Common use of Regulatory Filings and Regulatory Approvals Clause in Contracts

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial. (a) Immatics will be responsible for the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated Data. (b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereof, and (ii) any correspondence received from any Regulatory Authority). (c) At BMS’ written request following the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]) any and all Regulatory Materials for the Licensed Product, including providing true, accurate and complete hard and electronic copies thereof to BMS, provided Immatics may retain copies of such Regulatory Materials for the sole purpose of compliance with Applicable Law.

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical StudiesAt Infinity’s request, Immatics CMC ActivitiesAbbVie shall, promptly following the effectiveness of such termination, assign and Immatics GDP Trial. (a) Immatics will be responsible for the preparation of transfer to Infinity, all Regulatory Materials Filings, filings for any Immatics Pre-Clinical Studies, Immatics CMC Activities Pricing and Reimbursement Approval and Marketing Authorizations for Products that are held or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and approval controlled by or under authority of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (AbbVie or its Affiliate) in its nameAffiliates or Sublicensees as of the effective date of termination, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated Data. (b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities terminated country or the Immatics GDP Trial; providedTerritory, thatas 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 connection with its entirety, AbbVie shall also promptly transfer control of and responsibility for maintaining the global safety database for Products to Infinity (if previously held by AbbVie or its Affiliates), and Infinity shall accept such transfer and responsibility. If applicable Law prevents or delays the transfer of ownership of any such activities by ImmaticsRegulatory Filing, Immatics filing for Pricing and Reimbursement Approval or Marketing Authorizations to Infinity, AbbVie shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereofgrant, and (ii) any correspondence received from any Regulatory Authority). (c) At BMS’ written request following the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immaticsdoes hereby grant, to BMS (or its designee)Infinity an exclusive and irrevocable right of access and Right of Reference to such Regulatory Filing, promptly ([**]) any filing for Pricing and all Regulatory Materials Reimbursement Approval and Marketing Authorizations for the Licensed ProductProducts in the Territory or the terminated country, including providing trueas the case may be, accurate and complete hard and electronic copies thereof shall reasonably cooperate to BMS, provided Immatics may retain copies make the benefits of such Regulatory Materials Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Infinity or its designee(s). Infinity shall have the sole purpose of compliance with Applicable Lawright to grant licenses or sublicenses (as applicable) under the rights granted to it under this Section 12.3.6 to its Affiliates and Third Parties, through multiple tiers. For clarity, the rights and obligations in this Section 12.3.6 shall not apply to Regulatory Filings and Regulatory Approvals relating to or involving AbbVie Combination Compounds.

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial. (a) Immatics will be responsible for the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) 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 submissions to Regulatory Authorities costs and expenses related to the Immatics Generated Datatranslation 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. (b) Immatics OPKO shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings make available to Licensee all information and correspondence data Controlled by OPKO, its Affiliates and Third Party contract manufacturers and suppliers that Licensee reasonably indicates to OPKO is required to file Drug Approval Applications or obtain Regulatory Approval for the Product in the Field in the Licensee Territory, (ii) make its personnel with any Regulatory Authority for BMS’ review and approval prior relevant subject matter expertise available on a reasonable basis to submission thereofconsult with Licensee with respect thereto, and (iiiii) any correspondence received from any cooperate, and use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers and suppliers to cooperate, with Licensee to make changes, at Licensee’s reasonable cost, to the manufacturing of the Compound and/or Product that are required in order to ensure that the Compound and/or Product supplied to Licensee is compliant with requirements by Regulatory Authority)Authority and Applicable Laws in the Licensee Territory. (c) At BMS’ written request following the completion If OPKO has in its possession information of the Immatics GDP Trialnature described in Section 6.1(b)(i) above from an Other Licensee, Immatics but does not have the right to provide this information to Licensee for its use in the Field and the Licensee Territory, then OPKO shall assign and transferuse Commercially Reasonable Efforts to obtain those rights from such Other Licensee, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]*] to Licensee. (d) any OPKO represents that as of the Effective Date, Schedule 6.1(d) lists OPKO’s Other Licensees and all Regulatory Materials direct contract manufacturers and suppliers for the Licensed ProductProduct and, including providing trueto the best of OPKO’s knowledge, accurate all contract manufacturers and complete hard and electronic copies thereof to BMS, provided Immatics may retain copies of such Regulatory Materials suppliers for the sole purpose Product that are engaged by its direct contract manufacturers and suppliers, all of compliance with Applicable Lawwhom are subject to Sections 6.1(b) and 6.1(c), as applicable. To the extent there is any change to the Other Licensees or contract manufacturers or suppliers for the Product at any time during the Term, OPKO shall promptly inform Licensee by writing, upon which notice Schedule 6.1(d) shall be considered automatically amended to incorporate such change.

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial. (a) Immatics will be responsible for the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) Licensee shall be responsible for preparing and filing Drug Approval Applications and seeking and maintaining Regulatory Approval for the Product in the Field in the 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 License Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a copy 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, [***] 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 License Territory shall be borne solely by [***]. Notwithstanding the foregoing to the contrary, any submissions to Regulatory Authorities costs and expenses related to the Immatics Generated Datatranslation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the License Territory to be provided to OPKO by Licensee shall be borne by [***], while any costs and expenses related to the translation to 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 [***]. (b) Immatics OPKO shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior make available to submission thereofLicensee all information, data, and reports Controlled by OPKO or its Affiliates that Licensee reasonably indicates to OPKO is required to file Drug Approval Applications or obtain Regulatory Approval for the Product in the Field in the License Territory, (ii) any correspondence received from any Regulatory Authority)make its personnel with relevant subject matter expertise available on a \BA - 046396/000002 - 691149 v24 reasonable basis to consult with Licensee with respect thereto. Licensee shall reimburse the out-of-pocket expenses incurred by OPKO. (c) At BMS’ written request following If OPKO, its Affiliates or its contract manuracturers desire to protect their respective trade secrets, OPKO shall, or shall use reasonable efforts to cause its contract manufacturers to, submit and maintain an appropriate drug master files application(s) in accordance with the completion Applicable Law in the License Territory at the cost of OPKO or the contract manufacturers. (d) If OPKO does not have the rights to provide the information of the Immatics GDP Trialnature described in Section 7.1(b)(i) to Licensee for its use in the Field and the License Territory, Immatics then OPKO shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly (use [***] to [***]) any and all Regulatory Materials for the Licensed Product, including providing true, accurate and complete hard and electronic copies thereof to BMS, provided Immatics may retain copies of such Regulatory Materials for the sole purpose of compliance with Applicable Law.

