Pre-Candidate Selection Criteria Sample Clauses

Pre-Candidate Selection Criteria. In the event that a Compound achieves [ * ] of the Pre-Candidate Selection Criteria after Dynavax has completed the activities required to make such an assessment, it being understood by the Parties that drug discovery is an iterative problem-solving process and that multiple Compounds may be expected to be progressed in order to identify a Compound that merits advancement into IND-enabling studies, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a completed data package containing the complete set of the analyses, results and raw data from the Dynavax Program for such Compound (the “Pre-Candidate Selection Report”). Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting not more than [ * ] after receipt by GSK’s JSC representatives of such complete Pre-Candidate Selection Report to review such Pre-Candidate Selection Report and to confirm whether or not such Compound meets [ * ] of the Pre-Candidate Selection Criteria. In the event that the JSC agrees that all or substantially all of the Pre-Candidate Selection Criteria have been met, [ * ], and Dynavax shall use its Commercially Reasonable Efforts to continue to progress the Dynavax Program through to completion of the PoC Study or [ * ] Study, as applicable, subject to Section 2.7.2 below. If the JSC fails to agree that [ * ] of the Pre-Candidate Selection Criteria have been met, then the matter shall be resolved by [ * ] determines that all or substantially all of the Pre-Candidate Selection Criteria have been met, then the [ * ], and Dynavax shall use its Commercially Reasonable Efforts to continue to progress the Dynavax Program through to completion of the PoC Study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. [ * ] of the Pre-Candidate Selection Criteria have been met, then Dynavax shall complete any additional studies as are [ * ] Pre-Candidate Selection Criteria and progress such Compound through completion of the PoC study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. If the achievement of such criteria is [ * ], Dynavax shall instead progress a Backup Compound in place of the Compound that failed to meet the criteria, and Dynavax shall use its Commercially Reasonable Efforts to progress such Backup Compound through to completion of the PoC Study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. [ * ] = CERTAIN CONFIDENTIAL INFO...
Sample 1
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Pre-Candidate Selection Criteria. The JSC shall establish the Pre-Candidate Selection Criteria for each Dynavax Program within (a) [ * ] of the Effective Date for Back-up Compounds in the [ * ] TLR 7/9 Program and for the [ * ], or (b) [ * ] of the identification of each other Dynavax Program under Section 2.5. Such Pre-Candidate Selection Criteria shall be consistent with the generic criteria attached in Exhibit B, modified as necessary by mutual agreement of the JSC [ * ].
Sample 1
Pre-Candidate Selection Criteria. The JSC shall establish the Pre-Candidate Selection Criteria for each Dynavax Program within (a) [ * ] of the Effective Date for [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Back-up Compounds in the [ * ] TLR 7/9 Program and for the [ * ], or (b) [ * ] of the identification of each other Dynavax Program under Section 2.5. Such Pre-Candidate Selection Criteria shall be consistent with the generic criteria attached in Exhibit B, modified as necessary by mutual agreement of the JSC [ * ].
Sample 1

Related to Pre-Candidate Selection Criteria

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

  • Acquisition Target Not Selected Prior to the date hereof, the Company has not selected any business combination target and has not, nor has anyone on its behalf, initiated any substantive discussions, directly or indirectly, with any business combination target.

  • Development Milestones Subject to the terms and conditions of this Agreement, no later than [**] following the first occurrence of each event described below (each, a “Development Milestone”), on Product-by-Product basis Moderna shall pay Carisma the non-refundable and non-creditable amounts set forth below for each Product to achieve such event (each, a “Development Milestone Payment”): ​ Development MilestoneDevelopment Milestone Payment (in US$ millions) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] ​ Moderna shall provide written notice to Carisma of the achievement of each Development Milestone within [**] after such achievement. If a Development Milestone for a Product is achieved without the preceding Development Milestone(s) having been achieved for such Product, then the Development Milestone Payment for such preceding Development Milestone(s) shall be paid by Moderna to Carisma together with ​ ​ the Development Milestone Payment for the Development Milestone that was achieved. For example, if the [**] Development Milestone [**] in the table above is achieved for a Product but the [**] Development Milestone [**] in the table above had not been achieved for such Product, then Moderna would pay the Development Milestone Payment for both such [**] Development Milestone and [**] Development Milestone upon achievement of the [**] Development Milestone. Each of the Development Milestone Payments set forth above shall be payable one time only per Product. If Moderna or its Affiliates or Sublicensees Develops a Product that has achieved at least one Development Milestone and subsequently discontinues Development of such Product and Develops a different Product incorporating or directed to the same combination of Collaboration Targets (whether one Collaboration Target or multiple Collaboration Targets), then Moderna shall be required to pay Development Milestone Payments for such different Product only for Development Milestones that had not been achieved by such discontinued Product.

  • Purge Criteria In order to avoid the Aged History Retention fees, history data for regular or ordinary accounts (that is, non-tax advantaged accounts) must be purged if the confirmation date of the history transaction is prior to January 1 of the current year and history data for tax advantaged accounts (retirement and educational savings accounts) must be purged if the confirmation date of the history transaction is prior to January 1 of the prior year. All purged history information shall be retained on magnetic tape for 7 years.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Supplier Selection If Customer selects a seat or galley supplier that is not on the Boeing recommended list, such seat or galley will become BFE and the provisions of Exhibit A, Buyer Furnished Equipment Provisions Document, of the AGTA will apply.

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Acceptance Criteria a) The operational ground check, the engine performance check and the acceptance flight contemplated in clause 2.2, 2.3 and 2.4 shall be conducted using Airbus’ ISATM.

  • Development Plan As defined in Section 3.2(a).

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