Decision Making. The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows: (a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing: (i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *]; (ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and (b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.
Appears in 5 contracts
Samples: Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee JSC shall each act by unanimous agreement have the right to determine matters that are within the scope of its members, with each Party having one votethe JSC (as set forth in Section 2.2(d)) or are otherwise expressly allocated to the JSC as set forth in this Agreement. If [***]. The Parties shall cause their respective representatives on the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of JSC to use their good faith efforts to reach resolve all matters presented to them as expeditiously as possible. The representatives of each Party shall have collectively one (1) vote on behalf of such Party; provided, that no such vote taken at a unanimous meeting shall be valid unless a representative of each Party is present and participating in the vote. Disputes at the JSC shall be resolved as follows:
(i) In the event that the JSC, after a period of [***] days from the date a matter is submitted to it for decision (including if the Parties are unable to agree on an issuea Technology Collaboration Plan (or amendment thereto), fails Regeneron Target Evaluation Plan (or amendment thereto), Intellia Target Evaluation Plan (or amendment thereto), Product R&D Plan (or amendment thereto), or any other matter that must be resolved by the JSC), is unable to reach such make a unanimous decisiondecision [***], then either Party may refer require that the matter be submitted to the Executive Officers for a joint decision by providing written notice to the other Party formally requesting that the dispute be resolved by the Executive Officers and specifying the nature of the dispute with sufficient specificity to permit adequate consideration by such issue Executive Officers.
(ii) If the dispute is referred to the Executive Officers. Such , then the Executive Officers shall meet promptly thereafter diligently and shall negotiate in good faith attempt to resolve the issuesreferred dispute within [***] days after receiving such written notification or such longer period of time as the Executive Officers may agree in writing. All such referred disputes shall require a joint decision of both Parties’ Executive Officers.
(iii) If the Executive Officers cannot resolve such issue dispute within such [* * ***] of referral of days or other agreed period, such issue to the Executive Officers, the resolution of such issue shall dispute will be resolved as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.
Appears in 4 contracts
Samples: License and Collaboration Agreement (Intellia Therapeutics, Inc.), License and Collaboration Agreement (Intellia Therapeutics, Inc.), License and Collaboration Agreement (Intellia Therapeutics, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee JDC shall each act by unanimous agreement of its membersmake decisions unanimously, with each Party Party’s representatives collectively having one vote(1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers executives cannot resolve such issue the matter within [*** * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d)Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgenematter. Notwithstanding the foregoing, none the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of AcceleronFivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, Celgenein its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the Joint Development Committee or event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the Joint Commercialization Committee may right to continue such trial by itself at its expense. When *** make any decision inconsistent a final determination under this Section 3.4, that final determination must be consistent with the express terms of this Agreement without the prior written consent of each PartyAgreement.
Appears in 3 contracts
Samples: License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee JSC shall each act by unanimous agreement of its members, with consensus. The representatives from each Party having will have, collectively, one vote(1) vote on behalf of that Party. The JSC shall strive to seek consensus in its actions and decision making process. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJSC, the JSC is still unable after a period of [* * ***] (or such other period as the Parties may otherwise agree[***]) of good faith efforts [***] to reach a unanimous decision on an issue, fails to reach such a unanimous decisionmatter, then either Party may refer such issue matter to the Parties’ Executive Officers for attempted resolution by good faith resolution within [***] ([***]) [***] after such matter has been referred to the Executive Officers; provided, however, that the Parties acknowledge and agree that (i) the purpose of the JSC is to facilitate the efficient Development of Products primarily for the U.S. and (ii) if either Party reasonably believes and provides such belief that such [***] ([***]) [***] or [***] ([***]) [***] delay would hinder or delay any Development activities under the Development Plan or that have been committed to a Regulatory Authority by a particular date, then the Parties shall reduce such time periods as reasonably necessary to prevent such hindrance or delay. Such If the Executive Officers shall meet promptly thereafter and shall negotiate in good faith are not able to resolve the issues. If Executive Officers cannot resolve such issue matter within such [* * ***] of referral of ([***]) [***] period or the reduced period, then the Takeda Executive Officer shall have the right to decide such issue to the Executive Officersmatter; provided, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committeehowever, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is no amendment to the Developing Party and such issue relates Research Plan that materially changes the nature or scope of each item or task assigned to (x) ITI under Figure 1 of the approval of an Additional Development DiseaseInitial Research Plan, or three (y3) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial year time period of the relevant Licensed Compound Research Term, may be adopted or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement approved without the prior written consent of each PartyITI, not to be unreasonably withheld or delayed; and
(ii) with respect to the content of the Development Plan, the Takeda Executive Officer shall not make any determination that would materially change the nature or scope of ITI’s responsibilities explicitly assigned to ITI as provided thereunder without ITI’s prior written consent, not to be unreasonably withheld or delayed. Notwithstanding the foregoing, with respect to disputes arising from the JPC (as defined in Section 3.4) and referred to the JSC for resolution, the JSC’s decision will be non-binding and advisory only, and will not be subject to escalation to the Executive Officers. All disputes with respect to matters under the purview of the JPC shall be resolved in accordance with the terms of Article 9 and, if necessary, Section 14.3. Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Intra-Cellular Therapies, Inc.), License and Collaboration Agreement (Intra-Cellular Therapies, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Decision-Making Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one votevote (such vote to be cast by the Party’s co-chair to the extent such Party’s representatives do not unanimously agree on a decision). If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Decision-Making Committee, the representatives of the Parties cannot reach an agreement as to such matter within [***] after such matter was brought to such Decision-Making Committee for resolution or after such matter has been referred to such Decision-Making Committee, such disagreement shall, upon the written request of either Party, be referred to the JSC (in the case of disagreement of the JRDC, JCC or subcommittees of the JSC), or the Designated Senior Officers (in the case of disagreement of the JSC) for resolution, in each case, to discuss such matter in good faith for resolution. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Designated Senior Officers cannot resolve such issue any matter referred to them by the JSC within [* * ***] of referral after such matter has been referred to them, then such matters shall be finally and definitively resolved as set forth in Section 2.10(b) or otherwise by consensus. The Parties may by mutual written agreement determine to shorten the timeframes specified above in this Section 2.10. If any decision-making authority assigned to any Committee necessarily extends beyond the term of such issue Committee as set forth in Section 2.11, then such decision making authority shall be automatically transferred to Sanofi.
(b) For any matters submitted for resolution by the Executive Designated Senior Officers, the resolution Designated Senior Officer of Sanofi shall have final decision-making power with respect to such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issuematter; provided that, notwithstanding that the foregoingDesignated Senior Officer of Sanofi shall not have the right to exercise its final decision-making authority without RevMed’s consent to:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * ***];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * ***]
(iii) [***] following the earliest of: or
(xiv) [* * ***]. Notwithstanding anything to the contrary in this Agreement, except as expressly set forth in Section 4.2(a)(i)(A) and, if applicable, Section 4.2(a)(i)(B), [***]:
A. Sanofi cannot without cause exercise such final decision-making authority to [***] from one of its assigned activities under the applicable Research Plan or Development Plan and [***] similar activity;
B. for any proposal to [***], and (y) the Joint Development Committee’s decision JRDC shall first use good faith efforts to go forward with [***], a Phase 3 Clinical Trial of pending amendment thereto or as otherwise determined by the relevant Licensed Compound or Licensed Product; provided JRDC, that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * **]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined C. if [***] does not occur and if Sanofi [***] by [* * ***] following the earliest of: (x) without RevMed’s consent, then [* * ***] for a period of [***] in which such [***], provided that RevMed shall use good faith efforts to [***] during [***], and (y) the occurrence of provided further that Sanofi shall not be required to make any such [* * ***] during [***]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding Without limiting the foregoing, none Sanofi shall be deemed to have cause to [***], for example, in the case of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party[***].
Appears in 2 contracts
Samples: Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.), Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives having one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJSC, after the JSC cannot reach a decision as to such matter within [* * *] (or after such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter was brought to the JSC for resolution, such matter shall be referred to the [*] of Entasis and the [*] of Zai (the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues”) for resolution. If the Executive Officers cannot resolve such issue matter within [* * *] after such matter has been referred to them, then the following shall apply: (i) prior to [*], [*] has final decision-making authority over the [*], including [*]; provided, that [*] shall have final decision-making authority (after good faith consideration to [*] views) with respect to the [*]; (ii) following [*], [*] has final decision-making authority over matters that pertain solely to the [*]; (iii) [*] has final decision-making authority over [*] of referral such product or combination by or on behalf of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following outside the earliest of: (x) Territory, and after such [* * *], [*] has final decision making authority over such [*] in the Territory; (iv) [*] has final decision making over any material [*] activity for the Territory that it believes in good faith, based solely on scientific or patient safety concerns, would reasonably be expected to materially and adversely affect the [*] (e.g., [*]); and (yv) the Joint Development Committee’s [*] has final decision making over any decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that extent applicable to [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may Entasis shall not make any decision inconsistent that would materially increase Zai’s obligations or expenses above those set forth in the then-current Development Plan without Zai’s written consent. By way of illustration and not limitation, with respect to the express terms final decision-making of this Agreement without the prior written consent of each PartyParties set forth in Section 3.1(e), if the [*], but the [*], then the parties would discuss the [*] in good faith, with [*] having final decision-making authority with respect thereto.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Entasis Therapeutics LTD), License and Collaboration Agreement (Entasis Therapeutics LTD)
Decision Making. The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee JRC cannot, or Joint Commercialization Committeedoes not, after reach consensus on an issue at any JRC meeting or within a period of [* * ***] ([***]) Business Days thereafter (or such other period of time as mutually agreed by the Parties may otherwise agree) or by consensus of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionthe JRC), then upon the request of either Party may refer such issue Party, the disagreement will first be referred to the Executive Officers. Such Executive Senior Officers shall meet promptly thereafter and shall negotiate of the Parties, who will confer in good faith on the resolution of the issue. Any final decision mutually agreed to resolve by the issuesSenior Officers will be conclusive and binding on the Parties. If Executive the Senior Officers canare not resolve able to agree on the resolution of any such issue within [* * ***] of referral of ([***]) days after such issue was first referred to the Executive Officersthem, the resolution of then, if such issue decision is [***], [***] and, for all other decisions, shall be as follows:resolved consistent with the provisions of this Section 3.5 (Decision-Making):
3.5.1 subject to Section 3.5.3, if the matter concerns (a) if such issue properly originated at [***], including any [***] or (b) the Joint Development Committee[***], determined the final decision shall be made by the Developing Party Senior Officer of the relevant Licensed Compound or Licensed Product at issueGinkgo; provided that, notwithstanding the foregoing:
in no event may Ginkgo exercise its final-decision making authority, including in connection with amending an approved Workflow Development Plan, in any manner that would (i) [***] BLI’s obligations under such Workflow Development Plan, (ii) obligate or require BLI to increase its spending under such Workflow Development Plan by more than [***] percent ([***]%) of BLI’s spending obligation under such Workflow Development Plan or (iii) modify the Minimum Cumulative Purchase Commitment or the Full Purchase Target;
3.5.2 subject to Section 3.5.3, if Acceleron is the Developing Party and matter concerns [***], including any [***] (provided that any [***] shall not affect decision-making authority under this Section 3.5 (Decision-Making)), the final decision shall be made by the Senior Officer of BLI; provided that, in no event may BLI exercise its final-decision making authority, including in connection with amending an approved Workflow Development Plan, in any manner that would (a) [***] Ginkgo’s obligations under such issue relates Workflow Development Plan [***] or (b) obligate or require Ginkgo to increase its spending under such Workflow Development Plan by more than [***] percent (x[***]%) the approval of an Additional Ginkgo’s spending obligation under such Workflow Development DiseasePlan, or (yc) matters under Section 5.6.3(dmodify the Minimum Cumulative Purchase Commitment or the Full Purchase Target;
3.5.3 if the matter is determining (a) whether [***] or (b) whether [***] (including with respect to [***]), then such issue with respect to each, at either Party’s request, the dispute shall be determined resolved in an accelerated manner by a panel of three (3) independent Third Parties, each having expertise with respect to the subject matter of the applicable Workflow Development Plan (such panel, an “Expert Panel”), subject to the following process: (i) each Party will engage one independent Third Party expert for the Expert Panel [* * *];
**] after [***] to serve on the Expert Panel, (ii) regardless of which Party is the Developing Party, such issue shall be determined by within [* * ***] following the earliest of: (x) [* * ***]) days of any request to refer the matter to an Expert Panel or, if earlier, as promptly as reasonably practicable after each Party’s engagement of its Third Party Expert, the Parties’ two (2) Third Party experts shall mutually agree on a third (3rd) independent Third Party expert who will serve on such panel and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial as chairperson of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
panel, (iii) regardless the Expert Panel will reach a decision as to such matter (including whether [***]) as promptly as practicable, which may include having the JRC or Parties submit information in support of which the Expert Panel making a determination, but within no greater than [***] ([***]) days of the third (3rd) expert being chosen and (iv) [***] the Parties will be bound by the determination of the Expert Panel. Each Party is shall bear its own costs of participating in the Developing Partyproceeding, such issue including the costs incurred by its Third Party expert, and shall equally share the costs incurred by the third (3rd) Third Party expert selected jointly by the Parties’ two (2) Third Party Experts, except that, with respect to [***]. The Expert Panel shall be determined by and is empowered to request additional information or materials from one or both Parties as reasonably necessary for the Expert Panel to investigate and render a decision, [* * ***]. The Parties shall [***] following the earliest of: (x) [* * *], with all such requests and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partydecisions.
