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EXHIBIT 10.1
AMENDED AND RESTATED DISTRIBUTION AND SERVICES AGREEMENT
This Amended and Restated Distribution and Services Agreement is
effective as of the 1st day of January, 2000 by and between Biogen, Inc.,
through its offices located at 701 Green Valley Road, Suite 308, Greensboro, NC
27408 ("Biogen"), and Nova Factor, Inc., with principal offices located at 1620
Century Center Parkway, Suite 109, Memphis, TN 38134 ("Nova Factor").
WHEREAS, Biogen markets and sells AVONEX(R) (Interferon beta -1a)
worldwide in the treatment of multiple sclerosis;
WHEREAS, as part of its distribution network, Biogen has appointed a
limited number of preferred distributors to provide quality services to users of
AVONEX(R) and to provide data reporting and other services to Biogen;
WHEREAS, Biogen and Nova Factor are parties to a Distribution and
Services Agreement dated as of November 1, 1995, as amended (the "Original
Agreement") under which Nova Factor has been distributing AVONEX(R) as a
preferred distributor and providing data reporting and other services to Biogen.
WHEREAS, Biogen and Nova Factor desire to amend and restate the
Original Agreement so that Nova Factor continues as a preferred distributor of
AVONEX(R) in the United States on the terms and conditions set forth in this
Agreement.
NOW THEREFORE, in consideration of the premises and mutual covenants
herein contained in this Agreement, 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 greater than fifty percent (50%) of the
equity having the power to vote on or direct the affairs of the entity.
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1.3 "Average Wholesalers' Price" ("AWP") for purposes of this Agreement
shall mean the suggested wholesale price submitted by Biogen in
responding to inquiries from commercial publishers of pricing
information, as adjusted by Biogen from time to time in its sole
discretion. In the event Biogen decides not to submit a suggested
wholesale price to commercial publishers of pricing information, the
parties shall meet to discuss a revised definition of AWP for purposes
of this Agreement.
1.4 "Database" shall have the meaning set forth in Section 7.1.
1.5 "Facility" shall mean Nova Factor's facility located at 1620 Century
Center Parkway, Suite 109, Memphis, TN or any other Nova Factor
facility approved by Biogen prior to use by Nova Factor in connection
with services to be provided under this Agreement.
1.6 "FDA" shall mean the United States Food and Drug Administration.
1.7 "Home Delivery Customers" shall mean multiple sclerosis patients in the
Territory who want Product delivered to their homes or to such other
residence, office or similar locations as they may specify, not
including pharmacies.
1.8 "Nova Factor Collection Policy" shall have the meaning set forth in
Section 5.1 (iv).
1.9 *
1.10 "Product" shall mean Biogen's AVONEX(R) (Interferon beta -1a) for the
treatment of multiple sclerosis in the packaged form listed in Schedule
A hereto, as amended from time to time by the parties.
1.11 "Specifications" shall mean the Product specifications attached hereto
as Schedule B as amended by Biogen from time to time.
1.12 "SOP" shall mean the written standard operating procedures,
specifications and instructions approved by both parties as the same
may be amended from time to time by the parties.
1.13 "Territory" shall mean the United States of America.
2. APPOINTMENT AS PREFERRED DISTRIBUTOR
Subject to the terms and conditions contained in this Agreement, Biogen
hereby appoints Nova Factor, and Nova Factor hereby accepts
appointment, as a nonexclusive, preferred distributor of Product to
Home Delivery Customers. Nova Factor shall not sell Product
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other than to Home Delivery Customers without the prior written consent
of Biogen. Biogen expressly reserves the right to appoint other
distributors, to sell Product to wholesalers, pharmacy benefit managers
and other third parties and to sell Product directly. Biogen shall
provide Nova Factor with written notice at least thirty (30) days prior
to the effective date of any agreement between Biogen and a third party
under which Biogen grants the third party the right to sell Product to
Home Delivery Customers which such notice shall specify the name of the
third party.
3. ORDERS, DELIVERY, FORECASTS
3.1 Orders. The parties hereto agree that, during the term of this
Agreement, Nova Factor shall purchase Product from Biogen at the prices
set forth in Section 8, and, subject to the right of Biogen to allocate
supplies of Product under Section 3.9, Biogen shall supply Product to
Nova Factor, for sale and distribution to Home Delivery Customers. Nova
Factor shall order Product from Biogen in such quantities as are
necessary to meet the demand for Product from Nova Factor's Home
Delivery Customers. On average during any month, Nova Factor shall
submit orders not more frequently than once per week. All orders shall
be firm and Nova Factor shall not change or cancel an order without
prior approval from Biogen. All purchases of Product by Nova Factor
shall be on the terms and conditions set forth in this Agreement. No
purchase order, invoice or other form shall be deemed to vary the terms
of this Agreement.
3.2 Forecasts. To assist Biogen in managing its manufacturing operations,
Nova Factor shall furnish to Biogen, on the first day of each month, a
nonbinding forecast of Nova Factor's anticipated needs for Product for
such month and the following five months. Each forecast shall represent
Nova Factor's good faith best estimate of its Product needs.
Notwithstanding anything herein to the contrary, if Biogen receives an
order in any month which would cause the total amount ordered for such
month to exceed the amount shown on the first forecast for such month,
Biogen shall have the right, in its sole discretion, to reject the
order.
3.3 Minimum Inventory. As soon as Nova Factor's inventory falls to a
one-week supply of Product, Nova Factor shall submit an order to Biogen
for an additional two (2) weeks' supply of Product, based on Nova
Factor's most recent forecast.
3.4 Shipment by Biogen. Biogen shall ship Product to Nova Factor not more
frequently than weekly FOB Biogen's warehouse facility. Biogen shall
ship Product to Nova Factor by means of transportation (commercial
truck or better) determined by Biogen and at Biogen's cost. While
Biogen shall use reasonable efforts to avoid any delay in delivering
Product on the delivery dates agreed upon by the parties, failure to
deliver Product by the agreed upon date will not be sufficient cause
for termination of this Agreement by Nova Factor as long as the delay
does not extend beyond two (2) weeks from the agreed upon delivery
date, nor will Biogen be liable to Nova Factor for late delivery.
