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1.83 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.84 "Europe" means the European Union plus the United Kingdom and any European Major Market country that may cease to be in the European Union after the Effective Date. |
1.85 "European Major Market" means each of the United Kingdom, Germany, France, Italy, and Spain. |
1.86 "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. |
1.87 "Excipients" means (a) excipients that AbbVie cannot reasonably procure from a qualified Third Party within ninety (90) days, (b) excipients that are available only through a single global supplier, or (c) excipients that are non-compendial (e.g., lack a monograph on file with either the United States Pharmacopeia... |
1.88 "Excluded Entity" has the meaning set forth in Section 10.4.3 (Debarment and Exclusion). |
1.89 "Excluded Individual" has the meaning set forth in Section 10.4.3 (Debarment and Exclusion). |
1.90 "Excluded Intellectual Property" has the meaning set forth in Section 1.54 (Control). |
1.91 "Exclusive License" has the meaning set forth in Section 6.3.1 (Grants to AbbVie on the License Option Effective Date). |
1.92 "Existing HotSpot Patents" means (a) the HotSpot Patents existing as of the Effective Date and (b) all HotSpot Patents filed by or on behalf of HotSpot prior to or on the License Option Effective Date. The Existing HotSpot Patents existing as of the Effective Date are listed on Schedule 1.92 (Existing HotSpot Pate... |
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), formulate, optimize, transport, distr... |
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 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.4.5 (Debarment and Exclusion). |
1.96 "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). |
1.97 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.98 "Final Data Package" means the complete data package containing all data, findings, information and results of the Development and CMC activities and all supporting documentation (including regulatory correspondence and documentation) set forth in Schedule 1.98 (Final Data Package), which includes (a) all Informat... |
1.99 "Final License Option Expiration Date" means, subject to Section 3.5.2 (Information Reports and Final Data Package), the sixtieth (60th) day following delivery to AbbVie of the Final Data Package that contains all of the information required to be therein. |
1.100 "Final Offer" has the meaning set forth in Section 12.11.1 (Reverse Royalty). |
1.101 "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 necessary Regulatory Approvals for such Licensed Product have bee... |
1.102 "First Indication Phase II Completion" has the meaning set forth in Section 5.3.1 (HotSpot Cost-Sharing Option). |
1.103 "First Option Extension Payment" has the meaning set forth in Section 7.1.3(a) (Option Extension Payments). |
1.104 "Foreign Investment Law" means any new or amended public interest, foreign investment or national security laws, rules or regulations in any jurisdiction. |
1.105 "Fourth Option Extension Payment" has the meaning set forth in Section 7.1.3(d) (Option Extension Payments). |
1.106 "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 one thousand eight hundred (1800) hours per Calendar Year) of work performing activities pursuant to this Agreement. No additional payment shall be made with respect to any person who ... |
1.107 "FTE Costs" means, (a) with respect to AbbVie or its Affiliates for any period, if HotSpot exercises the Cost-Sharing Option, the applicable FTE Rate multiplied by the applicable number of FTEs of AbbVie or its Affiliates performing the Development activities related to a Licensed Product, or (b) with respect to ... |
1.108 "FTE Rate" means Four Hundred Thousand Dollars ($400,000), subject to adjustments effective on January 1 of each Calendar Year, with the first such annual adjustment to be made as of January 1, 2023, based on the applicable employment cost index published by the United States Department of Labor, Bureau of Labor ... |
1.109 "Generic Application" has the meaning set forth in Section 8.4.7 (Generic Competition). |
1.110 "Generic Competition" means, on a country-by-country or other jurisdiction-by-other jurisdiction basis and Licensed Product-by-Licensed Product basis, the first sale for monetary value for use or consumption by an end user of a Generic Product in such country or other jurisdiction by one (1) or more Third Party(i... |
1.111 "Generic Product" means, with respect to a Licensed Product, any product that is approved, or is sought to be approved in a country or jurisdiction, 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 determ... |
1.112 "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 succe... |
1.113 "Good Laboratory Practices" or "GLP" means the FDA's standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, and any equivalent standards promulgated by the EMA. |
1.114 "Good Manufacturing Practices" or "GMP" or "cGMP" means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Go... |
1.115 "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, re... |
1.116 "Grantback Product" means: (a) any Licensed Product (i) for which AbbVie's license rights under Section 6.1 (Grants to AbbVie on the Effective Date) and Section 6.3 (Grants to AbbVie on the License Option Effective Date) have terminated; (ii) that is or has been the subject of clinical Development activities or C... |
