Exhibit 10.65
Certain portions of this Exhibit have been omitted based upon a request for
confidential treatment pursuant to Rule 406 under the Securities Act of 1933.
The omitted portions have been filed separately with the Securities and
Exchange Commission.
DISTRIBUTION AND SERVICES AGREEMENT
This Distribution and Services Agreement is entered into as of this 28th
day of August, 1998 (the "Effective Date"), by and between Centocor, Inc., and
its Affiliates, with principal offices located at 000 Xxxxx Xxxxxx Xxxxxxx,
Xxxxxxx, Xxxxxxxxxxxx 00000 ("Centocor"), and Nova Factor, Inc., with principal
offices located at 0000 Xxxxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxx
00000 ("Nova Factor").
RECITALS
WHEREAS, Centocor has developed an anti-TNF chimeric monoclonal antibody
product known as Remicade(TM) (the "Product") for use as an agent in the
treatment of (a) inflammatory bowel diseases, including Crohn's Disease
(collectively referred to as "Inflammatory Bowel Disease"); (b) rheumatoid
arthritis, and (c) new indication(s) to be defined.
WHEREAS, as of the Effective Date, the Product has received commercial
marketing approval in the United States of America for certain indications of
Crohn's Disease from the United States of America Food and Drug Administration;
WHEREAS, Centocor is in the process of establishing a distribution network
for the sale of the Product in the United States of America;
WHEREAS, as a part of the distribution network, Centocor intends to
appoint a preferred retail distributor to provide retail assignment of benefits
services to users of the Product;
WHEREAS, Nova Factor, as both a retail and wholesale pharmacy, has the
facilities and expertise to distribute the Product to out-patient customers, to
provide reimbursement assistance and other customer services to its customers
and to provide data reporting and other services to Centocor;
WHEREAS, Centocor is willing to appoint Nova Factor as a preferred retail
distributor of the Product on the terms and conditions set forth in this
Agreement, and Nova Factor is willing to accept such appointment.
NOW, THEREFORE, in consideration of the promises and mutual covenants
herein contained, the parties hereby agree as follows:
1. DEFINITIONS
For purposes of this Agreement the following terms shall have the
following meanings:
1.1 "Adverse Event" shall have the meaning set forth in 21 CFR 600.80.
1.2 "Affiliates" shall mean, with respect to a given party, any
corporation, firm, partnership or other entity which directly or
indirectly controls or is controlled by or is under common control
with such party. For purposes of this Section 1.2, "control" shall
mean direct or indirect ownership of fifty percent (50%) or greater
of the equity having the power to vote on or direct the affairs of
the entity.
1.3 "Assignment of Benefits" ("AOB") shall mean the assignment by the
Outpatient Customer of Insurance Benefits for the Product to Nova
Factor as payment for the Product.
1.4 "AOB Services" shall have the meaning ascribed to such term in
Section 4.6 of this Agreement.
1.5 "Average Wholesale Price" ("AWP") for purposes of this Agreement
shall mean the estimated wholesale price submitted by Centocor for
the Product based on convention employed by First Data Bank, Blue
Book, Red Book, and Medispan. *
1.6 "Bad Debt" shall mean Insurance Benefits assigned to and accepted by
Nova Factor as payment for Product, including unpaid Outpatient
Customer co-pay amounts, which are uncollectible determined on an
accrual basis as provided by Generally Accepted Accounting
Principles ("GAAP").
1.7 "Contractual Allowance" shall mean any discount off Centocor AWP, or
rebate provided by Nova Factor to a third party health insurer,
government program or other third party benefits payor determined on
an accrual basis as provided by GAAP.
1.8 "Database" shall have the meaning set forth in Section 7.1.
1.9 "Documedics" shall mean Documedics, 000 Xxxxx Xxxxxx, Xxxxx 0000,
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000.
*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 and Exchange Commission.
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1.10 "Facility" shall mean Nova Factor's facility located at 0000 Xxxxxxx
Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx Xxxxxxxxx 00000.
1.11 "FDA" shall mean the United States of America Food and Drug
Administration.
1.12 "Infusion Provider" shall mean a Patient's treating physician or the
hospital outpatient clinic or infusion center, etc. at which a
Patient is administered Product.
1.13 "Insurance Benefit" shall mean the amounts paid by a Patient's third
party health insurer, government program or other third party payor
for Product.
1.14 "LHSI" shall mean Xxxxxxxxxx Healthcare Services, Inc., 000 Xxxx
Xxxxx, Xxxxxx, Xxxxxxxx and its Affiliates, where Product shall be
warehoused on Centocor's behalf.
1.15 "Outpatient Customers" shall mean (a) out-patient infusion Patients
or the Patient's Infusion Provider in the Territory who are referred
to Nova Factor by their treating physicians or (b) the Patient's
Infusion Provider (hospital, out-patient clinic, infusion center,
etc.) in the Territory; and the Patient, physician or Infusion
Provider has elected to assign the Product Insurance Benefit to a
third party as payment for the Product.
1.16 "Patient" shall mean an individual who is to be administered the
Product.
1.17 "Product" shall have the meaning ascribed to such term in the first
recital of this Agreement.
1.18 "Purchase Price" shall have the meaning ascribed to such term in
Section 8.1 of this Agreement.
1.19 "Retail" shall mean the provision of Product by a Centocor
distributor for the Product on a named Patient basis to an
Outpatient Customer, and the Insurance Benefit for such Product is
assigned to the Centocor distributor as payment for the Product.
1.20 "SOP" shall mean the written standard operating procedures prepared
by Centocor and agreed to by Nova Factor, as modified from time to
time by the mutual agreement of the parties, which will be used by
Nova Factor to provide certain services under this Agreement. In the
event of a conflict between the SOPs and this Agreement, the terms
of this Agreement shall govern. The SOPs will be completed within
sixty (60) days of the Effective Date, then appended to this
Agreement as Schedule "A", and incorporated herein by reference.
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1.21 "Territory" shall mean the United States of America.
1.22 "Triage Services" shall have the meaning ascribed to such term in
Section 5.2 of this Agreement.
1.23 "US" shall mean the United States of America.
2. APPOINTMENT AS PREFERRED DISTRIBUTOR
2.1 Subject to the terms and conditions in this Agreement, Centocor
hereby appoints Nova Factor and Nova Factor hereby accepts
appointment as a preferred Retail distributor of Product to
Outpatient Customers in the Territory on a Retail AOB basis.
Centocor expressly reserves the right to sell Product to
wholesalers, wholesale specialty distributors, hospitals, pharmacy
benefit managers and other third parties, to sell Product directly
and to appoint other distributors, retail or otherwise, inside and
outside of the Territory. Centocor shall provide Nova Factor with
written notice at least * (*) days prior to the effective date of
any agreement between Centocor and a Retail AOB distributor under
which Centocor grants the Retail AOB distributor the right to
provide Product to Outpatient Customers in the Territory on a Retail
AOB basis, which notice shall specify the name of the other Retail
AOB distributor but shall not specify any other business terms of
the Agreement with the other Retail AOB distributor. If Centocor
contracts directly with a Home Care Delivery Company for Home Care
Services, Centocor will notify Nova Factor of the existence of that
contract, but not the terms and conditions of that contract. Nova
Factor will not promote wholesale distribution and will not sell
Product directly to Infusion Providers unless specifically approved
in writing in advance by Centocor; except Nova Factor may (i)
provide wholesale distribution of Product on a named-patient basis
for Medicaid Patients in those states listed on Schedule "B"
attached hereto and incorporated herein by reference; and (ii)
provide wholesale distribution on a named-patient basis to those
hospitals or other entities listed on Schedule "C" attached hereto
and incorporated by reference. Schedule "C" may be amended by Nova
Factor with the prior written consent of Centocor.
