Common use of Regulatory Filings and Regulatory Approvals Clause in Contracts

Regulatory Filings and Regulatory Approvals. (a) Licensee shall be responsible for preparing and filing Drug Approval Applications and seeking and maintaining Regulatory Approval for the Product in the Field in each jurisdiction in the Licensee Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with Applicable Laws in the Licensee Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Except as expressly set forth in this Agreement, all costs and expenses incurred by Licensee in connection with the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee Territory shall be borne solely by Licensee. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee Territory to be provided to OPKO by Licensee shall be borne by OPKO, while any costs and expenses related to the translation to Chinese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licensee.

Regulatory Filings and Regulatory Approvals. At Infinity’s request, AbbVie shall, promptly following the effectiveness of such termination, assign and transfer to Infinity, all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Products that are held or controlled by or under authority of AbbVie or its Affiliates or Sublicensees as of the effective date of termination, with respect to the terminated country or the Territory, as the case may be, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to Infinity. If this Agreement is terminated in its entirety, AbbVie shall also promptly transfer control of and responsibility for maintaining the global safety database for Products to Infinity (a) Licensee if previously held by AbbVie or its Affiliates), and Infinity shall be responsible accept such transfer and responsibility. If applicable Law prevents or delays the transfer of ownership of any such Regulatory Filing, filing for preparing Pricing and Reimbursement Approval or Marketing Authorizations to Infinity, AbbVie shall grant, and does hereby grant, to Infinity an exclusive and irrevocable right of access and Right of Reference to such Regulatory Filing, filing Drug for Pricing and Reimbursement Approval Applications and seeking and maintaining Regulatory Approval Marketing Authorizations for the Product Products in the Field in each jurisdiction in Territory or the Licensee Territory, including preparing all documentation and reports necessary in connection therewithterminated country, as well the case may be, and shall reasonably cooperate to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Infinity or its designee(s). Infinity shall have the right to grant licenses or sublicenses (as securing data applicable) under the rights granted to it under this Section 12.3.6 to its Affiliates and market exclusivity where applicable Third Parties, through multiple tiers. For clarity, the rights and obligations in compliance with Applicable Laws in the Licensee Territory. All such Drug Approval Applications this Section 12.3.6 shall not apply to Regulatory Filings and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide relating to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Except as expressly set forth in this Agreement, all costs and expenses incurred by Licensee in connection with the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee Territory shall be borne solely by Licensee. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee Territory to be provided to OPKO by Licensee shall be borne by OPKO, while any costs and expenses related to the translation to Chinese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licenseeinvolving AbbVie Combination Compounds.

Regulatory Filings and Regulatory Approvals. (a) Licensee shall be responsible for preparing and filing Drug Approval Applications and seeking and maintaining Regulatory Approval for the Product in the Field in each jurisdiction in the Licensee License Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with the Act on Drugs and Medical Devices and other Applicable Laws in the Licensee License Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Upon OPKO’s request, Licensee shall, [***], provide an English translation thereof. Except as expressly set forth in this Agreement, all costs and expenses [***] incurred by Licensee in connection with the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee License Territory shall be borne solely by Licensee[***]. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee License Territory to be provided to OPKO by Licensee shall be borne by OPKO[***], while any costs and expenses related to the translation to Chinese Japanese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licensee[***].

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein, as between the Parties, TRANSCEPT (aitself or through its sublicensees) Licensee shall have the sole right to and be responsible for preparing and filing Drug Approval Applications submitting to applicable Regulatory Authorities any and seeking all Regulatory Materials for the Product and obtaining and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product in for the Field in each jurisdiction in within the Licensee Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with Applicable Laws in the Licensee Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Except as expressly set forth [***] Certain information in this Agreementdocument has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. in this Agreement or otherwise mutually agreed by the Parties in writing, all costs and expenses incurred by Licensee SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection with the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee Territory shall be borne solely by Licensee. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee Territory to be provided to OPKO by Licensee shall be borne by OPKO, while any costs and expenses related to the translation to Chinese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licenseeits obligations under this Section 5.2.