Decision-Making Authority. The JPC will make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JPC is unable to reach consensus regarding a matter before it, the issue will be presented by the JPC to the Parties’ Applicable Senior Officers for resolution. Once an issue has been presented to the Applicable Senior Officers, they will have fifteen (15) days to make a final determination regarding the issue in dispute. In the event that the Applicable Senior Officers are unable to reach a final determination within such fifteen (15) day period, then: (a) Council will have authority to make the final decision with respect to all issues relating to all clinical, regulatory, and development matters prior to the NDA Response Date and any matters thereafter for which the Council has sole financial responsibility under this Agreement; and (b) LICENSEE will have authority to make the final decision with respect to all issues not set forth in the foregoing (a) or Section 4.2.2(c), subject to LICENSEE fulfilling its obligations under this Agreement, including with respect to using Commercially Reasonable Efforts as required hereunder. For the avoidance of any doubt, LICENSEE will have exclusive right to establish pricing of the Licensed Product in the Territory. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Appears in 2 contracts
Sources: License Agreement, License Agreement (TherapeuticsMD, Inc.)
Decision-Making Authority. The JPC will JCC shall make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JPC JCC is unable to reach consensus regarding a matter before it, the issue will shall be presented by the JPC JCC to the Parties’ Applicable Senior Officers for resolution. Once an issue has been presented to the Applicable Senior Officers, they will shall have fifteen (15) days to make a final determination regarding the issue in dispute. In the event that the Applicable Senior Officers are unable to reach a final determination within such fifteen (15) day period, then:
then Acerus shall have the final decision making authority over (ai) Council will the management of and payment for clinical development activities associated with the Cardiovascular PMR and PMR Trial (including relating to any agreements relating thereto to be entered into by Aytu with the PMR Sponsor Group or any members thereof), and (ii) decisions relating to the manufacture of Product which do not affect or change in any way the Specification, the Product NDA, or any other Regulatory Submission, (provided that Acerus shall have the ability to make specification changes necessary for the approval of a any modified or changed dispenser used for the Product, subject to Aytu’s written consent, such consent not to be unreasonably withheld, delayed or conditioned, it being understood that the economic value of such specification changes to Aytu apart from considerations of compliance with applicable law, regulations, or regulatory guidance with respect to safety and efficacy required for approval shall not be taken into account when determining the reasonableness of Aytu in this regard; provided, however, that Acerus shall use all commercially reasonable efforts to cooperate with Aytu to minimize any adverse economic consequences (such as Product returns) that may arise as a result of the implementation of any such modified or changed dispenser for the Product, and Aytu shall have authority to make the final decision with respect to all other issues relating to all clinical, regulatory, regulatory and development matters prior to the NDA Response Date and any matters thereafter for which the Council has sole financial responsibility under this Agreement; and
(b) LICENSEE will have authority to make the final decision with respect to all issues not set forth in the foregoing (a) or Section 4.2.2(c), subject to LICENSEE fulfilling its obligations under this Agreement, including with respect to using Commercially Reasonable Efforts as required hereunder. For the avoidance of any doubt, LICENSEE will have exclusive right to establish pricing of the Licensed Product in the Territory. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONcommercialization.
