Common use of Diligence Clause in Contracts

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) day period.

Diligence. 5.1 LICENSEE shall use commercially reasonable best efforts to bring one or more LICENSED PRODUCTS to market, and/or market or one or more LICENSED PROCESSES to commercial use, use through a thorough, vigorous and diligent program for utilizing exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2Four years from Effective date: file 1st Investigational New Drug Application (IND) [XXX] 3) [XXX] 4) [XXX] For to the purposes of this Agreement, initiation of U.S Food and Drug Administration or a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug similar application to any foreign regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agencycommence clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated aboveand MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within thirty ten (3010) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety thirty (9030) days’ days written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) thirty-day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or market or one or more LICENSED PROCESSES to commercial use, use through a thorough, vigorous and diligent program for utilizing exploiting the PATENT RIGHTS same and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and use commercially reasonable efforts to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “"MILESTONES”'") by the 'he following dates: 1) [XXX]Completion of Phase I Clinical Trial on or before January 1, 2015. 2) [XXX]Completion of Phase II Clinical Trial on or before January 1, 2017. 3) [XXX]Completion of Phase III Clinical Trial on or before January 1, 2019. 4) [XXX] For the purposes of this AgreementFIRST COMMERCIAL SALE on or before January 1, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency2020. 5.3 LICENSEE must achieve each MILESTONE the MILESTONES on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was metindicated. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and Paragraph 5.2 MICHIGAN may terminate the Agreement this AGREEMENT effective on ninety thirty (9030) days’ days prior written noticenotice to LICENSEE, unless subject, however, to the rights of any SUBLICENSEE granted pursuant to Paragraph: provided, however , that any such termination shall not be effective if LICENSEE: (a) actually achieves such MILESTONE during such thirty (30) day period or (b) demonstrates that LICENSEE achieves has used commercially reasonable efforts to achieve such MILESTONE over the MILESTONE within entire course of this ninety AGREEMENT. If, as of the close of such thirty (9030) day period, there is a dispute as to whether LICENSEE has met the condition set forth in clause (a) or (b) of the preceding sentence, then such thirty (30) day period shall be automatically extended for thirty (30) days, during which time the parties shall hold good faith discussions in order to resolve such dispute. If the parties ultimately agree that LICENSEE has met the condition set forth in clause (b) above, the termination shall be deemed ineffective, and the panics shall negotiate in good faith a revised deadline for achieving such MILESTONE. In addition, regardless of whether LICENSEE can demonstrate that LICENSEE has met the condition set forth in clause (b) above, LICENSEE shall have the opportunity to present a revised timeline for achieving the MILESTONE at issue, and the approval to revise the timeline from MICHIGAN shall not be unreasonably withheld, provided that LICENSEE is otherwise in compliance with its other obligations under this AGREEMENT.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more a full scope of LICENSED PRODUCTS to market, and/or market or one or more LICENSED PROCESSES to commercial use, use through a thorough, vigorous and diligent program for utilizing exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX]Initiate Preclinical Animal Trials 12 months from Effective Date 2) [XXX]Initiate Phase I clinical Trial 24 months from Effective Date 3) [XXX] 4) [XXX] FIRST COMMERCIAL 48 months from Effective Date For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated aboveand MICHIGAN shall have reasonable discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN within thirty ten (3010) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety thirty (9030) days’ written days notice, unless LICENSEE achieves the MILESTONE within this ninety (90) thirty day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the notice to MICHIGAN referred to above.

