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EXHIBIT 10.12
AGREEMENT FOR THE DEVELOPMENT OF
THE THROMBOFLEX SYSTEM
This Agreement for the Development of the Thromboflex System (the
"Agreement") is made as of the 8th day of June 2000, (the "Effective Date"), by
and between Nova Biomedical Corporation, a Massachusetts corporation with its
principal place of business at 000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX ("Nova") and
GMP|Thromboflex, Inc., a Delaware corporation with its usual place of business
at Xxx Xxxx Xxxxxxx Xxxxxxxxx, Xxxxx 0000, Xxxx Xxxxxxxxxx, Xxxxxxx, 00000 (the
"Company"). Nova and Company are referred to collectively herein as the
"Parties."
RECITALS
WHEREAS, Nova is engaged in the business of designing, developing and
manufacturing instrument products based on customer specifications;
WHEREAS, Company is engaged in the development of a
thrombovisco-elastogram system based on Company's proprietary technology; and
WHEREAS, Company and Nova desire to enter into a cooperative agreement
for the design and development of a Thromboflex System product.
NOW, THEREFORE, in consideration of the foregoing and the covenants and
premises contained in this Agreement, the parties agree as follows:
1. DEFINITIONS
1.1 In this Agreement and the recitals hereto, the following terms
shall have the following meanings:
"AAA" shall have the meaning ascribed to such term in Section 7.9 of this
Agreement.
"BUSINESS DAY" means business days, Monday through Friday, excluding national
holidays.
"BREADBOARD SYSTEM" means the system described in Section 4.0 of the Program
Plan.
"COMPANY" shall have the meaning ascribed to such term in the Preamble.
"CONFIDENTIAL INFORMATION" shall have the meaning ascribed to such term in
Section 4.1 of this Agreement.
"DELIVERABLES" means those deliverables described in Section 2.1(b) and (e) of
this Agreement.
"DESIGN DATA" means data developed by Nova under this Agreement defining and
verifying the core technologies required to automate specified assays.
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"DESIGN HISTORY FILE" means a file created and maintained by Nova that documents
the Product development process.
"DEVELOPMENT PHASE" means the second phase of the Program Plan, the plans and
specifications of which are a Deliverable of the Research Phase.
"FDA" means the Food and Drug Administration.
"FIELD OF USE" means the industry and market segment targeted by Company for the
Product. For purposes of this Agreement, the Field of Use of the Product is
limited to a quantitative assessment of the contribution of platelet activity to
clotting of human whole blood and soluble clotting factors. All other existing
or future applications will be considered outside this Agreement.
"INDEMNIFIED PARTY" shall have the meaning ascribed to such term in Section 5.4
of this Agreement.
"INDEMNIFYING PARTY" shall have the meaning ascribed to such term in Section 5.4
of this Agreement.
"INTELLECTUAL PROPERTY RIGHTS" means trade secrets, copyrights, trademarks and
patents, including pending applications therefor and all related rights
worldwide.
"KNOW-HOW" means any practices, knowledge, skill or experience not embodied in
or otherwise contained in Technical Information.
"MANUFACTURING AGREEMENT" shall mean the production agreement for the Product to
be agreed upon by the parties and included as a Deliverable of the Development
Phase. The form of such agreement is attached hereto as Exhibit E. The parties
agree that the "Term" provision on page three of Exhibit E and the form of
Attachment 2 to Exhibit E may not be modified in the final Manufacturing
Agreement between the parties.
"NOTICES" shall have the meaning ascribed to such term in Section 7.8 of this
Agreement.
"NOVA" shall have the meaning ascribed to such term in the Preamble.
"NOVA STATEMENT OF RATES" means the Nova statement of hourly rates attached
hereto at Exhibit B.
"PAYMENT SCHEDULE" means the payment schedule for the payments by Company to
Nova for the Research Phase as attached hereto at Exhibit C, as the same shall
be modified by the parties for the remaining Phases of the Program Plan.
"PHASE" means each of the three stages of the Program Plan, consisting of the
"Research Phase," the "Development Phase" and the "Production Phase."
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"PRODUCT" means a point-of-care diagnostic device inclusive of consumables
utilizing Intellectual Property Rights, Technical Information and Know How owned
or licensed by Company that can provide in vitro diagnostic test results for
quantitative assays by measuring platelet contractile and
thrombovisco-elasticity as initially described in the Program Plan and to be
specifically defined in the Product Specifications. As used herein, the term
"point-of-care" shall mean, in present clinical practice, in vitro diagnostic
tests performed on a single sample using compact analyzers (desktop or portable
hand held devices) that produce test results on a rapid basis and do not require
a laboratory specialist.
"PRODUCT SPECIFICATIONS" means the specifications for the Product to be
developed pursuant to Section 2.1(e) of this Agreement. The Product
Specifications may be amended from time to time by written agreement of the
Parties.
"PRODUCTION PHASE" means the third phase of the Program Plan, the plans and
specifications of which are a Deliverable of the Development Phase.
"PROGRAM PLAN" means the complete research, development and production plan for
the Thromboflex System as initially described in Exhibit A.
"RESEARCH PHASE" means the first stage of the Program Plan, the Deliverables of
which are set forth in Section 4.1 of Exhibit A.
"TECHNICAL INFORMATION" means all technology, inventions, discoveries,
information, performance, costs, sales and other data, databases, Design Data,
schematics, designs, files (including Design History Files), formulas,
specifications, processes, methods, test data results, reports, know-how,
compositions and materials (whether or not patented or patentable) related to
the design, development, manufacture or operation of the Product.
"THROMBOFLEX SYSTEM" shall have the meaning ascribed in the Program Plan.
2. PRODUCT DEVELOPMENT
2.1 NOVA OBLIGATIONS. Nova agrees:
(A) To use its reasonable best efforts to cause the
completion of each Phase of the Program Plan within
the estimated budgets and time schedules described
therein;
(B) To deliver Deliverables that conform to the
specifications and functions set forth in the
specifications relating thereto, if applicable, for
each Phase within the timeframe and budget
established for the applicable Phase;
(C) To conform with and maintain the records necessary to
comply with the applicable regulatory requirements
for approval of the Product by the FDA, including but
not limited to, maintaining a Design History File
sufficient to meet the requirements of FDA and ISO
9001 regulations and requirements,
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and support Company in obtaining required regulatory
approvals as requested by Company;
(D) To provide Company with monthly progress reports
regarding the progress of the relevant Phases; and
(E) To perform the various tests and prepare and produce
the Deliverables for the Research Phase described in
Exhibit A attached hereto, within the estimated
budget and timeframe set forth in that Exhibit, which
Deliverables shall include the proposed Product
Specifications.
2.2 COMPANY OBLIGATIONS. Company agrees:
(A) To consult with and provide assistance to Nova during
the various Phases;
(B) To provide Nova with access to physicians who would
be potential users of the Product; and
(C) To review the Deliverables and the results of any
acceptance tests provided at the conclusion of each
Phase and determine whether the Deliverables in each
Phase are acceptable and how and whether to proceed
with the next Phase.
2.3 JOINT OBLIGATIONS. The Parties agree:
(A) To jointly conduct brainstorming sessions to develop
a broad base of methods and subsystems in order to
select and refine the Product Specifications; and
(B) To review during the Research Phase the laboratory
test results and other information developed during
that Phase with the goal of establishing the Product
Specifications and the Deliverables, milestones, and
related dates and associated budgets for the
Development Phase.
2.4 DEVELOPMENT TIMING, FEES AND EXPENSES.
(A) Time and Materials Basis. Nova will perform its
obligations set forth in the Program Plan, on a time and materials basis for the
estimated amounts and within the estimated timeframes for each Phase as agreed
to by the Parties. The payment schedule for the payments by Company to Nova for
the Research Phase is set forth in Exhibit C attached hereto. The payment
schedule for the remaining Phases shall be agreed to by the Parties prior to the
initiation of each Phase. To the extent that prepayments exceed the time and
material spent by Nova, such excess funds shall be applied to the next scheduled
payment, or, if requested by Company, returned to Company.
Nova shall use its reasonable best efforts to complete the
specified services and the Deliverables for no more than such amounts and within
the timeframes estimated for the applicable Phase or portion thereof. Should
Nova determine at any time that it might be necessary to exceed such estimated
amounts or estimated time to perform, or should the actual
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time and materials or timeframes for any Phase or portion thereof exceed the
estimates agreed to by the Parties hereto, Nova shall immediately notify Company
in writing. In such written notice Nova shall set forth Nova's best estimate of
the increase in cost and/or time to complete the pertinent Phase or portion
thereof and any other financial or time impacts on the overall Phase. Following
receipt of such notice, Company shall either instruct Nova to halt work under
this Agreement, to continue on a time and material basis, or to suspend work
pending further negotiation. If the Parties fail to agree in writing on the new
estimated costs or time to complete the pertinent services and/or the
Deliverables, Company may terminate this Agreement in accordance with Section 6
of this Agreement. Nova shall be under no obligation to continue to perform the
work on any Phase unless Company is paying Nova undisputed amounts on a timely
basis. Company will notify Nova of any disputed amounts within 30 Business Days
and Nova and Company agree to negotiate in good faith to resolve any
differences.
