1
EXHIBIT 10.19B
October 21, 1998
Respironics Georgia, Inc.
0000 Xxxxxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
RE: AMENDMENT TO PURCHASING AND LICENSING AGREEMENT
This letter serves to amend certain terms (the "Amendment") of the Purchasing
and Licensing Agreement (the "Agreement") dated June 19, 1996 by and between
Respironics Georgia, Inc., f/k/a/ Healthdyne Technologies, Inc. ("RIGA"), and
SpectRx, Inc. (SpectRx"). Capitalized terms used herein and not otherwise
defined shall have the meaning assigned to such terms in the Agreement.
The parties to this Amendment agree that the Agreement is hereby amended to
include or restate, as the case may be, the following terms and conditions.
1. A number of events have led to this Amendment and will be recited
below. First, RIGA merged with Respironics, Inc. effective February 11, 1998.
Second, the Milestone Deadline set forth in Section 14.5 of the Agreement has
passed without the milestone applicable thereto being achieved. Work to date
indicates that SpectRx will be able to complete a device that measures bilirubin
in accordance with the Revised PRD for use prior to phototherapy
("Pre-Phototherapy device"). The parties have agreed to utilize the
Pre-Phototherapy device in resetting certain milestones.
2. Immediately upon completion of the Pre-Phototherapy device meeting
the revised product requirement document dated September 15, 1998 and attached
hereto as Exhibit A ("Revised PRD"), [*]
3. If SpectRx is unable to achieve the performance goals for the [*] of
the Instrument as set forth in the Revised PRD, SpectRx will then enter into a
second amendment to the Agreement augmenting the marketing license provided for
therein to grant to RIGA an exclusive license (free of license fees and for the
Term set forth in Section 14.1) within the Territory for the following three
software and hardware application [*] to the extent these applications are
developed by SpectRx:
[*]
[*]
[*]
Although SpectRx intends to undertake a reasonable business effort development
program in [*] there is no assurance of success. If successful, [*] are
[*] to be redacted
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envisioned to encompass software and possibly a Disposable specific to the
application [*]
Although no license fees are due in respect of the upgrade products, RIGA agrees
to purchase the Instruments, Disposables and Accessories, in accordance with
Section 4 of the Agreement. The parties agree to negotiate price and other
similar terms in good faith, in a like manner to and consistent with the current
provisions contained in the Agreement governing the Instrument. In the event the
Disposable is developed, SpectRx and RIGA will follow the existing formula under
the Agreement for profit and expense distribution on disposable sales.
4. The first sentence of Section 14.5 of the Agreement is deleted and
replaced by the following:
In the event that RIGA or SpectRx has not filed a 510K submission for a
Pre-Phototherapy device and received regulatory clearance necessary for
the marketing and sale of that device in Canada by January 1, 1999
("Revised Section 14.5 Deadline"), RIGA shall have the right to assume
the Commercialization Efforts with respect to the Licensed Products as
set forth in Section 3.1 and on Exhibit E. The Revised Section 14.5
Deadline shall be extended by any delay caused by RIGA: (i ) in the
filing of such 510K submission; (ii) in the work preparatory thereto
required to be performed by RIGA, such as completion of clinical trials
and reporting as to same; or (iii) in the work required to be performed
by RIGA with respect to preparation for sales in Canada. RIGA
acknowledges that both of the conditions set forth in the first
sentence have been satisfied i.e., the referenced 510K submission has
been made and Canadian clearance has been obtained.
5. The transfer price in Section 6.1 is increased from [*]
6. The fourth sentence in Section 3.2 of the Agreement is deleted and
replaced by the following sentence:
Each such milestone payment shall be due and payable only upon
completion of the corresponding milestone as set forth in Exhibit E, as
amended.
7. The word "following" is deleted from the sixth sentence in Section
3.2 of the Agreement.
8. RIGA's address for notices in Section 16-8 of the Agreement is
changed as follows:
RIGA: Respironics, Georgia, Inc.
0000 Xxxxxxxxxx Xxxxxx
Xxxxxxxx Xxxxxxx 00000
Attention: Group Vice President
[*] to be redacted
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With a copy to: Respironics, Inc.
0000 Xxxxxxx Xxxxxxxxx
Xxxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: General Counsel
9. Everything in Exhibit E including and following the "FDA Approval"
milestone originally scheduled for May 15, 1997 is deleted and replaced by the
Amendment to Exhibit E attached hereto.
