FORM 8-K/A
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
June 26, 1996
Date of Report
(Date of earliest event reported)
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact name of registrant as specified in its charter)
Oregon 0-15360
(State or other jurisdiction (Commission File No.)
of incorporation or organization)
93-1099680
(I.R.S. Employer I.D. No.)
7620 S.W. Bridgeport Road
Portland, Oregon
(Address of principal executive offices)
97224
(Zip Code)
(503) 639-7221
(Registrant's telephone number including area code)
<PAGE>
ITEM 5. OTHER EVENTS
The Company has been developing a self-injection system for Schering AG,
German, under a multi-year contract signed in March 1994. On June 26, 1996,
the Company and Schering entered into a Supply Agreement which specifies the
terms under which the Company will manufacture and sell the self-injection
systems to Schering. Subject to Schering's satisfaction with certain product
test results and receipt of regulatory approval in the United States and
certain foreign countries, Bioject will manufacture the self-injection systems
exclusively for Schering AG which will distribute the systems on a worldwide
basis to multiple sclerosis patients using Betaseron. The agreement extends
for an initial term of eight years and provides for minimum amounts which must
be produced by Bioject and which must be purchased by Schering AG in order for
both parties to maintain their rights under the agreement. The Company has
commenced preparation to manufacture the self-injection systems, and initial
shipments under the agreement are scheduled to commence in the first quarter
of fiscal 1998.
ITEM 7. EXHIBITS
10.32 Supply Agreement between Schering Aktiengesellschaft and Bioject
Inc. dated June 26, 1996. Confidential treatment has been granted with
respect to certain portions of this exhibit pursuant to an Application for
Confidential Treatment filed with the Commission under Rule 24b-2(b) under the
Securities Exchange Act of 1934, as amended.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
DATED this 5th day of November, 1996.
BIOJECT MEDICAL TECHNOLOGIES INC.
By /s/ Peggy J. Miller
_____________________________
Peggy J. Miller
Vice President,
Chief Financial Officer
and Secretary
<PAGE>
EXHIBIT 10.32
NOTE: CONFIDENTAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL
TREATMENT UNDER RULE 24b-2(b) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
SUPPLY AGREEMENT
BETWEEN
SCHERING AKTIENGESELLSCHAFT
AND
BIOJECT INC.
June 26, 1996
<PAGE>
SUPPLY AGREEMENT
Table of Contents
1. Definitions
1.1 Affiliate
1.2 Agreement
1.3 Approved Sublicensees
1.4 Autoinjector; Modified Autoinjector; New Self-Injection Device
1.5 Best Efforts
1.6 Beta Molecule
1.7 Contract Year
1.8 Contract Quarter
1.9 Controls; Control
1.10 ELA/PLA
1.11 FDA
1.12 Field
1.13 GMPs
1.14 [confidential portion omitted]
1.15 Multiple Sclerosis
1.16 Party
1.17 Person
1.18 Product
1.19 Rest of the World Territory Year
1.20 Safety Study
1.21 Specifications
1.22 Syringe
1.23 Territory
1.24 Territory Year
1.25 Third Party
1.26 Total Minimums
1.27 United States Territory Year
2. Supply; Price; Minimum Quantities; Exclusivity
2.1 Supply
2.2 Price
2.3 Exclusivity Quantities
2.4 Exclusivity
2.5 Carbon Dioxide Cartridges
3. Forecasts; Orders; Manufacturing; Delivery; Payment; Packaging;
Reports; Taxes
3.1 Forecasts
3.2 Orders
3.3 Manufacturing
3.4 Delivery; Shipping
3.5 Title; Loss
3.6 Acceptance; Rejection
3.7 Payments for Products
3.8 Currency
3.9 Packaging and Labeling
3.10 Testing; Record Keeping; Inspection; Etc.
3.11 Recall Procedure; Complaints; Adverse Event Reporting; Etc.
3.12 Servicing, Refurbishing and Non-Warranty Repairs
3.13 Loans
3.14 Customer and Product Warranties; Indemnification
4. [confidential portion omitted] to [confidential portion omitted] Products
4.1 [confidential portion omitted] to [confidential portion
omitted] Products
4.2 [confidential portion omitted] Duration
4.3 Disclosure of [confidential portion omitted] to Schering
4.4 Inspection Right
4.5 Interim Production by Bioject
5. Term; Renewal; Termination; Survival
5.1 Term
5.2 Termination
5.3 Effect of Termination
6. Confidentiality
6.1 Confidentiality
6.2 Exceptions
6.3 IFN-Beta Information Disclosed to Bioject
7. Regulatory
8. Development and Licensing Agreement
9. Compliance with Regulations
10. Miscellaneous
10.1 Force Majeure
10.2 Notices
10.3 Assignment
10.4 Governing Law
10.5 Entire Agreement; Amendment
10.6 Independent Contractors
10.7 Counterparts
10.8 Severability
10.9 Headings
10.10 Publicity
10.11 Waiver
10.12 Superiority of Agreement
10.13 [confidential portion omitted] to [confidential portion
omitted]
Schedule A - Description of Product
Schedule B - Specifications
Schedule C - Prices
Schedule D - Minimum Quantities to be Ordered by Schering for
Shipment During Each Contract Year
Schedule E - Initial Orders for Shipment During the Specified
Months
Schedule F - Bioject Shipping Capability
Schedule G - Loan
Schedule H - Standard Product Packaging Specifications
Schedule I - Countries
Schedule J - Security Agreement
Schedule K - Limited Product Warranty
<PAGE>
Supply Agreement
This Supply Agreement, made as of the 26th day of June 1996, by and
between Bioject Inc., an Oregon corporation having its principal place of
business at 7620 S.W. Bridgeport Road, Portland, Oregon 97224 ("Bioject"), and
Schering Aktiengesellschaft, a corporation organized under the laws of
Germany, and having its principal place of business at Mullerstrasse 170-178,
13353 Berlin, Germany ("Schering").
RECITALS
Whereas, Schering has developed and received approval to market
injectable Interferon beta-1b (under the trade names inter alia of Betaseron
[registered] and Betaferon[registered]) (hereinafter called "Approved IFN-
Beta") in the United States and other countries for the treatment of multiple
sclerosis;
Whereas, Bioject and Schering have entered into a development and
licensing agreement, effective date March 28, 1994 (hereinafter called the
"Development and Licensing Agreement") regarding a portable, needle-free,
self-injection device that will be used for self-injections of "Approved
IFN-Beta" and other injectables that come within the scope of the license
granted to Schering in the Development and Licensing Agreement (hereinafter
called the "Product" as further defined in Section 1);
Whereas, Bioject and Schering intended in the Development and
Licensing Agreement to enter into an exclusive supply agreement, which will
specify the terms upon which Schering will purchase Products from Bioject;
NOW THEREFORE, in consideration of the foregoing and of the mutual
covenants and obligations hereinafter set forth, the sufficiency of which is
hereby acknowledged, Schering and Bioject agree as follows:
1. Definitions When capitalized, the following terms shall for
all purposes of this Agreement have the meanings specified in
this Section.
1.1 "Affiliate" shall mean a Person that directly, or
indirectly through one or more intermediaries, Controls, is
Controlled by or is under common Control with the Person
specified.
1.2 "Agreement" shall mean this document together with all
attachments and exhibits.
1.3 "Approved Sublicensees" shall mean any Person
sublicensed by Schering with Bioject's written consent under the
terms of this Agreement, which consent shall not be unreasonably
withheld.
1.4 "Autoinjector" shall mean Product (exclusive of the
[confidential portion omitted], syringe components and related
sterilization and packaging). "Modified Autoinjector" shall mean a
portable, needle-free self-injection product that looks and works
substantially the same as the Autoinjector but has been changed
in [confidential portion omitted] (e.g., [confidential portion
omitted]). [confidential portion omitted] shall mean any
portable, needle-free self-injection device developed and/or
manufactured by Bioject, which looks and works significantly
different than the Autoinjector and has at least [confidential
portion omitted] different component parts as compared to the
Autoinjector.
1.5 "Best Efforts" shall mean the level of endeavor which a
prudent business person would ordinarily expend in the normal
course of business to accomplish an important objective.
1.6 "Beta Molecule" shall mean [confidential portion omitted], any
[confidential portion omitted] or [confidential portion omitted]
(excluding [confidential portion omitted] and [confidential portion
omitted]) that specifically [confidential portion omitted] with one
or more [confidential portion omitted], or any product containing
[confidential portion omitted] as its active ingredient.
1.7 "Contract Year" shall mean each period of twelve
consecutive calendar months, with the first such period
commencing on [confidential portion omitted], or such later date
as the parties shall agree in writing.
1.8 "Contract Quarter" shall mean each period of three
consecutive calendar months commencing with the first day of the
first Contract Year (i.e., if the first Contract Year commences
on [confidential portion omitted], Contract Quarters shall commence
on March 1, June 1, September 1 and December 1 during the term of
this Agreement).
1.9 "Controls" or "Control" shall mean, in the case of any
Person, the possession of the power to direct or cause the
direction of the management and policies of such Person, whether
through the ownership of at least fifty percent (50%) of the
voting securities thereof or otherwise, and when used in the
context of "Control" of technology or information, shall mean
possession by a Person of the right to grant licenses or
sublicenses of such technology, or disclose such information,
without violating the terms of any agreement or other arrangement
with, or the rights of, any other Person or any legally binding
laws or regulations.
1.10 "ELA/PLA" shall mean the Establishment License
Application and Product License Application filed with the FDA by
Schering or Chiron Corporation pursuant to 21 CFR 601.2
and any amendments thereto relating to the approval, manufacture and
sale of the Product.
1.11 "FDA" shall mean the U.S. Food and Drug Administration of
the Department of Health and Human Services, or any successor
agency.
1.12 "Field" shall mean any [confidential portion omitted] for
[confidential portion omitted] or any [confidential portion
omitted].
1.13 "GMPs" shall mean all FDA Current Good Manufacturing
Practices regulations applicable to the Product.
1.14 [confidential portion omitted] shall mean all proprietary
information, with respect to the [confidential portion omitted]
and [confidential portion omitted] of the Product, including,
without limitation, all trade secrets, technical information, data,
techniques, discoveries, inventions, processes, know-how,
improvements, patents (including any extension, reissue or renewal
thereof) and patent applications that Bioject now has or may
hereafter conceive, develop, own or Control, which is necessary in
connection with the [confidential portion omitted] of the Product.
1.15 "Multiple Sclerosis" shall mean the [confidential portion
omitted] or [confidential portion omitted] of multiple sclerosis,
except the [confidential portion omitted] and [confidential portion
omitted] as a [confidential portion omitted] to [confidential
portion omitted] who [confidential portion omitted] from
confidential portion omitted] multiple sclerosis.
1.16 "Party" shall mean Schering and/or Bioject.
1.17 "Person" shall mean an individual, partnership, corporation,
joint venture, unincorporated association, or other entity, or a
government or department or agency thereof.
1.18 "Product" shall mean the portable, reusable needle-free
self-injection product for non-professional use to be developed
by Bioject pursuant to the Development and Licensing Agreement,
as shown in Schedule A, and all disposable syringe components to
be used with the self-injection product, including the [confidential
portion omitted], sterilization and standard packaging, as well as
all routine improvements, modifications and design revisions made by
Bioject.
1.19 "Rest of the World Territory Year" shall mean each period of
[confidential portion omitted], with the first period
commencing on: (i) the commencement of the first Contract Year;
or (ii) [confidential portion omitted] following the receipt of
official marketing approval of the Product from at least
[confidential portion omitted] of the countries listed on Schedule I
that currently comprise the [confidential portion omitted] (which
[confidential portion omitted] must include the countries marked
with an asterisk on Schedule I). If [confidential portion omitted]
regulatory approval is received on or before the commencement of
the first Contract Year, then (i) shall apply. If marketing
approval is received in both Territories on or before the
commencement of the first Contract Year, then both Territory Years
shall commence on the first day of the first Contract Year. If
marketing approval has not been received in either [confidential
portion omitted] or the United States by the commencement of the
first Contract Year pursuant to Section 1.7, the first approval
that is subsequently received (i.e., in the United States or in
[confidential portion omitted]) shall determine which Territory
Year shall be deemed to have commenced on the first day of the
first Contract Year. If [confidential portion omitted] is the
second Territory to receive marketing approval (i.e.,
[confidential portion omitted] approval is received after FDA
approval) and [confidential portion omitted] approval is received
after the commencement of the first Contract Year, the Rest of
the World Territory Year shall commence in accordance with
(ii) above.
1.20 "Safety Study" shall mean that safety study of the Product
to be performed by or on behalf of Schering, which is intended to
compare the side effects of Approved IFN-Beta treatment with
the [confidential portion omitted] with the side effects of
Approved IFN-Beta treatment with the [confidential portion
omitted] administration.
1.21 "Specifications" shall mean the written standards
established for the characteristics and quality of Product and
its constituents, components and packaging, which are set forth
on Schedule B, as it may be changed from time to time in
writing signed by the Parties.
1.22 "Syringe" shall mean the syringe components, including the
[confidential portion omitted], sterilization and packaging, of the
Product to be used with the Autoinjector.
1.23 "Territory" shall mean either the United States or the areas
outside the United States (the "Rest of the World").
1.24 "Territory Year" shall mean either United States Territory
Year or Rest of the World Territory Year.
1.25 "Third Party" shall mean any Person other than a
Party, or an Affiliate of a Party, to this Agreement.
1.26 "Total Minimums" shall mean the number of Autoinjectors or
Syringes specified under the applicable "Total Minimum" column in
Schedule D, which Schering must order for shipment during a
particular Contract Year to maintain exclusivity in both
Territories, with such adjustments as are permitted by
Section 2.3.
1.27 "United States Territory Year" shall mean each period of
[confidential portion omitted], with the first period commencing
on: (i) the commencement of the first Contract Year;
or (ii) [confidential portion omitted] following the receipt of
FDA approval of the Product. If FDA approval is received on or
before the commencement of the first Contract Year, then (i) shall
apply. If marketing approval is received in both Territories on or
before the commencement of the first Contract Year, then both
Territory Years shall commence on the first day of the first
Contract Year. If marketing approval has not been received in
either [confidential portion omitted] or the United States by the
commencement of the first Contract Year pursuant to Section 1.7,
the first approval that is subsequently received (i.e., in the
United States or in [confidential portion omitted]) shall determine
which Territory Year shall be deemed to have commenced on the
first day of the first Contract Year. If the United States is the
second Territory to receive marketing approval (i.e., FDA approval
is received after approval in [confidential portion omitted]) and
FDA approval is received after the commencement of the first
Contract Year, the United States Territory Year shall commence in
accordance with (ii) above.
2. Supply; Price; Minimum Quantities; Exclusivity
2.1 Supply. During the term of this Agreement Bioject
agrees to manufacture for Schering and Schering agrees to
purchase from Bioject such finished and packaged quantities of
the Product as may be reasonably required by Schering for sale
worldwide subject to the provisions of this Agreement.
Bioject agrees that, as part of its obligation to
manufacture and supply Schering with Products under
this Agreement, such Products will be supplied in
completely finished, labeled, and final packaged
quantities, ready for use, inclusive of [confidential portion
omitted] carbon dioxide cartridges and [confidential portion
omitted] of necessary batteries, containing all necessary and
appropriate packaging and labeling (including, but not
limited to, such packaging and labeling as is required by law
and agreed to by the Parties under the provisions of Section
3.9), suitable for sale by Schering, its Affiliates or
distributors to their respective customers in the Territory
and in accordance with Section 3.9 of this Agreement.
2.2 Price. In consideration of its purchase of Products and
the rights granted hereunder, Schering shall pay to Bioject a
purchase price for each Autoinjector and Syringe in accordance
with Schedule C hereto. Such purchase price shall be payable for
so long as Bioject continues to supply Product to Schering under
this Agreement. Payment of such amounts shall be made in
accordance with Schedule C and Section 3.7.
