EXHIBIT 10.6
AGREEMENT
BETWEEN HYMEDIX INTERNATIONAL, INC.
AND
PROCYTE CORPORATION
This AGREEMENT (this "Agreement"), dated as of November 15, 1995, is entered
into by and between PROCYTE CORPORATION, a Washington corporation ("ProCyte"),
and HYMEDIX INTERNATIONAL, INC., a Delaware corporation ("Hymedix").
RECITALS
A. Hymedix has useful polymer technology and experience in developing and
gaining regulatory approval of products for managing wounds based on its polymer
technology.
B. ProCyte has experience in developing, clinically testing, and GMP
manufacturing certain healthcare products.
C. ProCyte desires to support certain research and development at Hymedix
related to its polymer technology for wound care applications and desires to
acquire from Hymedix an exclusive license to make, have made, use and sell
products for the wound care field using Hymedix's technology, upon the terms and
conditions set forth herein.
D. Contemporaneously with this Agreement, ProCyte is entering into agreements
with certain key employees and a consultant of Hymedix and is receiving a
guarantee from Hymedix, Inc., a Delaware corporation and parent corporation of
Hymedix.
AGREEMENT
NOW, THEREFORE, in consideration of the promises and covenants contained herein,
the parties agree as follows:
SECTION 1. DEFINITIONS
As used herein:
1.1 "Affiliate" shall mean, with respect to a party, any other business entity
which directly or indirectly controls, is controlled by, or is under common
control with, the party. The direct or indirect ownership of at least fifty
percent (50%) of the voting securities of a business entity, or of an interest
in the assets, profits or earnings of a business entity, shall be deemed to
constitute control of the business entity. The current Affiliate of Hymedix is
its parent corporation Hymedix, Inc., a Delaware corporation. ProCyte currently
has no Affiliates.
1.2 "Xxxxx" shall mean Xxxxx Medical Products Co., a Wisconsin corporation.
1.3 "Xxxxx" shall mean X. Xxxxx Medical, Inc.
1.4 "Drug Approval" shall mean approval in the United States by the FDA of a
new drug application or product license application and comparable approvals in
other countries to market a Product as a drug.
1.5 "Drug Delivery Application" shall mean the [CONFIDENTIAL TREATMENT
REQUESTED], foreign counterparts thereof and any patents issuing thereon,
divisions, extensions, reexaminations, reissues, substitutions, renewals,
continuations or continuations in part thereof.
1.6 "[CONFIDENTIAL TREATMENT REQUESTED]" shall mean the [CONFIDENTIAL TREATMENT
REQUESTED] that Hymedix acquired in bulk form from [CONFIDENTIAL TREATMENT
REQUESTED] and from which Hymedix has been making various forms of its hydrogels
known as HYPAN-Registered Trademark-. The specifications for [CONFIDENTIAL
TREATMENT REQUESTED] are attached hereto as Exhibit 1.6.
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1.7 "Establishment of the Extrusion Process" shall have the meaning set forth
in Exhibit 1.7 attached hereto.
1.8 "Europa Agreement" shall mean the Distribution, Know-how Transfer,
Licensing and Manufacturing and Supply Agreement dated August 21, 1995 between
Europa Magnetics Corporation Limited, incorporated under the laws of England
("Europa"), and Hymedix, as supplemented and amended by a Supplemental Agreement
dated November 15, 1995.
1.9 "Europe" shall mean the countries set forth in Exhibit 1.9 attached hereto.
1.10 "Excluded Territory" shall mean the countries set forth in Exhibit 1.10
attached hereto so long as the Europa Agreement is in effect.
1.11 "FDA" shall mean the U.S. Food and Drug Administration or any successor
entity thereto.
1.12 "Field" shall mean wound care, including, but not limited to, the
treatment, management or care of any acute or chronic wound by dressings, by the
delivery of drugs or other agents to the wounds or by other methods or products,
whether such wound is caused, for example, by diabetic, venous stasis or
decubitus ulcers, by injury, by surgery, by xxxxx or by other events or means.
1.13 "Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents" shall mean all patents
and patent applications throughout the world, including any patents issuing
thereon, and any divisions, extensions, reexaminations, reissues, substitutions,
renewals, continuations or continuations in part thereof that claim as a new
composition of matter a polymer (including block co-polymer) resulting from a
modification of [CONFIDENTIAL TREATMENT REQUESTED] and that resulted from
inventive work during the Program by one or more employees or consultants for
both parties (or their Affiliates), whether or not relating to the Field, and as
to which the employees or consultants would be inventors under the patent laws
of the United States.
1.14 "Joint Technology" shall mean the Joint [CONFIDENTIAL TREATMENT REQUESTED]
Patents, Other Joint Patents and any trade secrets or know-how that resulted
from the joint efforts of the employees or consultants from both parties (or
their Affiliates) as a result of the Program, whether or not relating to the
Field.
1.15 "Key Hymedix People" shall mean [CONFIDENTIAL TREATMENT REQUESTED].
1.16 "Licensed Technology" shall mean the Patent Rights, Joint [CONFIDENTIAL
TREATMENT REQUESTED] Patents, Other Joint Patents and all copyrights, trade
secrets and know-how owned or controlled (including licensed) by Hymedix or an
Affiliate of Hymedix as of the date hereof or hereafter relating to polymers,
hydrogels or drug delivery, including, but not limited to, Joint Technology,
HYPAN structural hydrogels, HYPAN transient network hydrogels, HYPAN (including,
but not limited to, the various designations set forth in Exhibit 1.16 attached
hereto), Ionic HYPAN SA, Taupan, Tpan, Emulsion carriers, HySorb, HySkin, Hydro-
M, HyTide, HyFlex, HyFil, HyQ, HyPack, HyCream, any other related products and
any improvements thereto. Trade secrets and know-how include, but are not
limited to, data, materials, scientific and technical information, formulations,
methods of manufacture, mechanisms of action, sources, clinical uses and
results, regulatory filings, testing protocols, packaging, suppliers of raw
materials and packaging, etc.
1.17 "Major Country" shall mean the United States, France, Germany or the
United Kingdom.
1.18 "Major Market" shall mean the countries in Europe and the countries of
Canada, Japan (to the extent not in the Excluded Territory) and the United
States.
1.19 "Minor Market" shall mean all other countries of the Territory except
the countries of the Major Market.
1.20 "Net Sales" shall mean the gross amount invoiced for Product sold by
ProCyte, its Affiliates and sublicensees, less
(a) trade discounts, credits, rebates, allowances and adjustments for
rejections, recalls or returns;
(b) retroactive price reductions;
(c) sales, excise, value-added and similar taxes or duties imposed on the sale
and shown on the invoice or otherwise capable of documentation;
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(d) transportation, insurance and other handling expenses;
(e) cost of samples and free Product; and
(f) management fees described in and complying with 42 C.F.R. Section
1001.952(j) (or any successor) that are paid during the relevant time period
to group purchasing organizations and that specifically relate to the Product.
If amounts are invoiced in other than U.S. dollars, Net Sales shall be converted
to U.S. dollars at the rates of exchange in effect on the last business day of
the calendar quarter in which the invoice was issued (as reported in THE WALL
STREET JOURNAL, Western Edition), or in accordance with any other reasonable
method mutually agreed upon. The sale or transfer of Product between ProCyte,
its Affiliates or sublicensees, whether for internal use or for resale or other
disposition, shall not be included in the computation of Net Sales.
If a Product (a "Combination Product") contains or is sold in combination with
any pharmaceutical agent, device or other product ("Other Items"), Net Sales,
for purposes of calculating royalties on a Combination Product, shall be
calculated by multiplying the Net Sales of the Combination Product by the
fraction A/B, where A is the gross selling price of the Product sold separately
(i.e., without the Other Items) and B is the gross selling price of the
Combination Product. In the event the Product is not sold separately, Net Sales
shall be calculated by multiplying Net Sales of the Combination Product by the
fraction (B-X)/B, where X is the gross selling price of the Other Items sold
separately. In the event that no such separate sales are made, Net Sales shall
be calculated by multiplying Net Sales of the Combination Product by the
fraction C/(C + D), where C is the direct and indirect cost of making the
components of the Product (not including the Other Items) and D is the direct
and indirect cost of making the Other Items of the Combination Product, such
cost being determined in accordance with generally accepted accounting
principles.
1.21 "Other Joint Patents" shall mean all patents and patent applications
throughout the world, including any patents issuing thereon, and any divisions,
extensions, reexaminations, reissues, substitutions, renewals, continuations or
continuations in part thereof that are not Joint [CONFIDENTIAL TREATMENT
REQUESTED] Patents and that resulted from inventive work during the Program by
one or more employees or consultants for both parties (or their Affiliates),
whether or not relating to the Field, and as to which the employees or
consultants would be inventors under the patent laws of the United States.
1.22 "Patent Rights" shall mean the patents and patent applications set
forth in Exhibit 1.22 attached hereto (including the Drug Delivery
Application), any foreign counterparts thereof, any other patents or patent
applications owned or controlled (including licensed) by Hymedix or its
Affiliates as of the date hereof or hereafter relating to polymers, hydrogels
or drug delivery in the Territory (but not including Other Joint Patents and
Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents), and any patents issuing
thereon and any divisions, extensions, reexaminations, reissues, substitutions,
renewals, continuations or continuations in part thereof.
1.23 "Pharmaceutical Product" shall mean a Product containing a
pharmaceutical agent that has received Drug Approval in the country of sale and
for which the selling party (ProCyte or its particular Affiliate or
sublicensee) has a worldwide Profit Margin of greater than
[CONFIDENTIAL TREATMENT REQUESTED].
1.24 "Present HyFil Products" shall mean the two current forms (spray can
and 3 oz. tube) of the Hymedix product known as HyFil and such other finished,
packaged forms (e.g., Confidential Treatment Requested) of the current substance
known as HyFil (i.e., meeting the same substance specifications) as Xxxxx may
request Hymedix to make. The specification for the HyFil substance used in
Present HyFil Products is attached hereto as Exhibit 1.24.
1.25 "Product" shall mean any product for the Field that incorporates, is
based on or is made through the use of, any of the Licensed Technology.
1.26 "Profit Margin" for a Product shall mean the percentage calculated by
the following formula: 100% x (A - B)/A, where A is the average net sales price
during the quarter determined by dividing the Net Sales of the Product for the
quarter by the number of units of the Product sold and included
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in such Net Sales, and B is the manufacturing cost of a unit of the Product.
For purposes hereof, "manufacturing cost" means the direct, indirect and
overhead costs (including procurement, quality control and quality assurance)
to manufacture a unit of the Product calculated in accordance with generally
accepted accounting principles (accrual basis) for the preceding calendar year
or, if the Product was not manufactured during the preceding year, the Product's
projected manufacturing costs for the current calendar year.
1.27 "Program" shall mean the research and development program to be
conducted by Hymedix pursuant to Section 2.
1.28 "Royalty Step Down Date" shall mean [CONFIDENTIAL TREATMENT REQUESTED].
1.29 "Royalty Period" shall mean, on a country-by-country basis, for each
Product sold (a) in a Major Market, the date of expiration of the last to expire
of any patents containing a Valid Claim that covers the Product in the country
of sale and (b) in a Minor Market, [CONFIDENTIAL TREATMENT REQUESTED].
1.30 "Sixth Product" shall mean the sixth in a succession of six (6)
different Products that (a) are covered by a Valid Claim in a Major Country and
(b) ProCyte or its Affiliate or sublicensee has introduced to the market in the
Major Country after receiving regulatory approval to market in the Major
Country.
1.31 "SKY" shall mean S.K.Y. Polymers, Inc., a Delaware corporation, that is
majority-owned and controlled by Xx. Xxxxxxxx Xxxx.
1.32 "SKY Agreement" shall mean the License Agreement dated as of
November 1, 1993 by and between Hymedix and SKY, as supplemented and amended by
a Modification to the License Agreement dated November 14, 1994, an Amendment to
Modification to the License Agreement dated November 13, 1995 and a Modification
No. 2 to the License Agreement dated November 15, 1995.
1.33 "Xxxx Agreement" shall mean the Consulting Agreement dated as of
November 1, 1993 by and between Hymedix and Xx. Xxxxxxxx Xxxx.
