Regulatory Filing / Registration Change Control Sample Clauses

Regulatory Filing / Registration Change Control. The Client will determine whether changes to the Product or related to the Product will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to their Product marketing authorization. Upon request, Patheon will assist in the preparation and review of pertinent sections of new or supplemental regulatory applications before filing. The Client will give Patheon copies of sections of product registration/regulatory submissions that are relevant to Quality Agreement QG01-05-T001-01 Page7of18 the manufacture of the Product. The Client is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of marketing approval in a timely manner.
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Regulatory Filing / Registration Change Control. The Client will ensure product filing and registrations are in compliance with all Applicable Laws. The Client will determine whether changes to the Product or related to the Product will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to their Product marketing authorization. Upon request, Patheon will provide assistance in the preparation and review of pertinent sections of new or supplemental regulatory applications before filing. For EU products it is the responsibility of the Client to provide Patheon sites with the accurate Product registration information as per European legislations (cGMPs guide part I - chapters 1,4,6,7 and annex 16 / directives 2001/83/EC – title IV, articles 46, 48, 51 and 2003/94/EC article 5). Prior to submission of any new, or change to any existing applicable CMC, CTD, Regulatory File, Product Registration, etc., to any Regulatory Authority relating to the Product, the Client will provide Patheon copies of sections of the submissions that are relevant to the services provided. Specifically, Client will provide Patheon with a copy of any documentation which is or is equivalent to the Quality Module (Drug Product Section) of the Common Technical Document and any Master Manufacturing Services Agreement amendments thereto (all such documentation herein referred to as “CTD”) related to any Marketing Authorization, such as a US New Drug Application, US Abbreviated New Drug Application, US Biologics Licence Application, or EU Marketing Authorisation Application at least [**] days prior to filing such information with the Regulatory Authority. The parties agree that no inspections by any Regulatory Authority may be scheduled until Patheon has had an opportunity to review the requested documents and is satisfied with their accuracy. Patheon will communicate directly with the Regulatory Agency after discussions with Client. The Client is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of marketing approval in a timely manner.
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Regulatory Filing / Registration Change Control. The Client will determine whether changes to the CTM or related to the CTM will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to it’s CTM authorization. Upon request, Patheon will provide assistance in the preparation and review of pertinent sections of the initial CTM filing. The Client will provide Patheon copy of sections of CTM registration/regulatory submissions that are relevant to manufacture and/or service related to the CTM. The Client is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of approval in a timely manner. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions CTM Quality Agreement QG01-05-T002-01 age2of16
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Regulatory Filing / Registration Change Control. Prior to the DMF Approval, the Regulatory Consultant will be entitled to determine whether changes to (or related to) the Drug Resin Complex will impact a regulatory filing and will apply for and receive approval of any required manufacturing amendment, change or addition to the ANDA, subject to any other provisions in the Agreement. NEOS is responsible for all communications with FDA with respect to the ANDA as well as for the approval, maintenance, and updating of the ANDA in a timely manner. As such, only the Regulatory Consultant shall have access to the unredacted ANDA Filing and batch records containing CPI’s RC Confidential Information.
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Regulatory Filing / Registration Change Control. Penwest will determine whether changes to the Product or related to the Product will impact the current DMF and will apply for and receive approval for any required manufacturing amendment, change or addition to the Product DMF. Upon request, Patheon will provide assistance in the preparation and review of pertinent sections of new or supplemental regulatory applications before filing. Penwest will provide Patheon with copies of relevant sections of the Product DMF filings, as set forth in Section 7.8(b) of the MSA and Section 11.2 of the Technology Transfer Agreement. Penwest is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of the current DMF.
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Regulatory Filing / Registration Change Control. MDCO will determine whether changes to the Product or related to the Product will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to their Product marketing authorization. Upon request, Patheon will provide assistance in the preparation of pertinent sections of new or supplemental regulatory applications before filing. Patheon will also have the right to review the new or supplemental sections that apply to Patheon’s areas of responsibility before filing. MDCO will provide Patheon copies of sections of product registration/regulatory submissions that are relevant to the manufacture of the Product. MDCO is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of marketing approval in a timely manner.
Sample 1
Regulatory Filing / Registration Change Control. The Client will determine whether changes to the CTM or related to the CTM will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to it’s CTM authorization. Upon request, Patheon will provide assistance in the preparation and review of pertinent sections of the initial CTM filing. The Client will provide Patheon copy of sections of CTM registration/regulatory submissions that are relevant to manufacture and/or service related to the CTM. The Client is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of approval in a timely manner.
Sample 1
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Regulatory Filing / Registration Change Control. The Client will determine whether changes to the Product or related to the Product will impact a regulatory filing and will apply for and receive approval for any required manufacturing amendment, change or addition to their Product marketing authorization. Upon request, Patheon will assist in the preparation and review of pertinent sections of new or supplemental regulatory applications before filing. The Client is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of marketing approval in a timely manner.
Sample 1

