Transfer of NDA and IND Sample Clauses

Transfer of NDA and IND. The Parties agree and acknowledge that within 20 days after the Effective Date and receipt of ESPRIT’s written request, NOVAVAX shall provide ESPRIT with a letter addressed to the FDA authorizing and requesting that each NDA and IND owned by NOVAVAX and pertaining to the Licensed Product in the Territory, as the case maybe, be transferred, in its entirety, to the name of ESPRIT. NOVAVAX shall provide ESPRIT with a copy of the letter and ESPRIT shall promptly send a letter to the FDA accepting the NDA and IND. NOVAVAX will be entitled to copy and reference the NDA and IND, and any safety database or other safety information related to the Licensed Product, outside the Territory freely as it determines. Each party will notify the other immediately by telephone (with prompt written follow-up) of any inquiry, contact or communication received from any governmental regulatory agency or other official body (within or outside of the Territory) which relates to the Licensed Product or any component or ingredient thereof, and will promptly furnish the other party with copies of all written communications relating thereto sent to or received from such regulatory agency. ESPRIT shall consult with NOVAVAX prior to making a material modification to the NDA or IND pertaining to the Licensed Product, and shall consider in good faith NOVAVAX’s views with respect to the impact any such modification may have on the marketing and commercialization of the Licensed Product outside of the Territory. ESPRIT shall provide, at NOVAVAX’s expense, such cooperation as may be reasonably to assist NOVAVAX in referencing the NDA or IND pertaining to Licensed Product or safety information related to Licensed Product in connection with regulatory applications and approvals for Licensed Product outside of the Territory made by NOVAVAX or NOVAVAX’s licensees; provided that, in ESPRIT’s reasonable judgment, such assistance is not unduly burdensome to ESPRIT’s senior management. NOVAVAX hereby retains and ESPRIT hereby grants to NOVAVAX the perpetual exclusive, fully paid up right to use with the right to sublicense ((i) outside the Field and (ii) in the Field but outside the Territory) all data created by under or in connection with the NDA and the IND.
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Transfer of NDA and IND. In the event of any termination of this Agreement, (a) Esprit shall within three days prepare and send an executed letter to FDA authorizing the transfer of the NDA and the IND for the Licensed Product to Depomed, and Esprit shall also transfer to Depomed all regulatory documents, a chronology of discussions with FDA, and other information necessary to maintain compliance with the US regulatory authorities, and (b) Esprit will continue to provide Depomed with assistance, at Depomed’s expense during the six month period beginning on the termination date (or such longer period as may be reasonably required), ensuring the orderly transition of the Licensed Product and its corresponding regulatory approvals to Depomed. If so requested by Depomed, in connection with the transfer of the NDA and the IND for the Licensed Product to Depomed as contemplated by this Section 15.6, Esprit shall also (a) assign to Depomed any or all assignable customer contracts, customer orders, sublicenses and distribution agreements related to the Licensed Product, if so requested by Depomed and (b) provide to Depomed any and all sales, promotional and training material in Esprit’s possession at the time of such transfer.
Transfer of NDA and IND. Immediately following the Closing, the parties shall file with the FDA the information required pursuant to 21 C.F.R. Section 314.72 for the transfer of the NDA and IND for the GLIADEL Product from APPI to Guilford. APPI shall file the information required of a former owner as set forth in Exhibit C hereto, and Guilford shall file the information required of a new owner as set forth in Exhibit D hereto. APPI may retain an archival copy of such NDA and IND, including information required to be kept under applicable regulations.

Related to Transfer of NDA and IND

  • Transfer of License Notwithstanding the provisions of conditions 13.1 and 13.2, if Customer sells or transfers the Equipment in which the Software operates, Kodak shall offer to license the Software, and to provide services, to any bona fide end user (“Transferee”) pursuant to Kodak’s then current standard terms, conditions and fees, provided that the Transferee is not considered, in Kodak’s discretion, a competitor of Kodak or its parent, affiliates or subsidiaries. To the extent that the Software is licensed to a Transferee in accordance with this condition, Customer’s license to use the Software shall be deemed terminated. Kodak shall offer to provide de-installation services for the Customer and re-installation and certification for the Equipment and Software and services for the Transferee at Kodak’s then current applicable fees.

  • 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 Agreement Without prior written consent of the WFOE, the Existing Shareholders or the Domestic Company may not assign its rights and obligations hereunder to any third party.

