definiens: means the costs incurred by a Party or for its account, during the term and pursuantto this Agreement, that are specifically identifiable ( or reasonably allocable ) to the Development of a Co - DevelopedProduct in the Co - Development Territory and that are directed to achieving or maintaining Regulatory Approval of suchCo - Developed Product in the Co - Development Territory . The Development Costs shall include amounts that a Partypays to Third Parties involved in the Development of a Co - Developed Product ( [ * ] ), and all internal costs incurred bya Party in connection with the Development of such Co - Developed Product . Development Costs include the following:(a ) preclinical costs such as toxicology and formulation development, test method development, delivery systemdevelopment, stability testing and statistical analysis ; ( b ) Clinical Costs ; ( c ) expenses related to adverse eventreporting ; ( d ) Manufacturing Costs for a Co - Developed Product for use in preclinical and clinical activities including themanufacture, purchase or packaging of comparators or placebo for use in clinical trials ( with the manufacturing costsfor comparators or placebo to be determined in the same manner as 4 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of1934, as amended . Manufacturing Costs are determined for any Product, and with the manufacturing costs for active pharmaceuticalingredients used in combination with a Product to be included at the cost of the Party providing such activepharmaceutical ingredient, without additional mark - up ), as well as the direct costs and expenses of disposal of drugsand other supplies used in such Clinical Trials and any associated release testing and QA / QC development costs;(e ) [ * ] incurred in connection with [ * ], to the extent provided therein ; and ( f ) development of the Manufacturingprocess for a Co - Developed Product ( including with respect to any excipients or any active pharmaceutical ingredientincluded in such Co - Developed Products ) and related scale - up, manufacturing process validation, manufacturingprocess improvements, and qualification and validation of Third Party contract manufacturers ; ( g ) regulatory expensesrelating to Development activities for the purpose of obtaining Regulatory Approval for an indication for a Co - Developed Product ; ( h ) costs of real property rented specifically for Development activities ( to the extent actuallyused ) ; and ( i ) other out - of pocket development expenses including, without limitation institutional and advisory reviewboards, investigator meetings, quality of life studies, epidemiology and outcomes research