FOIA CONFIDENTIAL TREATMENT REQUESTED
Confidential Materials omitted and filed separate with the Securities and Exchange Commission
Triple asterisks denote omissions
(o) Dollar or $ means the lawful currency of the United States.
(p) Effective Date has the meaning given in the preamble.
(q) Field means the treatment of actinic keratosis and oncology indications in humans.
(r) Improvements means all inventions, modifications, improvements and Know-How, patentable or otherwise, made, created, developed, conceived or reduced to practice by or on behalf of a Party and/or any of its Affiliates during the Term, including without limitation developments in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage, indication, methods of use or packaging and/or sale of the Compound or Licensed Products.
(s) Infringement has the meaning set forth in SECTION 6.3(a)
(t) Intellectual Property means Patent Rights, Know-How, copyrights and works of authorship, Proprietary Information and all other intellectual property rights (except for trademarks, trade names and other source indicators), including any Improvements thereto.
(u) Investigational New Drug Application means an investigational new drug application described in 21 CFR §312.23, obtained for purposes of conducting Clinical Trials in accordance with the requirements of the Act and the regulations promulgated thereunder, or the similar or equivalent application or approval under applicable Laws in another country, including all supplements and amendments thereto relating to the use of the Compound or Licensed Product.
(v) Licensee Indemnified Parties has the meaning set forth in Section 10.1.
(w) Licensed Products means any topical or oral Products that contain the Compound.
(x) Know-How means all proprietary information and technology, including trade secret information, developments, discoveries, methods, techniques, formulations, Data, and other information, whether or not patentable, and any Improvements thereto.
(y) Law means all laws, statutes, rules, regulations, treaties, ordinances and other pronouncements of any governmental authority having the binding effect of law.
(z) Losses means any and all damages, awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties (including penalties imposed by any governmental authority), costs, fees, liabilities, obligations, losses, lost profits and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts) awarded or otherwise paid or payable to Third Parties.
(aa) Net Sales means the gross sales amount of Licensed Products invoiced to Third Parties by Licensee and its Affiliates, less the following deductions (to the extent included in such gross sales amount):
(i) quantity and/or cash discounts therefor;