MAA Sample Clauses

The MAA, or Mutual Arbitration Agreement, is a clause that requires both parties to resolve disputes through arbitration rather than through court litigation. Typically, this clause outlines the process for initiating arbitration, the types of disputes covered, and the rules or organizations that will govern the proceedings. For example, it may specify that employment-related claims must be arbitrated under the rules of the American Arbitration Association. The core function of the MAA is to provide a private, streamlined, and often less costly method for resolving conflicts, thereby reducing the burden and unpredictability of court proceedings for both parties.
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MAA. The Subscribed Shares shall have the preferences and rights set forth in the M&AA.
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MAA. During the Term, PolyPid and/or any of its Affiliates shall be responsible for and shall obtain, maintain and renew, at its sole cost, all MAA(s) and Marketing Authorization(s), issued by the Regulatory Authorities and which are necessary for the Packaging, use and Commercialization of the Product in the Territory. PolyPid and/or its Affiliates shall be the MA holder for the Product. All MAA filings and materials and associated documentation with respect to the Product shall be owned and held by PolyPid, and PolyPid hereby grants Partner the right to use or refer to PolyPid’s proprietary information over the Product (excluding, subject to clause 1.02(c), the Excluded Information), including, but not limited to, intellectual property related to the Product, filings, materials and documentation, all as required to perform its Packaging, testing, release, Commercialization and other obligations hereunder.
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MAA. For the Malaysian market, BHSB as the Marketing Authorization Holder ("MAH') for the Products in Malaysia, will then make a Marketing Authorization Application or other application filed with the Malaysian Ministiy of Health. For the related Territories, BHSB or its approved counterparts will make a similar application with the relevant Regulatory Authority in any country or territory.
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MAA. The JDC in collaboration with the JMC shall review and approve (1) the contents of each MAA for the Licensed Product in the Collaboration Territory, and (2) the CMC components of any MAA for the Licensed Product in the Territory. If the CMC components of any MAA for the Licensed Product have previously been approved as set forth above, the Lead Regulatory Party may submit such components (or subset thereof) to the applicable Regulatory Authorities without seeking additional approval; provided that if any material changes are made to such components or additional CMC information is required to be submitted together with such components, approval under this Section 5.5.1(a) shall be required.
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MAA. [*] within thirty (30) days of the fling of the first MAA for Product in the European Union or any country thereof.
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MAA. The term “
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MAA. The term “MAA” shall mean a Marketing Authorization Application or similar application filed with the EMEA after completion of human clinical trials to obtain marketing approval for a Product in the European Union.
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MAA. Effective January 1, 2020, the MAA will be defined as 200% of the national Medicare schedule. Effective January 1, 2022, the MAA will be defined as 190% of the national Medicare schedule. Notwithstanding the foregoing, the MAA applicable to Covered Mental Health/Substance Abuse Services and Supplies will continue to be defined as 240% of the national Medicare schedule. (Amend the following section of the VMEP: Section 2.)
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MAA. “MAA” shall mean any Marketing Approval Application (or supplemental MAA) for the Product, as filed with the EMA. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Related to MAA

  • Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • No Regulatory Approval By CenterState or Charter, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Authority; Approval (i) The Company has all requisite corporate power and authority and has taken all corporate action necessary to execute and deliver this Agreement, perform its obligations hereunder and to consummate the transactions contemplated by this Agreement, including the Offer and the Merger, subject, in the case of the Merger, to receipt of the Stockholder Approval (if required by the DGCL). This Agreement has been duly and validly executed and delivered by the Company and, assuming the due authorization, execution and delivery by each of the other parties hereto, constitutes a valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject, as to enforceability, to bankruptcy, insolvency, reorganization, moratorium and other Laws of general applicability relating to or affecting creditors’ rights and to general equity principles. At a meeting duly called and held prior to the execution and delivery of this Agreement, the Company Board unanimously adopted resolutions (A) determining that this Agreement and the transactions contemplated hereby, including the Offer, the Top-Up Option and the Merger, are advisable, fair to and in the best interests of the Company and the Stockholders, (B) approving and declaring advisable this Agreement and the transactions contemplated hereby and thereby, including the Offer, the Top-Up Option (including the issuance of the Top-Up Shares) and the Merger, on the terms and conditions set forth herein and therein and in accordance with the requirements of the DGCL, and such approval constitutes approval of this Agreement, the Support Agreement and the transactions contemplated hereby and thereby, including the Offer, the Top-Up Option and the Merger, for purposes of Section 203 of the DGCL, (C) directing that this Agreement be submitted to a vote at the Stockholders Meeting for adoption and approval (unless the Merger is consummated in accordance with Section 253 of the DGCL as contemplated by Section 2.3) and (D) subject to Section 5.2, recommending that the Stockholders accept the Offer, tender their Shares pursuant to the Offer and vote in favor of the adoption and approval of this Agreement and the transactions contemplated hereby, including the Merger if required by applicable Law (such recommendation, the “Company Board Recommendation”), which recommendation constitutes a recommendation and approval of the Company Board for purposes of any Takeover Statutes, and as of the date hereof, none of the aforesaid resolutions have been subsequently rescinded, modified or withdrawn. Assuming the accuracy of the representations and warranties set forth in Section 4.2(f), the Company Board has taken all actions necessary so that Parent and Merger Sub will not be prohibited by any “fair price,” “moratorium,” “control share acquisition,” “business combination” or other similar takeover statute, including Section 203 of the DGCL (collectively, the “Takeover Statutes”), from consummating the transactions contemplated hereby, including the Offer, the Top-Up Option and the Merger, in the manner contemplated hereby and to ensure that no Takeover Statute will impose any additional procedural, voting, approval or other restrictions on the timely consummation of the transactions contemplated hereby or restrict, impair or delay the ability of (x) Parent or Merger Sub to engage in any of the transactions contemplated hereby, including the Offer, the Top-Up Option and the Merger, or the Support Agreement or (y) Parent or Merger Sub, following the Acceptance Time and subject to the other provisions of this Agreement, to vote or otherwise exercise all rights as a stockholder of the Company.