Exhibit 10.27
CONTRACT FOR THE SALE AND DISTRIBUTION
OF GENENTECH HUMAN GROWTH HORMONE
This Contract for the Sale and Distribution of Genentech Human Growth
Hormone is entered into effective as of March 1, 1997 (the "Effective Date")
by and between Genentech, Inc., a Delaware corporation, of 000 Xxxxx Xxx
Xxxxx Xxxxxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, 00000-0000 ("Genentech")
and Nova Factor, Inc., a Tennessee corporation located 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-Registered Trademark- (somatrem for injection), Nutropin-Registered
Trademark- [somatropin (rDNA origin) for injection] and Nutropin
AQ-Registered Trademark- [somatropin (rDNA origin) injection]; and
WHEREAS, the Parties wish to enter into an agreement governing the sale of
Genentech HGH to Nova Factor and the distribution of such Genentech HGH (as
defined below) by Nova Factor; and
WHEREAS, Nova Factor is a biotech disease management company doing business
throughout the United States with respect to disease management and human
growth hormone products;
NOW, THEREFORE, the Parties agree as follows:
Section 1. Definitions
The following terms shall have the following meanings in this Agreement:
1.1 "Affiliate" shall mean any entity or person which controls, is
controlled by or is under common control with a Party, excluding Welsh,
Carson, Xxxxxxxx & Xxxxx and Associated Funds. For purposes of this
definition, "control" shall mean (a) in the case of corporate entities, the
direct or indirect ownership of at least thirty percent (30%) of the stock or
participating shares entitled to vote; and (b) in the case of a partnership,
the power customarily held by a general partner to direct the management and
policies of such partnership.
1.2 "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.
1.3 "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, as defined in Section 2.3(a) below.
1.4 "Government Program(s)" shall mean Medicaid, Medicare, Children's
Medical Services or other government or similar program.
1.5 "Genentech HGH" shall mean Protropin-Registered Trademark-,
Nutropin-Registered Trademark- and Nutropin AQ-Registered Trademark- or any
other product which is comprised of human growth hormone sold by Genentech.
1.6 "Unit" shall mean a quantity of Genentech HGH equivalent to ten (10)
milligrams.
Section 2. Sale and Distribution of Genentech HGH
2.1 Sale Price. Genentech shall sell Genentech HGH to Nova Factor, at a
cost equal to the lower of (1) $350 per Unit less the Discounts defined and
described in Section 2.2 below and Exhibits A and B attached hereto, or (2)
Genentech's then-current list price for Genentech HGH (currently $350 per
Unit), for distribution by Nova Factor. This price does not include
applicable sales tax. In the event Genentech lowers its list price for
Genentech HGH, the Parties agree to discuss in good faith, within thirty (30)
days thereafter, a potential discount off such revised list price following a
written request by either Party.
2.2 Discount. The total "Discount" applicable to Nova Factor in each
calendar quarter shall equal the sum of the discount percentages described in
Sections 2.2(a) and (b) below and Exhibits A and B attached hereto.
(a) Genentech HGH Base Discounts. Commencing as of the Effective Date,
Genentech shall sell Genentech HGH to Nova Factor at the discounted
prices shown in Exhibit A for the contract year indicated ("Base
Discount"). These prices to not include applicable sales taxes. The NDC
codes, Genentech's published direct list prices, carton sizes offered
and minimum order requirements are also shown on Exhibit A.
