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EXHIBIT 10.2
ADDITIONAL SERVICES AGREEMENT
This Additional Services Agreement is entered into as of this 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 has appointed Nova Factor as a preferred distributor of
Biogen's AVONEX(R) (Interferon beta - 1a) under the terms of a Distribution and
Services Agreement between the parties dated as of January 1, 2000 (the
"Distribution Agreement");
WHEREAS, under the Distribution Agreement, Nova Factor has agreed to
provide reimbursement assistance and other customer services to end-users of
AVONEX(R) and to provide data reporting and other services to Biogen;
WHEREAS, Biogen desires Nova Factor to perform certain additional
services for Biogen in connection with Biogen's customer services efforts
related to AVONEX(R) and Nova Factor is willing to provide such additional
services on the terms and conditions set forth in this Agreement;
NOW THEREFORE, in consideration of the premises and mutual covenants
contained in this Agreement, the parties hereby agree as follows:
1. DEFINITIONS.
1.1 "Access Program" shall mean the financial assistance program available
to certain end-users of Product funded by Biogen and administered for
Biogen by a third party administrator designated by Biogen.
1.2 "Adverse Event" shall have the meaning set forth in 21 CFR 600.80.
1.3 "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 1.3, "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.
1.4 "Alliance Kit" shall mean a plastic ziplock bag containing five
syringes, five MicroPins(R) and five needles intended for use with
Product.
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1.5 "Alliance Program" shall mean a program established by Biogen to
provide educational information and materials to persons using Product.
1.6 "Alliance Program Participant" shall mean an end-user of Product who
has enrolled in the Alliance Program.
1.7 "Emergency Component Shipment" shall have the meaning set forth in
Section 2.2(d).
1.8 "FDA" shall mean the United States Food and Drug Administration.
1.9 "Hotline Customer" shall mean an end-user who is referred to Nova
Factor via the Reimbursement Hotline.
1.10 "Incentive Plan" shall have the meaning set forth in Section 10.2.
1.11 "IND" shall mean an Investigational New Drug application filed with the
FDA.
1.12 "Investigator" shall mean a physician who, with the consent of Biogen,
has filed and will be conducting research under an
investigator-sponsored IND for investigational use of Product.
1.13 "Outcome Call" shall have the meaning set forth in Section 8.1 of this
Agreement.
1.14 "Program Fee" shall have the meaning set forth in Section 3.4.
1.15 "Program Participant" shall have the meaning set forth in Section 3.2.
1.16 *
1.17 *
1.18 "Reimbursement Hotline" shall mean telephone access to reimbursement
specialists at Nova Factor who are trained to answer or find answers to
reimbursement questions and problems related to Product which such
access is available through a telephone line at Nova Factor dedicated
to calls transferred from Biogen, all as more fully described in
Section 7.
1.19 *
1.20 "Replacement Components" shall mean diluent, syringes, MicroPins(R) and
needles intended for use with Product.
1.21 "Services" shall mean the services to be provided by Nova Factor under
this Agreement.
1.22 "Service Fee Schedule" shall mean the schedule of service fees attached
to this Agreement as Schedule A.
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1.23 "Service Report" shall have the meaning set forth in Section 10.2.
1.24 "SOPs" 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.
1.25 "Specifications" shall mean the specifications for Replacement
Components provided to Nova Factor by Biogen, as updated by Biogen from
time to time.
1.26 "Training Provider" shall mean Interim Healthcare, Inc. or such other
company as Biogen shall engage to provide Product administration
training services, and as to whose appointment Biogen shall notify Nova
Factor in writing at least 14 days in advance of the engagement.
1.27 "Triaged Customer" shall mean an end-user (other than a Hotline
Customer) who is referred to Nova Factor under the * or referred to
Nova Factor by a Biogen customer support specialist, as contemplated
under Distribution Agreement, but who decides not to use Nova Factor's
home delivery services for delivery of Product.
1.28 "Hours" In calculating time periods in hours or days throughout this
Agreement, except for purposes of Schedule C, weekends and holidays
shall be excluded from the calculation.