2.3 Exclusivity Quantities
(a) Schering agrees that, in order to maintain exclusivity, as
described in Section 2.4, it will order Autoinjectors and
Syringes for shipment, and Bioject agrees that it will
manufacture such Autoinjectors and Syringes in the minimum
quantities specified in Schedule D; provided, however, that the
Parties agree that Schering's failure to order such minimum
quantities shall not constitute a breach of this Agreement. In
the event that Schering fails to order the Total Minimum quantity
specified in Schedule D for shipment of Autoinjectors or Syringes
in any particular Contract Year, then, unless Bioject has
indicated to Schering that it is [confidential portion omitted],
Bioject will no longer [confidential portion omitted] Schering
with Product on [confidential portion omitted] in any [confidential
portion omitted] Contract Year, except that:
(i) subject to Schering's [confidential portion omitted]
commitment to order Autoinjectors and Syringes for
shipment in the First Contract Year, as specified
in Section 3.2(b), the Parties understand that the
Total Minimums [confidential portion omitted] throughout
the term of this Agreement to account for a later
commencement of either the United States Territory
Year or the Rest of the World Territory Year (but
not both Territories), with any such adjustment
not to exceed [confidential portion omitted] and any
delay of [confidential portion omitted] or less to
result in a pro rata adjustment;
(ii) Schering shall have the option of paying Bioject
a fee of [confidential portion omitted] per
Autoinjector or [confidential portion omitted] per
Syringe below the applicable minimum quantity
specified in Schedule D for that Contract Year in
order to retain exclusivity in one or both Territories
for subsequent Contract Years; provided, however,
Schering shall not be permitted to retain
exclusivity in a Territory through payment of
penalty fees unless at least [confidential portion omitted]
of the minimum quantities of Autoinjectors and
Syringes specified in Schedule D for that
Territory have been ordered for shipment during
the applicable Contract Year; and
(iii) in lieu of ordering the Total Minimums
(including allowable penalty payments)
for shipment in a Contract Year to retain
exclusivity in both Territories, Schering may
order the applicable minimum quantities of
Autoinjectors and Syringes (including allowable
penalty payments) for shipment into one Territory
and retain exclusivity in that Territory while
forfeiting exclusivity in the Territory in
which Schering has failed to order the minimum
quantities of Autoinjectors or Syringes (including
allowable penalty payments).
(b) Taking into account the permitted [confidential portion
omitted] delay, Schering will retain exclusivity in both the United
States and the Rest of the World if the Total Minimum quantity of
Autoinjectors and Syringes (including allowable penalty payments)
is ordered for shipment during any Contract Year; provided,
however, that any Autoinjectors or Syringes ordered for shipment
into a particular Territory during a Contract Year greater than
the applicable minimum quantities specified in Schedule D for
that Territory may be counted toward the satisfaction of the
minimum requirements specified in Schedule D for that Territory
during the next succeeding Contract Year (but not for any
subsequent Contract Years). Alternatively, Autoinjectors and
Syringes that are ordered for shipment into one Territory may
be counted toward the required minimums for the other Territory
during any particular Contract Year only if Schering has satisfied
the required minimums during that Contract Year for the Territory
into which the Autoinjectors and Syringes are to be shipped.
(c) If Schering fails to order the necessary minimum quantities
to retain exclusivity in one or both Territories: (i) the
restrictions on Bioject specified in Section 2.4 [confidential
portion omitted] with respect to each [confidential portion omitted]
for which the [confidential portion omitted] for shipment during
any Contract Year, with such [confidential portion omitted] to take
effect at the end of such Contract Year; and (ii) repayment of the
loans made by Schering pursuant to Section 3.13(a) shall be extended
by [confidential portion omitted] as specified therein.
2.4 Exclusivity. During the term of this Agreement and up
until such time as Schering [confidential portion omitted] in
one or both Territories in accordance with Section [confidential
portion omitted] or Section 4.1(g) hereof or until the restrictions
in this section are [confidential portion omitted] pursuant to
Section [confidential portion omitted] hereof:
(a) With respect to the Autoinjector and Modified Autoinjector,
Bioject agrees:
(i) not to [confidential portion omitted]
(except as permitted by subsection (iii) below)
or [confidential portion omitted] the Autoinjector
or Modified Autoinjector for use in the [confidential
portion omitted];
(ii) not to [confidential portion omitted] or
[confidential portion omitted] the Autoinjector
or Modified Autoinjector to any [confidential
portion omitted] for [confidential portion omitted]
or [confidential portion omitted] in [confidential
portion omitted], except as permitted by subsection
(iii) immediately below;
(iii) not to [confidential portion omitted] the
Autoinjector or Modified Autoinjector to any
[confidential portion omitted] for [confidential
portion omitted] self-injection (which may include
use in [confidential portion omitted]) until
[confidential portion omitted] without [confidential
portion omitted];
(iv) not to [confidential portion omitted] the
Autoinjector or Modified Autoinjector for
[confidential portion omitted] outside [confidential
portion omitted], except for use with a [confidential
portion omitted] and with the [confidential portion omitted]
of Schering (Schering agrees that it will [confidential
portion omitted] unless the proposed purchaser of the
Autoinjector or Modified Autoinjector is a
[confidential portion omitted] of [confidential portion
omitted]. The Parties agree that, in order for a [confidential
portion omitted] to be a [confidential portion
omitted] of [confidential portion omitted], the [confidential
portion omitted] must at that time have an [confidential
portion omitted] for [confidential portion omitted] in
[confidential portion omitted] that is in [confidential portion
omitted] or already has been [confidential portion omitted]
in the United States or in a country listed in Schedule I.
The Parties further agree that when Bioject wishes to
[confidential portion omitted] or [confidential portion
omitted] the Autoinjector or Modified Autoinjector for use with
a [confidential portion omitted], Bioject may have
[confidential portion omitted] of the Autoinjector or Modified
Autoinjector for [confidential portion omitted] with that
[confidential portion omitted] or, alternatively, Bioject may
have [confidential portion omitted] of the Autoinjector or
Modified Autoinjector as a [confidential portion omitted]
device. If the device is [confidential portion omitted] for
[confidential portion omitted] use, Bioject shall [confidential
portion omitted] or [confidential portion omitted] by the
[confidential portion omitted] to the permitted
[confidential portion omitted]); and
(v) that under no circumstances shall Bioject
[confidential portion omitted] to any [confidential
portion omitted] the Autoinjector or Modified Autoinjector
[confidential portion omitted] the [confidential portion
omitted] and [confidential portion omitted].
(b) With respect to any [confidential portion omitted]
developed by Bioject, Bioject agrees:
(i) not to knowingly [confidential portion omitted]
(except as permitted by subsection (iii) below) or
[confidential portion omitted] the [confidential portion
omitted] for use in [confidential portion omitted];
(ii) not to knowingly [confidential portion omitted]
or [confidential portion omitted] the [confidential
portion omitted] to any [confidential portion omitted]
for [confidential portion omitted] in [confidential
portion omitted], except as permitted by subsection
(iii) immediately below;
(iii) not to [confidential portion omitted] or
[confidential portion omitted] the [confidential
portion omitted] to any [confidential portion
omitted] for [confidential portion omitted]
self-injection (which may include use in
[confidential portion omitted]) until [confidential
portion omitted] and, after such date, to
[confidential portion omitted] to [confidential portion
omitted] the [confidential portion omitted] to use the
[confidential portion omitted] in [confidential portion
omitted]; provided, however, that, whether or not
[confidential portion omitted] its [confidential portion
omitted] in [confidential portion omitted], the [confidential
portion omitted] may also be used by [confidential
portion omitted] in [confidential portion omitted],
so long as Bioject has not knowingly [confidential
portion omitted] or [confidential portion omitted] the
[confidential portion omitted] to a [confidential
portion omitted] whose principal purpose with respect
to the [confidential portion omitted] is to
[confidential portion omitted] it for use in
[confidential portion omitted]; and
(iv) to notify Schering of any [confidential portion omitted]
that Bioject [confidential portion omitted] into with a
[confidential portion omitted] for the [confidential portion
omitted] of a [confidential portion omitted] for use outside
[confidential portion omitted].
(c) Bioject agrees not to [confidential portion omitted]
the [confidential portion omitted] or any [confidential portion
omitted] for use in [confidential portion omitted] and not to
knowingly [confidential portion omitted] or [confidential portion
omitted] the [confidential portion omitted] or any [confidential
portion omitted] to a [confidential portion omitted] whose principal
purpose with respect to the [confidential portion omitted] is to
[confidential portion omitted] it for use in [confidential portion
omitted].
(d) The Parties understand that [confidential portion
omitted] may be [confidential portion omitted], including
uses in [confidential portion omitted], and the Parties
agree that any such [confidential portion omitted] will
[confidential portion omitted] of this Agreement, unless
such use is a result of Bioject's [confidential portion omitted]
of that product in [confidential portion omitted] of Section 2.4.
The Parties further understand that Bioject [confidential portion
omitted] how any of its [confidential portion omitted] are
[confidential portion omitted] by [confidential portion omitted].
(e) If Schering [confidential portion omitted] in [confidential
portion omitted] pursuant to Section [confidential portion omitted],
but [confidential portion omitted] in the [confidential portion
omitted], the [confidential portion omitted] on Bioject in
this Section 2.4 will apply only to the [confidential portion
omitted] in which Schering has [confidential portion omitted].
2.5 Carbon Dioxide Cartridges
(a) Bioject agrees to sell to Schering [confidential portion
omitted] for use in the Autoinjector at a price of
[confidential portion omitted] for each box of [confidential
portion omitted] cartridges, plus insurance costs, import
and export duties, and freight, freight forwarding and unloading
charges. The foregoing price may be increased by Bioject, at the
commencement of the [confidential portion omitted] and annually
thereafter, to reflect increases in Bioject's costs, with the
increases to be no greater than the increases in the [confidential
portion omitted], or its successor) since the beginning of the prior
Contract Year. Bioject agrees that the foregoing price shall apply
if: (i) Schering purchases the cartridges in [confidential portion
omitted] the same or similar to the [confidential portion omitted]
then being used by Bioject for its B-2000 cartridges; or (ii)
Schering purchases the [confidential portion omitted]s in
distinctive [confidential portion omitted], provided that Schering
has paid the costs of [confidential portion omitted] and has paid
all [confidential portion omitted], if applicable, over the cost of
printing the [confidential portion omitted] that Bioject would
otherwise provide and, provided, further, that Schering requests no
more than [confidential portion omitted] different [confidential
portion omitted] (i.e., [confidential portion omitted] for
cartridges sold in the United States and [confidential portion
omitted] for cartridges sold in [confidential portion omitted]). The
Parties understand that, if Schering uses more than [confidential
portion omitted] of [confidential portion omitted] for the
cartridges, the Parties will negotiate in [confidential portion
omitted] to establish price(s) for the cartridges sold with the
additional versions of [confidential portion omitted], and Schering
will [confidential portion omitted] specified above with respect to
the [confidential portion omitted] and [confidential portion
omitted] of cartridges in the additional versions of [confidential
portion omitted].
(b) Orders for carbon dioxide cartridges shall be submitted
to Bioject on purchase orders separate from the orders submitted
for Autoinjectors and Syringes. The cartridge orders shall be
submitted [confidential portion omitted] or more before the
requested shipment date. Payment for the cartridge shall be in
accordance with Section 3.7. Bioject represents and warrants that it
will maintain sufficient inventory of carbon dioxide cartridges to
support all Autoinjectors Bioject has sold to Schering as of any
particular date.
3. Forecasts; Orders; Manufacturing; Delivery; Payment;
Packaging; Reports; Taxes
3.1 Forecasts. As soon as practicable following the
execution of this Agreement, Schering shall send to Bioject
Schering's initial forecast [confidential portion omitted]
of the quantity of Autoinjectors and Syringes which Schering
expects to purchase from Bioject during the [confidential
portion omitted]. Each time purchase orders are submitted
by Schering, a revised forecast [confidential portion omitted]
shall be transmitted by Schering to Bioject for the [confidential
portion omitted] beginning with the Contract Quarter following the
Contract Quarter to which the purchase order(s) apply. Except as
specified in Section 3.2(b), it is understood that forecasts
shall [confidential portion omitted] on the Parties.
3.2 Orders.
(a) Having regard to the forecasts hereinabove referred to,
Schering shall furnish Bioject with written purchase order(s)
(each, an "Order") at least [confidential portion omitted]
prior to the beginning of each Contract Quarter commencing with
the first Contract Quarter, for the quantities of Autoinjectors and
Syringes which Schering shall purchase, and which Bioject shall
deliver, during such Contract Quarter. No Order for a Contract
Quarter may exceed [confidential portion omitted] of Schering's
most recent forecast for that quarter unless the Order was
submitted at least [confidential portion omitted] before the
beginning of such Contract Quarter and unless a prepayment is
made in accordance with Section 3.2(c). Orders for any Contract
Quarter in excess of [confidential portion omitted] of the volume
forecast by Schering for such quarter or any revised forecast in
excess of [confidential portion omitted] of the volume previously
forecast which Bioject is not able to fill shall not trigger
Schering's alternate supply right under Section 4 of this Agreement
unless Schering has given Bioject a minimum of [confidential
portion omitted] notice of such excess, which notice cannot apply
to the first Contract Quarter of this Agreement. Orders
[confidential portion omitted] the quantities specified in Schedule
F.
Subject to the prior notice requirements set forth herein,
Bioject agrees to accommodate purchase order or forecast
revisions submitted in writing by Schering within the limits of
Schedule F. Each Order that complies with this Section 3.2 shall
be deemed accepted by Bioject upon receipt of such Order and
Bioject agrees to acknowledge each Order to Schering in writing
within [confidential portion omitted]. Each Order must specify
one or several delivery dates within the period of the Order and
must specify labeling and destination, all of which may be changed
as permitted by Section 3.4. The purchase order which will be
utilized for such Order shall be in such form as may be agreed to
by Bioject and Schering. If there is any conflict between the
terms of the purchase order for an Order and the terms of this
Agreement, the terms of this Agreement shall govern, unless the
Parties have otherwise expressly agreed in writing.
(b) Schering agrees that it will [confidential portion omitted]
the quantities of Autoinjectors and Syringes set forth in Schedule E
for shipment in the months specified in Schedule E.
(c) During the first Contract Year, Schering shall pay to
Bioject a deposit equal to [confidential portion omitted] of the
purchase price of Autoinjectors that are ordered for shipment
in any month in excess of the quantity specified in Schedule E
for such month. After the [confidential portion omitted], Schering
shall pay to Bioject a deposit equal to [confidential portion
omitted] of the purchase price of all Autoinjectors in excess of
[confidential portion omitted] that are ordered for shipment in any
month. The required deposit shall be paid within [confidential
portion omitted] from the date any excess Order is submitted to
Bioject.
3.3 Manufacturing.
(a) Bioject warrants that it shall manufacture and test
Products (i) in accordance with applicable [confidential
portion omitted], (ii) as described in the [confidential
portion omitted], (iii) in accordance with the Specifications
and (iv) according to all relevant regulatory requirements
applicable in the Territory.
(b) Bioject shall release all Products for delivery to
Schering after determining that the Products meet the
Specifications. A copy of the manufacturing (including
serial numbers) records and a sample of the Product shall
be shipped to Schering at the request of Schering. Any
changes to Specifications shall require the advance written
approval of Schering. Bioject agrees to notify Schering
immediately of any significant changes to Bioject's acceptance
testing procedures.
3.4 Delivery; Shipping
(a) Actual quantities of Products to be produced and delivered
shall be specified in the Orders submitted by Schering. Schering
reserves the right to postpone delivery dates (within the
Contract Quarter or Order period) or change labeling, until
[confidential portion omitted] prior to shipment, and Schering
reserves the right to change shipment destinations until
[confidential portion omitted] prior to shipment, provided the
labeling is appropriate for the new destination. Bioject warrants
and represents that it will have the capacity and capability to
ship those quantities of Autoinjectors and Syringes set forth in
Schedule F and that as of [confidential portion omitted] after the
date of this Agreement it will have the capacity and capability
to deliver sufficient Syringes to Schering to satisfy the market
for Syringes taking into consideration the cumulative maximum
quantity of Autoinjectors to be sold to Schering pursuant to
Schedule F. Bioject agrees to ship the quantity of Products set
forth in Schering's Order to the specified destinations, but in
no event to end-users. Bioject will then submit to Schering an
invoice for the total cost of Products, as set forth in Schedule C,
less any prepayments made by Schering pursuant to Section 3.2(c),
plus, notwithstanding that the Products will be shipped
[confidential portion omitted] (as defined in ICC Incoterms 1990)
[confidential portion omitted] in [confidential portion omitted].