Diligence. 5.1 LICENSEE 4.1 Licensee will secure at least [*] in funding (“Initial Funding”), as evidenced by bank statements or electronic account statements by [*]. If Licensee has not secured this amount of minimum funding by the date specified above, MSK shall have the right to terminate the Agreement upon [*] business days’ advance written notice, subject to Licensee’s right to cure any shortfall during said notice period. Licensee will secure financing (either debt or equity) with gross proceeds totaling [*] by [*] (the “First Raise”) and additional gross proceeds totaling Twenty-Five Million U.S. Dollars ($25,000,000) by December 31, 2018 (the “Second Raise”). If Licensee has not secured either of the First Raise or Second Raise by the applicable dates [*] = 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 406 of the Securities Act of 1933, as amended. Table of Contents specified above, MSK shall have the right to terminate the License with [*] business days’ written notice, subject to Licensee’s right to cure any shortfall during said notice period; provided, however, that if MSK terminates the License as provided herein, Section 5.1(a)(iv) shall become null and void (and no additional Shares as contemplated therein shall be due and owing unless previously issued or accrued to be issued). 4.2 Licensee shall use commercially reasonable best efforts to (i) bring Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Licensed Rights, and (ii) continue active, diligent marketing efforts for Licensed Products throughout the Term. Without limiting the foregoing, Licensee shall exercise its best efforts to achieve the following milestones: Licensee will use commercially reasonable efforts to bring one or more LICENSED PRODUCTS develop and commercialize Licensed Products. Specifically, Licensee will: (a) Either: (i) [*]; or (ii) [*]; (the achievement of the milestone described in this Section 4.2(a) the “[*] Milestone Achievement”). (b) [*] in exercise of commercially reasonable efforts in [*]. (c) [*]. 4.3 Licensee shall give MSK written notice and evidence within [*] days of the achievement of each of the above specific diligence obligations. 4.4 [*] all clinical trials conducted in the United States and sponsored by Licensee during the Term. Licensee shall have access to, and the right to marketutilize, and/or one or more LICENSED PROCESSES all data generated in clinical trials conducted by MSK relating to commercial usethe Licensed Rights, through including without limitation those trials that are ongoing as of the Effective Date. Further, Licensee shall [*] to the extent that [*]. 4.5 Licensee’s current projections of its business plan for the development of the Licensed Rights, including, for example, estimates of [*] planned for each phase of development of the Licensed Rights for a diligent program for utilizing [*] period, to the PATENT RIGHTS extent formed by Licensee, is annexed hereto and to continue diligent marketing efforts throughout the life made part of this Agreement. Licensee shall provide similar reports to MSK [*] to relay update and status information on Licensee’s business, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones progress, including projections of activity anticipated for the LICENSED PRODUCTS next [*]. 4.6 Licensee shall be solely responsible, at its sole cost and LICENSED PROCESSES expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale 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 406 of the Securities Act of 1933, as amended. Table of Contents Licensed Products (together “Regulatory Approval”). Licensee shall advise MSK, through information contained in annual reports described in Section 4.5 above, of its program of development for obtaining said approvals. 4.7 If Licensee is the “MILESTONES”subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product that (i) by the following dates: 1its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of manufacturing, sale, development, or marketing of Licensed Products efforts, (ii) [XXX] 2concerns a recall or potential recall of Licensed Products, (iii) [XXX] 3concerns a loss of life or material issue of safety, or (iv) [XXX] 4) [XXX] For the purposes may reasonably be expected to prevent Licensee’s compliance with its diligence obligations, then Licensee shall provide a copy to MSK without delay and keep MSK reasonably apprised of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agencyits response. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) day period.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring at least one LICENSED PRODUCT to market or more one LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES PROCESS to commercial use, use through a commercially reasonable diligent program for utilizing exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts using commercially reasonable efforts for any LICENSED PRODUCT that [***] = CONFIDENTIAL TREATMENT REQUESTED achieves regulatory approval throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and use commercially reasonable efforts to obtain and retain any necessary governmental approvals that are required to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES availableSUBLICENSEES . 