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EXHIBIT 10.3
AMENDED AND RESTATED CONTRACT FOR THE SALE AND DISTRIBUTION
OF GENENTECH HUMAN GROWTH HORMONE
This Amended and Restated Agreement is entered into effective April 8, 2000
("Effective Date'), by and between Genentech, Inc., a Delaware corporation with
offices at 0 XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000 ("Genentech")
and Nova Factor, Inc., a Tennessee corporation with offices at 0000 Xxxxxxx
Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxx 00000 ("Nova Factor"). Genentech
and Nova Factor are collectively referred to hereinafter as the "Parties" or
individually as a "Party".
WHEREAS, Genentech manufactures the recombinant human growth hormones
Protropin(R) (somatrem for injection), Nutropin(R) [somatropin (rDNA origin) for
injection], Nutropin AQ(R) [somatropin (rDNA origin) injection] and Nutropin(R)
Depot [somatropin (rDNA origin) for injectable suspension]; and
WHEREAS, the Parties entered into the Contract for the Sale and Distribution of
Genentech Human Growth Hormone effective March 1, 1997 ("1997 Agreement"), and
the Parties wish to amend the 1997 Agreement and restate their agreement
governing the sale of Genentech HGH (as defined below) to Nova Factor and the
distribution of such Genentech HGH by Nova Factor; and
WHEREAS, Nova Factor is a biotech contract pharmacy doing business throughout
the United States with respect to infusion care and human growth hormone
products;
NOW, THEREFORE, the Parties agree as follows:
1. Definitions
The following terms shall have the following meanings in this Agreement:
(a) "Affiliate" shall mean any entity or person which controls, is
controlled by or is under common control with a Party. For purposes of this
definition, "control" shall mean (a) in the case of corporate or limited
liability company entities, the direct or indirect ownership of at least
thirty percent (30%) of the stock, participating shares or member interest
entitled to vote; and (b) in the case of a partnership, the power
customarily held by a general partner owning at least a 50% interest in the
Partnership, and (c) in the case of a management contract the power to
direct the management of the other entity. The foregoing notwithstanding,
Roche Holding Ltd., a Swiss corporation, and its Affiliates (but
specifically excluding Genentech and any entity owned or controlled by
Genentech) shall not be considered Affiliates of Genentech for purposes of
this Agreement. Nova Factor shall provide Genentech with a list of all
current Affiliates, as defined below, beginning the Effective Date, which
shall be attached hereto as Exhibit A. Such list shall include each
Affiliate's name, address, class of trade, affiliation start date, type of
affiliation with Nova Factor (e.g., subsidiary, joint venture, etc.), Health
Industry Number ("HIN"), Drug Enforcement Agency Identification Number
("DEA"), and pharmacy department contact name, phone and fax number.
(b) "Appeal(s)" shall mean any and all reasonable appeals to a decision of a
third party payer to deny coverage for all or part of the pharmaceutical
costs of Genentech HGH.
(c) "Base Period" shall mean the six month period from October 1, 1999
through March 31, 2000.
(d) "Calendar Quarter" shall mean each full or partial calendar quarter
period from January 1 through March 31, April 1 through June 30, July 1
through September 30, October 1 through December 31 during the term of this
Agreement.
(e) "Calendar Year" shall mean each calendar year from January 1 through
December 31 during the term of this Agreement.
(f) "Competitive Unit" shall mean one milligram of Human Growth Hormone
Product, as defined below, which is prescribed for treatment of any FDA
approved indications for Genentech HGH.
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(g) "Contracted Customer" shall mean an entity with which Nova Factor
contracts to provide contract pharmacy services with respect to growth
hormone products to patients, or individuals enrolled as members, of such
entity.
(h) "Coverage Interruption" shall mean the date an insurance change or
termination becomes effective, the date of therapy restart on a patient
whose drug was therapeutically interrupted, or the date of determination of
lack of medical necessity by a third party payer.
(i) "Genentech HGH" shall mean those products listed in Exhibit B.
(j) "Genentech HGH Base Market Share" shall mean * to patients * by the sum
of (i) such total number of * to patients *, and (ii) the total number
of * to patients for *.
(k) "Genentech HGH Base Unit Volume" shall mean the total number of *.
(l) "Genentech HGH Market Share" shall mean the total number of * divided by
the sum of * and the *.
(m) "Genentech HGH Unit" shall mean one milligram of Genentech HGH product.
(n) "Genentech HGH Unit Volume" shall mean the total number of Genentech HGH
Units Purchased by Nova Factor during each Calendar Quarter.
(o) "Government Program" shall mean Medicaid, Medicare, Children's Medical
Services or other governmental or similar program.
(p) "Human Growth Hormone Product" shall mean any product (other than human
growth hormone manufactured and sold by Genentech) that contains human
growth hormone or an analog of human growth hormone, whether naturally
occurring or manufactured by any process, which is prescribed for treatment
of any FDA approved indications for Genentech HGH.
(q) "Naive Competitive Patient" shall mean any patient who for the first
time is prescribed and administered a Human Growth Hormone Product during
the term of this Agreement.
(r) "Naive Genentech HGH Patient" shall mean any patient who for the first
time is prescribed and administered Genentech HGH during the term of this
Agreement.
(s) "Naive Genentech HGH Patient Base Market Share" shall mean the total
number of *.
(t) "Naive Genentech HGH Patient Market Share" shall mean the total number
of *.
(u) "National Genentech HGH Market Sales" shall mean the * during each *
during each such * as determined by Genentech and subject to audit by Nova
Factor pursuant to Section 13 below.
(v) "National Nutropin Depot Market Sales" shall mean the total amount of *,
as defined below, during each * during each such * as determined by
Genentech and subject to audit by Nova Factor pursuant to Section 13 below.
(w) "Nutropin Depot Unit" shall mean one milligram of Nutropin Depot.
(x) For calculation purposes, "Dispensed" shall mean the transaction where a
Genentech HGH product or Human Growth Hormone Product is taken out of Nova
Factor's inventory and dispensed by Nova Factor to a patient, and
"Purchased" and/or "Purchases" shall mean the transaction where a Genentech
HGH product is ordered by and shipped to the purchasing entity.
2. Sales of Genentech HGH By Nova Factor. Genentech hereby appoints Nova Factor
as a non-exclusive national distributor to sell Genentech HGH and to perform the
services set out herein and Nova Factor hereby accepts such appointment. All
sales of Genentech HGH by Nova Factor to patients shall be pursuant to a
physician's prescription, except that Nova Factor may sell Genentech HGH
directly to physicians' offices. Nova
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Factor shall maintain the prescriptions for a period of at least four years or
as required by law, whichever is greater.
3. Genentech HGH Discounts/Rebates.
(a) Genentech HGH Discounts. The total "Discount" applicable to Genentech
HGH Purchased by Nova Factor in each Calendar Quarter during each year of
this Agreement shall equal the sum of the discount percentages described in
this Section 3 and Exhibits C, D and E attached hereto.
(1) Genentech HGH Base Discount.
(a) Base Discount. Commencing on the Effective Date and for each
Calendar Quarter throughout the term of this Agreement, Nova Factor
shall receive a discount off the then-current list price for
Genentech HGH in accordance with the discount schedule in Table 1 of
Exhibit C attached hereto for the time period indicated ("Base
Discount"). Genentech's published prices do not include applicable
sales taxes.
