text stringlengths 1 5.46k |
|---|
1.220 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.221 "Updated Disclosure Schedule" has the meaning set forth in Section 10.7. |
1.222 "Updated Existing Patents" has the meaning set forth in Schedule 10.7. |
1.223 "Updated In-Licensed Patents" has the meaning set forth in Schedule 10.7. |
1.224 "Updated Owned Patents" has the meaning set forth in Schedule 10.7. |
1.225 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected 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 invalidi... |
1.226 "Validated Hit" means the generation of chemical matter by Heptares which engages with the Option Target in screening assays and satisfies all of the criteria outlined in Appendix A in the Research Plan, except for any criteria which AbbVie has agreed in writing to waive. |
1.227 "Voting Stock" has the meaning set forth in Section 1.44. |
1.228 "Withholding Amount" has the meaning set forth in Section 7.11. |
1.229 "Withholding Party" has the meaning set forth in Section 7.11. |
1.230 "Working Group" has the meaning set forth in Section 2.3. |
ARTICLE 2 COLLABORATION MANAGEMENT |
2.1 Joint Governance Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC") which shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable suc... |
2.1.1 establish secure access methods (such as secure databases) for each Party to access Confidential Information; |
2.1.2 direct and monitor the Parties' activities under the Research Plans; |
2.1.3 determine (i) which Option Compound(s) or Option Product(s) for each Option Program shall be the subject of a Toxicology Study, and (ii) the duration of the Toxicology Study for an Option Program, up to a maximum of thirteen (13) weeks; |
2.1.4 review and approve any amendments or updates to the Research Plans in accordance with Section 3.1; provided that any such amendments or updates shall be memorialized in writing signed by a representative of the JGC from each Party; |
2.1.5 subject to Section 3.6.1, 3.7.1 and 3.8.3(ii), review and approve the Additional Target Research Plan, any Substitute Target Research Plan, and any Alternate Pharmacology Research Plan; and |
2.1.6 review the strategy, timing, content, topics for discussion and questions to be posed with FDA at any Pre-IND Meeting; |
2.1.7 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 Joint Committees. |
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 Heptares and locations designated by AbbVie. The chairperson of the JGC shall be responsible for calling meetings on no less than fifteen (15... |
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 one (1) representative appointed by each Party. Re... |
2.2.3 Decision-Making. The JGC shall take action in good faith by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) represen... |
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 Disbandment. If AbbVie does not exercise a License Option, then, the JGC shall disband upon the expiration of the last-to-expire Option Period. Subject to the remainder of this Section 2.2.5, if AbbVie exercises a License Option following delivery of an Option Data Package, then AbbVie may choose to discontinue a... |
2.2.6 Alliance Manager. Within thirty (30) after the Effective Date, 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 ... |
2.3 Working Groups. From time to time, 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, joint project team, joint finance group, and/or joint intellectual property group). Each such ... |
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 or any Working Group. |
ARTICLE 3 INITIAL DEVELOPMENT |
3.1 Research Plans. Each Research Plan shall be designed and implemented to enable the submission of a complete IND to the FDA in accordance with Applicable Law and ultimately to support the filing of Drug Approval Applications and obtaining Regulatory Approvals for the Licensed Product(s) in the Field in the Territory... |
3.2 Performance of the Research Plans. |
3.2.1 For each Option Program, Heptares shall perform the Research Plan Activities allocated to it under each Research Plan. Except for Research Plan Activities expressly assigned to AbbVie in an applicable Research Plan, Heptares shall be solely responsible for, and shall perform, the Research Plan Activities under th... |
3.2.2 If Heptares is in material breach of its obligation to perform any Research Plan Activities and fails to remedy such breach within ninety (90) days after written notice thereof from AbbVie, AbbVie shall have the right, at AbbVie's sole election, and without limitation to any other right or remedy available to Abb... |
3.2.3 Heptares shall have the right to subcontract its Research Plan Activities to a Third Party to the extent (i) expressly provided for in the applicable Research Plan or to those Third Parties listed in Schedule 3.2.3 (other than with respect to Manufacturing activities in support of the Research Plan Activities and... |
3.2.4 Heptares shall, and shall cause its Affiliates and subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to all Research Plan Activities, in sufficient detail to verify compliance with its obligations under this Agreement and which books and records shall (a) b... |
3.3 Material Research Plan Amendment. In the event that either Party proposes a Material Research Plan Amendment, such proposal shall be considered by the JGC. Amendments to the Research Plan reasonably expected to materially (a) change Heptares' FTE allocation under such Research Plan, (b) increase the costs and expen... |
