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1.140 "Terminated Territory" means each country or region with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.3, or, if this Agreement is terminated in its entirety, the entire Territory. |
1.141 "Terminated Territory Grantback Option" has the meaning set forth in Section 12.8.2. |
1.142 "Territory" means the entire world. |
1.143 "Third Party" means any Person other than Licensor, AbbVie and their respective Affiliates. |
1.144 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.145 "Third Party Provider" has the meaning set forth in Section 3.6. |
1.146 "Trademark" means any mark, word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain name, whether or not registered, and any registrati... |
1.147 "Transfer of Regulatory Documentation" has the meaning set forth in Section 3.7.2(a). |
1.148 "Trial Master File" means the documents maintained at clinical research sites and by the sponsor during the course of Clinical Studies for any Licensed Product, which enable the conduct of a Clinical Study and the quality of the data produced to be evaluated, proving that the Clinical Study was conducted by the i... |
1.149 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.150 "University Patent Rights" means the Patents licensed to Licensor pursuant to the UOFM License Agreement and listed on Schedule 1.150. |
1.151 "UOFM License Agreement" means that certain Patent License Agreement by and between the Regents of the University of Michigan and Licensor, dated April 13, 2015, as amended on December ___, 2020. |
1.152 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been rendered invalid by any of the following: (a) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of ... |
1.153 "Voting Stock" has the meaning set forth in Section 1.27. |
1.154 "Withholding Amount" has the meaning set forth in Section 6.9. |
1.155 "Withholding Party" has the meaning set forth in Section 6.9. |
1.156 "Working Group" has the meaning set forth in Section 2.5. |
ARTICLE 2 MANAGEMENT |
2.1 Joint Governance Committee. |
2.1.1 Formation. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC"). The JGC shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to ... |
2.1.2 Specific Responsibilities. The JGC shall oversee the activities relating to the Licensed Antibodies and the Licensed Products in accordance with the Initial Development Plan and Budget and the Operational Plan and Budget, and shall serve as a forum for the coordination of such activities. In particular, the JGC s... |
(a) oversee the Initial Development Activities performed pursuant to the Initial Development Plan and Budget; |
(b) oversee the Operational Activities performed pursuant to the Operational Plan and Budget; |
(c) serve as a forum to discuss and seek to resolve issues that arise during the performance of the Initial Development Plan and Budget or the Operational Plan and Budget; |
(d) oversee the selection (to the extent not specifically set forth in the Initial Development Plan and Budget or otherwise set forth on Schedule 3.6) and engagement of vendors and consultants that are providing Development services under the Initial Development Plan and Budget to ensure consistency with the Initial De... |
(e) periodically (no less often than quarterly) review and serve as a forum for discussing the Initial Development Plan and Budget, the Operational Plan and Budget, and review and approve Material Amendments or other amendments thereto; |
(f) review and approve the final GLP toxicology protocols, the Phase I/IA Trial and Phase I/IB Trial study protocols and manufacturing specifications, and serve as a forum for discussing and approving any amendments thereto; |
(g) subject to reasonable procedures to observe obligations of confidentiality owed to any Third Party, review and comment on any standard operating procedures (SOPs) required to be implemented pursuant to the Initial Development Plan and Budget and the Operational Plan and Budget; |
(h) review and serve as a forum for discussing all Information (including all Clinical Data) arising out of the Initial Development Plan and Budget; |
(i) prior to the License Option Exercise Closing Date, review and discuss regulatory activities and strategies for Licensed Antibodies and Licensed Products; |
(j) plan and oversee the conduct of activities set forth in Section 3.4; |
(k) establish secure access methods (such as secure databases) for each Party to access Confidential Information; and |
(l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
2.2 General Provisions Applicable to the JGC. |
2.2.1 Meetings and Minutes. The JGC shall meet quarterly, or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Licensor and locations designated by AbbVie. The Alliance Managers shall be permitted to attend any such JGC meetings (and for clarity, the A... |
2.2.2 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least two (2) representatives appointed by each Party. R... |
2.2.3 Dispute Resolution. If the JGC cannot, or does not, reach consensus on an issue, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and bindi... |
2.2.4 Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JGC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expres... |
2.2.5 Alliance Manager. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the JGC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an "Alliance Manager"). Each Party may replace its Allianc... |
2.3 Discontinuation of the JGC. The JGC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the JGC; (b) in the event of AbbVie's exercise of its License Option, completion of all activities set forth in Section 3.4; and (c) expiration of the License Option Period. Addition... |
2.4 Interactions Between the JGC 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 shall prevent a Part... |
2.5 Working Groups. |
2.5.1 From time to time, upon unanimous approval of the JGC, the JGC may establish and delegate duties to sub-committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (for example, a development team, joint project team, joint finance group, or joint in... |
2.5.2 CMC Working Group. Subject to Section 2.5.1, the JGC shall establish a CMC Working Group (the "CMC Working Group") promptly after the JGC's formation that shall be responsible for Manufacturing and supply matters delegated to it by the JGC. The CMC Working Group shall consist of an equal (and agreed upon) number ... |
