Common use of Reporting and Review Clause in Contracts

Reporting and Review. (i) The JDC will develop and implement procedures for drafting and review of Regulatory Materials for Development Candidates and Products in the Territory, which procedures will provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials. Such procedures will provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. Such procedures and related timelines will accommodate each Party’s reasonable requests to obtain the feedback of Regulatory Authorities with respect to potential submissions in order to permit each Party to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent. (ii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products in the Shared Territory, Unum will promptly notify SGI of all Regulatory Materials that Unum submits for such Development Candidates and Products and will promptly provide SGI with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. Unum will provide SGI with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Shared Territory, and SGI has the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of Unum will be the primary spokespeople at all meetings with Regulatory Authorities in the Shared Territory with regard to such matter. Unum also will promptly furnish SGI with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Shared Territory. (iii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products in the Licensed Territory, SGI will promptly notify Unum of all Regulatory Materials that SGI submits for such Development Candidates and Products and will promptly provide Unum with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. SGI will provide Unum with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Licensed Territory, and Unum has the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of SGI will be the primary spokespeople at all meetings with Regulatory Authorities in the Licensed Territory with regard to such matter. SGI also will promptly furnish Unum with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Licensed Territory.

Reporting and Review. (a) The BGN project representative(s) will submit to Gaslink the reports that have been agreed between BGN and Gaslink in relation to the performance by BGN of its functions pursuant to this Clause 8 and Schedule 9 and such other information on progress against any Project Agreement as Gaslink may reasonably request from time to time. (b) BGN shall undertake an audit programme agreed with Gaslink (both Parties acting reasonably) to verify that the performance by BGN of such of its functions pursuant to this Clause 8 of this Agreement and Schedule 9 as BGN and Gaslink may agree meets the Development Requirements and shall notify Gaslink of any failure or anticipated failure by BGN to comply with the Development Requirements of which BGN becomes aware. (c) Gaslink may conduct all reasonable inspections and reviews to ensure that work undertaken complies with the Development Requirements. Such inspections must be conducted at a reasonable time and on reasonable notice to BGN and in accordance with the Access Protocol. (d) If arising from the results of an audit programme, an inspection or otherwise Gaslink considers that the Development Requirements are not being complied with in any respect, it may notify BGN of such non- compliance giving reasons for its view. (e) Save in the event of a Dispute as to whether there has been such non- compliance, which shall be dealt with in accordance with the Dispute Resolution Mechanism, BGN shall remedy any such non-compliance to the satisfaction of Gaslink within such timeframe as Gaslink may reasonably specify. (f) The performance by BGN of its functions pursuant to this Clause 8 and Schedule 9 shall be reviewed against the Development Requirements by Gaslink and BGN at the Monthly Meetings. In advance of those meetings BGN will provide Gaslink with a report comprising: (i) The JDC will develop a high level activity report containing a detailed report of progress in respect of major projects and implement procedures for drafting and review a summary of Regulatory Materials for Development Candidates and Products progress in the Territory, which procedures will provide sufficient time for each Party to provide substantive comments prior to the filing respect of such Regulatory Materials. Such procedures will provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. Such procedures and related timelines will accommodate each Party’s reasonable requests to obtain the feedback of Regulatory Authorities with respect to potential submissions in order to permit each Party to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent.minor projects; (ii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products in the Shared Territory, Unum will promptly notify SGI of all Regulatory Materials that Unum submits for such Development Candidates and Products and will promptly provide SGI with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. Unum will provide SGI with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Shared Territory, and SGI has the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of Unum will be the primary spokespeople at all meetings with Regulatory Authorities in the Shared Territory with regard to such matter. Unum also will promptly furnish SGI with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Shared Territory.revised projects schedule; and (iii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products a management report outlining key development activities in the Licensed Territory, SGI will promptly notify Unum of all Regulatory Materials previous month and a report on the audit programme undertaken pursuant to Clause 8.3(b). (g) BGN shall comply with and discharge any liabilities it may incur under any Customer Charter in place from time to time that SGI submits for such Development Candidates and Products and will promptly provide Unum with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. SGI will provide Unum with reasonable advance notice of any scheduled meeting with respect is applicable to such matter with any Regulatory Authority in the Licensed Territory, and Unum has the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of SGI will be the primary spokespeople at all meetings with Regulatory Authorities in the Licensed Territory with regard to such matter. SGI also will promptly furnish Unum with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Licensed Territoryits functions as set out above.