2. REPLACEMENT AND RETURN SERVICES.
2.1 Replacement Product.
(a) Obligation. From time to time users of Product and physicians who
prescribe Product will require replacement Product. Nova Factor agrees
to act as a supplier of replacement Product for Biogen. Upon receipt of
each authorization from a Biogen customer support specialist to send
replacement Product to an end-user of Product or to a physician who has
purchased Product, Nova Factor shall supply replacement Product from
its inventory to the end-user at the end-user's home, other residence,
office or similar location, as designated by the end-user, or to the
physician at the physician's office, whether or not such person is a
customer of Nova Factor.
(b) Authorization. Authorization from Biogen's customer support
specialist for Nova Factor to supply replacement Product shall be in
the form of the transfer of the telephone call from the end-user or
physician on Biogen's customer support line to Nova Factor followed by
same-day written confirmation from the Biogen customer support
specialist that replacement Product may be sent, such written
confirmation to specify the quantity of replacement Product to be sent
and to be in a form mutually agreeable to the parties.
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(c) Shipment. Nova Factor shall supply replacement Product in one or
more single dose packs or in the full package of four dose packs, as
authorized by Biogen's customer support specialist. In no event shall
Nova Factor open or alter the packaging of single dose packs of
Product. Nova Factor shall package Product for shipment in insulated
shipping units in accordance with the applicable SOP. Nova Factor shall
ship replacement Product via Federal Express standard overnight
delivery service or another mutually agreed to overnight carrier for
delivery within twenty-four (24) hours of receipt of authorization from
Biogen and notification to the patient, provided that Nova Factor has
received a copy of the applicable prescription form. Nova Factor shall
use reasonable efforts to obtain the prescription form for an end-user,
as necessary, and to notify the end-user about the planned shipment in
each case within twenty-four (24) hours of receipt of authorization
from Biogen to ship replacement Product to such end-user. Nova Factor
shall notify the appropriate Biogen customer support specialist in the
event Nova Factor has not received the prescription form for an
end-user within forty-eight (48) hours of receipt of authorization from
Biogen.
2.2 Replacement Components.
(a) Obligation. In addition to the Product replacement services
specified under Section 2.1, Nova Factor shall, under the terms of this
Agreement, act as a supplier of Replacement Components to end-users of
Product (whether or not the end-users are Nova Factor customers) who
have requested Replacement Components and whose requests have been
approved by a Biogen customer support specialist.
(b) Authorization. Approval from a Biogen customer support specialist
for Nova Factor to supply Replacement Components shall be in the form
of the transfer of the telephone call from the end-user on Biogen's
customer support line to Nova Factor followed by same-day written
confirmation from the Biogen customer support specialist. Upon receipt
of a request from an end-user for Replacement Components, Nova Factor
shall, using a qualified Nova Factor pharmacist, determine whether the
supply of Replacement Components under the circumstances set forth by
the end-user is appropriate and allowable, without a prescription,
under applicable law.
(c) Supply. If Nova Factor determines that the supply of Replacement
Components is appropriate and allowable, without a prescription, under
applicable law, Nova Factor shall supply the approved quantity and type
of Replacement Components from a consignment inventory of Replacement
Components provided by Biogen or from such other supply as Biogen shall
approve and that is provided at Biogen's cost. Nova Factor shall send
Replacement Components to an end-user at the end-user's home, other
residence, office or similar location, as designated by the end-user.
In the event Nova Factor determines that a prescription is required for
the supply of Replacement Components to an end-user, Nova Factor shall
use reasonable efforts to obtain the prescription from the end-user's
physician within twenty-four (24) hours of the request. If Nova Factor,
having used reasonable efforts, is unable to obtain a prescription from
the
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end-user's physician within five (5) business days of receipt of the
request for Replacement Components or if Nova Factor otherwise
determines that the supply of Replacement Components to an end-user is
not appropriate, Nova Factor shall notify a Biogen customer support
specialist.
