Unsponsored Work definition
Examples of Unsponsored Work in a sentence
Proposing Party shall deliver to the JDC regular updates on such Unsponsored Work, and promptly following completion of the Unsponsored Work, a top-line summary of all Data resulting from such Unsponsored Work.
The Parties will enter into an appropriate Supply Agreement as set forth below in Section 5.3.2 to supply PIRS with any quantities of the CoDev Product necessary for Development (including any activities allocated to PIRS under the applicable CoDev Product Plan and any Unsponsored Work) and Commercialization activities.
The cost of any CoDev Product supplied for clinical purposes prior to commercial scale Manufacturing or on a commercial scale with a Third Party CMO will be shared equally by the Parties and will be included in Shared Costs pursuant to Section 1.234, except for supply for any Unsponsored Work, which shall be fully paid by the Proposing Party.
Notwithstanding the foregoing, the Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product.
For avoidance of doubt, each Party shall be solely responsible for any Unsponsored Work.
Any CoDev Product supplied for clinical purposes prior to commercial scale Manufacturing or on a commercial scale under a Party Supply Agreement, will be supplied at a price no greater than a CoDev Product’s [***] and will be included in Shared Costs pursuant to Section 1.234, except for supply for any Unsponsored Work, which shall be fully paid by the Proposing Party.
All Data resulting from any Unsponsored Work (collectively, “Additional Study Data”) shall be solely owned by the Party that performed the Unsponsored Work that produced such Data, subject to the rights and licenses, if any, granted to the other Party herein.
If the Additional Study Data is later included in the label of a CoDev Product that has received Marketing Approval anywhere in the world (whether or not such Marketing Approval is for the Non-Proposing Party’s respective Territory), the Non-Proposing Party shall reimburse the Proposing Party for [***] percent ([***]%) of the Development Costs associated with such Unsponsored Work, such amount to be deducted from any amounts owed to the Non-Proposing Party under Section 4(b) of Exhibit 1.189.
If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if the Proposing Party disputes the stated likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then such dispute shall be subject to Accelerated Arbitration.
Each Party shall be solely responsible for costs it incurs in the performance of any Unsponsored Work.