Common use of Regulatory Submissions and Regulatory Approvals Clause in Contracts

Regulatory Submissions and Regulatory Approvals. (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for the Products in the Field in the Territory. (b) Selecta will own all regulatory submissions, including all applications, for Regulatory Approvals for the Products in the Field in the 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. (c) Selecta will be the primary contact with each Regulatory Authority in the Territory and will be solely responsible for all communications with each Regulatory Authority that relate to any Regulatory Filing or Regulatory Approval in the Territory, provided, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval in the Territory in accordance with the terms of Section 3.2. In providing such assistance, 3SBio will not contact the Regulatory Authorities in the Territory without the prior written approval of Selecta, and, if contacted by a Regulatory Authority with respect to a Product in the Territory, will refer such contact to Selecta. (d) From and after receipt of each Regulatory Approval in the Territory, Selecta will have exclusive authority and responsibility to submit all reports or amendments necessary to maintain such Regulatory Approvals and to seek revisions of the conditions of each such Regulatory Approval. Selecta will have sole authority and responsibility in the Territory to seek and/or obtain any necessary Regulatory Authority approvals of any product label, or Regulatory Authority-approved prescribing information, package inserts, monographs and packaging used in connection with Products, as well as promotional material used in connection with Products, and for determining whether the same requires Regulatory Approval.

Regulatory Submissions and Regulatory Approvals. Sanofi will and hereby does, and will cause its Affiliates and Sublicensees to, (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for within a reasonable period of time after the Products in the Field in the Territory. (b) Selecta will own all regulatory submissions, including all applications, for Regulatory Approvals for the Products in the Field in the Territory. [***] Certain information in effective date of termination of 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. (c) Selecta will be the primary contact with each Regulatory Authority in the Territory and will be solely responsible for all communications with each Regulatory Authority that relate to any Regulatory Filing or Regulatory Approval in the Territory, provided, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval in the Territory in accordance with the terms of Section 3.2. In providing such assistance, 3SBio will not contact the Regulatory Authorities in the Territory without the prior written approval of Selecta, and, if contacted by a Regulatory Authority Agreement with respect to a Product Terminated Product, assign and transfer to Fulcrum or its designee all of Sanofi’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals (excluding the Territorydrug master file or equivalent maintained by Sanofi, will refer its Affiliates, Sublicensees or subcontractors) then Controlled by Sanofi or any of its Affiliates or Sublicensees, in each case, solely related to such contact to Selecta. (d) From and after receipt of each Regulatory Approval in the TerritoryTerminated Products, Selecta provided, that Sanofi will have exclusive authority the right to redact and responsibility to submit all reports or amendments necessary to maintain remove from such Regulatory Submissions, Regulatory Approvals and to seek revisions Reimbursement Approvals any business sensitive information of the conditions of each Sanofi, its Affiliates, Sublicensees or subcontractors contained in such Regulatory Approval. Selecta will have sole authority Submissions, Regulatory Approvals and responsibility in Reimbursement Approvals, and (b) to the Territory extent assignment pursuant to seek and/or obtain any necessary Regulatory Authority approvals of any product label, clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Fulcrum to cross-approved prescribing informationreference and rely upon any such Regulatory Submissions, package insertsRegulatory Approvals, monographs and packaging used Reimbursement Approvals (excluding (i) the drug master file or equivalent maintained by Sanofi, its Affiliates, Sublicensees or subcontractors and (ii) any business sensitive information of Sanofi, its Affiliates, Sublicensees or subcontractors, in each case (i) or (ii), contained in such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals) filed by Sanofi or any of its Affiliates or Sublicensees solely in connection with the Research, Development, Manufacture, Commercialization or other Exploitation of the Terminated Products. Sanofi will execute and deliver, as well as promotional material used in connection with Productsor will cause to be executed and delivered, to Fulcrum or its designee such endorsements, assignments, commitments, acknowledgements, and for determining whether other documents as may be necessary and reasonably requested by Fulcrum to assign, convey, transfer, and deliver to Fulcrum or its designee all of Sanofi’s or its applicable Affiliate’s or designee’s rights, title, and interests in and to all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals, including submitting to each applicable Regulatory Authority or other Governmental Authority in the same requires Terminated Regions a letter or other necessary documentation (with copy to Fulcrum) notifying such Regulatory ApprovalAuthority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Fulcrum of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals.

