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. 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. (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. 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. 3.2.1.1 BI agrees to co-operate with HORIZON in obtaining and maintaining all governmental approvals and registrations in the TERRITORY relevant to the chemistry, manufacturing and control (“CMC”) section of the registration dossier (and their foreign equivalents) for the PRODUCT as requested by HORIZON.
Regulatory Support. 5.3.1 TEKMIRA will be responsible for (a) designing and implementing stability study protocols for the testing of Investigational Medicinal Product and reporting out-of-specification results, if any, to OXFORD during the duration of the Clinical Trial; and (b) updating TEKMIRA’s regulatory filings for the Investigational Medicinal Product with all results generated in the performance of the stability studies. Parameters for the stability study design are set forth in Exhibit 5.3.1 attached hereto.
Regulatory Support. 6.1 BD shall provide to Buyer documentation related to the Product to support the marketing approval of Buyer’s End Product (the “Standard Regulatory Package”).
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.
