SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
-----------------------------------
AMENDMENT NO. 2 TO
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the quarterly period ended December 31, 1999
Commission File No. 0-15360
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact name of registrant as specified in its charter)
Oregon 93-1099680
- -------------------------------------- -----------------------------
(Jurisdiction of incorporation) (I.R.S. identification no.)
7620 SW Bridgeport Road
Portland, Oregon 97224
- -------------------------------------- -----------------------------
(Address of principal executive offices) (Zip code)
(503) 639-7221
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(Registrant's telephone number, including areas code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ]
At December 31, 1999 there were 5,828,784 outstanding shares of common stock of
the registrant.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
None during the quarter ended December 31, 1999.
Item 2. Changes in Securities
On July 15, 1999, the Board of Directors approved, subject to the shareholder
approval, a proposal to amend the Articles of Incorporation to effect a reverse
stock split by exchanging five outstanding shares of the Company's common stock
for one new share of the Company's common stock. At the Company's annual meeting
in September, 1999, the shareholders approved the amendment to the Company's
Articles of Incorporation to effect a one-for-five reverse stock split. On
October 13, 1999, a one-for-five reverse stock split was effected. Prior to the
reverse split, 29,011,236 shares of Common Stock were outstanding, as well as
options, warrants and convertible preferred stock to acquire an additional
24,378,928 shares of common stock. The reverse stock split decreased the number
of outstanding shares of common stock to approximately 5.8 million shares and
approximately 4.8 million shares were reserved for issuance upon exercise of
outstanding options, warrants and the conversion of convertible preferred stock.
In December 1996, the Company completed two private placements of units, each
unit consisting of one share of Common Stock and one warrant to purchase one
share of Common Stock at an exercise price of $5.00. Preferred Technology, Inc.
acted as agent in connection with the first placement and in connection
therewith, received a placement fee and a warrant to acquire shares of Common
Stock at an exercise price per share of $4.140625. In December 1999, warrants to
purchase 20,286 shares of Common Stock were exercised at $5.00 per share.
The warrants and the shares issued upon exercise of the warrants have been
issued pursuant to an exemption from registration under Rule 506 of Regulation D
and Section 4(2) of the Securities Act. In relying upon such exemption (1) the
Company did not engage in any "general solicitation," (ii) the purchaser
represented and the Company reasonably believed that the purchaser was an
accredited investor and had such knowledge and experience in financial and
business matters such that it was capable of evaluating the merits and risks of
the prospective investment and was able to bear the economic risk of such
investment, (iii) the purchaser was provided access to all necessary and
adequate information to enable the purchaser to evaluate the financial risk
inherent in making an investment, and (iv) the purchaser represented that it was
acquiring the shares for itself and not for distribution.
Aggregate proceeds to the Company from the warrant exercises totaled
approximately $101,000. In December, 1999, stock option exercises of 3,250
shares of common stock were exercised for an aggregate of approximately $8,129.
Item 3. Defaults Upon Senior Securities
None during the quarter ended December 31, 1999.
Item 4. Submission of Matters to a Vote of Security Holders
None during the quarter ended December 31, 1999.
Item 5. Other Information
On October 7, 1999, Michael Sember resigned from Bioject's Board of
Directors.
15
<PAGE>
Item 6. Exhibits and Reports on Form 8-K
EXHIBITS:
10.70 License and Distribution Agreement dated December 21, 1999
between Bioject, Inc. and Serono Laboratories, Inc.
(Confidential treatment has been granted pursuant to Rule
24b-2 under the Securities Exchange Act of 1934, as amended.
Confidential portions have been omitted and filed separately
with the SEC. This exhibit is being refiled following the
confidential treatment review.)
27.1 Financial Data Schedule
REPORTS ON FORM 8K:
None during the quarter ended December 31, 1999
16
<PAGE>
SIGNATURE
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.
BIOJECT MEDICAL TECHNOLOGIES INC.
(Registrant)
Date: March 16, 2000 /s/ James O'Shea
---------------------------------
James O'Shea
Chairman, Chief Executive Officer
and President
/s/ Christine M. Farrell
---------------------------------
Christine M. Farrell
Controller and Secretary
<PAGE>
EXHIBIT INDEX
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EXHIBIT
NUMBER EXHIBIT DESCRIPTION
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10.70 License and Distribution Agreement dated December 21, 1999
between Bioject, Inc. and Serono Laboratories, Inc. (Confidential
treatment has been granted pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended. Confidential
portions have been omitted and filed separately with the SEC.
This exhibit is being refiled following the confidential
treatment review.)
27.1 Financial Data Schedule
EXHIBIT 10.70
LICENSE AND DISTRIBUTION AGREEMENT
This License and Distribution Agreement (the "Agreement") is entered into and
effective this 21st day of December, 1999 ("Effective Date"), by and between
BIOJECT INC.
7620 S.W. Bridgeport Rd.
Portland, Oregon 97224
("Bioject")
AND:
SERONO LABORATORIES, INC.
100 Longwater Circle
Norwell, MA 02061
("Serono")
RECITALS:
A. Bioject designs, develops, manufactures and markets proprietary needle-free
drug delivery injection devices and related supplies; and
B. Serono has developed a proprietary human growth hormone and possesses
certain know-how and expertise in the marketing, selling and distributing
medical products and supplies, including drug delivery systems; and
C. Bioject and Serono desire to establish a relationship for the license and
distribution of the needle-free drug delivery injection devices and related
supplies specified herein, on the terms specified herein.
AGREEMENT:
In consideration of the mutual covenants contained herein, and for other good
and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties hereto agree as follows:
1. Grant of License: License Fee; Option. Subject to all of the terms and
conditions set forth in this Agreement:
1.1 License Grant. Bioject hereby grants to Serono an exclusive right (as
to Bioject and all other parties) and exclusive license (as to Bioject
and all other parties) under the patents listed in Schedule 2.1 and
related technology, know-how and technical information (collectively,
the "Licensed Technology") during the term of this Agreement to use,
have used, sell, have sold, import and have imported needle-free
devices, syringes and supplies listed on Schedule 1.1 of this
Agreement (the "Products") for use in the Field (defined below) in the
United States, its territories and possessions and Canada (the
"Territory"). The term Products shall include all upgrades,
improvements, modifications and enhancements to the Products made
during the term of this Agreement. The term Products shall not include
needle-free devices materially
<PAGE>
different from the existing Products in significant respects. The
specifications for each Product are set forth on Schedule 1.1 of this
Agreement (the "Specifications"). The Specifications shall be amended
from time to time by the parties for upgrades, improvements,
enhancements and other changes to the Products. New needle-free
devices of Bioject that do not constitute Products shall be subject to
the right of first offer in favor of Serono set forth in Section 21 of
this Agreement.