(b) Percent Decreases/Increases in Base Discount.
(i) For each Calendar Quarter that the Genentech HGH Unit Volume
decreases by at *, the Base Discount shall be reduced by *.
In the event that the total Genentech HGH Unit Volume for
all Calendar Quarters combined in a Calendar Year decreases
by *, then the Base Discount shall be reduced by * for a *.
Genentech HGH Base Unit Volume and Genentech HGH Unit Volume
for each Calendar Quarter shall be determined by Genentech
pursuant to Genentech's records and subject to audit by Nova
Factor pursuant to Section 13 below. Within thirty (30)
calendar days from the end of each Calendar Quarter during
the term of the Agreement, Genentech shall provide to Nova
Factor a report showing aggregate Genentech HGH Base Unit
Volume and aggregate Genentech HGH Unit Volume for each such
Calendar Quarter.
(ii) The Base Discount shall be reduced by an amount to be
mutually agreed upon in writing by Nova Factor and Genentech
for each Calendar Quarter that Genentech must pay a rebate
to a Contracted Customer on Genentech HGH Units Dispensed by
Nova Factor to patients, or individuals enrolled as members,
of such Contracted Customer.
(iii) For each Calendar Quarter for which (i) Nova Factor
provides Genentech with the reports listed in Section
8(b)(1) and (d) and Exhibits H and J below, in accordance
with the terms of such Section 8(b)(1) and (d) and Exhibits
H and J, and (ii) Exhibit J provided by Nova Factor reflects
that Nova Factor offered the Nursing Services Program
described in Section 8(d) and Exhibit F below to * shall be
added to the Base Discount commencing on * ("Data
Discount"). For any Calendar Quarter for which Nova Factor
fails to provide all such reports to Genentech in accordance
with the terms of Section 8(b)(1) and (d) and Exhibits H and
J, or Exhibit J fails to reflect that Nova Factor offered
such Nursing Services Program to at least * of (i) such
reports in accordance with the terms of such Section 8(b)(1)
and (d) and Exhibits H and J, and (ii) an Exhibit J which
reflects that Nova Factor offered such Nursing Services
Program to * immediately prior to such receipt.
(iv) In the event that Nova Factor provides the Financial
Hardship Program and the Nursing Services Program described
in Exhibit F below ("Programs") exclusively to patients who
are prescribed and administered Genentech HGH, * Genentech's
receipt of written evidence from Nova Factor of such
exclusivity ("Exclusivity Discount"). The Exclusivity
Discount shall remain in effect only so long as Nova Factor
continues to provide the Programs exclusively to patients
who are prescribed and administered Genentech HGH.
(2) Purchase Discount. For each Calendar Quarter that Nova Factor's
Purchases of Nutropin Depot Units as a percent of Nova Factor's total
Purchases of Genentech HGH Units * set forth in Table 1 of Exhibit D
attached hereto, the relevant additional discount amount set forth in
Table 1 of Exhibit D shall be added to the sum of the Base Discount and
any Data Discount and/or any Exclusivity Discount
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commencing on the * ("Purchase Discount"). For each Calendar Quarter
that Nova Factor's Purchases of Nutropin Depot Units as a percent of
Nova Factor's total Purchases of Genentech HGH Units *. In the event
that Nova Factor's Purchases of Nutropin Depot Units as a percent of
Nova Factor's total Purchases of Genentech HGH Units for all Calendar
Quarters combined in a Calendar Year *. Nova Factor's Nutropin Depot
Unit and Genentech HGH Unit Purchases for each Calendar Quarter and
National Nutropin Depot Market Sales and National Genentech HGH Market
Sales for each such Calendar Quarter shall be determined by Genentech
pursuant to Genentech's records. Within thirty (30) calendar days from
the end of each Calendar Quarter during the term of this Agreement,
Genentech shall provide to Nova Factor a report showing (i) Nova
Factor's total Purchases of Genentech HGH and Nutropin Depot for each
such Calendar Quarter, and (ii) the total amount of National Genentech
HGH Market Sales and National Nutropin Depot Market Sales for each such
Calendar Quarter.
(3) Naive Patient Genentech HGH Market Share Discount. For each Calendar
Quarter that Naive Genentech HGH Patient Market Share is *, plus any
Data Discount and/or any Exclusivity Discount, plus the relevant
Purchase Discount achieved commencing * in Table 2 of Exhibit E, *
("Naive Genentech HGH Patient Market Share Discount"). For each Calendar
Quarter that the Naive Genentech HGH Patient Market Share decreases by
at least *, the Base Discount shall be reduced by *. In the event that
the total Naive Genentech HGH Patient Market Share for all Calendar
Quarters combined in a Calendar Year *, then the Base Discount shall be
reduced by *.
(4) Naive Genentech HGH Patient Market Share Exclusions. Erroneous data
submitted to Genentech by Nova Factor shall not be included in the
calculation of the Naive Genentech HGH Patient Market Share. Erroneous
data shall include without limitation, duplicate Genentech HGH Units,
Genentech HGH Units with invalid prescription numbers and aberrant
Genentech HGH Unit amounts. Genentech shall provide written notice to
Nova Factor of any suspected erroneous data within thirty (30) calendar
days after Genentech's receipt of said erroneous data. Nova Factor shall
have fifteen (15) calendar days to respond from the date of Nova
Factor's receipt of such notice by providing Genentech with written
evidence of the validity of said erroneous data. Evidence of validity
shall include, but not be limited to, a physician prescription that does
not include any patient names or identifiers that would breach patient
confidentiality. In the event that Nova Factor fails to respond within
fifteen (15) calendar days of receipt of such notice, then said
erroneous data shall be excluded from the calculation of the Naive
Genentech HGH Patient Market Share.
(5) Affiliate Additions to and Deletions from the Discounts.
(a) Additions to the Discount/Discount Calculation.
(i) Additions to the Discount. For any entity that is added as
an Affiliate after the Effective Date of this Agreement
("Affiliate Addition"), the *, provided that Genentech
receives notice of such Affiliate Addition from Nova Factor
at least fifteen (15) calendar days prior to the date upon
which such Affiliate Addition is added as an Affiliate and
such notice includes the information set forth in the notice
requirements described in Section 8(c) below. In the event
that Nova Factor fails to provide such notice to Genentech
at least fifteen (15) calendar days prior to the date on
which such Affiliate Addition is added as an Affiliate in
accordance with the notice requirements of such Section
8(c), *; provided that such notice includes the information
set forth in the notice requirements of Section 8(c).