(d) Shipment. Nova Factor shall ship Replacement Components to
end-users via first-class mail unless the end-user requires an
emergency supply in which case Nova Factor shall ship the Replacement
Components via Federal Express standard overnight delivery service or
another mutually agreed to overnight carrier (an "Emergency Component
Shipment"). Nova Factor shall ship Replacement Components within
twenty-four (24) hours of receipt of the request, unless Nova Factor
determines that a prescription is required in which case Nova Factor
shall ship Replacement Components within twenty-four (24) hours of
receipt of the applicable prescription. Nova Factor shall package
Replacement Components in accordance with industry standards, and shall
include in the package a Nova Factor pharmacy label. If Replacement
Components are not received by the intended recipient, Nova Factor
shall use reasonable efforts to track and retrieve the missing
shipment.
(e) Quality Assurance. Unless Biogen otherwise approves, Nova Factor
shall, in fulfilling its supply obligation under this Section 2, use
only Replacement Components from the inventory that has been provided
by Biogen or from an inventory otherwise approved by Biogen. Nova
Factor shall handle and store all Replacement Components in accordance
with applicable SOPs. Nova Factor shall ensure for each shipment of
Replacement Components to an end-user that a registered pharmacist or
pharmacy technician acting under the direct supervision of a registered
pharmacist has verified that the Replacement Components being shipped
are the Replacement Components that were requested and authorized.
2.3 Other Suppliers. Biogen reserves the right to appoint other suppliers
of replacement Product and Replacement Components.
2.4 Cooperation. At Biogen's request, Nova Factor shall cooperate with
Biogen in investigating the need for replacement Product and
Replacement Components.
3. ACCESS PROGRAM SUPPLY SERVICES.
3.1 Service. In addition to the other services to be provided by Nova
Factor under this Agreement, Nova Factor shall act as a supplier of
Product to participants in Biogen's Access Program.
3.2 Enrollment and Contact. Biogen shall have sole responsibility for
enrolling participants in the Access Program. Upon enrollment by Biogen
of a participant in the Access Program (each a "Program Participant"),
one of Biogen's customer support specialists or a representative of
Biogen's Access Program administrator shall notify Nova Factor in
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writing of the name, address and telephone number of the Program
Participant and the amount of his or her spend-down, if any. Nova
Factor shall obtain a copy of the applicable prescription form for the
Program Participant. Within twenty-four (24) hours of receipt of notice
under the preceding sentence, Nova Factor shall contact the Program
Participant to obtain an order for Product. If the Program Participant
has a spend-down component as part of the Access Program, the Program
Participant may purchase the spend-down portion from Nova Factor or
from another source. If the spend-down portion is purchased from Nova
Factor, Nova Factor shall report on a monthly basis and either remit or
credit against fees owed to it by Biogen the proceeds from the sale to
Biogen. If the Program Participant purchases the spend-down portion
from another source, Nova Factor shall obtain proof of purchase for the
spend-down portion prior to shipping Product to the Program Participant
under this Agreement.
3.3 Supply. Nova Factor shall supply Product to Program Participants from
Nova Factor's inventory and shall deliver Product to the office of the
Program Participant's physician within forty-eight (48) hours of
receipt of each order. If the Program Participant requests delivery of
Product to a location other than his or her physician's office, or if
the physician refuses to accept delivery of the Product, Nova Factor
shall notify Biogen, and Biogen will work with the Program Participant
to determine an alternate shipping destination. Upon determination of
an alternate shipping location, Biogen shall notify Nova Factor in
writing of the address to which Product is to be shipped for the
Program Participant, and Nova Factor shall then ship the Product in
accordance with this Section. * Nova Factor shall package Product for
shipment in insulated shipping units in accordance with the applicable
SOP. Nova Factor shall ship Product to Program Participants via Federal
Express standard overnight delivery services or another mutually agreed
to overnight courier.