2.2 Nova Factor agrees to use commercially reasonable efforts to market,
sell and distribute the Product to managed care payors, and to work
with Centocor's marketing team, including without limitation,
outside contract sales representatives, if any, during the terms of
this Agreement to distribute the Product in the Territory in an
effective and diligent manner.
*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 and Exchange Commission.
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3. ORDERS, DELIVERY
3.1 The parties hereto agree that, commencing upon the date hereof and
continuing during the term of this Agreement, Centocor will sell the
Product to Nova Factor for resale by Nova Factor in the Territory
and Nova Factor shall purchase Product from Centocor at the Purchase
Price, subject to the right of Centocor to allocate supplies of
Product under Section 3.5 specified herein. Nova Factor shall order
Product from Centocor in such quantities as are necessary to meet
the demand for Product from Nova Factor's Outpatient Customers
provided that Nova Factor will keep a minimum stock of Product equal
to an average of * (*) * total sales to Outpatient Patient
Customers, which average shall be based on the previous * (*) *
sales of Product by Nova Factor. All purchases of Product by Nova
Factor shall be in accordance with SOPs, and in accordance with the
terms and conditions set forth in this Agreement.
3.2 Centocor shall cause LHSI to ship Product to Nova Factor FOB Point
of Origin. Product shall be transported from the LHSI warehouse
facility to the Facility by means of transportation selected by
Centocor. * will prepay all freight costs incurred to ship Product
from LHSI to Nova Factor's Facility. Title to Product shall transfer
to Nova Factor upon delivery of Product to the carrier. * will pay
any costs due to special shipping requests made by *. Centocor may
ship Product in installments as it deems advisable or necessary, in
accordance with SOPs. Risk of loss of Product will remain with
Centocor during transit from LHSI to the Facility and will transfer
to Nova Factor upon delivery of Product to the Facility.
3.3 Product supplied to Nova Factor hereunder shall be in final labeled
and packaged vials. Nova Factor shall unload each shipment of
Product immediately upon receipt at the Facility. Nova Factor shall
carefully examine Products upon delivery and shall immediately
notify Centocor's Customer Service Department and the carrier by
phone or fax of any claim of nondelivery of a portion of a shipment
or any defect or damage in any Product which is reasonably
discoverable upon visual inspection of the Product without unloading
individual shipping units. Along with notice of any defect or
damage, Nova Factor shall furnish to Centocor a detailed written
description of the nature of the defect or damage. In the event of
any such claim, Nova Factor shall hold the Product pending receipt
of Centocor's instruction concerning disposition and permit Centocor
to inspect the Product upon request. Centocor agrees to provide such
instruction promptly.
*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 and Exchange Commission.
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Upon receipt of notice of any defect or nondelivery, Centocor, at
its option, shall replace or repair any defective Product, in
accordance with the Centocor Wholesaler Returned Goods Policy
attached hereto as Schedule "D" and incorporated herein by
reference, as amended from time to time. The Product will be deemed
to have been received in good condition unless Nova Factor notifies
Centocor to the contrary within * (*) * of opening the shipment
container but in no event later than * (*) * following receipt by
Nova Factor. Nova Factor shall, at * expense, follow Centocor's
instructions to return to Centocor, LHSI or a third party disposal
company designated by Centocor, any Products delivered to Nova
Factor which are not in compliance with Centocor's FDA approved
quality assurance specifications. Nova Factor shall cooperate with
Centocor in investigating the cause of any suspected defect in
Product.
3.4 Nova Factor shall not alter Product packaging without Centocor's
written consent (except to remove Product from the shipping
containers) and shall not alter Product labeling except to add a
prescription label to Product, as permitted by applicable law. Nova
Factor shall at all times comply with the SOPs and information and
recommendations otherwise communicated by Centocor in writing with
respect to storage, handling and shipment of Products (including
storage of Product at 2-8 degrees Celsius, if requested by
Centocor), provided that if such information and recommendations are
materially different than those otherwise set forth in the SOPs and
result in a material increase in the costs incurred by Nova Factor
in performing its obligations under this Agreement, *. Nova Factor
shall pay for all costs associated with storage, handling and
shipment of Product from the Facility.
3.5 Notwithstanding anything herein to the contrary, in the event of a
shortage of Product, Centocor shall allocate available supplies of
Product in such manner that Nova Factor is treated as well as
Centocor's other direct customers in the Territory as determined by
Centocor. If Centocor is not able to supply Product to Nova Factor
in the quantities ordered by Nova Factor for more than * (*) * on
any occasion during the term of this Agreement because of a Product
shortage caused by factors other than the market demand exceeding
Centocor's full capacity to produce Product (including, but not
limited to, factors such as an FDA recall due to negligence or
intentional wrongdoing of Centocor, major plant shutdown, or similar
event), Nova Factor shall have the right to terminate this Agreement
upon * (*) * written notice.
*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 and Exchange Commission.
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3.6 Notwithstanding Section 3.5 above, should the FDA quarantine the
Product, Centocor shall have * (*) * from the date of receipt of
notice of quarantine from the FDA to cure the quarantine. In the
event Centocor has not cured the quarantine within * (*) * after
receipt of notice of quarantine from the FDA, Nova Factor may
terminate this Agreement upon expiration of * (*) * notice period.
4. CUSTOMER ORDERS AND IN-OFFICE DELIVERY
4.1 Centocor will provide such marketing, sales and patient/physician
education materials to be distributed by Nova Factor as shall be
deemed necessary by Centocor to promote the Product. Relevant
Patient and Infusion Provider marketing and sales literature
distributed by Centocor's sales force will describe the AOB program
offered through Nova Factor (as described in this Agreement), and
will contain a Nova Factor toll-free number as the point of contact
for enrollment in such program. Centocor and Nova Factor shall
mutually agree on the description of Nova Factor to be used in
Centocor's sales, marketing, and patient/physician educational
materials. Nova Factor shall maintain such telephone and fax lines
dedicated to calls from customers for Product as it determines to be
needed to service these customers.
4.2 In accordance with a Physician's prescription, Nova Factor shall
ship Product and the appropriate infusion-related medical supplies
listed in Schedule "E" attached hereto and incorporated herein by
reference, to Outpatient Customers at any office or other location
at which the Patient will receive infusion, such as a hospital,
clinic, or infusion center, all as designated by the Outpatient
Customer, via Federal Express standard overnight delivery service or
another mutually agreed to overnight carrier in accordance with SOPs
and at no cost to Centocor. Schedule "E" may be modified or changed
by mutual written agreement of Centocor and Nova Factor. Nova Factor
shall have sole responsibility for purchasing and shipping the
infusion-related medical supplies for the Product at no cost to
Centocor. Nova Factor shall use its best efforts to ship Product so
that Product having the earliest expiration date is shipped first
from available inventory. Nova Factor shall track each shipment of
Product to each Outpatient Customer and confirm receipt in
accordance with SOPS.
4.3 Nova Factor will, upon the request of the Outpatient Customer, work
with personnel to coordinate plans for outpatient Product
administration for Patients. Nova Factor will provide written and
telephone assistance regarding home administration of the Product to
Patients.
*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 and Exchange Commission.
