Product Filings Sample Clauses

Product Filings. The Administrator shall have the exclusive authority to make filings with respect to the Reinsured Policies with applicable Governmental Entities, in the name of and on behalf of the Ceding Company, to apply for amendments to any policy form, including any application, endorsement or rider; provided that the Administrator shall deliver to the Ceding Company, copies of any filings it makes with Governmental Entities relating to the Reinsured Policies prior to making such filings. The Ceding Company shall cooperate with the Administrator in seeking approval of any reasonable filing made pursuant to this Section 4.7.
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Product Filings. The Administrator shall have the exclusive authority to make filings with respect to the Covered Insurance Policies with applicable Governmental Bodies, in the name of and on behalf of HLIC, to apply for amendments to any policy form or any other document related to the Covered Insurance Policies, including, without limitation, any application, sales illustration related to new business, marketing material, endorsement or rider; provided that the Administrator shall deliver to HLIC copies of any filings it makes with Governmental Bodies relating to the Covered Insurance Policies prior to or contemporaneously with making such filings. HLIC shall use commercially reasonable efforts to assist the Administrator in seeking approval of any filing made pursuant to this Section 4.09. The Administrator shall reimburse HLIC for any reasonable and necessary out-of-pocket costs associated with such assistance. 17 [REDACTED] 18
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Product Filings. The Administrator shall have the authority to make filings with respect to the Covered Insurance Policies with applicable Governmental Authorities, in the name of and on behalf of MassMutual, to apply for amendments to any policy form or policy rate, including any application, endorsement or rider; provided, that (i) the Administrator shall deliver to MassMutual copies of any filings it makes with Governmental Authorities relating to the Covered Insurance Policies not later than ten (10) Business Days prior to making such filings and (ii) any such amendment which could reasonably be expected to materially interfere with the business, assets, liabilities, obligations, financial condition, results of operations or reputation of MassMutual or any of its Affiliates shall require the prior written consent of MassMutual, such consent not to be unreasonably withheld, conditioned or delayed. MassMutual shall cooperate with the Administrator in seeking approval of any filing made pursuant to this Section 4.05; provided, that all Actual Costs associated with such actions shall be paid or reimbursed by the Administrator.
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Product Filings. (i) All right, title and interest in and to NDA #20-497 and all amendments and supplements thereto and all related INDs filed with the FDA for the Product (but excluding any Drug Master Files filed with the FDA) (such filings and approvals, the “Product Filings”).
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Product Filings. Mundipharma shall be solely responsible for preparing, filing, obtaining and maintaining all Product Filings for Licensed Products (including Pediatric Licensed Product) in the Mundipharma Territory, and subject to Section 4.10, at Mundipharma’s sole expense; provided, however, that (i) Cidara shall be solely responsible for preparing, filing, obtaining and maintaining all INDs for the Lead Indication Trials in the Mundipharma Territory at Cidara’s sole expense, (ii) Cidara shall be the sole holder of such INDs, and (iii) Cidara shall provide to Mundipharma (A) a copy of each such IND, (B) copies of all draft material communications to the applicable Regulatory Authorities in connection with such INDs for review and comment by Mundipharma reasonably in advance of submission to such Regulatory Authorities, and (C) copies of all communications received by Cidara or its Affiliates from such Regulatory Authorities in connection therewith.
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Product Filings. The Administrator shall have the exclusive authority to make filings with respect to the Covered Insurance Policies with applicable Governmental Bodies, in the name of and on behalf of ILA, to apply for amendments to any policy form or any other docxxxnt related to the Covered Insurance Policies, including, without limitation, any application, sales illustration related to new business, marketing material, endorsement or rider; provided that the Administrator shall deliver to ILA copies of any filings it makes with Governmental Bodies relaxxxg to the Covered Insurance Policies prior to or contemporaneously with making such filings. ILA shall use commercially reasonable efforts to assist the Admixxxtrator in seeking approval of any filing made pursuant to this Section 4.09. The Administrator shall reimburse ILA for any reasonable and necessary out-of-pocket costs associaxxx with such assistance.
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Related to Product Filings

  • Patent Filings The Party responsible for Prosecution and Maintenance of any Patent Rights as set forth in Section 7.2.2 and Section 7.2.3 will endeavor to obtain patent protection for a Product as it Prosecutes and Maintains its other patents Covering products in development, using counsel of its own choice but reasonably acceptable to the other Party, in such countries as the responsible Party sees fit.

