BI RCV definition
Examples of BI RCV in a sentence
All payments to BI RCV made by Sophiris shall be made in Euros and within a period of […***…] as of the invoice date as set forth in the Billing Plan in Exhibit F and for Product, […***…] from the date the applicable invoice is received by Sophiris.
Sophiris and BI RCV each shall appoint as representatives individuals having seniority and decision-making power, at least one of whom must have scientific or technical expertise.
To BI RCV’s knowledge on the Effective Date, BI RCV is free to supply the BI RCV Confidential Information to Sophiris provided that any and all information and Materials provided to BI RCV by Sophiris do not infringe such third party Intellectual Property rights.
Exhibit R, BI RCV shall at its expense properly maintain and insure the equipment used in the manufacture of Product on an on-going basis.
If a Health Authority requests or requires that a change be made in the Process or to the Drug Substance Specifications or Product Specifications, or if changes to the Process or Product Specifications are required in order to comply with applicable laws or regulations (including, without limitation, GMP), then BI RCV shall make such changes in accordance with the Quality Agreement and SOPs (i.e., change control procedures) agreed in writing by Sophiris and BI RCV.
The Parties shall negotiate in good faith an agreement for manufacture of Drug Product and Diluent by BI RCV for Sophiris in accordance with the timelines of Sophiris’ filing of Product for market approval.
Sophiris acknowledges and agrees that BI RCV may subcontract specific Services under this Agreement or parts thereof to its Affiliate BIP, as well as to other third party subcontractors listed in Exhibit J.
In addition to the Product-dedicated equipment, Sophiris shall pay BI RCV costs for engineering, setting-up, automation, calibrating, cleaning and qualification related to such Product-dedicated equipment, as applicable and as set forth in.
The specific documents to be drafted in English or for which BI RCV will provide English language translations are outlined in the Quality Agreement.
For the avoidance of doubt, Taxes shall not include income taxes of BI RCV in Austria.