UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 10-QSB/A
AMENDMENT NO. 1
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarter ended September 30, 1999
Commission File Number: 0-24378
FIRST SCIENTIFIC, INC.
----------------------
(Exact name of small business issuer as specified in its charter)
DELAWARE 33-0611745
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(State or other jurisdiction (IRS Employer Identification No.)
of incorporation or organization)
1877 West 2800 South, Suite 200, Ogden, Utah 84401
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(Address of principal executive offices)
Registrant's telephone number, including Area Code: (801) 393-5781
Check whether the issuer (1) filed all reports required to be filed by
Sections 13 or 15(d) of the Exchange Act during the past 12 months (or for
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
These were 20,219,770 shares of common stock, $.001 par value, outstanding
as of November 8, 1999.
<PAGE>
FIRST SCIENTIFIC, INC.
FORM 10-QSB/A
AMENDMENT NO. 1
QUARTER ENDED SEPTEMBER 30, 1999
TABLE OF CONTENTS
PART II - OTHER INFORMATION
Item 1. Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . 13
Item 2. Changes in Securities and Use of Proceeds . . . . . . . . . . 14
Item 4. Submission of Matters to a Vote of Security Holders . . . . . 14
Item 6. Exhibits and Reports of Form 8-K. . . . . . . . . . . . . . . 2
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
<PAGE>
Item 6. Exhibits and Reports on Form 8-K.
(a) Exhibits
The following exhibits are filed herewith pursuant to Rule 601 of
Regulation S-B or are incorporated by reference to previous filings.
Exhibit # Description
--------- -----------
2.1 Agreement and Plan of Reorganization, dated August 10, 1998,
between the Registrant, Linco, Linco Acquisition Corp. and
Edward Walker*
3.1 Articles of Incorporation**
3.2 Bylaws**
3.3 Amendment to Articles of Incorporation changing name to First
Scientific, Inc. and effecting a forward stock split.*
3.4 Restated Bylaws*****
10.1 Non-qualified Stock Option Agreement with Jerral R. Pulley***
10.2 Non-qualified Stock Option Agreement with Peter Sundwall,
M.D.***
10.3 1998 Stock Incentive Plan ****
10.4 Agreement with Weldon Phillips*****
10.5 Employment Agreement with Randy Hales*****
10.6 Consulting Agreement with Jerral R. Pulley*****
10.7 Consulting Agreement with Edward Walker*****
10.8 Exclusive License and Supply Agreement with Convatec
(Confidential Treatment Requested for Certain Portions)******
27 Financial data schedule*****
_____________________
* Incorporated by reference to the same-numbered exhibit to the
Form 8-K filed October 2, 1998 by First Scientific with the
Securities and Exchange Commission.
** Incorporated by reference to the same-numbered exhibit to
the Company's Registration Statement on Form 10-SB, file
No. 0-24378.
*** Incorporated by reference from Annual Report on Form 10-KSB, as
filed on March 26, 1999.
**** Incorporated by reference from Quarter Report on Form 10-QSB, as
filed on June 15, 1999.
***** Incorporated by reference by reference from Quarter Report on
Form 10-QSB, As filed on November 15, 1999.
****** Filed herewith
(b) Reports on Form 8-K
There were no reports on Form 8-K during the reporting quarter.
15
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
REGISTRANT
FIRST SCIENTIFIC, INC.
Registrant
DATED: March 8, 2000. By: /s/ Randy L. Hales
-----------------------
Randy L. Hales, President and CEO
DATED: March 8, 2000. By: /s/ Gordon M. Davis
------------------------
Gordon M. Davis, Vice President
Administration/CFO (Principal
Financial and Accounting Officer)
16
<PAGE>
CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR CERTAIN PORTIONS OF THIS DOCUMENT
EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
between
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, INC.
and
FIRST SCIENTIFIC CORPORATION,
A WHOLLY OWNED SUBSIDIARY OF
FIRST SCIENTIFIC, INC.
