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1.183 "Terminated Licensed Products" has the meaning set forth in Section 9.8(a)(i). |
1.184 "Terminated Mission Compound" has the meaning set forth in Section 9.8(a)(iii). |
1.185 "Territory" means all countries of the world. |
1.186 "Third Party" means any Person other than Mission or AbbVie or an Affiliate of either of Mission or AbbVie. |
1.187 "Transition Agreement" has the meaning set forth in Section 9.10(a). |
1.188 "Unrestricted Mission Compound" means any Mission Compound or Mission Derived Compound that satisfies any of the following: |
(a) Any Excluded Mission Compound; |
(b) During the Stage 1A Period: all Mission Compounds or Mission Derived Compounds that do not Bind to any Pre-Selected DUB; |
(c) During the Stage 1B Period: all Mission Compounds or Mission Derived Compounds that following a DUB Selectivity Screen of such Mission Compound or Mission Derived Compound, satisfy any of the following with respect to an Initially Selected DUB: |
(i) The IC50 of such Mission Compound or Mission Derived Compound with respect to each Initially Selected DUB is greater than 10 μM; or |
(ii) with respect to Excluded DUB to which that Mission Compound or Mission Derived Compound is directed, three (3) times the log10 of the IC50 of such Mission Compound or Mission Derived Compound with respect to such Excluded DUB less five (5) times the log10 of the IC50 of such Mission Compound or Mission Derived Com... |
(d) During the Stage 2 Period: all Mission Compounds or Mission Derived Compounds that, following a DUB Selectivity Screen of such Mission Compound or Mission Derived Compound, satisfy any of the following with respect to a Selected DUB: |
(i) The IC50 of such Mission Compound or Mission Derived Compound with respect to each Selected DUB is greater than 10 μM; or |
(ii) with respect to the Excluded DUB to which that Mission Compound or Mission Derived Compound is directed, three (3) times the log10 of the IC50 of such Mission Compound or Mission Derived Compound with respect to such Excluded DUB less five (5) times the log10 of the IC50 of such Mission Compound or Mission Derived... |
provided, that, in each case ((i) and (ii)), such Mission Compound or Mission Derived Compound is not a DUB Hit; or |
(e) After the Stage 2 Period: all Mission Compounds or Mission Derived Compounds that, following a DUB Selectivity Screen of such Mission Compound or Mission Derived Compound, satisfy any of the following with respect to an Exclusively Licensed DUB: |
(i) The IC50 of such Mission Compound or Mission Derived Compound with respect to each Exclusively Licensed DUB is greater than 10 μM; or |
(ii) with respect to the Excluded DUB to which that Mission Compound or Mission Derived Compound is directed, three (3) times the log10 of the IC50 of such Mission Compound or Mission Derived Compound with respect to such Excluded DUB less five (5) times the log10 of the IC50 of such Mission Compound or Mission Derived... |
provided, that, in each case ((i) and (ii)), such Mission Compound or Mission Derived Compound is not a DUB Hit. |
1.189 "U.S." means the United States of America and its territories, districts and possessions. |
1.190 "Valid Claim" means (a) a claim of any Patent that has issued and is unexpired and whose validity, enforceability, or patentability has not been affected by any of the following: (i) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (ii) a holding, finding, or decision of i... |
1.191 "Withholding Party" has the meaning set forth in Section 6.6(b). |
ARTICLE 2 GOVERNANCE |
2.1 Joint Governance Committee. |
(a) Establishment of JGC. Within thirty (30) days after the Effective Date, the Parties will establish a joint governance committee (the "Joint Governance Committee" or "JGC") with the roles set forth in Section 2.1(c). Each Party will initially appoint three (3) representatives to the JGC. The JGC may change its size ... |
(b) Membership of JGC. Each of Mission and AbbVie will designate representatives with appropriate expertise to serve as members of the JGC. Each Party may at any time appoint different JGC representatives by written notice to the other Party, provided that such different representatives have the appropriate expertise t... |
