Conformity with FDA regulations and cGMP’s Sample Clauses

Conformity with FDA regulations and cGMP’s. Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, DPT warrants that all Products shall have been manufactured by DPT in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act.
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Conformity with FDA regulations and cGMP’s. Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, DPT warrants that all Products manufactured, held for sale, sold and shipped pursuant to this Agreement shall have been manufactured and shipped by DPT in substantial compliance with all applicable state and federal laws including, without limitation, FDA regulations and current, written Good Manufacturing Practices. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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Conformity with FDA regulations and cGMP’s. Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, DPT warrants that all Products manufactured, packaged, labeled, held for sale, and/or shipped pursuant to this Agreement shall have been manufactured, packaged, labeled, held for sale, and/or shipped by DPT in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act and any other applicable Texas law or FDA regulation. DPT warrants that no Product manufactured pursuant to this Agreement shall be adulterated or misbranded under the Act and that ownership and operation of its manufacturing, Packaging, Labeling and shipping facilities shall be in compliance with current Good Manufacturing Practices and applicable laws and FDA regulations. DPT further warrants and represents that none of its employees or representatives who will perform services pursuant to his Agreement have been debarred or are under consideration to be debarred by the United States Food and Drug Administration from working in or providing services to any pharmaceutical or biotechnology company under the Generic Drug Enforcement Act of 1992, as amended.
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Conformity with FDA regulations and cGMP’s. Subject to CUTANEA’s compliance with the provisions set forth in Section 5.2 and Section 5.4 hereof, Supplier warrants that all Products Manufactured, held for sale, sold and shipped pursuant to this Agreement shall have been Manufactured and shipped by Supplier in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act.
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Conformity with FDA regulations and cGMP’s. Subject to the provisions set forth in paragraphs 6.2 and 6.4 hereof, AMIDE represents and warrants that all Product manufactured, packaged, held for sale, stored, sold and shipped pursuant to this Agreement shall have been Manufactured, packed, stored and shipped by AMIDE in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act, the Specifications and all other applicable Laws, and shall not be adulterated, mismarked or otherwise be violative of any Laws.
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Conformity with FDA regulations and cGMP’s. Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, HARMONY warrants that all Products manufactured, held for sale, sold and shipped pursuant to this Agreement shall have been manufactured and shipped by HARMONY in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act.
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Related to Conformity with FDA regulations and cGMP’s

  • Conformity with Applicable Law The Manager, in the performance of its duties and obligations under this Agreement, shall act in conformity with the Registration Statement of the Trust and with the instructions and directions of the Board of Trustees of the Trust and will conform to, and comply with, the requirements of the 1940 Act and all other applicable federal and state laws and regulations.

  • Conformity with XXXXX Filing The Prospectus delivered to the Agent for use in connection with the sale of the Placement Shares pursuant to this Agreement will be identical to the versions of the Prospectus created to be transmitted to the Commission for filing via XXXXX, except to the extent permitted by Regulation S-T.

  • Conformity with Plan This Agreement is intended to conform in all respects with, and is subject to all applicable provisions of, the Plan. Inconsistencies between this Agreement and the Plan shall be resolved in accordance with the terms of the Plan. In the event of any ambiguity in this Agreement or any matters as to which this Agreement is silent, the Plan shall govern. A copy of the Plan is available upon request to the Administrator.

  • Compliance with Applicable Laws, Rules and Regulations The Dealer Manager represents to the Company that (a) it is a member of FINRA in good standing, and (b) it and its employees and representatives who will perform services hereunder have all required licenses and registrations to act under this Agreement. With respect to its participation and the participation by each Participating Dealer in the offer and sale of the Offered Shares (including, without limitation, any resales and transfers of Offered Shares), the Dealer Manager agrees, and, by virtue of entering into the Participating Dealer Agreement, each Participating Dealer shall have agreed, to comply with any applicable requirements of the Securities Act and the Exchange Act, applicable state securities or blue sky laws, and, specifically including, but not in any way limited to, NASD Conduct Rules 2340 and 2420, and FINRA Conduct Rules 2310, 5130 and 5141.

  • Conformity with EXXXX Filing The Prospectus delivered to the Agent for use in connection with the sale of the Placement Shares pursuant to this Agreement will be identical to the versions of the Prospectus created to be transmitted to the Commission for filing via EXXXX, except to the extent permitted by Regulation S-T.

  • Compliance with Regulatory Requirements Upon demand by Lender, Borrower shall reimburse Lender for Lender’s additional costs and/or reductions in the amount of principal or interest received or receivable by Lender if at any time after the date of this Agreement any law, treaty or regulation or any change in any law, treaty or regulation or the interpretation thereof by any Governmental Authority charged with the administration thereof or any other authority having jurisdiction over Lender or the Loans, whether or not having the force of law, shall impose, modify or deem applicable any reserve and/or special deposit requirement against or in respect of assets held by or deposits in or for the account of the Loans by Lender or impose on Lender any other condition with respect to this Agreement or the Loans, the result of which is to either increase the cost to Lender of making or maintaining the Loans or to reduce the amount of principal or interest received or receivable by Lender with respect to such Loans. Said additional costs and/or reductions will be those which directly result from the imposition of such requirement or condition on the making or maintaining of such Loans.

  • Compliance with Applicable Laws and Regulations (a) The Company shall not be required to issue or deliver any Shares pursuant to this Agreement pending compliance with all applicable federal and state securities and other laws (including any registration requirements or tax withholding requirements) and compliance with the rules and practices of any stock exchange upon which the Company’s Shares are listed.

  • Conformity with TIA Each amendment of this Indenture executed under this Article IX will conform to the requirements of the TIA as then in effect so long as this Indenture is qualified under the TIA.

  • Compliance with Laws, Rules and Regulations Tenant, at its sole cost and expense, shall comply with all laws, ordinances, orders, rules and regulations of state, federal, municipal, or other agencies or bodies having jurisdiction over use, condition, and occupancy of the Leased Premises. Tenant must use and maintain the Leased Premises in a clean, careful, safe, and proper manner and in compliance with all Applicable Laws, including Applicable Laws pertaining to health, safety, disabled persons, and the environment; provided, however, that Tenant shall not be required to make any structural changes or repairs to the Leased Premises unless the need for such structural changes or repairs is caused by Tenant, its agents, employees, invitees, or others for whom Tenant is responsible pursuant to the terms and provisions of this Lease. Notwithstanding anything to the contrary contained elsewhere in this section, it is expressly agreed and understood that Tenant’s obligation to comply with all Applicable Laws does not apply to any violations of Applicable Laws that (a) were in effect and (b) were being violated or with which the Leased Premises was not in compliance immediately prior to the time Tenant accepted the Leased Premises, including without limitation any existing environmental contamination. Tenant will comply with the rules and regulations of the Leased Premises adopted by Landlord in its reasonable discretion. All such rules and regulations and changes and amendments thereto will be sent by Landlord to Tenant in writing and shall thereafter be carried out and observed by Tenant.

  • Compliance with Laws and Regulations (a) The exercise of this option and the issuance of the Option Shares upon such exercise shall be subject to compliance by the Corporation and Optionee with all applicable requirements of law relating thereto and with all applicable regulations of any stock exchange (or the Nasdaq National Market, if applicable) on which the Common Stock may be listed for trading at the time of such exercise and issuance.

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