Commercialization Expenses definition

Commercialization Expenses means all actual costs and expenses (including labor) that are attributable to Commercialization activities, including Allocable Overhead. Commercialization Expenses shall include: (i) costs and expenses related to Phase III(b)/IV Studies related to Product, (ii) infrastructure required to support and maintain patient/safety surveillance as required by applicable Regulatory Authorities attributable to Product, including medical staff support and pharmacovigilence systems and procedures; (iii) out-of-pocket patent prosecution, enforcement and/or defense costs and expenses incurred by a Party in connection with claims instituted by either Party pursuant to Article 9 hereof, (iv) out-of-pocket costs and expenses of maintaining Regulatory Approvals in the Territory, (v) royalty and other amounts paid by a Party to Third Parties in connection with the use of Third Party technology related to the use or sale of Product, and all payments made to XOMA Ireland Limited under the Non-Exclusive XOMA Ireland License by Alexion (net of any amounts paid to Alexion by XOMA in respect thereof), (vi) the costs of product recalls, product liability claims, awards and damages, and Product liability insurance premiums, and (vii) costs and expenses incurred in connection with pricing and reimbursement matters, managed care and formulary management, and governmental affairs activities directly relating to a Product.

Commercialization Expenses has the meaning set forth in Schedule B.

Commercialization Expenses means, with respect to a Collaboration Product, (a) [***], (b) [***], (c) [***], (d) [***], (e) [***], (g) [***], and (h) other costs as mutually agreed by the Parties, all allocated to such Collaboration Product and calculated in accordance with the Collaboration Accounting Policies, consistently applied. This definition of Commercialization Expenses will be further elaborated in the commercialization agreement described in Section 8.4.

Examples of Commercialization Expenses in a sentence

• All other Manufacturing cost shall be payable by Alexion (and included in Development Expenses or Commercialization Expenses, as applicable) when incurred.

• Alexion may settle, compromise or otherwise dispose of any such proceeding that concerns the validity of any Product Trademark at its discretion, all costs of which will be considered Commercialization Expenses and all awards in connection therewith will be included in Gross Sales upon receipt.

• Xxxxxx shall bear all expenses of any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification, destruction and return of the affected Co-Developed Product and any refund to customers); provided, that, any such expenses shall be allocable as Co-Developed Costs or Commercialization Expenses and shared by the Parties in accordance with Section 5.3.

• The costs and expenses of such recall or removal in each country, including expenses and other costs or obligations to Third Parties, the cost and expense of notifying customers and costs and expenses associated with shipment of the recalled Product from a customer to either Alexion or XOMA shall be included in Commercialization Expenses; except as to any Product in a Future Indication as to which one Party has Opted Out and not Opted Back In, in which case the other Party shall bear such costs.

• The Parties shall collaborate in Commercializing each Collaboration Product in accordance with the relevant Commercialization Plan with the objective of achieving the commercial potential of the Collaboration Product and sharing equally in (a) all Joint Development Costs and Commercialization Expenses and (b) any Collaboration Product Profit.

More Definitions of Commercialization Expenses

Commercialization Expenses means all Cost of Sales, Distribution Costs, Marketing Costs, Sales Costs, General and Administrative Costs (in each case, to the extent not deducted from Net Sales under Section 1 hereof) of the Parties and their Affiliates with respect to the Collaboration Products.

Commercialization Expenses means all direct and indirect expenses incurred or to be incurred in connection with Commercializing the Licensed Product in the Territory, including A&P Expenses, Field Force Expenses, MSL expenses, costs associated with Managed Markets activities, market research costs, distribution costs and submission fees payable to DDMAC for review of Promotional Materials, to the extent such fees are now or hereafter payable pursuant to the Act or other applicable Laws.

Commercialization Expenses shall have the meaning provided in Exhibit B.

Commercialization Expenses means those expenses incurred by either Party (as detailed below) for the purpose of, and directly and specifically attributable to, the commercialization of Products in North America, and shall consist of the following expenses incurred: (a) by Takeda, or for its account: (1) Takeda Detailing Expenses, (2) any fees per-Detail paid to MacroGenics pursuant to the Co-Promotion Agreement; (3) Manufacturing Expenses, (4) Marketing Expenses, (5) Phase IV Trial Expenses, (6) reasonable out of pocket Third Party expenses arising from the selection, prosecution and enforcement of any Product-specific trademarks; and (b) by either Party, or for such Party’s account: (1) Internal Expenses and reasonable out of pocket Third Party expenses incurred for the training of each Party’s respective sales force, (2) reasonable out of pocket Third Party expenses arising from any infringement action initiated in accordance with Section 9.5; (3) any Product Liabilities that arise after Regulatory Approval, including reasonable out of pocket Third Party expenses related to such Product Liabilities; and (4) Third Party Obligations, arising under Section 8.9. For purposes of clarity, no general corporate overhead or fixed charges that are not directly and specifically attributable to the commercialization of Products shall constitute Commercialization Expenses (except as otherwise provided under the definition of Manufacturing Expenses). Commercialization Expenses shall not include: (a) expenses related to any Phase Ia Trial, Phase Ib Trial, Phase II Trial, or Phase III Trial, even if incurred after the First Commercial Sale of a Product in North America; (b) any expenses incurred by either Party more than [***] to the First Commercial Sale of a Product in North America; (c) costs that are deductible from Net Sales under the definition thereof; and (d) any Liabilities incurred by a Party as a result of such Party’s negligence, gross negligence, illegal conduct, willful misconduct or breach of such Party’s representations and warranties made hereunder and any such Liabilities will be treated as the sole and exclusive responsibility of the Party whose actions or omissions gave rise to such Liabilities.

Commercialization Expenses shall have the meaning set forth in Exhibit 1.189 (Profits and Losses).

Commercialization Expenses means the sum of (a) Sales and Marketing Expenses, and (b) Commercialization Costs.

Commercialization Expenses means the following costs of Commercialization activities actually performed by Providence or its Affiliates or their Third-Party subcontractors (but not by or on behalf of Sublicensees) with respect to a Product (to the extent not already deducted in calculating Net Sales), as approved by the JSC in the applicable Product Budget. Commercialization Expenses will be determined from books and records maintained in accordance with applicable Accounting Standards, consistently applied throughout the organization and across all products of the entity whose sales of Products are giving rise to Commercialization Expenses.