Appears in 1 contract
Sources: License and Supply Agreement (Aytu Bioscience, Inc)
Decision-Making Authority. The JPC will JCC shall make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JPC JCC is unable to reach consensus regarding a matter before itit within fifteen (15) days, the issue will shall be presented by the JPC to the Parties’ Applicable Senior Officers chief executive officers, for resolution. Once an issue has been presented to the Applicable Senior Officers, they will have fifteen attempted resolution by good faith negotiations during a period of thirty (1530) days to make a final determination regarding the issue in disputedays. In the event that the Applicable Senior Officers chief executive officers are unable to reach a final determination within such fifteen thirty (1530) day period, then:
then Acerus shall have the final decision making authority over such disputed matters; provided that (i) Acerus shall reasonably consider the input of Aytu’s members to the JCC with respect to such Commercial Pricing Strategy and the Master Production Plan; and (ii) subject to Applicable Law, if the matter relates specifically to matters affecting the Aytu Sales Channel, Aytu’s prior written approval shall be required, with such approval not to be unreasonably withheld or delayed. Notwithstanding anything to the contrary herein, any dispute regarding (a) Council will have authority to make the final decision level of monetary spending required by the approved Commercialization Plan or (b) whether Acerus reasonably considered Aytu’s input with respect to all issues relating to all clinical, regulatory, and development matters prior to the NDA Response Date and any matters thereafter for which Commercialization Plan or the Council has sole financial responsibility under this Agreement; and
(b) LICENSEE will have authority to make Commercial Pricing Strategy shall be resolved by the final decision with respect to all issues not binding Arbitration process set forth in the foregoing (a) or Section 4.2.2(c)15.11 herein. For clarity, each Party shall have final decision-making authority over salaries, hiring and firing decisions for its Sales Representatives, subject to LICENSEE fulfilling its obligations under this Agreement, including with respect to using Commercially Reasonable Efforts as required hereunderthe JCC requirements for qualifications for Sales Representatives. For further clarity, and without limitation to any of the avoidance foregoing, Aytu agrees to implement the decisions of the JCC such that those items from the definition of Net Revenue that are subject to the authority of the JCC do not deviate from what has been approved by the JCC (other than for any non-discretionary price adjustments taken by customers, provided that Aytu promptly notifies the JCC of any doubt, LICENSEE will have exclusive right to establish pricing of the Licensed Product in the Territory. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONsuch adjustments).
Appears in 1 contract
Sources: License and Supply Agreement (Aytu Bioscience, Inc)
Decision-Making Authority. A quorum for a meeting of the JSC shall require the presence of at least one representative for each Party. The JPC will make its JSC shall endeavor to reach decisions by consensus. Each Party, with each Party’s representatives through its representative members of the JSC, shall collectively having have one votevote for decision making purposes. If In the JPC event the JSC is unable to reach consensus regarding a matter before itan unanimous decision on any matter, the issue will matter shall promptly be presented by the JPC submitted to the Parties’ Applicable Senior Officers Executives of the Parties or his or her designee for resolutiondiscussion in good faith based on the goals of the Research Program. Once an issue has If the Senior Executives cannot agree within [**] of the matter having been presented referred to them, [**] shall have the final casting vote on such matter. Notwithstanding any provision of this Agreement to the Applicable Senior Officerscontrary, they will neither the JSC nor a Party through exercise of its final decision-making authority, shall have fifteen (15) days to make a final determination regarding the issue in dispute. In the event that the Applicable Senior Officers are unable to reach a final determination within such fifteen (15) day period, then:
authority to: (a) Council will decide on any matter which may have authority to make a negative impact on the final decision with respect to all issues relating to all clinical, regulatory, and development matters prior to the NDA Response Date and any matters thereafter for which the Council has sole financial responsibility under this Agreement; and
Research Support Payments (bincluding payment timing) LICENSEE will have authority to make the final decision with respect to all issues not set forth in the foregoing (a) or Section 4.2.2(c), subject to LICENSEE fulfilling its obligations due under this Agreement, including with respect to using Commercially Reasonable Efforts as required hereunder. For the avoidance of any doubt, LICENSEE will have exclusive right to establish pricing of the Licensed Product in the Territory. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS (b) require [**] costs which are [**], (c) approve budget-related aspects of any new or amended Research Plan(s), (d) amend, modify or waive compliance with this Agreement or otherwise determine any such matter in a manner inconsistent with the express terms of this Agreement, or (e) determine whether or not a breach of this Agreement has occurred. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONFor further clarity, the issues to be formally decided by the JSC are only those specific issues that are expressly provided in this Agreement to be decided by the JSC. Notwithstanding any provision of this Agreement to the contrary, to the extent [**] exercises its final decision-making authority on any matter that was opposed by [**] or that [**] did not expressly agree to, and the exercise of such final decision-making authority by [**] causes [**] to Default, such Default shall not be deemed a Default under the Agreement and shall be excused.
Appears in 1 contract
Sources: Collaboration and License Agreement (Cue Biopharma, Inc.)