TABLE OF CONTENTS
1 DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . 5
2 GRANT OF LICENSE AND DISTRIBUTION RIGHTS TO CONVATEC . . . . . 6
3 LICENCE FEE. . . . . . . . . . . . . . . . . . . . . . . . . . 7
4 EXCLUSIVE PURCHASE AND SUPPLY OF THE SOLUTION INGREDIENTS. . . 7
5 FURTHER OBLIGATIONS OF FIRST SCIENTIFIC. . . . . . . . . . . . 7
6 PRICING. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7 REGULATORY APPROVAL FOR SALE . . . . . . . . . . . . . . . . . 8
8 CONTRACT MANUFACTURING . . . . . . . . . . . . . . . . . . . . 8
9 SALES AND MARKETING. . . . . . . . . . . . . . . . . . . . . . 8
10 REGULATORY COMPLIANCE. . . . . . . . . . . . . . . . . . . . . 9
11 RIGHTS OF INSPECTION . . . . . . . . . . . . . . . . . . . . . 9
12 WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
13 TIME, MANNER ,AND CURRENCY OF PAYMENT. . . . . . . . . . . . . 11
14 PROTECTION OF LICENSE RIGHTS . . . . . . . . . . . . . . . . . 11
15 INFRINGEMENT OF LICENSED RIGHTS. . . . . . . . . . . . . . . . 11
16 INDEMNIFICATION. . . . . . . . . . . . . . . . . . . . . . . . 12
17 SOLUTION LIABILITY INSURANCE . . . . . . . . . . . . . . . . . 12
18 CONTINGENT MANUFACTURING OF THE SOLUTION . . . . . . . . . . . 13
19 SOLUTION SERVICE RIGHTS AND OBLIGATIONS. . . . . . . . . . . . 13
20 SOLUTION TESTING . . . . . . . . . . . . . . . . . . . . . . . 13
21 CONFIDENTIALITY. . . . . . . . . . . . . . . . . . . . . . . . 13
22 EFFECTIVE DATE AND TERM. . . . . . . . . . . . . . . . . . . . 14
23 TERMINATION FOR CAUSE. . . . . . . . . . . . . . . . . . . . . 14
24 RIGHTS AND OBLIGATIONS UPON EXPIRATION OR TERMINATION. . . . . 15
25 MAINTENANCE OF INTELLECTUAL PROPERTY . . . . . . . . . . . . . 15
26 RIGHTS OF FIRST REFUSAL. . . . . . . . . . . . . . . . . . . . 15
27 RELATIONSHIP . . . . . . . . . . . . . . . . . . . . . . . . . 16
28 PUBLICITY. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
29 ASSIGNMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 16
30 REPRESENTATIONS AND WARRANTIES . . . . . . . . . . . . . . . . 17
31 MISCELLANEOUS PROVISIONS . . . . . . . . . . . . . . . . . . . 17
SCHEDULES
A-LICENSES RIGHTS
B-SOLUTIONS
C-PRICING
D-FIRST SCIENTIFIC TESTING SERVICE / PRICING
<PAGE>
This Agreement, executed as of the 1st day of July, 1999, by and
between FIRST SCIENTIFIC CORPORATION (a Utah corporation) a
wholly-owned subsidiary of First Scientific, Inc. (a Delaware
corporation), with offices at 1877 West 2800 South, Suite. 200,
Ogden, Utah 84401, (hereinafter referred to as "FIRST SCIENTIFIC"
and/or Licensor) and CONVATEC, a Division of E.R. Squibb & Sons,
Inc., with offices at 200 Headquarters Park Drive, Skillman, New
Jersey 08558 (hereinafter referred to as "CONVATEC" and/or Licensee).
WITNESSETH:
WHEREAS, FIRST SCIENTIFIC represents and warrants that it owns
all of the right, title and interest in and to certain intellectual
property including information pertaining to the SOLUTION(such
rights and the SOLUTION hereinafter more particularly defined), that
it has the right to grant licenses with respect to such rights, and
that it may enter into and perform its obligations under this
AGREEMENT without breach of any prior agreement; and
WHEREAS, FIRST SCIENTIFIC has the necessary expertise and skill
required to supply and to manufacture or cause to be manufactured
the ingredients necessary to produce the SOLUTION as set forth
hereinafter; and
WHEREAS, CONVATEC is desirous of obtaining certain marketing
rights, distribution rights and licenses from FIRST SCIENTIFIC
relating to the aforementioned intellectual property, information
and the SOLUTION; and
WHEREAS, CONVATEC is desirous of securing a timely and
uninterrupted source of supply of the SOLUTION (hereinafter more
particularly defined) for all of its requirements of the
SOLUTION as a raw material for the manufacture by itself or by
third parties of other products; and
WHEREAS, FIRST SCIENTIFIC is willing to grant such marketing
rights, distribution rights and licenses upon the conditions herein
and, further, to undertake the obligations of supply and/or
manufacture of the SOLUTION for CONVATEC as more fully set forth
hereinafter;
NOW THEREFORE, for and in consideration of these premises and the
mutual promises hereinafter
contained, and other good and valuable consideration, the amount and
sufficiency of which is hereby
acknowledged, the parties hereto have mutually agreed as follows:
1 DEFINITIONS
The following terms as used in this AGREEMENT shall, unless the
context clearly indicates to the contrary, have the meanings set
forth in this Article:
1.1 "AGREEMENT" shall mean this document and all attachments or
schedules , as well as any amendments which may be made
hereafter, in accordance with Article 31.2 hereof.
1.2 "AFFILIATE" shall mean any corporation directly or
indirectly owning, owned by or under common ownership with
the corporate entity in question to the extent of at least
fifty percent (50%) of the voting shares, including
directors' qualifying shares owned beneficially by such
corporate entity, having the power to vote for directors.
1.3 "ALTERATION" shall mean any alteration, change, or
modification to the SOLUTION, as requested by CONVATEC
including, but not limited to, the applications, uses
composition, form, substance and/or properties of the
SOLUTION, and which relates to the FIELD OF USE. Any such
ALTERATIONS, changes or modifications shall be made under
separate license agreement(s)
1.4 "FIELD OF USE" shall mean the use of the SOLUTION in moist
towelettes for applications relating to patient bathing and
skin care in hospitals, nursing homes or professionally
administered home health care settings.
1.5 "FINAL PRODUCTS" shall mean any products within the FIELD OF
USE sold by CONVATEC into which the SOLUTION is incorporated.
