PMA Filings and Support Sample Clauses

PMA Filings and Support. GSK or its sublicensees shall be solely responsible for filing PMAs for the Product in the Territory for the use and sale of such Product, and for obtaining and maintaining approval of such PMAs, at GSK’s or its sublicensees’ cost and in GSK’s or its sublicensees’ discretion. To the extent practicable, GSK shall provide RGI with copies of drafts of PMAs prior to submission to the FDA or other Regulatory Authority within a reasonable amount of time to allow RGI to review and comment on such draft PMAs, and GSK shall consider all comments from RGI in good faith prior to submission. RGI shall, upon GSK’s reasonable request and at GSK’s expense, promptly provide additional assistance to GSK or its sublicensees, and make its personnel with appropriate expertise available to discuss with GSK or its sublicensees issues, in either case, in connection with PMA filings and other interactions with Regulatory Authorities regarding the BRAF Assay or other Product. Without limiting the foregoing, at GSK’s request and expense, RGI shall perform Studies (as described below in Section 5.3) in accordance with CLIA, using the BRAF Assay and tissue samples from clinical trials conducted by or on behalf of GSK, to the extent such testing is required to support a PMA submission to the Regulatory Authorities for the BRAF Assay or other Product.
Sample 1
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Related to PMA Filings and Support

  • SEC Filings and Press Releases To Agent and Lenders, promptly upon their becoming available, copies of: (i) all Financial Statements, reports, notices and proxy statements made publicly available by any Credit Party to its security holders; (ii) all regular and periodic reports and all registration statements and prospectuses, if any, filed by any Credit Party with any securities exchange or with the Securities and Exchange Commission or any governmental or private regulatory authority; and (iii) all press releases and other statements made available by any Credit Party to the public concerning material changes or developments in the business of any such Person.

  • Maintenance of Approvals: Filings, Etc The Fund shall at all times maintain in effect, renew and comply with all the terms and conditions of all consents, filings, licenses, approvals and authorizations as may be necessary under any applicable law or regulation for its execution, delivery and performance of this Agreement and the other Related Documents to which it is a party.

  • No Conflict; Required Filings and Consents (a) The execution, delivery and performance of the Transaction Agreements by the Company do not, and the completion of the sale of the Purchased Assets and the other transactions contemplated by the Transaction Agreements will not, (i) conflict with or violate the Company’s amended and restated certificate of incorporation, as amended, or the Company’s amended and restated bylaws, as amended, (ii) assuming that all consents, approvals, authorizations and Permits contemplated by clauses (i) through (v) of subsection (b) below have been obtained, and all filings and notifications described in such clauses of subsection (b) below have been made and any waiting periods thereunder have terminated or expired, conflict with or violate any Law applicable to the Purchased Assets or (iii) result in any breach or violation of or constitute a default (or an event, which, with notice or lapse of time or both, would become a default) or result in the loss of a benefit to which the Company or its subsidiaries are entitled with respect to the Purchased Assets, give rise to any right of termination, cancellation, adverse amendment or acceleration of, require notice or consent under, or result in the creation of a Lien (except a Permitted Lien) on any of the Purchased Assets pursuant to any Contract to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries (with respect to the Purchased Assets) or by which any Purchased Asset is bound, except, in the case of clauses (ii) and (iii), for any such conflict, violation, Lien, breach, default, loss, right, requirement of notice or consent or other occurrence which would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • No Conflict; Required Filings and Consent The execution and delivery by Primero of this Agreement and the performance by it of its covenants hereunder and the completion of the Transaction will not violate, conflict with or result in a breach of any provision of the constating documents of Primero, and except for Required Consents and Approvals or as would not, individually or in the aggregate, have or reasonably be expected to have a Primero Material Adverse Effect will not: (i) violate, conflict with or result in a breach of (A) any agreement, contract, indenture, deed of trust, mortgage, bond, instrument, Authorization, licence or permit to which Primero is a party, or by which it is bound or (B) any Law to which Primero is subject or by which it is bound; (ii) give rise to any right of termination, or the acceleration of any indebtedness, under any such agreement, contract, indenture, Authorization, deed of trust, mortgage, bond, instrument, licence or permit that relates to any of the Purchased Assets; or (iii) give rise to any rights of first refusal or rights of first offer, trigger any change in control or influence provisions or any restriction or limitation under any such agreement, Contract, indenture, Authorization, deed of trust, mortgage, bond, instrument, licence or permit, or result in the imposition of any encumbrance, charge or lien upon any of the Purchased Assets. Other than Required Consents and Approvals disclosed in Schedule H, no Authorization, consent or approval of, or filing with, any Governmental Entity or other authority is necessary on the part of Primero for the completion by it of its obligations under this Agreement or for the completion of the Transaction that would cause or result in any loss of any rights or assets or any interest therein held by Primero, except for such Authorizations, consents, approvals and filings as to which the failure to obtain or make would not, individually or in the aggregate, prevent or materially delay completion of the Transaction.

