Option Data Package Clause Samples

The Option Data Package clause defines the specific set of data or information that must be provided when an option under a contract is exercised. Typically, this clause outlines the types of documents, reports, or technical specifications that the party exercising the option must submit, and may set deadlines or formats for delivery. By clearly specifying these requirements, the clause ensures that all necessary information is available to facilitate the smooth execution of the option, reducing misunderstandings and delays.
Option Data Package. The term “
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Option Data Package. For each Declined NG Development Candidate, following completion of the first Clinical Study that includes the measurement of a biomarker or other attribute that would show activity of such Declined NG Development Candidate (the “Opt-In Study”), Summit shall provide written notice to Sarepta that includes (i) identification of the applicable Declined NG Development Candidate to which the applicable Declined NG Candidate Option applies, (ii) the Option Data Package for such Declined NG Development Candidate and (iii) an estimate of the Declined NG Candidate Development Costs incurred to date (an “Option Commencement Notice”).
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Option Data Package. No later than [*] before the anticipated achievement by Seagen of a Profit-Share Option Triggering Event with respect to any Licensed Product, Seagen shall provide or make available to Nurix a data package for such Licensed Product including (a) to the extent available and in Seagen’s possession and Control (for clarity, without requiring Seagen to conduct any additional Research or Development activities): (i) [*], (ii) [*], and (iii) [*]; and (b) [*], in each case, for such Licensed Product (clauses (a) and (b), collectively, the “Option Data Package”); provided, that Seagen shall have no obligation to provide an Option Data Package to Nurix for a given Licensed Product and Nurix shall have no right to exercise its Profit-Share Option with respect to such Licensed Product, in each case, if Nurix has previously exercised two (2) Profit-Share Options and the Parties have entered into a Profit-Share Product Agreement for the Profit-Share Products that were the subject of such exercises. If the applicable Profit-Share Option Triggering Event has not occurred within [*] of Seagen’s delivery of the applicable Option Data Package or if the Profit-Share Option Triggering Event was [*], then Seagen shall, within [*] Business Days following the applicable Profit-Share Option Triggering Event, provide Nurix with a written summary of material updates to the information provided by Seagen for the applicable Option Data Package and provide or make available to Nurix updated copies of the documents and information described in clause (a) above, as applicable, including any [*] with respect to such Licensed Product to the extent applicable (such written summary and updates, the “Supplementary Option Data Package”). For the avoidance of doubt, Seagen may, upon notice to Nurix or through a Committee, update its anticipated date of obtaining Regulatory Approval and Commercial launch in the U.S. for a Licensed Product from time to time, and Seagen shall notify Nurix of its anticipated date of obtaining Regulatory Approval and Commercial launch in the U.S. for a Licensed Product from time to time upon Nurix’s reasonable request.
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Option Data Package. Promptly following the completion of both (a) [***], and (b) a [***] performed in accordance with a study plan to be mutually agreed by the Parties, the Parties shall use commercially reasonable efforts to prepare a data package comprising all data and information generated under the Evaluation Plan as well as the results of such non-human primate PK study (the “Option Data Package”).
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Option Data Package. On an Option Program-by-Option Program basis with respect to a given Option Program, Denali will deliver to Biogen the following items as soon as reasonably practicable after Denali’s completion of the activities required to generate and review the information to be provided in the Option Data Package for such Option Program if such activities are completed prior to the expiration of the Option Term, but in any event no later than [***] prior to the anticipated date for Initiation of the first IND-Enabling Studies for a given Option Program: (a) the Option Data Package for such Option Program; (b) [***]; and (c) if such Option Data Package is for the Option TV Program, then at Denali’s election in accordance with Section 2.4.2(a) (Co-Co Opt In Notice), a Co-Co Opt In Notice. On an Option-Program-by-Option Program basis, if Denali reasonably believes [***], then no later than [***] prior to [***] anniversary of the Provisional Agreement Effective Date, instead of providing a full Option Data Package for such Option Program, Denali will deliver to Biogen a data package that includes [***] (the “Partial Option Data Package”), [***].