1.34 "Territory" shall mean the entire world, except the Excluded Territory
shall be excluded to the extent the Licensed Technology for the Field is
licensed to Europa under the Europa Agreement for the Field. The Territory
shall be increased to the extent countries comprising the Excluded Territory are
dropped from the territory covered by the Europa Agreement or to the extent
Europa's license rights under the Europa Agreement to the Intellectual Property
(as defined in the Europa Agreement), which is included in the Licensed
Technology, are reduced.
1.35 "Third Product" shall mean the third in a succession of three (3)
different Products that (a) are covered by a Valid Claim in a Major Country and
(b) ProCyte or its Affiliate or sublicensee has introduced to the market in the
Major Country after receiving regulatory approval to market in the Major
Country.
1.36 "Trademarks" shall mean the trademarks and tradenames of Hymedix and
its Affiliates related to polymers, hydrogels or Products, including, but not
limited to, the HySorb U.S. trademark set forth in Exhibit 1.36A attached hereto
and the trademark and tradenames set forth in Exhibit 1.36B attached hereto.
1.37 "Valid Claim" shall mean a claim of an issued, unexpired patent
included in the Patent Rights or Joint [CONFIDENTIAL TREATMENT REQUESTED]
Patents, but not including Other Joint Patents, which has not been (a) held
invalid or unenforceable by a final decision of a court or governmental agency
of competent jurisdiction, which decision is unappealable or was not appealed
within the time allowed therefor, or (b) admitted in writing to be invalid or
unenforceable by the holder(s) by reissue, disclaimer or otherwise.
SECTION 2. DEVELOPMENT
2.1 PROGRAM
ProCyte shall fund a research and development program related to the Licensed
Technology (the "Program") at Hymedix through December 31, 1997, with the
specific projects and goals identified
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and established by ProCyte after discussion with Hymedix. The amount of funding
to be provided by ProCyte shall be [CONFIDENTIAL TREATMENT REQUESTED]. At
ProCyte's request, Hymedix shall cause each of the Key Hymedix People to spend
up to [CONFIDENTIAL TREATMENT REQUESTED] working on the Program, and such other
Hymedix staff shall assist as appropriate. ProCyte may reallocate among the Key
Hymedix People the amount of time they are to spend on the Program [CONFIDENTIAL
TREATMENT REQUESTED] and request that certain of them travel, at ProCyte's
expense, to ProCyte's facility in Kirkland, Washington to provide services in
connection with the Program. It is recognized and agreed that Xx. Xxxxxxxx
Xxxx, a consultant to Hymedix, occasionally travels and may not be available
every week to provide services in connection with the Program. If any of the
Key Hymedix People are no longer employees or consultants to Hymedix or provide
such services to Hymedix, ProCyte may hire them directly pursuant to consulting
letters being signed contemporaneously with this Agreement and deduct from any
of its payments due under this Agreement the appropriate amounts for reasonable
compensation to such individuals. At ProCyte's option, the term of the Program
may be extended for one-year terms for up to two (2) years upon the same terms
and conditions.
2.2 REPORTS; INFORMATION
Hymedix shall submit to ProCyte a written report no less frequently than every
six (6) months which covers the then current technical status, the results
achieved, the improvements and inventions made, the problems being encountered
and other pertinent information relating to the Program. Hymedix shall keep,
and shall cause its consultants to keep, complete, accurate and authentic
accounts, notes, data and records of the research and development performed
under the Program in accordance with established laboratory practices and in
accordance with the directions of ProCyte for purposes of patent protection,
publication, etc. At the request of ProCyte, upon reasonable notice and during
reasonable business hours, ProCyte may inspect and make copies of such accounts,
notes, data and records subject to Section 9. ProCyte may require that certain
aspects of the Program and resulting Licensed Technology be kept confidential
and not be disclosed to others, except in accordance with applicable patent
laws. Any inventions, discoveries, improvements, results and data of Hymedix
(including its consultants) from the Program shall become Licensed Technology
under this Agreement. From time to time ProCyte may discuss and provide
information (e.g., market information) to Hymedix in connection with the
Program, which information shall be subject to Section 9.
2.3 MEETINGS
At ProCyte's request, ProCyte and Hymedix shall meet at mutually agreed upon
intervals (no less frequently than two times a year) to discuss and review the
progress and results of the Program and other ideas the parties have for
development of Licensed Technology for the Field. The meetings will be attended
by the Key Hymedix People requested by ProCyte and by specific Hymedix
scientists, staff and consultants requested by ProCyte. If ProCyte requests
that the meetings be held at ProCyte's facility or another facility out of state
from the Hymedix facility, ProCyte shall pay transportation and other related
travel expenses for the Hymedix individuals to attend the meetings. Hymedix
may, at its expense and discretion, send certain of its management personnel (up
to two (2) to attend the meetings.
SECTION 3. GRANT OF RIGHTS
3.1 LICENSE
Subject to the terms of this Agreement, Hymedix hereby grants to ProCyte the
sole and exclusive license (a) under the Licensed Technology to make, have made,
use and sell Products in the Territory for the Field and (b) under the Joint
[CONFIDENTIAL TREATMENT REQUESTED] Patents, Other Joint Patents, Joint
Technology and other Licensed Technology resulting from the Program to make,
have made, use and sell Products worldwide for the Field. The foregoing license
shall be exclusive even as to Hymedix and its Affiliates and shall include the
right of ProCyte to sublicense others. ProCyte shall notify Hymedix within ten
(10) days after granting any sublicenses.
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3.2 EFFORTS
ProCyte shall use reasonable and diligent efforts to develop and commercialize
Products utilizing the Licensed Technology.
3.3 HYFIL
ProCyte hereby grants back to Hymedix a nonexclusive sublicense, without the
right to further sublicense, under the current form of the Licensed Technology
to make, have made and sell to Xxxxx the Present HyFil Products, for resale by
Xxxxx in Canada, the United States and Mexico for the treatment, management or
care of wounds in humans, excluding drug delivery. Hymedix shall not make, have
made or sell Present HyFil Products for or to any other party in or for the
Territory. No royalties shall be payable by Hymedix to ProCyte for such
nonexclusive license; however, Hymedix shall be responsible for paying any
royalties or fees due third parties on such use of the Licensed Technology or
such sale of Present HyFil Products. As soon as Hymedix ceases supplying Xxxxx
the Present HyFil Products under its current relationship, the license set forth
in this Section 3.3 shall terminate. The license set forth in this Section 3.3
does not include any Licensed Technology developed after the date hereof
(including Joint Technology) nor any other property rights of ProCyte. Hymedix
shall promptly notify ProCyte when Hymedix's relationship with Xxxxx regarding
Present HyFil Products terminates.
SECTION 4. MILESTONE PAYMENTS
In partial consideration of the obligations, licenses, representations and
warranties of Hymedix hereunder, ProCyte shall deliver to Hymedix two hundred
thousand (200,000) shares of ProCyte's common stock pursuant to a Stock
Acquisition Agreement in the form attached hereto as Exhibit 4 and shall pay to
Hymedix the following amounts at the time indicated as reduced by the amounts
set forth in Sections 2.1, 11 and 13, provided that Hymedix is not then in
material breach of this Agreement:
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Payment Due Amount
---------------------- ------------------------
[CONFIDENTIAL TREATMENT REQUESTED]
ProCyte shall notify Hymedix within five (5) days of the first market
introductions described in Sections 4(c) and 4(d) unless the date of the market
introduction is after the date set forth in clause (ii) of each of such
Sections.
SECTION 5. ROYALTIES
5.1 AMOUNT
In partial consideration of the obligations, licenses, representations and
warranties of Hymedix hereunder and except as set forth in Section 5.2, ProCyte
shall pay (or cause its Affiliates or sublicensees to pay) to Hymedix a royalty
at one of the following rates with respect to the Net Sales by ProCyte and its
Affiliates and sublicensees during the Royalty Period:
(a) with respect to Products sold in a Major Market, the sale of which infringe
(but for this Agreement) a Valid Claim in the country of sale:
(i) [CONFIDENTIAL TREATMENT REQUESTED] of the Net Sales of such Products
that are not Pharmaceutical Products until the Royalty Step Down Date and then
[CONFIDENTIAL TREATMENT REQUESTED] of such Net Sales; or
(ii) [CONFIDENTIAL TREATMENT REQUESTED] of the Net Sales of such Products
that are Pharmaceutical Products until the Royalty Step Down Date and then
[CONFIDENTIAL TREATMENT REQUESTED] of such Net Sales; or
(b) with respect to Products sold in a Minor Market:
(i) [CONFIDENTIAL TREATMENT REQUESTED] of the Net Sales of such Products
that are not Pharmaceutical Products; or
(ii) [CONFIDENTIAL TREATMENT REQUESTED] of Net Sales of such Products that
are Pharmaceutical Products.
No royalties shall be due with respect to any other sales of Products, except as
set forth above in this Section 5.1, and no multiple royalties shall be payable
hereunder to Hymedix because the Product or its manufacture infringes (but for
this Agreement) more than one Valid Claim in the Patent Rights or Joint
[CONFIDENTIAL TREATMENT REQUESTED] Patents.
5.2 CREDITS/OFFSETS; WITHHOLDING
The foregoing royalty set forth in Section 5.1 shall be reduced by
(a) [CONFIDENTIAL TREATMENT REQUESTED] that ProCyte and its Affiliates and
sublicensees owe to a third party with respect to the Net Sales, provided that
the amount of royalties and fees to be applied as a reduction at any time shall
not exceed [CONFIDENTIAL TREATMENT REQUESTED] due pursuant to Section 5.1 prior
to any other credits, offsets or deductions, and (b) the payments made pursuant
to Sections 2.1, 11, 13 and 17 that are not credited, at ProCyte's election,
against the payments due under Section 4. In addition, all the payments made
under Section 4(c) and (d) may be credited against the foregoing royalty
obligation at a rate up to an amount equal to [CONFIDENTIAL TREATMENT REQUESTED]
of the Net Sales of Products that are not Pharmaceutical Products and
[CONFIDENTIAL TREATMENT REQUESTED] of the Net Sales of Products that are
Pharmaceutical Products. Any taxes levied by or for a jurisdiction on any
royalties due Hymedix may be withheld from the royalty payments due hereunder
and used to pay such taxes, confirmation of such payment being promptly provided
to Hymedix.
5.3 PAYMENT
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Royalties shall be paid within sixty (60) days after the end of each fiscal
quarter of ProCyte or its Affiliates or sublicensees. If Net Sales are in a
currency that cannot be converted to U.S. dollars and exported to the United
States, royalties on such Net Sales shall be calculated and paid in the currency
of the country of sale by depositing such royalties in a bank account
established in the name of Hymedix.
5.4 REPORTS
With each royalty payment, Hymedix shall receive a written report describing the
Net Sales for the quarter on which royalties are due, including a breakdown by
Product type and country.
5.5 BOOKS AND RECORDS
ProCyte shall keep accurate books of account and records for the purpose of
documenting the Net Sales on which royalties are due and the computation of all
royalties payable to Hymedix under this Agreement. Such books and records shall
be made available at least once per year at times selected by mutual agreement
of the parties for inspection, at Hymedix's expense, by an independent certified
public accountant selected by Hymedix and reasonably acceptable to ProCyte to
confirm the calculation of royalties due hereunder within the last three (3)
years. All matters reviewed by such accountant shall be subject to the terms of
Section 9. In addition, upon reasonable notice and at least once per year,
ProCyte will allow certain of its working papers for the calculation of
royalties, at its sole discretion, to be made available to up to two (2)
employees of Hymedix for an informal review and discussion of methodology at
ProCyte's offices.
SECTION 6. SUPPLY OF MATERIAL
6.1 [CONFIDENTIAL TREATMENT REQUESTED] AND HYPAN
Within ten (10) days of the date hereof, Hymedix shall deliver to ProCyte,
f.o.b. destination designated by ProCyte, [CONFIDENTIAL TREATMENT REQUESTED] of
[CONFIDENTIAL TREATMENT REQUESTED] at no charge or expense to ProCyte except for
transportation costs from Dayton, New Jersey, which ProCyte shall pay.