  • Authority; No Conflict; Required Filings and Consents (a) iPrint and Sub have all requisite corporate power and authority to execute and deliver this Agreement and all other documents to which they are or will be parties (the "iPrint Transaction Documents") and to consummate the ---------------------------- transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the other iPrint Transaction Documents to which iPrint or Sub is or will be a party and the consummation of the transactions contemplated hereby and thereby have been duly and validly approved and authorized by the board of directors of iPrint and Sub and, subject to obtaining the iPrint Stockholder Approval, as defined in Section 6.16, no other actions or proceedings on the part of the iPrint or Sub are necessary to authorize this Agreement and the other iPrint Transaction Documents and the transactions contemplated hereby and thereby. This Agreement has been, and the other iPrint Transaction Documents to which iPrint and/or Sub are parties have been or will be when they are executed by iPrint and/or Sub, as applicable, duly executed and delivered by iPrint and/or Sub and constitute, or will constitute when they are executed by iPrint and/or Sub, as applicable, the valid and binding obligations of iPrint and/or Sub, enforceable against iPrint and/or Sub, as the case may be, in accordance with their respective terms, except as such enforceability may be limited by (i) bankruptcy, insolvency, moratorium or other similar laws affecting creditors' rights generally and (ii) general principles of equity.

  • Required Filings and Consents None of the execution, delivery or performance of this Agreement by the Company or the consummation by the Company of the Merger or any other transaction contemplated by this Agreement will require (with or without notice or lapse of time, or both) any consent, approval, authorization or permit of, or filing or registration or qualification with or notification to, any Governmental Entity, other than (a) the filing and recordation of the Articles of Merger as required by the VBCA, (b) the Company Shareholder Approval, (c) compliance with any applicable requirements of the HSR Act, (d) the approval of each of the Vermont Public Service Board (the “VPSB”), the Federal Energy Regulatory Commission (the “FERC”), the Federal Communications Commission (the “FCC”) and the Nuclear Regulatory Commission (the “NRC”) (the approvals described in clauses (c) and (d), together with the approvals set forth on Section 3.5 of the Company Disclosure Letter, being referred to herein as the “Company Required Governmental Approvals”), (e) compliance with the applicable requirements of the Exchange Act, (f) filings as may be required under the rules and regulations of the New York Stock Exchange, (g) the notification of the transactions contemplated by this Agreement to the Committee on Foreign Investment in the United States (“CFIUS”) under Section 721 of Title VII of the Defense Production Act of 1950, as amended by the Omnibus Trade and Competitiveness Act of 1988, and (h) where the failure to obtain such consents, approvals, authorizations or permits of, or to make such filings, registrations with or notifications to, any Governmental Entity, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect.

  • Filings and Consents As promptly as practicable after the execution of this Agreement, each party to this Agreement (a) shall make all filings (if any) and give all notices (if any) required to be made and given by such party in connection with the Merger and the other transactions contemplated by this Agreement, and (b) shall use all commercially reasonable efforts to obtain all Consents (if any) required to be obtained (pursuant to any applicable Legal Requirement or Contract, or otherwise) by such party in connection with the Merger and the other transactions contemplated by this Agreement. The Company shall (upon request) promptly deliver to Parent a copy of each such filing made, each such notice given and each such Consent obtained by the Company during the Pre-Closing Period.

  • Authorizations and Filings No authorization, consent, approval, license, exemption or other action by, and no registration, qualification, designation, declaration or filing with, any Official Body is or will be necessary or advisable in connection with the execution and delivery of this Agreement, the Note or the other Loan Documents, consummation of the transactions herein or therein contemplated or performance of or compliance with the terms and conditions hereof or thereof.

  • No Conflicts; Required Filings and Consents (a) The execution and delivery of this Agreement by such Stockholder does not, and the performance of this Agreement by such Stockholder will not, (i) conflict with or violate any trust agreement or other similar documents relating to any trust of which such Stockholder is trustee, (ii) conflict with or violate any law, rule, regulation, order, judgment or decree applicable to such Stockholder or by which such Stockholder or any of such Stockholder's properties is bound or affected or (iii) result in any breach of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or give to others any rights of termination, acceleration or cancellation of, or result in the creation of a lien or encumbrance on any assets of such Stockholder, including such Stockholder's Subject Shares, pursuant to, any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which such Stockholder is a party or by which such Stockholder or any of such Stockholder's assets is bound or affected, except, in the case of clauses (ii) and (iii), for any such breaches, defaults or other occurrences that would not prevent or delay the performance by such Stockholder of such Stockholder's obligations under this Agreement.

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