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1.57 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.58 "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... |
1.59 "Good Reason" has the meaning set forth in Section 12.5. |
1.60 "Grantback Option" has the meaning set forth in Section 12.7.1(c). |
1.61 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.62 "HSR Filing" has the meaning set forth in Section 3.2.4. |
1.63 "Humanized 5H10 Antibody" means the Antibody described on Schedule 1.63. |
1.64 "In-Licensed Patents" has the meaning set forth in Section 10.2.3. |
1.65 "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 thereof in other countries or regulatory jurisd... |
1.66 "Indemnification Claim Notice" has the meaning set forth in Section 11.3. |
1.67 "Indemnified Party" has the meaning set forth in Section 11.3. |
1.68 "Indication" means, with respect to a Licensed Product, a diagnostic, prophylactic or therapeutic use for a disease or condition, with respect to which use at least one adequate and well-controlled Clinical Study is required to support the addition of such disease or condition to the indication statement of a pack... |
1.69 "Indirect Taxes" has the meaning set forth in Section 6.10. |
1.70 "Information" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, inventions (whether or not patentable), means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings,... |
1.71 "Initial Development Activities" means the activities set forth in the Initial Development Plan and Budget to be performed by Licensor (or, pursuant to Section 3.1.2, AbbVie). |
1.72 "Initial Development Plan and Budget" means a research and development plan and budget for the Licensed Antibodies and Licensed Products setting forth (a) in reasonable detail all activities to be performed by Licensor with respect to the Licensed Antibodies and Licensed Products through completion of the Phase I/... |
1.73 "Intellectual Property" has the meaning set forth in Section 12.6.1. |
1.74 "Joint Governance Committee" has the meaning set forth in Section 2.1.1. |
1.75 "Joint Intellectual Property Rights" has the meaning set forth in Section 7.1.2. |
1.76 "Joint Know-How" has the meaning set forth in Section 7.1.2. |
1.77 "Joint Patents" has the meaning set forth in Section 7.1.2. |
1.78 "Knowledge" means with respect to a given set of facts or information, the actual knowledge (following a reasonably diligent investigation based on known facts or information or of existing files and personnel) of Martin Phillips, John Oates, and Nick Lukacs. |
1.79 "LIBOR" means the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one (1) month published by the British Bankers' Association, as adjusted from time to time on the first London business day of each month. |
1.80 "License Option" has the meaning set forth in Section 3.2.3. |
1.81 "License Option Exercise Closing Date" has the meaning set forth in Section 3.2.4. |
1.82 "License Option Exercise Notice" has the meaning set forth in Section 3.2.3. |
1.83 "License Option Period" has the meaning set forth in Section 3.2.3. |
1.84 "Licensed Antibody" means (a) the Humanized 5H10 Antibody, (b) all Antibodies that bind to SCF248, and (c) any backup, derivative, follow-on Antibodies, and fragments of the Antibodies described in subparagraphs (a) and (b) above, that binds to SCF248, in each case with respect to subparagraphs (a) - (c) above, (i... |
1.85 "Licensed Product" means any product, or portion thereof, containing a Licensed Antibody, alone or in combination with one (1) or more other active ingredients, in any and all forms, in current and future formulations, dosages forms and strengths, and delivery modes. For clarity, Licensed Products that contain the... |
1.86 "Licensor" has the meaning set forth in the preamble hereto. |
1.87 "Licensor In-License Agreement" means (a) 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 Banks using Selexis Sure Cell Line DevelopmentTM Platform) and any final agreement entered into in respect of... |
1.88 "Licensor Indemnitees" has the meaning set forth in Section 11.1. |
1.89 "Licensor Know-How" means all Information that is (a) Controlled by Licensor 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 for the Exploitation of any Licensed Antibody or any Licensed Product, but excluding any Join... |
1.90 "Licensor Patents" means all of the Patents that are (a) Controlled by Licensor 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 ... |
1.91 "Licensor Product Patents" has the meaning set forth in Section 7.2.1(b). |
1.92 "Life Sciences Entity" means any pharmaceutical, biotechnology, medical device or diagnostic company, including any affiliate or any venture capital subsidiary or venture capital organization or division of a pharmaceutical, biotechnology, medical device or diagnostic company. |
1.93 "Losses" has the meaning set forth in Section 11.1. |
1.94 "MAA" has the meaning set forth in Section 1.46. |
1.95 "Major European Market" means each of the United Kingdom, France, Germany, Italy and Spain. |
1.96 "Major Regulatory Filing" means major regulatory filings and documents (including INDs, Drug Approval Applications, material labeling supplements, Regulatory Authority meeting requests, and core data sheets). |
1.97 "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, process... |
1.98 "Manufacturing Process" has the meaning set forth in Section 4.5.2. |
1.99 "Manufacturing Technology Transfer" has the meaning set forth in Section 4.5.2. |
1.100 "Material Amendment" means any amendment or other modification that would: (a) remove an activity specifically identified in the Initial Development Plan and Budget or the Operational Plan and Budget, as case may be; (b) change to the scope or resource allocation of any Initial Development Activities or Operation... |
1.101 "Mono Product" has the meaning set forth in Section 1.103(i). |
1.102 "Monthly Update" has the meaning set forth in Section 2.7. |
1.103 "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 or its Affiliates or Sublicensees in the Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transactio... |
