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.

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 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

• Accordingly, except as otherwise required by law, DURECT shall not correspond directly with the FDA or any other Regulatory Authority relating to the process of obtaining Product Registrations or any obtained Product Registration for the Licensed Products, without PTI’s prior permission.

• Subject to Section 6.3 below, the Parties understand and agree that PTI, itself or through its agents, shall have the sole right to correspond with and submit INDs, NDAs, regulatory applications and other filings to the FDA or other Regulatory Authorities to obtain Product Registration approvals to import, export, sell or otherwise commercialize the Licensed Products as PTI deems useful or necessary to fulfill its obligations hereunder.

• The Product Registration Data constitutes all data included in the Regulatory Filings.

• Seller is the sole and exclusive owner of all Regulatory Filings and Product Registration Data.

• Following such transfer, Seller shall not retain any rights in any 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 a recognition granted to regulated product in accordance with set requirements;

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 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 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.

Product Registration means a valid pharmaceutical product registration or marketing authorisation for the Product (including pricing approval, if applicable) granted by any Regulatory Agency as well as any other regulatory approval with respect to the Product or which are required for the manufacture, marketing, promotion, pricing, reimbursement and selling of any Product.

Product Registration means, with respect to the Product, all pharmaceutical registrations, marketing authorizations and applicable pricing and reimbursement approvals granted by any Governmental Authority to permit the manufacture, storage, promotion, sale and marketing of the Product.