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2.4.1 Discontinuation of the JGC. If AbbVie does not exercise the License Option during the License Option Period, then, the JGC shall disband upon the expiration of the License Option Period. If AbbVie exercises the License Option, the JGC shall disband upon completion of the activities contemplated by Sections 5.4 (P... |
2.4.2 Discontinuation of Working Groups. Each Working Group shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the Working Group; or (b) the JGC disbanding in accordance with Section 2.4.1 (Discontinuation of the JGC). Upon such termination, each Working Group shall have n... |
2.4.3 Discontinuation Upon Change in Control. Subject to Section 14.2.2 (Change in Control of Parvus), in the event of a Change in Control of Parvus, AbbVie shall have the right at any time and for any reason, effective upon written notice, to disband the JGC or one (1) or more Working Groups pursuant to Section 14.2.2... |
2.5 Interactions Between the JGC or a Working Group and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams, and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this Article 2 ... |
2.6 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate in, the JGC or any Working Group. |
ARTICLE 3 INITIAL DEVELOPMENT |
3.1 Performance of the Research and Development Plan. |
3.1.1 Except as otherwise expressly set forth in Section 3.6 (Completion of Research and Development Plan Activities after License Option Exercise), Parvus shall (a) be responsible for and shall perform the Research and Development Plan Activities allocated to it under the Research and Development Plan under the oversi... |
3.1.2 Parvus shall have the right to subcontract its Research and Development Plan Activities to a Third Party (a) listed in Schedule 3.1.2 (Approved Subcontractors) (such Schedule 3.1.2 (Approved Subcontractors) includes a list of all existing agreements with such Third Party subcontractors), or (b) with the prior wri... |
3.1.3 Parvus shall, and shall cause its Affiliates and subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to all Research and Development Plan Activities, in sufficient detail to verify compliance with its obligations under this Agreement and which books and recor... |
3.1.4 AbbVie Step-In Right upon Material Breach. |
(a) If Parvus is in material breach of its obligation to perform any Research and Development Plan Activities in accordance with this Agreement or the Research and Development Plan and fails to remedy such breach within ninety (90) days after written notice thereof from AbbVie, AbbVie shall have the right, at AbbVie's ... |
(b) If AbbVie so elects to assume and complete any of the Research and Development Plan Activities, to the extent requested by AbbVie in writing, Parvus shall (i) assign to AbbVie any or all Third Party agreements solely relating to such Research and Development Plan Activities (including agreements with contract resea... |
(c) With respect to all such Research and Development Plan Activities that involve Clinical Studies, at AbbVie's option, Parvus shall either (i) end such Clinical Studies with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment of pr... |
3.2 Periodic Reports; Information Reports and License Option Exercise Data Package. |
3.2.1 Within thirty (30) days following the end of each Calendar Quarter, Parvus shall provide to the JGC and AbbVie (a) a detailed written report, in a format to be agreed upon by the Parties, summarizing Parvus' Research and Development Plan Activities conducted during such Calendar Quarter and (b) access to or copie... |
3.2.2 Parvus shall deliver to AbbVie, within thirty (30) days after (a) the Completion of Stage 1 Activities in accordance with the Research and Development Plan, the Stage 1 Information Report and a Disclosure Letter, and (b) the Completion of Stage 2 Activities in accordance with the Research and Development Plan, th... |
3.2.3 If AbbVie has questions or comments with respect to a Licensed Compound or Licensed Product, any Research and Development Plan Activities conducted by Parvus or any of its Affiliates, or Information disclosed in or omitted from an Information Report, the License Option Exercise Data Package or Disclosure Letter o... |
3.2.4 AbbVie shall have (a) forty-five (45) days after the date Parvus provides the applicable final and complete Information Report and Disclosure Letter, and (b) ninety (90) days after the date Parvus provides the final and complete License Option Exercise Data Package and Disclosure Letter (the time period in each o... |
3.2.5 Any questions or comments submitted pursuant to Section 3.2.3 (Periodic Reports; Information Reports and License Option Exercise Data Package) shall be limited to (a) requests for Information or clarification that is necessary or useful for AbbVie to evaluate the applicable Information Report or License Option Ex... |
3.3 Costs and Expenses for Research and Development Plan Activities. Except as otherwise expressly set forth in Section 3.6 (Completion of Research and Development Plan Activities after License Option Exercise), Parvus shall be solely responsible for and shall bear (a) all costs and expenses incurred by or on behalf of... |