1.2 Changes to Products. Bioject shall make changes to the Products
reasonably requested by Serono, provided that Serono shall pay the
cost of engineering any change to Products requested by it. Bioject
shall promptly provide Serono with an estimate of such costs and
receive Serono's approval of such estimate before undertaking any
change to the Products. Bioject shall not make any other changes to
the Products without Serono's prior written approval, which shall not
be unreasonably withheld or delayed. Serono may withhold its approval
in all cases where the requested change would impact its regulatory
commitments or approvals with respect to human growth hormone or
delivery of human growth hormone using the Products.
1.3 Sub-distributors. Serono shall have the right to appoint
sub-distributors to assist in the marketing, sale and distribution of
the Products in the Territory for use in the Field, provided that
Serono shall be responsible for ensuring that such sub-distributors
conduct their activities with respect to the Products in compliance
with Serono's obligations under this Agreement.
1.4 Definition of Field. "Field" means the use of a needle-free injection
device and syringe to administer human growth hormone to humans, but
specifically excluding treatment of AIDS-wasting.
1.5 No Rights by Implication. No rights or licenses with respect to the
Products or the Licensed Technology are granted or deemed granted
hereunder or in connection herewith, other than those rights or
licenses expressly granted in this Agreement.
1.6 Option for Extended Territory. Bioject hereby grants to Serono an
option to extend the Territory to all countries of the world. This
option may be exercised by written notice of exercise to Bioject at
any time before ***. Prior to expiration of this option and in order
to preserve the benefit of this option to Serono, Bioject shall not
market, distribute or sell or permit any other person to market,
distribute or sell the Products for use in the Field anywhere in the
world. Serono shall pay Bioject $*** for extension of the Territory to
***. The first $*** of such payment shall be made upon exercise of the
option. The remaining $*** shall be paid *** (***) days after Serono
and Bioject shall have secured all regulatory approvals necessary for
Serono to market and sell human growth hormone for delivery with the
Products in Japan or all countries of the European Union. Such payment
shall be in addition to any other amounts due
-2-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
to Bioject under this Agreement. If this option is exercised and
payment is made as described in this Section 1.6, after exercise and
payment the term "Territory" shall mean all countries of the world. If
Serono for itself or one of its Affiliates exercises this option to
extend the Territory, the parties will negotiate in good faith any
necessary amendments to this Agreement to comply with applicable law
and regulatory requirements and, at the request of Serono, one or more
separate agreements between one or more Affiliates of Serono and
Bioject covering the extension Territory which shall be substantially
the same as this Agreement.
1.7 Affiliates of Serono. This Agreement shall be made for the benefit of
Serono and its Affiliates. Serono may designate one or more of its
Affiliates to exercise its rights, receive its benefits or perform its
obligations under this Agreement in whole or in part, provided that
Serono shall remain responsible for all obligations assigned by it to
its Affiliates under this Agreement. For purposes of this Agreement,
"Affiliate" of a party shall mean any corporation or other business
entity controlled by, controlling, or under common control with such
party.
2. Regulatory Matters.
2.1 Product Approvals in the United States and Canada. Bioject shall be
responsible for obtaining and maintaining all approvals, licenses and
permits necessary for manufacture of the Products and marketing,
selling and using the Products to administer Serono's human growth
hormone product in the United States and Canada, provided that Serono
shall be responsible for all approvals that relate to its human growth
hormone product generally. Bioject shall diligently pursue and provide
Serono with copies of the approval of its 510K application(s) for the
Products and all other regulatory approvals for the Products issued by
regulatory authorities in the United States and Canada.
2.2 Foreign Regulatory Approvals. After any exercise by Serono of its
option pursuant to Section 1.6 to extend the Territory to all
countries of the world, Bioject shall diligently obtain and maintain
all approvals, licenses and permits necessary for the import,
marketing, sale and use of Products to administer Serono's human
growth hormone product in all countries of the European Union, Japan
and such additional countries as designated by *** from time to time,
provided that Serono shall be responsible for all approvals that
relate to its human growth hormone product generally.
2.3 Regulatory Assistance by Serono. Serono will use all commercially
reasonable efforts to assist Bioject in obtaining and maintaining all
necessary regulatory approvals with respect to marketing, sale and use
of the Products to administer Serono's human growth hormone products
in the Territory.
2.4 Regulatory Approvals for Serono's Human Growth Hormone. Serono shall
be responsible for obtaining and maintaining all necessary
-3-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
regulatory approvals for the manufacture, market, sale and use of its
human growth hormone product, including by means of delivery with the
Products, in the United States and Canada and, if the option pursuant
to Section 1.6 is exercised, in Japan, all countries of the European
Union and all other countries in which Serono requests that Bioject
pursue regulatory approval for the Products.
2.5 Regulatory Assistance by Bioject. Bioject will use all commercially
reasonable efforts to assist Serono in obtaining and maintaining all
necessary regulatory approvals with respect to marketing, sale and use
of human growth hormone with the Products in the Territory. Without
limiting the foregoing, Bioject will provide Serono with (a) a
reasonable quantity of Products (but not less than ***) for use in any
required clinical trials at no charge (other than shipping costs), and
(b) reasonable access at no charge to Bioject's (i) records, study
results, research and other information and materials relating to the
Products and (ii) personnel for consultation. Bioject will also assist
Serono in the completion of all initial and periodic regulatory
filings relating to marketing, sale or use of human growth hormone
with the Products and make its facilities and records available for
inspection by the United States Food and Drug Administration ("FDA")
and international regulatory agencies.
2.6 Facility Inspections. Serono shall, upon reasonable notice to Bioject,
have the right to inspect the facilities in which the Products are
manufactured, tested or stored at any time during the term of this
Agreement and to observe the manufacture of the Products. Bioject
shall consult with Serono prior to any response to the FDA or other
regulatory authority relating to the Products, this Agreement or the
manufacture of the Products. Bioject will promptly notify Serono of
any FDA or other regulatory inspection related to the Products.
Bioject will promptly notify Serono of the results of any such
inspection and furnish Serono with a written description of actions
taken, if any, to remedy conditions cited in any such inspection.
2.7 Adverse Reactions and Reports. Bioject will be responsible for
completion and submission to the FDA of any form with respect to an
adverse reaction or event involving a Product sold hereunder or any
complaint that would require a field alert and all periodic and annual
reports, as and when appropriate, unless Serono is under any statutory
or regulatory obligation to make such or similar report or filing.
Each party will forward to the other, simultaneously with filing such,
a copy of each completed form with respect to an adverse reaction or
event or similar report or filing with respect to a Product sold
hereunder.
3. Appointment as Exclusive Distributor. Subject to the provisions of this
Agreement, Bioject hereby grants Serono the exclusive right to market, sell
and distribute the Products in the Field within the Territory directly and
indirectly, including through wholesalers and sub-distributors. Bioject
agrees that,
-4-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
during the term of this Agreement, it will not market, distribute or sell
or permit any other person to market, sell or resell the Products for use
in the Field in the Territory and that Bioject will take all commercially
reasonable actions to give full effect to the intention of this Section.
4. Purchase of Products by Serono.
4.1 Purchase and Sale. Subject to Section 4.2, Bioject agrees to sell the
Products to Serono in accordance with purchase orders submitted by
Serono, and Serono agrees to purchase the Products from Bioject
subject to the provisions of this Agreement.
