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Exhibit 10.21
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
This Agreement is made and entered into as of the day of , 1997, by
and between the PERIMMUNE, a Delaware Corporation ("PERIMMUNE"), maintaining an
office at 0000 Xxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000-0000 and SIGMA
DIAGNOSTICS, INC. "SIGMA", a Missouri corporation maintaining an office at 000
Xxxxx Xxxxx Xxxxxx, Xx. Xxxxx, Xxxxxxxx 00000.
WHEREAS, SIGMA desires to develop diagnostic assays useful for detecting
lipoprotein(a), Lp(a), and PERIMMUNE represents that it has the technical
expertise to develop hybridoma cell lines that produce antibodies for use in
such assay;
WHEREAS, SIGMA desires to grow such cell lines and harvest monoclonal
antibodies from said cell lines and to make, use and sell products manufactured
using such antibodies and desires to obtain the exclusive, worldwide rights to
harvest such antibodies and make, use and sell such products; and
WHEREAS, PERIMMUNE is willing to grant SIGMA such rights and license on
the terms and conditions set forth herein.
NOW THEREFORE, for and in consideration of the foregoing and the mutual
covenants and agreements contained herein, and certain other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following defined terms shall have the
meaning set forth in this Article 1.
1.1 "Affiliate" means any entity directly or indirectly controlling,
controlled by, or under common control with SIGMA. "Control" as used in this
Section 1.1 means the ownership of fifty percent (50%) or more of the entity in
question.
1.2 "Agreement" means this Agreement including all Exhibits attached to
this Agreement together with any written amendments of any of the foregoing.
1.3 "Approvals" means any or all approvals, registrations, licenses,
authorizations, visas or permits required by any governmental authority or
agency in order to import, offer for sale, sell, market, manufacture, have made
or use each Licensed Product.
1.4 "Cell Line Growth Information" means all information necessary to
establish a Licensed Cell Line in SIGMA'S possession which is growing and
producing Licensed Antibody in the quantity and with the properties reasonably
required by SIGMA. Cell Line Growth Information is not included in PERIMMUNE
Information.
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1.5 "Date Of This Agreement" means the date first set forth above and is
the Effective Date of this Agreement.
1.6 "Improvements" means all modifications, variations and revisions and
new models of the Licensed Product and/or the Licensed Antibodies, Licensed
Biologicals or Licensed Cell Lines licensed under this Agreement developed by
the parties hereto which relates or has consequence with respect to the Licensed
Product in any of the following ways: (1) improves the Licensed Products
performance; (2) reduces the cost of materials or components for the Licensed
Products; (3) reduces production, manufacturing or associated costs of the
Licensed Products; (4) increases the durability or continuous performance
characteristics of the Licensed Products; (5) expands the applications to which
the Licensed Product may be put; (6) increases or enhances the marketability or
commercial aspect of the Licensed Product; or (7) would, if implemented, replace
or displace the Licensed Product in one or more material commercial markets for
Licensed Products. Improvements may be patentable or unpatentable, and if
patentable, need not be patented.
1.7 "Licensed Antibody" means any antibody, fragment, derivative, or
conjugate thereof developed or discovered by PERIMMUNE or jointly by PERIMMUNE
and SIGMA during the Research and Development Period of this Agreement,
including without limitation, any glycosylated antibody specifically
immunoreactive with non-repetitive apolipoprotein(a) domains and not
immunoreactive with LDL or plasminogen with an affinity sufficient to be used in
a homogeneous turbidimetric assay having not more than a ten (10) minute
incubation period.
1.8 "Licensed Biological" means any biomaterial other than Licensed
Antibodies developed or discovered by PERIMMUNE or jointly by PERIMMUNE and
SIGMA during the Research and Development Period of this Agreement including,
without limitation, peptides and other biomaterial useful as a calibrator,
reference material or control.
1.9 "Licensed Cell Line" means the hybridoma cell line which will
produce the Licensed Antibody in the quantity reasonably required by SIGMA.
1.10"Licensed Patent" means any and all United States patents and patent
applications, all divisionals, continuations, continuations-in-part, reissues,
extensions or foreign counterparts thereof, now or hereafter owned or controlled
("controlled" being used in the sense of having the right to grant licensees
thereunder) by PERIMMUNE, covering the manufacture, use, sale, offer for sale
and/or importation of Licensed Antibodies, Licensed Biologicals, Licensed Cell
Lines, Licensed Products and/or Improvements.
1.11 "Licensed Product" means any product, including kits, which
comprises a Licensed Antibody.
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1.12 "Net Sales" means gross sales less, to the extent including in
gross sales, taxes, including sales taxes, duties, outward freight, insurance,
special handling and shipping charges, and to the extent actually allowed and
taken, discounts, non-affiliated brokers agents' commissions, returns and
allowances.
1.13 "Project Development" means research pertaining to the development
of Licensed Antibodies, Licensed Biologicals, Licensed Cell Lines and/or
Licensed Products performed during the Research and Development Period of this
Agreement.
1.14 "Project Funds" means those funds paid by SIGMA to PERIMMUNE for
the Project Development in accordance with this contract.
1.15 "Research and Development Period" shall mean the period commencing
on the Effective Date of this Agreement and terminating on the second
anniversary thereof.
1.16 "Project Team" means the individuals listed on Exhibit A attached
hereto and the research technicians under each of their direction and control
who are supported in whole or in part by the Project Funds.
1.18 "Information" means either PERIMMUNE Information, SIGMA
Information, Joint Project Information or Cell Line Information or any
combination of PERIMMUNE Information, SIGMA Information, Joint Information or
Cell Line Information, as the case may be.