Appears in 2 contracts
Samples: Collaboration Agreement (Soaring Eagle Acquisition Corp.), Collaboration Agreement (Berkeley Lights, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee (a) All decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter, the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as representatives of the Parties may otherwise agreecannot reach an agreement as to such matter within fifteen (15) of good faith efforts business days after such matter was brought to reach a unanimous decision on an issue, fails to reach such a unanimous decisionthe JSC for resolution, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [* * *] of referral of five (5) business days after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron Gemphire shall have the final decision making authority, which shall be exercised in its reasonable discretion, with respect to (A) Global Development Work, (B) the protocols for Clinical Trails, including the selection of any CRO, site and principal investigator therefor, and (C) any regulatory matters relating to Licensed Products for which Gemphire is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];Registration Holder.
(ii) regardless of Beijing SL shall have the final decision making authority, which Party shall be exercised in its reasonable discretion, with respect to (A) Commercialization, Medical Affairs and regulatory matters in the Beijing SL Territory, (B) Beijing SL Development Work, and (C) any regulatory matters relating to Licensed Products for which Beijing SL is the Developing PartyRegistration Holder, such issue shall be determined by [* * *] following in each case of (A), (B) and (C), to the earliest of: extent consistent with the terms and conditions of this Agreement; provided, however, that (x) [* * *]Gemphire shall have final decision making authority with respect to Clinical Trial Protocols, and (y) Gemphire shall have the Joint Development Committee’s decision right to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and veto the conduct of any Clinical Trial in the [* * *]; andBeijing SL Territory that it reasonably believes is an Adverse Risk to the Development or Commercialization of any Licensed Product in the Gemphire Territory.
(iii) regardless of which For all matters except those where either Party is shall have and can use the Developing Party, such issue shall be determined by [* * *] following the earliest of: final decision making authority described in (xi) [* * *], and (yii) of this subsection, neither Party shall have the occurrence final decision making authority and such matters can only be decided by unanimous vote of any [* * *]; andthe JSC.
(bc) if such issue properly originated at In case the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, CelgeneJSC is unable to come to a unanimous decision and neither Party has final decision making authority with respect to a matter in dispute as described in Section 3.3(b)(iii) above, the Joint Development Committee or Parties shall resolve such dispute through the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partydispute resolution methods described in Article 15 hereof.
Appears in 2 contracts
Samples: Licensing Agreement, License and Collaboration Agreement (Gemphire Therapeutics Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party having one vote. If To the Joint Development Committee or Joint Commercialization Committeeextent a Party has voted in favor of a particular action, after commencement of the implementation of such action it shall not be permitted to reverse such vote absent changed facts and circumstances that were not present at the time of the initial vote. In order to make any decision, any Committee must have present (in person or via telephone or videoconference) and voting at least one representative of each Party. Unless otherwise specified by the JSC, in the event that the JMC, the JMktgC or any other Subcommittee cannot or does not reach consensus with respect to a particular matter within the authority of such Subcommittee (a “Committee Deadlock”) after endeavoring for [* * *] (or days to do so, such other period as matter shall be referred to the Parties may otherwise agree) of good faith efforts JSC for discussion and attempted resolution. In the event that the JSC, after endeavoring for [*] days to do so, does not reach a unanimous decision on an issuewith respect to a Committee Deadlock, fails or with respect to reach such a unanimous decisionany other matter within the purview of the JSC as set forth in this Agreement, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue matter shall be decided as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is If the Developing Party and such issue disputed matter relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d)[*], then such issue [*] shall be determined by have final decision making authority, subject to [* * *];
(ii) regardless of which Party is If the Developing Party, such issue shall be determined by disputed matter relates to the [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that then [* * *] shall continue to determine any issues that relate have final decision making authority;
(iii) If the disputed matter relates to the budget for and the conduct of the [* * *], then [*] shall have final decision making authority; and
(iiiiv) regardless of which Party is If the Developing Party, such issue shall be determined by disputed matter relates to [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any then [* * *]; and
(b) if such issue properly originated at . For the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none avoidance of Acceleron, Celgenedoubt, the Joint Development Committee vesting of final decision authority in a particular Party pursuant to this Section 3.3(c) shall not give such Party any authority to (A) alter or amend the Joint Commercialization Committee may make terms and conditions of this Agreement, (B) waive either Party’s compliance with the terms and conditions of this Agreement or (C) determine any decision inconsistent issue in a manner that would conflict with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 2 contracts
Samples: Co Development and License Agreement (Minerva Neurosciences, Inc.), Co Development and License Agreement (Minerva Neurosciences, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee (a) All decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and.
(b) if I-Mab shall have final decision-making authority on matters related to the Development of the CD38 Product; provided however that I-Mab exercises its final decision making authority to increase the Development Budget for Development work within the Field as specified in the initial Development Plan (attached hereto as Exhibit B) or to add new clinical trials not set forth in the initial Development Plan, Everest shall have the right to opt-out Development Cost sharing for such issue properly originated at new work or clinical trials by written notice to I-Mab within thirty (30) days after the Joint receipt of I-Mab’s final decision. If Everest elects to opt-out such new work or clinical trials, then I-Mab shall be responsible for paying one hundred percent (100%) of the Development Cost for such new clinical trials, and the Product Profit/Loss Sharing shall be adjusted in accordance with Section 4.4(a). I-Mab shall not terminate the Development or sell its economic interest concerning the Development of CD38 Product without Everest’s prior written consent, which should not be unreasonably withheld.
(c) For matters related to the Commercialization Committeeof the CD38 Product, determined by CelgeneI-Mab and Everest shall jointly make commercially reasonable decisions. If JSC cannot reach unanimous decision on matters related to the Commercialization of the CD38 Product, then Everest shall have the final decision-making authority on such matters. Notwithstanding the foregoing, none if one Party or any of Acceleronits Affiliates and/or its related parties is engaged to be a Commercialization Party under this Agreement, Celgenethen the other Party that is not the Commercialization Party shall have a veto right relating to related party or connected party transactions related to the Commercialization of the CD38 Product. For clarity, Phase 4 Clinical Trials are Commercialization activities.
(d) I-Mab shall have day-to-day operational control over the Joint Development Committee or of the Joint CD38 Product and the Commercialization Committee may make any decision inconsistent Party shall have day-to-day operational control over the Commercialization of the CD38 Product, provided that such Party conducts such activities in accordance with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 2 contracts
Samples: Cd38 Product Collaboration Agreement (I-Mab), Cd38 Product Collaboration Agreement (I-Mab)
Decision Making. The Joint Development Committee and Joint Commercialization All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agreecannot reach an agreement as to such matter within thirty (30) of good faith efforts days after such matter was brought to reach a unanimous decision on an issuesuch Committee for resolution or after such matter has been referred to such Committee, fails to reach such a unanimous decision, then either Party may refer such issue disagreement shall be referred to the JSC (in the case of disagreement of the JRDC), the JEC (in the case of disagreement of the JSC), or the Chief Executive Officers of Miragen and the Chief Executive Officer of Servier or its designee (the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate ”) (in good faith to resolve the issuescase of disagreement of the JEC) for resolution. If the Executive Officers cannot resolve such issue matter within thirty (30) days after such matter has been referred to them, then [* * *] that is the subject of referral of such issue to the dispute [*]. For clarity, if the Executive Officers, the resolution of Officers cannot resolve such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates a matter that pertains to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], [*] will not be obligated to [*] and (y) [*]. For further clarity, if the Joint Development Committee’s decision Executive Officers cannot resolve such a matter that pertains to go forward with a Phase 3 Clinical Trial of [*], neither Party shall be obligated to [*] and [*]. Notwithstanding the relevant Licensed Compound or Licensed Product; provided that foregoing provision and any provision to the contrary, [* * *] shall continue have the final say with respect to determine any issues that relate to the budget for and the conduct of the decision which involves [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) including, by way of example, [* * *], and (y) the occurrence of any whether [* * *]; and
(b) if , or whether [*]), and neither Party shall be obligated to [*] on account of [*] for which [*] has exercised such issue properly originated at final say unless [*] agreed on by the Joint Commercialization CommitteeJSC, determined JEC or Executive Officers and [*]. [*] = Certain confidential information contained in this document, marked by Celgene. Notwithstanding the foregoingbrackets, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent is filed with the express terms Securities and Exchange Commission pursuant to Rule 406 of this Agreement without the prior written consent Securities Act of each Party1933, as amended.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)
Decision Making. The Joint Development Committee If the Parties disagree in the JSC on any issues related to the matters set forth in Section 5.3(iii), either Party may submit such disagreement for discussion by the CEOs of the Parties (it being understood that such matters are subject only to discussion, and Joint Commercialization Committee not agreement, by the JSC) and, in that event, the CEOs shall each act meet in person or by unanimous agreement of its members, with each Party having one votevideoconference to discuss such matters as promptly as practicable thereafter. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts are unable to reach a unanimous decision agreement in the JSC on an issueany matters forth in Section 5.3(ii) (it being understood that the matters in Section forth in 5.3(ii) are the only matters that are subject to agreement by the JSC), fails to reach such a unanimous decision, then either Party may refer submit such issue to dispute for joint resolution by the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve CEOs of the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be Parties as follows:
(a) if The submitting Party shall provide notice to the other Party of its decision to submit such issue properly originated at the Joint Development Committee, determined dispute for resolution by the Developing Party CEOs pursuant to this Section. Within [***] as of receipt of such notice, the relevant Licensed Compound CEOs shall set a date for their meeting or Licensed Product at issue; provided thatvideoconference, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue which date shall be determined by no more than [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * **] following of such written notice. Each Party shall bear its own costs and expenses in connection with the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; andCEO discussions.
(b) if If the CEOs of the Parties are unable to agree on a resolution, or either Party concludes that the matter will not be so resolved by the CEOs after the notice, then such issue properly originated at development plan and budget pertaining to Global Additional Development shall not be approved and the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without Section 4.1(b)(iii) shall apply, and if a Party believes that the prior written consent other Party is taking or intends to take any action with respect to a Product that could reasonably be expected to have a material adverse effect on obtaining or maintaining Regulatory Approval of each any Product in such Party’s territory or on Commercialization of any Product in such Party’s territory, then the Parties shall discuss such considerations in good faith in trying to reach a resolution. For clarity, although the JSC will discuss and monitor the matters set forth in Section 5.3(iv): (A) the terms of Section 6 (Manufacture and Supply) shall govern with respect to matters in Section 5.3(b); (B) the terms of Section 7 (Intellectual Property) shall govern with respect to matters in Section 5.3(d); (C) Catalyst shall have all rights, responsibilities and sole decision-making authority with respect to matters in Sections 5.3(a) and 5.3(c), subject to the terms of Section 4 (Development; Regulatory Matters; Commercialization); and (D) the terms of Section 13 (Governing Law; Dispute Resolution) shall govern with respect to matters in Section 5.3(e).
Appears in 1 contract
Samples: License and Collaboration Agreement (Catalyst Pharmaceuticals, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.6(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JSC for resolution. If the JSC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JSC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party and such issue relates final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development matters, except for:
(x1) the approval addition of an Additional Development Disease[ * ], or the cost of which would be [ * ]; and,
(y2) matters under Section 5.6.3(d)any material modification to a [ * ]; for the purpose of this clause, then such issue shall be determined by [“material modification” means any material changes to the agreed upon [ * * *];.
(ii) regardless of Licensee shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) Commercialization in the Licensee Territory, except with respect to the decision [ * * *] following a particular Product in a country, (2) Medical Affairs in the earliest of: (x) [* * *]Licensee Territory, and (y3) regulatory matters in the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of Licensee Territory that do not affect the relevant Licensed Compound or Licensed ProductExelixis Territory; provided that [* * *] Licensee’s decision shall continue to determine any issues that relate to be consistent with the budget for terms and the conduct conditions of the [* * *]; andthis Agreement, including without limitation Section 6.4(b) regarding pricing, and Section 6.3(c) regarding sales forecasts.
(iii) regardless of which Neither Party is shall have the Developing Party, such issue shall be determined by [final decision making authority with respect to the matters in Sections 3.6(b)(i)(1) and (2) or with respect to the decision not to [ * ] a particular Product in a particular country [ * *] following the earliest of: (x) [* * *], and the status quo shall persist with respect to such matter if the Parties are unable to agree.
(yc) Notwithstanding Section 3.6(a), [ * ] representative shall have the occurrence deciding vote on all tactical [ * ] matters for the Products [ * ], and such matter shall not be subject to [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of any [the Securities Exchange Act of 1934, as amended. escalation to [ * * *]; and
(b) if provided that such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent does not directly affect [ * ] and such decision shall be consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee (i) Except as otherwise set forth in this Agreement, all decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party having one (1) vote. If the Joint Development Committee or Joint Commercialization Committee, after JSC cannot agree on a matter for which the JSC has decision-making authority within [* * **] (or such other period as after the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionmatter was first considered by the JSC, then either Party may may, by written notice to the other, refer such issue matter to the Executive OfficersOfficers for discussion and attempted resolution in good faith. Such resolution, if any, of a referred matter by the Executive Officers shall meet promptly thereafter be final and binding upon the Parties and shall negotiate be considered a decision of the JSC for purposes of this Agreement. If within [**] after the matter was first submitted to the Executive Officers pursuant to this Section 4.2(f)(i) (or such longer time frame the Executive Officers may otherwise agree upon), the Executive Officers are unable to reach consensus, then, other than as set forth in Section 4.2(f)(ii), Editas shall have the deciding vote (which decision shall be made in good faith) with respect to any other matters within the purview of the JSC; provided that Editas shall consider in good faith to resolve the issues. If Executive Officers cannot resolve positions of Juno in making such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];final decision.
