Common use of Following Completion of First Clinical Trial Clause in Contracts

Following Completion of First Clinical Trial. (a) If Celgene fails to exercise its Option with respect to an Option Compound pursuant to Section 7.2.1, then during the Option Term, but subject to Section 7.3, Acceleron may further develop such Option Compound through completion of the first Phase 1 Clinical Trial for such Option Compound; provided that Acceleron shall provide Celgene prompt written notice of the final results of such first Clinical Trial for such Option Compound or Option Product. Acceleron’s notice shall include the following: (i) the amount of the Option Compound Development Costs incurred by Acceleron up until such date; (ii) an initial Development Plan/Budget, including a proposed Initial Development Disease; and (iii) all relevant data from the Clinical Trial, including all summary data tables, statistical analyses, and statistical reports related to the endpoints derived from such Clinical Trial, the underlying information used to create such summaries, case report forms (as available), and all other preclinical data generated; (iv) manufacturing data (including CMC); (v) any related correspondence (excluding non-substantive correspondence) or information received from or sent to any Regulatory Authority; (vi) a report of analysis of the top line data from a locked data base using validated programs for all of the primary and secondary endpoints (and exploratory, if applicable) for the compound tested in such Clinical Trial, as specified in applicable protocol and statistical analysis plan; (vii) a summary of all Acceleron Technology that covers the Option Compound tested in such Clinical Trial; and (viii) such other available information that is reasonably necessary or useful for Celgene to determine whether to exercise its Option. Furthermore, Acceleron will promptly provide Celgene with such additional information and access to records with respect to the applicable Option Compound in Acceleron’s possession or available to Acceleron from a Third Party, as Celgene may reasonably request; provided that such request for additional information shall not extend the [* * *] period for Celgene to exercise its Option pursuant to Section 7.2.2(b) unless Acceleron fails to provide the requested information in a timely fashion. (b) Within [* * *] following receipt of Acceleron’s notice pursuant to Section 7.2.2(a), Celgene may provide written notice to Acceleron stating its desire to exercise its Option for such Option Compound. In addition, at any time until the expiration of such [* * *] period, regardless of whether Acceleron has provided the notice pursuant to Section 7.2.2(a), Celgene may provide written notice to Acceleron stating its desire to exercise its Option with respect to any compound that has become an Option Compound pursuant to Section 7.2.1; provided that such right shall only apply with respect to Option Compounds that Acceleron has not already (x) granted any Third Party any rights or (y) filed an IND (which is accepted by the applicable Regulatory Authority) in a field outside of Use in Anemia, in each case, as permitted by Section 7.2.3. (c) If Celgene elects to exercise its Option under this Section 7.2.2 with respect to an Option Compound, it shall pay Acceleron [* * *] of the Option Compound Development Costs incurred by Acceleron with respect to such Option Compound through the date of Acceleron’s receipt of Celgene’s written notice of its election to exercise of such Option, which payment Celgene shall make within [* * *] days of providing Acceleron such written notice. Effective as of the date of Acceleron’s receipt of such payment from Celgene with respect to an Option Compound, Celgene’s Option with respect to such Option Compound shall be exercised and the definition of “Licensed Compound” hereunder shall automatically be deemed to include such Option Compound. Upon Celgene’s exercise of an Option, the initial Development Plan/Budget proposed by Acceleron (including the proposed Initial Development Diseases), with such changes as are determined by Celgene, in its sole discretion, shall be deemed part of the Development Plan/Budget and deemed approved by the Joint Development Committee.

Following Completion of First Clinical Trial. (a) If Celgene fails to exercise its Option with respect to an Option Compound pursuant to Section 7.2.1, then during the Option Term, but subject to Section 7.3, Acceleron may further develop such Option Compound through completion of the first Phase 1 Clinical Trial for such Option Compound; provided that Acceleron shall provide Celgene prompt written notice of the final results of such first Clinical Trial for such Option Compound or Option Product. Acceleron’s notice shall include the following: (i) the amount of the Option Compound Development Costs incurred by Acceleron up until such date; (ii) an initial Development Plan/Budget, including a proposed Initial Development Disease; and (iii) all relevant data from the Clinical Trial, including all summary data tables, statistical 55 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. analyses, and statistical reports related to the endpoints derived from such Clinical Trial, the underlying information used to create such summaries, case report forms (as available), and all other preclinical data generated; (iv) manufacturing data (including CMC); (v) any related correspondence (excluding non-substantive correspondence) or information received from or sent to any Regulatory Authority; (vi) a report of analysis of the top line data from a locked data base using validated programs for all of the primary and secondary endpoints (and exploratory, if applicable) for the compound tested in such Clinical Trial, as specified in applicable protocol and statistical analysis plan; (vii) a summary of all Acceleron Technology that covers the Option Compound tested in such Clinical Trial; and (viii) such other available information that is reasonably necessary or useful for Celgene to determine whether to exercise its Option. Furthermore, Acceleron will promptly provide Celgene with such additional information and access to records with respect to the applicable Option Compound in Acceleron’s possession or available to Acceleron from a Third Party, as Celgene may reasonably request; provided that such request for additional information shall not extend the [* * *] period for Celgene to exercise its Option pursuant to Section 7.2.2(b) unless Acceleron fails to provide the requested information in a timely fashion. . (b) Within [* * *] following receipt of Acceleron’s notice pursuant to Section 7.2.2(a), Celgene may provide written notice to Acceleron stating its desire to exercise its Option for such Option Compound. In addition, at any time until the expiration of such [* * *] period, regardless of whether Acceleron has provided the notice pursuant to Section 7.2.2(a), Celgene may provide written notice to Acceleron stating its desire to exercise its Option with respect to any compound that has become an Option Compound pursuant to Section 7.2.1; provided that such right shall only apply with respect to Option Compounds that Acceleron has not already (x) granted any Third Party any rights or (y) filed an IND (which is accepted by the applicable Regulatory Authority) in a field outside of Use in Anemia, in each case, as permitted by Section 7.2.3. (c) If Celgene elects to exercise its Option under this Section 7.2.2 with respect to an Option Compound, it shall pay Acceleron [* * *] of the Option Compound Development Costs incurred by Acceleron with respect to such Option Compound through the date of Acceleron’s receipt of Celgene’s written notice of its election to exercise of such Option, which payment Celgene shall make within [* * *] days of providing Acceleron such written notice. Effective as of the date of Acceleron’s receipt of such payment from Celgene with respect to an Option Compound, Celgene’s Option with respect to such Option Compound shall be exercised and the definition of “Licensed Compound” hereunder shall automatically be deemed to include such Option Compound. Upon Celgene’s exercise of an Option, the initial Development Plan/Budget proposed by Acceleron (including the proposed Initial Development Diseases), with such changes as are determined by Celgene, in its sole discretion, shall be deemed part of the Development Plan/Budget and deemed approved by the Joint Development Committee.