(ii) Additions to the Discount Calculation. The Genentech HGH
Units Purchased and/or Dispensed by Affiliate Additions to
Genentech HGH patients and/or Naive Genentech HGH Patients,
and Competitive Units Dispensed by such Affiliate Additions
to Naive Competitive Patients, for the Base Period and for
the Calendar Quarters following Genentech's receipt of
written notice from Nova Factor of such Affiliate Additions,
*; provided, however, that in order for Genentech HGH Units
Dispensed by such Affiliate Additions to Naive Genentech HGH
Patients and Competitive Units Dispensed by such Affiliate
Additions to Naive Competitive Patients *, Nova Factor must
provide to Genentech, at least two (2) calendar months prior
to the first day of such Calendar Quarter, (i) the Naive
Genentech HGH Patient Base Market Share report described in
Section 8(b)(2) and Exhibit I below for such Affiliate
Additions for the Base Period, and (ii) the Naive Genentech
HGH Patient Market Share report described in
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such Section 8(b)(2) and Exhibit I for such Affiliate
Additions for the Calendar Quarter period that occurs two
Calendar Quarters prior to such Calendar Quarter. By way of
example, if Genentech receives written notice from Nova
Factor on August 5, 2000, that an entity is to be added as
an Affiliate, *, i.e., to be included in the calculation of
the Discount that commences on *, Nova Factor must submit to
Genentech, at least two (2) calendar months prior to *, (i)
the Naive Genentech HGH Patient Base Market Share report
described in Section 8(b)(2) and Exhibit I below for such
Affiliate Addition for the Base Period, and (ii) the Naive
Genentech HGH Patient Market Share report described in such
Section 8(b)(2) and Exhibit I below for such Affiliate
Addition for the Calendar Quarter *.
(b) Deletions from the Discount/Discount Calculation. For any
entities that are deleted as Affiliates after the Effective Date
of this Agreement, the Genentech HGH Units Purchased by such
Affiliates shall be excluded from the Discount *, which notice
shall be provided in accordance with the notice requirements of
Section 8(c) below. The Genentech HGH Units Purchased and/or
Dispensed by such Affiliate deletions to Genentech HGH patients
and/or Naive Genentech HGH Patients, and Competitive Units
Dispensed by such Affiliate deletions to Naive Competitive
Patients, for the Base Period and for the Calendar Quarters
following Genentech's receipt of such notice, shall be excluded
from the calculation of the Discount beginning the first day of
the Calendar Quarter that * Genentech's receipt of such notice.
(6) Services. In consideration for the Base Discount, Nova Factor shall
offer all programs described in Exhibit F attached hereto to all
patients to whom it dispenses Genentech HGH and to which the program is
applicable.
(b)Genentech HGH Rebate. For each Calendar Quarter that Nova Factor has a
contractual arrangement with a Contracted Customer whereby Genentech HGH is
the exclusive human growth hormone utilized or purchased by such Contracted
Customer from Nova Factor, i.e., no other Human Growth Hormone Product is
utilized or purchased by such Contracted Customer from Nova Factor,
Genentech *, of such Contracted Customer within forty-five calendar (45)
days after receipt of the report described in Section 8(b) and Exhibit G
below.
4. Orders and Returns. All purchase orders for Genentech HGH shall be submitted
by Nova Factor to Genentech in writing, by telephone, via facsimile or
electronic data interchange ("EDI") at least two (2) business days prior to the
requested date of shipment. The Discount applicable to such purchase order shall
be the Discount in effect upon the date such purchase order is accepted by
Genentech. No order will be binding upon Genentech until accepted by Genentech,
and Genentech shall have no liability to Nova Factor for purchase orders that
are not accepted. Nova Factor's purchase orders submitted to Genentech for
purchase of Genentech HGH shall be governed by the terms of this Agreement.
Nothing contained in any purchase order shall modify any terms herein stated or
add any terms or conditions not stated herein. All Genentech HGH delivered to
Nova Factor under this Agreement shall be suitably packed for air freight
shipment in Genentech's shipping cartons, marked for delivery to the address
provided by Nova Factor with the relevant purchase order, and shall be shipped
to Nova Factor, FOB Origin. Genentech shall ship Nutropin AQ to Nova Factor in
temperature controlled, validated, insulated shipping containers. Genentech HGH
shall be delivered to Nova Factor via second day air freight with shipping costs
prepaid by Genentech. Shipping charges for overnight delivery requested by Nova
Factor for Genentech HGH in excess of the standard shipping method chosen by
Genentech, shall be borne by Nova Factor. Genentech HGH Purchased by Nova Factor
shall be returned for credit only upon prior authorization by Genentech.
Genentech HGH returns in any Calendar Quarter * for the previous Calendar
Quarter. The Discount percentage applicable to such credit will be the Discount
in effect upon the date the returned Genentech HGH is received by Genentech.
5. Nutropin AQ(R) and Nutropin Depot(TM) Shipping Requirements.
(a) Nutropin AQ(R). Nova Factor shall ship Nutropin AQ(R) via Standard
Overnight Service when external temperatures at any point in transit are
between -5(Degree) to 37(Degree) Celsius (23(Degree) to 100(Degree)
Fahrenheit), and via Priority Overnight Service with delivery by 10:30 a.m.
the following day when external temperatures are greater or less than the
foregoing parameters. Nova Factor shall ship, and shall require its agents
to ship, Nutropin AQ(R) to customers in accordance with Genentech's
validated shipping standards for Nutropin AQ.
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(b) Nutropin Depot(TM). Nova Factor shall ship, and shall require its agents
to ship, Nutropin Depot(TM) to customers in accordance with Genentech's
validated shipping standards for Nutropin Depot(TM).
6. Payment to Genentech. Nova Factor shall pay Genentech in full, including
payment of applicable taxes, for Genentech HGH furnished to Nova Factor by
Genentech in accordance with the following payment terms:
(a) From the Effective Date through *, Nova Factor's payment terms shall be
* from the date of the invoice from Genentech; and
(b) From *, through *, Nova Factor's payment terms shall be * from the date
of the invoice from Genentech; and
(c) From *, through the remaining term of this Agreement, Nova Factor's
payment terms shall be * from the date of the invoice from Genentech.
In the event that an Affiliate defaults in its payment to Genentech for any
Genentech HGH Purchased by such Affiliate in accordance with the payment
terms of this Section 6, Nova Factor shall be obligated to pay Genentech
for such Genentech HGH Purchased by such Affiliate within ten (10) calendar
days from the date of receipt of written notice from Genentech of such
Affiliate's default. All payments will be made by check or wire transfer to
Genentech's designated bank account on or before the morning of the due
dates described in Section 6(a), (b) or (c) above, as applicable, and
supporting documentation on the payment will be provided separately to
Genentech. Genentech's designated account is as follows, subject to change
by notice from Genentech:
If by wire transfer: If by check:
Bank: Mellon Bank Bank: Mellon Bank
Pittsburgh, PA Pittsburgh, PA
ABA Number: * Mail to: Genentech, Inc.
Account Name: Genentech, Inc. P.O. Box 360527
* * Xxxxxxxxxx, XX 00000
7. Product Availability; Responsibility for Expired, Damaged or Defective
Product. Genentech shall maintain a sufficient inventory of Genentech HGH
available to Nova Factor pharmacies to assure delivery thereof to a requesting
Nova Factor pharmacy by courier or mail within two (2) business days of
acceptance of a telephonic, EDI or written purchase order. In accordance with
Genentech's stated return of goods policy in effect at the relevant times,
Genentech shall reimburse or credit Nova Factor for any unused Genentech HGH
that is expired or defective, or that is damaged prior to or during shipment by
Genentech to a Nova Factor pharmacy, if it is returned to Genentech by Nova
Factor; provided that returns for each Calendar Quarter * by Nova Factor for the
previous Calendar Quarter. In the event of a product recall, Genentech shall
reimburse or credit Nova Factor for any unused Genentech HGH returned to
Genentech as a result of said recall, for the reasonable shipping costs and, for
the reasonable recall related administrative costs associated with said return.