4.2 Forecasts; Orders. On or before the *** (***) day of the months of ***
during the term of this Agreement, Serono will provide Bioject with a
written good-faith, non-binding *** (***) calendar month rolling
forecast of the *** that Serono expects to *** of the next *** (***)
calendar months. The first *** (***) calendar months of each rolling
forecast shall be binding. Serono will provide Bioject with firm
purchase orders from time to time setting forth the quantities and
forms of Products ordered and required delivery dates (a "Purchase
Order"). The quantities ordered in Purchase Orders will be no more
than *** (***) of the amount covered in Serono's binding forecast.
Bioject will use its reasonable commercial efforts to supply Products
in excess of such amount. Subject to the provisions of this Section
with respect to orders in excess of *** of Serono's forecast, Bioject
shall meet fully the requirements of each Purchase Order placed by
Serono hereunder. To the degree that either or both of the parties
find it convenient to employ their standard forms of purchase order or
acknowledgment of order in administering the terms of this Agreement,
it or they may do so but none of the terms and conditions printed or
otherwise appearing on such forms shall be applicable except to the
extent that it specifies information, such as quantities and delivery
dates, required to be furnished by either party hereunder.
Notwithstanding the foregoing or anything in this Agreement to the
contrary, the parties agree that Serono shall submit its first rolling
forecast after approval by the FDA of Bioject's 510K application(s)
for the Products and that Bioject shall have a period of up to 90 days
to fill the first order for Products submitted by Serono after
approval by the FDA of Bioject's 510K application(s) for the Products.
The terms and conditions set forth in this Agreement shall be the
exclusive contract terms between the parties with respect to Serono's
purchase of the Products.
4.3 Return. Serono may not return any Products ordered by it without
Bioject's express written consent. Such consent shall not be withheld
for return of defective Products or Products being returned under
Warranty provisions set forth in Section 12 (each, a "Pre-approved
Return"). Provision by Bioject of a return goods authorization number
("RGA#") to Serono shall constitute express written consent to return
-5-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Products but only for the Products and in the quantities and serial or
lot numbers specified by such RGA#. Except for Pre-approved Returns,
Products returned for credit are subject to a minimum restocking
charge of 20% of the original purchase price. Except for Pre-approved
Returns, used, opened or customer damaged products are not eligible
for credit.
4.4 Not a Requirements Contract. Serono has no obligation to purchase all
of its requirements of needle-free drug delivery injection devices or
related supplies from Bioject. Without limiting the foregoing, Serono
may qualify other sources of supply for needle-free drug delivery
injection devices and related supplies, purchase such devices and
related supplies from others and/or produce such devices and related
supplies for itself.
5. License Fees and Quotas. Serono agrees to pay to Bioject the license fees
set forth in Schedule 5. Serono agrees to purchase from Bioject the
quantities of Product described in Schedule 5 in order to maintain
exclusivity for the Territory. If Serono *** at the ***, Serono may *** by
making *** to Bioject in accordance with the ***.
6. Prices and Discounts.
6.1 Prices. Serono shall purchase Products F.O.B. Bioject's factory at the
prices set forth in Schedule 6.1, plus any applicable insurance and
taxes. Bioject shall ship and insure Products with transportation and
insurance carriers selected by Serono. Freight costs, handling,
insurance, sales or other taxes and export or import fees, as
applicable, will be prepaid by Bioject and added to the invoice to be
paid by Serono. Bioject's *** at the option of Bioject upon *** (***)
days' written notice to Serono but not before the *** of the date of
this Agreement or more often than *** in any *** (***) month period
thereafter. Any price increase shall not exceed ***.
6.2 Most Favored Customer. The prices for Products charged to Serono under
this Agreement shall at all times be equal to or lower than the prices
for similar products charged to any other customer who purchases a
similar or lesser volume of Products from Bioject taking into account
any price concessions reasonably resulting from such other purchaser's
payment of a higher license fee to Bioject, including, without
limitation, any wholesaler or distributor. If Bioject shall enter in
arrangements with any other customer who purchases a similar or lesser
volume of Products from Bioject providing for a lower price for any
similar products taking into account any price concessions reasonably
resulting from such other purchaser's payment of a higher license fee
to Bioject, then this Agreement shall thereupon be deemed amended to
provide the same price to Serono, and notice thereof and any credit
due shall promptly be given to Serono by Bioject. All other terms and
conditions of sale to Serono, including warranty provisions with
respect to the Products, shall at all times be at least as favorable
to Serono as those terms offered to any other customer with respect to
similar products, including any wholesaler or distributor. In the
event of any shortages or capacity limitations, Bioject shall supply
Products to Serono to the best of its ability and shall not favor any
other customer over Serono.
6.3 Customer Prices and Terms. Serono shall be solely responsible for the
prices and other terms and conditions upon which it resells or
otherwise
-6-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
disposes of the Products, and Serono hereby acknowledges that Bioject
has no control whatsoever with respect to such resale prices or other
terms and conditions of resale but Bioject reserves the right to
advertise its list prices for similar products from time to time.
7. Payment for Products.
7.1 Product Purchase Price. The full price of all Products including
applicable shipping, insurance and taxes along with payment for any
other items for which Serono owes payment to Bioject shall be paid in
U.S. Dollars no later than 45 days after Serono's receipt of Bioject's
invoice or on such other terms agreed to in writing by the parties in
advance of the obligation for such payments. Bioject shall not issue
any invoice prior to performing the service billed or shipping the
Products billed.
7.2 Late Charge. Any amount not paid when within 45 days of Serono's
receipt of Bioject's invoice shall accrue a late payment charge at the
rate of one percent (1%) per month thereafter, provided that the fee
charged shall not exceed the highest rate permitted under applicable
law. The late payment charge shall be payable by Serono
notwithstanding any other remedy elected by Bioject under this
Agreement, including without limitation termination of the Agreement
in accordance with Section 20.4, below.
8. Delivery, Shipment and Inspection.
8.1 Delivery; Shipment. Delivery of the Products purchased by Serono shall
be made F.O.B. Bioject's factory in the continental United States, and
Bioject will give Serono firm shipment dates of all shipments in
accordance with Serono's Purchase Orders. Products at the time of
delivery will be in good condition and packaged for shipment in
accordance with standard commercial practices and Serono's reasonable
instructions. Serono shall take title to the Products upon such
delivery and all risks of loss and expenses in connection with the
Product shall thereafter rest upon Serono including, without
limitation, all risks and expenses incurred in the storage, cartage
and transportation of the Products, as well as all insurance, fees,
charges, taxes, customs, duties and governmental charges or levies and
all other charges and expenses whatsoever thereafter incurred with
respect to the Products. At the request of Serono, but at the sole
expense of Serono, Bioject shall procure insurance coverage for
shipments of the Products.
8.2 Inspection. Serono shall promptly perform an external visual
inspection of shipping cartons containing Products following receipt.
Serono shall also perform quality assurance testing on a sample basis.
