EXHIBIT 10.4
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EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
This Agreement is made and entered into this 22nd day of December, 1999
(hereinafter "Effective Date") by and between Medi-Ject, a Minnesota
corporation, having a place of business at 000 Xxxxxxxx Xxxx, Xxxxx 000,
Xxxxxxxxxxx, Xxxxxxxxx 00000 (hereinafter "Medi-Ject") and Bio-Technology
General Corp., a Delaware corporation, having a place of business at 00 Xxxx
Xxxxxx Xxxxx, Xxxxxx, Xxx Xxxxxx 00000, (hereinafter, "BTG").
Whereas BTG has developed an injectable pharmaceutical for treating human
growth disorders which BTG will produce, promote, distribute and sell in
different pharmaceutical forms for administration in humans for which the
Devices are of potential use and wishes to extend its product package with the
Devices; and
Whereas Medi-Ject has expertise in the design, manufacture and sales of
needle-free injector devices; and
Whereas Medi-Ject owns valuable Medi-Ject Know How (hereinafter defined)
and has been granted patent protection relating to the disposable front-end
chamber and adaptor for such needle-free injector devices and Medi-Ject is
desirous of developing, Exclusively licensing and supplying such devices in the
Territory to BTG for use in the treatment of human growth disorders and further
indications in the Field; and
Whereas BTG and Medi-Ject previously entered into the First Agreement and
were frustrated in the performance of the First Agreement by virtue of BTG
having been preliminarily enjoined from importing and selling hGH in the United
States; and
Whereas Medi-Ject has acquired the rights to an improved Device(s) which is
a needle-free injector device system capable of delivering drugs through the
skin in a controlled manner; and
Whereas BTG and Medi-Ject, in contemplation of BTG eventually being able to
import and market, whether by itself or through one or more third parties, or
both, hGH in the United States, desire to modify and reaffirm their business
arrangement by substituting this Agreement for the First Agreement;
Now Therefore, in consideration of the foregoing and mutual covenants and
conditions set forth herein, the parties hereto mutually agree as follows:
ARTICLE 1 - DEFINITIONS
-----------------------
1.1 "Affiliate(s)" means any corporation or business entity controlled either
directly or indirectly by beneficial ownership of 50% or more of the voting
stock of, or a
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50% or greater interest in the income of, such corporation or other
business entity, or the maximum ownership permitted by law or
administrative practice.
1.2 "Agreement" means this Exclusive License and Supply Agreement entered into
by and between BTG and Medi-Ject as of the Effective Date.
1.3 "BTG Know How" means all confidential, pharmaceutical, scientific, medical
and marketing information and technical data invented, developed, generated
or acquired by BTG (other than Medi-Ject Know How) relating to the
development, manufacture, use or sale of hGH or the Devices including but
not limited to clinical, pharmaceutical and scientific data and information
required for registration and marketing purposes in the Field in the
Territory other than Improvements which are explicitly dealt with as
separate issues in this Agreement.
1.3 "Device(s)(s)" means those Medi-Ject needle-free injector devices,
including the injector identified in Appendix A, which:
(a) comprise a Disposable Adaptor, Disposable Front End Chamber and a
Power Pack, individually or in any combination,
(b) which exhibit pressure and delivery characteristics satisfactory for
use in humans in the Field, and
(c) which are conceived by, owned by, or licensed, with the right to
sublicense, to Medi-Ject as of the Effective Date,
and any Improvements thereon made by or for Medi-Ject during the term of
this Agreement.
1.5 "Disposable Adaptor(s)" means a system which is used as the interface
between a vial of medicant and the Disposable Front End Chamber.
1.6 "Dispute" shall have the meaning ascribed to it in Section 11.13.
1.7 "Disposable Front End Chamber(s)" means a system which is filled with
medicant at the time of administration and used to hold and administer the
medicant needle-free.
1.8 "Exclusive" and/or "Exclusively" means that only BTG, its sublicensees, its
Affiliates and its designated distributors have the right to sell the
Device(s) or any other product that is developed by Medi-Ject, for use in
the Field.
1.9 "Field" means using hGH to treat any human ailment.
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1.10 "First Agreement" means Exclusive License and Supply Agreement effective as
of June 27, 1995 entered into by and between BTG and Medi-Ject.
1.11 "First Commercial Sale" means the invoice date of the first sale of
Finished Device(s)(s) and /or the Device(s)(s) in the Field and in the
Territory by BTG to an Independent Third Party through customary commercial
channels of distribution after having obtained all necessary governmental
approvals.
1.12 "hGH" means authentic human growth hormone having an amino acid sequence
identical to the amino acid sequence of naturally occurring human growth
hormone produced using mammalian cells or genetically engineered
micro-organisms.
1.13 "Improvements" means inventions, discoveries, developments, ideas and
indications related to the Device(s) including its design, materials used,
manufacture or use, which are first reduced to practice during the term of
this Agreement and which are not encumbered by an Independent Third Party
confidential information agreement between either party and the Independent
Third Party. If any such confidentiality agreement should exist, both
Medi-Ject and BTG shall make all reasonable efforts to request permission
from such Independent Third Party to disclose such information to the other
party.
1.14 "Independent Third Party" means any party other than Medi-Ject, BTG and
their Affiliates.
1.15 "Medi-Ject Know How" means all confidential, engineering, scientific and
medical information, technical data and marketing studies developed or
acquired by or on behalf of Medi-Ject or under the control of Medi-Ject
(other than BTG Know How) relating to the development, manufacturing, use
and sale of Device(s)(s), including, but not limited to, engineering,
design, analytical and clinical data, product forms, control assays and
specifications, methods of manufacturing and preparation data and
specifically including all information contained in all health registration
dossiers filed in various countries of the world to the extent that such
information is and continues to be confidential and shall further include
all confidential Independent Third Party data which Medi-Ject has access to
and is free to disclose without restriction or compensation to such
Independent Third Party other than Improvements which are explicitly dealt
with as separate issues in this Agreement.
1.16 "Net-hGH-Sales" means gross invoice of hGH sold by BTG, its Affiliates, and
its sublicensees to Independent Third Party customers, less (a) returns,
quantity and cash discounts, fees for hGH product distribution to BTG and
allowances thereon actually allowed (but not including cash discounts for
prompt payment); (b) government, managed care and other contract rebates,
including governmental rebates required by law and retroactive price
reductions imposed by public authorities; (c) sale taxes, use taxes and
other similar taxes; (d) any transportation,
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handling and insurance charges borne by the party, its Affiliates or
sublicensees calculated as an average of such party's actual costs for all
of its products in this category.