1.19 "Joint Project Information" means, individually and collectively,
all manufacturing, analytical, and marketing information and technical know-how,
trade secrets and inventions conceived and/or reduced to practice and/or
acquired jointly by the parties during the Research Period of this Agreement and
for one (1) year thereafter and directed to the Licensed Antibodies, Licensed
Biologicals, Licensed Cell Lines, Licensed Patents and Licensed Products
including, but not limited to, specifications for ingredients and formulations,
information relating to regulatory and clinical work, testing or studies,
manufacturing methods and procedures.
1.20 "PERIMMUNE Information" means "PERIMMUNE Project Information" and
PERIMMUNE Ancillary Information."
(a) "PERIMMUNE Project Information" means, individually and
collectively, all manufacturing, analytical, and marketing information and
technical know-how, trade secrets and inventions conceived and/or reduced to
practice and/or acquired by PERIMMUNE during the Research Period of this
Agreement and for one (1) year thereafter and directed to the Licensed
Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed Patents and
Licensed Products including, but not limited to, specifications for ingredients
and formulations, information relating to regulatory and clinical work, testing
or studies, manufacturing methods and procedures.
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(b) "PERIMMUNE Ancillary Information" means, individually and
collectively, all manufacturing, analytical, and marketing information and
technical know-how, trade secrets and inventions directed to the Licensed
Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed Patents and
Licensed Products including, but not limited to, specifications for ingredients
and formulations, information relating to regulatory and clinical work, testing
or studies, manufacturing methods and procedures owned, controlled, conceived
and/or reduced to practice and/or acquired by PERIMMUNE before the date of this
Agreement.
1.21 "SIGMA Information" shall mean "SIGMA Project Information" and
"SIGMA Ancillary Information.
(a) "SIGMA Project Information" means, individually and collectively,
all manufacturing, analytical, and marketing information and technical know-how,
trade secrets and inventions conceived and/or reduced to practice and/or
acquired by SIGMA during the Research Period of this Agreement and for one (1)
year thereafter and directed to the Licensed Antibodies, Licensed Biologicals,
Licensed Cell Lines, Licensed Patents and Licensed Products including, but not
limited to, specifications for ingredients and formulations, information
relating to regulatory and clinical work, testing or studies, manufacturing
methods and procedures.
(b) "SIGMA Ancillary Information" means, individually and collectively,
all manufacturing, analytical, and marketing information and technical know-how,
trade secrets and inventions directed to the Licensed Antibodies, Licensed
Biologicals, Licensed Cell Lines, Licensed Patents and Licensed Products
including, but not limited to, specifications for ingredients and formulations,
information relating to regulatory and clinical work, testing or studies,
manufacturing methods and procedures owned, controlled, conceived and/or reduced
to practice and/or acquired by SIGMA before the date of this Agreement.
1.22 "SIGMA Patents" means any and all United States patents and patent
applications, all divisionals, continuations, continuations-in-part, reissues,
extensions or foreign counterparts thereof, now or hereafter owned or controlled
("controlled" being used in the sense of having the right to grant licensees
thereunder) by SIGMA, claiming an invention or inventions discovered or
developed solely by SIGMA or covering the manufacture, use, sale, offer for sale
and/or importation of Licensed Products and/or Improvements.
ARTICLE 11
RESEARCH AND DEVELOPMENT OF LICENSED CELL LINES
2.1 PROJECT DEVELOPMENT SCHEDULE. During the Research and Development
Period, the Project Team shall conduct Project Development on behalf of SIGMA in
accordance with the plan and schedule mutually agreed to by the parties hereto
and attached hereto as Exhibit B.
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2.2. PROJECT DEVELOPMENT REPORTING. A representative of the Project Team
shall advise SIGMA of the results of the Project Development and, at least once
every quarter during the Research Period, provide SIGMA with a written progress
report concerning the Research Project, provided however, PERIMMUNE shall notify
SIGMA as soon as reasonably possible of the reduction to practice of inventions
developed during Project Development and for a period of one (1) year
thereafter. At SIGMA'S request, a representative of the Project Team shall meet
with SIGMA from time to time to discuss the progress of the Project Development.
2.3 COMPLIANCE WITH REGULATIONS. All studies done in connection with the
Project Development shall be carried out in strict compliance with any
applicable Federal, state, or local laws, regulations or guidelines governing
the conduct of such research.
2.4 CHANGE IN PROJECT TEAM. PERIMMUNE shall promptly notify SIGMA of any
changes in the personnel comprising the Project Team.
ARTICLE III
PAYMENTS
3.1 PAYMENT SCHEDULE. SIGMA shall pay PERIMMUNE the Project Funds amount
of Three Hundred Forty Eight Thousand Dollars ($348,000) in the following
manner:
(a) on or before the Effective Date, SIGMA shall pay the sum of Eighty
Seven Thousand Dollars ($87,000);
(b) SIGMA shall make a second payment of Eighty Seven Thousand Dollars
$87,000 after PERIMMUNE provides SIGMA with proof that it has isolated
glycosylated monoclonal antibodies specifically immunoreactive with
non-repetitive apolipoprotein(a) domains and not immunoreactive with LDL
or plasminogen with an affinity consistent with a homogeneous
turbidimetric assay having not more than a ten (10) minute incubation
period;
(c) SIGMA shall make a third payment of Eighty Seven Thousand Dollars
$87,000 after PERIMMUNE has delivered to SIGMA ascites derived purified
monoclonal antibodies to SIGMA; and
(d) SIGMA shall make a final payment of Eighty Seven Thousand Dollars
$87,000 upon the delivery of a Licensed Cell Line. A Licensed Cell Line
will be considered delivered when it is in SIGMA'S possession and
growing and producing Licensed Antibody in the quantity and with the
properties reasonably required by SIGMA.