(B) No Other Compensation. The hourly rates prescribed in the
Nova Statement of Rates attached hereto as Exhibit B shall include compensation
for any costs or burden incurred by Nova, including (without limitation)
occupancy, utilities, payroll, management and overhead. Materials, supplies,
travel costs, and other out-of-pocket expenses will be billed separately and
charges for these items will not exceed Company's authorized amounts. No
royalty, profit-sharing, or other compensation whatsoever is to be provided to
Nova for the services or Deliverables in any Phase.
(C) Changes to the Nova Statement of Rates; Calculation of
Fees and Expenses. Nova may increase the hourly rates on the Nova Statement of
Rates during the project upon thirty (30) days' written notice to Company;
provided, however, that such increase shall not exceed five percent (5%), and
shall not occur within twelve (12) months of the Effective Date of this
Agreement, and no more frequently than once annually thereafter.
2.5 PAYMENT; MANNER OF PAYMENT.
(A) Invoices. Nova shall submit invoices to Company in
accordance with the Payment Schedule. Each invoice shall separately set forth a
summary of reimbursable travel expenses, if any, and will include a summary of
all time and material charges incurred since the Effective Date for the first
invoice and since the last invoice for all other invoices. Accompanying such
invoice will be a summary of the fees and expenses associated with each Phase or
portion thereof that has a separate estimate of cost. Supporting documentation
(e.g., time sheets, invoices, receipts for air travel, hotels, and rental cars)
if called for by Company shall be provided to Company. Terms for all invoices
will be net thirty (30) days from invoice date. Nova reserves the right to halt
the development work in the event Company has not paid an overdue invoice;
provided, however that Nova shall not be entitled to halt work if Company's
failure to pay an overdue invoice is due to a good faith dispute between the
parties concerning the content or calculation of any invoice. Nova shall provide
Company with at least fifteen (15) Business Days written notice of its intention
to halt work under this Section 2.5. Company shall have the right to credit any
excess amounts paid by it on previous invoices.
(B) Subcontractor Payments. Nova shall be responsible for
paying all invoices for fees and costs for which it subcontracts.
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2.6 NOVA EMPLOYEES AND SUBCONTRACTORS. Nova shall have each
employee and subcontractor involved in the development of any Product sign a
Non-Disclosure and Assignment of Inventions Agreement substantially in the form
attached hereto as Exhibit D.
2.7 REPRESENTATIONS AND WARRANTIES BY NOVA. Nova makes the
following representations and warranties for the benefit of Company, as a
present and ongoing affirmation of facts in existence at all times when this
Agreement is in effect:
(A) No Conflict. Nova represents and warrants that it is under
no obligation or restriction, nor will it assume any such obligation or
restriction that does or would in any way interfere or conflict with, or that
does or would present a conflict of interest concerning, the work to be
performed by Nova under this Agreement.
(B) Ownership Rights. Nova represents and warrants that except
to the extent Intellectual Property Rights, Technical Information, and Know How
are already owned by Nova prior to commence of work on the Product and
Deliverables (for which Company is granted a license under Section 3.2 below),
Company is and will be the sole owner of all Intellectual Property Rights,
Product and Know-How and Technical Information contained in or arising out of or
in connection with the Product and Deliverables. Nova represents and warrants
that it has and will have full and sufficient right to assign or grant the
rights and/or licenses granted in the Product and Deliverables pursuant to this
Agreement; and (iii) information pertaining to Product or Deliverables will not
be published by, through or under Nova under circumstances that would result in
a loss of any Company Intellectual Property Rights therein.
(C) Conformity, Performance, and Compliance. Nova represents
and warrants (i) that all Deliverables shall be prepared in a workmanlike manner
and with professional diligence and skill; (ii) that all Deliverables will
conform and perform to the specifications and functions set forth in the Product
Specifications or other requirements relating thereto; and (iii) that Nova will
perform the development work in compliance with applicable laws and regulations
for such Product.
(D) Cost Basis of Invoices. Nova represents and warrants as of
the date of this Agreement and as of the date of each invoice submitted to
Company that the amounts being invoiced will be applied only to the actual time
spent by Nova employees and the resulting charges will be based upon the hourly
rates set forth in Exhibit B and material costs incurred (plus 10% handling
charges) under the Project, prepared in accordance with generally accepted
accounting practices consistently applied throughout Nova, and any excess
amounts shall be returned to Company as provided in Section 2 above. Nova
further represents and warrants that the rates charged to Company under this
Agreement will be not more than the lowest then current rate received from other
customers of Nova.
3. INTELLECTUAL PROPERTY
3.1 LICENSE TO COMPANY TECHNOLOGY. Company hereby grants to Nova a
non-exclusive, royalty-free right and license to use the Technical Information,
Know How and Intellectual Property Rights of Company solely to perform the work
and provide the Deliverables
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described in Section 2.1 above, and (b) make the Product for sale or use by
Company. The foregoing rights include the right and license to grant sublicenses
to subcontractors to perform work and provide the Deliverables; provided,
however, that Nova must obtain Company's prior written consent before engaging
any subcontractor. The licenses granted under this Section 3.1 shall terminate
on the completion or termination of the development effort by Nova as described
in Section 2.1 of this Agreement.
3.2 LICENSE TO NOVA TECHNOLOGY. Nova hereby grants to Company an
irrevocable, perpetual, non-exclusive, worldwide, royalty-free, assignable,
transferable right and license, with the rights to sublicense, to use any Nova
owned Technical Information, Know How and Intellectual Property Rights in
connection with (a) making, using, importing or selling the Product or otherwise
utilizing the Deliverables, (b) executing, reproducing, displaying, performing,
distributing, and preparing derivative works based upon the Product or any
Deliverables, and (c) authorizing or sublicensing others from time to time to do
any or all of the foregoing.
3.3 OWNERSHIP OF PRODUCT AND INTELLECTUAL PROPERTY RIGHTS.
(A) Ownership of Product and Deliverables. Nova acknowledges
and agrees that Company shall own all rights to the Product and the
Deliverables, including all Intellectual Property Rights, Technical Information
and Know How incorporated in or arising out of or in connection with the
development of the Product and Deliverables and the manufacture, importation,
sale or use of the same. Nova agrees to execute any and all documents evidencing
Company's ownership of such property and interests.
(B) Patents and Copyrights. When patentable subject matter
conceived or first reduced to practice by Nova or Nova's agent(s) during the
term of the performance of work by Nova under this Agreement which relate to the
Product or any Deliverables or the manufacture or use of the same forms the
basis of one or more claims of a patent application filed by Company, Nova will
immediately notify Company of such fact and the names of the individual
employee(s) and/or agent(s) of Nova who created such patentable subject matter
shall be included in any patent application as an "inventor." Nova will, at
Company's expense, assist Company in obtaining patents on any such inventions.
Nova agrees to obtain the assignment of any such inventions from Nova's
employees or agents and to assign such inventions to Company. In the event that
copyrightable subject matter is created by Nova or Nova's agent(s) which can or
does form the basis of one or more copyright registrations filed by Company,
such copyrightable subject matter shall be considered a "work made for hire" and
Company shall be named as the "author" of such works. Nova will, at Company's
expense, assist Company in obtaining copyright registrations, and, if necessary,
shall assign or obtain the assignment of any such copyrightable works to
Company.
4. CONFIDENTIALITY.
4.1 GENERAL OBLIGATIONS. Company and Nova agree that, except as
otherwise specifically set forth in this Section 4, or, in the case of Nova,
created by Nova in the performance of this Agreement, all information disclosed
by either party to the other in
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connection with this Agreement, including all information concerning Product
Specifications, Technical Information, Intellectual Property Rights, the Program
Plan, the manufacture of any Deliverables, or any component thereof, business
information, processing plans, facility plans, marketing plans, financial
information, personnel information, forecasts, customer lists, and any documents
that contain or report on such information (collectively, the "CONFIDENTIAL
INFORMATION") are confidential to the party disclosing or owning such
information, and the other party agrees to take all steps reasonably necessary
to protect the secrecy and confidentiality of such information and the other
party's proprietary interest thereof, including the following:
(A) Each party shall use Confidential Information belonging to
the other party only for purposes contemplated by this Agreement and in the
manner specified by this Agreement, and, except as permitted herein, shall not
make any copies of, reproduce, attempt to copy, disclose, sell, assign,
sublicense, or transfer, in whole or in part, any such Confidential Information.
