JDC Decision-Making. (a) Provided Immunocore has exercised its Co-Development Option and up until the time that it exercises any Opt-Out Right, each Party will discuss and attempt to resolve any potential or evolving disagreement related to any Co-Development Plan through their primary contacts or Alliance Managers before it is brought before the JDC. With respect to the responsibilities of the JDC, each Party shall have one vote on all matters brought before the JDC and the JDC shall operate by unanimous vote. If the JDC is unable to achieve unanimity within [***] of any dispute being brought before the JDC, such matter may be referred to senior managers under Clause 21.1 at either Party’s discretion. Where any dispute remains unresolved for a further [***] after such referral, Lilly shall have the deciding vote, save that (a) Lilly shall not be able to make any amendments to the terms of this Agreement without Immunocore’s prior written agreement; and (b) to the extent that Immunocore is to perform any activities under a given Co-Development Plan, Lilly shall not be entitled to require Immunocore to increase any work effort under such Co-Development Plan by more than [***] of the total FTE obligation for Immunocore in any twelve (12) month period where Immunocore does not have sufficient internal resources to conduct such activities [***]; (c) any increase in budget will be subject to Clause 7.4; and (d) Lilly shall not be entitled to require that Immunocore perform any activity under the Co-Development Plan where Immunocore has not previously agreed to perform such activity under the Co-Development Plan (and save as provided under Clause 4.7). Each Party shall make decisions within the JDC in good faith. (b) Where Immunocore has not exercised the Co-Development Option in relation to any Selected Candidate (in which case the following shall apply from expiry of the period for exercise of the Co-Development Option) or where it exercises any Opt-Out Right in relation to any Joint Selected Candidate (in which case the following shall apply from date of exercise of such Opt-Out Right), Lilly shall take full responsibility for the Development Plan and all development, regulatory, manufacturing and commercialization matters relating to the relevant Selected Candidate (including any other Compounds developed as part of the Research Plan resulting in the Selected Candidate) and shall have sole decision making authority in relation to the performance of such activities. Clause 2.3.4(a) shall continue to apply in relation to any remaining Co-Development Plans.
Appears in 2 contracts
Sources: Development and License Agreement (Immunocore LTD), Development and License Agreement (Immunocore LTD)
JDC Decision-Making. (a) Provided Immunocore has exercised its Co-Development Option All decisions of the JDC shall be made by unanimous vote, with S▇▇▇▇’▇ representatives and up until the time that it exercises any Opt-Out Right, Pfizer’s representatives each Party will discuss collectively having [***] vote. If after reasonable discussion and attempt to resolve any potential or evolving disagreement related to any Co-Development Plan through good faith consideration of each of their primary contacts or Alliance Managers before it is brought views on a particular matter before the JDC. With respect , the representatives of S▇▇▇▇ and Pfizer cannot reach an agreement as to the responsibilities of the JDC, each Party shall have one vote on all matters brought before the JDC and the JDC shall operate by unanimous vote. If the JDC is unable to achieve unanimity such matter within [***] of any dispute being Business Days after such matter was brought before to the JDCJDC for resolution, such matter may disagreement shall be referred to senior managers under Clause 21.1 at either Party’s discretion. Where any dispute remains unresolved the Chief Executive Officer of S▇▇▇▇ (or his or her designee) and the Global President, Hospital Business Unit of Pfizer (or his or her designee) (collectively, the “Executive Officers XE "Executive Officers" \t "See 3.2(d)" ”) for a further resolution, who shall use good faith efforts to resolve such matter within [***] Business Days after it is referred to them and, if such referralmatter is resolved by the Executive Officers, Lilly such resolution shall have be implemented by and binding on the deciding vote, save that (a) Lilly shall not be able Parties. If the Executive Officers are unable to make reach consensus on any amendments to the terms of this Agreement without Immunocore’s prior written agreement; and (b) to the extent that Immunocore is to perform any activities under a given Co-Development Plan, Lilly shall not be entitled to require Immunocore to increase any work effort under such Co-Development Plan by more than matter during such [***] Business Day period, then:
(1) the Chief Executive Officer of S▇▇▇▇ shall have the right to make the final decision if such matter (A) involves the Development of, or Regulatory Approval for, a Licensed Product solely outside the Pfizer Territory and (B) could not reasonably be expected to have a material adverse effect on the Development of, Regulatory Approval for, Commercialization or Exploitation of the total FTE obligation for Immunocore Compound or a Licensed Product inside the Pfizer Territory;
(2) the Global President, Hospital Business Unit of Pfizer shall have the right to make the final decision if such matter (A) involves the Development of, Regulatory Approval for, a Licensed Product solely in any twelve the Pfizer Territory and (12B) month period where Immunocore does not involve S▇▇▇▇’▇ Retained Rights and (C) could not reasonably be expected to have sufficient internal resources to conduct a material adverse effect on the Development of, Regulatory Approval for, Commercialization or Exploitation of the Compound or a Licensed Product outside the Pfizer Territory;
(3) in all other cases, such activities [***]; (c) any increase in budget matter will be subject to Clause 7.4; and resolved in accordance with Section 14.10 (d) Lilly shall not be entitled to require that Immunocore perform any activity under the Co-Development Plan where Immunocore has not previously agreed to perform such activity under the Co-Development Plan (and save as provided under Clause 4.7Dispute Resolution). Each Party shall make decisions within the JDC in good faith.
