Common use of Compliance Audits Clause in Contracts

Compliance Audits. 11.1 Sunesis reserves the right to have a “person in plant” during any manufacturing or testing activities. 11.2 Sunesis reserves the right to conduct an annual audit, in person or by other means, of any work performed, and compliance to GMPs and other applicable regulations, as well as an initial qualification audit. For cause” audits may be scheduled in addition to the qualification and/or annual audit. “Man-in-plant” during Sunesis project work is not considered an audit. 11.2.1 If deviations or concerns are noted within the audit, AAIPS will provide a written response to Sunesis’ written audit report within four (4) weeks of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AAIPS, if any, and a timeline for such implementation. 11.3 Reasonable prior notice will be given before any visit or audit, and audits will be conducted at mutually agreed upon times. Prior to an audit, Sunesis will communicate to AAIPS the scope of the audit. 11.4 In the event of an inspection by any governmental or regulatory authority concerning the work being performed for Sunesis, AAIPS shall notify Sunesis promptly upon learning of such an inspection. AAIPS shall also supply Sunesis with copies of any FDA Form 483, any correspondence or portions of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. correspondence relating to Sunesis’ materials and shall inform Sunesis of the general findings and outcomes of such inspections. By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxxxxxxx Xxxxx Name: Xxxxxx X. Xxxxxxx Name: Xxxxxxxxxxx Xxxxx Title: Senior Vice President, Research & Development and Quality Title: VP, Quality & Regulatory Affairs Date: October 25, 2010 Date: October 25, 2010 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. This Master Services Agreement (“Agreement”) is made and entered into as of January 1, 2010 (the “Effective Date”), by and between Albany Molecular Research, Inc., having its principal place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000 (together with its subsidiaries hereinafter collectively referred to as “AMRI”) and Sunesis Pharmaceuticals, Inc., having its principal place of business at 000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 (hereinafter “SUNESIS”). AMRI and SUNESIS are referred to individually as a “Party” and together as the “Parties” throughout this Agreement.

Compliance Audits. 11.1 12.1. Sunesis reserves the right to have a “person in plant” during any manufacturing or testing activitiesactivities as mutually agreed upon by both parties. 11.2 12.2. Annually and/or for cause, Sunesis reserves the right to conduct an annual audit, in person or by other means, of any work performed, and audit to compliance to GMPs and other applicable regulations, as well as an initial qualification audit. For cause” audits may be scheduled in addition to the qualification and/or annual audit. “Man-in-plant” during Sunesis project work is not considered an audit. 11.2.1 If deviations or concerns are noted within the audit, AAIPS will provide a written response to Sunesis’ written audit report within four (4) weeks of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AAIPS, if any, and a timeline for such implementation. 11.3 Reasonable prior notice will be given before any visit or audit, and audits will be conducted at mutually agreed upon times. Prior to an audit, Sunesis will communicate to AAIPS AMRI the scope of the audit. 11.4 In the event of an inspection by any governmental or regulatory authority concerning the work being performed for Sunesis, AAIPS shall notify Sunesis promptly upon learning of such an inspection. AAIPS shall also supply Sunesis with copies of any FDA Form 483, any correspondence or portions of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 12.2.1. If deviations or concerns are noted within the audit, AMRI will provide a written response to Sunesis’ written audit report within 30 business days of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AMRI, if any, and a timeline for such implementation. 12.3. In the event of an inspection by any governmental or regulatory authority concerning the site at which Sunesis projects are performed, AMRI shall notify Sunesis promptly upon learning of such an inspection. AMRI shall also supply Sunesis with redacted copies of any FDA Form 483, any correspondence or portions or correspondence relating to Sunesis’ ’s materials and shall inform Sunesis of the general findings and arid outcomes of such inspections. 12.4. During the course of this project, Sunesis requests reasonable frequency of telephone and/or video conferences with the appropriate parties at AMRI, permission to visit AMRI and inspect progress as determined necessary, as well as periodic access to interim data generated in support of this project. SIGNATURES Sunesis AMRI By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxxxxxxx Xxxxx Xxxx X. Xxxx Name: Xxxxxx X. Xxxxxxx Name: Xxxxxxxxxxx Xxxxx Xxxx X. Xxxx Title: Senior Vice President, Research & Development and Quality Title: VPDirector, Quality & Regulatory Affairs Date: October 25November 30, 2010 Date: October 25December 17, 2010 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. This Master Services Agreement (“Agreement”) is made and entered into as of January 1Exhibit E Revenue Participation Report [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 2010 (the “Effective Date”)MARKED BY BRACKETS, by and between Albany Molecular ResearchHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, Inc., having its principal place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000 (together with its subsidiaries hereinafter collectively referred to as “AMRI”) and AS AMENDED. Sunesis Pharmaceuticals, Inc.Inc. [Insert Product Name] Revenue Participation Report by Country [Insert Quarterly Period] Location Date of First Commercial Sale Units Sold Gross Sales (in local currency) Net Sales (in local currency) FX Rate Net Sales (in U.S. dollars) [If Combination Product, having its principal place of business at 000 Xxxxxx Xxxxx Xxxxxxxxxpercentage attributed to Product] Revenue Participation Amount (in U.S. dollars) [Insert Country 1] [Insert Country 2] TOTALS [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Xxxxx 000MARKED BY BRACKETS, Xxxxx Xxx XxxxxxxxxHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, Xxxxxxxxxx 00000 (hereinafter “SUNESIS”)AS AMENDED. AMRI and SUNESIS are referred to individually as a “Party” and together as the “Parties” throughout this Agreement.Exhibit F