3.4 Participant Shipment Fees. As a condition to participation in the
Access Program, Program Participants will agree to pay a shipment fee
of * for each shipment of Product (other than the spend-down portion)
after the initial shipment (the "Program Fee"). Nova Factor shall bill
each Program Participant for the Program Fee, and shall send a
follow-up reminder letter following the third shipment of Product if
the Program Participant has not paid the Program Fee. Nova Factor shall
apply the Program Fees collected for any month against the amount of
the Access Program shipment fees owed by Biogen for such month under
the Service Fee Schedule. Nova Factor shall not bill Program
Participants for Product other than for the spend-down portion and for
the amount of the Program Fees. Except to the extent expressly set
forth in this paragraph, Nova Factor shall not be responsible for
collecting Program Fees from Program Participants.
3.5 Follow-up; Change in Status. Nova Factor shall, to the extent
consistent with applicable federal and state pharmacy laws, contact
each Program Participant approximately one week before the Program
Participant's supply of Product, assuming proper administration, will
be depleted to determine if the person needs a new supply of Product.
During each follow-up telephone call to a Program Participant under
this Section 3.5, Nova Factor shall confirm that the Program
Participant's insurance status or financial condition has not changed.
If the Program Participant's insurance status or financial condition
has changed, Nova Factor shall immediately notify Biogen or Biogen's
third party Access Program
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administrator. Nova Factor shall have no obligation to verify
information received from a Program Participant as to insurance status.
Nova Factor shall not ship Product to a Program Participant under this
Section after Nova Factor receives written notice from Biogen or
Biogen's third party Access Program administrator that the Program
Participant is no longer eligible to participate in the Access Program.
3.6 Progress Checks. To the extent allowable under applicable law, Nova
Factor's customer service representatives shall call each new Program
Participant one to three weeks after such person has received an
initial shipment of Product under this Section to check on the person's
progress. In checking on a Program Participant'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 Program Participants, conduct additional clinical efficacy and
customer satisfaction surveys provided by Biogen and report the
resulting information to Biogen in a manner consistent with any
applicable confidentiality restrictions. The parties shall negotiate,
in advance, the fee for each additional survey initiated by Biogen.
4. ALLIANCE PROGRAM.
4.1 Supply of Alliance Kits. As further additional services under this
Agreement, Nova Factor shall supply one Alliance Kit to each Alliance
Program Participant identified by Biogen. Nova Factor shall use its
best efforts not to send more than one Alliance Kit to each Alliance
Program Participant, and shall notify a Biogen customer support
specialist promptly in the event an Alliance Program Participant
submits more than one voucher. Nova Factor shall not ship Alliance Kits
to any Alliance Program Participant in any state in which a
prescription for any of the Replacement Components contained in the
Alliance Kits is required without having first obtained the necessary
prescription. In the event Nova Factor determines that a prescription
is required to supply an Alliance Kit to an Alliance Program
Participant, Nova Factor shall use reasonable efforts to obtain a
prescription from the end-user's physician within twenty-four (24)
hours of receipt of identification by Biogen. If Nova Factor, having
used reasonable efforts, is unable to obtain a prescription from an
end-user's physician within five (5) business days of receipt of
identification by Biogen, Nova Factor shall notify a Biogen customer
support specialist.
4.2 Delivery. Nova Factor shall ship Alliance Kits within two (2) business
days of receipt of identification by Biogen, unless Nova Factor
determines that a prescription is required in which case Nova Factor
shall ship Alliance Kits within two (2) business days of receipt of the
applicable prescription. Nova Factor shall send Alliance Kits via first
class mail, unless otherwise agreed by the parties. Nova Factor shall
package Alliance Kits in accordance with industry standards, and shall
include on the Alliance Kit a Nova Factor pharmacy label.
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4.3 Components.
(a) Source. Unless Biogen otherwise specifies, Nova Factor shall use
Replacement Components in the Alliance Kits from the inventory supplied
by Biogen.
(b) Quality Assurance. For each shipment of an Alliance Kit to an
end-user, Nova Factor shall ensure that a registered pharmacist or a
pharmacy technician acting under the direct supervision of a registered
pharmacist has verified that the Replacement Components contained in
the Alliance Kit are as specified in this Agreement.
