Regulatory Support. LTC will support HTG’s efforts to obtain Regulatory Approval before each Regulatory Authority as follows:
(a) within 30 days of HTG’s written request for same, provide HTG with a letter authorizing the Regulatory Authority (i) to reference and incorporate, as appropriate, into HTG’s filings the Documentation and LTC’s Device Master Record for the LTC Instrument or LTC Software, and (ii) to reproduce, make derivatives of, and incorporate the Documentation and the Device Master Record specified in that letter in connection with preparing, submitting, and prosecuting any filings in furtherance of Regulatory Approval;
(b) use commercially reasonable efforts to provide HTG with and relevant, applicable information related to LTC Instruments, LTC Software and LTC Consumables in the event such information is required by a Regulatory Authority in HTG’s submission of the HTG Assay to a Regulatory Authority;
(c) use commercially reasonable efforts to provide directly to the Regulatory Authority any Documentation requested by a Regulatory Authority in connection with in HTG’s submission of the HTG Assay to a Regulatory Authority;
(d) allow HTG or a Regulatory Authority to audit the relevant portion(s) of LTC’s facility(ies) where the LTC Products are manufactured, tested or stored, upon 45 days prior written notice (or such shorter period as may be required to comply with requested or ordered inspections by a Regulatory Authority), during normal business hours, no more often than one time per calendar year or more often as required of HTG by any Regulatory Authority, and at HTG’s sole expense, only to the extent necessary to satisfy HTG’s obligations under applicable law. LTC will reasonably cooperate in the conduct of any such audit. The locations, times, and dates for such audits will be mutually agreed upon in writing between the Parties before conducting the audit. HTG will comply with LTC’s reasonable requirements and directions for the conduct of the audit, including LTC’s obligation to protect its confidential information and that of its other clients. In certain cases, LTC may require that its standard confidentiality agreement is executed in advance of any such audit. LTC will maintain adequate records in accordance with applicable law relating to the manufacture and testing of LTC Products for no less than five years from the end of the calendar quarter in which the LTC Products to which they pertain were shipped to HTG. HTG will provide a confidential writ...
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. 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 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. 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 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. 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.
2.2.1.2 The Parties shall consult with each other concerning the scope and content of all regulatory filings, and shall jointly define the requirements for the necessary PRODUCT registration with the FDA so that BI RCV shall be able to fulfill its obligations under this AGREEMENT with respect to the CMC portion of such PRODUCT registration. With respect to any part of the CMC portion which contains BI RCV and/or BI Pharma KG INFORMATION, BI RCV shall be provided an opportunity to review and comment on such parts prior to submission to a HEALTH AUTHORITY as set forth in the QUALITY AGREEMENT.
Regulatory Support. Upon the request of Buyer, Seller shall be required to provide reasonable assistance to Buyer in connection with any regulatory or other governmental proceeding, including any proceeding in which Buyer is seeking to recover in rates any amounts paid by it to Seller under this Agreement and the Utility Agreements. Such reasonable assistance shall include assistance in response to discovery requests from the regulatory authority or intervening parties, the production of documents or other information made the subject of a reasonable request, and written or oral testimony before the regulatory authority. Buyer shall reimburse Seller for all reasonable expenses, including out-of-pocket and internal costs actually incurred by Seller pursuant to this Section 9.3.
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. 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. Except as otherwise expressly set forth herein, Sequenom shall be responsible for all filings necessary for approval to market Sequenom Products. Supplier agrees to promptly provide to Sequenom such information relating to the Supplier Products or the manufacture thereof as may be reasonably necessary or useful in connection therewith, all at Sequenom’s expense.
