cGMP Guidelines Sample Clauses

cGMP Guidelines cGMP guidelines shall include the principles detailed in the US Current Good Manufacturing Practices (21 CFR 210 and 211) and any other similar regulations in other countries in which REGULATORY APPROVAL has been obtained that cover the THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. standards of manufacture for any product intended for human use, as well as the Product Specifications, REGULATORY APPROVAL and any applicable product license, ANDA or NDA application, pharmacopoeia or formulary requirements.
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cGMP Guidelines cGMP guidelines shall include the principles detailed in the US Current Good Manufacturing Practices (21 CFR 210 and 211) that cover the standards of manufacture for any product intended for human use, as well as the Product Specifications and any applicable product license, the NDA application, pharmacopoeia or formulary requirements.
Sample 1
cGMP Guidelines. The principles detailed in the United States Current Good Manufacturing Practices (21 CFR, parts 210 and 211), as amended from time to time, will cover the standards of manufacture of BMIPP, as well as the product specifications and any applicable product license.
Sample 1
cGMP Guidelines. All systems used to Manufacture and supply Bulk Substance must be in compliance with the principles detailed in Section 1 of the [***] QTA. All systems used for manufacturing/testing oversight, batch release and certification at Sanofi must be in compliance with cGMPs. In addition to what is specified in Section 1 of the [***] QTA, KaloBios and Sanofi agree to jointly discuss any region-specific Chemistry, Manufacturing and Controls (“CMC”) requirements and their implementation in batches intended for KaloBios’ use, provided such requirements are communicated to Sanofi [***] prior to commencement of Manufacturing, or such longer time as may be required by Sanofi’s subcontractor.
Sample 1
cGMP Guidelines. All systems used to Manufacture and supply Filled Drug Product must be in compliance with the principles detailed in the Sanofi Internal Quality Agreement (Appendix 4). All systems used for Manufacturing/testing oversight, batch release and certification at Sanofi must be in compliance with cGMP. In addition to the principles specified above, KaloBios and Sanofi agree to jointly discuss any region-specific Chemistry, Manufacturing and Controls (“CMC”) requirements and their implementation in batches intended for KaloBios’ use, provided such requirements are communicated to Sanofi [***] prior to commencement of Manufacturing, or such longer time as may be required by Sanofi’s subcontractor.
Sample 1

Related to cGMP Guidelines

  • Guidelines The Corporation shall pay all expenses of operating, maintaining and repairing the automobile and shall procure and maintain automobile liability insurance in respect thereof, with such coverage insuring each Employee for bodily injury and property damage.

  • Trading Guidelines BNYMCM may, to the extent permitted under the Securities Act and the Exchange Act, purchase and sell Common Stock for its own account while this Agreement is in effect provided that (i) no such purchase or sale shall take place while an Issuance Notice is in effect (except to the extent BNYMCM may engage in sales of Issuance Shares purchased or deemed purchased from the Company as a “riskless principal” or in a similar capacity), (ii) in no circumstances shall BNYMCM have a short position in the Common Stock for its own account and (iii) the Company shall not be deemed to have authorized or consented to any such purchases or sales by BNYMCM. The Company hereby acknowledges and agrees that BNYMCM’s Affiliates may, subject to compliance with Regulation M under the Exchange Act and Section 5 of the Securities Act, if applicable, make markets in the Common Stock or other securities of the Company, in connection with which they may buy and sell, as agent or principal, for long or short account, shares of Common Stock or other securities of the Company, at the same time BNYMCM is acting as agent pursuant to this Agreement.

  • Collection Guidelines As long as it is the Servicer, CAC will comply in all material respects with the Collection Guidelines or otherwise as required by Applicable Law in regard to each Loan and Contract.

  • Investment Guidelines In addition to the information to be provided to the Sub-Advisor under Section 2 hereof, the Trust or the Advisor shall supply the Sub-Advisor with such other information as the Sub-Advisor shall reasonably request concerning the Fund’s investment policies, restrictions, limitations, tax position, liquidity requirements and other information useful in managing the Fund’s investments.

  • Policies and Procedures The employment relationship between the Parties shall be governed by the general employment policies and practices of the Company, except that when the terms of this Agreement differ from or are in conflict with the Company’s general employment policies or practices, this Agreement shall control.

  • Accounting Policies and Procedures Permit any change in the accounting policies and procedures of the Company or any Guarantor, including a change in fiscal year, provided, however, that any policy or procedure required to be changed by the Financial Accounting Standards Board (or other board or committee thereof) in order to comply with Generally Accepted Accounting Principles may be so changed.

  • Compliance Policies and Procedures To assist the Fund in complying with Rule 38a-1 of the 1940 Act, BBH&Co. represents that it has adopted written policies and procedures reasonably designed to prevent violation of the federal securities laws in fulfilling its obligations under the Agreement and that it has in place a compliance program to monitor its compliance with those policies and procedures. BBH&Co will upon request provide the Fund with information about our compliance program as mutually agreed.

  • Adherence to Inside Information Policies The Executive acknowledges that the Company is publicly-held and, as a result, has implemented inside information policies designed to preclude its executives and those of its subsidiaries from violating the federal securities laws by trading on material, non-public information or passing such information on to others in breach of any duty owed to the Company, or any third party. The Executive shall promptly execute any agreements generally distributed by the Company to its employees requiring such employees to abide by its inside information policies.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Wire Transfer Operating Guidelines Articles 4A of the Uniform Commercial ------------------------------------------------------------------------ Code ----

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