(b) Performance Discount. As used in this Section 2.2(b) only "previous
calendar quarter" shall refer to the first two (2) months of the
previous calendar quarter and the last month of the next preceding
calendar quarter. For each performance standard set forth in Exhibit B
("Performance Standard") that was met or exceeded by Nova Factor in the
previous calendar quarter, the relevant additional discount amount shall
be added to the Base Discount for the current calendar quarter, up to a
maximum of * percentage * (*%). For each incentive standard set
forth in Exhibit B ("Incentive Standard") that was met or exceeded by
Nova Factor in the previous calendar quarter, the relevant additional
discount amount shall be added to the base
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
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Discount for the current calendar quarter, up to a maximum of *
percentage * (*%), for a maximum total addition under this Section
2.2 (b) of * percentage * (*%) in the aggregate. For each
Performance Standard set forth in Exhibit B that Nova Factor failed to
meet in the previous calendar quarter, the relevant discount amount for
a failure to meet such standard shall be deducted from the Base Discount
for the current calendar quarter, up to a maximum deduction of *
percentage * (*%) ("Reduced Performance Standard"). For each
Incentive Standard set forth in Exhibit B that Nova Factor failed to
meet in the previous calendar quarter, the relevant discount amount for
a failure to meet such standard shall be deducted from the Base Discount
for the current calendar quarter, up to a maximum deduction of *
percentage * (*%), for a maximum total deduction under this Section
2.2(b) of * percentage * (*%) in the aggregate. The maximum
combined Base Discount, additional Performance Standard discount and
additional Incentive Standard discount shall not exceed *% in any
calendar quarter through December 31, 1998, and shall not exceed *% in
any calendar quarter from January 1, 1999 through termination or
expiration of this Agreement.
(c) Changes to the Discounts. The Discounts shall be effective
throughout the term of this Agreement unless and until Genentech alters
its list price for Genentech HGH, in which case the Parties shall
discuss in good faith the level of discount, if any, applicable to the
new list prices. In the event of changes in any laws or regulations of
any jurisdiction relating to the promotion, sale or pricing of
prescription drugs, or in the interpretation or application of any such
laws or regulations, Genentech reserves the right to discontinue the
Discounts provided hereunder in such jurisdiction upon sixty (60) days
prior written notice to Nova Factor.
2.3 Shipment Replacement Requirements.
*
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
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2.4 Orders. All purchase orders for Genentech HGH shall be submitted by
Nova Factor to Genentech either in writing or by telephone or via facsimile
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. The Discount percentage applicable to such credit
will be the Discount in effect upon the date the returned Genentech HGH is
received by Genentech.
2.5 Payment to Genentech. Nova Factor shall pay Genentech in full,
including payment of applicable taxes, for Genentech HGH furnished to Nova
Factor within * (*) days from the date of the invoice from Genentech
for the Genentech HGH supplied to Nova Factor (the "Due Date"). All payments
will be made by check or wire transfer to Genentech's designated bank account
on or before the morning of the Due Date, 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:
Bank: Mellon Bank
Pittsburgh, PA
ABA Number: 0430-00261
Account Name: Genentech, Inc.
Account Number: 005-9230
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
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If by check:
Bank: Mellon Bank
Pittsburgh, PA
Mail to: Genentech, Inc.
X.X. Xxx 000000
Xxxxxxxxxx, XX 00000-0000
2.6 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 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. In the event of a product recall, Genentech shall
reimburse or credit Nova Factor or any unused Genentech HGH returned to
Genentech as a result of said recall, for the reasonable shipping costs and,
upon mutual agreement, for the reasonable recall related administrative costs
associated with said return.
2.7 Nova Factor Reports and Audits.
(a) Nova Factor shall provide Genetech with a weekly and monthly report
as follows:
(1) The Nova Factor weekly reports shall utilize the form attached as
Exhibit I, 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.
(2) The Nova Factor monthly reports shall utilize the parameters and
information listed in Exhibit J attached hereto.
(3) Reports will be centrally generated by Nova Factor and will
contain transaction data from each of its distribution centers.
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(4) Reports will include any returns or negative transactions but
will not include inter-distribution center transfers.
(5) Nova Factor will retain sales transaction data for a four-year
period.
(6) 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.
(7) 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) an (3)
above) shall be provided commencing no later than January 1, 1997.
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 shall be sent to:
Genentech, Inc.
Attn: Sales Administration
000 Xxxxx Xxx Xxxxx Xxxx.
Xxxxx Xxx Xxxxxxxxx, XX 00000.
(8) Upon reasonable request by Genentech, Nova Factor agrees to
perform reconciliations of sales reports to verify or correct the
accuracy of the weekly and monthly reports.
