Failure to Reach Consensus. In the event that the members of the JDC cannot come to consensus within ten (10) days with respect to any matter over which the JDC has authority and responsibility, the matter shall be resolved as follows: (i) Prior to approval of the NDA for the Product in the U.S. Territory and subject to Section 4.2(a), Transcept’s representatives on the JDC shall have the right to decide such matter reasonably, except that in no event can Transcept’s representatives on the JDC unilaterally decide such matter in a manner that is contrary to the express terms of this Agreement. (ii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to Development of Product in the Transcept Territory or to Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory, the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution of such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties to the respective chief executive officers of Transcept and Purdue for resolution. If such chief executive officers are not able to mutually agree upon the resolution of such matter within [***] after submission to them, then, subject to the limitations of Section 3.9, [***] shall have the right to decide such matter reasonably, [***] legitimate interest under this Agreement, except that in no event can the [***] such matter in a manner that is contrary to the express terms of this Agreement; (iii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to the Development of Product in the U.S. Territory (but excluding Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory and any activity described in Section 4.1(b)), the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution to such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties with respect to such matter to the respective chief executive officers of Transcept and Purdue for resolution. If such chief executive officers are not [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. able to mutually agree upon the resolution to such matter within [***] after submission to them, then (A) if such matter pertains to [***] shall have the right to decide such matter [***] legitimate interest under this Agreement, except that in no event can the [***] such matter in a manner that is contrary to the express terms of this Agreement and (B) with respect to all matters other than [***], the Parties shall continue to operate under the status quo and [***]. For the avoidance of doubt, [***] under Section 3.10(b)(iii)(A) shall not diminish [***] set forth in Section 3.10(b)(ii) with respect to [***].
Appears in 1 contract
Samples: License and Collaboration Agreement (Transcept Pharmaceuticals Inc)
Failure to Reach Consensus. In the event that If the members of the JDC JSC cannot come to consensus within ten (10) days [****] with respect to any matter over which the JDC JSC has authority and responsibility, then the matter shall be resolved as follows:
(i) Prior to approval of the NDA for the Product in the U.S. Territory and subject to Section 4.2(a), Transcept’s representatives on the JDC shall have the right to decide such matter reasonably, except that in no event can Transcept’s representatives on the JDC unilaterally decide such matter in a manner that is contrary to the express terms of this Agreement.
(ii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to Development of Product in the Transcept Territory or to Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory, the JDC JSC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution of such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties to the respective chief executive officers of Transcept and Purdue for resolution. If such chief executive officers are not able to mutually agree upon the resolution of such matter within [***] after submission to them, then, subject to the limitations of Section 3.9, *]. If such [***] shall have the right to decide such matter reasonably, [***] legitimate interest under this Agreement, except that in no event can the [***] such matter in a manner that is contrary to the express terms of this Agreement;
(iii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to the Development of Product in the U.S. Territory (but excluding Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory and any activity described in Section 4.1(b)), the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution to such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties with respect to such matter to the respective chief executive officers of Transcept and Purdue for resolution. If such chief executive officers are not [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. able to mutually agree upon the resolution to such matter within [****] after of its submission to them, then (A) if PDL shall have the right to decide such matter in good faith, giving due consideration to the input of [****] and the economic interests of both Parties under this Agreement, except that any decision that primarily pertains to (i) the sale and marketing of Licensed Products in the Collaborative Fields in the ROW Territory, (ii) the Development of Licensed Products in the Collaborative Fields [****]that[****], (iii) the determination of a [****] in the Asthma Field for the purpose [****] of [****], (iv) selection or FDA approval of a Transplant Trademark or (v) [****] during the Transplant Co-Promotion Term, shall be decided by [****] in good faith, giving due consideration to the input of [****] and the economic interests of both Parties under this Agreement. With regard to 3.5(b)(v), if there is a dispute regarding the scope of the [****] not otherwise targeted by [****], then [****] shall have the right to decide such matter in good faith, giving due consideration to the input of [****] legitimate interest and the economic interests of both Parties under this Agreement, except that in no event can . Any dispute regarding the Parties’ relative percentages of [****] such matter obligations in the Transplant Field pursuant to Section 6.2(c) shall be decided pursuant to Section 18.2. Notwithstanding the foregoing, any decision: (1) related to [****] and [****] in the Transplant Field, (2) to initiate a development program for [****] for Licensed Products in a manner that is contrary Collaborative Field, or (3) to the express terms of this Agreement and (B) with respect to all matters other than select a vendor for such a [****], the Parties shall continue to operate under the status quo be made [****], and [***]. For *] shall have the avoidance of doubt, [right to make such decision if the JSC and the ***] under Section 3.10(b)(iii)(A) shall not diminish [***] set forth in Section 3.10(b)(ii) * Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to [***]the omitted portions.
Appears in 1 contract
Samples: Co Development and Commercialization Agreement (PDL Biopharma, Inc.)
