as amended.
HOWEVER, THAT, CLINICAL CONTENT WILL EXPRESSLY EXCLUDE PROTECTED HEALTH
INFORMATION AS DEFINED IN 45 C.F.R. 164.501.
1.4
"CONFIDENTIAL INFORMATION" MEANS ALL
CONFIDENTIAL OR OTHER PROPRIETARY INFORMATION OF A PARTY, WHETHER WRITTEN, ORAL
OR OTHERWISE, AND INCLUDING, BUT NOT LIMITED TO, KNOW-HOW OR OTHER INFORMATION,
WHETHER OR NOT PATENTABLE, REGARDING A PARTY'S TECHNOLOGY, PRODUCTS, BUSINESS
INFORMATION OR OBJECTIVES THAT IS DESIGNATED OR MARKED AS "CONFIDENTIAL" OR
ORALLY OR VISUALLY IDENTIFIED AS "CONFIDENTIAL" AND CONFIRMED AS SUCH IN WRITING
WITHIN THIRTY (30) DAYS AFTER SUCH DISCLOSURE.
1.5
"CONTROL" OR "CONTROLLED" MEANS WITH RESPECT
TO OWNERSHIP OF SAMPLES, CLINICAL CONTENT, TECHNOLOGY OR PATENT RIGHTS, THE
POSSESSION BY A PARTY OF THE RIGHT TO GRANT A LICENSE OR SUBLICENSE TO SUCH
SAMPLES, CLINICAL CONTENT, TECHNOLOGY OR PATENT RIGHTS AS PROVIDED HEREIN
WITHOUT VIOLATING ANY APPLICABLE LAWS AND STANDARDS.
1.6
"DESIGNATED BIOMARKERS" MEANS INDIVIDUALLY OR
COLLECTIVELY:
(A) [***]; (B) [***], AND (C) [***].
1.7
"GOVERNMENTAL ENTITY" MEANS ANY FEDERAL,
STATE, LOCAL OR FOREIGN GOVERNMENT (OR POLITICAL SUBDIVISION THEREOF), AGENCY,
AUTHORITY (INCLUDING, WITHOUT LIMITATION, REGULATORY AUTHORITY), COMMISSION,
COURT, TRIBUNAL, SOVEREIGN BODY OR OTHER GOVERNMENTAL OR QUASI-GOVERNMENTAL
AGENCY, ENTITY OR BODY.
1.8
"PATENT RIGHTS" MEANS THE RIGHTS AND
INTERESTS IN AND TO ISSUED PATENTS AND PENDING PATENT APPLICATIONS IN ANY
COUNTRY, INCLUDING ALL SUBSTITUTIONS, CONTINUATIONS, CONTINUATIONS-IN-PART,
DIVISIONALS, SUPPLEMENTARY PROTECTION CERTIFICATES, RENEWALS, ALL LETTERS PATENT
GRANTED THEREON, AND ALL REISSUES, REEXAMINATIONS, EXTENSIONS, CONFIRMATIONS,
REVALIDATION, REGISTRATIONS AND PATENTS OF ADDITION THEREOF.
1.9
"PRODUCT" MEANS ANY DIAGNOSTIC, PROPHYLACTIC,
THERAPEUTIC OR AMELIORATIVE PRODUCT THAT USES OR INCORPORATES THE DESIGNATED
BIOMARKERS, OR INCORPORATING APPROVED RESTRICTED BIOMARKERS ONLY IF THE PARTIES
AMEND THE AGREEMENT AS DESCRIBED IN SECTION 2.2(B), AND THAT IS VALIDATED UNDER
THE STUDY THROUGH USE OF THE SAMPLES, THE CLINICAL CONTENT AND/OR THE STUDY
TECHNOLOGY.
1.10
"PROTOCOL" MEANS THE MANNER AND METHODS BY WHICH
THE STUDY WILL BE CONDUCTED, A COPY OF WHICH IS ATTACHED HERETO AS APPENDIX 1.
1.11
"RESTRICTED BIOMARKERS" MEANS ANY BIOMARKERS OTHER
THAN THE DESIGNATED BIOMARKERS, UNLESS SUCH BIOMARKERS ARE INCLUDED IN THIS
AGREEMENT PURSUANT TO AN AMENDMENT AGREED TO IN WRITING BY AUTHORIZED SIGNERS
FROM BOTH PARTIES ACCORDING TO TERMS SET FORTH IN SECTION 2.2(B).
IF THIS
AGREEMENT IS SO AMENDED AND AGREED TO IN WRITING BY AUTHORIZED SIGNERS OF BOTH
PARTIES ACCORDING TO TERMS SET FORTH IN SECTION 2.2(B), THEN SUCH ADDITIONAL
APPROVED BIOMARKERS PREVIOUSLY CONSIDERED RESTRICTED BIOMARKERS SHALL BE
CONSIDERED "APPROVED RESTRICTED BIOMARKERS".
Confidential and proprietary
Do not disclose without express permission
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.
2
1.12
"RESTRICTED STUDY FIELD" MEANS ANY AREAS OUTSIDE
STUDY FIELD, WHICH ARE NOT PERMITTED IN THE CURRENT STUDY UNDER THE SAMPLES,
CLINICAL CONTENT AND TECHNOLOGY UNLESS THIS AGREEMENT IS AMENDED PURSUANT TO AN
AMENDMENT AGREED TO IN WRITING BY AUTHORIZED SIGNERS FROM BOTH PARTIES ACCORDING
TO TERMS SET FORTH IN SECTION 2.2(B).
1.13
"RESTRICTED TECHNOLOGY" MEANS ANY TECHNOLOGY USING