Schering reserves the right to specify the means of transportation,
the carrier, freight forwarding agent and/or insurer.
(b) The Parties acknowledge that the [confidential portion
omitted] may commence before receipt by Schering or Bioject of
[confidential portion omitted] to [confidential portion omitted]
the Autoinjector in either the United States or [confidential
portion omitted]. In such case, until [confidential portion omitted]
is obtained in one or the other Territory, Bioject agrees to
manufacture Autoinjectors and Syringes to Schering Orders
through completion but without country-specific packaging and
labeling and to hold such Products at Bioject's facilities until
packaging and labeling instructions are received from Schering after
[confidential portion omitted] is obtained in one or the other
Territory. Schering agrees that, notwithstanding the provisions of
Section 3.5, title to such Autoinjectors and Syringes shall pass to
Schering on the dates when such Products would otherwise have been
shipped to Schering in accordance with the dates specified in the
applicable Order and that payment will be made to Bioject in
accordance with Section 3.7 as if such Products had been delivered
according to such Order. Bioject agrees to provide Schering with
invoices and any other information and documentation necessary to
effect the provisions of this Section.
3.5 Title; Loss. Legal title and risk of loss with respect
to Product and carbon dioxide cartridges sold hereunder by
Bioject shall pass to Schering [confidential portion omitted]
(as defined in ICC Incoterms 1990) [confidential portion omitted]
with Schering agreeing to pay all costs as specified in
Section 3.4(a).
3.6 Acceptance; Rejection
(a) If [confidential portion omitted] deems it appropriate,
[confidential portion omitted] may elect to [confidential
portion omitted] on new Products to determine compliance with the
[confidential portion omitted], other requirements of the
[confidential portion omitted] and of other relevant [confidential
portion omitted] in the Territory, and [confidential portion
omitted] of the Product pursuant to [confidential portion omitted].
If [confidential portion omitted] such [confidential portion
omitted], [confidential portion omitted] shall [confidential portion
omitted] in writing of the [confidential portion omitted] of
Products delivered by Bioject and the reasons therefor. However,
[confidential portion omitted] shall be under no obligation to
[confidential portion omitted], and the [confidential portion
omitted] shall have no consequences on [confidential portion
omitted] and [confidential portion omitted] under Sections 3.6(b)
through 3.6(e).
(b) If [confidential portion omitted] notifies [confidential
portion omitted] of [confidential portion omitted] of Products,
Bioject, within [confidential portion omitted] of receipt of the
notice, may have an [confidential portion omitted] the [confidential
portion omitted], either at [confidential portion omitted], at
[confidential portion omitted], or at a [confidential portion
omitted] (shipping charges, if any, to be borne by the nonprevailing
Party). If there is any dispute as to whether the [confidential
portion omitted] is acceptable, such dispute shall be resolved by
having a [confidential portion omitted] observe the performance of
the [confidential portion omitted] or [confidential portion
omitted], as the case may be, by [confidential portion omitted] and
vice versa. If the discrepancy in observations or results cannot be
resolved, then the [confidential portion omitted] or [confidential
portion omitted] shall be performed by an independent, mutually-
acceptable, qualified [confidential portion omitted] who will render
a decision [confidential portion omitted]. The costs of the
[confidential portion omitted] or [confidential portion omitted]
shall be borne by the [confidential portion omitted].
(c) Subject to the provisions contained in Section 3.6(b),
[confidential portion omitted] shall be returned to Bioject
or disposed of at the direction of Bioject, in either case at
the [confidential portion omitted].
(d) [confidential portion omitted] may be reworked by Bioject
unless reworking is prohibited in the [confidential portion omitted]
or by applicable regulations.
(e) Bioject shall have [confidential portion omitted] after
receipt of a [confidential portion omitted] from [confidential
portion omitted] and delivery of such [confidential portion omitted]
to [confidential portion omitted] to repair or replace such
[confidential portion omitted] at Bioject's expense.
3.7 Payments for Products. Except for the prepayments required by
Section 3.2(c), Schering shall pay for all Autoinjectors and
Syringes delivered by Bioject within [confidential portion omitted]
after the later of: (i) delivery of Products to the destination
specified in the Order as regards all Products shipped for a period
of [confidential portion omitted] after the first shipment of
Products; or (ii) the receipt by Schering of the related invoice.
Thereafter, except for prepayments required by Section 3.2(c),
Schering shall pay for all Autoinjectors and Syringes delivered by
Bioject within [confidential portion omitted] after the later of:
(i) delivery of Products to the destination specified in the Order;
or (ii) the receipt by Schering of the related invoice.
3.8 Currency. All payments payable under this Agreement
shall be paid in U.S. dollars in immediately available funds to
an account designated by Bioject.
3.9 Packaging and Labeling. Products shall be packaged by
Bioject with such labeling and packaging inserts as Schering
reasonably proposes and that comply with applicable regulatory
requirements. The cost of such packaging and labeling shall be
allocated between the Parties as follows:
(a) Schedule H describes the standard packaging and labeling
for Autoinjectors and Syringes that are sold for use in the
United States. Bioject will, at its expense, make any changes to
the standard packaging and labeling that are necessary to comply
with applicable FDA requirements.
(b) With respect to Products to be sold in the countries
specified in Schedule I, Bioject will, at its expense, include
the standard packaging and labeling (as described in Schedule H)
with all Autoinjectors and Syringes sold to Schering for use in
such countries, and Bioject will, at its expense, provide such
standard packaging and labeling in the language used in the
destination country, provided that Schering, at its expense,
translates the words on the packaging and labeling from English
into the applicable foreign language. If any change in packaging
or labeling is required by regulatory requirements in the
countries specified in Schedule I beyond the standard specified
immediately above, Schering will pay Bioject the [confidential
portion omitted] of the changed packaging and labeling [confidential
portion omitted] of the standard packaging and labeling that Bioject
would otherwise provide.
(c) With respect to Products to be sold in countries other than
the United States and the countries specified in Schedule I,
Schering will pay Bioject the [confidential portion omitted] to the
standard packaging or labeling that are required by language or
regulatory requirements in such countries [confidential portion
omitted] of standard packaging and labeling, including the inventory
costs of maintaining packaging and labeling in additional languages.
(d) Any "aesthetic" or non-required packaging and
labeling changes requested by Schering will be paid for
by Schering following agreement by the Parties as to
the amounts to be charged to Schering by Bioject.
3.10 Testing; Record Keeping; Inspection; Etc. Bioject will:
(i) initiate and maintain all legally required documents and
records including, without limitation, all manufacturing records,
quality control and stability records, for such periods as
required by the FDA or any other relevant regulatory authority;
(ii) promptly notify Schering if any material out-of-specification
value is found in the testing program, and reach agreement with
Schering concerning a course of action; (iii) furnish Schering with
copies of all such records at Schering's request; (iv) if reasonably
requested by Schering, [confidential portion omitted] of retained
samples of Products returned by customers to [confidential portion
omitted] with the [confidential portion omitted]; (v) at Schering's
option and upon reasonable notice to Bioject, allow [confidential
portion omitted] or [confidential portion omitted] to [confidential
portion omitted] the entire process of manufacture, testing and
packaging of each lot, or selected lots of Products; and (vi) store,
ship and dispose of all wastes generated as a result of its
manufacture of Products in accordance with all applicable laws and
regulations.
3.11 Recall Procedure; Complaints; Adverse Event Reporting; Etc.
(a) If Bioject learns of any information that might give rise
to a recall or market withdrawal of Products or which involves a
complaint about the quality of Products, then Bioject shall
promptly provide notice thereof to Schering. With respect to
Products, and as between Schering and Bioject, initiation of any
recall or market withdrawal, or any investigation of any Product
complaint with the FDA (or for foreign distribution, similar
reports to foreign regulatory authorities) shall be at the
direction of and under the responsibility of [confidential portion
omitted] and [confidential portion omitted] shall be responsible
for all interaction with the [confidential portion omitted] and
[confidential portion omitted]. [confidential portion omitted]
will provide to [confidential portion omitted], prior to
communicating with the [confidential portion omitted] or
[confidential portion omitted] concerning any recall, market
withdrawal or field alert report involving Products, copies of all
such communications, and shall otherwise generally keep
[confidential portion omitted] informed of any such action.
[confidential portion omitted] will cooperate with [confidential
portion omitted] regarding all recall and market withdrawal
activities and agrees to be [confidential portion omitted] for all
reasonable [confidential portion omitted](but not [confidential
portion omitted] personnel) [confidential portion omitted]
associated with any such recall or market withdrawal that is a
result of a defect in the Product.
(b) Each Party will notify the other Party promptly after
becoming aware of any adverse event or significant medical
complaint relating to the Product, providing appropriate contact
information to allow for follow-up by such other Party.
[confidential portion omitted] will have sole responsibility for
reporting to the FDA any adverse event, as required under applicable
FDA law and regulations, and for notifying any other regulatory
bodies or government entities of any adverse event, as required by
law, of which [confidential portion omitted] becomes aware.
(c) Each of the Parties will comply with all applicable
regulations regarding customer complaints and adverse events,
including record retention and follow-up. Each Party will notify
the other Party of customer complaints requiring action or
follow-up by the other Party and will make available a copy of
all records regarding such complaints. The Parties agree to more
fully define in a separate document or operating procedure how
customer complaints will be documented and administered.
3.12 Servicing, Refurbishing and Non-Warranty Repairs
(a) Bioject agrees to provide routine servicing of
Autoinjectors after purchase by the end user, at a price for each
routine servicing of sixty-five dollars ($65) plus shipping.
Routine servicing will consist of cleaning the exterior of the
Autoinjector, testing and inspection of the Autoinjector to
finished product release procedures, and adjusting the output
pressure if needed. If any repairs are needed in addition to the
specified servicing tasks, the repairs to the Autoinjector will
be provided pursuant to Section 3.12(c), excluding the charge for
handling and diagnosis. Autoinjectors that have received routine
servicing shall have the same warranty as a new Autoinjector,
except the warranty shall be for three (3) months instead of two
(2) years.
(b) Refurbishing is performed when an Autoinjector is
transferred from one user to another. Bioject agrees to
refurbish any Autoinjector that Schering returns to Bioject in
reasonable condition within [confidential portion omitted] after
purchase by the initial user at a price of [confidential portion
omitted] plus shipping. Refurbishing consists of removing all
plastic exterior parts, cleaning the Autoinjector, testing and
inspecting the Autoinjector to finished product release procedures,
adjusting the output pressure if needed, installing new plastic
exterior parts, and repacking the Autoinjector in new packaging.
Refurbishing shall be done in accordance with GMPs and other
applicable regulatory requirements in the Territory. If any
repairs are needed in addition to the tasks specified above, the
repairs to the Autoinjector will be provided pursuant to Section
3.12(c), excluding the charge for handling and diagnosis.
Refurbished Autoinjectors shall have the same warranty as a new
Autoinjector, except that the warranty shall be for [confidential
portion omitted] instead of [confidential portion omitted].
(c) If an Autoinjector needs repairs beyond the routine
servicing and refurbishing to be provided by Bioject pursuant to
Sections 3.12(a) and 3.12(b) and beyond Bioject's warranty
obligations under Section 3.14, Bioject will use its Best Efforts
to repair the Autoinjector. Repairs consist of diagnosis of the
problem, disassembly and replacement of parts, reassembly,
cleaning the exterior of the Autoinjector, testing and inspecting
the Autoinjector to finished product release procedures, and
adjusting the output pressure if needed. The price of repairs is
based on charges for handling and diagnosis, parts, labor and
shipping. The charge for handling and diagnosis is fifty dollars
($50). Repair parts are billed at the purchase price paid
by Bioject plus forty percent (40%). Repair labor is billed in
1/4 hour increments at the rate of forty-five dollars ($45)
per hour. Shipping is charged based on actual cost. Following
diagnosis, Bioject agrees to provide Schering with an estimate
of the cost of repairing the Autoinjector, and Bioject will not
proceed to repair the Autoinjector until Bioject receives
approval from Schering.
(d) At the commencement of the [confidential portion omitted]
Contract Year and annually thereafter, Bioject shall have the right
to increase the prices specified above to reflect increases in
Bioject's costs, with the increases to be no greater than the
increases in the [confidential portion omitted] (as published by
[confidential portion omitted], or its successor) since the
beginning of the prior Contract Year.
3.13 Loans
(a) Schering has provided, or shall provide, Bioject with a
loan for the purchase of (i) Syringe molds and (ii) tooling and
molds for Autoinjectors in accordance with Schedule G hereof.
Bioject hereby acknowledges receipt of $450,000 of such amount
prior to the date of this Agreement. Bioject will pay Schering
interest on all amounts loaned hereunder (including the $450,000
already loaned) at the prime rate established by Wells Fargo Bank
and in effect as of the date of this Agreement, plus [confidential
portion omitted]. The interest rate payable by Bioject will be
adjusted annually on the first day of each Contract Year during the
term of this loan and the unpaid balance of the loan will bear
interest at that adjusted rate until the first day of the next
Contract Year. Bioject will make an interest-only payment on the
first day of the first Contract Year and on the first day of the
second Contract Year. On the first day of the second Contract Year,
the interest rate on the loan will be adjusted as provided above,
and the loan will be amortized over a twenty-four (24) month period
at that interest rate. Bioject will make twelve (12) equal monthly
payments of principal and interest commencing one (1) month after
the second Contract Year begins. On the first day of the third
Contract Year, the interest rate on the loan will be adjusted to the
prime rate in effect on that day, plus [confidential portion
omitted], and the loan will be amortized over the twelve (12)
remaining months at that rate. Bioject will make twelve (12) equal
monthly payments of principal and interest commencing one (1) month
after the third Contract Year begins. The loan will be paid in full
on or before the date that the fourth Contract Year begins.
Notwithstanding the preceding, the term of the loan will be
extended to forty-two (42) months from the first day of the
second Contract Year if Schering [confidential portion omitted] in
[confidential portion omitted] pursuant to Section 2.3. In that
event, the applicable interest rate will be adjusted annually as
provided above, the amount of the monthly payments of principal and
interest will be recalculated annually to amortize the unpaid
principal balance over the remaining term of the loan as
extended, and the loan will be paid in full on or before the date
six months after the fifth Contract Year begins.
(b) At Schering's option, Schering may loan Bioject $1.2 million
to automate the manufacture of Syringes. Commencing one (1) year
after such loan is made, or such earlier time as the automation
equipment has been tested and accepted by Bioject and is fully
operational, the price Schering will pay for Syringes will be
reduced to the automated price specified in Schedule C.
Bioject will pay Schering interest on the amount advanced
hereunder at the prime rate of Wells Fargo Bank in effect as of
the date the loan is made, plus [confidential portion omitted].
Bioject will make an interest-only payment at that rate on the
first anniversary of the loan. The interest rate payable by
Bioject will be adjusted annually beginning on the first
anniversary of the loan and the unpaid balance of the loan will
bear interest at that adjusted rate until the next anniversary of
the loan. On the first anniversary of the date that the loan is
made, the interest rate on the loan will be adjusted as provided
above, and the loan will be amortized over a thirty-six (36)
month period at that interest rate. Bioject will make twelve
(12) equal monthly payments of principal and interest commencing
one (1) month after the first anniversary of the date of the
loan. On the second anniversary of the date of the loan, the
interest rate on the loan will be adjusted to the prime rate in
effect on that day, plus [confidential portion omitted], and the
loan will be amortized over the twenty-four (24) remaining months
at that rate. Bioject will make twelve (12) equal monthly
payments of principal and interest commencing one (1) month after
the second anniversary of the date of the loan. On the third
anniversary of the date of the loan, the interest rate on the
loan will be adjusted to the prime rate in effect on that day,
plus [confidential portion omitted], and the loan will be
amortized over the twelve (12) remaining months at that rate.
Bioject will make twelve (12) equal monthly payments of principal
and interest commencing one (1) month after the third anniversary
of the date of the loan. The loan will be paid in full on or
before the fourth anniversary of the date of the loan.
(c) Forgiveness of the unpaid balance of the loans made by
Schering under Sections 3.13(a) and (b), and conversion of such
unpaid balance into Common Stock of Bioject Medical Technologies
Inc. ("BMT"), shall be governed by Section 5.3(c)(ii) and
5.3(d)(ii), respectively.