Thereafter, and from time to time, Hymedix shall deliver to ProCyte, f.o.b.
destination designated by ProCyte, within thirty (30) days such quantities of
[CONFIDENTIAL TREATMENT REQUESTED], as ordered from time to time at ProCyte's
sole discretion, up to an aggregate of [CONFIDENTIAL TREATMENT REQUESTED], for
which ProCyte shall pay cost plus twenty percent (20%), net thirty (30) days
after each delivery. After ProCyte has qualified another supplier of
[CONFIDENTIAL TREATMENT REQUESTED] pursuant to Section 6.2 and is satisfied with
the supply arrangements with the other supplier, the amount of Hymedix's
[CONFIDENTIAL TREATMENT REQUESTED] to be reserved for ProCyte pursuant to the
preceding sentence may be reduced from [CONFIDENTIAL TREATMENT REQUESTED], but
not earlier than one year after the date of this Agreement. In addition,
Hymedix shall, upon request, make and deliver to ProCyte f.o.b. Dayton, New
Jersey, within sixty (60) days of any orders any of the various grades and types
of HYPAN (with such other specifications as ProCyte may reasonably request) that
ProCyte may order, for which ProCyte shall pay [CONFIDENTIAL TREATMENT
REQUESTED], net thirty (30) days after each delivery. For purposes hereof,
"cost" shall mean (a) for [CONFIDENTIAL TREATMENT REQUESTED] to be delivered
pursuant to the second sentence of this Section 6.1, Hymedix's purchase price
for the [CONFIDENTIAL TREATMENT REQUESTED] [CONFIDENTIAL TREATMENT REQUESTED]
and its out-of-pocket costs for packaging, insurance and transportation to
ProCyte and (b) for HYPAN, Hymedix's direct, indirect and overhead manufacturing
costs and out-of-pocket costs for packaging. If requested, Hymedix shall
provide ProCyte with quotes of the maximum cost for manufacturing the forms of
HYPAN desired by ProCyte.
6.2 ALTERNATIVE SOURCE OF [CONFIDENTIAL TREATMENT REQUESTED]
Hymedix shall assist ProCyte in identifying, testing and qualifying another
party that will supply to ProCyte on a regular and reasonable basis in the
future [CONFIDENTIAL TREATMENT REQUESTED] meeting the same specifications and
having the same characteristics when used to
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make the various forms of polymers and hydrogels as [CONFIDENTIAL TREATMENT
REQUESTED]. ProCyte shall not be obligated to pay the milestone payment
described in Section 4(b) unless ProCyte has so qualified another party.
6.3 BOOKS AND RECORDS
Hymedix shall keep accurate books of accounts and records for the purpose of
documenting and calculating its costs in providing [CONFIDENTIAL TREATMENT
REQUESTED] and HYPAN to ProCyte pursuant to Section 6.1. Such books and records
shall be available for inspection as to any order or series of orders placed by
ProCyte on a day selected by mutual agreement of the parties for inspection, at
ProCyte's expense, by an independent certified public accountant selected by
ProCyte and reasonably acceptable to Hymedix. All matters reviewed by such
accountant shall be subject to the terms of Section 9. In addition, upon
reasonable notice and at its sole discretion, Hymedix may allow its books and
records to be made available to an employee of ProCyte for an informal review
and discussion of methodology at Hymedix offices.
SECTION 7. TECHNOLOGY TRANSFER
Upon execution of this Agreement, Hymedix shall deliver to ProCyte in written
form (a) all manufacturing protocols (including partial protocols) for its
Products, polymers and hydrogels licensed hereunder; (b) copies of all files
related to FDA applications and registrations (including correspondence and the
information described in items 1 through 6 of Exhibit 7 attached hereto); and
(c) Hymedix's market research in the Field. Hymedix shall promptly continue to
convey to ProCyte all other forms of the Licensed Technology. Hymedix shall
permit employees or consultants of ProCyte to examine in Hymedix's offices the
books, records and files of Hymedix relating to the information described in
Exhibit 7 attached hereto, in addition to other materials, and to make copies
thereof. To assist in further transfer, ProCyte may place its employees or
consultants in the laboratories and facilities of Hymedix and its Affiliates to
learn the Licensed Technology and may consult with, and Hymedix shall make
available to ProCyte, each of the Key Hymedix People [CONFIDENTIAL TREATMENT
REQUESTED] regarding the substance and use of the Licensed Technology. ProCyte
shall pay the reasonable travel costs for any Key Hymedix People that it
requests to travel to ProCyte's facility. As new Licensed Technology is
developed, Hymedix shall promptly and fully disclose it to ProCyte.
SECTION 8. REGULATORY
Hymedix shall, in writing and pursuant to ProCyte's instructions, notify the FDA
and other applicable regulatory agencies that ProCyte has been assigned the
registrations of Hymedix and its Affiliates in the Territory for Products for
the Field (all of which are identified in Exhibit 8 attached hereto) and that
ProCyte is the manufacturer and distributor of such Products in the Territory,
except to the extent that Hymedix and Xxxxx need to be identified as a
manufacturer and distributor, respectively, of Present HyFil Products. The form
of notification, assignment or any other papers to be filed or submitted to the
FDA shall be prepared by, and approved by, ProCyte after consultation with
Hymedix. Hymedix shall cooperate and assist in the transfer to ProCyte (and
upon request execute such assignments and other documents) of any other
regulatory filings, approvals applications, registrations, product listings and
any materials containing information related thereto, that may be in
preparation, for any Products for the Field that are being developed for
manufacture, distribution or sale in the Territory.
In the event the FDA or other regulatory agency notifies Hymedix or any of its
Affiliates of a problem or a concern with respect to use of the Licensed
Technology with humans, Hymedix shall promptly notify ProCyte orally and then
with a written summary and, except for the Present HyFil Products manufactured
and sold by Hymedix to Xxxxx, allow ProCyte to prepare and manage the response
to the FDA or other regulatory agency with respect to Products in the Territory
for the Field. In the event Hymedix or any of its Affiliates otherwise become
aware of a matter which may relate to the safety of using the Licensed
Technology with humans, Hymedix shall promptly notify ProCyte. In the event the
FDA or other regulatory agency notifies ProCyte or its Affiliates of a problem
or concern
23
with respect to the use of HYPAN with humans, ProCyte shall promptly notify
Hymedix orally and then with a written summary.
Hymedix hereby consents to, and shall cooperate and assist in, referencing any
master files of Hymedix or its Affiliates with the FDA or other regulatory
agencies [CONFIDENTIAL TREATMENT REQUESTED] by ProCyte and its Affiliates and
sublicensees in connection with any of their applications or filings with the
FDA or other regulatory agencies. Hymedix shall promptly notify ProCyte of any
additions or modifications to such master files.
SECTION 9. CONFIDENTIALITY
During the term of this Agreement and for a period of five (5) years thereafter,
each party shall keep confidential and not disclose or use (except as
contemplated by this Agreement) any proprietary or confidential information
received from the other party. The foregoing obligation of nondisclosure and
nonuse shall not apply to any information which (a) is independently developed
by the other party as shown by suitable documentary evidence, (b) is already
known to the recipient at the time of disclosure, (c) is or becomes public
knowledge through no fault of the recipient, (d) is received without an
obligation of confidentiality from a third party having the lawful right to
disclose same, (e) the disclosing party approves in writing may be disclosed, or
(f) is required by law to be disclosed, provided the recipient has used
reasonable efforts to secure confidential treatment of the information and given
prior written notice to the other party. With respect to Licensed Technology
that is proprietary or confidential information and subject to Section 2.2
regarding Licensed Technology resulting from this Program that ProCyte requests
be kept confidential by Hymedix, (i) Hymedix and its Affiliates shall keep
confidential and not disclose the Licensed Technology in accordance with this
Section 9, (ii) a party may disclose such information to its Affiliates,
sublicensees, consultants, outside contractors and clinical investigators, on a
need-to-know basis, on condition that such persons or entities agree to keep the
information confidential upon substantially the same terms as set forth herein,
(iii) a party or its Affiliates or sublicensees may disclose the information to
governmental or other regulatory authorities to the extent that such disclosure
is reasonably necessary to obtain patents or authorizations to conduct clinical
trials, provided the disclosing party shall request confidential treatment
thereof, and (iv) a party or its Affiliates or sublicensees may disclose the
information to the extent necessary to market Products commercially.
This Section 9 shall, after the date hereof, apply to all confidential or
proprietary information that the parties disclosed to each other or their
Affiliates prior to the date hereof. The parties' obligations prior to the date
hereof are governed by a Mutual Confidentiality and Non-disclosure Agreement
dated May 30, 1995.
SECTION 10. RIGHTS IN JOINT PATENTS
10.1 JOINT [CONFIDENTIAL TREATMENT REQUESTED] PATENTS
Subject to the term of this Agreement, ProCyte hereby grants to Hymedix a
royalty-free, exclusive license under its rights in the Joint [CONFIDENTIAL
TREATMENT REQUESTED] Patents to make, have made, use and sell products worldwide
outside of the Field. The foregoing license shall be exclusive even as to
ProCyte and its Affiliates. Hymedix shall notify ProCyte within ten (10) days
after granting any licenses to use the Joint [CONFIDENTIAL TREATMENT REQUESTED]
Patents outside of the Field. It is recognized and agreed that Hymedix's
interest in the Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents has been
licensed exclusively to ProCyte for the Field pursuant to Section 3.1(b).
10.2 OTHER JOINT PATENTS
It is recognized and agreed that Hymedix's interests in the Other Joint Patents
have been licensed exclusively to ProCyte for the Field pursuant to Section
3.1(b) and that the parties have retained, and have not granted license rights
to, their undivided interests in the Other Joint Patents for use outside the
Field.
SECTION 11. PATENT PROSECUTION AND MAINTENANCE
24
11.1 REEXAMINATION/REISSUE AND EUROPEAN PROSECUTION
ProCyte shall have the right, at its expense, to pursue in the United States
[CONFIDENTIAL TREATMENT REQUESTED] before the Patent and Trademark Office and
shall have the right, at its expense, to prosecute, issue and maintain the Drug
Delivery Application and, in European countries of its selection, [CONFIDENTIAL
TREATMENT REQUESTED]. All of ProCyte's reasonable expenses in connection
therewith may be deducted from payments due under Sections 4 and/or 5 at
ProCyte's election. Hymedix shall be promptly notified when ProCyte has paid in
excess of [CONFIDENTIAL TREATMENT REQUESTED] of such expenses. ProCyte shall
confer with Hymedix and its consultants (including Xx. Xxxxxxxx Xxxx) and
counsel regarding such reexamination/reissue, prosecution, issuance and
maintenance and shall provide to Hymedix copies of any official action within
thirty (30) days of receipt and advance copies of, for the opportunity for
Hymedix and its consultants and counsel to discuss and offer proposed changes
to, any proposed filing, submission or other correspondence by ProCyte or patent
counsel with respect thereto. In the event ProCyte elects to abandon such
reexamination/reissue or patent applications, it shall promptly notify Hymedix
(but in any event no later than thirty (30) days in advance of any deadline with
respect to the patent applications) and allow and assist Hymedix, at Hymedix's
election and expense, to pursue such reexamination/reissue or patent
applications.
11.2 PATENT RIGHTS
Except as provided in Section 11.1, Hymedix shall, at its expense, diligently
and in good faith file, prosecute, issue and maintain the Patent Rights in the
Major Markets and Japan. Hymedix shall confer with ProCyte and its counsel
regarding the filing, prosecution, issuance and maintenance of such Patent
Rights and shall provide to ProCyte copies of any official action within thirty
(30) days of receipt and advance copies of, with the opportunity for ProCyte to
discuss and offer proposed changes to, any proposed filing, submission or other
correspondence by Hymedix or its licensors and patent counsel. In the event
Hymedix elects to abandon or not file on any Patent Rights, it shall promptly
notify ProCyte (but in any event no later than thirty (30) days in advance of
any deadline) and allow and assist ProCyte, at ProCyte's election and expense,
to pursue such Patent Rights, in which event ProCyte's costs may be deducted
from payments due under Sections 4 and/or 5, at ProCyte's election, and such
Patent Rights shall be assigned to ProCyte and not be royalty bearing hereunder
(i.e., removed from the definition of Patent Rights and Valid Claim).