  • Transfer of Notes (a) Each Holder may Transfer up to 49% (in the aggregate) of its beneficial interest in its Note whether or not the related transferee is a Qualified Transferee without a Rating Agency Confirmation. Each Holder shall not Transfer more than 49% (in the aggregate) of its beneficial interest in its Note unless (i) prior to a Securitization of any Note, the other Holders have consented to such Transfer, in which case the related transferee shall thereafter be deemed to be a “Qualified Transferee” for all purposes under this Agreement, (ii) after a Securitization of any Note, a Rating Agency Confirmation has been received with respect to such Transfer, in which case the related transferee shall thereafter be deemed to be a “Qualified Transferee” for all purposes under this Agreement, or (iii) such Transfer is to a Qualified Transferee. Any such transferee must assume in writing the obligations of the transferring Holder hereunder and agree to be bound by the terms and provisions of this Agreement and the Servicing Agreement. Such proposed transferee (except in the case of Transfers that are made in connection with a Securitization) shall also remake each of the representations and warranties contained herein for the benefit of the other Holders. Notwithstanding the foregoing, without the non-transferring Holder’s prior consent (which will not be unreasonably withheld), and, if such non-transferring Holder’s Note is in a Securitization, without a Rating Agency Confirmation from each Rating Agency that has been engaged by the related Depositor to rate the securities issued in connection with such Securitization, no Holder shall Transfer all or any portion of its Note to any Borrower Party and any such Transfer shall be absolutely null and void and shall vest no rights in the purported transferee. (b) Except for a Transfer made in connection with a Securitization, or a Transfer made by an Initial Note Holder to an Affiliate, at least five (5) days prior to a transfer of any Note, the transferring Holder shall provide to the other Holders and, if any Certificates are outstanding, to the Rating Agencies, a certification that such transfer will be made in accordance with this Section 12, such certification to include (1) the name and contact information of the transferee and (2) if applicable, a certification by the transferee that it is a Qualified Transferee. (c) The Holders acknowledge that any Rating Agency Confirmation may be granted or denied by the Rating Agencies in their sole and absolute discretion and that such Rating Agencies may charge the transferring Holder customary fees in connection with providing such Rating Agency Confirmation. (d) Notwithstanding anything to the contrary contained herein, each Holder may pledge or transfer (a “Pledge”) its Note to any entity (other than any Borrower Party) that has extended a credit facility to such Holder or has entered into a repurchase agreement with such Holder and that, in each case, is either a Qualified Transferee or a financial institution whose long-term unsecured debt is rated at least “A” (or the equivalent) or better by each Rating Agency (a “Note Pledgee”), or to a Person with respect to which a Rating Agency Confirmation has been obtained, on terms and conditions set forth in this Section 12(d), it being further agreed that a financing provided by a Note Pledgee to any Holder or any Affiliate that controls such Holder that is secured by such Holder’s interest in its respective Note and is structured as a repurchase arrangement, shall qualify as a “Pledge” hereunder on the condition that all applicable terms and conditions of this Section 12(d) are complied with. A Note Pledgee that is not a Qualified Transferee may not take title to a Note without a Rating Agency Confirmation. Upon written notice, if any, by the pledging Holder to the other Holders and any Master Servicer that a Pledge has been effected (including the name and address of the applicable Note Pledgee), the other Holders agree to acknowledge receipt of such notice and thereafter agree: (i) to give such Note Pledgee written notice of any default by the pledging Holder in respect of its obligations under this Agreement of which default such Holder has actual knowledge and which notice shall be given simultaneously with the giving of such notice to the pledging Holder; (ii) to allow such Note Pledgee a period of ten (10) Business Days to cure a default by the pledging Holder in respect of its obligations to the other Holders hereunder, but such Note Pledgee shall not be obligated to cure any such default; (iii) that no amendment, modification, waiver or termination of this Agreement or the Servicing Agreement (if the pledging Holder had the right to consent to such amendment, modification, waiver or termination pursuant to the terms hereof) shall be effective against such Note Pledgee without the written consent of such Note Pledgee, which consent shall not be unreasonably withheld, conditioned or delayed and which consent shall be deemed to be given if Note Pledgee shall fail to respond to any request for consent to any such amendment, modification, waiver or termination within 10 days after request therefor; (iv) that the other Holders shall accept any cure by such Note Pledgee of any default of the pledging Holder which such pledging Holder has the right to effect hereunder, as if such cure were made by such pledging Holder; (v) that the other Holders or any Servicer shall deliver to Note Pledgee such estoppel certificate(s) as Note Pledgee shall reasonably request, provided that any such certificate(s) shall be in a form reasonably satisfactory to the other Holders; and (vi) that, upon written notice (a “Redirection Notice”) to any Master Servicer by such Note Pledgee that the pledging Holder is in default beyond any applicable cure periods with respect to the pledging Holder’s obligations to such Note Pledgee pursuant to the applicable credit agreement or other agreements relating to the Pledge between the pledging Holder and such Note Pledgee (which notice need not be joined in or confirmed by the pledging Holder), and until such Redirection Notice is withdrawn or rescinded by such Note Pledgee, Note Pledgee (or at any time that pledging Holder otherwise directs that such payment be made to Note Pledgee pursuant to a separate notice) shall be entitled to receive any payments that any Servicer would otherwise be obligated to make to the pledging Holder from time to time pursuant to this Agreement or any Servicing Agreement. Any pledging Holder hereby unconditionally and absolutely releases the other Holders and any Servicer from any liability to the pledging Holder on account of any Holder’s or Servicer’s compliance with any Redirection Notice believed by any Servicer or other Holders in good faith to have been delivered by a Note Pledgee. Note Pledgee shall be permitted to exercise fully its rights and remedies against the pledging Holder (and accept an assignment in lieu of foreclosure as to such collateral), in accordance with applicable law, the pledge agreement, repurchase agreement or similar agreement between the pledging Holder and the Note Pledgee and this Agreement. In such event, or if the pledging holder otherwise assigns its interests to the Note Pledgee, the other Holders and any Master Servicer shall recognize such Note Pledgee (and any transferee (other than any Borrower Party) that is also a Qualified Transferee at any foreclosure or similar sale held by such Note Pledgee or any transfer in lieu of foreclosure), and such Person’s successor and assigns, as the successor to the pledging Holder’s rights, remedies and obligations under this Agreement, and any such Note Pledgee or Qualified Transferee shall assume in writing the obligations of the pledging Holder hereunder accruing from and after such Transfer (i.e., realization upon the collateral by such Note Pledgee) and agrees to be bound by the terms and provisions of this Agreement. The rights of a Note Pledgee under this Section 12(d) shall remain effective as to any Holder (and any Servicer) unless and until such Note Pledgee shall have notified such Holder (and any Servicer, as applicable) in writing that its interest in the pledged Note has terminated.

