IDE Filing and Support Sample Clauses

IDE Filing and Support. RGI shall provide evidence and data related to the analytical and clinical validation of the BRAF Assay, and other assistance reasonably requested by GSK, to support submission of an IDE for the development of a Product designated as Investigational Use Only (“IUO”) for use in the conduct of clinical trials in accordance with 21 C.F.R. Part 809.10. Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omissions have been indicated by asterisks (“[***]”), and the omitted text has been filed separately with the Securities and Exchange Commission.
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Related to IDE Filing and Support

  • Training and Support Distributor shall train and support its personnel or subcontractors for the satisfactory completion of its obligations under this Agreement. Supplier will assist in training by furnishing Distributor with English training literature. Supplier may, at his sole discretion, provide Distributor with his own personnel for training.

  • Office and Support Staff During the Employment Period, the Executive shall be entitled to an office or offices of a size and with furnishings and other appointments, and to exclusive personal secretarial and other assistance, at least equal to the most favorable of the foregoing provided to the Executive by the Company and its affiliated companies at any time during the 120-day period immediately preceding the Effective Date or, if more favorable to the Executive, as provided generally at any time thereafter with respect to other peer executives of the Company and its affiliated companies.

  • Maintenance and Support Services Distributor shall provide Maintenance and Support Services to all of its Customers of Licensed Software as set forth in Sections 3.4(a) and 3.4(b) below. Distributor may require Customers to provide the own First-Line Support: however, in no event shall Siebel be responsible for First-Line or Second-Line Support. Subject to Distributor's payment of the Maintenance Fees set forth in EXHIBIT A Siebel shall provide Third-Line Support to Distributor in accordance with Siebel's then current Maintenance and Support Services Policy. Distributor shall be responsible for all support related to the Value Added Offering.

  • Maintenance and Support Licensee is solely responsible for providing all maintenance and support to its customers of the Licensed Products. Licensor has, and shall have, no obligation to provide any maintenance or support to Licensee or any of Licensee’s customers with respect to any Technology and/or Licensed Products.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Website Hosting and Notice Fee (Expense Allocation). The Distributor (and/or the Trust) shall bear the costs of posting, maintaining and managing the Fund Documents on the website hosted by the Company and the costs of preparing and mailing notice of the availability of the Fund’s Reports to Contract Owners (the notices required by paragraph (c) of Rule 30e-3) through the payment of a semi-annual Website Hosting and Notice Fee to the Company.

  • Access to Information and Services ..28 Section 7.01. Provision of Corporate Records......................................................28 Section 7.02. Access to Information...............................................................28 Section 7.03.

  • Compliance Support Services Provide compliance policies and procedures related to services provided by BNY Mellon and, if mutually agreed, certain of the BNY Mellon Affiliates; summary procedures thereof; and periodic certification letters. · Such Compliance Support Services are administrative in nature and do not constitute, nor shall they be construed as constituting, legal advice or the provision of legal services for or on behalf of a Fund or any other person, and such services are subject to review and approval by the applicable Fund and by the Fund’s legal counsel. · Provide access to Fund records so as to permit the Fund or TRP to test the performance of BNY Mellon in providing the services under this Agreement. · Such Compliance Support Services performed by BNY Mellon under this Agreement shall be at the request and direction of the Fund and/or its chief compliance officer (the “Fund’s CCO”), as applicable. BNY Mellon disclaims liability to the Fund, and the Fund is solely responsible, for the selection, qualifications and performance of the Fund’s CCO and the adequacy and effectiveness of the Fund’s compliance program.

  • Access and Cooperation Each Party will, and will cause its Other Indemnified Persons to, cooperate and assist in all reasonable respects regarding such Third Party Claim, including by promptly making available to such other Party (and its legal counsel and other professional advisers with a reasonable need to know) all books and records of such Person relating to such Third Party Claim, subject to reasonable confidentiality precautions.

  • Transition Seller will not take any action that is designed or intended to have the effect of discouraging any lessor, licensor, customer, supplier, or other business associate of the Company from maintaining the same business relationships with the Company after the Closing as it maintained with the Company prior to the Closing. The Seller will refer all customer inquiries relating to the business of the Company to the Purchaser from and after the Closing.

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