(9) Genentech, at its expense may have an independent certified
public account perform such audits as may be reasonably required on
Nova Factor's business records and activities to ensure compliance
with the terms of the Agreement. Genentech shall provide Nova Factor
with at least fifteen (15) business days advance notice of such
audits, and Nova Factor shall cooperate fully with the persons
conducting the audit, including full access to the necessary
facilities and records at all reasonable times, and copies, at
Genentech's expense, of all relevant records, provided; however, that
Genentech's audit right shall be limited to (i) bi-annual audits or
(ii) such other audits as Genentech may deem necessary, in its
reasonable judgment, to investigate quality assurance problems that
constitute material trends.
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(10) Nova Factor shall maintain for a period of at least four (4)
years all weekly and monthly reports and all correspondence with
Genentech HGH patients 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.
(11) Genentech agrees to return computer tapes to Nova Factor within
sixty (60) days of Genentech's receipt thereof.
(12) Nova Factor will furnish Genentech with un-audited quarterly
financial statements for Nova Factor and its Affiliates, within
forty-five (45) days of the end of the appropriate calendar quarter
and audited annual financial statements within ninety (90) days of
the end of the appropriate calendar year.
2.8 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
(b) store Genentech HGH at between 2deg. and 8deg. 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 with due regard for the need to guard against
potential abuse or diversion; and
(c) monitor refrigeration unit temperature by physically recording the
temperature, at a minimum, twice each day or by utilizing a constant
temperature recording device; and
(d) 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
(e) 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
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Section 3. Distribution of Genentech HGH
3.1 Dispensing Obligation. Subject to Section 4.1 of this Agreement and to
the extent 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.
3.2 Exceptions. Notwithstanding Section 3.1 above, Nova Factor shall not be
obligated to dispense Genentech HGH to patients:
(a) having no insurance or other third party payer coverage (or coverage
equal to an amount less than * percent (*%) 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
(b) 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 number of
patients denied service by Nova Factor each calendar year under this
Section 3.2(b) shall not exceed two percent (2%) of the total number of
patients with prescriptions or
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
8
statements of medical necessity for Genentech HGH who are referred to,
or dispensed or serviced by, Nova Factor during such year. In the event
that such number of patients exceeds or threatens to exceed two percent
(2%) because of factors beyond the reasonable control of the Parties,
then the Parties shall meet to discuss methods to remedy such problems.
3.3 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 Uninsured Patient's Program or in any other
manner Genentech chooses.
3.4 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, which approval may be
withheld at Genentech's sole discretion, other third parties; provided,
however, that Nova Factor hereby guarantees compliance by such Affiliates and
third parties with the terms of this Agreement.
3.5 Appeals and Collections. Nova Factor shall use its commercially
reasonable best 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 will 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.
3.6 Government Programs and UPP. For each patient who does not have third
party payer coverage or for who insurance coverage is in doubt, Nova Factor
will promptly and diligently assess that patient's eligibility for coverage
of Genentech HGH under all appropriate Government Programs. Nova Factor shall
use its best
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efforts to inform patients about meeting, and for patients with Government
Program coverage, maintaining eligibility and coverage by Government
Programs. If third party payer or Government 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 Uninsured Patients
Program.
3.7 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 3.2(b), which patients may be eligible for Genentech's
Uninsured Patients Program. 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.
