Elevation and Dispute Resolution. Each Party’s representatives on any committee will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC are unable to agree on a particular issue, such issue shall be referred, in the case of a matter governed by the JDC, to the Parties’ respective Chief Scientific Officers or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days, such issue shall be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this Section, (i) all matters relating to Development, including, without limitation, amendments and modifications to the Development Plan, must be determined by consensus of the Parties and (ii) [**]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts shall be requested to advise as to Development issues where consensus cannot be reached, with the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development Plan, then such Development Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Finally, in connection with any Commercialization decisions [**] establishing or significantly adjusting the Commercialization Budget, [**] all supporting data and analyses [**] and shall [**]. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Samples: Collaboration Agreement (Ironwood Pharmaceuticals Inc), Collaboration Agreement (Ironwood Pharmaceuticals Inc)
Elevation and Dispute Resolution. Each Party’s representatives on any committee the JSC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee the JSC will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC JSC are unable to agree on a particular issue within ten Business Days after the JSC first meets to consider the issue, the issue will be resolved as follows:
(a) Commercialization of the Product in the Territory and all related decisions shall be in Astellas’s reasonable discretion, and if the unresolved issue relates to Commercialization, such issue shall will be referred, resolved by Astellas in its reasonable discretion giving good faith consideration to Ironwood’s views on the case of a matter governed by the JDC, to the Parties’ respective Chief Scientific Officers or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days, such issue shall be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this Section, (i) all matters relating to Development, including, without limitation, amendments and modifications to the Development Plan, must be determined by consensus of the Parties and (ii) [**]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts shall be requested to advise as to Development issues where consensus cannot be reached, with the advice of such experts not to be unreasonably rejectedissue. Notwithstanding the foregoingforegoing sentence, if a matter for which consensus cannot all Commercialization Plans will be reached is addressed by consistent with the then current Development Plan, then such Development Plan and the activities required thereunder will control despite any inability provisions of the Parties to reach consensus. Finally, in connection with any Commercialization decisions [**] establishing or significantly adjusting the Commercialization Budget, [**] all supporting data and analyses [**] and shall [**]Launch Plan. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(b) If the unresolved issue relates to a proposed amendment to the Launch Plan, such dispute will be resolved through arbitration pursuant to Section 10.1.3, and the Arbitrators will be instructed solely to determine whether it is Commercially Reasonable to amend the Launch Plan as so proposed (and, if so determined, the Launch Plan shall be so amended), provided that Astellas may unilaterally amend the Launch Plan to the extent required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, after providing advance written notice to Ironwood with an explanation as to why such modifications and amendments are required, and such amendment and modification shall be deemed approved by the JSC.
(c) If the unresolved issue relates to Development, such issue will be referred to the Parties’ respective Chief Scientific Officers or equivalent or their designees. In the event such individuals are unable to resolve such issue within [**] Business Days, such issue will be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this Section 3.1.6, all matters relating to Development that are expressly within the scope of the responsibilities of the JSC under Section 3.1.3, including, without limitation, amendments and modifications to the Development and Regulatory Plan, must be determined by consensus of the Parties, provided that (i) neither Party shall withhold its consent unreasonably, and (ii) no consensus shall be required with respect to Development activities (including any modifications or amendments to the Development and Regulatory Plan, the Launch Plan, or study protocols) that are required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, and Astellas may modify and amend the Development and Regulatory Plan as necessary to comply with such Applicable Laws or requirements, subject to the requirements of Section 3.2.1. If a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then such Development and Regulatory Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Notwithstanding the foregoing, the Parties acknowledge and agree that Astellas shall control the Development of the Product in accordance with this Agreement and the then-effective Development and Regulatory Plan and shall have the right to conduct the Development and implement the Development and Regulatory Plan in its reasonable discretion in accordance with this Agreement (including without limitation the provisions of this Section 3.1.6, requiring that matters expressly within the responsibility of the JSC be decided on a consensus basis) and the Development and Regulatory Plan, as long as such activities will not adversely affect the development or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. commercialization of Products for the Forest Territory or the Almirall Territory.
