Examples of Pricing and Reimbursement Approvals in a sentence
Lian, or its relevant Affiliates or Sublicensees, will have the sole and exclusive right to file and hold all Regulatory Filings, and to apply for and maintain all Regulatory Approvals and Pricing and Reimbursement Approvals, in each case, for all Licensed Products in the Field in the Territory at Lian’s cost and expense in the name of Lian or any of its Affiliates and Sublicensees.
Subject to the terms and conditions of this Agreement, Lian will be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any Pricing and Reimbursement Approvals, as applicable, for Licensed Products in the Field from Regulatory Authorities or Governmental Authorities in the Territory.
In the event the Pricing and Reimbursement Approvals in a given country of the Licensee Territory is [ * ], Licensee shall have no obligation to launch the Product in such country.
The MSA will provide, among other things, that all Product supplied thereunder will meet the Product specifications set forth in the applicable Regulatory Filings and Regulatory Approvals and any Pricing and Reimbursement Approvals in the Territory and shall contain customary terms and conditions including: [***] and shall otherwise be consistent with the terms and conditions in this Article 5.
All regulatory filings submitted in connection with testing, or obtaining Marketing Authorizations to market, a Licensed Compound or Product in the Field, including all IND, MAA and NDA submissions and other regulatory filings and Pricing and Reimbursement Approvals relating to the Licensed Compounds and Products, shall be owned by and submitted by and in the name and at the sole expense of Infinity, an Infinity Related Party or a subcontractor.