1.17 "Patent Rights" means those patents and patent applications identified in
Appendix B and all patents and patent applications filed by, or issued,
licensed or assigned to Medi-Ject in the Territory and during the Term
which relate to the Device(s) and which are useful in the Field, together
with any and all patents that may issue or may have issued therefrom,
including any and all divisions, continuations, continuations-in-part,
extensions, additions or reissues of or to any of the aforesaid patent
applications.
1.18 "Power Pack" means a medical device that serves as the source of power for
needle-free injecting of humans.
1.19 "Territory" means the United States of America, its territories and
possessions.
ARTICLE 2 -- DESIGN AND DEVELOPMENT
-----------------------------------
2.1 Medi-Ject hereby agrees to Exclusively design, develop and provide to BTG,
Device(s)(s) for use in the Field having a range of power settings and
orifice sizes suitable for use with BTG's pharmaceutical drug and vehicle
as described in specifications from time to time which are approved by both
parties.
2.2 Medi-Ject and BTG each agree to maintain Medi-Ject Know How or BTG Know How
received by it from the other party and Improvements and status of the
Device(s) development as Confidential Information and will exercise due
care to prevent its unauthorized disclosure during and for a period of ten
(10) years after the termination of this Agreement. Further, BTG will
provide Medi-Ject with the results of the development studies relating to
the performance of the Device(s) which will be considered as Confidential
Information. Confidential Information shall further include but not be
limited to, all business, marketing, scientific and technical information
including all designs, prototypes, special tooling, and any other
information disclosed hereunder and under the Confidentiality Agreement
between the parties in existence prior to the date of this Agreement,
except any portion thereof which:
(a) is known to Medi-Ject, as evidenced by Medi-Ject's written records,
before the disclosure by BTG;
(b) is disclosed by Medi-Ject after acceptance of this Agreement by a
third party, who is not under contract to Medi-Ject and who has a
right to make such disclosure; or
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(c) is or becomes party of the public domain through no fault of Medi-
Ject;
(d) is known to BTG, as evidenced by BTG's written records, before the
disclosure by Medi-Ject;
(e) is disclosed to BTG after acceptance of this Agreement by a third
party, who is not under contract to BTG and who has a right make such
disclosure; or
(f) is or becomes party of the public domain through no fault of BTG;
(g) both parties acknowledge and agree to allow disclosure of such
information described in this Section 2.2 by the receiving party, if
such information is required by court order, provided that the
disclosing party shall give the other party an opportunity to review
and approve such disclosure, said review and approval not to be
unreasonably withheld or delayed by either party.
2.3 Both parties agree not to use each other's Know How for any purpose other
than agreed to in this Agreement.
2.4 Both parties shall cooperate to secure regulatory approval for use of the
Device(s) with hGH.
2.5 Medi-Ject will provide to BTG any Improvements in relation to the
Device(s).
2.6 BTG shall provide to Medi-Ject an annual summary, commencing with the first
calendar year after the First Commercial Sale, of its marketing plans for
the Devices for information only. Medi-Ject shall treat such annual
summaries from BTG as Confidential Information.
2.7 Medi-Ject shall make available to BTG, on a reasonable consultation basis,
such advice of its technical personnel as may reasonably be requested by
BTG in connection with the Device(s).
2.8 Throughout the term of this Agreement, Medi-Ject and BTG shall provide to
each other promptly but no longer than within three (3) business days after
receipt all reports (each party is aware of) on adverse effects, which may
affect human use of the Devices. Upon receipt of any such report, the
parties shall consult each other and decide what consequences the new
observations shall have for the future sale of the Devices in the Field in
the Territory. Nothing contained herein shall, however, be construed as
restricting the obligations of either party to make a timely report of such
matter to the relevant government authorities in the Territory.
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2.9 Medi-Ject at its own cost shall have a continuing right in the Territory to
use, have used, manufacture and have manufactured Device(s) in the Field
for investigational and developmental purposes only, provided always that
Medi-Ject shall first inform BTG of its intentions so to do and shall
ensure that the said developments are first made available to BTG and are
not to the detriment of BTG in the Field in the Territory.
2.10 BTG at its own cost shall have a continuing right in the Territory to test,
and have tested, competitive needle-free injector drug delivery products
which have the same intended use as the Device(s) in the Field for
investigational and developmental purposes only, provided always that BTG
shall first inform Medi-Ject of its intentions so to do and shall ensure
that said developments are first made available to Medi-Ject and are not to
the detriment of Medi-Ject in the Field in the Territory.
ARTICLE 3 -- LICENSE GRANT, LICENSING FEES AND ROYALTIES
--------------------------------------------------------
3.1 Medi-Ject hereby grants to BTG the Exclusive and sublicensable right in the
Field in the Territory, under the Patent Rights and Medi-Ject Know How and
Improvements only for the Field, to use, have used, sell and have sold, but
not manufacture, the Device(s) in the Territory for the Term of this
Agreement.
3.2 All proprietary rights and rights of ownership with respect to the Patent
Rights and Medi-Ject Know How shall at all times remain solely with
Medi-Ject and BTG shall have no proprietary rights in or to the Patent
Rights and Medi-Ject Know How other than those specifically granted herein.
3.3 All proprietary rights and rights of ownership with respect to BTG Know How
shall at all times remain solely with BTG and Medi-Ject shall have no
proprietary rights in or to BTG Know How other than those specifically
granted herein.
3.4 All proprietary rights and rights of ownership with respect to Improvements
pertaining to Devices shall at all times remain solely with Medi-Ject and
BTG shall have no proprietary rights in or to the Device(s) related
Improvements other than those specifically granted herein.
3.5 All proprietary rights and rights of ownership with respect to Improvements
pertaining to pharmaceutical drugs shall at all times remain solely with
BTG and Medi-Ject shall have no proprietary rights in or to the
pharmaceutical drug related Improvements other than those specifically
granted herein.
3.6 BTG shall exert its best reasonable efforts to commercialize and to create
a demand for the Devices in the Territory under its own trademarks.
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3.7 BTG will be responsible for ensuring that the use, promotion and sale of
the Device(s) within the Territory is in accordance with the legal and
regulatory requirements of the Territory.
3.8 The choice and use of any trademarks to be used with the Device(s) other
than those Trademark(s) already used by Medi-Ject, shall remain with BTG.
3.9 Ownership of and rights to the BTG chosen trademark(s) shall remain with
BTG during and beyond the term of this Agreement. The use of the
trademark(s) shall be free of royalties and any other payments.
3.10 Nothing in this Agreement shall be construed, either explicitly or
implicitly, to grant either party a license to use each other's trademarks.
3.11 In consideration for Medi-Ject's Exclusive license to BTG as per this
Agreement, BTG has paid to Medi-Ject and Medi-Ject hereby acknowledges
receipt of licensing fees in the amount of Two Hundred Fifty Thousand US
Dollars (US$250,000) which constitutes payment in full of the licensing
fee.
