Decision-Making Authority. The JCC shall make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JCC is unable to reach consensus regarding a matter before it, the issue shall be presented by the JCC to the Parties’ Applicable Senior Officers for resolution. Once an issue has been presented to the Applicable Senior Officers, they 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 Acerus shall have the final decision making authority over (i) 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 regulatory and commercialization.
Appears in 1 contract
Samples: License and Supply Agreement (Aytu Bioscience, Inc)
Decision-Making Authority. The JCC shall make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JCC is unable to reach consensus regarding a matter before itit within fifteen (15) days, the issue shall be presented by the JCC to the Parties’ Applicable Senior Officers chief executive officers, for resolution. Once an issue has been presented to the Applicable Senior Officers, they shall 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 Acerus shall have the final decision making authority over such disputed matters; provided that (i) Acerus shall reasonably consider the management input of Aytu’s members to the JCC with respect to such Commercial Pricing Strategy 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), Master Production Plan; 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 Applicable Law, if the matter relates specifically to matters affecting the Aytu Sales Channel, Aytu’s prior written consentapproval shall be required, with such consent approval not to be unreasonably withheldwithheld or delayed. Notwithstanding anything to the contrary herein, delayed any dispute regarding (a) the level of monetary spending required by the approved Commercialization Plan 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 (b) whether Acerus reasonably considered Aytu’s input with respect to safety the Commercialization Plan or the Commercial Pricing Strategy shall be resolved by the binding Arbitration process set forth in Section 15.11 herein. For clarity, each Party shall have final decision-making authority over salaries, hiring and efficacy required firing decisions for approval shall not be taken into account when determining its Sales Representatives, subject to the reasonableness of Aytu in this regard; providedJCC requirements for qualifications for Sales Representatives. For further clarity, however, that Acerus shall use all commercially reasonable efforts and without limitation to cooperate with Aytu to minimize any adverse economic consequences (such as Product returns) that may arise as a result of the implementation 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 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 regulatory and commercialization.adjustments).
Appears in 1 contract
Samples: License and Supply Agreement
Decision-Making Authority. The JCC shall make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JCC is unable to reach consensus regarding a matter before itit within fifteen (15) days, the issue shall be presented by the JCC to the Parties’ Applicable Senior Officers chief executive officers, for resolution. Once an issue has been presented to the Applicable Senior Officers, they shall 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 Acerus shall have the final decision making authority over such disputed matters; provided that (i) Acerus shall reasonably consider the management input of Aytu’s members to the JCC with respect to such Commercial Pricing Strategy 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), Master Production Plan; 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 Applicable Law, if the matter relates specifically to matters affecting the Aytu Sales Channel, Aytu’s prior written consentapproval shall be required, with such consent approval not to be unreasonably withheldwithheld or delayed. Notwithstanding anything to the contrary herein, delayed any dispute regarding (a) the level of monetary spending required by the approved Commercialization Plan 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 (b) whether Acerus reasonably considered Aytu’s input with respect to safety the Commercialization Plan or the Commercial Pricing Strategy shall be resolved by the binding Arbitration process set forth in Section 15.11 herein. For clarity, each Party shall have final decision-making authority over salaries, hiring and efficacy required firing decisions for approval shall not be taken into account when determining its Sales Representatives, subject to the reasonableness of Aytu in this regard; providedJCC requirements for qualifications for Sales Representatives. For further clarity, however, that Acerus shall use all commercially reasonable efforts and without limitation to cooperate with Aytu to minimize any adverse economic consequences (such as Product returns) that may arise as a result of the implementation 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 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 regulatory and commercializationadjustments).
Appears in 1 contract
Samples: License and Supply Agreement (Aytu Bioscience, Inc)
Decision-Making Authority. The JCC Each Party shall make its have one vote on a Committee. All decisions by consensus, with each Party’s of a Committee shall require unanimous agreement of the Parties. Any disagreement between the representatives collectively having one voteof the Parties on a Subcommittee shall be referred to the JSC for resolution. If the JCC JSC fails to unanimously agree on any matter that is unable to reach consensus regarding referred by a Subcommittee or any matter before itwithin the JSC’s responsibilities, the issue shall be presented by the JCC to the Parties’ Applicable Senior Officers for resolution. Once an issue has been presented to the Applicable Senior Officers, they shall have in each case within 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 Acerus shall have the final decision making authority over (i) 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 NDAdays, or any such other Regulatory Submissionperiod as the JSC representatives of the Parties may agree upon, (provided that Acerus shall have after the ability JSC has met and attempted to make specification changes necessary for the approval of a any modified or changed dispenser used for the Productagree on such matter, 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 then: with respect to safety all matters relating to Commercialization in the Territory, Licensee shall have final decision-making authority and efficacy required for approval the decision of Licensee with respect to such matters shall not be taken into account when determining final and binding on the reasonableness of Aytu in this regardParties; provided, however, that Acerus shall use all commercially reasonable efforts Teva may refer the following matters, ((A), (B) and (C)), 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 ProductExecutive Officers, and Aytu Licensee shall not have authority to make the final decision-making authority with respect to such matters: (A) selection of an alternative Product Xxxx, if applicable, as provided in Section 9.5(a); (B) any Commercialization matter with respect to which, in Teva’s reasonable judgment, Licensee’s final decision is reasonably likely to have a material adverse effect on Teva’s development and regulatory strategy for Licensed Products outside the Territory; and (C) any Commercialization matter with respect to which, in Teva’s reasonable judgment, Licensee’s final decision is inconsistent with Teva’s global brand strategy and positioning for Licensed Products (“Global Brand Strategy”); with respect to all Development of the Specialty Product matters (including Development of any New Indications for the Specialty Product) in the Territory, Teva shall have final decision-making authority and the decision of Teva’s chairperson of the JSC with respect to such matters shall be final and binding on the Parties; provided however, that in the event Licensee does not agree with the decision of Teva, Licensee may, by written notice to Teva (“Escalation Notice”), refer such matter to the Executive Officers for resolution. In addition, Teva may provide an Escalation Notice regarding (A) selection of an alternative Product Xxxx, if applicable as provided in Section 9.5(a), (B) any Commercialization matter decided by Licensee that, in Teva’s reasonable judgment, is reasonably likely to have a material adverse effect on Teva’s development and regulatory strategy for the Specialty Product outside the Territory, and (C) any Commercialization matter decided by Licensee that, in Teva’s reasonable judgment, is inconsistent with the Global Brand Strategy. The Executive Officers shall use good faith efforts to resolve any matter referred to them as soon as practicable. Any final decision that the Executive Officers mutually agree to in writing shall be conclusive and binding on the Parties; and if the Executive Officers are unable to resolve any matter set forth in an Escalation Notice within thirty (30) days after receiving such Escalation Notice (or such longer period as the Executive Officers may agree upon), then (A) with respect to any decisions that, in Teva’s reasonable judgment, are reasonably likely to have an adverse impact on the global safety profile of the Licensed Product or are inconsistent with the Global Brand Strategy, Teva shall have final decision-making authority and the decision of Teva’s Executive Officer with respect to such decisions shall be final and binding on the Parties, provided, however, that if the Parties mutually agree upon a Territory-specific Licensed Product brand strategy, including any Licensed Product positioning or key messaging for the Territory that is inconsistent with the Global Brand Strategy, Licensee shall have the right to implement such Territory-specific brand strategy, (B) subject to the foregoing clause (A), Licensee shall have final decision-making authority on all Commercialization matters, other issues relating than selection of an alternative Product Xxxx, if applicable, as provided in Section 9.5(a), and the decision of Licensee’s Executive Officer with respect to regulatory such matters shall be final and commercializationbinding on the Parties, and (C) all other matters set forth in an Escalation Notice that are not resolved by the Executive Officers, including selection of an alternative Product Xxxx, if applicable, as provided in Section 9.5(a) and, subject to clause (A), all Development matters in the Territory (including Development of New Indications for the Specialty Product in the Territory) shall be subject to the mutual agreement of both Parties and shall not be subject to arbitration or any other form of external dispute resolution and, unless and until such mutual agreement is reached or the Applicable Law or Regulatory Authority requires otherwise, the status quo shall be maintained.
Appears in 1 contract