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4.4 Nova Factor will provide the following services to each Outpatient
Customer requesting Product from Nova Factor: Nova Factor will
reasonably investigate whether the Patient qualifies for AOB
Services in accordance with Section 4.7 of this Agreement. If the
Patient qualifies for AOB Services, Nova Factor will provide such
AOB Services in accordance with Sections 4.5 through 4.9 of this
Agreement. If the Patient does not qualify for AOB Services because
the Patient's health insurer/governmental program/third party payor
does not utilize Nova Factor as a pharmacy, Nova Factor will
transfer the Patient's prescription to the pharmacy designated by
the Patient's health insurer/governmental program/third party payor
with Triage Services in accordance with Sections 5.1 and 5.2 of this
Agreement. If, after reasonable efforts (as defined in Section 4.7),
Nova Factor cannot obtain Insurance Benefits for Product requested
by an Outpatient Customer, Nova Factor will refer the Outpatient
Customer to * in accordance with Section 4.7 of this Agreement.
4.5 In Retail transactions, Nova Factor will obtain an AOB from the
Outpatient Customer and will xxxx the Outpatient Customer/insurance
company/ governmental program/other third party payor in Nova
Factor's name. Nova Factor shall use reasonable efforts to obtain
reimbursement clearance, if necessary, for anticipated subsequent
orders from an Outpatient Customer prior to actual receipt of the
subsequent order.
4.6 Nova Factor will use its Retail AOB service model ("AOB Services")
to distribute the Product to Outpatient Customers. Nova Factor will
offer a toll-free phone number where health care professionals in
clinics, physician's offices, infusion centers, or home care can:
o identify whether Patients have Insurance Benefits for the
Product;
o coordinate timely delivery of Product and supplies:
o arrange to have Product billed directly to the Outpatient
Customer's insurance company/governmental program/other
third-party payor.
*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 and Exchange Commission.
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Nova Factor Retail AOB Services will include the following:
A. Reimbursement services.
1. Accepting Patient referrals by toll free phone call or
fax.
2. Verification of Patient's Insurance Benefit.
3. Use reasonable efforts to obtain prior authorization for
therapy and other supporting documentation.
4. Initiating requests for formulary status or medical
review on a Patient specific basis.
5. Explaining the Outpatient Customer's Insurance Benefits
and their responsibility to the appropriate party.
6. Accepting the Outpatient Customer's AOB, which includes
consent for therapy, release of medical records, and
acknowledgement of financial responsibility.
7. Filing insurance claims on the Outpatient Customer's
behalf.
8. Use reasonable efforts to collect from the Outpatient
Customer's insurance company/governmental program/third
party payor.
9. Use reasonable efforts to appeal denied claims.
10. Use reasonable efforts to collect Outpatient Customer's
copayments and deductibles.
11. Coordination of Insurance Benefits with Outpatient
Customer's secondary insurance.
B. Pharmacy services.
1. Obtaining the prescription for the Product.
2. Filling the prescription and labeling the medications in
compliance with state pharmacy laws.
3. Providing current information about Product
administration procedures.
4. Coordinating planned delivery times with the
administration site so that the Product is available in
time for the Outpatient Customer's infusion appointment.
5. Shipping the Product to the administration site, and
following up via the Federal Express tracking system to
confirm receipt.
6. Providing information about procedures for Product
administration to healthcare professionals.
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7. Providing information about the Product for the
Outpatient Customer.
8. Computerized next shipment scheduling capability for
follow-up doses.
9. Follow-up calls to the prescriber to arrange the next
doses of Product.
C. Managed care sales support.
1. Contracting with various payor groups, Health
Maintenance Organizations, Preferred Provider
Organizations, PBM organizations, PPM organizations or
indemnity insurance carriers to obtain in-network
provider status.
2. Identifying patients with closed networks or for whom
Nova Factor is out-of-network and follow-up of these
contracting opportunities.
3. Collaboration with the Centocor managed care sales force
through sharing of information to achieve formulary
status for the Product and to gain network provider
status to Nova Factor.
4.7 Nova Factor will use reasonable effort to attempt to obtain
Insurance Benefits for all FDA approved indications for the Product.
For all referrals or non-FDA approved indications for the Product,
Nova Factor will refer the Patient to * for reimbursement clearance.
Patients referred to * for non-FDA approved indications for
reimbursement assistance will be referred back to Nova Factor for
Retail AOB Services once reimbursement clearance is obtained.
4.8 Nova Factor shall incur all billing and collection costs associated
with its sale of Product.
4.9 Nova Factor shall pay for all costs associated with distribution and
delivery of Product to its Outpatient Customers.
5. TRIAGE AND PATIENT-RELATED SERVICES
5.1 Nova Factor will accept referrals for the retail AOB Services
program, and will perform insurance verification. If Nova Factor is
in-network for the Patient's health plan, Nova Factor will serve the
Patient directly through Retail AOB Services. If Nova Factor is not
in-network due to either a closed network, lack of network
affiliation, or requirements for an in-state provider, Nova Factor
will refer the Outpatient Customer to the in-network provider
designated by the Patient's health insurer/governmental
program/other third party payor.
*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 and Exchange Commission.
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5.2 Reimbursement services will include accepting the referral and
collecting patient demographic information, following up with the
patient for additional information (prescription, drug card,
secondary insurance), contacting the insurance carrier to verify
benefits, obtaining prior authorization when permitted, and
notifying the patient of his or her insurance benefits and financial
responsibility. The triage process includes contacting the
in-network provider, transferring the prescription by phone or fax
as required by State Pharmacy laws, and following up with the
Infusion Provider to let prescriber know who will be providing
services ("Triage Services"). Nova Factor will use Triage Services
only for FDA approved indications for the Product.
6. OTHER SERVICES
6.1 Nova Factor shall provide a licensed pharmacist, who is properly
trained to answer Product-related questions or requests for
emergency supplies of Product, to answer telephone questions
relating to the Product posed by doctors and/or Outpatient Customers
(i) from 9:00 A.M. to 6:00 P.M. E.S.T., Monday through Friday,
except legal holidays, for routine calls and (ii) twenty-four hours
(24) per day for emergency calls. Nova Factor will not handle
requests for clinical information outside of the scope of Nova
Factor's usual pharmacist counseling which will be limited to
information covered in the Product package insert. Nova Factor shall
pay for all costs associated with the services provided pursuant to
this Section 6.1.
7. DATA AND REPORTS
7.1 Nova Factor shall maintain in a separate, Centocor-specific database
(the "Database") the information specified in Schedule "F" attached
hereto and incorporated herein by reference, for each customer and
each order. In addition, Nova Factor shall maintain in the Database,
by Outpatient Customer, any information Centocor reasonably requests
Nova Factor to track to the extent that collection of such other
information will not result in a material increase in the costs
incurred by Nova Factor in performing its obligations under this
Agreement.
7.2 As permitted by law, Nova Factor shall generate and furnish to
Centocor electronic or written reports at a mutually agreed upon
frequency from the Database as specified in Schedule "G" attached
hereto and incorporated herein by reference and such other reports
as Centocor may from time to
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time reasonably request to the extent that generation of such other
reports will not result in a material increase in the costs incurred
by Nova Factor in performing its obligations under this Agreement.
The reports shall identify Outpatient Customers only by number and
not by name. Physician-level data will be provided, as specified, on
a named basis. Reports shall include, without limitation, the
following information: physician name, physician practice name,
practice address, Patient number and Patient diagnosis.
8. PRICE, PAYMENT
8.1 Nova Factor shall purchase Product from Centocor at a price *
("Purchase Price"). Any changes in Purchase Price will be effective
upon written notice to Nova Factor. Nova Factor shall have the sole
responsibility and authority for determining the price at which it
will sell Product to its Outpatient Customers.
