1
EXHIBIT 10.76
AMENDMENT NO. 1 TO AMENDED AND RESTATED CONTRACT FOR THE SALE AND
DISTRIBUTION OF GENENTECH HUMAN GROWTH HORMONE
This Amendment No. 1 is entered into by and between Genentech, Inc., a Delaware
corporation, with offices at 0 XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
("Genentech") and Nova Factor, Inc., a Tennessee corporation located at 0000
Xxxxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxx 00000 ("Nova Factor") for
the purpose of amending that certain Amended and Restated Contract for the Sale
and Distribution of Genentech Human Growth Hormone between Genentech and Nova
Factor effective April 8, 2000 ("Agreement"). Genentech and Nova Factor are
collectively referred to hereinafter as the ("Parties"), or individually as a
("Party").
Genentech and Nova Factor now wish to amend certain terms of the Agreement as
described below. Accordingly, the parties hereby agree to amend the Agreement as
follows:
1. Subsection 10(a) is hereby deleted in its entirety and replaced with
the following language:
10. Distribution of Genentech HGH
(a) Dispensing Obligation. In accordance with applicable laws and
regulations, Nova Factor shall evaluate the reimbursement status of,
and dispense Genentech HGH to, all patients with a prescription for
Genentech HGH who are referred by any person or entity to Nova Factor.
Within three (3) business days of Nova Factor's receipt of each
prescription or other appropriate shipment request, Nova Factor shall
dispense Genentech HGH to patients without regard to third party payor
coverage of such patient's Genentech HGH; provided, however, that if
the patient or physician specifically requests a delay in dispensing or
if prior authorization is required for a Government Program patient,
both as documented by written records of Nova Factor, said three (3)
day time period for shipping shall not apply, and Nova Factor shall use
its commercially reasonable best efforts to ship the requested
Genentech HGH within thirty (30) days of such prescription or shipment
request. Notwithstanding the preceding provisions, Nova Factor shall
not dispense Genentech HGH if the patient has drug on hand at the time
of the referral. If prior authorization is required, regardless of
whether the payor is a Government Program or not, Nova Factor shall
[***] As [***] within three (3) days of the referral to Nova Factor,
the three (3) day time period [***].
2. Exhibit L is hereby deleted and replaced by Exhibit L attached hereto
and incorporated into the Agreement.
3. This Amendment No. 1 shall be effective upon execution by all of the
parties hereto.
4. All terms in this Agreement with initial capitalization shall have the
meanings assigned to such terms herein or in the Agreement.
5. The remaining terms and conditions of the Agreement shall remain in
full force and effect.
2
IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 1 to be
duly executed by their respective officers or representatives duly authorized so
to do.
NOVA FACTOR, INC. GENENTECH, INC.
By: /s/ Xxxxx Grow By: /s/ Xxxxx Xxxxx
---------------------------------- -----------------------------------
Name: Xxxxx Grow Name: Xxxxx Xxxxx
-------------------------------- ---------------------------------
Title: President Vice President, Managed Care and
------------------------------- Commercial Support
-----------------------------------
Date: 6/01/01 Date: 8/08/01
-------------------------------- ---------------------------------
0000 Xxxxxxx Xxxxxx Xxxxxxx, Xxx. 000 1 DNA Way
Memphis, TN 38134 Xxxxx Xxx Xxxxxxxxx, XX 00000
(000) 000-0000 (000) 000-0000
Notices to be Addressed to: Notices to be Addressed to:
President Vice President, Managed Care and
Commercial Support
With a copy to:
Corporate Secretary
2
3
EXHIBIT L
PERFORMANCE STANDARDS
Nova Factor shall monitor data elements and status codes on all patients
receiving Genentech HGH. Performance will be monitored on all patients receiving
Genentech HGH except patients with diagnosis codes relating to infertility.
Patients receiving Genentech HGH through the [***] program shall have their
first shipment from Nova Factor measured as a maintenance shipment. Genentech's
[***] program shall notify Nova Factor at least seven (7) calendar days in
advance of the expected exhaust date of patients who have previously received a
starter kit and have chosen Nova Factor as the designated provider of service.
----------------------------------------------------------------------------------------------------------------------
Performance Optimal Standard Suboptimal Failure to Meet
Standard Standard
----------------------------------------------------------------------------------------------------------------------
#1 Time to verify At least 90% 80-89% within 72 75-79% within 72 <75% within 72
coverage Within 72 hours hours hours hours
----------------------------------------------------------------------------------------------------------------------
#2 Time to Ship At least 90% 80-89% within 72 75-79% within 72 <75% within 72
within 72 hrs. of hours of referral hours of referral hours of referral
referral date for date for initial date for initial date for initial
initial shipment shipment and 72 shipment and 72 shipment and 72
and 72 hours hours prior to hours prior to hours prior to
prior to exhaust exhaust for exhaust for exhaust for
for maintenance maintenance maintenance maintenance
patients patients patients patients
----------------------------------------------------------------------------------------------------------------------
4
EXHIBIT L (cont.'d)
DESCRIPTION OF PERFORMANCE STANDARDS
[***]
2
5
EXHIBIT L (cont.'d)
Assumptions/Definitions
[***]
3