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3.2 RECOUPMENT OF PROJECT FUNDS. SIGMA shall recoup One Hundred Twenty
Four Thousand Dollars ($124,000) of the Project Funds paid to PERIMMUNE pursuant
to Section 3.1 hereof by withholding royalties due to PERIMMUNE pursuant to
Section 5.1 hereof. At PERIMMUNE's election, such election to be made prior to
the first royalty becoming due, SIGMA shall either: (a) retain one-third of the
total annual royalty due under Section 5.1 hereof until SIGMA has retained a
total of One Hundred Twenty Four Thousand Dollars $124,000; or (b) retain the
entire annual royalty due under Section 5.1 hereof, until SIGMA has retained a
total of One Hundred Twenty Four Thousand Dollars $124,000.
3.3 DIRECTION OF PAYMENTS. Payments under the terms of this Agreement
shall be made by check payable to:
PERIMMUNE, INC.
0000 Xxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Attn: Xx. Xxxxx Xxxxxx
ARTICLE IV
RIGHTS AND LICENSES
4.1 GRANT OF LICENSE. PERIMMUNE grants to SIGMA the exclusive worldwide,
right to use all Technical Information and Cell Line Growth Information which
PERIMMUNE furnishes SIGMA under this Agreement together with an exclusive right
to use Licensed Antibodies, Licensed Biologicals, Licensed Cell Lines and
Improvements thereto (such Improvements includes Improvements made or developed
solely by PERIMMUNE or jointly by PERIMMUNE and SIGMA) and an exclusive
worldwide license under Licensed Patents to: (a) use, possess and culture
Licensed Cell Lines to obtain Licensed Antibodies, or have Licensed Cell Lines
used, possessed and cultured to obtain Licensed Antibodies for SIGMA; (b) to
manufacture Licensed Products or have Licensed Products manufactured for SIGMA;
(c) to use and possess Licensed Antibodies, Licensed Biologicals, and Licensed
Products for all purposes; and (d) to distribute, market, import, sell and offer
for sale such Licensed Antibodies, Licensed Biologicals and/or Licensed Products
for all purposes to Affiliates and third parties together with the right to
extend to purchasers of Licensed Antibodies, Licensed Biologicals and/or
Licensed Products from SIGMA rights of the same scope as granted to SIGMA herein
to use, possess, distribute, market and sell such Licensed Antibodies, Licensed
Biologicals and/or Licensed Products.
4.2 RIGHT TO SUBLICENSE. SIGMA shall have the right to grant sublicenses
under this Agreement.
4.3 COMMERCIALIZATION. SIGMA shall commence marketing of a Licensed
Product as soon as reasonably feasible after establishing the Licensed Cell Line
from which said Licensed Antibody is obtained and obtaining the necessary
Approvals for Licensed Product in any country.
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4.4 SUPPLY AND TRANSFER OF MAB 2D1. If SIGMA desires to use anti-apo(a)
Mab 2D1 in a Licensed Product, PERIMMUNE agrees to sell and transfer Mab 2D1 to
SIGMA at a transfer price equal to the actual manufacturing cost of producing
Mab 2D1 plus ten percent (10%). PERIMMUNE shall keep true and accurate books and
records in such detail as to enable the transfer price of Mab 2D1 to be readily
computed. PERIMMUNE agrees, upon the request of SIGMA, to permit an independent
certified public accountant retained by SIGMA and to whom PERIMMUNE has no
reasonable objection, to have access during normal business hours to such books
and records relating to the transfer price of Mab 2D1 as may be necessary to
determine in respect of the transfer price for the most previous calendar year,
the correctness of such transfer price or to obtain information as to the
transfer price. Any such accountant shall agree in writing not to disclose any
information relating to the business of PERIMMUNE except that which should
properly be contained in any report to SIGMA due hereunder.
4.5 CELL LINE TRANSFER. If SIGMA demonstrates to PERIMMUNE at any time
during the term of this Agreement that SIGMA can manufacture Mab 2D1 for less
than the transfer price provided for in Section 4.4 hereof, PERIMMUNE shall
transfer the Mab 2D1 cell line together with any necessary licenses to SIGMA
and shall allow SIGMA to manufacture of Mab 2D1 for use in Licensed Products.
ARTICLE V
ROYALTIES/BOOKS AND RECORDS
5.1 ROYALTIES. SIGMA agrees to pay PERIMMUNE in United States dollars, a
royalty equal to seven percent (7%) of the Net Selling Price of the Licensed
Products covered by a claim in a Licensed Patent sold to third parties by or for
SIGMA or its Affiliates and its sublicensees. If a competing product equivalent
to a Licensed Product or a competing product comprising an antibody equivalent
to, or which competes with the epitope recognized by, a Licensed Antibody is
offered for sale by a third party, then the royalty rate payable on Licensed
Products shall be equal to three and one-half percent (3.5%) of the Net Selling
Price.
5.2 ROYALTY REPORTS AND PAYMENTS. SIGMA shall render an annual report to
PERIMMUNE within ninety (90) days after the end of each calendar year setting
forth the total of the Net Sales of Licensed Products sold by SIGMA during the
preceding calendar year and the amount of royalty due pursuant to Sections 5.1
hereof. SIGMA shall include with each report payment of the amount of royalty
shown by the report to be due minus the recoupment amount, if any, as provided
for in Section 3.2 hereof. All such reports, and all reports by accountants as
provided under Section 5.6 hereof, shall be maintained in confidence by
PERIMMUNE.