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3.5 Storage and Handling of Product. Nova Factor shall unload each shipment
of Product immediately upon receipt from Biogen in accordance with the
applicable SOP. Nova Factor shall store Product in a refrigerated
storage area at the Facility. Nova Factor shall notify Biogen prior to
moving Product to another location for storage and distribution. Nova
Factor shall use storage facilities and storage conditions for Product
which comply with applicable SOPs. Nova Factor shall at all times
handle and store Product in accordance with applicable SOPs. Nova
Factor shall at all times comply with the information and
recommendations communicated by Biogen in writing with respect to the
storage, handling and shipment of Products, provided that if such
information and recommendations are materially different than those
included in the SOPs or otherwise set forth in this Agreement and
result in a material increase in the costs incurred by Nova Factor in
performing its obligations under this Agreement, the parties shall
negotiate in good faith *. Nova Factor shall be responsible for all
costs associated with storage, handling and shipment from the Facility
of Product.
3.6 No Alteration. Nova Factor shall not alter Product packaging without
Biogen's consent (except to remove Product from the shipping
containers) and shall not alter Product labeling except to add a
prescription label to Product.
3.7 Inspection of Product; Remedies and Procedures for Defects. Nova Factor
shall carefully examine Products upon delivery and shall notify Biogen
within one (1) business day of any nondelivery of a portion of a
shipment or any defect in any Product which is reasonably discoverable
upon visual inspection of the Product without unloading individual
shipping units. Along with notice of any defect, Nova Factor shall
furnish to Biogen a detailed description of the nature of the defect.
Upon receipt of notice of any defect or nondelivery, Biogen, at its
option, shall replace or repair any defective Product or issue Nova
Factor a credit in the amount of the purchase price paid for any
defective Product or replace or issue Nova Factor a credit in the
amount of purchase price paid for any undelivered Product. Except as
set forth in Section 16, the preceding sentence sets forth Biogen's
sole liability with respect to Product defects reasonably discoverable
upon visual inspection of the Product without unloading individual
shipping units or with respect to Product that is not in accordance
with Nova Factor's order and Section 9.1 sets forth Biogen's sole
liability with respect to other Product defects and Biogen shall not be
otherwise liable to Nova Factor. In the absence of written notice from
Nova Factor to Biogen in accordance with the terms of this Section 3.7,
a shipment of Products shall be deemed to have been delivered and
accepted by Nova Factor as complete and in satisfactory condition. Nova
Factor shall, at Biogen's request and expense, follow Biogen's
instructions to return to Biogen or Biogen's third party disposal
company any
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Products delivered to Nova Factor which are not in compliance with the
Specifications. Nova Factor shall cooperate with Biogen in
investigating the cause of any defect in Product.
3.8 Title and Risk of Loss. Title to Product shall transfer to Nova Factor
upon delivery of Product to the carrier for shipment to the Facility.
Risk of loss of Product shall transfer to Nova Factor upon delivery of
Product to the Facility.
3.9 Shortages. Notwithstanding anything herein to the contrary, in the
event of a shortage of Product, Biogen reserves the right to allocate
available supplies of Product in its sole discretion. If Biogen is not
able to supply Product to Nova Factor in the quantities ordered by Nova
Factor for more than twelve (12) weeks on any occasion during the term
of this Agreement because of a Product shortage, Nova Factor shall have
the right to terminate this Agreement for material breach under Section
14.3 excluding the thirty (30) day cure period.
4. CUSTOMER ORDERS AND HOME DELIVERY
4.1 Contact with Customers. Marketing and sales literature distributed by
Biogen's sales force will contain a Biogen toll-free number as the
point of contact for all potential and existing customers for Product.
Biogen's customer service representatives shall include a description
of the AVONEX(R) Direct Delivery program to potential customers of
various purchase and delivery options for Product, and, if a potential
customer expresses interest in Nova Factor's home delivery program, the
Biogen customer service representative shall forward the call or direct
the customer to Nova Factor. Biogen and Nova Factor shall mutually
agree on the description of Nova Factor to be used by Biogen's customer
service representatives. Biogen shall provide Nova Factor with a copy
of the script used by Biogen's customer service representatives in
describing Product distribution options to potential customers. Nova
Factor shall maintain a telephone line dedicated to calls transferred
from Biogen and to calls from customers for Product. Nova Factor shall
answer all calls from customers for Product in accordance with a script
mutually agreeable to Biogen and Nova Factor. If the customer has
volunteered information to Biogen, Biogen shall transmit the
information to Nova Factor. During initial customer contact, Nova
Factor shall record information using the standard intake form approved
by the parties. Nova Factor shall direct to Biogen's customer service
operation all potential users of Product who contact Nova Factor
directly in accordance with a script mutually agreeable to Biogen and
Nova Factor.
4.2 Shipment to Customers.
(a) Shipment. Nova Factor shall ship Product to customers at their
homes or to any other residence, office or similar location designated
by customer, not including pharmacies,
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via Federal Express standard overnight delivery service or another
mutually agreed to overnight carrier. Nova Factor shall package
Products for shipment in insulated shipping units in accordance with
the applicable SOP. Nova Factor shall use its best efforts to ship
Products such that Product having the earliest expiration date is
shipped first from available inventory. Nova Factor shall track each
shipment of Product to customer and confirm receipt. If Product is not
received by the intended customer, Nova Factor shall use reasonable
efforts to track the missing shipment until found and, if found, shall
retrieve the missing shipment. Any shipment not delivered to the
intended recipient which is found shall be retrieved by Nova Factor
and, if determined by Nova Factor to be unusable, shall be disposed of
by Nova Factor, at Nova Factor's cost.
(b) Timing. Except for initial shipments made to a customer's home or
designated location and except where the customer's payor requires
preapproval of subsequent shipments, Nova Factor shall, subject to
Product availability, ship Product to a customer within 48 hours of
receipt of an order. Nova Factor shall use reasonable efforts to obtain
reimbursement clearance, if necessary, for anticipated subsequent
orders from a customer prior to actual receipt of the subsequent order.
Nova Factor shall ship each initial order and any subsequent order
which requires reimbursement clearance to a customer's home or
designated location within 48 hours of reimbursement clearance unless
Biogen and Nova Factor have agreed upon a first shipment program. At
Biogen's request, Biogen and Nova Factor shall work together to develop
a first shipment program to allow shipment of initial quantities of
Product to a patient prior to reimbursement clearance. If the parties
have agreed upon a first shipment program, Nova Factor shall comply
with the timelines for delivery of Product contained in the program.
4.3 Billing and Collection. Nova Factor shall be responsible for all
billing and collection in connection with its sales of Product. Nova
Factor shall not bundle sales of Product with other products or
services, provided that Nova Factor may list Product on the same
invoice with other products for the same customer if required by the
customer's insurance provider, as long as the Product price and any
negotiated discount from or allowance taken with respect to the Product
price are listed separately. Nova Factor may bundle shipments of
Product with other products for delivery to the same customer, provided
that such bundling is covered by an SOP.
4.4 Costs and Expenses. Nova Factor shall be responsible for all costs
associated with distribution and delivery of Products to its customers.
5. REIMBURSEMENT-RELATED SERVICES
5.1 Reimbursement-related Procedures. To ensure a consistent, high level of
services and to maintain consistency of communications with end-users
of Product, the parties have agreed that Nova Factor will, as part of
its commitment to its customers, provide the
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following services for each potential or existing Nova Factor customer
who contacts Nova Factor for home delivery of Product:
(i) Nova Factor shall collect the relevant insurance information
from each new customer who has insurance and shall obtain
confirmation of the existence and extent of insurance coverage
for Product from the customer's insurance provider or other
third party payor. Nova Factor shall use its best efforts to
confirm reimbursement coverage within one (1) week of receipt
of an order from a customer. Biogen understands that, despite
Nova Factor's best efforts, confirmation of reimbursement
coverage will often take longer than one (1) week.
(ii) Nova Factor shall accept assignment of benefits from each
customer with reimbursement coverage unless the customer's
insurance provider or other third party payor does not allow
assignment of benefits. To effect the assignment of benefits,
Nova Factor shall, within two (2) business days of initial
contact with each customer, provide to the customer the
applicable forms and instructions for assignment of benefits
and shall file the forms with the customer's insurance
provider or other third party payor at the time of Product
shipment and billing.
(iii) Upon receipt of the appropriate approval, Nova Factor shall
bill and submit the appropriate claims to each customer's
insurance provider, third party payor or other responsible
party, including Medicaid, but not including Medicare.
(iv) Consistent with applicable law and Nova Factor's standard
collection policy, a copy of which is attached hereto as
Schedule C (the "Nova Factor Collection Policy"), Nova Factor
shall use its best efforts to collect the amount allowed from
each customer's insurance provider or other third party payor,
and shall work with customers and negotiate with providers and
third party payors to maximize reimbursement coverage.
(v) Nova Factor shall bill patient co-payments, self-pays or
deductibles and shall use reasonable good faith efforts to
collect such payments consistent with applicable law and the
Nova Factor Collection Policy. Nova Factor shall provide
Biogen with a copy of any changes to the Nova Factor
Collection Policy prior to implementation of such changes.
(vi) Nova Factor shall make the intake coordinator function
available from 8:30 a.m. to 8:00 p.m., E.S.T., Monday through
Friday, except Nova Factor holidays, to answer customer,
insurance provider, third party payor and prescriber
reimbursement questions. Biogen will, in its sales and
marketing material, list Biogen's toll-free number as the
number for users of the Product to call with reimbursement
questions. When Biogen receives a telephone call from a Nova
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Factor customer with a reimbursement question, the Biogen
customer service representative will transfer the telephone
call to Nova Factor.
(vii) Nova Factor shall use its best efforts to resolve
reimbursement issues of customers who would like to purchase
Product from Nova Factor.
(viii) Biogen shall furnish to Nova Factor the criteria for
eligibility in Biogen's financial assistance program, and Nova
Factor shall direct potential customers who meet the criteria
to Biogen's customer service department and to Biogen's
assistance program administrator.
5.2 No Denial of Products. Nova Factor shall not deny Product to customers
who do not have insurance or who have insufficient insurance coverage
if the customer has the ability to self-pay.
5.3 Information to Biogen. At Biogen's request, Nova Factor shall provide
to Biogen information regarding reimbursement policies for Product
generated by Nova Factor in the course of providing services under this
Agreement.
5.4 Costs and Expenses. Nova Factor shall be responsible for all costs
associated with the services provided under this Section 5.
5.5 Compliance with Law. Nova Factor shall be responsible for assuring that
the services provided under this Section are carried out in a manner
consistent with applicable federal and state laws.
6. OTHER SERVICES
6.1 Licensed Pharmacist. Nova Factor shall ensure that a licensed
pharmacist, who is properly trained to answer Product-related questions
or requests for emergency supplies of Product, is available by
telephone (i) from 8:30 a.m. to 8:00 p.m. E.S.T., Monday through
Friday, except Nova Factor holidays, for routine calls and (ii)
twenty-four hours (24) per day for emergency calls. Biogen's customer
service representatives will direct any appropriate calls from Nova
Factor's customers received on Biogen's toll-free line to the Nova
Factor pharmacist.
6.2 Contact Regarding Re-supply. Nova Factor shall, to the extent
consistent with applicable federal and state pharmacy laws, contact
each of its customers approximately one week before the customer's
supply of Product, assuming proper administration, will be depleted to
determine if the customer needs a new supply of Product.
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6.3 Inquiry Regarding Training. Upon receipt of an order from a new
customer, Nova Factor shall inquire whether the customer has received
Product administration training. If the customer has not received
Product administration training or would like to receive additional
training, Nova Factor shall direct the patient to Biogen's customer
service department or such other contact as Biogen shall designate.
6.4 Materials. Nova Factor shall maintain an inventory of Product
educational materials developed and provided by Biogen. Nova Factor
shall, to the extent permissible under applicable laws, ship the
materials as requested by Nova Factor's customers or by its customers'
insurance providers or other third party payors. At Biogen's request,
Nova Factor shall include in shipments of Product business reply cards,
pamphlets or other informational material supplied by Biogen.
6.5 Follow-up. To the extent allowable under applicable law, Nova Factor's
customer service representatives shall call each new customer one to
three weeks after the customer has received an initial shipment of
Product to check on the customer's progress. In checking on the
customer's progress, Nova Factor shall use a script and checklist
mutually agreeable to the parties. At Biogen's request, Nova Factor
shall during its telephone conversations with customers conduct
additional clinical efficacy and customer satisfaction surveys provided
by Biogen and shall report the resulting information to Biogen in a
manner consistent with any confidentiality restrictions. The parties
shall negotiate, in advance, the fee for each additional survey
initiated by Biogen.
6.6 Compliance with Law. Nova Factor shall be responsible for assuring that
the services provided under this Section are carried out in a manner
consistent with applicable federal and state laws, including state
pharmacy laws.
7. DATA AND REPORTS
7.1 Data. Nova Factor shall maintain in a separate, Biogen-specific
database (the "Database") the information specified in Schedule D for
each customer and each order. In addition, Nova Factor shall maintain
in the Database information, by customer, regarding (i) *, (ii) *, and
(iii) * 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 Reports. Nova Factor shall generate and furnish to Biogen monthly and
weekly reports from the Database as specified in Schedule D and such
other reports as Biogen may from time to 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
customers only by number
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and not by name. At Biogen's request, Nova Factor will deliver the
reports specified under this Section electronically through a
reasonably secure internet connection in a format mutually approved by
both parties.
8. PAYMENT
8.1 Purchase Price and Service Discount. Nova Factor shall purchase Product
from Biogen at a price *. Nova Factor shall have sole responsibility
and authority for determining the price at which it will sell Product
to its customers.
8.2 Payment Due; Late Fee. All amounts due hereunder shall be payable by
check to Biogen in United States funds. Biogen shall invoice Nova
Factor for all amounts due hereunder. Payment by Nova Factor for all
invoices dated on or after January 1, 2000 shall be due within * days
from the date of the invoice. Invoices dated prior to January 1, 2000
shall be paid in accordance with the terms of this Agreement in effect
prior to January 1, 2000, Nova Factor shall pay interest on a per diem
basis on any amounts past due at an annualized rate of one and one-half
percent (1-1/2%) over the prime rate then in effect at Fleet Bank,
Boston, Massachusetts.
8.3 Costs and Expenses. 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.
8.4 Taxes. All prices 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
Biogen's income, Nova Factor shall be liable for and pay all taxes
imposed in connection with the activities contemplated hereunder.
8.5 Records and Audits. During the term of this Agreement and for a period
of three (3) years after termination or expiration of this Agreement,
Nova Factor shall keep complete and accurate records of sales of
Product in sufficient detail to enable Biogen to calculate and confirm
*. Nova Factor shall permit Biogen, during the term of this Agreement
and for a period of three (3) years after termination or expiration of
this Agreement, to examine periodically, but not more than once per
year during regular business hours, the books, ledgers and records of
Nova Factor for any year for the purpose of and to the extent necessary
to verify the information provided by Nova Factor *. The cost of such
examination shall be borne by Biogen unless it shall be established by
Biogen that, as a result of an error in information provided by Nova
Factor, there was a miscalculation *.
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8.6 Financial Condition; Security Interest; Guaranty.
(a) Financial Condition. At any time when in Biogen's reasonable
opinion the financial condition of Nova Factor or its parent
company so warrants, or if Nova Factor fails to make payments
when due or otherwise defaults under this Agreement, Biogen
may alter terms of payment (including requiring full or
partial payment in advance of delivery), suspend credit, delay
or cancel shipping, request quarterly financial statements or
other financial information on an ongoing basis, or pursue any
remedies available at law or under this Agreement.
(b) Security Interest. Nova Factor hereby grants to Biogen a
security interest in all Products as security for all payments
to be made by Nova Factor and the performance in full by Nova
Factor of its other obligations under this Agreement together
with the right, without liability and with or without notice
to Nova Factor, to repossess Products in the event of default
with respect to any such obligations. Biogen recognizes that
Nova Factor has previously granted a security interest to its
bank and that Biogen will not have a first lien on the
Products. This Agreement shall constitute a security agreement
with respect to such security interest, and Nova Factor hereby
appoints Biogen as its attorney-in-fact solely for the purpose
of signing and filing on Nova Factor's behalf any financing
statements or other documents that may be necessary or
appropriate to perfect such security interest and Nova Factor
agrees to sign any such documents and to take any such actions
as Biogen may reasonably request with respect to perfection
and/or enforcement of such security interest.
(c) Parent Guaranty. In connection with this Agreement, Nova
Factor's parent corporation will execute a form of guaranty
mutually agreeable to the parties under which the parent
corporation agrees to guaranty the obligations of Nova Factor
under this Agreement in the event of default by Nova Factor.
9. REPLACEMENTS AND RETURNS
9.1 Returns by Nova Factor. In the event Nova Factor returns or requests to
return a Product, Nova Factor shall promptly notify Biogen and Biogen
shall, upon return of Product, give Nova Factor a credit in the amount
of the purchase price paid by Nova Factor for the returned Product,
provided that the Product is returnable and returned under Biogen's
then current Return Goods Policy, a copy of which Biogen shall furnish
to Nova Factor, and provided that the reason for the return of the
Product does not arise from (i) the negligence or intentional
misconduct of Nova Factor or any of its agents or employees, (ii)
failure of Nova Factor to follow applicable SOPs or to otherwise comply
with the terms of this Agreement or (iii) misdelivery or loss of
Product by a carrier used by Nova Factor. For any return of Product
authorized by Biogen, Nova Factor shall send the
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Product, or shall instruct customers to send the Product, to Biogen or
Biogen's designated disposal company as specified and in the manner
described in the then current Return Goods Policy.
