text stringlengths 1 5.46k |
|---|
2.6 Collaboration Plans. |
2.6.1 Initial Collaboration Plans. The initial Collaboration Plan for each of the three (3) Initial Target Program Slots is attached as Exhibit B-1 hereto. For each Additional Target Program Slot, the Parties will, within thirty (30) days after the designation of the corresponding Collaboration Target pursuant to Secti... |
2.6.2 Amendments to Collaboration Plans. Either Party may propose an amendment to a Collaboration Plan by submitting (through a Subcommittee) such proposed amendment in writing to the JGC for review and approval. Upon approval of such proposed amendment in writing by the JGC, the applicable Collaboration Plan will be d... |
2.7 Conduct of Collaboration Activities. |
2.7.1 Responsibility. Anima will have sole responsibility for the conduct of all activities under each Collaboration Plan, except for any activities specifically allocated to AbbVie under a Collaboration Plan. Anima will bear all costs and expenses incurred by or on behalf of it in the performance of its activities und... |
2.7.2 Diligence; Data Package Submission. Anima will (a) perform and complete all activities under each Collaboration Plan in accordance with Section 2.7.3 (Timeline; Delays) and (b) use Commercially Reasonable Efforts to achieve the objectives set forth in each Collaboration Plan. Without limiting the foregoing, for e... |
2.7.3 Timeline; Delays. Anima will perform and complete all activities under each Collaboration Plan in accordance with the timelines set forth therein. If Anima fails to meet the timelines set forth in a Collaboration Plan, then Anima will not be deemed to be in breach of the obligation in the immediately preceding se... |
2.7.4 Information and Reports. On a Target Program Slot-by-Target Program Slot basis, within thirty (30) days following the end of each Calendar Quarter during the applicable Collaboration Term for such Target Program Slot, Anima will provide to AbbVie (a) a detailed, written progress report on the status of Anima's ac... |
2.7.5 Anima Discovered Compounds. On a Target Program Slot-by-Target Program Slot and License Option Exercise Data Package-by-License Option Exercise Data Package basis, prior to Anima's submission of a License Option Exercise Data Package to AbbVie with respect to a Target Program Slot, Anima will update its in-proces... |
2.8 IP Assignment Obligation. Except where applicable Law requires otherwise: (a) Anima shall cause all Persons (including any Affiliate or Third Party subcontractor) who perform activities for Anima or its Affiliates under this Agreement or who conceive, reduce to practice, generate, discover, develop, or otherwise ma... |
2.9 License Option. |
2.9.1 Grant of License Option. On a Target Program Slot-by-Target Program Slot basis, Anima hereby grants to AbbVie an exclusive first option, exercisable by AbbVie in its sole discretion during the applicable License Option Period, to obtain the AbbVie License with respect to the License Option Exercise Data Package a... |
2.9.2 License Option Period Extension. On a Target Program Slot-by-Target Program Slot basis, AbbVie may extend the end date of the License Option Period with respect to any Target Program Slot by paying to Anima the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program S... |
2.9.3 Exercise of License Option. |
(a) On a Target Program Slot-by-Target Program Slot basis, AbbVie may exercise a License Option during the applicable License Option Period by, subject to Section 2.11 (HSR), providing written notice thereof to Anima (each such notice, a "License Option Exercise Notice"). |
(b) Prior to AbbVie's exercise of a License Option during the applicable License Option Period, promptly upon AbbVie's request, Anima will provide to AbbVie (i) an updated disclosure schedule with respect to Anima's representations and warranties set forth in Section 11.2 (Representations, Warranties, and Covenants, as... |
(c) If AbbVie exercises a License Option in accordance with Section 2.9.3(a) but AbbVie does not pay to Anima the License Option Exercise Fee in accordance with Section 7.5 (License Option Exercise Fee) on or before the due date of such payment, then Anima shall deliver notice of such payment default to AbbVie and if A... |
2.10 Conduct of Post-License Option Exercise Activities. |
2.10.1 Activities under Collaboration Plan. If AbbVie exercises a License Option prior to the completion of activities under the applicable Collaboration Plan, then, unless otherwise requested by AbbVie in writing, Anima will remain responsible for completing all remaining activities under such Collaboration Plan durin... |
2.10.2 Post-License Option Exercise Activities. On a Target Program Slot-by-Target Program Slot basis, following AbbVie's exercise of the License Option with respect to a Target Program Slot, AbbVie may request during the applicable Collaboration Term that Anima conduct certain activities proposed by AbbVie with respec... |
2.11 HSR. |
