Cooperation by the Parties. During the relevant Country Transition Period, Merck and its Affiliates shall, upon request, reasonably cooperate with Cardiome to facilitate communications or other interactions with Regulatory Authorities and/or other governmental authorities in a Country that are reasonably necessary in connection with Cardiome’s planning and preparations for the transfer of Governmental Permits, including, without limitation, by providing Cardiome with copies of any material communications with Regulatory Authorities. Merck shall reasonably consider any requests by Cardiome for any consent or authorizations necessary to enable Cardiome to engage in direct communications with Regulatory Authorities in connection with the transfer of Governmental Permits for the Product. Cardiome shall not take any action which (i) may reasonably be expected to damage or impair the goodwill or reputation of Merck or its Affiliates, and/or (ii) would, without the prior written consent of Merck or its Affiliates, impose any new obligations or commitments (financial or otherwise) upon Merck and/or its Affiliates related to or in connection with the development, registration or commercialization of the Product in such Country. Cardiome shall keep Merck reasonably informed as to any communications with Regulatory Authorities and/or other developments related to the transition of Governmental Permits or any other Product Rights, and in particular shall promptly notify Merck with respect to any new developments related to such activities that may affect (x) the distribution or sale of the Product in a Country by Merck and/or its Affiliates during the relevant Country Transition Period, and/or (y) the rights and responsibilities of the Parties with respect to, and/or the timing of, the transfer and delivery of the Regulatory Product Rights in a Country to Cardiome or to an entity designated by Cardiome in writing.
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Samples: Transition Agreement (Cardiome Pharma Corp), Transition Agreement (Cardiome Pharma Corp)
Cooperation by the Parties. During the relevant Country Transition PeriodAt all times prior to [*] in a particular country, Merck and its Affiliates ALZA shall, upon requestand shall cause its applicable Affiliates to, reasonably cooperate with Cardiome GENUPRO and/or its designated Affiliates and/or Sublicensees to facilitate communications or other interactions with Regulatory Authorities and/or other governmental authorities in a Country any country that are reasonably necessary in connection with CardiomeALZA’s performance of its obligations under Section 5.3 or GENUPRO’s and/or its Affiliates’ and/or Sublicensees’ planning and preparations for the transfer of Governmental PermitsPermits or ALZA Regulatory Submissions, including, without limitation, by providing Cardiome GENUPRO and/or its Affiliates and/or Sublicensees with copies of any material communications with or from Regulatory AuthoritiesAuthorities (including meeting minutes). Merck ALZA shall reasonably consider and grant any reasonable requests by Cardiome GENUPRO and/or its designated Affiliates and/or Sublicensees for any consent or authorizations necessary to enable Cardiome GENUPRO and/or its designated Affiliates and/or Sublicensees to engage in direct communications with Regulatory Authorities in connection with the maintenance, filing, seeking, or transfer of ALZA Regulatory Submissions and Governmental Permits for the Agreement Product. Cardiome GENUPRO shall not not, and shall cause its Affiliates and/or Sublicensees to not, knowingly and intentionally take any action actions in the course of any such direct communications with any Regulatory Authorities in connection with any such transfer which (i) may reasonably be expected to materially damage or impair the goodwill or reputation of Merck ALZA or its Affiliates, Affiliates and/or (ii) would, without the prior written consent of Merck or its AffiliatesALZA, impose any new obligations or commitments (financial or otherwise) upon Merck and/or ALZA or its Affiliates related to or in connection with the development, registration or commercialization of the Agreement Product in such Countrycountry (except such obligations as ALZA has expressly agreed to under this Agreement or any Ancillary Agreement). Cardiome Prior to the Final Transfer Date for a particular country, ALZA shall keep Merck GENUPRO and/or its designated Affiliates and/or Sublicensees reasonably informed informed, and provide GENUPRO and/or its designated Affiliates and/or Sublicensees a reasonable opportunity to comment, as to any of ALZA’s or its Affiliates’ communications with Regulatory Authorities Authorities, filing or amendment of any Marketing Applications, pursuit of Regulatory Approvals, and/or other developments related to the transition of Governmental Permits Permits, ALZA Regulatory Submissions, or any other Product Rights, including but not limited to those actions contemplated by Section 5.3, and in particular shall promptly notify Merck GENUPRO and/or its designated Affiliates and/or Sublicensees with respect to any new developments related to such activities activities, including but not limited to those that may materially and adversely affect (x) the distribution development, manufacture, or sale commercialization of the Agreement Product in a Country country by Merck GENUPRO and/or its designated Affiliates during the relevant Country Transition Period, or Sublicensees and/or (y) the rights and responsibilities of the Parties with respect to, and/or the timing of, the transfer and delivery of the Regulatory Product Rights in a Country country to Cardiome GENUPRO and/or its Affiliates and/or Sublicensees. Prior to the Final Transfer Date in a particular country, ALZA shall provide GENUPRO and/or its designated Affiliates and/or Sublicensees with reasonable advance notice of any scheduled meeting or conference call between ALZA or its Affiliate and any Regulatory Authority relating to an entity any Governmental Permits or ALZA Regulatory Submissions, and GENUPRO and/or its Affiliates and/or Sublicensees shall have a right to have up to [*] ([*]) representatives of GENUPRO, [*], [*], and, if and as reasonably requested by GENUPRO and/or [*], participate in, any such meeting. Prior to [*] in a particular country, GENUPRO and/or its designated Affiliates and/or Sublicensees shall keep ALZA reasonably informed as to any of GENUPRO’s and/or its designated Affiliates’ and/or Sublicensees’ communications with Regulatory Authorities and/or other developments related to the transition of Governmental Permits, ALZA Regulatory Submissions, or any other Product Rights, and in particular shall promptly notify ALZA with respect to any new developments related to such activities that may materially and adversely affect (x) the sale of Agreement Product in a country by Cardiome ALZA and/or its Affiliates under the Sales Services Agreement and/or (y) the rights and responsibilities of the Parties with respect to, and/or the timing of, the transfer and delivery of the Product Rights in writinga country to GENUPRO and/or its Affiliates and/or Sublicensees. The rights and obligations of the Parties under this Section 6 are in addition to, and without limitation of, the Parties’ rights and obligations under the PV Agreements or any other Ancillary Agreement with respect to the matters addressed in this Section 6.
