Within the JSC. Subject to the exceptions specified below in this Section 4.6(b), all decisions within the JSC (whether originating there, or referred to it by an operating Committee) will be made by unanimous agreement. If a matter is referred by an operating [***], the [***] will use good faith efforts, in compliance with [***], to resolve promptly such matter. If the [***] is unable to reach unanimous agreement on any issue for which it is responsible, other than those addressed [***], within [***] after a Party affirmatively states that a decision needs to be made, either Party may elect to submit such issue to [***]in accordance with [***]. Notwithstanding the foregoing: (i) Unum will not be required to [***] for any of the reasons enumerated in Section 2.2 and Section 2.3; provided, for clarity, that (A) the extent and scope of any Arbitral Matter regarding the application of such Sections may be referred to dispute resolution in accordance with Article 17 (for clarity, [***], in each case will not be treated as an Arbitral Matter and will be determined by Unum as provided in such Sections, and ACTR Matters under such Sections will be subject to the following clause (iv)); and (B) SGI will have the tie-breaking vote with respect to the nomination of the A3 Antigen or any Replacement Antigen in all other cases; (ii) the selection of a Development Candidate for Development in accordance with Section 2.5 will be made only by [***], and, for clarity, [***] on the foregoing matter, then the Research Program for the relevant Collaboration Antigen will be terminated in accordance with Section 2.5 (and for clarity without escalation to the Executive Officers or arbitration under Article 17); (iii) the selection of the Product for Commercialization in accordance with Section 2.6 will be made only [***], and, for clarity, if there is [***] of the JSC on the foregoing matter, then a Party may exercise its Opt-Out Right with respect to such Development Candidate and associated Product in accordance with Section 3.2 (and for clarity without escalation to the Executive Officers or arbitration under Article 17); (iv) all ACTR Matters will be determined by Unum, provided that if the JSC is unable to agree on the existence or scope of an ACTR Matter and if after submission to the Executive Officers pursuant to Section 4.6(c) an agreement has not been reached, then the existence and scope of an ACTR Matter may be referred to dispute resolution in accordance with Article 17; (v) no dispute to the extent pertaining to a Party’s request to allocate any Development Costs (including costs associated with Supplemental Trials), costs associated with Voluntary Phase 4 Clinical Trials, or other costs that SGI expects or plans to incur with respect to the Licensed Territory in whole or in part to the Shared Territory in accordance with Section 6.2(a)(vi) or Section 8.3(a)(iii) that are not resolved by the JSC or following submission to the Executive Officers pursuant to Section 4.6(c) may be submitted to arbitration in accordance with Article 17, and, for clarity, should there be no resolution of the foregoing matter, then there will be no such allocation of Development Costs or other costs to the Shared Territory; (vi) all matters to the extent pertaining to the Development and Commercialization of Development Candidates and associated Products in the Licensed Territory (other than ACTR Matters, the discontinuation of a Clinical Trial that is contemplated by the then-current Late Clinical Development Plan for reasons other than safety, or the initiation of any Supplemental Trials or Voluntary Phase 4 Clinical Trials) will be decided by SGI without escalation to the Executive Officers or arbitration under Article 17; for clarity, decision-making regarding the initiation of Supplemental Trials or Voluntary Phase 4 Clinical Trials is addressed in Section 6.2(a) or Section 8.3(a), respectively; (vii) all matters to the extent pertaining to the Manufacture of the ACTR T-cells will be decided by Unum in accordance with Section 4.5(d); (viii) all matters to the extent pertaining to the Manufacture of the SGI Antibodies will be decided by SGI in accordance with Section 4.5(d); and (ix) all matters to the extent pertaining to the Research, Development or Commercialization of Reversion Products (other than ACTR Matters and Manufacturing) will be decided by the Continuing Party without escalation to the Executive Officers or arbitration under Article 17; provided that (A) all ACTR Matters will be determined pursuant to Section 4.6(b)(iv) and (B) all matters to the extent pertaining to Manufacturing will be determined pursuant to Sections 4.6(b)(vii) and 4.6(b)(viii).
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Samples: Collaboration Agreement (Unum Therapeutics, Inc.), Collaboration Agreement (Unum Therapeutics, Inc.)
