Regulatory Responsibilities. The Parties will share responsibility for leading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and Execution Version the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Party with respect to the submission of any MAA for such SYNGAP1 Co-Co Product, and (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each SYNGAP1 Co-Co Product in accordance with the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the relevant country, (ii) overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.
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.
Regulatory Responsibilities. Unless otherwise agreed between the Parties:
Regulatory Responsibilities. Each Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval of the applicable Product in the Territory. ARES TRADING shall be solely responsible for the preparation and submission of any and all Regulatory Materials for the Products in the Field in the Territory and shall own all such Regulatory Materials.
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. The Parties’ respective rights and obligations with respect to Regulatory Approvals in the Purchaser Territory, communications with Regulatory Authorities in the Purchaser Territory, and other regulatory matters relating to the Product in the Purchaser Territory are set forth in the License Agreement.
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. 6.1.1 Hana shall use its Commercially Reasonable Efforts to ensure that none of its Representatives who participate in any Development activities:
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.
Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, Licensee shall conduct all regulatory activities related to Development and Commercialization activities in its own or the Designated Parties’ name for Licensor, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Licensee shall be responsible for all of its costs and expenses in connection with obtaining and maintaining Regulatory Approvals for Products in the Territory.