(B) Except as permitted herein or otherwise permitted by the
other party in writing, either party may disclose Confidential Information only
to those of its employees and agents required to have knowledge of the same to
perform duties authorized by this Agreement.
(C) Each party shall promptly report to the other any conduct
relating to the other's Confidential Information inconsistent with the
provisions of this Section 4, and take such action as may be reasonably
necessary and legally permissible to terminate such conduct.
(D) Immediately upon termination of this Agreement for any
reason, each party shall return to the other party, or, if so requested by the
other party, destroy, all Confidential Information belonging to the other party
which is in that party's possession or control.
(E) Technical Information and Intellectual Property Rights
developed by or through Nova in the performance of its obligations under this
Agreement, shall be governed by Section 3.3 above and shall be considered
Confidential Information of Company.
4.2 EXCEPTIONS.
(A) GENERAL EXCEPTIONS. Except as permitted herein, Company's
and Nova's obligations of confidentiality shall not apply to Confidential
Information to the extent that such information (i) is rightfully possessed by
the other party prior to its receipt hereunder except for Company's Confidential
Information developed by or through Nova under this Agreement; (ii) is or later
becomes publicly available through no fault of the other party; (iii) is or
becomes available to the other party from third parties who in making such
disclosure breach no confidentiality relationship; (iv) is disclosed by the
other party on an unrestricted basis to other persons not privy to this
Agreement; (v) is independently developed by the other party without reference
to such information; or (vi) is required by governmental or court order, or by
law or regulation, to be disclosed, provided each party provides advance notice
to the other party prior to such disclosure. The claiming party shall have the
burden of proof with respect to any claimed exception set forth in this Section
4.
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4.3 NOTICES. Each party agrees to reproduce and include the
other's proprietary rights, notices or reasonable equivalents on any item that
contains Confidential Information. In addition, each party agrees to comply with
the other's marking requirements regarding any patented item.
4.4 PUBLICITY. Nova shall not disclose the existence, terms, or
conditions of this Agreement to any person or make any public statement
respecting this Agreement without the prior written consent of Company, except
that Nova may make such disclosures as are required by applicable law.
4.5 ENFORCEMENT. Each party acknowledges that use of Confidential
Information in a manner contrary to the provisions of this Agreement would cause
the other party irreparable harm for which money damages alone could not make
the injured party whole and, without limiting any other available remedies,
hereby consents to the full extent that it is able to do so to any injunctive
relief entered by any court of competent jurisdiction prohibiting it from such
violation of this Agreement. Each party shall allow the other reasonable access
to documentation to demonstrate compliance with this Agreement.
4.6 DURATION. Subject to extension by written agreement of the
parties, the obligations set forth in this Section 4 shall remain in force
during the term of, and for five (5) years after termination of, this Agreement.
5. INDEMNIFFICATION.
5.1 INTELLECTUAL PROPERTY INDEMNIFICATION. The parties shall
indemnify each other as follows:
(A) Agreement to Avoid Infringing. In performing services
under this Agreement, Nova and its agent(s) shall not knowingly design or
develop any items that infringe Intellectual Property Rights of any third party.
If Nova becomes aware of any such possible infringement in the course of
performing the development work described in Section 2.1 of this Agreement, Nova
shall immediately so notify Company in writing. However, Nova assumes no
responsibility for ensuring that the Product or the Deliverables do not infringe
Intellectual Property Rights of any third party. Upon acceptance of a
Deliverable, Company shall assume all responsibility for liability related to
the Deliverable and all resulting products including, but not limited to,
liability relating to infringement of patents or other Intellectual Property
Rights of any third party, provided that Nova shall remain responsible for
Product performance related warranties.
(B) Company Representation. Company represents and warrants
that, to the best of its knowledge, the use of Company Know-How, or Technical
Information and Intellectual Property Rights to design and develop the
Deliverables, the Product Specifications and the Product do not infringe any
Intellectual Property Rights of any third party.
(C) Nova Representation. Nova represents and warrants that, to
the best of its knowledge, the use of Nova and Company Know-How, Technical
Information and Intellectual Property Rights to manufacture the Product will not
infringe any Intellectual Property Rights of any third party.
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(D) Intellectual Property Indemnification. Company will defend
at its own expense any action against Nova or its agent(s) that is based on a
claim that the design, development, sale or other commercialization of the
Product infringes on the Intellectual Property Rights of a third party, and pay
those damages or costs finally awarded against Nova or its agent(s) in such
action, provided that Nova notifies Company promptly in writing of any such
action and gives Company sole control of the defense and any negotiations for
settlement or compromise of such action. Nova agrees to provide reasonable best
assistance to Company in connection with any such action.
5.2 GENERAL INDEMNIFICATION BY NOVA. Nova agrees to and hereby
does indemnify and hold harmless Company and Company's officers, directors,
employees, and agents from and against any and all losses, costs, liabilities or
expenses (including costs and reasonable fees of attorneys and other
professionals) arising out of or in connection with Nova's performance under or
breach of this Agreement to the extent that such claims arise out of or result
from any act or omission of Nova.
5.3 GENERAL INDEMNIFICATION BY COMPANY. Following acceptance of
the Deliverables, and except as set forth in Section 5.2, Company agrees to, and
hereby does, indemnify and hold harmless Nova and Nova's officers, directors,
employees, and agents from and against any and all losses, costs, liabilities or
expenses (including costs and reasonable fees of attorneys and other
professionals) arising out of or in connection with Company's breach of this
Agreement to the extent that such claims arise out of or result from (a) claims
by third parties; or (b) claims against Nova for personal injury or property
damage which arise out of (i) the sale or other distribution of Product by
Company, (ii) any representation made or warranty given by Company with respect
to any Product, (iii) the sale or use of any product which is not supplied by
Nova and which is sold or combined with a Product by Company, (iv) repairs or
services rendered by Company, or (v) the negligent act or omission of Company.
5.4 INDEMNIFICATION PROCEDURE. The party seeking indemnification
(the "INDEMNIFIED PARTY") shall (a) give the other party (the "INDEMNIFYING
PARTY") thirty (30) days written notice of such claim, (b) cooperate with the
Indemnifying Party, at the Indemnifying Party's expense, in the defense of such
claim, and (c) give the Indemnifying Party the right to control the defense and
settlement of any such claim, except that the Indemnifying Party shall not enter
into any settlement that affects the Indemnified Party's rights or interest
without the Indemnified Party's prior written approval. The Indemnified Party
shall have no authority to settle any claim on behalf of the Indemnifying Party.
6. TERM AND TERMINATION
6.1 TERM. This Agreement shall remain in force and effect from the
Effective Date until the Product is released for production pursuant to the
Manufacturing Agreement or the written termination of this Agreement as set
forth in this Section 6, which ever comes first.
6.2 TERMINATION BY COMPANY. Company may terminate this Agreement
in the event that (i) Nova fails to perform any of its material obligations
under this Agreement and such failure is not remedied within thirty (30) days
after receipt of written notice from Company; (ii)
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Nova fails to complete its obligations or provide the services and Deliverables
in each Phase or portion thereof within the timeframes and/or estimated budgets
agreed to by the Parties; (iii) the Parties are unable to reach agreement as to
how to proceed at the end of the Research Phase or Development Phase or any
gating event within any Phase; or (iv) Company decides to cease all design and
development work on a Product that incorporates Company Technology licensed from
Xx. Xxxxxxx.
(a) Inventory and Final Accounting
In the event of termination under this Subsection:
(i) All inventory purchased for Company by Nova will
be paid for by Company, and such inventory shall be
transferred to Company upon such payment; and
(ii) The final accounting will compensate Nova for
all reasonable, undisputed expenses in accordance with Section
6.4, incurred in connection with the performance through the
Phase or gating milestone within a Phase upon which
termination is based, or if termination is due to a material
breach by Nova, through the date notice of termination is
received by Nova; and
(iii) All Product, Deliverables or portions thereof,
Company Know-How, Company Technology, Company Intellectual
Property Rights and Confidential Information belonging to
Company shall be delivered to Company.
6.3 TERMINATION BY NOVA. Nova may terminate this Agreement if
Company fails to perform any of its material obligations under this Agreement
and such failure is not remedied within thirty (30) days after receipt of
written notice from Nova.