5.3 TIMING OF ROYALTIES ON SUBLICENSEE SALES. Royalties shall be payable
by SIGMA with respect to all of its sublicensees' Net Sales. Royalties shall not
become payable at the time of the sale, transfer or disposal among SIGMA and its
Affiliates or sublicensee, but shall become payable only when SIGMA or its
sublicensee sells such products to a third party.
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5.4 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable
because any Licensed Product is covered by more than one patent or patent claim
of the Licensed Patents.
5.5 WITHHOLDINGS. Any income or other tax which SIGMA is required to
withhold and pay on behalf of PERIMMUNE with respect to the royalties payable
under this Agreement shall be deducted from such royalties prior to remittance
to PERIMMUNE.
5.6 INSPECTION OF RECORDS. SIGMA shall keep true and accurate books and
records in such detail as to enable the royalties payable hereunder to be
readily computed. SIGMA agrees, upon the request of PERIMMUNE, within one
hundred-twenty (120) days following the receipt by PERIMMUNE of the report
required by Section 5.2 hereof, to permit an independent certified public
accountant retained by PERIMMUNE and to whom SIGMA has no reasonable objection,
to have access during normal business hours to such books and records relating
to the Net Sales of Licensed Products as may be necessary to determine in
respect of the report for the most previous calendar year, the correctness of
such report or payment or to obtain information as to the amount payable to
PERIMMUNE in case of the failure of SIGMA to report. Any such accountant shall
agree in writing not to disclose any information relating to the business of
SIGMA except that which should properly be contained in any report to PERIMMUNE
due hereunder.
5.7 TERMINATION OF ROYALTY OBLIGATION. In the event that any Licensed
Cell Line furnished to SIGMA pursuant to Section 3.1 becomes available to third
parties for commercial purposes through an act of or failure to act by
PERIMMUNE, the obligations of SIGMA set forth in this Article V shall terminate.
ARTICLE VI
SUPPLY OF TECHNICAL INFORMATION AND PUBLICATION
6.1 REQUEST FOR CELL LINE INFORMATION. PERIMMUNE agrees to furnish to
SIGMA, within fifteen (15) days from the date of a notice of request for
Technical Information by SIGMA, all requested Cell Line Information. Requests
for Cell Line Information by SIGMA shall be made by notice of compliance with
Section 13.1 below.
6.2 CONFIDENTIALITY. With respect to any Information, as defined in 1.8
hereof, that is designated by the parties as its confidential information by a
written notice to the non-owning party within thirty (30) days after the first
written disclosure of that Information by either party to the other, the
non-owning party shall, until five (5) years from the date of the expiration or
termination of this Agreement: (a) take all reasonable steps to prevent
disclosure of such Information to any third party and (b) not utilize any of
such Information for any purpose other than the purposes of this Research
Project as provided herein; provided, however, that the foregoing obligations of
confidentiality and non-use shall not preclude disclosure of such information in
a patent application or in the prosecution of a patent application pursuant to
Section 7.6 hereof, or extend to any of such Information which a non-owing party
can show:
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(i) by the non-owning party's prior written records was already in the
non-owning party's possession prior to (confidentiality agreement date);
(ii) such Information became generally available to the public through
issuance or publication of a patent application in which the information
is disclosed pursuant to Section 7.6 hereof;
(iii) such Information otherwise is or becomes generally available to
public through non fault of the non-owning party;
(iv) such Information is received by the non-owning party in good faith
from a third party on a non-confidential basis without violating any
obligation of secrecy to the owner party relating to the Information
disclosed; or
(v) written consent to disclose such Information was given by the owning
party.
6.3 DISCLOSURE OF CONFIDENTIAL INFORMATION. All PERIMMUNE confidential
disclosures shall be sent to SIGMA to the attention of Vice President of
Administration. All SIGMA confidential disclosure shall be sent to PERIMMUNE to
the attention of Xx. Xxxxx Xxxxxx. The parties agree that Information designated
confidential shall be disclosed to a restricted number of employees and such
employees shall be made aware of the confidential nature of the Information. The
parties shall use efforts fully commensurate with those employed for the
protection of its own confidential information to protect the Information
disclosed pursuant to Section 6.2 hereof and this Section 6.3.
6.4 Ownership of PERIMMUNE Ancillary Information. PERIMMUNE Ancillary
Information is owned solely by PERIMMUNE.
6.5 Ownership of PERIMMUNE Project Information. PERIMMUNE Project
Information shall be owned by SIGMA.
6.6 Ownership of SIGMA Information. SIGMA Information is, or shall be,
owned solely by SIGMA.
6.7 Ownership of Joint Project Information. Joint Project Information
shall be owned by SIGMA.
ARTICLE VII
OWNERSHIP OF INVENTIONS AND PATENTS
7.1 Ownership of Licensed Patents. PERIMMUNE shall have sole and
exclusive ownership of the Licensed Patents subject to SIGMA'S exclusive
worldwide license as provided in Article IV hereof.
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7.2 Ownership of SIGMA Patents. SIGMA shall have sole and exclusive
ownership of all SIGMA Patents.
7.3 Ownership of PERIMMUNE Improvements. PERIMMUNE shall have sole and
exclusive ownership rights to any Improvements made solely by PERIMMUNE whether
patentable or unpatentable subject to SIGMA's exclusive worldwide license as
provided in Article IV hereof.
7.4 Ownership of SIGMA Improvements. SIGMA shall have sole and exclusive
ownership rights to any Improvements made solely by SIGMA whether patentable or
unpatentable.
7.5 Ownership of Joint Improvements. Any Improvements made jointly by
SIGMA and PERIMMUNE shall be jointly owned by the parties hereto, subject to
SIGMA'S exclusive worldwide license as provided in Article IV hereof.
7.6 Filing Patents. PERIMMUNE shall be responsible for the preparation,
filing and prosecution of Licensed Patents as well as all costs and fees
associated therewith. PERIMMUNE shall apply for, seek prompt issuance of and
maintain during the term of this Agreement the patents and patent applications
in all jurisdiction where patent protection is available. The preparation,
prosecution and maintenance of all Licensed Patents shall be the primary
responsibility of PERIMMUNE; provided however, that SIGMA shall be afforded
reasonable opportunities to advise PERIMMUNE and shall cooperate with PERIMMUNE
in such preparation, prosecution and maintenance. PERIMMUNE shall promptly
advise SIGMA of the grant, lapse, revocation, surrender, or any threatened
invalidation or of its intention to abandon any such patent, application or
foreign counterpart. If PERIMMUNE chooses not to seek patent protection covering
an invention relating to the Project Research or chooses not to pay maintenance
fees due on a Licensed Patent it shall notify SIGMA immediately of such
decision. Upon request by SIGMA after receiving such notice, PERIMMUNE shall
assign ownership of such invention or Licensed Patent to SIGMA and execute the
necessary documents to enable SIGMA to seek patent protection of such invention
or maintain such Licensed Patent.
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ARTICLE VIII
REGULATORY AFFAIRS
8.1 Approvals. SIGMA shall have the responsibility to carry out, at its
own expense, all further regulatory and clinical work, testing or studies
relating to the Licensed Products as required or advisable for obtaining
Approvals. Sigma shall hold the 510(k) approval for all Licensed Products.
8.2 Assistance in Gaining Approvals. PERIMMUNE agrees to provide
reasonable assistance to SIGMA in making such applications, submissions or
filings as may be required or advisable in obtaining the Approvals required for
any Licensed Product to enable SIGMA to make, have made, import, use, market and
sell such Licensed Product in any country. Such assistance shall be provided at
not charge to SIGMA.
8.3 Notice of Reports to Government Authorities. Each party shall
promptly notify the other party of any information coming to its attention
concerning experience with any Licensed Product for which records and reports
are filed with any governmental authority, but shall not be liable for any
unintentional failure to do so.
ARTICLE IX
INFRINGEMENT
9.1 Suits Against SIGMA. In the event that any suit, action or other
proceeding shall be brought or threatened against SIGMA and/or any of its
Affiliates involving any claim of patent infringement or other violation of
intellectual property rights relating to the manufacture, use or sale of a
Licensed Product:
(a) SIGMA shall promptly send to PERIMMUNE copies of all papers which
shall have been served in such suit, action, or other proceeding.
PERIMMUNE shall, at its cost, indemnify, defend and hold SIGMA, its
officers, employees and Affiliates, harmless against any such claim,
including legal expenses and reasonable attorney fees. SIGMA and its
Affiliates agree to cooperate fully with PERIMMUNE, and will on
reasonable notice make available any of its employees, officers,
managers, trustees, agents, and other representatives to testify when
requested by PERIMMUNE, and will, on reasonable notice, make available
to the attorneys for PERIMMUNE all relevant records, papers,
information, samples, specimens and the like under an agreed upon
protective order effective to protect SIGMA's proprietary information
against public disclosure and/or disclosure to competition of SIGMA. If,
as a result of any such threatened or actual suit, action or other
proceeding, SIGMA is obligated to pay royalties and/or damages to a
third party, PERIMMUNE shall pay such royalty or damages on behalf of
SIGMA.
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(b) SIGMA'S obligation to pay royalties under Article IV shall be
suspended pending resolution of such suit, action or other proceeding.
SIGMA'S obligations under Article IV shall remain suspended until such
suit, action or other proceeding is resolved by dismissal thereof
together with: (i) a release of SIGMA from any past liability for the
manufacture, use or sale of Licensed Products; and (ii) a release or
license of SIGMA for the future manufacture, use and sale of Licensed
Products.
9.2(a) Notice and Prosecution of Infringement. PERIMMUNE will promptly
notify SIGMA of any counterfeiting, imitation or passing off of any
Licensed Product or suspected infringement of any Licensed Patents by a
third party of which PERIMMUNE becomes aware. PERIMMUNE and SIGMA shall
discuss and attempt to mutually agree as to any action, legal or
otherwise, which should be taken with respect to such suspected
infringement. PERIMMUNE shall have the right to bring any action for
infringement of the Licensed Patents, but if it chooses not to do so, or
fails to do so within a reasonable period of time, SIGMA may do so and
may join PERIMMUNE as a party to any such action. SIGMA shall have the
right to bring actions for counterfeiting, imitation or passing off
which do not involve patent infringement. In any such action so
instituted, each party will cooperate with the party bringing the action
in all respects, will on reasonable notice make any of its employees,
officers, directors, managers, trustees, agents, and other
representatives available to testify when appropriate and necessary and,
on reasonable notice, and will make available as necessary all relevant
records, papers, information, samples and specimens. Any and all
expenses incurred in the enforcement of Licensed Patents, (including
reasonable attorney's fees) whether by PERIMMUNE or SIGMA, and any and
all money or recoveries received in connection therewith shall be borne
or retained by the party bringing the action.
(b) In the event of any counterfeiting of any Licensed Product or
infringement of any Licensed Patents by any third party, SIGMA'S
obligation to pay royalties under Article IV shall be suspended pending
abatement of such counterfeiting or infringement, either by final
judgment of a court of competent jurisdiction from which no timely
appeal has been taken or by actual cessation of the counterfeiting or
infringement pursuant to a written agreement between Licensor and the
counterfeiter or infringer.
