DISEASES IN HUMANS [***] OR [***] PURSUANT TO THIS
AGREEMENT AND THE DESIGN INPUTS, WHICH ASSAY IS DESIGNED FOR USE ON THE BECKMAN
ANALYZERS.
1.7
"BNP CALIBRATOR AND CONTROLS" SHALL MEAN THE BNP CALIBRATOR AND
CONTROLS [***] OR ON [***] OR [***] PURSUANT TO THIS AGREEMENT AND THE DESIGN
INPUTS, WHICH CALIBRATOR AND CONTROLS ARE FOR USE WITH THE BNP ASSAY.
1.8
"CLINICAL PLAN" SHALL MEAN A PLAN AND SCHEDULE FOR ANY EXTERNAL OR
INTERNAL EVALUATIONS TO BE CARRIED OUT DURING VALIDATION AND U.S. CLINICAL
TRIALS FOR THE PURPOSE OF REGULATORY APPROVAL.
1.9
"CONFIDENTIAL INFORMATION" SHALL MEAN, WITH RESPECT TO A PARTY,
ALL INFORMATION OF ANY KIND WHATSOEVER, AND ALL TANGIBLE AND INTANGIBLE
EMBODIMENTS THEREOF OF ANY KIND WHATSOEVER, THAT IS DISCLOSED BY SUCH PARTY TO
THE OTHER PARTY AND IS MARKED AS CONFIDENTIAL AT THE TIME OF DISCLOSURE TO THE
OTHER PARTY OR IF NOT MARKED AS CONFIDENTIAL AT THE TIME OF THE INITIAL
DISCLOSURE IS SO MARKED AND DISCLOSED AGAIN TO THE OTHER PARTY WITHIN THIRTY
(30) DAYS OF THE INITIAL DISCLOSURE. BIOSITE'S CONFIDENTIAL INFORMATION
INCLUDES, WITHOUT LIMITATION, ALL NON-PUBLIC INFORMATION RELATING TO THE BIOSITE
ANTIBODIES. NOTWITHSTANDING THE FOREGOING, CONFIDENTIAL INFORMATION OF A PARTY
SHALL NOT INCLUDE INFORMATION WHICH THE OTHER PARTY CAN ESTABLISH BY WRITTEN
DOCUMENTATION (A) TO HAVE BEEN PUBLICLY KNOWN PRIOR TO DISCLOSURE OF SUCH
INFORMATION BY THE DISCLOSING PARTY TO THE OTHER PARTY, (B) TO HAVE BECOME
PUBLICLY KNOWN, WITHOUT FAULT ON THE PART OF THE OTHER PARTY, SUBSEQUENT TO
DISCLOSURE OF SUCH INFORMATION BY THE DISCLOSING PARTY TO THE OTHER PARTY,
(C) TO HAVE BEEN RECEIVED BY THE OTHER PARTY AT ANY TIME FROM A SOURCE, OTHER
THAN THE DISCLOSING PARTY, RIGHTFULLY HAVING POSSESSION OF AND THE RIGHT TO
DISCLOSE SUCH INFORMATION, (D) TO HAVE BEEN OTHERWISE KNOWN BY THE OTHER PARTY
PRIOR TO DISCLOSURE OF SUCH INFORMATION BY THE DISCLOSING PARTY TO THE OTHER
PARTY, OR (E) TO HAVE BEEN INDEPENDENTLY DEVELOPED BY EMPLOYEES OR AGENTS OR
AFFILIATES OF THE OTHER PARTY WITHOUT ACCESS TO OR USE OF SUCH INFORMATION
DISCLOSED BY THE DISCLOSING PARTY TO THE OTHER PARTY.
1.10
"DESIGN INPUTS" SHALL MEAN THE DETAILED PRODUCT REQUIREMENTS,
FUNCTIONAL SPECIFICATIONS AND TESTING METHODOLOGIES SET FORTH IN EXHIBIT A.
***Confidential Treatment Requested
2
1.11
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR
THE SUCCESSOR THERETO.
1.12
"FIRST COMMERCIAL SALE" SHALL MEAN THE FIRST SALE ANYWHERE IN THE
WORLD OF A BNP ASSAY BY BIOSITE OR ANY AFFILIATE OR AUTHORIZED DISTRIBUTOR OF
BIOSITE TO CUSTOMERS WHO ARE NOT AFFILIATES IN ANY COUNTRY AFTER ALL APPLICABLE
MARKETING AND PRICING APPROVALS (IF ANY) HAVE BEEN GRANTED BY THE APPLICABLE
GOVERNING HEALTH AUTHORITY OF SUCH COUNTRY. AS USED IN THIS DEFINITION,
"AUTHORIZED DISTRIBUTOR" INCLUDES [***] OF BIOSITE IN ANY COUNTRY UNDER THE
[***].
1.13
"FOREIGN PURCHASE PRICE" MEANS THE PRICE EQUAL TO (A) FOR THE FIRST
PRICING PERIOD, [***] PER [***] OF THE BNP ASSAYS, AND (B) FOR EACH SUBSEQUENT
PRICING PERIOD, THE PRICE PER [***] OF THE BNP ASSAYS FOR THE