FILINGS WITH FDA REGARDING TRANSFER OF NDAS Sample Clauses

FILINGS WITH FDA REGARDING TRANSFER OF NDAS. At the Closing, the parties shall file with the FDA the information required pursuant to 21 C.F.R. Section 314.72, or any successor regulation thereto, regarding the transfer of the NDAs from KING to NOVAVAX. KING shall file the information required of a former owner, and NOVAVAX shall file the information required of a new owner. The parties also agree to use their reasonable best efforts to take any and all other actions required by the FDA, or other necessary governmental agencies, if any, to effect the transfer of the NDA from KING to NOVAVAX. KING may retain an archival copy of the NDA, including supplements and records that are required to be kept under 21 C.F.R. Section 314.81, and KING shall treat such archived copies as Confidential Information (as defined in the Supply Agreement) of NOVAVAX and disclosure of such information shall be governed by the Supply Agreement.
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FILINGS WITH FDA REGARDING TRANSFER OF NDAS. At the Closing, the parties shall file with the FDA the information required pursuant to 21 C.F.R. Section 314.72, or any successor regulation thereto, regarding the transfer of the NDAs from GW to Monarch. GW shall file the information required of a former owner, and Monarch shall file the information required of a new owner. The parties also agree to use their reasonable best efforts to take any and all other actions required by the FDA, or other necessary governmental agencies, if any, to effect the transfer of the NDAs from GW to Monarch. GW may retain an archival copy of the NDAs, including supplements and records that are required to be kept under 21 C.F.R. Section 314.81, and GW shall treat such archived copies as Confidential Information (as defined in the Supply Agreement) of Monarch and disclosure of such information shall be governed by the Supply Agreement.

Related to FILINGS WITH FDA REGARDING TRANSFER OF NDAS

  • Transfer of Licenses Lessee shall use reasonable efforts (i) to transfer to Lessor or Lessor’s nominee all licenses, operating permits and other governmental authorizations and all contracts, including contracts with governmental or quasi-governmental entities, that may be necessary for the operation of the Hotel (collectively, “Licenses”), or (ii) if such transfer is prohibited by law or Lessor otherwise elects, to cooperate with Lessor or Lessor’s nominee in connection with the processing by Lessor or Lessor’s nominee of any applications for, all Licenses; provided, in either case, that the costs and expenses of any such transfer or the processing of any such application shall be paid by Lessor or Lessor’s nominee.

  • Transfer of Know-How To facilitate Licensee’s accomplishment of the responsibilities set forth in Section 4.01 above, within thirty (30) days of the Effective Date of this Agreement GenuPro shall in good faith supply Licensee with copies of the GenuPro Know-How, Lilly Know-How and Lilly Manufacturing Know-How pertinent to the development of the GenuPro Compound in the Field that GenuPro is able to provide using commercially reasonable efforts and which is in the possession of GenuPro on the Effective Date, and shall transfer to Licensee the legal title to any IND on the GenuPro Compound presently on file in GenuPro’s name with the FDA and any comparable filings in other countries of the Territory. GenuPro shall also facilitate transfer of GenuPro Compound manufacturing-related information (including any associated quality and analytical information) to Licensee from those Third Parties from which GenuPro or PPD has received quotations for manufacturing GenuPro Compound that GenuPro is not under any obligation to keep confidential from a third party. GenuPro will provide Licensee with all relevant information available and known to GenuPro or PPD concerning the safety, handling, use, disposal and environmental effects of the GenuPro Compound or as may be useful to Licensee to conduct the Project, including but not limited to any communications with regulatory agencies. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.

  • Certain Notifications Until Closing From the Signing Date until the Closing, the Company shall promptly notify the Investor of (i) any fact, event or circumstance of which it is aware and which would reasonably be expected to cause any representation or warranty of the Company contained in this Agreement to be untrue or inaccurate in any material respect or to cause any covenant or agreement of the Company contained in this Agreement not to be complied with or satisfied in any material respect and (ii) except as Previously Disclosed, any fact, circumstance, event, change, occurrence, condition or development of which the Company is aware and which, individually or in the aggregate, has had or would reasonably be expected to have a Company Material Adverse Effect; provided, however, that delivery of any notice pursuant to this Section 3.4 shall not limit or affect any rights of or remedies available to the Investor; provided, further, that a failure to comply with this Section 3.4 shall not constitute a breach of this Agreement or the failure of any condition set forth in Section 1.2 to be satisfied unless the underlying Company Material Adverse Effect or material breach would independently result in the failure of a condition set forth in Section 1.2 to be satisfied.