(d) The loans made under Sections 3.13(a) and 3.13(b) shall be
secured by means of a lien on the equipment and tooling purchased
with the loans. The Security Agreement is attached at Schedule J.
(e) Bioject agrees to keep the loan proceeds in a segregated
bank account to be used only for purchases stated in
Sections 3.13(a) and (b) above and to obtain statements of
account for Schering at Schering's request.
(f) Bioject agrees to allow Schering the right to audit all
transactions relating to the loans (including purchases made with
the loans).
(g) Bioject may prepay the loans described in this Section at
any time without premium or penalty.
3.14 Customer and Product Warranties; Indemnification
(a) Bioject shall provide a Limited Product Warranty with all
new Autoinjectors substantially in the form attached as Schedule K.
Bioject agrees to provide the same warranty for Autoinjectors that
have been serviced pursuant to Section 3.12(a) and for Autoinjectors
that have been refurbished pursuant to Section 3.12(b) as for new
Autoinjectors, except that the warranty for serviced Autoinjectors
will be for three (3) months instead of two (2) years and the
warranty for refurbished Autoinjectors will be for [confidential
portion omitted] instead of [confidential portion omitted]. Unless
prohibited by applicable laws or regulations, at Schering's option,
Schering may provide a warranty to users instead of having Bioject
provide the Limited Product Warranty to users. In such event,
Bioject shall provide the Limited Product Warranty to Schering for
such periods as are specified in this Section 3.14(a). In no event
shall Bioject be liable to any users of the Product as a result of
any warranty given by Schering that exceeds the Limited Product
Warranty provided by Bioject.
(b) The Parties acknowledge that Bioject's warranties
with respect to the Product are contained in Section 3.3(a) of
this Agreement and in Section 10 of the Development and Licensing
Agreement and that such warranties are not limited by the time
period specified in Section 3.14(a) hereof. The Parties agree
that Section 10 of the Development and Licensing Agreement is
hereby incorporated by reference into this Agreement and that such
provisions also shall apply to Bioject's warranties in Section
3.3(a) of this Agreement.
(c) Bioject shall administer claims under the Limited Product
Warranty in the same manner it administers claims under the
Limited Product Warranty provided with its professional model
needle-free injectors. At Bioject's option, it may replace,
repair or refund to Schering the purchase price of Autoinjectors
returned to Bioject in accordance with the Limited Product
Warranty.
4. [confidential portion omitted] to [confidential portion omitted]
Products
4.1 [confidential portion omitted] to [confidential portion
omitted] Products
(a) At any time during the term of this Agreement when Bioject
is supplying Autoinjectors and Syringes to Schering on an
exclusive basis,
(i) if Bioject fails for any reason,
including by reason of an event specified in
Section 10.1 hereof, to supply Schering with
either Autoinjectors or Syringes in accordance
with Orders submitted by Schering pursuant to
Section 3, and such failure continues for
[confidential portion omitted], and the quantity
of Autoinjectors or Syringes, as the case may be,
that Bioject is able to ship during such period
averages less than [confidential portion omitted]
of the Orders for Autoinjectors or Syringes submitted
by Schering for shipment during such period; provided,
however, that any failure to supply Autoinjectors
or Syringes that is due to a force majeure event
such as described in Section 10.1 shall require
Schering to wait for [confidential portion omitted]
after cessation of the force majeure event before it may
calculate whether Bioject's shipments during the
[confidential portion omitted] period have averaged
less than [confidential portion omitted] of the Orders
submitted by Schering during the period; or
(ii) if Schering is entitled to terminate this
Agreement in accordance with Section 5.2(b) or
Section 5.2(c) hereof,
then Schering may elect, in lieu of terminating this Agreement,
to [confidential portion omitted] Autoinjectors or Syringes, as
the case may be. In such event, Bioject shall [confidential
portion omitted] Schering a [confidential portion omitted] and
[confidential portion omitted] Autoinjectors or Syringes, as the
case may be, and Bioject shall, subject to the provisions of
Section 4.3 hereof, provide to Schering all [confidential portion
omitted] necessary to [confidential portion omitted] Schering to
[confidential portion omitted] Autoinjectors or Syringes. The
[confidential portion omitted] and [confidential portion omitted]
which may be granted pursuant to this Section 4.1 shall include a
[confidential portion omitted] to an [confidential portion omitted]
or a [confidential portion omitted] reasonably satisfactory to
Bioject, subject to the confidentiality provisions of Section 6;
provided, that Schering shall be [confidential portion omitted]
for the compliance by such [confidential portion omitted] or
[confidential portion omitted] reasonably satisfactory to Bioject
with all applicable terms of this Agreement.
(b) If Schering is granted such [confidential portion omitted]
to [confidential portion omitted], it shall have the right, but
not the obligation, to [confidential portion omitted] Autoinjectors
or Syringes; and the failure of Schering to [confidential portion
omitted], or have [confidential portion omitted], such Autoinjectors
or Syringes shall not cause Schering to be in breach of any
obligation it may have under this Agreement absent bad faith or
willful misconduct.
(c) Schering's [confidential portion omitted] for Bioject's
failure to [confidential portion omitted] Products, absent bad
faith or willful misconduct by Bioject, are, at Schering's option,
to [confidential portion omitted] this Agreement under Section
[confidential portion omitted], whichever applies, or to
exercise the [confidential portion omitted] to [confidential
portion omitted] provided in this Section 4.
(d) If Schering is granted the [confidential portion omitted]
to [confidential portion omitted] hereunder, Bioject will be paid
a [confidential portion omitted] of [confidential portion omitted]
for each Autoinjector and [confidential portion omitted] for each
Syringe [confidential portion omitted] under such [confidential
portion omitted].
(e) Whether Schering's [confidential portion omitted] has been
triggered shall be determined only as of the last day of each month,
and, if Schering's [confidential portion omitted] hereunder has been
triggered, Schering must exercise its right within [confidential
portion omitted] of such determination. A failure to exercise its
right after a determination does not preclude Schering from
exercising its right after any subsequent determination.
(f) If Schering is granted the [confidential portion omitted] to
[confidential portion omitted] hereunder for Autoinjectors or
Syringes, or both, Schering shall be entitled to [confidential
portion omitted] from Bioject the [confidential portion omitted]
and [confidential portion omitted] by Bioject in its [confidential
portion omitted] of the Autoinjectors or Syringes, as the case may
be, for a [confidential portion omitted] equal to the [confidential
portion omitted] of such [confidential portion omitted], less the
amount of depreciation calculated using a [confidential portion
omitted]). The [confidential portion omitted] of the [confidential
portion omitted] payable by Schering to Bioject shall be applied
against any unpaid balances on the loans made by Schering under
Section 3.13. Schering shall pay Bioject any amount in excess of
the unpaid loan balances within [confidential portion omitted] days
after the amount has been determined. If, after application of
Schering's price of the equipment and molds, Bioject continues to
owe Schering on the loans made under Section 3.13, Bioject shall
pay such amount, together with interest at the rate then in effect,
in twelve (12) equal monthly payments commencing on the date such
determination has been made.
(g) If Schering is granted the [confidential portion omitted] to
[confidential portion omitted] hereunder, the restrictions contained
in Section 2.4 shall terminate at the [confidential portion omitted]
of [confidential portion omitted] during which Schering has not paid
to Bioject an amount equal to the [confidential portion omitted]
that would be payable to Bioject under Section 4.1(d) if
Autoinjectors or Syringes, as the case may be, were being
[confidential portion omitted] in amounts necessary for Schering to
maintain exclusivity pursuant to Section 2.3 for that Contract Year;
provided, however, that for [confidential portion omitted] after the
grant of the [confidential portion omitted] to [confidential portion
omitted] hereunder, [confidential portion omitted] shall not apply.
(h) If Schering is granted the [confidential portion omitted] to
[confidential portion omitted] hereunder, Schering shall pay for all
inventory of Products that it has ordered and Bioject has already
finished, and Schering shall have the option to purchase all
[confidential portion omitted] in the [confidential portion omitted]
of Autoinjectors or Syringes, as the case may be, at Bioject's cost.
(i) If Schering is granted the [confidential portion omitted] to
[confidential portion omitted] hereunder, the restrictions on
Schering specified in Section 10.13 shall immediately terminate.
4.2 [Confidential portion omitted] Duration
(a) Any [confidential portion omitted] and [confidential portion
omitted] which may be granted hereunder shall be perpetual and
non-cancelable by Bioject.
(b) If Schering shall choose to terminate any [confidential
portion omitted] and [confidential portion omitted] that may be
granted hereunder, Schering and any [confidential portion omitted]
used by Schering shall return the [confidential portion omitted] to
Bioject or otherwise dispose of such [confidential portion omitted]
as instructed by Bioject.
4.3 Disclosure of [confidential portion omitted] to Schering
(a) If Bioject grants a [confidential portion omitted] to Schering
to [confidential portion omitted] Autoinjectors or Syringes
hereunder, Bioject shall, at Schering's reasonable request,
[confidential portion omitted] and [confidential portion omitted] to
[confidential portion omitted] as shall be [confidential portion
omitted] by [confidential portion omitted] to Bioject any or all of
the [confidential portion omitted], including [confidential portion
omitted] and other [confidential portion omitted] thereof, necessary
to enable Schering, its [confidential portion omitted] or a
[confidential portion omitted], as the case may be, to achieve the
[confidential portion omitted] to [confidential portion omitted]
Autoinjectors or Syringes and to exercise its rights under said
[confidential portion omitted]. Bioject will make available, at
Schering's expense, such other resources, including [confidential
portion omitted], to enable Schering to achieve the [confidential
portion omitted] to [confidential portion omitted] Autoinjectors
or Syringes, as Schering shall reasonably request. Bioject will
also disclose or provide a [confidential portion omitted] of
[confidential portion omitted] to [confidential portion omitted]
to Schering if and to the extent Schering requires such
[confidential portion omitted] to complete any regulatory
requirements in any country.
(b) If Bioject files, or has filed against it, a petition under
applicable bankruptcy laws, or has a receiver appointed for its
assets, and Schering is not entitled to terminate this Agreement
under Section 5.2(b), Bioject shall, at Schering's reasonable
request, disclose to such Persons as shall be designated by
Schering to Bioject such information relative to the
[confidential portion omitted] as shall enable Schering or such
Person to prepare to [confidential portion omitted] Autoinjectors
and Syringes; provided, however, that such [confidential portion
omitted] may not commence unless and until Schering would be
entitled to terminate this Agreement in accordance with Section
5.2(b).
(c) Schering shall not disclose any Product [confidential portion
omitted] or [confidential portion omitted] disclosed to it pursuant
to this Section to any other Person, whether or not such Person is
an Affiliate of Schering, without the express permission of Bioject,
nor may Schering use any of such [confidential portion omitted]
except as expressly permitted by this Agreement.
4.4 Inspection Right. If Schering shall [confidential portion
omitted], or have [confidential portion omitted], any Autoinjector
or Syringe pursuant to Section 4.1(a), Bioject shall have the right,
at all reasonable times, to [confidential portion omitted] the
[confidential portion omitted], as well as the methods of
[confidential portion omitted] used by Schering or any [confidential
portion omitted] or [confidential portion omitted] engaged in
[confidential portion omitted] of Product pursuant to Section 4.1(a)
in order that Bioject may satisfy itself that the [confidential
portion omitted] meets its [confidential portion omitted].
4.5 Interim Production by Bioject. Schering may elect under
this Section 4 to [confidential portion omitted] both Autoinjectors
and Syringes or either Autoinjectors or Syringes. In the event that
Schering elects to [confidential portion omitted] only
Autoinjectors, then Bioject agrees to continue to [confidential
portion omitted] Syringes at the applicable price set forth in
Schedule C for the term of this Agreement, including the first
[confidential portion omitted] period specified in Section
5.3(b)(iv). Bioject shall have no obligation to continue
to [confidential portion omitted] Autoinjectors if Schering is
[confidential portion omitted] only Syringes under this Section 4.
5. Term; Renewal; Termination; Survival
5.1 Term. This Agreement shall continue in force until the
expiration of eight (8) years from the date of this Agreement.
At least [confidential portion omitted] before expiration of this
Agreement, Schering shall give notice to Bioject if Schering wishes
to renew the Agreement for an additional term of not less than
[confidential portion omitted] years. If Bioject also wishes to
renew this Agreement, the Parties shall forthwith enter into good
faith negotiations for an extension and to determine the terms of
the renewal. If agreement has not been reached by the expiration of
this Agreement, this Agreement shall expire with the consequences
specified in Sections 5.3(a) and 5.3(b). In addition, Schering
shall pay for all Products shipped to Schering pursuant to Orders
submitted in accordance with this Agreement.
5.2 Termination. This Agreement may be terminated prior to
its expiration as follows:
(a) at any time, by Schering or Bioject if the other Party
shall materially breach any of the terms, conditions and
agreements contained herein to be kept, observed, and performed
by it, and such breach is not governed by any other provision in
this Section 5.2, then the non-breaching Party may terminate this
Agreement at its option and without prejudice to any of its other
legal and equitable rights or remedies except as specifically
provided in this Agreement, by giving the Party which committed
the breach [confidential portion omitted] written notice,
particularly specifying the breach, unless the notified Party
within such [confidential portion omitted] shall have cured the
breach. The Parties agree that any delay of [confidential portion
omitted] or more by Bioject in delivering Products that have been
ordered by Schering in accordance with this Agreement shall
constitute a material breach of this Agreement; provided, however,
that deliveries scheduled for [confidential portion omitted] may be
delivered in [confidential portion omitted] without being deemed
late. In calculating the length of any delivery delay, shipments
shall be deemed to satisfy the oldest unsatisfied Order. The
consequences of a termination of this Agreement by Bioject pursuant
to this Section are specified in Sections 5.3(a), 5.3(b) and 5.3(c).
The consequences of a termination of this Agreement by Schering
pursuant to this Section are specified in Sections 5.3(a), 5.3(b)
and 5.3(e). The Parties agree that, absent bad faith or willful
misconduct by Schering, a failure by Schering to order the required
minimums shall not constitute a breach of this Agreement (and the
consequences of any such failure are specified in Section
2.3(c)).
(b) at any time, if any assignment shall be made by either
Party for the benefit of creditors, or if a receiver, trustee in
bankruptcy or similar officer shall be appointed to take charge
of all of the property of either Party, or if either Party files
a voluntary petition under applicable bankruptcy laws or such a
petition is filed against either Party and is not dismissed
within sixty (60) days, the other Party may immediately terminate
this Agreement by giving written notice of termination.
Notwithstanding the foregoing, the Parties agree that, if Bioject
files, or has filed against it, a petition under applicable
bankruptcy laws, or has a receiver appointed for its assets, this
Agreement will not be terminated under this Section so long as
Bioject continues to meet its obligations to supply Products
hereunder, but that the provisions of Section 4.3(b) will then
apply. The consequences of a termination of this Agreement by
Bioject pursuant to this Section are specified in
Sections 5.3(a), 5.3(b) and 5.3(c). The consequences of a
termination of this Agreement by Schering pursuant to this
Section are specified in Sections 5.3(a), 5.3(b) and 5.3(e).
(c) at any time by Schering if there shall be a change of
control of Bioject and Bioject has not taken the lawful actions
necessary or appropriate to ensure that this Agreement remains a
binding and enforceable obligation of Bioject or, if applicable,
Bioject's successor. Change of control shall be deemed to
include the transfer of substantially all of the assets of
Bioject, or the merger of Bioject with one or more other Persons
(except a merger in which the shareholders of Bioject prior to
the merger constitute the holders of a majority of the capital
stock of the surviving entity following the merger). The
consequences of a termination of this Agreement pursuant to this
Section are specified in Sections 5.3(a), 5.3(b) and 5.3(e).
