Examples of Unsponsored Work in a sentence
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.
Each Party shall be solely responsible for costs it incurs in the performance of any 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.
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.
Each Party shall have access to and the right to use at no cost to such Party all Data resulting from Unsponsored Work and Territory Specific Work conducted by or on behalf of the other Party, its Affiliates and its Sublicensees, solely as necessary to comply with safety reporting or other similar regulatory requirements in its respective Territory, but not, for example, for Marketing Approval or pricing approval.
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.
If the Non-Proposing Party wishes to obtain access to and have the right to use the other Party’s Additional Study Data for any other reason (including obtaining Marketing Approval or pricing approval), it may do so by notice in writing to the Proposing Party at any time, provided that upon the exercise of such right, the Non-Proposing Party shall reimburse the Proposing Party for the cost it would have otherwise paid if it had agreed to co-fund such Unsponsored Work plus a premium of [***].
All Additional Study Data shall be solely owned by the Party that performed the Territory Specific Work or Unsponsored Work that produced such Data, subject to the rights and licenses, if any, granted to the other Party herein.
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.