Upon Designation as Option Compound. During the Option Term, but subject to Section 7.3, Acceleron may develop, through the filing of an IND, compounds that are to become Option Compounds; provided that Acceleron shall provide Celgene prompt written notice of any compound becoming an Option Compound by virtue of Acceleron filing an IND (which is accepted by the applicable Regulatory Authority) for such compound for Use in Anemia. Within [* * *] following receipt of such notice, Celgene may provide written notice to Acceleron stating its desire to exercise its option for such Option Compound to be a Licensed Compound hereunder (each such option, an “Option”). Effective as of the date of Acceleron’s receipt of such notice 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. The notice provided by Acceleron to Celgene that a compound has become an Option Compound shall include (a) a package of all relevant data with respect to such Option Compound, including relevant chemistry, biology, in vitro and in vivo pharmacology, drug metabolism and pharmacokinetics (DMPK) and pilot toxicology; (b) an initial Development Plan/Budget, including a proposed Initial Development Disease; (c) a summary of all Acceleron Technology that covers the applicable Option Compound tested; and (d) 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 unless Acceleron fails to provide the requested information in a timely fashion. 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.
Appears in 6 contracts
Samples: Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement, Collaboration, License and Option Agreement (Acceleron Pharma Inc)