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1.84 "FTE Rate" means Four Hundred Twenty-Five Thousand Dollars ($425,000), increased annually by two and one-half percent (2.5%) effective on January 1 of each Calendar Year during the Term of this Agreement, with the first such annual adjustment to be made as of January 1, 2023, or as otherwise agreed to by the Parti... |
1.85 "Generic Product" means, with respect to a Licensed Product, any product that is approved, or is sought to be approved, in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulat... |
1.86 "Good Clinical Practices" or "GCP" means Good Clinical Practice as promulgated by the FDA under and in accordance with the FFDCA, Title 21, Parts 312 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time-to-time, or any succes... |
1.87 "Good Laboratory Practices" or "GLP" means Good Laboratory Practices as promulgated by the FDA under and in accordance with the FFDCA, Title 21, Part 58 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time-to-time, or any suc... |
1.88 "Good Manufacturing Practices" or "GMP" or "cGMP" means the applicable regulatory standards and requirements for current good manufacturing practices promulgated by the FDA under and in accordance with the FFDCA, Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, and the guidelines and standards ... |
1.89 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.90 "HSR Clearance" means the earlier of (a) notification to the Parties from the FTC or DOJ of early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings, or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings; provided, however, ... |
1.91 "HSR Filing" means the filings by Plexium and AbbVie with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto. |
1.92 "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... |
1.93 "IND-Enabling Studies" mean the early studies required to demonstrate safety, efficacy and quality of a compound that will satisfy applicable regulatory requirements and that meets the standard necessary for submission as part of an IND filing with the FDA to allow dosing of such compound in humans. |
1.94 "Indemnification Claim Notice" has the meaning set forth in Section 11.4. |
1.95 "Indemnified Party" has the meaning set forth in Section 11.4. |
1.96 "Indirect Taxes" has the meaning set forth in Section 7.12. |
1.97 "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, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses,... |
1.98 "Intellectual Property" has the meaning set forth in Section 12.5.1. |
1.99 "Investigator's Brochure" means, in accordance with the definition in 21 C.F.R. §312.23(a)(5), a compilation of pre-clinical Information and Clinical Program Data with respect to a new investigational drug that is proposed for filing with a Regulatory Authority and used to provide relevant drug information to clin... |
1.100 "Invoiced Party" has the meaning set forth in Section 7.9. |
1.101 "Invoicing Party" has the meaning set forth in Section 7.9. |
1.102 "Joint IP" means the Joint Know-How and the Joint Patents. |
1.103 "Joint Know-How" means any and all Information and inventions that are conceived, reduced to practice, discovered, developed or otherwise made under this Agreement jointly by or on behalf of Plexium or its Affiliates or sublicensees, on the one hand, and AbbVie or its Affiliates, on the other hand, whether or not... |
1.104 "Joint Patents" means all of the Patents that claim inventions that are conceived, reduced to practice, discovered, developed or otherwise made under this Agreement jointly by or on behalf of Plexium or its Affiliates or sublicensees, on the one hand, and AbbVie or its Affiliates, on the other hand. |
1.105 "Joint Research Committee" or "JRC" has the meaning set forth in Section 2.1 |
1.106 "Knowledge" means the good faith understanding, after a reasonable investigation (which will not require any "freedom to operate" opinion or analysis) in accordance with reasonably prudent practices within the biopharmaceutical industry, of Plexium's Chief Executive Officer, Chief Scientific Officer, and Vice Pre... |
1.107 "License Option" has the meaning set forth in Section 4.1. |
1.108 "License Option Effective Date" means the date upon which AbbVie delivers to Plexium the License Option Exercise Notice for a Research Program; provided that, if AbbVie reasonably determines in good faith prior to the delivery of the License Option Exercise Notice that the transactions to be consummated upon the ... |
1.109 "License Option Exercise Notice" means AbbVie's written notice to Plexium exercising a License Option. |
1.110 "Licensed Compound" means, upon exercise of the License Option for a Research Program, (a) any Option Compounds from such Research Program, and (b) any compounds that are chemical derivatives (both derived from and derivations of), modifications or improvements or variants of any compound described in the foregoi... |
1.111 "Licensed IP" means (a) the Plexium Know-How, (b) the Plexium Product Patents, and (c) Plexium's rights in and to the Joint IP. |
1.112 "Licensed Product" means any product for use in the Field comprising a Licensed Compound, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes. For clarity, any Licensed Product for which Plexium ... |
1.113 "Licensed Program" means any Research Program with respect to which AbbVie has exercised its License Option. |
1.114 "Losses" has the meaning set forth in Section 11.1. |
1.115 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.116 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of a Compound, any Product, or any intermediate thereof, including process development, process qualification and ... |
1.117 "Material Research Plan Amendment" means any amendment to a Research Plan that includes (a) budgetary changes that, together with any prior amendments to such Research Plan, result in (i) a cumulative increase of five percent (5%) or more from the budget in such Research Plan, or (ii) the deletion or removal of R... |
1.118 "Mono Product" has the meaning set forth in Section 1.119. |
1.119 "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 wholesalers or Distributors), in bona fide arm's length transaction... |
(a) normal 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 (but which will not include, for the purpose of clarity, any tax, duty, or other charge imposed on or measured by net income (however denominated) or any fran... |
(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including coupons, 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 designed to assist in the administration of such Licensed Product; |
(g) any invoiced amounts from a prior period which are not collected and are reasonably 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; and |
(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. |
Net Sales shall not include transfers or dispositions 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 Affiliates or Sublicensees in respect of the Licensed Product, wheth... |
Subject to the above, Net Sales shall be calculated in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.10. |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and (B) products containing as their sole active ingredients the other active ingredients... |
If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredient in such Combination Product, the Net Sales attributable to ... |