9.2 Replacement Product. Nova Factor shall refer any Nova Factor customer
who requests replacement product to one of Biogen's customer support
specialists for authorization. Biogen's customer support specialists
shall within thirty (30) days of the referral authorize the supply of
replacement Product at no charge to a Nova Factor customer under
appropriate circumstances as determined by Biogen. Biogen shall not
authorize the supply of replacement Product to a Nova Factor customer
at no charge if the need for replacement Product arises from (i) the
negligence or intentional misconduct of Nova Factor or any of its
agents or employees, (ii) failure of Nova Factor to follow applicable
SOPs or to otherwise comply with the terms of this Agreement or (iii)
misdelivery or loss of Product by a carrier used by Nova Factor. If
Biogen determines not to supply replacement Product at no charge, Nova
Factor may purchase the replacement Product at the prices and on the
terms set forth in Section 8.
9.3 Return Goods Policy. Biogen may change its Return Goods Policy in its
sole discretion, provided that if any change results in a material
increase in the costs incurred by Nova Factor in performing its
obligations under this Agreement, the parties shall meet *.
9.4 Costs and Expenses. Except as otherwise expressly set forth herein,
Nova Factor shall be responsible for all costs and expenses associated
with fulfilling its obligations under this Section 9.
9.4 Cooperation. Nova Factor shall cooperate with Biogen in investigating
the need for any replacement Product or the reason for return of a
Product by a Nova Factor customer.
10. ADVERSE EVENT REPORTING AND CUSTOMER COMPLAINTS
10.1 Adverse Events. Nova Factor shall record and promptly report to Biogen
any Adverse Events which come to the attention of Nova Factor in
accordance with the relevant SOP provided by Biogen.
10.2 Other Customer Complaints. Nova Factor shall give notice by fax to
Biogen's customer service department within two (2) business days of
all customer complaints related to Product, other than Adverse Events,
and all labeling and package insert issues, specifying the nature of
the complaint or issue. Nova Factor shall send Biogen a monthly report
describing all customer complaints, including complaints related to
customer service. The parties shall mutually agree on Product
information to be used by Nova Factor in addressing customer
complaints, Adverse Events and labeling and package insert issues.
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10.3 Cooperation. Nova Factor shall cooperate with Biogen in responding to
or investigating any customer complaints and Adverse Events.
11. SUSPENSION OF DISTRIBUTION AND RECALLS
11.1 Suspension of Distribution. If requested by Biogen as the result of a
problem with Product quality or a directive from the FDA, Nova Factor
shall suspend distribution of Product. If the suspension continues for
more than * and Nova Factor shall have the right to terminate this
Agreement for material breach under Section 14.3 excluding the thirty
(30) day cure period. In addition, any amounts payable on invoices
pending during the period of the suspension shall not be due until the
suspension has ended, and late fees and interest shall not be due for
the period of the suspension.
11.2 Recalls. Biogen shall promptly notify Nova Factor of any recalls
initiated by Biogen or required by the FDA. Upon receipt of notice of a
recall from Biogen, Nova Factor shall immediately notify the affected
customers. Biogen 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. Biogen shall be responsible for the
mailing, shipping and reasonable administrative expenses incurred by
Nova Factor in connection with the recall as well as the cost of
replacement Product for Nova Factor's customers, provided that the
reason for the recall does not arise from (i) the negligence or
intentional misconduct of Nova Factor or any of its agents or employees
or (ii) failure of Nova Factor to follow applicable SOPs or to
otherwise comply with the terms of this Agreement. Nova Factor shall
cooperate in any recalls by providing relevant Product tracking
information to Biogen.
11.3 Records. Nova Factor shall maintain for two (2) years after termination
or expiration of this Agreement such information as shall be reasonably
required by Biogen to effect a Product recall after termination or
expiration of this Agreement, and shall make such information available
to Biogen, at Biogen's request, in the event of such a recall.
11.4 Cooperation. Nova Factor shall cooperate with Biogen in investigating
any Product failure which resulted in the need for a recall.
12. REPRESENTATIONS, WARRANTIES AND COVENANTS OF NOVA FACTOR
12.1 Compliance. 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
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extent disposal of Product is Nova Factor's responsibility under this
Agreement, and all applicable professional and industry standards and
good business practices.
12.2 Quality of Employees and Monitoring. Nova Factor shall use a dedicated,
well-trained, knowledgeable team of employees to handle Product and to
perform the services to be performed by Nova Factor under this
Agreement. Subject to applicable laws, Biogen shall have the right to
have an employee monitor from time to time Nova Factor's responses
during telephone calls transferred from Biogen's customer support line,
and Nova Factor shall cooperate with Biogen to enable such monitoring
activities. The customer shall be notified at the beginning of a call
to be monitored that monitoring for quality assurance purposes is to
occur, each such notification to be in accordance with a script
mutually agreeable to the parties.
12.3 *
12.4 Medicaid Provider Status. Nova Factor represents 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 F, and
agrees to maintain such eligibility during the term of the Agreement.
Nova Factor may amend Schedule F in its sole discretion to add
additional states and shall provide Biogen with prompt notice of any
such amendment, provided that Nova Factor shall not add any state to
Schedule F unless the 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 F (and shall provide notice to
Biogen of such removal) when the state no longer requires an in-state
pharmacy presence for eligibility in the state's Medicaid program.
12.5 Actions. Nova Factor shall not take any action which would materially
adversely affect its standing or that of Biogen in the industry or with
respect to Product customer base or which would undermine the image of
Product.
12.6 Quality Reviews. Nova Factor shall periodically, but not less
frequently than once per year, perform written quality reviews of Nova
Factor's performance in fulfilling its obligations under this
Agreement, and shall provide Biogen with copies of such reviews. Nova
Factor shall administer a validation checklist to each employee
performing services related to Product upon completion of such
employee's initial training and annually thereafter, and shall provide
Biogen with copies of such checklists.
