Regulatory Information Sharing. Each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any drafts), submitted or received by such Party in the U.S. and the Licensee Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following communications/correspondence with the Regulatory Authority: (i) summary of contact reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDA, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future Exelixis Licensee. Each of Licensee and Exelixis shall use Commercially Reasonable Efforts to grant the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future Exelixis Licensee, respectively. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future Exelixis Licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party.
Regulatory Information Sharing. Jazz shall lead all interactions with Regulatory Authorities with respect to the HemOnc Products and shall keep Pfenex reasonably informed on the regulatory development for the HemOnc Products through the JDC. Jazz shall provide Pfenex with drafts of all Regulatory Materials prepared by Jazz for the HemOnc Products reasonably in advance of filing where practicable for Pfenex’s review and comment. Jazz will consider in good faith any such comments where practicable. Jazz shall also promptly
Regulatory Information Sharing. Ohm shall provide Aptose with copies of any substantive Regulatory Materials submitted or received by Ohm relating to any Licensed Compound or Product promptly after the submission or receipt thereof. In addition, Ohm shall provide Aptose with written minutes or other records of any oral discussions with any Regulatory Authority pertaining to any Licensed Compound or Product promptly after such discussion. If any Regulatory Material to be provided under this Section 4.4(b) was originally created in a language other than the English language, Ohm shall provide an English translation along with the original document to Aptose.
Regulatory Information Sharing. Subject to applicable Laws, 3D Medicines shall (a) provide Aravive with the English translations (to the extent originated by 3D Medicines in Chinese), along with the original documents (in the electronic format in which it has been prepared by 3D Medicines) of draft package inserts, CTA and CTD, for Aravive’s review and comment, in connection with obtaining or maintaining any MAA approval for Licensed Products in the Field in the 3D Medicines Territory, at least [***] prior to the submission of such documents to the Regulatory Authority in the 3D Medicines Territory; and (b) shall keep Aravive informed of any material verbal or written communication or question relating to Licensed Products received by 3D Medicines from the Regulatory Authority in the 3D Medicines Territory. Except as required by applicable Laws, 3D Medicines, its Affiliates and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Aravive Territory regarding any Licensed Products. If such submission or communication is required by applicable Laws, 3D Medicines shall, if legally permitted, promptly notify Aravive in writing of such requirement and the content of such submission or communication.
Regulatory Information Sharing. Subject to applicable Laws, Kaken shall (a) provide Spruce with [***]; and (b) shall keep Spruce informed of any material verbal or written communication or question relating to Licensed Products received by Kaken from the Regulatory Authority in the Kaken Territory. Spruce shall have the right to comment on any such Regulatory Materials, and Kaken shall consider any reasonable comments of Spruce in good faith. Except as required by applicable Laws, Kaken, its Affiliates and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Spruce Territory regarding any Licensed Products. If such submission or communication is required by applicable Laws, Kaken shall, if legally permitted, promptly notify Spruce in writing of such requirement and the content of such submission or communication.
Regulatory Information Sharing. KVK shall (i) provide KemPharm with the original documents, in the electronic format in which it has been prepared by KVK, of any supplemental NDA x related to the Regulatory Activities for the Licensed Products, for KemPharm’s review and comment, in connection with obtaining or maintaining any NDA approval for Licensed Products in the Field in the Collaboration Territory, prior to the submission of such documents to the Regulatory Authority in the Collaboration Territory; (ii) provide KemPharm with the original documents, in the electronic format in which it has been prepared by KVK, of any annual report or other regulatory submission within a reasonable time after each has been submitted to FDA; and (iii) shall keep KemPharm informed of any material verbal or written communication or question relating to Licensed Products received by KVK from the Regulatory Authority in the Collaboration Territory. Except as required by applicable Law, KVK, its Affiliates and sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Retained Territory regarding any Licensed Products. If such submission or communication is required by applicable Law, KVK shall promptly notify KemPharm in writing of such requirement and the content of such submission or communication.
