Eligible Commercialization Expenses definition
Eligible Commercialization Expenses means the [***], in each case, to the extent such costs are included in the [***]. Eligible Commercialization Expenses specifically exclude (i) the cost of activities that [***], and (ii) any costs or expenses of a Party or its Affiliates to the extent [***]. If any cost or expense is specifically identifiable or reasonably allocable to more than one cost category set forth above in clause (a) through (f), then such cost or expense will only be counted as an Eligible Commercialization Expense with respect to one such category. [***]. For clarity, Eligible Commercialization Expenses will be recognized in accordance with applicable Accounting Standards.
Eligible Commercialization Expenses means the [***],
Eligible Commercialization Expenses means the FTE Costs and Out-of-Pocket Expenses incurred by or on behalf of a Party or its Affiliates that are directly attributable or reasonably allocable to Commercialization activities for the Products described in the applicable Commercialization Plan:
Examples of Eligible Commercialization Expenses in a sentence
The Parties will share the Eligible Commercialization Expenses for all Products for the Territory as set forth in Section 9.3 (Profit and Loss Share).
The Parties will share the Eligible Commercialization Expenses for all Profit-Share Products as set forth in Section 9.2.1 (Profit and Loss Share).
The Parties will share the Eligible Commercialization Expenses for all Products for the Profit-Share Territory as set forth in Section 10.2.1 (Profit and Loss Share), and Takeda will be solely responsible for all costs and expenses relating to the Commercialization of all Products in the Takeda Territory.
For Licensed Category 1 Products, all such expenses will be treated as Eligible Development Expenses or Eligible Commercialization Expenses (as applicable).
The Parties will share the Eligible Commercialization Expenses incurred in connection with the performance of Commercialization activities related to each Licensed Category 1 Product and Companion Diagnostic directed to each Licensed Category 1 Target as set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities).
ALJ shall be responsible for storage costs for Products for the Territory and such costs shall be deemed to be Eligible Commercialization Expenses for the purposes of the Agreement.
Each Party will keep complete, true, and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including in relation to Development Expenses, Eligible Commercialization Expenses, Gross Profit, Net Sales, Sublicense Revenue, and Category 2 Royalties.
More Definitions of Eligible Commercialization Expenses
Eligible Commercialization Expenses means, with respect to a Profit-Share Product and a period of the PSP P&L Share for such Profit-Share Product, all FTE Costs, Out-of-Pocket Costs, and other costs and expenses incurred by or on behalf of a Party or its Affiliates that are directly attributable to Commercialization activities for such Profit-Share Product in accordance with the applicable Co-Funded Commercialization Plan, including the following:
a. [***]; and
b. [***];
c. in each case, to the extent such costs are consistent with the applicable Co-Funded Commercialization Budget, plus applicable Allowable Overruns and [***], but expressly excluding [***].
d. Eligible Commercialization Expenses specifically exclude the cost of [***].
e. If any FTE Cost, Out-of-Pocket Cost, or other cost or expense is specifically identifiable or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted once (i.e., as an Eligible Commercialization Expense with respect to only one such category). No FTE Cost, Out-of-Pocket Cost, or other cost or expense included as an Eligible Commercialization Expense will also be included as an Eligible Development Expense or an Eligible Medical Affairs Expense. Eligible Commercialization Expenses will be recognized and calculated in accordance with the applicable Accounting Standards.
Eligible Commercialization Expenses means, on a Cost-Profit Sharing Product-by-Cost-Profit Sharing Product and Cost-Profit Sharing Country-by-Cost Profit Sharing Country basis, costs and expenses incurred by or on behalf of a Party or its Affiliates [***] such Cost-Profit Sharing Product and such Cost-Profit Sharing Country in accordance with the Co-Commercialization Plan/Budget with respect to the following:
(a) Manufacturing Costs for such Cost-Profit Sharing Products used for performance of Commercialization activities in such Cost-Profit Sharing Country (and not used in connection with Clinical Studies or other Development activities), or incurred in support of such Commercialization activities, all to the extent incurred [***];
(b) Sales and Marketing Costs for such Cost-Profit Sharing Products in such Cost-Profit Sharing Country;
(c) FTE Costs or Out-of-Pocket Costs pertaining to any obtaining or maintaining Pricing and Reimbursement Approvals or any filing and other Regulatory Authority fees associated therewith; and
(d) any other FTE Costs and Out-of-Pocket Costs agreed to be shared by the Parties as Eligible Commercialization Expenses under this Definitive LRRK2 Agreement. Eligible Commercialization Expenses specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses: (i) incurred by or on behalf of the performing Party or its Affiliates to the extent caused by such Party’s or its Affiliates’ action or omission that constitutes a breach under this Definitive LRRK2 Agreement by or on behalf of the performing Party; (ii) incurred after the Co-Funding End Date for a particular Cost-Profit Sharing Product and corresponding Cost-Profit Sharing Country to the extent a Denali Commercialization Opt-Out has occurred; or (iii) [***]. If any cost or expense [***] more than one Commercialization cost category set forth above, then such cost or expense will only be counted once (i.e., as an Eligible Commercialization Expense with respect to only one such category). No cost or expense included as an Eligible Commercialization Expense will (x) also be included as an Eligible Development Expense or an Eligible Medical Affairs Expense, (y) be (or have been) included in the calculation of Net Sales as a deduction from the total amount billed or invoiced on sales of the applicable Cost-Profit Sharing Product, or (z) be an amount for which one Party or the other is solely responsible under this Definitive LRRK2 Agreement. Eligible Commercialization Expenses will be recognized a...