3.4 Interim Development Reports. Within thirty (30) days following the end of each Calendar Quarter, each Party shall provide to the JGC (a) a detailed written report, in a format to be agreed upon by the Parties, summarizing that Party's Research Plan Activities, on an Option Program-by-Option Program basis, that shal... |
3.5 Reserved Option Programs. |
3.5.1 At any time between the Effective Date and one (1) year from the Effective Date (the "Reserved Option Program Pre-Option Period"), AbbVie shall have the right to activate a Reserved Option Program by written notice to Heptares (a "Reserved Option Program Activation Notice"). Upon delivery of a Reserved Option Pro... |
3.5.2 Notwithstanding any provision to the contrary set forth in this Agreement, Heptares and its Affiliates shall be free to pursue a Development program or conduct any Development activities for therapeutic agents directed at the Target of a Reserved Option Program in any Pharmacology, subject to the terms and condit... |
3.5.3 AbbVie's delivery of one or more Reserved Option Program Activation Notices(s) or Reserved Option Program Confirmation Notice(s) pursuant to this Section 3.5 will not be deemed under this Agreement to be the exercise or exhaustion of AbbVie's rights relating to the Additional Option Target under Section 3.6. |
3.5.4 For clarity, (i) if AbbVie does not deliver a Reserved Option Program Activation Notice pursuant to this Section 3.5 prior to the expiration of the Reserved Option Program Pre-Option Period, or (ii) if AbbVie does not deliver a Reserved Option Program Confirmation Notice within thirty (30) days of AbbVie's receip... |
3.6 Additional Option Programs. |
3.6.1 At any time between the Effective Date and the later of (i) two (2) years from the Effective Date, and (ii) thirty (30) days after completion of all Lead Optimization Activities (as defined in the Research Plan) for the GPR65 Program, AbbVie shall have the right to select an Additional Option Target in a Designat... |
3.6.2 The Parties shall perform the Research Plan Activities in the Additional Target Research Plan in accordance with Section 3.2, and Heptares shall deliver to AbbVie an Option Data Package upon completion of such Research Plan Activities in accordance with Section 3.10. |
3.6.3 Upon confirmation that the Additional Option Target selected by AbbVie is an Available Target and upon AbbVie's written confirmation that it wishes to proceed with such Target, (a) Heptares' Development program for therapeutic agents directed at the Additional Option Target shall be deemed to be an Option Program... |
3.7 Failed Option Target; Substitute Option Programs. |
3.7.1 In the event an Option Program reaches Technical Failure or fails to achieve a Validated Hit with respect to the Designated Pharmacology for an Option Target (each, a "Failed Option Target"), then (i) Heptares shall promptly notify AbbVie within ten (10) Business Days regarding its determination that such Designa... |
3.7.2 The Parties shall perform the Research Plan Activities in the Designated Pharmacology, as set out in the Substitute Target Research Plan (such performance, the "Substitute Option Program") in accordance with Section 3.2, and Heptares shall deliver to AbbVie an Option Data Package upon completion of such Research ... |
3.7.3 Upon confirmation that a Substitute Option Target selected by AbbVie is an Available Target, Heptares' Development program for therapeutic agents directed at such Substitute Option Target shall be conducted under the same Option Program as the most recent Failed Option Target under such Option Program. For clarit... |
3.7.4 AbbVie shall have the right to select a Substitute Option Target, on an Option Program-by-Option Program basis, (a) up to a maximum of three (3) occasions per Option Program as a result of Technical Failure, and (b) one (1) additional occasion after a Screening Enabled Stabilized Receptor that corresponds to an O... |
3.7.5 For clarity, no additional consideration is required in connection with Heptares' completion of Development activities under any Substitute Target Research Plan under this Section 3.7, except as expressly provided in Section 3.7.4. |
3.8 Pharmacologies |
3.8.1 Designated Pharmacologies. The Designated Pharmacology for the GPR65 Program and the Reserved Option Programs are set forth in the applicable Research Plans. With respect to each Option Target, the relevant Research Plan for each such Target shall provide for a program to Develop Option Compounds and Licensed Com... |
3.8.2 Heptares' Development of Alternate Pharmacologies Before Alternate Pharmacology Option End Date. Notwithstanding any provision to the contrary set forth in this Agreement, Heptares and its Affiliates shall be free to pursue a Development program or conduct any Development activities for therapeutic agents directe... |
3.8.3 Option on Alternate Pharmacology Before Alternate Pharmacology Option End Date. In the event that Heptares generates a Stabilized Receptor for a given Option Target in the Alternate Pharmacology before the Alternate Pharmacology Option End Date, Heptares shall provide to AbbVie notice in writing within five (5) B... |
