BY ANY LOCAL, STATE, AND
FEDERAL GOVERNMENTAL AUTHORITY OR AGENCY THAT GOVERNS OR APPLIES TO THEIR
RESPECTIVE DUTIES AND OBLIGATIONS HEREUNDER AND WITH ANY AND ALL RULES AND/OR
STANDARDS THAT ARE NOW OR HEREAFTER PROMULGATED BY ANY ACCREDITING OR
ADMINISTRATIVE BODY THAT GOVERNS OR APPLIES TO THEIR RESPECTIVE DUTIES AND
OBLIGATIONS HEREUNDER (THE "APPLICABLE LAWS AND STANDARDS").
THE APPLICABLE
LAWS AND STANDARDS WILL INCLUDE, BUT NOT BE LIMITED TO, THE HEALTH INSURANCE
PORTABILITY AND ACCOUNTABILITY ACT OF 1996 ("HIPAA"), THE REQUIREMENTS OF THE
DEPARTMENT OF HEALTH ("DOH"), JOINT COMMISSION ON THE ACCREDITATION OF
HEALTHCARE ORGANIZATIONS ("JCAHO") AND THE NATIONAL COMMITTEE ON QUALITY
ASSURANCE ("NCQA"), AS APPLICABLE.
WITHOUT LIMITING THE FOREGOING, EACH PARTY
AGREES TO CONFORM TO ALL LAWS, RULES, REGULATIONS AND POLICIES OF GOVERNING
AUTHORITIES WHICH HAVE JURISDICTION OVER THE USE AND TRANSFER OF PATIENT DATA.
ARTICLE 3 - PROVISION OF SAMPLES AND CLINICAL CONTENT
3.1
SUPPLY OF SAMPLES.
AS PART OF THE LIMITED
LICENSE GRANTED IN SECTION 4.1, GEISINGER WILL PROVIDE THE SAMPLES AND CLINICAL
CONTENT TO INTERLEUKIN IN ACCORDANCE WITH PROCEDURES SET FORTH IN THE PROTOCOL
AND WITHIN FIFTEEN (15) DAYS AFTER THE LATER OF THE EFFECTIVE DATE OR RECEIPT BY
GEISINGER OF THE FIRST INSTALLMENT OF THE OVERALL PAYMENT, AS PROVIDED IN
SECTION 6.2(A).
UNLESS OTHERWISE MUTUALLY AGREED BY THE PARTIES, PRIOR TO
PROVIDING THE SAMPLES, GEISINGER SHALL TEST, OR CAUSE TO BE TESTED, SUCH SAMPLES
IN ORDER TO DETERMINE WHETHER SUCH SAMPLES ARE USABLE SAMPLES IN THE STUDY AS
CONTEMPLATED BY THE PROTOCOL.
FOR EACH SAMPLE SHIPMENT, GEISINGER SHALL PREPARE
AND SUBMIT TO INTERLEUKIN A CERTIFICATE OF ANALYSIS, IN FORM AND CONTAINING SUCH
CONTENT AS IS MUTUALLY AGREEABLE TO THE PARTIES, THAT IDENTIFIES THE TEST
METHODS AND TEST RESULTS USED BY GEISINGER TO CONFIRM THAT THE SAMPLES ARE
USABLE SAMPLES (EACH, A "CERTIFICATE OF ANALYSIS" IDENTIFIED IN EXHIBIT 2).
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.
5
3.2
CONTINGENCY FOR USABLE SAMPLES.
(A)
WITHIN THIRTY (30) DAYS FOLLOWING ITS
RECEIPT OF EACH SHIPMENT OF SAMPLES AND THE APPLICABLE CERTIFICATE OF ANALYSIS,
INTERLEUKIN SHALL CONDUCT A REVIEW TO CONFIRM WHETHER SUCH SAMPLES ARE USABLE
SAMPLES BY:
(I) REVIEWING THE CERTIFICATE OF ANALYSIS AND/OR (II) CONDUCTING
INDEPENDENT ACCEPTANCE TESTING OF THE SAMPLES (THE "SAMPLE REVIEW").
UPON
COMPLETION OF THE SAMPLE REVIEW, INTERLEUKIN SHALL NOTIFY GEISINGER IN WRITING
WITHIN FOURTEEN (14) BUSINESS DAYS OF ITS DETERMINATION OF WHETHER THE SAMPLES
ARE NOT USABLE SAMPLES (SUCH NOTICE, THE "FAILED SAMPLE NOTIFICATION") OR ARE
USABLE SAMPLES (SUCH NOTICE, THE "SAMPLE ACCEPTANCE NOTIFICATION").
(B)
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN
SECTION 3.2(A), INTERLEUKIN'S USE OF SAMPLES IN THE CONDUCT OF THE STUDY, OTHER
THAN FOR CONDUCTING PCR EXPERIMENTS TO DETERMINE USABILITY OF SAMPLES, SHALL
RESULT IN IDENTIFICATION OF SUCH SHIPMENT OF SAMPLES AS USABLE SAMPLES, AND
THEREFORE, CONSTITUTE AN IMPLIED SAMPLE ACCEPTANCE NOTIFICATION, EVEN IF
INTERLEUKIN HAS NOT PROVIDED A WRITTEN