8. Nova Factor Reports and Audits.
(a) Exclusive Genentech HGH Report. Within thirty (30) calendar days after
the end of each Calendar Quarter, Nova Factor shall submit a report showing
those Contracted Customers with which it has a contractual arrangement
whereby Genentech HGH is the exclusive human growth hormone utilized by such
Contracted Customer. Such report shall contain the identical data elements
listed in Exhibit G attached hereto and shall be submitted on a 3.5" floppy
disk in Microsoft Excel(TM) or text format to the address shown in the
Exhibit G.
(b) Market Share Reports.
(1) Within thirty (30) calendar days after the Effective Date, Nova
Factor shall provide Genentech with a Genentech HGH Base Market Share
report by Nova Factor customer for all patients that were Dispensed
Genentech HGH Units *. Thereafter, on or before the last day of the
calendar month immediately
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following the last day of each Calendar Quarter, Nova Factor shall
provide Genentech with a Genentech HGH Market Share report by Nova
Factor customer for all patients that were Dispensed Genentech HGH Units
*. Such reports shall contain the identical data elements listed in
Exhibit H attached hereto, and shall be submitted on a 3.5" floppy disk
in Microsoft Excel(TM) or text format to the address shown in Exhibit H.
In addition, Nova Factor, with guidance and assistance from Genentech,
shall develop and implement mutually agreeable market share programs to
increase Genentech HGH Market Share. Along with the Calendar Quarter
Genentech HGH Market Share report described in this Section 8(b)(1),
Nova Factor shall also provide Genentech with a written update
describing in detail any and all market share programs developed and
implemented by Nova Factor throughout the term of this Agreement.
Information concerning *.
(2) Within thirty (30) calendar days after the Effective Date, Nova
Factor shall provide Genentech with a Naive Genentech HGH Patient Base
Market Share report by Nova Factor customer for all Naive Genentech HGH
Patients that were Dispensed Genentech HGH Units for the Base Period and
for all * that were * for the Base Period. Thereafter, on or before the
last day of the calendar month immediately following the last day of
each Calendar Quarter, Nova Factor shall provide Genentech with a Naive
Genentech HGH Patient Market Share report by Nova Factor customer for
all Naive Genentech HGH Patients that were Dispensed Genentech HGH
Units, and for all Naive Competitive Patients that were *, for each such
Calendar Quarter. Such reports shall contain the identical data elements
listed in Exhibit I attached hereto, and shall be submitted on a 3.5"
floppy disk in Microsoft Excel(TM) or text format to the address shown
in the Exhibit I.
(3) No patient specific data shall be provided by Nova Factor if such
disclosure would violate any statute or regulation of any governmental
entity.
(c) Exhibit A Update Reports. Nova Factor shall provide Genentech with
written notice of any entity to be added or deleted as an Affiliate under
Exhibit A at least fifteen (15) calendar days prior to the date of such
addition or deletion as an Affiliate. Additions to Exhibit A shall
automatically be included as Affiliates under Exhibit A, unless Genentech
notifies Nova Factor to the contrary within ten (10) calendar days after
Genentech's receipt of such written notice. Genentech's approval of such
additions shall not be unreasonably withheld. Such written notice from Nova
Factor shall include the date upon which such entity is to be added or
deleted as an Affiliate, as well as the entity's name, address, class of
trade, HIN, DEA, type of affiliation with Nova Factor, and pharmacy
department contact name, phone and fax number. For any addition, Nova Factor
shall also provide a copy of such addition's applicable license. Nova Factor
shall also provide Genentech with an updated Exhibit A, which includes all
Nova Factor Affiliates, within thirty (30) calendar days from the end of
each Calendar Quarter during this term of this Agreement. Such updated
Exhibit A shall include the information set forth in this subsection(c) and
shall be submitted on a 3.5" floppy disk in Microsoft Excel(TM) or text
format. The information provided shall be submitted to Genentech, Managed
Care Operations, Contract Administrator, 0 XXX Xxx, XX 00, Xxxxx Xxx
Xxxxxxxxx, XX 00000 on a 3.5" floppy disk in excel or text format.
(d) Nursing Services Program Report. Within thirty (30) calendar days from
the Effective Date, Nova Factor shall develop the Nursing Services Program
described in Exhibit F below. On or before the last day of the calendar
month immediately following the last day of each Calendar Quarter, Nova
Factor shall provide Genentech with a Nursing Services Program report, which
shall contain the identical data elements listed in Exhibit J attached
hereto, and shall be submitted on a 3.5" floppy disk in Microsoft Excel(TM)
or text format to the address shown in the Exhibit J.
(e) Nova Factor shall provide Genentech with a weekly and monthly report as
follows:
(1) The Nova Factor weekly and monthly reports shall utilize the
parameters and information listed in Exhibit K attached hereto, and
shall cover all patients for whom Nova Factor has received a
prescription or purchase order for Genentech HGH in such week, all
patients who have experienced a Coverage Interruption and an
interruption in a patient's insurance or third party payer coverage for
Genentech HGH due to a loss of employment or other event beyond the
reasonable control of the patient or the patient's guardian; provided,
however, that said reports shall not include patient names.
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(2) Reports will be centrally generated by Nova Factor and will contain
transaction data from each of its distribution centers.
(3) Reports will include any returns or negative transactions but will
not include inter-distribution center transfers.
(4) Nova Factor will retain sales transaction data for a four-year
period or as required by law, whichever is greater.
(5) The weekly sales reports shall be delivered to Genentech on the
second business day following the end of each week and the monthly sales
reports shall be sent to Genentech prior to the fifteenth (15th) day
following the close of a calendar month.
(6) The weekly and monthly sales report shall be reported in: (1) tape
transfer using 8 mm. cassette tape or 9-track reel-to-reel tape in ASCII
format, via overnight service, (2) hard copy, mailed, or (3) on-line
modem transfer from Nova Factor to Genentech in ASCII format; provided
however, that electronic formats only (formats (1) and (3) above) shall
be provided commencing no later than April 1, 2000. Nova Factor in
consultation with Genentech, will provide the hardware and software
necessary to maintain and report the weekly and monthly sales
transaction data described above. Written sales transaction reports
should be sent to:
Genentech, Inc.
Attn: Sales Administration
0 XXX Xxx
Xxxxx Xxx Xxxxxxxxx, XX 00000.
(7) Upon reasonable request by Genentech, Nova Factor agrees to perform
reconciliation's of sales reports to verify or correct the accuracy of
the weekly and monthly reports.
(8) Nova Factor shall maintain for a period of at least four (4) years
all weekly and monthly reports and all correspondence with patients who
are prescribed and administered Genentech HGH and their physicians and
third party payers, including, without limitation copies of Statements
of Medical Necessity, Explanations of Benefit, financial assistance
applications and other Appeals correspondence. Nova Factor shall use its
commercially reasonable best efforts to remedy all discrepancies
identified by Genentech in its audits.
