Transfer of Marketing Authorizations. Purchaser shall file, or shall cause its Affiliate or designee to file, applications for the transfer of the Marketing Authorizations for the Products in the Territory within [**] from the Closing Date. Purchaser shall provide Novartis with the status of the progress of the MA Transfer at least once a month and such report will be provided to Novartis not later than the 25th of each month following the Closing. Prior to the Purchaser filing its applications for the transfer of the Marketing Authorizations for the Products, Novartis shall provide a letter to the Purchaser indicating that a transfer of ownership of the MAs has taken place and permitting cross referencing of such original Novartis MA files or as otherwise needed to facilitate the MA Transfer as required by the Regulatory Authority.
Transfer of Marketing Authorizations. As promptly as reasonably practicable following the Termination Agreement Date, Palatin and AMAG shall (a) file the Transfer Letters with the FDA to transfer ownership of the Marketing Authorizations for the Products and (b) submit all appropriate and necessary documentation with respect to FDA approval by the applicable Governmental Authority of the removal of trademarks of AMAG or its Affiliates and the inclusion of Palatin’s name, corporate logo and National Drug Code on labeling for the Product, subject to the Transitional Trademark License Agreement. As promptly as reasonably practicable following the Termination Agreement Date, Palatin shall apply for and initiate applicable processes to obtain, establish and begin using its own National Drug Code for the Products, and shall promptly notify AMAG thereof. Notwithstanding the foregoing, Palatin shall only be entitled to promote, market, sell, distribute and/or otherwise Commercialize Product using AMAG’s National Drug Code in accordance with the requirements set forth in Schedule 3.7.
Transfer of Marketing Authorizations. Subject to Clause 5.1(b), Purchaser shall file, or shall cause its Affiliate or designee to file, or, if required by applicable law, Novartis, its Affiliate or designee shall file, applications for the transfer of the Marketing Authorizations for the Product in each country as soon as practicable and in any event no longer than [***] from the Closing Date with respect to all countries in the Territory; provided, however, that in the European countries, the Purchaser shall use its commercially reasonable efforts to file for the transfer of the Marketing Authorizations within [***] from the Closing Date. Purchaser shall provide Novartis with a detailed action submission plan for the transfer of the Marketing Authorizations for the Product (the “Marketing Authorization Plan”) within [***] from the Closing Date. The Marketing Authorization Plan shall include all requirements and actions necessary, to obtain approval of the Marketing Authorization transfer by the Regulatory Authorities in each country in the Territory (including, but not limited to, the establishment of the Purchaser’s Affiliate or local agent, requirements of a Certificate of the Pharmaceutical [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions Product, Regulatory Authority inspections and a list of documents to be provided by Novartis). Purchaser hereby acknowledges and agrees to file for the transfer of the Marketing Authorizations in each country of the Territory set forth in the Marketing Authorization Plan. Purchaser shall provide Novartis with the status of the progress of each transfer of Marketing Authorizations at least [***].
Transfer of Marketing Authorizations. Purchaser shall file, or shall cause its Affiliate or designee to file, or, if required by applicable Law, Novartis, its Affiliate or designee, shall file applications for the transfer of the Marketing Authorizations (“MA”) for the Product in each country of the Territory as soon as practicable and in any event within nine (9) months from the Closing Date. * * * Such plan shall include all requirements and action plans necessary, to obtain approval of the Marketing Authorization transfer by the Regulatory Authorities in each country in the Territory (including but not limited to the establishment of the Purchaser’s Affiliate or local agent, requirements for Certificate of the Pharmaceutical Product, Regulatory Authority inspections and a list of documents to be provided by Novartis). Purchaser shall provide Novartis with the status of the progress of each Market Authorization Transfer * * * until all Marketing Authorizations are transferred.