(ii) regardless Notwithstanding Section 4.2(f)(i), a Party shall not have the right to exercise a deciding vote (A) in a manner that effectively waives or modifies the terms of which this Agreement; (B) in a manner that negates any consent rights or other rights specifically allocated to the other Party under this Agreement, including making any decision that is stated to require the Developing mutual agreement or mutual consent of the Parties or that is at the sole discretion of a Party; (C) in a manner that would require the other Party to perform activities or incur any additional costs that the other Party has not agreed to perform or incur as set forth in this Agreement, or as otherwise agreed in writing by the other Party, such issue and, for clarity, no Research activities shall be determined required to be performed by [* * *] following Juno under this Agreement without Juno’s prior written consent, in its discretion; (D) in a manner that would require a Party to perform any act that it reasonably believes to be inconsistent with any Law, including any approval, order, policy, guidelines of a Regulatory Authority or ethical requirements or ethical guidelines; (E) to allocate intellectual property rights; (F) to determine that such Party has fulfilled any obligation under this Agreement or that the earliest of: other Party has breached any obligation under this Agreement; (xG) [* * *]to determine that any milestone events or other events have or have not occurred, including whether or not a given Collaboration RNP Complex satisfies the Lead Candidate Selection Criteria; or (H) to permit additional internal research uses by Editas of α-β T-Cells. In the event that any matter set forth in the preceding clauses (A) through (H) is unresolved through the JSC and subsequently such dispute cannot be resolved by the Executive Officers in accordance with Section 4.2(f)(i), then (1) for all such matters set forth in the preceding clauses (C) and (H), there shall be no change unless the Parties otherwise mutually agree in writing, and (y2) for all such matters set forth in the Joint Development Committee’s decision preceding clauses (A), (B), (D), (E), (F) or (G), either Party may require the specific issue to go forward with a Phase 3 Clinical Trial be referred for binding arbitration pursuant to Section 13.2. The Parties agree to share equally the cost of the relevant Licensed Compound or Licensed Productproceedings, including fees of the panel members; provided that [* * *] each Party shall continue to determine any issues that relate to the budget for bear its own attorneys’ fees and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], associated costs and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partyexpenses.
Appears in 1 contract
Samples: Collaboration and License Agreement (Editas Medicine, Inc.)
Decision Making. The Joint Development Committee Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and Joint Commercialization Committee except as provided in clauses (a) and (b) below, all decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] Executive Officers (or such other period as the Parties may otherwise agreetheir designees) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue matter within [* * ***] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as followsthen:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and matter concerns the conduct of activities under the [* * *]; and
(iii) regardless of Research Program which Party is are consistent with the Developing Partythen current Research Plan and Research Budget, then Syros shall have the final right to decide such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; andmatter;
(b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and
(c) if such matter concerns any issue properly originated at not covered by Section 4.3(a) or Section 4.3(b), then the Joint Commercialization Committee, determined status quo shall prevail with respect to such matter and no changes shall be made except by Celgeneagreement of the Parties. Notwithstanding the foregoing, none of Acceleron, CelgeneFor clarity, the Joint Development Committee Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the Joint Commercialization Committee may make de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any decision inconsistent with amendments to the express terms of this Agreement without Research Plan, or (iii) any decreases to the prior written consent of each PartyResearch Budget.
Appears in 1 contract
Samples: License and Collaboration Agreement (Global Blood Therapeutics, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JSC shall each act be made by unanimous agreement of its membersconsensus, with each Party having collectively one vote(1) vote in all decisions. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of reasonable discussion and good faith efforts consideration of both Party’s views on a particular matter before the JSC, the JSC is still unable after a period of ten (10) Business Days to reach a unanimous decision on an issue, fails to reach such a unanimous decisionmatter, then either Party may refer may, by written notice to the other, have such issue matter referred to the Executive OfficersOfficers of the Parties for resolution in accordance with Section 13.1. Such If the Executive Officers shall meet promptly thereafter and shall negotiate in good faith are able to resolve such matter within the issuesthirty (30) day period set forth in Section 13.1, then such resolution shall be deemed the decision of the JSC. If the Executive Officers canare not able to resolve such issue matter within [* * *] of referral of such issue to the Executive Officersthirty (30) day period, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) Subject to the diligence obligations set forth in Sections 4.5 and 6.4, GSK’s JSC representative shall have final decision-making authority with respect to such unresolved matter if Acceleron it is within the Developing Party JSC’s authority, it is not a Selected Claim, and such issue relates to it pertains to: (xA) the approval of an Additional Development Disease, XXXXXX; or (yB) matters under Section 5.6.3(d), then such issue shall be determined by [* * *]XXXXXX;
(ii) regardless of which Party If such unresolved matter is the Developing Partya Selected Claim, then such issue matter shall be determined resolved by [* * *] following an independent Third Party expert experienced in the earliest of: development and commercialization of pharmaceutical products (xthe “Expert”). Within ten (10) [* * *]Business Days after such thirty (30)-day period, and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial JSC shall agree upon the Expert and, as promptly as possible thereafter, the Parties shall jointly retain the Expert. The Parties shall bear all costs of the relevant Licensed Compound or Licensed Product; provided that [* * *] Expert equally. XXXXXX. The determination of the Expert shall continue to determine any issues that relate to be binding on the budget for Parties and the conduct of Parties shall act in accordance with the [* * *]; andExpert’s decision;
(iii) regardless If such unresolved matter is referred to the JSC pursuant to Section 3.3 concerning the patent prosecution or enforcement action by GSK in the Licensed Territory, then such matter shall be resolved by an independent Third Party patent counsel experienced in the prosecution and enforcement of which patents for pharmaceutical products (the “Patent Expert”). Within ten (10) Business Days after the thirty (30)-day period referenced in Section 3.3, the JSC shall agree upon the Patent Expert and, as promptly as possible thereafter, the Parties shall jointly retain the Patent Expert. The Parties shall bear all costs of the Patent Expert equally. XXXXXX. The determination of the Patent Expert shall be binding on the Parties and the Parties shall act in accordance with the Patent Expert’s decision; or
(iv) For any unresolved matter not addressed in subsection (i), (ii) or (iii) above, then the status quo shall persist with respect to the unresolved matter unless either Party brings a litigation in accordance with Section 13.2. For clarity, once a Party has brought a Selected Claim or a patent prosecution or enforcement action to the JSC, the other Party shall cease and shall not initiate any activity that is the Developing Party, basis for such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee Selected Claim or the Joint Commercialization Committee may make any decision inconsistent with patent prosecution or enforcement action in question until such time as the express terms of this Agreement without JSC or Executive Officers have resolved the prior written consent of matter, or the Expert or the Patent Expert (as applicable) has made a decision, in each Partycase that allows such other Party to proceed.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Impax Laboratories Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement (a) At all times, the representatives of its members, with each Party having one vote. If on the Joint Development Committee or Joint Commercialization CommitteeJDC will take into consideration the view of the representatives of the other Party regarding the matters under consideration by the JDC, after and the objective of the JDC will be to reach agreement by [* * ***] on matters after reasonable and open discussion. Each Party, but not each representative of a Party, will have [***] vote on all matters coming before the JDC. In the event the JDC cannot reach agreement on a matter by [***] within [***] after such matter is first discussed at a JDC meeting (or such and other period as than in the case of a determination of whether a Tumor Study has achieved Successful Completion under Section 5.3(c)), the matter will be referred promptly to the Senior Executives of the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to for resolution through [***] negotiations. In the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve event that the issues. If Executive Officers Senior Executives cannot resolve such issue reach agreement on a matter within [* * ***] of referral of such issue matter being referred to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined them by the Developing Party JDC, Xxxxxxxx may, in its discretion and subject to Section 3.3(b) and (c), cast a deciding vote with respect to any matter, and such deciding vote will then be deemed the final decision of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; andJDC.
(b) if such issue properly originated at Notwithstanding anything to the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgenecontrary in Section 3.3(a), the Joint following matters will not be subject to a deciding vote of Xxxxxxxx: (i) a proposed material amendment to the Development Committee or Plan and/or Budget (including with respect to [***]), in which case both Parties’ representatives must reach [***] on such material amendment; (ii) whether a Tumor Study has achieved Successful Completion under Section 5.3(c), in which case both Parties’ representatives must reach [***] on whether Successful Completion has been achieved; and (iii) selection of the Joint Commercialization Committee initial SM2 from the Designated ARC Molecules, in which case Millennium will have the right, in its sole discretion, to cast a deciding vote, and such deciding vote will then be deemed the final decision of the JDC.
(c) Xxxxxxxx may make any decision not exercise its right to finally resolve a matter pursuant to Section 3.3(a): (i) in a manner that is inconsistent with the express terms of this Agreement without (including in a manner that excuses Xxxxxxxx from any of its obligations, or negates any rights granted to Millennium, under this Agreement); (ii) that is stated in this Agreement to require the prior written consent mutual agreement of each Partythe Parties; or (iii) in a manner that would require Millennium to perform any act that it reasonably believes to be inconsistent with any Applicable Law or any approval, order, policy or guidelines of any Regulatory Authority.
Appears in 1 contract
Decision Making. The Joint Development Committee and Joint Commercialization Committee (a) All decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter, the Joint Development Committee or Joint Commercialization Committee, after representatives of the Parties cannot reach an agreement as to such matter within [* * *] (or after such other period as matter was brought to the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionJSC for resolution, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [* * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Rigel shall have the Developing Party final decision making authority, which shall be exercised in its reasonable discretion, with respect to Joint Development Work, Rigel’s Independent Work, Rigel Only Development Work, and such issue relates to all manufacturing matters, except for:
(x1) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial cost of the relevant Licensed Compound or Licensed Product; provided that which [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii2) regardless any material modification to [*]; for the purpose of which Party is this subsection (2), “material modification” means any material change to [*]; provided that any such material modification with respect to activities in the Developing PartyKissei Territory does not adversely affect and are not reasonably expected to adversely affect the Development, such issue manufacture, or Commercialization of the Product in the Kissei Territory; and provided further that Rigel’s decision with respect to any of the foregoing shall be determined by [* * *] following consistent with the earliest of: terms and conditions of this Agreement.
(xii) [* * *]Kissei shall have the final decision making authority, which shall be exercised in its reasonable discretion, with respect to (1) Commercialization in the Kissei Territory, (2) Medical Affairs in the Kissei Territory, (3) regulatory matters in the Kissei Territory, except with respect to Rigel’s Independent Work in the Kissei Territory, and (y4) Kissei’s Independent Work in the occurrence Kissei Territory and Kissei Only Development Work, in each case (1) – (4) that do not adversely affect and are not reasonably expected to adversely affect the Development, manufacture, or Commercialization of the Product in the Rigel Territory; provided that Kissei’s decision with respect to any [* * *]; andof the foregoing shall be consistent with the terms and conditions of this Agreement.
(biii) if Neither Party shall have the final decision making authority with respect to the matters in Sections 3.3(b)(i)(1) and (2), and the status quo shall persist with respect to such issue properly originated at matter unless and until the Joint Commercialization CommitteeParties are able to agree. [*] = Certain confidential information contained in this document, determined marked by Celgene. Notwithstanding the foregoingbrackets, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent has been omitted and filed separately with the express terms Securities and Exchange Commission pursuant to Rule 24b-2 of this Agreement without the prior written consent Securities Exchange Act of each Party1934, as amended.
Appears in 1 contract
Samples: Collaboration and License Agreement (Rigel Pharmaceuticals Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JSC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives having one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJSC, after the JSC cannot reach a decision as to such matter within [* * ********] (or after such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter was brought to the JSC for resolution, such matter shall be referred to the [********] of Entasis and the [********] of Zai (the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues”) for resolution. If the Executive Officers cannot resolve such issue matter within [* * ********] after such matter has been referred to them, then the following shall apply: (i) prior to [********], [********] has final decision-making authority over the [********], including [********]; provided, that [********] shall have final decision-making authority (after good faith consideration to [********] views) with respect to the [********]; (ii) following [********],[********] has final decision-making authority over matters that pertain solely to the [********]; (iii) [********] has final decision-making authority over [********] of referral such product or combination by or on behalf of [********] outside the Territory, CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. [********] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. and after such issue [********],[********] has final decision making authority over such [********] in the Territory; (iv) [********] has final decision making over any material [********] activity for the Territory that it believes in good faith, based solely on scientific or patient safety concerns, would reasonably be expected to materially and adversely affect the [********] (e.g., [********]); and (v) [********] has final decision making over any decision to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates extent applicable to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * ********];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may Entasis shall not make any decision inconsistent that would materially increase Zai’s obligations or expenses above those set forth in the then-current Development Plan without Zai’s written consent. By way of illustration and not limitation, with respect to the express terms final decision-making of this Agreement without the prior written consent of each PartyParties set forth in Section 3.1(e), if the [********], but the [********], then the parties would discuss the [********] in good faith, with [********] having final decision-making authority with respect thereto.