Reporting and Review. (i) The JDC will shall develop and implement procedures for drafting and review of Regulatory Materials for Development Candidates and Products in the Shared Territory, the EU, and Japan, which procedures will shall provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials. Such procedures will shall provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will shall permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. However, such procedures shall not require any translation of any such materials. Such procedures and related timelines will shall accommodate each PartyAstellas’s reasonable requests to obtain the feedback of Regulatory Authorities in the Licensed Territory with respect to potential submissions in order to permit each Party Astellas to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent. (ii) With respect to regulatory matters in any country or jurisdiction in support of Regulatory Approvals for Development Candidates and Products in the Shared Territory, Unum will the EU and Japan, each Party shall promptly notify SGI the other Party of all Regulatory Materials that Unum it submits for such Development Candidates and Products and will shall promptly provide SGI the other Party with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. Unum The lead regulatory Party primarily responsible for each matter will provide SGI the non-responsible Party with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Shared Territorysuch countries, and SGI has the non-responsible Party shall have the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of Unum the lead regulatory Party primarily responsible for each matter will be the primary spokespeople at all meetings with Regulatory Authorities in the Shared Territory with regard to such matter. Unum The lead regulatory Party also will shall promptly furnish SGI the other Party with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Shared TerritoryAuthority. (iii) With respect to regulatory matters in any country or jurisdiction in support of Regulatory Approvals for Development Candidates and Products any country or jurisdiction in the Licensed Territory other than the Shared Territory, SGI will promptly notify Unum the EU and Japan, Astellas shall provide to Medivation annual updates of all Regulatory Materials that SGI submits for such Development Candidates and Products and will promptly provide Unum with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. SGI will provide Unum with reasonable advance notice of any scheduled meeting its regulatory activities, including updates with respect to such matter filings of Regulatory Materials made, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with any the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. meetings held with Regulatory Authority in the Licensed TerritoryAuthorities, and Unum has the right Regulatory Approvals received in such countries and shall respond to participate in any such meeting, reasonable requests by Medivation for additional information from time to the extent permitted by Applicable Law. Representatives of SGI will be the primary spokespeople at all meetings with Regulatory Authorities in the Licensed Territory with regard to such matter. SGI also will promptly furnish Unum with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Licensed Territorytime.

Reporting and Review. (i) The JDC will shall develop and implement procedures for drafting and review of Regulatory Materials for Development Candidates and Products in the Shared Territory, the EU, and Japan, which procedures will shall provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials. Such procedures will shall provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will shall permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. However, such procedures shall not require any translation of any such materials. Such procedures and related timelines will shall accommodate each PartyAstellas’s reasonable requests to obtain the feedback of Regulatory Authorities in the Licensed Territory with respect to potential submissions in order to permit each Party Astellas to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent. (ii) With respect to regulatory matters in any country or jurisdiction in support of Regulatory Approvals for Development Candidates and Products in the Shared Territory, Unum will the EU and Japan, each Party shall promptly notify SGI the other Party of all Regulatory Materials that Unum it submits for such Development Candidates and Products and will shall promptly provide SGI the other Party with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. Unum The lead regulatory Party primarily responsible for each matter will provide SGI the non-responsible Party with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Shared Territorysuch countries, and SGI has the non-responsible Party shall have the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of Unum the lead regulatory Party primarily responsible for each matter will be the primary spokespeople at all meetings with Regulatory Authorities in the Shared Territory with regard to such matter. Unum The lead regulatory Party also will shall promptly furnish SGI the other Party with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Shared TerritoryAuthority. (iii) With respect to regulatory matters in any country or jurisdiction in support of Regulatory Approvals for Development Candidates and Products any country or jurisdiction in the Licensed Territory other than the Shared Territory, SGI will promptly notify Unum the EU and Japan, Astellas shall provide to Medivation annual updates of all Regulatory Materials that SGI submits for such Development Candidates and Products and will promptly provide Unum with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. SGI will provide Unum with reasonable advance notice of any scheduled meeting its regulatory activities, including updates with respect to such matter filings of Regulatory Materials made, meetings held with any Regulatory Authority in the Licensed TerritoryAuthorities, and Unum has the right Regulatory Approvals received in such countries and shall respond to participate in any such meeting, reasonable requests by Medivation for additional information from time to the extent permitted by Applicable Law. Representatives of SGI will be the primary spokespeople at all meetings with Regulatory Authorities in the Licensed Territory with regard to such matter. SGI also will promptly furnish Unum with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Licensed Territorytime.

