Copies of Regulatory Filings Sample Clauses

Copies of Regulatory Filings. Protalix shall provide to Chiesi, at Chiesi’s expense, copies in electronic form of any regulatory filings in the Territory relating to the Licensed Product, including any clinical trial authorizations (including any regulatory filings in the Territory seeking approval to conduct a study or clinical trial of the Licensed Product), other filings with Regulatory Authorities, supplements or amendments thereto, written correspondence with Regulatory Authorities regarding such regulatory filings, and existing written minutes of meetings and memoranda of formal conversations between Protalix (including, to the extent practicable, Protalix’s investigators) and Regulatory Authorities and any other document required to maintain the Regulatory Approvals (e.g. Trial Master Files) in Protalix’s possession (but, for clarity, excluding any informal communications, i.e., e-mails) to the extent Protalix has the right to access and provide to Chiesi such materials.
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Copies of Regulatory Filings. Protalix shall provide to Pfizer, at Pfizer’s expense, complete copies of any regulatory filings in Israel relating to the Licensed Product, including INDs, NDAs, filings with the Regulatory Authorities, supplements or amendments thereto, all written correspondence with Regulatory Authorities regarding such regulatory filings, and all existing written minutes of meetings and memoranda of conversations between Protalix (including, to the extent practicable, Protalix’s investigators) and Regulatory Authorities in Protalix’s possession (or in the possession of any of Protalix’s agents and subcontractors, such as contract research organizations used by Protalix), to the extent Protalix has the right to access and provide to Pfizer such materials. To the extent available, Protalix shall provide such copies to Pfizer in electronic form.
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Copies of Regulatory Filings. To the extent not already provided by Pfizer, Pfizer shall provide to Protalix, at Protalix’s expense, complete copies of any regulatory filings in Brazil relating to the Licensed Product, including INDs, NDAs, filings with the Regulatory Authorities, supplements or amendments thereto, all written correspondence with Regulatory Authorities regarding such regulatory filings, and all existing written minutes of meetings and memoranda of conversations between Pfizer (including, to the extent practicable, Pfizer’s investigators) and Regulatory Authorities in Pfizer’s possession (or in the possession of any of Pfizer’s agents and subcontractors, such as contract research organizations used by Pfizer), to the extent Pfizer has the right to access and provide to Protalix such materials. To the extent available, Pfizer shall provide such copies to Protalix in electronic form.
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Copies of Regulatory Filings. The parties acknowledge that Protalix has provided to Pfizer complete copies of all regulatory filings in the Territory (other than Israel) relating to the Licensed Product, including INDs, filings with the FDA or other Regulatory Authorities, supplements or amendments thereto, all written correspondence with the FDA or other Regulatory Authorities regarding such regulatory filings, and all existing written minutes of meetings and memoranda of conversations between Protalix (including, to the extent practicable, Protalix’s investigators) and the FDA or other Regulatory Authorities in Protalix’s possession (or in the possession of any of Protalix’s agents and subcontractors, such as contract research organizations used by Protalix), to the extent Protalix had the right to access and provide to Pfizer such materials.
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Copies of Regulatory Filings. Protalix shall provide to Pfizer, at Pfizer’s expense, complete copies of any regulatory filings in the Territory relating to the Licensed Product, including INDs, filings with FDA or other Regulatory Authorities, supplements or amendments thereto, all written correspondence with FDA or other Regulatory Authorities regarding such regulatory filings, and all existing written minutes of meetings and memoranda of conversations between Protalix (including, to the extent practicable, Protalix’s investigators) and FDA or other Regulatory Authorities in Protalix’s possession (or in the possession of any of Protalix’s agents and subcontractors, such as contract research organizations used by Protalix), to the extent Protalix has the right to access and provide to Pfizer such materials. To the extent available, Protalix shall provide such copies to Pfizer in electronic form.
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Copies of Regulatory Filings. Except to the extent prohibited by Requirements of Law, each of the Parties hereto shall provide to the other copies of all filings and material correspondence with all Governmental Authorities with respect to the filings and consents described in Section 4.3.5.
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Copies of Regulatory Filings. Each Operating Party shall provide to the other Parties copies of all Regulatory Filings for Products submitted to Regulatory Authorities in the Territory within a reasonable time following the filing thereof. In addition, the Parties shall share all correspondence and communications, other than Regulatory Filings, with Regulatory Authorities relating to a Product in the Territory. Confidential material omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions.
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Copies of Regulatory Filings. Each Party shall provide to the other Party copies of all Regulatory Filings for Products submitted to Regulatory Authorities in the Territory within a reasonable time following the filing thereof. In addition, the Parties shall share all correspondence and communications, other than Regulatory Filings, with Regulatory Authorities relating to a Product in the Territory.
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Copies of Regulatory Filings. Except to the extent prohibited by Requirements of Law and except for any Section 4(c) documents filed with the HSR notification and report form, each of the parties hereto shall promptly, but in any event within three (3) Business Days, provide to the other party copies of all filings and material correspondence with and from all Governmental Authorities with respect to the filings and consents described in this Section 4.3.
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Related to Copies of Regulatory Filings