3.4 Manufacturing Prior to License Option Exercise. Prior to the License Option Effective Date and subject to Section 3.6 (Completion of Research and Development Plan Activities after License Option Exercise), Parvus shall Manufacture (or cause to be Manufactured), all Licensed Compounds, Licensed Products, comparators... |
3.5 Regulatory Matters Prior to License Option Exercise. Prior to the License Option Effective Date, the following shall apply: |
3.5.1 Parvus shall have the sole right and responsibility to prepare, submit and maintain all INDs necessary to perform the Research and Development Plan Activities under the Research and Development Plan, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that ... |
3.5.2 Parvus shall prepare the patient informed consent form for the Clinical Studies conducted under the Research and Development Plan (as may be amended from time to time in accordance with this Agreement, the "ICF") and provide a draft thereof to AbbVie for its review and comment no later than ten (10) Business Days... |
3.5.3 Subject to the immediately following sentence, Parvus shall provide AbbVie with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development of Licensed Compounds or Licensed Products received by Parvus or its Affiliates from, or forwarde... |
3.5.4 Parvus shall provide AbbVie with prior written notice, to the extent Parvus or its Affiliates has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory relating to a Licensed Product, within two (2) Business D... |
3.6 Completion of Research and Development Plan Activities after License Option Exercise. If AbbVie exercises the License Option prior to completion of the Research and Development Plan Activities, then, AbbVie shall have the right to elect, at AbbVie's sole discretion, to conduct or have Parvus conduct, at Parvus' sol... |
ARTICLE 4 LICENSE OPTION |
4.1 License Option Grant to AbbVie. Parvus hereby grants to AbbVie an exclusive (including with regard to Parvus and its Affiliates) option to obtain an Exclusive License (the "License Option"), exercisable by AbbVie in its sole discretion during the License Option Period as set forth in Section 4.2 (Exercise and Exten... |
4.2 Exercise and Extension of the License Option. AbbVie shall have the right to exercise, in its sole discretion, the License Option by delivering to Parvus the Exercise Notice at any time during the License Option Period, provided that, as a condition to retaining the License Option following each of the Stage 1 Lice... |
4.3 Antitrust Clearances. |
4.3.1 If AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice that the transaction to be consummated upon the exercise of the License Option requires AbbVie to (i) file, or cause to be filed, any documents to consummate the transactions contemplated in connection with the exercise of ... |
(a) In furtherance of this Section 4.3.1 (Antitrust Clearances), and unless agreed otherwise by mutual consent, AbbVie and Parvus shall use Commercially Reasonable Efforts to prepare and file any filing required to obtain such Option Antitrust Consents or Option Foreign Investment Consents promptly after delivery of th... |
(b) AbbVie shall be responsible for all filing fees in connection with any necessary filing(s) to be made pursuant to this Section 4.3.1 (Antitrust Clearances), and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred in connection with any filing(s) made pursuant to this Sect... |
4.3.2 AbbVie and Parvus shall each use Commercially Reasonable Efforts to resolve as promptly as practicable any objections that may be asserted by any Governmental Authority with respect to the transactions notified in any Option Antitrust Consent or Option Foreign Investment Consent listed in the Exercise Notice. Not... |
4.3.3 Parvus will use reasonable efforts to cooperate with AbbVie and furnish to AbbVie, or AbbVie's legal advisers, in accordance with any Applicable Law, any and all information required to prepare and submit any necessary filing(s) to be made after obtaining any Option Antitrust Consents or Option Foreign Investment... |
4.4 Termination of License Option. If (a) upon the expiration of the License Option Period AbbVie has not delivered the Exercise Notice pursuant to Section 4.2 (Exercise and Extension of the License Option), (b) AbbVie does not pay the applicable Option Continuation Payment after provision of the applicable Option Cont... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE |
5.1 In General. Rights and Responsibilities. From and after the License Option Effective Date, AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall (a) have the Exclusive License, (b) subject to Sections 3.6 (Completion of Research and Development Plan Activities after License Optio... |
5.1.2 Agreements with Third Parties. Subject to Section 5.5 (Technology Transfer), upon the License Option Effective Date, at the request of AbbVie, Parvus shall (i) assign to AbbVie any or all agreements with Third Parties (including subcontractors, contract research organizations, clinical sites, investigators, and m... |
