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Confidential | | EXECUTION COPY |
1.36“Indication” means any specific disease or medical condition that a Product is intended to treat, prevent, cure, or ameliorate.
1.37“Initiation” of a clinical trial means the dosing of the first study subject in such clinical trial.
1.38“Invention” means any process, method, composition of matter, article of manufacture, discovery or finding that is developed, discovered, made, generated, conceived, and/or reduced to practice as a result of a Party (including its Affiliates, sublicensees and their respective subcontractors) carrying out its obligations under this Agreement, whether or not patentable.
1.39 “[***]” has the meaning set forth in Section 14.6(b).
1.40“Joint Inventions” has the meaning set forth in Section 9.1.
1.41“Joint Patents” has the meaning set forth in Section 9.1.
1.42“Know-How” means any information and materials, including but not limited to, discoveries, improvements, processes, methods, protocols, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, but excluding any Patent Rights.
1.43“Licensed Compound” means (a) Portola’s proprietary dual Syk-JAK inhibitor cerdulatinib, the chemical structure of which is set forth inExhibit A, and (b) any backup compounds listed inExhibit A or otherwise agreed to by the Parties, in each case of (a) and (b) including salt form, base form, pro-drug, ester, ether, isomer, metabolite, crystalline polymorph, and hydrate of solvate thereof.
1.44“Licensed Field” means the treatment of all Indications through topical application of the Product to the skin other than oncology Indications.
1.45“Manufacturing Cost” means, with respect to the Licensed Compound supplied by Portola to Dermavant under Section 6.1(a) of this Agreement:
(a) if such Licensed Compound is manufactured by Portola’s Third Party contract manufacturer, (i) Portola’s actual Third Party cost (expressed on a per unit manufactured basis) of manufacturing, processing, testing, and packaging such Licensed Compound, and (ii) any reasonable costs incurred by Portola for manufacturing oversight and quality assurance with respect to such Licensed Compound; and
(b) if such Licensed Compound is manufactured by Portola itself, the actual, fully-burdened cost of manufacturing, processing, testing, and packaging such Licensed Compound, including without limitation raw materials, direct labor and benefits, and the proportionate share of indirect manufacturing costs. For clarity, such fully-burdened cost shall be calculated in accordance with GAAP.
1.46“Manufacturing Transfer Period” has the meaning set forth in Section 6.2(a).
CERTAINCONFIDENTIALINFORMATIONCONTAINEDINTHISDOCUMENT,MARKEDBY [***],HASBEENOMITTEDBECAUSE DERMAVANT SCIENCES LTD.HASDETERMINEDTHEINFORMATION (I)ISNOTMATERIALAND (II)WOULDLIKELYCAUSECOMPETITIVEHARMTO DERMAVANT SCIENCES LTD.IFPUBLICLYDISCLOSED.
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