If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product... |
If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the ... |
1.120 "Neutral" has the meaning set forth in Schedule 13.7.3. |
1.121 "Non-Binding Budget" means, with respect to a Licensed Product, a non-binding budget that sets forth a good faith estimate of costs associated with Development activities anticipated to be conducted by AbbVie from the date of delivery of such non-binding budget until the First Commercial Sale of such Licensed Pro... |
1.122 "Non-Breaching Party" has the meaning set forth in Section 12.2.1. |
1.123 "Opt-Out Product" means the Cost-Sharing Product after Plexium effects a Shared Cost Opt-Out. |
1.124 "Option Compound" means any compound, and all of the compounds in the chemical series of which such compound is a part, which (a) is generated by or on behalf of Plexium under an applicable Research Program, and (b) satisfies the Preliminary Hit Criteria for an applicable Research Plan. For clarity, (y) upon AbbV... |
1.125 "Option Data Package" means, on a Research Program-by-Research Program basis, with respect to each Option Compound for an applicable Research Plan, (i) any Information that is required to be provided to AbbVie upon completion of an applicable Research Plan as set forth in such Research Plan, and (ii) an Option Da... |
1.126 "Option Period" means, on a Research Program-by-Research Program basis, the period commencing on the Effective Date and expiring on the earlier of (a) the License Option Effective Date for such Research Program, and (b) ninety (90) calendar days after delivery by Plexium to AbbVie of the applicable Option Data Pa... |
1.127 "Option Product" means any product for use in the Field comprising an Option Compound, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes. Upon AbbVie's exercise of a License Option for any Rese... |
1.128 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.129 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any such patents or applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or... |
1.130 "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... |
1.131 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) clinical data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security and Pri... |
1.132 "Phase I" means a human clinical trial of a Licensed Compound 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 Authoriti... |
1.133 "Phase IB" means a human clinical trial of a Licensed Compound or Licensed Product which provides for the first introduction of a pharmaceutical product into patients having the disease of interest with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology ... |
1.134 "Phase II" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a s... |
1.135 "Phase III" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
1.136 "Plexium" has the meaning set forth in the preamble hereto. |
1.137 "Plexium Background Technology" means all Information (including, to the extent applicable, Regulatory Documentation) Controlled by Plexium 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... |
1.138 "Plexium Indemnitees" has the meaning set forth in Section 11.1. |
1.139 "Plexium Know-How" means all Information that is (a) conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of Plexium (or its Affiliates or sublicensees) under or in connection with this Agreement, (b) not publicly known, and (c) necessary or reasonably useful for the Exploitatio... |
1.140 "Plexium Platform" means Plexium's proprietary DELPhe platform for the generation of compounds that modulate cellular targets including protein degradation processes. |
1.141 "Plexium Platform Patents" means any Patent Controlled by Plexium that claims, or provides a written description that supports a claim directed at, the Plexium Platform. |
1.142 "Plexium Product Patents" mean any Product Patent that is conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of Plexium (or its Affiliates or sublicensees) under or in connection with this Agreement, and that Plexium owns in accordance with Section 8.1.1. |
1.143 "Preliminary Hit Criteria" has the meaning set forth in the applicable Research Plan. |
1.144 "Pricing and Reimbursement Approval" means such approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged to consumers or will be reimbursed by governmental authorities in a country or other jurisdiction in the Territory where governmental authorities of such co... |
1.145 "Pro Rata Percentage" shall mean (a) with respect to Plexium, thirty percent (30%), and (b) with respect to AbbVie, seventy percent (70%). |
1.146 "Pro-Rated Cost-Sharing Royalty" has the meaning set forth in Section 7.7.1(c). |
1.147 "Processing" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise m... |
1.148 "Product" means an Option Product or Licensed Product, as applicable. |
1.149 "Product Information" has the meaning set forth in Section 9.1. |
1.150 "Product Infringement" has the meaning set forth in Section 8.3.1. |
1.151 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and ... |
1.152 "Product Patents" means any Patent Controlled by AbbVie, Plexium or their respective Affiliates that claims, or provides a written description that supports a claim directed at, a Compound or Product, a genus covering such Compound or Product, or a composition containing a Compound or genus covering a Compound, o... |
1.153 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Exploitation of Licensed Products (including the Cost-Sharing Product) in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (ex... |
1.154 "Program" means a Research Program or Licensed Program, as applicable. |
1.155 "Qualified Hit Criteria" has the meaning set forth in the applicable Research Plan. |
1.156 "Regulated Party" has the meaning set forth in Section 10.5. |
1.157 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Compound or Licensed Product in such country or other ju... |
1.158 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activit... |
1.159 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official co... |
1.160 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection or Patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization peri... |
1.161 "Rejected Compound" means any compound, including all of the compounds in the chemical series of which such compound is a part, which both (a) is generated by or on behalf of Plexium under an applicable Research Program, and (b) meets any one of the following: (i) does not satisfy the Preliminary Hit Criteria, pr... |
1.162 "Remaining Replaced Research Program Budget" has the meaning set forth in Section 3.4.1. |
1.163 "Replaced Research Program" has the meaning set forth in Section 3.4.1. |
1.164 "Research" means the research, testing and other activities as set forth in the applicable Research Plan, including, but not limited, to any preclinical development and any other such research processes or formulation development activities. |
1.165 "Research Plan" means, for each Research Program, the research plan mutually agreed upon by the Parties that sets forth (a) the Research Plan Activities, (b) the timeline and budget for such activities, and (c) all Information that is required to be provided to AbbVie upon completion of such research plan, includ... |
1.166 "Research Plan Activities" means the Research activities set forth in a Research Plan. |
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