8.2 Nova Factor shall prepare and provide to Centocor * (*) * after the
end of each calendar quarter, a calendar quarterly report in the
format set forth in Schedule "H" attached hereto and incorporated
herein by reference, which report will show the * for the calendar
quarter and * for the calendar quarter. *
8.3 All amounts due under Section 8.1 above are payable by electronic
funds transfer to Centocor in US Dollars. Centocor shall invoice
upon shipment to Nova Factor for all amounts due hereunder. *
8.4 Centocor shall pay Nova Factor for Triage Services provided under
Section 5 of this Agreement an amount equal to *. Nova Factor shall
invoice Centocor monthly for this amount and all billed amounts are
due within thirty days of the date of receipt of invoice by
Centocor.
8.5 Except as otherwise expressly set forth herein, Nova Factor shall be
responsible for all costs and expenses associated with fulfilling
its obligations under this Agreement, including reimbursement and
AOB Services.
8.6 All Product prices (including Purchase Price) are exclusive of
federal, state and local excise, sales, use and other taxes levied
or imposed on the sale, shipment, delivery, ownership, possession or
resale of Product or any other activities contemplated under this
Agreement. Except for taxes on Centocor's income, Nova Factor shall
be liable for and pay all taxes imposed in connection with the
activities contemplated hereunder.
*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 and Exchange Commission.
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8.7 *
9. REPLACEMENT AND RETURNS
9.1 In the event Nova Factor, or a Nova Factor Outpatient Customer,
returns or requests to return a Product, Centocor will accept return
of such Product and replace, or give a credit to Nova Factor for,
the Product in accordance with the Centocor Wholesaler Return Goods
Policy, attached hereto as Schedule "D", and incorporated herein by
reference, as amended by Centocor from time to time. Centocor will
accept such returns of Product under such policy from, and provide
replacement Product or credit to, only Nova Factor. Nova Factor
shall be solely responsible for returns of Product from, and
replacements and/or credits for Product to, Nova Factor Outpatient
Customers.
10. ADVERSE EVENT REPORTING AND CUSTOMER COMPLAINTS
10.1 Nova Factor will not be responsible for FDA reporting of Adverse
Events Nova Factor will comply with those policies and instructions
concerning adverse events which are set out on Schedule "I" attached
hereto and incorporated herein by reference. Nova Factor will
immediately report to Centocor any Product problems such as
defective or mislabeled Product.
11. SUSPENSION OF DISTRIBUTION AND RECALLS
11.1 If requested by Centocor as the result of a problem with Product
quality or directive from the FDA, Nova Factor shall suspend
distribution of Product. If the suspension continues for more than *
(*) *, Centocor will repurchase the Product held in inventory by
Nova Factor at the Purchase Price paid by Nova Factor including all
contractual discounts, Nova Factor will ship the repurchased Product
to Centocor at * expense and Nova Factor shall have the right to
terminate this Agreement upon * (*) * written notice.
11.2 Centocor shall promptly notify Nova Factor of any recalls of Product
initiated by Centocor or required by the FDA. Upon receipt of notice
of a recall of Product from Centocor, Nova Factor shall notify as
appropriate the affected customers. Centocor shall provide Nova
Factor with the form of letter to be used in connection with notice
of any recall which shall contain the appropriate instructions as to
whether the customer should return or dispose of the affected
Product. *. Nova Factor shall cooperate in any recalls by providing
Product tracking information reasonably requested by Centocor.
*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 and Exchange Commission.
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11.3 Nova Factor shall maintain for two (2) years after termination or
expiration of this Agreement such information as shall be reasonably
required by Centocor to effect a Product recall after termination or
expiration of this Agreement, and shall make such information
available to Centocor, at Centocor's request, in the event of such a
recall.
11.4 Nova Factor shall cooperate with Centocor in investigating any
Product failure which resulted in the need for a recall.
12. REPRESENTATIONS, WARRANTIES AND COVENANTS OF NOVA FACTOR
12.1 Nova Factor is a corporation duly organized, validly existing and in
good standing under the laws of the State of Tennessee.
12.2 In performing its obligations under this Agreement, Nova Factor
shall comply with all applicable laws and regulations, including
federal and state pharmacy laws, laws relating to the disposal of
pharmaceutical products and hazardous wastes, to the extent disposal
of Product is Nova Factor's responsibility under this Agreement, and
all applicable professional and industry standards and good business
practices.
12.3 Nova Factor represents and warrants that it is currently eligible to
participate as a provider in the Medicaid program in each state in
the Territory except those states listed on Schedule "J", attached
hereto and incorporated herein by reference, and covenants that it
will maintain such eligibility during the term of this Agreement.
Nova Factor may amend Schedule "J" in its sole discretion to add
additional states and shall provide Centocor with prompt notice of
any such amendment, provided that Nova Factor shall not add any
state to Schedule "J" unless that state has changed its laws to
require an in-state pharmacy presence for eligibility in its
Medicaid program. Nova Factor shall remove a state from Schedule "J"
(and shall provide notice to Centocor of such removal) when the
state no longer requires an in-state pharmacy presence for the
eligibility in the state's Medicaid program.
12.4 Nova Factor covenants that it shall not take any action which would
materially adversely affect its standing or that of Centocor in the
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pharmaceutical industry or with respect to Product customer base or
which would undermine the image of Product.
12.5 Nova Factor represents and warrants that it now has and shall
maintain in full force during the term of this Agreement all federal
and state pharmacy, wholesaler, retailer and other licenses or
approvals required by Nova Factor to fulfill its obligations under
this Agreement, except as otherwise set forth in Section 12.3, and
except that Nova Factor shall not be required to maintain its
licenses in any state which amends its laws and regulations to
require an in-state pharmacy presence as a requirement for licensing
if the new requirement would materially increase the costs incurred
by Nova Factor in performing its obligations under this Agreement.
Nova Factor covenants that it shall provide Centocor with notice of
any communications with pharmacy licensing boards which relate to
potential problems with facilities, operations or procedures used by
Nova Factor in its distribution of Product, including notices of
inquiries, investigations or inspections and resulting findings.
12.6 Nova Factor covenants that it shall not make any performance claims
or engage in any promotional activities with respect to Product
except for the distribution of Product literature prepared by
Centocor and any other activities expressly approved by Centocor.
12.7 Nova Factor shall not use the trademarks or tradenames of Centocor
except to the extent contained in Product literature provided by
Centocor and on Product labels or as otherwise approved by Centocor.
12.8 Nova Factor represents and warrants that it has the authority to
enter into this Agreement and that its execution of this Agreement
and its performance of its obligations hereunder will not conflict
with and is not prohibited by any other agreement to which Nova
Factor is a party.
12.9 No consent, approval, order of authorization of, or registration,
qualification, designation, declaration or filing with, any federal,
state or local government authority is required in connection with
the consummation by Nova Factor of the transactions contemplated by
this Agreement.
12.10 Nova Factor covenants to Centocor that it will: (i) comply fully
with all laws applicable to Nova Factor and its activities under
this Agreement; (ii) notify Centocor in writing of any material
civil, criminal or administrative action brought against Nova
Factor, its directors, officers, employees or agents which is likely
adversely to affect Nova Factor's ability to perform its obligations
under this Agreement, and promptly to provide Centocor with
reasonably detailed information regarding Nova
- 15 -
Factor's handling and disposition of any such action; and (iii) not
initiate any voluntary communications with regulatory agencies
relating to the Product without Centocor's prior knowledge.
13. REPRESENTATIONS AND WARRANTIES OF CENTOCOR
13.1 Centocor is a corporation duly organized, validly existing and in
good standing under the laws of the Commonwealth of Pennsylvania.
13.2 Centocor shall not use the trademark or tradenames of Nova Factor
except to the extent necessary for activities contemplated under
this Agreement.