Reporting and Review. (a) BGN will submit to Gaslink the reports that have been agreed between BGN and Xxxxxxx in relation to the performance by BGN of its functions pursuant to this Clause 8 and Schedule 9 and such other information including in relation to progress against any Project Agreement as Gaslink may reasonably request from time to time. (b) BGN shall undertake an audit programme agreed with Gaslink (both Parties acting reasonably) to verify that the performance by BGN of such of its functions pursuant to this Clause 8 of this Agreement and Schedule 9 as BGN and Gaslink may agree meets the Development Requirements and shall notify Gaslink of any failure or anticipated failure by BGN to comply with the Development Requirements of which BGN becomes aware and on request by Gaslink shall provide Gaslink a copy of all or any part of the audit reports. (c) Gaslink may conduct all reasonable inspections, audits and reviews to ensure that work undertaken complies with the Development Requirements. Such inspections must be conducted at a reasonable time and on reasonable notice to BGN and in accordance with the Access Protocol. (d) If arising from the results of an audit programme, an inspection or otherwise Gaslink considers that the Development Requirements are not being complied with in any respect, it may notify BGN of such non- compliance giving reasons for its view. (e) Save in the event of a Dispute as to whether there has been such non- compliance, which shall be dealt with in accordance with the Dispute Resolution Mechanism, BGN shall remedy any such non-compliance to the satisfaction of Gaslink within such timeframe as Gaslink may reasonably specify. (f) The performance by BGN of its functions pursuant to this Clause 8 and Schedule 9 shall be reviewed against the Development Requirements by Gaslink and BGN at the Monthly Meetings. In advance of those meetings BGN will provide Gaslink with a report comprising: (i) The JDC will develop a high level activity report containing a detailed report of progress in respect of major projects and implement procedures for drafting and review a summary of Regulatory Materials for Development Candidates and Products progress in the Territory, which procedures will provide sufficient time for each Party to provide substantive comments prior to the filing respect of such Regulatory Materials. Such procedures will provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. Such procedures and related timelines will accommodate each Party’s reasonable requests to obtain the feedback of Regulatory Authorities with respect to potential submissions in order to permit each Party to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent.minor projects; (ii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products in the Shared Territory, Unum will promptly notify SGI of all Regulatory Materials that Unum submits for such Development Candidates and Products and will promptly provide SGI with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials. Unum will provide SGI with reasonable advance notice of any scheduled meeting with respect to such matter with any Regulatory Authority in the Shared Territory, and SGI has the right to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of Unum will be the primary spokespeople at all meetings with Regulatory Authorities in the Shared Territory with regard to such matter. Unum also will promptly furnish SGI with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Shared Territory.revised projects schedule; and (iii) With respect to regulatory matters in support of Regulatory Approvals for Development Candidates and Products a management report outlining key development activities in the Licensed Territory, SGI will promptly notify Unum of all Regulatory Materials previous month and a report on the audit programme undertaken pursuant to Clause 8.3(b). (g) BGN shall comply with and discharge any liabilities that SGI submits for such Development Candidates and Products and will promptly provide Unum with a copy (which may be wholly or partly incurred under any Customer Charter in electronic form) of such Regulatory Materials. SGI will provide Unum with reasonable advance notice of any scheduled meeting with respect place from time to such matter with any Regulatory Authority in the Licensed Territory, and Unum has the right time that is applicable to participate in any such meeting, to the extent permitted by Applicable Law. Representatives of SGI will be the primary spokespeople at all meetings with Regulatory Authorities in the Licensed Territory with regard to such matter. SGI also will promptly furnish Unum with copies of all material correspondence to or from, and minutes of all such meetings with, any Regulatory Authority in the Licensed Territoryits functions as set out above.