(c) Role of JGC. The JGC will be responsible for: (i) the overall management and oversight of the Research Program; (ii) discussing and approving amendments to the Research Plan; (iii) monitoring and reviewing the progress of the Research Program, and providing a forum for the Parties to exchange data, results and othe... |
(d) JGC Meetings. The JGC will hold meetings at such times and places as the co-chairpersons may determine. Unless the Parties agree otherwise, the JGC will meet at least once every Calendar Quarter during the Stage 1 Period and the Stage 2 Period and the JGC will meet at least twice per Calendar Year thereafter until ... |
(e) Additional Attendees. Other employees of a Party or any of its Affiliates who are involved in the Research Program or the Exploitation of Licensed Compounds or Licensed Products may attend meetings of the JGC as non-voting participants. In addition, with the consent of each Party (not to be unreasonably withheld), ... |
(f) Decisions. Decisions of the JGC shall be made by consensus. If the JGC is unable to reach consensus with respect to any decision within fifteen (15) days of a matter first being voted upon by the JGC, the disputed matter shall then be immediately referred to the Alliance Managers for further review and resolution, ... |
(g) Limitations on Decision-Making. Notwithstanding anything to the contrary set forth in this Agreement, neither the JGC nor AbbVie's Executive Officer (in the exercise of AbbVie's decision-making authority) will have the authority to (i) require a Party to violate any Applicable Law, the requirements of any Regulator... |
(h) Dissolution of JGC. The JGC shall dissolve upon filing of the first Drug Approval Application for a Licensed Product or at such other time as may be agreed by the Parties in writing. Upon dissolution of the JGC, the JGC shall have no further roles or responsibilities under this Agreement, and the JGC shall be repla... |
2.2 Collaboration Lead Optimization Oversight Committee. |
(a) Establishment of the CLOOC. Immediately following the commencement of Stage 2, the Parties will establish a Collaboration Lead Optimization Oversight Committee ("CLOOC") as a subcommittee of the JGC. The CLOOC will be comprised of up to four (4) scientist representatives of each Party, and may change its size from ... |
(b) Membership of the CLOOC. Each of Mission and AbbVie will designate representatives with appropriate scientific expertise to serve as members of the CLOOC, including project leadership, medicinal chemistry, disease biology, and DMPK. Each Party may at any time appoint different CLOOC representatives by written notic... |
(c) Role of the CLOOC. The primary responsibility of the CLOOC will be to guide the lead optimization activities of molecules through the Stage 2 Period to enable the identification of Licensed Compounds and AbbVie Compounds, including selecting which molecules will be made and tested in the various assays and models (... |
(d) CLOOC Meetings. The CLOOC will hold meetings at such times and places as the co-chairpersons may determine. |
(e) Additional Attendees. Other employees of a Party or any of its Affiliates who are involved in the Research Program may attend meetings of the CLOOC as non-voting participants and, with the consent of each Party (not to be unreasonably withheld), Third Party consultants, representatives, or advisors who are involved... |
(f) Decisions. The CLOOC shall have no decision-making authority, and all decisions within the role of the CLOOC shall be immediately referred to the JGC for resolution in accordance with Section 2.1(f). |
(g) Dissolution of the CLOOC. The CLOOC shall dissolve upon completion of the Research Program. |
2.3 Alliance Managers. Each of the Parties will appoint one representative who possesses a general understanding of Development issues to act as its alliance manager (each, an "Alliance Manager"). The role of the Alliance Manager is to act as a primary point of contact between the Parties to assure a successful relatio... |
(a) provide a single point of communication both internally within the Parties' respective organizations and between the Parties, including after such time as the JGC is dissolved; |
(b) plan and coordinate any cooperative efforts under this Agreement, if any, and internal and external communications; |
(c) take responsibility for ensuring that JGC activities, such as the conduct of required JGC meetings, occur as set forth in this Agreement and that relevant action items, if any, resulting from such meetings are appropriately carried out or otherwise addressed; and |
