FD&C Act Matters Sample Clauses

FD&C Act Matters. Xxxxxx represents and covenants as of the date of this Agreement and continuously during the term of this Agreement that it is not debarred pursuant to Section 335(a) or 335(b) of the FD&C Act. Xxxxxx represents that it has not been debarred under the Act in the past five (5) years. Xxxxxx will not employ or use the services of any person or entity to perform the Production of Product who is debarred under the Act or to Xxxxxx’x knowledge has engaged in activities that could lead to being debarred under the Act.
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Related to FD&C Act Matters

  • Securities Act Matters Each Member understands that, in addition to the restrictions on transfer contained in this Agreement, he or she must bear the economic risks of his or her investment for an indefinite period because the Interests have not been registered under the Securities Act.

  • Patent Matters Exhibit A is an accurate listing by owner, inventor(s), serial number, filing date, country, and status of all patents and patent applications Controlled by Pfenex as of the Effective Date that may be necessary or useful for the development, manufacture, use, offer for sale, sale or import of the Products as contemplated herein.

  • Antitrust Matters Buyer shall (a) file and cause its Affiliates to file, within four (4) weeks of the date hereof or such other date as the Parties agree based on the advice of antitrust counsel, all reports, filings and other documents required or requested of Buyer or its Affiliates by the FTC, the Justice Department, or any other Government Entity under any applicable Antitrust Laws in connection with the transactions contemplated by this Agreement, (b) comply at the earliest practicable date with any request received by Buyer or any of its Affiliates from the FTC, the Justice Department or any such other Government Entity under any applicable Antitrust Laws for additional information concerning the transactions contemplated by this Agreement, (c) cooperate with Seller in connection with any filing under applicable Antitrust Laws with respect to the transactions contemplated by this Agreement and in connection with resolving any investigation or other inquiry concerning such transactions that is commenced by any of the FTC, the Justice Department or any other Government Entity pursuant to any applicable Antitrust Laws, (d) promptly inform Seller of any material communication made to or received by Buyer or any of its Affiliates from the FTC, the Justice Department or any other Government Entity regarding any of the transactions contemplated hereby, (e) use commercially reasonable efforts to obtain all licenses, permits, consents, approvals, exemptions, authorizations or waivers necessary or appropriate under the Antitrust Laws from the FTC, the Justice Department and any other Government Entity in order to avoid or terminate any action or proceeding by any of them with respect to, and to permit the consummation of in the most expeditious manner practicable, the transactions contemplated by this Agreement, and (f) promptly furnish to Seller such information concerning Buyer or its Affiliates as Seller needs to perform its obligations under Section 5.5 of this Agreement. Without limiting the foregoing, Buyer shall not (i) withdraw and re-file its Premerger Notification and Report Form, (ii) extend any waiting period or comparable period or (iii) enter into any agreement not to consummate the Contemplated Transactions, except, in each case, with the prior written consent of Seller. The foregoing covenants in this Section 6.2 do not require Buyer or any of its Affiliates to (A) defend against or oppose any formal administrative complaint, lawsuit, motion for preliminary or permanent injunction, temporary restraining order or other actions brought by any Governmental Authority or private party seeking to block the Transaction under the Antitrust Laws, or (B) propose, negotiate, offer to commit to enter into or effect, by consent decree, hold separate order or otherwise, sell, offer to sell or otherwise dispose of, any acute care hospital of Buyer or its Affiliates or hold separate such acute care hospital properties pending such sale or other disposition. Buyer shall be responsible for paying any required filing fees under the HSR Act.

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.

  • Subject Matter The subject matter of this contract is services generally on the subject of portable restrooms and pumping services. Detailed services to be provided by Contractor are described in Attachment A.

  • Laws Applicable to Construction; Consent to Jurisdiction The interpretation, performance and enforcement of this Agreement shall be governed by the laws of the State of Delaware without reference to principles of conflict of laws, as applied to contracts executed in and performed wholly within the State of Delaware. In addition to the terms and conditions set forth in this Agreement, the Restricted Stock Units are subject to the terms and conditions of the Plan, which is hereby incorporated by reference.

  • Other Regulatory Matters The Investment Adviser represents and warrants that (1) it and each Fund is and will remain: (a) an “eligible contract participant” under 7 U.S.C. Section 1A, as amended, and 17 CFR Section 1.3(m), and (b) a “qualified eligible person” under CFTC Rule 4.7; (2) that it is registered as a commodity pool operator and is a member of the NFA, where applicable, or it is not required to be registered with the CFTC or to be a member of the NFA; and (3) that it will provide Subadviser reasonable advance notification (in no event less than 30 days) of any decision to: (a) alter its operation of any Fund for which the Investment Adviser has claimed an exclusion or exemption from registration as a commodity pool operator on behalf of a Fund, to then register and operate as a commodity pool operator on behalf of the Fund, or (b) if the investment adviser is registered as a commodity pool operator on behalf of the Fund, to operate such Fund under an exclusion or exemption from registration with the CFTC.

  • Advice of Counsel, No Strict Construction Each of the parties represents to each other party hereto that it has discussed this Agreement with its counsel. The parties hereto have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.

  • Regulatory Matters The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.

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