Product Approval definition

Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

Product Approval means the approval by any Approval Authority of the right to market or sell a Product.

Product Approval means those regulatory or other approvals required for the manufacture, importation, promotion, pricing, marketing and sale of the Product in any particular country.

Examples of Product Approval in a sentence

• Notwithstanding the foregoing, where any Product Approval Documentation or Product Filing Documentation is required by applicable Law or any Regulatory Authority to be prepared and submitted by the Seller, the Product Approval Holder or the Product Filing Holder, the Seller shall be responsible for preparing and submitting, or shall cause the relevant Product Approval Holder or Product Filing Holder to prepare and submit, such Product Approval Documentation or Product Filing Documentation.

• Each party shall cooperate with and provide all reasonable assistance and information required by the other party to prepare, or cause the preparation of, the Product Approval Documentation and the Product Filing Documentation.

• Until the Next Gen Product Approval Requirements are met (i) SunPower will not be obligated to purchase such Next Gen Product, and (ii) Enphase shall continue to supply the Product being superseded or discontinued by such Next Gen Product.

• Except as specifically required under this Agreement or the Transition Services Agreement, the Seller shall not (and shall procure that the relevant Product Approval Holder or Product Filing Holder shall not) make any amendments or variations of any Product Approval or Product Filing without the Buyer’s prior written consent.

• For the avoidance of doubt, unless expressly stated, the Product Approval Documentation and the Product Filing Documentation referred to in this Article 8 excludes all business as-usual documents to be prepared and finalised by the Seller in accordance with Part 2 (Regulatory Affairs) of Exhibit B to the Transition Services Agreement (“BAU Documentation”).

More Definitions of Product Approval

Product Approval means final FDA approval to market commercially in the U.S.A. the specified Product for use in humans.

Product Approval means all Regulatory Approvals material to, or legally required for, the development, testing (including the conduct of clinical trials), manufacturing, processing, distribution, marketing, storage, labeling, packaging, promotion, sale, offer for sale or use of any Products.

Product Approval means with respect to each Lithobid Product, the NDA set forth opposite the name of such Lithobid Product on Schedule I hereto, together with the Supplement.

Product Approval means the approval by MHLW of a registration of the Product that allows for the importation, marketing, promotion, distribution and sale of the Product in the Territory as medical devices for the treatment of Major Depressive Disorder indications that are substantially similar to the Major Depressive Disorder indications for which the Products are approved in the United States with substantially the same conditions as approved in the United States.

Product Approval means all authorizations, permits and approvals that are issued by a Regulatory Authority and necessary for the use, distribution, promotion and/or sale of a Product in a particular country or jurisdiction, including pricing and reimbursement approval.

Product Approval means, with respect to a Licensed Product in a country in the Territory, Regulatory Approval for such Licensed Product in such country, excluding any required pricing or reimbursement approval in such country for such Licensed Product.

Product Approval means final FDA approval to market commercially the specified product for use by humans or animals.