Examples of Authorization; Approvals in a sentence
BI shall be solely responsible for, and shall use Diligent Efforts in the Major Markets in connection with, the submission of information, communicating with, and seeking Marketing Authorization Approvals from, Governmental Authorities in respect of Products and will keep Vitae informed, through the Joint Steering Committee or applicable subcommittee, of all significant issues arising therefrom.
BI shall be fully responsible for bearing all costs and expenses associated with undertaking and completing said registration activities in the Territory, including, but not limited to, the costs of preparing and prosecuting applications for such Marketing Authorization Approvals and fees payable to regulatory agencies in obtaining and maintaining same.
BI shall be responsible for maintaining the Marketing Authorization Approvals obtained under this Section 8.2, and BI shall solely own all such approvals in the Territory.
When making Standard Service Authorization Approvals the Contractor shall make a decision and provide notice to the Enrollee and Provider as expeditiously as the Enrollee’s health condition requires, but no later than 14 calendar days from the receipt of the request for Service Authorization.
Clinigen will, in accordance with the priorities agreed by the Joint Steering Committee, exercise Diligent Efforts in pursuing any further required Marketing Authorization Approvals necessary to Commercialize the Licensed Product in each Country of the Territory.
Theravance will, in accordance with the priorities agreed by the Joint Steering Committee, exercise Diligent Efforts in providing Clinigen with evidence confirming that there is, within the marketing authorization dossier for the Licensed Product, an authorized manufacturing site which fulfills the requirements set out in Article 41 of Directive 2001/83/EC and otherwise provide Clinigen the information necessary to maintain the Marketing Authorization Approvals.
Clinigen shall bear all costs and expenses associated with obtaining any further Marketing Authorization Approvals for the Licensed Product in each Country of the Territory during the Term.
JULPHAR agrees to provide to DANCE, as requested, with all information and data in JULPHAR’s possession or control for DANCE to obtain and maintain Market Authorization Approvals for the Product in any country, including information relating to the Production Site, or the methodology, raw materials used in the manufacture, processing or packaging of API, or any other matters, if proven by DANCE, that are required or requested to be provided to the EMA, FDA or any other Governmental Authority.
Without limiting the foregoing, BI shall use Diligent Efforts to (i) advance at least ****for type 2 diabetes or another Core Indication ready for Phase I Studies; (ii) advance ****through Development in accordance with the stage gates identified in the then current Development Plan for such Product; (iii) efficiently Develop the Products; and (iv) obtain Marketing Authorization Approvals to market the Products in Major Markets (as contemplated in Section 8.2).
For guidance on cost sharing in grants and CAs, please see the ADS 303.3.10 and 2 CFR 200.307 for U.S. NGOs. For non-US NGOs, all cost sharing would be subject to the Required as Applicable Provision “Cost Sharing” in the Mandatory Reference for ADS Chapter 303, Standard Provisions for Non-U.S. Nongovernmental Organizations.