Regulatory Submissions and Regulatory Approvals. (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for the Products in the Field in the Territory. (b) Selecta will Fovea shall own all regulatory submissions, including all applications, for Regulatory Approvals for of the Products Product in the Field in the Fovea Territory, and shall be responsible for seeking and obtaining all Regulatory Approvals of the Product in the Field in the Fovea Territory as provided in the Core Development Plan. Dyax shall own all regulatory submissions, including all applications, for Regulatory Approvals of the Product in the Dyax Territory and shall, at Dyax’s sole discretion, be solely responsible for seeking and obtaining all Regulatory Approvals for the Product in the Dyax Territory. Each Party shall have access to all data contained or referenced in such submissions or applications for Regulatory Approvals of the Product, including without limitation all reports, correspondence and conversation logs, in each case as may be reasonably necessary to enable (i) Fovea to exercise its rights, and fulfill its obligations, under this Agreement to Develop, Manufacture and Commercialize the Product in the Field in the Fovea Territory and to perform its obligations under the Core Development Plan, and (ii) Dyax to Develop, Manufacture and Commercialize the Product outside the Fovea Territory and to exercise its retained rights with respect to all products containing the Compound. Each Party shall provide appropriate notification of such right of the other Party to the Regulatory Authorities. (b) In the event that Fovea fails to use Diligent Efforts to seek any Regulatory Approval of the Product in any country of the Fovea Territory as provided in the Core Development Plan, Dyax shall have the right to seek such Regulatory Approval, in Dyax’s or Fovea’s name, upon [*****] Certain information prior notice to Fovea and in this document has been omitted and filed separately such case Fovea shall cooperate with Dyax’s efforts to obtain such Regulatory Approval in any such country and, if necessary, shall designate Dyax as its agent for such purpose; provided that, if Fovea provides Dyax with assurances reasonably satisfactory to Dyax of Fovea’s plan for immediately resuming Diligent Efforts to obtain such Regulatory Approval of the Securities and Exchange Commission. Confidential treatment has been requested with respect Product within such [*****] period, then Dyax shall not undertake such efforts to the omitted portionsobtain such Regulatory Approval for so long as Fovea continues to use Diligent Efforts to obtain such Regulatory Approval. (c) Selecta Dyax will be have the primary right to participate in all material meetings and other contact with each Regulatory Authority Authorities pertaining to Development or Regulatory Approval of the Product in the Fovea Territory. To the extent reasonably possible and practicable, Fovea shall provide Dyax with reasonable advance notice of all such meetings and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact. Fovea will have the * Confidential Treatment Requested. Omitted portions filed with the Commission. right to participate in all material meetings and other contact with Regulatory Authorities pertaining to Development or Regulatory Approval of the Product in the Field in the Dyax Territory but only if and to the extent such participation would be reasonably useful to the development of the Product in the Field in the Fovea Territory. To the extent reasonably possible and practicable, Dyax shall provide Fovea with reasonable advance notice of all such meetings and other contact and advance copies of all related documents and other relevant information relating to such meetings or other contact. (d) Each Party shall provide the other Party with drafts (in English) of any material documents or other material correspondence pertaining to Regulatory Approvals of the Product in the Field in such Party’s Territory to be submitted by such Party to Regulatory Authorities, including without limitation any proposed labeling, sufficiently in advance of submission so that the other Party may review and comment on such documents and other correspondence and have a reasonable opportunity to influence the substance of such submissions in a manner consistent with the goal of obtaining Regulatory Approvals of the Product in the Field in the Territory and will of the submitting Party as quickly as reasonably practicable. The non-submitting Party’s approval of such submissions shall not be solely responsible for all communications with each Regulatory Authority that relate unreasonably withheld or delayed. Each Party shall promptly provide to the other Party copies (in English) of any Regulatory Filing material documents or Regulatory Approval other material correspondence pertaining to the Product in the TerritoryField, providedincluding without limitation all proposed labeling, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a received from Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval Authorities in the Territory of the submitting Party. Each Party shall promptly provide the other