definiens: shall mean the cGMP manufacturing of the Bulk Substance by or on behalf of [COMPANY], which term isexclusive of any formulation, filling and/or packaging . For greater certainty the verb as used herein with acapitalized shall automatically make reference to the performance of the Manufacturing by or on behalf of [COMPANY] . TheParties have agreed that [COMPANY] may sub - contract the Manufacturing of Bulk Substance to a CMO such as [ * * * ] Notwithstanding the foregoing, with regard to Filled Drug Product, shall mean the cGMP manufacturing ofthe Filled Drug Product by or on behalf of [COMPANY], which term is exclusive of any labelling, packaging or final release for usein human clinical trials . The Parties have agreed that [COMPANY] may sub - contract the various aspects of Manufacturing of FilledDrug Product to a CMO such as [ * * * ] .”(p ) shall mean the Quality Agreement attached hereto as Schedule A, as may be amended and/or restatedfrom time to time, detailing certain quality and technical aspects of the formulation and filling of the Bulk Substance andFilled Drug Product . ”(q ) shall mean the specifications for the Bulk Substance or Filled Drug Product as agreed upon by the Partiesfrom time to time . The Specifications may be amended from time to time by mutual agreement of the Parties and the mostrecent version shall automatically succeed the previous version, which latest version shall then be incorporated herein byreference . Specifications which apply to both Bulk Substance and Filled Drug Product are attached hereto as Schedule B