5. SUPPLY OF PRODUCT FOR PHYSICIAN INVESTIGATIVE USE.
5.1 Service. As further additional services under this Agreement, Nova
Factor shall, upon receipt of written authorization from Biogen, supply
Product from Nova Factor's inventory to Investigators. Nova Factor
shall package Product for shipment in insulated shipping units in
accordance with the applicable SOP. Nova Factor shall ship Product to
the location specified by the Investigator via Federal Express standard
overnight delivery service or another mutually agreed to overnight
courier for delivery within twenty-four (24) hours of receipt of the
applicable authorization from Biogen. If the Investigator requests
delivery of the Product to an end-user's home, Nova Factor shall obtain
the necessary prescription from the physician. Product shall be
supplied to Investigators under this Section at no cost to the
Investigator.
5.2 Quantities. For the initial shipment of Product to an Investigator
under this Section, Nova Factor shall deliver one package of Product (a
one month's supply). For the next shipment to the Investigator, Nova
Factor shall deliver two (2) packages of Product (a two (2) months'
supply). For the final order of Product to an Investigator under a
Biogen authorization, Nova Factor shall deliver three (3) packages of
Product (a three (3) months' supply). Nova Factor shall not deliver
more than a total of six (6) packages (a six months' supply) of Product
to any Investigator without further authorization from Biogen.
Notwithstanding anything herein to the contrary, in no event shall Nova
Factor ship Product to any Investigator in a quantity more than the
Investigator ordered or otherwise specified or in a quantity more than
Biogen authorized or otherwise approved.
6. *
7. REIMBURSEMENT HOTLINE.
7.1 Hotline Services. As additional services under this Agreement, Nova
Factor shall operate a Reimbursement Hotline through which end-users,
physicians, nurses, pharmacies,
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payors, providers and others referred to Nova Factor by Biogen's
customer support specialists will be able to obtain assistance in
answering reimbursement-related questions and resolving
reimbursement-related issues and problems. Nova Factor shall make the
Reimbursement Hotline accessible as one of the connection options
available through the Nova Factor telephone line dedicated to calls
transferred from Biogen's customer support specialists. Services to be
provided by Nova Factor as part of the Reimbursement Hotline shall
include, but shall not be limited to, using reasonable efforts * If an
end-user or other person referred to Nova Factor on the Reimbursement
Hotline has any questions related to Medicare coverage for Product,
Nova Factor shall, unless otherwise specified by Biogen, transfer the
person to the third party service provider designated by Biogen to
provide further assistance on Medicare issues.
7.2 Delivery Options. In presenting the delivery options available to an
end-user referred to Nova Factor via the Reimbursement Hotline, Nova
Factor shall follow a script which accurately describes all potential
methods of delivery available to the end-user and which is in a form
mutually agreeable to Nova Factor and Biogen. If the end-user decides
not to use Nova Factor's home delivery services for delivery of
Product, Nova Factor shall use reasonable efforts to obtain the name,
telephone number and fax number of the desired dispensing pharmacy, and
shall provide to the dispensing pharmacy, by telephone or fax, all of
the information in Nova Factor's possession regarding the end-user.
7.3 Staffing. Nova Factor shall use qualified and properly trained
reimbursement specialists to answer calls on the Reimbursement Hotline.
The number of reimbursement specialists made available by Nova Factor
to answer calls on the Reimbursement Hotline shall be determined by the
volume of calls, and shall be that number which is sufficient to ensure
a high level of customer service and satisfaction. The parties
acknowledge that a "high level of customer service and satisfaction"
for purposes of the preceding sentence shall mean the answering of
eight-five percent (85%) of telephone calls within thirty (30) seconds.
If Biogen believes that the number of reimbursement specialists made
available by Nova Factor to answer calls on the Reimbursement Hotline
is not sufficient to ensure a high level of customer service and
satisfaction, Biogen shall notify Nova Factor and the parties shall
meet to determine what mutually agreeable corrective actions Nova
Factor shall take.