Party with copies of all other material documents and correspondence pertaining to the Product in the Field after they have been submitted to, or received from, Regulatory Authorities in the Territory of the submitting Party. (e) Each Party shall have the right to make regulatory submissions and applications (including, without limitation, the filing of an IND) in the Territory of the other Party if and to the extent that such regulatory submissions and applications are required for purposes of such Party performing or carrying out its Development activities pursuant to, and in accordance with, the provisions of this Agreement. Unless otherwise agreed by the Parties, each Party shall own all INDs filed by it for purposes of performing its Development responsibilities with respect to the Product as permitted under this Agreement. Each Party shall have the right to cross-reference and make any other use of the other Party’s INDs for the Product that it would have if it were the owner, including without limitation access to all data contained or referenced in such INDs, in each case as may be reasonably necessary to enable such Party to Develop, Manufacture or Commercialize the Product in and for its Territory in accordance with the terms of Section 3.2this Agreement. (f) Fovea and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to the Product in the Fovea Territory. In providing such assistanceDyax and its Affiliates shall control all pricing and reimbursement approval proceedings relating to the Product in the Dyax Territory. To the extent consistent with applicable law, 3SBio will not contact Dyax shall have the right to attend all meetings between Fovea and Regulatory Authorities relating to pricing and reimbursement approvals relating to the Product in the Fovea Territory. To the extent consistent with applicable law, Fovea shall provide Dyax with reasonable advance notice of all such meetings and advance copies of all related documents and other relevant information relating to such meetings or proceedings. At a reasonable time prior to any meeting between a Party and Regulatory Authorities relating to the pricing and reimbursement approvals for the Product in such Party’s Territory, to the extent consistent with applicable law, such Party shall solicit the other Party’s input and feedback on the substantive issues to be discussed by such Party with the applicable * Confidential Treatment Requested. Omitted portions filed with the Commission. Regulatory Authorities at such meeting with respect to pricing and reimbursement approvals in the Territory without of such Party. To the extent consistent with applicable law, each Party shall provide the other Party with drafts of all submissions relating to pricing and reimbursement approvals relating to the Product in the Territory of such Party (in English) for the other Party’s review and comment prior written approval to their submission. Furthermore, to the extent consistent with applicable law, Fovea shall provide Dyax with copies (in English) of Selectaany material documents or other material correspondence pertaining to pricing and reimbursement approvals relating to the Product in the Major European Countries, andand upon request, if contacted by the remaining countries of the Fovea Territory, and Dyax shall, to the extent consistent with applicable law, provide Fovea with copies (in English) of any material documents or other material correspondence pertaining to pricing and reimbursement approvals relating to the Product in the United States. (g) At each meeting of the JSC, each Party shall make a presentation regarding (i) such Party’s strategy relating to seeking and obtaining Regulatory Authority Approval of the Product, and (ii) such Party’s progress in seeking and obtaining Regulatory Approval of the Product in such Party’s Territory. At each meeting of the JSC, each Party shall also provide to the JSC an update of such Party’s past and future planned interactions with Regulatory Authorities with respect to a matters relevant to Regulatory Approval of the Product in such Party’s Territory. At each meeting of the TerritoryJSC, will refer such contact to Selecta. (d) From the JSC shall discuss each Party’s strategy and after receipt of each progress in seeking and obtaining Regulatory Approval in the Territory, Selecta will have exclusive authority and responsibility to submit all reports or amendments necessary to maintain such Regulatory Approvals and to seek revisions of the conditions of each Product in such Regulatory Approval. Selecta will have sole authority and responsibility in the Territory to seek and/or obtain any necessary Regulatory Authority approvals of any product label, or Regulatory Authority-approved prescribing information, package inserts, monographs and packaging used in connection with ProductsParty’s Territory, as well as promotional material used in connection such Party’s past and future planned interactions with ProductsRegulatory Authorities, and for determining whether the same requires Regulatory ApprovalJSC shall have the opportunity to comment on and provide substantive feedback to each Party on such matters.