Eligible Commercialization Expenses means all FTE Costs, Out‑of‑Pocket Costs, and other costs and expenses incurred by or on behalf of Takeda or its Affiliates that are attributable to Commercialization activities for the Products in the Profit-Share Territory in accordance with the applicable Co-Funded Commercialization Plan, including the following
Eligible Commercialization Expenses means all FTE Costs, Out‑of‑Pocket Costs, and other costs and expenses incurred by or on behalf of Takeda or its Affiliates that are attributable to Commercialization activities for the Products in the Profit-Share Territory in accordance with the applicable Co-Funded Commercialization Plan, including the following
(a) [***];
(b) [***] that is specifically allocated to sales of such Product; and
(c) costs and expenses that are attributable to [***]; in each case, to the extent such costs are consistent with the applicable Co-Funded Commercialization Budget, plus applicable Allowable Overruns [***]. If any FTE Cost, Out-of-Pocket Cost, or other cost or expense is specifically identifiable or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted once (i.e., as an Eligible Commercialization Expense with respect to only one such category). No FTE Cost, Out-of-Pocket Cost, or other cost or expense included as an Eligible Commercialization Expense will also be included as an Eligible Development Expense or an Eligible Medical Affairs Expense. Costs attributable to sales personnel will be calculated in accordance with Section 1.81(c) and not as FTE Costs. Eligible Commercialization Expenses will be recognized and calculated in accordance with the applicable Accounting Standards.
Eligible Commercialization Expenses means the FTE Costs and Out-of-Pocket Expenses incurred by or on behalf of a Party or its Affiliates that are directly attributable or reasonably allocable to Commercialization activities for the Products described in the applicable Commercialization Plan:
(a) Manufacturing Costs for Products used for Commercialization (including for inventory build);
(b) Distribution Costs;
(c) FTE Costs and Out-of-Pocket Expenses associated with (i) the development of the Commercialization Plan and each update or amendment thereto, (ii) marketing of such Product, (iii) marketing (including telemarketing), promotion, advertising, professional education, symposia and opinion leader development, and Promotional Materials (including the development thereof), (iv) activities related to obtaining reimbursement from payers and costs of sales and marketing data, and (v) market research and strategic planning activities for such Product;
(d) to the extent provided in Section 13.3 (Certain Indemnified Losses), Liabilities from Third Party claims arising from the Commercialization (or Manufacture in support of Commercialization) of the Products for the Territory; and
(e) FTE Costs and Out-of-Pocket Expenses that are attributable to the establishment and maintenance of sales personnel (including a field-based sales force and regional managers) to the extent such personnel are, or will be, assigned to selling such Product, in each case, to the extent such costs and expenses (as applicable) are included in the applicable Commercialization Budget, plus applicable Allowable Overruns and costs or expenses otherwise approved by the PCC, but expressly excluding Overhead Costs and capital expenditures. If any FTE Cost or Out-of-Pocket Expense is directly attributable or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted once (i.e., as an Eligible Commercialization Expense with respect to only one such category). Eligible Commercialization Expenses specifically exclude (i) the cost of activities that promote a Party’s, its Affiliates’ or Sublicensees’ business as a whole without being specific to the Commercialization of any Product, and (ii) any costs or expenses incurred by or on behalf of a Party or its Affiliates to the extent caused by such Party or its Affiliates’ or Sublicensees’ action or omission that constitutes a breach of or default under this Agreement by or on behalf of such Party. No FTE Cost or...