10. Exhibit G is deleted in its entirety and replaced by the Amendment
to Exhibit G attached hereto.
11. Except as expressly provided for herein, the Agreement shall remain
in full force and effect and nothing herein shall be construed as a modification
or waiver by RIGA or SpectRx of any rights or remedies under the Agreement.
Please countersign and return one copy of this letter as confirmation of RIGA's
agreement to all statements and amended terms herein.
Sincerely,
SPECTRX, INC.
---------------------------------
Xxxx Xxxxxxx
President and CEO
Accepted and agreed to:
RESPIRONICS GEORGIA, INC.
---------------------------------
Name
-----------------------------
Title
----------------------------
[*] to be redacted
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EXHIBIT 10.19B
EXHIBIT A
BILICHEK(TM)
PRODUCT REQUIREMENT DOCUMENT (PRD)
Rev. 1.4
This document describes application, market, intended use, end user, (and
predicate device) for serum chemistry with regard to BiliChek.
Following are the device related product requirements based on inputs from
various sources (see customer market research report).
1.0 ASSUMPTIONS
1.1 Dimensions and weight - see attached Specifications Sheet
1.2 RESPIRONICS, mutually agreed by SpectRx, Inc., has ultimate right to
make any changes to these requirements.
1.3 Schedule, cost specifications, quality or quantity goals may change by
mutual agreement of SpectRx and RESPIRONICS.
1.4 All other RESPIRONICS/SpectRx contractual agreements are met, including
ISO, FDA, other requirements.
1.5 BiliChek system has four components:
1) Hand-held device
2) Charger base with space for an extra battery
3) Disposable tip
4) Optional Printer (available after launch).
1.6 End user, RN, Nursing Assistants, RRT, Neonatal transport, Specialists,
Non-HCP (Health Care Professional)
5) Neonatologist
6) Pediatrician
7) Homecare phototherapy service - Non-HCP
1.7 Printer to be available after launch of product (delivery within one
year of final specifications).
2.0 FUNCTIONS AND FEATURES
2.1 Non-invasively read and display results in units of 0.1 mg/dL or 000
umol/L of total serum bilirubin prior to the initiation of phototherapy
or exchange transfusion. Note the conversion factor for umol/L is 17.1
x mg/dL.
2.2 Performance Specifications - Pre, During, and Post Phototherapy
1) Operating Range 0.0-20 mg/dL
2) Correlation
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Reference Methodology: HPLC
r > 0.90
RMSE < 1.5 mg/dL
SD < 1.5 mg/dL (Xxxxx and Xxxxxx)
x 1.5 mg/dL
3) Precision (means of CV on three measurements from the same
baby) < 7%
4) There will be no statistical difference in performance between
the various populations segmented by race, gestational age,
weight, sex, post-natal age etc.
2.3 Optical radiation output will not cause retinal burn. Device shall not
exceed the optical radiation Threshold Limit Values (TLV's) as
determined by the American Conference of Governmental Industrial
Hygienists for light, near infrared radiation and UV radiation.
2.4 [*]. Total measurement time (including calibration) to obtain a reading
shall not exceed sixty (60) seconds.
2.5 Calibration good for five (5) applications after which device requires
another calibration and a replacement of disposable tip.
2.6 [*].
2.7 Does not require any input such as age, etc. of patient before
displaying a reading. (Requirements for phototherapy application to be
determined).
2.8 Simple, easy to follow user prompts and messages as described in the
User Flow (ATTACHMENT C).
2.9 Battery backed up time, date and last reading.
1) Battery life - minimum 100 tests on fully charged battery pack
2) Low battery LCD icon
3) When battery is discharged the device will not take a
measurement and a Discharged Battery icon will be displayed.
4) Last reading maintained until device is powers off or is
recalibrated.
2.10 Field upgradeable and serviceable by trained technicians or hospital
bio-meds, and trained personnel
1) Battery
2) [*]
3) [*]
2.11 Forty-eight hour turnaround for factory replacement.
2.12 Have built-in error messages, test point, diagnostic features for
minimal downtime in troubleshooting device failures, using
off-the-shelf test fixtures.
2.13 Can be used by end user with no special training required.
2.14 Operator and service manual.
1) Operator's manual by RESPIRONICS
2) Service manual by SpectRx
[*] To be redacted
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3.0 HAND HELD DEVICE PHYSICAL
3.1 General
3.1.1 Must meet FDA/EMC regulatory guidelines (Attachment A).
3.1.2 It will be a hand-held device, easily packaged and transportable using
off-the-shelf and easily available packaging materials.