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Elevation and Dispute Resolution. Each Party’s representatives on any committee will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC are unable to agree on a particular issue, such issue shall be referred, in the case of a matter governed by the JDC, to the Parties’ respective Chief Scientific Officers or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days, such issue shall be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this Section, (i) all matters relating to Development, including, without limitation, amendments and modifications to the Development Plan, must be determined by consensus of the Parties and (ii) [***]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts shall be requested to advise as to Development issues where consensus cannot be reached, with the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development Plan, then such Development Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Finally, in connection with any Commercialization decisions [***] establishing or significantly adjusting the Commercialization Budget, [***] all supporting data and analyses [***] and shall [***]. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Appears in 1 contract
Elevation and Dispute Resolution. Each Party’s representatives on any committee the JDC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee will [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC are unable to agree on a particular issue, such issue shall will be referred, in the case of a matter governed by the JDC, referred to the Parties’ respective Chief Scientific Officers or equivalent or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 15 days, such issue shall will be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this SectionSection 3.1.1(f), (i) all matters relating to Development, including, without limitation, amendments and modifications to the Development Plan, must be determined by consensus of the Parties and (ii) [**]Parties. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts shall will be requested to advise as to Development issues where consensus cannot be reached, with the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development Plan, then such Development Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Finally, in connection with any Commercialization decisions [**] establishing or significantly adjusting the Commercialization Budget, [**] all supporting data and analyses [**] and shall [**]. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Appears in 1 contract
Elevation and Dispute Resolution. Each Party’s representatives on any committee the JSC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee the JSC will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC JSC are unable to agree on a particular issue within ten Business Days after the JSC first meets to consider the issue, the issue will be resolved as follows:
(a) Commercialization of the Product in the Territory and all related decisions shall be in Astellas’s reasonable discretion, and if the unresolved issue relates to Commercialization, such issue will be resolved by Astellas in its reasonable discretion giving good faith consideration to Ironwood’s views on the issue. Notwithstanding the foregoing sentence, all Commercialization Plans will be consistent with the provisions of the Launch Plan.
(b) If the unresolved issue relates to a proposed amendment to the Launch Plan, such dispute will be resolved through arbitration pursuant to Section 10.1.3, and the Arbitrators will be instructed solely to determine whether it is Commercially Reasonable to amend the Launch Plan as so proposed (and, if so determined, the Launch Plan shall be referredso amended), in provided that Astellas may unilaterally amend the case of a matter governed Launch Plan to the extent required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, after providing advance written notice to Ironwood with an explanation as to why such modifications and amendments are required, and such amendment and modification shall be deemed approved by the JDCJSC.
(c) If the unresolved issue relates to Development, such issue will be referred to the Parties’ respective Chief Scientific Officers or equivalent or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days[**] Business Days, such issue shall will be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this SectionSection 3.1.6, (i) all matters relating to DevelopmentDevelopment that are expressly within the scope of the responsibilities of the JSC under Section 3.1.3, including, without limitation, amendments and modifications to the Development and Regulatory Plan, must be determined by consensus of the Parties Parties, provided that (i) neither Party shall withhold its consent unreasonably, and (ii) [**]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts no consensus shall be requested to advise as required with respect to Development issues where consensus cannot be reachedactivities (including any modifications or amendments to the Development and Regulatory Plan, the Launch Plan, or study protocols) that are required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, and Astellas may modify and amend the advice Development and Regulatory Plan as necessary to comply with such Applicable Laws or requirements, subject to the requirements of such experts not to be unreasonably rejectedSection 3.2.1. Notwithstanding the foregoing, if If a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then such Development and Regulatory Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. FinallyNotwithstanding the foregoing, the Parties acknowledge and agree that Astellas shall control the Development of the Product in connection accordance with any Commercialization decisions [**] establishing or significantly adjusting this Agreement and the Commercialization Budget, [**] all supporting data then-effective Development and analyses [**] Regulatory Plan and shall [**]. [**] = Portions have the right to conduct the Development and implement the Development and Regulatory Plan in its reasonable discretion in accordance with this Agreement (including without limitation the provisions of this exhibit have been omitted pursuant to Section 3.1.6, requiring that matters expressly within the responsibility of the JSC be decided on a confidential treatment request. An unredacted version consensus basis) and the Development and Regulatory Plan, as long as such activities will not adversely affect the development or commercialization of this exhibit has been filed separately with Products for the CommissionForest Territory or the Allergan Territory.