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 on, the JGC or any Working Group. |
2.7 Monthly Updates. On a monthly basis during the period during which Licensor is performing Initial Development Activities, Licensor shall provide to AbbVie summary updates, and make the relevant experts of Licensor reasonably available to discuss, the following Information to the extent in the possession or Control ... |
ARTICLE 3 DEVELOPMENT AND REGULATORY |
3.1 Development Activities. |
3.1.1 Amendments. Either Party, directly or through its representatives on the JGC, may propose amendments to the Initial Development Plan and Budget or the Operational Plan and Budget from time to time as appropriate, including in light of changed circumstances. Any and all such amendments shall be subject to approval... |
3.1.2 Initial Development Activities; Assumption of Activities. Licensor shall perform the Initial Development Activities set forth in the Initial Development Plan and Budget and the Operational Activities set forth in the Operational Plan and Budget. Licensor shall use Commercially Reasonable Efforts to achieve the ob... |
3.2 AbbVie Option. |
3.2.1 Data Package. As soon as practicable, but in all cases within forty five (45) days after the completion of those activities under the Initial Development Plan and Budget, Licensor shall provide AbbVie with the Data Package. AbbVie shall have the opportunity to review and inspect the Data Package and to ask questi... |
3.2.2 Early Exercise Data Package. AbbVie may, but shall not be obligated to, deliver to Licensor a written notice requesting an Early Exercise Data Package at any time on or after the Effective Date and on or prior to the date of AbbVie's receipt of the Data Package. Upon Licensor's receipt of any such notice, Licenso... |
3.2.3 License Option Exercise Notice. Upon the Effective Date, Licensor hereby grants to AbbVie the exclusive right, but not the obligation, to obtain the licenses set forth in Section 5.1.2 (the "License Option"). AbbVie shall have the right to exercise its License Option by providing written notice of such election t... |
3.2.4 Exercise of the License Option. |
(a) AbbVie shall be deemed to have entered into the licenses set forth in Section 5.1.2 on the later of (a) Licensor's receipt of the License Option Exercise Notice; (b) the expiration or earlier termination of any waiting period (or any extension thereof) under the HSR Act in the U.S. or, if applicable, a comparable w... |
(b) If AbbVie provides the License Option Exercise Notice during the License Option Period, upon AbbVie's request, the Parties shall work together in good faith to conduct an analysis of whether any filings or notifications are or may be required to be filed under the HSR Act (the "HSR Filing") or any similar applicabl... |
3.3 Post-Exercise Development Activities; Development Reporting. Following the License Option Exercise Closing Date, except for Licensor's responsibilities in the conduct of the Initial Development Plan and Budget, AbbVie shall have the sole right to Exploit (and shall control all aspects of Exploitation), including se... |
3.4 Supply of Technology for Development Purposes. |
3.4.1 Initial Transfer. As soon as reasonably practicably following the License Option Exercise Closing Date, Licensor shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to AbbVie (which obligation may be satisfied by granting personnel designated by AbbVie controlled... |
3.4.2 Existing-Inventory Transfer. As soon as reasonably practicable following after the License Option Exercise Closing Date, at its cost and expense (a) Licensor shall assign, convey and transfer all current inventory of Licensed Antibody and Licensed Product in existence and in the possession or Control of Licensor ... |
3.5 Expenses and Invoicing. Except as expressly set forth in this Agreement, each Party shall bear all costs and expenses associated with the activities for which such Party is responsible under this Agreement, the Initial Development Plan and Budget, and the Operational Plan and Budget; provided, that Licensor shall b... |
3.6 Subcontracting. Each Party shall have the right to subcontract any of its Development activities to a Third Party (such Third Party, together with any Person that such Third Party subsequently subcontracts to, a "Third Party Provider"); provided, that Licensor must (a) furnish AbbVie with advanced written notice th... |
3.7 Regulatory Matters. |
3.7.1 Pre-Exercise Regulatory Activities. Prior to the License Option Exercise Closing Date, the following shall apply: |
(a) Licensor shall have the sole right and responsibility to prepare, obtain and maintain all INDs necessary to perform its obligations under the Initial Development Plan and Budget, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided, that the form and content o... |
(b) Subject to the immediately following sentence, Licensor shall provide AbbVie with (i) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development of Licensed Antibodies or Licensed Products received by Licensor or its Affiliates from, or forwa... |
(c) Licensor shall provide AbbVie with prior written notice, to the extent Licensor 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... |
3.7.2 Post-Exercise Regulatory Activities. Effective on the License Option Exercise Closing Date, the following shall apply: |
(a) No later than thirty (30) days after the License Option Exercise Closing Date, Licensor shall transition and assign to AbbVie all INDs for Licensed Antibodies and Licensed Products. The Parties acknowledge that it may take time for AbbVie to establish the system to process the Transfer of Regulatory Documentation a... |
(b) As between the Parties, AbbVie, at its sole expense, shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other regulatory submissions, and to conduct communications with the Regu... |
(c) All Regulatory Documentation (including all Regulatory Approvals and Product Labeling) specifically relating to the Licensed Antibodies or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or des... |
