Common use of API Specifications Clause in Contracts

API Specifications. The referenced API(s) must be manufactured, packaged, labeled (if necessary) and handled according to the written specifications and procedures as outlined in this agreement. Changes to the specifications shall be mutually agreed upon and approved in writing by both parties. In testing starting materials, intermediates and API(s) [***] the analytical methods requiring validation. Methods which appear in the current compendia or other recognized standard references should be written in sufficient detail to describe specific equipment and analytical parameter ranges. Product aspect methods such as appearance, color and clarity of solution shall also be written. For those analytical methods developed by Formosa, documentation supporting the development and validation of the analytical method shall be supplied upon request to NGX. Each lot of API will be sampled and tested in accordance with the agreed upon [***] procedures, Regulatory Requirements, and must meet the specifications as outlined in this agreement.