5.1.3 Parvus Platform IP. Notwithstanding the foregoing, if (a) AbbVie exercises the License Option prior to completion of the Research and Development Plan Activities, or (b) upon a Change in Control of Parvus pursuant to Section 14.2.2 (Change in Control of Parvus), AbbVie elects to undertake one (1) or more activiti... |
5.2 Diligence. From and after the License Option Effective Date, AbbVie shall use Commercially Reasonable Efforts to obtain Regulatory Approval for one (1) Licensed Product in one (1) Indication in the United States and the EU3; provided that such obligation is expressly conditioned upon Parvus and its Affiliates perfo... |
5.3 Licensed Compounds and Licensed Product Supply. On AbbVie's written request, Parvus shall supply pre-clinical and clinical requirements of Licensed Compound, Licensed Product, comparators, co-administered agents and placebo ("Program Materials") to support the conduct of Phase I Studies and Phase II Studies followi... |
5.4 Program Transition. Subject to Section 5.5 (Technology Transfer), upon AbbVie's request from and after License Option Effective Date, Parvus shall transfer to AbbVie all of its right, title, and interest in and to, and shall deliver to AbbVie, (a) all Parvus Licensed Materials that are, or are necessary for the Exp... |
5.5 Technology Transfer. Notwithstanding Section 5.4 (Program Transition), following the License Option Effective Date, or as otherwise agreed upon by the Parties, at a time reasonably requested by AbbVie in writing in advance with respect to any Licensed Compound and Licensed Product, Parvus shall effect a full transf... |
5.5.1 With respect to the Manufacturing Technology Transfer, Parvus shall provide, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers to provide all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party contract m... |
(a) Parvus shall make available, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, all Manufacturing-related Informati... |
(b) Parvus shall cause all appropriate employees and representatives of Parvus and its Affiliates, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its Third Party contract manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or desi... |
(c) Without limiting the generality of Section 5.5.1(b) (Technology Transfer), Parvus shall cause all appropriate analytical and quality control laboratory employees and representatives of Parvus and its Affiliates, and shall use Commercially Reasonable Efforts to cause all appropriate analytical and quality control la... |
(d) Parvus shall take such steps, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers to take such steps, as are reasonably necessary or useful to assist AbbVie (or its Affiliate or designated Third Party contract manufacturer, as applicable) in obtaining any nec... |
(e) Parvus shall provide, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party contract manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate o... |
(f) Without limiting or duplicating the other provisions of this Section 5.5.1 (Technology Transfer), from and after the License Option Effective Date and on a continuing basis, Parvus, without additional consideration, shall disclose and transfer to AbbVie or its designated Affiliate all Information within the Parvus ... |
(g) AbbVie shall reimburse Parvus for (i) all documented Out-of-Pocket Costs and (ii) all FTE Costs for activities requiring efforts exceeding four-hundred (400) FTE hours in the aggregate ("Excess Efforts"), in each case (i) and (ii) reasonably incurred by Parvus or its Affiliates directly in connection with activitie... |
Except as set forth in Section 3.1.4(b) (AbbVie Step-In Right upon Material Breach) and Section 5.1.3 (Parvus Platform IP), and without limiting the Exclusive License granted to AbbVie, Parvus shall not be obligated under this Section 5.5 (Technology Transfer) or any other provision of this Agreement to enable AbbVie t... |
5.6 Regulatory Matters after License Option Exercise. On and after the License Option Effective Date, the following shall apply: |
5.6.1 AbbVie shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Regulatory Authorities, for all applicable Licensed Com... |
5.6.2 All Regulatory Documentation (including all Trial Master Files, Regulatory Approvals, Product Labeling and INDs) prepared pursuant to this Agreement relating to a Licensed Compound or Licensed Product with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie o... |
5.6.3 Effective as of the License Option Effective Date, Parvus hereby assigns to AbbVie all of Parvus' and its Affiliates' right, title, and interest in and to all Regulatory Documentation (including all Trial Master Files, Regulatory Approvals, Product Labeling and INDs) relating to any Licensed Compound or Licensed ... |
