Option Data Package definition

Option Data Package means, with respect to a particular Collaboration Product, the information set forth on Schedule 1.173.

Option Data Package means: (a) the POC Trial Report and all Data generated by or under authority of Xencor in performing the Core Collaboration Period Development Activities; and (b) such other existing information within the Xencor Know-How as Amgen reasonably requests: (i) no later than […***…] after delivery to Amgen of the POC Trial Report, if Xencor performs the Phase 2 POC Trial, or if Amgen directs the performance of the Phase 2 POC Trial by Xencor’s contractors in accordance with Schedule M pursuant to exercise of the Completion Right in accordance with Section 3.3(d); or (ii) no later than […***…] after data lock of the Phase 2 POC Trial, if Amgen performs the Phase 2 POC Trial in accordance with Schedule M pursuant to exercise of the Completion Right in accordance with Section 3.3(a), 0 or 3.3(c).

Option Data Package means, for each Collaboration Target, (i) a document setting forth the available data resulting from the Phase I Studies conducted by BPM for such Collaboration Target, including the applicable Option Data Criteria, (ii) the availability of the data for such Phase I Studies in an organized and clean format in the Clinical Study database for such Collaboration Target through the Option Data Package Trigger for such Collaboration Target, and (iii) if applicable, the availability of the data of any Phase I Studies conducted by Roche in an organized and clean format for a […***…] through the Option Data Package Trigger for such […***…]. For clarity, “BPM’s Portion” of the Option Data Package shall mean the items set forth in clauses (i) and (ii) of this Section 1.82.

Examples of Option Data Package in a sentence

• The initial Split Territory Global Development Plan for each Split Territory Agreement Product shall be included in the Option Data Package for such Split Territory Agreement Product provided by Voyager to Genzyme under Section 3.2.1 (Option Notice; Option Data Package).

• Strategic level incident management (local incident): If required to form, the Council’s Gold Team will consist of the Chief Executive, or deputy, and some or all of the Corporate Leadership Team (CLT).

• Unless the DAC elects to utilize the Genzyme PD Technology in accordance with Section 4.5 (Use of Genzyme PD Technology) or unless otherwise agreed by Genzyme, the initial Split Territory Global Development Plan for the PD Agreement Product will contain all of the Development activities set forth in the Collaboration R&D Plan for the PD Collaboration Program attached hereto as Schedule 4.3.1-2 that are not yet completed at the time of the delivery of the Option Data Package.

• On an Option-by-Option basis, as promptly as practicable following Voyager’s delivery of an Option Data Package to Genzyme, but not later than the applicable Option Exercise Date with respect to such Option, Genzyme shall determine whether any filing or notification is necessary or advisable under any applicable Antitrust Law if Genzyme were to exercise the respective Option pursuant to this Agreement.

• In addition, Voyager shall be required to promptly provide supplemental update(s) to Genzyme if new material information becomes available to Voyager that would have been included in the Option Data Package had such information been available to Voyager at the time the Option Notice was delivered (including any Safety Concern or Serious Adverse Event information).

More Definitions of Option Data Package

Option Data Package is defined in Section 11.2.1 (Option Data Package).

Option Data Package has the meaning set forth in the Master Agreement.

Option Data Package means, with respect to a Declined NG Development Candidate, the information and materials set forth on Schedule 1.64.

Option Data Package means, with respect to each Option Program, the information and materials set forth on Schedule 1.116 (Option Data Package).

Option Data Package means, with respect to each Option Product, a package of documents or information to be provided or made available to Roche containing the following: (a) the information set forth on Schedule 1.170; (b) a reasonably detailed summary of all Development activities undertaken by or on behalf of Sarepta or any of its Affiliates or Sublicensees with respect to such Option Product; (c) all Regulatory Submissions related to such Option Product, if any, and a summary of all substantive correspondence to or from any Regulatory Authority related to such Option Product, if any; (d) a list of any and all Patent Rights Covering such Option Product, and a description of the material Sarepta Know-How related to such Option Product; (e) an updated disclosure letter containing all applicable disclosures related to the representations and warranties set forth in Section 11.1 (Mutual Representations and Warranties) and Section 11.2 (Additional Sarepta Warranties) with respect to such Option Product; and (f) copies of all material agreements between Sarepta and any Third Party pursuant to which Sarepta is granted rights with respect to an Option Product or any agreement with any CMO related to the Manufacture of an Option Product. 79445843_10

Option Data Package means, on an Option Program-by-Option Program basis, a data package that includes [***] set forth on Schedule 1.162 (Option Data Package) for such Option Program, subject to any amendments to the [***] to be included in such package that the Parties may agree to from time to time.

Option Data Package means, with respect to an Option Product, the Initial Option Data Package or, if applicable, the Final Option Data Package for such Option Product.