Within the JSC. Subject to the exceptions specified below in this Section 4.6(b2.7(b), all decisions within the JSC (whether originating there, or referred to it by an operating Committee) will shall be made by unanimous agreementconsensus. If a matter is referred by an operating [***]Committee to the JSC, the [***] will it shall use good faith efforts, in compliance with [***]Section 2.7(d), to resolve promptly such matter. If the [***] JSC is unable to reach unanimous agreement consensus on any issue for which it is responsible, responsible other than those addressed [***]below, within [***] after a Party affirmatively states that a decision needs to be made, either Party may elect to submit such issue to [***]the Parties’ Executive Officers in accordance with [***]Section 2.7(c). Notwithstanding the foregoing, but subject to Section 16.6:
(i) Unum will not be required to [***] for any of the reasons enumerated in Section 2.2 and Section 2.3; provided, for clarity, that (A) the extent and scope of any Arbitral Matter regarding the application of such Sections may be referred to dispute resolution in accordance with Article 17 (for clarity, [***], in each case will not be treated as an Arbitral Matter and will be determined by Unum as provided in such Sections, and ACTR Matters under such Sections will be subject to the following clause (iv)); and (B) SGI will shall have the tie-breaking vote final say with respect to the nomination following matters (without obligation to refer such matter to the Executive Officers):
(1) [*] of any [*] or [*] of the A3 Antigen [*] for a [*] in the [*] for the [*], to the extent necessary to maintain the [*] that are agreed upon in the [*] (it being understood that [*] do not include any determination of whether and when (A) to [*] that are not contemplated by [*] or (B) 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 the securities exchange act of 1934, as amended.
(2) [*] in the [*] regarding the [*] (or [*] equivalents (e.g., [*]) contemplated in the [*], to the extent necessary to maintain the [*] that are agreed upon in the [*], provided that such [*] shall exclude the determination of the [*] to be [*] or other [*] in connection with the [*] (or [*] equivalents), which determination shall remain subject to consensus decision-making by the [*] (it being understood that the recommendation by the [*] and determination by the [*] regarding whether to [*] for the [*] or both shall not constitute a [*] pursuant to this Section 2.7(b)(i)(2), and shall remain subject to consensus decision-making by the [*]); and
(3) prior to [*] of [*] for [*] the [*], as applicable, [*] (including [*]) supporting [*] of the [*] for a [*] in the [*], as applicable, to the extent necessary to maintain the [*] that are agreed upon in the [*]; provided that [*] may not exercise its final say with respect to any Replacement Antigen such [*] with respect to the [*] in all other cases;a manner that would result in a significant adverse impact to the [*] of such [*] in the [*] (it being understood that [*] matters reserved for [*]’s final say do not include (x) the selection after the Effective Date of [*] or the entering into of any agreement therewith after the Effective Date, which selection or agreement is inconsistent with the [*] or (y) the selection of [*] of the [*] to [*] and the recommendation to the [*] of [*] should be selected for purposes of [*], each of which shall remain subject to consensus decision making by the [*]).
(ii) the selection of a Development Candidate for Development in accordance with Section 2.5 will be made only by [***], and, for clarity, [***] on shall have the foregoing matter, then the Research Program for the relevant Collaboration Antigen will be terminated in accordance with Section 2.5 (and for clarity without escalation to the Executive Officers or arbitration under Article 17);
(iii) the selection of the Product for Commercialization in accordance with Section 2.6 will be made only [***], and, for clarity, if there is [***] of the JSC on the foregoing matter, then a Party may exercise its Opt-Out Right with respect to such Development Candidate and associated Product in accordance with Section 3.2 (and for clarity without escalation to the Executive Officers or arbitration under Article 17);
