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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... |
1.128 "Licensed Product" means any product containing a Licensed Antibody, alone or in combination with one (1) or more New Technologies, in any and all forms, presentations, delivery systems, dosages, and formulations. |
1.129 "Licensed Trem2 Antibody" means any Antibody that (a) specifically binds Trem2 and a principal therapeutic mechanism of action of which is mediated as a result of such binding and (b) claimed in the Existing Patents or Licensor Program Patents or made by or on behalf of Licensor or its Affiliates under this Agree... |
1.130 "Licensor" has the meaning set forth in the preamble hereto. |
1.131 "Licensor Background Know-How" means all Information that is (a) Controlled by Licensor or any of its Affiliates on the Execution Date or at any time during the Term, (b) not generally known, (c) developed or invented outside the scope of this Agreement, and (d) reasonably necessary or useful for the Development,... |
1.132 "Licensor Background Patents" means all Patents that are (a) Controlled by Licensor or any of its Affiliates on the Execution Date or at any time during the Term, (b) developed or invented outside the scope of this Agreement, and (c) reasonably necessary or useful for the Development, Manufacture, or Commercializ... |
1.133 "Licensor Commercialization Opt Out" has the meaning set forth in Section 6.3.1. |
1.134 "Licensor Competing Product" has the meaning set forth in Section 5.10.1(a). |
1.135 "Licensor Continued Funding Notice" has the meaning set forth in Section 6.5.2(b)(ii). |
1.136 "Licensor Development Opt Out" has the meaning set forth in Section 3.7.2. |
1.137 "Licensor Indemnitees" has the meaning set forth in Section 11.1. |
1.138 "Licensor Funded AbbVie Program Patents" means AbbVie Program Patents claiming one or more invention(s) that were invented prior to Licensor's exercise of a Licensor Opt Out with respect to the Collaboration Program in connection with which such inventions were made. |
1.139 "Licensor Opt Out" means a Licensor Development Opt Out or Licensor Commercialization Opt Out, as applicable. |
1.140 "Licensor Opt Out Date" means the effective date of a Licensor Development Opt Out or Licensor Commercialization Opt Out, as applicable, taking into account the required advance notice period. |
1.141 "Licensor Patent" has the meaning set forth in Section 13.2.1(a). |
1.142 "Licensor Program Know-How" means all Information and inventions that are, as between the Parties, conceived, discovered, developed, or otherwise made solely by or on behalf of Licensor or its Affiliates or sublicensees or subcontractors as a result of performance of this Agreement. Licensor Program Know-How expr... |
1.143 "Licensor Program Patents" mean all Patents that claim inventions that, as between the Parties, are conceived, discovered, developed, or otherwise made solely by or on behalf of Licensor or its Affiliates or sublicensees or subcontractors as a result of performance of this Agreement. Licensor Program Patents expr... |
1.144 "Licensor's Proportionate Share" has the meaning set forth in Section 3.7.1(e)(iii). |
1.145 "Losses" has the meaning set forth in Section 11.1. |
1.146 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.147 "Major Markets" means the United States, France, Germany, Italy, Spain and the United Kingdom. |
1.148 "Major Regulatory Filings" has the meaning set forth in Section 3.8.2(c). |
1.149 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of the Licensed Antibody, any Licensed Product, or any intermediate thereof, including process development, proces... |
1.150 "Manufacturing Cost" with respect to the Licensed Antibody or a Licensed Product has the meaning set forth on Schedule 1.150. |
1.151 "Manufacturing Process" has the meaning set forth in Section 3.5.3. |
1.152 "Manufacturing Technology Transfer" has the meaning set forth in Section 3.5.3. |
1.153 "Markings" has the meaning set forth in Section 4.7. |
1.154 "Material Amendment" has the meaning set forth in Section 2.4.3(a)(i). |
1.155 "Medical Affairs Activities" means, 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, including activities of medical scientific liaisons and the... |
1.156 "Medical Affairs Costs" means those FTE Costs (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs, including costs for independent contractors engaged as permitted under this Agreement, incurred by or on behalf of AbbVie in accordance with Accounting Standards after the Effective Date ... |
1.157 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.158 "Net Sales" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including Third Party wholesalers or Distributors), in bona fide arm's length... |
(a) trade, cash and quantity discounts; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; |
(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Licensed Product; |