Regulatory Information Sharing. Terns shall (a) provide Genfit with the English translations (to the extent originated by Terns in Chinese), along with the original documents (in the electronic format in which it has been prepared by Terns) of draft package inserts, CTA and CTD, for Genfit’s review and comment, in connection with obtaining or maintaining any MAA approval for Licensed Products in the Field in the Terns Territory, prior to the submission of such documents to the Regulatory Authority in the Terns Territory; and (b) shall keep Genfit informed of any material verbal or written communication or question relating to Licensed Products received by Terns from the Regulatory Authority in the Terns Territory. Except as required by applicable Law, Terns, its Affiliates and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Genfit Territory regarding any Licensed Products. If such submission or communication is required by applicable Law, Terns shall, if legally permitted, promptly notify Genfit in writing of such requirement and the content of such submission or communication.
Regulatory Information Sharing. SymBio shall provide Eagle with drafts of Regulatory Materials to be submitted by or on behalf of SymBio in the SymBio Territory, other than routine or immaterial Regulatory Materials, excluding any portions of such Regulatory Materials provided by Eagle to SymBio, translated into English when necessary or reasonably requested by Eagle, sufficiently in advance of submission to allow for Eagle’s review and comment, and SymBio shall reasonably consider comments provided by Eagle within such review and comment period; provided, however, that SymBio shall not be required to delay submission of any Regulatory Materials if to do so would cause SymBio to fail to meet the filing deadline stipulated in Section 4.4(ii) or any deadline required by applicable Law or requested by any Regulatory Authority in the SymBio Territory, and the Parties shall cooperate to provide SymBio with adequate time to comply with its obligations and to reduce the administrative burden of SymBio where practical. In addition to the foregoing, SymBio shall promptly provide Eagle with copies, translated into English, of any Regulatory Materials received by SymBio or its Affiliates or sublicensees relating to Licensed Product in the SymBio Territory, other than immaterial Regulatory Materials, and shall keep Eagle reasonably informed of any material verbal communication or question relating to Licensed Product received by SymBio or its Affiliates or sublicensees from any Regulatory Authority in the SymBio Territory. If requested by SymBio in order for SymBio to prepare or submit Regulatory Materials or otherwise address questions received from a Regulatory Authority in the SymBio Territory, Eagle shall provide SymBio with all Data Controlled by Eagle and reasonably requested by SymBio required to prepare any such submission and assist in the preparation of responses based on information in CMC related documents in Eagle’s possession or Control and not otherwise already provided by Eagle to SymBio. Any transfer by Eagle of CMC Information as set forth in this Section 5.4 is conditioned on SymBio establishing appropriate firewalls or equivalent means to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, SymBio shall ensure that any CMC Information provided by or on behalf of Eagle pursuant to this Section 5.4 shall only be disclosed to those ident...
Regulatory Information Sharing. Notwithstanding anything herein to the contrary, Ipsen shall (a) keep Exicure informed of any [***] relating to the Licensed Products received by Ipsen from the Regulatory Authorities in the Territory; and (b)(i) provide Exicure with [***] for Exicure’s review and comment, in connection with obtaining or maintaining Regulatory Approval for Licensed Products in the [***], [***], (ii) allow Exicure reasonable time to translate, review and provide comment, and (iii) consider Exicure’s comments [***] in the [***] submitted to the applicable Regulatory Authorities, [***].
Regulatory Information Sharing. Each Party shall provide the JSC with drafts of all Regulatory Materials prepared by such Party for the Initial Product(s) being developed under a PDP in the U.S. for review and comment by the JSC, prior to the submission of such documents to the FDA and shall consider in good faith any comments received from the JSC. Without limiting the foregoing, the Parties shall work together to prepare and submit the NDA filing in the U.S. for the Initial Product(s) being developed under any PDP on behalf of, and in the name of, Company. Each Party shall also promptly provide the JSC and the other Party with copies of all Regulatory Materials for the Initial Product(s) being developed under a PDP which are submitted to or received from the FDA in the U.S.
