Product Registration definition

Product Registration means, with respect to a Licensed Product, a NDA approved by the FDA in the United States or any other government approval required by a government or Regulatory Authority of a country in the Territory necessary to permit the marketing, import, use and sale of a Licensed Product in such country. Product Registration shall include governmental approval of pricing and/or reimbursement in jurisdictions where such approval is required (either legally or commercially) for commercial sale of a Licensed Product.

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Product Registration means, with respect to a Product, any and all approvals, marketing authorizations, licenses, registrations (except manufacturing establishment registrations) or authorizations of any Governmental Authority necessary to commercially distribute, sell or market such Product in the applicable Fields in the applicable Territory or any applications to obtain such approvals, marketing authorizations, licenses, registrations or authorizations.

Product Registration means such approval as may be granted by a relevant regulatory authority to use, sell, supply, advertise or store a certain plant protection product or fertilizer in a particular jurisdiction;

Examples of Product Registration in a sentence

WUND shall ensure that all materials, advertisements and promotional activities comply with, and WUND shall be solely responsible and liable for any failure of such materials and activities to comply with Applicable Law, Labeling and Product Registration for any of the Product, notwithstanding any review or approval of such materials or activities by ZGM.
WUND shall not at any time do, and neither shall WUND permit its agents or representatives to do, any act in violation of Product Registration in the Territory.
WUND shall, on a timely basis, provide to ZGM all information that ZGM determines is necessary and relevant to ZGM’s to fulfill its obligations hereunder to fulfill Product Registration maintenance requirements (including, but not limited to Product sales distribution information).
In the event that ZGM sends a Procedural Review Notice to WUND, WUND shall promptly comply with the procedures set forth in this Section 5.9. WUND shall ensure that all marketing and advertising materials and activities comply with the applicable Labeling and Product Registration for any of the Product and with Applicable Law, including, without limitation, addressing any other issues or concerns that were the subject of such letter or notice.
ZGM shall keep WUND informed on a timely basis as to any developments that would have a material adverse effect on a Product Registration.

More Definitions of Product Registration

Product Registration means the approvals, permits, applications, licenses or registrations (including but not limited to the NDA) for the Product which have been received in order to market or sell same in the Territory.

Product Registration means permission from any governmental authority allowing a device or a software to be lawfully distributed for commercial use in a country, including establishment registration and device or software listing with the Federal Communications Commission.

Product Registration means any permit, approval, authorization, clearance, qualification, designation, licensure, registration, or marketing or other authorization or notarization by the U.S. Food & Drug Administration (FDA) or comparable Governmental Entity, in each case as necessary to market, promote, or sell any Product.

Product Registration means with respect to any country, the registrations, permits, licenses, consents, authorizations and other approvals and pending applications and requests therefor, required by applicable Governmental Authorities relating to the marketing, sale, distribution, pricing and reimbursement of the Product in such country, including, without limitation, INDs and NDAs, marketing authorizations, and any supplements or amendments to any of the foregoing, and any other equivalent of the foregoing, in each case whether now existing or owned or hereafter arising or acquired for the Product, including, without limitation, those listed on Schedule IV of the Security Agreement, and including all filings and files with respect thereto, including, without limitation, all documents referred to in the complete regulatory chronology for each Product registration.

Product Registration means a recognition granted to regulated product in accordance with set requirements;

Product Registration means, with respect to a Product in a particular country or territory, the registration or regulatory approval granted by the applicable governmental authority in such country or territory allowing for such Product to be marketed, distributed, sold or imported there.

Product Registration means a list of all governmental authorizations granted to Seller by, or applications therefor pending with, any Governmental or Regulatory Authority in the Territory to manufacture, market, import, distribute and/or sell any of the Products in the Territory, except for those Governmental or Regulatory Authority authorizations that the failure to possess would not be material to the operation of the business related to the Products taken as a whole.