interim data analysis performed pursuant to the Pre Exercise Development Plan and Budget, but in no case later than the date of completion of the PoC Trial. |
1.116 "Initial Post Exercise Development Plan and Budget" has the meaning set forth in Section 3.2.1. |
1.117 "In-License Agreement" means the Existing In-License Agreements and any other agreement between Licensor or its Affiliate and a Third Party under which AbbVie is granted a sublicense under this Agreement. |
1.118 "Intellectual Property" has the meaning set forth in Section 12.7.1. |
1.119 "Joint Commercialization Committee" or "JCC" has the meaning set forth in Section 2.3.1. |
1.120 "Joint Development Committee" or "JDC" has the meaning set forth in Section 2.2.1. |
1.121 "Joint Program Know-How" means all Information and inventions that (a) are conceived, discovered, developed, or otherwise made jointly by or on behalf of the Parties (or their Affiliates or sublicensees or subcontractors) as a result of performance of this Agreement, and (b) are Controlled by the Parties or any o... |
1.122 "Joint Program Patents" mean all Patents that (a) claim inventions that are conceived, discovered, developed, or otherwise made jointly by or on behalf of the Parties (or their Affiliates or sublicensees or subcontractors) as a result of performance of this Agreement, and (b) are Controlled by the Parties or any ... |
1.123 "Joint Steering Committee" has the meaning set forth in Section 2.1.1. |
1.124 "Knowledge" means the good faith understanding of the facts and information, with respect to such facts and information of the chief executive officer, the president, the executive vice-president, any vice president, including the vice president for research, the vice president for product development, the vice p... |
1.125 "Last Agreed Post Exercise Development Plan and Budget" means with respect to a Collaboration Program: (a) the budget contained in the Initial Post Exercise Development Plan and Budget for Core Development Costs with respect to such Collaboration Program and (b) if a modification of such budget was approved by Li... |
1.126 "Licensed Antibody" means a Licensed CD33 Antibody or a Licensed Trem2 Antibody, as applicable. |
1.127 "Licensed CD33 Antibody" means any Antibody that (a) specifically binds CD33 and a principal therapeutic mechanism of action of which is mediated as a result of such binding and (b) is claimed in the Existing Patents or Licensor Program Patents or made by or on behalf of Licensor or its Affiliates under this Agre... |
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