6.4 EFFECT OF TERMINATION. Upon any termination pursuant to
Section 6.2 or Section 6.3, Nova shall be responsible for terminating the work
of any subcontractors which Nova engages. In addition, Nova shall be responsible
for any costs incurred by any subcontractors after the effective date of
termination by Company except for any additional costs due to activities
requested by Company. In the event of termination, Nova shall submit an invoice
to Company covering all unpaid fees and costs through the effective date of
termination as well as any additional costs due to activities requested in
writing by Company. Company agrees to pay the undisputed amount of any such
invoice within thirty (30) Business Days of receipt of such invoices.
Termination of this Agreement shall not affect the parties' obligations or
rights pursuant to Sections 2.6, 3, 4, 5 and 7; which Sections shall survive
such termination.
7. MISCELLANEOUS
7.1 RELATIONSHIP OF PARTIES. The Parties are not partners,
employees, agents or legal representatives of the other party for any purpose.
Neither party shall have the authority to enter into any contracts in the name
of or on behalf of the other party.
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7.2 FURTHER ASSURANCES. Each party shall, at the request and
expense of the other party, do such acts or things as the other party may
reasonably require for the purpose of obtaining, registering, maintaining,
enforcing and preserving any of the Intellectual Property Rights of the other
party related to the Product, Deliverables or such party's Technology, as
applicable; provided, however, that each party has the exclusive right to enjoin
any infringement by a third party of any Intellectual Property Rights of the
party related to such party's Technology. In the event that any unlawful copying
of the Product, infringement of a party's rights in the Product, or
infringement, application or registration by a third party of the rights of
either party comes to the attention of either party, such party shall
immediately inform the other in writing, stating the full facts of the
infringement, application or registration known to it, including the identity of
the suspected infringer, applicant or registrant, the place of the asserted
infringement, application or registration and evidence thereof. Each of the
parties agrees to cooperate fully with the other party at the expense of such
other party if such other party sues to enjoin such infringements or to oppose
or invalidate any such application or registration.
7.3 NONASSIGNABILITY; BINDING ON SUCCESSORS. Either party may
assign or otherwise transfer this Agreement only in connection with a sale of
all or a significant portion of its assets, or of its business, whether via
merger or otherwise. Except as permitted in the preceding sentence, neither
party shall assign any of its rights or obligations under this Agreement without
the express written consent of the other party. Any attempted assignment under
this Agreement without such consent shall be void. In the case of any permitted
assignment or transfer of or under this Agreement, this Agreement or the
relevant provisions shall be binding upon the executors, heirs, representatives,
administrators and assigns of the parties hereto.
7.4 SEVERABILITY. In the event any provision of this Agreement is
held to be invalid or unenforceable, the valid or enforceable portion thereof
and the remaining provisions of this Agreement will remain in full force and
effect.
7.5 FORCE MAJEURE. Neither party shall be liable to the other for
its failure to perform any of its obligations under this Agreement, except for
payment obligations, during any period in which such performance is delayed
because rendered impracticable or impossible due to circumstances beyond its
reasonable control, including without limitation earthquakes, governmental
regulation, fire, flood, labor difficulties, civil disorder, and acts of God,
provided that the party experiencing the delay promptly notifies the other party
of the delay.
7.6 WAIVER. Any waiver (express or implied) by either party of any
breach of this Agreement shall be in writing and shall not constitute a waiver
of any other or subsequent breach.
7.7 ENTIRE AGREEMENT; AMENDMENT. This Agreement and any Exhibits
attached hereto constitute the entire, final, complete and exclusive agreement
between the parties and supersede all previous agreements or representations,
written or oral, with respect to the subject matter of this Agreement. This
Agreement may not be modified or amended except in a writing signed by a duly
authorized representative of each party.
7.8 NOTICES. All notices, communications, requests, demands,
consents and the like ("NOTICES") required or permitted under this Agreement
will be in writing and will be deemed
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given and received (i) when delivered personally, (ii) when sent by confirmed
telecopy, (iii) ten (10) days after having been duly mailed by first class,
registered or certified mail, postage prepaid, or (iv) three (3) business days
after deposit with a commercial overnight carrier, with written verification of
receipt. All Notices will be addressed as follows:
If to Company:
GMP|Thromboflex, Inc.
Xxx Xxxx Xxxxxxx Xxxxxxxxx, Xxxxx 0000
Xxxx Xxxxxxxxxx, Xxxxxxx 00000
Attention: Xxxxxxx Xxxxx, Vice President
Telephone: 000-000-0000
Facsimile: 000-000-0000
If to Nova:
Nova Biomedical Corporation
000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Xxxxxxx X. XxXxxx, Ph.D., Vice President -
Business Development
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other address as the person to whom Notice is to be given may have
furnished to the other in writing in accordance herewith, except that Notices of
change of address will be effective only upon receipt. A Notice given by any
means other than as specified herein will be deemed duly given when actually
received by the addressee.
7.9 CHOICE OF LAW, ARBITRATION. This Agreement is made in
accordance with and shall be governed and construed under the laws of the state
of Delaware, and in no event shall this Agreement be governed by the United
Nations Convention on Contracts for the International Sale of Goods. Except as
otherwise provided in this Agreement, any dispute, controversy or claim arising
out of or relating to this Agreement shall be finally decided by binding
arbitration conducted in English and in accordance with the then-current rules
of the American Arbitration Association ("AAA"). There shall be one arbitrator
selected in accordance with AAA rules. Any award issued by the arbitrator shall
be final and non-appealable for both parties. The parties shall bear the costs
of such arbitration equally, and the prevailing party (as determined by the
arbitrator) in any such arbitration or any judicial enforcement or review
proceeding shall be entitled to its reasonable attorneys' fees and costs in
addition to any award ordered by the arbitrator.
7.10 RIGHTS AND REMEDIES CUMULATIVE. The rights and remedies
provided in this Agreement shall be cumulative and not exclusive of any other
rights and remedies provided by law or otherwise.
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7.11 CAPTIONS AND SECTION REFERENCES. Captions and section headings
appearing in this Agreement are inserted only as a matter of convenience and in
no way define, limit, construe or describe the scope or extent of such section
or in any way affect such section.
7.12 AUTHORITY TO ENTER INTO AND EXECUTE AGREEMENT; PRIOR GRANTS.
Each party represents and warrants to the other that it has the right, full
power and lawful authority to enter into this Agreement for the purposes herein
(including the granting of licenses and transfer of ownership of intellectual
property under this Agreement) and to carry out its obligations hereunder. Each
party further warrants to the other that it has no other outstanding agreements
or obligations inconsistent with the terms and provisions hereof and that it has
not made any prior grants of rights in or to the Product, Company Technology or
the Nova Technology to any third party which are inconsistent or would interfere
in the performance of this Agreement.
7.13 PUBLICITY. All notices to third parties and all other
publicity concerning this Agreement shall be jointly planned and coordinated
between the parties. Neither party shall act unilaterally in this regard without
the prior written approval of the other party, which approval shall not be
unreasonably withheld, and which shall be deemed to be given when disclosure is
specifically required by law. All related communications within each party's
organization shall be of a confidential nature.
7.14 NON-SOLICITATION. The parties to this Agreement agree not to
solicit or hire each other's personnel without the advanced written consent of
the other party. This term shall survive the termination of this Agreement for a
period of one year.
7.15 COUNTERPARTS. This Agreement may be executed in counterparts
with the same force and effect as if each of the signatories had executed the
same instrument.
14
15
IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their
duly authorized representatives as of the Effective Date.
GMP|THROMBOFLEX, INC.
By:
------------------------------------
Name: Xxxx Xxxxxxx, M.D.
Title: President
NOVA BIOMEDICAL CORPORATION
By:
------------------------------------
Name: Xxxx X. Xxxxxxx
Title: Chief Operating Officer
Exhibit A - Program Plan
Exhibit B - Nova Statement of Rates
Exhibit C - Payment Schedule
Exhibit D - Form of Non-Disclosure and Assignment of Inventions Agreement for
Nova Employees/Subcontractors
Exhibit E - Example of Nova Manufacturing Agreement
15
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EXHIBIT A - PROGRAM PLAN
GMP Thromboflex
Project Xxxxxxx
Program Plan
6/8/00
1
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TABLE OF CONTENTS
1.0 INTRODUCTION.................................................................................................3
1.1 EVOLUTION...............................................................................................3
2.0 BACKGROUND...................................................................................................3
2.1 TVE TECHNOLOGY DESCRIPTION..............................................................................3
3.0 PRODUCT FEATURES.............................................................................................4
4.0 OUTLINE PROGRAM PLAN.........................................................................................5
4.1 RESEARCH PHASE..........................................................................................5
4.2 DEVELOPMENT PHASE.........................................................................................7
4.3 PRODUCTION PHASE..........................................................................................7
5.0 COST AND TIME ESTIMATE........................................................................................8
5.1 COMPLETE DEVELOPMENT PROGRAM............................................................................9
6.0 FLOWCHART OF THROMBOFLEX DEVELOPMENT PROCESS.............................................................10
2
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1.0 INTRODUCTION
Xx. Xxxx Xxxxxxx, of Massachusetts General Hospital, has developed a method
which provides a quantitative assessment of the contribution of platelet
activity to clotting of human, whole blood. This unique, patented, in vitro
method dynamically measures the changes in elastic and viscous properties of
whole blood as the clotting process proceeds. The resulting
thrombovisco-elastogram, TVE, allows for a measure of platelet function,
independent of soluble plasma clotting factors. This document proposes to
develop the TVE method as part of an automated system for near patient use,
within a hospital environment (the Thromboflex System).