1.6 "LICENSED RIGHTS" shall mean the trade secret(s) and/or
copyright(s), and/or patent(s) and/or application(s)
embodied in precisely the same percentages of the exact
components specified in Schedule A, LICENSED RIGHTS,
attached hereto and any and all other copyright(s),
patent(s) and/or application(s) that may issue from time to
time in the name of Licensor, whether secured by Licensor or
by Licensee including any and all renewals, divisions,
continuations, continuations-in-part, reissues, or
extensions of or to any of the aforesaid trade secret(s),
copyright(s), patent(s) and application(s) which pertain to
the SOLUTION
1.7 "SOLUTION' shall mean the exact solution XXXXXXX
(CONFIDENTIAL TREATMENT REQUESTED) produced by the precise
formula described and specified in Schedule B, SOLUTION,
attached hereto.
1.8 "TECHNOLOGY" shall mean all information and know-how which
relate to the manufacturing, marketing, use, distribution or
sale of the SOLUTION (including, by way of illustration,
manufacturing procedures, clinical data, medical uses and
methods, product forms, specifications, customer lists, and
marketing information), which FIRST SCIENTIFIC has
heretofore developed or acquired.
1.9 "TERM OF AGREEMENT". The initial term of this AGREEMENT
shall be deemed to begin on July 1, 1999, and shall
terminate on XXXXXXXXXXXXXXXXXX. (CONFIDENTIAL TREATMENT
REQUESTED).
1.10 "TERRITORY" shall mean all countries of the world, without
exception, and shall further include all market segments and
customers within the FIELD OF USE, without exception.
2 GRANT OF LICENSE AND DISTRIBUTION RIGHTS TO CONVATEC
2.1 FIRST SCIENTIFIC hereby grants to CONVATEC and its
AFFILIATES a royalty-free, exclusive license in the
TERRITORY, including the right to grant sublicenses in
such circumstances as deemed necessary or appropriate by
CONVATEC to further the commercial purposes of this
AGREEMENT, under TECHNOLOGY and LICENSED RIGHTS to
manufacture, use, distribute, market and/or sell the
SOLUTION and/or FINAL PRODUCTS in the FIELD OF USE.
FIRST SCIENTIFIC agrees, for the term of this AGREEMENT
and any renewals, not to grant a license subsequent to
the effective date of this AGREEMENT to any party, to
use, distribute, market or sell the SOLUTION in the
FIELD OF USE in the TERRITORY except as otherwise
permitted hereinafter. Notwithstanding the foregoing,
FIRST SCIENTIFIC does not grant a license hereunder
covering other formulations containing dimethicone.
Further, the modification of botanical and fragrance
components of the SOLUTION formula shall not be
construed as still constituting the SOLUTION, and thus
such modified formulations shall remain the sole and
exclusive proprietary formulations of FIRST SCIENTIFIC,
and FIRST SCIENTIFIC shall have unrestricted rights to
license and/or sell such modified formulas and products
derived therefrom. FIRST SCIENTIFIC further hereby
grants CONVATEC the exclusive right, including the right
to grant sublicenses in such circumstances as deemed
necessary or appropriate by CONVATEC to further the
commercial purposes of this AGREEMENT , to use
TECHNOLOGY to manufacture, use, distribute, market
and/or sell the SOLUTION and/or FINAL PRODUCTS in the
FIELD OF USE in the TERRITORY. FIRST SCIENTIFIC further
hereby appoints CONVATEC as the Exclusive Distributor
and Seller of the SOLUTION in the FIELD OF USE in the
TERRITORY. CONVATEC hereby accepts such appointment.
FIRST SCIENTIFIC shall not, during the term of this
AGREEMENT , appoint any party other than CONVATEC as a
manufacturer, marketer, distributor or seller of the
SOLUTION in the FIELD OF USE in the TERRITORY except as
otherwise permitted hereinafter, nor shall FIRST
SCIENTIFIC itself engage in such activities except by
prior written agreement with CONVATEC.
3 LICENSE FEE
3.1 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXX (CONFIDENTIAL TREATMENT REQUESTED)
4 EXCLUSIVE PURCHASE AND SUPPLY OF THE SOLUTION INGREDIENTS
4.1 CONVATEC agrees, for the term of this AGREEMENT and any
renewals, to purchase or cause to be purchased exclusively
from FIRST SCIENTIFIC all of its requirements of the
SOLUTION, except distilled water, per Schedule B. FIRST
SCIENTIFIC agrees, for the term of this AGREEMENT and any
renewals, to supply exclusively to CONVATEC or CONVATEC's
contract manufacturer the precise SOLUTION ingredients
and/or concentrate the FIELD OF USE within the TERRITORY.
FIRST SCIENTIFIC further agrees, for the term of this
AGREEMENT and any renewals, not to supply any other party
which is not a permitted assignee or contract manufacturer
of CONVATEC hereunder, with the SOLUTION or the exact
formulation SOLUTION in the FIELD OF USE within the
TERRITORY, except as otherwise permitted hereinafter.
5 FURTHER OBLIGATIONS OF FIRST SCIENTIFIC
5.1 FIRST SCIENTIFIC and CONVATEC shall each, at all times
during the term of this AGREEMENT , provide reasonable
notice and cooperation in the defense and resolution of any
legal actions in respect of the SOLUTION, including those
relating to the potential infringement of patent, copyright,
trade secret or other intellectual property issues.
5.2 Upon execution of this AGREEMENT and throughout the term
hereof, FIRST SCIENTIFIC shall maintain and inform
CONVATEC of any and all regulatory registration,
approval and/or applications for approval of the sale
and marketing of the SOLUTION, which FIRST SCIENTIFIC
has undertaken and which are pending before any
regulatory authority in any country of the TERRITORY.