(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 invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
(g) 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) reasonably allocable to sales of the Licensed Products; |
(h) 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 Products; and |
(i) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes; provided that Net Sales shall include transfers or dispositions with respect to or for governmental purposes where AbbVie records revenue. Net Sales shall include the amount o... |
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 the Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.8. |
If a Licensed Product is sold in any country or other jurisdiction in the form of a Combination Product, then the Net Sales for such Combination Product in such country or other jurisdiction shall be calculated as follows: |
(i) 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 Antibody contained in such Combination Product (the "Mono Product") and (B) products containing as their sole active ingredients the other active ingredi... |
(ii) 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 ingredients in such Combination Product, the Net Sales attributab... |
(iii) 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 P... |
(iv) 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... |
1.104 "Neutral" has the meaning set forth on Schedule 13.7.3. |
1.105 "Non-Breaching Party" has the meaning set forth in Section 12.2.1. |
1.106 "Operational Activities" means the activities set forth in the Operational Plan and Budget to be performed by Licensor. |
1.107 "Operational Plan and Budget" means a plan and budget detailing Licensor's staffing, training, and subcontracting activities that Licensor would be required to carry-out during the License Option Period, which Operational Plan and Budget is attached as Schedule 1.107, as the same may be amended from time to time ... |
1.108 "Owned Patents" has the meaning set forth in Section 10.2.3. |
1.109 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.110 "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 and right to claim priority from any of these patents or applications... |
1.111 "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... |
1.112 "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... |
1.113 "Phase I/IA Trial" means a human Clinical Study 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 ... |
1.114 "Phase I/IB Trial" means a human Clinical Study of a Licensed Antibody or Licensed Product incorporating dose escalation and cohort expansion studies as described in the Initial Development Plan and Budget (as it may be amended from time to time in accordance with Section 3.1.1). |
1.115 "Phase II Trial" means a human Clinical Study of a Licensed Antibody 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, ... |
1.116 "Phase III Trial" means a human Clinical Study 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 ... |
1.117 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.118 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. |
1.119 "Post CSR Option Period" has the meaning set forth in Section 12.7.2(e). |
1.120 "Pre-IND Meeting" has the meaning set forth in Section 3.7.1(a). |
1.121 "Prior CDA" has the meaning set forth in Section 13.9. |
1.122 "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... |
1.123 "Product Information" has the meaning set forth in Section 9.1. |
1.124 "Product Infringement" has the meaning set forth in Section 7.3.1. |
1.125 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the full prescribing information for such Licensed Product as approved by the Regulatory Authority for such country or other jurisdiction, including any required patient information, and (b) all l... |
1.126 "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 in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks... |
1.127 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 5.8.3. |
1.128 "Reduction Conditions" has the meaning set forth in Section 6.6.3(c). |
1.129 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Antibody or Licensed Product in such country or other ju... |
1.130 "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, EMA and PMDA) regulating or otherwise exercising authority with respect to a... |
1.131 "Regulatory Data" has the meaning set forth in Section 3.7.2(e). |
1.132 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other Major Regulatory Filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities... |
1.133 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory and a Licensed Product, 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... |
1.134 "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the latest to occur of (a) the expiration, invalidation, ... |
1.135 "SCF248" means that specific protein known as UniProtKB(P21583-1) in addition to any other known aliases and including all allelic variants, splice variants, single nucleotide polymorphisms and post-translational modifications and other variant forms thereof. |
1.136 "Segregate" means, with respect to a Competing Product, to use commercially reasonable efforts to segregate the Development, Commercialization or other Exploitation activities relating to such Competing Product in the Field from Development, Commercialization or other Exploitation activities with respect to Licen... |
1.137 "Senior Officer" means, with respect to Licensor, its Chief Executive Officer or his/her designee, and with respect to AbbVie, its Chief Scientific Officer or his/her designee. |
1.138 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie or its Affiliate under the grants in Section 5.1, as provided in Section 5.2, but excluding any sublicense granted to a Third Party by AbbVie or its Affiliates as a result of the settlement of a bona fid... |
1.139 "Term" has the meaning set forth in Section 12.1.1. |
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