1.1 EVOLUTION
This document, dated this 8th day of June, 2000 (the "Effective Date") is the
latest in a series of documents written as the product concept has evolved. Many
changes from the preceding document (TVE System, Product Development Plan,
9/13/99, ref TVE/program 5.doc) are included within. The inclusion of a Bread
Board System as part of the Research Phase is the most significant change and
reflects two significant modifications to the Product concept:
a. The inclusion of the measurement of platelet contractile
pressure in base technology.
b. The evolution of the Product from a tabletop unit to a
portable unit employing a single-use disposable.
Because of the uncertainties associated with these changes, details within the
Product Development Stage of this document have not been included.
2.0 BACKGROUND
At present, a number of tests are commonly used to determine the hemostasis of a
patient: PT, APTT, ACT, Platelet Count, Fibrinogen and Hematocrit.
Unfortunately, proper values of these parameters do not ensure that a patient
will not bleed excessively during and after surgery. While platelet dysfunction
is known to be a cause of micro-vascular bleeding, a practical and reliable
method of assessment of platelet function in the clotting process is not
available. The visco-elasticity (TVE) and platelet contractile pressure or force
per unit area (PCP) in a clot are functions of both the platelet activity and
the contribution of soluble plasma clotting factors. Assessment of these two
characteristics are the basis of this Product development.
2.1 TVE TECHNOLOGY DESCRIPTION
The Thromboflex System adds platelet function to the list of measurable factors
affecting the hemostasis of a patient. The system is used to determine the
present hemostasis of a patient.
- The operator prepares a single whole blood sample.
- A single disposable is placed within the unit.
- The operator injects the sample into the disposable.
- The instrument measures the visco-elasticity and the platelet
contractile pressure as the blood clots.
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- The instrument presents two measured results: Platelet
Activity and/or APTT.
- A calculated value of soluble plasma factors (fibrinogen
content) and of Platelet Function if the operator enters a
Platelet Count.
3.0 PRODUCT FEATURES
- A fully automated, portable system.
- A "point of care" or near patient device.
- Operated by laboratory personnel, perfusionists, or
anesthesiologists.
- Uses 1 ml of whole blood drawn with or without citrate in a
syringe.
- May be integrated into a hospital's LIS (laboratory
information system).
- For Platelet Function, the system measures:
- 'E*max, the maximum rate of change in elasticity
corrected for Hct.
- T (`E*max), the time at which the maximum rate of
change in elasticity occurs.
- P(pc) the pressure that is a result of the
contracting clot.
- Estimates Hct to allow for the `E*max correction.
- For APTT, the system measures:
- T (E(0)), the time when clotting begins as determined
from the elasticity vs. time plot.
- Employs a unique, disposable sample chamber patentable by
GMP|Thromboflex, Inc.
- Analysis time = one minute.
- Throughput = twelve (12) tests per hour.
- Analysis temperature = 37 (degree) C.
PRODUCT DESIGN CONCEPT DRAWING
[PHOTO]
4
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4.0 OUTLINE PROGRAM PLAN
The following outlines the complete program plan including both research and
development efforts:
RESEARCH PHASE (BREADBOARDS)
- MARKET RESEARCH STUDY
- PRE-BREADBOARD RESEARCH RESULTS
- DESIGN REVIEW SESSIONS
- SYSTEM ARCHITECTURE DESIGN DESCRIPTION
- RESEARCH BREAD BOARD 1 RESULTS AND INITIAL SPECIFICATIONS
- (3) ADVANCED BREAD BOARDS RESULTS
- PROOF OF CONCEPT / SPECIFICATIONS FOR DEVELOPMENT PHASE
DEVELOPMENT PHASE (PROTOTYPES)
- PREPARE A GMP THROMBOFLEX BUSINESS PLAN
- ENGINEERING MODEL
- PROTOTYPE(2)
- FINALIZE MANUFACTURING AGREEMENT WITH NOVA BIOMEDICAL
PRODUCTION PHASE (PILOT UNITS & PRODUCTION UNITS)
- PILOT PRODUCTION
- INITIATE MANUFACTURING PER GMP THROMBOFLEX BUSINESS PLAN
(1) BREADBOARD IS DEFINED AS A MODEL THAT WORKS LIKE THE FINAL PRODUCT
(2) PROTOTYPE IS DEFINED AS MODEL THAT LOOKS AND WORKS LIKE THE FINAL PRODUCT
4.1 RESEARCH PHASE
The following are the Research Phase Deliverables by Nova Biomedical Corporation
4.1.1 Market Research Study which
- Defines the market potential for single use device (SUD) and a
multiple use device (MUD).
- Defines the competition - all players (start-ups and
established diagnostic companies).
- Characterizes all competitive products inclusive of features,
benefits and pricing.
- Opinions from industry leaders as to device requirements:
"what is needed to improve diagnosis of bleeding and/or
hyper-coagulability.
- Defines a Product Specification for an SUD and MUD as well as
the associated market pricing.
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4.1.2 Pre-Breadboard research resulting in laboratory test results which
demonstrate the ability of an SUD to permit the development of TVE and PCP as
measurable tests to assure a patient's hemostasis.
4.1.3 Conduct Design Review Session at which GMP|Thromboflex, Inc. shall select
the SUD or MUD approach and the required functionality and desired performance
requirements for the selected device type.
4.1.4 System Architecture Design Description following decisions by
GMP|Thromboflex, Inc. as to the selection of either the SUD or MUD.
4.1.5 Report containing the laboratory test results from the Research Bread
Board and the initial performance specifications.
The initial phase will establish methods to produce the required
measures of the clotting process. During this phase:
- The measurement methods will be demonstrated.
- Reference methods will be established.
- The initial performance specifications will be established.
4.1.6 Report containing the laboratory test results of the three (3) Advanced
Bread Boards
Following the design resulting from the initial bread board effort,
three (3) semi-automated systems will be constructed in a rapid manner.
These systems will provide stable and reproducible results. This stage
will include:
- The construction of three (3) identical systems.
- The initial design and construction of a disposable sample
chamber which will include:
- Manual sample entry.
- Automated reagent addition and mixing.
4.1.7 Proof of Concept/Specifications for the Development Phase
This stage of the first Phase is a research effort to establish the
basic performance characteristics of the Product. The three (3)
Advanced Bread Board units will be utilized to:
- Establish the performance of the Platelet Function measurement
on patients undergoing specific therapies including
angioplasty and by-pass surgery.
- Evaluate the effect of fractionated heparin and unfractionated
heparin products on the measurement of Platelet Function.
- Determine a scale and calibration method for Platelet
Function.
- Establish the measurement of APTT.
The results of this Research Phase will be used to establish the
Product Specifications for the Development Phase.
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4.2 DEVELOPMENT PHASE
The following are the anticipated components of this phase and may change
as the Research Phase progresses, particularly if an SUD is selected.
4.2.1 Engineering Model
This is the initial stage of the Product Development Phase. A
limited number (3-5) of fully automated systems will be
constructed. These systems will allow for:
- The continued research effort to demonstrate proof of
technology for all the assays.
- The research and development of the reagents and
disposables required for the production systems.
- Estimates of the production cost of the final Product
and its disposables.
- Features of the Engineering Model Phase are:
- A number of identical, "works like",
fully-automated systems.
- Pilot production level, disposable sample
xxxxxxxx to support the automated systems.
- The initial documents required within the
Design History File, including a Marketing
Requirements document and a Program Plan
document.
4.2.2 Prototype
This is the initial step toward the manufacture of the final
product.
- A first design of the final product will be
completed.
- The final design of the disposable will be completed.
- Identical, "works like" and "looks like" systems will
be constructed to be used for clinical trials and
on-site evaluations.
- Instrument components will be made as the final
product but without the cost savings associated with
production methods and tooling.
- Limited production tooling for the disposables will
be developed along with the necessary factor-specific
reagents.