Section 4. Distribution Relationship
4.1 Exclusivity. In consideration of the benefits provided to Nova Factor
under this Agreement, Nova Factor agrees for itself not to sell and shall
cause its Affiliates not to sell during the term of this Agreement without
Genentech's prior written consent any product (other than Genentech HGH)
containing human growth hormone or an analog of human growth hormone, or
whose principal effect is that of human growth hormone, whether
naturally-occurring or manufactured by any process. Notwithstanding the
foregoing, Nova Factor shall have the right to distribute or sell any third
party's human growth hormone product measured in 2x5 mg unit cartons (or
their equivalent) (a "Third Party Unit") in a volume equal to * percent
(*%) of the combined Nova Factor and Affiliate sales volume, in 10 mg
equivalent units of Genentech HGH, for the preceding year. This sales volume
shall be adjusted, in a manner mutually agreed to by Genentech and Nova
Factor, to account for current and future Affiliate sales, in 10 mg
equivalent units of Genentech HGH, for the preceding year, payer formulary
restrictions, and sales of competitive product for indications for which
Genentech HGH does not have FDA approval. Said amount may be revised upward
or downward upon mutual agreement of Genentech and Nova Factor. At the end of
each calendar quarter, Nova Factor shall provide a statement to Genentech
setting forth the number of Third Party Units distributed by Nova Factor and
its Affiliates, which amount shall be subject to audit by Genentech in
accordance with Section 2.7(a)(9). In the event that in any year, based upon
such quarterly reports, Nova Factor and its Affiliates distribute Third Party
Units above the * percent (*%) limit described in
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
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the second sentence of this paragraph, Nova Factor shall pay to Genentech 85%
of Nova Factor's average purchase price of Genentech HGH during that year for
each Third Party Unit distributed by Nova Factor or its Affiliates during
such year in excess of said amount. Nova Factor also agrees and shall cause
its Affiliates not to distribute or sell Genentech HGH during the term of
this Agreement outside of the United States or its territories or possessions
without the prior written consent of Genentech, which consent shall be given
or withheld in Genentech's sole discretion.
4.2 Substitution and Counter-Detailing of Human Growth Hormone 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 product(s) for prescriptions written for Genentech HGH 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 Single Point of
Contact 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 Managed Distribution System
operated by Healthcare Delivery Systems, Inc. and implemented by Genentech
for the distribution of Genentech HGH through a network of pharmacies
licensed to dispense Genentech HGH ("GMDS"), or (3) promote GMDS. Nova Factor
may inform its customers of its status as an authorized dispensing pharmacy
within GMDS; provided, however, that Nova Factor shall not so inform its
customers in 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 GMDS provider to another delivery
option. 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.
Section 5. Term; Termination
5.1 Term. The term of this Agreement shall commence as of the Effective Date
and continue through December 31, 1999, unless extended by mutual agreement
of the Parties for additional one-year periods.
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5.2 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 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.
5.3 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, and Genentech's obligations of reimbursements accrued as
of the termination date under the programs described in Section 2 above,
which obligations of reimbursement shall first be set off against obligations
of Nova Factor to Genentech, and if any reimbursement credits remain after
set-off after a reasonable period for reconciliation of all outstanding
claims, shall be paid in cash. The provisions of Sections 6.6 and 6.14 shall
survive any termination of this Agreement.
5.4 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 with or into, another entity, including an Affiliate
(the "Acquiring Entity") Nova Factor shall so notify Genentech in writing at
least ninety (90) days prior to the date of occurrence of such event, and
Genentech shall have the right to terminate this Agreement at any time until
ninety (90) 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) days prior to the occurrence
of such event. If Genentech so
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terminates this Agreement, Nova Factor agrees for itself, its Affiliates and
for any such entity that, without Genentech's prior written consent, neither
it nor the Acquiring Entity nor any party affiliated with either of them
shall sell to any patient receiving Genentech HGH at the time of said
termination, for a period of two (2) years following the date of such
acquisition, a human growth hormone product or a product which can be
substituted for Genentech HGH using any of the assets or facilities or
programs developed or used by Nova Factor under this Agreement.
Section 6. Miscellaneous
6.1 Endowment. During the term of this Agreement, Genentech shall fund an
independent, non-profit endowment to assist financially and medically needy
patients, with prescriptions for Genentech HGH.
6.2 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.
6.3 Force Majeure. Nonperformance of either Party 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.
6.4 Entire Agreement. This Agreement is the entire agreement between the
Parties hereto, and supersedes any and all prior agreements between the
Parties (other than the Release Agreement), whether oral or written, relating
to the subject matter hereof. 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.
6.5 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.