11.3 JOINT [CONFIDENTIAL TREATMENT REQUESTED] PATENTS
Hymedix shall have the right, at its expense, to diligently and in good faith
file, prosecute, issue and maintain the Joint [CONFIDENTIAL TREATMENT REQUESTED]
Patents in the Major Markets and Japan. Hymedix shall confer with ProCyte and
its counsel regarding the filing, prosecution, issuance and maintenance of all
Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents and incorporate all requested
changes. Hymedix shall provide to ProCyte copies of any official action within
thirty (30) days of receipt and advance copies of, with the opportunity for
ProCyte to revise, any proposed filing, submission or other correspondence by
Hymedix or its patent counsel. In the event Hymedix elects to abandon or not
file on any Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents, it shall promptly
notify ProCyte (but in any event no later than thirty (30) days in advance of
any deadline) and allow and assist ProCyte, at ProCyte's election and expense,
to pursue such Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents, in which event
ProCyte's costs may be deducted from payments due under Sections 4 and/or 5, at
ProCyte's election, and such Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents
shall be assigned to ProCyte and not be royalty bearing hereunder (i.e., removed
from the definition of Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents and
Valid Claim). In the event of such assignment, Hymedix's license rights under
Section 10.1 shall terminate, and Hymedix shall have no further right or
interest in such Joint [CONFIDENTIAL TREATMENT REQUESTED] Patent.
11.4 OTHER JOINT PATENTS
25
ProCyte shall have the right, at its expense, to diligently and in good faith
file, prosecute, issue and maintain the Other Joint Patents in the Major
Countries, Japan and such other countries in the Territory designated by
ProCyte. Hymedix shall promptly reimburse ProCyte for [CONFIDENTIAL TREATMENT
REQUESTED] of ProCyte's expenses with respect to such Other Joint Patents.
ProCyte shall confer with Hymedix and its counsel regarding the filing,
prosecution, issuance and maintenance of all Other Joint Patents and shall
provide to Hymedix copies of any official action within thirty (30) days of
receipt and advance copies of, with the opportunity for Hymedix to discuss and
offer proposed changes to, any proposed filing, submission or other
correspondence by ProCyte or its patent counsel. In the event ProCyte elects to
abandon or not file on any Other Joint Patents, it shall promptly notify Hymedix
(but in any event no later than thirty (30) days in advance of any deadline) and
allow and assist Hymedix, at Hymedix's election and expense, to pursue such
Other Joint Patents.
11.5 COOPERATION
Each party shall cooperate and assist the other party in connection with the
filing, prosecution, issuance, reexamination and maintenance of Patent Rights,
Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents and Other Joint Patents. Where
appropriate, each party shall sign, or cause to have signed, all documents
relating to the patent applications or patents for the Patent Rights, Joint
[CONFIDENTIAL TREATMENT REQUESTED] Patents and Other Joint Patents.
SECTION 12. ENFORCEMENT OF PATENTS
12.1 EXCLUSIVE LICENSE RIGHTS
Upon learning of the infringement of the Patent Rights in the Territory for the
Field or infringement of the Joint [CONFIDENTIAL TREATMENT REQUESTED] Patents or
Other Joint Patents to the extent exclusively licensed to a party hereunder, a
party shall promptly notify the other party in writing of the infringement and
the evidence pertaining to such infringement. The party whose exclusive license
rights hereunder are being infringed shall have three (3) months from the date
of learning of the infringement to xxxxx the infringement or to file suit
against at least one of the infringers, at its sole expense, following
consultation with the other party. The party who has a right to bring an
infringement suit shall not be obligated to bring or maintain more than one such
suit at any time with respect to infringers of the same patent. If counsel
reasonably concludes that the other party is a necessary or indispensable party
to such suit, the party bringing the suit may use the name of, or join, the
other party.
If the party who has the right to bring the infringement suit does not bring the
suit within the time set forth in the preceding paragraph, the other party shall
have the right to take whatever action it deems appropriate in its own name or,
if required by law, in the name of the party whose exclusive license rights are
being infringed.
All monies recovered upon the final judgment or settlement of any infringement
suit shall, after reimbursement of the expenses of the parties bringing any such
suit (including reasonable attorneys' fees), be shared by the parties in a ratio
of [CONFIDENTIAL TREATMENT REQUESTED] where [CONFIDENTIAL TREATMENT REQUESTED]
goes to the party who brought the suit and [CONFIDENTIAL TREATMENT REQUESTED]
goes to the other party.
12.2 OTHER JOINT PATENTS
Upon learning of the infringement of the Other Joint Patents outside of the
Field, a party shall promptly notify the other party in writing of the fact and
supply the other party with all evidence pertaining to such infringement.
ProCyte shall have the first right to xxxxx the infringement or file suit
against at least one of the infringers, at its sole expense, after consultation
with Hymedix. All other procedures, rights and obligations with respect to such
infringement suit or the right of Hymedix to bring an infringement suit in the
event the infringement is not abated or the suit is not filed by ProCyte shall
be governed by Section 12.1 MUTATIS MUTANDIS.
12.3 ASSISTANCE
26
Both parties shall fully cooperate with and assist each other in matters
pertaining to infringement suits brought under Section 12.1 or 12.2.
12.4 SETTLEMENT
The party bringing the infringement suit covered by this Section 12 shall not
settle the suit or otherwise consent to an adverse judgment in such suit in a
manner that diminishes the rights or interests of the other party without the
other party's written consent, which consent shall not be unreasonably withheld.
The other party shall have the right to participate, at its expense and with
counsel of its choosing, in an infringement suit brought by the other party to
the extent its rights in any patents or other proprietary rights are being
challenged.
SECTION 13. INFRINGEMENT OF THIRD-PARTY PATENTS
In the event ProCyte or its Affiliates or sublicensees are sued for infringement
of a patent or other proprietary right of a third party (or bring a suit for
declaratory judgment of noninfringement or invalidity) in connection with and
related to the use of the Licensed Technology, any royalties due with respect to
such Product and any milestone payments due pursuant to Section 4 may be
withheld during the pendency of such suit. Any costs and expenses (including
reasonable attorneys' fees) incurred in defending such suit and any settlement
or judgments may be deducted from such withheld royalties or milestone payments
and, if insufficient, from any future royalties or milestone payments. Any
withheld royalties or milestone payments not applied to such costs, expenses,
judgment or settlement shall be promptly paid to Hymedix after such judgment or
settlement.
SECTION 14. WARRANTIES AND REPRESENTATIONS
14.1 BOTH PARTIES
Each party hereby represents and warrants to the other that:
(a) It (i) is a corporation duly organized, validly existing and in good
standing under the laws of the state in which it is incorporated, (ii) has the
corporate power and authority and the legal right to own and operate its
property and assets, to lease the property and assets it operates under lease,
and to carry on its business as it is now being conducted, and (iii) is in
compliance with all requirements of applicable law, except to the extent that
any noncompliance would not have a material adverse effect on its properties,
business, financial or other condition or ability to perform its obligations
under this Agreement.
(b) It (i) has the corporate power and authority and the legal right to enter
into this Agreement and to perform its obligations hereunder and (ii) has taken
all necessary corporate action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder.
This Agreement has been duly executed and delivered on its behalf and
constitutes a legal, valid and binding obligation, enforceable against it in
accordance with its terms.
(c) All necessary consents, approvals and authorizations of all governmental
authorities and other persons required to be obtained in connection with its
execution, delivery and performance of this Agreement have been obtained.
(d) Notwithstanding anything to the contrary in this Agreement, its execution,
delivery and performance of this Agreement (i) will not conflict with or violate
any requirement of applicable laws or regulations and (ii) will not conflict
with, violate or breach or constitute a default or require any consent under any
of its contractual obligations.
14.2 HYMEDIX
Hymedix hereby represents and warrants to ProCyte that:
(a) Notwithstanding anything to the contrary in this Agreement, its execution,
delivery and performance of this Agreement will not conflict with, violate,
breach or constitute a default or require any consent under any contractual
obligations of its Affiliates, including Hymedix, Inc.
(b) Hymedix and its Affiliates have not granted, and will not grant during the
term of this Agreement, any rights or licenses in the Licensed Technology in the
Territory for the Field.
(c) Exhibit 1.22 contains a list of all current patents and patent applications
owned or controlled (including licensed) by Hymedix or its Affiliates that
Hymedix believes may have some usefulness in
27
the Territory for the Field and that are included in the Licensed Technology.
All such patents and patent applications have been assigned to Hymedix or, with
respect to [CONFIDENTIAL TREATMENT REQUESTED], have been licensed to SKY, which
has sublicensed them to Hymedix pursuant to the SKY Agreement.
(d) Except for Licensed Technology licensed by Hymedix under the SKY Agreement,
all the current Licensed Technology is owned by Hymedix and none of it is
licensed from third parties. The Licensed Technology is free and clear of any
liens, claims, encumbrances or rights of others for use in the Territory for the
Field.
(e) True and correct copies of the Europa Agreement, SKY Agreement and Xxxx
Agreement have been delivered to ProCyte, which agreements have not been
modified, changed, waived or materially breached in any respect. True and
correct copies of all other agreements of Hymedix or its Affiliates relating to
any of the Licensed Technology or any products to be made through the use of the
Licensed Technology have been delivered to ProCyte, which agreements have not
been modified, changed or waived in any respect. Except for the SKY Agreement
and Xxxx Agreement, Hymedix and its Affiliates have no other agreements or
understandings with SKY or Xx. Xxxxxxxx Xxxx.
(f) Hymedix or its Affiliates have not received or been notified of any claim
of infringement or misappropriation of any alleged rights asserted by another
party that relate to the Licensed Technology in the Territory for the Field.
(g) The making, using and selling of polymers and hydrogels described in the
patents and patent applications set forth in Exhibit 1.22, the six (6) current
products of Hymedix for wound care set forth in Exhibit 8 or other Products
based on the Licensed Technology will not infringe any rights of others and will
not require a license from, or royalty payment to, another party, other than to
SKY, which Hymedix shall pay.
(h) Hymedix and its Affiliates are not aware of any patents, pending patent
applications or proprietary rights of any third party which could materially
affect the ability of ProCyte to use the Licensed Technology as licensed
hereunder.
(i) SKY or Xx. Xxxxxxxx Xxxx does not have any patents, pending patent
applications, patentable inventions or trade secrets that have not been licensed
to Hymedix and included in the Licensed Technology in the Territory that could
be useful for the Field.
(j) Except for Xx. Xxxxxxxx Xxxx, who is an outside consultant to Hymedix, all
of the other [CONFIDENTIAL TREATMENT REQUESTED] Key Hymedix People and the other
employees of Hymedix have signed agreements (the form of which has been provided
to ProCyte) that require them to assign to Hymedix any patentable inventions and
trade secrets that relate to polymers, hydrogels or drug delivery that they may
conceive or make during the term of their employment with Hymedix, whether or
not made in the course of employment.
(k) All consultants and employees of Hymedix and its Affiliates are obligated
to keep confidential and not disclose to others any of the Licensed Technology
or information received from ProCyte upon terms substantially the same as those
set forth in Section 9.
(l) SKY and Xx. Xxxxxxxx Xxxx are obligated to license or assign to Hymedix any
patentable inventions or trade secrets that they may make or develop, the terms
of any license or assignment to be in accordance with the SKY Agreement and Xxxx
Agreement.
(m) Hymedix and its Affiliates are not aware of any party that has infringed or
misappropriated, or is or may soon be infringing, the Licensed Technology in the
Territory for the Field.
(n) All adverse events and other material problems (including comments and
concerns of the FDA and other regulatory agencies) with respect to the use of
any Product with or in humans (or in preclinical testing with animals) have been
disclosed to ProCyte.
(o) Hymedix and its Affiliates are not aware of any inherent properties of the
polymers or hydrogels made through the use of, or covered by, the Licensed
Technology that make any of them unsuitable for use in wound care, drug delivery
or extrusion of thin films or other forms.
28
(p) Hymedix has disclosed to ProCyte all material information relating to the
use of the Licensed Technology in the Territory for the Field.
(q) Hymedix has disclosed to ProCyte all specifications, analytical methods,
records and data (including QC instability testing) relating to the
[CONFIDENTIAL TREATMENT REQUESTED].
(r) Hymedix and its Affiliates are not aware of any problem that [CONFIDENTIAL
TREATMENT REQUESTED] Industries, Inc. has had in delivering [CONFIDENTIAL
TREATMENT REQUESTED] to others or any reason why it cannot provide acceptable
[CONFIDENTIAL TREATMENT REQUESTED] to ProCyte that would be equivalent to
[CONFIDENTIAL TREATMENT REQUESTED].
