Exhibit 10.33
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
11st day of November, 1995 by and between Biogen, Inc., with principal offices
located at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 ("Biogen"), and Nova
Factor, Inc., with principal offices located at 0000 Xxxxxxxxx Xxxx., Xxxxx
000, Xxxxxxx, XX 00000 ("Nova Factor").
WHEREAS, Biogen has filed a Product License Application with the
United States Food and Drug Administration for approval to market and sell
Biogen's AVONEX-TM- beta interferon-1a in the United States in the
treatment of multiple sclerosis;
WHEREAS, Biogen is in the process of establishing a distribution
network for the sale of AVONEX-TM-;
WHEREAS, as part of its distribution network, Biogen intends to
appoint preferred distributors to provide quality services to users of
AVONEX-TM- and to provide data reporting and other services to Biogen;
WHEREAS, Nova Factor has the facilities and expertise to distribute
AVONEX-TM- to customers at their homes, to provide quality reimbursement
assistance and other customer services to its customers and to provide data
reporting and other services to Biogen;
WHEREAS, Biogen is willing to appoint Nova Factor as a preferred
distributor of AVONEX-TM- 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 premises 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 greater than fifty percent
(50%) of the equity having the power to vote on or direct the
affairs of the entity.
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 "Commercial Launch" shall mean the date on which Biogen makes
Product available for commercial sale after receipt from the FDA of
approval to manufacture Product at Biogen's Cambridge facility and
approval to market and sell Product in the Territory.
1.5 "Database" shall have the meaning set forth in Section 7.1.
1.6 "Facility" shall mean Nova Factor's facility located at 0000
Xxxxxxxxx Xxxx., Xxxxx 000, Xxxxxxx, XX 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,
provided that a new facility which conforms to the plans referenced
in Section 20 shall be deemed to have been approved by Biogen.
1.7 "FDA" shall mean the United States Food and Drug Administration.
1.8 "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.
1.9 "Nova Factor Collection Policy" shall have the meaning set forth in
Section 5.1 (iv).
1.10 "PLA/ELA filing" shall mean the Product License Application and
Establishment License Application filed by Biogen with respect to
Product.
1.11 *
1.12 "Product" shall mean Biogen's AVONEX-TM- beta interferon-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.
1.13 "Specifications" shall mean the Product specifications attached
hereto as Schedule B as amended by Biogen from time to time.
1.14 "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.
1.15 "Territory" shall mean the United States of America.
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
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2. APPOINTMENT AS PREFERRED DISTRIBUTOR
2.1 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 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 The parties hereto agree that, commencing upon Commercial Launch and
continuing 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 3.6,
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. 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. Biogen shall assist
Nova Factor in preparing forecasts for the first three months after
Commercial Launch. 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. 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. Biogen shall notify Nova Factor of
receipt from the FDA of approval to manufacture Product at Biogen's
Cambridge facility and of approval to market and sell Product in the
Territory and of the date of Commercial Launch.
3.2 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
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(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.
3.3 Nova Factor shall unload each shipment of Product immediately upon
receipt from Biogen in accordance with the applicable SOP. The parties
acknowledge that preparation of the SOPs will continue after execution
of this Agreement and Biogen and Nova Factor shall each use reasonable
efforts and shall each cooperate with the other to develop a set of
mutually agreeable SOPs within three (3) months after execution of this
Agreement. 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 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. 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.
3.4 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 3.4, a shipment of Products
shall be deemed to have been delivered and accepted by Nova
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
4
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 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.
3.5 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.
3.6 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 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 customers for Product. Biogen's customer service
representatives shall include Nova Factor in their description 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 or has previously been in contact with Biogen's third party
reimbursement agency, Biogen or the agency shall transmit the
information to Nova Factor. At Biogen's request, Nova Factor shall
assist Biogen in developing a standard intake form for initial customer
contact. 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 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, 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
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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.
4.3 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.
4.4 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.
4.5 Nova Factor shall be responsible for all costs associated with
distribution and delivery of Products to its customers.
5. REIMBURSEMENT-RELATED SERVICES
5.1 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 following services for each potential or existing
Nova Factor customer who contacts Nova Factor for home delivery of
Product:
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(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 xxxx
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 xxxx 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 9:00 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 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. If Biogen has engaged
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a third party to provide reimbursement support services to
Biogen, Nova Factor shall direct certain reimbursement inquiries
to such third party and share relevant information with such
third party, as specified in guidelines established by Biogen.
(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.
5.2 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 Nova Factor shall be responsible for all costs associated with the
services provided under this Section 5.
