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.

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Commercialization Expenses has the meaning set forth in Schedule B.

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.

Examples of Commercialization Expenses in a sentence

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.
All other Manufacturing cost shall be payable by Alexion (and included in Development Expenses or Commercialization Expenses, as applicable) when incurred.
Within forty-five (45) days after the end of each calendar quarter, Alexion shall submit a written report to XOMA setting forth in reasonable detail Gross Sales (including Sales Returns and Allowances), Marketing/Development Partner Revenues and Allowable Expenses (including Cost of Goods Sold, Distribution Expenses, Sales and Marketing Expenses and Commercialization Expenses) incurred by or on behalf of Alexion in the Territory during such calendar quarter.
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.
The cost of insurance required by this Article 22 with respect to the Collaboration Product shall be treated as a Joint Development Cost or an “other cost” for the purposes of calculating Commercialization Expenses, as applicable.

More Definitions of Commercialization Expenses

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.

Commercialization Expenses shall have the meaning set forth on Exhibit A.

Commercialization Expenses mean those expenses incurred by either Party (as detailed below) for the purpose of, and directly and specifically attributable to, the Commercialization of the Licensed Products in the Territory, and shall consist of the following expenses: (a) Distribution Costs; (b) Health Care Reform Fees; (c) Manufacturing Costs for commercial supply in the Territory; (d) Marketing Expenses; (e) Other Commercialization Costs; (f) Patent and Trademark Prosecution and Enforcement Costs incurred in any country of the Territory from and after the First Commercial Sale of a Licensed Product in the country; (g) Product Liabilities; (h) Recall Expenses; (i) Regulatory Maintenance Costs; (j) Selling Expenses; and (k) Third Party Patent Costs incurred in a country from and after the First Commercial Sale of a Licensed Product in the country. Commercialization Expenses shall not include: (w) expenses related to any Clinical Trial even if incurred after the First Commercial Sale of a Licensed Product in any country of the Territory; (x) costs that are deductible from Net Sales under the definition thereof; (y) any losses, damages, fees, costs and other 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 losses, damages, fees, costs and other liabilities will be treated as the sole and exclusive responsibility of the Party whose actions or omissions gave rise to such losses, damages, fees, costs and other liabilities; or (z) fines, penalties, assessments or other financial sanctions levied by any governmental authority on either Party. All of such costs shall be as determined from the books and records of the applicable Party and its Affiliates maintained in accordance with the Accounting Standards. Notwithstanding anything in this definition to the contrary, only those Commercialization Expenses that are contemplated by, and materially consistent with, the Commercialization Plan and Commercialization Budget for the Licensed Product shall be chargeable as Commercialization Expenses. For purposes of clarity, no general corporate overhead or fixed charges, such as depreciation, shall constitute Commercialization Expenses (except as otherwise provided under the definition of Manufacturing Costs).

Commercialization Expenses means the fees and expenses payable to Quintiles for the Commercialization Services.

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.

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

Commercialization Expenses means those Third Party Expenses incurred by a Party, or for its account, after the Effective Date and expenses of FTEs, calculated at the FTE Rate, to the extent directly and reasonably allocable to the Commercialization of Products (whether incurred prior to or after receipt of Marketing Approval) and that are consistent with the Commercialization Budget (subject to Section 8.2(c)), including [*]. Commercialization Expenses include [*], but do not include [*]. Notwithstanding the foregoing, Commercialization Expenses do not include (a) [*], (b) [*], (c) [*], (d) [*], and (e) [*]. The determination of each Party’s Commercialization Expenses shall be in accordance with the applicable Accounting Standard.