3.12 Licensing fees and all other payments by BTG to Medi-Ject accruing in this
Agreement shall be paid in United States currency. Medi-Ject shall invoice
BTG in United States currency.
3.13 BTG shall pay to Medi-Ject royalties as follows in the event BTG uses its
right to use or have used, sell or have sold the Device(s) in the Field in
the Territory:
(a) BTG shall pay Medi-Ject a cumulative royalty on all hGH sold for use
with Device(s). The cumulative royalty shall be calculated based on
the Net-hGH Sales using Device(s) within the Territory after First
Commercial Sale where Device(s) is used or sold with hGH, and the
cumulative royalty rate shall be based on increased hGH marketshare,
in dollars, as follows:
% hGH Marketshare in dollars % Cumulative Royalty
using Device(s) to Medi-Ject
---------------------------- --------------------
0 to 10 1.0
10 to 15 2.5
>15 4.0
(b) BTG shall promptly give notice to Medi-Ject of the date of the First
Commercial Sale in the Field in the Territory.
(c) In the event the royalty rates set forth hereabove exceed those
allowable by applicable law or governmental rule or regulation, they
shall be so modified as to conform to the maximum royalty rate
allowable.
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3.14 Royalties due to Medi-Ject under Section 3.13 of this Agreement shall
accrue when payment for Device(s) are invoiced by BTG to any Independent
Third Party in the Territory in accordance with the provisions below.
3.15 Royalties occurring hereunder shall be due and payable on the sixtieth
(60th) day following the close of each quarterly period (March, June,
September, December).
3.16 Royalties accruing hereunder shall be paid to Medi-Ject or Medi-Ject's
designee, duly named by Medi-Ject in written notice to BTG.
3.17 Royalties and all other payments by BTG to Medi-Ject accruing in this
Agreement shall be paid in United States of America dollar currency.
3.18 If at any time, legal restrictions in the Territory prevent the prompt
payment of royalties or any portion thereof accruing hereunder, the parties
shall promptly meet to discuss suitable and reasonable alternative methods
of reimbursing Medi-Ject the amount of such running royalties.
3.19 Each payment of royalties made to Medi-Ject hereunder shall be accompanied
by a written report, signed by a financial officer of BTG, showing the
Net-hGH-Sales and Net-hGH-Sales using the Device(s) for the months of the
quarterly period for which payment is being made. In the event that no
royalty is due to Medi-Ject hereunder for any such quarterly period, BTG
shall so report.
3.20 BTG shall maintain and keep for a period of at least three (3) years,
complete and accurate records in sufficient detail to enable any royalties
which shall have accrued hereunder to be determined.
3.21 Upon the request of Medi-Ject, but not exceeding once in any calendar year
period, with a minimum of two (2) weeks notice from Medi-Ject, BTG shall
permit during normal business hours an independent public accountant,
selected by Medi-Ject and reasonably acceptable to BTG to have access to
all such records of BTG's as may be necessary to verify the accuracy of the
royalty reports and payment submitted to Medi-Ject hereunder.
(a) Any such inspection of BTG's records shall be at Medi-Ject's expense,
except that if any such inspection reveals a deficiency in an amount
of running royalty actually paid to BTG hereunder in any quarterly
period of two percent (2%) or more of the amount of such running
royalty actually due to Medi-Ject hereunder, then the expense of such
inspection shall be borne promptly by BTG. If such inspection reveals
a surplus in the amount of running royalty actually paid to Medi-Ject
by BTG, Medi-Ject shall reimburse BTG the surplus.
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ARTICLE 4 -- SUPPLY AND MARKETING
---------------------------------
4.1 Medi-Ject agrees to Exclusively supply and BTG agrees to purchase all its
requirements of Device(s) in the Field and in the Territory from Medi-Ject
for an initial lterm of the longer of five (5) years following the First
Commercial Sale of a Device(s) in the Field in the Territory or expiration
of the last material Patent Right coverage for Device(s).
4.2 The price of a Device(s) shall be $200 per Power Pack, $3.00 per Disposable
Adaptor and $3.00 per Disposable Front End Chamber.
(a) The prices for the Disposable Adaptor and the Disposable Front End
Chamber are based on the assumption that the FDA will approve the
Device(s) and that such approval will permit each to be used at least
five (5) times before disposal. If such approval for such multiple
uses is not granted or, if granted, the market does not accept
multiple uses, then the parties shall meet and negotiate in good faith
a lower price for each taking into account BTG's need for competitive
pricing in the market, which price will in any event be not less than
Medi-Ject's cost to produce each item.
(b) The prices may be increased or decreased only by mutual agreement of
the parties taking into account the cost of goods, contributions to
Medi-Ject, manufacturing costs Medi-Ject must incur and competitive
disadvantage that Medi-Ject might incur to manufacture the Device(s)
for BTG to comply with the terms of this Agreement and fully taking
into account BTG's need for competitive pricing in the market.
4.3 Should additional tooling be necessary to expand production of Device(s)
for BTG, BTG agrees to pay for any unique tooling costs required for
Medi-Ject to commercially manufacture BTG's requirements of the Device(s).
Any tooling which is uniquely designed for BTG's exclusive use in the Field
in the Territory will be prenotified to BTG as to cost, use and design. BTG
will decide if, and when, it wants Medi-Ject to proceed, in which case BTG
will pay for such tooling. The uniquely designed tooling will be owned,
controlled and maintained by Medi-Ject subject to Section 2.2. BTG shall
approve such additional proposed expenses prior to such expenses being
incurred.
4.4 Medi-Ject will be responsible for diligently filing and prosecuting a
510(K) for BTG's Device(s) with the U.S. Food and Drug Administration
(FDA), and other such counterpart regulatory applications in the Territory
as BTG chooses, it being understood that BTG will reimburse all Expenses
incurred by Medi-Ject for filing such regulatory applications in the
Territory selected by BTG provided that BTG approves such Expenses prior to
such Expenses being incurred. BTG will be responsible for diligently
developing and generating appropriate data for
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regulatory filings in the Territory to seek approval to market the
Device(s) as part of BTG's hGH Product. BTG shall be responsible for
maintaining all regulatory authority in the Territory for the BTG
pharmaceutical drug associated with this Agreement.
4.5 Both parties shall have full access to each other's necessary and
appropriate documentation to allow for regulatory submissions.
(a) BTG shall own and maintain all pharmaceutical registrations licenses
and market authorizations based on said pharmaceutical registration
licenses for the term of this Agreement and beyond unless otherwise
provided for in this Agreement. BTG will provide Medi-Ject a written
copy of all documentation used in the regulatory process which allows
BTG to utilize effectively the Device(s) with hGH and obtain approval
from the FDA for First Commercial Sale in the Territory.
