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.
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.
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.

Related to FDA and Other Regulations

  • Pollution and Other Regulations Each of the Credit Parties:

  • Government and Other Regulations This Option is subject to all laws, regulations and orders of any governmental authority which may be applicable thereto and, notwithstanding any of the provisions hereof, the Holder agrees that the Holder will not exercise the Option granted hereby nor will the Company be obligated to issue or sell any shares of stock hereunder if the exercise thereof or the issuance or sale of such shares, as the case may be, would constitute a violation by the Holder or the Company of any such law, regulation or order or any provision thereof. The Company shall not be obligated to take any affirmative action in order to cause the exercise of this Option or the issuance or sale of shares pursuant hereto to comply with any such law, regulation, order or provision.

  • Regulatory and Other Approvals Purchaser will (a) take all reasonable steps necessary or desirable, and proceed diligently and in good faith and use all reasonable efforts, at the earliest commercially practicable dates, to obtain all consents, approvals or actions of, to make all filings with and to give all notices to Governmental or Regulatory Authorities or any other Person required of Purchaser to consummate the transactions contemplated hereby and by the Operative Agreements, including those described in Section 3.03 of the Disclosure Schedule and Purchaser Required Regulatory Approvals or for Purchaser to own, operate or maintain, on and after the Closing, the Assets substantially as such assets are currently owned, operated and maintained by Seller, (b) provide such other information and communications to such Governmental or Regulatory Authorities or other Persons as such Governmental or Regulatory Authorities or other Persons may reasonably request in connection therewith and (c) provide reasonable cooperation to Seller in obtaining Seller Required Regulatory Approvals and all other consents, approvals or actions of, making all filings with and giving all notices to Governmental or Regulatory Authorities or other Persons required of Seller to consummate the transactions contemplated hereby and by the Operative Agreements. Prior to making any filings with a Governmental or Regulatory Authority pursuant to this Section 5.01, Purchaser agrees to provide copies of such filings to Seller. Nothing in this Agreement shall require Purchaser to institute litigation or to pay or agree to pay any sum of money or make financial accommodations (other than the payment or incurrence of customary expenses and filing or other fees) in order to obtain any necessary consent, approval or authorization including, without limitation, the Purchaser Required Regulatory Approvals. Purchaser will provide prompt notification to Seller 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 Seller of any communications (and, unless precluded by Law, provide copies of any such communications that are in writing) with any Governmental or Regulatory Authority or other Person regarding any of the transactions contemplated by this Agreement or any of the Operative Agreements.

  • Regulatory and Other Authorizations Each party hereto shall use its commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of any Governmental Authority that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals.

  • Regulatory and Other Matters (a) The parties shall, and shall cause their respective Subsidiaries to, cooperate with each other and use their respective commercially reasonable efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings with any Third Party or Governmental Entity and to take any further actions reasonably requested by the other party to obtain as promptly as practicable the Required Approvals and other consents required to be obtained in connection with the Merger and the other transactions contemplated by this Agreement. MDLY and SIC shall have the right to review in advance, and, to the extent practicable, each will consult with the other on, in each case subject to Applicable Laws relating to the confidentiality of information, all information relating to MDLY or SIC, as the case may be, and any of their respective Subsidiaries, that appear in any filing made with, or written materials submitted to, any Third Party or any Governmental Entity in connection with obtaining the Required Approvals. In exercising the foregoing right, each of the parties shall act reasonably and as promptly as reasonably practicable. The parties shall consult with each other with respect to the obtaining of the Required Approvals and each party will keep the other apprised of the status of matters relating to completion of the transactions contemplated by this Agreement.

  • Regulatory and Other Notices Promptly after Borrower’s receipt thereof, copies of any notices or other communications received from any Governmental Authority with respect to any matter or proceeding the effect of which could reasonably be expected to have a Material Adverse Effect.

  • 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;

  • Government and Other Approvals No approval, consent, exemption or other action by, or notice to or filing with, any governmental authority is necessary in connection with the execution, delivery or performance of the Loan Documents required hereunder.

  • 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.

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