6 PRICING
6.1 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
(CONFIDENTIAL TREATMENT REQUESTED)
7 REGULATORY APPROVAL FOR SALE
7.1 During the term of this AGREEMENT and any renewals, CONVATEC
shall be responsible for all registrations or approvals
necessary to market the SOLUTION and/or FINAL PRODUCT in the
FIELD OF USE in such countries of the TERRITORY in which
CONVATEC shall determine regulatory registration or approval
therein is necessary or desirable, and CONVATEC agrees to assume
all rights relating to such regulatory approval. FIRST
SCIENTIFIC shall reasonably cooperate and assist with any
regulatory filings deemed necessary or desirable by CONVATEC.
8 CONTRACT MANUFACTURING
8.1 CONVATEC shall have its contract manufacturer issue Purchase
Orders for all of CONVATEC'S requirements of the SOLUTION
ingredients during the term of this AGREEMENT.
8.2 FIRST SCIENTIFIC shall reach agreement with CONVATEC'S contract
manufacturer for the timely transport and delivery of SOLUTION
ingredients or reasonable and customary commercial terms using
the pricing agreed on herein.
9 SALES AND MARKETING
9.1 CONVATEC shall be responsible for establishing resale prices for
the SOLUTION and/or FINAL PRODUCTS in the FIELD OF USE within
the TERRITORY. CONVATEC shall be responsible for advertising,
promotional and educational materials required for the SOLUTION
and/or FINAL PRODUCTS.
10 REGULATORY COMPLIANCE
10.1 FIRST SCIENTIFIC shall manufacture the SOLUTION ingredients or
have the SOLUTION ingredients manufactured in accordance with
United States FDA Drug CGMPs (21 CFR Parts 2 I 0 and 2 I 1) as
may be applicable to the regulatory classification of the
SOLUTION in the FIELD OF USE, as determined by CONVATEC. FIRST
SCIENTIFIC agrees to supply validating test data as requested
by CONVATEC. FIRST SCIENTIFIC shall maintain traceability
records on the goods manufactured and cooperate with CONVATEC
in the event CONVATEC shall ever initiate any remedial action
for the SOLUTION and/or technologies or procedures used to
manufacture the SOLUTION covered by this agreement. If the
remedial action is required as a result of FIRST SCIENTIFIC's
negligence, FIRST SCIENTIFIC shall bear the expense, but
otherwise CONVATEC shall bear the expense. FIRST SCIENTIFIC
shall notify CONVATEC promptly in writing in the event a
governmental agency issues an inspection report or other
finding of non-compliance in connection with the SOLUTION
and/or technologies or procedures used to manufacture the
SOLUTION, its manufacture, storage or handling and shall
provide CONVATEC with a copy of any such report or finding,
edited for data or information not related to CONVATEC or the
SOLUTION. CONVATEC shall have the right to participate with
FIRST SCIENTIFIC in the preparation of any response to said
finding of non-compliance. CONVATEC shall be responsible for
creating all warnings, precautions, and labels required for the
SOLUTION, although FIRST SCIENTIFIC shall assist CONVATEC in
the preparation of these materials as requested. CONVATEC shall
promptly advise FIRST SCIENTIFIC of all changes, amendments,
additions, deletions and/or modifications to any such SOLUTION
labeling. In the event that a particular market within the
TERRITORY of this AGREEMENT shall require information regarding
the SOLUTION in addition to that contained in specifications
attached hereto, FIRST SCIENTIFIC shall provide said
information to CONVATEC if FIRST SCIENTIFIC has such
information available to it. CONVATEC shall be responsible, in
accordance with 2 I CFR 2 I I. 198, for the reporting to FDA
of all OTC pharmaceutical reportable events as required. Copies
of all SOLUTION complaints received by CONVATEC shall be
forwarded to FIRST SCIENTIFIC on a timely basis. FIRST
SCIENTIFIC agrees to assume responsibility, at the request of
CONVATEC, for the investigation of any SOLUTION complaint
received by CONVATEC; FIRST SCIENTIFIC shall provide copies of
all such complaint investigations to CONVATEC upon completion
of the investigation.
11 RIGHTS OF INSPECTION
11.1 FIRST SCIENTIFIC shall allow representatives of CONVATEC and/or
of BRISTOL-MYERS SQUIBB COMPANY to inspect and evaluate those
areas of the FIRST SCIENTIFIC testing facilities and
manufacturing sites devoted to the manufacture, testing and
storage of the SOLUTION as needed pursuant to CONVATEC or
BRISTOL-MYERS SQUIBB COMPANY auditing procedures. Similarly,
CONVATEC shall afford FIRST SCIENTIFIC the same inspection,
evaluation and audit opportunities to its contract manufacturer
with CONVATEC's presence. Each party shall provide the other
with as much advance notification as possible prior to such
inspections and in any event a minimum of five (5) business
days. CONVATEC shall have the right of inspection during normal
business hours; further provided, however, CONVATEC shall
undertake to complete its initial evaluation of such areas of
such site promptly following the execution of this AGREEMENT
and, in any event, within thirty (30) days following the date
of this AGREEMENT. In addition, FIRST SCIENTIFIC shall
cooperate with CONVATEC in attempting to obtain the right to
inspect with FIRST SCIENTIFIC's presence any raw material
vendors' manufacturing facilities, as may be reasonable or
necessary.
