Global Development Strategy definition
Examples of Global Development Strategy in a sentence
An initial version of the Global Development Strategy has been provided to MTPC prior to the Effective Date.
Each Genzyme Territory Development Plan shall be consistent with the requirements of the then-current Global Development Strategy (provided that Alnylam did not exercise its deciding vote with respect thereto pursuant to Section 5.6.3 ([***]).
Any Global Development Strategy may be amended from time to time only by the PJSC responsible for the applicable Regional Licensed Product.
The initial Global Development Strategy for ALN-AT3 will be included in the Option Data Package, mutually agreed upon by the Parties prior to Genzyme’s exercise of the Co-Co/Global Option with respect to ALN-AT3 in accordance with the Master Agreement, and then attached hereto as Schedule 2.2.1-2.
Apollo shall have the right to take the lead in proposing changes and revisions to the Development Plan, including the addition of Product development and registration activities, provided that any such amendment to the Development Plan is consistent with the Global Development Strategy and the Target Product Profile, and any and all amendments to the Development Plan shall be subject to the JDC’s review and approval.
For each Co-Co Licensed Product, the Development activities that are necessary or useful to be undertaken for such Co-Co Licensed Product to achieve initial Regulatory Approval for each of the indications to be sought pursuant to the Global Development Strategy in at least all of the MMCs in a proximal fashion (including the design of necessary or useful Clinical Studies) will be set forth in reasonable detail in a written work plan and time table (each, a “Global Development Plan”).
With respect to each Global Study performed by ADCT, ADCT shall perform such Global Study in accordance with: (a) the applicable clinical study protocol, Additional Global Study Plan (solely with respect to any Additional Global Study that is a Co-Funded Global Study) and the Global Development Strategy, as applicable; and (b) all Applicable Laws and clinical standards.
All Development activities conducted by ADCT in respect of the Products in the ADCT Territory will be materially in accordance with the Global Development Strategy.
Any Global Development Strategy may be amended from time to time only by the PJSC responsible for the applicable Co-Co Licensed Product.
Within [**] days after the Effective Date, ADCT shall provide to the JSC for review and discussion an updated version of the Global Development Strategy.