Regulatory Responsibilities Clause Samples

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.

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. 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. Section 3.4(a) of the D&L Agreement is hereby deleted in its entirety and replaced with the following: (a) It is understood that Alvogen has substantial experience and knowledge with filing NDAs pursuant to Section 505(b)(2) and Pfenex has substantial experience and knowledge with the Product. Therefore, the Parties agree as follows: (i) Within ten (10) days of the Amendment Effective Date, the Executive Steering Committee shall form a Working Committee to consult with the Parties and oversee the filing or submission of Regulatory Materials to the FDA with respect to the Product, including the NDA for Product. Such Working Committee will be comprised of three (3) employees of Alvogen (or its Affiliate) appointed by Alvogen and three (3) employees of Pfenex appointed by Pfenex. Each Party shall appoint one (1) employee to serve as the co-chair of the Working Committee. The Working Committee shall make all decisions by consensus pursuant to the terms set forth in Section 7.4(a). If the Working Committee is unable to reach a decision as to any matter within its authority after a period of ten (10) Business Days, then the matter may be escalated to either Party’s Chief Executive Officer as set forth in Section 7.4(b); (ii) Subject to Section 3.4(a)(i), (A) prior to the Transfer Notice, Pfenex shall have the sole right to control filing or submission of Regulatory Materials to the FDA with respect to the Product including the NDA for Product, subject to Section 3.1, and shall be responsible for managing all communications and interactions with the FDA with respect to Product in the Territory and (B) from and after the Transfer Notice, Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the FDA with respect to Product including the NDA Approval for Product, subject to Section 3.2, and shall be responsible for managing all communications and interactions with the FDA with respect to Product in the Territory; and (iii) In either case of Section 3.4(a)(ii)(A) or Section 3.4(a)(ii)(B), and subject to Section 3.4(a)(i), the following provisions shall apply. Prior to the filing of any Regulatory Materials (including the NDA) for Product with the FDA, the filing Party (the “Filing Party”) shall provide a copy thereof to the other Party (through the Executive Steering Committee, the “Reviewing Party”) for its review and comment. The Reviewing Party shall have fifteen (15) Business Days from the date it receives a copy of any Re...

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Field in the 3D Medicines Territory. 3D Medicines shall be responsible for filing each CTA in the Field in the 3D Medicines Territory for each Licensed Product. 3D Medicines shall be responsible for filing each MAA in the Field in the 3D Medicines Territory for each Licensed Product in 3D Medicines’ name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory. 3D Medicines shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) Aravive shall provide all reasonable assistance and cooperation to 3D Medicines as 3D Medicines may reasonably request, at 3D Medicines’ sole cost and expense, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Aravive’s possession and control, in each case as requested by Regulatory Authorities at 3D Medicines’ cost, and (iii) providing 3D Medicines with additional Regulatory Materials in the Aravive Territory as requested by Regulatory Authorities in the 3D Medicines Territory within a reasonable timeframe commensurate with the volume of 3D Medicines’ reasonable request. In the event that Aravive believes that such requests are not reasonable or are otherwise burdensome to Aravive, then such matter shall be promptly submitted to the JSC for review and discussion. Without limiting the foregoing, Aravive shall provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive has prepared a CTD for regulatory filings in the Field in the Aravive Territory, in a manner sufficient for filing in the U.S. within [***] after comple...

Regulatory Responsibilities. Following the approval by the FDA of an ANDA, ▇▇▇▇ shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, ▇▇▇▇ shall be responsible for all adverse event reporting as required by the Act. ▇▇▇▇ agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. ▇▇▇▇ 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. 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.