12 WARRANTY
12.1 FIRST SCIENTIFIC warrants that all the SOLUTION shall be free
from defects in materials, workmanship and fabrication. FIRST
SCIENTIFIC also warrants that the SOLUTION shall meet the
appropriate descriptions and specifications set forth in
Schedule B (the SOLUTION), attached hereto, and that no changes
in the referenced descriptions and !specifications or
manufacturing process of the SOLUTION, nor changes of any other
nature which could reasonably result in a change in the
regulatory status of the SOLUTION, shall be made without the
prior notice to and consultation of CONVATEC including the
opportunity to object to such change. FIRST SCIENTIFIC also
agrees that CONVATEC may inspect the manufacture of the
SOLUTION and packaging components in accordance with Article 11
of this Agreement to ascertain that it is being carried out in
accordance with the FDA Drug CGMPs (21 CFR Parts210 and 211)
outlined by U.S. FDA, CONVATEC and BRISTOL-MYERS SQUIBB COMPANY
quality assurance standards and that FIRST SCIENTIFIC will use
reasonable commercial efforts to make any necessary changes
thereto, as mutually agreed between CONVATEC and FIRST
SCIENTIFIC, upon receipt of written request by CONVATEC after
such inspection provided such changes conform to all
descriptions and specifications of Schedule B hereto. These
warranties shall survive acceptance and payment for a
reasonable period, and shall run to CONVATEC, its permitted
assigns, and to customers and users of the SOLUTION, providing
the SOLUTION is used as directed and in a normal manner. FIRST
SCIENTIFIC shall replace all goods which do not conform to the
descriptions and specifications of Schedule B, or otherwise
meet the aforesaid warranties, as validated by FIRST SCIENTIFIC
at no charge when requested to do so by CONVATEC and agreed to
by FIRST SCIENTIFIC, and shall assume all shipping and handling
costs of so doing. Notwithstanding any other provision in this
AGREEMENT to the contrary, the foregoing shall be the sole and
exclusive remedy under this paragraph, at law or otherwise for
CONVATEC. Neither FIRST SCIENTIFIC nor CONVATEC, nor any of
their Affiliates, shall be liable to the other for any claim or
damage, including, without limitation, consequential,
incidental, special, punitive and exemplary damages, whether
arising hereunder, at law, in contract or in tort, or otherwise.
13 TIME, MANNER, AND CURRENCY OF PAYMENT
13.1 Payments to FIRST SCIENTIFIC which have accrued under the
provisions of this Agreement and are payable directly by
CONVATEC shall be due and payable with net fifty (50) day
terms, and shall be paid in United States Dollars. In respect
of any payments required of CONVATEC by this AGREEMENT, the
payment obligation of CONVATEC shall be deemed satisfied by the
issuance of written instruments of payment or wire transfer
made payable to First Scientific Corporation.
13.2 Terms for any payments to FIRST SCIENTIFIC by CONVATEC'S
contract manufacturer shall be negotiated between FIRST
SCIENTIFIC and the contract manufacturer along reasonable and
customary provisions in the trade. However, should CONVATEC'S
contract manufacturer fail to pay FIRST SCIENTIFIC according to
net sixty (60) days from invoice date terms because of
bankruptcy filing, or because of a dispute with CONVATEC,
CONVATEC guarantees to pay FIRST SCIENTIFIC upon being notified
by FAX of the contract manufacturer's failure to pay FIRST
SCIENTIFIC.
14 PROTECTION OF LICENSED RIGHTS
14.1 In the event CONVATEC acquires information that any of the
LICENSED RIGHTS appear to cover the exact same formulation of
the SOLUTION being sold or distributed in the FIELD OF USE by a
third party during the term of this AGREEMENT or any renewals
hereof, CONVATEC shall promptly so notify FIRST SCIENTIFIC, and
FIRST SCIENTIFIC shall use all reasonable commercial efforts to
enforce and assert all valid rights for the SOLUTION ;
provided, however, that if FIRST SCIENTIFIC does not wish to
assert such rights, it shall so notify CONVATEC and obtain
consent of CONVATEC to refrain from assertion of the rights,
which consent shall not be unreasonably withheld. FIRST
SCIENTIFIC agrees that, except as specifically authorized
herein, during the term of this AGREEMENT, or any renewal
hereof, it shall not grant a license or rights to the exact
fragrance/botanical blend, as described in Schedule A, to any
third party .
15 INFRINGEMENT OF LICENSED RIGHTS
15.1 In the event CONVATEC, after exhausting the procedures set
forth in Article 14, above, reasonably determines that
continued distribution of the SOLUTION hereunder is not
warranted without obtaining a royalty bearing license from a
third party, then CONVATEC and FIRST SCIENTIFIC shall mutually
agree, after good faith negotiations, upon an adjustment to the
pricing herein specified or other mutually acceptable solution.
If any injunction should result from a claim of patent,
copyright or trademark infringement so as to prevent CONVATEC
from distributing the SOLUTION hereunder, FIRST SCIENTIFIC
shall reimburse CONVATEC for any and all payments made by CONVATEC
to FIRST SCIENTIFIC for the SOLUTION used to make the SOLUTION so
enjoined, provided the SOLUTION is returned to FIRST SCIENTIFIC, at
the expense of FIRST SCIENTIFIC.