During the period of time between the date that AbbVie receives the Alternate Pharmacology Notice and Alternate Pharmacology Option End Date, upon AbbVie's request, Heptares will: (a) provide AbbVie with any Information in Heptares' or its Affiliates' Control relating to such Alternate Pharmacology reasonably requested... |
In the event that AbbVie serves an Alternate Pharmacology Exercise Notice, the Parties shall use reasonable efforts to agree on a Research Plan for the applicable Target in the Alternate Pharmacology (the "Alternate Pharmacology Research Plan") within sixty (60) days of such notice or as otherwise agreed upon by the Pa... |
Upon the Parties' agreement of any Alternate Pharmacology Research Plan, AbbVie will pay to Heptares an Alternate Pharmacology Option Fee in accordance with Section 7.1.4, and the milestones and royalties shall be payable in respect of the Option Program for the Alternate Pharmacology, in the same amounts as set out in... |
For clarity, AbbVie's selection of an Alternate Pharmacology for an Option Target pursuant to this Section 3.8 will not be deemed under this Agreement to be the exercise or exhaustion of AbbVie's Additional Option Target under Section 3.6. |
3.8.4 Development of Alternate Pharmacology after Alternate Pharmacology Option End Date. After the Alternate Pharmacology Option End Date, Heptares and its Affiliates and sublicensees shall be free to Exploit any products directed to the applicable Option Target in the Alternate Pharmacology and Heptares will be free ... |
3.9 Toxicology Study Option Compound Selection. |
3.9.1 Upon Candidate Selection for an Option Target, AbbVie shall have the right to determine the duration of each such Toxicology Study, in each case, pursuant to Section 2.2.3(a)(i)(y). If AbbVie selects a Toxicology Study that is longer than a twenty eight (28) day Toxicology Study, AbbVie shall pay to Heptares an a... |
3.9.2 If the results of a Toxicology Study for an Option Target do not meet the safety margins set forth in the applicable Research Plan, then AbbVie shall have the right to select, at AbbVie's sole discretion, (a) a new Option Compound for the particular Option Target to be the subject of a second Toxicology Study, or... |
3.10 Option Data Package. |
3.10.1 Within forty-five (45) days of the completion of the Research Plan Activities for an Option Program, Heptares shall (a) deliver to AbbVie the complete Option Data Package, (b) provide AbbVie with electronic access to all data resulting from the Option Data Package and any other Information Controlled by Heptares... |
3.10.2 AbbVie shall have ninety (90) days after the date Heptares provides an Option Data Package in which to review such Option Data Package, and, if AbbVie believes in good faith that any of the Information required to be included in such Option Data Package is missing, then AbbVie shall have the right to request in ... |
3.10.3 In addition to an Option Data Package, during the applicable Option Period, Heptares shall promptly provide to AbbVie any additional Information related to the applicable Option Compounds, Option Products, or Research Plan Activities that Heptares or any of its Affiliates Controls, as reasonably requested by Abb... |
3.10.4 For purposes of Section 3.10.3, "additional Information" shall be Information (a) then in existence, and (b) with respect to Information not then in existence, Information that shall not require the conduct by Heptares of any additional Development activities or any additional analyses other than additional anal... |
3.11 Expenses. Heptares shall be solely responsible for and shall bear (a) all Development costs (i) incurred by or on behalf of it and its Affiliates in connection with the performance of Research Plan Activities allocated to Heptares for each Option Program, or (ii) reasonably incurred by or on behalf of AbbVie and i... |
3.12 Completion of Research Plans After Exercise of License Option. If AbbVie exercises an applicable License Option prior to completion of the applicable Research Plan Activities, Heptares shall be responsible for completing any Research Plan Activities allocated to Heptares under any Research Plan that are unfinished... |
3.13 Manufacturing in Support of Research Plans and First In Human Clinical Studies. |
3.13.1 Heptares shall Manufacture (or cause to be Manufactured), at Heptares' sole cost and expense, a supply of all pre-clinical requirements of the Option Compounds, Option Products, comparators, co-administered agents and placebo for performance of the Research Plan Activities for each Option Program, including, sub... |
3.13.2 Heptares shall Manufacture (or have Manufactured), at Heptares' sole cost and expense, a supply of Licensed Compounds and Licensed Products that AbbVie may reasonably request for Conducting a first-in-human Clinical Study. Heptares will use the services of a Third Party contract manufacturing organization or Thi... |
3.14 Manufacturing Technology Transfer. Following the exercise of an applicable License Option, upon AbbVie's written request with respect any Licensed Compound and Licensed Product within an applicable Option Program, Heptares shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate o... |
3.14.1 With respect to each Manufacturing Technology Transfer, Heptares shall provide, and shall cause its Affiliates and Third Party CMOs to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party CMO, as applicable) to implement the applicable Manufacturing ... |
