Examples of NDA Approval Date in a sentence
The Acquiror agrees and acknowledges that, following the Closing until the Evamist NDA Approval Date, the Seller shall have the right to use any and all Purchased Assets solely and to the extent necessary for carrying out the Seller’s right hereunder to prosecute the Evamist NDA and obtain the Evamist NDA Approval.
Until the Evamist NDA Approval Date, the Seller shall control the prosecution of the Evamist NDA before the FDA, subject to the terms and conditions of this Section 8.5. Unless and until the Evamist FDA Submissions are assigned to the Acquiror pursuant to Section 8.5(b), the Seller shall use efforts (consistent with the past practices of the Seller with respect to the Evamist NDA and other NDAs of the Seller), at its expense, to obtain Evamist NDA Approval as soon as practicable.
Compliance with meeting the statutory provision for public libraries in Wales is interpreted via the Welsh Public library Standards (WPLS) issued by Welsh Government which provide detailed guidance on aspects of the service for local authorities.
Provided that where any Phase IV Clinical Trial is required by the FDA in the Territory after the NDA Approval Date, the Parties shall promptly agree in good faith the plans and protocols for such Additional Study and the Licensee shall be entitled to conduct the same as a Clinical Study, at its sole cost and expense.
Any additional hours of Services provided in a given week (in excess of the eight (8) hour budget plus any additional hours carried over from previous weeks), other than for Services related to clinical development and regulatory approval processes provided prior to the Evamist NDA Approval Date), will be charged to Recipient at the rate of $250 per hour.
Salix shall use all Due Diligence efforts to achieve Launch of the Xxxxxx Product as soon as reasonably practicable after the NDA Approval Date and to maximise Sales of the Xxxxxx Product in the Territory during the Xxxxxx Royalty Term.
As of the NDA Approval Date, Evoke shall maintain product liability insurance for the Product of at least ten million dollars ($10,000,000) naming Eversana as an additional insured under such policy, it being understood and agreed that Eversana shall not need to obtain any product liability insurance during the Term.
The Agreement shall take into effect as of the Effective Date and shall remain in effect for a term of five (5) years from the NDA Approval Date unless earlier terminated as provided hereunder (the “Term”).
Following discussion of this pre-Launch forecast between the Parties Licensee shall place firm binding purchase orders on Licensor covering the period between NDA Approval Date and the end of the First Full Quarter, such purchase orders not to specify a delivery date earlier than ninety (90) days after the date upon which such purchase orders are dated and submitted to Licensor.
Completion of Deliverable E5.1 ensures that the format and content of E5.3 can be planned/sourced well in advance of completion to allow sufficient time to refine the business case to its best version.