Phase 1 Data Package Sample Clauses

The "Phase 1 Data Package" clause defines the specific set of data, documents, and deliverables that must be provided upon completion of the first phase of a project or agreement. Typically, this package includes technical reports, test results, design documents, or other relevant materials generated during Phase 1, and it outlines the format, timing, and method of delivery. By clearly specifying what constitutes the Phase 1 Data Package, the clause ensures both parties have a mutual understanding of deliverable expectations, thereby reducing the risk of disputes and facilitating smooth project progression.
Phase 1 Data Package. If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program. If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***]. If [***], the Phase 1 Option Term with respect to such Program shall [***]. For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
View SourceView Similar (3)
Phase 1 Data Package. In the event that (i) Celgene exercises its Celgene Phase 1 Portion Participation Right, and (ii) Celgene completes the PRX019 Phase 1 Clinical Trial, then Celgene shall notify Prothena of Data Lock for the PRX019 Phase 1 Clinical Trial (such date of Data Lock is the “End of Phase 1 Date” (as such term is defined hereunder) regardless of the date of ▇▇▇▇▇▇▇’s notice to Prothena thereof). For the avoidance of doubt, CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. subject to Celgene’s obligations to make royalty payments pursuant to Section 5.2 and milestone payments pursuant to Sections 5.3 and 5.4, [***] payable by Celgene upon exercise by Celgene of the Celgene Phase 1 Portion Participation Right.
View Source
Phase 1 Data Package. Within [***] days after Data Lock for the PRX019 Phase 1 Clinical Trial (or such earlier time as reasonably requested by Celgene in writing), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package. If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in ARTICLE 7. Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] days after receiving such Phase 1 Data Package, notify Prothena of any reasonable requests for additional then-existing information and records related thereto that is within Prothena’s (or its Affiliates’) possession or Control, and Prothena shall respond to such requests within [***] Business Days thereof. If Prothena does not provide such reasonably requested additional information to Celgene (or its designee) within such [***] Business Day period, the Celgene Decision Term shall be extended by a period of time equal to the number of days after such [***] Business Day period during which Prothena fails to provide such reasonably requested additional information. For the avoidance of doubt, during the period from the end of the End of Phase 1 Date until the end of the Celgene Decision Term, no further activities shall be conducted by or on behalf of Prothena with respect to the Licensed Program (including the Licensed Target, Licensed Antibodies or Licensed Products thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
View Source

Related to Phase 1 Data Package

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in ▇▇▇▇▇, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.