Appears in 1 contract
Decision Making. The Joint Development Each of CEGEDIM's and GRAND CARD's representatives on a Steering Committee and Joint Commercialization shall, collectively, have one vote (the “Party Vote”) on all matters brought before the Steering Committee, which Party Vote shall be determined by majority vote of such representatives present at any meeting. Each Steering Committee meeting shall each act operate as to matters within its jurisdiction by unanimous agreement of its members, with each Party having one vote. If the Joint Development Steering Committee or Joint Commercialization Committeefails to achieve a unanimous vote with respect to any matter, CEGEDIM and GRAND CARD shall use their commercially reasonable best efforts to resolve such dispute as rapidly as possible on a fair and equitable basis. In the event that CEGEDIM and GRAND CARD fail to resolve such dispute (the “Dispute”) within ten (10) business days after [* * *] (or such other period as the Steering Committee failed to achieve a unanimous vote with respect to the applicable matter, then the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith agree to resolve the issuesDispute through mediation as hereinafter provided in this Subsection 5.3.3(B). If Executive Officers the Parties cannot resolve such issue agree on a person to act as mediator within [* * *] of referral five (5) days after the end of such issue ten (10) business day period, then each Party shall select an independent person within such five (5) day period and such two (2) independent persons shall, within five (5) days after their selection, agree on a third independent person who shall serve as the sole mediator with respect to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Dispute. If either Party of fails to select its independent person within the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
five (i5) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d)day period, then such issue Party shall be determined deemed to have waived its right to participate in the selection of the mediator and the independent person selected by [* * *];
(ii) regardless of which the other Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: sole mediator with respect to the Dispute. Each Party shall submit to the sole mediator a written presentation of such Party's position with respect to the Dispute within ten (x10) [* * *]days after selection of the sole mediator, and the Parties shall make their representatives on the Steering Committee available for such mediation sessions as the sole mediator may request. The sole mediator shall decide the Dispute within ten (y10) days after the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial end of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget ten (10) day period for and the conduct submission of the [* * *]; and
(iii) regardless of written presentations, which Party is the Developing Party, such issue decision shall be determined by [* * *] following final and binding on the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by CelgeneParties. Notwithstanding the foregoing, none with regard to any Intellectual Property (as defined in Section 8) matters, all of Acceleron, Celgene, the Joint Development Committee foregoing time periods will be reasonably shortened or expedited if necessary to meet any official deadlines from the Joint Commercialization Committee may make U.S. Patent and Trademark Office or any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partyforeign patent offices.
Appears in 1 contract
Decision Making. The Joint Development Committee Each Party’s designees on the JSC, JDC and Joint Commercialization Committee JCC shall, collectively, have one (1) vote (the “Party Vote”) on all matters brought before the respective Committee. Except as expressly provided in this Section 3.1.3 (Decision Making), each of the JSC, JDC and JCC shall each act decide as to all matters within its jurisdiction by unanimous agreement Party Vote; provided, however, that no such Committees shall have the authority to amend or modify, or waive compliance with, this Agreement, and, provided further, that the Party Vote of each Party shall be subject to the approval of such Party’s management. In the event that a Party’s management does not concur with the Party Vote of such Party, such Party shall notify the other Party in writing (which may be by email) of such disapproval within [*] days after the Party Vote, but as promptly as possible. In the event that a Party does not give notice of its membersdisapproval of any Committee decision as provided for herein, such Party shall be deemed to have ratified any such Committee decision. In the event of a tie Party Vote of the designees of Ono and Progenics on the JDC or JCC as to matters within the jurisdiction of such Committees, or in the event a Party’s management does not approve of the vote cast, the co-chairpersons of the JDC or JCC shall refer the matter to the JSC for resolution. In the event that such a matter cannot be resolved by the JSC within [*] days of it being referred to the JSC, or in the event of a tie Party Vote of the designees of Ono and Progenics on the JSC with each Party having one voterespect to any other matter within the JSC’s jurisdiction, the co-chairpersons of the JSC shall refer the matter to [*]. In the event that such matters cannot be resolved by these executives after good faith negotiations within [*] days, then the matter shall be referred to the [*]. If the Joint Development Committee or Joint Commercialization Committeeafter good faith discussions by [*], after agreement cannot be reached within [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisiondays, then either Party may refer such issue to the Executive Officers. Such Executive Officers [*] shall meet promptly thereafter and shall negotiate in good faith decide upon a mechanism to resolve the issuesmatter. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
Appears in 1 contract
Decision Making. 3.2.5.1. Other than as set forth herein, in order to make any decision required of it hereunder with respect to any approval, the JSC must have present (in person, by videoconference or telephonically) at least one member of each Party. The Joint Development Committee and Joint Commercialization Committee Parties will endeavor to make decisions of the JSC by consensus.
3.2.5.2. The JSC shall each act attempt in good faith to resolve any disputes or failure to agree by unanimous agreement of its members, consent (with each Party having one vote). If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers JSC cannot resolve such issue dispute or failure to agree within [* * ***] ([***]) days of referral of the matter being referred to it, such issue to the Executive Officers, the resolution of such issue matter shall be resolved as follows:
(a) if such the issue properly originated at will be promptly presented to the Joint [***] of AstraZeneca (or person of equivalent seniority for the applicable stage of Development Committeeor commercialization) and [***] of Pieris US (the “Senior Representatives”), determined or their respective designees, for resolution. Such Senior Representatives, or their respective designees, will meet in person or by teleconference as soon as reasonably possible thereafter, and use their good faith efforts to mutually agree upon the Developing Party resolution of the relevant Licensed Compound dispute, controversy or Licensed Product at claim.
(b) In the event such Senior Representatives cannot resolve such issue; provided that, notwithstanding using good faith efforts, within [***] ([***]) days of the matter being referred to them, AstraZeneca’s [***] shall have the casting vote to resolve such issue.
(c) Notwithstanding the foregoing:
(i) Following the Effective Date but prior to Phase 1 Study Completion for the Lead Product, if Acceleron is either Party wishes to deviate from the Developing Party and initial Lead Product Development Plan, the other Party’s consent shall be required if such issue relates to deviation would (x1) the approval of an Additional Development Disease[***], or (y2) matters under Section 5.6.3(d), then such issue shall be determined by [* * ***];
(ii) regardless . Any delay of which Party is the Developing Party, such issue shall be determined Phase 1 Study Initiation by more than [* * ***] following (if not mutually agreed by the earliest of: (xParties) [* * *], and (y) shall only occur if required by Applicable Law or the Joint Development Committee’s decision mandatory instruction of a Regulatory Authority made in accordance with Applicable Law. Subject to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, AstraZeneca shall have final say regarding all matters relating to the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.Lead Product
Appears in 1 contract
Samples: License & Collaboration Agreement (Pieris Pharmaceuticals, Inc.)
Decision Making. The Joint Development Committee Except as set forth in this Section 2.3.4, decisions of the JCC and Joint Commercialization Committee lower level committees shall each act be made by unanimous agreement consensus of its members, with all members present; provided that at least one representative of each Party having one voteis present and so approves. If Non‑attending members of the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as JCC may represent themselves by proxies in any decision. In the Parties may otherwise agree) event that the JCC cannot reach consensus any matter within the authority of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionthe JCC, then either Party may refer the resolution and/or course of conduct shall be determined by Array, in its sole discretion, provided that: (i) if the JCC cannot reach consensus regarding a material modification of the Commercialization Plan and Budget, such issue matter shall first be referred to the Executive Senior Officers. Such Executive Officers , who shall meet promptly thereafter and shall negotiate attempt in good faith to resolve the issues. If Executive Officers cannot resolve such issue disagreement within [* * *] of referral thirty (30) days of such issue matter being referred to the Executive Officers, the resolution of such issue shall be as follows:
them (a) and if such issue properly originated at matter is not resolved within such 30-day period, Array may then exercise its deciding vote with respect to such matter); (ii) in exercising such deciding vote, Array will consider Oncothyreon’s position in good faith; and (iii) in no event shall Array in exercising such final decision-making authority have the Joint Development Committeeright to (A) unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement, determined by (B) excuse Array from any of its obligations specifically enumerated under this Agreement, or (C) reduce the Developing Party rights of Oncothyreon specifically enumerated under this Agreement. For the relevant Licensed Compound or Licensed Product at issue; provided thatavoidance of doubt, notwithstanding the foregoing:
subject to Section 10.2.3, Array’s use of its final decision-making authority (i) if Acceleron is to increase the Developing Party budget in the Commercialization Plan and such issue relates to (x) the approval of an Additional Development DiseaseBudget, or (yii) matters under Section 5.6.3(dto establish a Commercialization Plan and Budget containing activities related to Commercialization of the Product in the United States (which activities the Parties acknowledge will in part be conducted by Oncothyreon if Oncothyreon elects to Co-Promote the Product in the United States), then such issue shall not be determined construed to “unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by [* * *];
this Agreement” as described in clause (iiA) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partypreceding sentence.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Array Biopharma Inc)
Decision Making. The Joint Development Committee 6.5.1 Subject to Sections 6.5.2 and 6.7, all decisions of each Joint Commercialization Committee and each Joint Commercialization Project Team related to the North America Commercialization and NA/Ex-NA Commercialization of a Joint Development Product shall, to the extent permitted by applicable Law, be made by the unanimous decision of Millennium and Aventis and shall each act by unanimous agreement not be inconsistent with the Global Commercialization Plan; PROVIDED HOWEVER, for clarity, Aventis shall have the sole discretion in any decision that is relevant solely to the Commercialization of its membersa Joint Development Product outside of North America ("ROW Commercialization"), as long as such decision is not inconsistent with each Party having one vote. If the Global Commercialization Plan.
6.5.2 The objective of the Joint Commercialization Committee and each Joint Commercialization Project Team shall be to reach agreement by consensus on all matters falling within its authority hereunder with the goal of realizing the best overall commercial potential of Joint Development Products on a global basis. In the event that the Joint Commercialization Committee or any Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts Project Team is unable to reach a unanimous decision on an issuewith respect to any proposed action requiring its vote, fails to reach such a unanimous decision[**]; provided, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within however, [* * **] of referral of such issue pursuant to this Section 6.5.2 to determine which Party shall perform a particular Commercialization activity or whether Millennium has the Executive Officers, the resolution of such issue capability or capacity to perform a particular Commercialization activity.
6.5.3 All decisions [**] pursuant to Section 6.5.2 shall be as followsmade:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party only after referral of the relevant Licensed Compound matter [**]; PROVIDED, HOWEVER, [**], as may be reasonably required, to meet deadlines imposed by Third Parties (e.g., deadlines for responses imposed by regulatory authorities) or Licensed Product at issue; provided thatas otherwise needed to respond to competition in the market. For clarity, notwithstanding [**] to decide the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d)matter, then such issue shall be determined by [* * *]*] to decide the matter;
(iib) regardless with the goal of which Party is realizing the Developing Party, such issue shall be determined by best overall commercial potential of Joint Development Products on a global basis;
(c) in a manner [* * **] following the earliest of: (x) relative [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine in any issues that relate to the budget for and the conduct of the [* * *]significant respect; and
(iiid) regardless of which Party is the Developing Party, such issue shall be determined by in a manner that [* * **] following in the earliest of: quarterly determination and reconciliation under Section 8.2.2 of actual financial results, including without limitation Net Sales, NA/Ex-NA Expense, NA Development Costs, NA Commercialization Expense and Pre-tax Profit or Loss. For clarity, nothing in this subsection (xd) shall [* * *], and (y) *] make the occurrence of any final determination [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party*] .
Appears in 1 contract
Samples: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee JSC shall each act operate by unanimous agreement of its membersconsensus, with each Party having one voteRanbaxy’s member designees having, [***] and Epirus’s member designees having, [***] in all decisions. The JSC shall use Commercially Reasonable Efforts to make timely decisions and to resolve disputes. If the Joint Development Committee JSC is unable to resolve any dispute, controversy, or Joint Commercialization Committee, after claim arising under this Agreement within [* * ***] (or days after it first addresses such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionmatter, then (a) Ranbaxy shall have [***] with respect to any decision relating to the [***] in the [***], with the exception of [***] shall have [***] related to [***] and (b) Epirus shall have [***] related to [***] as well as [***] with respect to any decision relating solely to the [***], provided that prior to either Party may refer such issue exercising the [***] set forth in (a) and (b), any dispute, controversy or claim unable to be resolved by the JSC shall be referred to the Executive Officers. Such Executive Officers Head – Global Business Development & Acquisitions of Ranbaxy and the Senior Vice President of Business Development of Epirus (“Executives”), who shall meet promptly thereafter and shall negotiate have a period of [***] to consider attempt in good faith to resolve the issuesissue. If Executive Officers cannot resolve such issue within Notwithstanding Ranbaxy’s [* * ***] of referral concerning [***] in the [***], if Epirus reasonably believes that any such [***], Epirus shall provide written notice of such issue belief to Ranbaxy, and if the Executive OfficersParties [***], the resolution of such issue decision shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined [***] by the Developing Party of [***] in accordance with the relevant Licensed Compound or Licensed Product at issueforegoing sentence; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * **] following involves the earliest of: (x) [* * ***] of any [***] by or on behalf of [***], instead of [***] by the [***], Epirus may [***] of its [***] (which shall be based on a [***] that such [***]) and both Parties shall [***] and ensure that [***] concerns are addressed. If the Parties are [***] on the conduct of such [***] within such [***], Ranbaxy shall not [***]. Notwithstanding Epirus’s [***], if Ranbaxy reasonably believes that [***] in the [***], Ranbaxy shall provide written notice of such belief to Epirus, and if the Parties [***], such decision shall be [***] by the [***] in accordance with the foregoing sentence; provided that, if [***] involves the [***] of any [***], instead of [***] by the [***], Ranbaxy may [***] of its [***] (ywhich shall be based on a [***] that such [***]) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial and both Parties shall [***] and ensure that [***] concerns are addressed. The reporting obligations of the relevant Licensed Compound or Licensed Product; provided that parties with respect to development & commercialization and , all other reporting obligations of the each parties are towards the mutual beneficial relationship of the parties and any [* * ***] shall continue to determine any issues that relate to be discussed between the budget for and the conduct of the parties [* * ***]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.
Appears in 1 contract
Samples: License Agreement (EPIRUS Biopharmaceuticals, Inc.)
