definiens: with respect to any Party, shall mean any entity controlling, controlled by, or under common control with, such Party . For these purposes, shall refer to : ( i ) the possession, directly or indirectly, of t he power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract or otherwise, or ( ii ) the ownership, directly or indirec tly, of at least 50 % of the voting securities or other ownership interest of an entity . 1.3 shall mean the third party, excluding subcontract ors, acting on behalf of or . 1.4 shall mean the then - current good manufacturing practice s required by the applicable regulatory authority, for the manuf acture and testing of pharmaceutical materials, as they may be updated from time to time . GMP s shall include applicable quality guidelines promulgated unde r the International Conference on Harmonization and the World Health Organization ( WHO ) GMP guidelines . 1.5 means either : ( a ) any pharmaceutical product containing Compound and at least one other active ingredi ent that is not the Compound ; or ( b ) any combination of the Compound and another pharmaceutical pr oduct that contains at least one other active ingredient that i s not the Compound where such products are not formulated together but are sold together as a single product and invoiced as one product . All references to Product in this Agreement shall be deemed to include Combination Product . 1.6 shall mean the chemical compound designated as SCY-078, which is [ * ] [ * ] = Certain confidential information contained in this document, ma rked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, a s amended . Prepared by R.R. Donnelley Financial -- EX-10.10 https://www.sec.gov/Archives/edgar/data/1178253/000 1193125141047 ..