Joint Committee Dispute Resolution. (a) If a Joint Committee (other than the JSC) cannot, or does not, reach consensus on an issue at a meeting or within a period of [***] thereafter, then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC may be called for such purpose. If the JSC cannot, or does not, reach consensus on an issue, including any dispute *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. arising in another Joint Committee, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] after such issue was first referred to them, then: (i) if such dispute is related to a Collaboration Program for which AbbVie has not exercised its Option, such dispute shall be finally and definitively resolved by [***]; provided, that [***]. As used herein, a “Material Amendment” to the Pre Exercise Development Plan and Budget shall mean [***]; (ii) if such dispute is related to a Collaboration Program for which AbbVie has exercised its Option, such dispute shall be finally and definitively resolved by [***], provided, that [***]; (iii) if such dispute is related to Additional Licensor Development Activities for which AbbVie has not exercised the AbbVie Opt In in accordance with Section 3.3.4, such dispute shall be finally and definitively resolved by [***]; and (iv) if such dispute is related to any activities for an Additional Indication under Additional Licensor Development Activities following AbbVie’s exercise of the AbbVie Opt In in accordance with Section 3.3.4, such dispute shall be finally and definitively resolved by [***]. (b) Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC and not within a Party’s sole decision-making authority, shall be resolved pursuant to Section 13.7.
Appears in 2 contracts
Samples: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Joint Committee Dispute Resolution. (a) If a Joint Committee (other than the JSC) JRC, the JDC or the JCC cannot, or does not, reach consensus unanimous agreement on an issue at a meeting or within a period of […***…] thereafter([…***…]) Business Days thereafter or such other period as the Parties may agree, then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC may be called for such purpose. If the JSC cannot, or does not, reach consensus unanimous agreement on an issue, including any dispute *** Certain information in this agreement has been omitted and filed separately with arising from the Securities and Exchange Commission. JRC, JDC or JCC, at a meeting or within a period of […***…] indicates that text has been omitted and is ([…***…]) Business Days thereafter or such other period as the subject of a confidential treatment request. arising in another Joint CommitteeParties may agree, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within […***…] ([…***…]) days after such issue was first referred to them, then:
(i) if such dispute is related relates to any proposed amendment to the Potentiator IND Success Criteria, the Corrector IND Success Criteria, the Potentiator POC Success Criteria, or the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a Collaboration Program for which AbbVie has not exercised its Optionnew Potentiator Standard or Combination Standard, as applicable, such dispute shall be resolved […***…];
(ii) if such dispute relates to any proposed modification to the length of the Discovery Term, […***…];
(iii) if such dispute relates to any proposed amendment to the Discovery Work Plan (including the Discovery Budget), such dispute shall be finally and definitively resolved by […***]; provided, that [***]. As used herein, a “Material Amendment” to the Pre Exercise Development Plan and Budget shall mean [***…];
(iiiv) if such dispute is related relates to a Collaboration Program for which AbbVie has exercised its Optionthe approval of the initial Potentiator POC Development Plan (including the Potentiator POC Budget) or any amendment thereto, such dispute shall be finally and definitively resolved by […***], provided, that [***…];
(iiiv) if such dispute is related relates to Additional Licensor the approval of the initial Corrector/Combination Product POC Development Activities for which AbbVie has not exercised Plan (including the AbbVie Opt In in accordance with Section 3.3.4Corrector/Combination Product POC Budget) or any amendment thereto, such dispute shall be finally and definitively resolved by […***…]; and;
(ivvi) if such dispute is related relates to any activities for an Additional Indication under Additional Licensor Development Activities following AbbVie’s exercise the approval of the AbbVie Opt In in accordance with Section 3.3.4initial Potentiator Post-POC Development Plan (including the Potentiator Post-POC Development Budget) or any amendment thereto, such dispute shall be finally and definitively resolved by […***…].;
(vii) if such dispute relates to the approval of the initial Corrector/Combination Product Post-POC Development Plan (including the Corrector/Combination Product Post-POC Development Budget) or any amendment thereto, such dispute shall be finally and definitively resolved by […***…];
(viii) if such dispute relates to the approval of any CMC Amendment, such dispute shall be finally and definitively resolved by […***…];
(ix) if such dispute relates to the approval of the initial Galapagos Territory Development Plan or any amendment thereto, such dispute shall be finally and definitively resolved by […***…];
(x) if such dispute relates to whether any Molecule satisfies the Potentiator IND Success Criteria or the Corrector IND Success Criteria, as applicable, such dispute shall be resolved […***…];
(xi) if such dispute relates to whether any Product satisfies the Potentiator POC Success Criteria or the Corrector/Combination Product POC Success Criteria, as applicable, such dispute shall be resolved […***…];
(xii) if such dispute relates to whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the AbbVie Territory or whether a Drug Approval Filing with respect to any Product will be made in any country or jurisdiction in the AbbVie Territory, such dispute shall be finally and definitively resolved by […***…];
(xiii) if such dispute relates to whether the Development activities under a Post-POC Development Plan or Galapagos Territory Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Galapagos Territory or whether a Drug Approval Filing with respect to any Product will be made in any country or jurisdiction in the Galapagos Territory, such dispute shall be finally and definitively resolved by […***…];
(xiv) if such dispute relates to any issue originally within the jurisdiction of the JCC (including the contents of the Co-Promotion Plan, the Galapagos Territory Commercialization Plan, or any amendment thereto), then such issue shall be finally and definitively resolved by […***…];
(xv) if such dispute relates to whether to obtain a Third Party license pursuant to Section 7.6, the Party that will negotiate such license, or the terms of such license, then such issue shall be finally and definitively resolved by […***…];
(xvi) if such dispute relates to whether to continue Development of (a) a Back-Up Potentiator Product under the Potentiator Post-POC Development Plan as contemplated by Section 3.7.1(ii)(3) or (b) Disputes a Back-Up Combination Product under the Corrector/Combination Product Post-POC Development Plan as contemplated by Section 3.7.2(ii)(3), in each case ((a) and (b)) such issue shall be finally and definitively resolved by […***…]; and
(xvii) if such dispute relates to whether a new country shall be designated as an Approved Country, […***…]. Except as otherwise expressly set forth in this Agreement, disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC and not within Joint Committees, including any alleged breach of this Agreement by a Party’s sole decision-making authority, shall be resolved pursuant to Section 13.7.
Appears in 2 contracts
Samples: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)
Joint Committee Dispute Resolution. (a) If a Joint Committee (other than the JSC) JRC, the JDC or the JCC cannot, or does not, reach consensus unanimous agreement on an issue at a meeting or within a period of [...***...] thereafterBusiness Days thereafter or such other period as the Parties may agree, then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC may be called for such purpose. If the JSC cannot, or does not, reach consensus unanimous agreement on an issue, including any dispute *** Certain information in this agreement has been omitted and filed separately with arising from the Securities and Exchange Commission. JRC, JDC or JCC, at a meeting or within a period of [...***...] indicates that text has been omitted and is Business Days thereafter or such other period as the subject of a confidential treatment request. arising in another Joint CommitteeParties may agree, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. the Senior Officers are not able to agree on the resolution of any such issue within [...***...] days after such issue was first referred to them, then:
(i) if such dispute is related relates to any proposed amendment to the Potentiator IND Success Criteria, the C1 IND Success Criteria, the C2 IND Success Criteria, the P+C1 Dual Combination Product POC Success Criteria, the Triple Combination End of Phase 1 Success Criteria, the Triple Combination Heterozygous Success Criteria, or the Triple Combination Homozygous Success Criteria or the inclusion therein of a Collaboration Program for which AbbVie has not exercised its Optionnew Combination Standard, as applicable, such dispute shall be resolved [...***...];
(ii) if such dispute relates to any proposed modification to the length of the Discovery Term, [...***...];
(iii) if such dispute relates to any proposed amendment to the Discovery Work Plan (including the Discovery Budget), such dispute shall be finally and definitively resolved by [...***]; provided, that [***]. As used herein, a “Material Amendment” to the Pre Exercise Development Plan and Budget shall mean [***...];
(iiiv) subject to clauses (v) and (vi) below, if such dispute is related relates to a Collaboration Program for which AbbVie has exercised its Optionany proposed amendment to the Combination Product POC Development Plan (including the Combination Product POC Budget), such dispute shall be finally and definitively resolved by [...***], provided, that [***...];
(iiiv) if such dispute is related relates to Additional Licensor (a) the Corrector Molecules, Potentiator Molecules, Dual Combination Products and Triple Combination Products to be Developed in Phase 1s under the Combination Product POC Development Activities Plan or (b) whether to discontinue any Phase 1 under the Combination Product POC Development Plan with respect to any particular Molecule or any particular Molecule(s) contained in a Combination Product or to select for which AbbVie has not exercised Development in a Phase 1 under the AbbVie Opt In Combination Product POC Development Plan a new Molecule or a Combination Product containing one (1) or more new Molecules, in accordance each case ((a) and (b)) such dispute shall be finally and definitively resolved by [...***...];