(b) Where Immunocore has not exercised the Co-Development Option in relation to any Selected Candidate (in which case the following shall apply from expiry of the period for exercise of the Co-Development Option) or where it exercises any Opt-Out Right in relation to any Joint Selected Candidate (in which case the following shall apply from date of exercise of such Opt-Out Right), Lilly shall take full responsibility for the Development Plan and all development, regulatory, manufacturing and commercialization matters relating to the relevant Selected Candidate (including any other Compounds developed as part of the Research Plan resulting in the Selected Candidate) and shall have sole decision making authority in relation to the performance of such activities. Clause 2.3.4(a) shall continue to apply in relation to any remaining Co-Development Plans.
Appears in 1 contract
JDC Decision-Making. (a) Provided Immunocore has exercised its Co-Development Option All decisions of the JDC shall be made by unanimous vote, with NPLH’s representatives and up until the time that it exercises any Opt-Out Right, Everest’s representatives each Party will discuss collectively having [***] vote. If after reasonable discussion and attempt to resolve any potential or evolving disagreement related to any Co-Development Plan through good faith consideration of each of their primary contacts or Alliance Managers before it is brought views on a particular matter before the JDC. With respect , the representatives of NPLH and Everest cannot reach an agreement as to the responsibilities of the JDC, each Party shall have one vote on all matters brought before the JDC and the JDC shall operate by unanimous vote. If the JDC is unable to achieve unanimity such matter within [***] of any dispute being Business Days after such matter was brought before to the JDCJDC for resolution, such matter may disagreement shall:
(a) be referred to senior managers under Clause 21.1 at either Party’s discretion. Where any dispute remains unresolved the Chief Executive Officer of ▇▇▇▇▇ Parent (or his or her designee) and the Chief Executive Officer of Everest (or his or her designee) (collectively, the “Executive Officers”) for a further resolution, who shall use good faith efforts to resolve such matter within [***] Business Days after it is referred to them and, if such referralmatter is resolved by the Executive Officers, Lilly such resolution shall have be implemented by and binding on the deciding vote, save that (a) Lilly shall not be able to make any amendments to the terms of this Agreement without Immunocore’s prior written agreement; and Parties.
(b) If the Executive Officers are unable to the extent that Immunocore is to perform reach consensus on any activities under a given Co-Development Plan, Lilly shall not be entitled to require Immunocore to increase any work effort under such Co-Development Plan by more than matter during such [***] Business Day period, then (i) the Chief Executive Officer of Everest shall have the right to make the final decision if such matter (A) involves the Development of, Regulatory Approval for, Commercialization or other Exploitation of the total FTE obligation for Immunocore Compound or a Licensed Product solely in any twelve the Territory and (12B) month period where Immunocore does not involve NPLH’s Retained Rights and could not reasonably be expected to have sufficient internal resources a material adverse effect on the Development of, Regulatory Approval for, Commercialization or Exploitation of the Compound or a Licensed Product outside the Territory; (ii) the Chief Executive Officer of ▇▇▇▇▇ Parent shall have the right to conduct make the final decision if such activities [***]matter either (A) involves the Development of, Regulatory Approval for, Commercialization or other Exploitation of the Compound or a Licensed Product solely outside the Territory, or NPLH’s Retained Rights, or (B) involves the Development of, Regulatory Approval for, or Commercialization or other Exploitation of the Compound or a Licensed Product in the Territory but could reasonably be expected to have a material adverse effect on the Development of, Regulatory Approval for, or Commercialization or Exploitation of the Compound or a Licensed Product outside the Territory; or (iii) in all other cases, such matter will be resolved in accordance with Section 14.10 (Dispute Resolution).
(c) any increase If NPLH does not participate in budget will be subject to Clause 7.4; and (d) Lilly shall not be entitled to require that Immunocore perform any activity under the Co-Development Plan where Immunocore has not previously agreed to perform such activity under the Co-Development Plan (and save as provided under Clause 4.7). Each Party shall make decisions within establishing the JDC in good faith.