Decision Making. The Joint Development Committee Except as set forth in this Section 2.3.4, decisions of the JCC and Joint Commercialization Committee lower level committees shall each act be made by unanimous agreement consensus of its members, with all members present; provided that at least one representative of each Party having one voteis present and so approves. If Non-attending members of the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as JCC may represent themselves by proxies in any decision. In the Parties may otherwise agree) event that the JCC cannot reach consensus any matter within the authority of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionthe JCC, then either Party may refer the resolution and/or course of conduct shall be determined by Array, in its sole discretion, provided that: (i) if the JCC cannot reach consensus regarding a material modification of the Commercialization Plan and Budget, such issue matter shall first be referred to the Executive Senior Officers. Such Executive Officers , who shall meet promptly thereafter and shall negotiate attempt in good faith to resolve the issues. If Executive Officers cannot resolve such issue disagreement within [* * *] of referral thirty (30) days of such issue matter being referred to the Executive Officers, the resolution of such issue shall be as follows:
them (a) and if such issue properly originated at matter is not resolved within such 30-day period, Array may then exercise its deciding vote with respect to such matter); (ii) in exercising such deciding vote, Array will consider Oncothyreon’s position in good faith; and (iii) in no event shall Array in exercising such final decision-making authority have the Joint Development Committeeright to (A) unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement, determined by (B) excuse Array from any of its obligations specifically enumerated under this Agreement, or (C) reduce the Developing Party rights of Oncothyreon specifically enumerated under this Agreement. For the relevant Licensed Compound or Licensed Product at issue; provided thatavoidance of doubt, notwithstanding the foregoing:
subject to Section 10.2.3, Array’s use of its final decision-making authority (i) if Acceleron is to increase the Developing Party budget in the Commercialization Plan and such issue relates to (x) the approval of an Additional Development DiseaseBudget, or (yii) matters under Section 5.6.3(dto establish a Commercialization Plan and Budget containing activities related to Commercialization of the Product in the United States (which activities the Parties acknowledge will in part be conducted by Oncothyreon if Oncothyreon elects to Co-Promote the Product in the United States), then such issue shall not be determined construed to “unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by [* * *];
this Agreement” as described in clause (iiA) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partypreceding sentence.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Oncothyreon Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JSC shall each act be made by unanimous agreement of its membersconsensus, with each Party having Party’s representatives having, collectively, one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJSC, the JSC cannot reach consensus as to such matter within […***…] after [* * *] such matter was brought to the JSC for resolution (or […***…] if the particular matter is with respect to any issue under consideration by the JSC pursuant to Sections 3.2(b)(iii), (iv) or (v)), such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter shall be referred to the Chief Executive Officer of Zymeworks (or an executive officer of Zymeworks designated by the Chief Executive Officer of Zymeworks who has the power and authority to resolve such matter) and the Chief Executive Officer of BeiGene (or an executive officer of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) (collectively, the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues”) for resolution. If the Executive Officers cannot resolve such issue matter within [* * …***…] of referral of after such matter has been referred to them (or […***…] if the particular matter is with respect to any issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined originally under consideration by the Developing Party of the relevant Licensed Compound JSC pursuant to Sections 3.2(b)(iii), (iv) or Licensed Product at issue; provided that(v)), notwithstanding the foregoing:then:37
(i) if Acceleron is Subject to Section 3.2(f)(ii), BeiGene shall have the Developing Party and such issue relates final decision-making authority for matters within the scope of the JSC’s decision-making authority with respect to (x1) any […***…] for Licensed Products in the approval of an Additional Development DiseaseField in the Territory […***…], or (y2) matters under Section 5.6.3(d)all […***…] with respect to Licensed Products, then such issue including […***…], in the Field in the Territory; and (3) all […***…] activities leading up to and including the […***…] and any […***…], as applicable, for Licensed Products in the Field from […***…] in the Territory; provided that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be determined by expected to [* * …***…];.38
(ii) regardless Zymeworks shall have the final decision-making authority for matters within the scope of the JSC’s decision-making authority with respect to (1) the […***…]; (2) any […***…] activities which Party is […***…]; (3) any Development, manufacture or Commercialization activities in the Developing PartyTerritory that would reasonably be expected to […***…] of 36 Competitive Information – Commercially Sensitive Terms. 37 Competitive Information – Commercially Sensitive Terms. 38 Competitive Information – Commercially Sensitive Terms and Exclusivity Information. the Licensed Product; or (4) any Development, such issue shall manufacture or Commercialization activities in the Territory that would reasonably be determined by [* * *] following the earliest of: (x) [* * *], and expected to (y) the Joint Development Committee’s decision to go forward with result in a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * …***…] shall continue to determine any issues that relate related to the budget for and Licensed Product outside the conduct of the Territory or (z) otherwise [* * …***…]; and
(iii) regardless provided, that, Zymeworks shall not exercise its final decision-making authority in a manner that would […***…] under this Agreement, including any of BeiGene’s obligations or expenses […***…] agreed between the Parties without BeiGene’s written consent, which Party is the Developing Partywill not be unreasonably withheld, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee delayed or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.conditioned.39
Appears in 1 contract
Samples: License and Collaboration Agreement (Zymeworks Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.5(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JEC for resolution. If the JEC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JEC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development and such issue relates regulatory matters that may be reasonably expected to affect the Exelixis Territory, except for:
(x1) the approval [ * ], the costs of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall which would be determined by [[ * * *];
(2) any material modification to a [ * ]. For clarity, the foregoing shall include any material modification to [ * ]. As used in this clause, “material modification” means any material changes to the agreed upon [ * ]; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(3) any modification to the Development Budget, the costs of which would be [ * ]; and/or
(4) the addition or inclusion of [ * ], whether the Parties [ * ] or not.
(ii) regardless of Notwithstanding Section 3.5(b)(i), Collaborator shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) Commercialization in the Collaborator Territory (except for [ * ]), (2) regulatory matters in the Collaborator Territory that are reasonably expected not to directly affect the Exelixis Territory (including, [ * *] following the earliest of: (x) [* * *]), and (y3) immediate treatment that is reasonably necessary to protect patient safety in any Development activities held in the Joint Development CommitteeCollaborator Territory; in each case provided that Collaborator’s decision to go forward shall be consistent with a Phase 3 Clinical Trial the terms and conditions of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; andthis Agreement.
(iii) regardless of which Neither Party shall have the final decision making authority with respect to the matters in Sections 3.5(b)(i)(1), 3.5(b)(i)(2), 3.5(b)(i)(3), and 3.5(b)(i)(4) and the status quo shall persist with respect to such matter unless and until the Parties mutually agree; provided, however, that with respect to any material modification in order to fulfill a [ * ] in Section 3.5(b)(i)(2), Exelixis’ consent through the JDC shall not be unreasonably withheld, delayed, or conditioned.
(c) Notwithstanding Section 3.5(a) and (b), [ * ] representative shall have the deciding vote on all tactical or strategic [ * ] matters for the Products in Collaborator Territory ([ * ]), and such matter shall not be subject to escalation to [ * ]; provided that such decision is the Developing Party, reasonably expected not to directly affect [ * ] and such issue decision shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee (a) Decisions of the JDC shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives to the JDC collectively having one vote. If In the Joint Development Committee or Joint Commercialization Committeeevent of a disagreement among the JDC with respect to a matter to be decided by the JDC as specified herein, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter shall be referred to the Executive Officers. Such Executive Senior Officers who shall meet promptly thereafter and shall negotiate attempt in good faith to resolve the issuessuch disagreement. If Executive Officers they cannot resolve such issue within [* * *] thirty (30) days of referral of such issue the matter being referred to the Executive Officersthem, then subject to Sections 3.4(b) and (c) below, the resolution and/or course of such issue conduct shall be as follows:determined by Novartis, in its sole discretion.
(ab) if such issue properly originated at Notwithstanding Section 3.4(a) above, decisions regarding the Joint Development Committee[***], determined shall be made by the Developing Party mutual agreement of the Parties and shall not be subject to Novartis’ deciding vote and (ii) with respect to major decisions [***] shall be made in accordance with Section 3.4(a), provided, that if Novartis exercises its deciding vote, such vote will be exercised with due regard for the principle that the Array Lead Indication will be developed and resourced in accord with the spirit of the initial Development Plan and Development Budget, unless Novartis concludes, based on a good faith review of scientific data and other relevant Licensed scientific and commercial factors, that the best interests of the Product or such Array Compound requires changes to the Development Plan or Licensed Product at issue; provided that, notwithstanding Development Budget in respect of the Array Lead Indication.
(c) Notwithstanding the foregoing, in no event shall Novartis in exercising its final decision-making authority described in Sections 3.4(a) and 3.4(b) have the right:
(i) if Acceleron is to modify or amend the Developing Party terms and conditions of this Agreement or to determine any such issue relates to (x) in a manner that would conflict with the approval express terms and conditions of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];this Agreement; or
(ii) regardless of which Party is the Developing Partyapprove or adopt any amendment, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound modification or Licensed Product; provided that [* * *] shall continue to determine any issues that relate update to the budget for and Development Plan or Development Budget or take any other action (including approving a disputed financial report) which would (A) unilaterally impose an obligation on Array beyond those expressly provided in or contemplated by this Agreement, (B) excuse Novartis from any of its obligations specifically enumerated under this Agreement, or (C) reduce the conduct rights of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of Array specifically enumerated under this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Decision Making. The Joint Development (i) All decisions required by this Agreement to be made by any Committee (including for clarity each Subcommittee and Joint Commercialization Committee Working Group) shall each act be decided by unanimous agreement of its membersvote, with each Party having one vote. If Party’s representatives [***].
(ii) In the Joint Development Committee event that a Subcommittee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, Working Group fails to reach [***], then such disagreement shall be referred to the JSC for resolution. For clarity, each Party shall have the right to make determinations in its discretion with respect to such Party’s Party Tactical Matters, provided that such determinations are consistent with the Development and Regulatory Activity Plan, the Commercialization Plan and Budget, the Manufacturing Budget, or Medical Affairs Plan and Budget, as applicable, the terms of this Agreement, and applicable Law, except that disputes as to whether or not a unanimous matter is a Party Tactical Matter may be escalated in accordance with this Section 3.4(b)(ii) and, if applicable, Section 3.4(b)(iv).
(iii) In the event that the JSC fails to reach [***] and such matter is not subject to a Party’s final decision-making authority under Section 3.4(b)(iv)(A) and Section 3.4(b)(iv)(B), then either Party may, by written notice to the other Party, have such matter referred to the Senior Executives, who shall meet promptly and negotiate in good faith pursuant to Section 17.1. If despite such good faith efforts, the Senior Executives are unable to resolve such disagreement, then either Party may refer submit such issue dispute for resolution via arbitration in accordance with Section 17.2.
(iv) Except with respect to any matters that this Agreement provides must be consented or agreed to, or approved by, the other Party, anything to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate contrary contained in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as followsthis Agreement:
(aA) if such issue properly originated at Seres shall be entitled to make the Joint Development Committee, determined by the Developing Party final determination with respect to any disagreement regarding a matter for which approval or resolution of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron JSC is the Developing Party and such issue relates to (x) the approval of an Additional Development Diseaseexpressly required herein, or (y) matters under that is submitted to the JSC for resolution in accordance with Section 5.6.3(d3.4(b)(ii), then such issue shall be determined by that is primarily related to [* * ***];
(ii) regardless ; provided, in each case of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * **], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided [***], that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * **]; and
(iiiB) regardless of which Party is the Developing Party, such issue Licensee shall be determined by entitled to make the final determination with respect to any disagreement regarding a matter for which approval or 28 resolution of the JSC is expressly required herein, or that is submitted to the JSC for resolution in accordance with Section 3.4(b)(ii), that is primarily related to [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none provided that in each case of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party[***] and [***].
Appears in 1 contract
Decision Making. The Joint Development Decisions of each Committee and Joint Commercialization Committee with decision-making authority shall each act be made by unanimous agreement of its members, with each Party having one vote. If In the Joint Development event such Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such unanimous agreement with respect to a unanimous particular matter within its decision-making authority, then then, either Party may refer such issue may, by written notice to the Executive Officersother Party (an “Escalation Notice”), have such matter referred to the following individuals of each Party or his/her designee (the “Negotiators”): for disputes originating in the JRC, the heads of research of each Party shall serve as Negotiators; and the Negotiators for disputes originating in the JDC and the JMC shall be the heads of clinical development and manufacturing, respectively. Such Executive Officers The Negotiators shall meet promptly thereafter and shall negotiate in good faith to resolve the issuessuch matter. If the Negotiators are unable to resolve such matter within thirty (30) days of the date of the applicable Escalation Notice, or such longer period of time as the Negotiators may agree, the matter shall be referred to the Chief Executive Officers cannot of the Parties, who shall meet promptly and negotiate in good faith to resolve such issue matter. If the Chief Executive Officers are unable to resolve such matter within [* * *] thirty (30) days, or such longer period of referral of such issue to time as the Chief Executive Officers, the resolution of such issue shall be as followsOfficers may agree:
(a) if Celgene shall cast the deciding vote on any such issue properly originated at matter before the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issueJCC; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if except as set forth in Section 3.5 below, Array shall cast the deciding vote on any such issue properly originated at matter before the Joint Commercialization CommitteeJRC; (c) except as set forth in Section 3.5 below, determined the deciding vote on any such matter before the JDC shall be made by Celgenean arbitrator in accordance with Section 2.3 below, provided, however, that, Celgene shall have the exclusive right to select the indication for each Development Compound from the list attached hereto as Schedule 2.2.3(c); and (d) Array shall cast the deciding vote on any such matter before the JMC. Notwithstanding the foregoing, none of Acceleron, neither Party nor the arbitrator (for matters subject to Section 2.3 below) shall have the right to cast the deciding vote in any manner that would unilaterally impose a financial obligation on Array or Celgene, as the Joint Development Committee case may be, beyond the commitments set forth herein or the Joint Commercialization Committee cause it to violate any obligation or agreement it may make have with any decision inconsistent with the express terms of this Agreement without the prior written consent of each Third Party.