  • Certain Notifications and Required Actions After the date of this Agreement, the Company shall promptly advise the Representatives in writing of: (i) the receipt of any comments of, or requests for additional or supplemental information from, the Commission; (ii) the time and date of any filing of any post-effective amendment to the Registration Statement or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus; (iii) the time and date that any post-effective amendment to the Registration Statement becomes effective; and (iv) the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus or the Prospectus or of any order preventing or suspending the use of any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus, or of any proceedings to remove, suspend or terminate from listing or quotation the Shares from any securities exchange upon which they are listed for trading or included or designated for quotation, or of the threatening or initiation of any proceedings for any of such purposes. If the Commission shall enter any such stop order at any time, the Company will use its best efforts to obtain the lifting of such order at the earliest possible moment. Additionally, the Company agrees that it shall comply with all applicable provisions of Rule 424(b), Rule 433 and Rule 430B under the Securities Act and will use its reasonable efforts to confirm that any filings made by the Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission.

  • Transfer of Intellectual Property The Executive hereby agrees to transfer to the Company and/or its subsidiaries and consolidated affiliated entities all intellectual property rights in the works created during the Employment or other intellectual property rights deemed to be occupational works in accordance with applicable laws and regulations (the “Occupational Works”). The “intellectual property rights” as referred to in this Agreement means all current and future intellectual property rights, including but not limited to patent rights, trademarks or copyrights in any country, whether registered or not. The Executive agrees that, throughout the course of the Employment and at all times thereafter, the Executive shall execute necessary documents and take necessary action to implement transfer of the Occupational Works to the Company or its consolidated affiliated entities. The Executive acknowledged that the Company shall, where permitted by applicable laws and regulations, hold all rights and interests in the Occupational Works, including any patent or copyrights. The Executive further agrees that, throughout the course of the Employment and at all times thereafter, the Executive and his or her heirs, assignees and representatives will, upon the Company’s requests, assign exclusively to the Company or any of its subsidiaries and consolidated affiliated entities any right, title and interest in the Occupational Work and assist in the preparation and execution of all applications and instruments and carry out other tasks or procedures necessary in accordance with applicable laws and regulations for the Company to obtain and maintain the patent and other intellectual property right in any applicable jurisdictions and/or protecting the rights and interests of the Company and/or any of its subsidiaries and consolidated affiliated entities in the Occupational Works.

  • Limitation on Transfer of Ownership Rights (a) No sale or other transfer of record or beneficial ownership of a Class R Certificate (whether pursuant to a purchase, a transfer resulting from a default under a secured lending agreement or otherwise) shall be made to a Disqualified Organization or an agent of a Disqualified Organization. The transfer, sale or other disposition of a Class R Certificate (whether pursuant to a purchase, a transfer resulting from a default under a secured lending agreement or otherwise) to a Disqualified Organization shall be deemed to be of no legal force or effect whatsoever and such transferee shall not be deemed to be an Owner for any purpose hereunder, including, but not limited to, the receipt of distributions on such Class R Certificate. Furthermore, in no event shall the Trustee accept surrender for transfer, registration of transfer, or register the transfer, of any Class R Certificate nor authenticate and make available any new Class R Certificate unless the Trustee has received an affidavit from the proposed transferee in the form attached hereto as Exhibit H. Each holder of a Class R Certificate by his acceptance thereof, shall be deemed for all purposes to have consented to the provisions of this Section 5.08(a).

  • Certain Amendments Nothing herein shall be construed to prevent the Company from amending, altering, eliminating or reducing any plans, benefits or programs so long as the Executive continues to receive compensation and benefits consistent with Sections 3 through 6.

  • Certain Additional Actions Regarding Intellectual Property If any Event of Default shall have occurred and be continuing, upon the written demand of the Collateral Agent, each Pledgor shall execute and deliver to the Collateral Agent an assignment or assignments of the registered Patents, Trademarks and/or Copyrights and Goodwill and such other documents as are necessary or appropriate to carry out the intent and purposes hereof. Within five (5) Business Days of written notice thereafter from the Collateral Agent, each Pledgor shall make available to the Collateral Agent, to the extent within such Pledgor’s power and authority, such personnel in such Pledgor’s employ on the date of the Event of Default as the Collateral Agent may reasonably designate to permit such Pledgor to continue, directly or indirectly, to produce, advertise and sell the products and services sold by such Pledgor under the registered Patents, Trademarks and/or Copyrights, and such persons shall be available to perform their prior functions on the Collateral Agent’s behalf.

  • Transfer of Interest in Agreements The Purchaser has the right to assign its interest under this Agreement, in whole or in part, to the Trustee, as may be required to effect the purposes of the Pooling and Servicing Agreement, without the consent of the Seller, and the assignee shall succeed to the rights and obligations hereunder of the Purchaser. Any expense reasonably incurred by or on behalf of the Purchaser or the Trustee in connection with enforcing any obligations of the Seller under this Agreement will be promptly reimbursed by the Seller.

  • Filings, Registrations and Recordings Each document (including any Uniform Commercial Code financing statement) required by the Security Documents or under law or reasonably requested by the Administrative Agent to be filed, registered or recorded in order to create in favor of the Administrative Agent, for the benefit of the Lenders, a perfected Lien on the Collateral described therein, prior and superior in right to any other Person (other than with respect to Liens expressly permitted by Section 7.3), shall be in proper form for filing, registration or recordation.

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