(9) Genentech agrees to return computer tapes to Nova Factor within
sixty (60) days of Genentech's receipt thereof.
f. Performance Standards. Nova Factor shall monitor and keep records of the
performance standards set forth in Exhibit L attached hereto. Nova Factor
shall not be required to report to Genentech the data elements and status
codes relating to such performance standards. Nova Factor shall be obligated
to meet the "Standard" performance standard described in Exhibit L attached
hereto. Any failure to meet such standard *. Nova Factor shall immediately
notify Genentech of its failure to meet such performance standard at any
time and its plan for correcting the default. Any such default shall be
remedied within thirty (30) days of Nova Factor's notification of such
default or Genentech's notification to Nova Factor that such default has
occurred. Genentech shall have the right, during any audit, to audit the
records of Nova Factor with respect to such performance standards.
9. Nova Factor Services: Records; Handling; Control; Licensure. Nova Factor
shall:
(a) in the event of a recall, supply Genentech with a complete record of
accountability within one (1) business day of receiving Genentech's request
for such record; and
(c) store Genentech HGH at between 2(degree) and 8(degree) Celsius in a
limited access refrigeration unit which will be locked during non-working
hours and protected by a suitable alarm system, and dispense Genentech HGH
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with due regard for the need to guard against potential abuse or diversion;
and
(d) monitor refrigeration unit temperature by physically recording the
temperature, at a minimum, twice each day or by utilizing a constant
temperature recording device; and
(e) maintain on a current basis all licenses and certifications as a
registered pharmacy as required by applicable federal, state or local laws
in all jurisdictions where Nova Factor delivers Genentech HGH; and
(f) maintain in each branch involved in the distribution of Genentech HGH, a
minimum Genentech HGH inventory level sufficient to meet two (2) weeks
anticipated demand for that branch.
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 payer 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 (3) day time frame 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 will
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
payor is a government entity or not, Nova Factor *. As *, the criteria set
forth above shall be deemed to have been met. Nova Factor shall also refer
the *, mail order is less expensive for the patient, or if Nova Factor is an
out of network provider.
(b) Exceptions. Notwithstanding Section 10(a) above, Nova Factor shall not
be obligated to dispense Genentech HGH to patients:
(1) having no insurance or other third party payer coverage (or coverage
equal to an amount less than fifty percent (50%) of Nova Factor's
acquisition cost for Genentech HGH for such patient) for Genentech HGH
after a duly diligent evaluation by Nova Factor of such patient's
eligibility for all reasonable payer sources, including, without
limitation, a Government Program; or
(2) where the patient, physician or payer repeatedly and consistently
refuses to assist with the reimbursement process, to complete the
required documentation necessary to process the reimbursement request,
or to process a request for coverage, as demonstrated by: (i) a failure
to respond to at least three (3) consecutive Nova Factor contacts, at
least one (1) of which is a written contact and all of which are
documented in Nova Factor's written records; or (ii) a failure to
substantially comply with the material requirements of a contract
between the payer and the patient or physician; or (iii) a failure by
the patient to pay Nova Factor within a reasonable time frame, Nova
Factor agrees that it shall use its commercially reasonable best efforts
to remedy the refusal, including, without limitation, contacting and
cooperating with Genentech to resolve the issue with the patients, payer
or provider, and exhausting all legal options under the federal, state,
ERISA or other applicable reimbursement standards to resolve the
coverage or claim request; provided, however, that the *, or *. In the
event that such number of patients exceeds or threatens to exceed *
beyond the reasonable control of the Parties, then the Parties shall
meet to discuss methods to remedy such problems.
c. Notice to Genentech. Promptly (which means Nova Factor shall use its
commercially reasonable best efforts to notify within three (3) business
days) after Nova Factor learns that a patient either lacks or is not
eligible for any third party payer coverage for Genentech HGH, or at least
fifteen (15) business days prior to Nova Factor terminating or electing not
to ship to a patient during Appeals or due to a refusal to cooperate or
otherwise, Nova Factor shall notify Genentech of such patient and the
reasons for such patient's non-eligibility or lack of coverage, or for Nova
Factor's refusal to service, as the case may be, and Genentech may provide
Genentech HGH to such patient through its * or in any other manner Genentech
chooses.
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d. Delivery Obligations. Nova Factor shall deliver Genentech HGH to the home
of each patient or to such other delivery point as may be designated by the
patient. Nova Factor may distribute Genentech HGH through its Affiliates
and, with the prior written approval of Genentech, such approval not to be
unreasonably withheld, to other third parties; provided, however, that Nova
Factor hereby guarantees compliance by such Affiliates and third parties
with the terms of this Agreement.
e. Appeals and Collections. Nova Factor shall use its commercially
reasonable efforts to obtain reimbursement from the patient and/or the third
party payer or other payer, including in the event of a denial of insurance
coverage, prosecuting all Appeals. Said Appeals shall include at least the
following steps unless such step is not available: (a) obtaining a written
denial of payment which sets forth the rationale for such denial; (b)
sending a written appeal to the third party payer setting forth
comprehensively the nature of the appeal and providing all relevant support
for the appeal; and (c) sending a written appeal to the next higher level of
appeal at that third party payer. As a general matter, Nova Factor shall
ship on first level Appeals, and on second level Appeals when the clinical
information of the patient falls within reasonable medical review criteria
for treating growth hormone inadequacy. Nova Factor is not required to ship
on patients with pre-existing clauses, lack of coverage for injectables, or
no Rx coverage.
f. Governmental Programs and UPP. For each patient who does not have third
party payer coverage or for whom insurance coverage is in doubt, Nova Factor
will promptly refer the patient * to assess that patient's eligibility for
coverage of Genentech HGH under all appropriate Governmental Programs. Nova
Factor shall use its best efforts to inform patients about meeting and, for
patients with Governmental Program coverage, maintaining eligibility and
coverage by Governmental Programs. If third party payer or Governmental
Program coverage for Genentech HGH is not available, Nova Factor shall
promptly contact such patient to determine the patient's ability to pay for
the Genentech HGH with his or her individual funds. In the event that such
patient is unable to pay for the Genentech HGH individually, Nova Factor
shall promptly advise Genentech so that Genentech may consider the patient
for Genentech's *.
g. Patient Assistance Program. Nova Factor shall develop and administer a
patient assistance program in accordance with applicable law and regulations
to assist patients financially unable to afford Genentech HGH therapy;
provided; however, that Nova Factor shall not have any obligation related to
patients having no third party payer coverage for Genentech HGH therapy as
described in Section 10(b)(1) which patients may be eligible for Genentech's
*. Nova Factor shall develop its own financial criteria for patients and
shall review each patient's financial status on a case-by-case basis, all in
conformance with applicable laws, rules and regulations.
h. Genentech Single Point of Contact. Genentech has developed a *
reimbursement service program which is administered by Genentech or its
subcontractor for patients with prescriptions for Genentech HGH *. Attached
hereto as Exhibit M is a description of the *. Nova Factor shall be entitled
to refer any patient for whom it has a prescription for Genentech HGH to
such Program, provided that it complies with the requirements for
distributors described in Exhibit M.
i. Discontinuation of Provider Relationship. If at any time during the term
of this Agreement, Nova Factor should discontinue acting as a Genentech HGH
provider for a Nova Factor customer, then Nova Factor shall immediately
notify Genentech and in any event shall provide Genentech with no less than
sixty (60) business days prior written notice prior of such discontinuation
of its Genentech HGH provider relationship with such Nova Factor customer.