(b) Where Immunocore has not exercised the Co-Development Option in relation to any Selected Candidate (in which case the following shall apply from expiry of the period for exercise of the Co-Development Option) or where it exercises any Opt-Out Right in relation to any Joint Selected Candidate (in which case the following shall apply from date of exercise of such Opt-Out Right), Lilly shall take full responsibility for the Development Plan and all development, regulatory, manufacturing and commercialization matters relating appoint members to the relevant Selected Candidate (including any other Compounds developed as part of the Research Plan resulting in the Selected Candidate) and JDC, Everest shall have sole decision the votes and the decision-making authority in relation power of NPLH with respect to the performance of such activities. Clause 2.3.4(a) shall continue JDC unless and until NPLH appoints members to apply in relation to any remaining Co-Development Plansthe JDC.
Appears in 1 contract
JDC Decision-Making. (a) Provided Immunocore has exercised its Co-Development Option and up until the time that it exercises any Opt-Out Right, each Each Party will shall discuss and attempt to resolve any potential or evolving disagreement related to any the Development Program through its respective Project Co-Development Plan through their primary contacts or Alliance Managers Leaders before it is brought before the JDC. With respect to the responsibilities of the JDC, each Party shall have one vote on all matters brought before the JDC and the The JDC shall operate as to matters within its responsibility by unanimous Party vote, with each Party having one vote. If the JDC is unable to achieve unanimity unanimous Party vote within [***] after the dispute matter is brought to a vote before the JDC then the following will apply:
(a) CG shall cast the deciding vote for:
(i) [***] and
(ii) [***],
(iii) [***].
(b) Kissei shall cast the deciding vote for [***].
(c) Notwithstanding the forgoing and for the avoidance of doubt:
(i) neither the JDC nor either Party shall have the authority to (1) impose any financial obligations on either Party or its Affiliates other than those explicitly required by this Agreement, (2) resolve any dispute regarding the existence of amounts of any dispute being brought before the JDCpayment owed under this Agreement, (3) impose on either Party or its Affiliates, an obligation to allocate such matter may be referred to senior managers under Clause 21.1 at either Party’s discretion. Where or its Affiliate’s tangible or intangible resources or assets in a certain manner (except as contemplated in the Development Plan) or (4) amend or modify, or waive its own compliance with, this Agreement;
(ii) neither the JDC nor Kissei shall have the right to increase the level of CG’s FTEs dedicated to conducting research under the Development Plan;
(iii) neither the JDC nor Kissei shall have any dispute remains unresolved authority over CG Territory Activities other than to discuss and exchange information with respect to CG Territory Activities;
(iv) Kissei shall not have the right to (1) change the scope of, or otherwise amend, the Development Plan, (2) approve any proposal to substitute the Initial Indication with an Other Indication in the Development Plan, (3) approve any addition or replacement of any Product, (4) determine whether Kissei may conduct (or appoint, license, or otherwise authorize or facilitate any Affiliate or Third Party to conduct) activities directed to the research or development of any Collaboration Compound or Product for an Other Indication as set forth in Section 2.2 (Certain Activities) or (5) determine whether to provide Product to support any investigator-initiated study of such Product as set forth in Section 2.2.2 (Certain Activities);
(v) Further, if the JDC is unable to achieve a further unanimous agreement within [***] after such referral, Lilly shall have the deciding vote, save that (a) Lilly shall not be able to make any amendments to the terms of this Agreement without Immunocore’s prior written agreement; and (b) to the extent that Immunocore is to perform any activities under a given Co-Development Plan, Lilly shall not be entitled to require Immunocore to increase any work effort under such Co-Development Plan by more than [***] of the total FTE obligation following matters are brought to vote before the JDC, then such matter(s) shall be submitted for Immunocore in any twelve resolution pursuant to Article 15 (12) month period where Immunocore does not have sufficient internal resources to conduct such activities [***]; Dispute Resolution): (c1) any increase matter set forth in budget will be subject to Clause 7.4; and subparagraph 3.6(c)(iv) above, (d2) Lilly shall not be entitled to require that Immunocore perform any activity under the Co-Development Plan where Immunocore has not previously agreed to perform such activity under the Co-Development Plan (and save as provided under Clause 4.7). Each Party shall make decisions dispute within the JDC in good faith.
regarding Section 7.4.3 (b) Where Immunocore has not exercised the Co-Development Option in relation to any Selected Candidate (in which case the following shall apply from expiry of the period for exercise of the Co-Development Option) or where it exercises any Opt-Out Right in relation to any Joint Selected Candidate (in which case the following shall apply from date of exercise of such Opt-Out RightRoyalty Payment Offsets), Lilly shall take full responsibility for the Development Plan including, without limitation and all developmentby way of example, regulatory, manufacturing and commercialization matters relating to the relevant Selected Candidate any dispute under Section 7.4.3(a)(iii) (including any other Compounds developed as part of the Research Plan resulting in the Selected Candidate) and shall have sole decision making authority in relation to the performance of such activities. Clause 2.3.4(a) shall continue to apply in relation to any remaining Co-Development Plans.
Appears in 1 contract
Sources: License and Collaboration Agreement (CG Oncology, Inc.)