(iv) all ACTR Matters will be determined by Unum, provided that if the JSC is unable to agree on the existence or scope of an ACTR Matter and if after submission to the Executive Officers pursuant to Section 4.6(c) an agreement has not been reached, then the existence and scope of an ACTR Matter may be referred to dispute resolution in accordance with Article 17;
(v) no dispute to the extent pertaining to a Party’s request to allocate any Development Costs (including costs associated with Supplemental Trials), costs associated with Voluntary Phase 4 Clinical Trials, or other costs that SGI expects or plans to incur final say with respect to the Licensed Territory in whole or in part following matters (without obligation to the Shared Territory in accordance with Section 6.2(a)(vi) or Section 8.3(a)(iii) that are not resolved by the JSC or following submission refer such matter to the Executive Officers pursuant to Section 4.6(c) may be submitted to arbitration in accordance with Article 17, and, for clarity, should there be no resolution of the foregoing matter, then there will be no such allocation of Development Costs or other costs to the Shared Territory;Officers):
(vi1) all matters to the extent pertaining to the Development Exploitation of Collaboration Molecules and Commercialization Products (including a decision to pursue any [*] of Development Candidates and associated Products in a Product) with respect to the Licensed Territory (Territory, other than ACTR Matters, the discontinuation of (x)(A) [*] (including a Clinical Trial [*]) that is not contemplated by the then-current Late Clinical Development Plan for reasons other than safety, [*] or (B) the initiation [*] of any Supplemental Trials [*], in each case ((A) and (B)) which [*] believes reasonably and in good faith may result in [*], and (y) a [*] a [*] or Voluntary Phase 4 Clinical Trials) will be decided by SGI without escalation to the Executive Officers or arbitration under Article 17; for clarity, decision-making regarding the initiation of Supplemental Trials or Voluntary Phase 4 Clinical Trials is addressed in Section 6.2(a) or Section 8.3(a), respectivelya [*];
(vii2) following [*], all matters [*] (including [*]) in the Territory (it being understood that such [*] do not include the selection of [*] of the [*] to [*] and the recommendation to the extent pertaining [*] of [*] should be selected for purposes of [*], each of which shall remain subject to consensus decision making by the Manufacture of the ACTR T-cells will be decided by Unum in accordance with Section 4.5(d[*]);
(viii3) all matters [*] of the [*] with respect to Products;
(4) issues relating to the extent pertaining [*] of [*] set forth in a [*] if [*] desires that such [*] should be [*] than [*] desires it to be; provided that in such event, [*] shall, if it elects to [*], be [*] for [*] of [*] beyond the [*] that [*] [*], shall be permitted to [*] from any [*] from [*] with respect to [*] hereunder (provided that no [*] shall [*] any [*] by [*], with any [*] that is [*] by the foregoing limitation being [*], subject at all times to such limitation), and shall be permitted to [*] with respect to any [*] in the event of termination or expiration of this Agreement with respect to the Manufacture of the SGI Antibodies will be decided by SGI in accordance with Section 4.5(d)[*]; and
(ix5) all matters [*] to the extent pertaining necessary to maintain the [*] that are agreed upon in the [*];
(6) so long as [*] is not [*] pursuant to the Research[*], Development or Commercialization of Reversion Products (other than ACTR Matters and Manufacturing) will be decided by the Continuing Party without escalation issues relating to the Executive Officers or arbitration under Article 17[*] of [*] and [*]; provided that and
(A7) all ACTR Matters will be determined issues relating to [*] and [*], and their [*] equivalents, with respect 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 Section 4.6(b)(iv) and (B) all matters to rule 24b-2 of the extent pertaining to Manufacturing will be determined pursuant to Sections 4.6(b)(vii) and 4.6(b)(viii)securities exchange act of 1934, as amended.
