definiens: means, with respect to a Collaboration Compound or Product forany period, subject to the provisions of this Agreement, the following expenses that are incurredby a Party or any of its Affiliates and are directly attributable or reasonably allocable to theCommercialization of such Product in the Territory during such period:(i)Manufacturing Costs with respect to ( a ) all quantities of such Product sold duringsuch period and ( b ) all quantities of such Product and any active pharmaceuticalingredient included therein, packaging and components related thereto ( includingany inventories of such Product, as well as any packaging, active pharmaceuticalingredient and other component inventories with respect to such Product, built up inadvance and in anticipation of Launch of such Product ) written off for financialaccounting purposes, in each case ( ( a ) or ( b ) ) regardless of whether suchManufacturing Costs were incurred prior to or after the Cost Sharing Effective Date;(ii)Sales and Marketing Costs;(iii)Regulatory Expenses that are reasonably allocable to the Commercialization of aProduct, including regulatory filing fees, user fees and similar expenses payable toRegulatory Authorities, and incurred after Regulatory Approval of the Product in theapplicable country in the Territory, including in connection with obtaining pricing orreimbursement approval;(iv)Medical Education Costs;2 [ * ] = Portions of this exhibit have been omitted pursuant to a confidential treatment request . Anunredacted version of this exhibit has been filed separately with the Securities and ExchangeCommission.(v)the FTE and direct out - of - pocket costs incurred in connection with the planning andconduct of any Phase IV Clinical Trials, including Manufacturing Costs for(1 ) Product for use in Phase IV Clinical Trials and ( 2 ) the manufacture, purchase orpackaging of comparators or placebo for use in Phase IV Clinical Trials ( with themanufacturing costs for comparators or placebo to be determined in the samemanner as Manufacturing Costs are determined for any Product ), as well as thedirect costs and expenses of disposal of drugs and other supplies used in suchPhase IV Clinical Trials;(vi)costs of branding and communications plan for Phase III Clinical Trials and lifecycle management studies;(vii)costs associated with patient assistance and indigent / expanded access programs;(viii)Distribution Costs;(ix)costs of real property rented or leased specifically for CollaborationCommercialization activities ( except to the extent used by a Party for non - Collaboration activities);(x)Trademark Costs and the Parties ’ FTE and direct out - of - pocket costs incurred inconnection with obtaining and maintaining drug naming approvals for a Product;(xi)Third Party License Payments;(xii)fees and other amounts payable to [COMPANY] ’s distributors in the [COMPANY] DistributionCountries under the applicable agreements with such distributors;(xiii)import duties and similar charges with respect to such Collaboration Compound orProduct to the extent not included in Manufacturing Costs;(xiv)amounts written off by reason of uncollectible debt, to the extent consistent with therelevant Party ’s business practices for its other pharmaceutical products, asdetermined on a country‑by‑country basis ; and(xv)Patent Costs;provided, that, in each of clauses ( i ) - ( viii ) above, such expenses shall be included within for a Product only to the extent consistent with the applicable Pre - LaunchCommercialization Plan and Budget or Annual Commercialization Plan and Budget for suchProduct as adjusted, if applicable, pursuant to Section 2.14 and Section 4.7 and shall not beincluded to the extent they constitute Negligently Incurred Commercialization Costs