Transfer of NDA Sample Clauses

Transfer of NDA. Upon FDA Approval of Bio-E-Gel for the Launch Indication, BPA agrees to assign, and hereby assigns, all right, title and interest in and to its NDA for Bio-E-Gel for the Launch Indication to Company, shall promptly transfer all documentation related to such NDA to Company and agrees to take all such further commercially reasonable action and promptly execute such further documents as may be reasonably necessary or desirable to give full effect to such assignment (including without limitation filing any related documents with the FDA). After such transfer Company shall be solely responsible for (i) post FDA Approval regulatory obligations for the Product, including without limitation the preparation and submission of annual reports, the reporting of adverse events, and cooperating with governmental regulatory agencies; (ii) communication with third parties regarding the Product in the Field in the Territory, including without limitation responding to complaints and medical inquiries; (iii) investigating all complaints and adverse drug experiences related to the Product in the Field in the Territory; and (iv) conducting any voluntary or involuntary recalls of Product in the Territory, including without limitation recalls required by any governmental authority and recalls deemed reasonably necessary by Company or BPA.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Transfer of NDA. Subject only to the respective obligations of the parties set forth in the Transition Services Agreement: (i) On the Closing Date, the parties shall file with the FDA all of the documents and information required by the FDA to effect the transfer of the NDA in the Territory from Synthon or any Affiliate to JDS or an Affiliate of JDS designated by JDS. Synthon shall file and shall cause its Affiliates to file all of the documents and the information required of a former owner, including but not limited to a letter acknowledging the transfer of ownership of the NDA, and JDS shall file the information required of a new owner. Each of JDS and Synthon shall take any and all other actions required by the FDA or other relevant Regulatory Authorities, if any, to effect the transfer of the NDA from Synthon or its Affiliate to JDS or its designated Affiliate as soon as reasonably practicable. Synthon may retain an archival copy of the NDA, including supplements and records that are required to be kept under 21 C.F.R. §314.81. (ii) From and after the Closing Date, JDS shall assume from Synthon or its Affiliate all responsibility for any and all fee obligations for holders or owners of approved NDAs relating to the Product in the Territory, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (iii) From and after the Closing Date, JDS shall assume all regulatory responsibility with respect to the Product including those related to (A) the marketing and promotion of the Product in the Territory; (B) Adverse Drug Reaction reporting relating to the Product in the Territory; and (C) the filing of NDAs and / or supplements to NDAs for product line extensions, extensions of the expiry date and additional product claims or additions to the labeling of the Product.
Sample 1
Transfer of NDA. Within twenty days after receiving Esprit’s written request, Depomed shall provide Esprit with a letter addressed to FDA authorizing and requesting that each of the NDA and IND owned by Depomed and pertaining to Licensed Product in the Territory be transferred, in its entirety, to the name of Esprit. Depomed shall provide Esprit with a copy of the letter and Esprit shall immediately send a letter to FDA accepting the NDA and IND. Depomed 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 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 Depomed prior to making a material modification to the NDA or IND pertaining to the Licensed Product, and shall consider in good faith Depomed’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 Depomed’s expense, such cooperation as may be reasonably necessary to assist Depomed 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 Depomed or Depomed’s licensees; provided that, in Esprit’s reasonable judgment, such assistance is not unduly burdensome to Esprit’s senior management. In furtherance and not in limitation of the immediately preceding sentence, Depomed may request that Esprit supplement, at Depomed’s expense, the NDA related to the Licensed Product (e.g., to include additional data related to the Licensed Product) in connection with regulatory applications and approvals for Licensed Product outside of the Territory, which modifications will be subject to the written approval of Esprit, not to be unreasonably withheld.
Sample 1
Transfer of NDA. On the Transition Date (or an earlier date agreed upon by the Parties), the Parties shall file with the FDA all of the documents and information required by the FDA to effect the transfer of the NDA from Strakan or any Affiliate to Orexo or an Affiliate of Orexo designated by Orexo. Strakan shall file and shall cause its Affiliates to file all of the documents and the information required of a former owner, including but not limited to a letter acknowledging the transfer of ownership of the NDA, and Orexo shall file the information required of a new owner. Each of Orexo and Strakan shall take any and all other actions required by the FDA or other relevant regulatory authorities, if any, to effect the transfer of the NDA from Strakan or its Affiliate to Orexo or its designated Affiliate as soon as reasonably practicable after the Transition Date (or other agreed upon date). Strakan may retain an archival copy of the NDA, including supplements and records that are required to be kept under applicable Law.
Sample 1
Transfer of NDA. No later than five (5) Business Days after Purdue’s delivery (or deemed delivery) of the Purdue Notice pursuant to Section 4.2(b), Purdue shall pay to Transcept a non-refundable, non-creditable payment of thirty million dollars (US $30,000,000); provided, however, that if the first approval of an NDA for a Product by the FDA for marketing in the U.S. Territory is received by Transcept after June 30, 2010, such payment shall be reduced by two million dollars (US $2,000,000) for each thirty (30) day period between the date of receipt of such approval and June 30, 2010.
Sample 1
Transfer of NDA. NRP hereby assigns and transfers the NDA to Emmaus and agrees to take all reasonable or necessary steps to effect such transfer with the FDA. Emmaus hereby accepts such assignment and transfer.
Sample 1
Transfer of NDA. In the event that Alexza obtains the approval of the Existing NDA for the Product for the treatment of the Initial Indication as described in Section 4.4(a) above, then within [ * ] ([ * ]) days after Alexza obtains such approval by the FDA of such NDA, Alexza shall transfer to BLS, [ * ], the approval of the NDA to enable BLS to commercialize the Product in the Field in the Territory and to manage any additional development of the Product in the Territory in connection with the treatment of the Initial Indication.
Sample 1
AutoNDA by SimpleDocs
Transfer of NDA. (a) Nycomed hereby assigns all right, title and interest in and to the NDA for the Product to BioSante, shall promptly transfer all documentation related to such NDA in Nycomed’s possession to BioSante, and agrees to take all further commercially reasonable action and promptly execute such further documents as may be reasonably necessary to give full effect to such assignment, including without limitation, submitting a letter to the FDA requesting transfer of the NDA to BioSante together with any related documents necessary to effect such transfer. For the avoidance of doubt, the foregoing activities by Nycomed shall be rendered without additional charge to BioSante and are included in the payment being made pursuant to Section 3.1. (b) BioSante shall cooperate with Nycomed, and take all further commercially reasonable action, promptly comply with all reasonable requests by Nycomed and promptly execute any documents as may be reasonably necessary, to give full effect to the foregoing assignment. In any event, from and after the Effective Date, BioSante shall be responsible for the payment of all fees and expenses in connection with the maintenance of the NDA, and in connection with the foregoing transfer. Once the NDA for the Product is transferred to BioSante, BioSante shall be responsible for all obligations, responsibilities and liabilities with respect to the NDA, and Nycomed’s obligations with respect to the NDA shall cease, except as specifically provided in this Agreement.
Sample 1

