Examples of Initial NDA in a sentence
The Development Costs of any such additional Clinical Trial required in connection with the Initial NDA pre-NDA Approval Date shall be paid by the Licensor, provided that a sum equal to the first [*] dollars ($[*]) and [*] per cent ([*]%) of any Development Costs exceeding [*] dollars ($[*]) shall be reimbursed by the Licensee, by being paid in addition to the milestone payable under Clause 10.10, upon payment of such milestone.
For the avoidance of doubt, during the Manufacturing Period all decisions relating to the Specification and methods of manufacturing shall be made solely by Licensor provided that Licensor shall give Licensee reasonable notice in writing of any changes prior to effecting them and provided that such changed Specification is still in accordance with the Initial NDA and any subsequent NDA.
Licensee shall be responsible for the preparation, submission and prosecution of all necessary Regulatory Authority filings and applications required to obtain all label extensions or label changes to the Initial NDA, to obtain any subsequent NDA for the Product and to Commercialise Product in the Territory.
Notwithstanding Forma’s right to prepare and submit the Initial NDA hereunder, Forma shall not have the right to agree upon any Post-Approval Commitments (other than with respect to the Post-Approval Commitment to conduct a pediatric Clinical Study and a post-approval bioequivalent Clinical Study for a new formulation for the Licensed Product) as a condition of obtaining Regulatory Approval for the Initial NDA without Company’s prior written consent, not to be unreasonable withheld.
As set forth in Section 24(xiii), this section supersedes the Initial NDA (as such term is defined in Section 24(xiii)).
Prior to assignment of the Approved NDA, subject to the terms and conditions of this Agreement, including this Section 2.8 and Section 2.9, Forma shall be responsible for all regulatory matters relating to the Initial NDA, including overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Initial NDA (the “Forma Regulatory Activities”) as necessary for Regulatory Approval.
Borrower or Operating Lessee shall prepare and submit (or shall cause the Mortgage Loan Parties or Manager to prepare and submit) to Lender by December 1st of each year during the Term, for approval by Lender, which approval shall not be unreasonably withheld or delayed, a proposed pro forma budget for each Individual Property for the succeeding calendar year (individually and collectively, the “Annual Budget”), and, promptly after preparation thereof, any revisions to such Annual Budget.
Forma shall be responsible for paying all costs, including the Out-of-Pocket Costs incurred by Forma that are associated with obtaining Regulatory Approval of the Licensed Product with respect to the Initial NDA in accordance with the Transition Plan.
BLP further agrees to continue to provide Pharmos with BLP Technical Documentation as Pharmos may reasonably deem necessary or appropriate solely in order for Pharmos to obtain and thereafter maintain Regulatory Authority approval of the Initial NDA and any subsequent NDA as Pharmos may from time to time reasonably request during the Term.
The Initial NDA resolved the request for relief by providing the IE access to the denied computer models.