1.117 "HotSpot" has the meaning set forth in the preamble hereto. |
1.118 "HotSpot Compounds or Products" has the meaning set forth in Section 8.3.2(c) (Patent Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents). |
1.119 "HotSpot Existing Compounds" means the compounds Controlled or invented by HotSpot or any of its Affiliates prior to the Research Term that are Directed To the Collaboration Target, including, without limitation, the compounds set forth on Schedule 1.119 (HotSpot Existing Compounds); provided, however, that "HotS... |
1.120 "HotSpot Existing Mature Program Compounds" means the compounds Controlled or invented by HotSpot or any of its Affiliates that are disclosed in the Patents listed on Schedule 1.120 (HotSpot Existing Mature Program Patents). |
1.121 "HotSpot Indemnitees" has the meaning set forth in Section 11.1 (Indemnification of HotSpot). |
1.122 "HotSpot Know-How" means all Information that is (a) Controlled by HotSpot or any of its Affiliates as of the Effective Date or at any time during the Term, (b) not generally known, and (c) necessary or reasonably useful to Develop, Manufacture, Commercialize or otherwise Exploit the Licensed Compounds or the Lic... |
1.123 "HotSpot Patents" means all Patents that are (a) Controlled by HotSpot or any of its Affiliates as of the Effective Date or at any time during the Term, and (b) necessary or reasonably useful (or, with respect to Patent applications, would be necessary or reasonably useful if such Patent applications were to issu... |
1.124 "HotSpot Platform Patents" has the meaning set forth in Section 8.3.2(c) (Patent Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents). |
1.125 "HotSpot Platform Technology" means HotSpot's proprietary Smart Allostery™ platform and all Information and intellectual property to the extent related to the operation of such platform (but not, for clarity, the data and Information generated using such platform with respect to a particular target or any compoun... |
1.126 "HotSpot Product Patents" has the meaning set forth in Section 8.3.2(c) (Patent Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents). |
1.127 "HotSpot Program Data" means all Information that is (a) generated by HotSpot or any of its Affiliates as of the Effective Date or at any time during the Term using the HotSpot Platform Technology that relates specifically to the Collaboration Target, or any Compounds or Products, and (b) necessary or reasonably ... |
1.128 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.129 "In-License Agreements" means any agreement between HotSpot and a Third Party under which AbbVie is granted a sublicense under this Agreement (a) that was in effect on or prior to the Effective Date, or (b) that is entered into after the Effective Date in accordance with Sections 6.10.1 and 6.10.2(b) (In-License ... |
1.130 "In-Licensed Patents" has the meaning set forth in Section 10.2.5 (Additional Representations and Warranties of HotSpot). |
1.131 "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... |
1.132 "IND Acceptance" means with respect to an IND, the earlier to occur of: (a) receipt by HotSpot, its Affiliate or a sublicensee of written confirmation from a Regulatory Authority or other applicable Person that Clinical Studies may proceed under such IND, or (b) expiration of the applicable waiting period after w... |
1.133 "IND-Enabling Studies" mean the early certain 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. |
1.134 "Indemnification Claim Notice" has the meaning set forth in Section 11.5 (Notice of Claims). |
1.135 "Indemnified Party" has the meaning set forth in Section 11.5 (Notice of Claims). |
1.136 "Indication" means, with respect to a Licensed Product, a use to which such Licensed Product is intended to be put for the treatment, prevention or cure of a distinct recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recogn... |
1.137 "Indirect Taxes" has the meaning set forth in Section 7.14 (Indirect Taxes). |
1.138 "Inflation Reduction Act" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as it may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, ... |
1.139 "Information" means all (a) 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 pro... |
1.140 "Information Reports" means the Stage 1 Information Report, Stage 2 Information Report, Stage 3 Information Report, and Stage 4 Information Report. |
1.141 "Initial AbbVie Cost-Sharing Plan and Budget" has the meaning set forth in Section 5.3.1 (HotSpot Cost-Sharing Option). |
1.142 "Initial Review Period" has the meaning set forth in Section 3.5.2 (Information Reports and Final Data Package). |
1.143 "INN" has the meaning set forth in Section 8.7.1 (Ownership and Prosecution of Product Trademarks). |
1.144 "Interest Rate" means one hundred (100) basis points above SOFR or the maximum applicable legal rate, if less. |
1.145 "Invoiced Party" has the meaning set forth in Section 7.10 (Other Invoiced Amounts). |
1.146 "Invoicing Party" has the meaning set forth in Section 7.10 (Other Invoiced Amounts). |
1.147 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 2.1 (Joint Governance Committee). |
