Regulatory Submission definition

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

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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 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, ▇▇▇▇, and other applications for Regulatory Approval and their equivalents.

Examples of Regulatory Submission in a sentence

• The Regulatory Submission Party shall provide the other Party with notice of all meetings, conferences and discussions (including without limitation, advisory committee meetings or any other meeting of experts convened by any Regulatory Authority concerning any topic relevant to the Collaboration Product) promptly after the scheduling of such meeting, conference or discussion.

• The Party that does not, at the time of such meeting, own the Regulatory Submission for the Collaboration Product that is the subject of such meeting shall be entitled to have one (1) or more representatives, as appropriate under the circumstance and at its sole cost, present at all such meetings.

• Synergy shall be solely responsible, at its expense, for preparing, filing, and managing any Regulatory Submission and for maintaining any Regulatory Approval for the Licensed Products in the Territory.

• NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory.

• If the Parties’ Executive Officers are unable to reach agreement on the content of such Jointly-Agreed Regulatory Submission within a period of [***], then the Regulatory Responsible Party will have final decision-making authority with respect to the content of such Jointly-Agreed Regulatory Submission.

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 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;

Regulatory Submission means with respect to a regulatory jurisdiction, any and all submissions, which are necessary to obtain a 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 any submission made to a Regulatory Authority with respect to a Product, any New Drug Application (“NDA”), or Abbreviated New Drug Application (“ANDA”), and any supplement or amendment to any of the foregoing, and any applications for pricing or reimbursement approvals for the Product.

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