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.
Sales” means, with respect to a Licensed Product, [*****]:
Specific Regulations” shall mean all judgments, decrees, orders or similar decisions issued by any Governmental Authority
specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind
by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s
activities contemplated by this Agreement.
means: (i) all national, regional and international patents and patent applications, including provisional patent applications;
(ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application
claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals
and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing
patent applications ((i) and (ii)), including utility models, petty patents, innovation patents and design patents and certificates
of invention; (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including
revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of
the foregoing patents or patent applications ((i), (ii) and (iii)); and (v) any similar rights, including so-called pipeline
protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions
to any of such foregoing patent applications and patents.
means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity
or organization, including a Governmental Authority.
1 Clinical Trial” means a human clinical trial of a pharmaceutical product candidate, in healthy volunteers or patients,
that generally provides for the first introduction into humans of such product candidate, with the principal purpose of obtaining
data regarding any or all of the safety, metabolism, pharmacokinetic properties and clinical pharmacology, and potentially early
evidence on effectiveness, of such product candidate, as described or contemplated by 21 C.F.R. §312.21(a).