4.2.3 Pilot Production
The final phase of the development process results in the
following:
- A complete production design and necessary
documentation.
- Identical, "works like," "looks like," and "built
like" systems will be constructed.
- Instrument components will be made on limited
production tooling but in the same manner as the
final components.
- The disposables will be manufactured in reduced
quantities on final production tooling.
4.3 PRODUCTION PHASE
The components, if any, of this phase will be agreed upon at the end of
the Development Phase.
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5.0 COST AND TIME ESTIMATE
The following is an outline of the Research Phase in calendar weeks:
-----------------------------------------------------------------------------------------------------------
DELIVERABLE TIME TO DELIVER, WEEKS START DATE ESTIMATED COSTS
-----------------------------------------------------------------------------------------------------------
Market Research Study 4-6 Effective Date $ 42,000
-----------------------------------------------------------------------------------------------------------
Pre-Breadboard Research Results 6-8 Effective Date $330,000
-----------------------------------------------------------------------------------------------------------
Results from Design Review 2 2 months after $ 50,000
Session Effective Date
-----------------------------------------------------------------------------------------------------------
System Architecture Design 3 months after
Description Effective Date
-----------------------------------------------------------------------------------------------------------
Results from Research Bread 10
Board / Initial Specs
-----------------------------------------------------------------------------------------------------------
Results from Advanced Bread 20
Boards
-----------------------------------------------------------------------------------------------------------
Proof of Concept / Specs for 4
Development Phase
-----------------------------------------------------------------------------------------------------------
The following staffing is required for the Research Phase:
--------------------------------------------------------------------------------------------
PERSON USAGE MAN-WEEKS RATE/HR COST
--------------------------------------------------------------------------------------------
Program Manager 0.3 10 $125 50,000
--------------------------------------------------------------------------------------------
Med. Tech. 1.0 34 $ 70 95,000
--------------------------------------------------------------------------------------------
EE/SW Eng. 1.0 34 $125 170,000
--------------------------------------------------------------------------------------------
Mechanical Eng. 2.0 68 $125 340,000
--------------------------------------------------------------------------------------------
Support 0.5 17 $ 70 48,000
--------------------------------------------------------------------------------------------
TOTAL 4.8 163 $703,000
--------------------------------------------------------------------------------------------
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The following capital equipment is required for all Phases of the
product development.
----------------------------------------------------------
ITEM COST
----------------------------------------------------------
Hematology Instrument $40,000
----------------------------------------------------------
Stress Analysis Program $10,000
----------------------------------------------------------
Hemodyne Instrument $20,000
----------------------------------------------------------
Computer $ 5,000
----------------------------------------------------------
TOTAL $75,000
----------------------------------------------------------
- The estimated material cost for three (3) Advanced Breadboard
Systems is $30,000.
- The marketing study will cost approximately $42,000.
- The total cost of the Research Phase is estimated to be
$850,000.
5.1 COMPLETE DEVELOPMENT PROGRAM
The following outlines the program cost and duration in calendar
months.
PHASE COST MONTHS
----- ---- ------
RESEARCH PHASE $850,000 9
DEVELOPMENT PHASE TO BE DETERMINED 20 TO 24
TOOLING TO BE DETERMINED
TOTAL COST TO BE DETERMINED
The costs for the following are specifically not included in the above
estimates:
1. Any costs associated with marketing the product, including the
development of a marketing and sales/distribution plan.
2. Any costs for the actual manufacturing of the system or
disposables during the Product Development Phase.
3. Any costs incurred during Clinical Evaluations conducted by
GMP outside of Nova Biomedical.
9
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6.0 FLOWCHART OF THROMBOFLEX DEVELOPMENT PROCESS
THROMBOFLEX DEVELOPMENT PROCESS
[CHART]
10
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EXHIBIT B
NOVA STATEMENT OF RATES (PER HOUR*)
NOVA Support Service Rate
($/hour)
--------
Program Director $190
Program Manager $115
Senior Scientist/Engineer $115
Scientist/Engineer $100
Technician $ 70
Drafting $ 40
Manufacturing Engineering $125
Human Resources $100 plus agency fee
Business Development $150
Finance $125
Materials/Purchasing 10% material overhead rate on all purchases
Information Systems $125
Facilities/Construction $ 60
Administrative Support $ 40
* Plus expenses and materials
27
EXHIBIT C
PAYMENT SCHEDULE
The following summary is the payment schedule for the development of the
Thromboflex System, due at the beginning of the month specified.
MONTH PAYMENT DUE
----- -----------
RESEARCH PHASE
1 (Effective Date) $ 283,333
4 $ 283,333
7 $ 283,333
SUB TOTAL $ 850,000
DEVELOPMENT PHASE TO BE DETERMINED
PRODUCTION PHASE TO BE DETERMINED
TOTAL PROGRAM PLAN AMOUNT TO BE DETERMINED
RESEARCH PHASE $ 850,000
DEVELOPMENT PHASE TO BE DETERMINED
TOOLING TO BE DETERMINED
TOTAL TO BE DETERMINED
28
EXHIBIT D
FORM OF NON-DISCLOSURE AND ASSIGNMENT OF TECHNICAL INFORMATION
AGREEMENT FOR NOVA EMPLOYEES/SUBCONTRACTORS
In consideration of, and as a condition of the undersigned working on the
development of the products which are the subject of that certain AGREEMENT FOR
THE DEVELOPMENT OF THE THROMBOFLEX SYSTEM for GMP|Thromboflex, Inc. (the "NOVA
Agreement") between GMP|Thromboflex, Inc., a Delaware corporation (the
"Company") and NOVA Biomedical Corporation ("NOVA"), the undersigned agrees as
follows:
1. Purpose of Agreement. The undersigned understands that it is critical for
Company to preserve and protect its "Confidential Information" (as defined in
Section 6 below), all rights in "Technical Information" (as defined in Section 2
below) and in all related intellectual property rights, and the exclusive rights
of Company to own and use the information and other intellectual property rights
created in the course of performing the activities under the NOVA Agreement.
Accordingly, the undersigned is entering into this Confidentiality Agreement
(this "Agreement") as a condition of working for NOVA.
2. Disclosure of Technical Information. The undersigned will promptly disclose
in confidence to Company directly or through NOVA, all technology, inventions,
discoveries, information, performance, costs, sales and other data, databases,
schematics, designs, files, formulas, specifications, processes, methods, test
data, reports, know-how, compositions and materials, mask works and trade
secrets (collectively "Technical Information") that are made, conceived or first
reduced to practice or created, either alone or jointly with others, during the
period the undersigned is providing services for Nova or the Company, whether or
not such Technical Information is patentable, copyrightable or protectible as a
trade secret.
3. Work for Hire; Assignment of Technical Information. The undersigned
acknowledges and agrees that any copyrightable works prepared by the undersigned
within the scope of the activities conducted under the NOVA Agreement are "works
for hire" under the Copyright Act and that Company will be considered the author
and owner of such copyrightable works. The undersigned further agrees that
Company will own all Technical Information is made, conceived or first reduced
to practice or created, either alone or jointly with others, during the period
the undersigned is providing services for Nova or Company, whether or not such
Technical Information is patentable, copyrightable or protectible as a trade
secret, and shall assign all such Technical Information to Company.
4. Assignment of Other Rights. In addition to the foregoing assignment of
Technical Information to Company, the undersigned hereby irrevocably transfers
and assigns to Company any and all "Moral Rights" (as defined below) that the
undersigned may have in or with respect to any Technical Information. The
undersigned also hereby forever waives and agrees never to assert any and all
Moral Rights it may have in or with respect to any Technical Information, even
1
29
after termination of the NOVA Agreement. "Moral Rights" mean any rights to claim
authorship of Technical Information, to object to or prevent the modification of
any Technical Information, or to withdraw from circulation or control the
publication or distribution of any Technical Information, and any similar right,
existing under judicial or statutory law of any country in the world, or under
any treaty, regardless of whether or not such right is denominated or generally
referred to as a "moral right".
5. Assistance. The undersigned agrees to assist Company in every proper way to
obtain for Company and enforce patents, copyrights, mask work rights, trade
secret rights and other legal protections for Company's Technical Information in
any and all countries. Such obligations of the undersigned under this paragraph
will continue beyond the termination of this Agreement provided that Company
will compensate the undersigned at a reasonable rate after such termination for
time or expenses actually spent by the undersigned at Company's request on such
assistance.
6. Confidential Information. The undersigned hereby acknowledges and agrees that
any information of a confidential or secret nature that may be disclosed to the
undersigned by Company and any information developed by the undersigned in the
course of, or arising out of the performance of the undersigned's obligations in
connection with the NOVA Agreement shall belong to Company ("Confidential
Information"). Such Confidential Information includes, but is not limited to,
specifications, processing plans, facility plans, marketing plans, product
plans, business strategies, financial information, forecasts, personnel
information, customer lists and other Technical Information.