Related to Regulatory Filing / Registration Change Control

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Filing Registration Statement The Company shall use its best efforts to, as expeditiously as possible after receipt of a request for a Demand Registration pursuant to Section 2.1, prepare and file with the Commission a Registration Statement on any form for which the Company then qualifies or which counsel for the Company shall deem appropriate and which form shall be available for the sale of all Registrable Securities to be registered thereunder in accordance with the intended method(s) of distribution thereof, and shall use its best efforts to cause such Registration Statement to become effective and use its best efforts to keep it effective for the period required by Section 3.1.3; provided, however, that the Company shall have the right to defer any Demand Registration for up to thirty (30) days, and any Piggy-Back Registration for such period as may be applicable to deferment of any demand registration to which such Piggy-Back Registration relates, in each case if the Company shall furnish to the holders a certificate signed by the President or Chairman of the Company stating that, in the good faith judgment of the Board of Directors of the Company, it would be materially detrimental to the Company and its shareholders for such Registration Statement to be effected at such time; provided further, however, that the Company shall not have the right to exercise the right set forth in the immediately preceding proviso more than once in any 365-day period in respect of a Demand Registration hereunder.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Copies of Registration Statement The Company will furnish the Dealer Manager with one signed copy of the Registration Statement, including its exhibits, and such additional copies of the Registration Statement, without exhibits, and the Prospectus and all amendments and supplements thereto, which are finally approved by the Commission, as the Dealer Manager may reasonably request for sale of the Shares.

  • Proxy Statement; Registration Statement (a) As promptly as practicable after the execution of this Agreement, (i) BCAC (with the assistance and cooperation of the Company as reasonably requested by BCAC, including delivery of the financial statements of the Company for the twelve (12) month period ended December 31, 2021 in accordance with Section 7.14) shall prepare and file with the SEC a joint information statement/proxy statement (as amended or supplemented, the “Proxy Statement”) to be sent to the stockholders of BCAC and from which the Company may derive an information statement that it can send to the stockholders of the Company relating to (A) with respect to the Company’s stockholders, the action to be taken by certain stockholders of the Company pursuant to the Written Consent and (B) with respect to BCAC’s stockholders, the meeting of BCAC’s stockholders (the “BCAC Stockholders’ Meeting”) to be held to consider approval and adoption of (1) this Agreement and the Merger, (2) the issuance of BCAC Common Stock as contemplated by this Agreement, (3) the second amended and restated BCAC Certificate of Incorporation as set forth on Exhibit C, (4) the Equity Plan, (5) the ESPP, (6) the classes of the members of the BCAC Board as of immediately following the Effective Time, (7) the election of the Initial Post-Closing BCAC Directors to serve as the members of the BCAC Board as of immediately following the Effective Time and until their respective successors are duly elected or appointed and qualified and (8) any other proposals the parties mutually deem necessary to effectuate the Merger (collectively, the “BCAC Proposals”), and (ii) BCAC shall prepare and file with the SEC a registration statement on Form S-4 (together with all amendments thereto, the “Registration Statement”) in which the Proxy Statement shall be included as a prospectus, in connection with the registration under the Securities Act of the shares of BCAC Common Stock (A) to be issued to the stockholders of the Company pursuant to this Agreement (other than any signatories to the Stockholder Support Agreement that are not executive officers, directors, affiliates, founders or their family members or holders of 5% or more of the voting equity securities of the Company) (the “Resale Stockholders”) and (B) held by the stockholders of BCAC immediately prior to the Effective Time. The Company shall furnish all information concerning the Company as BCAC may reasonably request in connection with such actions and the preparation of the Proxy Statement and Registration Statement. BCAC and the Company each shall use their reasonable best efforts to (i) cause the Registration Statement when filed with the SEC to comply in all material respects with all Laws applicable thereto, (ii) respond as promptly as reasonably practicable to and resolve all comments received from the SEC concerning the Registration Statement, (iii) cause the Registration Statement to be declared effective under the Securities Act as promptly as practicable, and (iv) to keep the Registration Statement effective as long as is necessary to consummate the Transactions. Prior to the effective date of the Registration Statement, BCAC shall take all or any action required under any applicable federal or state securities laws in connection with the issuance of shares of BCAC Common Stock, in each case to be issued or issuable to the stockholders of the Company pursuant to this Agreement. As promptly as practicable after finalization of the Proxy Statement, each of the Company and BCAC shall mail the Proxy Statement to their respective stockholders. Each of BCAC and the Company shall furnish all information concerning it as may reasonably be requested by the other party in connection with such actions and the preparation of the Registration Statement and the Proxy Statement.

