Between Gilead and its CMOs Sample Clauses

Between Gilead and its CMOs. During the term of this TDA, Gilead shall have quality agreements in place with each of its Contract Manufacturers that Manufacture Territory Combination Product for supply hereunder. Such quality agreements shall, at a minimum, have terms governing GMP compliance as are customary in the pharmaceutical industry.
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Between Gilead and its CMOs. During the term of this JDA with respect to one or more countries, Gilead shall have quality agreements in place with each of its Contract Manufacturers that Manufacture Territory Combination Product for supply under this JDA, and those that Manufacture the API (other than Supplied RPV) contained therein. Such quality agreements shall, at a minimum, have terms governing GMP compliance as are customary in the pharmaceutical industry.

Related to Between Gilead and its CMOs

  • Strategy As an organization without operational services (fuel, maintenance, etc.), and in consideration that the majority of potential issues come from boat maintenance whereby the boats are personal property, the predominant strategy will be the minimization of on-site waste. With this approach, the organization will have minimal potential impact on the environment and reduce regulatory risk. To accomplish this, requirements will be established by policy, periodic communications shall occur, and audits will be utilized to provide feedback for improvement.

  • Pro Forma Financial Information The pro forma financial statements included in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus include assumptions that provide a reasonable basis for presenting the significant effects directly attributable to the transactions and events described therein, the related pro forma adjustments give appropriate effect to those assumptions, and the pro forma adjustments reflect the proper application of those adjustments to the historical financial statements amounts in the pro forma financial statements included in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus. The pro forma financial statements included in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus comply as to form in all material respects with the application requirements of Regulation S-X under the Exchange Act.

  • Value Engineering The Supplier may prepare, at its own cost, a value engineering proposal at any time during the performance of the contract. The value engineering proposal shall, at a minimum, include the following; a) the proposed change(s), and a description of the difference to the existing contract requirements; b) a full cost/benefit analysis of the proposed change(s) including a description and estimate of costs (including life cycle costs) the Procuring Entity may incur in implementing the value engineering proposal; and c) a description of any effect(s) of the change on performance/functionality.

  • Capitalization of the Company and its Subsidiaries The Company's authorized capital stock consists solely of (a) 20,000,000 shares of common stock, $0.05 par value per share ("Company Common Stock"), and (b) 10,000,000 shares of preferred stock, $1.00 par value per share ("Company Preferred Stock"). As of October 31, 1997, (i) 3,891,981 shares of Company Common Stock were issued and outstanding, (ii) 201,385 shares of Company Common Stock were issuable upon the exercise of outstanding options, an additional 230,749 shares of Company Common Stock were issuable upon the exercise of options that are not currently outstanding but are reserved for issuance upon the designation of optionees by the Board of Directors of the Company and 154,175 shares of Company Common Stock were issuable upon the exercise or conversion of outstanding warrants or convertible securities granted or issuable (on a contingent basis or otherwise) by the Company, and (iii) no shares of Company Preferred Stock were issued and outstanding. Since October 31, 1997, except as disclosed in Section 4.4 of the Company Disclosure Schedule, the Company has not issued any shares of its capital stock except upon the exercise of such options, warrants or convertible securities. Each outstanding share of capital stock of the Company and each Subsidiary is duly authorized and validly issued, fully paid and nonassessable and free of any preemptive rights. As of the date hereof, other than as set forth above, in the Company SEC Documents (as defined in Section 4.7) or in Section 4.4 to the Company Disclosure Schedule, there are no outstanding shares of capital stock or subscriptions, options, warrants, puts, calls, agreements, understandings, claims or other commitments or rights of any type relating to the issuance, sale or transfer by the Company or either Subsidiary of any securities of the Company or either Subsidiary, nor are there outstanding any securities which are convertible into or exchangeable for any shares of capital stock of the Company or either Subsidiary; and neither the Company nor either Subsidiary has any obligation of any kind to issue any additional securities or to pay for securities of the Company or either Subsidiary or any predecessor. The Company has no outstanding bonds, debentures, notes or other similar obligations the holders of which have the right to vote generally with holders of Company Common Stock.

  • Financial Forecasts You understand that any financial forecasts or projections are based on estimates and assumptions we believe to be reasonable but are highly speculative. Given the industry, our actual results may vary from any forecasts or projections.

  • Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.

  • Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.‌ (i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. (ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.

  • Certified and Minority Business Enterprises Reports Upon Customer request, the Contractor shall report to the requesting Customer the Contractor’s spend with certified and other minority business enterprises in the provision of commodities or services related to the Customer’s orders. These reports shall include the period covered, the name, minority code, and Federal Employer Identification Number of each minority business utilized during the period; commodities and services provided by the minority business enterprise, and the amount paid to each minority business enterprise on behalf of the Customer.

  • Strategies The ESC will seek to achieve employment stability strategies as follows: - current and multi-year strategies should be developed within the resources available. Such strategies could include, but not necessarily be limited to, planning, retraining, identifying ways of determining employees= skills, training and experience previously achieved, early retirement, voluntary exit programs, alternative assignment, secondment, employee career counselling, job sharing, job trading, job shadowing, and professional development; - discussions between the parties which explore these possible strategies would assist in the development of appropriate enhancements to Employment Stability; - data which is relevant to employment stability shall be made available to both parties.

  • Return of Products No Products or part shall be returned to Seller without an approved Return Goods Authorization (“RMA”) from Seller. Custom and special order Products are non-returnable. Returns are subject to a restocking fee.

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