Transfer of Marketing Authorizations. [***] of each of the Final Marketing Authorization and the Swiss MA, subject to the terms and conditions of this Agreement, Nektar shall transfer and assign to Daiichi Sankyo any and all right, title, and interest in and to such Final Marketing Authorization and the Swiss MA, and Nektar will [***] submit to the applicable Health Authorities a letter (with a copy to Daiichi Sankyo) or other communication required by the applicable Health Authorities, notifying such Health Authorities of each such transfer.
Transfer of Marketing Authorizations. (a) Subject to applicable European Union laws and regulations, Ipsen shall use reasonable commercial efforts to hold the Marketing Authorizations in its name until such Market Authorizations have been transferred to Auxilium or Transferee on a country by country basis.
(b) Ipsen, Auxilium and Transferee shall cooperate to expeditiously transfer all Marketing Authorizations, as well as all regulatory, and pharmacovigilence documents deemed necessary for continuation of Product sale and maintenance of each Marketing Authorization in the Territory.
(c) Auxilium shall (and shall cause the Transferee to) use its best efforts to assist Ipsen in transferring all the Marketing Authorizations in a timely manner. It is the intent of Auxilium and the Transferee that all Marketing Authorizations be transferred to the Transferee.
(d) After the Notification Date, and subject to Ipsen having been provided sufficiently in advance with all relevant information required to file the Marketing Authorizations transfers in each country by Auxilium and/or Transferee, Ipsen shall take all necessary measures within its control to transfer the Marketing Authorizations (i) for [**], each within [**] of the Notification Date and (ii) [**] within [**] of the Notification Date. Ipsen shall not be responsible for any delay in the transfer of the Marketing Authorization(s) caused by Regulatory Authorities, Auxilium, Transferee or by any other causes which are not within Xxxxx’x control. If the Transfer Dates for [**] are beyond the [**] period, or [**] beyond the [**] period, as a result of such delays by Regulatory Authorities, then these periods shall be extended by the amount of time attributable to such delays.
(e) In the event that the requested transfer of any Marketing Authorization is denied by a Regulatory Authority, the Parties will discuss in good faith the appropriate measures to be taken.
(f) The Parties acknowledge that the use of the dossier to support a second round of MRP applications for the product and any information contained therein, including any update of such documentation, will be made solely by Transferee (or Auxilium) at Transferee’s (or Auxilium’s) costs.
Transfer of Marketing Authorizations. Promptly after the Closing, the parties shall file applications or notices with the applicable Governmental Authority in each country in the Territory *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to transfer the record applicant holder of the Transferred Regulatory Documentation, including all related marketing authorizations, from WFHC to Shire. The parties further agree to use all reasonable commercial efforts, to take any and all other actions required by any such Governmental Authority ineach country in the Territory, which may be necessary to effect the transfer of the Transferred Regulatory Documentation, including all related marketing authorizations, from WFHC to Shire. Shire shall bear the filing fees and all reasonable costs of contract research organizations or other agents required to effect the transfer of record applicant holder from WFHC to Shire in each country in the Territory. To the extent WFHC incurs reasonable out-of-pocket costs and expenses in furtherance of the transfers of the Transferred Regulatory Documentation to Shire, Shire shall reimburse WFHC for all such amounts within thirty (30) days of Shire’s receipt of an invoice from WFHC specifying such amounts and providing reasonable documentation of the source of the related out-of-pocket costs and expenses provided that any such individual cost and expense in excess of U.S.$5,000 has been approved in writing by Shire before it is incurred by WFHC.
Transfer of Marketing Authorizations. Purchaser shall file, or shall cause to file, in accordance with a transition plan to be finalized and agreed to by Purchaser and Novartis not later than 30 days after Closing (“Transition Plan”; the current draft is attached to this Agreement as Annex 8), applications for the transfer of the Marketing Authorizations for the Product in the Field in each country of the Territory within nine (9) months from the Closing Date. Should there be any variations in a country in the Territory which exists as at the Closing Date and which prevents, by operation of applicable law, the Purchaser from filing for transfer of the MA in such country, then in such country the Purchaser shall have a period of three (3) months from the date of completion of such variation to make the appropriate filing contemplated by this Clause 5.1 it being understood and agreed by the Parties that such extended period shall in no event be longer than eighteen (18) months from the Closing Date. Purchaser shall provide Novartis with a detailed action submission plan for the transfer of the Marketing Authorizations for the Product in the Territory promptly following the Closing Date. Such plan shall comply with the Transition Plan and include all requirements and actions necessary to obtain approval of the Marketing Authorization transfer by the Regulatory Authorities in each relevant country in the Territory (including, if necessary, for example the establishment of the Purchaser’s Affiliate or local agent, requirements of a Certificate of the Pharmaceutical Product, Regulatory Authority inspections).