(i) Heptares shall make available, and shall cause its Affiliates and Third Party CMOs to make available, to AbbVie (or its Affiliate or designated Third Party CMO, as applicable) from time to time as AbbVie may reasonably request, all material Manufacturing-related Information and materials relating to the applicable ... |
(ii) Heptares shall cause all appropriate employees and representatives of Heptares and its Affiliates, and use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party CMOs, at AbbVie's cost, to meet with employees or representatives of AbbVie (or its Affiliate or desig... |
3.14.2 Heptares shall promptly disclose to AbbVie (a) all modifications, enhancements and improvements to each Manufacturing Process transferred to AbbVie pursuant to this Section 3.14, and (b) any other Manufacturing process, in each case ((a) and (b)) conceived, reduced to practice, discovered, developed or otherwise... |
3.15 Regulatory Matters. |
3.15.1 With respect to an applicable Option Product, upon reasonable request by AbbVie, Heptares shall, promptly following such request, request a pre-IND meeting for such Option Product with FDA (the "Pre-IND Meeting"). Subject to Section 2.2.3, the JGC shall review and agree upon the strategy, timing, content, topics... |
3.15.2 AbbVie shall have the sole right, at its sole discretion, to prepare, obtain and maintain all INDs or other Regulatory Approvals or documentation with respect to any Reserved Compound, Reserved Product, Compound or Product provided that AbbVie shall not file any of the foregoing prior to exercising the applicabl... |
3.15.3 At any time during the Term, if Heptares receives any correspondence from any Regulatory Authority related to any Reserved Compound, Reserved Product, Compound or Product, Heptares shall provide a copy of such correspondence to AbbVie within five (5) days of such receipt. In the event the correspondence relates ... |
ARTICLE 4 LICENSE OPTION |
4.1 License Option Grant to AbbVie. On an Option Program-by-Option Program basis, Heptares hereby grants to AbbVie an exclusive (including with regard to Heptares and its Affiliates) option to obtain an Exclusive License to such Option Program (each a "License Option"), exercisable by AbbVie in its sole discretion duri... |
4.2 Exercise of the License Option. At any time during the Option Period, on an Option Program-by-Option Program basis, AbbVie shall have the right to exercise such Option Program's License Option by delivering to Heptares a License Option Exercise Notice for such Option Program. |
4.3 Consequences of Exercise. |
4.3.1 If AbbVie exercises a License Option, from and after the License Option Effective Date, AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall have an Exclusive License for the applicable Option Program and, subject to Section 4.2, such Option Program shall become a Licensed Pro... |
4.3.2 In the case of any agreement with any Third Party that relates to the conduct of a Research Plan for a Licensed Program, Heptares shall promptly identify such agreement and provide, or if consent is required use reasonable efforts to seek consent to provide, a copy thereof to AbbVie. In the event such agreement d... |
4.4 HSR. |
4.4.1 If AbbVie reasonably determines in good faith prior to the delivery of a single or multiple License Option Exercise Notice(s) that the transactions to be consummated upon the exercise of the applicable License Option(s) require one or more HSR Filings, AbbVie shall provide such License Option Exercise Notice(s) t... |
4.4.2 In connection with the Parties activities under this Section 4.4, AbbVie and Heptares shall each use commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by the FTC or the DOJ with respect to the transactions notified in the HSR Filings. Nothing in this Section... |
4.4.3 AbbVie shall be responsible for all filing fees in connection with the filing of submissions to the FTC and DOJ under the HSR Act, and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred by it in preparing submissions or responses or responding to any Second Request or ... |
4.4.4 If the exercise by AbbVie of a single or multiple License Option(s) under Section 4.2 requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of such License Option(s) and the granting of the applicable Exclusive License(s) shall be tolled until the HSR Clearance ... |
4.5 Termination of License Option. If (a) upon the expiration of an Option Period AbbVie has not delivered a License Option Exercise Notice for the applicable Option Program pursuant to Sections 4.2 or 4.4.1, or (b) prior to the expiration of an Option Period AbbVie has delivered a License Option Exercise Notice pursua... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE |
5.1 In General. From and after the License Option Effective Date for each Licensed Program, AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right and responsibility, subject to Section 3.12, to Exploit Licensed Compounds and Licensed Products in the Field in the Territory at its own cost a... |
5.2 Diligence. From and after the License Option Effective Date for each Licensed Program, AbbVie shall use Commercially Reasonable Efforts to (i) obtain Regulatory Approval for one Licensed Product for a single Indication in the United States, Japan and any three (3) of the Major European Markets; and (ii) after AbbVi... |
5.3 Manufacturing after License Option Effective Date. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.