13.3 Centocor shall be responsible for testing Product and ensuring that
Product complies, when shipped to Nova Factor, with all applicable
laws, regulations, directives and requirements of the FDA, including
without limitation, standards of identity, strength, quality and
purity, packaging and labeling requirements, product warning
requirements, product design and safety requirements and advertising
requirements.
13.4 Centocor represents that it has the authority to enter into this
Agreement and that its execution of this Agreement and its
performance of its obligations hereunder will not conflict with and
is not prohibited by any other Agreement to which Centocor is a
party.
13.5 No consent, approval, order of authorization of, or registration,
qualification designation, declaration or filing with, any federal,
state or local government authority is required in connection with
the consummation by Centocor of the transactions contemplated by
this Agreement, other than the commercial marketing approval for the
Product discussed in the second recital of this Agreement.
13.6 Centocor covenants to Nova Factor that it will: (i) comply fully
with all laws applicable to Centocor and its activities under this
Agreement; (ii) notify Nova Factor in writing of any material civil,
criminal or administrative action brought against Centocor, its
directors, officers, employees or agents which is likely adversely
to affect Centocor's ability to perform its obligations under this
Agreement, and promptly to provide Nova Factor with reasonably
detailed information regarding Centocor's handling and disposition
of any such action; and (iii) notify Nova Factor after Centocor's
voluntary communications with regulatory agencies which may
materially affect Centocor's ability to perform its obligations
under this Agreement.
- 16 -
14. DISCLAIMER AND LIMITATION OF REMEDIES
14.1 EXCEPT AS STATED IN SECTIONS 13.3, 13.4, 13.5 and 13.6 OF THIS
AGREEMENT, CENTOCOR MAKES NO WARRANTY, EXPRESS OR IMPLIED, REGARDING
THE PRODUCT SOLD TO NOVA FACTOR.
14.2 Except for Section 17.1, Nova Factor's sole and exclusive remedy for
delivery of defective or nonconforming Product will be to receive
credit or like quantity of replacement goods, upon the return of
defective or nonconforming Product. Under no circumstances will
Centocor be liable for any incidental or consequential damages based
on Product purchased by Nova Factor.
15. TERM AND TERMINATION
15.1 The Agreement will be for a three (3) year term and will
automatically renew from year to year thereafter unless either party
should terminate the Agreement upon notice as set forth below.
15.2 * may terminate this Agreement for *, at any time upon * (*) * prior
written notice.
15.3 Upon receipt or delivery of a termination notice or * (*) * prior to
the expiration of this Agreement at the end of the term, as
applicable, the parties shall begin to transition distribution of
Product for Nova Factor's customers to a party to be designated by
Centocor. Transition of distribution under this section shall mean
the following:
(i) At Centocor's request, Nova Factor shall provide written
notice to all of Nova Factor's customers of the change in
distributors; and
(ii) Nova Factor shall transfer a copy of the Database and customer
information including prescription files to Centocor,
provided, that if the applicable patient confidentiality laws
prohibit transfer of the customer's name to Centocor, Nova
Factor shall transfer the Database and customer information
using customer numbers instead of names; and
(iii) Nova Factor's obligation to order additional Product shall
cease and Centocor shall repurchase any Product held in
inventory by Nova Factor within * (*) * after the date of
termination at *. All such inventory shall be returned to
Centocor at * cost.
15.4 Sections 9, 10, 11, 14, 15, 16, 17, 18 and 22.9 shall survive
termination or expiration of this Agreement.
*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 and Exchange Commission.
- 17 -
16. REGULATORY, INSPECTIONS, AUDITS
16.1 Nova Factor shall provide to Centocor all documents and information
requested by the FDA or by Centocor in support of its regulatory
filings. Copies of all documents to be provided to the FDA shall be
provided to Centocor in advance, if practicable, or otherwise within
two (2) business days of delivery to the FDA. Nova Factor shall
notify Centocor immediately upon receipt of notice of any inspection
by the FDA directed specifically toward Product, and Centocor shall
have the right to have an employee present at any such inspection,
if allowed by law. In addition, Nova Factor shall notify Centocor of
any FDA correspondence or inspections that concern Nova Factor
generally and which are not related to a non-Centocor product. Nova
Factor shall notify Centocor immediately of any notices, requests
for information or other communications related to Product from the
U.S. Department of Health and Human Services or any other government
agency or any state healthcare program or other state agency and to
the extent permitted under the applicable law, shall give Centocor
copies of such communication.
16.2 Nova Factor shall provide to Centocor, at Centocor's request, any
information reasonably required in connection with Centocor
investigations relating to recalled or returned Product or any
requests or investigations by or filings with governmental bodies,
including the FDA or in support of Centocor's applications to the
FDA. Nova Factor shall respond within two (2) business days to any
reasonable requests for information by Centocor.
16.3 Nova Factor shall from time to time submit to inquiries, audits and
inspections by Centocor during normal business hours or at any other
time during which the services being audited are ongoing, including
but not limited to, audits of regulatory and quality assurance
standard operating procedures and FDA correspondence referenced in
Section 16.1 above. Centocor shall give Nova Factor at least two (2)
business days prior notice of any audit or inspection and shall bear
the costs of such audit or inspection.
16.4 Nova Factor shall permit Centocor's auditors, or its designated
representatives to have reasonable access, upon five (5) business
days
- 18 -
prior written notice to Nova Factor and during normal business
hours, to Nova Factor's financial books and records as may be
reasonably necessary to verify all documentation and/or address any
financial issues regarding the Product and services provided under
this Agreement.
17. INDEMNIFICATION
17.1 Centocor shall at all times during the term of this Agreement and
thereafter, defend, indemnify and hold Nova Factor and its officers,
directors, agents and employees harmless from and against any and
all claims, suits, damages, liabilities, costs and expenses,
including but not limited to court costs and reasonable attorney's
fees, incurred in connection with any third-party claim arising out
of the use of any Product, except to the extent caused by or based
upon (i) the negligence or intentional misconduct of Nova Factor or
any of its officers, directors, agents and employees or (ii) the
breach by Nova Factor of any of the terms of this Agreement.
17.2 Nova Factor shall at all times during the term of this Agreement and
thereafter, defend, indemnify and hold Centocor and its officers,
directors, agents and employees harmless from and against any and
all claims, suits damages, liabilities, costs and expenses,
including but not limited to court costs and reasonable attorney's
fees, incurred in connection with any third-party claim arising out
of the (i) negligence or intentional misconduct of Nova Factor or
any of its officers, directors, agents and employees or (ii) breach
by Nova Factor of any of the terms of this Agreement.
17.3 A party seeking indemnification under this Section shall give prompt
notice of the claim to the other party and, provided that the
indemnifying party is not contesting the indemnity obligation, shall
permit the indemnifying party to control any litigation relating to
such claim and disposition of any such claim, provided that the
indemnifying party shall act reasonably and in good faith with
respect to all matters relating to the settlement or disposition of
any claim as the settlement or disposition relates to the parties
being indemnified under this Section and the indemnifying party
shall not settle or otherwise resolve any claim without prior notice
to the indemnified party. The indemnified party shall cooperate with
the indemnifying party in its defense of any claim for which
indemnification is sought hereunder.
17.4 In no event shall Nova Factor be liable for loss of profit or any
other incidental or consequential damages to Centocor.
17.5 In no event shall Centocor be liable for loss of profit or any other
incidental or consequential damages to Nova Factor.