Serono shall notify Bioject in writing within sixty (60) days after
arrival of any packing shortages or of any other failure of the
Products to conform to this Agreement based on its external visual
inspection of the shipping
-7-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
cartons and actual sample testing. Subject to Section 12 hereof,
Serono further shall notify Bioject in writing of any other failures
of the Product to conform to the Agreement within sixty (60) days
after the date of Serono's actual discovery thereof. All notifications
shall be accompanied by packing slips, inspection reports and all
other documents supporting Serono claims.
8.3 Partial Shipments. Bioject shall, if requested by Serono, have the
right to make partial shipments; each partial shipment shall be deemed
a separate sale and payment therefore shall become due in accordance
with the provisions of this Agreement.
9. Assistance and Training. Bioject shall, as reasonably requested by Serono,
render advice to Serono in connection with Serono's soliciting orders,
familiarize Serono with the operation of the Products, and render
assistance to Serono in training Serono's employees in connection with
soliciting orders for the Products.
Any training and assistance requested by Serono which necessitates travel
or other additional out-of-pocket costs to Bioject shall be at Serono's
expense and shall be due and payable within 45 days of invoicing.
10. Additional Obligations of Serono.
10.1 Personnel. Serono shall engage qualified representatives who are
familiar with the Products and their uses to sell the Products.
10.2 Promotions. Serono shall refrain from false or misleading sales or
promotions concerning the Products.
10.3 Territory. Serono shall refrain from establishing or maintaining any
branch, warehouse or distribution facility for the Products outside of
the Territory. Serono shall not engage in any advertising or
promotional activities relating to the Products directed primarily to
customers outside the Territory. Serono shall not solicit orders
directly from any prospective purchaser with its principal place of
business located outside the Territory.
If Serono receives any order from a prospective purchaser whose
principal place of business is known to Serono to be located outside
the Territory, Serono shall promptly refer that order to Bioject.
Serono shall not knowingly accept any such orders. Serono may not
deliver or tender (or cause to be delivered or tendered) any Product
outside of the Territory.
10.5 Compliance With Laws. Serono shall comply with all applicable
requirements of law, including without limitation requirements of the
FDA and of any similar non-U.S. government agency; shall obtain at its
own expense all licenses, permits, certificates or regulatory
clearances
-8-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
which are required under applicable law to conduct its business and to
resell the Products as contemplated herein; and shall comply with all
other laws, rules and regulations applicable to such business.
10.6 Customer Complaints. Serono shall provide, upon Bioject's request,
copies of customer complaints received by Serono concerning the
Products. Serono shall cooperate fully with Bioject in dealing with
customer complaints concerning the Products and shall, at Bioject's
cost and expense, take such action as Bioject reasonably may request
to resolve such complaints.
10.7 Training. Serono also shall provide ongoing training services to its
customers who are medical professionals administering Serono's human
growth hormone product with the Products to the extent necessary to
assure that such personnel are adequately trained to utilize the
Products.
10.8 Inventory. Serono shall have the system capabilities to trace
shipments of Products by customer via product code and lot. Serono
agrees to maintain inventory levels of Bioject Products appropriate
for the Field and the Territory.
11. Advertising, Demonstration and Training Materials.
11.1 Materials. Bioject will furnish to Serono, at its own cost, copies of
all sales and promotional materials such as sales literature,
technical data, instruction manuals, technical journal reprints and
training videos, with respect to the Products as Serono may reasonably
request from time to time. All such materials shall be in such formats
as Serono may reasonably request to permit Serono to develop its own
custom version of the materials for use in marketing the Products as a
delivery system for Serono's human growth hormone product. Bioject
shall cooperate with Serono to produce versions of Bioject's standard
materials which are appropriate for use by Serono in marketing the
Products as a delivery system for Serono's human growth hormone
product. Any materials loaned to Serono such as film or artwork for
the purpose of Serono preparing its own promotional material must be
promptly returned to Bioject no later than the date specified in
writing by Bioject or, if not specified, 30 days after being made
available by Bioject for such use. Should Serono fail to return such
items to Bioject after written request, Bioject will invoice Serono
for the replacement cost of such items and Serono will pay for the
cost of such items in accordance with Section 7.1 of this Agreement.
11.2 Translation. Serono shall translate, at its own expense, all user and
technical manuals, and advertising and marketing information, into the
languages of its customers accurately. Serono agrees to provide
Bioject with copies of such materials prior to their use or
dissemination by
-9-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Serono. Serono further agrees to provide Bioject with advance copies
of any other promotional and technical materials regarding the
Products prepared by Serono for review and approval by Bioject, such
approval not to be unreasonably withheld or delayed.
11.3 Demonstration Units. Bioject agrees to furnish to Serono, at Bioject's
own cost, a reasonable number of Products necessary to provide
demonstrations to interested, potential customers. The quantity of
Products supplied by Bioject to Serono for demonstration purposes
shall be not less than *** needle-free devices and associated
supplies. As of the date of this Agreement, *** demonstration devices
have been delivered by Bioject to Serono.
12. Warranties, Limitation and Disclaimer of Warranties and Limitation
Remedies.
12.1 Warranty. Bioject represents and warrants to Serono (and to its
distributors, customers and users of the Products) that the Products
shall be free from defects in materials and workmanship for a period
of eighteen (18) months from the date of delivery by Serono or its
distributors or wholesalers to the end user. Serono shall be
responsible for providing reasonable proof of the shipment date. This
Warranty does not apply to Products which have been altered, used for
a purpose other than one for which they were manufactured, or used in
any manner inconsistent with Bioject's written instructions.
This Warranty expires absolutely at the end of eighteen (18) months
following sale of the Products by Serono or its distributors or
wholesalers to the end user. No defects discovered after the end of
such period are covered by this Warranty.
The Warranty set forth in Section 12.1 herein applies to demonstration
Products only so long as they are used as demonstration Products and
shall terminate upon the earlier of 18 months from the date of first
use or the time of the first use for other than demonstration purpose.
12.2 Claim for Breach of Warranty. Serono (or its distributor, customer or
any end user) shall notify Bioject in writing of any defect within
sixty (60) days following the time prescribed in Section 12.1 and, at
Bioject's request, shall send the part or item believed to be
defective to Bioject, F.O.B. Bioject's designated facility for
examination and inspection. Serono (or its distributor, customer or
any end user) shall furnish in writing the serial number of each such
Product and a description of the alleged defect. Bioject shall not be
responsible for any defect due to alteration or improper use of the
Products. Bioject will return any repaired or replacement items to
Serono (or its distributor, customer or any end user), F.O.B.
Bioject's facility. Bioject will provide reimbursement or credit for
shipping costs with respect to Products found to have a defect covered
by this Warranty. With respect to Products that are defective, but do
not cause personal injury, death or a
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
recall and provided that the defects are not so frequent or numerous
so as to constitute a substantial failure to supply Products in
accordance with Serono's forecasts and Purchase Orders, the exclusive
remedy for breach of Bioject's Warranty hereunder shall be, at
Bioject's option, repair or replacement of the units of Products which
were not as warranted or refund of the purchase price with respect
thereto.