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Elevation and Dispute Resolution. Each Party’s representatives on any committee the JSC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee the JSC will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC JSC are unable to agree on a particular issue within ten Business Days after the JSC first meets to consider the issue, the issue will be resolved as follows:
(a) Commercialization of the Product in the Territory and all related decisions shall be in Astellas’s reasonable discretion, and if the unresolved issue relates to Commercialization, such issue will be resolved by Astellas in its reasonable discretion giving good faith consideration to Ironwood’s views on the issue. Notwithstanding the foregoing sentence, all Commercialization Plans will be consistent with the provisions of the Launch Plan.
(b) If the unresolved issue relates to a proposed amendment to the Launch Plan, such dispute will be resolved through arbitration pursuant to Section 10.1.3, and the Arbitrators will be instructed solely to determine whether it is Commercially Reasonable to amend the Launch Plan as so proposed (and, if so determined, the Launch Plan shall be referredso amended), in provided that Astellas may unilaterally amend the case of a matter governed Launch Plan to the extent required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, after providing advance written notice to Ironwood with an explanation as to why such modifications and amendments are required, and such amendment and modification shall be deemed approved by the JDCJSC.
(c) If the unresolved issue relates to Development, such issue will be referred to the Parties’ respective Chief Scientific Officers or equivalent or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days[**] Business Days, such issue shall will be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this SectionSection 3.1.6, (i) all matters relating to DevelopmentDevelopment that are expressly within the scope of the responsibilities of the JSC under Section 3.1.3, including, without limitation, amendments and modifications to the Development and Regulatory Plan, must be determined by consensus of the Parties Parties, provided that (i) neither Party shall withhold its consent unreasonably, and (ii) [**]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts no consensus shall be requested to advise as required with respect to Development issues where consensus cannot be reached, with activities (including any modifications or amendments to the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then the Launch Plan, or study protocols) that are required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, and Astellas may modify and amend the Development and Regulatory Plan as necessary to comply with such Development Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. FinallyApplicable Laws or requirements, in connection with any Commercialization decisions [**] establishing or significantly adjusting the Commercialization Budget, [**] all supporting data and analyses [**] and shall [**]. subject [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. to the requirements of Section 3.2.1. If a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then such Development and Regulatory Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Notwithstanding the foregoing, the Parties acknowledge and agree that Astellas shall control the Development of the Product in accordance with this Agreement and the theneffective Development and Regulatory Plan and shall have the right to conduct the Development and implement the Development and Regulatory Plan in its reasonable discretion in accordance with this Agreement (including without limitation the provisions of this Section 3.1.6, requiring that matters expressly within the responsibility of the JSC be decided on a consensus basis) and the Development and Regulatory Plan, as long as such activities will not adversely affect the development or commercialization of Products for the Forest Territory or the Almirall Territory.
Appears in 1 contract
Samples: License Agreement
Elevation and Dispute Resolution. Each Party’s representatives on any committee the JSC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee the JSC will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC JSC are unable to agree on a particular issue within ten Business Days after the JSC first meets to consider the issue, the issue will be resolved as follows:
(a) Commercialization of the Product in the Territory and all related decisions shall be in Astellas’s reasonable discretion, and if the unresolved issue relates to Commercialization, such issue will be resolved by Astellas in its reasonable discretion giving good faith consideration to Ironwood’s views on the issue. Notwithstanding the foregoing sentence, all Commercialization Plans will be consistent with the provisions of the Launch Plan.
(b) If the unresolved issue relates to a proposed amendment to the Launch Plan, such dispute will be resolved through arbitration pursuant to Section 10.1.3, and the Arbitrators will be instructed solely to determine whether it is Commercially Reasonable to amend the Launch Plan as so proposed (and, if so determined, the Launch Plan shall be referredso amended), in provided that Astellas may unilaterally amend the case of a matter governed Launch Plan to the extent required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, after providing advance written notice to Ironwood with an explanation as to why such modifications and amendments are required, and such amendment and modification shall be deemed approved by the JDCJSC.