(b) Medi-Ject will have the exclusive right to cross reference BTG's
regulatory filings within the Field with the FDA on a worldwide basis
for all indications not in the Field and not in the Territory.
(c) BTG agrees to file all necessary documents required to allow Medi-Ject
to exercise such rights to cross reference such BTG regulatory
filings.
(d) Medi-Ject shall own all 510(K) or other such counterpart regulatory
applications and market authorizations based on said 510(K) or other
regulatory applications for the Term and beyond unless otherwise
provided for in this Agreement.
4.6 Medi-Ject will be responsible for and have sole control over and shall
diligently prosecute and maintain the application for, prosecution of and
maintenance of any patent applications and patents which incorporate any
Improvements that may result from this Agreement or any Medi-Ject Know How
that is related to Device(s). Such patents will be owned by Medi-Ject as
per Article 3. The cost associated with the application for prosecution of
the maintenance of the patent applications and patents shall be borne by
Medi-Ject.
4.7 BTG shall be Exclusively responsible and shall, whenever legally permitted
to do so, use reasonable best efforts to diligently market and sell the
Device(s) in the Field in the Territory by itself, or through Affiliates or
sublicensees as BTG may elect in its sole discretion.
(a) BTG shall at all times maintain written communication with Medi-Ject
as to its plans to market, continued marketing, and sales of Device(s)
in the Territory. Such information shall be used by Medi-Ject only for
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information purposes and shall be treated by Medi-Ject as BTG's
Confidential Information.
(b) Subject to any delay pursuant to Section 6.6, BTG and Medi-Ject shall
cooperate to effect the filing set forth in Section 4.4 and any
filings for governmental approval to market the Device(s) which are
required to be made by BTG, within six (6) months of the date that BTG
is legally permitted to sell hGH in the Territory; provided, however,
that the Device(s) is in the final form required by BTG and available
in sufficient quantities to conduct any evaluations or the like
required for filing and assuming further that no clinical trials are
required -- any delay occasioned by any failure of one or more of
these conditions shall extend the six (6) month period accordingly.
(c) Subject to any delay pursuant to Section 6.6, the First Commercial
Sale shall occur within six (6) months of the date that all necessary
governmental approvals have been obtained.
4.8 BTG shall promptly give notice to Medi-Ject of the date of the First
Commercial Sale.
4.9 With the understanding that Medi-Ject has developed considerable expertise
in the use and handling of needleless injectors, Medi-Ject will upon its
own approval, which will not be unreasonably withheld, offer its services
for training BTG and other nominated personnel during the product
development period prior to First Commercial Sale. BTG may wish to avail
itself of this expertise and shall reimburse Medi-Ject for all Expenses
associated with Medi-Ject providing such training.
ARTICLE 5 -- ORDERS OF DEVICES
------------------------------
5.1 The parties shall meet after first regulatory submission of the Device(s)
to negotiate in good faith an ordering schedule.
(a) These negotiations will incorporate Medi-Ject's anticipated need for
six (6) months' notice for initial commercialization, the need for a
rolling twelve (12) month forecast, and BTG's need to agree batch
sizes, ordering dates and delivery dates.
(b) The parties shall reach agreement on a reasonable initial order
amount.
5.2 BTG agrees to send to Medi-Ject at least six (6) months before the intended
shipping date of each order, a firm and binding purchase agreement for such
order; provided that such binding purchase agreement can be amended
positively
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or negatively by up to twenty-five percent (25%) by BTG within
ninety (90) days after the original such binding purchase agreement has
been issued by BTG to Medi-Ject; BTG may make such adjustment to a binding
purchase agreement provided such adjustment to a binding purchase agreement
does not impact on the ability of Medi-Ject to deliver Device(s) to BTG on
the agreed upon delivery date of the original binding purchase order.
5.3 Quantities of Device(s) to be supplied shall conform to the specification
approved by both parties and for manufacture or such other specification
agreed to in writing from time to time between the parties.
5.4 Medi-Ject shall invoice BTG upon each shipment of Device(s) and BTG shall
pay the full balance of each purchase agreement within thirty (30) days of
delivery by Medi-Ject to the carrier designated by BTG.
5.5 Title and risk of loss with respect to Device(s) shipped by Medi-Ject for a
given BTG purchase agreement shall pass to BTG upon delivery by Medi-Ject
to the carrier designated by BTG.
5.6 Medi-Ject shall package at Medi-Ject's cost the Device(s) in containers
suitable for transport by BTG's designated carrier.
5.7 Medi-Ject will ship the Device(s), appropriate product package and bulk
accessories in numbers ordered by BTG, to up to three (3) destinations as
designated by BTG.
(a) BTG shall be responsible for distribution of the Device(s) from these
designated points.
ARTICLE 6 -- REPRESENTATIONS AND WARRANTIES
-------------------------------------------
6.1 Medi-Ject warrants that it is the Exclusive owner of all rights, title and
interest in and to the Patent Rights and Medi-Ject Know How and that it is
free to enter into this Agreement and to carry out all of the provisions
hereof including its agreement to grant to BTG an Exclusive license with
respect to the Devices in the Field and in the Territory.
6.2 Medi-Ject indemnifies and agrees to hold BTG harmless against disputes
arising from Independent Third Parties as more fully set in this Article 6.
6.3 Medi-Ject hereby represents that, to the best of its knowledge, none of the
Patent Rights infringe on the patents or other legally protected
proprietary rights of any Independent Third Party in the Territory.
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6.4 Medi-Ject and BTG shall each give to the other prompt written notice of any
claim or action made against either of them alleging that the manufacture,
use or sale of the Devices or the Improvements in the Territory infringe
the rights of an Independent Third Party.
(a) Medi-Ject and BTG agree to cooperate and collaborate with each other
in undertaking a full investigation of the situation and in taking
such action as they shall agree is appropriate in the circumstances in
defense or prosecution of such infringement.
6.5 In the event of the threat of institution of any suit by a third party
against Medi-Ject, BTG or its Affiliates or sublicensees for patent
infringement involving the manufacture, use, sale, distribution or
marketing of Device(s), Improvements or hGH in the Territory, the party
threatened or sued shall promptly notify the other party in writing.
(a) In the event the suit is brought for patent infringement involving the
manufacture, use, sale, distribution or marketing of the Device(s),
Medi-Ject shall have the sole right to control the defense, which
shall include, but is not limited to, the right to choose counsel, the
right to control the strategy of the case and the right to control and
enter into any settlements. The cost of the defense and any damages
awarded shall be borne by Medi-Ject.
(b) In the event the suit is brought for patent infringement involving the
manufacture, use, sale, distribution or marketing of hGH, BTG shall
have the sole right to control the defense, which shall include, but
is not limited to, the right to choose counsel, the right to control
the strategy of the case and the right to control and enter into
settlements. The cost of the defense and any damages awarded shall be
borne by BTG.