7. Confidentiality. At all times, both during the term of the NOVA Agreement and
after its termination, the undersigned will keep and hold all such Confidential
Information in strict confidence and trust. The undersigned will not use or
disclose any Confidential Information without the prior written consent of
Company, except as may be necessary to perform its obligations under the NOVA
Agreement. Upon termination of work under the NOVA Agreement, the undersigned
will promptly deliver to Company all documents and materials of any nature
pertaining to the work done for Company. The undersigned agrees not to remove
from the control of Company any documents or materials or copies thereof
containing any Confidential Information.
8. Freedom to Use. The undersigned acknowledges and agrees that he or she has no
interests in, or rights to use, any of the Confidential Information, Technical
Information, or other intellectual property belonging to Company and that
Company has the right to make or have made, use, sell or have sold, and import
any product or services utilizing all or any of the Confidential Information,
Technical Information or other intellectual property rights without any
obligation to, or participation by, the undersigned.
9. Injunctive Relief. In the event of a breach or threatened breach of this
Agreement by the undersigned, the undersigned acknowledges that Company will
suffer irreparable harm and will therefore be entitled to injunctive relief to
enforce this Agreement.
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10. Hiring of Employees. For a period of one year following the last day that
the undersigned performs any work related to the Nova Agreement, the undersigned
agrees not to solicit any of Company's employees to work for third parties
without the prior written agreement of Company, even if the request for hiring
is initiated by the employee.
11. Governing Law; Severability. This Agreement will be governed by and
construed in accordance with the laws of the State of Massachusetts, without
giving effect to that body of laws pertaining to conflict of laws. If any
provision of this Agreement is determined by any court or arbitrator of
competent jurisdiction to be invalid, illegal or unenforceable in any respect,
such provision will be enforced to the maximum extent possible given the intent
of the parties hereto. If such clause or provision cannot be so enforced, such
provision shall be stricken from this Agreement and the remainder of this
Agreement shall be enforced as if such invalid, illegal or unenforceable clause
or provision had (to the extent not enforceable) never been contained in this
Agreement. Notwithstanding the forgoing, if the value of this Agreement based
upon the substantial benefit of the bargain for the undersigned or Company is
materially impaired, which determination as made by the presiding court or
arbitrator of competent jurisdiction shall be binding, then this Agreement will
not be enforceable against such affected party and both parties agree to
renegotiate such provision(s) in good faith.
12. Titles and Headings. The titles, captions and headings of this Agreement are
included for ease of reference only and will be disregarded in interpreting or
construing this Agreement.
13. Entire Agreement. This Agreement constitutes the entire agreement and
understanding of the undersigned with respect to the subject matter of this
Agreement, and supersedes all prior understandings and agreements, whether oral
or written, with respect to the specific subject matter hereof.
14. Amendment and Waiver. This Agreement may be amended only by a written
agreement executed by the undersigned and agreed to by Company. Any amendment
effected in accordance with this Section will be binding upon Company and the
undersigned and each of their respective successors and assigns. No delay or
failure to require performance of any provision of this Agreement shall
constitute a waiver of that provision as to that or any other instance. No
waiver granted under this Agreement as to any one provision herein shall
constitute a subsequent waiver of such provision or of any other provision
herein, nor shall it constitute the waiver of any performance other than the
actual performance specifically waived.
15. Successors and Assigns; Assignment. Except as otherwise provided in this
Agreement, this Agreement, and the rights and obligations of the
undersigned, will be binding upon and inure to the benefit of his/or her
successors, assigns, heirs, executors, administrators and legal representatives.
Company may assign any of its rights and obligations afforded under this
Agreement.
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31
16. Further Assurances. The undersigned agrees to execute such further documents
and instruments and to take such further actions as may be reasonably necessary
to carry out the purposes and intent of this Agreement, as the same may be
requested by Nova or Company.
17. Beneficiaries of the Agreement. The undersigned acknowledges and agrees
that Nova and Company are each beneficiaries of this Agreement and may enforce
the obligations of the undersigned hereunder.
AGREED AND ACCEPTED.
-------------------------------------
-------------------------------------
PRINT NAME
-------------------------------------
DATE
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EXHIBIT E - FORM OF MANUFACTURING AGREEMENT
Manufacturing Agreement
For
THROMBOFLEX
By and Between
Nova Biomedical Corporation
AND
GMP|Thromboflex, Inc.
[DATE]
1
33
GMP/NOVA BIOMEDICAL MANUFACTURING AGREEMENT
FOR THROMBOFLEX
TABLE OF CONTENTS
PAGE
INTRODUCTION 3
TERM 3
ROLES AND RESPONSIBILITIES 3
PRODUCT 3
SECTION 1/PRODUCT DESIGN 3
SECTION 2/COVENANTS 3
SECTION 3/DISTRIBUTION/WAREHOUSING 5
SECTION 4/PRODUCTION ENGINEERING COSTS 5
SECTION 5/PRICING/VOLUME 6
SECTION 6/COST OF REWORK OR SCRAP 8
SECTION 7/MANUFACTURING ENGINEERING 8
SECTION 8/PRODUCT CHANGES 8
SECTION 9/WARRANTY 9
SECTION 10/NOTICE 10
SECTION 11/GOVERNING LAW; ARBITRATION 10
SECTION 12/LIABILITY/INSURANCE 11
SECTION 13/TERMINATION 11
SECTION 14/TERMS OF PAYMENT 12
SECTION 15/INDEMNIFICATIONS 12
SECTION 16/PRODUCT RECALL 14
SECTION 17/DISCLOSURE OF INFORMATION 14
SECTION 18/COMPLIANCE WITH LAW 15
SECTION 19/MISCELLANEOUS 15
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GMP|THROMBOFLEX, INC./NOVA BIOMEDICAL
MANUFACTURING AGREEMENT
FOR THROMBOFLEX
INTRODUCTION:
THIS MANUFACTURING AGREEMENT is effective this ___ day of _____, 200_
("Effective Date") between NOVA Biomedical Corporation, a Massachusetts
corporation with offices at 000 Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxxxx
("NOVA"), and GMP|Thromboflex, Inc., a Delaware corporation with offices at One
East Broward Boulevard, Suite 1701, Ft. Xxxxxxxxxx, XX 00000 ("GMP" and together
with NOVA collectively referred to as the "parties").
TERM:
Unless terminated earlier as provided in Section 13, this Manufacturing
Agreement shall have an initial term ("Initial Term") which will run from the
Effective Date until four (4) years after the date ("Commencement of
Production") which is the later of: (i) the date NOVA has received the first
purchase order for production units; and (ii) the date the documentation to
build the units has been released for production by GMP. Subject to the
termination provisions of Section 13, the Initial Term shall be automatically
renewed, without further notice or action by either party, for additional and
successive terms of one year each ("Renewal Terms" and together with the Initial
Term collectively referred to as the "Term") unless either party gives written
notice to the other of the intention not to renew not less than 180 days prior
to the end of the Initial Term or any Renewal Term, as the case may be.
ROLES AND RESPONSIBILITIES:
PRODUCT:
The product (the "Product") is a point of care thrombo-visco elastogram system,
known as "______________", having the design specifications set forth in
Attachment 1; which Product has been developed under that certain AGREEMENT FOR
THE DEVELOPMENT OF THE THROMBOFLEX SYSTEM, dated June 8, 2000, by and between
the parties (the "Development Agreement"). GMP owns all rights to the Product.
SECTION 1/PRODUCT DESIGN
GMP is responsible for the Product design and performance and will provide NOVA
with design documentation and specifications, which design and specifications
have been developed under the Development Agreement. GMP will be responsible for
obtaining all United States Food and Drug Administration ("FDA") and other
agency approvals, as needed, to market the Product.
SECTION 2/COVENANTS
COVENANTS AND DUTIES OF GMP
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Except as otherwise provided in this Agreement, GMP will purchase all of its
production requirements for the Product from NOVA during the Term. In the event
that an order for Products is rejected as provided below, or NOVA fails to
timely deliver Products meeting the applicable specifications, GMP shall
thereafter have the right to manufacture, or have manufactured from a second
source, Products and NOVA agrees to cooperate with GMP in facilitating such
production by providing the necessary engineering drawings, specifications and
other information related to the manufacture of the Product. Once the Nova
problem is resolved, Nova will return to 100% production of the products. NOVA
shall perform such services at its own expense.
GMP shall render prompt technical support to NOVA on a continuing basis when
reasonably requested by NOVA.