(d) upon [confidential portion omitted] written notice:
(i) prior to Schering's [confidential portion omitted]
to [confidential portion omitted], by Schering if the
[confidential portion omitted] shows results which are
reasonably considered unfavorable by Schering, whether the
problems are [confidential portion omitted] or [confidential
portion omitted]--any termination by Schering under this
subsection shall have the consequences specified in
Sections 5.3(a), 5.3(b) and 5.3(d);
(ii) by Schering, if [confidential portion omitted]
to [confidential portion omitted] Products has not
been received in at least [confidential portion
omitted] (as defined in Section 1.19 or 1.27, as
applicable) by such date as Schering deems appropriate;
or, after [confidential portion omitted], by Bioject, if
[confidential portion omitted] to [confidential portion
omitted] Products has not been received in at least
[confidential portion omitted] (as defined in Section
1.19 or 1.27, as applicable). If the reason for the
failure to receive such [confidential portion omitted]
is [confidential portion omitted] in both Territories,
a termination under this subsection shall have the
consequences specified in Sections 5.3(a), 5.3(b) and
5.3(d). If the reason for the failure to receive such
[confidential portion omitted] is [confidential portion
omitted] in either of the Territories, a termination under
this section shall have the consequences specified in
Sections 5.3(a), 5.3(b) and 5.3(e);
(iii) by Schering, whether or not regulatory approval
has been obtained to market the Product, if Schering
receives any information that reasonably leads it to
believe that Approved IFN-Beta cannot [confidential
portion omitted] or [confidential portion omitted]
by the [confidential portion omitted] (i.e., a
[confidential portion omitted] problem)--any termination
under this subsection shall have the consequences
specified in Sections 5.3(a), 5.3(b) and 5.3(d);
(iv) by either Party, whether or not regulatory
approval has been received to market the Product
(except that Schering may not terminate this Agreement
under this subsection (iv) based on information from the
[confidential portion omitted]), if [confidential
portion omitted] or [confidential portion omitted]
(as described in 21 CFR [confidential portion omitted]
et seq) have developed with respect to the Product
which limit Schering's ability to sell the Product
(i.e., a [confidential portion omitted] problem)--any
termination under this subsection shall have the
consequences specified in Sections 5.3(a), 5.3(b)
and 5.3(e); or
(v) by Schering, if the FDA or any regulatory
authority in a country marked with an asterisk
on Schedule I requests a [confidential portion
omitted] beyond the [confidential portion
omitted]--any termination under this subsection
shall have the consequences specified in Sections
5.3(a), 5.3(b) and 5.3(d).
Notwithstanding the foregoing, a Party wishing to
terminate under subsection (iii) or (iv) of this
Section 5.2(d) must have used its good faith efforts
for at least [confidential portion omitted] to resolve
the problem prior to giving notice to terminate under such
subsection.
(e) by Schering, upon [confidential portion omitted]
notice, upon the occurrence of any condition specified
in Section 4.1(a)(i), which condition continues for a
period of [confidential portion omitted], during which
Schering is not able to cause any [confidential portion
omitted] reasonably acceptable to Bioject to commence
performing Bioject's [confidential portion omitted]
pursuant to this Agreement, and Bioject and Schering
are not able to agree upon a date by which Bioject
shall resume [confidential portion omitted] the
Autoinjector or Syringe, as the case may be. The
consequences of a termination of this Agreement pursuant
to this Section are specified in Sections 5.3(a), 5.3(b)
and 5.3(e).
(f) automatically, if the Development and Licensing Agreement
terminates or expires in accordance with its terms. The
consequences of an automatic termination of this Agreement upon
the termination of the Development and Licensing Agreement are
specified in Sections 5.3(a) and 5.3(b). If the termination is
pursuant to Section 12.1 of the Development and Licensing
Agreement, Section 5.3(c) hereof also will apply. If the
termination is pursuant to Section 12.2 of the Development and
Licensing Agreement, Section 5.3(d) hereof also will apply. If
the termination is pursuant to Section 12.9 of the Development
and Licensing Agreement, Section 5.3(e) hereof also will apply.
If the termination is pursuant to Section 12.10 of the
Development and Licensing Agreement, and Bioject is the breaching
Party, Section 5.3(e) hereof also will apply, and, if Schering is
the breaching Party, Section 5.3(c) also will apply.
5.3 Effect of Termination
(a) Except as otherwise provided in Section 6 or this Section
5.3, expiration or termination of this Agreement shall result in
the termination of all provisions hereof, including, without
limitation, the purchase, order and supply obligations herein
contained.
(b) The following provisions shall apply to the expiration or
termination of this Agreement for any reason:
(i) Except as necessary to enable Schering or
an agent to [confidential portion omitted]
Autoinjectors or Syringes pursuant to Section
4.2(a), Schering shall return to Bioject the
[confidential portion omitted], if any, in its
possession, or otherwise dispose of such
[confidential portion omitted] as instructed by Bioject.
(ii) Schering shall have the right to complete
the sale of its inventory of Products in the
Territory; provided that Schering's obligations
hereunder to comply with the provisions of Sections
2 and 3 in connection with such completion of sale
shall remain in effect; and provided further, that
if requested by Bioject, Schering shall
[confidential portion omitted] with Bioject for
the sale of Schering's [confidential portion omitted]
to Bioject on [confidential portion omitted] by
the Parties at such time.
(iii) Neither Party shall have liability
to the other Party for damages of any kind solely
as a result of the fact of such expiration or
termination, whether on account of the loss by
Schering of present or prospective sales,
investments or goodwill arising solely from
statutes that relate to termination of
distributors or licensees, and each Party hereby
waives any rights which may be granted to it by
such statutes. The remedies for termination of
this Agreement or breach of any provision of this
Agreement shall be as specified in this Agreement,
and, absent bad faith and willful misconduct, such
remedies are the Parties' exclusive remedies. In
the event of bad faith or willful misconduct, the
non-breaching Party may pursue other legal
remedies again the other Party including, without
limitation, monetary damages for breach of
contract. In no event shall either Party be
liable to the other Party for indirect, incidental
or consequential damages.
(iv) For [confidential portion omitted] following
expiration or termination of this Agreement,
Bioject will use its [confidential portion omitted]
to sell to Schering on a non-exclusive basis such
Syringes as Schering shall order, with the Syringes to
be sold to Schering at the applicable Syringe price
specified on Schedule C. At any time before the
end of such [confidential portion omitted], if the Parties
agree, Bioject may provide a license, in exchange
for a [confidential portion omitted] acceptable to Bioject,
to any [confidential portion omitted] reasonably
satisfactory to Schering (or to Schering, if Schering so
agrees) to [confidential portion omitted] of Syringes as
Schering shall require. During the following [confidential
portion omitted], if Schering wants additional Syringes,
Bioject will use its [confidential portion omitted] to
provide a [confidential portion omitted], in exchange
for a [confidential portion omitted] acceptable to Bioject,
to a [confidential portion omitted] (or to Schering, if
Schering so agrees) to [confidential portion omitted]
such additional Syringes.
(v) For [confidential portion omitted] following
expiration or termination of this Agreement,
Bioject will use its [confidential portion omitted] to
sell to Schering on a non-exclusive basis such
Autoinjectors as Schering shall order, with the
Autoinjectors to be sold to Schering at [confidential
portion omitted] the Autoinjectors, as determined by
applying [confidential portion omitted].
(vi) Schering shall pay to Bioject all applicable
[confidential portion omitted] as specified in
Section 4.1(d).
(c) Certain terminations, as specified in the various
subsections of Section 5.2, result in the following consequences
in addition to those specified in Sections 5.3(a) and 5.3(b):
(i) Schering shall be liable for the
purchase price, less any prepayments made pursuant
to Section 3.2(c), of all Products that Schering
has ordered and that have been completed prior to
the date of termination, and shall be liable to
Bioject for all costs Bioject has incurred, but
not to exceed the applicable purchase price, with
respect to Products ordered by Schering that are
being manufactured (but are not completed) by the
date of termination.
(ii) All unpaid principal and interest
on loans made by Schering under Sections 3.13(a)
and (b) (including the $450,000 loaned prior to the
date of this Agreement) shall be forgiven immediately.
(iii) The restrictions on Bioject specified in Section
2.4 shall immediately terminate.
(iv) The restrictions on Schering specified in
Section 10.13 shall apply for [confidential portion
omitted] after termination or until [confidential
portion omitted], whichever occurs earlier.
(d) Certain terminations, as specified in the various
subsections of Section 5.2, result in the following consequences
in addition to those specified in Sections 5.3(a) and 5.3(b):
(i) Schering shall be liable for the
purchase price, less any prepayments made pursuant
to Section 3.2(c), of all Products that Schering
has ordered and that have been completed prior to
the date of termination, and shall be liable to
Bioject for all costs Bioject has incurred, but
not to exceed the applicable purchase price, with
respect to Products ordered by Schering that are
being manufactured (but are not completed) by the
date of termination.
(ii) All unpaid principal and interest
on loans made by Schering under Sections 3.13(a)
and (b) (including the $450,000 loaned prior to the
date of this Agreement) shall be converted into Common
Stock of BMT pursuant to Section 11 of the Development
and Licensing Agreement as though the unpaid principal
and interest were license or development fees, except
that the price at which shares of Common Stock shall be
deliverable upon conversion of the unpaid principal and
interest shall be the greater of: (a) three dollars fifty
cents ($3.50) per share of Common Stock; or
(b) one hundred percent (100%) of the thirty (30)-
calendar-day average of the average of the closing
bid and asked prices for shares of Common Stock
for the period ending on the date on which the
conversion shall be deemed to have occurred
(determined pursuant to Section 11.3 of the
Development and Licensing Agreement), as such
prices are quoted on NASDAQ. The foregoing
conversion price shall be subject to adjustment
pursuant to Section 11.5 of the Development and
Licensing Agreement.
(iii) Bioject agrees not to [confidential portion omitted]
the Autoinjector in [confidential portion omitted] to any
[confidential portion omitted] other than Schering for
[confidential portion omitted] after termination or
until [confidential portion omitted], whichever occurs earlier.
(e) Certain terminations, as specified in the various
subsections of Section 5.2, result in the following consequences
in addition to those specified in Sections 5.3(a) and 5.3(b):
(i) Bioject shall continue to be liable for
repayment of the loans under Section 3.13 hereof
(including the $450,000 advanced before the date of
this Agreement) in accordance with the provisions of
Section 3.13.
(ii) Schering will not be required to accept
shipment of, or pay for, any Products it receives
after termination.
(iii) Bioject agrees not to [confidential portion omitted]
the Autoinjector in [confidential portion omitted] to any
[confidential portion omitted] other than Schering for
[confidential portion omitted] after termination or until
[confidential portion omitted], whichever occurs earlier.
6. Confidentiality
6.1 Confidentiality Except as expressly permitted in this
Section 6.1, Schering shall maintain the confidentiality of all
[confidential portion omitted] and not disclose any such
[confidential portion omitted] to any person (including its own
employees and agents), other than persons who have agreed,
prior to such disclosure, to protect the confidentiality of
such information, and shall hold the same in confidence and
shall use the same only for the purposes specified herein.
Notwithstanding anything in this Agreement to the contrary,
Schering may disclose such [confidential portion omitted] to
[confidential portion omitted] or [confidential portion omitted]
on a confidential basis to the extent necessary to enable them to
[confidential portion omitted] and [confidential portion omitted]
their [confidential portion omitted] in the Territory; provided,
however, that Schering shall be responsible for any failure by
any such [confidential portion omitted] or [confidential portion
omitted] to: (i) maintain the confidentially of such information
(except as provided in Section 6.2); (ii) use it only for the
purposes specified herein; and (iii) disclose it only to
employees who need to know such information for such purposes
and who are bound by obligations substantially similar to those
in this Section prior to such disclosure. This Section 6 shall
survive expiration or termination of this Agreement for any reason.
6.2 Exceptions
(a) The obligations of confidentiality and restrictions on use
imposed upon Schering by Section 6.1 shall not apply to any
[confidential portion omitted] that was: (i) required to be
disclosed by law, government order, or judicial decree; or
(ii) in the public domain before the date of this Agreement or
subsequently came into the public domain other than through any
disclosure or delivery thereof by Schering; or (iii) lawfully
received by Schering without an obligation of confidentiality
from a source other than Bioject; or (iv) disclosed with the
prior written approval of Bioject; or (v) independently developed
by Schering.
(b) Notwithstanding anything to the contrary contained in this
Agreement, Schering and its [confidential portion omitted] and
[confidential portion omitted] may disclose or deliver any
[confidential portion omitted] to any [confidential portion
omitted] or [confidential portion omitted] to the extent that
such disclosure or delivery is necessary for compliance with
any law or regulation in the Territory.
6.3 IFN-Beta Information Disclosed to Bioject. Bioject shall be
obligated to maintain the confidentiality of any IFN-Beta
information owned or developed by Schering and disclosed
or delivered to Bioject by Schering to the same extent that
Schering is obligated to maintain the confidentiality of
[confidential portion omitted] pursuant to Section 6.1, except that
Bioject may share information on adverse events with [confidential
portion omitted] or other [confidential portion omitted]. Such
obligation on the part of Bioject shall be subject to the same
exceptions and conditions that are applicable to Schering's
maintenance of the confidentiality of [confidential portion omitted]
pursuant to Section 6.2.
7. Regulatory
7.1 (a) As the [confidential portion omitted] of the Product,
[confidential portion omitted] agrees to be responsible for
obtaining and maintaining [confidential portion omitted] and
[confidential portion omitted] in the countries listed in Schedule
I. If the Product needs to be [confidential portion omitted] to
obtain [confidential portion omitted] and [confidential portion
omitted] in the countries [confidential portion omitted] on Schedule
I or [confidential portion omitted], Bioject will [confidential
portion omitted] of making such [confidential portion omitted].
If the Product needs to be [confidential portion omitted] to obtain
[confidential portion omitted] and [confidential portion omitted]
in any country listed on Schedule I that is [confidential portion
omitted], Bioject and Schering will [confidential portion omitted]
the cost of making such [confidential portion omitted]. If
[confidential portion omitted] to [confidential portion omitted] and
[confidential portion omitted] outside the [confidential portion
omitted] and the [confidential portion omitted], Schering will
[confidential portion omitted] of obtaining such [confidential
portion omitted] and [confidential portion omitted] (including the
[confidential portion omitted] of making any required changes to the
Product to obtain such [confidential portion omitted]). Bioject
agrees to supply Schering with copies of any and all approvals and
correspondence relating to [confidential portion omitted] and
[confidential portion omitted] for which it is responsible.
(a) [confidential portion omitted] shall be responsible for
obtaining and maintaining [confidential portion omitted] to
[confidential portion omitted] in the United States. [Confidential
portion omitted] agrees to supply [confidential portion omitted]
with copies of any and all approvals and correspondence relating to
the [confidential portion omitted] with the [confidential portion
omitted] relating to the Product. Schering further agrees to supply
Bioject with copies of any and all correspondence and other
information emanating from the [confidential portion omitted]
relating to [confidential portion omitted] for the Product.
7.2 Bioject agrees to inform Schering immediately of any
regulatory action or activity (including investigations and
inspections) taken against Bioject by the FDA or any other
regulatory agency regarding the Product. Schering agrees to
inform Bioject immediately of any formal regulatory action or
activity taken against Schering or its suppliers by the FDA or
any other regulatory agency regarding Approved IFN-Beta or any
other medication for which Products are being distributed by
Schering, if such action is related to the Product or the
Product's performance with the medication. The Parties agree to
cooperate with each other in responding to any regulatory action
or activity relating to the Product.
8. Development and Licensing Agreement
8.1 The Parties hereby agree that with the execution of
this Agreement they shall be deemed to have satisfied and
fulfilled the requirements of Section 4 of the Development and
Licensing Agreement.
8.2 The Parties further agree that this Agreement shall
modify the Development and Licensing Agreement as follows:
(a) The following sections of the Development and Licensing
Agreement are hereby replaced by the specified provisions of this
Agreement, and the references to "this Agreement" in the
specified sections of this Agreement are hereby deemed to be
references to "the Development and Licensing Agreement" when such
sections are used as replacement sections in the Development and
Licensing Agreement: (i) Section 2.4 of this Agreement shall
replace Sections 3.1(c) through 3.1(g) of the Development and
Licensing Agreement; (ii) Section 10.13 of this Agreement shall
replace Section 2.4 of the Development and Licensing Agreement;
and (iii) Section 5.1 of this Agreement shall replace Sections
3.2 and 12.12 of the Development and Licensing Agreement, and the
effect of the expiration of the Development and Licensing
Agreement shall be as specified in Section 12.13 thereof.
(b) Sections 12.3 through 12.8 and 12.11 of the Development and
Licensing Agreement are hereby deleted.