  • Regulatory Filings Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records.

  • 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;

  • Approvals of Regulatory Authorities Niagara Bancorp shall have received all required approvals of Regulatory Authorities of the Merger (without the imposition of any conditions that are in Niagara Bancorp's reasonable judgment unduly burdensome); and all notice and waiting periods required thereunder shall have expired or been terminated;

  • Reports; Regulatory Matters (a) The Company and each Company Subsidiary has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2004 with (i) the Federal Reserve Board, (ii) the FDIC, (iii) the Office of the Comptroller of the Currency, (iv) the NASD, (v) any state banking agency, insurance commission or other state regulatory authority, (vi) the SEC, (vii) any foreign regulatory authority and (viii) any SRO (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed by them since January 1, 2004, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by a Regulatory Agency or Governmental Entity in the ordinary course of the business of the Company and its Subsidiaries, no Regulatory Agency or Governmental Entity has initiated since January 1, 2004 or has pending any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. Since January 1, 2004, no Regulatory Agency or Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. There is no unresolved violation, criticism or exception by any Regulatory Agency or Governmental Entity with respect to any report or statement relating to any examinations or inspections of the Company or any Company Subsidiary. Since January 1, 2004, there has been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or Governmental Entity with respect to the business, operations, policies or procedures of the Company or any Company Subsidiary.

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • 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.

  • Regulatory Reports (a) Since January 1, 2009 Seller has filed or furnished on a timely basis with the Commission all final registration statements, prospectuses, annual, quarterly or current reports and definitive proxy statements or other communications (other than general advertising materials), forms, reports, schedules, statements or other documents required to be filed or furnished by it pursuant to the Securities Act of 1933, as amended (the “1933 Act”), the Securities Exchange Act of 1934, as amended (the “1934 Act”), or the rules and regulations promulgated by the Commission (all such filed or furnished documents, together with all exhibits and schedules thereto and all information incorporated therein by reference, the “Seller SEC Documents”). Seller has previously delivered or made available to Acquiror an accurate and complete copy of each such Seller SEC Document. As of their respective filing dates (and, in the case of registration statements and proxy statements, as of the dates of their effectiveness and the dates of mailing, respectively), except to the extent that any Seller SEC Document has been amended by a subsequently filed Seller SEC Document prior to the date hereof, in which case, as of the date of such amendment, each such final registration statement, prospectus, annual, quarterly or current report and proxy statement or other communication, form, report, schedule, statement or other document, as of its date, complied in all material respects with all applicable Laws (including, without limitation, the 1933 Act, the 1934 Act and the Xxxxxxxx-Xxxxx Act of 2002, as amended) and did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading; provided, that information as of a later date filed publicly shall be deemed to modify information as of an earlier date. To the Knowledge of Seller, there is no fact or circumstance that, individually or in the aggregate, materially and adversely has affected, is so affecting or could reasonably be expected in the future to so affect, the business, financial condition, results of operations or prospects of Seller and Seller Sub, taken individually or as a whole, that is required to be disclosed under the 1933 Act or the 1934 Act but has not been disclosed in such final registration statement, prospectus, annual, quarterly or current reports and definitive proxy statement or other communications, forms, reports, schedules, statements or other documents. None of Seller’s Subsidiaries is required to file periodic reports with the Commission.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Necessary Filings 3 2.2. No Liens.........................................................3 2.3.

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