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Filings and Correspondence Sample Clauses

Filings and Correspondence. Shionogi shall promptly provide BioCryst with (i) copies of all Regulatory Filings relating to the Territory submitted by Shionogi (in the original language) and (ii) copies of material correspondence with Regulatory Authorities in the Territory (including minutes of meetings, telephone conferences and/or discussions with such Regulatory Authority) (in the original language). Shionogi agrees to assist BioCryst the English translation of such documents at BioCryst’s cost.
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Filings and Correspondence. Certain information has been omitted from this exhibit in places marked “[***]” because it is both not material and would likely cause competitive harm to the registrant if publicly disclosed.
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Filings and Correspondence. 36 3.17.2 Manufacturing............................................ 36 3.17.3 Labeling and Marketing................................... 36 3.17.4 Disclosure............................................... 36 3.17.5 No Fraud................................................. 36
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Filings and Correspondence. (a) With respect to any filings and correspondence with respect to Products for Co-Development Indications for the Joint Development Territory, Astellas shall promptly provide Maxygen with (i) copies of all Regulatory Filings including copies of all material correspondence with the relevant Regulatory Authorities (including minutes of any meetings, telephone conferences or discussions with relevant Regulatory Authorities to the extent prepared or obtained for Astellas’ own use); (ii) reasonable advanced notice (to the extent practicable) of meetings, scheduled or unscheduled, with relevant Regulatory Authorities that pertain to such Product; and (iii) updates on regulatory affairs strategies developed for the purposes of above from time-to-time. Astellas shall afford representatives of Maxygen an opportunity to comment on such Regulatory Filings, and shall consider such comments, and, to the extent not prohibited by Law, shall afford representatives of Maxygen an opportunity to attend and actively participate in all such meetings with relevant Regulatory Authorities as observers (or as participants in the case of discussions regarding any CMC component of a Regulatory Filing). Without limiting the foregoing, * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Astellas shall have no obligation to obtain translations of any documents provided pursuant to this Section 6.2.3(a), but shall provide translations of such documents into English to the extent prepared or obtained for its own use. Maxygen shall not be prohibited from obtaining translations of such for its own purposes. (b) With respect to any filings and correspondence with respect to Products for Co-Development Indications for the Joint Development Territory, in addition to the consultation set forth in Section 6.2.3(a) with respect to Regulatory Filings and meetings with Regulatory Authorities, the contents and subject matter of, and strategy for, any MAA, all correspondence submitted to Regulatory Authorities related to clinical trial design, all proposed Product labeling and Product labeling decisions with any Regulatory Authorities, and all post-Marketing Approval labeling decisions with Regulatory Authorities (including the final approved labeling), and post-Marketing Approval labeling changes or expansions, shall be subject to oversight by the Commit...
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Filings and Correspondence. PRO DUCT has made all -------------------------- filings with (i) the Food and Drug Administration (the "FDA"), including all --- establishment registrations, all product listings, all 510(k) notifications and pre-marketing approval (PMA) applications, and (ii) the Food and Drug Branch of the Department of Health of the State of California (the "FDB") required to market its products. The only --- products currently marketed by PRO DUCT are: the InDuct Breast Aspirator, the InDuct Breast MicroCatheter, the InDuct Breast Ultra Slim and Tapered MicroDilators, the InDuct Accessory Kit, and the InDuct Contour Cover and Cell Preservative Kit (the "Products"). Copies of all such filings with the FDA and -------- FDB, including all filings for any amendments or supplements, and of any material correspondence between PRO DUCT and the FDA and the FDB with respect to such filings for PRO DUCT's products have been made available to CYTYC.
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Filings and Correspondence. Distributor shall inform Manufacturer of the content of Manufacturer’s Confidential Information disclosed in the filings with Regulatory Authorities when the development report is provided to Manufacturer pursuant to Section 2(e).
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Filings and Correspondence 
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Related to Filings and Correspondence

  • Correspondence The Employer agrees that all correspondence between the Employer and the Union related to matters covered in this Agreement, shall be sent to the President of the Union or designate. The Employer agrees that a copy of any correspondence between the Employer or Employer's official and any employees in the bargaining unit covered by this Agreement, pertaining to the interpretation or application of any clause in this Agreement, shall be forwarded to the President of the Union or designate.

  • NOTICES AND CORRESPONDENCE Notices regarding the subject matter of this Agreement or breach or termination thereof shall be in writing and shall be addressed in duplicate to the last known address of each other party, marked respectively to the attention of its President and, if any, its General Counsel.

  • Delivery of SEC Correspondence To supply the Underwriters with copies of all correspondence to and from, and all documents issued to and by, the Commission in connection with the registration of the Stock under the Securities Act or any of the Registration Statement, any Preliminary Prospectus or the Prospectus, or any amendment or supplement thereto or document incorporated by reference therein.

  • Notifications The Subrecipient will send to each labor union or representative of workers with which it has a collective bargaining agreement or other contract or understanding, a notice, to be provided by the agency contracting officer, advising the labor union or worker’s representative of the Subrecipient’s commitments hereunder, and shall post copies of the notice in conspicuous places available to employees and applicants for employment.

  • Information True and Correct All information heretofore or hereafter furnished by or on behalf of the Collateral Manager in writing to the Borrower, any Lender, any Agent, the Paying Agent or the Facility Agent in connection with this Agreement or any transaction contemplated hereby is and will be true and complete in all material respects and does not omit to state a material fact necessary to make the statements contained therein not misleading;

  • SUBMISSIONS You acknowledge and agree that any questions, comments, suggestions, ideas, feedback, or other information regarding the Site ("Submissions") provided by you to us are non-confidential and shall become our sole property. We shall own exclusive rights, including all intellectual property rights, and shall be entitled to the unrestricted use and dissemination of these Submissions for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You hereby waive all moral rights to any such Submissions, and you hereby warrant that any such Submissions are original with you or that you have the right to submit such Submissions. You agree there shall be no recourse against us for any alleged or actual infringement or misappropriation of any proprietary right in your Submissions.

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

  • Regulatory Authorizations Each Party represents and warrants that it has, or applied for, all regulatory authorizations necessary for it to perform its obligations under this Agreement.

  • Approvals No authorization, approval or consent of any court, governmental body, regulatory agency, self-regulatory organization, or stock exchange or market or the stockholders of the Company is required to be obtained by the Company for the issuance and sale of the Securities to the Buyer as contemplated by this Agreement, except such authorizations, approvals and consents that have been obtained.

  • True and Correct Information All information, reports, exhibits, schedules, financial statements or certificates of Seller, any Affiliate thereof or any of their officers furnished to Buyer hereunder and during Buyer’s diligence of Seller are and will be true and complete in all material respects and do not omit to disclose any material facts necessary to make the statements herein or therein, in light of the circumstances in which they are made, not misleading. All required financial statements, information and reports delivered by Seller to Buyer pursuant to this Agreement shall be prepared in accordance with U.S. GAAP, or, if applicable, to SEC filings, the appropriate SEC accounting regulations.

Most Referenced Clauses

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