  • HSR Act Filings All filings required under the HSR Act have --------------- been made and the applicable waiting period has expired or been earlier terminated without the receipt of any objection or the commencement or threat of any litigation by a Governmental Authority of competent jurisdiction to restrain the consummation of the transactions contemplated by this Agreement.

  • 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.

  • Public Filings The documents filed by the Company (the "Public Filings") with the Commission at the time they were filed with the Commission, complied in all material respects with the requirements of the 1933 Act, the Securities Exchange Act of 1934, as amended (the "1934 Act"), and the rules and regulations promulgated thereunder, as applicable. The Public Filings do not include 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.

  • SEC Filings AMAO has filed all documents required to be filed by AMAO under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof (the “SEC Filings”), and AMAO has filed such materials on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Documents prior to the expiration of any such extension, except for its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2021, June 30, 2021 and September 30, 2021. As of their respective filing dates, the SEC Documents complied in all material respects with the requirements of the Securities Act and the Exchange Act as applicable to the SEC Filings and the rules and regulations of the Commission promulgated thereunder, except for a warrant accounting issue (the “Warrant Accounting Issue”) and a classification error related to temporary equity and permanent equity made in AMAO’s historical financial statements where, at the closing of AMAO’s initial public offering, AMAO improperly valued its common stock subject to possible redemption (the “Temporary Equity Issue”). None of the SEC Documents, contained, when filed or, if amended prior to the date of this Agreement, as of the date of such amendment with respect to those disclosures that are amended, any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading, except for the Warrant Accounting Issue and the Temporary Equity Issue. There are no material outstanding or unresolved comments in comment letters from the Commission staff with respect to any of the SEC Filings. Except for the Warrant Accounting Issue and the Temporary Equity Issue, the financial statements contained in the SEC Filings have been prepared in accordance with United States generally accepted accounting principles applied on a consistent basis during the periods involved (“GAAP”), except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects the financial position of AMAO and its consolidated subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments.

  • SEC Filings and Press Releases To Agent and Lenders, promptly upon their becoming available, copies of: (i) all Financial Statements, reports, notices and proxy statements made publicly available by any Credit Party to its security holders; (ii) all regular and periodic reports and all registration statements and prospectuses, if any, filed by any Credit Party with any securities exchange or with the Securities and Exchange Commission or any governmental or private regulatory authority; and (iii) all press releases and other statements made available by any Credit Party to the public concerning material changes or developments in the business of any such Person.

  • 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.

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

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • Documents & Data; Licensing of Intellectual Property This Agreement creates a non-exclusive and perpetual license for City to copy, use, modify, reuse, or sublicense any and all copyrights, designs, and other intellectual property embodied in plans, specifications, studies, drawings, estimates, and other documents or works of authorship fixed in any tangible medium of expression, including but not limited to, physical drawings or data magnetically, electronically or otherwise recorded or stored, which are prepared or caused to be prepared by Consultant under this Agreement (“Documents & Data”). All Documents & Data shall be and remain the property of City, and shall not be used in whole or in substantial part by Consultant on other projects without the City's express written permission. Within thirty (30) days following the completion, suspension, abandonment or termination of this Agreement, Consultant shall provide to City reproducible copies of all Documents & Data, in a form and amount required by City. City reserves the right to select the method of document reproduction and to establish where the reproduction will be accomplished. The reproduction expense shall be borne by City at the actual cost of duplication. In the event of a dispute regarding the amount of compensation to which the Consultant is entitled under the termination provisions of this Agreement, Consultant shall provide all Documents & Data to City upon payment of the undisputed amount. Consultant shall have no right to retain or fail to provide to City any such documents pending resolution of the dispute. In addition, Consultant shall retain copies of all Documents & Data on file for a minimum of five (5) years following completion of the Project, and shall make copies available to City upon the payment of actual reasonable duplication costs. In addition, before destroying the Documents & Data following this retention period, Consultant shall make a reasonable effort to notify City and provide City with the opportunity to obtain the documents.

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