definiens: shall mean the [ … * … ] meeting the specifications mutually agreed by the P arties, [ … * … ] for calculating cost of goods, which shall include [ … * … ] . Cost of Goods shall not include [ … * … ] . It is understood that the [ … * … ] . In addition, the [ … * … ] . As used in this Section 1.6, [ … * … ] in Sections 8.2 and 8.3 below . ” New Section 1.18 shall be added to the Agreement as follows ( and all subsequent definitions in Section 1 and related section references shall be deemed renu mbered accordingly ): shall mean all processe s and activities typically engaged in by a person o r entity in the pharmaceutical industry for formulati on and packaging of : ( a ) placebo tablets ; and ( b ) t he Product from the Compound supplied ( directly or ind irectly ) by [COMPANY] ; including, without limitation, vendor selection, contract negotiation, vendor mana gement, scheduling, manufacturing process and formulation development, validation and scale - up, c oating, packaging, labeling and shipping, storage, quality control and assurance, release testing, pro cess improvement and support for inspections . ” * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B -2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDE D