Exhibit 10.35
ADDENDUM AND AMENDMENT NO. 2 TO
DISTRIBUTION AND SERVICES AGREEMENT
This Addendum and Amendment to Distribution and Services Agreement is
entered into as of this 21st day of May 1997 by and between Biogen, Inc.,
through its offices located at 000 Xxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxxxxxx,
XX 00000 ("Biogen"), and Nova Factor, Inc., with principal offices located at
0000 Xxxxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, XX 00000 ("Nova Factor").
WHEREAS, Biogen has appointed Nova Factor as a preferred distributor of
Biogen's AVONEX-Registered Trademark- (Interferon beta - 1a) under the terms
of a Distribution and Services Agreement between the parties dated as of
November 1, 1995, as amended by Amendment No. 1 to Distribution and Services
Agreement, dated as of May 17, 1996, (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-Registered Trademark- 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 components purchased by Nova
Factor to all end-users (whether or not customers of Nova Factor) who have a
need for such replacement components, as determined by a qualified Nova
Factor pharmacist and as approved by a Biogen customer support specialist,
(ii) to supply Alliance Kits, as defined below, to participants in Biogen's
Alliance Program, and (iii) at Biogen's request, to supply Product, as
defined in the Distribution Agreement, to physicians for investigational use
under investigator-sponsored INDs approved by Biogen, and Nova Factor is
willing to provide such additional services to Biogen on the terms and
conditions set forth in this Addendum;
WHEREAS, in addition to providing for additional services, the parties
desire to include in this Addendum an amendment to the Distribution Agreement
to reflect a new arrangement regarding the fee paid to Nova Factor for
supplying replacement Product to end-users;
NOW THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereby agree as follows:
I DEFINITIONS.
The capitalized terms used in this Addendum that are defined in the
Distribution Agreement shall have the meanings assigned to such terms in
the Distribution Agreement. In addition, the following terms shall have
the following meanings:
1.1 "Additional Services" shall mean the services to be provided by Nova
Factor under this Addendum.
1.2 "Alliance Kit" shall mean a plastic ziplock bag containing five
syringes, five MicroPins-Registered Trademark- and five needles intended
for use with Product.
1.3 "Alliance Program" shall mean a program established by Biogen to provide
educational information and materials to persons using Product.
1.4 "Alliance Program Participant" shall mean an end-user of Product who has
enrolled in the Alliance Program.
1.5 "Emergency Shipment" shall have the meaning set forth in Section 2.2.
1.6 "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.
1.7 "IND" shall mean an Investigational New Drug application filed with the
FDA.
1.8 "Replacement Components" shall mean diluent, syringes,
MicroPins-Registered Trademark- and needles intended for use with Product.
1.9 "Service Report" shall have the meaning set forth in Section 5.1.
1.10 "Specifications" shall mean the specifications for Replacement
Components provided to Nova Factor by Biogen, as updated by Biogen from
time to time.
2. SUPPLY OF MISCELLANEOUS REPLACEMENT COMPONENTS.
2.1 As additional services under the Distribution Agreement, Nova Factor
shall, under the terms of this Addendum, 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.
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. 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 its inventory of
Replacement Components to the 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-
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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 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.
2.2 Nova Factor shall ship Replacement Components to end-users via
third-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 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.
2.3 Nova Factor shall purchase and store the Replacement Components that it
supplies to end-users under this Section 2, at Nova Factor's cost. In
fulfilling its supply obligation under this Section 2, Nova Factor shall
use only those Replacement Components that conform to the Specifications.
Nova Factor shall perform appropriate quality control testing to confirm
that Replacement Components conform to Specifications, including but not
limited to (i) inspection of incoming inventory shipments to verify
conformance of Replacement Components to Specifications, (ii) documentation
of such inspections and (iii) for each shipment to an end-user verification
by a registered pharmacist or pharmacy technician acting under the direct
supervision of a registered pharmacist that the Replacement Components
being shipped are the Replacement Components that were requested and
authorized.
2.4 The parties agree that, notwithstanding anything herein to the contrary,
Section 9 of the Distribution Agreement, including the payment provisions
of Section 9.7, shall no longer apply to the supply of replacement diluent,
but rather replacement diluent shall be treated in the same manner as other
Replacement Components under the terms of this Addendum.
3. ALLIANCE PROGRAM
3.1 As further additional services under the Distribution Agreement, Nova
Factor shall, under the terms of this Addendum, supply one Alliance Kit
to each Alliance Program Participant who submits a completed Alliance
Program voucher to Nova Factor. 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
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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 the voucher. 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 the voucher, Nova Factor shall notify a
Biogen customer support specialist.
3.2 Nova Factor shall ship Alliance Kits within two (2) business days of
receipt of the applicable voucher, 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 third 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.
3.3 Nova Factor shall purchase the Replacement Components used in the
Alliance Kits and store the Alliance Kits, all at Nova Factor's cost. Prior
to commencement of the Alliance Program by Biogen, Nova Factor shall have
purchased * of each Replacement Component contained in the Alliance Kit
for use in the Alliance Kits (the "Initial Inventory"). At Nova Factor's
request, in the event Nova Factor does not use the Initial Inventory by
December 31, 1997, Biogen shall repurchase the unused portion of the
Initial Inventory from Nova Factor, at a cost of $* per repurchased
Alliance Kit. In fulfilling its supply obligation under this Section 3,
Nova Factor shall use in the Alliance Kits only those Replacement
Components that conform to the Specifications. Nova Factor shall perform
appropriate quality control testing to confirm that Replacement Components
contained in the Alliance Kits conform to Specifications, including but not
limited to (i) inspection of incoming inventory shipments to verify
conformance of Replacement Components to Specifications, (ii) documentation
of such inspections and (iii) for each shipment to an end-user verification
by a registered pharmacist or a pharmacy technician acting under the direct
supervision of a registered pharmacist that the Replacement Components
contained in the Alliance Kit are as specified under this Addendum.
