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1.146 "Sublicensee" has the meaning set forth in Section 4.2 (Sublicensing Rights). |
1.147 "Target Program Slot" means a collaboration program for the conduct of discovery, research, and development activities pursuant to a Collaboration Plan. Each Target Program Slot will correspond to a single Collaboration Plan and, at any given time, a single Collaboration Target. Target Program Slot includes the I... |
1.148 "Term" has the meaning set forth in Section 13.1 (Term). |
1.149 "Terminated Product" means each Royalty-Bearing Product that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Royalty-Bearing Products shall be Terminated Products. |
1.150 "Terminated Target" means each Collaboration Target that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Collaboration Targets shall be Terminated Targets. |
1.151 "Terminated Territory" has the meaning set forth in Section 13.5 (Effects of Termination in Terminated Territory). |
1.152 "Territory" means worldwide. |
1.153 "Third Party" means any Person that is neither a Party nor an Affiliate of a Party. |
1.154 "Third Party Infringement Claim" has the meaning set forth in Section 9.5 (Infringement Claims by Third Parties). |
1.155 "Third Party Right" means any Patent Right, Know-How, or other intellectual property right of a Third Party in any country in the Territory. |
1.156 "Trademark" means any word, name, symbol, color, shape, designation, or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design, ... |
1.157 "UK" means the United Kingdom of Great Britain and Northern Ireland. |
1.158 "United States" or "U.S." means the United States of America and all of its territories and possessions. |
1.159 "UPenn" has the meaning set forth in Section 1.161 ("UPenn Technology"). |
1.160 "UPenn Agreement" has the meaning set forth in Section 1.161 ("UPenn Technology"). |
1.161 "UPenn Technology" means "Penn Patent Rights," "Technical Information," and "Know-How," in each case as defined in the Patent License Agreement between Anima Biotech Inc. and The Trustees of the University of Pennsylvania ("UPenn"), dated June 25, 2010, as amended by that certain First Amendment to Patent License... |
1.162 "Voting Stock" has the meaning set forth in Section 1.34.1 ("Change of Control"). |
1.163 "Withholding Amount" has the meaning set forth in Section 7.16.2 (Withholding Taxes). |
ARTICLE 2 DEVELOPMENT; LICENSE OPTION |
2.1 Overview. On a Target Program Slot-by-Target Program Slot basis, during the applicable Collaboration Term for such Target Program Slot, Anima will perform and complete certain discovery, research, and development activities in accordance with the terms of this Agreement and the applicable Collaboration Plan to gene... |
2.2 Target Program Slots. |
2.2.1 Initial Target Program Slots. The initial Collaboration Targets for the first three (3) Target Program Slots as of the Effective Date (each, an "Initial Target Program Slot") are identified as "Initial Collaboration Targets" in Exhibit A-1 attached hereto. |
2.2.2 Additional Target Program Slots. At any time following the Effective Date and until the five- (5-) year anniversary thereof, AbbVie will have the right to select up to three (3) additional Target Program Slots (each, an "Additional Target Program Slot") in accordance with the terms of this Section 2.2.2 (Addition... |
2.3 Collaboration Target Substitution. On a Target Program Slot-by-Target Program Slot basis, AbbVie will have the right to substitute the Collaboration Target with respect to each Target Program Slot with an Available Target up to a total of two (2) times per Target Program Slot (i.e., replace the original Collaborati... |
2.4 Gatekeeper. Within thirty (30) days after the Effective Date, the Parties will appoint an independent Third Party legal counsel reasonably acceptable to both Parties (the "Gatekeeper") to carry out the functions of the Gatekeeper as set out in this Agreement, provided that Anima will not unreasonably withhold, dela... |
2.5 Selection of Available Targets. All Reserved Targets shall be deemed to be Available Targets. A target that is not a Reserved Target may only be deemed to be an Available Target in accordance with the terms of this Section 2.5 (Selection of Available Targets), unless the Parties otherwise mutually agree that such t... |
2.5.1 Available Targets and Excluded Targets. If, during the period when AbbVie has the right to select an Additional Target Program Slot pursuant to Section 2.2.2 (Additional Target Program Slots) or substitute a Collaboration Target pursuant to Section 2.3 (Collaboration Target Substitution) (the "Gatekeeping Term"),... |
2.5.2 Available Target Selection. After the Gatekeeper has determined that a Proposed Target is an Available Target, upon AbbVie's request, Anima will perform in silico target feasibility analysis with respect to such Proposed Target (to the extent not already performed by Anima), at Anima's expense, and provide AbbVie... |
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... |
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