Transfer of Regulatory Filings. GSK shall, at its sole ------------------------------ expense, transfer to Adolor, or shall cause its designee(s) to transfer to Adolor, ownership of all regulatory filings made or filed for the Terminated Collaboration Product (to the extent that any are held in GSK's or such designee(s)'s name), if permitted by applicable Laws and regulations.
Transfer of Regulatory Filings. GSK shall [*] transfer to Theravance, or shall cause its designee(s) to transfer to Theravance, ownership of all regulatory filings made or filed for any Terminated Respiratory Commercialized Alliance Product (to the extent that any are held in GSK's or such designee(s)'s name) but only where the Terminated Respiratory Commercialized Alliance Product is a single agent product and contains the Theravance Compound as a single agent, and such transfer to be as permitted by applicable Laws and regulations. GSK shall cooperate as reasonably necessary to permit Theravance to exercise its rights hereunder; provided, however, that if such transfer cannot be effected by GSK in a particular Country [*] of the effective date of termination for such Terminated Respiratory Commercialized Alliance Product (for example., as a result of Theravance not having the appropriate entity in any such Country to whom ownership of such regulatory filing(s) would be required to be transferred) then GSK, after the expiration of such aforesaid period, shall forthwith be entitled to surrender ownership of such regulatory filing(s) and/or applications for cancellation in respect of such Country.
Transfer of Regulatory Filings. GSK shall [*] transfer to Theravance, or shall cause its designee(s) to transfer to Theravance, ownership of all regulatory filings made or filed for any such Terminated Non-Respiratory Development Alliance Product (to the extent that any are held in GSK's or such designee(s)'s name), and such transfer to be as permitted by applicable Laws and regulations. GSK shall cooperate as reasonably necessary to permit Theravance to exercise its rights hereunder; provided, however, that if such transfer cannot be effected by GSK in a particular Country within [*] of the effective date of termination for such Terminated Non-Respiratory Development Alliance Product (for example, as a result of Theravance not having the appropriate entity in any such Country to whom ownership of such regulatory filing(s) would be required to be transferred) then GSK, after the expiration of such aforesaid period, shall forthwith be entitled to surrender ownership of such regulatory filing(s) and/or applications for cancellation in respect of such Country.
Transfer of Regulatory Filings. As soon as practicable, but no later than [ * ], the Parties shall cooperate to transfer the EMA MAA filing from TMC for Cometriq in MTC to Licensee, including Marketing Authorization Holder status (including commitments and obligations listed in the MAA, and Exelixis shall ensure with TMC that such transfer shall occur, except that Exelixis shall complete the EMA post-marketing commitment of Study XL184-401, with the costs of such study to be shared in accordance with Section4.5), and the Pediatric Investigation Plan, provided that Licensee shall be responsible for all Regulatory Filings and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. interactions with the EMA with respect to such studies and Regulatory Filings, maintaining Orphan Drug Status, and all further EMA requirements with respect to such studies and Regulatory Filings. Without limiting the foregoing, such transfer efforts shall include (a) providing supporting documentation, responding to requests by applicable Regulatory Authorities and other reasonable efforts in connection with the MAA Approvals, (b) preparing and filing Regulatory Filings in countries of the Licensee Territory where Sobi and/or TMC has not as of the Effective Date filed Regulatory Filings and it is or it becomes commercially reasonable to do so. Licensee’s rights and obligations as a regulatory sponsor with respect to each particular Regulatory Filing under Article 5 shall commence upon the completion of such transfer.
Transfer of Regulatory Filings. Except as set forth in Section 5.2, Exelixis shall, in each case as may be required to enable Licensee to submit and file Regulatory Filings and obtain MAA Approvals for Products in the Licensee Territory:
(i) transfer to Licensee all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, other than INDs relating to Clinical Trials conducted and sponsored by Exelixis pursuant to the GDP;
(ii) to the extent that such transfer is not permitted under Applicable Laws, Exelixis shall provide to Licensee a right of reference or use to such Regulatory Approvals and Regulatory Filings. Exelixis shall provide appropriate notification of Licensee’s access and reference rights to the applicable Regulatory Authorities (including, to the extent applicable, an informed consent letter under Article 10c of Directive 2001/83/EC as amended), at the expense of Licensee seeking such right of reference. For the purposes of this Agreement, “right of reference” shall mean the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any equivalent regulation outside the US, including Article 10c of Directive 2001/83/EC, as each may be amended from time to time;
(iii) provide to Licensee copies in electronic form of all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory including those related to CMC, manufacturing and product development, validation and manufacturing for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, regulatory dossiers in Exelixis’ possession or Control, and the Drug Master File; and
(iv) to the extent any variations to the chemistry, manufacturing, and controls (“CMC”) section of the Regulatory Filing are required to conform with a variation that is initiated by Exelixis at its sole discretion, Exelixis shall reimburse Licensee for all associated fees that are paid by Licensee in filing such variations; provided that, for variations required to comply with Applicable Laws or any requirement of a Regulatory Authority, (a) Exelixis shall remain responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Exelixis Territory, and (b) Licensee shall be responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Autho...