(vi) if such dispute relates to (a) the Corrector Molecules, Potentiator Molecules, Dual Combination Products and Triple Combination Products to be Developed in Phase 2s (including the Triple Combination Phase 1b/2a Clinical Study) under the Combination Product POC Development Plan or (b) whether to discontinue any Phase 2 under the Potentiator Post-POC Development Plan with Section 3.3.4respect to a Potentiator Product or any Phase 2 (including the Triple Combination Phase 1b/2a Clinical Study) under the Combination Product POC Development Plan with respect to any particular Molecule or any particular Molecule(s) contained in a Combination Product or to select for Development in a Phase 2 (including the Triple Combination Phase 1b/2a Clinical Study) under the Combination Product POC Development Plan a new Molecule or a Combination Product containing one (1) or more new Molecules, in each case ((a) and (b)) such dispute shall be finally and definitively resolved by [...***...];
(vii) if such dispute relates to any proposed amendment to the Combination Product Post-POC Development Plan (including the Heterozygous Population Post-POC Development Budget or the Homozygous Population Post-POC Development Budget), such dispute shall be finally and definitively resolved by [...***...]; and;
(ivviii) if such dispute is related relates to any activities for an Additional Indication under Additional Licensor Development Activities following AbbVie’s exercise the approval of the AbbVie Opt In in accordance with Section 3.3.4initial Potentiator Post-POC Development Plan (including the Potentiator Post-POC Development Budget) or any amendment thereto, such dispute shall be finally and definitively resolved by [...***...];
(ix) if such dispute relates to the approval of any CMC Amendment, such dispute shall be finally and definitively resolved by [...***...]; * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
(bx) Disputes arising between if such dispute relates to the Parties in connection with or relating to this Agreement approval of the initial Galapagos Territory Development Plan or any document amendment thereto, such dispute shall be finally and definitively resolved by [...***...];
(xi) if such dispute relates to whether any Molecule satisfies the Potentiator IND Success Criteria, the C1 IND Success Criteria, or instrument delivered the C2 IND Success Criteria, as applicable, such dispute shall be resolved [...***...];
(xii) if such dispute relates to whether any P+C1 Dual Combination Product satisfies the P+C1 Dual Combination Product POC Success Criteria, such dispute shall be resolved [...***...];
(xiii) if such dispute relates to whether any Triple Combination Product satisfies the Triple Combination End of Phase 1 Success Criteria, the Triple Combination Heterozygous Success Criteria, or the Triple Combination Homozygous Success Criteria, as applicable, such dispute shall be resolved [...***...];
(xiv) if such dispute relates to whether any IND will be submitted for any Potentiator Molecule, Corrector Molecule, or Combination Product, as applicable, in connection herewithany country in the Territory, such dispute shall be finally and that are outside definitively resolved by [...***...];
(xv) if such dispute relates to whether the Development activities under the Combination Product Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Triple Combination Product in any country or jurisdiction in the AbbVie Territory or whether a Drug Approval Filing with respect to any Triple Combination Product will be made in any country or jurisdiction in the AbbVie Territory, such dispute shall be finally and definitively resolved by [...***...];
(xvi) if such dispute relates to whether the Development activities under the Potentiator Post-POC Development Plan support the filing of a Drug Approval Application for the Potentiator Product in any country or jurisdiction in the AbbVie Territory or whether a Drug Approval Filing with respect to the Potentiator Product will be made in any country or jurisdiction in the AbbVie Territory, such dispute shall be finally and definitively resolved by [...***...];
(xvii) if such dispute relates to whether the Development activities under the Combination Product Post-POC Development Plan or Galapagos Territory Development Plan support the filing of a Drug Approval Application for the applicable Triple Combination Product in any country or jurisdiction in the Galapagos Territory or whether a Drug Approval Filing with respect to any Triple Combination Product will be made in any country or jurisdiction in the Galapagos Territory, such dispute shall be finally and definitively resolved by [...***...];
(xviii) if such dispute relates to whether the Development activities under the Potentiator Post-POC Development Plan support the filing of a Drug Approval Application for the Potentiator Product in any country or jurisdiction in the Galapagos Territory or whether a Drug Approval Filing with respect to the Potentiator Product will be made in any country or jurisdiction in the Galapagos Territory, such dispute shall be finally and definitively resolved by [...***...];
(xix) if such dispute relates to any issue originally within the jurisdiction of the JSC and not within a Party’s sole decisionJCC (including the contents of the Co-making authorityPromotion Plan, the Galapagos Territory Commercialization Plan, or any amendment thereto), then such issue shall be finally and definitively resolved by [...***...];
(xx) if such dispute relates to whether to obtain a Third Party license pursuant to Section 13.77.6, the Party that will negotiate such license, or the terms of such license, then such issue shall be finally and definitively resolved by [...***...]; * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
(xxi) if such dispute relates to whether to continue Development of a Back-Up Combination Product under the Combination Product Post-POC Development Plan as contemplated by Section 3.7.2(iv), such issue shall be finally and definitively resolved by [...***...]; and
(xxii) if such dispute relates to whether a new country shall be designated as an Approved Country, [...***...
Appears in 1 contract