(c) A new Section 12.15 is hereby added to the Development and
Licensing Agreement, which shall read as follows: "This
Agreement shall automatically terminate upon the expiration or
termination of the Supply Agreement. The effect of such
termination shall be as specified in paragraph 12.13 of the
Development and Licensing Agreement."
(d) All references in the Development and Licensing Agreement
to "First License Term" and [confidential portion omitted] shall
be interpreted as being coexistent with the term of this Agreement,
including all renewals hereof.
9. Compliance with Regulations
9.1 Each Party will comply with, and cause any of their
Affiliates performing any of their respective rights or
obligations hereunder to comply with, all laws and regulations
applicable to such rights and obligations.
9.2 Each Party agrees to comply with the United States
Export Administration regulations applicable to such Party in
effect from time to time, including the obtaining of any export
licenses necessary for the sale and distribution of Products
outside of the United States.
9.3 This Agreement is expressly made subject to any laws,
regulations, orders or other restrictions on the export of
technical data or technology which may be imposed from time to
time by the government of the United States or any other
government within the Territory.
10. Miscellaneous
10.1 Force Majeure. If either Party is prevented from
performing, or is unable to perform, any of its obligations under
this Agreement, due to any act of God, fire, casualty, flood,
war, strike, lock out, failure of public utilities, injunction or
any act, exercise, [confidential portion omitted], [confidential
portion omitted], epidemic, destruction of production facilities,
insurrection, inability to procure energy sufficient to meet its
production or performance needs, inability to procure important
materials, equipment or transportation to enable it to meet its
production or performance needs but only if such inability is due
to a Third Party's force majeure, or any other cause beyond the
reasonable control of the Party invoking this provision, and if
such Party shall have used its Best Efforts to avoid such
occurrence and minimize its duration and has given prompt written
notice to the other Party, then the affected Party's performance
shall be excused and the time for performance shall be extended
for the period of delay or ability to perform due to such
occurrence, provided, that, without the consent of the other
Party, no such extension shall exceed [confidential portion omitted]
nor shall cumulative extensions hereunder exceed [confidential
portion omitted].
10.2 Notices
(a) All notices to Bioject other than routine correspondence
relating to purchase orders, forecasts, and revisions shall be
addressed to:
Bioject Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Attention: Chairman
with a copy addressed to:
Tonkon, Torp, Galen,
Marmaduke & Booth
Attorneys at Law
1600 Pioneer Tower
888 S.W. Fifth Avenue
Portland, Oregon 97204-2099
Attention: Carol Dey Hibbs
Purchase orders, forecasts, revisions and routine
correspondence relating thereto shall be addressed to:
Bioject Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Attention: Chief Financial Officer
(b) All notices to Schering other than routine correspondence
relating to purchase orders, forecasts, and revisions shall be
addressed to:
Schering Aktiengesellschaft
Mullerstrasse 170-178
13353 Berlin, Germany
Attention: Rechtsabteilung
with copies addressed to:
Schering Berlin Inc.
110 East Hanover Avenue
Cedar Knolls, New Jersey 07927
Attention: Vice President, Law & Secretary
Schering Berlin Venture Corp.
110 East Hanover Avenue
Cedar Knolls, New Jersey 07927
Attention: President
Berlex Biosciences
15049 San Pablo Avenue
Richmond, California 94804
Attention: Executive Director and General Counsel
Routine correspondence relating to purchase orders, forecasts, invoices and
revisions shall be addressed to:
Schering Aktiengesellschaft
Mullerstrasse 170-178
13353 Berlin, Germany
Attention: FB Einkauf
with a copy addressed to:
Berlex Laboratories, Inc.
300 Fairfield Road
Wayne, New Jersey 07470-7358
Attention: Purchasing Manager
(c) Notice shall be deemed effective upon the earlier of actual
receipt, or the third business day following the date deposited
with a reputable overnight courier. All notices given hereunder
shall be in writing.
10.3 Assignment. Neither this Agreement nor any rights granted
hereby may be assigned by either Party voluntarily or by
operation of law, without the other Party's prior written
consent; provided, however, that either Party may assign this
Agreement without the consent of the other Party: (i) to its
Affiliates, if the assigning Party guarantees the full
performance of its Affiliates' obligations hereunder; or (ii) to
a Third Party purchasing substantially all the assets or voting
stock of the assigning Party, if such Third Party agrees to be
bound by this Agreement. In addition, Schering may assign
certain rights and obligations to Approved Sublicensees according
to the provisions of this Agreement. Any attempted assignment in
contravention of this Section 10.3 shall be null and void.
10.4 Governing Law. This Agreement shall be governed by and
construed under the laws of the state of Oregon without regard to
choice-of-law principles of that state. In no event will this
Agreement be interpreted in accordance with the Convention for
the International Sale of Goods. Both Parties agree that any
litigation arising out of this Agreement shall be heard in
Portland, Oregon unless they shall agree otherwise.
10.5 Entire Agreement; Amendment. This Agreement and the
Development and Licensing Agreement constitute the entire
agreement between the Parties. No waiver, consent, modification
or change of terms of this Agreement shall bind either Party
unless in a writing signed by both Parties, and then such waiver,
consent, modification or change shall be effective only in the
specific instance and for the specific purpose given. All
amendments shall be in a writing signed by both Parties. There
are no understandings, agreements, representations or warranties,
express or implied, not specified herein or in the Development
and Licensing Agreement regarding this Agreement or the subject
matter thereof.
10.6 Independent Contractors. No agency, partnership or joint
venture is hereby established. Neither Party shall be
responsible for the acts or omissions of the other Party.
Neither Schering nor Bioject shall enter into, or incur, or hold
itself out to Third Parties as having authority to enter into or
incur on behalf of the other Party any contractual obligations,
expenses or liabilities whatsoever.
10.7 Counterparts. This Agreement may be executed simultaneously
in several counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the
same instrument.
10.8 Severability
(a) In the event any portion of this Agreement shall be held
illegal, void or ineffective, the remaining portions hereof shall
remain in full force and effect.
(b) If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such
terms or provisions shall be deemed inoperative to the extent
that they may conflict therewith and shall be deemed to be
modified to conform with such statute or rule of law.
10.9 Headings. Section and paragraph headings contained in this
Agreement are included for convenience only and form no part of
the agreement between the Parties.
10.10 Publicity
(a) Except as required by or advisable under law, governmental
regulation or judicial order, neither Party shall directly or
indirectly make any public announcement or publicity concerning
this Agreement or the subject matter hereof without the prior
written consent of the other Party and agreement upon the nature,
text and timing of such announcement, which approval and
agreement shall not be unreasonably withheld. Such approval and
agreement shall be deemed to be given if no response is given to
the other Party within two working days of receipt of the
proposed text from the Party intending to make such announcement.
(b) Bioject hereby acknowledges that Schering is restricted in
the use of the Schering name in the United States and Canada.
10.11 Waiver. The waiver by either Party of a breach or a default
of any provisions of this Agreement by the other Party shall not
be construed as a waiver of any succeeding breach of the same or
any other provisions, nor shall any delay or omission on the part
of either Party to exercise or avail itself of any right, power
or privilege that it has, or may have hereunder, operate as a
waiver of any right, power or privilege by such Party.
10.12 Superiority of Agreement. The parties agree that the
provisions of this Agreement and of the Development and Licensing
Agreement, together with any amendments or other changes approved
by both Parties in writing hereto or thereto, shall prevail over
any inconsistent statements or provisions contained in any
documents passing between the parties, including, but not limited
to, any purchase order, acknowledgment, confirmation, or notice.
10.13 [confidential portion omitted] to [confidential portion
omitted].
(a) Nothing in this Agreement or the Development and Licensing
Agreement shall be construed as [confidential portion omitted] or
[confidential portion omitted] from [confidential portion omitted]
or [confidential portion omitted] and [confidential portion omitted]
any [confidential portion omitted], for use in [confidential portion
omitted], except that, during any [confidential portion omitted]
under this Agreement, [confidential portion omitted] shall not,
without the prior written consent of [confidential portion omitted],
[confidential portion omitted] or [confidential portion omitted]
for [confidential portion omitted] in [confidential portion
omitted], or contract with a [confidential portion omitted] to do
so. [confidential portion omitted] cannot withhold consent, if
[confidential portion omitted] has given [confidential portion
omitted] the opportunity to [confidential portion omitted] to
[confidential portion omitted] outlining the terms under which
[confidential portion omitted] would be willing to [confidential
portion omitted] the [confidential portion omitted] and
[confidential portion omitted] has [confidential portion omitted] in
[confidential portion omitted] the [confidential portion omitted]
presented by [confidential portion omitted]. If, after [confidential
portion omitted] and [confidential portion omitted] the
[confidential portion omitted] in [confidential portion omitted],
[confidential portion omitted] begins to [confidential portion
omitted] for [confidential portion omitted] in [confidential portion
omitted], or contracts with [confidential portion omitted] to do so,
then the [confidential portion omitted] on [confidential portion
omitted] contained in Section [confidential portion omitted] shall
[confidential portion omitted].
(b) In addition, during any [confidential portion omitted],
[confidential portion omitted] agrees that, if it is [confidential
portion omitted] or [confidential portion omitted] for the
[confidential portion omitted] or [confidential portion omitted] of
[confidential portion omitted] or [confidential portion omitted] for
the [confidential portion omitted] of [confidential portion omitted]
that are not within [confidential portion omitted], it will promptly
discuss the proposed activity with [confidential portion omitted]
and give [confidential portion omitted] the opportunity to
[confidential portion omitted] to [confidential portion omitted]
outlining the terms under which [confidential portion omitted] would
be willing to [confidential portion omitted] the [confidential
portion omitted] and that [confidential portion omitted] will
[confidential portion omitted] in [confidential portion omitted] any
[confidential portion omitted] presented by [confidential portion
omitted].
(c) The Parties agree that the [confidential portion omitted] in
this Section 10.13 shall not apply at any time when [confidential
portion omitted] has been [confidential portion omitted] the
[confidential portion omitted] Autoinjectors or Syringes pursuant
to the [confidential portion omitted] that may be [confidential
portion omitted] pursuant to Section [confidential portion omitted]
of this Agreement, or with respect to any [confidential portion
omitted] in which [confidential portion omitted] has [confidential
portion omitted], or at any time when the restrictions on Bioject
contained in Section [confidential portion omitted] have
[confidential portion omitted] under Section 10.13(a).
IN WITNESS WHEREOF, this Agreement has been duly executed as a
sealed instrument effective as of the date specified above.
BIOJECT INC. SCHERING AKTIENGESELLSCHAFT
By: /S/ JAMES O'SHEA By: /S/ X
/S/ Y
Title: Chairman Title: Head Rep. Europe
Member of Board of Directors
Date: 6/18/96 Date: 25/6/96 26/6/96
-------------------------------
<PAGE>
Schedule A
(Description of Product)
Autoinjector
A portable, CO(2) powered reusable device (designed to
Schering specifications under terms of the Development and Licensing
Agreement dated March 28, 1994) which when combined with a [confidential
portion omitted] disposable syringe is capable of administering needle-free
subcutaneous injections. (See Drawing A)
Syringe
A [confidential portion omitted] disposable container (designed to Schering
specifications under terms of the Development and Licensing
Agreement dated March 28, 1994) having a plunger at one end and a
very small orifice at the other end through which medication is
rapidly expelled. The Syringe, before use, comes affixed with a
[confidential portion omitted], both of which are [confidential
portion omitted] by a [confidential portion omitted] and
[confidential portion omitted] with a [confidential portion
omitted] and all of which are [confidential portion omitted]
using [confidential portion omitted]. (See Drawing B)
[confidential portion omitted]
A [confidential portion omitted] which can be [confidential portion omitted]
to the [confidential portion omitted] of the [confidential portion omitted]
and is used for [confidential portion omitted] into the [confidential
portion omitted] from [confidential portion omitted].
Nothing in the above descriptions or attached drawings is intended to modify
or supersede Product Specifications as set forth in Schedule B.
DRAWING A: The graphic shows a detailed drawing of the Autoinjector to be
produced for Schering for use with the drug Betaseron.
DRAWING B: The graphic shows the components of the syringe which are used by
an individual to prepare the Betaseron for injection. The drawing further
specifies which of the components are supplied by Bioject and which are to be
supplied by the individual.
<PAGE>
Schedule B
BIOJECT
BETASERON INJECTION DEVICE
(BID)
PRODUCT SPECIFICATION
Draft Rev. 1.5
[confidential portion omitted]
Approvals:
Berlex Laboratories /S/ Klaus Marten 12-May-95
Klaus Marten Date
Bioject Inc. /S/ Richard R. Stout May 12, 1995
Richard R. Stout, MD Date
<PAGE>
1. PURPOSE
This specification defines the design requirements for a
Berlex/Schering Betaseron Injection Device (BID). The
specification is intended for [confidential portion omitted].
The preliminary product external specifications (Schedule A of
the Development and licensing Agreement) remain in effect except
when specifically addressed and stated in this specification.
2. SYSTEM DESCRIPTION
The BID is a needle-free delivery system capable of
administering Betaseron subcutaneously in an accurate and
easy operation by the Multiple Sclerosis (MS) patient.
The system will be comprised of reusable and disposable
elements. The reusable element is the injector. The
disposable elements are the syringe, the [confidential portion
omitted], and the syringe cap.
The BID system is for MS patients undergoing Betaseron
treatment and is designed to make self-administration easier
and safer. With the BID syringe and [confidential portion omitted],
the reconstitution of the drug is accomplished by drawing 1.2 ml of
Diluent [confidential portion omitted] and then injecting the Diluent
into the Betaseron vial. After the white cake of the Betaseron is
completely dissolved, the volume, up to 1.0 ml, is drawn back
[confidential portion omitted]. The [confidential portion omitted]
is removed [confidential portion omitted] and the [confidential portion
omitted] is installed [confidential portion omitted]. The [confidential
portion omitted] is then loaded into the injector and is ready for a
self-injection. Just prior to injection the [confidential portion
omitted] is removed.
3. SYSTEM REQUIREMENTS
3.1 FUNCTIONAL REQUIREMENTS
3.1.1 [confidential portion omitted]
The system will be capable of injecting a [confidential
portion omitted] from [confidential portion omitted] to
[confidential portion omitted] of Betaseron with
[confidential portion omitted] of [confidential portion
omitted]. The [confidential portion omitted] must be
easily done by the user. Once the [confidential portion
omitted] is set, the device will [confidential
portion omitted] until the user [confidential portion
omitted] it. The user reconstitutes the entire contents of
the drug and draws [confidential portion omitted] the
amount to be injected.
3.1.2 Subcutaneous Injection
The system shall deliver Betaseron subcutaneously.
3.2 ENVIRONMENTAL REQUIREMENTS
3.2.1 Operation Temperature and Humidity
The system shall operate accurately within a
temperature range of [confidential portion omitted]
to [confidential portion omitted] and [confidential
portion omitted] to [confidential portion omitted]
relative humidity (non condensing).
[confidential portion omitted] operating temperature
requirement will be tested and examined)
3.2.2 Storage Requirement, Temperature and
Humidity
The system shall withstand the following storage
conditions and continue to operate to
specification for the operational life.
TEST CONDITIONS
* [confidential portion omitted] (minimum) at
[confidential portion omitted] (minimum)
* [confidential portion omitted] (minimum) at
[confidential portion omitted] (minimum) and
[confidential portion omitted] relative
humidity (maximum)
SHELF LIFE REQUIREMENTS
* [confidential portion omitted] (minimum) at
[confidential portion omitted] and
[confidential portion omitted] relative
humidity without battery installed (if applicable)
3.2.3 Operational Orientation
The system shall meet the requirements herein when
operated at [confidential portion omitted].
3.3.4 Operational vibration and shock
The performance of the device must not be changed
unintentionally (for example by shock, vibration,
and touching the front panel).
3.3 SAFETY REQUIREMENTS
The product shall be designed such that failure or
fault will not adversely affect the safe operation of
the product. This shall be confirmed through a Failure
Mode Effects Analysis.
3.3.1 Syringe Plunger [confidential portion omitted]
The syringe plunger will have a [confidential
portion omitted] in order to avoid [confidential
portion omitted] of the plunger.
3.3.2 [confidential portion omitted]
The [confidential portion omitted] will
[confidential portion omitted] when the
[confidential portion omitted] of the [confidential
portion omitted] is [confidential portion omitted].