ARTICLE X
PRODUCT LIABILITY
10.1 Products Liability. (a) Except as otherwise provided in Article IX,
SIGMA shall defend, indemnify and hold PERIMMUNE harmless from and
against any and all loss, claims, suits, proceedings, expenses,
recoveries and damages, including costs and attorney's fees arising out
of, based on, or caused by any use and/or sale of any Licensed Product
manufactured by SIGMA, except that, SIGMA shall have no obligation to
defend or indemnify or to hold PERIMMUNE harmless with respect to any
damages, losses or liabilities arising out of a negligent act of
PERIMMUNE.
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(b) PERIMMUNE shall defend, indemnify and hold SIGMA harmless from and
against any and all loss, claims, suits, proceedings, expenses,
recoveries and damages, including costs and attorney's fees arising out
of, based on, or caused by any use of Technical Information furnished to
SIGMA by PERIMMUNE, except that, PERIMMUNE shall have no obligation to
defend or indemnify or to hold SIGMA harmless with respect to any
damages, losses or liabilities arising out of a negligent act of SIGMA.
ARTICLE XI
TERM AND TERMINATION
11.1 Term. This Agreement shall be in full force and effect for an
initial term of five (5) years from the effective date hereof and will be
automatically extended for additional one (1) year terms unless SIGMA gives
written notice to PERIMMUNE terminating the automatic extension of this
Agreement at least thirty (30) days prior to the beginning of a renewal period
or unless sooner terminated as provided for in Section 11.2 hereof.
11.2 Termination. Notwithstanding anything herein to the contrary,
either party shall have the right to terminate this Agreement by giving written
notice to be given at least ninety (90) days prior to the effective date of
termination, in the event:
(a) of any material default of this Agreement by the other party which
continues in default for more than ninety (90) days, and if, after
receiving written notice of such default from the non-defaulting party,
the default is not cured or remedied within ninety (90) days;
(b) action is taken to dissolve the other party.
11.3 Conditions Upon Termination. Upon expiration or termination of this
Agreement for any reason, SIGMA:
(a) shall, within sixty (60) days from the date thereof, destroy all
Licensed Cell Lines or return them to PERIMMUNE; and
(b) shall have the right, for a period of one (1) year from the date
thereof, to sell all Licensed Products on hand, and to produce and sell
Licensed Products from Licensed Antibodies on hand, subject to the
obligations of SIGMA to submit reports and pay royalties, as provided
for in Articles IV and V hereof.
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ARTICLE XII
WARRANTIES
12.1 Representations and Warranties of SIGMA. SIGMA hereby makes the
following representations and warranties to PERIMMUNE, which representations and
warranties, together with all other representations and warranties of SIGMA in
this Agreement, are true and correct on the date hereof:
(a) SIGMA is a corporation duly organized, validly existing and in good
standing under the laws of the State of Missouri and has all requisite
corporate power and authority to enter into this Agreement and perform
its obligations hereunder.
(b) Neither the execution or delivery of this Agreement, nor the
consummation of the transactions contemplated herein, will: (a) violate
or conflict with any provision of the Incorporation or By-laws of SIGMA,
as each may have been amended; (b) with or without the giving of notice
or the lapse of time or both (i) result in a breach of, or violate, or
be in conflict with or constitute a default under, or result in the
termination or cancellation of, or accelerate the performance required
under, any security instrument, mortgage, note, debenture, indenture,
loan, lease, contract, agreement or other instrument, to which SIGMA is
a party or by which it or any of its properties or assets may be bound
or affected, or (ii) result in the loss or adverse modification of any
lease, franchise, license or other contractual right or other
authorization granted to or otherwise held by SIGMA; (c) require the
consent of any party to any such agreement or commitment to which SIGMA
is a party or by which any of its properties or assets are bound; (d)
result in the creation or imposition of any lien, claim or encumbrance
upon any property or assets of SIGMA; or (e) require any consent,
approval, authorization, order, filing, registration or qualification of
or with any court or governmental authority or arbitrator to which SIGMA
is subject or by which any of its properties or assets may be bound or
affected.
(c) All action to authorize the execution and delivery of this Agreement
and the consummation of the transactions contemplated herein have been
duly taken, and this Agreement constitutes the valid and binding
obligation of SIGMA enforceable in accordance with its terms.
(d) There are no claims (relating to patent infringement or any other
matters), actions, suits, proceedings, arbitrations or investigations
pending or, to the best of SIGMA's knowledge, threatened, against SIGMA
which if adversely determined would adversely affect Licensed
Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed Products
or Licensed Patents (or the patentability thereof) or other technology
practiced by SIGMA, or SIGMA's ability to enter into or carry out this
Agreement or use of Licensed Antibodies, Licensed Biologicals, Licensed
Cell Lines, Licensed Products or Licensed Patents.
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12.2 Representations and Warranties of PERIMMUNE. PERIMMUNE hereby makes
the following representations and warranties to SIGMA, which representations and
warranties, together with all other representations and warranties of PERIMMUNE
in this Agreement, are true and correct on the date hereof:
(a) PERIMMUNE is a corporation duly organized, validly existing and in
good standing under the laws of the State of Maryland and has the power
and authority to enter into this Agreement and perform its obligations
hereunder;
(b) Neither the execution or delivery of this Agreement, nor the
consummation of the transactions contemplated herein, will: (a) violate
or conflict with any provision of the Incorporation or By-laws of SIGMA,
as each may have been amended; (b) with or without the giving of notice
or the lapse of time or both (i) result in a breach of, or violate, or
be in conflict with or constitute a default under, or result in the
termination or cancellation of, or accelerate the performance required
under, any security instrument, mortgage, note, debenture, indenture,
loan, lease, contract, agreement or other instrument, to which PERIMMUNE
is a party or by which it or any of its properties or assets may be
bound or affected, or (ii) result in the loss or adverse modification of
any lease, franchise, license or other contractual right or other
authorization granted to or otherwise held by PERIMMUNE; (c) require the
consent of any party to any such agreement or commitment to which
PERIMMUNE is a party or by which any of its properties or assets are
bound; (d) result in the creation or imposition of any lien, claim or
encumbrance upon any property or assets of PERIMMUNE; or (e) require any
consent, approval, authorization, order, filing, registration or
qualification of or with any court or governmental authority or
arbitrator to which PERIMMUNE is subject or by which any of its
properties or assets may be bound or affected.