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial. (a) Immatics Unless the Parties agree otherwise, Bayer will be responsible use Commercially Reasonable Efforts to: (i) obtain Scientific Advice from the EMEA; or (ii) file for Regulatory Approval in one or more countries in Europe based on the data provided by ZGEN in the initial eCTD for the preparation Initial Licensed Product described in paragraph 1(a) of all Regulatory Materials for any Immatics Pre-Clinical StudiesExhibit G regarding one or more of the Initial Licensed Products within [ * ] after the Effective Date; provided, Immatics CMC Activities however, that Bayer shall not be in breach of this Agreement, and ZGEN shall have no right to terminate this Agreement if, despite Bayer’s Commercially Reasonable Efforts, Bayer fails to accomplish the task in subparagraph (i) or (ii) above within such [ * ] time period. For the sake of clarity, Bayer may choose between the two options set forth above but it must pursue one unless the Parties mutually agree otherwise. Bayer shall provide a summary of the results of Scientific Advice to ZGEN within [ * ] of receipt. Notwithstanding the foregoing, if Bayer fails to accomplish the task in subparagraph (i) or (ii) above within such [ * ] period, then Bayer will provide to ZGEN, as soon as practicable after ZGEN’s request, a written report setting forth in reasonable detail the activities undertaken, results achieved and problems experienced by Bayer and such other matters that demonstrate the Commercially Reasonable Efforts applied by Bayer in connection with its efforts to accomplish one or the Immatics GDP Trial; provided that other of such Regulatory Materials tasks. Bayer shall be subject make qualified personnel available to answer questions relating to the prior review report and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period additional supporting documentation as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated DataZGEN may reasonably request. (b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult Bayer will prepare and coordinate with BMS with respect thereto file (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authoritiesat its sole cost and expense) and Immatics shall accommodate own all right, title and comply interest in all Regulatory Filings designed to obtain or support Regulatory Approval in the Bayer Territory and all Regulatory Approvals in the Bayer Territory. All such Regulatory Filings and Regulatory Approvals will be maintained in accordance with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereof, and (ii) any correspondence received from any Regulatory Authority)Section 15.3.2. (c) At BMS’ written request following ZGEN will prepare and file (at its sole cost and expense) and shall own all right, title and interest in all Regulatory Filings designed to obtain or support Regulatory Approval in the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]) any ZGEN Territory and all Regulatory Materials for Approvals in the ZGEN Territory. All such Regulatory Filings and Regulatory Approvals will be maintained in accordance with Section 15.3.2. (d) Each Party will provide the other Party with copies of all Regulatory Filings, Regulatory Approvals and all material official correspondence submitted to or received from Regulatory Authorities relating to Licensed ProductProducts (and Bulk Drug Substance incorporated therein) in, in the case of ZGEN, the United States and, in the case of Bayer, any Major Country, without undue delay after submission or receipt of the same. Prior to a Party submitting such Regulatory Filings or material correspondence with Regulatory Authorities in the United States or any Major Country, including providing trueproposals for changes to labeling (which, accurate with respect to Collaboration Products, shall also be subject to Section 7.3), such Party will use reasonable efforts to afford the other Party the opportunity to review and complete hard and electronic copies thereof to BMS, provided Immatics may retain copies of comment on such Regulatory Materials for Filings or material correspondence. Each Party will notify the sole purpose other Party and, at the request and expense of compliance the other Party, provide copies to the other Party, of any Regulatory Filings, Regulatory Approvals or official correspondence submitted to or received from Regulatory Authorities that are material to the Development or Commercialization of Licensed Product in every other country in the notifying Party’s portion of the Territory. Notwithstanding the foregoing, each Party will provide the other Party with Applicable Lawnotice of any safety-related correspondence, reports or complaints received from any Regulatory Authority within [ * ] of receipt of the same.

Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies5.2.1 Except as expressly provided herein, Immatics CMC Activitiesas between the Parties, TRANSCEPT (itself or through its sublicensees) shall have the sole right to and Immatics GDP Trial. (a) Immatics will be responsible for the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject preparing and submitting to the prior review and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated Data. (b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereof, and (ii) any correspondence received from any Regulatory Authority). (c) At BMS’ written request following the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]) any and all Regulatory Materials for the Licensed ProductProduct 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, including providing trueRegulatory Authority communications and review of Regulatory Materials, accurate and complete hard Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and electronic copies thereof expense, to BMSmake available as described in the following sentence information in SNBL’s Control or otherwise execute, provided Immatics may retain copies 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 sole purpose Product for the Field within the Territory. Except as expressly set forth in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection with its obligations under this Section 5.2. 5.2.2 To the extent that SNBL has not filed a Device Master File as of compliance the Effective Date and elects to prepare, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and provide comments; provided that, to the extent that any portion of the Device Master File or other similar confidential Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary of such portion. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval for the Product, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with Applicable Lawrespect to any comment or suggestion provided by TRANSCEPT, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2.