(s) The Marketing and Distribution Agreement dated as of July 30, 1993 between
Xxxxx and Hymedix has been terminated. Neither Xxxxx nor Xxxxx have any rights
or licenses with respect to the Licensed Technology, except Xxxxx'x right to
distribute the Present HyFil Products as described in Section 3.3 for the
foreseeable future.
(t) Hymedix has delivered to ProCyte true and complete copies of all
manufacturing protocols (including partial protocols) and specifications for its
polymers and hydrogels licensed hereunder and all of its files related to
applications and registrations (including correspondence) with the FDA and other
regulatory agencies.
(u) Hymedix owns and has validly registered the trademarks "HySorb" and "HYPAN"
and such registrations and Hymedix's rights therein have not been challenged or
disputed.
(v) Hymedix and its Affiliates are not aware of any party that has infringed or
intends to make unauthorized use of any of the Trademarks.
(w) Hymedix and its Affiliates have not received or been notified of any claim
that the use of the Trademarks will infringe or violate any alleged rights of
another party.
(x) The use of the Trademarks will not infringe or violate the rights of
another party and will not require a license from, or royalty payment to,
another party.
(y) Hymedix and its Affiliates are not aware of any trademarks or tradenames
which could materially affect the ability of ProCyte to use the Trademarks as
assigned and licensed hereunder.
14.3 PROCYTE
ProCyte hereby represents and warrants to Hymedix that all consultants and
employees of ProCyte are obligated to keep confidential and not disclose to
others any of the Licensed Technology or information received from Hymedix upon
terms substantially the same as those set forth in Section 9.
SECTION 15. COVENANTS
Hymedix covenants and agrees that:
15.1 Hymedix and its Affiliates shall not knowingly sell or provide, whether
directly or indirectly, any form of [CONFIDENTIAL TREATMENT REQUESTED] or other
form of [CONFIDENTIAL TREATMENT REQUESTED], polymers, HYPAN or Product to anyone
who Hymedix or its Affiliates know or have reason to suspect will use or sell
such material in the Territory for the Field, except for Present HyFil Products
that it may supply to Xxxxx for the foreseeable future pursuant to Section 3.3.
15.2 Hymedix and its Affiliates shall not disclose proprietary Licensed
Technology (whether under an obligation of confidentiality or otherwise) to a
party who they know or reasonably suspect will use such Licensed Technology in
the Territory for the Field.
15.3 Hymedix shall not waive or fail to exercise any of its rights or breach
or fail to perform any of its obligations under the SKY Agreement and Xxxx
Agreement. Hymedix shall not amend or modify the terms of the SKY Agreement and
Xxxx Agreement that relate to or affect the Licensed Technology in the Territory
for the Field, including royalties, fees, licenses, rights and other terms.
15.4 Hymedix shall not terminate the Xxxx Agreement prior to [CONFIDENTIAL
TREATMENT REQUESTED]. Hymedix shall not terminate the SKY Agreement prior to
the last to expire of any patents included in the Technology (as defined in the
SKY Agreement) licensed to Hymedix under the SKY Agreement for the Field and
shall not terminate its monthly license maintenance fee payments pursuant
to Section 5 of the SKY Agreement prior to [CONFIDENTIAL TREATMENT REQUESTED]
29
without the prior written consent of ProCyte. It is recognized that, under the
most recent amendment to the SKY Agreement (i.e., "Modification No. 2 to the
Licensed Agreement"), upon termination of the monthly license maintenance fee
payments Hymedix will not have license rights to any Technology developed, made
or conceived thereafter by SKY, but the license rights for the then-existing
Technology will continue.
15.5 Hymedix shall pay all royalties and fees (including monthly maintenance
fees) due SKY under the SKY Agreement and Xxxx Agreement.
15.6 Hymedix shall not increase the rights of Europa in the Excluded
Territory for the Field, or increase the amount of Licensed Technology covered
by the Europa Agreement, without the prior written consent of ProCyte. It is
recognized that ProCyte has licensed, in the Excluded Territory, rights under
this Agreement to Products for drug delivery and certain other Licensed
Technology not covered by the Europa Agreement, including, for example, Joint
Technology. Hymedix shall not provide or license to Europa any Joint Technology
or other Licensed Technology resulting from the Program.
SECTION 16. INDEMNIFICATION
ProCyte shall indemnify and hold harmless Hymedix, its Affiliates, directors,
employees and agents from any liability for damage to or loss of property or
injury to or death of any persons arising out of ProCyte's possession or use of
the Licensed Technology, except to the extent such damage, loss, injury or death
results from the negligence or willful misconduct of Hymedix. Upon receipt by
Hymedix of any claim or suit with respect to which ProCyte is required to
provide indemnification hereunder, Hymedix shall promptly notify ProCyte and
permit ProCyte to handle and control the defense of such claim or suit. ProCyte
shall have the sole right to settle such claim or suit.
Hymedix shall indemnify and hold harmless ProCyte, its Affiliates, directors,
employees and agents from any liability, claim, damage, loss, cost or expense
(including reasonable attorneys' fees) arising from or related to any breach of
this Agreement by Hymedix (including a breach of representation or warranty) or
[CONFIDENTIAL TREATMENT REQUESTED].
SECTION 17. TRADEMARKS
17.1 ASSIGNMENT OF HYSORB TRADEMARK
Hymedix hereby assigns and transfers to ProCyte all right, title and interest in
and to the registered Trademark "HySorb" that is set forth in Exhibit 1.36A, any
other rights of Hymedix or its Affiliates to the "HySorb" name anywhere in the
Territory and any goodwill connected with its use in the United States and the
Territory. Hymedix shall cooperate with ProCyte, and sign such other documents
as may be reasonably requested, to effectuate such assignment and transfer.
Upon termination of this Agreement prior to the end of its term set forth in
Section 18.1, ProCyte shall reassign to Hymedix the Trademark, rights and
goodwill for "HySorb."
17.2 GRANT OF EXCLUSIVE LICENSE
Except for the "HySorb" Trademark, which has been assigned pursuant to
Section 17.1, Hymedix hereby grants to ProCyte a royalty-free, worldwide,
exclusive right and license (with right to sublicense) to use the Trademarks in
the Territory for the Field.
17.3 ENFORCEMENT OF TRADEMARKS
In the event a party becomes aware of any infringement or unauthorized use by
others of the Trademarks, other than the "HySorb" Trademark (the "Other
Trademarks"), in the Territory for the Field, the party shall promptly notify
the other party in writing of the infringement or unauthorized use and Hymedix
shall have the initial right to bring a suit to xxxxx the infringement or
unauthorized use. In the event Hymedix does not bring a suit within thirty (30)
days of learning of the infringement or unauthorized use, ProCyte, at its
discretion and expense, may bring suit in its own name, or, if required by law,
in the name of Hymedix, retaining all proceeds from any judgment or settlement
of such suit.
17.4 QUALITY CONTROL; USE OF -Registered Trademark-
30
ProCyte shall use commercially reasonable efforts to ensure that its use of the
Other Trademarks does not materially impair the goodwill or reputation of the
Other Trademarks. Hymedix shall ensure that it and its licensees of the Other
Trademarks outside of the Field adhere to established standards of quality so as
not to impair the goodwill, reputation or value of the Other Trademarks.
ProCyte shall appropriately use the symbol "-Registered Trademark-" in
connection with the HYPAN-Registered Trademark- Trademark.
17.5 REGISTRATIONS BY PROCYTE
At its expense, ProCyte shall have the right, but not the obligation, to
register the Other Trademarks in any countries in the Territory for the Field
and to register the trademark "HySorb" in any countries in the Territory.
Hymedix shall cooperate with and assist ProCyte in the registrations for the
Trademarks where appropriate. ProCyte may deduct from any royalties due under
Section 5 [CONFIDENTIAL TREATMENT REQUESTED] of its costs and expenses in
registering the Other Trademarks.
SECTION 18. TERM AND TERMINATION
18.1 TERM
This Agreement shall remain in full force and effect until the expiration of the
last to expire of any patents included in the Patent Rights or Joint
[CONFIDENTIAL TREATMENT REQUESTED] Patents. Upon expiration of the term of this
Agreement, ProCyte shall have a fully paid-up, royalty-free, perpetual license
to use the Licensed Technology nonexclusively and to use the Trademarks
exclusively in the Territory for the Field.
18.2 TERMINATION
(a) ProCyte shall have the right to terminate this Agreement at any time upon
sixty (60) days' prior written notice to Hymedix. After such notice of
termination, ProCyte shall not have any obligation to make a milestone payment
due under Section 4 that accrues after such notice but before the effective date
of termination (i.e., for purposes of the milestone payments in Section 4, the
date of notice shall be deemed the date of termination). In the event ProCyte
terminates this Agreement in accordance with this Section 18.2(a), ProCyte shall
grant to Hymedix, at its request, a royalty-free, nonexclusive, worldwide
license (with right to sublicense) to use any improvements to the Licensed
Technology made by ProCyte during the term of this Agreement that are only
usable in connection with the Licensed Technology and that are of no further
value to ProCyte; provided, however, that at the time of any sublicensing of
such improvements by Hymedix, Hymedix shall notify ProCyte and shall pay to
ProCyte its costs and expenses in making such improvements. In addition,
ProCyte shall have the right to terminate any portion of its license hereunder
as to any patent included in the Patent Rights or Joint [CONFIDENTIAL TREATMENT
REQUESTED] Patents at any time upon sixty (60) days' prior written notice to
Hymedix. The effective date for termination of this Agreement or any portion of
the license, as provided in this Section 18.2, shall be sixty (60) days after
written notice to Hymedix or such later date as may be specified in the written
notice to Hymedix. Upon termination, neither party shall have any rights or
obligations under this Agreement or with respect to the portion of the
terminated license, as the case may be, except as provided in Section 19.7.
(b) If ProCyte fails to makes any payment due hereunder to Hymedix, Hymedix
shall have the right to terminate this Agreement fifteen (15) days after giving
ProCyte notice of such failure and Hymedix's intent to terminate unless ProCyte
makes such payment within such fifteen (15) day period. If ProCyte commits any
material breach of this Agreement, Hymedix shall have the right to terminate
this Agreement ninety (90) days after giving ProCyte notice of such breach and
Hymedix's intent to terminate unless ProCyte has cured or commenced steps to
diligently cure the breach within such ninety (90) day period. Upon
termination, any sublicensee who is not then in material breach shall have its
sublicense converted to a direct license from Hymedix under the terms and
conditions of this Agreement, as further limited and restricted by the terms of
the original sublicense.
(c) Either party may immediately terminate this Agreement effective upon giving
written notice of termination to the other party in the event that:
31
(i) the other party institutes any bankruptcy, insolvency,
liquidation or receivership proceedings or proceedings for
reorganization under bankruptcy or comparable laws concerning its
operations;
(ii) the other party has a petition filed against it for any of the
proceedings provided in (i) above, the effectiveness of which is
not stayed or dismissed within sixty (60) days after the filing
thereof; or
(iii) the other party shall make a general assignment for the benefit
of creditors.
18.3 DISPOSITION OF PRODUCTS
Upon termination of this Agreement or a portion of the license, ProCyte (and its
Affiliates and sublicensees) shall have the right to complete any work in
progress and sell or otherwise dispose of any affected Product within the next
twelve (12) months; provided, however, that royalties and reports shall continue
to be due on any Net Sales of such Product in accordance with this Agreement.
SECTION 19. MISCELLANEOUS
19.1 COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument.
19.2 MODIFICATION
No amendment or modification hereof shall be valid or binding upon the parties
unless made in writing and signed by authorized representatives of the parties.
19.3 INTEGRATION
This Agreement embodies the entire understanding of the parties and shall
supersede all previous communications, representations or understandings, either
oral or written, between the parties relating to the subject matter hereof.
19.4 SEVERABILITY
In case any one or more of the provisions contained in this Agreement shall for
any reason be held to be invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other provisions
hereof, but this Agreement shall be construed as if such invalid or illegal or
unenforceable provisions had never been contained herein.
19.5 INDEPENDENT Contractors
Nothing in this Agreement shall constitute or be deemed to constitute a
partnership or agency between the parties hereto.
19.6 HEADINGS
The headings of this Agreement are inserted for convenience only and shall not
be used in the interpretation of this Agreement.
