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.
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.
Transfer of NDA. Subject only to the respective obligations of the parties set forth in the Transition Services Agreement:
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.
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.
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.
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.
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.