- 19 -
18. CONFIDENTIALITY
18.1 Nova Factor agrees to treat any confidential or proprietary
information obtained from Centocor and any confidential or
proprietary information generated by Nova Factor in performing its
obligations under this Agreement, including, but not limited to,
information regarding Centocor's pricing policies and reimbursement
for the Product, information regarding the cost of providing
services to Centocor, the Database, the information in the Database,
and anything derived therefrom, (collectively, the "Centocor
Information") as the confidential and exclusive property of
Centocor, and agrees not to disclose any of the Centocor Information
to any third party without first obtaining the written consent of
Centocor. Notwithstanding this provision, Nova Factor may disclose
Centocor Information to Nova Factor's accountants, bankers,
auditors, and attorneys on an as needed basis and may also disclose
such information in response to requirements of law or governmental
regulations or in response to subpoena or other lawful process. Nova
Factor may provide Patient usage data to managed care organizations,
but may not provide pricing, discount or other information relating
to Product acquisition cost. Nova Factor agrees that it will use any
Centocor Information only for purposes of performing its obligations
hereunder and for no other purpose without the prior written consent
of Centocor. Nova Factor further agrees to take all practicable
steps to ensure that the Centocor Information will not be used by
its directors, officers, or employees, except on like terms of
confidentiality as aforesaid, and will be kept confidential by them.
The above provisions of confidentiality shall not apply to that part
of the Centocor Information which Nova Factor is able to demonstrate
by documentary evidence:
(a) was in Nova Factor's possession prior to receipt from
Centocor; or
(b) was generally available to the public at the time of receipt
from Centocor; or
(c) became generally available to the public through no fault of
Nova Factor, its directors, officers, or employees; or
(d) was lawfully received by Nova Factor from some third party not
disclosing the information on behalf of Centocor and having a
right of further disclosure; or
- 20 -
(e) is required by law to be disclosed, provided that Nova Factor
notifies Centocor prior to any such disclosure so as to permit
Centocor to oppose same by appropriate legal action.
Nova Factor agrees that, at Centocor's request, it shall return to
Centocor all parts of the Centocor Information existing in
documentary form, not including pharmacy records, and will, at
Centocor's request, return or destroy any copies thereof made by
Nova Factor, its directors, officers or employees except that Nova
Factor shall retain a copy of the Database, subject to the ongoing
obligation of confidentiality. Nova Factor shall not dispose of the
information in the Database without first offering in writing, given
at least sixty (60) days prior to such disposal, to deliver the
information to Centocor.
18.2 Centocor agrees to treat confidential or proprietary information
obtained from Nova Factor, (not including the Database, or
information about insurers' reimbursement policies with respect to
Product) and anything derived therefrom, (collectively, the "Nova
Factor Information") as the confidential and exclusive property of
Nova Factor, and Centocor agrees not to disclose any of the Nova
Factor Information to any third party without first obtaining the
written consent of Nova Factor, provided that Centocor may disclose
Nova Factor Information to any third party providing reimbursement
related services to Centocor as long as the third party is obligated
to Centocor to keep such information confidential. Notwithstanding
this provision, Centocor may disclose Nova Factor Information to
Centocor's accountants, bankers, auditors, and attorneys on an as
needed basis and may also disclose such information in response to
requirements of law or governmental regulations or in response to
subpoena or other lawful process. Such confidential information
shall include, but shall not be limited to, FDA files, training
materials, methods of doing business, financial information and
operating procedures. Centocor agrees that it will use any Nova
Factor Information only for purposes of activities contemplated
hereunder and for no other purpose without the prior written consent
of Nova Factor. Centocor further agrees to take all practicable
steps to ensure that the Nova Factor Information will not be used by
its directors, officers, or employees, except on like terms of
confidentiality as aforesaid, and will be kept confidential by them.
The above provisions of confidentiality shall not apply to that part
of the Nova Factor Information which Centocor is able to demonstrate
by documentary evidence:
(a) was in Centocor's possession prior to receipt from Nova
Factor; or
- 21 -
(b) was generally available to the public at the time of receipt
from Nova Factor; or
(c) became generally available to the public through no fault of
Centocor, its directors, officers and employees, or
(d) was lawfully received by Centocor from some third party not
disclosing the information on behalf of Nova Factor and having
a right of further disclosure; or
(e) is required by law to be disclosed, provided that Centocor
notifies Nova Factor prior to any such disclosure so as to
permit Nova Factor to oppose same by appropriate legal action.
Centocor agree that, at Nova Factor's request, it shall return to
Nova Factor all parts of the Nova Factor Information existing in
documentary form and will, at Nova Factor's request, return or
destroy any copies thereof made by Centocor, its directors, officers
or employees.
18.3 Nothing contained herein shall be deemed to grant to either party
any rights or licenses under any patent applications or patents or
to any know-how, technology, inventions or other intellectual
property rights of the other party.
18.4 The obligations of the parties under this Section 18 shall continue
during the term of this Agreement and for a period ending five (5)
years after termination or expiration of this Agreement.
19. INSURANCE
19.1 Nova Factor agrees (i) to obtain and maintain at its cost and
expense, while this Agreement is in effect, commercial general
liability insurance, including products liability insurance with
coverage limits of not less than $1,000,000.00 per occurrence; and
$3,000,000.00 in the aggregate, and (ii) not to cancel the insurance
or reduce the coverage without giving at least thirty (30) days
prior written notice to Centocor. Nova Factor shall cause Centocor
to be a notice party on each insurance policy such that Centocor
shall receive notice of any cancellation or change in policy. At the
request of Centocor, Nova Factor shall provide Centocor with a copy
of a certificate of insurance to verify that insurance with the
required coverage is in effect. In the event of cancellation or
termination of the coverage described herein, Nova Factor shall
immediately obtain substitute or replacement coverage.
- 22 -
19.2 Centocor agrees to maintain, at its cost and expense while this
Agreement is in effect, general public liability, products liability
and property damage insurance with coverage limits of not less than
$1,000,000.00 per occurrence; and $3,000,000.00 per annum aggregate.
Centocor shall cause Nova Factor to be a notice party on each
insurance policy such that Nova Factor shall receive notice of any
cancellation or change in policy. At the request of Nova Factor,
Centocor will provide Nova Factor with a copy of a certificate of
insurance to verify that insurance with the required coverage is in
effect, and shall provide that notice of cancellation of termination
thereof shall be provided in advance to Nova Factor. In the event of
cancellation or termination of the coverage described herein,
Centocor shall immediately obtain substitute or replacement
coverage.
20. TRAINING
Nova Factor will prepare a training manual and orientation program for
Nova Factor personnel to familiarize the personnel with the Product and
the market. Any training manual or orientation program regarding the
Product must be approved by Centocor in writing prior to implementation.
Nova Factor shall allow Centocor to audit Nova Factor's personnel training
sessions.
21. NONCOMPETITION
21.1 During the term of this Agreement, Nova Factor shall not promote,
sell or distribute in the Territory another company's treatment for
inflammatory bowel disease, rheumatoid arthritis, or *, unless
agreed to in writing by Centocor * (*) days prior to such promotion,
sale or distribution. After termination of this Agreement for any
reason, Nova Factor shall not promote, sell or distribute in the
Territory another company's treatment for inflammatory bowel
disease, rheumatoid arthritis, or * for a period of * (*) *
following the date of termination.
21.2 In the event Centocor enters into a signed written agreement which
grants a Retail AOB distributor other than Nova Factor the right to
provide Product to Outpatient Customers in the Territory on a Retail
AOB basis, the restrictions of Section 21.1 shall not apply. Nova
Factor shall provide Centocor with written notice at least * (*) *
prior to the effective date of any agreement between Nova Factor and
another company promoting, selling or distributing in the Territory
treatment for inflammatory bowel diseases, rheumatoid arthritis or
*.