11. Substitution and Counter-Detailing of Genentech HGH Products. Except as may
be required by applicable law, Nova Factor agrees that it shall not substitute,
generically or therapeutically, any other Human Growth Hormone Products for
prescriptions written for Genentech HGH, or any other Genentech HGH products for
prescriptions written for Nutropin Depot, to patients covered under this
Agreement, but specifically excluding patients who are covered under a
Government Program. Nova Factor and its Affiliates shall not counter-detail
Genentech HGH. * Nova Factor and its Affiliates agree not to (1) promote
against, counter-detail, or disparage the Genentech * system to be administered
by Genentech or its subcontractor for patients with prescriptions of Genentech
HGH, (2) promote against, counter-detail, or disparage the Genentech * operated
by * and implemented by Genentech for the distribution of Genentech HGH through
a network of pharmacies licensed to dispense Genentech HGH *, or (3) promote *.
Nova Factor may inform its customers of its status as an authorized dispensing
pharmacy within *; provided, however, that Nova Factor shall not so inform its
customers in
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writing unless Genentech has previously approved, in writing, such written
materials, which approval shall not be unreasonably withheld. Nova Factor and
its Affiliates shall not convert or attempt to convert patients referred to Nova
Factor as a * provider to another delivery option. In the event that Genentech
elects to contract with an entity, other than * to operate *, Nova Factor
warrants and agrees that it shall cooperate with Genentech in transitioning
Genentech HGH patients to such entity. Nova Factor agrees that it shall make no
representation, guarantee or warranty about Genentech HGH, whether in writing or
orally, except as is contained in written materials delivered to Nova Factor by
Genentech for use in promoting and selling Genentech HGH or as may otherwise be
agreed to by Genentech in writing. Genentech shall have the right to approve
Nova Factor promotional materials which contain pertinent facts relative to
Genentech HGH and all such materials shall comply with applicable regulatory
requirements and shall not contain misrepresentations, either about Genentech
HGH or a competitive product, or disparage a competitive product.
12. Term; Termination.
(a) Term. The term of this Agreement shall commence as of the Effective Date
and shall remain in effect, unless terminated as provided below, until
December 31, 2002, or until approval by the Food and Drug Administration of
a new growth hormone product to be marketed and sold by Genentech, whichever
occurs first. At least sixty (60) calendar days prior to the end of each
year of this Agreement, the Parties shall conduct a business review to
review and discuss the overall performance of this Agreement.
(b) Termination Events. The foregoing notwithstanding, this Agreement may be
terminated by a Party: (a) upon any material breach of this Agreement by the
other Party which breach is not cured within sixty (60) days of written
notice by the non-breaching Party; or (b) immediately upon giving notice (i)
upon the institution by or against the other Party of insolvency,
receivership or bankruptcy proceedings or any other proceedings for the
settlement of the other Party's debts, (ii) upon the other Party's making an
assignment for the benefit of its creditors, or (iii) upon the other Party's
dissolution. This Agreement may also be terminated upon mutual agreement of
the Parties hereto.
(c) Effect of Termination. Upon termination, if requested by Genentech, Nova
Factor shall return all unused Genentech HGH to Genentech and shall be
reimbursed by Genentech for the reasonable shipping expenses of the return
and the purchase price of the Genentech HGH returned if the purchase price
was previously paid by Nova Factor. If Genentech does not request such
unused Genentech HGH to be returned, Nova Factor may sell such unused
Genentech HGH to patients or return it to Genentech for credit. Nova Factor
shall also return, if so requested by Genentech, all sales aids and other
associated material supplied to Nova Factor by Genentech. Termination shall
not relieve either Party of obligations incurred prior to termination,
including Nova Factor's obligation to pay for Genentech HGH ordered by and
delivered to it under this Agreement, provided that Genentech has not
requested return of that Genentech HGH. The provisions of Section 14(e) and
(l) shall survive any termination of this Agreement.
(d) Change In Control. If Nova Factor or any of its Affiliates or all or
substantially all of either of their assets are to be acquired by whatever
means, including merger within or into, another entity, including an
Affiliate (the "Acquiring Entity"), Nova Factor shall so notify Genentech in
writing at least sixty (60) business days prior to the date of occurrence of
such event, and Genentech shall have the right to terminate this Agreement
at any time until forty-five (45) business days after Genentech's receipt of
written notice from Nova Factor. In addition, Genentech shall have the right
to terminate this Agreement if Nova Factor or its Affiliates acquires all or
substantially all of the assets of an entity or a division of any entity
which in either case sold Genentech HGH within one year preceding such
purchase. Nova Factor shall notify Genentech in writing at least sixty (60)
business days prior to the occurrence of such event. If Genentech so
terminates this Agreement, Nova Factor agrees for itself, its Affiliates and
for any such entity that for a fourteen (14) month period (Restricted
Period) thereafter it shall not switch Restricted Patients from a Genentech
HGH product to a competitive Human Growth Hormone Product unless it receives
a prescription from a physician specifically written for the competitive
Human Growth Hormone Product. During the Restricted Period, Nova Factor
further agrees that it shall not engage in any activities directed to payers
or Restricted Patients or their physicians which are designed to switch
Restricted Patients to a Human Growth Hormone Product which is competitive
to Genentech HGH. During the Restricted Period, Nova Factor shall dispense
Genentech HGH to Restricted Patients, except pursuant to any prescription
specifically written for a Human Growth Hormone Product and comply with its
reporting obligations hereunder and obligations under the terms of this
Agreement in so far as the obligations relate to servicing the Restricted
Patients during the Restricted Period. During the Restricted
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Period, Genentech agrees that to facilitate Nova Factor serving said
patients, it shall sell Genentech HGH to Nova Factor at the then-current
discount at the time of Agreement termination. For this purpose, "Restricted
Patients" shall mean (i) those patients who on the date of the termination
of this Agreement are then receiving Genentech HGH from Nova Factor, and
(ii) new patients for whom Nova Factor receives a prescription for Genentech
HGH or generic prescription. Notices hereunder shall not be required to be
given if disclosure would cause Nova Factor or its Affiliates to be in
violation of the federal or state securities laws and Genentech in any event
agrees to keep such notices in strict confidence.
13. Audit. Either Party at its own expense may perform, or have an independent
third party auditor who has agreed to a confidentiality agreement reasonably
acceptable to the other Party perform, such audits as may be reasonably required
on a Party's business records and activities to ensure compliance with the terms
of the Agreement. Each Party shall provide the other Party with at least fifteen
(15) business days advance notice of such audits, and a Party shall cooperate
fully with the persons conducting the audit, including full access to the
necessary facilities and records at all reasonable times during business hours,
and copies, at such Party's expense, of all relevant records, provided; however,
that a Party's audit right shall be limited to bi-annual audits. Notwithstanding
the foregoing, Genentech shall also have the right to audit as Genentech may
deem necessary, in its reasonable judgment, to investigate quality assurance
problems that constitute material trends.
14. Miscellaneous.
(a) Relationship. Neither Party is in any way the legal representative or
agent of the other, nor authorized or empowered to assume any obligation of
any kind, implied or expressed, on behalf of the other Party, without the
express written consent of the other.
