definiens: shall mean the following pharmaceutical preparati ons that contain or comprise Compound as sole active ingredient . The dosage forms of the formulat ion agreed for both development and commercializati on are as follows : [ * * * ] sachet of Product equal to [ * * * ] of Compound, and [ * * * ] sachet of Product equal to [ * * * ] of Compound each of formulation EF108 ; as further Deve loped pursuant to this Agreement . The parties also agree currently that a dosage form and strength of a to b e determined sachet of Product equal to [ * * * ] of Compound will be developed and may or may not be commerciali zed, and that a dosage form and strength of [ * * * ] sachet of Product equal to [ * * * ] of Compound may or may not be developed and if dev eloped may or may not be commercialized ( as will be determined by USL after consultation with Orion, with the understanding tha t any work required under the then current Development Pl an for the development and/or commercialisation of said dosage forms and strengths that requires incrementa l expenditures compared to the manufacturing capaci ty of Orion existing as of the Date of Agreement, shall b e reimbursed by USL to Orion at Orion ’s Party Inter nal Development Rate for work performed by Orion, or at Orion ’s out of pocket cost for work performed by a qualified independent contractor as contemplated in, and subject to, Section 4.4.3(a ) ) . The Product sh all also include such additional dosage forms or strengths o f Product that may eventually be approved by applic able Regulatory Authorities, should Regulatory Approval for any additional or other dosage form(s ) or stren gths of Product be sought during the Term pursuant to this Agreement