Examples of Regulatory Submission in a sentence
All Governmental Approvals or Regulatory Submissions for the Agreement Products, which are held in the name of DISTRIBUTOR as a result of Applicable Law requiring DISTRIBUTOR to be so named on such Governmental Approval or Regulatory Submission, shall be transferred to EVOLUS or, if such transfer is prohibited under Applicable Law, shall be held for the beneficial use by EVOLUS if such is not contrary to Applicable Law.
ECRIN PARTNER shall be responsible for carrying out its Tasks as described in the Tasks list Lines 1-38, regarding Initial Regulatory Submission (see Appendix 1).
To find out if a scheduled deposit has been made, see Documentation of Transfers below.
In the event Hana licenses or sublicenses its rights to Sphingosomal Vincristine after the FDA approves the Sphingosomal Vincristine NDA or a Designated EU State approves a Regulatory Submission that is equivalent to an NDA, INEX shall be entitled to receive [*] of any Licensing/Sublicensing Revenue payable to Hana by such Licensee or Sublicensee.
Within thirty (30) days from the date of the first Regulatory Submission, Paladin shall deliver to Bioniche, a written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the Territory by Paladin or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”).