7.4 Direct Delivery Customers. Nothing in this Agreement or in the
operation of the Reimbursement Hotline shall be deemed to limit in any
way the obligation of Nova Factor to provide reimbursement-related
services under the terms of Section 5 of the Distribution Agreement to
those end-users who order Product from Nova Factor. Services provided
by Nova Factor to end-users under Section 5 of the Distribution
Agreement will not be considered Reimbursement Hotline services for
purposes of Section 7 of this Agreement.
7.5 Customer Satisfaction Survey. At Biogen's request from time to time,
Nova Factor shall, at no additional cost to Biogen, send customer
satisfaction surveys to Hotline Customers in a form mutually agreed
upon by the parties. The completed surveys shall be sent to Biogen.
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7.6 Reliance on Payor Information. Nova Factor shall have no liability for
relying upon information provided by third party payors concerning
coverage in the event that such information shall subsequently prove to
be incorrect, and Nova Factor may include a disclaimer to that effect
in any communication with end-users or others regarding coverage by
third party payors.
7.7 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.
8. *
9. DATA AND REPORTS.
9.1 Data. Nova Factor shall maintain the information specified in Schedule
B related to the Services in a Biogen-specific database (the
"Database") (which may be the same database maintained under the
Distribution Agreement).
9.2 Reports. Nova Factor shall generate and furnish to Biogen at the end of
each month reports from the Database as specified in Schedule B which
such reports shall include a service report, specifying the type and
quantity of Services performed in a format mutually agreeable to the
parties (the "Service Report"). 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 the parties.
9.3 Other Information. Nova Factor shall furnish to Biogen such additional
information related to Services as Biogen may from time to time
reasonably request to the extent generating such information will not
result in a material increase in the costs incurred by Nova Factor in
performing Services under this Agreement.
9.4 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 maintain true and accurate records of the Services provided by
Nova Factor under this Agreement in sufficient detail to enable Biogen
to verify the amounts payable to Nova Factor under this Agreement. 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 under this Agreement.
The cost of such
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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 in the Service Fees or incentive
payments for any quarter resulting in an over payment by Biogen of more
than $10,000; provided that in no event shall audit costs borne by Nova
Factor exceed $10,000 per audit.
10. PAYMENT.
10.1 Service Fees. In consideration of the Services rendered by Nova Factor
to Biogen under this Agreement, Biogen shall pay Nova Factor in
accordance with the Service Fee Schedule attached to this Agreement as
Schedule A.
10.2 *
10.3 Invoices. Nova Factor shall invoice Biogen at the end of each month for
amounts due hereunder with respect to Services shown on the Service
Report for such month and for any incentives earned under the Incentive
Plan. The invoice shall be accompanied by data necessary to support the
amount of incentive payments being sought by Nova Factor under the
Incentive Plan. All amounts due hereunder shall be payable by check to
Nova Factor in United States funds. Payment by Biogen shall be due
within thirty (30) days from the date of the invoice.
10.4 Product Credit. Within thirty (30) days of receipt of the Service
Report for any month, Biogen shall issue to Nova Factor a credit memo
in an amount equal to the quantity of Product shipped during the month
from Nova Factor's inventory under the terms of Sections 2.1, 3.1 and
5.1 of this Agreement multiplied by the then current purchase price for
Product *. Nova Factor may apply credits given under this Section
against purchases of Product under the Distribution Agreement. Credits
may not be assigned or transferred by Nova Factor to a third party, and
no cash payments shall be made on account of any credit, except where
Nova Factor has credit due on the termination of the Distribution
Agreement. Nova Factor shall not unilaterally apply any credit against
or make any deductions from payment due to Biogen under the
Distribution Agreement without prior written notice to and approval of
Biogen. Credits shall be applied under the Distribution Agreement on a
first-in, first-out basis.
10.5 Other Costs and Expenses. Except as otherwise set forth herein, Nova
Factor shall be responsible for all costs and expenses associated with
fulfilling its obligations and performing Services under this
Agreement. In no event shall Nova Factor charge an end-user, insurance
provider or any other third party for any Services provided under this
Agreement.
