definiens: means all written, printed or graphic material provided by CRTX and intended for use by a Party 's Sales Representatives during a Call, or during marketing sponsored speaker programs including, but not limited to, visual aids, file cards, premium items, clinical studi s, reprints, drug information updates and any other promotional suppo items or advertising that CRTX ( following consultation with ( i ) the Comm ttee during the Pre - Launch Period and the Launch Period or ( ii ) DEY in acco ance with Section 4.4(8 ) thereafter ), deems necessary or appropriate in conn ction with the Promotion of Product . Promotional Materials shall include only those materials describing FDA - approved indicated uses, safety, ef ectiveness, contraindications, side effects, warnings and other relevant charact ristics of a Product that meet the regulations as outlined in the Code f Federal Regulations . Promotional Materials shall not include any Product ackaging, Product labeling or Sample labeling