Regulatory Approval definition

Regulatory Approval means the approval of the applicable Regulatory Authority necessary for the marketing and sale of a product in a country (or countries), and including the expansion or modification of the label for additional indications or uses.

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Regulatory Approval means all approvals (including pricing and reimbursement approvals required for marketing authorization), product and/or establishment licenses, registrations or authorizations of all regional, federal, state or local regulatory agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a regulatory jurisdiction.

Regulatory Approval means any and all approvals (including price and reimbursement approvals, if required), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a Product in such jurisdiction.

Examples of Regulatory Approval in a sentence

• As an inducement to IPI to enter into this Agreement, Licensee shall use diligent and commercially reasonable efforts to develop, seek regulatory and pricing/reimbursement approval for and commercialize Products for the benefit of the public and to make Products that have gained any Regulatory Approval in at least one jurisdiction available to the public in such jurisdiction.

• When requested by MDT, ADC shall use Commercially Reasonable Efforts to provide support, including participation in joint meetings with Governmental Authorities, as necessary to assist in obtaining and maintaining Regulatory Approval of the ADC-MDT System.

• Each Party shall provide the assistance described in this Section 3.4 and shall otherwise cooperate with the other Party as reasonably necessary to obtain or maintain Regulatory Approval of the ADC MDT Glucose Sensors and the ADC-MDT System, including providing reasonably requested information or documents.

• Neither Party will make any such updates or changes without first giving the other Party [***] prior written notice and full cooperation in accordance with Section 4.1. Notwithstanding the foregoing, subject to Section 4.2, each Party may implement as soon as practicable any changes that are required to comply with any applicable Regulatory Approval, Applicable Law, cGMPs or by concerns related to the safety, efficacy or cybersecurity of such Party’s applicable products.

• Any such information or documents that are non-public shall be used by the receiving Party solely for the purpose of obtaining or maintaining Regulatory Approval.

More Definitions of Regulatory Approval

Regulatory Approval means the technical, medical and scientific licenses, registrations, authorizations and approvals (including approvals of Approval Applications, supplements and amendments, pre- and post- approvals, and labeling approvals) of any Regulatory Authority, necessary for the Research, Development, clinical testing, commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of a pharmaceutical product in a regulatory jurisdiction, including Marketing Approval.

Regulatory Approval means any and all approvals (including pricing and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority necessary to Exploit the Product in any country in the Territory, including any (a) approval of a Product, Marketing Authorization and supplements and amendments thereto; (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto); (c) labelling approval; and (d) technical, medical, and scientific licenses.

Regulatory Approval means, with respect to a product, all approvals, licenses, registrations or authorizations necessary to market and sell such product in a particular jurisdiction in the Territory (including applicable approvals of labeling, price and reimbursement for such product in such jurisdiction).

Regulatory Approval means the receipt from a Regulatory Authority by Licensee, its Affiliates, or Sublicensees of approval to lawfully market a Licensed Product in the corresponding jurisdiction in the Territory.

Regulatory Approval means any authorization, approval, license, registration, or permit required or issued by any Regulatory Agency.

Regulatory Approval means, with respect to a product in a country, the approval of the applicable Regulatory Authority necessary for the marketing and sale of such product in such country.

Regulatory Approval means, in any given country, the granting by the Regulatory Authorities in that country of all approvals that are necessary for the manufacturing, distributing, marketing, sale, pricing and reimbursement of a drug product.