(c) All action to authorize the execution and delivery of this Agreement
and the consummation of the transactions contemplated herein have been
duly taken, and this Agreement constitutes the valid and binding
obligation of PERIMMUNE enforceable in accordance with its terms.
(d) There are no claims (relating to patent infringement or any other
matters), actions, suits, proceedings, arbitrations or investigations
pending or, to the best of PERIMMUNE's knowledge, threatened, against
PERIMMUNE which if adversely determined would adversely affect the
Licensed Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed
Products or Licensed Patents (or the patentability thereof) or other
technology practiced by PERIMMUNE, or PERIMMUNE's ability to enter into
or carry out this Agreement or use of Licensed Antibodies, Licensed
Biologicals, Licensed Cell Lines, Licensed Products or Licensed Patents.
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(e) As of the date hereof, PERIMMUNE warrants that (i) it has no
knowledge that the manufacture, use, importation or sale of any Licensed
Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed Products
or Licensed Patents under this Agreement either alone or in combination,
nor any method of using such Licensed Antibodies, Licensed Biologicals,
Licensed Cell Lines, Licensed Products or Licensed Patents infringes any
patent or other industrial property right of a third party; and (ii) it
has not received any notification from any third party alleging or
suggesting that the manufacture, use, importation or sale of any such
Licensed Antibodies, Licensed Biologicals, Licensed Cell Lines, Licensed
Products or Licensed Patents does or would infringe any patent or other
industrial property. PERIMMUNE shall disclose to SIGMA any information
regarding adverse patent rights which it is, or becomes, aware of
relating to Licensed Antibodies, Licensed Biologicals, Licensed Cell
Lines, Licensed Products or Licensed Patents.
ARTICLE XII
MISCELLANEOUS
13.1 Notices. Any notices or report or other communication permitted or
required under this Agreement shall be in writing and sent by certified mail,
express mail, Federal Express, postage paid, return receipt requested, addressed
to the party to whom the notice is to be given. All notices, reports or other
communications made hereunder shall be deemed to have been made on the date
postmarked. Changes in address shall be accomplished by a notice in compliance
with this Section 13.1. The current address for each party is as follows:
PERIMMUNE SIGMA DIAGNOSTICS, INC.
0000 Xxxxxxx Xxxxx 000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000 Xx. Xxxxx, Xxxxxxxx 00000
Attn: Xx. Xxxxx Xxxxxx Attn: Vice President, Administration
13.2 Marking. SIGMA agrees to refer, in it sales literature and package
materials for Licensed Products, to the numbers of representative patent(s)
licensed under Licensed Patents.
13.3 Assignability. Neither this Agreement nor any agreement
incorporated herein nor any rights or obligations hereunder or thereunder may be
assigned by PERIMMUNE without prior written consent of SIGMA, and any attempted
assignment without SIGMA's prior written consent shall be void and of no effect.
This Agreement may be assigned by SIGMA and shall be binding upon and inure to
the benefit of the successor or assign of SIGMA.
13.4 Force Majeure. Neither party shall be liable in damages for, nor
shall this Agreement be terminable or cancelable by reason of any delay or
default in such party's performance hereunder if such default or delay is caused
by events beyond such party's reasonable control including, but not limited to,
acts of God, regulation or law or other action of any government or agency
thereof, war or insurrection, civil commotion, destruction or
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production facilities or materials by earthquake, fire, flood or storm, labor
disturbances, epidemic, or failure of suppliers, public utilities or common
carriers. Each party shall endeavor to resume its performance hereunder if such
performance is delayed or interrupted by reason of force majeure. Each party
shall notify the other, in writing, not less often than monthly, of the nature
and progress of such endeavors.
13.5 Severability. Should any part of this Agreement be held
unenforceable or in conflict with the applicable laws or regulations of any
jurisdiction, the invalid or unenforceable part or provision shall be replaced
with a provision which accomplishes, to the extend possible, the original
business purpose of such part or provision in a valid and enforceable manner,
and the reminder of this Agreement shall remain binding upon the parties.
13.6 Waiver. Waiver by either party of a default or breach or a
succession of defaults or breaches, or any failure to enforce any right
hereunder shall not be deemed to constitute a waiver of any subsequent default
or breach with respect to the same or any other provision hereof, and shall not
deprive such party of any right to terminate this Agreement arising by reason of
any subsequent default or breach.
13.7 Dispute Resolution. In the event of any controversy or claim
arising under or in relation to this agreement, including any issue about
payment of amounts due, the parties shall, in good faith, attempt to resolve the
controversy or claim by negotiation. If the controversy or claim cannot be
resolved within sixty (60) days, then it shall be settled exclusively by
arbitration in accordance with the Arbitration Rules of American Arbitration
Associations (AAA) and shall be held in Washington D.C. There shall be three
arbitrators: one selected by the party who requests arbitration who shall notify
the other party of the person selected at the time that notice of arbitration is
sent; one selected by the other party within ten (10) days of receipt of notice
of arbitration and one selected by the parties jointly within ten (10) days
thereafter or, failing their agreement, selected pursuant to the rules of AAA.