Appears in 1 contract
Samples: Drug Discovery and Development Agreement (Array Biopharma Inc)
Decision Making. The Joint Development Decisions of a Committee and Joint Commercialization Committee shall each act will be made by unanimous agreement of its membersvote, with each Party Party’s representatives on such Committee collectively having one vote. No vote of a Committee may be taken unless at least one of each Party’s representatives is present for such Committee vote. Notwithstanding any other provision of this Agreement to the contrary, no Committee will have decision-making authority whatsoever with regard to [***]. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development JDC, JMC or other subcommittee of the JSC, the applicable Committee or Joint Commercialization Committeecannot reach a decision as to such matter, such Committee will bring the matter to the attention of the JSC for resolution. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the JSC cannot reach a decision as to such matter within [* * ***] (or days after such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter was brought to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive OfficersJSC for resolution, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is the Developing Party and such issue relates subject to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d3.2(g)(ii), then such issue shall be determined by LaNova will have final decision-making authority for matters relating to [* * ***];
(ii) regardless if TPTX reasonably believes [***], the matter shall be referred to the Parties’ respective Alliance Managers, who will promptly meet and attempt in good faith to resolve such matter within [***] days. If such Alliance Manager are unable to resolve such matter within such [***] day period, then, at the written request of which Party is the Developing either Party, the matter will be referred to the Parties’ respective Senior Executives, who will promptly meet and attempt in good faith to resolve such issue matter within [***] days. If such Senior Executives are unable to resolve such matter within such [***] day period, then the [***].
(iii) subject to Section 3.2(g)(iv), TPTX will have final decision-making authority for matters relating to [***];
(iv) if LaNova reasonably believes [***] (A) [***], (B) [***], or (C) [***], the matter shall be determined by referred to the Parties’ respective Alliance Managers, who will promptly meet and attempt in good faith to resolve such matter within [* * ***] following days. If such Alliance Manager are unable to resolve such matter within such [***] day period, then, at the earliest of: (x) written request of either Party, the matter will be referred to the Parties’ respective Senior Executives, who will promptly meet and attempt in good faith to resolve such matter within [* * ***] days. If such Senior Executives are unable to resolve such matter within such [***] day period, then [***]. For clarity, TPTX will have final decision-making authority [***], and LaNova will have final decision-making authority [***].
(yv) A Party’s Senior Executive, in the Joint Development exercise of his or her decision-making authority, will give good faith consideration to, and take into account, the other Party’s position. Notwithstanding any other provision of this Article 3 to the contrary, neither any Committee’s decision to go forward with , including the JSC, nor a Phase 3 Clinical Trial Senior Executive in the exercise of the relevant Licensed Compound foregoing decision-making authority, will have the right: (A) to modify or Licensed Productamend the terms and conditions, or waive any term or condition, of this Agreement; provided that [* * *] shall continue (B) to determine any issues issue in a manner that relate would conflict with the terms and conditions of this Agreement; (C) to the budget for and the conduct of the [* * *]; and
(iii) regardless of which make any determination that a Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: in breach (xor not) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without Agreement; or (D) to make a decision that is expressly stated to require the prior mutual written agreement or mutual written consent of each Partythe Parties. The Parties intend that all matters within the scope of a Committee’s decision-making authority will be resolved by the Parties in accordance with this Section 3.2(g), and no matter within the scope of a Committee’s authority will be subject to the dispute resolution provisions set forth in Section 15.4.
Appears in 1 contract
Samples: License Agreement (Turning Point Therapeutics, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.6(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JSC for resolution. If the JSC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JSC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party and such issue relates final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development matters, except for:
(x1) the approval addition of an Additional Development Disease[ * ], or the cost of which would be [ * ]; and,
(y2) matters under Section 5.6.3(d)any material modification to a [ * ]; for the purpose of this clause, then such issue shall be determined by [“material modification” means any material changes to the agreed upon [ * * *];.
(ii) regardless of Licensee shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) Commercialization in the Licensee Territory, except with respect to the decision [ * * *] following a particular Product in a country, (2) Medical Affairs in the earliest of: (x) [* * *]Licensee Territory, and (y3) regulatory matters in the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of Licensee Territory that do not affect the relevant Licensed Compound or Licensed ProductExelixis Territory; provided that [* * *] Licensee’s decision shall continue to determine any issues that relate to be consistent with the budget for terms and the conduct conditions of the [* * *]; andthis Agreement, including without limitation Section 6.4(b) regarding pricing, and Section 6.3(c) regarding sales forecasts.
(iii) regardless of which Neither Party is shall have the Developing Party, such issue shall be determined by [final decision making authority with respect to the matters in Sections 3.6(b)(i)(1) and (2) or with respect to the decision not to [ * ] a particular Product in a particular country [ * *] following the earliest of: (x) [* * *], and the status quo shall persist with respect to such matter if the Parties are unable to agree.
(yc) Notwithstanding Section 3.6(a), [ * ] representative shall have the occurrence of any [deciding vote on all tactical [ * ] matters for the Products [ * *], and such matter shall not be subject to escalation to [ * ]; and
(b) if provided that such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent does not directly affect [ * ] and such decision shall be consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.6(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JSC for resolution. If the JSC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JSC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party and such issue relates final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development matters, except for:
(x1) the approval addition of an Additional Development Disease[ * ], or the cost of which would be [ * ]; and,
(y2) matters under Section 5.6.3(d)any material modification to a [ * ]; for the purpose of this clause, then such issue shall be determined by [“material modification” means any material changes to the agreed upon [ * * *];.
(ii) regardless of [ * ] shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) [ * ], except with respect to the decision [ * *] following the earliest of: a particular Product in a country, (x2) [Medical Affairs [ * * *], and (y3) regulatory matters [ * ] that do not affect the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product[ * ]; provided that [[ * * *] decision shall continue to determine any issues that relate to be consistent with the budget for terms and the conduct conditions of the [* * *]; andthis Agreement, including without limitation Section 6.4(b) regarding pricing, and Section 6.3(c) regarding sales forecasts.
(iii) regardless of which Neither Party is shall have the Developing Party, such issue shall be determined by [final decision making authority with respect to the matters in Sections 3.6(b)(i)(1) and (2) or with respect to the decision not to [ * ] a particular Product in a particular country [ * *] following the earliest of: (x) [* * *], and the status quo shall persist with respect to such matter if the Parties are unable to agree.
(yc) Notwithstanding Section 3.6(a), [ * ] representative shall have the occurrence of any [deciding vote on all tactical [ * ] matters for the Products [ * *], and such matter shall not be subject to escalation to [ * ]; and
(b) if provided that such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent does not directly affect [ * ] and such decision shall be consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.5(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JEC for resolution. If the JEC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JEC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development and such issue relates regulatory matters that may be reasonably expected to affect the Exelixis Territory, except for:
(x1) the approval [ * ], the costs of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall which would be determined by [[ * * *];
(2) any material modification to a [ * ]. For clarity, the foregoing shall include any material modification to [ * ]. As used in this clause, “material modification” means any material changes to the agreed upon [ * ];
(3) any modification to the Development Budget, the costs of which would be [ * ]; and/or
(4) the addition or inclusion of [ * ], whether the Parties [ * ] or not.
(ii) regardless of Notwithstanding Section 3.5(b)(i), Collaborator shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) Commercialization in the Collaborator Territory (except for [ * ]), (2) regulatory matters in the Collaborator Territory that are reasonably expected not to directly affect the Exelixis Territory (including, [ * *] following the earliest of: (x) [* * *]), and (y3) immediate treatment that is reasonably necessary to protect patient safety in any Development activities held in the Joint Development CommitteeCollaborator Territory; in each case provided that Collaborator’s decision to go forward shall be consistent with a Phase 3 Clinical Trial the terms and conditions of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; andthis Agreement.
(iii) regardless of which Neither Party shall have the final decision making authority with respect to the matters in Sections 3.5(b)(i)(1), 3.5(b)(i)(2), 3.5(b)(i)(3), and 3.5(b)(i)(4) and the status quo shall persist with respect to such matter unless and until the Parties mutually agree; provided, however, that with respect to any material modification in order to fulfill a [ * ] in Section 3.5(b)(i)(2), Exelixis’ consent through the JDC shall not be unreasonably withheld, delayed, or conditioned.
(c) Notwithstanding Section 3.5(a) and (b), [ * ] representative shall have the deciding vote on all tactical or strategic [ * ] matters for the Products in Collaborator Territory ([ * ]), and such matter shall not be subject to escalation to [ * ]; provided that such decision is the Developing Party, reasonably expected not to directly affect [ * ] and such issue decision shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. 3.2.5.1. Other than as set forth herein, in order to make any decision required of it hereunder with respect to any approval, the JSC must have present (in person, by videoconference or telephonically) at least one member of each Party. The Joint Development Committee and Joint Commercialization Committee Parties will endeavor to make decisions of the JSC by consensus.
3.2.5.2. The JSC shall each act attempt in good faith to resolve any disputes or failure to agree by unanimous agreement of its members, consent (with each Party having one vote). If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers JSC cannot resolve such issue dispute or failure to agree within [* * ***] ([***]) days of referral of the matter being referred to it, such issue to the Executive Officers, the resolution of such issue matter shall be resolved as follows:
(a) if such the issue properly originated at will be promptly presented to the Joint [***] of AstraZeneca (or person of equivalent seniority for the applicable stage of Development Committeeor commercialization) and [***] of Pieris US (the “Senior Representatives”), determined or their respective designees, for resolution. Such Senior Representatives, or their respective designees, will meet in person or by teleconference as soon as reasonably possible thereafter, and use their good faith efforts to mutually agree upon the Developing Party resolution of the relevant Licensed Compound dispute, controversy or Licensed Product at claim.
(b) In the event such Senior Representatives cannot resolve such issue; provided that, notwithstanding using good faith efforts, within [***] ([***]) days of the matter being referred to them, AstraZeneca’s [***] shall have the casting vote to resolve such issue.
(c) Notwithstanding the foregoing:
(i) Following the Effective Date but prior to Phase 1 Study Completion for the Lead Product, if Acceleron is either Party wishes to deviate from the Developing Party and initial Lead Product Development Plan, the other Party’s consent shall be required if such issue relates to deviation would (x1) the approval of an Additional Development Disease[***], or (y2) matters under Section 5.6.3(d), then such issue shall be determined by [* * ***];. Any delay of the Phase 1 Study Initiation by more than [***] (if not mutually agreed by the Parties) shall only occur if required by Applicable Law or the mandatory instruction of a Regulatory Authority made in accordance with Applicable Law. Subject to the foregoing, AstraZeneca shall have final say regarding all matters relating to the Lead Product Development Plan. For clarity, following [***], subject to the terms and conditions of this Agreement, AstraZeneca shall have final decision making authority for matters related to the Development of the Lead Product thereafter.
(ii) regardless For the Collaboration Products and any Lead Product Back-Up Hits, prior to Lead Candidate stage, Pieris shall have final decision-making authority for matters related to the discovery of which Party is Anticalin proteins against Designated Targets or the Developing PartyLead Product Target, including panning strategies, optimization strategies and Pieris resources devoted to such issue shall be determined by [* * *] following work, provided, however, that the earliest of: Parties will jointly (xa) [* * *]define and mutually agree the success criteria for Lead Candidate contained in each initial Collaboration Product Development Plan, and (yb) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget select hits resulting from initial screening for and the conduct of the [* * *]; andan optimization campaign.
(iii) regardless of which Party is the Developing Party, such issue The Technical Candidate Drug Criteria for each Collaboration Product shall be determined established by AstraZeneca in good faith in accordance with its usual methodology and standards for setting such criteria in consultation with Pieris no later than [* * ***] following the earliest of: (x[***]) [* * ***] after achieving [***] stage and shall be consistent with the guidelines for such criteria set forth in Exhibit 1.40. AstraZeneca shall provide Pieris with a copy of the Technical Candidate Drug Criteria for each Collaboration Product and it shall be included in the applicable Collaboration Product Development Plan once established. Any changes to such Technical Candidate Drug Criteria after establishment in accordance with this subsection (iii) must be mutually agreed by the Parties.
(iv) Subject to Section 4.4.5.2, in all instances after Pieris has exercised a Lead Product CoDev Option or a CoDev Product CoDev Option ([***], [***] Split or [***] Cap), any decisions that impact an agreed-upon budget shall require both Parties to consent and neither Party shall be required to pay for cost increases of more than [***] percent (y) the occurrence of any [* * ***]; and
(b%) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partyunless it agrees in writing.
Appears in 1 contract
Samples: License & Collaboration Agreement (Pieris Pharmaceuticals, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization All decisions of each Committee shall each act be made by unanimous agreement of its members[***], with each Party Party’s representatives collectively having one [***] vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee JDC, JCC or Joint Commercialization Committeeanother subcommittee of the JSC, after the representatives of the Parties cannot reach an agreement as to such matter within [* * ***] (or after such other period as matter was brought to such Committee for resolution, such disagreement shall be referred to the JSC for resolution. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer matter within [***] after such issue matter was brought to the JSC for resolution or after such matter has been referred to the JSC, such disagreement shall be referred to the Chief Executive Officer of ARS and the Chief Executive Officer of ALFRESA or its designee (collectively, the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the ”) for resolution of such issue shall be as follows:
(a) if If such issue properly originated at matter relates to [***], then the Joint Development Committee, determined by the Developing Party Executive Officers shall discuss in good faith a resolution of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by matter that addresses both [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) if the Joint Development Committee’s Executive Officers cannot resolve such matter within [***] after such matter has been referred to them, the [***] shall be entitled to make the final decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Productregarding such matter; provided that [* * *] such decision shall continue to determine any issues that relate to the budget for and the conduct be made in good faith consideration of the other Party’s views on the matter, that such decision is not reasonably expected to directly affect [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) that such decision shall be consistent with the occurrence terms and conditions of any [* * *]; andthis Agreement.