16 INDEMNIFICATION
16.1 FIRST SCIENTIFIC shall indemnify, hold harmless and defend
CONVATEC from and against any and all claims, costs, demands,
liabilities, losses, damages, and expenses of whatever nature,
including reasonable attorney's fees, made against or sustained
by CONVATEC in respect of death or personal injury caused by
the negligence of FIRST SCIENTIFIC, but not in respect of
consequential loss or damage of CONVATEC (whether for loss of
profit or otherwise). CONVATEC shall indemnify, hold harmless
and defend FIRST SCIENTIFIC from and against any and all
claims, costs, demands, liabilities, losses, damages and
expenses of whatever nature, including reasonable attorney's
fees, made against or sustained by FIRST SCIENTIFIC in respect
of death or personal injury caused by the negligence of
CONVATEC, but not in respect of consequential loss or damage of
FIRST SCIENTIFIC (whether for loss of profit or otherwise).The
provisions of this paragraph shall survive the termination of
this AGREEMENT.
16.2 Notwithstanding anything herein to the contrary, no indemnity
obligation contained in the preceding paragraph shall apply
unless the party claiming indemnification notifies the other
party as soon as reasonably practicable of any matters in
respect of which the indemnity may apply and of which the
notifying party has knowledge and gives the other party the
opportunity to control the response thereto and the defense
thereof; provided, however, that the party claiming
indemnification will have the right to participate in any legal
proceedings to contest and defend a claim for indemnification
involving a third party and to be represented by its own
attorneys, all at such party's cost and expense; provided
further, however, that no settlement or compromise of an
asserted third-party claim may be made without the prior
written consent of the party claiming indemnification, which
consent will not be unreasonably withheld.
17 SOLUTION LIABILITY INSURANCE
17.1 Each party shall furnish the other with certificates of
insurance evidencing the following coverages and providing for
at least thirty (30) days prior written notice of cancellation
or material modification. CONVATEC retains the right to
self-insure any or all of the following exposure consistent
with past practice.
During the term of this contract, each party shall maintain at its
own expense the following kinds of insurance with minimum limits as
set forth below. Each party shall have its Commercial General
Liability Policy endorsed to name the other as an additional
insured.
Kind(s) of Insurance Minimum Limits
--------------------- -------------------
$1,000,000 single occurrence
Commercial General $2,000,000 aggregate limit per
Liability Occurrence for Bodily Injury
And Property Damage
18 CONTINGENT MANUFACTURING OF THE SOLUTION
18.1 In the event of the inability or failure by FIRST SCIENTIFIC to
supply the SOLUTION in accord with agreed upon delivery
schedules, which inability or failure continues for a period in
excess of thirty (30) days, FIRST SCIENTIFIC will arrange a
temporary alternative source of supply to the full satisfaction
of CONVATEC in order to satisfy the requirements set forth in
this AGREEMENT or in any agreement negotiated with CONVATEC'S
contract manufacturer. If FIRST SCIENTIFIC demonstrates
repeated inability over any consecutive ninety (90) day period
to supply the SOLUTION, then CONVATEC shall have the right to
arrange its own source of supply and pay FIRST SCIENTIFIC a
royalty equal to the actual savings, if any, resulting from
such alternative supply.
19 SOLUTION SERVICE RIGHTS AND OBLIGATIONS
19.1 FIRST SCIENTIFIC agrees to provide certain testing services as
set forth in Schedule D,"FIRST SCIENTIFIC TESTING
SERVICES/PRICING" attached hereto, including but not limited to
batch stability testing. FIRST SCIENTIFIC agrees that its
advisory and support services as set forth in Schedule D may be
canceled by CONVATEC at any time upon six (6) months' written
notice, without prejudice to all other rights and obligations
of the parties under this AGREEMENT. Any annual stability
testing beyond that set forth in Schedule D will be conducted
by Bristol-Myers Squibb Company, or an alternate facility at
CONVATEC's discretion, at CONVATEC's expense.
20 SOLUTION TESTING
20.1 Included in the purchase price for SOLUTION is initial raw
material testing by FIRST SCIENTIFIC. Upon receipt of SOLUTION
by CONVATEC's contract manufacturer, samples of each SOLUTION
ingredient will be drawn and sent to FIRST SCIENTIFIC. FIRST
SCIENTIFIC shall perform the following testing services
pursuant to this section: (1) an identification test for each
SOLUTION ingredient, and (2) a quantitative analysis of assay
for each active drug ingredient.
21 CONFIDENTIALITY
22.1 Each party undertakes to keep secret and confidential and not
to disclose to any third party or to use, except as it is
necessary in carrying out the purpose of this AGREEMENT ,
during the term of this AGREEMENT and for a period of five (5)
years thereafter, any information, data or know-how disclosed
to it by the other party except:
(1) information, data or know-how which at the time of disclosure
is in the public domain or publicly known or available;
(2) information, data or know-how which, after disclosure, becomes
part of the public domain or publicly known or available by
publication or otherwise, except by breach of this AGREEMENT by
the receiving party;
(3) information, data or know-how which the receiving party can
establish by competent proof was in its possession at the time of
disclosure by the other party;
(4) information, data and know-how which the receiver receives from
a third party; provided, however, that such information was
not obtained by said third party from the other party; and
(5) information, data and know-how which the receiver derives
independently of such disclosure
22 EFFECTIVE DATE AND TERM
22.1 This AGREEMENT is deemed effective as set forth in Article 1.9.
The AGREEMENT shall thereafter renew automatically each year
for an additional term of one ( 1 ) year , unless either party
provides the other with written notice at least six (6) months
prior to the expiration date of its intent not to renew,
subject to the pricing terms and conditions provided in Article
6. 1 .
