Failure to Reach Consensus. In the event that the Job Evaluation Committee cannot reach consensus on the matter(s) before it, the matter(s) shall be referred to the Job Evaluation Referee as outlined in 23.11.
Failure to Reach Consensus. If the JOC is unable to decide a matter requiring JOC approval by consensus, then the matter shall be escalated to the […***…]. However:
Failure to Reach Consensus. In the event that the members of the JSC cannot come to consensus within ten (10) Business Days with respect to any matter over which the JSC has authority and responsibility as set forth in Section 3.3, the JSC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith to the respective chief executive officers of VIVUS and Licensee for resolution. If such chief executive officers are not able to mutually agree upon the resolution to such matter within ten (10) Business Days after submission to them, then, subject to the limitations of Section 3.4, (a) the chief executive officer of VIVUS shall have the right to decide matters relating to a regulatory issue prior to transfer of the Product Marketing Authorization to Licensee, except that in no event can the chief executive officer of VIVUS unilaterally decide such matter in a manner that (i) creates or would reasonably be expected to create a material safety issue with respect to the Product; (ii) undermines or would reasonably be expected to undermine the validity of any Regulatory Approval in the Licensee Territory; (iii) impedes or may impede in any way the supply of Product to Licensee, or (iv) is contrary to the terms of this Agreement or any other written agreement between the Parties; and (b) to the extent such matter relates to a Development or Commercialization issue, or relates to a regulatory issue (after transfer of the Product Marketing Authorization to Licensee), the chief executive officer of Licensee shall have the right to decide such matter, except that in no event can the chief executive officer of Licensee unilaterally decide such matter in a manner that (i) creates or would reasonably be expected to create a material safety issue with respect to the Product; (ii) undermines or would reasonably be expected to undermine the validity of any Regulatory Approval in the VIVUS Territory, or (iii) is contrary to the terms of this Agreement or any other written agreement between the Parties.
Failure to Reach Consensus. If any steering committee is unable to decide a matter by consensus, then:
Failure to Reach Consensus. If the JRC is unable to decide a matter by consensus, then Roche shall have the final decision authority on any matter. However, a unilateral decision by Roche shall not result in any material change of the day to day use or operational allocation of Pieris’ personnel, equipment and resources, or in any material increase in the overall level of resources to be committed by Pieris to the Research Plan unless Roche compensates Pieris accordingly.
Failure to Reach Consensus. Except as set forth in Section 3.6, in the event that the members of the JSC cannot come to consensus within fifteen (15) days with respect to any matter over which the JSC has authority and responsibility, the JSC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Parties’ respective Chief Executive Officers or their respective designees. If such individuals are not able to mutually agree upon the resolution to such matter within fifteen (15) days after the JSC’s submission to them, then the Chief Executive Officer of Galectin Therapeutics shall have the right to decide such matter, taking into account and seeking reasonably to accommodate (i) Procaps’ legitimate interest under the Agreement and (ii) the operating principals in Section 3.7; provided, that in no event can the Chief Executive Officer of Galectin Therapeutics unilaterally decide such matter in a manner that would violate the limitations set forth in Section 3.4 or increase Procaps’ costs to Pursue Approval or Market and Distribute the Product greater than ten percent (10%) of the amount set forth in the then current Approval Plan or Marketing and Distribution Plan, as applicable, unless such increase is necessitated by the requirement, order or request of a Regulatory Authority. Notwithstanding the foregoing, consensus of the JSC or mutual agreement of the Chief Executive Officers shall be necessary with respect to any decision that materially impairs or is reasonably likely to impair any rights or assets of either Party or any of their respective Affiliates, and unless and until the JSC reaches consensus or the Chief Executive Officers reach mutual agreement on any such matter, the Parties shall continue to operate under the status quo with respect to such matter and neither Party shall have the right, without the prior written consent of the other Party, to take any action that departs from the status quo with respect to such matter.
Failure to Reach Consensus. In the event that the members of the JC cannot come to consensus within [ * ] with respect to any matter over which the JC has authority and responsibility, the JC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by Senior Management. Until and only if Senior Management is able to mutually agree upon the resolution to such matter, the Parties shall continue to operate under the status quo and neither Party shall have the right, without the consent of the other Party, to implement any changes to the status quo that would result from resolution of such matter.
Failure to Reach Consensus. If the JRC is unable to decide a matter by consensus, then the matter shall be escalated as set forth in Section 6.6.4.
Failure to Reach Consensus. In the event that the members of the JDC [***] with respect to any matter over which the JDC has authority and responsibility, the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Parties’ respective Executive Officers. If such individuals are not able to mutually agree upon the resolution to such matter [***] after the JDC’s submission to them, then, the Executive Officer of GNE [***]. In no event shall the Executive Officer of GNE decide any matter [***], or in any other manner [***].
Failure to Reach Consensus. If the JSC is unable to decide a matter by consensus, then subject to Section 4.3.8, (a) Roche shall have the final decision making authority in the area of (i) development and regulatory matters in the Roche Retained Field, unless Dermira can [*****] demonstrate that a specific clinical study as contemplated by Roche would be [*****] under this Agreement, (ii) Medical Affairs Activities and Promotion in the Roche Retained Field, including the decision regarding the trademark for the Roche Retained Field, and (iii) Manufacturing of Drug Substance and Drug Product under this Agreement during any period of time during which Roche remains responsible for such activity, and (b) Dermira shall have the final decision making authority in all other areas, except that the following decisions shall [*****]: (1) decisions regarding the Know-How Transfer to Dermira (2.4.1), and (2) the implementation and process to determine sales portion from Roche Retained Field. In addition, until the submission of the first BLA, material changes to the Development Plan will require mutual agreement of the Parties unless such change is required by a Regulatory Authority.
