Transfer of Regulatory Materials. As soon as reasonably practicable after the grant of Regulatory Approval for a Product, the Company will take the actions reasonably necessary to transfer ownership and, as applicable, physical possession to Nestlé of all Regulatory Approvals, material Regulatory Submissions, correspondence and related information (including any investigational new drug applications, NDAs and other Regulatory Approvals) for HMPL-004 and such Product in the Territory and will notify the appropriate Regulatory Authorities of such transfer of ownership. All costs associated with such actions will be borne by the Company.
Transfer of Regulatory Materials. Juno shall transfer, promptly after the License Agreement Effective Date (but subject to Section 2.3.2), to Celgene any and all Regulatory Materials (including any foreign counterparts of the IND and BLA) for all Licensed Candidates, Licensed Products and Licensed Diagnostic Products in or for the ROW Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Materials and Regulatory Approvals and supplements thereto relating to Licensed Candidates, Licensed Products and Licensed Diagnostic Products in and for the ROW Territory. [***] 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.
Transfer of Regulatory Materials. In the event Lilly holds as of the Effective Date any IND or other regulatory materials or obligations related to Compound or Product, the responsibilities of the Parties with respect to such activities shall be as set * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. forth on Exhibit C. Except as expressly set forth on Exhibit C or in the Services Agreement, Lilly shall have no responsibility to make or maintain any filings with any Drug Regulatory Agency with respect to Compound, Modified Compound or Product.
Transfer of Regulatory Materials. Jounce shall transfer to Celgene, promptly after the Celgene Lead Effective Date (but subject to Section 2.4.2), any and all CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Materials (including any foreign counterparts of the IND and BLA) for all the Co-Co Candidate, Co-Co Products and Co-Co Diagnostic Products in or for the Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Materials and Regulatory Approvals and supplements thereto relating to the Co-Co Candidate, Co-Co Products and Co-Co Diagnostic Products in and for the Territory.
Transfer of Regulatory Materials. Jounce shall transfer to Celgene, promptly after the Jounce Lead Effective Date (but subject to Section 2.4.2), any and all Regulatory Materials (including any foreign counterparts of the IND and BLA) for all the Co-Co Candidate, Co-Co Products and Co-Co Diagnostic Products in or for the ROW Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Materials and Regulatory Approvals and supplements thereto relating to the Co-Co Candidate, Co-Co Products and Co-Co Diagnostic Products in and for the ROW Territory.
Transfer of Regulatory Materials. At Summit’s option, Sarepta shall as promptly as practicable transfer to Summit or Summit’s designee (i) possession and ownership of all governmental or regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. correspondence, conversation logs, filings and approvals (including all Regulatory Approvals and pricing and reimbursement approvals) relating to the Development, Manufacture or Commercialization of the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies), (ii) copies of all data, reports, records and materials and other sales and marketing related information in Sarepta’s possession or Control to the extent that such data, reports, records, materials or other information relate to the Development, Manufacture or Commercialization of the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies), including all non-clinical and clinical data relating to the applicable Terminated Licensed Product(s), and customer lists and customer contact information and all adverse event data in Sarepta’s possession or Control relating to the applicable Terminated Licensed Product(s); provided that Sarepta shall use Commercially Reasonable Efforts to obtain for Summit the right to access all such data, reports, records, materials and other sales and marketing related information and (iii) all records and materials in Sarepta’s possession or Control containing Confidential Information of Summit relating to the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies). Sarepta shall further appoint Summit as Sarepta’s or Sarepta’s Related Parties’ agent for all applicable Terminated Licensed Product(s)-related matters involving Regulatory Authorities in the Sarepta Territory (or the in the applicable Terminated Country(ies), if applicable) until all applicable Regulatory Approvals and other regulatory filings have been transferred to Summit or its designee.
Transfer of Regulatory Materials. (a) Prior to the Closing, the Parties shall agree upon procedures to (i) transfer the Regulatory Materials from Equillium to Xxx from the perspective of the applicable Regulatory Authorities and (ii) ensure a smooth transition from Equillium to Ono of all of the activities required to be undertaken by the holder of the Regulatory Materials, including adverse event reporting, annual reports to the FDA, handling and tracking of complaints and communications with investigators.