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Within the JSC. Subject to the exceptions specified below in this Section 4.6(b), all All decisions within the JSC (whether originating there, or referred to it by an operating a Committee) will shall be made by consensus (or by unanimous agreementwritten consent). If a matter is referred by an operating [***]a Committee to the JSC, the [***] will JSC shall use good faith efforts, in compliance with [***]Section 2.6(c), to resolve promptly such matter. If the [***] JSC is unable to reach unanimous agreement consensus on any issue for which it is responsibleresponsible within [***] of such matter being referred to it, other than those addressed in Sections 2.6(b)(i)-(iii) below, then the JSC may elect to submit such issue for resolution in accordance with Section 14.2. Notwithstanding the foregoing, if the JSC is unable to reach consensus within such [***] period with respect to the following matters then the following shall apply:
(i) [***] shall have final decision-making authority with respect to [***]; provided, however, such final decision-making shall, in each case, be made only by mutual agreement of the Parties for the following matters:
(A) modifications to an approved Lead Product Development Plan or approved Joint Commercialization Plan that would reasonably be expected to result in an increase or decrease of more than [***] in the then-current Joint Development Cost Budget or then-current Joint Commercialization Budget, as applicable;
(B) [***], within modifications to an approved Lead Product Development Plan or approved Joint Commercialization Plan for a subsequent Calendar Year [***] after a Party affirmatively states that a decision needs would reasonably be expected to be maderesult in an increase or decrease of more than [***] in the then-current Joint Development Cost Budget or then-current Joint Commercialization Budget, either Party may elect to submit such issue as applicable;
(C) [***]; and
(D) [***];
(ii) [***] shall have final decision-making authority with respect to [***]in accordance with [***]. Notwithstanding ; and
(iii) (A) notwithstanding the foregoing:
foregoing clauses (i) Unum will not be required and (ii),with respect to [***] for any of the reasons enumerated in Section 2.2 and Section 2.3; provided, for clarity, that (A) the extent and scope of any Arbitral Matter regarding the application of such Sections may be referred to dispute resolution in accordance with Article 17 (for clarity, [***], in each case will not be treated as an Arbitral Matter and will be determined by Unum as provided in such Sections, and ACTR Matters under such Sections will be subject to the following clause (iv)); and (B) SGI will have the tie-breaking vote with respect to the nomination of the A3 Antigen or any Replacement Antigen in all other cases;
(ii) the selection of a Development Candidate for Development in accordance with Section 2.5 will be made only by [***], and, for claritySecond Generation Compound, [***] on the foregoing matter, then the Research Program for the relevant Collaboration Antigen will be terminated in accordance shall have final decision-making authority with Section 2.5 (and for clarity without escalation respect to the Executive Officers or arbitration under Article 17);
(iii) the selection Development of the Product for Commercialization in accordance with Section 2.6 will be made only such Second Generation Compound [***], and, for clarity, if there is [***] of the JSC on the foregoing matter, then a Party may exercise its Opt-Out Right with respect to such Development Candidate and associated Product in accordance with Section 3.2 (and for clarity without escalation to the Executive Officers or arbitration under Article 17);
(iv) all ACTR Matters will be determined by Unum, provided that if the JSC is unable to agree on the existence or scope of an ACTR Matter and if after submission to the Executive Officers pursuant to Section 4.6(c) an agreement has not been reached, then the existence and scope of an ACTR Matter may be referred to dispute resolution in accordance with Article 17;
(v) no dispute to the extent pertaining to a Party’s request to allocate any Development Costs (including costs associated with Supplemental Trials), costs associated with Voluntary Phase 4 Clinical Trials, or other costs that SGI expects or plans to incur with respect to the Licensed Territory in whole or in part to the Shared Territory in accordance with Section 6.2(a)(vi) or Section 8.3(a)(iii) that are not resolved by the JSC or following submission to the Executive Officers pursuant to Section 4.6(c) may be submitted to arbitration in accordance with Article 17, and, for clarity, should there be no resolution of the foregoing matter, then there will be no such allocation of Development Costs or other costs to the Shared Territory;
(vi) all matters to the extent pertaining to the Development and Commercialization of Development Candidates and associated Products in the Licensed Territory (other than ACTR Matters, the discontinuation of a Clinical Trial that is contemplated by the then-current Late Clinical Development Plan for reasons other than safety, or the initiation of any Supplemental Trials or Voluntary Phase 4 Clinical Trials) will be decided by SGI without escalation to the Executive Officers or arbitration under Article 17; for clarity, decision-making regarding the initiation of Supplemental Trials or Voluntary Phase 4 Clinical Trials is addressed in Section 6.2(a) or Section 8.3(a), respectively;
(vii) all matters to the extent pertaining to the Manufacture of the ACTR T-cells will be decided by Unum in accordance with Section 4.5(d);
(viii) all matters to the extent pertaining to the Manufacture of the SGI Antibodies will be decided by SGI in accordance with Section 4.5(d); and
(ix) all matters to the extent pertaining to the Research, Development or Commercialization of Reversion Products (other than ACTR Matters and Manufacturing) will be decided by the Continuing Party without escalation to the Executive Officers or arbitration under Article 17; provided that (A) all ACTR Matters will be determined pursuant to Section 4.6(b)(iv) and (B) all matters to the extent pertaining to Manufacturing will be determined pursuant to Sections 4.6(b)(vii) and 4.6(b)(viii).
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