  • Transfer of Data The Participant consents to the Company or any Affiliate thereof processing data relating to the Participant for legal, personnel, administrative and management purposes and in particular to the processing of any sensitive personal data relating to the Participant. The Company may make such information available to any Affiliate thereof, those who provide products or services to the Company or any Affiliate thereof (such as advisers and payroll administrators), regulatory authorities, potential purchasers of the Company or the business in which the Participant works, and as may be required by law.

  • No Transfer of License This license is personal to you and may not be sublicensed, assigned, or transferred by you to any other person without publisher's written permission.

  • Transfer of Materials To facilitate the conduct of activities under the Research Plan or an Additional Research Plan, as applicable, either Party (the “Transferor Party”) may, at its election, provide Materials to the other Party (the “Transferee Party”) solely as mutually agreed by the Parties or as set forth in the Research Plan or any Additional Research Plan. All such Materials (a) will remain the sole property of the Transferor Party, (b) will be used only in the exercise if the Transferee Party’s rights or fulfillment of the Transferee Party’s obligations under this Agreement, (c) except as provided in the Research Plan or Additional Research Plan or as otherwise agreed by the Parties, (i) will remain solely under the control of the Transferee Party, (ii) will not be used or delivered by the Transferee Party to or for the benefit of any Third Party, and (iii) will not be used in research or testing involving human subjects, and (d) will be subject to all additional restrictions and obligations that the Transferor Party has identified in a written notice to the Transferee Party as being necessary for the Transferor Party to comply with its obligations to Third Parties with respect to the applicable Material, which notice is provided at or prior to the delivery of such Materials to the Transferee Party. Without limitation to ARTICLE 7, all Materials supplied under this Section 2.1.9 are supplied “as is”, with no warranties of fitness for a particular purpose, and must be used with prudence and appropriate caution in any experimental work, as not all of their characteristics may be known. Following the completion of the activities for which the applicable Materials were supplied under this Section 2.1.9 or upon the Transferor Party’s earlier request, the Transferee Party will either destroy or return to the Transferor Party, at the Transferor Party’s sole discretion, all Materials provided by the Transferor Party that are unused; provided that Vertex will have the right to retain and continue to use any Materials provided by Company that Vertex has the right to Exploit under the license granted to Vertex pursuant to Section 4.1.1.

  • Transfer of Technology 1. The Parties agree to exchange views and information on their law and international practices on the protection and enforcement of intellectual property rights, affecting transfer of technology. This shall, in particular, include exchanges on measures to facilitate information flows, business partnerships, and voluntary licensing and subcontracting agreements. Particular attention shall be paid to the conditions necessary to create an adequate enabling environment for technology transfer in the host countries, including issues such as the domestic legal framework and the development of human capital. 2. When measures are taken with regard to technology transfer, the legitimate interests of the intellectual property right holders shall be protected.

  • Transfer of Note Each provision of this Note shall be and remain in full force and effect notwithstanding any negotiation or transfer hereof and any interest herein to any other Holder or participant.

  • Transfer of Possession Possession of the Property shall be transferred to Purchaser at the time of Closing subject to the Permitted Encumbrances.

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