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: Master Collaboration Agreement (Ironwood Pharmaceuticals Inc), Master Collaboration Agreement (Ironwood Pharmaceuticals Inc)
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: Master Collaboration Agreement (Forest Laboratories Inc)
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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