Related to Transfer of NDA

  • 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 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 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 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 Funds From such funds as may be available for the purpose in the relevant Fund Custody Account, and upon receipt of Proper Instructions specifying that the funds are required to redeem Shares of the Fund, the Custodian shall wire each amount specified in such Proper Instructions to or through such bank or broker-dealer as the Trust may designate.

  • 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 Rights This Agreement shall be binding on any successors of the parties. Neither party shall have the right to assign its interests in this Agreement to any other party, unless the prior written consent of the other party is obtained.

  • 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 Units (i) Except as expressly provided in this Agreement, a Member may not sell, exchange, transfer, assign, pledge, hypothecate or otherwise dispose of all or any portion of any of such Member's Units or any interest therein (a "Transfer") (except for a Transfer by Internet World to any Person or by any Member to a Permitted Transferee) without the written consent of the Board, which consent may be withheld for any reason. The Company shall not register any Transfer of a Member's Units or any interest therein, and any such Transfer or registration of Transfer shall be null and void, without the written consent of the Board. An assignee who has not been admitted as a Member shall be entitled only to allocations and distributions with respect to such interest in accordance with this Agreement, and shall have no right to any information or, to the fullest extent permitted by law, accounting of the affairs of the Company, shall not be entitled to inspect the books or records of the Company and shall not have any of the rights of a Member under the Act or this Agreement, but shall otherwise assume in writing prior to such Transfer, other than a pledge (in respect of which such compliance shall be required after sale or foreclosure), all obligations of the assignor hereunder as if such assignee were the assignor; no such assignment shall be valid unless the assumption of obligations described in this sentence has been executed. Neither a Transfer of Units nor the admission of the Transferee thereof as a Member shall discharge the transferor from any obligation hereunder. (ii) The restrictions contained in this SECTION 2.6(a) shall not apply with respect to any Transfer of Units or any part thereof by any Member (a) among its Affiliates, (b) to any lender to whom a Member's Units or any part thereof are assigned or pledged pursuant to a loan agreement, (c) to any Member's spouse or children or to a trust or the trustee or 8 68 trustees of a trust directly or indirectly for the benefit of the Member's spouse, children or a charitable organization, (d) to the Member's executors, administrator, testamentary trustee, legatees or beneficiaries upon the Member's death, or (e) by gift (all such transferees shall be collectively referred to as the "Permitted Transferees"); PROVIDED, that the Permitted Transferee shall execute a counterpart of this Agreement; and PROVIDED, FURTHER that the restrictions contained in this Agreement shall continue to apply to the Units after such Transfer by reference to the original Member; and PROVIDED, FURTHER, that the transferor shall remain liable for all of its obligations under this Agreement that survive.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!