Development Candidate Data Package Clause Samples
The Development Candidate Data Package clause defines the requirements and contents of a set of documents and data that must be provided regarding a product or compound under development. Typically, this package includes technical data, research results, manufacturing information, and other relevant materials necessary for evaluating the development candidate's suitability for further advancement. By specifying what must be included and when it should be delivered, this clause ensures that all parties have access to comprehensive and standardized information, facilitating informed decision-making and reducing misunderstandings during the development process.
Development Candidate Data Package. With respect to each Program, at such time as Aurigene in good faith believes that it has generated a Development Candidate, Aurigene shall promptly present such Development Candidate to the SOC for designation as such and provide to Curis all data and information generated by or on behalf of Aurigene with respect to such prospective Development Candidate and Program Compounds (“Development Candidate Data Package”). During the applicable Option Period for such Program, Aurigene shall make qualified Aurigene representatives reasonably available to Curis (at a SOC meeting or otherwise) for discussion of such Development Candidate Data Package. Each Development Candidate Data Package shall be subject to review by the SOC to determine whether or not such Development Candidate Data Package includes all of the Information with respect to the activities outlined and agreed upon in the R&D Plan and that the proposed Development Candidate meets the relevant Target Molecular Profile criteria, and if the SOC determines that such Development Candidate Data Package does not include all such Information, the SOC shall unanimously identify the necessary data and information not included in such Development Candidate Data Package. If the SOC cannot unanimously reach a determination of whether or not the Development Candidate Data Package includes all such Information, then then the Parties shall submit the matter to an independent Third Party expert with at least 15 years of experience in pharmaceutical industry practices with respect to the development of pharmaceutical products for resolution, which expert shall be agreed upon by both Parties or, failing such agreement, designated by the International Centre for Dispute Resolution located in New York City, NY. The sole authority of such expert will be to determine whether or not the Development Candidate Data Package is complete, and such expert’s determination shall be final and binding upon the Parties. The independent Third Party expert shall be required to make his or her determination within [**] days after selection of the independent Third Party expert. The Parties shall initially bear the fees and expenses of such expert equally, but the prevailing Party shall reimburse the other Party for the documented fees and expenses of such expert paid by the prevailing Party.
Development Candidate Data Package. For each Collaboration Program, ▇▇▇▇▇ will notify the applicable Neurology JDC in writing within [***] days after designating a Development Candidate and will provide such Neurology JDC the applicable Development Candidate Data Package.
Development Candidate Data Package. For each Collaboration Target for which Nurix has nominated a Development Candidate within the Collaboration Target Research Term, Nurix will provide Sanofi with a Development Candidate Data Package promptly after such nomination. Following such receipt by Sanofi, Sanofi will promptly notify Nurix if Sanofi in good faith believes such Development Candidate Data Package is incomplete or otherwise inconsistent with the requirements of Schedule 1.62. If Sanofi so notifies Nurix that such Development Candidate Data Package is incomplete or inconsistent, then Nurix shall [*] For purposes of determining License Extension Fee Timeframes, the date of [*] shall be used.
Development Candidate Data Package. Unless otherwise mutually agreed by the Parties, Ionis’ RMC shall only approve a Compound as a potential Development Candidate for a Collaboration Program if such Compound satisfies the [***] set forth in the ASO Development Candidate Identification Plan with respect to such Collaboration Program. In addition, unless otherwise mutually agreed by the Parties, each Backup Compound set forth in the Development Candidate Data Package for a Collaboration Program must satisfy the [***] set forth in the ASO Development Candidate Identification Plan with respect to such Collaboration Program. For each Collaboration Program, Ionis will provide Biogen, through the JSC, with a complete Development Candidate Data Package promptly following the date Ionis’ Research Management Committee approves a Compound as a potential Development Candidate after Ionis’ completion of Ionis’ activities set forth in the applicable ASO Development Candidate Identification Plan. Within [***] days of receipt of a Development Candidate Data Package pursuant to this Section 1.4.2(a), Biogen or an Affiliate will notify Ionis of any omissions or deficiencies that Biogen or its Affiliate believes in good faith cause the Development Candidate Data Package to be incomplete with respect to the potential Development Candidate or any Backup Compound described therein (“Development Candidate Data Package Deficiency Notice”). Ionis will promptly, and in any event within [***] days of receipt of the Development Candidate Data Package Deficiency Notice, resubmit a complete Development Candidate Data Package to Biogen or its designated Affiliate, including any information that Biogen identified in the Development Candidate Data Package Deficiency Notice. If the Parties do not agree as to whether the Development Candidate Data Package is complete, the matter will be referred to the Executives for resolution. The Executives will meet promptly and negotiate in good faith to resolve the dispute and agree upon a complete Development Candidate Data Package.
Development Candidate Data Package. For each Collaboration Program, Isis will notify the applicable Neurology JDC in writing within [***] days after designating a Development Candidate and will provide such Neurology JDC the applicable Development Candidate Data Package.