Section 1.65 "Litigation Condition" shall have the meaning set forth in Section 11.03(b).
Section 1.66 "Long Acting Muscarinic Antagonist" or "LAMA" means an inhaled agent that selectively binds muscarinic acetylcholine receptors, blocking or inhibiting M3 muscarinic acetylcholine receptor activity, and has a duration of action sufficient to require dosing no more than twice per day for the treatment of respiratory disorders in humans. LAMAs include tiotropium, glycopyrrolate/glycopyrronium, umeclidinium, aclidinium, oxitropium and dexpyrronium.
Section 1.67 "Losses" means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses, lost profits and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts), in each case awarded to Third Parties and required to be paid to Third Parties with respect to a Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, together with all documented out-of-pocket costs and expenses incurred by the Indemnified Party in complying with any judgments, orders, decrees, stipulations and injunctions that arise from or relate to a Claim of a Third Party.
Section 1.68 "MAA" means a marketing authorization application or any amendments or supplements thereto submitted to the EMA in the EU. For purposes of this Agreement, the term "MAA" shall also mean any comparable marketing authorization or approval filings in the other ROW Countries in the Territory.
Section 1.69 "Manufacturing Cost" means, with respect to Licensed Product, the fully allocated direct and indirect costs incurred by MYLAN or its Affiliates determined in accordance with GAAP and consistent with MYLAN's internal accounting practices, consistently applied, for the manufacture of Licensed Product (provided that any such indirect costs are reasonably allocable to such Licensed Product), which costs may include:
(a) the cost of materials (including API Compound), components, supplies and other resources directly or indirectly consumed, in each case including freight, insurance, shipping, packaging and other similar costs associated with acquiring such items;
(b) labor (including salaries, wages and current period employee benefits), including management salary and benefits allocable to the manufacture of Licensed Product;
(c) the net cost or credit of any value-added taxes or duties actually paid or utilized (and not reimbursed or reimbursable) on account of such Licensed Product;
(d) Third Party costs for the manufacture of Licensed Product, including facilities fees, transportation costs, customs, duty and transit insurance costs;
***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.