23 TERMINATION FOR CAUSE
23.1 Failure by FIRST SCIENTIFIC or CONVATEC or of any of their
AFFILIATES or sublicensees to comply with any of the
obligations and conditions herein contained, unless such
failure results from or is caused by applicable laws or
regulations, shall entitle the other party to give to the party
in default notice requiring it to make good such default. If
such default is not made good within six (6) months after
receipt of such notice, the notifying party shall be entitled
(without prejudice to any of its other rights conferred on it
by this AGREEMENT) to terminate this AGREEMENT by giving notice
to take effect immediately. The right of either party to
terminate this AGREEMENT , as herein above provided, shall not
be affected in any way by its waiver of, or failure to take
action with respect to, any previous default.
23.2 Either party shall have the option to terminate this AGREEMENT
at any time in the event that the other party is adjudicated
bankrupt, or a receiver of that party's business is appointed,
or that party shall take an assignment for the benefit of creditors,
or a petition under Chapter 11 of the Bankruptcy Act shall be filed
on behalf of that party.
24 RIGHTS AND OBLIGATIONS UPON EXPIRATION OR TERMINATION
24.1 Expiration or termination of this AGREEMENT for any reason
shall be without prejudice to:
(1) the right of FIRST SCIENTIFIC to receive all revenues accrued
and as yet unpaid on the effective date of such expiration or
termination;
(2) the rights and obligations provided in Articles 16 and 21
hereof, and
(3) any other remedies which either party may then or thereafter
have hereunder or otherwise.
24.2 Upon the expiration or termination of this AGREEMENT, CONVATEC
shall notify FIRST SCIENTIFIC of the amount of the SOLUTION
that CONVATEC, its AFFILIATES, sublicensees and contract
manufacturers then have on hand, and CONVATEC, its AFFILIATES
and sublicensees shall then be permitted by FIRST SCIENTIFIC to
sell such amount of the , however, FIRST SCIENTIFIC shall
SOLUTION, as well as any unsold FINAL PRODUCT. have the right,
at its option, to buy from CONVATEC all, but not less than all,
of the remaining SOLUTION, but not any remaining FINAL PRODUCT,
at CONVATEC'S acquisition cost.
25 MAINTENANCE OF INTELLECTUAL PROPERTY
25.1 FIRST SCIENTIFIC and CONVATEC each agrees to take all necessary
action to maintain trade secret(s), copyright(s), patent(s), and
all other intellectual property protection in effect during the
term of this AGREEMENT.
26 RIGHTS OF FIRST REFUSAL
26.1 FIRST SCIENTIFIC hereby grants CONVATEC a sixty (60) day Right
of First Refusal with respect to competing products, using or
containing dimethicone, which may compete in the FIELD OF USE.
In such case, said offer of rights shall be in the form of written
notice by FIRST SCIENTIFIC to CONVATEC, after which the parties shall
negotiate in good faith toward an agreement with regard to such competing
product(s) in the FIELD OF USE in the TERRITORY. If after sixty (60)
days from such notice, no agreement is reached, FIRST SCIENTIFIC may
then, and only then, offer said rights of sale and distribution in the
TERRITORY to any third party on whatever terms FIRST SCIENTIFIC may deem
opportune.
27 RELATIONSHIP
27.1 The relationship between FIRST SCIENTIFIC and CONVATEC is
intended to be that of Licensor and Licensee, supplier and
distributor or seller and buyer. Neither FIRST SCIENTIFIC nor
CONVATEC, their employees, agents and representatives shall
under any circumstances be considered agents, partners, joint
venturers or representatives of the other. Neither FIRST
SCIENTIFIC nor CONVATEC shall act or attempt to act, or
represent itself, directly or by implication, as agent, joint
venturer or representative of the other or in any manner assume
or attempt to assume or create any obligation or liability of
any kind, nature or sort expressed or implied on behalf of or
in the name of the other.
28 PUBLICITY
28.1 Neither party shall issue any press release or other publicity
materials, or make any presentation with respect to the
existence of this Agreement or the terms and conditions hereof
without the prior written consent of the other party, which
consent shall not be unreasonably withheld or delayed. This
restriction shall not, however, apply to normal investor
relations publicity or disclosures required by law or
regulation, including as may be required in connection with any
filings made with the Securities and Exchange Commission or by
the disclosure policies of a major Stock Exchange, or in the
reasonable judgment of FIRST SCIENTIFIC management, in normal
investor relations reports, in which event the party required
by law or regulation to disclose shall give the other party, at
least ten (10) days in advance of the anticipated date of
disclosure, written notice of its intent to disclose such
information and a copy of such proposed disclosure for review.
