Global Development Program definition
Examples of Global Development Program in a sentence
ArriVent’s activities with respect to each Joint Global Study shall be deemed part of the Joint Global Development Program carried out by ArriVent under the License Agreement for the purpose of fulfilling Arri Vent’s diligence obligation under the License Agreement.
If the Parties agree that Array will conduct any development activities under the Global Development Program, then any change to the Global Development Plan that materially alters the nature, scope or timing of activities to be conducted by Array, or which otherwise materially modifies or changes the obligations of Array under the Global Development Plan, shall require the prior agreement of Array.
Without limiting Roche’s rights to review, discuss, and approve the Joint Global Development Plan through the JDC and the JSC, Sarepta will have the right, without seeking JDC review or JSC approval, to make operational decisions with respect to the performance of the Development activities within the Joint Global Development Program to the extent consistent with the then-current Joint Global Development Plan.
Akebia may prepare amendments or updates to the Current Global Development Plan, including any (a) new protocols proposed by Akebia for any additional clinical or non-clinical study that is not an [***] and is to be included in the Current Global Development Program, and (b) material revisions proposed by Akebia to the protocol of any clinical or non-clinical [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request.
Following receipt of Regulatory Approval from the EMA for the Licensed Product in each Initial Indication, Licensee will be responsible for preparing, filing, and submitting, directly or through its Affiliates and permitted sublicensees, all Regulatory Submissions in the E.U. relating to the Current Global Development Program.
Each Party shall use Commercially Reasonable Efforts to perform the research and development activities allocated to it under the Discovery Program or Global Development Program in accordance with this Agreement.
At each JDC meeting, Sarepta and Roche will each provide the JDC with a written summary of the activities conducted by or on behalf of such Party under the Joint Global Development Program (in the case of Sarepta) and the Roche Territory Development Program (in the case of Roche) since the last JDC meeting, including patient enrollment and the ongoing status of all Clinical Trials under the applicable plan.
For each Product, [***], Amgen shall prepare and present to the JDC a reasonably detailed, written global development plan (a “Global Development Plan”) pursuant to which the Global Development Program for such Product will be performed.
In addition to the foregoing, on a quarterly basis, Akebia shall provide the JDC with a written summary of any Development, manufacturing, and regulatory activities related to the Licensed Compound and the Licensed Products outside of the Territory that materially impact the Current Global Development Program.
Until the [***], Akebia will have the sole right to publish any clinical data or other clinical or nonclinical results from such programs or any other results under the Current Global Development Program; provided that Akebia shall [***].