3.1.3 User grip intuitive and comfortable.
3.1.4 Resistant to scratches and normal abuse including during transport.
3.1.5 Cleanable by specified off-the-shelf available agents, not prone for
infection hazards. Low stain risk. Smooth surface to reduce harboring
of bacteria.
1) Kleen-a-septic
2) Alcohol
3) 1% Bleach
3.2 Ports
3.2.1 IR Data port conforming to IRDA standards (IRDA Standards Version 1.0
[1994]).
3.3 Inputs
3.3.1 Electrical/Power Input
3.3.1.1 Input voltage through four (4) pins through housing from associated
battery pack.
3.3.1.2 Limit switch at disposable interface as unit triggers only with
disposable in place.
3.3.2 Terminal Input
3.3.2.1 Use standard, off-the-shelf, IRDA output port.
3.3.2.2 Bi-directional communication with IRDA compatible terminals.
3.3.3 Keypad Input
3.3.3.1 Three (3) "soft" keys per concept, linked to display prompts:
1) Top two soft keys:
a) turn power on
b) set the display configuration
c) escape error conditions
d) turn on the backlight display
e) send results through MA port
2) Bottom soft key used for calibration and skin measurements
3.3.4 Data Input
3.3.4.1 Ability to customize system time, date, automatic 'off' time, etc.
3.3.4.2 Ability to set parameters such as units of measure (mg/dL or umol/L),
date (MM/DD) or DD/MM) and time (12 hour or 24 hour format).
[*] To be redacted
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3.4 Outputs
3.4.1 Data Output
3.4.1.1 Output results with units of measure, measurement time and measurement
date via LCD display and/or external IRDA compatible printers or
terminals.
3.4.2 Display Output
3.4.2.1 High contrast, back-lit LCD with three digit readout for measurement,
low battery icon, discharged battery icon, time and date.
3.4.3 Annunciators, Advisories & Warnings
3.4.3.1 Audible annunciator with two distinct signals: one for valid, the other
for invalid entered, detected, displayed or transferred data.
3.4.3.2 Display indicates when calibration is required.
3.4.3.3 Display indicates when measurement sequence is ready.
3.4.3.4 Display indicates when batteries are low and when unit requires a
charge.
3.4.3.5 Display indicates invalid reading by returning an error code.
3.5 Bulb/Light Source
3.5.1 [*]
a) Easy to access and replace bulb assembly by end user.
b) No special tools, techniques, or skills needed to replace
bulb.
c) [*]
4.0 CHARGE BASE PHYSICAL
4.1 General
4.1.1 Must meet all regulatory requirements (per Attachment A).
4.1.2 It will be able to be mounted on a wall, or on a counter.
4.1.3 Resistant to scratches and normal abuse including during transport.
4.1.4 Cleanable by specified, off-the-shelf agents, not prone to infection
hazards (per 3.1.5).
4.2 Inputs
4.2.1 Electrical/Power Input
4.2.1.1 Input voltage from 87-250 Vac. 50/60 Hz.
4.2.1.2 Meets specifications for voltage fluctuations per regulatory standards
(Attachment A).
4.2.1.3 [*]
4.2.1.4 Meet CSA, UL, IEC 601 safety standard, and international symbol and
color requirements.
[*] To be redacted
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4.3 Outputs
4.3.1 Electrical Output
4.3.1.1 Output will be into a minimum of two charging pins on hand-held unit.
4.3.2 Display Output 4.3.2.1 LED indicates electrical contact.
4.3.2.2 LED indicates if hand held is currently under charge.
4.3.2.3 LED indicates charge is complete.
5.0 BATTERY
5.1 Unit will have a removable rechargeable battery pack ( similar to
cellular phone concept) which will allow an operator to replace the
battery with another battery.
5.2 Base will have the ability to charge an additional battery pack ( in
addition to pack that is located in the hand held unit)
5.3 Fully charging in less than [*] hours.
5.4 Battery will hold a charge (under normal circumstances) for 30 days
5.5 Base unit will have an option to do a deep discharge of the battery
prior to charging.
6.0 PRINTER
6.1 IR interface with device
6.2 [*]
6.3 [*]
6.4 Dimensions
a) weight (TBD)
b) height (TBD)
c) length (TBD)
d) width (TBD)
6.5 Battery life - minimum [*] on a full charge.
7.0 DISPOSABLE CALIBRATION TIP PHYSICAL
7.1 General
7.1.1 It will meet regulatory requirements. (See Attachment A).
7.1.2 It will be a stackable piece.
7.1.3 It will be single-use.
7.1.4 The calibration target will be backed with a protective peel away cover
that also serves to protect the patient contact surface from debris.
