definiens: means, with respect to a Profit - Sharing Product or a Royalty - Bearing Product, the reasonable internal and external costs of a Party incurred in Manufacturing such RNAi Therapeutic Product ( including [ * * ] to the extent that such costs are reasonably allocated to the Manufacture of such RNAi Therapeutic Product, and product testing and release activities relating to quality assurance and quality control ), including : ( a ) to the extent that such RNAi Therapeutic Product is sourced from a Party, fully allocated cost of Manufacture of such RNAi Therapeutic Product, consisting of direct material and direct labor costs, plus Manufacturing overhead reasonably attributable to such RNAi Therapeutic Product ( including without limitation all directly incurred Manufacturing variances and a reasonable allocation of related Manufacturing administrative and facilities costs ( such reasonable allocation shall [ * * ] ) to be provided for such RNAi Therapeutic Product, but excluding [ * * ] ), all calculated in accordance with generally accepted accounting principles in the United States consistently applied by the applicable Party, [ * * ], and ( b ) to the extent that such RNAi Therapeutic Product is sourced from a Third Party manufacturer, the actual price paid by a Party to the Third Party for the Manufacture, supply and packaging of such RNAi Therapeutic Product plus any additional reasonable costs incurred by the Party relating to managing the Third Party relationship . Cost of Goods Sold shall not include royalties paid to Third Parties . If the non - Manufacturing Party believes in good faith that the Cost of Goods Sold charged by the Manufacturing Party for such RNAi Therapeutic Product [ * * ] or that a Third Party manufacturer, or an alternative Third Party manufacturer, [ * * ] such RNAi Therapeutic Product [ * * ] Cost of Goods Sold, then the Parties [ * * ] the non - Manufacturing Party 's [ * * ], and the non - Manufacturing Party shall [ * * ] by the JSC or JCC, as the case may be . The non - Manufacturing Party 's [ * * ] the cost of goods [ * * ] shall be [ * * ] ; provided, however, that the non - Manufacturing Party may [ * * ] in the event that the Manufacturing Party [ * * ] Cost of Goods Sold for an RNAi Therapeutic Product that is [ * * ] for the equivalent period . If the JSC or JCC [ * * ] shall provide the non - Manufacturing Party [ * * ]