2.11.1 If AbbVie determines in its sole discretion prior to the delivery of the License Option Exercise Notice for a License Option that the transactions to be consummated upon the exercise of the License Option require HSR Filings, then AbbVie may provide the License Option Exercise Notice for the License Option to An... |
2.11.2 In connection with the Parties' activities under this Section 2.11 (HSR), AbbVie and Anima 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 S... |
2.11.3 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... |
2.11.4 Tolling of Obligations. If the exercise by AbbVie of a License Option under Section 2.9.3 (Exercise of License Option) requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of the License Option (including payment of any License Option Exercise Fee) and the gra... |
2.12 No Exercise of License Option. On a Target Program Slot-by-Target Program Slot basis, if AbbVie does not exercise a License Option with respect to a Target Program Slot in accordance with Section 2.9.3 (Exercise of License Option) during the applicable License Option Period (including, for clarity, if not extended... |
ARTICLE 3 MANAGEMENT OF THE COLLABORATION |
3.1 Joint Governance Committee. Within fifteen (15) days after the Effective Date, the Parties shall establish a joint governance committee (the "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described in this ARTICLE... |
3.2 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 3.5 (Decision-Making): |
(a) review and decide whether to approve (and if so decided, approve in writing) each proposed Collaboration Plan and any proposed amendment to a Collaboration Plan; |
(b) review the progress reports submitted by Anima under Section 2.7.4 (Information and Reports); |
(c) serve as an initial forum for discussion of any issues or disputes arising from the conduct of the activities under each Collaboration Plan; |
(d) review and discuss any delay, as described in Section 2.7.3 (Timeline; Delays); |
(e) determine the end date of the Collaboration Term with respect to a Target Program Slot; |
(f) form working groups, subcommittees, or directed teams as the JGC deems necessary to oversee particular projects or activities or otherwise to achieve the objective and intent of this Agreement (each, a "Subcommittee", and the JGC and any Subcommittee, a "Committee"); |
(g) review and resolve any reports, recommendations, or disputes of any Subcommittee; |
(h) assign responsibilities that may fall within the purview of more than one (1) Subcommittee to a particular Subcommittee; and |
(i) perform such other responsibilities as may be assigned to the JGC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 3.2 (Responsibilities) and, further, the JGC's authority shall be subject to the limitations set forth in Section 3.5.3 (Escalation to the Parties; Limitations on Authority). |
3.3 Meetings and Minutes. The JGC shall meet quarterly or as otherwise agreed to by the Parties (including on an ad hoc basis), but in any event shall have at least two (2) in-person or video conference meetings per Calendar Year. Each other Committee shall meet quarterly, or more frequently as agreed to by the Parties... |
3.4 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work and the work of each Subcommittee, to the extent that such rules are not inconsistent with this Agreement. A quorum of a Committee shall exist whenever there is present at a meeting at least one (1) repres... |
3.5 Decision-Making. |
3.5.1 Escalation to JGC. Except as otherwise provided herein, all decisions of a Committee shall be made by consensus, with all of a Party's voting members collectively having one (1) vote. Decisions of a Committee shall be made by unanimous vote. If a Subcommittee is incapable of reaching unanimous agreement on a matt... |
3.5.2 Escalation to the Executive Officers. If the JGC cannot agree on a matter within ten (10) Business Days (or such other time period as mutually agreed by the Parties) after it has met and attempted to reach such decision, then either Party may, by written notice to the other, refer such issue to the Executive Offi... |
3.5.3 Escalation to the Parties; Limitations on Authority. If the Executive Officers are unable to resolve the matter within ten (10) Business Days after the matter is referred to them (or such other time period as mutually agreed by the Parties), then: |
(a) Neither Party will have final decision-making authority with respect to the approval of an initial Collaboration Plan with respect to any Additional Target Program Slot or the approval of an amendment to any existing Collaboration Plan in a Target Program Slot; provided that, notwithstanding any provision to the co... |
(i) includes at least those elements and approximate timelines set forth in an existing Collaboration Plan that are scientifically applicable to the activities under such new or as-amended Collaboration Plan; |
(ii) is substantially similar in scientific detail and rigor to an existing Collaboration Plan; and |
(iii) solely with respect to any proposed amendment to an existing Collaboration Plan: (A) does not increase Anima's overall expenditure for the applicable Target Program Slot, as determined by Anima and as compared to the original Collaboration Plan for such Target Program Slot, by more than Five Hundred Thousand Doll... |
