definiens: means, collectively, all countries in the Territo ry for which Vanda places Orders hereunder ; has the meaning specified in Section 4.2(a ) ; means, collectively, all packaging components required to be used in order to produce the Product s in accordance with the Specifications, other than the Printed Packaging Components ; means labels, inserts or other printed materials affixed to or accompanying Product(s ) as required by the Specific ations ; Product(s ) ” means the products listed on Schedule A hereto ; has the meaning specified in Section 6.3(c ) ; means the agreement between the parties hereto se tting out the quality assurance standards to be applicable to the Manufacturing per formed by [COMPANY], which agreement shall be finaliz ed and entered into by the parties within thirty ( 30 ) days after the Effective Date and may be amended fr om time to time by mutual written agreement of the par ties ; means all excipients or other starting materials used to manufacture a batch of bulk, unpackaged Product(s ), excluding the Active Materia ls ; - 5 - * * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION . CONFIDENTIAL TREATMENT HAS BEEN REQUEST ED WITH RESPECT TO THE OMITTED PORTIONS