4. PHYSICIAN INVESTIGATIVE USE
4.1 As further additional services under the Distribution Agreement, Nova
Factor shall, upon receipt of written authorization from Biogen, supply
Product from Nova Factor's inventory to Investigators. Nova Factor shall
package and ship Product to the location specified by the Investigator in
accordance with Section 4.2 of the Distribution Agreement 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.
4.2 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
* 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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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.
5. SERVICE REPORT.
5.1 At the end of each month, Nova Factor shall furnish to Biogen a report
(the "Service Report") specifying *. The parties may change the format
of the Service Report at any time upon mutual agreement. At Biogen's
request, Nova Factor shall provide to Biogen weekly reports containing
some or all of the information specified in this Section.
5.2 The information contained in the Service Report shall be maintained in
the Database.
6. PAYMENT.
6.1 In consideration of the Additional Services rendered by Nova Factor to
Biogen under this Addendum, Biogen shall pay to Nova Factor the following
fees:
Type of Service Fee
Non-Emergency Shipment of Replacement Components $* per shipment
Emergency Shipment of Replacement Components $* per shipment
Shipment of Alliance Kits $* per shipment
Shipment of Product to Investigator $* per unit of Product
shipped (four dose
package)
* 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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Notwithstanding anything herein to the contrary, commencing with the
first quarter in which Nova Factor *. Biogen shall not have
any payment obligation with respect to any shipment of Product or
Replacement Components that is not authorized by a Biogen customer
support specialist or with respect to any shipment of an Alliance Kit
that is sent other than pursuant to a completed Alliance Program voucher.
6.2 Nova Factor shall invoice Biogen at the end of each month for amounts
due hereunder with respect to Additional Services shown on the Service
Report for 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.
6.3 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 4.1 of this Addendum multiplied by
the applicable Credit Price for the month (as defined in the Distribution
Agreement). Nova Factor may apply credits given under this Section against
subsequnt 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. 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.
Credits shall be applied on a first-in, first-out basis.
6.4 Except as otherwise set forth herein, Nova Factor shall be responsible
for all costs and expenses associated with fulfilling its obligations
under this Agreement. In no event shall Nova Factor charge an end-user,
insurance provider or any other third party for any Additional Services
provided under this Addendum.
7. TERMINATION.
Biogen may terminate all or a portion of the Additional Services at any
time upon thirty (30) days' prior written notice to Nova Factor without
terminating the Distribution Agreement. Biogen's repurchase obligation
under Section 3.3 of this Addendum with respect to unused Initial
Inventory shall survive termination of the Additional Services.
8. NOVA FACTOR COVENANTS
8.1 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.
* 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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8.2 Nova Factor shall be responsible for ensuring that the Additional
Services are carried out in a manner consistent with applicable federal
and state laws and regulations and relevant professional standards.
8.3 The Additional Services provided under this Addendum shall be deemed to
be obligations of Nova Factor under the Distribution Agreement, and the
terms of the Distribution Agreement shall apply to the Additional
Services with the same force and effect as such terms are applied to the
services origianlly specified in the Distribution Agreement.
9. AMENDMENT TO DISTRIBUTION AGREEMENT.
9.1 Section 9.7 of the Distribution Agreement is amended to be and read in
its entirety as follows:
"9.7 (a) In consideration of the services rendered by Nova
Factor to Biogen under this Section 9, Biogen shall pay to
Nova Factor the followign fees (the "Shipment Fees"):
Service Fee
------- ---
Shipment of replacement $* per end-user per shipment
Product in accordance with
Section 9.4 to an end-user
who is not a Nova Factor
customer.
Shipment of replacement $* per end-user per shipment
Product in accordance with
Section 9.4 to an end-user
who is a Nova Factor
customer.
Shipment of Product to a $* per unit of Product
Program Participant in shipped (four dose package)
accordance with Section
9.5.
Notwithstanding anything herein to the contrary,
commencing with the first quarter in which Nova Factor *.
Notwithstanding anything herien to the contrary, shipment of
multiple one does packs or multiple packages of four dose
packs to a single patient shall be deemed one shipment for
purposes of this Section 9.7.
* 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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(b) Nova Factor shall invoice Biogen at the end of each
month for amounts due under this Section 9 with respect to
Product shown on 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."
9.2 The sixth sentence of Section 9.4 of the Distribution Agreement is
amended to be and read in its entirety as follows:
"Nova Factor shall package and ship replacement Product in
accordance with Section 4.2 for delivery within forty-eight
(48) hours of receipt of authorization from Biogen, provided
that Nova Factor has received a copy of the applicable
prescription form".
9.3 Section 22.3 of the Distribution Agreement is amended to add the
following party to receive copies of notices sent to Biogen under the
Distribution Agreement:
Biogen, Inc.
000 Xxxxx Xxxxxx Xxxx
Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: National Accounts Manager
9.4 Except as otherwise expressly set forth herein, all of the terms and
conditions of the Distribution Agreement shall remain in full force and
effect.
IN WITNESS WHEREOF, the parties have executed this Addendum on the date
first above written.
BIOGEN, INC.
By: /s/ Xxxx X. Xxxxxxxxxxxxxx
--------------------------------
Xxxx X. Xxxxxxxxxxxxxx
Vice President-Marketing and Sales
By: /s/ Xxxxxxx Xxxxxx
--------------------------------
Xxxxxxx Xxxxxx
Director of National Accounts
NOVA FACTOR, INC.
By: /s/ Xxxxx Grow
--------------------------------
Title: President
--------------------------------
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