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10.6 Payment Due; Late Fee. Biogen 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.
11. TERM; TERMINATION.
11.1 Term. This Agreement shall become effective as of 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.
11.2 Termination of Portion of Services. Biogen may terminate any portion of
the Services at any time * written notice to Nova Factor without
terminating the entire Agreement.
11.3 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.
11.4 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 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.
11.5 Transition. Upon receipt or delivery of a termination notice by Nova
Factor with respect to all or any part of the Services or ninety (90)
days prior to expiration of this Agreement at the end of the term, as
applicable, the parties shall begin transition of the Services (or any
part thereof being terminated) to a party to be designated by Biogen.
After receipt of the termination notice with respect to all or any part
of the Services, and during the period thereafter ending six (6) months
after termination, Nova Factor shall use reasonable efforts to
cooperate with Biogen in ensuring the smooth transition of the Services
(or any part thereof being terminated), provided that after termination
of this Agreement, Biogen shall upon receipt of Nova Factor's invoice
reimburse Nova Factor for its reasonable expenses associated with such
cooperation.
11.6 Transfer of Database and Files. Upon termination, Nova Factor shall
transfer to Biogen a copy of the Database and files related to
reimbursement policies applicable to Product, provided that if
applicable patient confidentiality laws prohibit transfer of an
end-user's name, Nova Factor shall transfer the Database using customer
numbers, instead of names.
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11.7 Return of Inventory. Within ten (10) days of termination of the
Agreement, Nova Factor shall at Biogen's cost return to Biogen all
Replacement Components and Alliance Kits then held in consignment
inventory at Nova Factor.
11.8 Survival. Sections 11.5, 11.8, 12.12, 13.4, 14.1, 15, 16 and 20.7 shall
survive termination or expiration of this Agreement.
12. REPRESENTATIONS, WARRANTIES AND COVENANTS OF NOVA FACTOR.
12.1 Judgment under Pharmacy Laws. Nova Factor understands that Biogen's
approval and transfer to Nova Factor of a request for Replacement
Components or the submission of a voucher by an Alliance Program
Participant shall not be deemed to replace, in whole or in part, the
exercise by the Nova Factor pharmacist of his or her judgment under
applicable pharmacy law as to whether the shipment of Replacement
Components or Alliance Kits is permissible under applicable pharmacy
laws.
12.2 Adverse Event Reporting. Nova Factor shall record and promptly report
to Biogen any Adverse Events which come to the attention of Nova Factor
in the performance of Services in accordance with the relevant SOP
provided by Biogen.
12.3 Limitation on Promotional Activities. Nova Factor shall not engage in
any promotional activities with respect to Product or the *, the Access
Program or the Reimbursement Hotline, other than the distribution of
literature approved by Biogen and other activities expressly authorized
by Biogen. Nova Factor shall not use any promotional materials which
refer to Product, the *, the Access Program or the Reimbursement
Hotline unless such promotional materials have been approved in writing
in advance by Biogen. Any promotional literature or verbal
representations describing Nova Factor's role in the *, the Access
Program or the Reimbursement Hotline shall be approved in advance in
writing by Biogen.
12.4 Compliance with Law and Professional Standards. In performing its
obligations under this Agreement, Nova Factor shall comply with all
applicable laws and regulations, including but not limited to, federal
and state pharmacy laws, laws relating to the disposal of
pharmaceutical products and hazardous wastes, to the extent disposal of
Product, Replacement Components and Alliance Kits is Nova Factor's
responsibility under this Agreement, and all applicable professional
and industry standards and good business practices.
12.5 Quality of Team. 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 made
* - Confidential Treatment Requested
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in connection with Services. Nova Factor shall cooperate with Biogen to
enable such monitoring activities. The end-user 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.
12.6 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.
12.7 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 upon completion of such employee's initial training
and annually thereafter, and shall provide Biogen with copies of such
checklists.