29 ASSIGNMENT
29.1 CONVATEC or FIRST SCIENTIFIC may assign its rights under this
AGREEMENT in whole or in part to any AFFILIATE or AFFILIATES,
which shall be substituted directly for it hereunder. At the
request of the assigning party , the non-assigning party shall
enter into a separate counterpart agreement with any such
AFFILIATE. This AGREEMENT shall not otherwise be assignable by
either party without the prior written consent of the other
party, which consent shall not be unreasonably withheld,
provided, however, that either party may assign this AGREEMENT
to a purchaser or successor of substantially all of its
business related to the subject matter of this AGREEMENT
30 REPRESENTATIONS AND WARRANTIES
30.1 FIRST SCIENTIFIC: FIRST SCIENTIFIC represents and warrants that
it is a duly authorized corporation existing under the laws of
the State of Utah, in good standing; that it has the full
right, power and authority to enter into this AGREEMENT, and in
doing so, it will not violate, breach or infringe upon the
right of any third party under any other agreement,
understanding, venture, or undertaking or violate any statute,
law, order or regulation of any relevant governmental body;
that the person executing this AGREEMENT is vested by FIRST
SCIENTIFIC with full authority to bind it to same; that it owns
all of the right, title and interest in and to the United
States and foreign trade secrets, copyrights, patent rights,
and information pertaining to the SOLUTION; and that no right
or license has been granted prior to the date of this AGREEMENT
which in any way conflicts with the provisions of this AGREEMENT
30.2 CONVATEC: CONVATEC represents and warrants that it is an
unincorporated division of E. R. Squibb & Sons, Inc., (A
Bristol-Myers Squibb Company), a duly authorized corporation of
the State of Delaware, in good standing; that it has the full
right, power and authority to enter into this AGREEMENT and, in
doing so, it will not violate, breach or infringe upon the
right of any third party under any other agreement,
understanding, venture or undertaking or violate any , that the
person executing statute, law, order or regulation of any
relevant governmental body. this AGREEMENT is vested by
CONVATEC with full authority to bind it to same; and that no
right or license has been granted prior to the date of this
AGREEMENT which in any way conflicts with the provisions of
this AGREEMENT.
31 MISCELLANEOUS PROVISIONS
31.1 NOTICES. Any notice or report required or permitted to be given
or made under this AGREEMENT by one of the parties hereto to
the other shall be in writing and shall be deemed to have been
sufficiently given or made for all purposes if mailed by
registered mail, postage prepaid, addressed to such other party
at its respective address as follows:
To FIRST SCIENTIFIC
First Scientific Corporation
Doug Warren
President
1877 West 2800 South Suite 200
Ogden, Utah 84401
To CONVATEC
CONVATEC
100 Headquarters Park Drive
Skillman, New Jersey 08558
Attention: Sr. Vice President, Technical Operations
or to such other address as the addressees shall furnish in writing
to the addressors.
31.2 ENTIRE AGREEMENT AND AMENDMENTS. This AGREEMENT and the
SCHEDULES attached contain the entire understanding of the
parties with respect to the matter contained herein. The
parties hereto may, from time to time during the term of this
AGREEMENT - modify, vary or alter any of the provisions of this
AGREEMENT , but only by a written instrument duly executed by
all parties hereto.
31.3 GOVERNING LAW. This AGREEMENT shall be construed in accordance
with the laws of the United States, State of New Jersey,
without regard to conflicts of laws provisions which would
result in the law of any other jurisdiction being applied.
31.4 NON-WAIVER No failure by either party to assert its rights in
the event of any default by the other party in the due
observance or performance of any covenant, condition or
limitation thereunder shall be deemed a waiver of such rights,
nor shall any such waiver be implied from any conduct of either
party. No waiver by either party with respect to any such
default shall affect the rights of that party in the event of
any subsequent default of like or different kind.
31.5 SEVERABILITY. In the event that any part or parts of this
AGREEMENT shall be finally held illegal or unenforceable by any
court or administrative body of competent jurisdiction, such
determination shall not affect the remaining provisions of this
AGREEMENT , which shall remain in full force and effect;
provided, however, that if such determination renders
impossible the substantial performance of this AGREEMENT, then
this AGREEMENT shall terminate
31.6 FORCE MAJEURE. The obligations of either party to perform under
this AGREEMENT shall be excused if such failure to perform or
any delay is caused by matters such as acts of God, strikes,
civil commotion, riots, wars, revolution, acts of government,
or governmental agencies or instrumentalities (including,
without limitation, courts and judicial bodies), invasions,
fire, explosion, flood, delay of carrier, energy shortages, or
any other cause whether similar or dissimilar to those
enumerated which is reasonably beyond the control of the party
obligated to perform. Upon the occurrence of such an event, the
duties and obligations of the parties shall be suspended for
the duration of the event preventing proper performance under
this AGREEMENT; provided, however, that if such suspension
shall continue in excess of ninety (90) days, the parties shall
attempt to arrive at a mutually acceptable compromise within
the spirit and intent of this AGREEMENT
IN WITNESS WHEREOF, the parties have caused this AGREEMENT to be
effective as of the date first above written.
FIRST SCIENTIFIC CORPORATION CONVATEC, a Division of
E.R. Squibb & Sons, Inc.
By. /s/ Douglas R. Warren By. /s/ Costa Papastephanou
-------------------------- --------------------------
Douglas R Warren Costa Papastephanou
President / CEO Senior Vice President
Technical Operations
Date. 8 August 1999 Date. 8 August 1999
----------------------- --------------------------
SCHEDULE A - LICENSED RIGHTS
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SCHEDULE B - SOLUTION
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(CONFIDENTIAL TREATMENT REQUESTED)
SCHEDULE C - PRICING
(CONFIDENTIAL TREATMENT REQUESTED)
SCHEDULE D - FIRST SCIENTIFIC TESTING SERVICES / PRICING
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(CONFIDENTIAL TREATMENT REQUESTED)
