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.
Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially
all of such Party’s consolidated total assets; or
For the purpose
of this definition of Change of Control: (i) “person” and “group” have the meanings given such terms
under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any
group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the
aforesaid Act; (ii) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid
Act; and (iii) the terms “beneficially owned” and “beneficially own” shall have meanings correlative
to that of “beneficial owner.”
means Swiss Francs.
“Clinical Trial” means a human clinical trial designed to evaluate
the safety, efficacy, tolerability or appropriate dosage of a Licensed Product, as the context requires, including Phase 1 Clinical
Trials, Phase 2 Clinical Trials or Phase 3 Clinical Trials.
means, chemistry, Manufacturing and controls with respect to a product, which includes (i) Manufacturing process development records
for such product, (ii) all chemistry, Manufacturing and control procedures necessary for the Manufacture of such product, and
(iii) sourcing and testing of all raw materials and components used in the Manufacture of such product.
means, with respect to any product, any and all activities directed to the preparation for sale of, offering for sale of or sale
of such product, including activities related to marketing, promoting, distributing and importing such product, and interacting
with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing”
mean to engage in Commercialization and “Commercialized” has a corresponding meaning.
Reasonable Efforts” means with respect to the performance of activities with respect to any Licensed Compound or Licensed
Product by a Party, [*****].
means a customer's written, oral or electronic communication that alleges deficiencies related to the identity, quality, purity,
durability, reliability, safety, or effectiveness or performance of a distributed drug product, drug/device combination product,
medical device, animal health premix, API (active pharmaceutical ingredient), process intermediate or fermentation product. Complaints
include: Adverse Events, adverse drug experiences, adverse drug reactions, company identified reportable malfunctions (CIRM),
lack of drug effect (LODE) and product complaints.