Regulatory Support Clause Samples
The Regulatory Support clause outlines the obligations of one or both parties to assist each other in complying with relevant laws, regulations, or government requirements related to the agreement. This may involve providing necessary documentation, responding to regulatory inquiries, or updating procedures to meet new legal standards. Its core function is to ensure that both parties can effectively navigate regulatory environments, reducing the risk of non-compliance and associated penalties.
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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. To the extent practicable, Eagle shall notify MDCO within ten (10) business days prior to any inspection (of which Eagle is aware) by the FDA or other regulatory agency relating to Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder and, within twenty-four (24) hours after such inspection, shall furnish MDCO with a copy of all documentation, including any Form 483 and the Third Party Manufacturer’s response thereto, relating to such inspection. In addition, Eagle shall notify MDCO within five (5) business days after its receipt of any other written regulatory actions or communications (other than ministerial, non-substantive communications) relating to the Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder. The Parties shall confer with each other with respect to any response regarding such action or communication and the best means to comply with such action or communication, but the final response shall be within Eagle’s final decision-making authority.
Regulatory Support. Upon either Party's request, the other Party shall support any reasonable efforts by the requesting party to protect and preserve the Licenses and Channels, including lobbying the FCC or any other Governmental Authority to oppose any rulemakings or other proceedings that would adversely affect the Licenses or Channels and the rights of Licensee and Clearwire to hold and use the Licenses and Channels as contemplated by this Agreement.
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. Upon request, Supplier shall provide information necessary for ▇▇▇▇ to obtain regulatory approval for the marketing, sale, and distribution of ▇▇▇▇ 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. ▇▇▇▇▇▇▇ or the respective sub-distributors of ▇▇▇▇▇▇▇ shall provide BIOMATERIALI with all reasonable required support to comply with any local regulatory law and requirement including but not limited to assisting and executing all documents necessary to satisfy all regulatory requirements in the jurisdictions in which the Products are distributed, whenever is mandatory or necessary to register the Products in such country.
Regulatory Support. Except as otherwise expressly set forth herein, Senti shall be responsible for all filings necessary for approval to conduct clinical trials of and market Products. Provider will provide to Senti such Services as stated in the applicable SoW for cooperation with reporting obligations and/or the provision of information relating to the Product or the Manufacture, including the Manufacturing Process, thereof as may be necessary or useful for Senti to apply for, obtain and maintain Regulatory Approvals for each Product in any country or regulatory jurisdiction, including, without limitation, information relating to the Facilities, or the process, methodology, raw materials and intermediates used in the Manufacture of each Product and all information required to be submitted in the CMC section of an IND or a BLA or other regulatory filings, or required or requested to be provided to any Regulatory Authority. No later than six (6) months or such shorter period as may be required under relevant regulations following completion or permanent cessation of the Services at the applicable Facility, Senti shall: (a) file an update to any applicable regulatory filings relating to the Product to indicate a change in manufacturer; and (b) provide to Provider written confirmation of its compliance with this sentence.
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.
(b) Notwithstanding the above or anything in this Agreement or Appendix E to the contrary, ORPHAN is solely responsible for (i) its use of any documentation provided by Catalytica, including without limitation use in any regulatory submission to the FDA or any other regulatory agency inside or outside of the United States, (ii) document control and retention, (iii) determining the suitability of any documentation provided by Catalytica hereunder for use in any regulatory submission; and (iv) all regulatory submission, CMC and other regulatory strategies.
(c) Catalytica may, at its option, retain copies of any documentation [ * ] = 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. provided to ORPHAN hereunder; provided, however, that Catalytica cannot and does not provide any assurances that Catalytica’s records will match or otherwise correspond to any submission that ORPHAN may provide to the FDA or any other regulatory agency inside or outside the United States.
(d) ORPHAN shall provide Catalytica with all documents reasonably requested by Catalytica relating to the FDA’s pre-approval inspection of Catalytica’s manufacturing facility, including, but not limited to, development reports, CMC sections of ORPHAN’S NDA and stability data. In addition, ORPHAN shall provide to Catalytica at least thirty (30) days prior to filing with the FDA a copy of ORPHAN’S annual report (see 21 C.F.R. Section 314.81(b)(2)(iv)) with respect to the manufacture and control of the Product [ * ]. Notwithstanding the foregoing or anything in this Agreement to the contrary, ORPHAN shall be solely respons...
Regulatory Support. Fujifilm will provide routine regulatory support to Sponsor for the Program directly related to Drug Substance at Sponsor’s request that will include:
I. Review and comment on the initial and the routine [***];
II. Support of [***] and responses to any [***];
III. Updates to [***]; and
IV. Site [***]. Any additional regulatory support, including without limitation support of any regulatory submissions outside of the United States, [***], which exceeds reasonable expectations of the Parties established upon Agreement execution, will be mutually agreed upon by the parties and provided by Fujifilm based on a Change Order or separate agreement.
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.