7.1.5 User grip and device attachment is intuitive and comfortable.
7.1.6 Resistant to scratches and normal abuse including during transport.
7.1.7 Shelf Life of the calibrator tip will be a minimum of 24 months
[*] To be redacted
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8.0 ENVIRONMENTAL CONDITIONS
8.1 Must meet all US and Canadian regulatory requirements. (See Attachment
A).
8.2 Operate within specifications between 5 degrees to 40 degrees C (41
degrees to 104 degrees F). Be undamaged and fully operational after
storage at -40 degrees to 60 degrees C (-40 degrees F to 140 degrees
F). Must not fail in such a way as to be a hazard to users.
8.3 Operate within specifications between [*]. Not be damaged by [*] for a
duration of at least 24 hours.
8.4 Meet CISPR11, Class B Radiated and Conducted Electromagnetic Emissions.
9.0 SHOCK, VIBRATION & DROP
(In no case will the device lose or corrupt stored data, or display
incorrect results).
9.1 Must meet all US and Canadian regulatory requirements. (See Attachment
A).
10.0 LABORATORY REGULATIONS
10.1 A simple, easy to use [*] method for checking [*], [*] will be
developed pending market/regulatory agencies requirements.
[*] To be redacted
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ATTACHMENT A
1. System will meet all US and Canadian regulatory requirements defined
below.
a. FDA Guidance, Nov 93, Reviewers Guidance for Premarket Notification
Submissions.
b. QSR 21 CFR, Code of Federal Regulations, Part TBD (NEED CONFIRMATION OF
CITATION).
c. UL 2601-1: 1993
d. CSA C22.2, No. 601.1
e. Office of Device Evaluations, Guidelines for Content for Pre-Market
Submission for Medical Devices containing Software, (Draft), 1997
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ATTACHMENT B
Specifications
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ATTACHMENT C
User Flow
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AMENDMENT TO EXHIBIT E
REMAINING MILESTONES
---------------------------------------------------------------------------------------------------------------------------
Original Estimated Date Revised Estimated Dollars(1) Milestone
Date (In Thousands)
---------------------------------------------------------------------------------------------------------------------------
[*] Fourth Qtr/98 [*] FDA approval of pre-phototherapy claim
---------------------------------------------------------------------------------------------------------------------------
[*] TBA [*] [*]
---------------------------------------------------------------------------------------------------------------------------
[*] TBA [*] Acceptance by RIGA of quantities delivered
pursuant to first purchase order pre-phototherapy
claim
---------------------------------------------------------------------------------------------------------------------------
[*] TBA [*] Acceptance by RIGA of quantities delivered
pursuant to first purchase order [*]
---------------------------------------------------------------------------------------------------------------------------
[*] TBA [*] First anniversary of acceptance of first purchase
order quantities pre-phototherapy claim delivered
by SpectRx
---------------------------------------------------------------------------------------------------------------------------
[*] TBA [*] First anniversary of acceptance of first purchase
order quantities [*] delivered by SpectRx
---------------------------------------------------------------------------------------------------------------------------
-----------------------
(1) Payment due at time of milestone completion
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AMENDMENT TO EXHIBIT G
MINIMUM UNIT SALES
INSTRUMENT
Column A OR Column B
---------------------------------------------------------------------------------------------------------------------------
Year after 510K Clearance for Pre-Phototherapy [*]
Pre-Phototherapy device 510K Clearance
---------------------------------------------------------------------------------------------------------------------------
0-1 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
Year 2 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
Year 3 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
Year 4 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
Year 5 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
After Year 5 [*] [*]
---------------------------------------------------------------------------------------------------------------------------
The minimum unit sales for the Instrument will be the relevant total under
Column A until, if ever, the [*] has received 510K clearance. Thereafter, the
minimum unit sales shall be the total under Column B.
MINIMUM UNIT SALES DISPOSABLE
RIGA's minimum unit sales for Disposables from SpectRx will be:
Year 2 Following Commercialization: [*]
Year 3 Following Commercialization: [*]
Year 4 Following Commercialization: [*]
Year 5 Following Commercialization: [*]
Year 6 Following Commercialization
and Onward: [*]
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