Regulatory Responsibilities Sample Clauses

Regulatory Responsibilities. Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Products including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material *Confidential Treatment Requested. correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.
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Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, Licensee will be responsible, at its sole cost and expense, for all regulatory activities related to Development activities, as described in Section 4.1, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Each Party shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Specialty Product in accordance with the strategy for obtaining Regulatory Approval of the Specialty Product in the Territory as set forth in the Development Plan or otherwise approved by the JSC pursuant to Section 3.3‎3.3. Licensee, directly or through its Affiliates, shall use Commercially Reasonable Efforts to obtain Regulatory Approval in the Territory. Notwithstanding the foregoing, Licensee shall be the Party responsible for achieving the regulatory milestones set forth on Exhibit G (the “Regulatory Milestones”). If Licensee fails to achieve any Regulatory Milestone with the time periods allotted for such Regulatory Milestone in Exhibit G, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control, then Teva shall have the option in its sole discretion upon written notice to Licensee to: (i) extend the time period allotted for the achievement of the applicable Regulatory Milestone; or (ii) convert the exclusive rights granted to Licensee in Section 2.1(a) with respect to the given Specialty Product into nonexclusive rights, provided however, that Teva has called for the consultation(s) on such failure to achieve any Regulatory Milestone but both Parties are still unable to reach a solution within three (3) months as from the date of the first consultation. All Regulatory Approvals and other Regulatory Materials relating to the Licensed Products in the Territory shall be submitted in the name of, and shall be owned by, Teva or its Affiliate1. Bidding. Licensee shall be responsible for bidding activities for all Licensed Products in the Territory. Licensee shall keep Teva informed (through the Alliance Managers, the JDC or other means of communication) of any material issues concerning bidding process for all Licensed Products in the Territory, including updates of any discussion and correspondence with any Regulatory Authority with respect thereto. Licensee shal...
Regulatory Responsibilities. Unless otherwise agreed between the Parties:
Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof.
Regulatory Responsibilities. As between the Parties, AxxxXxxx shall have the exclusive right and sole responsibility and decision-making authority, to prepare, file, seek and maintain all regulatory materials necessary for the Development and Commercialization of any Compound or Product in the Field in the Territory, and to interact with Regulatory Authorities in connection therewith. Without limiting the foregoing, ArriVent will, as between the Parties, be solely responsible for all regulatory matters relating to any Compound or Product, including (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to any Compound or Product; and (b) interfacing, corresponding and meeting with each Regulatory Authority with respect to any Compound or Product. Aarvik shall, at ArriVent’s cost, provide reasonable assistance to ArriVent in connection with the regulatory matters related to any Compound or Product upon ArriVent’s request. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Regulatory Responsibilities. (a) From and after the date hereof, Distributor shall assume (subject to Section 6(f) and Section 7(b)) at Distributor’s expense all responsibilities for the PMA application and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation program.
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Regulatory Responsibilities. Sutro shall obtain and maintain any and all regulatory and governmental permits, licenses and approvals that are necessary for Sutro to Manufacture the Product(s) for SutroVax or its Affiliates in accordance with the terms of this Supply Agreement and Applicable Law. As between the Parties, SutroVax shall have the sole responsibility for all Regulatory Approvals of the Vaccine Compositions.
Regulatory Responsibilities. (i) As between the Parties, subject to Section 9.2(c)(iii), the Party designated in accordance with the provisions of this Agreement as the LRP with respect to a particular set of Development, Manufacturing or Commercialization activities for a particular Development Candidate, Product Candidate or Product in a particular country in the Territory shall have the right and responsibility (but subject to the other Party’s rights of participation as set forth herein) for preparing, obtaining, and maintaining Drug Approval Applications, other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, with respect to the specific activities for which it is designated as LRP.
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