19.7 SURVIVAL
The rights and obligations of the parties under Sections 5.5, 6.3, 9, 16, 17.1
(in the case of early termination), 18.1 (in the case of expiration), 18.2(a)
(in the case of early, voluntary termination) and 18.3 and any accrued
obligations shall survive expiration or termination of this Agreement.
19.8 GOVERNING LAWS
This Agreement shall be governed by and construed in accordance with the laws of
the State of Washington (regardless of its or any other jurisdiction's
choice-of-law principles).
19.9 USE OF NAMES, TRADE NAMES AND TRADEMARKS
Except as provided in Section 17, nothing contained in this Agreement shall be
construed as conferring any right to use in advertising, publicity or other
promotional activities any name, trade
32
name, trademark or other designation of either party hereto (including any
contraction, abbreviation or simulation of any of the foregoing) except where,
upon advice of counsel, such use is required to comply with any law or
regulation of a governing body having jurisdiction over a party or over the
making, using or selling of any Product.
19.10 PRESS RELEASES; DISCLOSURE OF AGREEMENT
Attached hereto as Exhibit 19.10 is the form of press release that the parties
shall use in connection with the initial public announcement of this Agreement.
Neither party shall make any other press release, public announcement or
statement regarding this Agreement without first consulting with the other party
and allowing ProCyte to coordinate such activities. The financial and
commercial terms set forth in this Agreement shall be treated as confidential
information under Section 9 and shall not be disclosed without the prior written
consent of the other party. The parties shall seek confidential treatment for
the financial and commercial terms set forth in this Agreement in the event they
are required to file this Agreement with the Securities and Exchange Commission
and shall provide to the other party for prior approval any redacted version of
this Agreement to be submitted to the Securities and Exchange Commission for
filing.
19.11 NOTICES AND COMMUNICATIONS
Any notice or any other communication required or permitted to be given to a
party pursuant hereto shall be sufficiently given if delivered personally or by
telecopy or express courier service (expenses prepaid) to the address set forth
below:
ProCyte: ProCyte Corporation
00000 - 000xx Xxx. X.X., Xxxxx 000
Xxxxxxxx, XX 00000-0000
X.X.X.
Attn: President
FAX: (000) 000-0000
Hymedix: Hymedix International, Inc.
0000 Xxxxx 000
Xxxxxx, XX 00000
X.X.X.
Attn: President
FAX: (000) 000-0000
or to such other address as the party shall designate by written notice given to
the other party.
19.12 WAIVERS
No waivers of any right under this Agreement shall be deemed effective unless
contained in a writing signed by the party charged with such waiver, and no
waiver of any right arising from any breach or failure to perform shall be
deemed to be a waiver of any future right or of any other right arising under
this Agreement.
19.13 REVIEW OF AGREEMENT
This Agreement has been submitted to the scrutiny of both parties and their
counsel and shall be given a fair and reasonable interpretation in accordance
with the words hereof, without consideration or weight being given to its being
drafted by or for one of the parties.
19.14 RIGHTS OF BANKRUPTCY
All rights in the Licensed Technology granted under or pursuant to this
Agreement by Hymedix are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code,
33
licenses of rights to "intellectual property" as defined under Section 101 of
the U.S. Bankruptcy Code. ProCyte, as licensee of such rights under this
Agreement, shall retain and may fully exercise all its rights and elections
under the U.S. Bankruptcy Code. In the event of the commencement of a
bankruptcy proceeding by or against Hymedix under the U.S. Bankruptcy Code,
ProCyte shall be entitled to complete access to (or a complete duplicate of, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and the same, if not already in ProCyte's possession,
shall be promptly delivered to ProCyte (a) upon any such commencement of a
bankruptcy proceeding upon ProCyte's written requests therefor, unless Hymedix
elects to continue to perform all of its obligations under this Agreement or (b)
if not delivered under (a) above, upon the rejection of this Agreement by or on
behalf of Hymedix and upon written request therefor by ProCyte.
34
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed as of the date first above written.
PROCYTE CORPORATION
BY:
-------------------------------
Xxxxxx Xxxxxx, President & CEO
HYMEDIX INTERNATIONAL, INC.
BY:
-------------------------------
Xxxxxxx X. Xxxxxxx, Xx., President
35
EXHIBIT 1.6
SPECIFICATIONS FOR [CONFIDENTIAL TREATMENT REQUESTED]
36
EXHIBIT 1.7
ESTABLISHMENT OF THE EXTRUSION PROCESS
The "Establishment of the Extrusion Process" shall be deemed to have occurred
when:
[CONFIDENTIAL TREATMENT REQUESTED]
37
EXHIBIT 1.9
EUROPE
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Holland
Iceland
Ireland
Italy
Luxembourg
Norway
Portugal
Spain
Sweden
Switzerland
Turkey
United Kingdom
38
EXHIBIT 1.10
EXCLUDED TERRITORY
Afghanistan
Bahrain
Bangladesh
Bhutan
Brunei
Burma
Republic of China, including Xxxxxx, Xxxxxxxx Xxxxx
Xxxxxx
Xxxx Xxxx
Xxxxx
Indonesia
Iran
Iraq
Israel
Japan
Xxxxxx
Xxxxxxxxx
Xxxxx (Xxxxx xxx Xxxxx)
Xxxxxx
Xxxx
Lebanon
Malaysia
Maldives
Xxxxxxxx Islands
Mongolia
Nepal
Oman
Pakistan
Philippines
Qatar
Saudi Arabia
Singapore
Sri Lanka
Syria
Turkey
Thailand
United Arab Emirates
Vietnam
Yemen (Aden and Sana)
39
EXHIBIT 1.16
VARIOUS HYPAN DESIGNATIONS
HN50
HN68
HN80
HN86
HN3517
HN5017
HN6017
QT100
SA100H
SR150H
SR150N
SS201
TC200
40
EXHIBIT 1.22
PATENTS AND PATENT APPLICATIONS
[CONFIDENTIAL TREATMENT REQUESTED]
41
EXHIBIT 1.24
SPECIFICATIONS FOR HYFIL
(ALSO REFERRED TO AS HYDRO-M AND HYGELL)
[CONFIDENTIAL TREATMENT REQUESTED]
42
EXHIBIT 1.36A
REGISTERED TRADEMARK ASSIGNED TO PROCYTE
XXXX: "HySorb"
OWNER: Hymedix International, Inc.
DATE OF REGISTRATION: April 18, 1995
REGISTRATION NUMBER: US 1,890,410
43
EXHIBIT 1.36B
TRADEMARKS AND TRADENAMES LICENSED TO PROCYTE
REGISTERED TRADEMARK LICENSED TO PROCYTE
XXXX: "HYPAN"
OWNER: Hymedix International, Inc.
DATE OF REGISTRATION: October 18, 1983
REGISTRATION NUMBER: US 1,254,158
TRADENAMES LICENSED TO PROCYTE
HyBurn
HyCream-TM-
HyFlex
Hydro-M
HyPack
Hy-Q
HydroSkin
HyTide
T-PAN
44
EXHIBIT 4
STOCK ACQUISITION AGREEMENT
This STOCK ACQUISITION AGREEMENT (this "Agreement"), dated as of November 15,
1995, is entered into by and between PROCYTE CORPORATION, a Washington
corporation (the "Company"), and HYMEDIX INTERNATIONAL, INC., a Delaware
corporation ("Hymedix").
RECITAL
1. Contemporaneously with this Agreement, the Company and Hymedix are
entering into a License Agreement as of the date hereof (the "License
Agreement").
2. In connection with the License Agreement, Hymedix desires to acquire,
and the Company desires to issue to Hymedix, shares of Common Stock of the
Company, upon the terms and conditions as set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the promises and mutual covenants contained
herein, the parties agree as follows:
1. SHARES AND CONSIDERATION; ESCROW
In consideration of the rights of the Company and the obligations,
representations and warranties of Hymedix as set forth in the License Agreement,
the Company hereby agrees to issue and deliver to Hymedix 200,000 shares of
Common Stock of the Company (the "Shares"), subject to the terms of this
Agreement. Promptly upon execution of this Agreement, the Company shall deliver
to Hymedix, or instruct its transfer agent to deliver to Hymedix, one or more
certificates representing the Shares (the "Certificates"). Upon receipt of the
Certificates, Hymedix shall deliver the Certificates and four executed
Assignments Separate from Certificate with respect to the shares represented by
the Certificates (the "Assignments") to the Company, both to be held by the
Company pursuant to the terms of this Agreement for a two-year vesting period.
The Company will accept the Assignments only in the event that the Shares are
forfeited pursuant to Section 5 of this Agreement (such an event, a
"Forfeiture"). Upon the expiration of each six months during the two-year
vesting period, if no Forfeiture has occurred, the Company shall release 50,000
Shares represented by the Certificates and one of the Assignments and deliver
them to Hymedix. Notwithstanding the foregoing, the Company may place stop-
transfer instructions with respect to any unvested portion of the Shares during
the two-year vesting period.
2. REPRESENTATIONS AND WARRANTIES OF HYMEDIX
Hymedix hereby represents and warrants to the Company as of the date of this
Agreement as follows:
2.1 ABILITY TO BEAR RISK
Hymedix is in a financial position to hold the Common Stock and is able to bear
the economic risk and withstand a complete loss of its investment in the Shares.
2.2 HIGH DEGREE OF RISK
HYMEDIX RECOGNIZES THAT THE SHARES AS AN INVESTMENT INVOLVE A HIGH DEGREE OF
RISK. Hymedix is aware that the Company has not been profitable in the past.
Hymedix recognizes that the Company is in the research and development stage and
has not yet developed a marketable product and that there can be no assurance
that the Company will be able to develop a marketable product or that such
product will be accepted in the marketplace. There can be no
45
assurance that the Company will be able to obtain its projected goals and the
Company may need significant additional capital to be successful, which capital
may not be readily available when and as needed.
2.3 PROFESSIONAL ADVICE
Hymedix has obtained, to the extent it deems necessary, its own professional
advice with respect to the risks inherent in the investment in the Shares, the
condition of the Company and the suitability of the investment in the Shares in
light of Hymedix's financial condition and investment needs.
2.4 SOPHISTICATION
Hymedix, either alone or with the assistance of its professional advisor, is a
sophisticated investor, is able to fend for itself in the transactions
contemplated by this Agreement, and has such knowledge and experience in
financial and business matters that it is capable of evaluating the merits and
risks of the investment in the Shares.
2.5 ACCESS TO INFORMATION
Hymedix has been given access to full and complete information regarding the
Company, including, in particular, the Company's annual report and proxy
statements for the last two fiscal years, its reports on Forms 10-K, 10-Q and 8-
K for the last two fiscal years, its reports on Form 10-Q for the first three
quarters of the current fiscal year and information regarding the current
financial condition of the Company and the risks associated therewith, and has
utilized such access to its satisfaction for the purpose of obtaining
information about the Company; particularly, Hymedix has either attended or been
given reasonable opportunity to attend a meeting with representatives of the
Company for the purpose of asking questions of, and receiving answers from, such
representatives concerning the terms and conditions of the issuance of the
Shares and to obtain any additional information, to the extent reasonably
available, necessary to verify the accuracy of information provided about the
Company.
2.6 PURCHASE ENTIRELY FOR OWN ACCOUNT
The Shares will be acquired for investment for Hymedix's own account, not as a
nominee or agent, and not with a view to the distribution of any part thereof;
Hymedix has no present intention of selling, granting any participation in or
otherwise distributing the same in a manner contrary to the Securities Act of
1933, as amended (the "Act"), or any applicable state securities or Blue Sky
law, or entering into any agreement or arrangement with any person to sell,
transfer or grant participations to such person or to any third person, with
respect to any of the Shares.
2.7 DUE DILIGENCE
Hymedix has been solely responsible for its own due diligence investigation of
the Company and the Company's business, and its analysis of the merits and risks
of the investment made pursuant to this Agreement, and is not relying on anyone
else's analysis or investigation of the Company, its business or the merits and
risks of the Shares other than professionals employed specifically by Hymedix to
assist Hymedix. In taking any action or performing any role relative to the
arranging of the investment being made pursuant to this Agreement, Hymedix has
acted solely in its own interest and not in that of any other person, and no
other person has acted as an agent or fiduciary for Hymedix.