(b) AbbVie will have final decision-making authority with respect to any JGC determination of the end date of a Collaboration Term. |
(c) Except as provided in clauses (a)-(b), neither Party shall have final decision-making authority with respect to the applicable matter, the status quo will prevail, and either Party may propose to resolve the applicable matter by an ADR proceeding pursuant to the procedures set forth in Schedule 14.2.2 (ADR Procedur... |
Any decision made by the Executive Officers in accordance with Section 3.5.2 (Escalation to the Executive Officers) or by a Party in accordance with this Section 3.5.3 (Escalation to the Parties; Limitations on Authority) shall be considered a decision made by the JGC. |
3.6 Limits on Decision-Making. Notwithstanding anything to the contrary in this Agreement, including Section 3.5 (Decision-Making), in no event shall either Party alone have the power or authority to: |
(a) make any determination that such Party has fulfilled its obligations under this Agreement or that the other Party has breached this Agreement; |
(b) make any decision that is expressly stated to require the mutual agreement of the Parties or approval of the other Party; or |
(c) impose any requirement on the other Party to perform any act that the other Party reasonably believes to be inconsistent with any applicable Law. |
3.7 Alliance Managers. Promptly after the formation of the JGC, each Party shall appoint an employee (who may not be a then-current member of the JGC) to act as alliance manager for such Party (each, an "Alliance Manager"). Each Alliance Manager shall thereafter be permitted to attend meetings of the JGC as a nonvoting... |
3.8 Discontinuation of Committees. Unless otherwise agreed by the Parties, on a Target Program Slot-by-Target Program Slot basis: |
3.8.1 Upon AbbVie's exercise of the License Option with respect to a Target Program Slot, no Committee shall have any decision-making role with respect to the applicable Target Program Slot, except that the JGC may determine (a) the end date of the Collaboration Term with respect to such Target Program Slot provided th... |
3.8.2 Upon the end of the Collaboration Term with respect to a Target Program Slot, the role of any Committee with respect to the Target Program Slot shall be automatically disbanded and the Alliance Manager roles with respect to such Target Program Slot shall be automatically terminated, and for clarity, following the... |
3.9 Interactions Between a Committee 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 3 (Management of ... |
3.10 Subcommittees. Subject to the terms of this Agreement, each Subcommittee shall be constituted and shall operate as the JGC determines; provided that each Subcommittee shall have equal representation from each Party, unless otherwise mutually agreed. Each Subcommittee and its activities shall be subject to the over... |
3.11 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, a Committee. |
3.12 Authority. Each Party will retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested in a Committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree i... |
ARTICLE 4 GRANT OF LICENSES |
4.1 Licenses to AbbVie. |
4.1.1 Commercial Licenses. Subject to the terms and conditions of this Agreement, on a Target Program Slot-by-Target Program Slot basis, upon AbbVie's exercise of a License Option with respect to a Target Program Slot in accordance with Section 2.9.3 (Exercise of License Option), and subject to Section 2.11.4 (Tolling ... |
4.1.2 Collaboration Activities License. Subject to the terms and conditions of this Agreement, Anima (on behalf of itself and its Affiliates), hereby grants to AbbVie and its Affiliates during the Collaboration Term, a non-exclusive, royalty-free, non-transferable (except in accordance with Section 14.3 (Assignment)), ... |
4.2 Sublicensing Rights. AbbVie shall have the right to grant and authorize sublicenses under the rights granted to it under Section 4.1 (Licenses to AbbVie) to any Third Parties through multiple tiers (each such Third Party, a "Sublicensee"). Each Sublicensee shall be subject to a written agreement that is consistent ... |
4.3 UPenn Rights. Notwithstanding any provision to the contrary in this Agreement, the AbbVie License and the AbbVie Collaboration Activities License shall not include a license or sublicense under the UPenn Technology and Anima shall not, and shall ensure that its Affiliates and subcontractors do not, disclose any UPe... |
4.4 No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right, or other right in any Know-How, Patent Rights, or other intellectual property rights of the other Party or any of its Affiliat... |
4.5 Confirmatory Patent License. Anima shall, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AbbVie considers ap... |
4.6 In-License Agreements. On a Target Program Slot-by-Target Program Slot basis, if at any time during the applicable In-License Agreement Notification Period Anima or any of its Affiliates enters into an agreement with a Third Party pursuant to which Anima or its Affiliate in-licenses or otherwise acquires rights tha... |
