Regulatory Support. Upon request, Supplier shall provide information necessary for Xxxx to obtain regulatory approval for the marketing, sale, and distribution of Xxxx products into which Supplier's Products are incorporated. Such information may include specific details relating to raw materials, composition, ingredients, and other items.
Regulatory Support. If requested by CUMBERLAND, and at CUMBERLAND’S cost at reasonable fees to be agreed by the parties, FAULDING shall provide CUMBERLAND with reasonable assistance in relation to the Development of, and applications for regulatory approval for, pharmaceutical products other than the Drug Product which are identified by CUMBERLAND, including but not limited to the preparation of development reports, stability reports, manufacturing documentation and instructions for use necessary to support applications for regulatory approval.
Regulatory Support. 2.2.5.1. BI Austria shall provide all site-relevant documentation (both from itself and from BI Pharma KG) and all data relevant for compiling the CMC section necessary for InterMune's drafting of the BLA supplement required by the FDA due to the change of manufacturer for the GENENTECH PRODUCT. BI Austria agrees to co-operate with InterMune in obtaining and maintaining all US governmental approvals and registrations relevant to the CMC section of the registration dossier (and their foreign equivalents) as requested by InterMune.
Regulatory Support. In the event customer receives a direct request from a regulatory body with supervisory authority over Customer or Customer’s Affiliates (“Regulator”) to provide specific information related to its use of the Covered Service or such Regulator formally requires a direct right to audit Workday, Workday will use commercially reasonable efforts to support the Customer in responding to such Regulatory Support request, and prioritize any such request. For the avoidance of doubt, the scope of Regulatory Support assistance will be limited to the controls applicable to the Covered Service. If Customer requests an audit scope other than the specific requirement from the Regulator, Customer must acquire the Annual Audit and pay the Annual Audit Fee. The following topics are excluded from the Regulatory Support offering: • Subprocessor physical and environmental safeguards for data centers; • Subprocessor operational management of infrastructure platforms; and • Subprocessor data center tours.
Regulatory Support. Silence shall support AZ, as AZ may from time to time specifically request in writing to Silence, as may be reasonably necessary to file INDs for the Licensed Product and in the activities in support thereof, including providing all documents or other materials Controlled by Silence or any of its Affiliates as may be necessary or useful for AZ or any of its Affiliates or its or their Sublicensees to file INDs for the Licensed Product. Except to the extent prohibited by Applicable Law, all - 58 / 130 - Confidential regulatory documentation (including all Regulatory Approvals) relating to the Licensed Products with respect to the Territory developed or granted after the effective date of AZ’s exercise of the Option applicable to such Licensed Product shall be owned by and shall be held in the name of AZ or its designated Affiliate, Sublicensee or designee, and Silence, as of the Option Exercise Effective Date of such Option exercise, hereby assigns to AZ all of its right, title, and interest in and to all such regulatory documentation (including such Regulatory Approvals). On a per Licensed Product basis, under no circumstances shall Silence be required to expend more than [***] FTE hours in performing its obligations under this Section 8.5. Notwithstanding the foregoing, the Parties agree that the provision of all Manufacturing and CMC-related Information shall be governed by the terms of the Supply Agreement and not the terms of this Section 8.5.
Regulatory Support. (a) Catalytica will provide ORPHAN with standard regulatory support as identified under the heading “Regulatory Support” in Appendix E attached hereto. In addition, Catalytica shall provided ORPHAN with regulatory consulting services as identified under the heading “Regulatory Consulting” in Appendix E attached hereto. Regulatory support services, as identified in Appendix E, shall be at no additional charge to ORPHAN; regulatory consulting services shall be billed at Catalytica’s standard hourly rates and payable pursuant to Section 7.7 of this Agreement. Additional regulatory services and/or documentation may be provided by Catalytica, subject to agreement of the parties and subject to additional charges.
Regulatory Support. Bioverativ may request regulatory support that is related to the Manufacture of Drug Substance. Biogen shall use commercially reasonable efforts to provide the following support services and shall be reimbursed by Bioverativ for reasonable costs incurred in connection therewith and in accordance with Schedule 6 attached hereto: (a) providing regulatory information, drafts and filings that Biogen already has in its possession and (b) answering questions reasonably necessary for the preparation of regulatory filings for the products. For purposes of clarity, Biogen shall not be required to hire and/or transfer from other projects any regulatory full-time equivalents in order to meet the regulatory support needs described in this Section 12.1. In any event, Biogen will provide to Bioverativ free of charge copies of any regulatory filings prepared by Biogen relating to changes to Regulatory Approvals that arise from CMC-related changes for the products.
Regulatory Support. Except as otherwise expressly set forth herein, Talis shall be responsible for all filings necessary for approval to market Talis’ own products incorporating the Products. thX agrees to promptly provide to Talis such information relating to the Product or the manufacture thereof as may be necessary or useful in connection therewith.
Regulatory Support. 2.2.1.1 BI RCV agrees to co-operate with VIDARA in obtaining and maintaining all US governmental approvals and registrations relevant to the CMC section of the registration dossier (and their foreign equivalents) as requested by VIDARA.
Regulatory Support. Purchaser and Supplier shall use commercially reasonable efforts to respond to all reasonable requests for information from, and in making all required filings with, federal, state or local governmental or regulatory authorities having jurisdiction to make such requests or require such filings. Supplier shall obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by appropriate governmental and regulatory authorities with respect to the performance of its obligations hereunder.