21.3 In the event the FDA quarantines the Product or requires recall of
the Product from the market in the Territory, the restrictions of
Section 21.1 shall not apply.
22. MISCELLANEOUS
22.1 This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective successors and assigns, provided
that neither party shall have the right to assign this Agreement or
its rights and obligations hereunder without the prior written
consent of the other party, which such consent shall not be
unreasonably withheld, except that
*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 and Exchange Commission.
- 23 -
Centocor may assign this Agreement or its rights and obligations
hereunder to its Affiliates or successors in business who assume and
agree to be bound by the terms hereof provided the entity has
demonstrated financial ability to carry out Centocor's obligations
hereunder.
22.2 This Agreement constitutes the entire and only agreement between the
parties relating to the subject matter hereof, and all prior
negotiations, representations, agreements and understandings are
superseded hereby. No agreements amending, altering or supplementing
the terms hereof may be made except by means of a written document
signed by the duly authorized representatives of both parties.
22.3 Any notice required by this Agreement shall be given by prepaid,
first class, certified mail, return receipt requested, or by air
courier, hand delivery, or facsimile, to the parties at the
following addresses:
If to Centocor:
Centocor, Inc.
000 Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, Xxxxxxxxxxxx 00000
Attn: Corporate Secretary
Fax: (000) 000-0000
If to Nova Factor:
Nova Factor, Inc.
0000 Xxxxxxx Xxxxxx Xxxxxxx
Xxxxx 000
Xxxxxxx, Xxxxxxxxx 00000
Attn: President
Fax: (000) 000-0000
- 24 -
with a copy to:
Xxxxxx X. Xxxx, Xx.
Xxxxxxxxx Xxxxx Xxxxxxx Xxxxxx
Xxxxxxx & Xxxxxx, PLLC
Xxxxxxxx Plaza
00 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxx 00000-0000
Fax: (000) 000-0000
Any notice sent under this Section shall be deemed delivered within
five (5) days if sent by mail and within twenty-four (24) hours if
sent by fax, courier or hand delivery.
22.4 Neither party shall be liable for any failure or delay caused by
fires, flood, earthquakes, peril of the sea, accidents, explosions,
sabotage, strikes, or other labor disturbances (regardless of the
reasonableness of the demands of labor), civil commotions, riots,
invasions, wars, acts, restraints, requisitions, regulations, or
directions of governmental authorities, shortages of labor, fuel,
power, or raw material, inability to obtain equipment or supplies,
inability to obtain or delays in transportation, acts of God, or any
other cause beyond its reasonable control ("Force Majeure").
22.5 Headings included herein are for convenience only, and shall not be
used to construe this Agreement.
22.6 For purposes of this Agreement, Nova Factor and its employees and
agents shall not be deemed agents, servants, partners, joint
venturers or employees of Centocor. Thus, they do not have the
authority to take action on Centocor's behalf or to bind Centocor
without Centocor's prior written consent. Nova Factor, its employees
and agents are acting in the capacity of independent contractors of
Centocor. Centocor is not responsible for withholding, and shall not
withhold, FICA or taxes of any kind from any payments it owes to
Nova Factor. Nova Factor is responsible to provide any and all
compensation, benefits and/or insurance to its employees and agents.
Nova Factor employees and agents are not eligible to participate in,
nor are they eligible for coverage under, any of Centocor's benefit
plans, programs, employment policies, procedures or workers'
compensation insurance.
22.7 If any provision of this Agreement shall be found by a court to be
void, invalid or unenforceable, the same shall either be reformed to
comply with applicable law or stricken if not so conformable, so as
not to affect the validity or enforceability of this Agreement,
except if the principal intent
- 25 -
of the Agreement is frustrated by such reformation or deletion, in
which case this Agreement shall terminate.
22.8 Failure of either party to enforce a right under this Agreement
shall not act as a waiver of that right or the ability to later
assert that right relative to the particular situation involved or
to terminate this Agreement as a result of any subsequent default or
breach.
22.9 Neither Nova Factor nor Centocor shall make any news release or
other public statement, whether to the press, stockholders or
otherwise, disclosing the terms of this Agreement or of any
amendments hereto, or to performance hereunder or the existence of
the arrangement between the parties without the prior written
approval of the other party, which approval shall not be
unreasonably withheld, or unless required by law.
22.10 This Agreement shall be construed and enforced in accordance with
the laws of the Commonwealth of Pennsylvania, excluding choice of
law rules.
22.11 This Agreement may be executed in counterparts, including
counterparts transmitted by facsimile, each of which shall
constitute an original and all of which shall be considered one and
the same Agreement. Counterparts or facsimile copies executed by
Centocor and Nova Factor shall have the same effect as if the
signatures to each counterpart or facsimile copy were on the same
document and copies of such documents shall be deemed valid as
originals. Centocor and Nova Factor agree to exchange copies of the
Agreement with original signatures as soon as practicable after the
execution of the facsimile copies.
IN WITNESS WHEREOF, the parties have executed this Agreement effective as
of the date first above written.
CENTOCOR, INC. NOVA FACTOR, INC.
By: /s/ Xxxxx Xxxxxxxxx By: /s/ Xxxxx Grow
--------------------------------- -----------------------
Title: Vice President/General Manager Title: President
------------------------------ --------------------
Dated: 8/27/99 Dated: 8/27/98
------------------------------ --------------------
--------------------------------------------------------------------------------
- 26 -
SCHEDULE A
SOP'S
(To be furnished by Centocor within 60 days of contract execution)
SCHEDULE B
States with network pharmacy relationships for Medicaid patients
Alabama
Colorado
Delaware
Florida
Georgia
Kansas
Massachusetts
Maine
North Carolina
Texas
Vermont
Wisconsin
SCHEDULE C
Nova Factor Hospital Relationships
Xxxxxx X. xxXxxx Institute Children's Hospital Wilmington, DE.
Xxxx Children's Medical Center Fort Worth, TX.
Xxxx Children's Home Care
Children's Medical Center of Dallas Dallas, TX.
Texas Pharmaceutical Health Resources
Children's Memorial Hospital Chicago, IL.
CM Factor Care
National Children's Medical Center Washington, D.C.
Preferred Pediatrics
Xxxxxxxx Children's Hospital at Emory University Atlanta, GA.
Georgia Health Resources
Xxxx Xxxxxx University Hospital Dallas, TX.
Campus Home Health Care
SCHEDULE D
Centocor Inc.
Wholesaler Returned Goods Policy
1. Returned Goods - General
a) No returns will be accepted without prior authorization for credit
or exchange.
b) All returned cartons must have affixed a "Return Goods
Authorization" shipping label.
C) All returned cartons must be clearly marked with the return goods
authorization number.
d) Centocor will only accept physical receipt of returned product
through its designated warehouse and shipping firm:
Xxxxxxxxxx Healthcare Systems, Inc.,
000 Xxxx Xxxxx
Xxxxxx, XX 00000
Telephone (000)000-0000
Fax (877)438 -2368
e) Centocor will not accept returns of product directly from hospital
accounts.
f) Xxxxxxxxxx Healthcare Systems, Inc. will supply appropriate shipping
and packaging instructions for returns.
2. Returnable Items
a) In-date product, with prior approval by Centocor Customer Service
Department.
b) Product shipped in error.
c) Product damaged in transit.
d) Product dated less than two (2) months before and less than six (6)
months after stated expiration date.
e) Product returned pursuant to an official drug recall.
f) Product discontinued by Centocor.
