Regulatory Information Sharing. To the extent that such Regulatory Filings that relate to the activities in the requesting Party’s territory, each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of Regulatory Filings prepared (including any drafts and supporting information), submitted or received by such Party in the Exelixis Territory including the U.S. and the Collaborator 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 include any communications/correspondence with the Regulatory Authority regarding label changes, IND annual reports and cover letters, and documents related to regulatory milestones and dates (e.g., submissions and validations). If any Regulatory Filing to be provided under this Section 5.2 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 other Exelixis licensee. Each of Collaborator and Exelixis shall reasonably endeavor to grant access and rights for the other Party to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or other Exelixis licensee, respectively. For clarity, a Party’s provision to the other Party of copies of Regulatory Filings prepared, submitted, or received in each Party’s territory is expressly conditioned upon the receiving Party granting to the providing Party the right to share with the providing Party’s own licensee for its territory copies of any and all Regulatory Filings prepared, submitted, or received by the receiving Party in its territory. Should either Party fail to obtain such access and rights from any Sublicensee or Exelixis licensee, such Party shall not have the right to grant access or rights to such Sublicensee or other 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. 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. Advaccine shall (a) provide Inovio with the original documents (in the electronic format in which it has been prepared by Advaccine) of draft package inserts, CTA and CTD, and, at Inovio’s request, together with English translations (to the extent originated by Advaccine in Chinese), for Inovio’s review and comment, in connection with obtaining or maintaining any MAA approval for the Products in the Field in the Advaccine Territory, prior to the submission of such documents to the Regulatory Authority in the Advaccine Territory; and (b) shall keep Inovio informed of any material verbal or written communication or question relating to the Products received by Advaccine from the Regulatory Authority in the Advaccine Territory. Except as required by applicable Law, (i) Advaccine, its Affiliates and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Inovio Territory regarding any Products. If such submission or communication is required by applicable Law, Advaccine shall, if legally permitted, promptly notify Inovio in writing of such requirement and the content of such submission or communication; (ii) except to the extent in connection with the exercise of its retained rights under Section 2.1(b), Inovio, its Affiliate and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Advaccine Territory regarding any Products. If such submission or communication is required by applicable Law, Inovio shall, if legally permitted, promptly notify Advaccine in writing of such requirements 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. Advaccine shall (a) provide Inovio with copies of the original documents (in the electronic format in which it has been prepared by Advaccine) of draft package inserts, CTA and CTD, and, at Inovio’s request, together with English translations (to the extent originated by Advaccine in Chinese), for Inovio’s review and comment, in connection with obtaining or maintaining any MAA approval for the Products in the Field in the Advaccine Territory, prior to the submission of such documents to the Regulatory Authority in the Advaccine Territory; and
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. Luoxin shall (a) provide Synergy with the English summary of major information, along with the original documents (in the electronic format in which it has been prepared by Luoxin) of the draft Chinese package insert and Common Technical Document (CTD), for Synergy’s review and comment, in connection with obtaining or maintaining any MAA approval for Licensed Products in the Field in the Luoxin Territory, at least forty-five (45) days prior to the submission of such documents to the Regulatory Authority in the Luoxin Territory; and (b) keep Synergy informed of any material verbal or written communication or question relating to Licensed Products received by Luoxin from the Regulatory Authority in the Luoxin Territory. Notwithstanding the foregoing, Luoxin shall only be required to provide Synergy with the draft Chinese package insert and CTD via an electronic data room (without the ability to download or print), unless a Regulatory Authority in the Synergy Territory requires a copy of the CTD that was filed in the Luoxin Territory. Except as required by applicable Law, Luoxin, its Affiliates and sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Synergy Territory regarding any Licensed Products. If such submission or communication is required by applicable Law, Luoxin shall immediately notify Synergy in writing of such requirement and the content of such submission or communication.
Regulatory Information Sharing. SAMR shall (a) provide Aridis with Regulatory Materials used by it in the Applicable Territory according to such procedures as are agreed by the JSC (the JSC shall reasonable accommodate Aridis’ request for advance submission of relevant Regulatory Materials related to Limited License Products); and (b) shall keep Aridis informed of any material verbal or written communication or question relating to Limited License Products and AR-201 Product received by SAMR from a Regulatory Authority in the Applicable Territory. Except as required by applicable Law, SAMR, its Affiliates and sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority except in an Applicable Territory regarding any Licensed Products. If such submission or communication is required by applicable Law, SAMR shall immediately notify Aridis in writing of such requirement and the content of such submission or communication.