12.3 Product Meets Specifications and cGMPs. Bioject represents and
warrants that all Products delivered to Serono hereunder shall: (i)
have been manufactured in accordance with this Agreement, current Good
Manufacturing Practices and all applicable laws, regulations and
rules, all as in effect from time to time; and (ii) meet the
Specifications for the Products and all commitments made in regulatory
filings for the Products. Bioject further represents and warrants that
no Product shall be adulterated or misbranded as those terms are used
under the Federal Food, Drug and Cosmetic Act, as amended, due to any
action or omission of Bioject.
12.4 Product Approvals; Licensing. Bioject has secured (or will secure) and
will maintain in effect all approvals, licenses and permits necessary
for the manufacture, marketing, sale and use of the Products to
administer Serono's human growth hormone product in the United States
and Canada and, after and exercise of the option to extend the
Territory to all countries of the world, in Japan and all countries of
the European Union and such other foreign countries requested by ***.
Bioject represents and warrants that it has obtained and will maintain
on a current basis and will comply with all licenses, permits and
approvals of applicable governmental agencies as may be required for
its facilities and the manufacture of the Products and to perform its
obligations hereunder. Bioject represents and warrants that it has not
received any notice of adverse findings or similar regulatory letters
from regulatory agencies with respect to the Products or similar
products or the facilities in which the Products will be manufactured.
Bioject has disclosed to Serono all information relevant to the safety
and efficacy of the Products and similar products in its possession as
of the date hereof, and will disclose to Serono promptly and on a
continuous basis all additional such information obtained in the
future.
12.5 Compliance with Laws. Bioject represents and warrants that it shall
comply in all respects with all federal, state, and local laws,
regulations and other requirements applicable to the Products and the
performance of Bioject's obligations under this Agreement.
12.6 DISCLAIMER OF WARRANTY. EXCEPT AS EXPRESSLY PROVIDED IN THE ABOVE
WARRANTY, BIOJECT MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS, WHETHER AS TO
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER
MATTER. NO AGENT, EMPLOYEE OR REPRESENTATIVE OF BIOJECT HAS ANY
AUTHORITY
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
TO BIND BIOJECT TO ANY AFFIRMATION, REPRESENTATION OR WARRANTY, EXCEPT
AS STATED HEREIN.
12.7 Maximum Liability. The maximum liability of one party to the other for
economic losses under this Agreement, including with respect to claims
under Section 13 (Indemnification), shall be $***. This limitation
shall not apply to recalls of a Product, claims, costs and losses
arising from personal injury or death caused by use of the Products or
Serono's growth hormone product, or any breach of Sections 1.6, 3 or
17.
12.8 Warranties of Serono. Any warranties or representations, or any
remedies for breach thereof, which Serono may provide to its customers
which are different from or in addition to the warranties and remedies
provided by Bioject under this Agreement shall be solely the
responsibility of Serono, and Bioject shall not be bound thereby in
any manner whatsoever.
13. Indemnification.
13.1 Definition of Claims. For purposes of this Agreement, "Claims" shall
mean any and all claims, demands, losses, liabilities, lawsuits,
proceedings, damages, settlement amounts and costs and expenses,
including, without limitation, attorneys' fees and costs.
13.2 Indemnification by Bioject. Bioject shall indemnify, defend, and hold
Serono, its wholesalers and distributors and their Affiliates and the
officers, directors, employees, agents, representatives and
independent contractors of each of them, harmless from and against any
and all Claims arising from or related to: (i) injury, death or other
loss caused by use of the Products; or (ii) Bioject's negligence,
willful misconduct or breach of this Agreement or any undertaking,
covenant, representation or warrant contained herein. The Parties
acknowledge and agree that acceptance by Serono of any Product or
expiration of any warranty set forth in Section 12 shall not affect
its rights to indemnification hereunder.
13.3 Indemnification by Serono. Except with respect to any matter covered
by Section 13.1 above, Serono shall indemnify, defend, and hold
Bioject and its Affiliates and the directors, officers, employees,
agents, representatives and independent contractors or each of them,
harmless from and against any and all Claims arising from or related
to: (i) injury, death or other loss caused by use of Serono's human
growth hormone product; or (ii) Serono's negligence, willful
misconduct or breach of this Agreement or any undertaking, covenant,
representation or warranty contained herein.
13.4 Procedures. Any party seeking indemnification hereunder (the
"Indemnified Party") shall give the other party (the "Indemnifying
Party") prompt written notice of the Claims for which indemnification
is sought.
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Failure of an Indemnified Party to provide notice of a Claim to the
Indemnifying Party shall affect the Indemnified Party's right to
indemnity only to the extent such failure shall have a material
adverse effect on the Indemnifying Party's ability to defend or the
nature or amount of liability. Claims shall be defended by the
Indemnifying Party with counsel selected by it. The Indemnified Party
shall have the right to be represented by advisory counsel and other
representatives, at its own expense. The Indemnifying Party shall keep
the Indemnified Party reasonably informed as to the status of the
Claim. The Parties shall render to each other such assistance as may
be reasonably required for the proper and adequate defense of a Claim.
Except as otherwise provided in Section 13.4, the Indemnifying Party
shall not make any settlement of any Claim without the written consent
of the Indemnified Party, which consent shall not be unreasonably
withheld or delayed. Notwithstanding the foregoing, the Indemnifying
Party may make any settlement which solely involves the payment of
money and which the Indemnifying Party actually pays.
14. Mandatory Insurance.
14.1 By Bioject.
(a) During the term of this Agreement, Bioject shall procure and
maintain in full force and effect, at its own cost and expense, insurance
against the risks specified in this Agreement in amounts not less than the
amounts specified in (b), below.
(b) Bioject shall maintain the following minimum coverages with
respect to the matters covered by this Agreement:
(1) Worker's Compensation insurance in compliance with the
Worker's Compensation laws of the state or states in which
Bioject has employees performing work under this Agreement, and
employer's liability insurance with respect to such employees
with a minimum limit of $100,000/occurrence.
(2) Commercial general liability insurance including premises,
broad form property damage, contractual, products/completed
operations coverage, with a minimum limit of $5,000,000 each
occurrence.
(c) Terms of such coverage shall be evidenced by certificates of
insurance issued by a recognized insurer rated by A.M. Best A-(XV) or
better, to be furnished by Bioject to Serono at the inception of this
Agreement and as may be reasonably requested thereafter. Such certificates
shall name Serono and its Affiliates or their agents, employees or
directors, as additional insured, as their interests may appear, and
provide that thirty (30) days' written notice shall be given to Serono
prior to cancellation, modification or expiration of any of the terms of
coverage of any policy.
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
14.2 By Serono.
(a) During the Term of this Agreement Serono shall procure and
maintain in full force and effect, at its own cost and expense, insurance
against the risks specified in this Agreement in amounts not less than the
amounts specified in (b), below.
(b) Serono shall maintain the following minimum coverages with respect
to the matters covered by this Agreement:
(1) Workers' Compensation insurance in compliance with the
Worker's Compensation laws of the state or states in which Serono
has employees performing work under this Agreement, and
employer's liability insurance with respect to such employees
with a minimum limit $100,000/occurrence.
(2) Commercial general liability insurance including premises,
broad form property damage, contractual, products/completed
operations coverage, with a minimum limit of $5,000,000 each
occurrence.
(c) Terms of such coverage shall be evidenced by certificates of
insurance issued by a recognized insurer rated by A.M. Best A-(XV) or
better, to be furnished by Serono to Bioject at the inception of this
Agreement and as may be reasonably requested thereafter. Such certificates
shall name Bioject and its Affiliates, or their agents, employees or
directors as an additional insured, as their interests may appear, and
provide that thirty (30) days' written notice shall be given to Bioject
prior to cancellation, modification or expiration of any of the terms of
coverage of any policy.
15. Recall of Product.
15.1 Notice. In the event either party has reason to believe that any
Product should be recalled or withdrawn from distribution such party
shall immediately inform the other in writing in a factual,
non-judgmental manner.
15.2 Decision. The decision as to whether or not to initiate a recall may
be made by Serono after consultation with Bioject. Serono shall
conduct any recall.
15.3 Bioject's Liability. If such recall is required because of failure of
a Product to conform to the warranties in Section 12 or due to any
other defect relating to the Products, then the costs and expenses of
such recall shall be paid or reimbursed by Bioject and, at Serono's
option, Bioject shall replace such recalled Products or issue a credit
in favor of Serono or refund the purchase price of such recalled
Products.
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
15.4 Serono's Liability. If such recall is required because of a negligent
act or omission by Serono in the handling, storage or distribution of
a Product, then such recall shall be conducted by Serono at its sole
cost and expense and Serono shall not be entitled to any such credits,
replacements or refunds from Bioject.
16. Independent Contractor. This Agreement does not designate either party as
an agent, employee, joint venturer, partner, franchisee or legal
representative of the other party for any purpose whatsoever. Neither party
is granted, and at no time shall imply or claim that it possesses, any
right or authority to assume or create any obligation or responsibility on
behalf or in the name of the other party or to bind it in any manner
whatsoever. The Products purchased by Serono shall be owned by Serono, and
Serono shall handle the same at its own risk, assuming directly all
responsibility for its costs and expenses related to this Agreement and all
contingencies of profit and loss with respect to its performance of its
responsibilities and duties under this Agreement, Serono shall have the
sole right to control the manner in which it performs its responsibilities
and duties under this Agreement, subject to no control by Bioject except as
otherwise expressly provided in this Agreement and shall not be entitled to
any assistance from Bioject with respect to the performance of such duties
except as otherwise expressly provided in this Agreement. Serono is solely
responsible for making, and represents that it has made, its own
determination concerning the availability of a market for the Product and
acknowledges that Bioject has made no claims, representations or statements
to the effect (a) that there is a market for the Products; (ii) that
Bioject will locate customers for Serono; or (iii) that Serono will earn a
profit in the business of distributing the Products. Serono and Bioject
shall each indemnify and save each other harmless from and against all
claims, damages, losses, liabilities, expenses and costs (including
reasonable attorneys' fees) related to or arising out of any action of
conduct, or failure to act, of or by Serono and Bioject, their employees or
agent, including those purported but not actually authorized in writing by
any authorized officer of Bioject or Serono.
17. Protection of Confidential Information and Trademarks.
17.1 Information. Serono and Bioject acknowledge that they may acquire from
the other, certain trade secrets and confidential information relating
to know-how, technical data, service, promotion and sale of the
Products or human growth hormone, and the identity of customers and
potential customers. Serono and Bioject agree that the foregoing is of
substantial value in their respective businesses and each agrees to
keep the same confidential and not to disclose it to any person during
or after the term hereof. Notwithstanding the foregoing, Bioject
acknowledges that Serono possesses substantial information regarding
the market, customers and potential customers for and other
information about human growth hormone and human growth hormone
delivery systems. All of this existing information, including
additional information obtained or developed by Serono during the
course of this Agreement,
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
shall be the confidential information of Serono and Bioject shall not
acquire any interest therein.
17.2 Exceptions to Mutual Confidentiality Obligations. The obligation to
maintain in confidence all confidential information shall survive the
termination of this Agreement, but shall not apply to any information:
(a) which was known to the receiving party at or prior to the time of
its disclosure by the disclosing party as evidenced by the receiving
party's written records; (b) which becomes lawfully known to the
receiving party without any obligation of confidentiality at any time
through a third party not in breach of an obligation of
confidentiality; (c) which is or becomes known to the general public
through no fault of the receiving party; (d) which is independently
developed by the receiving party; (e) which the receiving party is
required by law to disclose, provided notice of such disclosure shall
be given promptly to the disclosing party so that it may take
reasonable actions to avoid and minimize the extent of such
disclosure.
17.3 Regulatory Exception of Serono. Serono shall be entitled to submit and
disclose to any regulatory authority and in any regulatory application
any and all information, including confidential information of
Bioject, required by law or regulation or deemed necessary by Serono
to obtain approvals for the marketing, sale and use of its human
growth hormone product with the Products in the Territory.
17.4 Bioject's Trademarks. Bioject hereby authorizes Serono to use
Bioject's trademarks and trade names for the Products solely in
connection with advertising, promoting, selling, or servicing the
Products during the term of this Agreement. Serono may not use the
name "Bioject" in its corporate or business name, or in any other
manner which Bioject deems adverse to its interest.
17.5 Serono's Trademarks. The Products shall be "private-labeled" with
tradenames and trademarks designated by Serono. Serono shall own and
have the exclusive right, title and interest in and to all such
tradenames and trademarks during and after the term of this Agreement.
Bioject shall have no right to use such tradenames or trademarks
except as directed by Serono during the term of this Agreement.
17.6 Termination. The authorization to use names, trademarks and trade
names owned by Bioject shall terminate effective upon termination of
this Agreement for any reason, and Serono thereupon shall cease all
use of names, trademarks, or trade names owned or used by Bioject,
except for a Product already owned by Serono.
17.7 Patent Prosecution and Infringement. Bioject shall, at its cost,
prepare and diligently prosecute patent applications covering the
Products in the
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Territory and continuations, divisions, renewals and reissues thereof.
Bioject shall diligently enforce its patent rights.
18. Inventions and Indemnitees.
18.1 Inventions, Modifications, and Improvements in the Field. New
techniques, inventions, processes, and know-how (hereinafter "New
Developments") relating to the Products or the Field may be developed
by Serono, Bioject or by Serono and Bioject jointly during the
performance of this Agreement. Serono shall own any New Developments
which are developed solely by Serono. To the extent that any such New
Developments are created by Bioject or jointly by Bioject and Serono,
in either case, at the direction or expense of Serono pursuant to
Section 1.2, then Serono shall have ownership of such New Developments
and Bioject shall have a non-transferable, non-exclusive,
royalty-free, worldwide, perpetual license to make and use the New
Developments as long as Bioject's use does not compromise Serono's
proprietary or confidential information. Notwithstanding the grant of
such license, Bioject shall not use any such New Development to
compete, or assist third parties to compete, directly or indirectly,
with Serono in the sale of human growth hormone for any therapeutic
use. Bioject agrees to cooperate in the filing and prosecution of all
New Development patent applications owned by Serono and to take all
other actions requested by Serono to vest ownership of all New
Developments in Serono.