6.6 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 or to the
business of the disclosing Party ("Confidential Information") acquired by
virtue of the position of the receiving Party under this Agreement shall not
be
13
disclosed or made use of outside this Agreement; provided, however, that the
foregoing shall not apply to information (a) which 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 mutually acceptable 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.
This Section 6.6 shall survive any termination of this Agreement for a period
of five (5) years from disclosure to the receiving Party.
6.7 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.
6.8 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.
6.9 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.
6.10 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.
6.11 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.
6.12 Headings. The headings in this Agreement are intended
14
solely for convenience of reference and shall be given no effect in the
construction or interpretation of this Agreement.
6.13 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 telefacsimile, 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 telefacsimile.
6.14 Limitation on Liability. If either Genentech or Nova Factor terminates
this Agreement in accordance with the provisions of Section 5 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.
6.15 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.
6.16 Records. To the extent required by Section 1861 (v)(1)(I) of the Social
Security Act, 42 U.S.C. Section 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.
6.17 Compliance with Laws. Each Party shall be responsible for
15
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.
6.18 Government Reporting. All Parties acknowledge and agree that each is
required to comply with all of their respective reporting obligations pursuant
to Section 1128(b) of the Social Security Act and 42 C.F.R. Section 1001.952,
including the accurate and complete reporting of the value of the Discounts.
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/ Xxx Xxxxxxxx
-------------------- --------------------------
Name: /s/ Xxxxx Grow Name: /s/ Xxx Xxxxxxxx
-------------------- --------------------------
Title: President Title: Vice President, Sales
------------------ ------------------------
Address: Address:
0000 Xxxxxxx Xxxxxx Xxxxxxx 000 Xxxxx Xxx Xxxxx Xxxxxxxxx
Xxxxx 000 Xx. Xxx Xxxxxxxxx, XX 00000-0000
Xxxxxxx, XX 00000 (000) 000-0000
(000) 000-0000
Notices to be Addressed to: Notices to be Addressed to:
Chief Executive Officer Vice President--
Sales and Marketing
With a copy to:
Corporate Secretary
16
EXHIBIT A
---------
1. The contract term, Base Discount percentages and discounted prices per
vial are shown below:
Base Discount Genentech HGH
Contract Year Percentage Price per 10mg vail
------------- ------------- -------------------
March 1, 1997 through *% *
June 30, 1997
July 1, 1997 through *% *
December 31, 1997
January 1, 1998 through *% *
June 30, 1998
July 1, 1998 through *% *
December 31, 1998
January 1, 1999 through *% *
December 31, 1999
2. Following are the NDC codes, published direct list prices, carton sizes
offered and minimum order requirements for Genentech HGH:
a. One 5 mg carton of Protropin (somatrem for injection) (NDC
50242-015-02) or Nutropin [somatropin (rDNA origin) for injection]
(NDC 50242-072-02) contains two (2) 5 mg vials of Genentech HGH and
one (1) vial containing 10 mL of diluent (benzyl alcohol preserved
Bacteriostatic Water for injection). The current published list price
per carton is $350.00 (or $175.00 per 5 mg vial).
b. One 10 mg carton of Protropin (somatrem for injection) (NDC
50242-016-20) or Nutropin [somatrophin (rDNA origin) for injection]
(NDC 50242-018-20) contains two (2) 10 mg vials of Genentech HGH and
two (2) vials containing 10 mL of diluent (benzyl alcohol preserved
Bacteriostatic Water for injection). The current published list price
per carton is $700.00 (or $350.00 per 10 mg vial).
The minimum order for all Protropin and Nutropin is one carton
containing two 5 mg or two 10 mg vials.
c. Nutropin AQ (NDC 50242-0114-11) is supplied as 10 mg (approximately
30 IU) of sterile liquid somatropin per vial. Each carton contains
six single vial cartons containing one 2 xX xxxx of Nutropin AQ
[somatronpin (rDNA origin) injection] (5 mg/mL). The current published
list price per carton is $2,100 (or $350 per 10 mg vial). The minimum
order is one carton containing six 10 mg vial cartons of Nutropin AQ.
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
