OR COVERING RESTRICTED BIOMARKERS, OR USING DESIGNATED BIOMARKERS IN RESTRICTED
STUDY FIELD.
1.14
"SAMPLES" MEANS, AS DEFINED IN THE PROTOCOL,
(A) DNA BIOLOGICAL MATERIAL FROM 824 INDIVIDUALS TO BE PROVIDED BY GEISINGER TO
INTERLEUKIN AS DESCRIBED IN THIS AGREEMENT, THE EXACT QUANTITIES AND
CHARACTERISTICS OF WHICH ARE SET FORTH IN THE PROTOCOL AND (B) ANY DNA
BIOLOGICAL MATERIAL IN ADDITION TO THE DNA BIOLOGICAL MATERIAL PROVIDED BY
GEISINGER TO INTERLEUKIN UNDER SUBSECTION (A) THAT IS PROVIDED BY GEISINGER TO
INTERLEUKIN PURSUANT TO SECTION 3.2(D)(III) AND MEETS THE CRITERIA ESTABLISHED
IN THE PROTOCOL (THE "ADDITIONAL SAMPLES").
FOR PURPOSES OF CLARITY, (A) IF THE
[***] SAMPLE OPTION AND/OR THE [***] SAMPLE OPTION IS EXERCISED BY INTERLEUKIN
ACCORDING TO TERMS SET FORTH IN SECTIONS 3.3 AND/OR 3.4 (WHETHER PARTIAL OR FULL
EXECUTION), THEN SAMPLES SHALL ALSO INCLUDE THE [***] SAMPLE(S) AND/OR THE [***]
SAMPLE(S), AS THE CASE MAY BE, COVERED BY SUCH OPTION AND (B) SAMPLES WILL NOT
CONTAIN ANY PROTECTED HEALTH INFORMATION AS DEFINED IN 45 C.F.R. 164.501 (2002).
1.15
"STUDY" MEANS THE INVESTIGATION AND USE OF THE
SAMPLES AND CLINICAL CONTENT DESCRIBED IN THE PROTOCOL.
1.16
"STUDY FIELD" MEANS THE USE OF DESIGNATED
BIOMARKERS FOR GENETIC SCREENING PURPOSES RELATED TO WEIGHT LOSS, OBESITY, AND
METABOLIC SYNDROME, AS DESCRIBED IN THE PROTOCOL, INCLUDING DIABETES AND
DISLIPIDEMIA.
1.17
"STUDY RESULTS" MEANS ANY AND ALL DATA AND
INFORMATION PRODUCED IN THE CONDUCT OF THE STUDY.
1.18
"STUDY TECHNOLOGY" MEANS ANY TECHNOLOGY THAT IS
CONCEIVED OR FIRST REDUCED TO PRACTICE BY EITHER PARTY, OR JOINTLY BY THE
PARTIES, AFTER THE EFFECTIVE DATE AND BEFORE THE TERMINATION DATE, AS A RESULT
OF CONDUCTING THE STUDY AND IDENTIFIED IN WRITTEN FORM IN THE STUDY RESULTS.
1.19
"TECHNOLOGY" MEANS TECHNICAL OR OTHER INFORMATION,
WHETHER PATENTABLE OR NOT, AND WHETHER IN WRITTEN OR VERBAL FORM, INCLUDING
KNOW-HOW, EXPERIENCE, FORMULAE, CONCEPTS, DISCOVERIES, TRADE SECRETS,
INVENTIONS, MODIFICATIONS, IMPROVEMENTS, DATA (INCLUDING ALL CHEMICAL,
PRECLINICAL, PHARMACOLOGICAL, CLINICAL, PHARMACOKINETIC, TOXICOLOGICAL,
ANALYTICAL AND QUALITY CONTROL DATA), RESULTS, DESIGNS, IDEAS, ANALYSES,
METHODS, TECHNIQUES, ASSAYS, RESEARCH PLANS, PROCEDURES, TESTS, PROCESSES
(INCLUDING MANUFACTURING PROCESSES, SPECIFICATIONS AND TECHNIQUES), LABORATORY
RECORDS, REPORTS, SUMMARIES, AND INFORMATION CONTAINED IN SUBMISSIONS TO, AND
INFORMATION FROM, REGULATORY AUTHORITIES.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
3
1.20
"TERM" MEANS THE PERIOD COMMENCING ON THE
EFFECTIVE DATE AND CONTINUING FOR A PERIOD OF TWELVE (12) MONTHS, UNLESS
EXTENDED OR TERMINATED EARLIER IN ACCORDANCE WITH PROVISIONS IDENTIFIED IN
ARTICLE 10.
1.21
"TERMINATION DATE" MEANS THE FIRST ANNIVERSARY OF
THE EFFECTIVE DATE, UNLESS EXTENDED OR TERMINATED EARLIER IN ACCORDANCE WITH
PROVISIONS IDENTIFIED IN ARTICLE 10.
1.22
"THIRD PARTY" MEANS ANY ENTITY OTHER THAN
GEISINGER OR INTERLEUKIN AND THEIR RESPECTIVE AFFILIATES.
1.23
"USABLE SAMPLE" MEANS (A) A DNA SAMPLE THAT CAN BE
USED TO GENERATE A GENOTYPE CALL USING A [***], (B) AN [***] TISSUE PRESERVED IN
RNALATER OR (C) [***] THAT IS NOT DEGRADED WHEN EXAMINED