definiens: means the Product developed and licensed by Alkerme s to [COMPANY] under the License Agreement and for which [COMPANY] f iled a Regulatory Application on May 1, 2012 in the dosage strengths specified in Schedule 1 ( including such additional dosage strengths or additional packaging configurations that may be sub sequently added by mutual agreement through a written amendment to Schedule 1 ) that is packaged and labelled for commercial sale in the Territory or that is provided, if expressly agreed by the Parties, in bulk packaging for onward packaging and commercial sale in the Territo ry . For clarity, unless expressly agreed and amended by the Parties in writing pursuant to Clause 23.10, this Agreement shall not govern the commercial supply of any second or subsequent formu lations of Product developed by [COMPANY] and [COMPANY] under the License Agreement or any Product manufactured for sale or u se outside the Territory