Failure to Reach Consensus. In the event that the members of the JDC JSC cannot come to consensus within ten (10) days *** with respect to any matter over which the JDC JSC has authority and responsibilityresponsibility as set forth in Section 3.3, the matter shall be resolved as follows:
(i) Prior to approval of the NDA for the Product in the U.S. Territory and subject to Section 4.2(a), Transcept’s representatives on the JDC shall have the right to decide such matter reasonably, except that in no event can Transcept’s representatives on the JDC unilaterally decide such matter in a manner that is contrary to the express terms of this Agreement.
(ii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to Development of Product in the Transcept Territory or to Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory, the JDC JSC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution of such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties to the respective chief executive officers of Transcept VIVUS and Purdue Licensee for resolution. If such chief executive officers are not able to mutually agree upon the resolution of to such matter within [***] * after submission to them, then, subject to the limitations of Section 3.93.4, [***] (a) the chief executive officer of VIVUS shall have the right to decide such matter reasonably, [***] legitimate interest under this Agreementmatters 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 ***; (ii) *** or would reasonably be expected to ***; (iii) impedes or may impede in any way the supply of Product to Licensee, or (iv) is contrary to the express terms of this Agreement;
Agreement or any other written agreement between the Parties; and (iiib) After approval to the extent such matter relates to a Development or Commercialization issue, or relates to a regulatory issue (after transfer of the NDA for the Product in the U.S. Territory, for any matter pertaining Marketing Authorization to the Development of Product in the U.S. Territory (but excluding Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory and any activity described in Section 4.1(b)Licensee), the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution to such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties with respect to such matter to the respective chief executive officers officer of Transcept and Purdue for resolution. If such chief executive officers are not [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. able to mutually agree upon the resolution to such matter within [***] after submission to them, then (A) if such matter pertains to [***] Licensee shall have the right to decide such matter [***] legitimate interest under this Agreementmatter, 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 ***; (ii) *** or would reasonably be expected to ***, or (iii) is contrary to the express terms of this Agreement and (B) with respect to all matters or any other than [***], written agreement between the Parties shall continue to operate under the status quo and [***]. For the avoidance of doubt, [***] under Section 3.10(b)(iii)(A) shall not diminish [***] set forth in Section 3.10(b)(ii) with respect to [***]Parties.
Appears in 1 contract
Samples: License and Commercialization Agreement (Vivus Inc)
Failure to Reach Consensus. In the event that the members of the JDC JSC cannot come to consensus within ten (10) days Business Days with respect to any matter over which the JDC JSC has authority and responsibilityresponsibility as set forth in Section 3.3, the matter shall be resolved as follows:
(i) Prior to approval of the NDA for the Product in the U.S. Territory and subject to Section 4.2(a), Transcept’s representatives on the JDC shall have the right to decide such matter reasonably, except that in no event can Transcept’s representatives on the JDC unilaterally decide such matter in a manner that is contrary to the express terms of this Agreement.
(ii) After approval of the NDA for the Product in the U.S. Territory, for any matter pertaining to Development of Product in the Transcept Territory or to Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory, the JDC JSC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution of such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties to the respective chief executive officers of Transcept VIVUS and Purdue Licensee for resolution. If such chief executive officers are not able to mutually agree upon the resolution of to such matter within [***] ten (10) Business Days after submission to them, then, subject to the limitations of Section 3.93.4, [***] (a) the chief executive officer of VIVUS shall have the right to decide such matter reasonably, [***] legitimate interest under this Agreementmatters 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 express terms of this Agreement;
Agreement or any other written agreement between the Parties; and (iiib) After approval to the extent such matter relates to a Development or Commercialization issue, or relates to a regulatory issue (after transfer of the NDA for the Product in the U.S. Territory, for any matter pertaining Marketing Authorization to the Development of Product in the U.S. Territory (but excluding Development of Product in the U.S. Territory in support of Regulatory Approval in the Transcept Territory and any activity described in Section 4.1(b)Licensee), the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Alliance Managers. If such Alliance Managers are not able to mutually agree upon the resolution to such matter within ten (10) days after the JDC’s submission to them, then the Alliance Managers shall submit the respective positions of the Parties with respect to such matter to the respective chief executive officers officer of Transcept and Purdue for resolution. If such chief executive officers are not [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. able to mutually agree upon the resolution to such matter within [***] after submission to them, then (A) if such matter pertains to [***] Licensee shall have the right to decide such matter [***] legitimate interest under this Agreementmatter, 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 express terms of this Agreement and (B) with respect to all matters or any other than [***], written agreement between the Parties shall continue to operate under the status quo and [***]. For the avoidance of doubt, [***] under Section 3.10(b)(iii)(A) shall not diminish [***] set forth in Section 3.10(b)(ii) with respect to [***]Parties.
Appears in 1 contract
Samples: License and Commercialization Agreement (Petros Pharmaceuticals, Inc.)