18.2 Indemnity by Bioject. Bioject shall indemnify, defend and hold Serono,
its Affiliates and their respective officers, directors and employees
from and against any damages, liabilities, costs and expenses
(including reasonable attorneys' fees and court costs) (collectively,
"Damages") arising out of claims that proper use of the Products in
the Field, in accordance with its instructions infringe on the
intellectual property rights of third parties; provided, however,
that: (a) Serono shall have promptly provided Bioject with written
notice thereof and reasonable cooperation, information, and assistance
in connection therewith; and (b) Bioject shall have sole control and
authority with respect to the defense, settlement, or compromise
thereof; provided, however, that any settlement or compromise that
would impose liability on Serono shall require Serono's prior written
consent.
18.3 Indemnity by Serono. Serono shall indemnify, defend and hold Bioject,
its Affiliates and their respective officers, directors and employees
from and against any damages, liabilities, costs and expenses
(including reasonable attorneys' fees and court costs) (collectively,
"Damages") arising out of claims that proper use of any human growth
hormone, in accordance with its instructions infringe on the
intellectual property rights of third parties; provided, however,
that: (a) Bioject shall have promptly provided Serono with written
notice thereof and reasonable cooperation, information, and assistance
in connection therewith; and
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
(b) Serono shall have sole control and authority with respect to the
defense, settlement, or compromise thereof; provided, however, that
any settlement or compromise that would impose liability on Bioject
shall require Bioject's prior written consent.
18.4 Notification of Suit. Each indemnified party shall give the
indemnifying party written notice of any suit or action described in
Section 18.2 or 18.3 wherein indemnification is claimed. Such notice
shall be given within 30 days after acquiring such knowledge or at
least five days prior to the expiration of time in which a response
must be filed with a court or other judicial body, whichever is first
to occur.
19. Initial Term and Renewal. Unless sooner terminated as hereinafter provided,
this Agreement shall continue in force for three years from the Effective
Date. Thereafter, this Agreement may be renewed only by written agreement
of the parties.
20. Termination. This Agreement may be terminated as set forth below.
20.1 Mutual Termination. This Agreement may be terminated by mutual written
agreement executed by both parties.
20.2 Termination by Serono. Serono may terminate this Agreement without
cause or reason at any time upon 90 days notice to Bioject.
20.3 Delay in Regulatory Approval. Either party may terminate this
Agreement at any time after *** if Bioject shall not have secured
approval from the FDA of the marketing, sale and use of the Products
as a delivery system for Serono's human growth hormone.
20.4 Breach. Either Serono or Bioject may terminate this Agreement
effective upon sending written notice to the other, if a party fails
to pay the other any amount when due or commits any other breach or
default hereunder or otherwise fails to perform any of its duties or
responsibilities hereunder; provided that such failure to pay or such
other breach, default or nonperformance shall have continued for a
period of thirty (30) business days following receipt by a party of a
written notice from the other specifying the nature of such failure to
pay or such other breach, default or nonperformance. Notwithstanding
such termination, Serono shall continue to be obligated to accept and
pay for any of the Product ordered by Serono prior to the sending of
such notice. Similarly, any late payment charges accruing pursuant to
Section 7.3 above, survive such termination.
20.5 Insolvency. If (a) a party becomes insolvent; or a petition in
bankruptcy is filed by or against a party; or a party makes an
assignment for the benefit of its creditors; or a receiver or trustee
is appointed for any of a party's property; or (b) a party fails to
cure or remedy any breach, default or non-performance for which
written 30-day notice has been sent by a
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
party, then the other party may (i) terminate this Agreement,
effective upon the sending of written notice of such termination; (ii)
suspend its performance hereunder and stop any shipments in transit;
(iii) declare all amounts unpaid hereunder to be due and payable
immediately; or (iv) exercise any and all other remedies provided by
applicable law.
21. New Needle Free Devices. Bioject shall inform Serono on a quarterly basis
of each needle-free device that Bioject or any of its Affiliates is
developing or has acquired rights. If Serono *** to *** to the *** pursuant
to Section *** then, thereafter, as Bioject *** in or to *** which is not
*** and which could be ***, Bioject shall promptly provide Serono with ***.
The *** shall propose terms on which Serono may *** to *** and *** for ***,
and, alternatively, ***. Upon receipt of a ***, Serono shall have *** to
either *** of *** in the *** for the *** or provide a *** to Bioject. If
Serono *** of the *** for the ***, the parties shall prepare and execute an
agreement reflecting the terms of their arrangement. If Serono provides a
***, Bioject shall *** and *** for a *** to establish ***. If Serono does
not accept the terms of Bioject's *** and the parties do not agree on terms
pursuant to which Serono could ***, then Bioject may, at any time
thereafter, grant *** with respect to *** to *** on ***. Bioject shall not
discuss or negotiate for the *** with respect to a *** for *** until it has
provided any *** to Serono and the applicable time periods have expired.
22. Remedies Cumulative. The remedies provided herein to Bioject and to Serono
shall be cumulative and in addition to all other remedies which it may
exercise in equity or at law, and its exercise of any one or more of such
remedies, or a waiver of its right to exercise any other remedy or remedies
at the same time or at any other time shall not be deemed to be a waiver of
any other remedy of Bioject or Serono.
23. Duties Upon Termination. Upon termination, at the request of Serono,
Bioject shall fill all of Serono's orders for the Products as set forth in
the binding portion of its rolling forecast and Serono shall purchase and
pay for all Products subject to such orders. Serono may continue to sell
Products until it has disposed of its inventory.
24. Survival. Termination shall not affect the continued operation or
enforcement of the following Sections of this Agreement: 12, 13, 15, 17.1,
17.2, 17.5, 18, 22, 23, 25, 27, 29, 30 and 31.
25. Nonliability for Termination. If either party shall terminate this
Agreement in accordance with the terms hereof, then such terminating party
shall not be liable to the terminated party for any losses, damages,
expenditures, investments or commitments made by such terminated party
pursuant to or in connection with this Agreement, whether related to such
terminated party's lost business, lost profits, lost goodwill or otherwise.
26. Force Majeure. Neither party shall be deemed to be in breach hereof or
liable to other party or any other person in any manner on account of any
delay in delivery or other performance caused in whole or in part by, or
otherwise
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
materially related to the occurrence of any contingency beyond such party's
reasonable control, including without limitation, fire, flood, riot,
hostilities, strikes or other labor disputes, freight embargoes or
transportation delays; shortage of labor; inability to secure fuel, energy,
materials, supplies or power at reasonable prices from regular sources or
on account of shortages thereof; delays or failures of any of such party's
suppliers to deliver; acts of God or of a public enemy; or any existing or
future laws, acts or regulations of the Federal or of any state or local
government (including specifically but not exclusively any orders, rules or
regulations issued by an official, court or agency of any such government)
affecting the conduct of such party's business with which such party, in
its judgment and discretion, deems it advisable to comply as its legal
duty.