2.8 RESTRICTED SECURITIES
Hymedix realizes that the issuance of the Shares hereunder has not been
registered under the Act, the Shares are characterized under the Act as
"restricted securities", and, therefore, the Shares cannot be sold or
transferred unless they are subsequently registered under the Act or an
exemption from such registration is available. Hymedix's financial condition is
such that it is not likely that it will
46
be necessary to dispose of any of the Shares in the foreseeable future. In this
connection, Hymedix represents that it is familiar with Rule 144 of the
Securities and Exchange Commission (the "SEC"), as presently in effect, and
understands the resale limitations imposed thereby and by the Act.
2.9 EXEMPTION RELIANCE
Hymedix has been advised that the Shares are not being registered under the Act
or the applicable state securities laws, but are being offered and sold pursuant
to exemptions from such laws, and that the Company's reliance upon such
exemptions is predicated in part on Hymedix's representations contained herein.
Hymedix represents that it has not been organized for the specific purpose of
investing in the Shares.
2.10 RESIDENCY
For purposes of the application of state securities laws, Hymedix represents
that it is domiciled in the State of New Jersey.
2.11 LEGENDS
(a) It is understood that the Certificates evidencing the Shares will bear a
legend as follows:
"The securities evidenced by this certificate have not been registered under the
Securities Act of 1933, as amended, of the United States of America (the "Act"),
or the securities laws of any state of the United States of America, and no
interest in such securities may be sold, distributed, assigned, offered, pledged
or otherwise transferred, directly or indirectly, in the United States of
America, its territories or possessions, or to a citizen, national, resident or
entity organized or chartered under the laws of the United States of America,
its territories or possessions, unless (i) there is an effective registration
statement under the Act and applicable state securities laws covering any such
transaction, (ii) this corporation receives an opinion of legal counsel for the
holder of these securities satisfactory to this corporation stating that such
transaction is exempt from registration under the Act and applicable state laws,
or (iii) this corporation otherwise satisfies itself that such transaction is
exempt from registration.
The securities evidenced by this certificate are subject to certain resale
restrictions as set forth in a stock acquisition agreement between the Company
and the registered holder, a copy of which is on file at the principle office of
the Company."
(b) In addition, until the Shares become vested in Hymedix pursuant to the
provisions of Section 5 of this Agreement, the Certificates evidencing the
Shares will bear the following legend:
"The securities represented by this certificate are subject to forfeiture
pursuant to the terms of a Stock Acquisition Agreement dated as of November 15,
1995 between this corporation and Hymedix International, Inc., a copy of which
is available upon request at the principal office of this corporation."
2.12 ACKNOWLEDGMENT
HYMEDIX, BY EXECUTION OF THIS AGREEMENT, ACKNOWLEDGES THAT IT UNDERSTANDS THAT
THE COMPANY IS RELYING UPON THE ACCURACY AND COMPLETENESS OF ITS REPRESENTATIONS
AND WARRANTIES SET FORTH IN THIS SECTION 2 IN DECIDING WHETHER TO ISSUE SHARES
OF COMMON STOCK TO HYMEDIX AND IN COMPLYING WITH THE COMPANY'S OBLIGATIONS UNDER
APPLICABLE SECURITIES LAWS.
3. RESTRICTIONS ON TRANSFER
3.1 COMPLIANCE WITH SECURITIES LAWS
Without in any way limiting the representations set forth above and subject to
the forfeiture provisions set forth in Section 5 of this Agreement, Hymedix
further agrees not to make any disposition of all or any portion of the Shares
unless and until:
47
(a) There is then in effect a registration statement under
the Act covering such proposed disposition and such disposition is made in
accordance with such registration statement;
(b)(i) Hymedix shall have notified the Company of the proposed
disposition and shall have furnished the Company with a detailed statement of
the circumstances surrounding the proposed disposition 10 days prior to said
disposition and (ii) if reasonably requested by the Company, Hymedix shall have
furnished the Company with an opinion of counsel, reasonably satisfactory to the
Company, that such disposition will not require registration of such shares
under the Act; or
(c)(i) Hymedix shall have notified the Company of the proposed
disposition and shall have furnished the Company with a detailed statement of
the circumstances surrounding the proposed disposition at least 10 days prior to
said disposition and (ii) the Company shall have otherwise been satisfied that
such proposed disposition complies in all respects with SEC Rule 144 or any
successor rule providing a safe harbor for such disposition without
registration.
3.2 TRANSFEREE CONSIDERATIONS
In addition to the foregoing provisions of Section 3.1 above, Hymedix agrees
that:
(a) Hymedix shall notify the Company of any proposed
disposition of all or any portion of the Shares and shall furnish the Company
with a detailed statement of the circumstances surrounding the proposed
disposition at least 10 days prior to said disposition; and
(b) Hymedix shall provide the Company or its agent an
opportunity to arrange the private sale to one or more parties of the Shares
proposed to be transferred and shall cooperate fully with the Company or such
agent in such process; if, prior to the later of (i) 10 days after the date the
notice referred to in paragraph (a) is received by the Company and (ii) the
proposed closing date of the transfer, the Company or its agent identifies a
party or parties who agree or offer in writing to purchase the Shares proposed
to be transferred, Hymedix shall give due consideration to such offer.
4. REGISTRATION RIGHTS
The Registration Rights attached hereto as Exhibit A are hereby incorporated
into and made a part of this Agreement as if set forth herein; provided,
however, that no portion of the Shares that are unvested pursuant to the terms
of Section 5 of this Agreement may be sold pursuant to any registration provided
for in the Registration Rights.
5. FORFEITURE OF SHARES
(a) During the period ending two years from the date of this Agreement,
Hymedix shall forfeit any unvested portion of the Shares and the Company will
accept the Assignment of such Shares if:
(i) Hymedix is in material breach of the License Agreement
or this Agreement (a "Material Breach") and Hymedix has not cured such Material
Breach within
48
90 days from the receipt of notice from the Company that such Material Breach
has occurred; or
(ii) The Company has notified Hymedix that it has terminated
the License Agreement.
(b) The Shares shall become vested in Hymedix and shall be released by the
Company to Hymedix pursuant to the terms of this Agreement at the rate of 50,000
Shares (25% of the Shares) for each six month period during the two-year vesting
period.
6. NO REVOCATION OR ASSIGNMENT
Hymedix may not cancel, terminate or revoke this Agreement, and this Agreement
shall be binding upon its successors. Except for a transfer of its Registration
Rights pursuant to Section 8 of the Registration Rights, Hymedix will not
transfer or assign this Agreement or any of its interest herein.
7. INDEMNIFICATION
Notwithstanding the provisions of the Registration Rights regarding
indemnification for Violations in connection with registration of the Shares,
Hymedix shall indemnify, hold harmless and defend the Company and its
affiliates, agents and attorneys with respect to any and all loss, damage,
expense, claim, action or liability any of them may incur as a result of the
breach or untruth of any of the representations and warranties set forth in this
Agreement. If the Company or anyone acting on its behalf discovers any breach
or untruth of any such representations and warranties, the Company may, at its
option, forthwith rescind the issuance of the Shares to Hymedix.
8. SEVERABILITY
If one or more provisions of this Agreement are held to be unenforceable under
applicable law, such provision shall be excluded from this Agreement, and the
balance of this Agreement shall be interpreted as if such provision were so
excluded and shall be enforceable in accordance with its terms.
9. COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument.
10. ENTIRE AGREEMENT
This Agreement constitutes the full and entire understanding and agreement
between the parties with respect to the subject matter hereof and supersedes all
prior agreements with respect to the subject matter hereof.
11. GOVERNING LAW
Hymedix agrees that this Agreement shall be enforced, governed, and construed in
all respects in accordance with the laws of the State of Washington, as applied
to contracts executed and fully performed in the State of Washington.
HYMEDIX HAS BEEN ADVISED, PRIOR TO THE ISSUANCE OF THE SHARES, THAT NEITHER THE
ISSUANCE OF THE SHARES NOR ANY OFFERING MATERIALS HAVE BEEN REVIEWED BY ANY
ADMINISTRATOR UNDER THE ACT, THE WASHINGTON STATE SECURITIES ACT, AS AMENDED,
THE NEW JERSEY UNIFORM SECURITIES LAW (1967), AS AMENDED, OR ANY OTHER
APPLICABLE SECURITIES ACT (THE "ACTS") AND THAT THE SECURITIES HAVE NOT BEEN
REGISTERED UNDER ANY OF THE ACTS AND THEREFORE CANNOT BE RESOLD UNLESS THEY ARE
REGISTERED UNDER THE ACTS OR UNLESS AN EXEMPTION FROM SUCH REGISTRATION IS
AVAILABLE.
49
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first written above.
PROCYTE CORPORATION
By:
----------------------------
Its: President & CEO
HYMEDIX INTERNATIONAL, INC.
By:
----------------------------
Its:
------------------------
50
EXHIBIT A
REGISTRATION RIGHTS
1. DEFINITIONS.
For purposes of this Agreement, the following terms not otherwise defined shall
have the following respective meanings:
(a) The term "register," "registered" and "registration" refer to a
registration effected by preparing and filing a registration statement or
similar document in compliance with the Act, and the declaration or ordering of
effectiveness of such registration statement or document;
(b) The term "Registrable Securities" means (i) the Shares held by
Holders (as defined below), and (ii) any Common Stock of the Company issued as
(or issuable upon the conversion or exercise of any warrant, right or other
security which is issued as) a dividend or other distribution with respect to,
or in exchange for or in replacement of, the Shares held by Holders, excluding
in all cases, however, any Common Stock sold by a person in a transaction in
which its rights under this Agreement are not assigned and any Common Stock that
is, at the time of registration, transferable by the holder thereof in a single
brokerage transaction under the provisions of Rule 144 promulgated under the
Act, or any successor to such Rule; and
(c) The term "Holder" means any person owning or having the right to
acquire Registrable Securities who is a party to this Agreement as of the date
hereof and any assignee thereof in accordance with Section 8 hereof.
2. COMPANY REGISTRATION.
For the one year period beginning on the second anniversary of this Agreement
and ending on the third anniversary of this Agreement, if (but without any
obligation to do so) the Company proposes to register (including for this
purpose a registration effected by the Company for shareholders other than the
Holders) any shares of Common Stock under the Act in connection with the public
offering of such securities solely for cash (other than a registration relating
solely to the sale of securities to participants in a Company stock plan, or a
registration on any form that does not include substantially the same
information as would be required to be included in a registration statement
covering the sale of the Registrable Securities), the Company shall, at such
time, promptly give each Holder written notice of such registration. Upon the
written request of each Holder given within 20 days after mailing of such notice
by the Company, the Company shall, subject to the provisions of Section 5
hereof, use its best efforts to cause to be registered under the Act all of the
Registrable Securities that each such Holder has requested to be registered. In
the event that the Company decides for any reason not to complete the
registration of shares of Common Stock other than the Registrable Securities,
the Company shall have no obligation under this Section 2 to continue with the
registration of the Registrable Securities. Any request pursuant to this
Section 2 to register Registrable Securities as part of an underwritten public
offering of Common Stock shall specify that such Registrable Securities are to
be included in the underwriting on the same terms and conditions as the shares
of Common Stock otherwise being sold through underwriters under such
registration.
3. FURNISH INFORMATION.
It shall be a condition precedent to the obligations of the Company to take any
action pursuant to this Agreement that the selling Holders shall furnish to the
Company such information regarding themselves, the Registrable Securities held
by them and the intended method of disposition of such securities as shall be
reasonably required to effect the registration of their Registrable Securities
and to execute such documents in connection with such registration as the
Company may reasonably request.
4. EXPENSES OF REGISTRATION.
In connection with any registration pursuant to this Agreement, the Company
shall be responsible for the payment of all expenses of the registration, with
the exception of underwriting commissions and discounts which shall be paid by
the Company, the Holders and any other selling securityholders in
51
proportion to the aggregate value of the securities offered for sale by each of
them. The expenses to be paid by the Company shall include, without limitation,
all SEC, blue sky, stock exchange and NASD registration and filing fees,
printing and duplicating expenses, fees and disbursements of its counsel and
accountants, blue sky legal fees and disbursements, transfer agents' and
registrars' fees and expenses, fees and expenses of any experts used in
connection with the registration, and any fees and expenses of underwriters
customarily paid by issuers or sellers of securities, but excluding any
underwriting commissions and discounts.