(c) In the event the suit is brought for patent infringement involving the
manufacture, use, sale, distribution or marketing of both hGH and the
Device(s), then Medi-Ject and BTG shall jointly control the defense,
which shall include, but is not limited to, the right to choose
counsel, the right to control the strategy of the case and the right
to control and enter into settlements. Any dispute regarding the
control of the defense shall be determined in accordance with Section
11.11. The cost of the defense and any damages awarded shall be shared
equally.
6.6 It is understood and agreed to by the parties that it shall not be a breach
of this Agreement if BTG, at any one or more times during the term of this
Agreement, does not sell or stops selling Device(s) in the Territory
because:
Page 14 of 26
(a) BTG is, at any one or more times during the Term of this Agreement,
enjoined from selling hGH or Improvements or Device(s), or
(b) BTG is, at any one or more times during the Term of this Agreement,
sued as a result of the manufacture, use, sale, distribution or
marketing of the Device(s) or Improvements or hGH;
provided, however, that BTG must resume sale of Device(s) in the Territory
whenever: (i) it is not enjoined from selling any one or more of Device(s),
Improvements and hGH, or (ii) a court of competent jurisdiction makes a
final, non-appealable determination that permits BTG to sell Device(s),
Improvements and hGH in the Territory. If a court of competent jurisdiction
makes a final, non-appealable determination precluding BTG from
manufacturing, using, selling, distributing or marketing Device(s) or
Improvements or hGH in the Territory, BTG may elect, in its sole
discretion, to terminate this Agreement upon written notice to Medi-Ject
without any liability to Medi-Ject.
6.7 In the event that either party determines that an Independent Third Party
is making, using or selling a product that may infringe the Patent Rights,
it shall promptly notify the other party in writing.
(a) Medi-Ject, in its sole discretion, may elect to bring suit against
such alleged infringer.
(b) Medi-Ject shall have the sole right to control the prosecution of the
case, which shall include, but is not limited to, the right to chose
counsel, the right to control the strategy of the case and the right
to control and enter into any settlements; provided, however, that
Medi-Ject shall not settle any such suit without the prior written
approval of BTG, which approval shall not be unreasonably withheld.
(c) BTG agrees to provide all reasonable assistance to Medi-Ject that is
requested by Medi-Ject. Medi-Ject shall pay all expenses incurred by
BTG.
(d) The cost of prosecuting the case shall be borne by Medi-Ject.
(e) Any recoveries shall belong solely to Medi-Ject.
(f) If ninety (90) days after receiving a written request from BTG to do
so, Medi-Ject elects not to bring suit, BTG shall have the right to
commence, prosecute and control an infringement action in BTG's name
and at its own expense, provided however, that BTG shall not settle
any such suit without the prior approval of Medi-Ject, which approval
shall not be unreasonably withheld or delayed. Medi-Ject agrees to
provide all
Page 15 of 26
reasonable assistance to BTG that is requested by BTG. Any monetary
recovery shall belong solely to BTG.
6.8 To the best of Medi-Ject's knowledge, Medi-Ject warrants all elements
contained in Medi-Ject Know How and in the registration dossiers, the
Patent Rights and all other information and data in the form of statements,
facts and figures and all information under which this Agreement is
concluded are true and accurate.
6.9 Medi-Ject warrants that it manufactures to International Quality Assurance
standards, that all Devices are manufactured to GMP.
6.10 Throughout the term of this Agreement and with reasonable written notice,
but not normally exceeding once in any calendar year period both parties
agree and their respective suppliers shall permit, during normal business
hours, an inspection of its development, manufacturing and control
facilities by personnel of, or chosen by the party conducting the
inspection.
6.11 Medi-Ject warrants that all Device(s) delivered hereunder shall conform to
the specifications agreed to by both parties, shall be fit for its intended
use(s) in the Field, shall be free from defects in workmanship and
materials as per specification agreed to by both parties and as such will
be supplied with a one (1) year guarantee from normal usage.
ARTICLE 7 -- REJECTED DEVICES OR SHORTAGES
------------------------------------------
7.1 Notwithstanding any payment made by BTG for Devices in Section 5.4, BTG may
reject any Device(s) which fails to meet specifications as agreed by both
parties. BTG shall, within thirty (30) days after its receipt of any
shipment of Device(s), notify Medi-Ject in writing of any claim relating to
any shortage in quantity of any shipment of Device(s).
(a) In the event of such shortage, Medi-Ject shall make up the shortage
within thirty (30) days of receiving such notice, at no additional
cost to BTG.
(b) In the event of rejection of Device(s), BTG shall confirm the
rejection in writing and Medi-Ject shall replace the rejected
Device(s) within ninety (90) days of receiving such notice at no
additional cost to BTG.
(c) In all instances of rejections, Medi-Ject shall make arrangement with
BTG for the return or destruction of any rejected Device(s), such
return shipping charges to be paid by Medi-Ject.
Page 16 of 26
ARTICLE 8 -- INDEMNIFICATION
---------------------------
8.1 Medi-Ject will indemnify and hold BTG harmless against any and all
liability, damage, loss, cost or expense resulting from any third party
claims made or suits brought against BTG which arise from Medi-Ject's
willful maleficence in the use or sale of any Device(s) herein or
Medi-Ject's breach of the representations and warranties set forth herein.
(a) In evidence thereof, within one (1) month of the Effective Date of
this Agreement, Medi-Ject will provide BTG with a certificate of
insurance and copy of such policy showing BTG to be named on
Medi-Ject's product liability insurance.
8.2 BTG will indemnify and hold Medi-Ject harmless against any and all
liability, damage, loss, cost or expense resulting from any third party
claims made or suits brought against Medi-Ject which arise from BTG's
willful maleficence in the use or sale of any Device(s) in the Field
including but not limited to non-compliance by BTG, BTG's affiliates and
Sublicensees, with written instructions given by Medi-Ject in connection
with the Devices and any and all claims relating to the manufacture, use or
sale of any such pharmaceutical product used with the Device(s).
(a) In evidence thereof, within one (1) month of the Effective Date of
this Agreement, BTG will provide Medi-Ject with a certificate of
insurance and copy of such policy showing Medi-Ject to be named on
BTG's product liability insurance.
8.3 The party seeking indemnification shall promptly notify the other party of
any claims asserted against it for which such indemnification is sought,
and shall promptly deliver to the party from whom indemnification is sought
a true copy of any summons or other process, pleading or notice issued in
any lawsuit or other proceeding to assert or enforce such claim.