5.6.4 AbbVie shall have the sole right to determine and initiate all recalls, market suspensions or market withdrawals undertaken with respect to the Licensed Compounds and Licensed Products, and AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall be solely responsible for the exec... |
5.7 Records and Reports. AbbVie shall, and shall cause its Affiliates and Sublicensees to, maintain books and records pertaining to Development and Commercialization activities conducted by or on behalf of AbbVie, in each case in accordance with AbbVie's standard records retention policies. Following the License Option... |
5.8 Booking of Sales; Distribution. AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute Licensed Products in the Territory and to perform o... |
5.9 Product Trademarks. AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall have the sole right to determine and AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall own the Product Trademarks to be used with respect to the Exploitation of t... |
5.10 Inflation Reduction Act. If at any time during the Term, the United States Department of Health and Human Services designates a Licensed Product as a Selected Drug subject to Maximum Fair Price negotiation, AbbVie shall be solely and exclusively responsible for such process and shall control all decisions with res... |
ARTICLE 6 GRANT OF RIGHTS |
6.1 Grants to AbbVie on the Effective Date. Parvus (on behalf of itself and its Affiliates) hereby grants to AbbVie on the Effective Date and during the License Option Period, a non-exclusive, royalty-free license, with the right to sublicense in accordance with Section 6.3 (Sublicenses), under the Parvus Licensed Know... |
6.2 Grants to AbbVie on the License Option Effective Date. Subject to Sections 4.3 (Antitrust Clearances) and 6.5.1 (Retention of Rights), Parvus (on behalf of itself and its Affiliates) hereby grants to AbbVie, effective as of the License Option Effective Date: |
6.2.1 an exclusive (including with regard to Parvus and its Affiliates), royalty-bearing license, with the right to sublicense in accordance with Section 6.3 (Sublicenses), under the Parvus Licensed Know-How, Parvus Licensed Patents, Parvus' interest in the Joint Know-How and Joint Patents, subject to Section 6.2.2 (Gr... |
6.2.2 subject to the assignments contemplated by Section 5.6 (Regulatory Matters after License Option Exercise), an exclusive (including with regard to Parvus and its Affiliates, except as provided in Section 5.6 (Regulatory Matters after License Option Exercise)) license and right of reference, with the right to subli... |
6.2.3 subject to Section 8.1.6 (Ownership of Corporate Names), a non-exclusive license, with the right to grant sublicenses in accordance with Section 6.3 (Sublicenses), to use Parvus' Corporate Names solely as required to Exploit the Licensed Compounds and Licensed Products in the Field in the Territory and for no oth... |
6.2.4 The Parties acknowledge and agree that the licenses and rights granted by Parvus to AbbVie under Section 6.1 (Grants to AbbVie on the Effective Date) and Section 6.2 (Grants to AbbVie on the License Option Effective Date) include certain Patents and Information that Parvus Controls through the UTI-MGH License, an... |
6.3 Sublicenses. AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of Sublicensees, under the licenses and rights of reference granted in Section 6.1 (Grants to AbbVie on the Effective Date) and 6.2 (Grants to AbbVie on the License Option Effective Date), to its A... |
6.4 Distributorships. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Territory to Commercialize a Licensed Product (with or without packaging rights), in circumstances wher... |
6.5 Retention of Rights. |
6.5.1 Notwithstanding the Exclusive License, Parvus retains the right to practice under the Parvus Licensed Know-How and Parvus Licensed Patents solely as necessary to perform the Unfinished Research and Development Plan Activities in accordance with Section 3.6 (Completion of Research and Development Plan Activities a... |
6.5.2 Except as expressly provided in this Agreement, Parvus grants no right or license to AbbVie, including any rights or licenses under the Parvus Licensed Know-How, the Parvus Licensed Patents, the Joint Patents, the Joint Know-How, the Regulatory Documentation, the Parvus Corporate Names, or any other Patent or int... |
6.5.3 Except as expressly provided in this Agreement, AbbVie grants no right or license, including any rights or licenses to AbbVie's interest in the AbbVie Patents, AbbVie Know-How, Joint IP, Regulatory Documentation, or any other Patent or intellectual property rights not otherwise expressly granted in this Agreement... |
6.6 Confirmatory Patent License. Parvus shall, if requested to do so by AbbVie, promptly enter into confirmatory license agreements in the form or substantially the form reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in any country in the Terr... |
6.7 Exclusivity. |
6.7.1 Parvus Exclusivity. During the Term, Parvus shall not, and shall cause its Affiliates not to (i) directly or indirectly Commercialize or Manufacture any Competing Product in the Field in any country or other jurisdiction in the Territory, or (ii) license, authorize, appoint, or otherwise enable any Third Party to... |