5. UNDERWRITING REQUIREMENTS.
The Company shall not be required under Section 2 hereof to include any of the
Holders' securities in an underwritten offering of the Company's securities
unless such Holders accept the terms of the underwriting as agreed upon between
the Company and the underwriters selected by it. If the total amount of
securities, including Registrable Securities, requested by shareholders to be
included in such offering exceeds the amount of securities that the underwriters
reasonably believe compatible with the success of the offering, then the Company
shall be required to include in the offering only that number of such
securities, including Registrable Securities, which the underwriters believe
will not jeopardize the success of the offering. The securities of selling
shareholders to be included in the registration in the event of such a reduction
shall be apportioned pro rata among the selling Holders according to the total
amount of securities requested to be sold in such registration by such Holders
and then pro rata among any other selling shareholders (if any) according to the
total amount of securities otherwise entitled to be included therein owned by
each such other selling shareholder, or in such other proportions as shall
mutually be agreed to by such selling shareholders.
6. DELAY OF REGISTRATION
No Holder shall have any right to obtain or seek an injunction restraining or
otherwise delaying any registration of the Company as the result of any
controversy that might arise with respect to the interpretation or
implementation of this Agreement.
7. INDEMNIFICATION.
In the event any Registrable Securities are included in a registration statement
under this Agreement:
(a) To the extent permitted by law, the Company will indemnify and
hold harmless each Holder, the partners, officers, agents, employees and
directors of each Holder, any underwriter (as defined in the Act) for such
Holder and each person, if any, who controls such Holder or underwriter within
the meaning of the Act or the Securities Exchange Act of 1934, as amended (the
"1934 Act"), against any losses, claims, damages or liabilities (joint or
several) to which they may become subject under the Act, the 1934 Act or other
federal or state law, insofar as such losses, claims, damages or liabilities (or
actions in respect thereof) arise out of or are based upon any of the following
statements, omissions or violations (collectively, a "Violation"): (i) any
statement or alleged statement of a material fact contained in such registration
statement, including any preliminary prospectus or final prospectus contained
therein, or any amendments or supplements thereto, untrue in light of the
circumstances under which they were made, (ii) the omission or alleged omission
to state therein a material fact required to be stated therein, or necessary to
make the statements therein, in light of the circumstances under which they were
made, not misleading, or (iii) any violation or alleged violation by the Company
of the Act, the 1934 Act, any state securities law or any rule or regulation
promulgated under the Act, the 1934 Act or any state securities law. The
Company shall reimburse each such Holder, partner, officer, agent, employee or
director, underwriter or controlling person for any legal or other expenses
reasonably incurred by them in connection with investigating or defending any
such loss, claim, damage, liability or action; PROVIDED, HOWEVER, that the
indemnity agreement contained in this Section 7(a) shall not apply to amounts
paid in settlement of any such loss, claim, damage, liability or action if such
settlement is effected without the consent of the Company, which consent shall
not be unreasonably withheld, nor shall the Company be liable in any such case
for any such loss, claim, damage, liability or action to the extent that it
arises out of or is based upon a Violation which occurs in reliance upon and in
conformity with written information
52
furnished expressly for use in connection with such registration by, or on
behalf of, any such Holder, underwriter or controlling person.
(b) To the extent permitted by law, each selling Holder will
indemnify and hold harmless the Company, each of its officers, directors, agents
or employees, each person, if any, who controls the Company within the meaning
of the Act, any underwriter and any other Holder selling securities in such
registration statement or any of its partners, officers, directors, agents or
employees or any person who controls such Holder, against any losses, claims,
damages or liabilities (joint or several) to which the Company or any such
officer, director, agent, employee, controlling person, or underwriter, or other
such Holder or its partner, officer, director, agent, employee or controlling
person may become subject, under the Act, the 1934 Act or other federal or state
law, insofar as such losses, claims, damages or liabilities (or actions in
respect thereof) arise out of or are based upon any Violation, in each case to
the extent (and only to the extent) that such Violation occurs in reliance upon
and in conformity with written information furnished by, or on behalf of, such
Holder expressly for use in connection with such registration. Each such Holder
will reimburse any legal or other expenses reasonably incurred by the Company or
any such partner, officer, director, agent, employee, controlling person,
underwriter or other such Holder, partner, officer, director, agent, employee or
controlling person in connection with investigating or defending any such loss,
claim, damage, liability or action; PROVIDED, HOWEVER, that the indemnity
agreement contained in this Section 7(b) shall not apply to amounts paid in
settlement of any such loss, claim, damage, liability or action if such
settlement is effected without the consent of the indemnifying Holder, which
consent shall not be unreasonably withheld.
(c) Promptly after receipt by an indemnified party under this Section
7 of notice of the commencement of any action (including any governmental
action), such indemnified party shall, if a claim in respect thereof is to be
made against any indemnifying party under this Section 7, deliver to the
indemnifying party a written notice of the commencement thereof, and the
indemnifying party shall have the right to participate in, and, to the extent
the indemnifying party so desires, jointly with any other indemnifying party
similarly notified, to assume the defense thereof with counsel mutually
satisfactory to the parties; PROVIDED, HOWEVER, that an indemnified party shall
have the right to retain its own counsel, with the fees and expenses to be paid
by the indemnifying party, if, in the reasonable opinion of counsel for the
indemnifying party, representation of such indemnified party by the counsel
retained by the indemnifying party would be inappropriate due to actual or
potential differing interests between such indemnified party and any other party
represented by such counsel in such proceeding. The failure to deliver written
notice to the indemnifying party within a reasonable period of time of the
commencement of any such action shall relieve such indemnifying party of any
liability to the indemnified party under this Section 7 to the extent
prejudicial to its ability to defend such action, but the omission so to deliver
written notice to the indemnifying party will not relieve it of any liability
that it may have to any indemnified party otherwise than under this Section 7.
8. TRANSFER OF REGISTRATION RIGHTS.
The rights of a Holder under this Agreement may be assigned or transferred in
connection with any transfer of Shares by the Holder, provided that (a) the
transferee, upon completion of the transfer, holds at least 50,000 of the
Registrable Securities, (b) the Company is given prior notice of such transfer
of rights, and (c) such transferee agrees in writing to be bound by this
Agreement.
9. "MARKET STAND-OFF" AGREEMENT.
For five years from the date of this Agreement, each Holder hereby agrees that
such Holder shall not, to the extent requested by the Company and an underwriter
of Common Stock (or other securities) of the Company, sell or otherwise transfer
or dispose of any Registrable Securities for 180 days following the effective
date of a registration statement of the Company filed under the Act in
connection with an offering of the Company's Common Stock; PROVIDED, HOWEVER,
that all officers and directors of the Company and all other persons with
registration rights (whether or not pursuant to this Agreement) enter into
similar agreements.
53
In order to enforce the foregoing covenant, the Company may impose stop-transfer
instructions with respect to the Registrable Securities of the Holders (and the
shares or securities of every other person subject to the foregoing restriction)
until the end of such period.
10. AMENDMENTS AND WAIVERS.
Any term of this Agreement may be amended and the observance of any term may be
waived (either generally or in a particular instance and either retroactively or
prospectively) only with the written consent of the Company and the holders of
at least 60% of the aggregate of the shares of Common Stock that are Registrable
Securities.
54
EXHIBIT 7
TECHNOLOGY TRANSFER INFORMATION
[CONFIDENTIAL TREATMENT REQUESTED]
55
EXHIBIT 8
HYMEDIX 510(k) REGISTRATIONS FOR THE FIELD
1. Hydro-M Wound Gel (also known as HyFil Wound Gel or Hygel)
2. HyTide Saline Wound Gel
3. HyFlex Cushioned Film Dressing
4. HySorb Absorbent HydroGel Foam Dressing
5. HyPack Wound Filler
6. HydroSkin Wound Plug
56
EXHIBIT 19.10
PRESS RELEASE
FOR IMMEDIATE RELEASE
November 16, 1995
8:30 a.m. EST
PROCYTE CONTACT
Xxxxx X. Xxxxxx, Vice President
(000)000-0000
HYMEDIX CONTACT
Xxxxxxx Xxxxxxx, President
(000)000-0000
PROCYTE ACQUIRES FIVE FDA-CLEARED WOUND CARE PRODUCTS
PROPRIETARY POLYMER TECHNOLOGY FORMS BASIS
FOR EARLY PRODUCT LAUNCHES IN FAST-GROWING SECTOR
(Kirkland, Washington) -- PR Newswire -- ProCyte Corporation (Nasdaq/NMS:
PRCY) today said it has acquired from HYMEDIX International, Inc. (Bulletin
Board: HYMX) the worldwide rights outside of Asia to five wound care products
that have received market clearance from the U.S. Food and Drug Administration,
broadening the company's planned entry into the $300 million market for moist
wound dressings.
The products include proprietary transparent thin film wound dressings,
aquagel sheet dressings, exudate absorbers and wound moisturizers, all based on
a multi-block copolymer structure that is especially well-suited for wound care
applications, including chronic and acute wounds, xxxxx and surgical wounds,
according to ProCyte.
The company said that the newly licensed products compliment its
internally-developed Iamin-Registered Trademark- gel wound dressing, for which
FDA clearance to market is pending under the 510(k) pre-market notification
guidelines.
ProCyte said it expects the first of its wound care products to be
available to long-term care, hospital and home healthcare professionals by mid-
1996, following equipment scale-up and design and validation of improved
manufacturing processes at its Redmond, WA commercial manufacturing plant.
The facility was commissioned last year and will require certain equipment
additions for the initial product launch.
Although specific terms were not disclosed, ProCyte said the agreement with
HYMEDIX calls for an upfront cash and common stock payment to HYMEDIX, plus
future milestone payments of additional cash and royalties.
"Our intent was to quickly establish an innovative and medically-responsive
wound care portfolio with a broad range of essentially market-ready products,"
said Xxxxxx Xxxxxx, ProCyte's president and chief executive officer. "This
unique polymer technology gives us the initial
57
marketing capability for a serious wound care products business with near-term
revenue potential. We can then leverage this with new product developments out
of our own labs."
ProCyte has considerable research and development experience in the field
of wound care, and has helped to pioneer the clinical assessment and treatment
of wounds.
The U.S. market for moist wound dressings, which include the polymer-based
products ProCyte acquired, is expected to reach $500 million in industry-wide
sales by 1999. Industry sources say the market growth for moist wound dressings
and all other wound care products and systems is being driven by an increasing
incidence of wounds associated with advanced age, during which surgeries and
chronic wounds tend to occur more frequently.
The centerpiece for ProCyte's newly-acquired products is a versatile
polymer technology, called HYPAN-Registered Trademark-. HYPAN-Registered
Trademark- polymers may be manufactured by a patented method to provide a
uniquely variable number of structural aquagels, useful in the construction of
synthetic moist wound dressings and related products.
ProCyte also has the worldwide rights outside of Asia for all future wound
care applications of the HYPAN-Registered Trademark- technology for synthetic
moist wound dressings and related products.
As part of its agreement with HYMEDIX, ProCyte also gained exclusive
worldwide rights for the drug delivery applications of the HYPAN-Registered
Trademark- technology for wound care. ProCyte plans to continue its research
and development efforts in wound treatment and healing, and to study the drug
delivery aspects of the technology for enhanced delivery of antibiotics,
anti-infectives and other compounds to wounds.
HYPAN-Registered Trademark- polymers are synthetic materials that ProCyte
believes can be manufactured in a cost-effective manner. HYPAN-Registered
Trademark- polymers are also believed to provide maximum performance at low
concentrations, to have excellent biocompatibility profiles and to be both
stable and sterilizable. The remarkable structural flexibility of these
aquagels is expected to make them ideally suited to broad-based applications in
wound management and treatment, particularly since they address the breadth of
chronic and acute wounds.
HYMEDIX is a development-stage company based in New Jersey. The company is
actively commercializing its polymer-based BIONIQ-TM- line of personal care
moisturizing creams, which have recently been introduced through direct response
television. HYMEDIX currently has research and development contracts in place
for other medical products and drug delivery applications of its
HYPAN-Registered Trademark- polymers outside the field of wound care.
ProCyte is a development stage pharmaceutical company. It has been
actively pursuing a threefold corporate strategy, including development of its
own proprietary copper-based compounds, providing contract manufacturing, and
seeking to acquire late-stage products or technology. ProCyte has three
copper-based compounds in clinical development, including drug candidates for
treatment of inflammatory bowel disease and hair growth.
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