to different [***] applications as long as [***] is achieved for
each [***] application.
The [***] instrument should be tested according to the standards of the
appropriate [***] prior to being delivered to [***].
[***] testing (which
should be the same as the [***] testing mentioned in the [***] section of this
document) can be performed at [***] or [***], and the results of that testing,
along with the [***] of [***] product [***] testing for the instrument, will be
presented to the [***] to amend the current [***].
While the [***] and [***]
documentation may be required for the [***] for the instrument itself, it is
[***] that extensive [***] documentation will be required for the [***]
submission.
However, the [***] will [***] audit [***].
In addition, results of
the [***] testing will [***] be required for the [***] amendment as well as
[***] or [***].
This concludes the Regulatory Strategy.
Schedule 5.2.1a
eSAS 2 Development Costs
1.
REIMBURSABLE FTE RATE.
[$[***] PER FTE PER CALENDAR YEAR]
2.
ESAS 2 DEVELOPMENT COSTS INCLUDED WITHIN FTE LABOR RATE.
ESAS
2 DEVELOPMENT COSTS INCLUDED WITHIN FTE LABOR RATE CONSIST OF ALL ATTRIBUTABLE
COSTS ASSOCIATED WITH THE DEVELOPMENT OF THE ESAS 2 INSTRUMENT AND MODIFICATIONS
TO ASSOCIATED INSTRUMENT SYSTEM PLATFORMS THAT MAY BE REQUIRED FOR SUCH ESAS 2
INSTRUMENT (CALCULATED IN ACCORDANCE WITH UNITED STATES GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES, OR AS OTHERWISE MUTUALLY AGREED IN WRITING BETWEEN THE
PARTIES) INCURRED PRIOR TO THE COMPLETION DATE AND INCLUDES PILOT DEVELOPMENT;
VALIDATION STUDIES NECESSARY FOR PRODUCT AND PROCESS LICENSURE; CLINICAL
STUDIES; LICENSING ACTIVITIES; AND THE MANUFACTURE AND ULTIMATE DISPOSITION OF
CONFORMANCE LOTS OF MATERIAL, CALCULATED AS FOLLOWS:
(A)
SHARED DEVELOPMENT COSTS INCLUDE: RESEARCH AND DEVELOPMENT ASSOCIATED WITH
THE ESAS 2 DEVELOPMENT PROGRAM; CLINICAL STUDIES; VALIDATION EXCLUSIVELY
ASSOCIATED WITH THE PARTICULAR ANALYTE; DEVELOPMENT LOTS; DOCUMENT PREPARATION
SPECIFIC TO THE DEVELOPMENT;
(B)
THE PLANNED RESOURCES, AND THE ASSOCIATED COSTS, WILL BE BROKEN OUT ON A
MONTHLY BASIS AND ANALYZED AGAINST THE RESOURCE PLAN INCLUDED WITHIN THE
TECHNICAL PLAN, AND REFLECTED IN THE BUDGET;
(C)
SALARIED STAFF COSTS INCLUDED WITHIN THE BUDGET WILL BE ADJUSTED TO REFLECT
ACTUAL STAFF COSTS.
SALARY INFORMATION MAY BE AGGREGATED TO PROTECT THE
IDENTITY OF INDIVIDUALS.
THIS SALARY INFORMATION WILL BE VERIFIABLE ON A NEED
TO KNOW BASIS TO A SELECT NUMBER OF PERSONNEL FROM EACH COMPANY;
(D)
COST FOR WAGE LABORERS PLUS THE APPLICABLE OVERHEAD CHARGE FOR SUCH LABOR
(CALCULATED AT THE RATES AND CHARGES DESCRIBED IN SECTION 5.2.1) PAID TO
PERSONNEL DESCRIBED IN THE RESOURCE PLAN, INCLUDING THE ESAS 2 DEVELOPMENT
PROGRAM PROJECT MANAGER AND PERSONNEL ENGAGED TO PERFORM QA TESTING FOR THE ESAS
2 DEVELOPMENT PROGRAM;
(E)
COSTS FOR ENGINEERING PROTOTYPES AND MANUFACTURING PILOT MODULES REQUIRED
FOR THE ESAS 2 DEVELOPMENT PROGRAM;
(F)
COSTS OF INVENTORY CONSUMED IN THE ESAS 2 DEVELOPMENT PROGRAM, INCLUDING
RAW MATERIAL, INTERMEDIATES AND FINISHED GOODS, AND CONFORMANCE LOTS, WHETHER
REJECT OR NOT, THAT ARISE FROM THE ESAS 2 DEVELOPMENT PROGRAM OR ARE NECESSARY
TO SUPPORT THE ESAS 2 DEVELOPMENT PROGRAM, AND SCRAP MATERIAL,