(b) If such matter relates to [***], then the Executive Officers shall discuss in good faith a resolution of the matter, and if the Executive Officers cannot resolve such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgenematter within [***] after such matter has been referred to them, the Joint Development Committee or [***] shall be entitled to make the Joint Commercialization Committee may make any final decision inconsistent regarding such matter; provided that such decision shall be made in good faith consideration of the other Party’s views on the matter, that such decision is not reasonably expected to directly affect [***], and that such decision shall be consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Silverback Therapeutics, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Joint Development Committee or Joint Commercialization Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. a Committee, after [* * *] (or such other period as the representatives of the Parties may otherwise agree) of good faith efforts cannot reach an agreement as to reach a unanimous decision on an issuesuch matter within [ * ] after such matter was brought to such Committee for resolution, fails then, except as provided in Section 3.5(c), if such disagreement arose within the JDC or JCC, it shall be referred to reach the JEC for resolution. If the JEC cannot resolve such a unanimous decisionmatter within [ * ], or if the disagreement first arose within the JEC, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [[ * * *] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is Exelixis shall have the Developing Party final decision making authority, which shall be exercised in its reasonable discretion, with respect to Development and such issue relates regulatory matters that may be reasonably expected to affect the Exelixis Territory, except for:
(x1) the approval [ * ], the costs of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall which would be determined by [[ * * *];
(2) any material modification to a [ * ]. For clarity, the foregoing shall include any material modification to [ * ]. As used in this clause, “material modification” means any material changes to the agreed upon [ * ];
(3) any modification to the Development Budget, the costs of which would be [ * ]; and/or
(4) the addition or inclusion of [ * ], whether the Parties [ * ] or not.
(ii) regardless of Notwithstanding Section 3.5(b)(i), Collaborator shall have the final decision making authority, which Party is the Developing Party, such issue shall be determined by [exercised in its reasonable discretion, with respect to (1) Commercialization in the Collaborator Territory (except for [ * ]), (2) regulatory matters in the Collaborator Territory that are reasonably expected not to directly affect the Exelixis Territory (including, [ * *] following the earliest of: (x) [* * *]), and (y3) immediate treatment that is reasonably necessary to protect patient safety in any Development activities held in the Joint Development CommitteeCollaborator Territory; in each case provided that Collaborator’s decision to go forward shall be consistent with a Phase 3 Clinical Trial the terms and conditions of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; andthis Agreement.
(iii) regardless Neither Party shall have the final decision making authority with respect to the matters in Sections 3.5(b)(i)(1), 3.5(b)(i)(2), 3.5(b)(i)(3), and 3.5(b)(i)(4) and the status quo shall persist with respect to such matter unless and until the Parties mutually agree; provided, however, that with respect to any material modification in order to fulfill a [ * ] in Section 3.5(b)(i)(2), Exelixis’ consent through the JDC shall not be unreasonably withheld, delayed, or conditioned.
(c) Notwithstanding Section 3.5(a) and (b), [ * ] representative shall have the deciding vote on all tactical or strategic [ * ] matters for the Products in [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of which Party the Securities Exchange Act of 1934, as amended. Collaborator Territory ([ * ]), and such matter shall not be subject to escalation to [ * ]; provided that such decision is the Developing Party, reasonably expected not to directly affect [ * ] and such issue decision shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent consistent with the express terms and conditions of this Agreement without the prior written consent of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Decision Making. (i) The Joint Development Committee JSC is an advisory body only, and Joint Commercialization Committee shall each act by unanimous agreement the rights and authorities of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agreeare set forth in this Agreement, including Section 3.4(c)(ii) and 3.4(c)(iii). The Parties shall use Commercially Reasonable Efforts to cause their respective members of good faith efforts the JSC to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate act in good faith to resolve and cooperate with one another. Any disagreement between the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue Parties shall be first submitted to the Executive OfficersAlliance Managers in order to facilitate a resolution and then, the resolution of such issue shall be as follows:
(a) if such issue properly originated not resolved, at the Joint Development Committee, determined by the Developing Party election of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing either Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision referred for resolution pursuant to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by CelgeneArticle 14. Notwithstanding the foregoing, none each Party has final decision-making authority with respect to certain matters pursuant to 3.4(c)(ii) and 3.4(c)(iii), and no decision made in accordance with such final decision-making authority shall be subject to any dispute resolution mechanism or procedure under Article 14. Notwithstanding anything else in this Agreement or the Manufacturing and Supply Agreement, in no event shall either Party exercise its final decision-making authority in a manner that would have the effect of Acceleronmodifying, Celgeneor would otherwise be in conflict with, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without or the Manufacturing and Supply Agreement.
(ii) Except as otherwise set out in this Agreement, Pluristem shall have final decision-making authority regarding any and all matters relating to:
1. the Development and Commercialization of Products in Pluristem’s Domain; and
2. Manufacture of Products, subject to the terms of the Manufacturing and Supply Agreement; provided that, if Pluristem exercises its decision-making authority under this Agreement, including under this Section 3.4(c)(ii) , Pluristem will make a good faith effort to consult with UTC prior to making any decision that is reasonably likely to be material to UTC, and, if UTC requests, provide to UTC a reasonably detailed written consent explanation of the basis for such decision. If the Parties disagree on such decision, Pluristem agrees, at UTC’s request, to make available a member of Pluristem’s Executive Committee within ten (10) business days to discuss such matter; provided, however, that such a discussion will not affect Pluristem’s right to exercise its final decision-making authority with respect to such decision.
(iii) Except as otherwise set out in this Agreement, UTC shall have final decision-making authority regarding any and all matters relating to the Development and Commercialization of Products in the Field, provided that, if UTC exercises its decision-making authority under this Agreement, including under this Section 3.4(c)(iii), UTC will make a good faith effort to consult with Pluristem prior to making any decision that is reasonably likely to be material to Pluristem, and, if Pluristem requests, provide to Pluristem a reasonably detailed written explanation of the basis for such decision. If the Parties disagree on such decision, UTC agrees, at Pluristem’s request, to make available an executive officer of UTC within ten (10) business days to discuss such matter; provided, however, that such a discussion will not affect UTC’s right to exercise its final decision-making authority with respect to such decision.
(iv) When exercising its decision-making authority under this Agreement, each PartyParty shall:
1. keep the other Party closely informed about its activities related to the decision;
2. closely consult with the other Party on such activities and the possible decision(s) to be made and confer in good faith with the other Party respecting same;
3. exercise its decision-making authority in accordance with the principles set forth in Section 4.1.
Appears in 1 contract
Samples: Exclusive License Agreement (Pluristem Therapeutics Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee (a) All decisions of the JSC, with respect to any matter over which the Parties mutually agree in good faith in writing following the Effective Date the JSC shall each act have decision-making authority (“JSC Decision Matters”), shall be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter subject to the Joint Development Committee or Joint Commercialization Committeedecision of the JSC, after [* * *the representatives of the Parties cannot reach an agreement as to such matter within [ ] (or [ ]) [ ] after such other period as matter was brought to the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decisionJSC for resolution, then either Party at any time may refer such issue to the Executive Officers. Such Executive Senior Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Senior Officers cannot resolve a JSC Decision Matter within [ ] ([ ]) [ ] after such issue within [* * *] of referral of such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingthen:
(i) if Acceleron is the Developing Party and such issue relates Eyenovia shall have final decision making authority, which shall be exercised in its reasonable discretion, with respect to any JSC Decision Matter concerning (x1) the approval Development and Commercialization of an Additional Development Disease, the Products outside the Territory or (y2) matters under Section 5.6.3(d)any intellectual property issues directly pertaining to the Products outside the Territory, then in each case (1) – (2) provided that the exercise of such issue shall be determined by [* * *]final decision making authority does not have a material adverse effect, and is not reasonably expected to have a material adverse effect, on the Development or Commercialization of the Products in the Territory;
(ii) regardless of Arctic Vision shall have final decision making authority, which Party is the Developing Party, such issue shall be determined by [* * *] following exercised in its reasonable discretion, with respect to any JSC Decision Matter concerning (1) the earliest of: Development and Commercialization of the Products in the Territory or (x2) [* * *]any intellectual property issues directly pertaining to the Products in the Territory, in each case (1) – (2) provided that the exercise of such final decision making authority does not have a material adverse effect, and (y) is not reasonably expected to have a material adverse effect, on the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial or Commercialization of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to Products outside the budget for and the conduct of the [* * *]; andTerritory.
(iii) regardless of which Neither Party is the Developing Party, such issue shall be determined have final decision making authority with respect to any JSC Decision Matter not covered by [* * *] following the earliest of: (xSections 3.3(b)(i) [* * *]or 3.3(b)(ii), and (y) the occurrence of any [* * *]; and
(b) if status quo shall persist with respect to such issue properly originated at JSC Decision Matter unless and until the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each PartyParties agree.
Appears in 1 contract
Samples: License Agreement (Eyenovia, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JSC shall each act be made by unanimous agreement of its membersconsensus, with each Party having Party’s representatives having, collectively, one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJSC, the JSC cannot reach consensus as to such matter within […***…] after [* * *] such matter was brought to the JSC for resolution (or […***…] if the particular matter is with respect to any issue under consideration by the JSC pursuant to Sections 3.2(b)(iii), (iv) or (v)), such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue matter shall be referred to the Chief Executive Officer of Zymeworks (or an executive officer of Zymeworks designated by the Chief Executive Officer of Zymeworks who has the power and authority to resolve such matter) and the Chief Executive Officer of BeiGene (or an executive officer of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) (collectively, the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues”) for resolution. If the Executive 32 Competitive Information – Commercially Sensitive Terms. 33 Competitive Information – Commercially Sensitive Terms. Officers cannot resolve such issue matter within [* * …***…] of referral of after such matter has been referred to them (or […***…] if the particular matter is with respect to any issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined originally under consideration by the Developing Party of the relevant Licensed Compound JSC pursuant to Sections 3.2(b)(iii), (iv) or Licensed Product at issue; provided that(v)), notwithstanding the foregoing:then:34
(i) if Acceleron is Subject to Section 3.2(f)(ii), BeiGene shall have the Developing Party and such issue relates final decision-making authority for matters within the scope of the JSC’s decision-making authority with respect to (x1) any […***…] for Licensed Products in the approval of an Additional Development DiseaseField in the Territory […***…], or (y2) matters under Section 5.6.3(d)all […***…] with respect to Licensed Products, then such issue including […***…], in the Field in the Territory; and (3) all […***…] activities leading up to and including the […***…] and any […***…], as applicable, for Licensed Products in the Field from […***…] in the Territory; provided that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be determined by expected to [* * …***…];.35
(ii) regardless Zymeworks shall have the final decision-making authority for matters within the scope of the JSC’s decision-making authority with respect to (1) the […***…]; (2) any […***…] activities which Party is […***…]; (3) any Development, manufacture or Commercialization activities in the Developing PartyTerritory that would reasonably be expected to […***…] of the Licensed Product; or (4) any Development, such issue shall manufacture or Commercialization activities in the Territory that would reasonably be determined by [* * *] following the earliest of: (x) [* * *], and expected to (y) the Joint Development Committee’s decision to go forward with result in a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * …***…] shall continue to determine any issues that relate related to the budget for and Licensed Product outside the conduct of the Territory or (z) otherwise [* * …***…]; and
provided, that, Zymeworks shall not exercise its final decision-making authority in a manner that would […***…] under this Agreement, including (iiiA) regardless any of which Party is BeiGene’s obligations or expenses […***…] agreed between the Developing Party, such issue shall be determined by [* * *] following the earliest of: Parties and/or (xB) [* * *], and (y) the occurrence of any [* * …*]; and
**…] involving a Licensed Product (b) if such issue properly originated at including the Joint Commercialization CommitteeZW25 Multi-Regional Registrational Study), determined by Celgene. Notwithstanding the foregoingin any case without BeiGene’s written consent, none of Acceleronwhich will not be unreasonably withheld, Celgene, the Joint Development Committee delayed or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.conditioned.36
Appears in 1 contract
Samples: License and Collaboration Agreement (Zymeworks Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization (a) All decisions of each Committee shall each act be made by unanimous agreement of its membersvote, with each Party Party’s representatives collectively having one (1) vote. If the Joint Development Committee or Joint Commercialization after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, after [* * *] the representatives of the Parties cannot reach an agreement as to such matter within fifteen (15) Business Days (or such other longer period as the Parties may otherwise agreesuch representatives mutually agree upon) of good faith efforts after such matter was brought to reach a unanimous decision on an issue, fails to reach such a unanimous decisionCommittee for resolution, then either Party at any time may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve for resolution.
(b) If the issues. If Executive Officers cannot resolve such issue matter within [* * *] fifteen (15) Business Days (or such longer period as such Executive Officers mutually agree upon) after such matter has been referred to them, then:
(i) Aurinia shall have the final decision-making authority with respect to: (A) the Global Brand Plan, subject to Section 6.6; (B) Manufacture (excluding Packaging) of Products for the Otsuka Territory, provided that Aurinia’s final decision-making authority with respect to any such Manufacturing decision shall be subject to and limited by the terms of the Supply Agreements and Quality Agreements for Product; (C) the conduct of any Non-Clinical Study of the Compound or the Product, the conduct or sponsorship of any Clinical Trials and the support or supply of Product in the Field to any Investigator-Initiated Trials, to the extent such Non-Clinical Studies, Clinical Trials or Investigator-Initiated Trials require the consent of Aurinia in accordance with Section 4.2(g); (D) the consent to the filing or prosecution of any patent application for an Invention as set forth in Section 10.1(a); (E) the global publication strategy and the publication, consent to publication or dissemination of publications as set forth in Section 13.4; and (F) the interpretation, in light of Aurinia’s global pharmacovigilance data, of adverse events in the Aurinia Territory and in the Otsuka Territory (including as pertains to any Aurinia Domain Product) of which Aurinia becomes aware in compliance with the Pharmacovigilance Agreement and Applicable Law.