5.2 Without limiting As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use commercially reasonable efforts to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] dates specified below. For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. The MILESTONES are: 1) submitting an IND to the FDA by August 31, 2013. 2) initiating a Phase I clinical trial by December 31, 2013. [***] MICHIGAN acknowledges and agrees that LICENSEE has fully satisfied its obligations regarding achievement of MILESTONES 1 and 2 above, and that no Delay Option (as defined below) was utilized. 5.3 LICENSEE shall have the right to extend by [***] the time it has to achieve the above diligence milestones, such date to be calculated from the dates shown in Paragraph 5.2, as applicable (“Delay Option”). To exercise the Delay Option, LICENSEE must: (i) give MICHIGAN notice in writing at least ten (10) days prior to the MILESTONE deadline that LICENSEE is exercising its Delay Option; and (ii) pay MICHIGAN a non-refundable and non-creditable fee of $[***], which shall be due with such notice, and upon such payment, all the above diligence milestone dates shall be extended by [***]. 5.4 Subject to Paragraph 5.3, LICENSEE must use commercially reasonable efforts to achieve each MILESTONE on or before the deadline dates indicated aboveindicated. LICENSEE shall notify MICHIGAN within thirty ten (3010) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE believes that it is or will be unable to achieve any MILESTONE by such deadline (as the deadline may have been extended pursuant to Paragraph 5.3) despite its using commercially reasonable efforts, LICENSEE may request to amend or extend the MILESTONES, and MICHIGAN will not unreasonably withhold consent or approval of any such request to amend or extend the MILESTONE if such proposed request is supported by a detailed showing by LICENSEE of: (a) its commercially reasonable efforts to achieve such MILESTONE events during the Agreement (including the amount of monetary investment therein), (b) due diligence in its performance of research and development of LICENSED PRODUCTS and/or LICENSED PROCESSES, and (c) plans for future development and sale of LICENSED PRODUCTS and LICENSED PROCESSES. If LICENSEE fails to use commercially reasonable efforts to meet any MILESTONE under this Article Paragraph by the date of any [***] = CONFIDENTIAL TREATMENT REQUESTED the applicable MILESTONE deadlinedeadline (as extended), and MICHIGAN justifiably withholds consent to LICENSEE’S request to amend or extend as described in the previous sentence, then LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety thirty (9030) days’ written notice, unless LICENSEE achieves commences using commercially reasonable efforts to achieve the MILESTONE within this ninety (90) thirty day period.,

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX**] 2) [XXX**] 3) [XXX**] 4) [XXX**] For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) day period.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more a full scope of LICENSED PRODUCTS to market, and/or market or one or more LICENSED PROCESSES to commercial use, use through a thorough, vigorous and diligent program for utilizing exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated aboveand MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN within thirty ten (3010) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety thirty (9030) days’ written days notice, unless LICENSEE achieves the MILESTONE within this ninety (90) thirty day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the notice to MICHIGAN referred to above.

Diligence. 5.1 LICENSEE shall 3.1. EXACT agrees to use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program make (i) Diagnostic Services,(ii) Licensed Reagents and (iii) Kits available for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout benefit of the life of this Agreement, in each case general public consistent with prudent business practices regulatory compliance and judgmentpublic safety. 3.2. LICENSEE has EXACT’s material failure to perform in accordance with any subsection of Section 3.1 above shall be grounds for Genzyme to terminate the responsibility license under Section 2.1 above with respect to do all that is legally required and commercially reasonable Diagnostic Services, Licensed Reagents or Kits, as applicable, pursuant to obtain and retain any governmental approvals Section 7.8 hereof by delivering written notice of its intention to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEESterminate to EXACT. If EXACT disputes Genzyme’s determination, (i) EXACT shall deliver written notice of such dispute within ten (10) business days after its receipt of notice from Genzyme of its intent to terminate, (ii) the commercialization matter shall be referred to arbitration pursuant to Article 11hereof and (iii) EXACT’s license under Section 2.1 above to the Diagnostic Services, Licensed Reagents or Kits, as applicable, and EXACT’s obligations with respect thereto shall continue in full force and effect until the resolution of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES availablearbitration. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated above3.3. LICENSEE shall notify MICHIGAN within Within thirty (30) days after the Original Effective Date and subsequently no later than May 1 and November 1 of each such deadline as year, commencing on November 1, 1999, EXACT shall provide a written report to whether or not such MILESTONE was metGenzyme on its research, development and commercialization efforts with respect to (i) Diagnostic Services, (ii)Licensed Reagents and (iii) Kits (each individually), which report shall cite specific goals and objectives in researching, developing and commercializing the licensed technology and methodology and progress in meeting these goals and objectives. If LICENSEE fails Genzyme does not receive any such report(s) in a timely manner, it shall notify EXACT of such delinquency in writing. EXACT shall have thirty (30) days from its receipt of such notice to meet provide Genzyme with any MILESTONE under this Article and all overdue report(s). Failure by the date of any MILESTONE deadline, LICENSEE will be deemed EXACT to be in material breach provide such overdue report(s) within said thirty (30) day period may constitute grounds for termination of this AgreementAgreement by Genzyme as provided for in Section 7.5 hereof; provided, and MICHIGAN may terminate however, that the Agreement effective on ninety number of days elapsed since EXACT first received notice from Genzyme of the delinquent reports shall be counted for purposes of determining the sixty (90) days’ written notice, unless LICENSEE achieves the MILESTONE within this ninety (9060) day periodperiod described in Section 7.5 hereof.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more develop and commercialize LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, within the TERRITORY through a thorough, vigorous and diligent program for utilizing the PATENT RIGHTS and to continue employ active and diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgmentfor approved LICENSED PRODUCTS or LICENSED PROCESSES. LICENSEE has the responsibility to do all that is legally required and shall use commercially reasonable efforts to obtain and retain any governmental approvals necessary to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement requirements of this paragraph Paragraph 5.1 shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to use reasonable efforts to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1(a) Initiation of Phase I Study by [XXX*]. 2(b) Initiation of PHASE II STUDY by [XXX*]. 3(c) Initiation of PHASE III STUDY by [XXX*]. 4(d) FIRST COMMERICIAL SALE by [XXX] For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency*]. 5.3 LICENSEE must use reasonable efforts to achieve each MILESTONE on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN DUKE within thirty (30) ten days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article 5 by the date of any such MILESTONE deadlinedeadline and such failure results from LICENSEE’s failure to use reasonable efforts to achieve such MILESTONE, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN DUKE may terminate the Agreement effective on ninety (90) thirty days’ prior written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) such thirty-day period. For clarity, the achievement of a MILESTONE by a SUBLICENSEE shall be deemed to be the achievement of such MILESTONE by LICENSEE. DUKE acknowledges that LICENSEE’s ability to timely achieve the MILESTONE may be impacted by delays outside of LICENSEE’s reasonable control. When LICENSEE identifies any such delays that will impact its ability to timely achieve the MILESTONE, LICENSEE shall promptly notify DUKE. DUKE shall not reasonably withhold or deny its consent to any revisions to milestone data for the applicable MILESTONE.

Diligence. 5.1 LICENSEE (a) Subject to the terms of Section 4.5, Licensee shall use commercially reasonable efforts in pursuing the development, commercialization and marketing of Products. Without limiting the foregoing, Licensee shall be deemed to bring one or more LICENSED PRODUCTS to markethave exercised commercially reasonable efforts, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life diligence requirements of this AgreementSection 2.2(a) shall be deemed to have been met, and UWA may not issue a Diligence Breach Notice pursuant to Section 2.2(b), if, on a Product-by-Product basis, Licensee, together with its Affiliates and sublicensees: (1) is actively engaged in, or has plans to engage in, pre-clinical or clinical development efforts with respect to, or commercialization of, such Product in any country or jurisdiction within the Territory; (2) as to the Product known as AVI-4658, meets the respective requirements set forth on Schedule 2.2, with each case consistent with prudent business practices such requirement being deemed a separate and judgment. LICENSEE has the responsibility to do all independent condition (each, a “Milestone”); provided that is legally required and commercially reasonable to obtain and retain if patent infringement issues prevent Licensee from meeting any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonablesuch Milestone, then the requirement timing for such Milestone shall be tolled until such issues are resolved and