Regulatory Submissions and Regulatory Approvals. (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for the Products in the Field in the Territory. (b) Selecta will own all regulatory submissions, including all applications, for Regulatory Approvals for the Products in the Field in the 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. (c) Selecta will be the primary contact with each Regulatory Authority in the Territory and will be solely responsible for all communications with each Regulatory Authority that relate to any Regulatory Filing or Regulatory Approval in the Territory, provided, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval in the Territory in accordance with the terms of Section 3.2. In providing such assistance, 3SBio will not contact the Regulatory Authorities in the Territory without the prior written approval of Selecta, and, if contacted by a Regulatory Authority with respect to a Product in the Territory, will refer such contact to Selecta. (d) From and after receipt of each Regulatory Approval in the Territory, Selecta will have exclusive authority and responsibility to submit all reports or amendments necessary to maintain such Regulatory Approvals and to seek revisions of the conditions of each such Regulatory Approval. Selecta will have sole authority and responsibility in the Territory to seek and/or obtain any necessary Regulatory Authority approvals of any product label, or Regulatory Authority-approved prescribing information, package inserts, monographs and packaging used in connection with Products, as well as promotional material used in connection with Products, and for determining whether the same requires Regulatory Approval.

Regulatory Submissions and Regulatory Approvals. Torii will and hereby does, and will cause its Affiliates and Sublicensees to, (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for the Products in the Field in the Territory. (b) Selecta will own all regulatory submissions, including all applications, for Regulatory Approvals for the Products in the Field in the Territory. no later than [***] Certain information after the effective date of termination of this Agreement, assign and transfer to BioCryst or its designee all of Torii’s rights, title, and interests in this document has been omitted and to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for the Licensed Product then owned or Controlled by Torii or any of its Affiliates or Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit BioCryst to cross-reference and rely upon any Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed separately by Torii with respect to such Licensed Product. Torii will execute and deliver, or will cause to be executed and delivered, to BioCryst or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to assign, convey, transfer, and deliver to BioCryst or its designee all of Torii’s or its applicable Affiliate’s or designee’s rights, title, and interests in and to all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals to BioCryst, including submitting to each applicable Regulatory Authority or other Governmental Authority in the Securities Territory a letter or other necessary documentation (with copy to BioCryst) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to BioCryst of all such assigned Regulatory Submissions, Regulatory Approvals, and Exchange CommissionReimbursement Approvals. Confidential treatment has been requested In addition, upon BioCryst’s written request, Torii will, at its cost and expense, provide to BioCryst copies of all material related documentation, including material non-clinical, preclinical, and clinical data related to the Licensed Product that are held by or reasonably available to Torii or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, including with respect to any amendments to the SDE Agreement, provided that BioCryst will assume all safety and safety database activities with respect to the omitted portionsLicensed Product no later than 60 days after the effective date of termination of this Agreement. (c) Selecta will be the primary contact with each Regulatory Authority in the Territory and will be solely responsible for all communications with each Regulatory Authority that relate to any Regulatory Filing or Regulatory Approval in the Territory, provided, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval in the Territory in accordance with the terms of Section 3.2. In providing such assistance, 3SBio will not contact the Regulatory Authorities in the Territory without the prior written approval of Selecta, and, if contacted by a Regulatory Authority with respect to a Product in the Territory, will refer such contact to Selecta. (d) From and after receipt of each Regulatory Approval in the Territory, Selecta will have exclusive authority and responsibility to submit all reports or amendments necessary to maintain such Regulatory Approvals and to seek revisions of the conditions of each such Regulatory Approval. Selecta will have sole authority and responsibility in the Territory to seek and/or obtain any necessary Regulatory Authority approvals of any product label, or Regulatory Authority-approved prescribing information, package inserts, monographs and packaging used in connection with Products, as well as promotional material used in connection with Products, and for determining whether the same requires Regulatory Approval.