12.7 Licenses. Nova Factor represents that it now has and shall maintain in
full force during the term of this Agreement all federal and state
pharmacy, wholesaler and other licenses or approvals required by Nova
Factor to fulfill its obligations under this Agreement, except as
otherwise set forth in Section 12.4, and except that Nova Factor shall
not be required
* - Confidential Treatment Requested
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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 shall provide Biogen with notice of any
communications with pharmacy licensing boards or the FDA 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.
12.8 Limitation on Promotion. Nova Factor 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 Biogen
and any other activities expressly approved by Biogen.
12.9 Use of Trademarks. Nova Factor shall not use the trademarks or
tradenames of Biogen except to the extent contained in Product
literature provided by Biogen and on Product labels or as otherwise
approved by Biogen.
12.10 Financial Statements. Nova Factor shall furnish to Biogen copies of
quarterly and annual financial statements of Nova Factor (including
balance sheet and income statements). Nova Factor shall promptly notify
Biogen of any significant change to the business or financial condition
of Nova Factor or its parent or any changes in its ownership or control
or the control of its parent. The financial statements provided to
Biogen by Nova Factor and its parent under this Section shall be
treated by Biogen as confidential information of Nova Factor under
Section 17.2, except to the extent publicly available.
12.11 Authority. Nova Factor 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 Nova Factor is a party.
12.12 Limitation on Liability. In no event shall Nova Factor be liable for
loss of profit or any other incidental or consequential damages of
Biogen.
12.13 Customer Lists. In no event shall Nova Factor use the list of its
Product customers except for purposes of performing services under this
Agreement or as otherwise approved by Biogen. Nova Factor shall not
make its Product customer list or any portion thereof available to any
third party other than third party payors (with respect to their
respective covered persons), its lender, or its auditors or attorneys.
13. REPRESENTATIONS, WARRANTIES AND COVENANTS OF BIOGEN
13.1 Compliance with Law. Biogen shall be responsible for testing Product
and ensuring that Product complies, when shipped to Nova Factor, with
all applicable laws, regulations,
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directives and requirements of the FDA, including without limitation,
packaging and labeling requirements, product warning requirements,
product design and safety requirements and advertising requirements.
13.2 Use of Trademarks. Biogen shall not use the trademark or tradenames of
Nova Factor except to the extent necessary for activities contemplated
under this Agreement.
13.3 Warranty. Biogen warrants that, as of the date of shipment to Nova
Factor, Product will conform to the Specifications, will not be
adulterated or misbranded within the meaning of the Federal Food, Drug
and Cosmetic Act and will not be articles which may not, under the
provisions of the Act, be introduced into interstate commerce. THE
WARRANTIES CONTAINED IN THIS SECTION 13.3 ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES. BIOGEN DISCLAIMS ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ALL WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Except as
otherwise set forth in Section 16, Biogen's sole liability and Nova
Factor's sole remedy for breach of warranty under this Agreement shall
be for Biogen to repair or replace the defective Product or to credit
Nova Factor's account in accordance with Section 3.7 and Section 9.1.
In no event shall Biogen be liable for loss of profit or any other
incidental or consequential damages of Nova Factor.
13.4 License. Biogen represents and warrants to Nova Factor that Biogen has
a license from the FDA to market and sell Product in the Territory.
13.5 Authority. Biogen 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 Biogen is a party.
14. TERM AND TERMINATION
14.1 Term. This Agreement shall become effective on the date hereof and,
unless earlier terminated in accordance with this Section, shall
continue in effect for an initial term of three (3) years from the
effective date. The parties may extend this Agreement by mutual written
agreement.
14.2 Voluntary Termination. Either party may terminate this Agreement for
any reason, at any time upon ninety (90) days' prior written notice to
the other party.
14.3 Termination for Breach. Either party may terminate this Agreement (i)
for a material breach by the other party upon thirty (30) days' prior
written notice unless the breaching party cures the breach within such
thirty (30) day period or (ii) in the event of any
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proceedings, voluntary or involuntary, in bankruptcy or insolvency, by
or against the other party, or the appointment with or without the
other parties' consent of a receiver for such party.
14.4 Transition. Upon receipt or delivery of a termination notice by Nova
Factor or ninety (90) days prior to 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 Biogen. Transition of distribution under this Section
14.4 shall mean the following:
(i) Biogen shall as soon as possible begin referring Nova
Factor customers who contact Biogen's customer service
department to the designated distributor.
(ii) At Biogen's request, Nova Factor shall provide notice to
all of Nova Factor's customers of the change in distributors.
(iii) Nova Factor shall complete any reimbursement clearances
and Product shipments then underway, but otherwise shall refer
customers to the designated distributor.
(iv) Nova Factor shall transfer a copy of the Database and
customer information, including prescription files, to the
designated distributor, provided that if applicable patient
confidentiality laws prohibit transfer of the customers' name
to the designated distributor, Nova Factor shall transfer the
Database and customer information using customer numbers
instead of names, and shall notify customers of their
respective customer numbers.
(v) Nova Factor's obligation to order additional Product when
its inventory falls to a one-week supply shall cease and
Biogen shall repurchase any Product held in inventory by Nova
Factor on the date of termination at the price paid for the
Product by Nova Factor.
After receipt of the termination notice and during the period
thereafter ending six months after termination, Nova Factor shall use
reasonable efforts to cooperate with Biogen in ensuring the smooth
transition of the services provided by Nova Factor under this Agreement
to the distributor designated by Biogen, provided that after
termination of this Agreement, Biogen shall reimburse Nova Factor for
its reasonable out-of-pocket, non-personnel-related expenses associated
with such cooperation.
14.5 Survival. Sections 9, 10, 11, 12.13, 14.4, 15, 16, 17 and 21.7 shall
survive termination or expiration of this Agreement.
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15. REGULATORY, INSPECTIONS, AUDITS
15.1 Information; Notices. Nova Factor shall provide to the FDA or, at
Biogen's request, shall provide to Biogen all documents and information
requested by the FDA or by Biogen in support of its regulatory filings.
Copies of all documents to be provided to the FDA shall be provided to
Biogen in advance, if practicable, or otherwise within two (2) business
days of delivery to the FDA. Nova Factor shall notify Biogen
immediately upon receipt of notice of any inspection by the FDA
directed specifically toward Product, and Biogen shall have the right
to have an employee present at any such inspection, if allowed by law.