(a) The indemnifying party reserves the right to control the
investigation, trial and defense of such lawsuit or action (including
all negotiations to effect settlement) any appeal arising therefrom
and to employ or engage attorneys of its own choice, provided,
however, that such indemnifying party may not settle any such lawsuit,
claim or action if such settlement includes non-monetary or equitable
relief that would materially and adversely affect the indemnified
party, without the consent of that party, which shall not be
unreasonable withheld.
Page 17 of 26
(b) The party seeking indemnification may, at its own cost, participate in
such investigation, trial and defense of such lawsuit or action and
any appeal arising therefrom.
(c) The party seeking indemnification, its employees, agents and
representatives shall provide full cooperation to the indemnifying
party at all times during the pendency of the claim or lawsuit,
including, without limitation, providing the party with all reasonably
available information concerning the claim.
ARTICLE 9 -- FORCE MAJEURE; FAILURE TO SUPPLY
---------------------------------------------
9.1 Any delay in the performance of any of the duties or obligations of either
party hereto shall not be considered a breach of this Agreement provided
that such delay is caused by or is the result of any acts of God, acts of
the public enemy, insurrections, riots, labor disputes, including strikes,
lockouts or boycotts, fires, explosions, floods, or other unforeseeable
causes beyond the control and without the fault or negligence of the party
so affected. The party so affected shall give prompt notice to the other
party of such cause as rapidly as possible.
9.2 If Medi-Ject fails, as set forth in Section 9.1, to supply all or part of
the Licensed Product quantities ordered by BTG as per Section 5.1, BTG may,
in its discretion, (a) require Medi-Ject to supply the undelivered
Device(s) at a future date mutually agreed upon or (b) decrease the
quantity of Device(s) originally ordered by BTG and deficient from
Medi-Ject by that quantity not supplied by Medi-Ject due to Medi-Ject
informing BTG force majeure due to Section 9.1.
9.3 If Medi-Ject is unable to supply BTG partly or in total of the quantities
ordered by BTG over a period of three (3) months, Medi-Ject is obligated to
find another manufacturing source and has to guarantee the supply of BTG's
requirements of the Device(s) at the then current Medi-Ject price of
Device(s) in the Field in the Territory, (a) if Medi-Ject cannot find
another manufacturing source to satisfy Medi-Ject manufacturing commitments
as per Section 9.2(b), BTG may decrease the quantity of Device(s)
originally ordered by BTG and deficient from Medi-Ject by that quantity not
supplied by Medi-Ject due to Medi-Ject informing BTG force majeure due to
Section 9.1, and seek supply from an Independent Third Party to which
Medi-Ject will provide under strict confidentiality and limitation any
necessary know-how, information, licenses or tooling to the third party to
produce only enough Device(s) to fulfill Medi-Ject's delinquent quantity
obligation to BTG during Section 9.1 provisions.
(a) When Medi-Ject can once again supply BTG's requirements, the third
party supply commitments will be terminated and all know-how,
Page 18 of 26
information, licenses and tooling transfer to the party for
manufacturing during Section 9.1 provisions will at Medi-Ject's sole
discretion be destroyed or transferred, and Medi-Ject will resume
supplying BTG with Device(s).
(b) During Independent Third Party manufacturing of Device(s) as per
Section 9.3(a), Medi-Ject will not guarantee pricing of Device(s) in
the Field in the Territory.
9.4 During Medi-Ject's default as described in Section 9.2(b), if BTG's pricing
received from the Independent Third Party exceeds Medi-Ject's Device(s)
pricing as per Section 4.2, BTG's obligation to pay royalties to Medi-Ject
for sales of Device(s) provided by the Independent Third Party and sold by
BTG shall cease until such time that: (a) pricing by Independent Third
Party is equal or less than Medi-Ject's pricing as per Section 4.2 or (b)
Medi-Ject resumes manufacturing of BTG's Device(s).
ARTICLE 10 -- TERM AND TERMINATION
----------------------------------
10.1 This Agreement shall commence upon the Effective Date and shall continue in
effect for the longer of five (5) years following the First Commercial Sale
of Device(s) in the Field in the Territory or expiration of all patent
coverage for Device(s) unless earlier terminated as provided below.
10.2 Notwithstanding the provisions of Section 10.1, if any party shall enter
into liquidation either voluntary or compulsory (except for the purpose of
amalgamation or reconstruction previously approved of in writing) or in any
manner assign this Agreement or make any assignment for the benefit of
creditors or cease or threaten to cease to carry on business or is unable
to pay its debts as they fall due this Agreement shall terminate
immediately.
(a) To protect BTG's interests in the event Medi-Ject is acquired or
enters into a Chapter 11 proceeding or other bankruptcy proceeding or
into any liquidation, dissolution or winding up of the affairs of the
corporation either voluntary or compulsory, or in any manner assigns
this Agreement or makes any assignment for the benefit of creditors or
ceases or threatens to cease to carry on business or is unable to pay
its debts as they fall due, Medi-Ject will within fifteen (15) days of
the Effective Date, place in escrow with an Independent Third Party
designated by BTG, all Know How, information, licenses and tooling
required to manufacture Device(s) and such escrowed items along with
any inventory of Devices shall be immediately transferred to BTG upon
the occurrence of any of the
Page 19 of 26
aforesaid events, the licenses granted to BTG pursuant to Article 3
shall be deemed and shall become fully-paid, perpetual and
irrevocable.
10.3 Except as provided in Section 6.6, either party may terminate upon the
breach of any material provision of this Agreement if the breach is not
cured within ninety (90) days after receipt of written notice thereof to
the breaching party.
(a) Should, however, the other party remedy the default upon which said
notice is based within the said ninety (90) day period, the notice
shall be without effect and this Agreement shall continue in full
force and effect.
10.4 In the event that this Agreement is terminated prior to the date of its
expiration in the Territory, due to the fault of BTG, BTG shall promptly
make an accounting to Medi-Ject of the inventory of all Devices which it
and its agents and distributors have on hand in the Territory, if any, as
of the date of such termination and said parties shall thereafter have the
right for a period of six (6) months after the said termination to sell
such inventory of the Devices.
(a) Medi-Ject will instruct BTG, and BTG will comply with said
instructions, to dispose of any remaining inventory of the Device(s)
in accordance with regulatory requirements or return remaining
inventory of Device(s) to Medi-Ject. BTG shall pay all expenses for
such disposal or return of Device(s).
10.5 Except as provided in Section 6.6, termination of this Agreement, due to
the fault of either party, shall be without prejudice to any other rights
or remedies then or thereafter available to either party under this
Agreement or otherwise.
10.6 Termination of the Agreement prior to the expiration of its term shall not
affect in any way either party's waiver of or failure to take action with
respect to any previous default hereunder.