Compliance Audits. 11.1 12.1. Sunesis reserves the right to have a “person in plant” during any manufacturing or testing activitiesactivities as mutually agreed upon by both parties. 11.2 12.2. Annually and/or for cause, Sunesis reserves the right to conduct an annual audit, in person or by other means, of any work performed, and audit to compliance to GMPs and other applicable regulations, as well as an initial qualification audit. For cause” audits may be scheduled in addition to the qualification and/or annual audit. “Man-in-plant” during Sunesis project work is not considered an audit. 11.2.1 If deviations or concerns are noted within the audit, AAIPS will provide a written response to Sunesis’ written audit report within four (4) weeks of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AAIPS, if any, and a timeline for such implementation. 11.3 Reasonable prior notice will be given before any visit or audit, and audits will be conducted at mutually agreed upon times. Prior to an audit, Sunesis will communicate to AAIPS AMRI the scope of the audit. 11.4 In the event of an inspection by any governmental or regulatory authority concerning the work being performed for Sunesis, AAIPS shall notify Sunesis promptly upon learning of such an inspection. AAIPS shall also supply Sunesis with copies of any FDA Form 483, any correspondence or portions of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 12.2.1. If deviations or concerns are noted within the audit, AMRI will provide a written response to Sunesis’ written audit report within 30 business days of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AMRI, if any, and a timeline for such implementation. 12.3. In the event of an inspection by any governmental or regulatory authority concerning the site at which Sunesis projects are performed, AMRI shall notify Sunesis promptly upon learning of such an inspection. AMRI shall also supply Sunesis with redacted copies of any FDA Form 483, any correspondence or portions or correspondence relating to Sunesis’ ’s materials and shall inform Sunesis of the general findings and arid outcomes of such inspections. 12.4. During the course of this project, Sunesis requests reasonable frequency of telephone and/or video conferences with the appropriate parties at AMRI, permission to visit AMRI and inspect progress as determined necessary, as well as periodic access to interim data generated in support of this project. By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxxxxxxx Xxxxx Xxxx X. Xxxx Name: Xxxxxx X. Xxxxxxx Name: Xxxxxxxxxxx Xxxxx Xxxx X. Xxxx Title: Senior Vice President, Research & Development and Quality Title: VPDirector, Quality & Regulatory Affairs Date: October 25November 30, 2010 Date: October 25December 17, 2010 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. This Master Services Agreement (“Agreement”) is made and entered into as of January 1[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 2010 (the “Effective Date”)MARKED BY BRACKETS, by and between Albany Molecular ResearchHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, Inc., having its principal place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000 (together with its subsidiaries hereinafter collectively referred to as “AMRI”) and Sunesis Pharmaceuticals, Inc., having its principal place of business at 000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 (hereinafter “SUNESIS”). AMRI and SUNESIS are referred to individually as a “Party” and together as the “Parties” throughout this AgreementAS AMENDED.

Compliance Audits. 11.1 Sunesis reserves the right to have a “person in plant” during any manufacturing or testing activities. 11.2 Sunesis reserves the right to conduct an annual audit, in person or by other means, of any work performed, and compliance to GMPs and other applicable regulations, as well as an initial qualification audit. For cause” audits may be scheduled in addition to the qualification and/or annual audit. “Man-in-plant” during Sunesis project work is not considered an audit. 11.2.1 If deviations or concerns are noted within the audit, AAIPS will provide a written response to Sunesis’ written audit report within four (4) weeks of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AAIPS, if any, and a timeline for such implementation. 11.3 Reasonable prior notice will be given before any visit or audit, and audits will be conducted at mutually agreed upon times. Prior to an audit, Sunesis will communicate to AAIPS the scope of the audit. 11.4 In the event of an inspection by any governmental or regulatory authority concerning the work being performed for Sunesis, AAIPS shall notify Sunesis promptly upon learning of such an inspection. AAIPS shall also supply Sunesis with copies of any FDA Form 483, any correspondence or portions of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. correspondence relating to Sunesis’ materials and shall inform Sunesis of the general findings and outcomes of such inspections. SIGNATURES Sunesis Pharmaceuticals, Inc. AAIPharma Services Corp. By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxxxxxxx Xxxxx Name: Xxxxxx X. Xxxxxxx Name: Xxxxxxxxxxx Xxxxx Title: Senior Vice President, Research & Development and Quality Title: VP, Quality & Regulatory Affairs Date: October 25, 2010 Date: October 25, 2010 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. MASTER SERVICES AGREEMENT This Master Services Agreement (“Agreement”) is made and entered into as of January 1, 2010 (the “Effective Date”), by and between Albany Molecular Research, Inc., having its principal place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000 (together with its subsidiaries hereinafter collectively referred to as “AMRI”) and Sunesis Pharmaceuticals, Inc., having its principal place of business at 000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 (hereinafter “SUNESIS”). AMRI and SUNESIS are referred to individually as a “Party” and together as the “Parties” throughout this Agreement.