Independent Activities definition
Examples of Independent Activities in a sentence
The rights of reference granted to a Party hereunder shall not include any portion of the other Party’s Regulatory Materials that is supported by Independent Activities that [***].
Each Party and its Affiliates shall only conduct Development activities with respect to the Licensed Product (a) in accordance with the Global Product Development Plan or (b) as Independent Activities.
During the SGI Manufacturing Period, SGI shall, itself or through one or more Third Party contract manufacturers, supply to MPI quantities of the Licensed Product reasonably required by MPI to carry out MPI Independent Activities, on the terms set forth in the Non-Commercial Supply Agreement.
Any Independent Activities Regulatory Documentation resulting solely from Independent Activities for which Galapagos is the Independent Activities Party shall be owned solely by Galapagos and, notwithstanding anything to the contrary herein, Gilead shall not have the right to use such Independent Activities Regulatory Documentation for any purpose, except as set forth in Sections 7.4(c) or 7.5 or as otherwise agreed in writing by Galapagos.
Any Independent Activities Regulatory Documentation resulting solely from Independent Activities for which Gilead is the Independent Activities Party shall be owned solely by Gilead and, notwithstanding anything to the contrary herein, Galapagos shall not have the right to use such Independent Activities Regulatory Documentation for any purpose, except as set forth in Sections 7.4(c) or 7.5 or as otherwise agreed in writing by Gilead.
In the case of Independent Activities, the supplying Party may charge a ▇▇▇▇-up equal to the lowest of (i) […***…] percent […***…] of the Development Manufacturing Costs, (ii) such Party’s ▇▇▇▇-up used for […***…] or (iii) the ▇▇▇▇-up agreed by the Parties in the applicable Clinical Supply Agreement.
To the extent any Member would have any rights or claims against the other Member as a result of the Independent Activities of such Member or its Affiliates, whether arising by statute, common law or in equity, the same are hereby waived with respect to the operation of the Company except as provided below.
Notwithstanding Section 4.2(b), as between the Parties, the Independent Activities Party shall solely own all right, title and interest in and to all Regulatory Materials and Regulatory Approvals to the extent resulting solely from the applicable Independent Activities (“Independent Activities Regulatory Documentation”).
Any Independent Activities Data generated by or on behalf of Galapagos shall be deemed to be Galapagos Foreground Know-How and, notwithstanding anything to the contrary herein, Gilead shall not have the right to use such Independent Activities Data (other than safety data), except as set forth in Sections 7.4(c) or 7.5 or as otherwise agreed in writing by Galapagos.
To the extent any Member would have any rights or claims against the other Member as a result of the Independent Activities of such Member or its Affiliates, whether arising by statute, common law, or in equity, the same are hereby waived.