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. 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. (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.
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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. 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 
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Related to Filings and Correspondence

  • Correspondence Any notice or payment required to be given to either party under this Agreement shall be deemed to have been properly given and effective:

  • Correspondence, Statements and Confirmations The Financial Institution will promptly send copies of all statements, confirmations and other correspondence concerning any Collateral Account and, if applicable, any financial assets credited thereto, simultaneously to the Grantor and the Secured Party.

  • 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.

  • 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;

  • 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 This Appendix C also includes information regarding exchange controls and certain other issues of which the Participant should be aware with respect to the Participant’s participation in the Plan. The information is based on the securities, exchange control and other laws in effect in the respective countries as of January 2017. Such laws are often complex and change frequently. As a result, the Company strongly recommends that the Participant not rely on the information in this Appendix C as the only source of information relating to the consequences of the Participant’s participation in the Plan because the information may be out of date at the time that the RSUs vest or the Participant sells Shares acquired under the Plan. In addition, the information contained herein is general in nature and may not apply to the Participant’s particular situation and the Company is not in a position to assure the Participant of a particular result. Accordingly, the Participant is advised to seek appropriate professional advice as to how the relevant laws in the Participant’s country may apply to the Participant’s situation. If the Participant is a citizen or resident of a country other than the one in which the Participant is currently residing and/or working (or if the Participant is considered as such for local law purposes) or if the Participant moves to another country after receiving the grant of the RSUs, the information contained herein may not be applicable to the Participant in the same manner. JAPAN

  • Information True and Correct All information heretofore or hereafter furnished by or on behalf of the Borrower in writing to 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 and will not omit to state a material fact necessary to make the statements contained therein not misleading.

  • Filings and Approvals Cooperate with the other in the preparation and filing, as soon as practicable, of (A) the Applications, (B) the Proxy Statement, (C) all other documents necessary to obtain any other approvals, consents, waivers and authorizations required to effect the completion of the Merger and the other transactions contemplated by this Agreement, and (D) all other documents contemplated by this Agreement;

  • Filings and Recordings The Administrative Agent shall have received all filings and recordations that are necessary to perfect the security interests of the Administrative Agent, on behalf of the Secured Parties, in the Collateral and the Administrative Agent shall have received evidence reasonably satisfactory to the Administrative Agent that upon such filings and recordations such security interests constitute valid and perfected first priority Liens thereon (subject to Permitted Liens).

  • Receipt of Correspondence The Partners agree that the General Partner shall send to the Limited Partner and the Special Limited Partner within five days of receipt a copy of any correspondence relative to the Apartment Housing's noncompliance with the Mortgage, relative to the Apartment Housing's noncompliance with the Tax Credit rules or regulations, relative to the acceleration of the Mortgage and/or relative to the disposition of the Apartment Housing.

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