Option Data Package Sample Clauses

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. (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
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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. 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:
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Option Data Package 
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Related to Option Data Package

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner [*]. Each Party shall document all non-clinical studies and clinical trials in formal written study reports according to applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP). Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to the original [*].

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • License Terms This license is for one full Semester. It cannot be cancelled or terminated except under the conditions cited in this license.

  • Deliverables Upon satisfactory completion of the work authorization, the Engineer shall submit the deliverables as specified in the executed work authorization to the State for review and acceptance.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

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