(d) As of the License Option Exercise Closing Date, Licensor hereby assigns to AbbVie all of its rights, title and interests in and to all existing Regulatory Documentation (including any existing Regulatory Approvals). Licensor will duly execute and deliver, or cause to be duly executed and delivered, such instruments... |
(e) Within five (5) Business Days after the License Option Exercise Closing Date, Licensor will promptly provide to AbbVie copies of or access to all non-clinical data and Clinical Data, and other Information, results and analyses with respect to any Development activities that are Controlled by Licensor or any of its ... |
3.7.3 Recalls. AbbVie shall make every reasonable effort to notify Licensor promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Product in the Territory, and shall include in such noti... |
3.7.4 Compliance. Each Party shall perform or cause to be performed, any and all of its activities, including Initial Development Activities, in good scientific manner and in compliance with all Applicable Law. |
3.7.5 Records. Each of Licensor and AbbVie shall, and shall ensure that its Third Party Providers, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall be complete and accurate and shall properly reflect al... |
3.7.6 Record Inspection. AbbVie shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of Licensor maintained pursuant to Section 3.7.5. AbbVie shall maintain such records and the information disclosed therein in confidence in accordance with ARTICLE 9. |
3.7.7 No Guarantee of Success. Without limiting Licensor's obligations to (a) perform the Initial Development Activities in accordance with the Initial Development Plan and Budget and the Operational Activities in accordance with the Operational Plan and Budget, and (b) use Commercially Reasonable Efforts to achieve th... |
ARTICLE 4 COMMERCIALIZATION |
4.1 In General. Effective on the License Option Exercise Closing Date, AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to Commercialize Licensed Antibodies and Licensed Products in the Territory at its own cost and expense, subject to and in accordance with the terms of this Agreemen... |
4.2 Commercialization Diligence. Without limiting AbbVie's express obligations under this Agreement, including with respect to any Initial Development Activities assumed by AbbVie pursuant to Section 3.1.2, following the License Option Exercise Closing Date, AbbVie shall use Commercially Reasonable Efforts to Commercia... |
4.3 Booking of Sales; Distribution. Effective on the License Option Exercise Closing Date, subject to the terms and conditions of this Agreement, AbbVie shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Product... |
4.4 Product Trademarks. Effective on the License Option Exercise Closing Date, AbbVie shall have the sole right to determine and own the Product Trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis. Licensor shall not, and shall not permit its Affiliates to, attack, dispu... |
4.5 Commercial Supply of Licensed Antibodies or Licensed Products. |
4.5.1 Commercial Supply of Licensed Antibodies or Licensed Products. Effective on the License Option Exercise Closing Date, as between the Parties, AbbVie shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Antibodies and Licensed Products for commercial sale in the ... |
4.5.2 Manufacturing Technology Transfer Upon AbbVie's Request. AbbVie shall have the right, at any time and from time to time after the License Option Exercise Closing Date, to require Licensor to effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer, and whi... |
(a) Licensor shall make available, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to make available (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effec... |
(b) Licensor shall cause all appropriate employees and representatives of Licensor and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its Third Party manufacturers to meet with (including by using Commercially Reasonable Efforts to ne... |
(c) Without limiting the generality of clause (b) above, Licensor shall cause all appropriate analytical and quality control laboratory employees and representatives of Licensor and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate analytical and quality control employe... |
(d) Licensor shall take such steps, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to take such steps (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Eff... |
(e) Licensor shall provide, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), su... |
Except to the extent that a Manufacturing Technology Transfer is requested in connection with a breach of this Agreement, in connection with any obligations of Licensor to provide personnel and support to AbbVie set forth in this Section 4.5.2, Licensor's support obligations shall be limited to an aggregate of two hund... |
4.5.3 Subsequent Manufacturing Technology Transfer. Without limiting the foregoing, in the event that Licensor makes any invention, discovery, or improvement that is necessary or reasonably useful for the Manufacture of a Licensed Antibody or a Licensed Product during the Term, Licensor shall promptly disclose such inv... |
ARTICLE 5 GRANT OF RIGHTS |
5.1 Grants to AbbVie. |
5.1.1 Upon the Effective Date, Licensor (on behalf of itself and its Affiliates) hereby grants AbbVie a co-exclusive (with Licensor), royalty-free license, with the right to grant sublicenses in accordance with Section 5.2, under the Licensor Patents, the Licensor Know-How, and Licensor's interests in the Joint Patents... |
5.1.2 Upon the License Option Exercise Closing Date, Licensor (on behalf of itself and its Affiliates) hereby grants to AbbVie: |
(a) an exclusive (including with regard to Licensor and its Affiliates, except as provided in Section 5.5) license (or sublicense), with the right to grant sublicenses in accordance with Section 5.2, under the Licensor Patents, the Licensor Know-How, and Licensor's interests in the Joint Patents and the Joint Know-How,... |
(b) an exclusive (including with regard to Licensor and its Affiliates, except as provided in Section 5.5) license and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 5.2, under all Regulatory Approvals and any other Regulatory Documentation that Licens... |
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