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Option Data Package. (a) On a Program-by-Program basis, within [***] after Merus completes [***] the Research Plan for such Program, Merus shall deliver to Gilead, through the JSC, a data package for such Program (the “Option Data Package”), certain required contents of which shall be set forth in the applicable Research Plan attached hereto as Schedule 3.3 for Program #1, and to be set forth in the subsequent Research Plans for Program #2 and Program #3, if Gilead exercises the Program #3 Option. Each Option Data Package shall contain [***]. For clarity, [***]. 301144389 v2 (b) Within [***] after the delivery of the Option Data Package for a Program, the Parties shall convene a JSC meeting to discuss the Option Data Package. Within [***] following such JSC meeting, Gilead may make reasonable inquiries to Merus for further clarification and information in connection with the data and information included in such Option Data Package, and [***] other than those assays, analyses and data generation expressly set forth in the applicable Research Plan. If (i) the Parties agree at a JSC meeting that the Option Data Package is complete, (ii) [***] period following such JSC meeting, or (iii) [***], then the Option Data Package will be deemed to be in final form on the date that is [***] after the JSC meeting or the date on which Merus has provided all information that was required to be included in such Option Data Package pursuant to subclause (iii), if later, for the purposes of determining the time remaining in the License Option Term in which Gilead may exercise the License Option.
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Option Data Package. On an Option Program-by-Option Program basis, Denali will deliver to Biogen a data package regarding [***] to be identified in the Definitive ROFN and Option Agreement (the “Option Data Package”) as soon as reasonably practicable after Denali’s completion of the activities required to generate and review such data if such activities are completed prior to the expiration of the Option Term, but no later than [***] prior to the Initiation of IND-Enabling Studies under a given Option Program. Without limiting the foregoing, the Option Data Package for each Option Program shall contain such data that is [***]. On an Option-Program-by-Option Program basis, [***], then no later than [***] prior to [***] anniversary of the Effective Date Denali shall deliver to Biogen a data package that includes the data available to Denali at such time that would have been included in the Option Data Package (the “Partial Option Data Package”).
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Option Data Package 
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Related to Option Data Package

  • Manufacturing Technology Transfer With respect to the Category 2 Programs and Category 3 Programs, at any time after the Effective Date, and, with respect to the Category 1 Programs, only if Arrowhead is unable or unwilling to Manufacture for Sarepta any Licensed C1 Compound or Licensed C1 Product, or Arrowhead is in material breach of, or there is a supply failure (as defined therein) under, the relevant clinical or commercial supply agreement with respect to such Licensed C1 Compound or Licensed C1 Product, Sarepta may request in writing the transfer from Arrowhead or Arrowhead’s CMO to Sarepta or (a) any CMO set forth on Schedule 5.4 (Approved Sarepta CMO) or (b) with Arrowhead’s prior written consent (not to be unreasonably withheld, conditioned or delayed) any other CMO designated by Sarepta (the CMOs set forth on Schedule 5.4 (Approved Sarepta CMO) and any such other Arrowhead approved CMOs, each, an “Approved Sarepta CMO”), copies or samples of all Arrowhead Know-How that is necessary or reasonably useful to enable the Manufacture of the Licensed Compounds and Licensed Products (the “Arrowhead Manufacturing Know-How”). Promptly following any such written request by ▇▇▇▇▇▇▇ and within [***] days after such written request, the JMC will prepare, and submit to the JSC to review, discuss, and determine whether to approve, a written Manufacturing technology transfer plan that provides for (i) Arrowhead or Arrowhead’s Third Party CMO transferring copies of relevant documentation, samples of Drug Substance, and copies of other embodiments of such Arrowhead Manufacturing Know-How (including data within reports, notebooks, and electronic files), and (ii) Arrowhead making available its technical Personnel on a reasonable basis and as more specifically specified therein to consult with Sarepta with respect to such transferred Arrowhead Manufacturing Know-How (such plan, the “Manufacturing Technology Transfer Plan”). The Manufacturing Technology Transfer Plan will include a budget of the Out-of-Pocket Costs (including any amounts that Arrowhead will pay to its Subcontractors, including CMOs) to be incurred by Arrowhead in the performance of the activities set forth in the Manufacturing Technology Transfer Plan (the “Manufacturing Technology Transfer Budget”). Pursuant to the timelines set forth in the Manufacturing Technology Transfer Plan that is agreed to by the Parties, and in any event no later than [***] days thereafter, Arrowhead will work with Sarepta to complete the transfer of the Arrowhead Manufacturing Know-How and other activities set forth in the Manufacturing Technology Transfer Plan on the timelines and in accordance with the budget set forth therein. Sarepta will reimburse Arrowhead for its Out-of-Pocket Costs, but for clarity not its FTE Costs, incurred in completing such transfer in accordance with the Manufacturing Technology Transfer Plan in accordance with the Manufacturing Technology Transfer Budget. Any additional assistance to be provided by Arrowhead in connection with Arrowhead Know-How that has been transferred pursuant to a completed Manufacturing Technology Transfer Plan may be requested by Sarepta and provided by Arrowhead pursuant to a separate written agreement between the Parties providing for reasonable compensation to be paid to Arrowhead for providing such additional assistance.