  • COOPERATION IN PREPARATION OF REGISTRATION STATEMENT The COMPANY and STOCKHOLDERS shall furnish or cause to be furnished to VPI and the Underwriters all of the information concerning the COMPANY and the STOCKHOLDERS required for inclusion in, and will cooperate with VPI and the Underwriters in the preparation of, the Registration Statement and the prospectus included therein (including audited and unaudited financial statements, prepared in accordance with generally accepted accounting principles, in form suitable for inclusion in the Registration Statement). The COMPANY and the STOCKHOLDERS agree promptly to advise VPI if, at any time during the period in which a prospectus relating to the offering is required to be delivered under the 1933 Act, any information contained in the prospectus concerning the COMPANY or the STOCKHOLDERS becomes incorrect or incomplete in any material respect, and to provide the information needed to correct such inaccuracy. VPI will give the COMPANY and the STOCKHOLDERS an opportunity and a reasonable amount of time to review and comment on a substantially final draft of the Registration Statement prior to filing, and with respect to all amendments thereto, VPI will give the COMPANY and STOCKHOLDERS an opportunity to review and comment on those portions of such amendments that relate to the COMPANY. Insofar as the information contained in the Registration Statement relates solely to the COMPANY or the STOCKHOLDERS, as of the effective date of the Registration Statement the COMPANY represents and warrants as to such information with respect to itself, and each STOCKHOLDER represents and warrants, as to such information with respect to the COMPANY and himself or herself, that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading and that the STOCKHOLDERS and the COMPANY have had the opportunity to review and approve such information. If, prior to the 25th day after the date of the final prospectus of VPI utilized in connection with the IPO, the COMPANY or the STOCKHOLDERS become aware of any fact or circumstance which would change (or, if after the Closing Date, would have changed) a representation or warranty of the COMPANY or the STOCKHOLDERS in this Agreement or would affect any document delivered pursuant hereto in any material respect, the COMPANY and the STOCKHOLDERS shall immediately give notice of such fact or circumstance to VPI. However, subject to the provisions of Section 7.8, such notification shall not relieve either the COMPANY or the STOCKHOLDERS of their respective obligations under this Agreement, and, subject to the provisions of Section 7.8, at the sole option of VPI, the truth and accuracy of any and all warranties and representations of the COMPANY, or on behalf of the COMPANY and of STOCKHOLDERS at the date of this Agreement and on the Pre-Closing Date and on the Closing Date, contained in this Agreement (including the Schedules and Annexes hereto) shall be a precondition to the consummation of this transaction.

  • Publication of Registration Data Registry Operator shall provide public access to registration data in accordance with Specification 4 attached hereto (“Specification 4”).

  • Registration Statement; Joint Proxy Statement (a) As promptly as practicable after the execution of this Agreement, Bergen and IVAX shall jointly prepare and IVAX and Bergen shall file with the SEC a document or documents that will constitute (i) the prospectus forming part of the registration statement on Form S-4 of BBI (together with all amendments thereto, the "Registration Statement"), in connection with the registration under the Securities Act of (A) the BBI Common Stock to be issued to IVAX's shareholders pursuant to the IVAX Merger and (B) the BBI Common Stock to be issued to Bergen's shareholders pursuant to the Bergen Merger, and (ii) the Joint Proxy Statement with respect to the Mergers relating to the special meeting of each of IVAX's shareholders (the "IVAX Shareholders' Meeting") and Bergen's shareholders (the "Bergen Shareholders' Meeting" and, together with the IVAX Shareholders' Meeting, the "Shareholders' Meetings") to be held to consider approval of this Agreement and the Mergers contemplated hereby (such document, together with any amendments thereto, the "Joint Proxy Statement"). Copies of the Joint Proxy Statement shall be provided to AMEX and the NYSE in accordance with the rules of such exchanges. Each of the parties hereto shall use all reasonable efforts to cause the Registration Statement to become effective as promptly as practicable, and, prior to the effective date of the Registration Statement, the parties hereto shall take all action required under any applicable Laws in connection with the issuance of shares of BBI Common Stock pursuant to the Mergers. Bergen or IVAX, as the case may be, shall furnish all information concerning Bergen or IVAX as the other party may reasonably request in connection with such actions and the preparation of the Registration Statement and Joint Proxy Statement. As promptly as practicable after the effective date of the Registration Statement, the Joint Proxy Statement shall be mailed to the shareholders of Bergen and IVAX. Each of the parties hereto shall cause the Joint Proxy Statement to comply as to form and substance in all material respects with the applicable requirements of (i) the Exchange Act, (ii) AMEX and the NYSE, (iii) the Securities Act and (iv) the FBCA, the NJBCA and the DGCL.

  • Contents of Registration Statement (i) The Registration Statement, when it became effective, did not contain and, as amended or supplemented, if applicable, will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, (ii) the Registration Statement and the Prospectus comply and, as amended or supplemented, if applicable, will comply in all material respects with the Securities Act and the applicable rules and regulations of the Commission thereunder and (iii) the Prospectus does not contain and, as amended or supplemented, if applicable, will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, except that the representations and warranties set forth in this paragraph do not apply to statements or omissions in the Registration Statement or the Prospectus based upon information relating to any Underwriter furnished to the Company in writing by such Underwriter through you expressly for use therein.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

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