Transfer of Regulatory Materials. Subject to and upon BLSI's payment to BA of the license fee set forth in Section 4.1(b), BA hereby agrees to assign to BLSI BA's rights in any Regulatory Materials for BA-210 or Cethrin(R) and Compounds and Licensed Products containing BA-210 or Cethrin(R), including but not limited to the IND therefore and any foreign equivalents. Thereafter, BLSI or its sublicensees shall hold title to such IND (and foreign equivalents), and shall assume full responsibility for such IND (and foreign equivalents). In addition, BA promptly shall execute any and all other instruments, forms of assignment or other documents and take such further actions as BLSI may reasonably request in order to give effect to or evidence the foregoing assignment.
Transfer of Regulatory Materials. Promptly after the Effective Date, LMI will transfer to GEHC, all of the rights and obligations of LMI as owner/sponsor of the Licensed Product IND and all other Regulatory Materials for the Precursor, Licensed Compound, or Licensed Product that are necessary to transfer such Licensed Product IND to GEHC in the Territory (such transfer, the “Transfer”). Until the Effective Transfer Date, LMI will be the owner/sponsor of the Licensed Product IND and all other Regulatory Materials for the Licensed Product in the Territory and will have all rights and obligations relating thereto, including pharmacovigilance responsibilities; provided that GEHC will reimburse LMI for any approved costs or expenses incurred by LMI after the Effective Date in connection with exercising such rights or fulfilling such obligations. LMI will take all steps reasonably necessary to effect the Transfer, including submitting to each applicable Regulatory Authority within *** after the Effective Date a letter or other necessary documentation (with a copy to GEHC) notifying such Regulatory Authority of the transfer of such ownership of the Licensed Product IND. During the period commencing on the Effective Date and ending on Effective Transfer Date, LMI will not take any action related to the Licensed Product IND or any other Regulatory Materials without the prior written approval of GEHC. Within *** after the Effective Transfer Date, LMI will provide GEHC with complete copies of the Regulatory Materials for the Precursor, Licensed Compound, Licensed Product in the Territory, including all correspondence and regulatory files relating thereto. Until the end of the Handover Period, at GEHC’s reasonable request and at no cost to GEHC, LMI will make its employees and representatives reasonably available to GEHC in accordance with the Transition Plan to supply background on the Licensed Product IND and other Regulatory Materials for the Precursor, Licensed Compound, and Licensed Product in the Territory. As the result of and effective as of such Transfer, GEHC will act as the sponsor of the Licensed Product IND for the Licensed Product in the Territory, and will take over from LMI all responsibilities of sponsors as defined under the FD&C Act, other FDA regulations, and all other Applicable Laws, including pharmacovigilance responsibilities. Commencing on the Effective Date, and thereafter during the Term, GEHC will bear all approved Third Party expenses incurred in connection with the transf...
Transfer of Regulatory Materials. Forma Inc. shall transfer, in accordance with the Transition Activities, to Celgene any and all Clinical Test Data, Regulatory Data, Regulatory Filings (including any INDs and CTAs and any foreign counterparts thereof) and Regulatory Approvals for all Licensed Compounds and Licensed Products which Forma Inc. has the right to transfer under the applicable existing agreements with Third Parties, and thereafter Celgene (or its designee) shall hold title to and file all such Clinical Test Data, Regulatory Data, Regulatory Filings and Regulatory Approvals and supplements thereto relating to Licensed Compounds and Licensed Products, provided, that Forma Inc. may retain copies of any such Clinical Test Data, Regulatory Data, Regulatory Filings and Regulatory Approvals that a Regulatory Authority requires Forma Inc. to retain under Law. For any such Clinical Test Data which Forma Inc. cannot transfer under the applicable agreements with Third Parties, Forma Inc. shall use reasonable efforts to obtain consent to effectuate such transfer, and Celgene shall reimburse Forma Inc.’s reasonable out-of-pocket costs and expenses incurred in obtaining such consent.