(ii) Otsuka shall have the final decision-making authority with respect to; (A) pricing for Product for Europe, including list price ranges and pricing and reimbursement strategy; (B) Commercialization of Products in the Otsuka Territory, provided that such Commercialization is consistent with the Global Brand Plan or, if applicable, the Otsuka Territory-Specific Brand Plan, including matters related to obtaining or maintaining Pricing or Reimbursement Approvals (including applications for Pricing or Reimbursement Approvals and their prosecutions in Europe) but excluding approval of any alternative or additional Product Marks for the Otsuka Territory; (C) Medical Affairs for the Otsuka Territory, provided that such Medical Affairs Activities are consistent with the Local Medical Affairs Plan; (D) Otsuka Initial Development and all Regulatory Activities in the Otsuka Territory; (E) Otsuka Territory Additional Development except to the extent such Development includes any Non-Clinical Study of the Compound or the Product, the conduct or sponsorship of any Clinical Trials and the support or supply of Product to any Investigator-Initiated Trials that, in each case, require the consent of Aurinia in accordance with Section 4.2(g); (F) local pharmacovigilance in the Otsuka Territory in compliance with the Pharmacovigilance Agreement and Applicable Law; and (G) Packaging of Products for the Otsuka Territory; unless, in each case of (B) through (F) above, in Aurinia’s reasonable judgment, such Commercialization, Medical Affairs, Otsuka Initial Development or Otsuka Territory Additional Development is likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product in the Aurinia Territory or Commercialization of any Product in the Aurinia Territory.
(iii) The following matters are subject to the mutual agreement of both Parties, and shall not be subject to referral to the Executive Officers, expert determination, arbitration or any other form of external dispute resolution and are not subject to Aurinia’s or Otsuka’s decision-making authority pursuant to sub-clause (i) or (ii) of this Section 3.4(b): (A) the decision whether or not to pursue together any Global Additional Development in accordance with Section 4.2(e)(i), or to agree on a regulatory milestone in accordance with Section 4.2(c) or to agree on the payment to be made by Otsuka in connection with its opt-in right in accordance with Section 4.2(e)(iii); (B) the Aurinia Initial Development, and (C) approval of (x) any development plan and budget for agreed-to Global Additional Development, or (y) any alternative or additional Product Marks for the Otsuka Territory. In addition, the approval of any Otsuka Territory-Specific Brand Plan shall be subject to mutual agreement of the Parties after referral to the Executive Officers, and shall not be subject to expert determination, arbitration or any other form of external dispute resolution and are not subject to Aurinia’s or Otsuka’s decision-making authority pursuant to sub-clause (i) or (ii) of this Section 3.4(b).
(iv) Aurinia shall have sole decision-making authority in its sole discretion with respect to the following matters without any obligation to inform a Committee (except as set out below), or submit any such matter to the Executive Officers, expert determination, arbitration or any other form of external dispute resolution and are not subject to Aurinia’s or Otsuka’s decision-making authority pursuant to sub-clause (i) or (ii) of this Section 3.4(b): (A) Commercialization of Products in the Aurinia Territory (subject to Section 3.1(g) with respect to any discussions at the JCC) and Commercialization of Aurinia Domain Products worldwide, including matters related to pricing or obtaining or maintaining Pricing or Reimbursement Approvals for Products in the Aurinia Territory and with respect to Aurinia Domain Products worldwide; (B) Clinical Trials and other Development (other than agreed-to Global Additional Development) for the Product in the Aurinia Territory (subject to Section 3.1(a) with respect to a forum for discussion at the JCC) and clinical trials and other development of Aurinia Domain Products; and (C) clinical trials of Aurinia Domain Products that are ongoing or planned as of the Effective Date and Clinical Trials of Product in the Aurinia Territory that are ongoing or planned as of the Effective Date other than Clinical Trials to be conducted as part of Aurinia Initial Development (which are subject to mutual agreement of both Parties in accordance with Section 3.4(b)(iii)).
(v) If a Committee decision cannot be resolved by the Executive Officers in accordance with this Section 3.4(b) and none of Sections 3.4(b)(i), 3.4(b)(ii), 3.4(b)(iii), and 3.4(b)(iv) apply to such decision, then the decision may be referred by either Party to be resolved by expert determination in accordance with Section 15.3. In addition, if a Party overrules the other Party’s final decision-making authority pursuant to Section 3.4(b)(ii) based on a determination that, in such Party’s reasonable judgment, a decision by the other Party is likely to have a material adverse effect, and if the other Party disputes such determination of a likely material adverse effect, such dispute shall be resolved by expert determination in accordance with Section 15.3.
(vi) In the event that Aurinia notifies in good faitx Xxxxxx xx a result of discussions pursuant to Section 3.1(s) or otherwise that any action that Otsuka is taking or intends to take is likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product in the Aurinia Territory or Commercialization of any Product in the Aurinia Territory, and Aurinia refers such issue to the Executive OfficersOfficers for resolution, and if the resolution of such issue shall decision cannot be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined resolved by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Executive Officers in accordance with Section 5.6.3(d3.4(b), commences and diligently pursues an expert determination in accordance with Section 15.3, then Otsuka shall not take such issue shall be determined action until such Disputed Matter is resolved by [* * *];
(iithe Executive Officers in accordance with Section 3.4(b) regardless of which Party is the Developing Partyor absent such resolution, an expert determination in accordance with Section 15.3 concludes that such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, action will not cause such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Partymaterial adverse effect.
Appears in 1 contract
Samples: Collaboration and License Agreement (Aurinia Pharmaceuticals Inc.)
Decision Making. (1) The Joint Development Committee JSC shall make decisions and Joint Commercialization Committee shall each act take action (A) by unanimous agreement consensus of its membersthe members present at a meeting at which a quorum exists, with each Party ensuring that its representatives make such decisions in good faith, and having one vote. a single vote irrespective of the number of representatives of such Party in attendance, or (B) by a written resolution signed by at least both co-chairpersons appointed by each Party.
(2) If the Joint Development Committee or Joint Commercialization Committee, after JSC does not reach consensus on any matter within its authority (a “Deadlocked Matter”) within a period of [* * *] (or such other period as the Parties may otherwise agreeagree in writing) of good faith efforts to reach a unanimous decision on an issue, fails after it has met and attempted to reach such a unanimous decisionconsensus, then either Party may may, by written notice to the other Party, refer such issue the Deadlocked Matter [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. to the Executive Officers. Such ; provided, however, that, if the Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cando not resolve reach agreement on such issue Deadlocked Matter within [* * *] of referral of after such issue Deadlocked Matter is referred to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committeethen, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:subject to Section 2.1.4(c)(3):
(i) if Acceleron is Protagonist shall have the Developing Party and such issue final decision-making right with respect to any Deadlocked Matter to the extent it relates to (x) [*], except that, irrespective of [*], Xxxxxxx shall have the approval of an Additional Development Diseasefinal decision-making right with respect to [*] and to the extent [*], or (y) matters under Section 5.6.3(d), then such issue which decision shall be determined by [* * *]final and binding on the Parties;
(ii) regardless of Xxxxxxx shall have the final decision-making right with respect to any Deadlocked Matter to the extent it relates to [*] (other than as described in Section 2.1.4(c)(2)(i) above) and/or [*], which Party is the Developing Party, such issue decision shall be determined by final and binding on the Parties; provided, however, that Xxxxxxx may not exercise its final decision-making authority under this Section 2.1.4(c)(2)(ii) to (A) make any Fundamental Development Plan Change [* * *] without Protagonist’s consent, which shall not be unreasonably withheld, delayed or conditioned, unless [*], or (B) decrease the number of Protagonist Research FTEs performing Research Activities under the 2nd Generation Development Plan below [*] during the Initial Funding Term, or below [*] following the earliest of: Initial Funding Term (xsubject to [*]), without Protagonist’s consent, which shall not be unreasonably withheld, delayed or conditioned;
(iii) Xxxxxxx shall have the final decision-making right with respect to any Deadlocked Matter to the extent it relates to [* * *] (other than as described in Section 2.1.4(c)(2)(i) above), which decision shall be final and binding on the Parties except that Xxxxxxx may not exercise its final decision-making authority under this Section 2.1.4(c)(2)(iii) to [*], and (y) the Joint Development Committeewithout Protagonist’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound consent, which shall not be unreasonably withheld, delayed or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]conditioned; and
(iv) Neither Party shall have the final decision-making right with respect to any Deadlocked Matter, including the right to effect any Fundamental Development Plan Change, except as described in Sections 2.1.4(c)(2)(i), (ii) and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *]), and (y) in such event the occurrence of any [* * *]matter shall remain deadlocked and the status quo shall persist unless and until the Parties reach agreement on such matter; and
(b) if such issue properly originated at provided, however, that, to the Joint Commercialization Committee, determined by Celgene. Notwithstanding extent the foregoing, none of Acceleron, CelgeneDeadlocked Matter is with respect to a Fundamental Development Plan Change, the Joint Parties shall proceed under the then-current Plan (including the then-current Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each PartyBudget) having last been approved by both Parties.
Appears in 1 contract
Samples: License and Collaboration Agreement (Protagonist Therapeutics, Inc)
Decision Making. The Joint Development Committee and Joint Commercialization Committee JSC shall each act by unanimous agreement of its membersmake decisions unanimously, with each Party Party’s representatives collectively having one vote(1) vote and at least one (1) representative from each Party present. If In the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as event the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers JSC cannot resolve such issue reach an agreement regarding a decision within [the JSC’s authority for a period of [ * * *] of referral of such issue to ], then, except as otherwise set forth in this Section 2.1(d) below, for the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoingCollaboration:
(i) Exelixis shall make the final determination in its sole discretion if Acceleron such decision is regarding the Developing Party [ * ] of Collaboration Compound(s) prior to [ * ], provided that Genentech shall make the final determination in its sole discretion if such decision is regarding whether Exelixis [ * ] with respect to [ * ]; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and such issue relates filed separately with the Securities and Exchange Commission pursuant to (x) Rule 24B-2 of the approval Securities Exchange Act of an Additional Development Disease1934, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];as amended.
1. and (ii) regardless of which Party is Genentech shall make the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) final determination in its sole discretion if such issue properly originated at decision is regarding the Joint Commercialization Committee[ * ] of Licensed Product(s) [ * ] (although notwithstanding Genentech’s sole discretion under this Section, determined by CelgeneGenentech continues to be subject to [ * ]). Notwithstanding the foregoing, none of Acceleron[ * ], CelgeneExelixis shall have final decision making authority for all matters relating to: (x) [ * ]; and (y) [ * ]. [ * ], Genentech will have final decision making authority for all matters related to the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent [ * ]. When either Party makes final determinations under this Section, that final determination shall be consistent with the express terms of this Agreement without Agreement. Disputes regarding matters not within the prior written consent responsibilities of each Partythe JSC shall be resolved pursuant to Section 15.3.”
Appears in 1 contract
Decision Making. The Joint Development Committee and Joint Commercialization Committee All decisions of the JDC shall each act be made by unanimous agreement of its membersconsensus, with each Party having Party’s representatives having, collectively, one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the Joint Development Committee or Joint Commercialization CommitteeJDC, after the JDC cannot reach consensus as to such matter within [* * ***] after such matter was brought to the JDC for resolution, such matter shall be referred to the Chief Executive Officer of Leap (or an executive officer of Leap designated by the Chief Executive Officer of Leap who has the power and authority to resolve such other period as matter) and the Parties may otherwise agreeChief Executive Officer of BeiGene (or an executive officer of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) of good faith efforts to reach a unanimous decision on an issue(collectively, fails to reach such a unanimous decision, then either Party may refer such issue to the “Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues”) for resolution. If the Executive Officers cannot resolve such issue matter within [* * ***] of referral of after such issue matter has been referred to the Executive Officersthem, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:then:28
(i) if Acceleron is Subject to Section 3.2(f)(ii), BeiGene shall have the Developing Party and such issue relates final decision-making authority for matters within the scope of the JDC’s decision-making authority with respect to (x1) any [***] for Licensed Products in the approval of an Additional Development DiseaseField in the Territory, or (y2) matters under Section 5.6.3(d)all [***] with respect to Licensed Products, then such issue shall be determined by including [* * ***];, in the Field in the Territory; and (3) all [***] activities leading up to and including the [***] and any [***], as applicable, for Licensed Products in the Field from [***] in the Territory; provided that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be expected to [***].29
(ii) regardless Leap shall have the final decision-making authority for matters within the scope of which Party is the Developing PartyJDC’s decision-making authority with respect to any Development, such issue shall manufacture or Commercialization activities in the Territory that would reasonably be determined by expected to (y) result in a [* * ***] following related to a Licensed Product outside the earliest ofTerritory or outside the Field or (z) otherwise [***]; provided, that, Leap shall not exercise its final decision-making authority in a manner that would: (xA) [* * ***] under this Agreement, including (i) any of BeiGene’s obligations or expenses [***] agreed between the Parties and/or (ii) any [***] involving a Licensed Product (including a Multi-Regional Clinical Trial), in any case; or (B) [***], and (y) the Joint Development Committeewithout BeiGene’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound written consent, which will not be unreasonably withheld, delayed or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.conditioned.30
Appears in 1 contract
Samples: Exclusive Option and License Agreement (Leap Therapeutics, Inc.)
Decision Making. The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
: (i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
; (ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
and (b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.
Appears in 1 contract