3.4 QUALITY AND REGULATORY REQUIREMENTS
The BID System shall be designed in compliance with
applicable US, [confidential portion omitted], and
[confidential portion omitted] quality and regulatory
requirements.
3.5 PACKAGING AND LABELING REQUIREMENTS
3.5.1 Shipping Vibration and Shock
The product will meet the requirements herein
following exposure, in the normal shipping
container, to vibration and shock per
[confidential portion omitted].
3.5.2 Labeling
Labeling including directions for use, will conform
to US, [confidential portion omitted], and
[confidential portion omitted] regulatory requirements.
4. INJECTOR REQUIREMENTS
4.1 PHYSICAL REQUIREMENTS
4.1.1 Injector Weight
The injector will weigh less than [confidential
portion omitted], excluding the power sources and
the syringe.
4.1.2 Cartridge Weight
The CO(2) cartridge will weigh less than [confidential
portion omitted].
4.1.3 Injector Size
The injector will be a hand-held, portable device and
shall not be longer than [confidential portion omitted].
4.2 FUNCTIONAL REQUIREMENTS
4.2.1 [confidential portion omitted] Information
The injector will have an [confidential
portion omitted]. The following information
will be [confidential portion omitted]:
1) [confidential portion omitted] for
[confidential portion omitted] of the
[confidential portion omitted].
2) [confidential portion omitted] for
[confidential portion omitted].
4.2.2 Noise
The injector will make [confidential portion omitted].
4.2.3 Portability
The injector will be portable and will be operated
by a carbon dioxide cartridge (for drug delivery)
and batteries (for display and sensing controls). The
batteries shall be available worldwide.
4.2.4 Injection Per Charge
The injector will be capable of providing a
minimum of [confidential portion omitted]
injections per CO(2) cartridge.
4.2.5 Battery Life
The batteries will last at least for [confidential portion
omitted] based on one injection every other day.
4.2.6 Minimum Effort Operation
The injector will be easily self-operated by MS
patients. The actuation of the device will require
minimal effort with only [confidential portion omitted].
The syringe, batteries and CO(2) cartridge will be easily
replaced by the patient. A full volume will be
properly injected, regardless of how long the
actuation is depressed.
4.2.7 Ergonomic Design and Patient Compatibility
The injector will be easy to grip. The displays
and controls shall be designed for physically
impaired MS patients. The product shall be
compatible with either [confidential portion omitted].
A [confidential portion omitted] will be provided, which
can be attached to the device (and to [confidential
portion omitted] if necessary) to [confidential portion
omitted] the injector from being [confidential portion
omitted] while giving an injection.
4.2.8 Ease of Making Syringe Interface
The syringe will easily drop into the injector and
will be easy to lock into place.
4.2.9 [confidential portion omitted]
After the injection, the injector will
[confidential portion omitted] for the [confidential
portion omitted] injection. [Confidential portion
omitted] shall be required by the operator other than to
remove the [confidential portion omitted].
4.2.10 Detection of [confidential portion omitted]
The injector will [confidential portion omitted] only if
the syringe is [confidential portion omitted] and will
not operate with any other syringe per [confidential
portion omitted].
4.3 RELIABILITY
4.3.1 Operational Life
The injector will meet the requirements herein
following [confidential portion omitted].
4.3.2 Cleaning
The surfaces of the injector shall be
significantly smooth with a minimum of pockets and
crevices in order to facilitate cleaning.
4.3.3 Failure Resistance Due to Dropping
The unpackaged injector will fail safe if it falls
from a height of [confidential portion omitted] onto
a [confidential portion omitted], and impacting
[confidential portion omitted] of the injector. At least
[confidential portion omitted] of all cases, the
injector will meet [confidential portion omitted] defined
herein after being drop-tested from a height of
[confidential portion omitted] onto a [confidential
portion omitted].
4.3.4 Corrosion Resistance
The injector will be designed to resist corrosion
from normal use, not including immersion, soaking
or attempts to sterilize with unapproved methods.
5. SYRINGE AND [confidential portion omitted] REQUIREMENTS
5.0 GENERAL REQUIREMENTS
The Syringe and the [confidential portion omitted] will meet the
requirements of the US and [confidential portion omitted]
or if not regulated there, the respective [confidential
portion omitted]. All requirements will be met after sterilization.
5.1 PRODUCT MARKINGS AND GRADUATION
The disposable sterile syringe will have graduation
marks from [confidential portion omitted] to [confidential
portion omitted] and [confidential portion omitted] increments
up to [confidential portion omitted]. All labeling (including
syringe graduations) must fit within a [confidential portion
omitted] rectangular area. All printing shall be in Black. The
ink shall be resistant to flaking and smearing and compatible with
the normal site preparation solutions such as isopropyl alcohol.
5.2 TOXICITY
5.2.1 Tripartite
All syringe materials contacting the injectable
solution shall conform to the Tripartite
Bio-compatibility Guidelines for short-term,
externally communicating, indirect blood path
devices.
5.2.2 Pyrogenicity
The contents of the sterile syringe package shall
be non-pyrogenic based on using the [confidential
portion omitted] method for US requirement, and
[confidential portion omitted] according to
[confidential portion omitted] requirement.
5.3 STERILITY
The syringe and packaging shall be compatible with
[confidential portion omitted] sterilization and preferably
[confidential portion omitted]. [confidential portion omitted]
must not be detectable with a detection limit of
[confidential portion omitted] in an extract made under
practical conditions of use, prepared with [confidential
portion omitted]. The sterilization method must be
described and all requirements must be met after
sterilization. The contents of the sterile package
shall be sterile, which will be assured by the methods
defined in respective pharmacopoeiae.
5.4 PARTICULATE MATTER
The fluid path of the syringe and the [confidential portion omitted]
shall be free of particulate matter visible with the
unaided eye at a distance [confidential portion omitted]
with good lighting and both black and white backgrounds.
The maximum level of microscopic particulate matter in the
fluid path of the syringe within an extract made under practical
conditions of use prepared with [confidential portion omitted]
shall meet the following limits:
1) Less than [confidential portion omitted] with a
diameter of [confidential portion omitted] volume
of the syringe
2) Less than [confidential portion omitted] with a
diameter of [confidential portion omitted] volume
of the syringe
5.5 VOLUME RANGE & ACCURACY
The syringe shall be capable of delivering volumes from
[confidential portion omitted] to [confidential portion
omitted]. The calculated accuracy of the volume shall
meet [confidential portion omitted], standard syringe accuracy
requirements.
1) Accuracy of [confidential portion omitted] of
expelled volume when volume is equal to or
greater than half of nominal capacity
2) Accuracy of ([confidential portion omitted] of
nominal capacity + [confidential portion omitted]
of expelled volume) when volume is less than half of
nominal capacity.
5.6 RESIDUAL VOLUME
The residual volume of the medication held in the
syringe after injection shall meet the requirements of
[confidential portion omitted].
5.7 MEDICATION COMPATIBILITY
The syringe and [confidential portion omitted] are intended for
use with Betaseron solutions. The solution contacting
components will have compatibility with the intended
solutions in the syringe.
5.8 [confidential portion omitted]
The syringe body shall be sufficiently [confidential portion
omitted] to [confidential portion omitted] and [confidential
portion omitted] the volume of the medication, particles, air
bubbles, sediment, drug color, etc. after the syringe is filled
with medication.
5.9 [confidential portion omitted] INTEGRITY
The [confidential portion omitted] will be fail safe when
exposed with the injector interface to a [confidential portion
omitted] of [confidential portion omitted] normal [confidential
portion omitted] for [confidential portion omitted]. Maximum peak
injection [confidential portion omitted] inside the syringe
is [confidential portion omitted]. The [confidential portion
omitted] yields a [confidential portion omitted] of [confidential
portion omitted]. [confidential portion omitted] is the
[confidential portion omitted] applied to disposable syringes.
5.10 [confidential portion omitted] DIAMETER
The [confidential portion omitted] diameter will be sized
[confidential portion omitted] enough to achieve a subcutaneous
injection and [confidential portion omitted] enough to allow easy
[confidential portion omitted] with minimum [confidential portion
omitted] formation.
5.11 [confidential portion omitted]
The syringe body will be [confidential portion omitted] with
approximately [confidential portion omitted] of [confidential
portion omitted] to reduce the plunger [confidential portion
omitted] for syringe filling and injection. The [confidential
portion omitted] will have a nominal [confidential portion omitted]
of [confidential portion omitted] and must meet [confidential
portion omitted] and [confidential portion omitted].
5.12 PLUNGER COLOR
The plunger shall be [confidential portion omitted].
5.13 PLUNGER [confidential portion omitted]
The plunger [confidential portion omitted] for an empty syringe
must be [confidential portion omitted] enough to [confidential
portion omitted] reconstitution and meet [confidential portion
omitted].
5.14 [confidential portion omitted] COLOR/[confidential portion omitted]
The [confidential portion omitted] color shall show significant
[confidential portion omitted] in color to the index marking.
5.15 [confidential portion omitted] MATERIAL
The [confidential portion omitted] will be made from an
[confidential portion omitted] material. The [confidential portion
omitted] material will fulfill the requirements for [confidential
portion omitted] closures given in [confidential portion omitted].
5.16 LEAKAGE
The [confidential portion omitted] will not leak (no visible drops
with the unaided eye at one foot) [confidential portion omitted]
and must meet [confidential portion omitted] requirements.
5.17 [confidential portion omitted]
A [confidential portion omitted] will be supplied to enable the
patient to protect the [confidential portion omitted] from
[confidential portion omitted]. The [confidential portion omitted]
is to be designed not to [confidential portion omitted] the
medication and provides a sufficient [confidential portion omitted]
(preferred [confidential portion omitted] in distance) between the
[confidential portion omitted] of the [confidential portion omitted]
and the bottom of the [confidential portion omitted] when the
[confidential portion omitted] is [confidential portion omitted].
5.18 ACCIDENTAL [confidential portion omitted] RETENTION
The [confidential portion omitted] will stay attached to the
[confidential portion omitted] if the injector is accidentally
[confidential portion omitted].
5.19 [confidential portion omitted]
5.19.1 The [confidential portion omitted] will be compatible
with both specified [confidential portion omitted] vial.
5.19.2 The [confidential portion omitted] will be easy to
grip and easy to affix and remove from the vial and
the syringe by the MS patient.
<PAGE>
AMENDMENT: 1
BETASERON INJECTION DEVICE (BID) PRODUCT SPECIFICATION
Amendment to Rev. 1.5
[confidential portion omitted]
[confidential portion omitted]
Revise Paragraph 5.11 from:
". . .The [confidential portion omitted] will have a nominal [confidential
portion omitted] of [confidential portion omitted] and must meet
[confidential portion omitted] and [confidential portion omitted]."
to:
". . .The [confidential portion omitted] will have a nominal [confidential
portion omitted] between [confidential portion omitted] and [confidential
portion omitted] and must meet [confidential portion omitted] and
[confidential portion omitted]."
Approvals:
Berlex Laboratories /S/ Klaus Marten 14-June-95
Klaus Marten Date
Bioject Inc. /S/ Richard R. Stout 14-June-95
Richard R. Stout, MD Date
<PAGE>
AMENDMENT 2
BETASERON INJECTION DEVICE (BID) PRODUCT SPECIFICATION
Amendment to Rev. 1.5 [confidential portion omitted]
including [confidential portion omitted] Amendment 1
Additions shown as underlined, for example "words added"
-----------
Deletions shown as strike through, for example "(DELETE: words deleted)"
Revise Section 1 as follows:
This specification defines the design requirements for a Berlex/Schering
Betaseron Injection Device. (BID). (DELETE: "The specification is intended for
[confidential portion omitted]. The preliminary product external
specifications (Schedule A of the Development and licensing Agreement) remain
in effect except when specifically addressed and stated in this
specification.")
Revise Section 3.2.1 as follows:
The system shall operate accurately within a temperature range of
[confidential portion omitted] to [confidential portion omitted] and
[confidential portion omitted]to [confidential portion omitted] relative
humidity (non condensing).
(DELETE: "(The [confidential portion omitted] operating temperature
requirement will be tested and examined.)")
Revise Section 3.3.4 as follows:
3.(DELETE: "3") 2 4 Operational Vibration and Shock
-
The performance of the device must not be changed unintentionally. (for
example: by shock, vibration, and touching the (DELETE: "front") back panel).
----
Revise Section 4.1.3 as follows:
The injector will be a hand-held, portable device and shall not be
longer than [confidential portion omitted] (DELETE: [confidential portion
------------------------------
omitted]).
Revise Section 4.2.6 as follows:
(DELETE: "The injector will be easily self-operated by MS patients.")
The device will be self operated by MS patients who are capable of
- ------------------------------------------------------------------
operating the device. The actuation of the device will require
- ---------------------
minimal effort with only [confidential portion omitted]. The syringe,
batteries and CO(2) cartridges will be easily replaced by the patient. A full
volume will be properly injected, regardless of how long the actuator
actuation is depressed.
Revise Section 4.3.1 as follows:
The injector will meet the requirements herein following [confidential portion
omitted]. Recommended service of the device will be every [confidential
-------------------------------------------------------------
portion omitted] or [confidential portion omitted], whichever comes first.
- --------------------------------------------------------------------------
Revise Section 4.3.2 as follows:
4.3.2 Cleaning and Appearance of Exterior
--------------------------
The surfaces of the injector shall be sufficiently (DELETE: "significantly")
------------
smooth with a minimum of pockets and crevices in order to
facilitate cleaning. The exterior surfaces shall be of [confidential portion
-------------------------------------------------------
omitted] and generally have a smooth appearance of the quality
- -------------------------------------------------------------
comparable to the B2000 injector.
- ---------------------------------
Revise Section 4.3.3 as follows:
The unpackaged injector will fail safe if it falls from a height of
[confidential portion omitted] onto a [confidential portion omitted],
and impacting [confidential portion omitted] of the injector. At least
[confidential portion omitted] of all cases, the injector will meet
[confidential portion omitted] defined herein after being drop-tested from a
height of [confidential portion omitted].
------------------------------
(DELETE: [confidential portion omitted]) onto a [confidential portion omitted].
Add Section 5.20 as follows:
5.20 Syringe Shelf Life
- -----------------------
The packaged syringe shall have a shelf life for sterility for a
- ----------------------------------------------------------------
period of [confidential portion omitted].
- -----------------------------------------
Approvals:
Schering AG /S/ Henrik Jochens 25/6/96
Henrik Jochens Date
Bioject Inc. /S/ Mike Deily 6/18/96
Mike Deily Date
<PAGE>
Schedule C
Prices
Autoinjector Prices
Ordered for shipment during the first
Contract Year (between[confidential portion
omitted][1] [confidential portion omitted]
Ordered for shipment during the second
Contract Year (between [confidential portion
omitted][1] [confidential portion omitted]
Thereafter [1] [confidential portion omitted]
Syringe Prices
Minimum Annual Unit
Quantities Ordered for Non-Automated Automated
Shipment During Contract Year Syringe Syringe
[confidential portion omitted]
After the later of [confidential
portion omitted] or after
cumulative orders of
[confidential portion Non-Automated Automated
omitted] units Syringe Syringe
[confidential portion omitted]
Non-Automated Syringe pricing is effective commencing with the
first Contract Year. Automated Syringe pricing is effective and
supersedes Non-Automated Syringe pricing one year from the date
that funds are advanced by Schering pursuant to Section 3.13(b)
of this Agreement, or such earlier time as the automation
equipment has been tested and accepted by Bioject and is fully
operational.
[1] Dates will change if necessary to coincide with Contract Years
under this Agreement.
The price Schering will pay for each Syringe ordered for shipment
during any particular Contract Year will be based preliminarily
on the number of Syringes Schering has forecast it will order for
shipment during that Contract Year. Immediately after the end of
each Contract Year, the number of Syringes actually ordered for
shipment during that Contract Year will be calculated and the
actual price that Schering must pay for each such Syringe will be
calculated in accordance with the above table. If any adjustment
is necessary to reflect the price that should have been paid for
the Syringes ordered for shipment, such adjustment will be paid
by the respective Party within [confidential portion omitted]
after the amount of the adjustment has been determined.