5.4 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 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 9:00 a.m. to 6:00
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 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.
6.3 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 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.
8
6.5 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 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 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) any other
information Biogen 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 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 and not by name.
8. PAYMENT
8.1 Nova Factor shall purchase Product from Biogen at a price *
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
9
* Nova Factor shall have sole responsibility and authority for
determining the price at which it will sell Product to its customers.
8.2 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 shall be due within * (*) days
from the date of the invoice or on such other payment terms as the
parties shall mutually agree. Biogen shall have the right to charge
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 the Bank of Boston, Boston, Massachusetts.
8.3 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 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 any pay all taxes imposed in connection
with the activities contemplated hereunder.
8.5 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 * Nova Factor exceed $* per audit.
8.6 *
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
10
9. REPLACEMENTS AND RETURNS
9.1 In the event Nova Factor or a Nova Factor customer returns or requests
to return a Product, Nova Factor shall promptly notify Biogen and
Biogen shall, upon return of Product, unless the customer requests
replacement 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 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 If a Nova Factor customer requests replacement Product for Product
returned under Biogen's then current Return Goods Policy or under
circumstances in which Biogen will otherwise furnish replacement
Product at no charge under the Return Goods Policy, Nova Factor shall
furnish the replacement Product to the customer from Nova Factor's
inventory. At the end of each month, Nova Factor shall furnish Biogen
with a list specifying (i) the quantity of replacement Product supplied
to customers under circumstances in which Biogen will supply
replacement Product at no charge under its then current Return Goods
Policy and (ii) the name of the relevant customers. Biogen shall
deliver to Nova Factor an amount of Product equal to the amount used by
Nova Factor as replacement Product consistent with Biogen's then
current Return Goods Policy, at no cost to 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. Biogen shall not supply replacement Product to Nova
Factor 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. 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 *.
9.3 In the event that in any quarter the quantity of Products returned by
Nova Factor's customers under the Return Goods Policy or the quantity
of replacement Product provided to Nova Factor by Biogen, at no cost,
for Nova Factor's customers exceeds *% of the total quantity of
Product sold by Nova Factor in the quarter, the parties shall meet to
negotiate in good faith *.
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
11
9.4 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 Nova Factor shall notify the designated contact in Biogen's Drug Safety
and Medical Information Group (or such other person as Biogen may
designate), by telephone, immediately (but in no event later than one
(1) business day) after receipt of notice of an Adverse Event
associated with the Product or after Nova Factor or any of its agents
or employees becomes aware of an Adverse Event associated with the
Product. Nova Factor shall confirm each notice of an Adverse Event by
providing to Biogen within two (2) business days a written report in
the format required for Adverse Events by the FDA, or, at Biogen's
request, in the format provided by Biogen. All communications and
reports regarding Adverse Events shall be sent to: Biogen, Inc., 00
Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, Attention: Director - Drug
Safety and Medical Information Group, Fax No. (000) 000-0000, or to
such other address as Biogen may from time to time designate.
10.2 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
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.
10.3 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 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 * (*) *
Biogen will repurchase the Product held in inventory by Nova Factor at
* 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.
11.2 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
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
12
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 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 Nova Factor shall cooperate with Biogen in investigating any Product
failure which resulted in the need for a recall.
12. REPRESENTATIONS AND WARRANTIES OF NOVA FACTOR
12.1 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. 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.
12.2 *
12.3 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
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
13
Medicaid program.
12.4 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.
12.5 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.
12.6 Nova Factor represents that it now has and shall maintain a 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 12.3, 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 shall provide Biogen 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.
12.7 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.
12.8 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.
12.9 Nova Factor shall furnish to Biogen copies of quarterly and annual
financial statements of Nova Factor and its parent (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 any changes in its ownership or control. 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.
12.10 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.
14
12.11 In no event shall Nova Factor be liable for loss of profit or any
other incidental or consequential damages of Biogen.
13. REPRESENTATIONS AND WARRANTIES OF BIOGEN
13.1 Biogen 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, packaging and labeling requirements, product
warning requirements, product design and safety requirements and
advertising requirements.
13.2 Biogen shall not use the trademark or tradenames of Nova Factor
except to the extent necessary for activities contemplated under
this Agreement.
13.3 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 3.4 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 Biogen represents and warrants to Nova Factor that at the time of
the first shipment of Product to Nova Factor, Biogen will have
received approval from the FDA to market and sell Product in the
Territory.
13.5 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 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 date of
Commercial Launch.