(a) Development in the United States. During the Term, Parvus shall not, and shall cause its Affiliates not to (i) directly or indirectly Develop any Competing Product in the Field in the United States, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly Develop any Compet... |
(b) Development outside the United States. As of the Effective Date and until receipt of Regulatory Approval for a Licensed Product, Parvus shall not, and shall cause its Affiliates not to (i) directly or indirectly Develop any Competing Product in the Field in the Territory outside the United States, or (ii) license, ... |
6.7.2 Change in Control of Parvus. Notwithstanding Section 6.7.1 (Parvus Exclusivity) and in addition to the rights of AbbVie set forth in Section 14.2.2 (Change in Control of Parvus), if, as a result of a Change in Control, Parvus or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party (... |
6.7.3 Acknowledgement. Each Party acknowledges and agrees that (a) this Section 6.7 (Exclusivity) has been negotiated by the Parties, (b) the time limitations on activities set forth in this Section 6.7 (Exclusivity) are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequa... |
6.8 In-License Agreements. |
6.8.1 Prior to the License Option Effective Date, Parvus shall have the sole right, but not the obligation, at its sole cost and expense, to enter into any agreement with a Third Party related to Information, Regulatory Documentation, materials, Patents, or other intellectual other property rights of such Third Party i... |
(a) if such Related Third Party IP is solely related to a Licensed Compound, a Licensed Product, a Unique Component or the Exploitation thereof (and not, for example, to Parvus Platform Technology or any other components, compounds or products controlled by Parvus or its Affiliates), then Parvus shall not enter into an... |
(b) if such Related Third Party IP is related both to (i) a Licensed Compound or a Licensed Product, a Unique Component or the Exploitation thereof, and (ii) Parvus Platform Technology or any other components, compounds or products controlled by Parvus, then (A) if such Related Third Party IP is necessary for the Explo... |
6.8.2 On and after the License Option Effective Date: |
(a) As between the Parties, AbbVie shall have the sole right, but not the obligation, to negotiate and obtain a license or other right under Related Third Party IP that is solely related to a Licensed Compound, a Licensed Product, a Unique Component or the Exploitation thereof (and not, for example, related to Parvus P... |
(b) As between the Parties, Parvus shall have the sole right, but not the obligation, to negotiate and obtain a license or other right under Related Third Party IP that is solely related to the Parvus Platform Technology from any Third Party; and |
(c) If a Party becomes aware of Related Third Party IP that is necessary for the Exploitation of both (i) a Licensed Compound, Licensed Product or Unique Component or the Exploitation thereof, and (ii) Parvus Platform Technology or any other components, compounds or products controlled by Parvus from any Third Party, t... |
6.8.3 If Parvus or any of its Affiliates, after the Effective Date, becomes a party to a license, sublicense or other agreement, with the right to license or sublicense (as applicable), in respect of Related Third Party IP under Section 6.8.1(a), Section 6.8.1(b), Section 6.8.2(b) or Section 6.8.2(c) (In-License Agreem... |
6.8.4 Parvus shall be solely responsible for any license fees, milestones, royalties, or other payments owed to Third Parties under or in connection with any In-License Agreement existing as of the Effective Date (whether or not any such In-License Agreement is disclosed to AbbVie prior to the Effective Date). |
6.9 IBD-Associated Antigen Immunoassay Testing. |
6.9.1 Either Party shall be entitled at any time to conduct a Qualified Immunoassay Test with respect to any antigen that has not yet been determined to be an Other IBD-Associated Antigen in order to determine whether such antigen is an Other IBD-Associated Antigen, provided, however, that, prior to a Party's initiatin... |
6.9.2 Promptly following completion of a Required QIT conducted pursuant to Section 6.9.1 and the receipt by the Testing Party of the results thereof, the Testing Party shall provide the other Party with a copy of the report provided by the relevant testing services company, including any underlying data and other info... |
6.9.3 Any Required QIT conducted in accordance with Section 6.9.1 by the approved Third Party laboratory services company in accordance with the approved protocols and procedures, shall be dispositive of whether the relevant antigen constitutes an Other IBD-Associated Antigen absent manifest error, in which case any Di... |
6.9.4 Notwithstanding the foregoing, this Section 6.9 (IBD-Associated Antigen Immunoassay Testing) shall not apply to any Excluded Antigen. |
ARTICLE 7 PAYMENTS AND RECORDS |
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