Exhibit 10.34
AMENDMENT NO. 1 TO DISTRIBUTION AND SERVICES AGREEMENT
This Amendment No. 1 to Distribution and Services Agreement is entered
into as of this 17th day of May, 1996 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
Xxxxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, XX 00000 ("Nova Factor"). Except
as otherwise set forth herein, the capitalized terms used in this Amendment
shall have the meanings assigned to such terms in the Distribution and
Services Agreement between the parties dated as of November 1, 1995 (the
"Distribution Agreement").
WHEREAS, Biogen has appointed Nova Factor as a preferred distributor of
Biogen's AVONEX-TM- (Interferon beta - 1a);
WHEREAS, under the terms of the Distribution Agreement, Nova Factor has
agreed to provide reimbursement assistance and other customer services to
end-users of the Product and to provide data reporting and other services to
Biogen;
WHEREAS, as additional services under the Distribution Agreement, Biogen
desires Nova Factor (i) to supply replacement Product, as authorized by
Biogen, to all end-users and physicians, whether or not customers of Nova
Factor and (ii) to supply Product to participants in Biogen's AVONEX-TM-
Access Program-TM-, and Nova Factor is willing to provide such additional
services to Biogen on the terms and conditions set forth in this Amendment;
WHEREAS, to reflect the additional services to be provided by Nova Factor,
the parties desire to amend the Distribution Agreement as set forth herein;
NOW THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereby agree as follows:
1. Section 9 of the Distribution Agreement shall be amended to be and read
in its entirety as follows:
"9. REPLACEMENTS, RETURNS AND AVONEX-TM- ACCESS PROGRAM-TM
9.1 In the event Nova Factor returns or requests to return a Product,
Nova Factor shall promptly notify Biogen and Biogen shall, upon
return of Product, 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 Nova Factor shall refer any Nova Factor customer who requests
replacement Product to one of Biogen's customer support
specialists for authorization. Biogen's customer support
specialist shall authorize the supply of replacement Product at no
charge to a Nova Factor customer under appropriate circumstances
as determined by Biogen. Biogen shall not authorize the supply of
replacement Product to a Nova Factor customer at no charge if the
need for replacement product arises from (i) the negligence or
intentional misconduct of Nova Factor or any of its agents or
employees, (ii) failure of Nova Factor to follow applicable SOPs
or to otherwise comply with the terms of this Agreement or (iii)
misdelivery or loss of Product by a carrier used by Nova Factor.
If Biogen determines not to supply replacement Product to a Nova
Factor customer at no charge, Nova Factor may purchase replacement
product at the prices and on the terms set forth in Section 8.
9.3 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, *.
9.4 In addition to the other services to be provided by Nova Factor
under this Agreement, Nova Factor shall act as a supplier of
replacement Product and replacement diluent for Biogen. Upon
receipt of each authorization from a Biogen customer support
specialist to send replacement Product or diluent to an end-user
of Product or to a physician who has purchased Product, Nova
Factor shall supply replacement Product or diluent 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. Authorization from Biogen's
customer support specialist for Nova Factor to supply replacement
Product or diluent 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 or diluent 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. 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 and ship replacement Product
and diluent in accordance with Section 4.2 for delivery within
* 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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twenty-four (24) hours of receipt of authorization from Biogen,
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 a patient, as necessary, within
twenty-four (24) hours of receipt of authorization from Biogen to
ship replacement Product to such patient. Nova Factor shall notify
the appropriate Biogen customer support specialist in the event
Nova Factor has not received the prescription form for a patient
within forty-eight (48) hours of receipt of authorization from
Biogen. Vials of replacement diluent used by Nova Factor in
fulfilling its obligation under this Section shall be purchased
and properly stored by Nova Factor, at Nova Factor's cost. Nova
Factor shall use diluent which has been manufactured by Xxxxxx
Laboratories Inc. and which conforms to the specifications for the
diluent used in the Product administration packages.
Notwithstanding anything herein to the contrary, shipments made
by Nova Factor under this Section 9.4 *.