10.7 Except as provided in Section 6.6, BTG may terminate this Agreement at any
time during the supply period (Article 4) with one hundred eighty (180)
days written notice to Medi-Ject of intent to terminate provided that all
outstanding invoices, purchase orders and other payments due to Medi-Ject
as per this Agreement are paid-in-full by BTG prior to such termination.
10.8 If a delay in performance is caused by those acts set forth in Section 9.1,
excluding any delay pursuant to Section 6.6, and such delay last more than
six (6) months, any party shall have the right to immediately terminate
this Agreement.
10.9 Upon termination of this Agreement for any reason, all licenses granted
hereunder, except as provided in Section 10.2(a), shall immediately
terminate and each party shall return all Know How and Confidential
Information to the party
Page 20 of 26
from which it was received, provided, however, that if Section 10.2(a) is
applicable, BTG shall retain all Know How and Confidential Information
received from Medi-Ject.
10.10 Except as provided in Section 10.2(a), BTG agrees that it will not use any
Medi-Ject Know How or Confidential Information of Medi-Ject, either during
or at any time after termination of this Agreement, to develop a competing
product to the Device(s)(s) unless such product has been authorized by
Medi-Ject.
10.11 Medi-Ject agrees that it will not use any BTG Know How or Confidential
Information of BTG, either during or at any time after termination of this
Agreement, to develop a competing product to BTG's hGH product unless such
product has been authorized by BTG.
ARTICLE 11 - MISCELLANEOUS
--------------------------
11.1 This Agreement constitutes the entire understanding between the parties
with reference to the subject matter hereof and no statements or other
agreements, oral or written, shall vary or modify the written terms. This
Agreement may be modified by mutual written agreement of the parties.
11.2 All representations, warranties, covenants and agreements set forth in this
Agreement and all duties and obligations of the parties hereunder shall
survive final payment and the acceptance of Device(s).
11.3 The parties expressly agree and contract that it is not the intention of
either party to violate any public policy, statutory or common laws, rules,
regulation, treatises or decisions of any government or agency thereof of
any country. If any word, sentence, paragraph, clause or combination
thereof of this Agreement is judicially or administratively interpreted or
construed as being in violation or any such provisions in any country, such
words, sentences, paragraphs, clauses of combinations thereof shall be
inoperative in each such country and the remainder of this Agreement shall
remain binding upon the parties hereto.
11.4 Sections 2.2, 4.5, 8.1, 8.2, 8.3, 10.2, 10.4, 10.9, 10.10, 10.11, 11.2,
11.7 and Article 12 shall survive this Agreement.
11.5 This Agreement shall be binding upon and shall inure to the benefit of the
parties hereto and their respective assigns and successors in interest;
provided, however, neither party shall assign this Agreement in whole or in
part without the written consent of the other, which consent shall not be
unreasonably withheld.
Page 21 of 26
11.6 All notices hereunder shall be in writing and shall be sent by registered
or certified airmail, facsimile, telex, to the following addresses for the
respective parties or to such other address as either party may specify by
notice to the other party during the term of this Agreement:
If to Medi-Ject:
Medi-Ject Corporation
000 Xxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxxx, Xxxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to BTG
President
Bio-Technology General Corp.
00 Xxxx Xxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Such notice shall be effective as of its date of sending of mailing or
transmission.
11.7 The validity and interpretation of this Agreement shall be governed by and
construed in accordance with the laws of the State of Minnesota in the
United States of America.
11.8 All titles and captions in the Agreement are for convenience only and
shall not be of any meaning or substance.
11.9 Any waiver by any party hereto of any breach of any term or condition of
the Agreement shall not constitute a waiver of any other breach of the
same or any other term or condition.
11.10 This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
11.11 Neither party will issue any press release, SEC filings, prospectus or any
other public announcement relating to this Agreement or its terms without
obtaining the other party's prior written approval which approval will not
be unreasonably withheld or delayed, provided that both parties allow
disclosure of information to
Page 22 of 26
comply with the country, state and local laws and regulations in the
Territory. The term "press release", as used herein, includes follow-up
correspondence, press kits, and the like which may be provided in response
to inquiries from the media or others.
11.12 BTG shall be deemed an independent contractor of Medi-Ject and, as such,
BTG shall not be entitled to any benefits applicable to employees of
Medi-Ject. Nothing contained in this Agreement shall be construed or
implied to create an agency, partnership, or employer and employee
relationship between BTG and Medi-Ject. At no time shall one make
commitments or incur any charges or expenses for or in the name of the
other party except as specifically provided herein.
11.13 Any dispute, controversy or claim arising out of or relating to this
Agreement (hereinafter collectively referred to as "Dispute") shall be
attempted to be settled by the parties, in good faith, by submitting each
such Dispute to appropriate senior management representatives of each
party in an effort to effect a mutually acceptable resolution thereof. In
the event that no mutually acceptable resolution is achieved, then the
parties shall submit the Dispute to arbitration, as set forth in Section
11.14, below.
11.14 Any Dispute relating to, arising out of or in connection with this
Agreement or the performance or non-performance of either party any
permitted assignee thereunder shall be submitted to arbitration under the
Commercial Arbitration Rules and regulations of the American Arbitration
Association.
(a) In connection therewith, three (3) arbitrators shall constitute the
panel of arbitrators.
(b) Each party shall bear its own expenses in connection with any such
arbitration.
(c) The costs and expenses of the arbitration itself shall be borne by
the parties equally unless the determination by the panel of
arbitrators includes an award of costs, in which case expenses shall
be borne in accordance with such award.
(d) The decision and award of the panel of arbitrators shall be final and
conclusive upon the parties, in lieu of all other legal, equitable or
judicial proceedings between them, and no appeal or judicial review
of the award or decision of the panel of arbitrators shall be taken,
but rather any such
Page 23 of 26
award or decision may be entered as a judgment and enforced in any
court having jurisdiction over the party against whom enforcement is
sought.
(e) The place of arbitration shall be Philadelphia, Pennsylvania.
(f) The arbitration shall be conducted in the English language.
ARTICLE 12 -- FIRST AGREEMENT
-----------------------------
12.1 The First Agreement is terminated as of the Effective Date and this
Agreement substituted therefor. The parties agree and acknowledge that
each and every dispute, controversy or claim which did arise or could have
arisen out of or relating to the First Agreement is extinguished and
resolved and settled as of the Effective Date and that neither party has,
had or shall have any obligation or liability to the other with respect to
any such dispute, controversy or claim.
The parties intending to be bound hereby have caused this Agreement to be signed
by their duly-authorized representatives as of the Effective Date.