27. Entire Agreement; Modification and Waiver. This Agreement, together with
the Schedules attached hereto, constitute the complete understanding and
contract with respect to the subject matter hereof. Neither Bioject nor
Serono shall be bound by any purported rescission, addition, modification,
or waiver of any provision hereof, or any purported waiver, or any breach
hereof unless such rescission, addition, modification or waiver is set
forth in a writing signed by an authorized agent of either Bioject or
Serono, respectively.
28. Nonassignment. Except as provided in Section 1.7, neither party may assign,
transfer or sell all or any part of its right, benefits or privileges
hereunder without the other party's prior written consent. Any attempt to
do so without such prior consent shall be wholly void. This Agreement will
be transferred and assigned on all legal successors of Bioject and Serono
and (i) any successor to Serono's business of selling human growth hormone
for the treatment of growth deficiencies or (ii) any successor to Bioject's
business of selling needle-free devices.
29. Public Announcements. Neither Serono nor Bioject will originate any
publicity, news release, or other public announcement or comments, written
or oral, whether to the press, stockholders or otherwise, related to this
Agreement without the consent of the other party, except as may be required
by law. The party making any announcement which it reasonably believes to
be required by law will first give the other party an opportunity to review
the form and content of any such announcement and comment upon it before it
is made.
30. Notices. Any notice required or permitted to be made or given under this
Agreement shall be in writing and transmitted by hand, prepaid certified
mail, air courier or telecopier addressed to the party to whom the notice
is given at its address or telecopier number shown below or at such other
address as the addressee shall have theretofore furnished in writing to the
other party.
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***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Until changed, the address of Bioject shall be as follows:
Bioject, Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Attention: President
Telecopier: (503) 624-9002
with a copy to:
Michael Redmond
Bioject Inc.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Telecopier: (503) 624-9002
Until changed, the address of Serono shall be:
Serono Laboratories, Inc.
100 Longwater Circle
Norwell, MA 02001
Attention: President
Telecopier: (781) 982-9478
with a copy to:
Serono Laboratories, Inc.
100 Longwater Circle
Norwell, MA 02001
Attention: General Counsel
Telecopier: (781) 878-6954
Notices or written communications shall be deemed to have been sufficiently
made or given (i) if by in-hand delivery or by telecopier with confirmed
transmission, when performed, (ii) if mailed, five (5) days after being
deposited in the mail, postage prepaid; or (iii) if by air courier, one (1) day
after delivery to the air courier company.
31. Construction of Agreement, Controlling Law. This Agreement, which is in
English, shall be interpreted in accordance with the commonly understood
meaning of the words and phrases hereof in the United States of America,
and it and performance of the parties hereto shall be construed and
governed according to the laws of the State of New York applicable to
contracts made to be fully performed therein.
SCHEDULES 1.1 (Specifications) 2.1 (Patents), 5 (License Fees and Purchase
Quotes) AND 6.1 (Product Pricing) ATTACHED HERETO ARE A MATERIAL PART OF THIS
AGREEMENT AND ARE INCORPORATED HEREIN BY THIS REFERENCE.
-21-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
in the manner appropriate to each, effective as of the date entered on the first
page hereof.
BIOJECT, INC. SERONO LABORATORIES, INC.
By: ---------------------------- By: ------------------------------
Title: ------------------------- Title: ---------------------------
-22-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
SCHEDULE 1.1
SPECIFICATIONS
Description: ***.
Weight: ***
Size: ***
Dosage Range: ***
Dosage Scale Graduation: ***
Duration of Injection: ***
Jet Nozzle Sizes: ***
Jet Pressure Setting: ***
-23-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
SCHEDULE 2.1
LICENSED PATENTS
United States Patent No. 5,782,802
Any other U.S. or foreign patents applicable to the Products held by or
licensed to Bioject.
-24-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
SCHEDULE 5
LICENSE FEES AND PURCHASE QUOTAS
License Fees
o Serono shall pay Bioject a one-time $*** license fee for the exclusive
license and distribution right of the Products for the Field in the United
States, its territories and possessions and Canada upon execution of this
agreement.
o Serono shall pay Bioject a one-time $*** additional license fee in two
installments pursuant to Section 1.6 if it elects to extend the exclusive
license in the Field to all countries of the world.
Annual Purchase Quotes
o For each twelve month period after FDA approval of Bioject's 510K
application for marketing, sale and use of the Products as a delivery
system for Serono's human growth hormone, Serono shall make the following
purchases of Products in order to maintain exclusivity in the United States
and Canada:
***
***
***
***
***
Notwithstanding the foregoing, if Serono's purchase of Products during any
such twelve month period is less than the quota, Serono may make a payment equal
to one-half of the shortfall and maintain exclusivity.
Serono shall purchase $*** of Products within *** after written notice from
Bioject that Bioject has received FDA approval of its 510K application for the
marketing, sale and use of the Products as a delivery system for Serono's human
growth hormone product.
o For each twelve month period after the first anniversary of any exercise by
Serono of its option to extend the Territory to all countries of the world
and approval of Bioject's application for marketing, sale and use of the
Products as a delivery system for Serono's human growth hormone in either
Japan or all countries of the European Union, Serono shall make the
following purchases of Products in order to maintain exclusivity in all
countries of the world (including the United States and Canada):
***
***
***
***
***
-25-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
Notwithstanding the foregoing, if Serono's *** during any *** is ***,
Serono may *** to ***. The *** shall be *** of the *** the *** and the *** by
Serono during the applicable period. Bioject shall have *** to *** in
consideration of *** because the purpose of *** is to *** for *** to ***.
-26-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<PAGE>
SCHEDULE 6.1
PRODUCT PRICING
Product Price
*** $***
Supplies Price
*** $***
*** $***
Serono: ----------
Bioject: ----------
Date: ----------
-27-
***Confidential portions omitted and submitted separately to the Securities and
Exchange Commission. An application for confidential treatment has been
submitted pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> MAR-31-2000
<PERIOD-END> DEC-31-1999
<CASH> 3,146,022
<SECURITIES> 0
<RECEIVABLES> 165,504
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<INVENTORY> 892,439
<CURRENT-ASSETS> 4,255,855
<PP&E> 4,631,902
<DEPRECIATION> (3,133,553)
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<CURRENT-LIABILITIES> 906,024
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0
14,454,761
<COMMON> 50,324,121
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<TOTAL-LIABILITY-AND-EQUITY> 6,294,938
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<CGS> 1,337,999
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<INCOME-PRETAX> (2,903,070)
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<INCOME-CONTINUING> (3,816,815)
<DISCONTINUED> 2,402,880
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