definiens: means, with respect to a Candidate or Product, th e [ * * * ] cost incurred by either Party or any of their respective Affiliates in Manu facturing such Candidate or Product ( including all activities related to CMC, formulation and process development, and scale - up ) in accordance with this Agreement and consistent with the applicable Resear ch Plan, Development Plan, Development Supply Agreement, Commercial Supply Agreement, or In - Vivo SCD Commercial Supply Agreement [ * * * ], including : ( a ) to the extent that such Candidate or Product is Manufactured by a Third Party contract manufacturer : ( i ) the [ * * * ] External Costs paid by a Party or its Affiliates to the Third Party contra ct manufacturer ( or to a Party, if one Party supplies to the other Party Candidate or Product Manufacture d by a Third Party contract manufacturer ) for the Man ufacture and supply thereof ( including packaging and labeling ), determined in accordance with the bo oks and records of such Party or its Affiliates maintained in accordance with Accounting Standards, plus ( ii ) a [ * * * ] amount to cover such Party ’s Internal Costs incurred in engaging and overseeing such Third Party contract manufacturer ; and ( b ) to the extent that such Candidate or Product is Manufa ctured by a Party or its Affiliates : [ * * * ] material costs, depreciation of capital expenditures, Extern al Costs, and Internal Costs attributable to the Manufacture of such Candidate or Product, determine d in accordance with the books and records of such Party or its Affiliates maintained in accordan ce with Accounting Standards and as consistently ap plied to other products Manufactured by the Party Manufactur ing ; provided, that Manufacturing Costs calculated in accordance with clause ( b ) will not include any allocation of [ * * * ]