(d) be the point of first referral in all matters of conflict resolution. |
2.4 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, the CLOOC and any other subcommittees established by the JGC. |
ARTICLE 3 RESEARCH PROGRAM |
3.1 Research Program; Research Plan. |
(a) Research Program. The Parties shall collaborate in carrying out a research program consisting of two (2) stages as described in this ARTICLE 3, including in conducting the activities set forth in the Research Plan (such research program being the "Research Program"). Each Party shall perform the activities allocate... |
(b) Research Plan. The JGC will review the Research Plan at least once per Calendar Quarter and, from time to time, the JGC will amend the Research Plan as appropriate, including in connection with changes in costs, personnel or resources, or the completion, commencement or cessation of activities not contemplated by t... |
3.2 Stage 1. |
(a) Stage 1 Activities. Stage 1A of the Research Program ("Stage 1A") and Stage 1B of the Research Program ("Stage 1B" and, together with Stage 1A, "Stage 1") will consist of the activities described in this Section 3.2 and any other activities described as Stage 1 activities in the Research Plan. During Stage 1A, the ... |
(b) Selected DUB. Within the later of (a) eighteen (18) months after the Effective Date and (b) sixty (60) days after the receipt by AbbVie of all the Stage 1B Minimum Deliverables (the "Stage 1 Period"), AbbVie will have the right to select up to four (4) DUBs out of the Initially Selected DUBs (each of the four, a "S... |
3.3 Stage 2. |
(a) Stage 2 of the Research Program ("Stage 2") will consist of the activities described in this Section 3.3, the screening by AbbVie of AbbVie's Compound Library to determine any AbbVie Compounds that Bind to the Selected DUBs using assays transferred to AbbVie by Mission, and any other activities described as Stage 2... |
(b) On a Selected DUB-by-Selected DUB basis, during the period commencing on the applicable Stage 2 Commencement Date and ending on the later of (a) sixty (60) days after receiving the data and other Information required to be provided by Mission under the Research Plan relating to the Stage 2 activities and (b) thirty... |
3.4 DUB Selectivity Screen. Within thirty (30) days of completion of the Stage 1A Period the Parties shall finalise the Agreed Assays with respect to DUBs for which there were no Agreed Assays as of the Effective Date and listed on Schedule 1.15 and include assays for each of the Initially Selected DUBs in the list of ... |
3.5 Disclosure of Information. At each meeting of the JGC, Mission and AbbVie will each provide a report summarizing in reasonable detail the work performed and the results achieved by it under the Research Program since the last such report. Mission shall provide to AbbVie access to or copies of all data and written r... |
3.6 Research Program Records. Each Party will maintain reasonably complete and accurate records of all work conducted in the performance of the Research Program and all results, data, inventions and developments made in the performance of the Research Program. Such records will be in sufficient detail and in good scien... |
3.7 Protection of Patent Rights. In order to protect the Parties' Patent rights in any inventions conceived or reduced to practice during or as a result of the Research Program, each Party agrees to maintain a policy that requires its employees to record all inventions generated by them in standard laboratory notebooks... |
3.8 Subcontracting. Each Party will be permitted to subcontract the work for which it is responsible in the performance of the Research Program, without the consent of the other Party, solely to any of the Persons listed in the Research Plan or approved by the JGC in advance (each such Person listed in the Research Pla... |
3.9 Disclosure of Research Information. Mission shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to AbbVie Mission Background Know-How, Mission Program Know-How, Joint Program Know-How, and any other Information claimed or covered by any Mission Background Patent, M... |
ARTICLE 4 GRANTS OF RIGHTS; EXCLUSIVITY |
4.1 Licenses to AbbVie. |
(a) Subject to the terms and conditions of this Agreement (including the exclusivity obligations hereunder set forth in Section 4.10), Mission hereby grants to AbbVie a non-exclusive license (with no right to grant sublicenses other than as specifically set forth in Section 3.8 and/or the Research Plan) under the Missi... |
