Specific Performance Milestone Events definition

Specific Performance Milestone Events has the meaning set forth in Section 6.4.2.

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Specific Performance Milestone Events for a Product on the timeline set forth in SCHEDULE 5.1.1; provided, however, [***].

Specific Performance Milestone Events for a Collaboration Product on the timeline set forth in Schedule 5.1.4; provided, however, [***].

Examples of Specific Performance Milestone Events in a sentence

Each CTD will be consistent with the Specific Performance Milestone Events for the applicable Collaboration Program.
If the Parties are unable to agree upon the Specific Performance Milestone Events for a particular Collaboration Program, the matter will be resolved in accordance with Section 12.1, including, for the avoidance of doubt, mediation pursuant to Section 12.1.2, if necessary.
The components of the Strategic Plan applicable to such Development Candidate will be consistent with Section 1.1 and Bayer’s Specific Performance Milestone Events and estimated timelines set forth in Schedule 1.6.2.
In addition, the Parties acknowledge that each of the Specific Performance Milestone Events for a given Product [***], each time the Strategic Plan is modified in accordance with this Agreement.
Roche will use Commercially Reasonable Efforts to Develop, Manufacture and Commercialize Products, including to meet the timelines and milestones set forth in the Isis Development Candidate-R&D Plan, the IDCP and the Specific Performance Milestone Events.
Roche will use Commercially Reasonable Efforts to Develop, Manufacture and Commercialize Products, including to meet the timelines and milestones set forth in the Development Plan, the IDCP and the Specific Performance Milestone Events.
Ionis will use Commercially Reasonable Efforts to meet the timeline for the Phase 2 GA Trial as determined by the JSC and the applicable JDC, including to meet the Specific Performance Milestone Events in Appendix 2.
Isis will not be required to conduct any Development activities for a Development Candidate if the Initial Development Plan, Specific Performance Milestone Events and the corresponding Cost Estimates have not been agreed to pursuant to this Section 1.10.2.
If the CSC cannot unanimously agree upon the Specific Performance Milestone Events for a particular Collaboration Program within [***] days after the date the CSC started discussing such Specific Performance Milestone Events, the matter will be referred to expert resolution pursuant to Section 12.1.4. Ionis will update each Initial Development Plan as needed, but at least once Annually, and submit it to the applicable Neurology JDC for its review and approval.
If the CSC cannot unanimously agree upon the Specific Performance Milestone Events for a particular Collaboration Program within [***] days after the date the CSC started discussing such Specific Performance Milestone Events, the matter will be referred to expert resolution pursuant to Section 12.1.4. Isis will update each Initial Development Plan as needed, but at least once Annually, and submit it to the applicable Neurology JDC for its review and approval.

More Definitions of Specific Performance Milestone Events

Specific Performance Milestone Events has the meaning set forth in Section 5.1.4. “[***]” means the form of the [***].

Specific Performance Milestone Events has the meaning set forth in Section 1.6.2. “Strategic Plan” has the meaning set forth in Section 1.1. The initial Strategic Plan agreed to by the Parties as of the Effective Date is attached hereto as Appendix 2. “Sublicensee” means a Third Party to whom a Party or its Affiliates or Sublicensees has granted a sublicense or license under any Licensed Technology or Bayer Technology, as the case may be, licensed to such Party in accordance with the terms of this Agreement. “[***]” has the meaning set forth in [***]. “Territory” means worldwide. “Third Party” means a Person other than the Parties or their respective Affiliates. “Third Party Claims” has the meaning set forth in Section 10.1. “Third Party Obligations” means any financial and non-financial encumbrances, obligations, restrictions, or limitations imposed by an agreement between a Party and a Third Party that relate to a Product or an Exclusive Target, including field or territory restrictions, covenants, milestone payments, diligence obligations, sublicense revenue, royalties, or other payments. “Trade Dress” means any package design of Bayer such as Bayer’s wave design. “Trademark” means any trademark owned and controlled by Bayer and used by Bayer in connection with the marketing of the Product. “United States” or “U.S.” means the fifty states of the United States of America and all of its territories and possessions and the District of Columbia. “[***]” has the meaning set forth in [***]. “Valid Claim” means a claim (i) of any issued, unexpired United States or foreign Patent Right, which will not, in the country of issuance, have been donated to the public, disclaimed, nor held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision, or (ii) of any United States or foreign patent application within a Patent Right, which will not, in the country in question, have been cancelled, withdrawn, abandoned nor been pending for more than seven years, not including in calculating such seven-year period of time in which such application is in interference or opposition or similar proceedings or time in which a decision of an examiner is being appealed. Notwithstanding the foregoing, on a country-by-country basis, a patent application pending for more than seven years will not be considered to have any Valid Claim for purposes of this Agreement unless and until a patent meeting the criteria set forth in clause (i) above with respect to such application issue...

Specific Performance Milestone Events provided, however, if [***] issues arise that are outside of Novartis’ reasonable control that impede achievement of any such Specific Performance Milestone Event on the stated timeline, the Parties will meet and discuss in good faith through the JDCC and revise the date by which the applicable Specific Performance Milestone Event will be or can be achieved.

Specific Performance Milestone Events for a Product on the timeline set forth in Appendix 5; provided, however, if (X) regulatory or Development issues arise that are outside of Roche’s reasonable control and make achievement of any such Specific Performance Milestone Event on the stated timeline impossible, or (Y) an Isis Development Candidate is being Developed but Roche subsequently decides to Develop a Brain Shuttle Development Candidate in lieu of such Isis Development Candidate, the Parties will meet and negotiate in good faith to revise, consistent with any applicable Isis In-License Agreements, the date by which the applicable Specific Performance Milestone Event must be achieved; and (B) Commercially Reasonable Efforts as it applies to Isis’ Development of a Product hereunder includes use of Commercially Reasonable Efforts to perform the Isis R&D Activities designated under the R&D Plans in accordance with the timelines set forth therein. However, Roche (and its Affiliates) does not always seek to market its own products in every country or seek to obtain regulatory approval in every country or for every potential indication. As a result, the exercise of diligence by Roche is to be determined by judging ▇▇▇▇▇’▇ commercially reasonable efforts in the Major Markets, taken as a whole.

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