Transfer of Regulatory Responsibility. Celgene shall become the Lead Party for Regulatory Interactions for any Co-Co Product upon an Jounce Opt-Out Notice being delivered to Celgene.
Transfer of Regulatory Responsibility. At such time as Celgene is assigned or is entitled to assume lead or sole responsibility for Regulatory Interactions with respect to a Program under this Section 5.1, upon Celgene’s written request to Agios,
Transfer of Regulatory Responsibility. Jounce shall be responsible for Regulatory Interactions for any Monotherapy Product in the United States and any of its Non-Collaboration Combination Products anywhere in the Territory. Celgene shall be responsible for Regulatory Interactions for any Monotherapy Product in the ROW Territory and any of its Non-Collaboration Combination Products anywhere in the Territory. Responsibility for Regulatory Interactions for Collaboration Combination Products shall be in accordance with and subject to the applicable Co-Development & Co-Commercialization Agreement for such Collaboration Combination Product’s corresponding Co-Co Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Transfer of Regulatory Responsibility. Vendor and Purchaser shall each use their best efforts to transfer the FDA and Canadian registrations and permits and to transfer regulatory responsibilities for the Products from Vendor to Purchaser as expeditiously as possible following the Time of Closing.
Transfer of Regulatory Responsibility. LICENSOR shall use Transitional Commercially Reasonable Efforts to ensure that ALZA or its Affiliates shall be responsible for regulatory matters in each Group A Market Country, Group B Market Country, and Group C Market Country during the Regulatory Transfer Transition Period in that country, and LICENSEE shall assume regulatory responsibility on the Regulatory Transfer Date in each country. In the event that exceptional action or inaction by a Regulatory Authority in a country prevents completion of such transfer prior to expiry of the Regulatory Transfer Transition Period, LICENSEE agrees to allow LICENSOR to, and LICENSOR shall, negotiate with ALZA in good faith an extension of the Regulatory Transfer Transition Period for that country to effectuate such regulatory transfer, including reasonable compensation for ALZA, the cost of which will be paid by LICENSEE, and any such extension agreed to by ALZA and LICENSOR shall be effective for purposes of this Schedule 4. Notwithstanding the foregoing, in the event ALZA has performed substantially all activities necessary to effect such regulatory transfer such that only minimal activity is needed by ALZA, LICENSOR shall use Commercially Reasonable Efforts to ensure that ALZA shall complete the transfer at no cost to LICENSEE, provided that the foregoing shall not be construed to require LICENSOR to incur any costs or expenses or payment obligations to ALZA or any Affiliate thereof.
Transfer of Regulatory Responsibility. Notwithstanding the foregoing, BeiGene shall become the Lead Party for all Regulatory Interactions for any and all Products on and after the earlier to occur of (i) the Co-Development Opt-Out Date and (ii) the POC Milestone Date.
Transfer of Regulatory Responsibility. As of the Amendment Effective Date, BeiGene shall become the Lead Party for all Regulatory Interactions for any and all Candidates and Products, and BioAtla will promptly transfer to BeiGene all Regulatory Documentation Controlled by BioAtla. BioAtla will transfer to BeiGene or its designated Affiliate all BioAtla Know-How and any materials constituting BioAtla Know-How related to Candidates and the Products that are necessary or reasonably useful for BeiGene to assume responsibility as the Lead Party of any Clinical Studies of the Candidates and the Products initiated or planned to be initiated as of the Amendment Effective Date. Upon BeiGene’s request and at BeiGene’s sole discretion, BioAtla will cooperate to transfer to BeiGene or its designated Affiliated any Third Party contracts constituting BioAtla Know-How related to any such Clinical Trials (including any clinical site agreements or clinical research organization agreements), and BioAtla will be solely responsible for any costs incurred in terminating or suspending any such Third Party contracts that are not transferred to BeiGene (and any such shut-down costs will not be considered Development Costs subject to sharing under the Agreement).
Transfer of Regulatory Responsibility. Pharmascience shall be responsible for transferring the Canadian registrations and permits and transferring regulatory responsibilities for the Products in the Territory from Connetics or SmithKline to Pharmascience as expeditiously as possible. Without limiting the foregoing, Pharmascience shall be responsible for effecting the transfer of all Health Protection Branch (HPB) registrations and permits, and Connetics will provide reasonable assistance to Pharmascience in such transfer.
Transfer of Regulatory Responsibility. Celgene shall become the Lead Party for Regulatory Interactions for any Licensed Product upon an Agios Opt-Out Notice being delivered to Celgene.
Transfer of Regulatory Responsibility. Except as expressly set forth in any Ancillary Agreement (and subject to the Parties’ compliance with, and the terms of, the PV Agreements), ALZA shall be responsible for regulatory matters in each Group A Market, Group B Market, Group C Market, and Group E Market country during the Regulatory Transfer Transition Period in that country and GENUPRO (directly or through its Affiliates and/or Sublicensees) shall assume regulatory responsibility on the [*] in each country. In the event that action or inaction by a Regulatory Authority in a country prevents completion of such transfer prior to expiry of the Regulatory Transfer Transition Period, the Parties agree to negotiate in good faith an extension of the Regulatory Transfer Transition Period for that country to effectuate such regulatory transfer, including compensation for ALZA. Notwithstanding the foregoing, in the event ALZA has performed substantially all activities necessary to effect such regulatory transfer such that only minimal activity is needed by ALZA, ALZA shall complete the transfer at no cost to GENUPRO. [*] Confidential treatment requested.