(f) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system comprising equipment, instrumentation, one (1) or more devices, or other mechanical compone... |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
(h) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of the Licensed Products; |
(i) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Licensed Product; and |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (i) above. |
Net Sales shall not include transfers or dispositions without charge or for a price less than Manufacturing Cost for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliate... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.7. |
In the event a Licensed Product is sold as part of a Bundle, the Net Sales for such Bundle shall be calculated as follows: |
(i) If AbbVie, its Affiliate, or Sublicensee separately sells in substantial volumes in such country or other jurisdiction in the same reporting period, (A) the Licensed Product contained in such Bundle (the "Mono Product") and (B) the Other Product contained in such Bundle, the Net Sales attributable to such Bundle sh... |
(ii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction as described above substantial volumes of one (or both) of the Mono Product and the Other Product in such Bundle in the same reporting period, the Net Sales attributable to such Bundle shall be determined by th... |
1.159 "Neutral" has the meaning set forth on Schedule 13.7.3. |
1.160 "New Technology" means any technology that could be added to or otherwise used to modify an Antibody in order to alter the pharmacological activity or other direct therapeutic effect of such Antibody (including technologies that increase blood brain barrier access, provide for tissue or cell targeting, or provide... |
1.161 "Non-Breaching Party" has the meaning set forth in Section 12.2. |
1.162 "Non-Controlling Party" has the meaning set forth in Section 7.2.2. |
1.163 "Non-Material License(s)" has the meaning set forth in Section 10.2.7. |
1.164 "Notice of Approval" has the meaning set forth in Section 6.5.2(b)(i). |
1.165 "Open Label Extension Study" means, with respect to each Collaboration Program, the open label extension trial for such Collaboration Program described in the Pre Exercise Development Plan and Budget. |
1.166 "Option" has the meaning set forth in Section 5.1.1. |
1.167 "Option Exercise Date" has the meaning set forth in Section 5.1.1. |
1.168 "Option Exercise Notice" has the meaning set forth in Section 5.1.1. |
1.169 "Option Period" has the meaning set forth in Section 5.1.1. |
1.170 "Other Antitrust Laws" has the meaning set forth in Section 12.1.1. |
1.171 "Other Income" means any payment or income (other than Net Sales) received by AbbVie or its Affiliate from a Third Party that is reasonably attributable to a Licensed Antibody or Licensed Product, including any such payment received in connection with the grant of a Sublicense or other right or activity with resp... |
1.172 "Other Product" means any standalone pharmaceutical product, which pharmaceutical product is not covered by a Valid Claim of the Licensor Background Patents, Licensor Program Patents, Joint Program Patents or Licensor Funded AbbVie Program Patents. For purposes of clarity, it is understood that New Technologies s... |
1.173 "Out-of-Pocket Costs" means amounts paid to Third Party vendors or contractors, under arm's length arrangements for services or materials provided by them directly in the performance of activities under the Post Exercise Development Plan and Budget or the Commercialization Plan and Budget, to the extent such serv... |
1.174 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.175 "Party Development Activities" means Development activities conducted in support of obtaining or maintaining Regulatory Approval of a Licensed Product in a country or other jurisdiction in the Territory. |
1.176 "Patent Costs" means those FTE Costs of in-house legal counsel and related personnel (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental aut... |
1.177 "Patent Term Extension" has the meaning set forth in Section 7.2.5. |
1.178 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, includ... |
1.179 "Person" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or polit... |
1.180 "Phase 0" means an exploratory, trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing v... |
1.181 "Phase I" means a clinical trial of a Licensed Antibody or Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, in... |
1.182 "Phase II" means a clinical trial of a Licensed Antibody or Licensed Product, the principal purpose of which is to explore safety and efficacy in the target patient population, which is designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study recomm... |
1.183 "Phase III" means a human clinical trial of a Licensed Antibody or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Antibody or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
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