Commencing [confidential portion omitted] after shipment of the
first Autoinjector, Schering shall have the right to audit
Bioject's costs of manufacturing Autoinjectors. If the cost of
manufacturing Autoinjectors, as determined by applying generally
accepted accounting principles (GAAP), is [confidential portion
omitted] or more lower than the price set forth above for any period
being audited, then Schering will be entitled to a credit against
future purchases of the difference above [confidential portion
omitted] as regards all Autoinjectors purchased during the period
being audited.
At the commencement of the fourth Contract Year and annually
thereafter, Bioject shall have the right to increase the
Autoinjector and Syringe prices to reflect increases in the cost
of manufacturing Autoinjectors or Syringes, as the case may be,
with such increases to be no greater than the increases in the
[confidential portion omitted] (as published by [confidential portion
omitted], or its successor) since the beginning of the prior Contract
Year.
Notwithstanding the foregoing, Schering's purchase price for
Autoinjectors and Syringes will not be higher than the purchase
price paid by a Third Party to Bioject under comparable
circumstances, as permitted by this Agreement. Bioject shall
inform Schering of any lower purchase price for Autoinjectors and
Syringes agreed with a Third Party.
<PAGE>
Schedule D
Minimum Quantities To Be Ordered By Schering
for Shipment During Each Contract Year
Autoinjector Minimums
Contract U.S. Rest of the World Total
Year Territory Year Territory Year Minimum
1 [confidential portion omitted]
2 [confidential portion omitted]
3 [confidential portion omitted]
4 [confidential portion omitted]
5 [confidential portion omitted]
6 [confidential portion omitted]
7 and thereafter [confidential portion omitted]
Syringe Minimums
Contract U.S. Rest of the World Total
Year Territory Year Territory Year Minimum
1 [confidential portion omitted]
2 and thereafter [confidential portion omitted]
<PAGE>
Schedule E
Initial Orders for Shipment
During the Specified Months
Months Autoinjectors Syringes
Total [confidential portion omitted]
Note: The above dates will change if necessary to commence
with the first Contract Year under this Agreement.
Schering's obligation to order and purchase Syringes will be
adjusted if Bioject's delivery of Autoinjectors is delayed.
<PAGE>
Schedule F
Bioject Shipping Capability
Number of Number of
Months Autoinjectors Syringes
[confidential portion omitted]
per month
sufficient to satisfy
the Autoinjector market
in accordance with
Section 3.4
Schering shall make prepayments as required by Section 3.2(c).
Note: The above dates will change if necessary to commence with
the first Contract Year under this Agreement.
<PAGE>
Schedule G
Loan
<TABLE>
<S> <C> <C> <C> <C> <C>
Loan to be Made by Date Specified * ** ** [confidential portion omitted]
SCHERING Syringe Molds Loan th $ 450 [confidential portion omitted]
SCHERING Device Tooling and Syringe
Syringe Equipment Loan th $ [confidential portion omitted]
_____________________________________________________________
Total Loans th $ 450 [confidential portion omitted]
Cumulative Amount th $ 450 [confidential portion omitted] 1,606
_____________________________________________________________
Delivery
* Loaned prior to execution of this Agreement.
** To be loaned within five (5) days after execution of this Agreement.
</TABLE>
<PAGE>
Schedule H
Standard Product Packaging Specification
Syringe Packaging Specification
General
The syringe affixed with [confidential portion omitted], case, and
[confidential portion omitted] is packaged in a two level packaging
system consisting of inner cartons and a shipping carton. Each carton
level has labeling conforming to applicable FDA regulatory requirements.
Inner Carton
The syringe affixed with [confidential portion omitted], case, and
[confidential portion omitted] is packaged in a paper board inner carton in
quantities of [confidential portion omitted] per box. The instructions-for-
use are printed on each inner carton. The rationale for this carton size
is the requirement for monthly shipping to the end user, who injects every
other day.
Shipping Carton
[confidential portion omitted] ([confidential portion omitted]
syringes) are packaged in a corrugated paper shipping carton.
The rationale for this carton size is the requirement for shipping
using a standard pallet size, as well as for sterilizing in standard
sterilizer carrier sizes.
Autoinjector Packaging Specification
General
The injector is packaged in a three level packaging system
consisting of a case, a unit carton, and a shipping carton. Each
level has labeling conforming to applicable FDA regulatory
requirements.
Case
Each injector is packaged in a plastic blow molded case comparable
in size, shape, materials, functionality, and quality to the case
used to package the Biojector B2000 injector. The case also
includes [confidential portion omitted] gas cartridges and [confidential
portion omitted] AA batteries.
Unit Carton
Each case is packaged in a corrugated paper unit carton. One set
of instructions for use is provided with each unit carton. The
instructions for use manual is comparable in size, number of pages,
shape, materials, and quality to the instructions for use manual
for the Biojector B2000 injector. The manual is printed in black
and white and in English.
Shipping Carton
[confidential portion omitted] unit cartons are packaged in a corrugated
paper shipping carton.
<PAGE>
Schedule I
Countries
[confidential portion omitted]
* See Sections 1.19, 5.2(d)(v) and 7.1.
<PAGE>
Schedule J
Security Agreement
SECURITY AGREEMENT
THIS SECURITY AGREEMENT (the "Agreement") is made as of the
____ day of __________, 1996, between Bioject Inc. an Oregon
corporation (the "Company"), and Schering Aktiengesellschaft, a
corporation organized under the laws of Germany (the "Secured
Party").
RECITALS
A. Prior to the date of this Agreement, Secured Party's
affiliate Berlex Laboratories, Inc. made a loan to the Company in
the amount of $450,000. That loan was evidenced by a Secured
Promissory Note dated April 22, 1996 (the "Berlex Note") and was
secured in accordance with a Security Agreement dated April 22,
1996 (the "Berlex Security Agreement").
B. Secured Party has purchased the Berlex Note and has
agreed to make additional advances to the Company as provided in
Section 3.13 of a Supply Agreement between the Company and the
Secured Party dated the same date as this Agreement (the "Supply
Agreement"). All sums due under the Berlex Note are now
reflected in the Supply Agreement, and the Berlex Note is
cancelled and the Berlex Security Agreement is terminated upon
the execution of this Agreement; and
C. The Company has agreed to grant to Secured Party a
security interest in certain assets of the Company as security
for the prompt payment by the Company of its obligations to repay
sums borrowed under Section 3.13 of the Supply Agreement as it
may be modified or amended from time to time (the "Obligations").
NOW, THEREFORE, in consideration of the mutual covenants and
agreements set forth herein and for other good and valuable
consideration, the receipt and adequacy of which are hereby
acknowledged, the parties hereby agree as follows:
1. Security Interest. Pursuant to the provisions of the
Oregon Uniform Commerce Code (the "Code"), the Company hereby
grants to Secured Party a security interest in the following (the
"Collateral"):
1.1 The deposit account, which will contain only the
proceeds of the Berlex Note and the additional amounts loaned to
the Company pursuant to Section 3.13 of the Supply Agreement
until such time as the Equipment (as defined in Section 1.2) is
purchased, plus interest earned on that deposit account (the
"Deposit Account").
1.2 All of the Company's right, title and interest in and
to any and all tooling and equipment purchased by the Company in
connection with the Supply Agreement with sums from the Deposit
Account, including but not limited to, syringe molds, tooling and
molds for Autoinjectors, and equipment to automate the
manufacture of syringes.
1.3 Any and all proceeds whether receivable or received
from or upon the sale, lease, license, use, exchange or other
disposition, whether voluntary or involuntary, of any Equipment,
including "proceeds" as defined in Section 9-306 of the Code, any
and all proceeds of any insurance, indemnity, warranty or
guaranty payable to or for the account of the Company from time
to time with respect to any of the Equipment, and any and all
other amounts from time to time paid or payable under or in
connection with any of the Equipment. Proceeds pursuant to this
Agreement include (i) whatever is now or subsequently received by
the Company upon the sale, exchange, collection or other
disposition at anytime of Equipment, whether such proceeds
constitute inventory, accounts, accounts receivable, general
intangibles, instruments, securities, credits, documents, letters
of credit, chattel paper, documents of title, warehouse receipts,
leases, deposit accounts, money, contract rights, goods or
equipment, and (ii) any such items which are now or subsequently
acquired by the Company with any proceeds of Collateral.
2. Performance Secured. The security interest granted
hereby secures the prompt payment of the Obligations.
3. Covenants of the Company. The Company covenants and
agrees, unless compliance is waived in writing by Secured Party,
that:
3.1 Maintenance of Collateral. The Company will properly
maintain and care for the Collateral.
3.2 Sale of Collateral. The Company will not sell,
transfer, trade or otherwise dispose of all or substantially all
of the Collateral, except with the consent of Secured Party or as
expressly contemplated in Section 1.2.
3.3 Change in Company. The Company will notify Secured
Party in writing of any proposed or actual change of the
Company's name, identity or corporate structure.
3.4 Payment of Taxes. The Company will pay prior to
delinquency all taxes, liens and assessments which are levied or
assessed against the Collateral.
3.5 Perfection Filing. The Company will file the Form UCC-
1 Financing Statement (the "UCC-1") in the form mutually agreed
upon with the Office of the Oregon Secretary of State within five
(5) business days after the date of this Agreement.
4. Events of Default. The occurrence of any of the
following shall constitute an Event of Default under this
Agreement:
4.1 Payment of Notes. The Company fails to make any
payment of principal or interest when required with respect to
the Obligations.
4.2 Bankruptcy, Insolvency, etc. Commenced by the Company.
If the Company:
(a) shall commence any proceeding or any other action
relating to it in bankruptcy or seek reorganization, arrangement,
readjustment of its debts, dissolution, liquidation, winding-up,
composition or any other relief under the United States
Bankruptcy Act, as amended, or under any other insolvency,
reorganization, liquidation, dissolution, arrangement,
composition, readjustment of debt or any other similar act or
law, of any jurisdiction, domestic or foreign, now or hereafter
existing;
(b) shall admit its inability to pay its debts as they
mature in any petition or pleading in connection with any such
proceeding;
(c) shall apply for, or consent to or acquiesce in, an
appointment of a receiver, conservator, trustee or similar
officer of it or for all or substantially all of its assets and
properties; or
(d) shall make a general assignment for the benefit of
creditors.
4.3 Bankruptcy, Insolvency, etc. Commenced Against the
Company. If any proceedings are commenced or any other action is
taken against the Company in bankruptcy or seeking reorganization,
arrangement, readjustment of its debts, dissolution, liquidation, winding-up,
composition or any other relief under the United States Bankruptcy Act, as
amended, or under any other insolvency, reorganization, liquidation,
dissolution, arrangement, composition, readjustment of debt or any other
similar act or law, of any jurisdiction, domestic or foreign, now or hereafter
existing; or a receiver, conservator, trustee or similar person for the
Company or for all or substantially all of its assets and properties is
appointed; and in each such case, such event continues for ninety (90) days
undismissed, unbonded and undischarged.
5. Secured Party's Remedies after Default. Upon the
occurrence of an Event of Default, Secured Party may, after
delivering written notice of such Event of Default to the
Company, do any one or more of the following:
5.1 Accelerate Obligations. Declare the outstanding
principal balance of the Obligations, together with the accrued
but unpaid interest thereon, immediately due and payable.
5.2 Actions Against the Company. Proceed against the
Company with or without proceeding against the Collateral secured
hereby.
5.3 Actions Against the Collateral. Exercise all of the
rights and remedies provided to Secured Party by this Agreement,
by the Code as then in effect, or any other applicable law.
6. General Provisions.
6.1 Construction. This Agreement shall be governed,
construed and enforced in accordance with the internal laws of
the State of Oregon. All terms not defined herein are used as
set forth in the Code.
6.2 Entire Agreement. This Agreement, together with the
agreements and documents referred to herein, constitute the
entire agreement among the parties hereto with respect to the
subject matter hereof and supersede all prior and contemporaneous
negotiations, agreements and understandings.
6.3 Notices. All payments, notices, requests, demands and
other communications hereunder shall be in writing and shall be
deemed to have been duly given (i) upon delivery if personally
delivered or delivered by facsimile or (ii) on the third business
day following the date deposited with a reputable overnight
courier, to the party at the following address or at such other
address as shall be given in writing by either party to the other
party:
Secured Party: Schering Aktiengesellschaft
Mullerstrasse 170-178
13353 Berlin, Germany
The Company: Bioject Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Attention: Chairman
6.4 Successors and Assigns. This Agreement shall inure to
the benefit of, and shall be binding upon, the parties and their
respective successors and assigns.
6.5 Severability. If one or more provisions of this
Agreement are held to be unenforceable under applicable law, such
provision shall be excluded from this Agreement and the balance
of the Agreement shall be interpreted as if such provision were
so excluded and shall be enforceable in accordance with its
terms.
6.6 Further Assurances. Each party hereto will execute,
acknowledge, and deliver any further assurances, documents and
instruments reasonably requested by the other party hereto for
the purpose of creating and perfecting Secured Party's security
interest in the Collateral hereunder, including (without
limitation) any financing statement, amended financing statement,
continuation statement, or other instrument permitted or required
by the Code or other applicable law.
6.7 Cooperation. The Company and Secured Party each agrees
from time to time to execute and deliver, or cause to be executed
and delivered, such further instruments and do and cause to be
done such further acts as may be necessary or appropriate to
carry out more effectively the provisions of this Agreement.
6.8 Amendments and Waiver. The rights of Secured Party
hereunder and under any financing statement, amended financing
statement, continuation statement, or other document or
instrument creating or perfecting the Secured Party's security
interest in the Collateral may be amended or waived at any time
by the written consent of the Secured Party and the Company.
6.9 Termination. Upon payment in full of the Obligations,
the security interest provided under this Agreement shall
automatically terminate and shall be deemed null and void.
Secured Party agrees to execute all appropriate instruments or
other documentation (including one or more UCC-3 Termination
Statements) to evidence the termination of such security
interest.
6.10 Counterparts. This Agreement may be executed in one or
more counterparts, each of which shall be deemed an original but
all of which together shall constitute one and the same
instrument.
IN WITNESS WHEREOF, the undersigned have executed this
Agreement, effective as of the date first written above.
THE COMPANY: BIOJECT INC.
By: James O'Shea
Its: Chairman
SECURED PARTY: SCHERING AKTIENGESELLSCHAFT
By: [confidential portion omitted]
Its: [confidential portion omitted]
<PAGE>
Schedule K
Limited Product Warranty
TWO YEAR LIMITED WARRANTY
Bioject Inc. warrants that at the time of shipment this medical
device will perform according to published specifications and
will be free from defects in materials and workmanship. BIOJECT
MAKES NO OTHER WARRANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. Bioject's sole liability will be to repair, or, at
Bioject's option, replace, any defective parts for a period of
two years following the date of delivery to the original end user
purchaser. Some states do not allow limitations on how long an
implied warranty lasts, so the above limitation may not apply to
you. Purchaser must give Bioject prompt notice of any defect.
Upon receipt of notice of a potential defect, Bioject will, at
its expense, provide a prepaid mailer for purchaser to use when
returning this medical device to Bioject. Any claim for breach
of this warranty must be made or asserted within two years from
the date of purchase. Bioject will have no further liability to
purchaser, whether in contract, tort, or otherwise, and, in any
event, BIOJECT WILL NOT BE LIABLE FOR LOST PROFITS OR ANY
SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND. Some
states do not allow the exclusion or limitation of incidental or
consequential damages, so the above limitation or exclusion may
not apply to you. This warranty gives you specific legal rights,
and you may also have other rights which vary from state to
state.
This warranty applies only to the original end user purchaser and
only to use under the direction of a physician; it does not cover
usage other than as described in the Instruction Manual. This
warranty does not apply if warranty work is provided by anyone
other than Bioject nor will this warranty apply to damage
resulting from accident, transportation, misuse, abuse, failure
to follow operating instructions, alteration, failure to provide
a proper operation environment, or use other than as directed by
the Instruction Manual.
HOW TO OBTAIN SERVICE
For warranty service, call or write us at the address below. We
value you as a satisfied customer. If you have a question or
concern, please let us know. Please include device number,
serial number, date of original purchase and the date you first
received the device.
IMPORTANT
To assure you receive all communications and updates from
Bioject, please complete and return the Warranty Registration
Card at once. Thank you.
Bioject Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
800-683-7221