4.7 Rights in Bankruptcy. |
4.7.1 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by Anima to AbbVie, including those set forth in Section 4.1 (Licenses to AbbVie) (collectively, the "Bankruptcy Code Intellectual Property") are and shall otherwise be deemed to be, for purposes of Section ... |
4.7.2 Rights of Non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against Anima under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, then AbbVie shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Bankruptcy Cod... |
ARTICLE 5 POST-LICENSE OPTION EXERCISE ACTIVITIES |
5.1 Anima Transition Obligation Upon License Option Exercise. On a Target Program Slot-by-Target Program Slot basis, upon AbbVie's request following the exercise of a License Option by AbbVie with respect to a Target Program Slot, without additional consideration to Anima: |
5.1.1 within thirty (30) days after the applicable License Option Effective Date, Anima shall transfer to AbbVie: (a) copies of all data, reports, records, materials, and other information within the Licensed IP and (b) the file wrappers and other documents and materials relating to the prosecution, defense, maintenanc... |
5.1.2 without limiting Section 5.1.1(b), Anima shall assist and cooperate with AbbVie, as AbbVie may reasonably request, in the transition of the prosecution, maintenance, enforcement, and defense of the applicable Anima Collaboration Patents; and |
5.1.3 Anima shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under or as AbbVie may reasonably request in connection wi... |
5.2 AbbVie Development and Commercialization. On a Target Program Slot-by-Target Program Slot basis, following the applicable License Option Effective Date with respect to such Target Program Slot, other than any remaining activities allocated to Anima under the applicable Collaboration Plan or any applicable Post-Lice... |
5.3 AbbVie Diligence Obligation. Following initiation of IND-Enabling Studies for the first Royalty-Bearing Product under this Agreement, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for such first Royalty-Bearing Product in the Field in the United States and three (3) Majo... |
ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES |
6.1 Compliance. All activities to be conducted by a Party under this Agreement shall be conducted in compliance with applicable Laws, including all applicable good laboratory practice requirements and good clinical practice requirements. |
6.2 Regulatory Activities. |
6.2.1 From and after the exercise by AbbVie of a License Option, AbbVie shall, as between the Parties, have the sole right to prepare, obtain, and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, and other submissions fo... |
6.2.2 From and after the exercise by AbbVie of a License Option, all Regulatory Filings (including all Regulatory Approvals) in the Territory relating to the applicable Royalty-Bearing Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee, or... |
6.3 Performance by Affiliates and Sublicensees. Notwithstanding any provision to the contrary set forth in this Agreement, AbbVie shall have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate or Sublicensee (subject to Section 4.2 (Sublice... |
6.4 Subcontracting. |
6.4.1 AbbVie shall have the right to engage Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners, or Distributors) to perform any of its activities under this Agreement. |
6.4.2 Anima and its Affiliates shall have the right to subcontract its activities under this Agreement to any Affiliate or Third Party subcontractor to the extent expressly provided for in a Collaboration Plan or otherwise with the prior written approval of AbbVie, such approval not to be unreasonably withheld; provide... |
6.5 Records and Audits. Each Party shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current, and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development, Manufacturing, and Commercialization activities under t... |
ARTICLE 7 UPFRONT FEE; MILESTONES AND ROYALTIES; PAYMENTS |
7.1 Upfront Fee. No later than ten (10) days following the Effective Date, AbbVie shall pay Anima a one-time non-refundable, non-creditable upfront payment of Forty-Two Million Dollars ($42,000,000). |
7.2 Additional Target Program Fee. On an Additional Target Program Slot-by-Additional Target Program Slot basis, AbbVie shall pay to Anima a one-time non-refundable, non creditable payment corresponding to the period during which the Additional Target Program Slot Designation Date occurs, as set forth in the table belo... |
Time Period During Which Additional Target Program Slot Designation Date Occurs |
Before or on two- (2-) year anniversary of the Effective Date |
After two- (2-) year anniversary of the Effective Date and before or on three- (3-) year anniversary of the Effective Date |
After three- (3-) year anniversary of the Effective Date and before or on four- (4-) year anniversary of the Effective Date |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.