First Commercial Sale. The term “First Commercial Sale” shall mean with respect to each Licensed Product, the first sale of such Licensed Product by Licensee, its Affiliate or its Sublicensee to a third party following all necessary regulatory approvals in the applicable country.
Appears in 2 contracts
Samples: License Agreement (Immunomedics Inc), License Agreement (Immunomedics Inc)
First Commercial Sale. The term “First Commercial Sale” shall mean mean, with respect to each a Licensed ProductProduct in a country in the Territory, the first sale for use or consumption by the general public of such Licensed Product by Licenseein such country following Regulatory Approval of such Licensed Product in such country. Sales or transfers of Licensed Products which are not for value, its Affiliate and sales or its Sublicensee to transfers of reasonable quantities of Licensed Products for Clinical Trial purposes or for compassionate or similar use, shall not be considered a third party following all necessary regulatory approvals in the applicable countryFirst Commercial Sale.
Appears in 2 contracts
Samples: License Agreement (Verastem, Inc.), License Agreement (Verastem, Inc.)
First Commercial Sale. The term “First Commercial Sale” shall mean with respect to each Licensed Productthe date on which, the first sale of such following Regulatory Approval in any country, a Licensed Product is first sold by Licensee, its Affiliate an Affiliate, or its a Sublicensee to a third party following all necessary regulatory approvals in the applicable countrysuch country (other than sales for purposes of resale, performing research or development, or compassionate use).
Appears in 1 contract
Samples: License Agreement (Cempra, Inc.)
First Commercial Sale. The term “First Commercial Sale” shall mean mean, with respect to each any Licensed ProductProduct and any country of the world, the first sale of such Licensed Product by Licensee, its Affiliate or its Sublicensee under this Agreement to a third party following all necessary regulatory approvals Third Party in such country, after such Licensed Product has been granted Regulatory Approval by the applicable competent Regulatory Authorities in such country.
Appears in 1 contract
Samples: Development and License Agreement (SCOLR Pharma, Inc.)
First Commercial Sale. The term “First Commercial Sale” shall mean with respect to means, in each Licensed Productcountry of the Territory, the first sale of such a product or service using the Licensed Product Technology by LicenseeLICENSEE, its Affiliate affiliates or its Sublicensee Sublicensees, to a third party following all necessary regulatory approvals third-parties, in each case for use or consumption of such product or service in such country by the applicable country.general public. ___________ ___________ LICENSOR LICENSEE
Appears in 1 contract
Samples: Intellectual Property License and Consulting Agreement (INTREorg SYSTEMS INC.)
First Commercial Sale. The term “First Commercial Sale” shall mean with respect to each Licensed Product, a Product means the first sale or other disposal of such Licensed Product by Licensee, its Affiliate or its Sublicensee to in a third party following all necessary regulatory approvals country in the applicable countryTerritory after receipt of Marketing Authorization.
Appears in 1 contract
Samples: Development and Exclusive Distribution Agreement (Akorn Inc)
First Commercial Sale. The term “First Commercial Sale” shall mean mean, with respect to each Licensed any Product, the first sale for end use or consumption of such Licensed Product in a country after all required approvals, including marketing and pricing approvals, have been granted by Licensee, its Affiliate or its Sublicensee to a third party following all necessary regulatory approvals in the applicable governing Regulatory Authority of such country.
Appears in 1 contract
First Commercial Sale. The term “First Commercial Sale” shall mean mean, with respect to each any Licensed ProductProduct and with respect to any country of the Territory, the first sale of such Licensed Product by Licensee, its Affiliate or its Sublicensee to a third party following all necessary regulatory approvals Third Party in the applicable such country after such Licensed Product has been granted Regulatory Marketing Authorization by a competent Regulatory Authority for such country.
Appears in 1 contract
First Commercial Sale. The term “First Commercial Sale” shall mean means, with respect to each Licensed Productany Product and with respect to any country of the Territory, the first sale of such Licensed Product by Licensee, its Affiliate or its Sublicensee to a third party following all necessary regulatory approvals Third Party in the applicable such country after such Product has been granted Regulatory Marketing Approval by a Regulatory Authority having jurisdiction for such country.. [*] CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION Table of Contents
Appears in 1 contract
Samples: License and Co Development Agreement (Progenics Pharmaceuticals Inc)
First Commercial Sale. The term “First Commercial Sale” shall mean with respect to each any Licensed ProductProduct and with respect to any country in the Territory, the first sale Commercial Sale of such Product to a Third Party in such country after such Licensed Product has been granted Regulatory Approval by Licensee, its Affiliate or its Sublicensee to a third party following all necessary regulatory approvals in the applicable Regulatory Authority having jurisdiction for such country.
Appears in 1 contract
Samples: Psma/PSMP License Agreement (Progenics Pharmaceuticals Inc)