AVAILABLE PRODUCT

AVAILABLE PRODUCT. Shall mean a Drug Candidate that either: 1. (a) is composed of a combination of two or more Pharmaceutical Products, each said Pharmaceutical Product being suitable for administration to patients as part of a co-therapy regimen in which neither Pharmaceutical Product is in any way altered with respect to its registration in the FDA Orange Book registry; or (b) is a single Pharmaceutical Product suitable for administration to... patients without being in any way altered with respect to its registration in the FDA Orange Book registry. For the purposes of this definition, "PHARMACEUTICAL PRODUCT" shall mean a drug product which has been approved by the FDA with a corresponding dosage and formulation registered in the FDA Orange Book, and is legally available for sale in the United States. View More