(b) Force Majeure. Nonperformance of either Party, other than the payment of
money, shall be excused to the extent that performance is rendered
impossible by strike, fire, earthquake, flood, governmental acts or orders
or restrictions, failure of suppliers, or any other reason where failure to
perform is beyond the control and not caused by the negligence of the
nonperforming Party.
(c) Entire Agreement. This Agreement is the entire agreement between the
Parties hereto, and supersedes any and all prior agreements between the
Parties whether oral or written, relating to the subject matter hereof.
Notwithstanding the foregoing, the Parties acknowledge the full and complete
satisfaction of all obligations due to the other under that certain Contract
For the Sale and Distribution of Genentech Human Growth Hormone, between
Genentech and Nova Factor dated March 1, 1997. No amendments or
modifications of the terms of the Agreement shall be binding on either Party
unless reduced to writing and signed by both Parties.
(d) Binding Effect. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and their respective successors and assigns;
provided, however, that this Agreement shall not be assignable by either
Party without the other's written consent except to a wholly-owned
subsidiary of such Party, the corporate parent of such Party, or a
corporation controlled by the corporate parent of such Party.
(e) Confidentiality. Nova Factor and Genentech shall take all reasonable
steps and do all things reasonably necessary to ensure that any information
relating to Genentech HGH, including the terms of this Agreement, the
information relating to Genentech HGH provided in the Nova Factor weekly and
monthly reports described in Section 8(e) and Exhibit K, or to the business
of the disclosing Party ("Confidential Information") acquired by virtue of
the position of the receiving Party under this Agreement, including, without
limitation, information received through the exercise of a party's audit
rights, shall not be disclosed or made use of outside this Agreement;
provided, however, that the foregoing shall not apply to Confidential
Information (a) which a receiving Party can show was known to it prior to
disclosure by the disclosing Party; (b) which is or becomes public knowledge
through no fault of the receiving Party; (c) which is lawfully disclosed to
the receiving Party by a third party; (d) which is required to be disclosed
pursuant to court order; or (e) which in the written opinion of legal
counsel is required to be disclosed pursuant to federal or state law or
regulation (including, without limitation, securities laws); provided that,
in the case of (d) and (e) above, a reasonable opportunity is afforded the
disclosing Party to challenge the requirement for such disclosure and/or
request confidential treatment. Nova Factor shall be prohibited from
providing or selling any data relating to Genentech HGH to a third party,
except that Confidential Information specifically related to a third party
payer's covered lives may
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be disclosed to such third party payer. This Section 14(e) shall survive any
termination of this Agreement for a period of five (5) years from disclosure
to the receiving Party.
(f) Publicity. Nova Factor shall not originate any news release or public
announcement, written or oral, to any person relating to this Agreement or
to Genentech HGH except as previously agreed to by Genentech in writing and
as in the written opinion of counsel to Nova Factor is required by law to be
made. Except as required by law, Genentech shall seek approval from Nova
Factor prior to utilizing Nova Factor's name in any written promotional
material.
(g) Waiver. Neither the waiver by either Party hereto of any breach of or
default under any of the provisions of this Agreement, nor the failure of
either Party to enforce any of the provisions of this Agreement or to
exercise any right hereunder, shall be construed as a waiver of any
subsequent breach or default, or as a waiver of any such rights or
provisions hereunder.
(h) Severability. If any part of this Agreement shall be invalid or
unenforceable under applicable law, such part shall be ineffective to the
extent of such invalidity or unenforceability only, without in any way
affecting the remaining parts of this Agreement.
(i) Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California. No provision of this
Agreement shall be applied or construed in a manner inconsistent with
applicable federal and state laws and regulations.
(j) Enforceability. It is the explicit intention of the Parties hereto that
no person or entity other than the Parties hereto, except governmental
authorities to the extent required by law, is or shall be entitled to bring
any action to enforce any provision of this Agreement against either of the
Parties hereto.
(k) Headings. The headings in this Agreement are intended solely for
convenience of reference and shall be given no effect in the construction or
interpretation of this Agreement.
(l) Notices. Except as otherwise provided, all notices which may be required
pursuant to this Agreement (a) shall be in writing, (b) shall be addressed,
if to a Party, to the person and address set forth at the end of this
Agreement (or to such other person or address as either Party may so
designate from time to time), or addressed, if to a patient, to the
patient's last known address, (c) shall be deemed to have been given three
(3) business days from the date of postmark if sent by mail or on the date
of delivery if transmitted by courier or telegram or on the date of
transmission if sent by telex or facsimile, and (d) shall be mailed, postage
prepaid, by first-class mail, registered mail, or certified mail, return
receipt requested, or transmitted by courier for hand delivery, or by
telegram, telex or facsimile with confirmation of transmission.
(m) Limitation on Liability. If either Genentech or Nova Factor terminates
this Agreement in accordance with the provisions of Section 12 above or if
Genentech or any governmental agency effects the nationwide withdrawal of
the sale of Genentech HGH for any reason, neither Party shall be liable to
the other for any special, incidental or consequential damages caused
directly or indirectly by such termination or withdrawal, whether arising
under this Agreement or relating to any injury or damage to business,
earnings, profits or goodwill suffered by that Party, including, without
limitation any liability for compensation, reimbursement or damages on the
account of the loss of prospective profits or anticipated sales or on
account of expenditures, inventory, investments, leases or commitments in
connection with the business or goodwill of either Party.
(n) Affiliates. It is recognized and agreed that during the term of this
Agreement, Nova Factor may distribute Genentech HGH to patients through its
Affiliates and such distribution shall be construed as a distribution by
Nova Factor and all provisions of this Agreement shall apply to such
distribution and to the patients to whom Genentech HGH is distributed by
Affiliates of Nova Factor.
(o) Records. To the extent required by ss. 1861 (v)(1)(I) of the Social
Security Act, 42 U.S.C. ss. 1395x(v)(1)(I), as amended, Genentech shall,
upon proper written request, allow the United States Department of Health
and Human Services, the Comptroller General of the United States and their
duly authorized representatives, access to this Agreement and to books,
documents and records necessary to verify the nature and extent of the costs
incurred pursuant to this Agreement at any time during the term of this
Agreement and for an additional period of four (4) years following the last
date goods are furnished under this Agreement.
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(p) Compliance with Laws. Each Party shall be responsible for compliance
with all state and federal laws, rules and regulations applicable to its
performance hereunder, including, without limitation, those of the Food and
Drug Administration and of Government Programs.
(q) Government Disclosure and Reporting Obligations. Genentech shall inform
Nova Factor of all Discounts and rebates payable hereunder to enable it to
comply with its reporting and informational obligations pursuant to Section
1128B(b) of the Social Security Act and 42 C.F.R. ss.1001.952, and all other
similar or related federal and state laws and regulations. Genentech hereby
informs Nova Factor that it must provide, upon request by the Secretary of
Health and Human Services or a state agency, information relating to the
Discounts and/or rebates provided by Genentech hereunder.
(r) Counterparts. This Agreement may be executed in counterparts, including
facsimile copies thereof, each of which shall be deemed an original, but all
of which taken together shall constitute one and the same instrument.
IN WITNESS WHEREOF, Genentech and Nova Factor have caused this Agreement to
be executed by their duly authorized representatives effective as of the day and
year first written above.
