Regulatory Submission definition

Regulatory Submission means any submission or filing made in furtherance of obtaining and maintaining any Regulatory Approvals.

Regulatory Submission means with respect to a regulatory jurisdiction, any and all submissions, which are necessary to obtain and maintain a Regulatory Approval.

Regulatory Submission means in respect of a Royalty Product, the package or packages of data, pre-clinical and clinical trial data and materials, information, results, materials and samples (including any Test and Regulatory Data and/or the drug master file or part thereof) submitted to a Regulatory Authority in support of a Marketing Approval Application or any other Regulatory Approval;

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”).

More Definitions of Regulatory Submission

Regulatory Submission means applications for Regulatory Approval, notification, and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture, or Commercialize the Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigative new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs, and packaging for the Product in the Territory.

Regulatory Submission means the filing of an application for a commercial marketing authorization for (a) a Packaged Product for delivery of a Program Compound using the Device, (b) the Device or (c) any product based on any Alternative Technology, as the case may be.

Regulatory Submission means any application to a Regulatory Authority seeking (a) approval to administer an investigational Product to humans, including INDs, or (b) Regulatory Approval.

Regulatory Submission means submission of the dossier described in the definition of “Submitted for Regulatory Approval” to appropriate Regulatory Authorities whose purpose is to allow for the sale of a Product in any country.

Regulatory Submission means a marketing authorisation application filed with the FDA, EMA, or any comparable application or filing with any analogous Governmental Authority in the Territory,

Regulatory Submission means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical, diagnostic, or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all written or electronic correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, XXXx, and other applications for Regulatory Approval and their equivalents.

Regulatory Submission means a submission of a regulatory package, referring to one Event, to a regulatory authority whose purpose is to allow for the commercial production, culture or importation for food, feed, and industrial use in the jurisdiction governed by such regulatory authority. All regulatory submissions will be made by Mahyco.