9.5 (a) 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 AVONEX-TM- Access
Program-TM- (the "Program"). Biogen shall have sole responsibility
for enrolling participants in the Program. Upon enrollment by
Biogen of a participant in the Program (each a "Program
Participant"), one of Biogen's customer support specialists or a
representative of Biogen's third party reimbursement support
services vendor shall notify Nova Factor in writing of the name,
address and telephone number of the Program Participant and shall
send 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.
(b) 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 with 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 and ship
Product to Program Participants in accordance with Section 4.2.
(c) As a condition to participation in the Program, Program
Participants will agree to pay a shipment fee of $* for each
shipment of Product after the initial shipment (the "Program
Fee"). Nova Factor shall xxxx each Program Participant for the
Program Fee, and shall send a follow-up reminder letter following
the third
* 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.
3
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 Shipment Fees owed by
Biogen for such month under Section 9.7. Nova Factor shall not
xxxx Program Participants for Product other than in 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.
(d) Nova Factor shall treat each Program Participant as a Nova
Factor customer under this Agreement, except that shipments to
Program Participants shall be identified separately in the
Database and in reports provided to Biogen under Section 8.1.
Notwithstanding anything herein to the contrary, shipments made by
Nova Factor to Program Participants under this Agreement *.
(e) During each follow-up telephone call to a Program Participant
under Section 6.2, 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 reimbursement support
services vendor. 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 reimbursement support
services vendor that the Program Participant is no longer eligible
to participate in the Program.
9.6 At the end of each month, Nova Factor shall furnish to Biogen a
report (the "Supply Report") specifying (A) for each shipment of
replacement Product or diluent (i) *. Within thirty (30) days of
receipt of the Supply 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 Section 9.4 and 9.5 of this Agreement (with
* 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
individual one dose packs treated as one-quarter of a Product)
multiplied by the applicable Credit Price for the month (as
defined below). Notwithstanding the foregoing, Biogen shall only
issue credit memos in multiples of the full four does
administration pack. Any fraction of a full four does pack for
which credit is due shall be added to the credit memo for the next
period. *. Nova Factor may apply credits given under this Section 9
against subsequent purchases of Product under this 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. Nova Factor shall not unilaterally apply any credit
against or make any deductions from payment due to Biogen without
the prior written approval of Biogen. Nova Factor shall apply
credits on a first-in, first-out basis.
9.7 In consideration of the services rendered by Nova Factor to Biogen
under this Section 9, Biogen shall pay to Nova Factor a fee of $*
for each shipment of replacement Product or diluent by
Nova Factor in accordance with Section 9.4 and for each shipment
of Product to a Program Participant shipped by Nova Factor in
accordance with Section 9.5 (the "Shipment Fee"), provided that
the Shipment Fee shall be reduced to $* for each shipment
commencing with the first quarter in which * . Notwithstanding
anything herein to the contrary, shipment of multiple one dose
packs or multiple packages of four dose packs or vials of diluent
to a single patient shall be deemed one shipment for purposes of
this Section 9.7. Nova Factor shall invoice Biogen at the end of
each month for amounts due hereunder with respect to Product shown
in the Supply Report for such month. The amount due for any month
as shown on the applicable invoice shall be the Shipment Fees due
for such month less the Program Fees collected by Nova Factor
during such month. 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.
9.8 Except as otherwise expressly set forth herein, Nova Factor shall
be responsible for all costs and expenses associated with
fulfilling its obligations under this Section 9.
9.9 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.
2. Except as otherwise expressly set forth herein, all of the terms and
conditions of the Distribution Agreement shall remain in full force and
effect.
* 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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IN WITNESS WHEREOF, the parties have executed this Agreement on the date
first above written.
BIOGEN, INC.
By: /s/ Xxxxxxx X. Xxxx
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Xxxxxxx X. Xxxx
Vice President - Marketing and Sales
NOVA FACTOR, INC.
By: /s/ Xxxxx Grow
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Title: President
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