FDA and Other Regulations Sample Clauses

FDA and Other Regulations. COMPANY represents and warrants that any Products made or Sold by COMPANY or its Affiliates pursuant to this Agreement shall comply with all applicable federal and state law regulations, including but not limited to regulations of the Federal Drug Administration, the Environmental Protection Agency, and their state equivalents. COMPANY further warrants to include in any sublicense agreement in which a Sublicensee is granted the right to make and sell Licensed Products, that such agreement shall include a comparable covenant by the Sublicensee.
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FDA and Other Regulations. Except as set forth in Schedule 2.07, ReGen, and the products sold and intended to be sold by ReGen, are in compliance in all material respects with all current and otherwise applicable statutes, rules, regulations, standards, guides or orders administered or issued by the Federal Drug and Food Administration or other applicable regulatory bodies. Except as set forth in Schedule 2.07, ReGen does not know of any facts which are reasonably likely to cause: (a) the denial, withdrawal, recall or suspension of any product sold or intended to be sold by ReGen, (b) a change in the marketing classification or labeling of any such products, or (c) a termination or suspension of the marketing of any such products.
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FDA and Other Regulations. Any Sublicensee shall represent and warrant that any Licensed Products made or sold by it or its Affiliates under this license shall comply with all applicable federal and state law regulations, including but not limited to regulations of the Federal Drug Administration, the Environmental Protection Agency, and their state equivalents.
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FDA and Other Regulations. DERMAdoctor, and its products, including each of the products in each of the jurisdictions listed in Schedule 4.22 of the Disclosure Schedules, are and have been in compliance with all applicable Laws administered or issued by the FDA, European Medicines Agency or any similar Governmental Authority, including the Federal Food, Drug, and Cosmetic Act Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (as implemented into the national Laws of EU Member States), and all other applicable Laws regarding developing, testing, manufacturing, marketing, distributing or promoting, labeling, or complaint handling or adverse event reporting in connection with the Business Products.
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Related to FDA and Other Regulations

  • Pollution and Other Regulations Each of the Credit Parties:

  • Regulatory and Other Approvals Seller will (a) proceed diligently and in good faith and use its best efforts, as promptly as practicable, to obtain all consents, approvals or actions of, to make all filings with and to give all notices to Governmental Authorities or any other Person required of Seller, including without limitation any consents required with respect to Seller’s interests in Assumed Contracts, to consummate the transactions contemplated hereby and by the Related Agreements, (b) provide such other information and communications to such Governmental Authorities or other Persons as Buyer or such Governmental Authorities or other Persons may reasonably request in connection therewith and (c) cooperate with Buyer as promptly as practicable in obtaining all consents, approvals or actions of, making all filings with and giving all notices to Governmental Authorities or other Persons required of Buyer to consummate the transactions contemplated hereby and by the Related Agreements. Seller will provide prompt notification to Buyer when any such consent, approval, action, filing or notice referred to in clause (a) above is obtained, taken, made or given, as applicable, and will advise Buyer of any communications (and, unless precluded by Law, provide copies of any such communications that are in writing) with any Governmental Authority or other Person regarding any of the transactions contemplated by this Agreement or any of the Related Agreements. Seller knows of no reason relating to Seller why the approvals, consents or waivers of governmental authorities required to complete the transactions contemplated hereby will not be obtained in a timely manner.

  • Compliance with Laws and Other Requirements (A) Tenant shall cause the Premises to comply in all material respects with all laws, ordinances, regulations and directives of any governmental authority having jurisdiction including, without limitation, any certificate of occupancy and any law, ordinance, regulation, covenant, condition or restriction affecting the Building or the Premises which in the future may become applicable to the Premises (collectively "Applicable Laws").

  • SEC and Other Reports promptly upon their becoming available, one copy of (i) each financial statement, report, notice or proxy statement sent by the Company or any Subsidiary to public securities holders generally, and (ii) each regular or periodic report, each registration statement (without exhibits except as expressly requested by such holder), and each prospectus and all amendments thereto filed by the Company or any Subsidiary with the Securities and Exchange Commission and of all press releases and other statements made available generally by the Company or any Subsidiary to the public concerning developments that are Material;

  • System Protection and Other Control Requirements Developer shall provide, install and test relay protection systems at the Merchant Transmission Facility to interface with those systems installed by Connecting Transmission Owner at the West 49th Street Substation.

  • Non-Discrimination and Other Requirements A. Section 504 applies only to Contractor who are providing services to members of the public. Contractor shall comply with § 504 of the Rehabilitation Act of 1973, which provides that no otherwise qualified handicapped individual shall, solely by reason of a disability, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination in the performance of this Agreement.

  • Other Regulations No Borrower or any Material Subsidiary is subject to regulation under the Investment Company Act of 1940, the Public Utility Holding Company Act of 1935, the Federal Power Act, the Interstate Commerce Act, any state public utilities code or any other Governmental Rule that limits its ability to incur Indebtedness.

  • Bills and Other Disbursements Upon receipt of Instructions, the Custodian shall pay, or cause to be paid, all bills, statements, or other obligations of a Fund.

  • Financial and Other Reports 6 (A) Owner/IRS Relationship. Owner is required to file all required Internal Revenue Service (IRS) 7 forms and meet all IRS requirements. Owner agrees to provide Broker with appropriate IRS forms (e.g., W-9) 8 before any funds are disbursed to Owner.

  • Utilities and Other Services 4.4.1 The Tenant shall arrange, at its own cost and expense, for the installation, connection and supply of all utilities and any other services required by it at or in relation to the Premises.

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