1.148 "Joint IP" has the meaning set forth in Section 8.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.149 "Joint Know-How" means any and all Information that is conceived, reduced to practice, discovered, developed or otherwise made under this Agreement, jointly by or on behalf of HotSpot or its Affiliates, on the one hand, and AbbVie or its Affiliates, on the other hand, under this Agreement, whether or not patented... |
1.150 "Joint Patents" means all Patents that claim inventions that are conceived, reduced to practice, discovered, developed or otherwise made under this Agreement jointly by or on behalf of HotSpot or its Affiliates or its or their Sublicensees, on the one hand, and AbbVie or its Affiliates or its or their Sublicensee... |
1.151 "Knowledge" means (a) with respect to HotSpot and its Affiliates, the actual knowledge of the Chief Executive Officer, Chief Operating Officer, Chief Scientific Officer, Chief Business Officer, Chief Development Officer, Vice President of Corporate Strategy and Vice President, Head of Immunology, together with th... |
1.152 "Large Pharmaceutical Company" means, at any given time, any pharmaceutical, biotechnology, medical device or diagnostic company that (a) in aggregate with its affiliates, has (i) a market capitalization of Fifteen Billion Dollars ($15,000,000,000) or greater, and (ii) annual revenue greater than Two Billion Doll... |
1.153 "Lead Development Candidate Compound" means a Collaboration Compound Directed To the Collaboration Target that is selected by AbbVie as the lead development candidate in accordance with this Agreement. |
1.154 "License Option" has the meaning set forth in Section 4.1 (License Option Grant to AbbVie). |
1.155 "License Option Effective Date" means the date upon which AbbVie delivers to HotSpot the License Option Exercise Notice in accordance with the terms of this Agreement; provided that, if AbbVie reasonably determines in good faith prior to the delivery of the License Option Exercise Notice that the transactions to ... |
1.156 "License Option Exercise Notice" means AbbVie's written notice to HotSpot exercising the License Option during the License Option Period. |
1.157 "License Option Extension Notice" means AbbVie's written notice to HotSpot extending the License Option Period prior to the Stage 1 License Option Expiration Date, Stage 2 License Option Expiration Date, Stage 3 License Option Expiration Date, or Stage 4 License Option Expiration Date, as applicable. |
1.158 "License Option Period" means the period commencing on the Effective Date and ending on the Applicable Expiration Date. |
1.159 "Licensed Compound" means, after the License Option Effective Date, (a) the Lead Development Candidate Compound, (b) all other Collaboration Compounds, (c) all compounds that are Directed To the Collaboration Target that are developed by or on behalf of AbbVie (either solely or together with HotSpot) under this A... |
1.160 "Licensed Product" means, after the License Option Effective Date, any product comprising a Licensed Compound, alone or in combination with one (1) or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes. For clarity, a Licensed Pro... |
1.161 "Licensed Product Patents" means all HotSpot Patents that solely claim Compounds, Products or the Exploitation thereof and do not claim any compound or product Controlled by HotSpot that is not a Compound or Product or the exploitation thereof. |
1.162 "Licensed Program" means the Collaboration Program after the License Option Effective Date. |
1.163 "Losses" has the meaning set forth in Section 11.1 (Indemnification of HotSpot). |
1.164 "MAA" has the meaning set forth in Section 1.81 (Drug Approval Application). |
1.165 "Manufacture" and "Manufacturing" means all activities related to the synthesis, scale-up, 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 qualific... |
1.166 "Manufacturing Process" has the meaning set forth in Section 5.6 (Manufacturing Technology Transfer). |
1.167 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.6 (Manufacturing Technology Transfer). |
1.168 "Maximum Fair Price" has the meaning set forth in Section 1191(c)(3) of the Social Security Act. |
1.169 "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 Compounds or Licensed Products, including activities of medical scientific liaisons, the pro... |
1.170 "Medicare Price" means, in respect of a Licensed Product, the average negotiated price (as defined in Section 1860D-2(d) of the Social Security Act) under prescription drug plans or MA-PD plans for such Licensed Product during the plan year immediately prior to the Initial Price Applicability Year (as defined in ... |
1.171 "Modified Product" has the meaning set forth in Section 1.116 (Grantback Product). |
1.172 "Mono Product" has the meaning set forth in Section 1.174 (Net Sales). |
1.173 "NDA" has the meaning set forth in Section 1.81 (Drug Approval Application). |
1.174 "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) trade, cash and quantity discounts; |
(b) rebates or retroactive price reductions, 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 specifically 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 the 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 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; |
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