(c) If the unresolved issue relates to Development, such issue will be referred to the Parties’ respective Chief Scientific Officers or equivalent or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 days[**] Business Days, such issue shall will be referred to the Chief Executive Officers of each Party or their designees for resolution. Subject to the remaining provisions of this SectionSection 3.1.6, (i) all matters relating to DevelopmentDevelopment that are expressly within the scope of the responsibilities of the JSC under Section 3.1.3, including, without limitation, amendments and modifications to the Development and Regulatory Plan, must be determined by consensus of the Parties Parties, provided that (i) neither Party shall withhold its consent unreasonably, and (ii) [**]. The Parties will from time to time identify a panel of mutually agreed consultants with expertise in pharmaceutical development to assist the JDC in the resolution of development issues and, upon the request of either Party, such experts no consensus shall be requested to advise as required with respect to Development issues where consensus cannot be reached, with activities (including any modifications or amendments to the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then the Launch Plan, or study protocols) that are required to comply with Applicable Laws or requirements imposed by Regulatory Authorities, and Astellas may modify and amend the Development and Regulatory Plan as necessary to comply with such Development Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. FinallyApplicable Laws or requirements, in connection with any Commercialization decisions [**] establishing or significantly adjusting the Commercialization Budget, [**] all supporting data and analyses [**] and shall [**]. subject [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. to the requirements of Section 3.2.1. If a matter for which consensus cannot be reached is addressed by the then current Development and Regulatory Plan, then such Development and Regulatory Plan and the activities required thereunder will control despite any inability of the Parties to reach consensus. Notwithstanding the foregoing, the Parties acknowledge and agree that Astellas shall control the Development of the Product in accordance with this Agreement and the then-effective Development and Regulatory Plan and shall have the right to conduct the Development and implement the Development and Regulatory Plan in its reasonable discretion in accordance with this Agreement (including without limitation the provisions of this Section 3.1.6, requiring that matters expressly within the responsibility of the JSC be decided on a consensus basis) and the Development and Regulatory Plan, as long as such activities will not adversely affect the development or commercialization of Products for the Forest Territory or the Almirall Territory.
Appears in 1 contract
Elevation and Dispute Resolution. Each Party’s representatives on any committee will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee will use reasonable efforts to reach consensus on all decisions. In the event of a deadlock regarding a particular issue on which the members of a committee cannot reach consensus, such issue will be resolved as follows: In the event that the members of the JDC or JCC are unable to agree on a particular issueissue within [***] days of such issue being first presented to such committee, such issue shall be referredreferred to [***] of each Party or their designees for resolution and, in the case of a matter governed by the JDC, to the Parties’ respective Chief Scientific Officers or their designees, and in the case of a matter governed by the JCC, to the Parties’ respective heads of marketing or their respective designees, for attempted resolution of such matter. In the event such individuals are unable to resolve such issue within 30 [***] days, such issue [***], provided that [***] shall be referred reasonably consider [***] hereunder and shall [***] consistent with the goal of obtaining Regulatory Approval for Products as soon as practicable and to commercialize the Products where all Regulatory Approval necessary for marketing and distribution is obtained and, provided further, that no amendment to the Chief Executive Officers of each Party Territory Development Plan that allocates responsibilities or their designees for resolution. Subject activities to the remaining provisions of this Section, (i) all matters relating to Development, including, without limitation, amendments and modifications to the Development Plan, must Albireo may be determined approved by consensus of the Parties and (ii) [***]. The Parties will from time to time identify a panel For the avoidance of mutually agreed consultants with expertise in pharmaceutical development to assist doubt, no decision of the JDC in JDC, JCC or [***] may be made that would (i) reduce the resolution of development issues and, upon the request of either Party, such experts shall be requested to advise as to Development issues where consensus cannot be reached, with the advice of such experts not to be unreasonably rejected. Notwithstanding the foregoing, if a matter for which consensus cannot be reached is addressed by the then current Development Plan, then such Development Plan and the activities required thereunder will control despite any inability obligations of the Parties under this Agreement; or (ii) reasonably be expected to reach consensus. Finallyhave a material adverse effect on Portions of this Exhibit, in connection with any Commercialization decisions 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. the Global Development Plan or commercialization of the Albireo Compound in China, the US and/or the EU. Notwithstanding clause (ii) of this Section 3.4, the JDC, JCC and [***] establishing may decide to undertake any activity required pursuant to Applicable Law and/or written instructions from the competent Regulatory Authority in a country in the Territory to obtain Regulatory Approval of a Product for CIC or significantly adjusting the Commercialization BudgetConstipation-Predominant Irritable Bowel Syndrome (“IBS-C”) in such country, provided that, [**] all supporting data and analyses [**] and shall use Commercially Reasonable Efforts to [**]. [**] = Portions to avoid or minimize the adverse effects of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commissionsuch activity.
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