Filings and Correspondence Clause Samples

The Filings and Correspondence clause establishes the parties' responsibilities regarding the preparation, submission, and management of official documents and communications related to the agreement. It typically outlines which party is responsible for making required filings with government agencies, regulatory bodies, or other third parties, and may specify procedures for sharing copies of correspondence or notifications between the parties. This clause ensures that all necessary legal and regulatory steps are properly handled and that both parties remain informed, thereby reducing the risk of missed deadlines or miscommunication.
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. 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. (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. 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. 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. Regulatory Submissions. Subject to the terms of this Agreement, KalVista will be responsible for the preparation and submission of all Regulatory Submissions for the Licensed Product in the Field in the Territory. KalVista will provide Kaken with an opportunity to review and comment on all Regulatory Submissions to be submitted to any Regulatory Authority in the Territory by or on behalf of KalVista for the Licensed Product in the Field in the Territory. KalVista will consider in good faith and implement, all reasonable comments thereon from Kaken that are provided in a timely manner so as to meet the applicable submission or response deadline for such Regulatory Submission. Kaken will cooperate in order to assist KalVista in its efforts to prepare and submit those Regulatory Submissions that are required to obtain, support, or maintain any Regulatory Approvals or Reimbursement Approvals for the Licensed Product in the Field in the Territory.
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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.

  • 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.