Transfer of Marketing Authorizations. 3.1 For purposes of this Termination Agreement (hereinafter “Agreement”), the transfer of a Marketing Authorization in a specific country is not complete until all applicable regulatory requirements relating to the transfer have been met and TMC, Lantheus or a designated third party is approved as the Marketing Authorization Holder for the Product by the appropriate regulatory authority in the country.
3.2 Immediately after execution of this Agreement, the Parties shall cooperate with the purpose of completing as quickly as possible a transfer of the Marketing Authorization for countries in the EU (EMEA centralized MAA) to TMC. Should a transfer to TMC (or any other third party designated by EPIX) not have been completed by November 30, 2009, BSP shall be entitled to withdraw the Marketing Authorization for the EU. However, if due to the Article 20 Procedure the transfer of the Marketing Authorization is delayed in a way so that the transfer is not completed by November 30, 2009, BSP shall remain Marketing Authorization Holder in the EU an additional month after November 30, 2009 for each month of Delay. For the purpose of this Section 3.2, Delay means any period after execution of this Termination Agreement where, due to the Article 20 Procedure, a notification for the transfer of the Marketing Authorization in the EU can not be filed or is not processed by the EMEA.
3.3 BSP has already initiated, upon agreement with EPIX, the transfer of the Marketing Authorization for Switzerland to a TMC Associate. Immediately after execution of this Agreement and receipt of the amount of USD 10,500,000 in accordance with Section 10.2, the Parties shall cooperate and use commercially reasonable efforts with the purpose of completing as quickly as possible a transfer of the Marketing Authorization for Canada and Australia to Lantheus as set forth herein. Should a transfer of the Marketing Authorization to Lantheus not have been completed by November 30, 2009 for the respective countries, BSP shall be entitled to withdraw the Marketing Authorization for the respective countries.
3.4 With regard to Xxxxxx-Xxxxxxxxxxx, Xxxxxx, Xxxxx, Xxxxxxx and Serbia, BSP shall remain the holder of the Marketing Authorization and without any obligation to market the Product, until EPIX has designated in writing a third party to whom the Marketing Authorization shall be transferred. Should a transfer of the Marketing Authorization to a designated third party not have been completed by Nov...
Transfer of Marketing Authorizations. Purchaser shall file, or shall cause its Affiliate or designee to file, or, if required by applicable Law, Novartis, its Affiliate or designee shall file, applications for the transfer of the Marketing Authorizations for the Product in each country of the Territory as soon as practicable following the Closing Date and in any event within nine (9) months from the Closing Date unless otherwise provided in the Implementation Plan. Purchaser hereby acknowledges and agrees to file for the transfer of the Marketing Authorization in each country of the Territory in accordance with the Implementation Plan attached at Annex 4. Purchaser shall provide Novartis with a detailed submission action plan for the transfer of the Marketing Authorizations for the Product within three (3) months from the Closing Date. Such plan shall comply with Annex 4 and include all requirements and actions necessary, to obtain approval of the Marketing Authorization transfer by the Regulatory Authorities in each country in the Territory (including but not limited to the establishment of the Purchaser’s Affiliate or local agent, requirements of a Certificate of the Pharmaceutical Product, Regulatory Authority inspections and a list of documents to be provided by Novartis). Purchaser shall provide Novartis with the status of the progress of each MA Transfer in writing at least monthly.
