Regulatory Responsibilities Sample Clauses

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. 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.

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. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

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. (b) Supplier agrees to conduct at its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical or other testing to be performed at Supplier’s location and all manufacturing, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor in connection with the PMA application, other regulatory applications in the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect or condition which may render any of the Products in violation of the United States Food, Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Products. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier in the preparation of PMA application modules. (d) All Territory regulatory approvals (including the PMA application) shall be applied for, issued and registered in Distributor’s name. Commencing immediately, the ownership of t...

Regulatory Responsibilities. (i) Generally. The Parties’ joint regulatory strategy with respect to the Development of the Memantine-Donepezil FDC Products for Commercialization in the Field in the Territory is as specified in the Regulatory Plan and further detailed in the Development Plan. Notwithstanding anything to the contrary in this Section 4.2(e), [*] all substantive submissions and communications made to Regulatory Authorities in the Territory (including the FDA) with respect to any Memantine-Donepezil FDC Product shall be subject to the prior approval of the JDC in writing and shall be provided to the JDC at least [*] (or less time as may be required by Regulatory Authorities in the Territory) prior to the intended date of submission or communication. (ii) Interaction with Regulatory Authorities. Forest shall be responsible for[*] (subject to the oversight of the JDC [*]), interactions with Regulatory Authorities in the Territory (including the FDA) with respect to the Development of the Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field. Notwithstanding the foregoing, [*], Forest shall promptly provide Adamas with prior written or email notice of all meetings, conferences and discussions scheduled with the FDA concerning all Memantine-Donepezil FDC Products (including advisory committee meetings and any other meeting of experts convened with the FDA concerning the Memantine-Donepezil FDC Products) within [*] after Forest or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give Xxxxxx a reasonable opportunity to attend such meetings, conferences and discussions). Adamas shall be entitled to have representatives of Adamas (or its Affiliates) with appropriate expertise [*] at all such meetings, conferences or discussions with the FDA relating to Memantine-Donepezil FDC Products, which at a minimum shall mean that Adamas and its Affiliates shall have the right to have [*]. Forest shall provide Adamas with reasonable advance notice, as set forth above, of all such meeting, conferences or discussions with the FDA and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. advance copies of all substantive submissions and written communications to the...

Regulatory Responsibilities. 5.1.1. For the avoidance of doubt, ViroPharma’s rights under the licenses granted in Section 2.1 include the exclusive right to: (a) obtain orphan drug designation for Licensed Products from the FDA in accordance with 21 CFR 316 and from the applicable foreign Regulatory Authority in accordance with the applicable requirements administered by such Regulatory Authority, (b) implement Clinical Trials and related Development activities that are conducted in support of Regulatory Authorizations for Licensed Products or Commercialization of Licensed Products, (c) obtain and maintain Regulatory Authorizations for the Licensed Products in the Field in the Territory, including all regulatory filings and applications for relevant Regulatory Authorizations, and (d) prepare and deliver other communications with Regulatory Authorities in regard to the Development and Commercialization of Licensed Products in the Field in the Territory, including (i) all correspondence submitted to Regulatory Authorities related to the design, conduct or results of non-clinical trials and Clinical Trials for Licensed Products, (ii) all correspondence submitted to Regulatory Authorities related to the Manufacture of Licensed Products, (iii) all pricing and reimbursement approval proceedings relating to the Exploitation of any Licensed Product, (iv) all drug naming approval proceedings, and (v) all proposed Labeling; provided, however, that the foregoing list of rights does not constitute, and shall not be deemed to constitute, independent obligations of ViroPharma, it being acknowledged and agreed that ViroPharma’s obligations with respect to the Development and Commercialization of Licensed Products are set forth, in their entirety, in Sections 3.1 and 4.1. 5.1.2. Subject to Article 12, all Regulatory Authorizations and related submissions relating to Licensed Products in the Field in the Territory shall be the property of ViroPharma and held in the name of ViroPharma.

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 Product 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 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. ELITE will, at its own cost and expense, continue to own and maintain the applicable Regulatory Approvals necessary to market the Products in the Territory. ELITE shall be responsible for all regulatory and safety reporting requirements associated with ownership of the Regulatory Approval, including, without limitation, adverse event reports, annual reports mandated by the applicable Laws in the Territory. Additionally, ELITE shall be responsible for complying with applicable Laws to appropriately categorize and report changes to the FDA, including without limitation, amendments, supplements, and annual reports. All communications by ELITE with the FDA relating to the Products as marketed in the Territory shall be promptly provided in writing to LANNETT, and ELITE shall promptly provide to LANNETT copies of all documents sent to or received from the FDA regarding the Products.