PREVIOUS PRICING
PERIOD ADJUSTED (IN ACCORDANCE WITH SECTION 6.1.7) BY THE [***] OR [***] OF THE
[***] FOR THE APPLICABLE MEASUREMENT PERIOD AS COMPARED TO THE [***] FOR THE
IMMEDIATELY PRECEDING MEASUREMENT PERIOD.
1.14
"GMP" SHALL MEAN CURRENT GOOD MANUFACTURING PRACTICES AS PRESCRIBED
FROM TIME TO TIME BY THE FDA.
1.15
"GUIDELINES" SHALL MEAN THE GUIDELINES AND REQUIREMENTS FOR THE
PARTIES' OBLIGATIONS REGARDING THE [***] OF BNP ASSAY AND BNP CALIBRATOR AND
CONTROLS ATTACHED HERETO AS EXHIBIT B (AS MODIFIED FROM TIME TO TIME BY THE
JOINT COMMITTEE IN ACCORDANCE WITH SECTION 5.7).
1.16
"JOINT COMMITTEE" SHALL MEAN THE JOINT COMMITTEE DESCRIBED IN
SECTION 5.7.
1.17
"MARKER" SHALL MEAN (A) [***], WITH OR WITHOUT THE [***] SEQUENCE,
OR (B) ANY [***] THEREOF (HOWEVER DERIVED), INCLUDING WITHOUT LIMITATION THE
[***] COMMONLY KNOWN AS [***] AND THE [***] COMMONLY KNOWN AS [***].
1.18
"MEASUREMENT PERIOD" MEANS, FOR THE CURRENT PRICING PERIOD, THE
MOST RECENT [***], PRIOR TO THE DATE [***] BEFORE THE START OF THE CURRENT
PRICING PERIOD, FOR WHICH DATA (AS DETERMINED BY [***] OR SUCH OTHER PARTY
MUTUALLY ACCEPTABLE TO THE PARTIES AND AGREED TO IN WRITING) IS AVAILABLE FOR
SALES TO [***] OF ASSAYS [***] THAT MEASURE OR DETECT THE PRESENCE OR ABSENCE OF
THE MARKER. IF THE MOST RECENT SUCH DATA PROVIDED BY [***] (OR SUCH OTHER PARTY
AGREED TO BY THE PARTIES THEN PROVIDING SUCH DATA) IS ONLY AVAILABLE FOR A
PERIOD ENDING MORE THAN [***] PRIOR TO THE START OF THE CURRENT PRICING PERIOD,
THE PARTIES SHALL AGREE UPON A DIFFERENT, MUTUALLY ACCEPTABLE PARTY TO PROVIDE
SUCH DATA OR DATA SUBSTANTIALLY SIMILAR TO THAT DESCRIBED IN THIS SECTION.
1.19
"PERSON" SHALL MEAN AN INDIVIDUAL, CORPORATION, PARTNERSHIP,
LIMITED LIABILITY COMPANY, TRUST, BUSINESS TRUST, ASSOCIATION, JOINT STOCK
COMPANY, JOINT
***Confidential Treatment Requested
3
VENTURE, POOL, SYNDICATE, SOLE PROPRIETORSHIP, UNINCORPORATED ORGANIZATION,
GOVERNMENTAL AUTHORITY OR ANY OTHER FORM OF ENTITY NOT SPECIFICALLY LISTED
HEREIN.
1.20
"PRICING PERIOD" MEANS EACH [***] PERIOD ENDING ON EACH [***] AND
[***] FOLLOWING THE FIRST COMMERCIAL SALE.
1.21
"PRODUCT RISK ANALYSIS" SHALL MEAN A FORMAL RISK ASSESSMENT OF BNP
ASSAY, USING FAILURE MODES AND EFFECTS ANALYSIS (FMEA), RISK ANALYSIS, OR OTHER
APPROVED TOOL.
1.22
"PROJECT" SHALL HAVE THE MEANING AS DEFINED IN SECTION 3.2.1.
1.23
"PROTOTYPE ACCEPTANCE" SHALL HAVE THE MEANING AS DEFINED IN SECTION
3.3.
1.24
"PROTOTYPES" SHALL MEAN DEVELOPMENT PROTOTYPES OF THE BNP ASSAY AND
BNP CALIBRATOR AND CONTROLS.
1.25
"RELEASE SPECIFICATIONS" SHALL MEAN THE DETAILED PRODUCT
REQUIREMENTS, FUNCTIONAL SPECIFICATIONS AND TESTING METHODOLOGIES FOR THE FINAL
BNP ASSAY OR BNP CALIBRATOR AND CONTROL, AS SUCH REQUIREMENTS, SPECIFICATIONS
AND METHODOLOGIES SHALL BE DEVELOPED BY THE PARTIES IN ACCORDANCE WITH
SECTION 3.5 AND AS MAY BE MODIFIED FROM TIME TO TIME UPON MUTUAL WRITTEN
AGREEMENT OF THE PARTIES.
1.26
"TECHNICAL VALIDATION REPORT" SHALL MEAN A SUMMARY REPORT FOR ALL
TESTING CONDUCTED AS PART OF THE MANUFACTURING VALIDATION PLAN, INCLUDING PILOT
BUILD RESULTS, DEMONSTRATING CONFORMANCE OF THE PROTOTYPES TO THE DESIGN INPUTS.
1.27
"TECHNICAL VERIFICATION REPORT" SHALL MEAN A SUMMARY OF ALL TESTING
RESULTS