15
14.2 Either party may terminate this Agreement for any reason, at any
time after the first anniversary of the Commercial Launch, upon
ninety (90) days prior written notice given after the first
anniversary of Commercial Launch. In addition, Biogen shall have
the right to terminate this Agreement immediately in the event the
FDA rejects the PLA/ELA filing, or if Biogen withdraws its PLA/ELA
filing.
14.3 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 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 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.
(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-
16
personnel-related expenses associated with such cooperation.
14.5 Sections 9, 10, 11, 14.4, 15, 16, 17, and 22.7 shall survive
termination or expiration of this Agreement.
15. REGULATORY, INSPECTIONS, AUDITS
15.1 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 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 of 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 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 at 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 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.
16.2 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
17
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 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 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 information regarding Biogen's
pricing policies and 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),
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.
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;
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
18
(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.
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 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 * ) 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:
(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.
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.
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities Exchange Commission.
19
17.3 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.
17.4 Notwithstanding anything to the contrary contained in Section 12.7,
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 under an agreement 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 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.
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 jointly prepare a
training manual and orientation program for Nova Factor and Biogen
personnel to familiarize the personnel with the Product and the market.
20. FACILITIES EXPANSION
Nova Factor plans, at its sole expense, to extend its existing
facilities and modify its existing procedures and processes. A
facility expansion plan and procedures modification
20
plan are attached as Schedule G.
21. COMPETITIVE PRODUCTS
As long as Nova Factor is the only home delivery preferred distributor
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.
22. MISCELLANEOUS
22.1 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.
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 Biogen:
Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Vice President - Marketing and Sales
with a copy to Vice President-General Counsel
Fax: (000) 000-0000
21
If to Nova Factor, Inc.:
Nova Factor, Inc.
0000 Xxxxxxxxx Xxxx.
Xxxxx 000
Xxxxxxx, XX 00000
Attention: Chief Executive Officer
Fax: (000) 000-0000
with a copy to:
Xxxxxx X. Xxxx, Xx.
Xxxxxxxxx Xxxxx Xxxxxxx
Xxxxxx Xxxxxxx & Xxxxxx
Xxxxxxxx Plaza
00 Xxxxxx Xxx., Xxxxx 000
Xxxxxxx, XX 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.
22.5 Headings included herein are for convenience only, and shall not be
used to construe this Agreement.
22.6 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.
22.7 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.
22.8 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
22
reformation or deletion in which case this Agreement shall terminate.
22.9 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.
22.10 This Agreement shall be construed and enforced in accordance with the
laws of the Commonwealth of Massachusetts.
22.11 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 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.
23
IN WITNESS WHEREOF, the parties have executed this Agreement on the date
first above written.
BIOGEN INC.
By: /s/ [illegible]
--------------------
Title: President/CEO
--------------------
NOVA FACTOR, INC.
By: /s/ Xxxxx Grow
--------------------
Title: President
24
SCHEDULE A
PRODUCTS
Package containing four AVONEX-TM- beta interferon - 1a administration dose
packs
SCHEDULE B
SPECIFICATIONS
Each AVONEX-TM- beta interferon - 1(a) administration dose pack contains:
1 single-use vial of AVONEX-TM- interferon beta - 1(a)
(containing 30 mcg Interferon beta - 1a, Albumin Human, USP,
Sodium Chloride, USP, Dibasic Sodium Phosphate, USP and
Monobasic Sodium Phosphate, USP)
1 single-use vial of diluent (containing 10mL (10cc) Sterile
Water for Injection USP)
2 alcohol swabs
1 Syringe
1 MicroPin-Registered Trademark-
1 needle
1 adhesive bandage
SCHEDULE C
*
*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 D
*
*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 E
*
*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.
*
*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.
*
*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.
*
*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 F
EXCLUSION FOR MEDICAID ELIGIBILITY
California
Colorado
Delaware
District of Columbia
Florida
Hawaii
Kansas
Maine
Massachusetts
Nevada
New Jersey
North Carolina
Rhode Island
South Carolina
Vermont
West Virginia
Wisconsin
SCHEDULE G
FACILITIES EXPANSION AND PROCEDURE MODIFICATION PLAN
Blueprint of "Tenant Layout For Nova Factor, Century Center-Building C, Memphis,
Tennessee", Project No. 9563, dated 9/8/95, prepared by The Xxxxx Firm, Inc., 00
Xxxxxx Xxxxxxxx, Xxxxxxx, Xxxxxxxxx.
[Blueprints are intentionally omitted.]
