Commercialization Activities definition

Commercialization Activities means activities relating to the manufacture of a Collaboration Product for sale to end users, or to the marketing and sale of a Collaboration Product, including Pre-Marketing activities, which in the Co-Promotion Territory is undertaken pursuant to a Marketing and Sales Plan.

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Commercialization Activities means the marketing, promotion, including Detailing, Distribution, selling and other activities for the commercialization of Combination Product in the Field (including obtaining and maintaining any pricing approvals under applicable regulations and guidelines and securing local or national drug plan reimbursement).

Commercialization Activities means, on a Collaboration Product-by-Collaboration Product basis, all global Commercialization activities undertaken with respect to such Collaboration Product.

Examples of Commercialization Activities in a sentence

• Each Obligor adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to its Products and all Product Development and Commercialization Activities related thereto.

• All required and material notices, registrations and listings, supplemental applications or notifications, reports (including annual reports, field alerts, Device reports or other reports of adverse experiences) and all other required and material filings with respect to the Products or any related Product Development and Commercialization Activities have been filed with the FDA, WHO, ▇▇-▇▇▇▇ EMA, HPRA, Health Canada, ANVISA and all other applicable Governmental Authorities.

• All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to all material Products have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities.

• Each Obligor adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.

• All required and material notices, registrations and listings, supplemental applications or notifications, reports (including annual reports, field alerts, Device reports or other reports of adverse experiences) and all other required and material filings with respect to the Products or any related Product Development and Commercialization Activities by such Obligor have been filed with the FDA and all other applicable Governmental Authorities.

More Definitions of Commercialization Activities

Commercialization Activities means those Commercialization activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

Commercialization Activities means the LFB Biotech Commercialization Activities and/or the GTC Commercialization Activities, as the context suggests.

Commercialization Activities has the meaning provided in Section 7.1.

Commercialization Activities means utilization of the Broadband Infrastructure for the generation of revenue from non-Commission entities and participation in a revenue sharing arrangement with the Commission.

Commercialization Activities means any activities approved by VIRNETX that are necessary or desirable to generate revenue from the VIRNETX Patents anywhere in the world by means of VIRNETX granting a License to an Approved Counterparty.

Commercialization Activities means on a [***] basis, the Commercialization activities conducted by or under the authority of Sanofi in the Territory under this Agreement.

Commercialization Activities means activities conducted by a Party in relation to Commercialization of Products under a Development & Commercialization Agreement in a country where such Party is not the Commercialization Lead Party following the exercise by such Party of (a) the Commercialization Opt-In Right, or (b) the delivery by such Party of a Juno Co-Commercialization Notice pursuant to Section 3.1.2 of the Celgene Lead Co-Co Agreement, or a Celgene Co-Commercialization Notice pursuant to Section 3.1.2 of the Juno Lead Co-Co Agreement, as further described in Section 3.1.6 of the Celgene Lead Co-Co Agreement, Section 3.1.7 of the Juno Lead Co-Co Agreement (each as applicable), and the Commercialization Opt-In Terms for the applicable Development & Commercialization Agreement.