Appears in 1 contract
Samples: License and Asset Transfer Agreement (Furiex Pharmaceuticals, Inc.)
Cooperation by the Parties. During At all times prior to the relevant Country Transition PeriodFinal Transfer Date in a particular country in the Territory, Merck LICENSOR shall use Commercially Reasonable Efforts to ensure that ALZA and its Affiliates shall, upon requestapplicable Affiliates, reasonably cooperate with Cardiome LICENSEE to facilitate communications or other interactions with Regulatory Authorities and/or other governmental authorities in a Country the Territory that are reasonably necessary in connection with CardiomeALZA’s performance of the obligations described under Section 2.3 of this Schedule 4 or LICENSEE’s and/or its Affiliates’ planning and preparations for the transfer of Governmental PermitsProduct Registrations or Regulatory Submissions, including, without limitation, by providing Cardiome LICENSEE with copies of any material communications with or from Regulatory AuthoritiesAuthorities (including meeting minutes). Merck LICENSOR shall reasonably use Commercially Reasonable Efforts to cause ALZA to consider and grant any reasonable requests by Cardiome LICENSEE for any consent or authorizations necessary to enable Cardiome LICENSEE to engage in direct communications with Regulatory Authorities in connection with the maintenance, filing, seeking, or transfer of Governmental Permits for the ProductRegulatory Submissions and Product Registrations. Cardiome LICENSEE shall not not, and shall ensure that its Affiliates and/or Sublicensees do not, knowingly and intentionally take any action actions in the course of any such direct communications with any Regulatory Authorities in connection with any such transfer which (i) may reasonably be expected to materially damage or impair the goodwill or reputation of Merck ALZA or its Affiliates, Affiliates and/or (ii) would, without the prior written consent of Merck or its AffiliatesALZA, impose any new obligations or commitments (financial or otherwise) upon Merck and/or ALZA or its Affiliates related to or in connection with the development, registration or commercialization of the Product in such Countrycountry. Cardiome Prior to the Final Transfer Date for a particular country in the Territory, LICENSOR shall keep Merck use Commercially Reasonable Efforts to (a) ensure that ALZA keeps LICENSOR and LICENSEE reasonably informed informed, provides LICENSOR and/or LICENSEE a reasonable opportunity to comment, as to any of ALZA’s or its Affiliates’ communications with Regulatory Authorities Authorities, filing or amendment of any Product Registration Applications, pursuit of Regulatory Approvals, and/or other developments related to the transition of Governmental Permits Product Registrations, Regulatory Submissions, or any other Product RightsAssets, including but not limited to those actions contemplated by Section 2.3 of this Schedule 4, and in particular shall promptly notify Merck notifies LICENSOR and/or LICENSEE with respect to any new developments related to such activities activities, including but not limited to those that may materially and adversely affect (x) the distribution development, manufacture, or sale commercialization of the Existing Product in a Country country by Merck and/or its Affiliates during the relevant Country Transition Period, LICENSEE and/or (y) the rights and responsibilities of the Parties LICENSOR or ALZA with respect to, and/or the timing of, the transfer and delivery of the Regulatory Product Rights Assets in a Country country to Cardiome LICENSEE and/or its Affiliates, (b) promptly share any information received from ALZA in the course of the foregoing with LICENSEE (to the extent not provided directly to LICENSEE by ALZA or any Affiliate thereof), and (c) follow LICENSEE’s reasonable direction with respect to an entity designated LICENSOR’s exercise of such Commercially Reasonable Efforts under clause (a) in this sentence. LICENSOR shall use Commercially Reasonable Efforts to ensure that, prior to the Final Transfer Date in a particular country in the Territory, ALZA shall provide reasonable advance to LICENSOR and/or LICENSEE notice of any scheduled meeting or conference call between ALZA or its Affiliate and any Regulatory Authority relating to any Product Registrations or Regulatory Submissions, and LICENSEE shall have a right to have up to two (2) representatives of LICENSEE attend, and, if and as reasonably requested by Cardiome LICENSEE, participate in, any such meeting. Prior to the Final Transfer Date in writinga particular country in the Territory, LICENSEE shall keep ALZA reasonably informed as to any of LICENSEE’s communications with Regulatory Authorities and/or other developments related to the transition of Product Registrations, Regulatory Submissions, or any other Product Assets in the Territory, and in particular shall promptly notify ALZA with respect to any new developments related to such activities in the Territory that may materially and adversely affect (x) the sale of Existing Product in a country in the Territory by ALZA and/or its Affiliates during any Transition Period and/or (y) the rights and responsibilities of LICENSOR, LICENSEE and ALZA with respect to, and/or the timing of, the transfer and delivery of the Product Assets in a country in the Territory to LICENSEE.
Appears in 1 contract