Regulatory Materials Clause Samples
The "Regulatory Materials" clause defines and governs the use, reference, or compliance with laws, regulations, and official guidance relevant to the agreement. It typically specifies which regulatory documents are applicable, how updates or changes to these materials are handled, and may require parties to stay informed about relevant legal developments. This clause ensures that all parties are aware of and adhere to the necessary legal standards, reducing the risk of non-compliance and legal disputes.
Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority.
(b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Sect...
Regulatory Materials. Promptly following the Inventory Sell Down Period:
(i) Hospira shall promptly assign and transfer to Pfenex all Regulatory Materials for Product that are held or controlled by or under authority of Hospira or its Affiliates, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the Regulatory Materials to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all Applicable Laws with regard to such Regulatory Materials.
(ii) Hospira shall cause each of its Affiliates to transfer any such Regulatory Materials to Pfenex if this Agreement terminates or expires.
(iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material to Pfenex, Hospira shall grant, and does hereby grant, to Pfenex an exclusive (except as to Hospira to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for Product, and shall cooperate fully to make the benefits of such Regulatory Materials available to Pfenex or its designee(s).
(iv) Hospira shall provide to Pfenex copies of all such Regulatory Materials.
(v) Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Materials. Unless terminated for Safety Reasons in accordance with section 13.2(b), upon CytomX’s written request, BMS shall use commercially reasonable efforts to provide CytomX with copies of preclinical and clinical data for Compounds or Products directed to the terminated Collaboration Target and Regulatory Materials for any Compounds or Product(s) targeting the terminated Collaboration Target in all country(ies) or territories that are held or controlled by or under authority of BMS, its Affiliates or Sublicensees, that are necessary for the Development and/or Commercialization of Probodies (other than any specific terminated Compound(s) or Product(s)) with respect to the terminated Collaboration Target in such country(ies) or territories.
Regulatory Materials. 5.5.1. During the Term, to the extent permitted by and subject to the requirements under Applicable Law, each Party (the “Sharing Party”) will share with the other Party (a) all material Regulatory Materials Controlled by the Sharing Party or its Affiliates or Sublicensees for the Licensed Compounds or Licensed Products promptly after each such item is available to the Sharing Party, and (b) all other Regulatory Materials for the Licensed Compounds or Licensed Products and any supporting materials related to the Licensed Compounds or Licensed Products Controlled by the Sharing Party or its Affiliates or Sublicensees, in each case ((a) and (b)), within [**] of request by the other Party or as otherwise requested by the JSC; provided that all such materials in clause (a) and (b) are necessary, or determined by the Sharing Party in good faith to be reasonably useful, for the other Party’s completion and submission of regulatory filings in the other Party’s Territory.
5.5.2. To the extent any Regulatory Materials or supporting materials to be submitted or filed by the Sharing Party with a Regulatory Authority incorporate the other Party’s data, the Sharing Party will (a) to the extent reasonably practicable under the circumstances, share with the other Party such regulatory filings and documents reasonably in advance of submission to provide the other Party a reasonable opportunity to review; (b) reasonably consider any comments provided in a timely manner from the other Party for purposes of ensuring that such submission or filing will not adversely affect the Development or Commercialization of the applicable Licensed Product in such other Party’s Territory, and (c) keep the other Party reasonably informed on all responses and follow-on communications made by or to the Regulatory Authorities related to such Regulatory Materials or supporting materials. All such Regulatory Materials and supporting materials provided under this Section 5.5 (Regulatory Materials) will be provided in their original language, and if the original language of any such materials is not English, then also translated into English (which translated version will be provided within [**] of the original), which translation will be at the providing Party’s sole expense.
Regulatory Materials. Takeda or its Affiliates own all Regulatory Materials to be assigned to Licensee hereunder, and to Takeda’s Knowledge, Takeda and its Affiliates have maintained and retained all material Regulatory Materials that are required to be maintained or retained pursuant to and in accordance with Applicable Law, and all such information is true, complete, and correct in all material respects.
Regulatory Materials. AstraZeneca shall transfer and assign to FibroGen all Regulatory Materials and Regulatory Approvals for Products in the terminated regions, if any, that are Controlled by AstraZeneca or its Affiliates or Sublicensees.
Regulatory Materials. To the extent permitted by applicable Laws, [***].
Regulatory Materials. Facet shall transfer and assign to Trubion in the form and format in which such materials are maintained by Facet in the ordinary course of business, all Regulatory Materials for Products in the Territory that are Controlled by Facet or its Affiliates or permitted sublicensees.
Regulatory Materials. Gilead shall grant to Galapagos a right of reference under all Regulatory Materials and Regulatory Approvals Controlled by Gilead, in each case, that relate to any applicable Reversion Product(s) in or for the benefit of the applicable Terminated Region(s), unless and until such Regulatory Materials or Regulatory Approvals are assigned to Galapagos pursuant to any Transition Agreement.
Regulatory Materials. The Transition Agreement shall require Gilead to transfer and assign to Galapagos all Regulatory Materials and Regulatory Approvals in and for the benefit of the Terminated Regions solely relating to Reversion Products that are owned by Gilead or its Affiliates. The Transition Agreement shall contain terms governing the coordination of the Party’s ongoing regulatory responsibilities with respect to Licensed Products.