Nova Factor shall notify Biogen 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 applicable law, shall give Biogen copies of
such communications.
15.2 Recalls, Returns or Investigations. Nova Factor shall provide to
Biogen, at Biogen's request, any information reasonably required in
connection with Biogen 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 Biogen's
applications to the FDA. Nova Factor shall respond within two (2)
business days to any reasonable requests for information by Biogen.
15.3 Audits and Inspections. Nova Factor shall from time to time submit to
inquiries, audits and inspections by Biogen during normal business
hours or at any other time during which the services being audited are
ongoing. Biogen shall give Nova Factor a least two (2) business days'
prior notice of any audit or inspection and shall bear the costs of
such audit or inspection.
16. INDEMNIFICATION
16.1 Biogen Indemnification of Nova Factor. Biogen 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
attorneys' fees, incurred in connection with any third-party claim
arising out of the use of any Product by an end-user, except to the
extent caused by (i) the negligence or intentional misconduct of Nova
Factor or any of its officers, directors, agents or employees or (ii)
breach by Nova Factor of any of the terms of this Agreement or (iii)
acts of Nova Factor or any of its officers, directors, agents or
employees which are outside the scope of this Agreement.
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16.2 Nova Factor Indemnification of Biogen. Nova Factor shall at all times
during the term of this Agreement and thereafter defend, indemnify and
hold Biogen 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
attorneys' fees, incurred in connection with any third-party claim
arising out of (i) the negligence or intentional misconduct of Nova
Factor or any of its officers, directors, agents or employees, (ii)
breach by Nova Factor of any of the terms of this Agreement, or (iii)
acts of Nova Factor or any of its officers, directors, agents or
employees which are outside the scope of this Agreement.
16.3 Procedures. 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. CONFIDENTIALITY
17.1 Nova Factor Obligation. Nova Factor agrees to treat any confidential or
proprietary information obtained from Biogen and any confidential or
proprietary information generated by Nova Factor in performing its
obligations under this Agreement, including customer lists, information
regarding Biogen's pricing policies, information regarding
reimbursement for the Product, information regarding the cost of
providing services to Biogen and the information in the Database, and
anything derived therefrom, (collectively, the "Biogen Information") as
the confidential and exclusive property of Biogen, (except for the
information in the Database which shall be joint property of Biogen and
Nova Factor. subject to the limitations on Nova Factor's use of
customer lists as set forth in Section 12.13), and agrees not to
disclose any of the Biogen Information to any third party without first
obtaining the written consent of Biogen. Nova Factor agrees that it
will use any Biogen Information only for purposes of performing its
obligations hereunder and for no other purpose without the prior
written consent of Biogen. Nova Factor further agrees to take all
practicable steps to ensure that the Biogen 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.
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The above provisions of confidentiality shall not apply to that part of
the Biogen Information which Nova Factor is able to demonstrate by
documentary evidence:
(a) was in Nova Factor's possession prior to receipt from Biogen
and prior to being generated under this Agreement; or
(b) was in the public domain at the time of receipt from Biogen;
or
(c) became part of the public domain 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 Biogen and having a
right of further disclosure; or
(e) is required by law to be disclosed, provided, however that
Nova Factor gives Biogen sufficient advance written notice to
permit Biogen to seek a protective order or other similar
order with respect to such Information.
Nova Factor agrees that, at Biogen's request, it shall return to Biogen
all parts of the Biogen Information existing in documentary form, not
including pharmacy records and will, at Biogen'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 Biogen.
17.2 Biogen Obligation. Biogen agrees to treat any confidential or
proprietary information obtained from Nova Factor, (not including the
Database, information about insurers' reimbursement policies with
respect to Product and information used to calculate the *) and
anything derived therefrom, (collectively, the "Nova Factor
Information") as the confidential and exclusive property of Nova
Factor, and Biogen 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 Biogen may disclose Nova Factor
Information to any third party providing reimbursement-related services
to Biogen as long as the third party is obligated to Nova Factor to
keep such information confidential. Biogen 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. Biogen 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 Biogen is able to demonstrate by
documentary evidence:
* - Confidential Treatment Requested
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(a) was in Biogen's possession prior to receipt from Nova Factor;
or
(b) was in the public domain at the time of receipt from Nova
Factor; or
(c) became part of the public domain through no fault of Biogen,
its directors, officers or employees; or
(d) was lawfully received by Biogen 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, however that
Biogen gives Nova Factor sufficient advance written notice to
permit Nova Factor to seek a protective order or other similar
order with respect to such Information.
Biogen agrees 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 Biogen, its directors, officers or employees.
17.3 No Implied Licenses. 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.
17.4 Publicity. Notwithstanding anything to the contrary contained in
Section 12.8, Nova Factor shall be permitted to disclose to potential
and existing customers of Nova Factor as well as to potential
purchasers of stock or assets of Nova Factor or other potential sources
of capital (i) that Nova Factor distributes Product and performs
services under agreements with Biogen and (ii) the general nature of
the relationship with Biogen. Nova Factor shall also be permitted to
make such public statements regarding its relationship with Biogen as
may be required by law, regulation or by obligations pursuant to any
listing agreement with any securities exchange. Nova Factor shall not
disclose the terms of this Agreement to any third party or, except as
expressly set forth in this Section, make any public announcement of
the existence of its relationship with Biogen without the prior written
consent of Biogen except to its auditors and lawyers or as required by
law.
17.5 Length of Obligation. The obligations of the parties under this Section
17 shall continue during the term of this Agreement and for a period
ending five (5) years after termination or expiration of this
Agreement.
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18. INSURANCE
Nova Factor agrees (i) to obtain and maintain, while this Agreement is
in effect, commercial general liability insurance, including product
liability insurance, with coverage limits of not less than $1,000,000
per occurrence and $3,000,000 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 Biogen. Nova Factor shall cause
Biogen to be a notice party on each insurance policy such that Biogen
shall receive notice of any cancellation or change in the policy. At
the request of Biogen, Nova Factor shall provide Biogen with a copy of
a certificate of insurance to verify that insurance with the required
coverage is in effect.
