CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
Category” means [*****].
Commercial Sale” means, [*****].
Indication” means [*****].
means the equivalent of the work of one (1) employee full time for one (1) Calendar Year [*****] of work directly related to the
Development of a Licensed Product. No additional payment shall be made with respect to any person who works [*****] and any person
who devotes [*****] (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro rata basis based upon
Costs” means [*****].
Rate” means [*****].
means, with respect to a Party or its Affiliates or its or their Sublicensees, United States generally accepted accounting principles,
International Financial Reporting Standards or such other similar national standards as such Party, Affiliate or its or their
Sublicensee adopts, in each case, consistently applied.
Product” means, with respect to a Licensed Product, any pharmaceutical product that (i) contains an active ingredient
the same as or similar to the Licensed Compound in such Licensed Product, (ii) is distributed by a Third Party which is not a
Sublicensee or Affiliate thereof under a Drug Approval Application approved by a Regulatory Authority (a) in the U.S. pursuant
to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in
the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including
an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such
provision) or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions based on a demonstration
of bioequivalence or similarity to such Licensed Product and in reliance, in whole or in part, on the prior approval (or on safety
or efficacy data submitted in support of the prior approval) of such Licensed Product, and (iii) may be substituted under Applicable
Law as a therapeutic equivalent to such Licensed Product when dispensed without the intervention of a physician or other health
care provider with prescribing authority.
Clinical Practices” or “cGCP” means the then-current standards for
clinical trials for pharmaceuticals, as set forth in the FFDCA or other Applicable Law, and such standards of good clinical practice
as are required by the Regulatory Authorities of the United States and European Union and other organizations and Governmental
Authorities in countries for which any Licensed Product is intended to be Developed, to the extent such standards are not less
stringent than United States Good Clinical Practices.