FDA and EMA Sample Clauses

FDA and EMA applications on approval of Arimoclomol and patients early access program: To the extent possible, which is not guaranteed by the Seller in any way, the Buyer shall take over and continue all patients early access programs for the Seller worldwide and shall continue the ongoing approval processes at the FDA and EMA, subject to applicable consents and permissions. With respect to the FDA application, the Parties acknowledge that both Parties and their respective counsels, consultants and employees shall corporate on regulatory matters pertaining to Arimoclomol prior to the meeting with the FDA on 14 July 2022. This cooperation includes to the extent necessary the sharing of data between the Parties, including confidential and privileged information. All costs for the Parties’ consultants and counsels assisting in this respect after Closing, on request of the Buyer, must be paid by the Buyer.
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Related to FDA and EMA

  • Labor and Employee Matters Seller is not a party to any employment or collective bargaining or similar agreements with the Designated Employees.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Labor and Employment Matters (a) Except as set forth in Section 3.25 of the Company Disclosure Schedule, (i) there is no labor strike, material labor dispute, slowdown, stoppage or lockout actually pending, or, to the knowledge of the Company, threatened against the Company or any of its Subsidiaries, and during the past three years there has not been any such action, (ii) no labor organization claims to represent the employees of the Company or any of its Subsidiaries, (iii) neither the Company nor any of its Subsidiaries is a party to or bound by any collective bargaining or similar agreement governing terms and conditions of employment with any labor organization, (iv) none of the employees of the Company or any of its Subsidiaries is represented by any labor organization and the Company does not have any knowledge of any current organizing activities on behalf of any labor organization among the employees of the Company or any of its Subsidiaries, nor, to the knowledge of the Company, does any question concerning representation exist concerning such employees, (v) there is no pending, or to the knowledge of the Company, threatened material unfair labor practice charge or complaint against the Company or any of its Subsidiaries before the National Labor Relations Board or any similar state or foreign agency, (vi) there is no material grievance arising out of any collective bargaining agreement, (vii) no material charges with respect to or relating to the Company or any of its Subsidiaries are pending before the Equal Employment Opportunity Commission or any other agency responsible for the prevention of unlawful employment practices, (viii) neither the Company nor any of its Subsidiaries has received notice of the intent of any federal, state, local or foreign agency responsible for the enforcement of labor or employment laws to conduct an investigation with respect to or relating to the Company or any of its Subsidiaries and no such investigation is in progress, (ix) the Company has procedures in place for collecting information about employee eligibility on Form I-9, collects such information and follows applicable Laws governing U.S. citizenship in all material respects, and (x) there are no material complaints, lawsuits or other proceedings pending or, to the knowledge of the Company, threatened in any forum by or on behalf of any present or former employee of the Company or any of its Subsidiaries alleging breach of any express or implied contract of employment, any law or regulation governing employment or the termination thereof or other discriminatory, wrongful or tortious conduct in connection with the employment relationship.

  • Parties and Purpose This agreement (the “Agreement”) is entered by and between certain portfolios and classes thereof, specified below and in Schedule C, of Franklin Xxxxxxxxx Variable Insurance Products Trust, an open-end management investment company organized as a statutory trust under Delaware law (the “Trust”), Franklin/Xxxxxxxxx Distributors, Inc., a California corporation which is the principal underwriter for the Trust (the “Underwriter,” and together with the Trust, “we” or “us”), the insurance company identified on Schedule A (together “you”) and your distributor, on your own behalf and on behalf of each segregated asset account maintained by you that is listed on Schedule B, as that schedule may be amended from time to time (“Account” or “Accounts”). The purpose of this Agreement is to entitle you, on behalf of the Accounts, to purchase the shares, and classes of shares, of portfolios of the Trust (“Portfolios”) that are identified on Schedule C, consistent with the terms of the prospectuses of the Portfolios, solely for the purpose of funding benefits of your variable life insurance policies or variable annuity contracts (“Contracts”) that are identified on Schedule D. This Agreement does not authorize any other purchases or redemptions of shares of the Trust.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Officers and Employees (a) The day-to-day operational management of the Company may be exercised by such officers of the Company as may be appointed from time to time in accordance with this Section 4.3 (the “Officers”). The Managers may appoint such Officers as they may determine from time to time. The Officers, subject to the direction and control of the Managers, shall do all things and take all actions necessary to run the business of the Company. Each Officer shall have the powers and duties as may be prescribed to him or her by the Managers and, to the extent not so prescribed, as generally pertain to their respective offices. Each Officer shall hold office at the pleasure of the Managers. Each Officer shall serve until the earlier of his or her death, resignation or removal, and any Officer may be removed at any time, with or without cause, by the Managers. Any vacancy in any office shall also be filled by the Managers. Any Officer may resign at any time by delivering his or her written resignation to the Managers.

  • Reliance and engagement letters Each Finance Party and Secured Party confirms that each of the Arranger and the Agent has authority to accept on its behalf (and ratifies the acceptance on its behalf of any letters or reports already accepted by the Arranger or Agent) the terms of any reliance letter or engagement letters relating to the Reports or any reports or letters provided by accountants in connection with the Finance Documents or the transactions contemplated in the Finance Documents and to bind it in respect of those Reports, reports or letters and to sign such letters on its behalf and further confirms that it accepts the terms and qualifications set out in such letters.

  • Labor and Employment The Company is and each of its Plans are in compliance in all material respects with those provisions of ERISA, the Code, the Age Discrimination in Employment Act, and the regulations and published interpretations thereunder which are applicable to the Company or any such Plan. The Company is in compliance in all material respects with all labor and employment laws, rules, regulations and requirements of all applicable domestic and foreign jurisdictions. There are no pending or threatened labor disputes, work stoppages or strikes.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Officers, Directors and Employees JML has one officer and director, namely Xxxxx Polos, and has no employees.

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