19. TRAINING
Nova Factor shall be responsible for insuring that the personnel
handling Product, dealing with customers and payors and performing the
services contemplated under this Agreement are properly trained to
perform their functions. Biogen and Nova Factor will use a jointly
prepared training manual and orientation program for Nova Factor and
Biogen personnel to familiarize the personnel with the Product and the
market.
20. COMPETITIVE PRODUCTS
As long as Nova Factor is * approved by Biogen, other than distributors
authorized to sell to Medicaid customers in the states listed on
Schedule F, Nova Factor shall not distribute, as a reseller or as a
consignee, or provide reimbursement assistance with respect to, any
products which compete with Product in the treatment of multiple
sclerosis.
21. MISCELLANEOUS
21.1 Binding; Assignment. This Agreement shall be binding upon and shall
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 Biogen 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 Biogen's obligations hereunder.
21.2 Entire Agreement; Amendment. This Agreement and the Additional Services
Agreement between the parties dated as of the date hereof constitute
the entire and only agreement between the parties relating to the
subject matter hereof, and all prior negotiations,
* - Confidential Treatment Requested
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representations, agreements and understandings are superseded hereby,
including the Original Agreement. 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.
21.3 Notices. 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 Biogen:
Biogen, Inc.
14 Cambridge Center
Cambridge, MA 02142
Attention: Vice President - Sales and Marketing
Fax: (617) 679-2333
with a copy to Vice President-General Counsel
Fax: (617) 679-2617
If to Nova Factor, Inc:
Nova Factor, Inc.
1620 Century Center Parkway
Suite 109
Memphis, TN 38134
Attention: President
Fax: (901) 385-3666
with a copy to:
1640 Century Center Parkway
Suite 101
Memphis, Tennessee 38134
Attention: Thomas W. Bell, Jr., Esq.
Fax: (901) 385-3689
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.
21.4 Force Majeure. 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
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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.
21.5 Headings. Headings included herein are for convenience only, and shall
not be used to construe this Agreement.
21.6 Independent Parties. For the purposes of this Agreement, the parties
shall be, and shall be deemed to be, independent contractors and not
agents or employees of the other party. No party shall have authority
to make any statements, representations or commitments of any kind, or
to take any action, which shall be binding on the other party, except
as may be explicitly provided for herein or authorized in writing.
21.7 No Publicity. Except as required by law, neither party shall use the
name of the other party or of any employee of the other party in
connection with any publicity without the prior written approval of the
other party.
21.8 Severability. 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 of the Agreement is
frustrated by such reformation or deletion in which case this Agreement
shall terminate.
21.9 No Deemed Waiver. 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.
21.10 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the Commonwealth of Massachusetts.
21.11 Arbitration. Unless waived by the parties, any dispute, controversy or
claim between the parties arising out of or relating to this Agreement
either during or after the term hereof (including the question as to
whether any particular matter is arbitrable) shall be solely and
finally settled by arbitration conducted in Memphis, Tennessee, if the
arbitration is initiated by Nova Factor or in the Boston, Massachusetts
metropolitan area, if the arbitration is initiated by Biogen, in
accordance with the Commercial Arbitration Rules of the American
Arbitration Association then in force (the "Rules"). The party
requesting arbitration shall serve upon the other party to the
controversy, dispute or claim a written demand for arbitration stating
the substance of the controversy, dispute or claim, the contention of
the party requesting arbitration, and the name and address of the
arbitrator
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appointed by it. The recipient of such demand shall within twenty (20)
days after such receipt appoint an arbitrator and notify the party
requesting arbitration of the identity of the arbitrator so selected,
and the two arbitrators shall appoint a third, and the decision or
award of any two arbitrators shall be final and binding upon the
parties In the event that the two arbitrators fail to appoint a third
arbitrator within twenty (20) days of the appointment of the second
arbitrator, either arbitrator, or any party to the arbitration, may
apply to a judge of the United States District Court for the district
in which the arbitration is held for the appointment of the third
arbitrator and the appointment of such arbitrator by such judge or such
application shall have precisely the same force and effect as if such
arbitrator had been appointed by the two arbitrators. If for any reason
the third arbitrator cannot be appointed in the manner prescribed by
the preceding sentence, either regularly appointed arbitrator, or
either party to the arbitration, may apply to the American Arbitration
Association for appointment of the third arbitrator in accordance with
the Rules. If the parties upon whom the demand for arbitration has been
served fail or refuse to appoint an arbitrator within twenty (20) days,
the single arbitrator shall have the right to decide alone, and such
arbitrator's decision or award shall be final and binding upon the
parties. The decision of the arbitrator shall be in writing and shall
set forth the basis therefor. The parties shall abide by all awards
rendered in arbitration proceedings, and all such awards may be
enforced and executed in any court having jurisdiction over the party
against whom enforcement of such award is sought. The party losing the
dispute which was submitted to arbitration shall pay the administrative
charges, arbitrator's fees, and related expenses of arbitration, and
each parties legal fees incurred in connection with any such
arbitration. This agreement to arbitrate shall be specifically
enforceable under the prevailing arbitration law.
IN WITNESS WHEREOF, the parties have executed this Agreement on the
date first above written.
BIOGEN, INC. BIOGEN, INC.
By: /s/ Michael W. Bonney By: /s/ Darlene Romine
---------------------------------- -------------------------------
Michael W. Bonney Darlene Romine
Vice President - Sales and Marketing Director of National Accounts
NOVA FACTOR, INC.
By: /s/ David D. Stevens
-------------------------------
Title: Chairman
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Schedule A
Products
*
* - Confidential Treatment Requested
27
Schedule B
*
* - Confidential Treatment Requested
28
Schedule C
*
* - Confidential Treatment Requested
29
Schedule D
Data and Reports
30
Schedule E
Pricing Discount
31
Schedule F
Exclusion for Medicaid Eligibility
*
* - Confidential Treatment Requested