BIO-TECHNOLOGY GENERAL CORP. MEDI-JECT CORPORATION
By: /s/ X. Xxxx By: /s/ Franklis Pass
------------------------------ -------------------------------
Name: X. Xxxx Name: Franklin Pass
---------------------------- -----------------------------
Title: CEO Title: Chairman & CEO
--------------------------- ----------------------------
Page 24 of 26
APPENDIX A - DEVICE
MJ7 Product Description
The MJ7 is a needle-free drug delivery system composed of a power pack, a
needle-free syringe assembly, an adapter assembly for drawing drug from a
traditional glass vial and an adapter cap to serve as a container closure for
the drug vial. The power pack is reusable and is connected with the needle-free
syringe when injecting or aspirating drug. The device is hand-held and spring
powered. The delivered dose can be varied by the user up to the maximum of 0.5
ml in 0.01 ml increments. The needle-free syringe, adapter assembly and adapter
cap are the only drug or injection site contacting materials, and these parts
and assemblies are provided to the end user as sterile. The device is readied
for use, or armed, by manually compressing a spring using a rotating or twisting
motion. A similar but opposite twisting motion is used to dose the needle-free
syringe when it is attached to the power pack. The drug to be delivered is
injected by holding the device against the injection site with slight pressure
and in a fashion that the needle-free syringe is in intimate contact with the
injection site. Pushing a button which releases the energy stored in the spring
triggers the injection. This device includes a safety mechanism that prevents
inadvertent firing of the device. The safety is automatically set in the "safe"
or non-firing mode when the device is armed. The safety prevents device
actuation by preventing the button from being pushed. The device is primarily
cylindrical in shape with a maximum diameter of approximately 1-inch. The length
of the device is approximately 6 inches when the spring is fully compressed and
the needle-free syringe is not attached. The device is approximately 7 3/4
inches when the device is fully extended at a dosage setting of 0.5 ml and the
needle-free syringe is attached. The weight of the device is approximately 1/3
lbs. (135 grams) without the disposable components.
[PICTURE OF MJ7]
Page 25 of 26
APPENDIX B - PATENTS
U. S. PATENTS - ISSUED
--------------------------- --------------------------------------- -------------------------------------- -------------------------
U. S. Patent No. Name Inventor(s) Date of Patent
--------------------------- --------------------------------------- -------------------------------------- -------------------------
4,507,113 HYPODERMIC JET INJECTOR XXXXXX, XXXXXXX X. MARCH 26, 1985
--------------------------- --------------------------------------- -------------------------------------- -------------------------
Des.304,616 MEDICAMENT INJECTOR XXXXXX, XXXXXXX X.; XXXXXXXX, XXXXX NOVEMBER 14, 1989
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,062,830 DRY DISPOSABLE NOZZLE ASSEMBLY FOR XXXXXX, XXXXXXX X. NOVEMBER 5, 1991
MEDICAL JET INJECTOR
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,697,917 NOZZLE ASSEMBLY WITH ADJUSTABLE XXXXXXXX, XXXXX X.; XXXXXX, XXXXX; DECEMBER 16, 1997
PLUNGER TRAVEL GAP XXXXXXXXX, XXXX
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,722,953 NOZZLE ASSEMBLY FOR INJECTION DEVICE XXXXXX, XXXXX; XXXXXXXXX, XXXX MARCH 3, 1998
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,769,138 NOZZLE AND ADAPTER FOR LOADING XXXXXXXX, XXXXX X.; XXXXXX, XXXX 23, 1998
MEDICAMENT INTO AN INJECTOR XXXXXXX; XXXXXX, XXXXX; XXXXXXXXXX,
XXXXXX
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,800,388 PLUNGER/RAM ASSEMBLY ADAPTED FOR A XXXXXX, XXXXX; XXXXXXXXX, XXXX SEPTEMBER 1, 1998
FLUID INJECTOR
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,836,911 INJECTION DEVICE HAVING POSITIONING XXXXXXXXX, XXXXXXX; MULHAUSER, NOVEMBER 17, 1998
MEANS XXXX; XXXXXX, XXXX
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,846,233 COUPLING DEVICE FOR MEDICAL INJECTION XXXXXX, XXXXXXX X.; XXXXXX, XXXX DECEMBER 8, 1998
SYSTEM F.; XXXXXXXX, XXXXX X.; XXXXXXX,
XXXXX X.; XXXXX, XXXXX X.; XXXXXXX,
XXXXXX X.
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,865,795 SAFETY MECHANISM FOR INJECTION DEVICES XXXXXX, XXXXX; XXXXXXXXX, XXXX FEBRUARY 2, 1999
--------------------------- --------------------------------------- -------------------------------------- -------------------------
5,891,085 NOZZLE ASSEMBLY WITH LOST MOTION XXXXXX, XXXXXXX X.; XXXXXX, XXXX APRIL 6, 1999
CONNECTION FOR MEDICAL INJECTOR F.; XXXXXXXX, XXXXX X.; XXXXXXX,
ASSEMBLY XXXXX X.; XXXXX, XXXXX X.; XXXXXXX,
XXXXXX X.
--------------------------- --------------------------------------- -------------------------------------- -------------------------
Page 26 of 26
U. S. PATENTS - ISSUED (Continued)
-------------------------- ------------------------------------------- ------------------------------------- -----------------------
U. S. Patent No. Name Inventor(s) Date of Patent
-------------------------- ------------------------------------------- ------------------------------------- -----------------------
5,921,967 PLUNGER FOR NOZZLE ASSEMBLY XXXXXXXX, XXXXX X.; XXXXXX, XXXXX; JULY, 13, 1999
XXXXXXXXXX, XXXXXX; XXXXXXXXX, XXXX
-------------------------- ------------------------------------------- ------------------------------------- -----------------------
5,875,976 LOCKING MECHANISM FOR NOZZLE ASSEMBLY XXXXXX, XXXXXXX; XXXXXX, XXXXX; MARCH 2, 1999
XXXXXXXXXX, XXXXXX
-------------------------- ------------------------------------------- ------------------------------------- -----------------------
APPLICATIONS - FILED
-------------------------- ------------------------------------------------ ----------------------------------- --------------------
Application No. Name Inventor(s) Reference No.
-------------------------- ------------------------------------------------ ----------------------------------- --------------------
60/094,163 LOADING MECHANISM FOR MEDICAL INJECTOR ASSEMBLY XXXXXX, XXXXX X.; XXXXX, JR. XXXX 8066-047
R.; XXXXXX, XXXXXXX X.
-------------------------- ------------------------------------------------ ----------------------------------- --------------------
60/094,167 INJECTION-ASSISTING PROBE FOR MEDICAL INJECTOR XXXXXX, XXXXX X.; XXXXXXXX, XXXXX 8066-048
ASSEMBLY L.; XXXXX, XXXX X.; XXXXXX,
XXXXXX X.; XXXXXXXXXXXX, XXXXX
-------------------------- ------------------------------------------------ ----------------------------------- --------------------