(b) Subject to the terms and conditions of this Agreement (including the exclusivity obligations hereunder set forth in Section 4.10 and the effects of termination provided for in Section 9.8), Mission hereby grants to AbbVie, effective upon exercise of the Stage 2 Option and payment of the Exclusively Licensed DUB Fee... |
4.2 Sublicensing by AbbVie. 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 4.1(b), to its Affiliates and other Persons; provided that any such sublicenses shall be consistent with th... |
4.3 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 or in any country or other jurisdiction of the Territory, to distribute, market, and sell the... |
4.4 Licenses to Mission. |
(a) Subject to the terms and conditions of this Agreement (including the exclusivity obligations hereunder set forth in Section 4.10), AbbVie hereby grants to Mission a non-exclusive license (with no right to grant sublicenses other than as specifically set forth in Section 3.8 and/or the Research Plan) under the AbbVi... |
(b) Subject to the terms and conditions of this Agreement (including the exclusivity obligations hereunder set forth in Section 4.10 and the effects of termination provided for in Section 9.8), AbbVie hereby grants to Mission a fully-paid-up, royalty free, perpetual and irrevocable exclusive license with the right to g... |
4.5 Mission Compounds and Mission Derived Compounds. Prior to a DUB Selectivity Screen with respect to each Selected DUB, Mission shall not have the right to research, Develop or Exploit any Mission Compound or Mission Derived Compound that Binds to such Selected DUB without the prior written consent of AbbVie; provide... |
4.6 Restricted AbbVie Compounds. Neither Party shall have the right to research, Develop or Exploit any Restricted AbbVie Compound other than in connection with the performance of its activities under the Collaboration without the prior written consent of the other. For clarity, either Party shall have the right to con... |
4.7 Restricted Mission Compounds. Except as set forth in the next sentence, neither Party shall have the right to research, Develop or Exploit any Restricted Mission Compound other than in connection with the performance of its activities under the Collaboration without the prior written consent of the other. Notwithst... |
4.8 No Other Rights; Retained Rights. Except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by a Party to the other Party. All rights with respect to Information, Patent or other intellectu... |
4.9 Confirmatory Patent License. Each Party shall if requested to do so by the other immediately enter into confirmatory license agreements in the form or substantially the form set forth in Schedule 4.9 for the purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as... |
4.10 Exclusivity. |
(a) Stage 1. During the Stage 1 Period: |
(i) each Party agrees that neither it nor any of its Affiliates will undertake any research with a view to identifying any inhibitors of any DUBs for neuroscience Indications, other than in connection with the performance of its activities under the Research Program; and |
(ii) Mission agrees that neither it nor any of its Affiliates will Exploit (other than for internal research purposes) or grant any rights to a Third Party to any Pre-Selected DUB, Initially Selected DUB, or Selected DUB; |
provided that, for clarity, in the case of Mission, the foregoing restrictions shall not apply to any Excluded DUB or any Excluded Mission Compound: |
(b) Stage 2. During the Stage 2 Period, (i) Mission agrees that, except with respect to AbbVie and the Collaboration, it will not undertake, or permit any of its Affiliates to undertake, on its or their own behalf or together with any Third Party, any Exploitation of any Selected DUB and (ii) AbbVie agrees that it will... |
(c) AbbVie Derived Compounds. Except with respect to AbbVie under the Collaboration, each Party agrees that it and its Affiliates will not undertake, on its or their own behalf or through or with any Third Party, any Exploitation of any AbbVie Derived Compound, without the prior written consent of the other Party provi... |