12.8 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, 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 performing Services, including notices of
inquiries, investigations or inspections and resulting findings.
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 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.
12.11 Limitation on Liability. In no event shall Nova Factor be liable for
loss of profit or any other incidental or consequential damages of
Biogen.
12.12 End-User Lists. In no event shall Nova Factor use the lists of
end-users generated in the course of Services except for purposes of
performing Services for Biogen under this Agreement except as otherwise
approved by Biogen. Nova Factor shall not make its end-user list or any
portion thereof available to any third party.
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13. REPRESENTATIONS AND WARRANTIES 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, 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 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.
13.4 Limitation on Liability. In no event shall Biogen be liable for loss of
profit or any other incidental or consequential damages of Nova Factor.
14. REGULATORY, INSPECTIONS, AUDITS
14.1 Information. Nova Factor shall provide to Biogen, at Biogen's request,
any information reasonably required in connection with Biogen
investigations relating to Services 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.
14.2 Audits, 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.
15. INDEMNIFICATION.
15.1 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
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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.
15.2 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.
15.3 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.
16. CONFIDENTIALITY.
16.1 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 Services
under this Agreement, including information regarding end-users,
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 end-user lists as
set forth in Section 12.12), 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;
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.
16.2 Biogen Obligation. Biogen agrees to treat any confidential or
proprietary information obtained from Nova Factor, (not including the
Database, information regarding end-users, and information about
insurers' reimbursement policies with respect to Product) and anything
derived therefrom, (collectively, the "Nova Factor Information") as the
confidential and exclusive property of Nova Factor, and 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
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(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.
16.3 No Implied License. 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.
16.4 Publicity. Notwithstanding anything to the contrary contained in
Section 12.3, 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 performs services and distributes
Product 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.
16.5 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.
17. 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
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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.
18. TRAINING.
Nova Factor shall be responsible for insuring that the personnel
handling Product and Replacement Components, 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, Services and the market.
19. COMPETITIVE PRODUCTS
As long as Nova Factor is providing Services under this Agreement, Nova
Factor shall not perform services which are similar to the Services
then being provided under this Agreement with respect to any products
which compete with Product in the treatment of multiple sclerosis.
20. MISCELLANEOUS
20.1 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.
20.2 Entire Agreement; Amendments. This Agreement and the Distribution
Agreement constitute 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.
20.3 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:
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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: General Counsel
Thomas W. Bell, Jr.
Accredo Health, Incorporated
1640 Century Center Parkway
Suite 101
Memphis, Tennessee 38134
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.
20.4 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 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.
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20.5 Headings. Headings included herein are for convenience only, and shall
not be used to construe this Agreement.
20.6 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.
20.7 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.
20.8 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.
20.9 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.
20.10 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the Commonwealth of Massachusetts.
20.11 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 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
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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 Addendum on the date
first above written.
BIOGEN, INC.
By: /s/ Michael W. Bonney
----------------------------------------
Michael W. Bonney
Vice President - Sales and Marketing
By: /s/ Darlene Romine
----------------------------------------
Darlene Romine
Director of National Accounts
NOVA FACTOR, INC.
By: /s/ David D. Stevens
----------------------------------------
Title: Chairman
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SCHEDULE A
SERVICE FEE SCHEDULE
Activity Fee
-------- ---
Shipment of Replacements Components *
Shipment of replacement Product to non-Nova Factor *
customers or shipment of Product to Investigators
Shipment of replacement Product to Nova Factor customers *
Shipment of Product to Access Program Participants *
Shipment of Alliance Kits *
Services related to Reimbursement Hotline and Hotline *
Customers
Outcome calls to Triaged Customers *
Shipment of Product to Access Program Participants who *
require reimbursement services
* - Confidential Treatment Requested
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SCHEDULE B
DATA AND REPORTS
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SCHEDULE C
*
* - Confidential Treatment Requested
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Exhibit 1
*
* - Confidential Treatment Requested
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Exhibit 2
*
* - Confidential Treatment Requested
27