3. Non-Returnable Items
a) Product not in the original packaging, product whose contents have
been adulterated, or which show signs of tampering.
b) Product obtained in violation of state or Federal regulations.
c) Product damaged or made unsaleable due to improper storage,
handling, or shipping by customer.
d) Product involved in a fire sale, sacrifice or bankruptcy sale, or
has been acquired in other than normal channels of trade
distribution.
e) Product sold on a non-returnable basis.
f) Product damaged by fire or water and/or other insurable hazards.
g) Product more than six (6) months beyond expiration.
4. Credits
a) Credit for approved returns will be issued upon receipt of product.
b) All credits will be issued to designated wholesalers.
c) No debit memos will be accepted.
Centocor, Inc.
RETURN GOODS AUTHORIZATION
Date: Control #:
--------------------------------------------------------------------------------
Xxxx to: Credit To:
----------------------------------------------
Customer Name:
--------------------------------------------------------------------------------
Address:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Telephone:
---------------------------------------
Fax:
---------------------------------------
Person Requesting:
---------------------------------------
Product: #To Be Returned:
--------------------------------------------------------------------------------
NDC #: Lot #: Expiration Date:
--------------------------------------------------------------------------------
Invoice #:
---------------------------------------
Price:
---------------------------------------
Reason for Return:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Institution Credit*: (attach list if necessary)
------------------------------------------------
*Note: all authorizations must have a Purchase Order # & Invoice #
--------------------------------------------------------------------------------
Authorized by: (Signed Name)
--------------------------------------------------------------------------------
(Printed Name)
--------------------------------------------------------------------------------
Date
-----------------------------
Internal
--------
Authorized by: (Signed Name)
--------------------------------------------------------------------------------
(Printed Name)
--------------------------------------------------------------------------------
Date
-----------------------------
- 2 -
Centocor, Inc.
Terms and Conditions of Sale
Pricing & Orders:
Purchaser may mail, fax, phone or transmit electronically orders for products
marketed by Centocor, Inc. Centocor, Inc. sells its products through licensed
wholesale distributors at published price in effect on the date of receipt of
order. Prices are subject to change without prior notice.
Prices are invoiced at list price and are only subject to the applicable cash
discount(s) listed on the invoice. Centocor's terms are 2%, 30 days, net 31 from
date of invoice. Centocor reserves the right to charge back the Purchaser for
any unearned discount taken.
All purchase orders for Centocor products are subject to these term and
conditions of sale and any additional or inconsistent provisions contained in
any purchase order or other document provided by the Purchaser are not binding
unless accepted in writing by Centocor, Inc. Centocor, Inc. reserves the right
to limit the quantities of products and drop shipments to be shipped pursuant to
any order or to refuse any order prior to shipment.
Emergency drop shipments may be made to designated customers of the Purchaser.
Products must be ordered in unit packages as described in the Centocor, Inc.
Price List.
Title, Shipment, Delivery:
Title to and Risk of loss of Centocor, Inc. products passes to Purchaser upon
delivery to a common carrier. Centocor will pay the cost of freight and
insurance to Purchaser's location. Purchaser will pay any costs due to special
shipping requests. Centocor, Inc. reserves the right to make shipments in
installments as it deems advisable or necessary, and all such installments
shipped separately will be separately invoiced and paid.
Inspection:
Immediately upon receipt of a shipment of Centocor, Inc.'s products, Purchaser
must inspect the products and notify their carrier and Centocor, Inc.'s Customer
Service Department by phone or by Fax of any claims for shortages, overages,
defects or damage. In the event of any such claim, Purchaser must hold the
products pending receipt of Centocor Inc.'s instruction concerning disposition
and permit Centocor, Inc. or it's representative to inspect them upon request.
Purchaser will follow procedures described in Returns. If Purchaser fails to
notify Centocor, Inc. within 2 days from receipt of order, the products will be
deemed to have been received in good condition in the quantities stated on the
invoice and to have been accepted by Purchaser.
Warranty and Indemnification:
Centocor, Inc. warrants that, as of the date of shipment, Centocor, Inc.'s
products will not be adulterated or misbranded within the meaning of the United
States Food, Drug, and Cosmetic Act and will not be articles that may not be
introduced into interstate commerce under such act. Centocor, Inc. will defend
Purchaser and indemnify it against any claim based on the failure of a Centocor,
Inc. product purchased directly from Centocor, Inc. to meet appropriate
standards of identity, strength, quality, and purity, provided that Purchaser
gives Centocor, Inc. prompt notice of the assertion of the claim, or service of
a complaint and fully cooperates in the defense thereof by counsel of Centocor,
Inc.'s choice. This warranty and indemnification does not apply if the claim
results from Purchaser's negligence or it's alteration, misuse, or improper
testing, handling or storage of the product.
Sole and Exclusive Remedies:
Except as stated in the preceding section, Centocor, Inc. makes no warranty,
express or implied, regarding the products sold to Purchaser. Purchaser's sole
and exclusive remedy for delivery of defective or nonconforming products will be
to receive credit or like quantity of replacement goods, upon the return of
defective or nonconforming product. Under no circumstance will Centocor, Inc. be
liable for any incidental or consequential damages based on product purchased by
Purchaser.
Returns:
Customer agrees to abide by Centocor's published Return Goods Policy.
Product Recall:
Centocor, Inc. will compensate Purchaser for the reasonable direct expense
incurred in performing all requested product recall services.
Other Terms:
Credit. Purchaser must furnish financial information requested by Centocor, Inc.
to establish and maintain it's financial responsibility. Centocor reserves the
right to require cash payment before shipment or on delivery if, in its sole
judgement, Purchaser's financial responsibility has become impaired.
Change of Ownership. Purchaser must notify Centocor, Inc., in writing of any
sale or transfer of majority ownership or controlling interest in Purchaser and
any change of address or Distribution centers at least 30 days before such
action.
Confidential Information. All information provided to the Purchaser concerning
Centocor, Inc. or it's products that is designated confidential must not be
disclosed except with the written permission of Centocor, Inc.
Taxes & Other Charges. Purchaser will pay, or reimburse Centocor, Inc. for, any
use tax, sales tax, duty, inspection or testing fee, or any other tax, fee or
charge of any nature imposed by any governmental authority on purchases of
Centocor, Inc.'s products by Purchaser. If Purchaser claims an exemption from
any tax, it must inform, and provide copies to, Centocor, Inc. of all applicable
exemptions.
By placing orders for Centocor, Inc. products Purchaser will accept the above
terms and conditions.
- 2 -
SCHEDULE E
Infusion-Related Medical Supplies
o NaCl 0.9% 250 ml in non-PVC infusion container
o Non-PVC IV administration set with in-line 1.2 micron filter and infusion
regulator
o 50 ml sterile water for injection
o Five alcohol wipes
o IV bag label
SCHEDULE F
Centocor Reports
*
*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 and Exchange Commission.
SCHEDULE G
Database for Reports
*
*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 and Exchange Commission.
SCHEDULE H
*
*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 and Exchange Commission.
SCHEDULE I
Policy for Adverse Event Reporting
1. Nova Factor is not responsible for FDA reporting of adverse events.
2. When adverse events are identified through contacts with either patients
or health care professionals, Nova Factor will transfer the call to the
Centocor Medical Affairs Department.
3. In the event that Nova Factor cannot transfer the call directly to the
Centocor Medical Affairs Department, Nova Factor will instruct the caller
to contact the Medical Affairs Department and will inform the caller of
the appropriate phone number.
SCHEDULE J
States for which Nova Factor cannot Serve Medicaid Patients due to Requirements
for
an In-State Provider
District of Columbia
Hawaii
Indiana
Nevada
Rhode Island
South Carolina
West Virginia