(d) Exclusively Licensed DUBs. On an Exclusively Licensed DUB-by-Exclusively Licensed DUB basis, following AbbVie's exercise of the Stage 2 Option (including payment to Mission of the Exclusively Licensed DUB Fee), except with respect to AbbVie under the Collaboration, (i) until the expiration or termination of this Ag... |
(e) Exception to Mission's Obligations. Notwithstanding Section 5.1(b), if over a six (6) month period after the fifth (5th) anniversary of the payment of the Exclusively Licensed DUB Fee and prior to the receipt of Regulatory Approval for a Licensed Product, AbbVie does not have a Licensed Compound in Active Developme... |
(f) Permitted Activities under Calico Agreement. Notwithstanding this Section 4.10, but without limiting AbbVie's other obligations under this Agreement, the restrictions and limitations applicable to AbbVie in this Section 4.10 shall not apply to activities of AbbVie or any of its Affiliates (or its or their Third Par... |
(g) Mission Change of Control Transaction. |
(i) Mission (or its successor) shall provide AbbVie with written notice of any Change of Control Transaction of Mission within ten (10) Business Days following the closing date of such transaction. |
(ii) In the event that Mission is acquired in a Change of Control Transaction, then the intellectual property of the Acquirer held or developed by such Acquirer prior to or after such acquisition (other than intellectual property developed by such Acquirer in the course of conducting Mission's activities under this Agr... |
(iii) Nothing in this Section 4.10 shall apply to or bind any Acquirer of Mission; provided that in the event of a Change of Control Transaction involving Mission, if the Acquirer (which prior to, on or after such Change of Control) has a program or otherwise is engaged (either directly or through an Affiliate, or in c... |
(h) AbbVie Change of Control Transaction. Nothing in this Section 4.10 shall apply to or bind any Acquirer of AbbVie; provided that in the event AbbVie undergoes a Change of Control Transaction with an Acquirer that has any Prohibited Programs, then the Acquirer and AbbVie will either: (i) institute commercially reason... |
4.11 In-License Agreements. During the Term, neither Mission nor any of its Affiliates shall, without AbbVie's prior written consent, enter into any agreement with a Third Party related to Information, Regulatory Materials, material, Patents, or other intellectual other property rights directed solely to Licensed Compo... |
ARTICLE 5 EXPLOITATION OF LICENSED COMPOUNDS AND LICENSED PRODUCTS |
5.1 Development. |
(a) Development Responsibility. Except for Mission's responsibilities in the conduct of the Research Program, as between AbbVie and Mission, AbbVie shall have the sole right, responsibility and obligation to Develop Licensed Compounds and Licensed Products in the Field in the Territory, at its own cost and expense. For... |
(b) Development Diligence. With respect of each Exclusively Licensed DUB, following exercise of the applicable Stage 2 Option, AbbVie shall use Commercially Reasonable Efforts to Develop at least one (1) Licensed Compound and Licensed Product in the Field throughout the Major Markets that knocks down or inhibits tau, a... |
(c) Development Records. AbbVie shall prepare and maintain and shall cause its Affiliates and Sublicensees to prepare and maintain reasonably complete and accurate records which shall properly reflect all work done and results achieved in the performance of Development of Licensed Compounds and Licensed Products in the... |
(d) Development Reports. After exercise of the Stage 2 Option, at each meeting of the JGC (or after dissolution of the JGC, at least twice per calendar year, through the Alliance Managers or other designees of the Parties), until Regulatory Approval is obtained in all of the Major Markets with respect to each Licensed ... |
(e) Clinical Holds. AbbVie shall notify the Mission Alliance Manager promptly (but in no event later than forty-eight (48) hours) following AbbVie's receipt of any notice of a clinical hold by a Regulatory Authority with respect to a Licensed Product in the Territory. |
(f) Use of Third Parties. AbbVie may retain Third Party contractors to perform Development activities for DUB Hits subject to the terms of this Agreement. Any such Third Party contractor performing Development activities hereunder shall not be Debarred/Excluded and shall enter into a written agreement with AbbVie that ... |
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