Required Studies (Non-EMEA) Sample Clauses

Required Studies (Non-EMEA). In the event that any Regulatory Authority in the GSK Territory (other than the EMEA) requires or requests in writing that Required Studies (other than those already initiated by Sepracor as of the Effective Date) be performed as a condition of, or in connection with, granting Marketing Approval, [**] whether or not to conduct such Required Studies and continue to [**] in such country. If [**] shall undertake such Required Studies [**]. In the event that [**] does not [**], in relation to countries other than those within the European Union or for which a date for accession to the European Union has been agreed, Sepracor may, but shall not be obligated to, terminate the Agreement with respect to the particular country or countries where such Regulatory Authority has required such clinical trials and [**], and the Agreement shall remain in full force and effect in the rest of the GSK Territory. For the avoidance of doubt, a [**] shall not be deemed a failure to exercise its Commercially Reasonable Efforts. In the event that [**] to undertake such Required Study, and Sepracor believes that the use of the results of any Required Study could be of material benefit to Sepracor in the Sepracor Territory, for example, if the Required Study were the development of a [**] of the Product, the Parties [**].
Sample 1
AutoNDA by SimpleDocs

Related to Required Studies (Non-EMEA)

  • Absence of Sensitive Payments The Company has not, nor has any ----------------------------- Subsidiary, or, to the Company's knowledge, any of its or any Subsidiary's officers, directors, employees or Representatives, (a) made any contributions, payments or gifts to or for the private use of any governmental office, employee or agent where either the payment or the purpose of such contribution, payment or gift is illegal under the laws of the United States or the jurisdiction in which made, (b) established or maintained any unrecorded fund or asset for any purpose or made any false or artificial entries on its books, or (c) made any payments to any person with the intention or understanding that any part of such payment was to be used for any purpose other than that described in the documents supporting the payment.

  • Purpose; Incorporation by Reference of Auction Procedures and Settlement Procedures (a) On each Auction Date, the provisions of the Auction Procedures will be followed by the Auction Agent for the purpose of determining the Applicable Rate for the of APS, for the next Dividend Period therefor. Each periodic operation of such procedures is hereinafter referred to as an "Auction."

  • Authority; Noncontravention; Voting Requirements (a) The Company has all requisite corporate power and authority to execute and deliver this Agreement, to perform its obligations hereunder and to consummate the Transactions. The execution, delivery and performance by the Company of this Agreement and the consummation by it of the Transactions, have been duly authorized by all necessary corporate action on the part of the Company, and except for obtaining the Company Stockholder Approval, if required, no other corporate action on the part of the Company is necessary to authorize the execution, delivery and performance by the Company of this Agreement or the consummation by it of the Transactions. This Agreement has been duly executed and delivered by the Company and, assuming due authorization, execution and delivery by the other parties hereto, constitutes legal, valid and binding obligations of the Company, enforceable against the Company in accordance with its terms, except that such enforceability may be limited by bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other similar applicable Law affecting creditors’ rights generally and by general principles of equity (the “Bankruptcy and Equity Exception”).

  • Additional Submissions – Information Access The claimant shall then have the opportunity to submit written comments, documents, records and other information relating to the claim. The Company shall also provide the claimant, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the claimant's claim for benefits.

  • Actions Not Requiring Proper Instructions Unless otherwise instructed by the Trust, the Custodian shall with respect to all Securities held for the Fund:

  • Compliance with Tender Offer Rules Nothing contained in this Agreement shall prohibit the Company or its Board of Directors from taking and disclosing to the stockholders of the Company a position contemplated by Rules 14d-9 and 14e-2(a) promulgated under the Exchange Act; provided that the content of any such disclosure thereunder shall be governed by the terms of this Agreement. Without limiting the foregoing proviso, the Company shall not effect a Change of Recommendation unless specifically permitted pursuant to the terms of Section 6.3(d).

  • Certain Notifications and Required Actions After the date of this Agreement, the Company shall promptly advise the Representatives in writing of: (i) the receipt of any comments of, or requests for additional or supplemental information from, the Commission; (ii) the time and date of any filing of any post-effective amendment to the Registration Statement or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus; (iii) the time and date that any post-effective amendment to the Registration Statement becomes effective; and (iv) the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus or the Prospectus or of any order preventing or suspending the use of any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus, or of any proceedings to remove, suspend or terminate from listing or quotation the Shares from any securities exchange upon which they are listed for trading or included or designated for quotation, or of the threatening or initiation of any proceedings for any of such purposes. If the Commission shall enter any such stop order at any time, the Company will use its best efforts to obtain the lifting of such order at the earliest possible moment. Additionally, the Company agrees that it shall comply with all applicable provisions of Rule 424(b), Rule 433 and Rule 430B under the Securities Act and will use its reasonable efforts to confirm that any filings made by the Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission.

  • Compliance with PRC Overseas Investment and Listing Regulations Each of the Company and its Subsidiaries and Affiliated Entities has complied, and has taken all reasonable steps to ensure compliance by each of its shareholders, directors and officers that is, or is directly or indirectly owned or controlled by, a PRC resident or citizen with any applicable rules and regulations of the relevant PRC government agencies (including but not limited to the Ministry of Commerce, the National Development and Reform Commission, the China Securities Regulatory Commission (“CSRC”) and the State Administration of Foreign Exchange (the “SAFE”)) relating to overseas investment by PRC residents and citizens (the “PRC Overseas Investment and Listing Regulations”), including, without limitation, requesting each such Person that is, or is directly or indirectly owned or controlled by, a PRC resident or citizen, to complete any registration and other procedures required under applicable PRC Overseas Investment and Listing Regulations (including any applicable rules and regulations of the SAFE).

  • Acknowledgement of Anti-Predatory Lending Policies Buyer has in place internal policies and procedures that expressly prohibit its purchase of any High Cost Mortgage Loan.

  • Purpose; Incorporation by Reference of Auction Procedures (a) On each Auction Date, the provisions of the Auction Procedures will be followed by the Auction Agent for the purpose of determining the Applicable Rate for each series of Preferred Shares, for each Dividend Period. Each periodic operation of such procedures is hereinafter referred to as an "Auction."

Time is Money Join Law Insider Premium to draft better contracts faster.