Pre Final Legal Clearance Launch Sample Clauses

Pre Final Legal Clearance Launch. 6.2.1 Notwithstanding any other provision in this Agreement, the Parties agree that, if ANDA Final Approval for an ANDA filed by Sandoz or any of its Affiliates for the Product has been obtained and a District Court Decision has been obtained but Final Legal Clearance has not yet been obtained, Sandoz may, in its sole discretion, decide whether to proceed with U.S. Launch, or to defer U.S. Launch until Final Legal Clearance. Upon deciding to proceed with Pre Final Legal Clearance Launch, Sandoz shall promptly notify Momenta of such decision and shall use Commercially Reasonable Efforts to Commercialize the Product. 6.2.2 Notwithstanding anything else herein to the contrary, the Parties agree that, consistent with the provisions of Section 12.1(c), Sandoz shall bear, and Momenta shall not be responsible for, any damages of Aventis in the event that Sandoz or its Affiliates are held liable for [**] under Patent Litigation, other than with respect to Momenta's responsibility for a portion of Settlement Costs pursuant to the provisions of Section 4.3.
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Pre Final Legal Clearance Launch. Notwithstanding any other provision in this Agreement, the Parties agree that if Application Final Approval for a Product has been obtained in a country in the relevant Territory but Final ROW Legal Clearance or Final U.S. Legal Clearance (as applicable) has not yet been obtained with respect to such Product in such country, Sandoz may, in its sole discretion, after reasonable consultation with and due consideration of input from Momenta, decide whether to proceed with Launch of such Product in such country, or to defer Launch until Final ROW Legal Clearance or Final U.S. Legal Clearance, respectively, has been obtained with respect to such Product in such country; subject to the penultimate sentence of Section 5.2. Upon deciding to proceed with Pre Final Legal Clearance Launch with respect to such Product in such country, Sandoz shall promptly notify Momenta of such decision.
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Related to Pre Final Legal Clearance Launch

  • HSR Clearance All applicable waiting periods under the HSR Act shall have expired or been terminated.

  • FINRA Clearance On or before the date of this Agreement, the Representative shall have received clearance from FINRA as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

  • Final Approval Hearing “Final Approval Hearing” shall mean the hearing at which the Court will consider and finally decide whether to enter the Final Judgment.

  • CERTIFICATION REGARDING BOYCOTTING CERTAIN ENERGY COMPANIES (Texas law as of September 1, 2021) By submitting a proposal to this Solicitation, you certify that you agree, when it is applicable, to the following required by Texas law as of September 1, 2021: If (a) company is not a sole proprietorship; (b) company has ten (10) or more full-time employees; and (c) this contract has a value of $100,000 or more that is to be paid wholly or partly from public funds, the following certification shall apply; otherwise, this certification is not required. Pursuant to Tex. Gov’t Code Ch. 2274 of SB 13 (87th session), the company hereby certifies and verifies that the company, or any wholly owned subsidiary, majority-owned subsidiary, parent company, or affiliate of these entities or business associations, if any, does not boycott energy companies and will not boycott energy companies during the term of the contract. For purposes of this contract, the term “company” shall mean an organization, association, corporation, partnership, joint venture, limited partnership, limited liability partnership, or limited liability company, that exists to make a profit. The term “boycott energy company” shall mean “without an ordinary business purpose, refusing to deal with, terminating business activities with, or otherwise taking any action intended to penalize, inflict economic harm on, or limit commercial relations with a company because the company (a) engages in the exploration, production, utilization, transportation, sale, or manufacturing of fossil fuel-based energy and does not commit or pledge to meet environmental standards beyond applicable federal and state law, or (b) does business with a company described by paragraph (a).” See Tex. Gov’t Code § 809.001(1).

  • Exchange Clearance On the Closing Date, the Firm Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance. On the first Option Closing Date (if any), the Option Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance.

  • Legal Compliance Contractor represents and warrants that it shall secure all notices and comply with all applicable laws, ordinances, rules and regulations of any governmental entity in conjunction with the performance of obligations under the Contract. Prior to award and during the Contract term and any renewals thereof, Contractor must establish to the satisfaction of the Commissioner that it meets or exceeds all requirements of the Bid and Contract and any applicable laws, including but not limited to, permits, licensing, and shall provide such proof as required by the Commissioner. Failure to comply or failure to provide proof may constitute grounds for the Commissioner to terminate or suspend the Contract, in whole or in part, or to take any other action deemed necessary by the Commissioner. Contractor also agrees to disclose information and provide affirmations and certifications to comply with Sections 139-j and 139-k of the State Finance Law.

  • Final Approval After Acceptance, Engineer shall perform any required modifications, changes, alterations, corrections, redesigns, and additional work necessary to receive Final Approval by the County. "Final Approval" in this sense shall mean formal recognition that the Engineering Services have been fully carried out.

  • CERTIFICATION REGARDING CERTAIN FOREIGN-OWNED COMPANIES IN CONNECTION WITH CRITICAL INFRASTRUCTURE (Texas law as of September 1, 2021) By submitting a proposal to this Solicitation, you certify that you agree to the following required by Texas law as of September 1, 2021: Proposing Company is prohibited from entering into a contract or other agreement relating to critical infrastructure that would grant to the company direct or remote access to or control of critical infrastructure in this state, excluding access specifically allowed by the Proposing Company for product warranty and support purposes. Company, certifies that neither it nor its parent company nor any affiliate of company or its parent company, is (1) owned by or the majority of stock or other ownership interest of the company is held or controlled by individuals who are citizens of China, Iran, North Korea, Russia, or a designated country; (2) a company or other entity, including governmental entity, that is owned or controlled by citizens of or is directly controlled by the government of China, Iran, North Korea, Russia, or a designated country; or (3) headquartered in China, Iran, North Korea, Russia, or a designated country. For purposes of this contract, “critical infrastructure” means “a communication infrastructure system, cybersecurity system, electric grid, hazardous waste treatment system, or water treatment facility.” See Tex. Gov’t Code § 2274.0101(2) of SB 1226 (87th leg.). The company verifies and certifies that company will not grant direct or remote access to or control of critical infrastructure, except for product warranty and support purposes, to prohibited individuals, companies, or entities, including governmental entities, owned, controlled, or headquartered in China, Iran, North Korea, Russia, or a designated country, as determined by the Governor.

  • ENHANCED AND SUPPLEMENTAL SERVICES BY COUNTY 8 1. Enhanced services for events on CITY property. At the request of CITY, 9 through its City Manager, SHERIFF may provide enhanced law enforcement 10 services for functions, such as community events, conducted on property 11 that is owned, leased or operated by CITY. SHERIFF shall determine 12 personnel and equipment needed for such enhanced services. To the 13 extent the services provided at such events are at a level greater than that 14 specified in Attachment A of this Agreement, CITY shall reimburse COUNTY 15 for such additional services, at an amount computed by SHERIFF, based on 16 the current year’s COUNTY law enforcement cost study. The cost of these 17 enhanced services shall be in addition to the Maximum Obligation of CITY 18 set forth in Subsection G-2 of this Agreement. SHERIFF shall xxxx CITY 19 immediately after each such event. 20 2. Supplemental services for occasional events operated by private

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

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