the parties shall in good faith negotiate and agree on an appropriate modification to the timing of this paragraph such Milestone, if necessary; (3) as to the Product known as AVI-4658, fails to meet any Milestone designated in Schedule 2.2 hereto, but, after the parties meet to discuss the status of Licensee’s development efforts, Licensee demonstrates that Licensee’s efforts amounted to commercially reasonable efforts under the circumstances, in which case the parties shall in good faith negotiate and agree on an appropriate modification to the relevant Milestone(s); or (4) as to the Product known as AVI-4658, fails to meet any Milestone designated in Schedule 2.2 hereto, and the proviso in subsection (2) does not apply, but Licensee, its Affiliates or Sublicensees initiate a [†††] trial of a different Product within [†††] after the date upon which Licensee, its Affiliate or Sublicensee failed to meet such Milestone, in which case the Milestones obligations designated in Schedule 2.2 hereto shall apply with respect to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, different Product instead of AVI-4658 for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] For the purposes of this AgreementSection 2.2; provided that if patent infringement issues prevent Licensee from meeting any such Milestone for such different Product, initiation of a clinical trial then the timing for such Milestone shall mean that date upon which be tolled until such patent infringement issues are resolved or the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by parties in good faith negotiate and agree on an appropriate drug regulatory agency modification to the timing of such Milestone. (b) Subject to the terms of Section 2.2(a), if UWA believes that Licensee has failed to meet its diligence obligations as set forth in Section 2.2(a), UWA may give Licensee written notice of the deficiency (“Diligence Breach Notice”). Licensee shall thereafter have one hundred and twenty (120) days to cure the deficiency. If Licensee fails to cure the deficiency within such one hundred and twenty (120) day period, UWA may terminate this Agreement with a therapeutic agent or process that has been manufactured according respect to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline Product upon written notice to Licensee, provided, however, that UWA may not terminate this Agreement with respect to any Product as to whether which Licensee is actively engaged in, or not such MILESTONE was methas plans to engage in, pre-clinical or clinical development efforts or commercialization in any country or jurisdiction within the Territory. If LICENSEE fails Such right to meet any MILESTONE under terminate this Article by the date of any MILESTONE deadline, LICENSEE will Agreement as to a given Product shall be deemed to be in material UWA’s sole remedy for Licensee’s breach of this Agreement, and MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within this ninety (90) day periodSection 2.2.

Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If . 5.2 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the commercialization of multiple PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then throughout the requirement life of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES availableAgreement. 5.2 Without limiting 5.3 As part of the diligence required by Paragraph 5.15.2, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by set forth in Appendix C. (a) MICHIGAN acknowledges that the following dates: 1) [XXX] 2) [XXX] 3) [XXX] 4) [XXX] For technology licensed to LICENSEE is very early stage. Its successful commercialization into LICENSED PRODUCTS will require considerable additional research, testing, funding, regulatory approval, strategic alliances, and substantial commitments to third parties, and may require LICENSEE to secure additional intellectual property rights. The MILESTONES are believed to be appropriate and reasonable as of the purposes Effective Date of this Agreement, initiation but are inherently speculative and based upon events that are not completely under the control of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agencyLICENSEE. 5.3 (b) LICENSEE must will use reasonable efforts to achieve each MILESTONE the MILESTONES on or before the deadline dates indicated above. LICENSEE on Appendix C and shall notify MICHIGAN within thirty (30) days after each if it appears that its achievement of such deadline as to whether or not such MILESTONE was metMILESTONES is unrealistic. If LICENSEE fails to meet any MILESTONE under this Article by on Appendix C, fails to provide a reasonable explanation for such failure, and fails to provide a commercially reasonable, adjusted schedule for achieving such MILESTONE, and if such failure continues for sixty (60) days after the date of any MILESTONE deadline (or revised MILESTONE deadline), LICENSEE will be deemed to be in material breach of this Agreement, Agreement and MICHIGAN may terminate the this Agreement effective on ninety thirty (9030) days’ written days notice, unless LICENSEE achieves the MILESTONE within this ninety thirty (9030) day periodperiod or unless LICENSEE reasonably disputes the basis for the termination.