Common use of Samples for the United States Clause in Contracts

Samples for the United States. 7.2.1 Make-Up of Package and Package Inserts of Samples. In the ------------------------------------------------- United States, packaging, package inserts and outserts, Sample labels and labeling shall each contain appropriate reference to Adolor and GSK with equal exposure and prominence as may be permitted under applicable FDA rules and regulations including, without limitation, 21 C.F.R. (S) 201.1(h). The Parties agree to cooperate and use Commercially Reasonable Efforts to secure such approval from the FDA.