No arbitrator shall be related to, employed by, or have at any time a
substantial ongoing business relationship with any party hereto or any of their
respective affiliates. The losing party in the arbitration shall reimburse the
prevailing party for all costs and expenses, including reasonable attorneys
fees, incurred in connection with the arbitration. The decision of the
arbitrators shall be final and binding on the parties and judgement upon the
award rendered by the arbitrators may be entered by any court having
jurisdiction thereof. The provisions of this arbitration clause shall not be
applied to the determination of questions affecting validity or scope of any
trademarks, patents or other intellectual property.
13.8 Entire Agreement. This Agreement represents the entire
understanding between the parties as to the Date Of This Agreement with respect
to the subject matter hereof, and supersedes all prior agreements, negotiations,
understandings, representations, statements, and writings, between the parties
relating thereto. No modification, alteration, waiver or change in any of the
terms of this Agreement shall be valid or binding upon the parties hereto unless
made in writing and specifically referring to this Agreement and duly executed
by each of the parties hereto.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized representatives as of the day and
year first written above.
PERIMMUNE SIGMA DIAGNOSTICS, INC.
By: /s/X. X. XXXXX, XX. By: /S/ XXXXXXX X. XXXXXXX
------------------------------- -------------------------------
Printed Name: X. X. Xxxxx, Xx. Printed Name: Xxxxxxx X. Xxxxxxx
--------------------- ----------------------
Title: Pres & CEO Title: CEO
---------------------------- ----------------------------
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STATE OF Maryland )
)
COUNTY OF Xxxxxxxxxx )
On this 30th day of June, 1997, before me, a Notary Public, personally
appeared Xxxxxxx X Xxxxx, Xx., to me known to be the persons described in and
who executed the foregoing assignment and acknowledged that he/she executed same
as his/her free act and deed.
IN TESTIMONY WHEREOF, I have hereunto set my hand and seal the date and
year last above written.
[SIG]
-------------------------------
Notary Public
My commission expires: May 15, 0000
XXXXX XX Xxxxxxxx )
)
COUNTY OF St. Louis )
On this 26th day of June, 1997, before me, a Notary Public, personally
appeared Xxxxxxx X. Xxxxxxx to me known to be the persons described in and
executed the foregoing assignment and acknowledged that he/she executed same as
his/her free act and deed.
IN TESTIMONY WHEREOF, I have hereunto set my hand and seal the date and
year last above written.
/s/ XXXXX X. XXXXXX
-------------------------------
Notary Public
My commission expires:
XXXXX X. XXXXXX
NOTARY PUBLIC- NOTARY SEAL
STATE OF MISSOURI
ST LOUIS COUNTY
MY COMMISSION EXPIRES: AUG 21, 2000
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EXHIBIT A
Xxxxx X. Xxxxxx, Ph.D.-Director, In Vitro Products Division
Xxxxx Xxxxxx-Xxxxxx, Ph.D.-Manager, CVD Products; Apo-Tek Product Manager
Xxxxxxx X. Xxxxxx-Senior Research Scientist/Project Manager,
Diagnostic Products
Xxxxxx Xxxxxxxxx, Ph.D.-Research Associates, Diagnostic Products
Xxxxxx Xxxxxx, Ph.D.-Senior Scientist, Molecular Biology
Xxxxx Xxxxxxxx-Research Scientist, Diagnostics Products
Xxxxx Xxx-Research Specialist, Diagnostics Products
Xxxxxxx Xxxxxx-Animal Technician, Animal Resource Facility
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EXHIBIT B
PROJECT DEVELOPMENT SCHEDULE AND PLAN
Phase I (2 June 1997 - 12 July 1997)
- Development of Lp(a) antigens and immunization of Mice
- PerImmune provides 50mg of mAb 2DI and 4mg of purified Lp(a) to Sigma
Phase II (14 July 1997 - 31 October 1997)
- Hybridoma fusion, characterization and cloning of 10 cell lines
- Selection of mAbs meeting specifications described in Section 1.7 "Licensed
Antibodies"
Phase III (3 November 1997 - 6 March 1998)
- Ascites production of 10 mAbs
- PerImmune provides 4mg of purified Lp(a) to Sigma
Phase IV (9 March 1998 - 27 November 1998)
- PerImmune transfers selected monoclonal bybridoma cell lines to Sigma
- Sigma establishes conditions and GMP processes for production of mAbs in
hollow fiber bioreactors
Phase V (30 March 1998 - 11 September 1998)
- Development of Calibrators and Controls
Phase VI (14 September 1998 - 9 October 1998)
- Sigma demonstrates homogenous immunoturbidometric Lp(a) assay equivalent to
Apo-Tek Lp(a) product
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STATE OF MARYLAND )
)
COUNTY OF XXXXXXXXXX )
On this 30th day of June 1997, before me, a Notary Public, personally
appeared Xxxxxxx X. Xxxxx, Xx. to me known to be the persons described in and
who executed the foregoing assignment and acknowledged that he/she executed same
as his/her free act and deed.
IN TESTIMONY WHEREOF, I have hereunto set my hand and seal the date and
year last above written.
/s/ XXXXXX XXXXXXX XXXXXXXX
-----------------------------
Notary Public
My commission expires: May 15, 0000
XXXXX XX XXXXXXXX )
)
COUNTY OF ST. LOUIS )
On this 26 day of June 1997, before me, a Notary Public, personally
appeared Xxxxxxx X. Xxxxxxx to me known to be the persons described in and who
executed the foregoing assignment and acknowledged that he/she executed same as
his/her free act and deed.
IN TESTIMONY WHEREOF, I have hereunto set my hand and seal the date and
year last above written.
/s/ XXXXX X. XXXXXX
-----------------------------
Notary Public
My commission expires: Aug. 21, 2000
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