NOVA FACTOR, INC. GENENTECH, INC.
By: /s/ Xxxxx Grow By: /s/ Xxxxxxxx X. Xxxxxxxx
------------------------------ ----------------------------------
Name: Xxxxx Grow Name: Xxxxxxxx X. Xxxxxxxx
Title: President Title: Vice President, Sales
Date: 4/12/2000 Date: 4/7/2000
Address: Address:
0000 Xxxxxxx Xxxxxx Xxxxxxx 0 XXX Xxx
Xxxxxxx, XX 00000 So. Xxx Xxxxxxxxx, XX 00000-0000
(000) 000-0000 (000) 000-0000
Notices to be Addressed to: Notices to be Addressed to:
President Vice President - Sales
With a copy to: With a copy to:
Xxxxxx X. Xxxx, Xx. Corporate Secretary
0000 Xxxxxxx Xxxxxx Xxxxxxx
Xxxxx 000
Xxxxxxx, Xxxxxxxxx 00000
(000) 000-0000
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EXHIBITS
Exhibit A - Nova Factor Affiliates
Exhibit B - Genentech HGH Products
Exhibit C - *
Exhibit D - *
Exhibit E - *
Exhibit F - Base Discount Programs
Exhibit G - Exclusive Genentech HGH Dispensing Report
Exhibit H - Genentech HGH Market Share Report
Exhibit I - Naive Patient Genentech HGH Market Share Report
Exhibit J - Nursing Alliance Program Report
Exhibit K - Nova Factor Weekly Report
Exhibit L - Performance Standards
Exhibit M - *
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EXHIBIT A
NOVA FACTOR AFFILIATES
Accredo Health, Incorporated
Hemophilia Health Services, Inc.
AHI Pharmacies, Inc.
Sunrise Health Management, Inc.
Southern Health Systems, Inc.
PARTNERSHIPS
Texas Health Pharmaceutical Resources
Children's Home Care/Drug Therapies
Childrens Home Services
CM Factorcare
Childrens Biotech Pharmacy Services
Childrens Hemophilia Services
MANAGEMENT RELATIONSHIPS
LeBonheur Childrens Medical Center, Inc.
Xxxxxx X. xxXxxx Institute Children's Hospital
Dallas Childrens Medical Center
Xxxx Childrens Medical Center
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EXHIBIT B
GENENTECH HGH
Protropin(R) (somatrem for injection)
Nutropin(R) [somatropin (rDNA origin) for injection]
Nutropin AQ(R) [somatropin (rDNA origin) injection]
Nutropin Depot(TM)[somatropin (rDNA origin) for injectable suspension)
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EXHIBIT C
*
* - Confidential Treatment Requested
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EXHIBIT D
*
* - Confidential Treatment Requested
20
EXHIBIT E
*
* - Confidential Treatment Requested
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EXHIBIT F
BASE DISCOUNT PROGRAMS
1. THERAPY DATA
Nova Factor provides weekly and monthly data to Genentech's Sales
Administration department. The data elements included in Exhibit K provide
Genentech with information to evaluate current and future activity by product,
physician, branch and patient identifiers. There reports include all patient
identifiers with any activity (new referral, active, on hold, discontinued,
Uninsured Patient Program or lost to the distributor).
2. NATIONAL MEDICAID PHARMACY NETWORK
Nova Factor maintains a national pharmacy network, providing service to
all states,except those listed on Exhibit F Schedule 1 which may be changed by
Nova Factor from time to time upon notice to Genentech.
3. REIMBURSEMENT & ADMISSIONS
*
4. FINANCIAL HARDSHIP PROGRAM
Nova Factor's Financial Hardship program (which is in no way promoted
or indicated as a service offering), is available for those patients who
demonstrate a need in meeting their co-payment obligations. Nova Factor shall
determine the patients' eligibility and work with the families to enroll them
into the program.
5. VERIFICATION & SHIPMENT STANDARDS
Nova Factor provides patients with high levels of care access and
responsiveness in accordance with the performance standards set forth in Exhibit
L below.
6. COMPLIANCE & PERSISTENCY PROGRAM
*
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7. COMMUNICATION COMPLIANCE PROGRAM
*
8. CUSTOMER SATISFACTION DATA
Customer satisfaction surveys & data analysis performed on an annual
basis.
9. PATIENT EDUCATION & TRAINING
Nova Factor shall provide comprehensive nursing services for ALL Naive
Patients and ongoing training as needed on Genentech's growth hormone products,
through Nova Factor's strategic Nursing Services Program. Specifically, services
consist of providing Injection site training for patients.
10. NURSING SERVICES PROGRAM SURVEY
*
11. DAILY INVENTORY RECONCILIATION - LOT TRACKING
Nova Factor's automated pharmacy system shall have the capability to
detect lot tracking in the event of product recall.
12. ANCILLARIES SUPPLIES PROVIDED
All ancillary hGH supplies shall at Nova Factor's discretion be
provided as part of Nova Factor's service to patients receiving Genentech HGH.
Nova Factor shall not at any time during the term of this Agreement provide
fewer ancillary hGH supplies to Genentech HGH patients than to other Human
Growth Hormone patients.
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EXHIBIT F
SCHEDULE I
STATES WITHOUT SERVICE
Connecticut
Washington, D.C.
Hawaii
Massachusetts
Maine
Nevada
Oregon
Rhode Island
Wisconsin
West Virginia
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EXHIBIT G
EXCLUSIVE GENENTECH HGH DISPENSING REPORT
*
* - Confidential Treatment Requested
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EXHIBIT H
GENENTECH HGH MARKET SHARE REPORTBU
*
Insert Exhibit H
* - Confidential Treatment Requested
26
EXHIBIT I
NAIVE GENENTECH HGH PATIENT MARKET SHARE REPORT
*
* - Confidential Treatment Requested
27
EXHIBIT J
*
* - Confidential Treatment Requested
28
EXHBIT K
*
* - Confidential Treatment Requested
29
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 hours 75-79% within 72 <75% within 72 hours
coverage within 72 hours hours
-------------------------------------------------------------------------------------------------------------
#2 Time to Ship At least 90% 80-89% within 72 hours 75-79% within 72 <75% within 72 hours
within 72 hrs. of of referral date for hours of referral of referral date for
referral date for initial shipment and date for initial initial shipment and
initial shipment 72 hours prior to shipment and 72 72 hours prior to
and 72 hours exhaust for hours prior to exhaust for
prior to exhaust maintenance patients exhaust for maintenance patients
for maintenance maintenance patients
patients
-------------------------------------------------------------------------------------------------------------
* - Confidential Treatment Requested
30
EXHIBIT L (CONT.'D)
DESCRIPTION OF PERFORMANCE STANDARDS
*
* - Confidential Treatment Requested
31
EXHIBIT L (CONT.'D)
ASSUMPTIONS/DEFINITIONS:
*
* - Confidential Treatment Requested
32
EXHIBIT M
*
* - Confidential Treatment Requested
33
EXHIBIT M (CONT.'D)
*
* - Confidential Treatment Requested
34
EXHIBIT M (CONT.'D)
*
* - Confidential Treatment Requested
35
EXHIBIT M (CONT.'D)
*
* - Confidential Treatment Requested