Transfer of Regulatory Filings. Roche shall take such actions as reasonably necessary to transfer to GBT copies of any regulatory filings such as all IND related documents and all documents related to other filings and correspondence with or to and from any Regulatory Authority with respect to the Compound or Products (collectively, “Transfer”), and shall take such actions as may be necessary to inform Regulatory Authorities of this Transfer. Roche hereby grants to GBT a right of cross-reference to all regulatory materials filed by Roche or its Affiliates in the Territory related to the Compound or any Product, for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the commercialization of, Products in the Field in the Territory. Roche shall take all actions reasonably requested by GBT to enable GBT to exercise such right of cross-reference. All activities contemplated by this Section 4.3 shall be conducted by Roche at no cost to GBT. Promptly, but no later than [***] after the Effective Date, Roche shall transfer to GBT the latest available version of the Clinical Investigator’s Brochure, all final pre-clinical and clinical study reports and clinical study protocols, all clinical data and all relevant historical clinical safety data (safety information on serious adverse events shall be provided in CIOMS format and Safety information on non-serious adverse events shall be provided in English Line Listing format, subject to safety data transfer as set forth in Section 8.3) at no charge to GBT.
Transfer of Regulatory Filings. Following the Second Restated Effective Date and in accordance with the Transition Plan, GSK will assign and transfer (or cause to be assigned and transferred) to Amicus or its designee (or to the extent not so assignable, GSK shall take reasonable actions to make available to Amicus or its designee the benefits of) all regulatory submissions and filings (including all INDs and XXXx), and all modules prepared for such regulatory submissions and filings, related to the Compound and the Products in the Territory, including such regulatory submissions and registrations made or owned by GSK or its Affiliates.
Transfer of Regulatory Filings. GSK shall [*] transfer to Theravance, or shall cause its designee(s) to transfer to Theravance, ownership of all regulatory filings made or filed for any Terminated Non-Respiratory Commercialized Alliance Product (to the extent that any are held in GSK's or such designee(s)'s name) and such transfer to be as permitted by applicable Laws and regulations. GSK shall cooperate as reasonably necessary to permit Theravance to exercise its rights hereunder; provided, however, that if such transfer cannot be effected by GSK in a particular Country [*] of the effective date of termination for such Terminated Non-Respiratory Commercialized Alliance Product (for example, as a result of Theravance not having the appropriate entity in any such Country to whom ownership of such regulatory filing(s) would be required to be transferred) then GSK, after the expiration of such aforesaid period, shall forthwith be entitled to surrender ownership of such regulatory filing(s) and/or applications for cancellation in respect of such Country. [*]=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.
Transfer of Regulatory Filings. (a) Within ten (10) days of the Effective Date, GW shall prepare and deliver to Triangle, one complete photocopy of GW's US IND for FTC (US Ind #[***]). Thereafter, GW shall promptly prepare and submit to FDA (with a copy to Triangle) a Letter of Authorization to enable Triangle to incorporate by reference any information contained in US IND #[***] with respect to the Licensed Compound. After the Letter of Authorization has been processed by FDA, GW shall promptly submit to FDA (with a copy to Triangle) a request to inactivate US IND #[***]; and GW shall not thereafter make any request to reactivate such IND filing.
(b) Within ten (10) days of the Effective Date, GW shall prepare and deliver to Triangle, one complete photocopy of GW's Canadian IND for FTC (HPB file number [***]). Thereafter, GW shall promptly take such actions as are necessary to inactivate (or to effectuate the Canadian regulatory equivalent of inactivate) the Canadian IND, while still allowing Triangle the opportunity to incorporate by reference any of the information contained in the Canadian IND with respect to the Licensed Compound. GW shall not thereafter make any request to reactivate the Canadian IND filing.
Transfer of Regulatory Filings. Upon expiration of this Agreement or termination by Supplier pursuant to Section 8.1(a)(i), Section 8.1(a)(2) or Section 8.2(a)(1), RDR and RDO shall promptly transfer to Supplier or its designee any regulatory filings, approvals or authorizations pertaining to Products owned or controlled by them, their Affiliates or any sublicensee.