GMP agrees to provide to NOVA on a timely basis all engineering change notices
with respect to the Product.
COVENANTS AND DUTIES OF NOVA
NOVA shall manufacture and sell to GMP all Products which GMP shall order by
delivery of purchase orders to NOVA at least 90 days prior to the requested
delivery date; provided, however, that in the event NOVA is unable to meet the
terms of the GMP purchase order, it shall notify GMP within five (5) business
days after receipt of the order with proposed order modifications. If GMP does
not expressly agree in writing to such proposed order modifications, such order
shall be deemed rejected. The terms of this Agreement shall otherwise govern.
Except for any order modifications agreed to by GMP, in writing, all terms and
conditions in this Agreement shall prevail over the terms and conditions
contained in any purchase order.
To shorten lead-times from the 90-day time period, NOVA will inventory long
lead-time items at GMP's expense if so requested by GMP.
NOVA understands and agrees that it is providing manufacturing services
hereunder as a customer-transparent contractor of GMP under GMP's name. NOVA's
name shall not appear on the Products or any documentation, except that NOVA's
name may appear on serial number labels, so long as such labels are not visible
to GMP's customers, and in documents relating to obtaining regulatory approval
of the Product. Nothing in this Agreement shall be deemed to grant NOVA any
right to use GMP's name for any purpose other than as expressly provided herein.
NOVA shall at all times use commercially reasonable efforts, skill, and
experience to manufacture all Products in strict conformity with all applicable
Product specifications and all applicable U.S. and European Union laws and
regulations. NOVA shall not make any change in or deviate in any way from such
specifications except pursuant to an Engineering Change Order ("ECO") approved
as provided in Section 8 of this Agreement.
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NOVA shall manufacture Products in its plant in Waltham, Massachusetts, unless
GMP authorizes NOVA in writing to manufacture Products in another plant
location.
Products shall be packaged and labeled in accordance with GMP's requirements and
specifications.
NOVA shall report to GMP, as soon as possible, all delays related to the
manufacture and/or shipping of Products to GMP. GMP shall have the right to
cancel (without penalty) any order for any untimely-shipped Product.
NOVA represents and warrants to GMP that: (1) NOVA has the right to enter into
this Agreement; (2) all necessary actions, corporate and otherwise, have been
taken to authorize NOVA's execution and delivery of this Agreement and the same
is the valid and binding obligation of NOVA; (3) all licenses, consents and
approvals necessary for NOVA to carry out all of the transactions contemplated
in this Agreement have been obtained by NOVA; (4) NOVA has the experience and
technical capacity to fulfill its obligations under this Agreement; (5) NOVA has
and shall pass to GMP good title to the Products free and clear of all liens and
encumbrances; (6) no claim or action is pending or threatened against NOVA or,
to NOVA's knowledge, against any supplier of NOVA that could adversely affect
the ability of NOVA to produce the Products or the right of GMP or any customer
of GMP to use the Products for their intended use; and (7) the rates, margins
and overheads charged to GMP under this Agreement and the terms and conditions
associated with the Product are and, during the Term, shall be no less favorable
to GMP than the terms and conditions offered to any other customer of NOVA.
SECTION 3/DISTRIBUTION/WAREHOUSING
The Products shall be sold by NOVA to GMP at the prices indicated in Attachment
0, XXX, Xxxxxxx, Xxxxxxxxxxxxx. NOVA shall ship the Products via mutually agreed
carriers to GMP or to GMP's customers as directed by GMP, with the cost of such
freight and insurance paid by GMP.
GMP shall be responsible for payment of all export and import duties, local
sales taxes and similar charges with respect to the Products.
Title and ownership and risk of loss to the Products shall pass to GMP FOB
NOVA's facility in Waltham, Massachusetts or on receipt of a written request
from GMP to hold completed and invoiced goods at NOVA for future shipment,
provided (i) NOVA uses commercially reasonable storage methods; and (ii) GMP
reimburses NOVA for any reasonable storage costs incurred by NOVA.
SECTION 4/PRODUCTION ENGINEERING COSTS
Prior to Commencement of Production, NOVA will complete all tasks related to
implementing production such as building the Product structure, developing the
Device Master Record ("DMR"), creating assembly procedures and testing
approaches, designing
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and fabricating test fixtures and assembly jigs, and generating the
documentation package from a 3D data base.
Certain non-recoverable engineering may be required by GMP, which involves the
development of injection molding tool specifications and design or product
design to enhance the manufacturing of the product. GMP will pay for this
non-recoverable engineering work. These non-recoverable engineering charges
shall be billed to GMP at a labor rate of $100 per hour for engineers and $85
per hour for technicians, plus material and NOVA's current and auditable
material overhead costs. Non-recoverable engineering charges will be noted in
Attachment 2 and will not be reflected in the per unit charge.
Following Commencement of Production, NOVA will provide to GMP all manufacturing
engineering, drafting and documentation required to manufacture the Product and
to conform to FDA and ISO 9000 regulations. NOVA shall maintain its
documentation in compliance with GMP's and FDA's specifications.
The NOVA price to GMP indicated in Attachment 2 includes the costs of all
manufacturing engineering necessary to implement production subsequent to
Commencement of Production and, except as noted in Section 3, all packaging and
handling charges.
GMP will reimburse NOVA for all capital equipment/tooling costs needed to
implement production (e.g., molds, computers, automatic test equipment) or at
its discretion provide the capital equipment/tooling to NOVA. GMP shall be the
sole owner of all such equipment and tooling. The estimate for the total costs
reimbursable by GMP under this Section 4 will be set forth in Attachment 2.
GMP shall have the right to use all of the information created by NOVA as
described in this Section 4 for use in connection with the Product, improvements
and enhancements thereon and the manufacture of the same.
SECTION 5/PRICING/VOLUME
The Pricing Schedule for different volumes shall be set forth in Attachment 2.
NOVA will develop the price based on actual material costs using this Pricing
Schedule and will provide GMP with a costed copy of the Xxxx of Materials and
direct labor times and costs used to calculate price if so requested by GMP.
NOVA will sell the Products to GMP at a price, which depends on forecasted
annual volume as set forth in Attachment 2. The formula utilizes NOVA standards
for labor and material plus material and labor overhead rates and margins, which
rates, margins and overheads are calculated to recover the costs and expenses of
NOVA associated with the work performed by NOVA for GMP, are calculated
annually, and are subject to audit by GMP or its representatives. The rates,
margins and overhead rates used to determine the price of the Products to be
charged to GMP shall be no less favorable to GMP than the rates, margins and
overhead rates charged any other customer of NOVA for similar unit volume. The
transfer price to GMP
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will fluctuate based on actual material and labor cost. The labor rates may be
adjusted on an annual basis.
Prior to Commencement of Production, GMP will provide NOVA with a twelve (12)
month rolling forecast estimating the number of Products, according to GMP's
market projections, that GMP anticipates it will purchase from NOVA (the
"Rolling Forecast"). GMP will thereafter update the Rolling Forecast every three
(3) months on a rolling basis. NOVA will use this forecast to procure materials
and plan capacity.
GMP will also provide NOVA with a forecast confirmation 90 days in advance of
the first day of the month in which a build is to take place, for delivery
availability by the first day of the following month. Subject to GMP's right to
reject non-conforming Products which are subject to Nova warranty obligations
under Section 9 herein, GMP agrees to accept all Products based on the 90 days
forecast. Orders within this 90 days window are not subject to change.
NOVA may place orders with its suppliers based on these annual forecasts in
order to achieve the best price for GMP, however, GMP shall not be liable for
inventory of parts, work-in-process, or any excess inventory reasonably based on
forecasts beyond the 90 day forecast number. NOVA will provide data to document
the basis of price changes if requested by GMP.
A cost reduction program will be established which will define the estimated
reduction in cost resulting from changes in production techniques, changes to
the Xxxx of Materials, or changes to the Product specifications. Savings will
result in a price reduction equivalent to the costs saved. In the event savings
are realized by joint NOVA/GMP investment in capital equipment, the savings will
be negotiated and shared based on the contribution by either party.
At least three (3) months prior to the end of (i) the one year anniversary of
the Commencement of Production and (ii) each subsequent anniversary, both
parties may negotiate regarding the rates, margins, overhead rates, and labor
rates for the following year or such rates may continue at the existing
schedule.
The parties agree to review each change to the specifications of the Product and
determine if such change directly affects material or labor costs. If such
change impacts these costs, the price of the Product shall be adjusted
accordingly.
Prior to the implementation of any Product change both parties will agree on who
is responsible for costs arising out of failures due to the Product change, but
NOVA agrees that it shall be responsible for costs and expenses associated with
its breach of Product warranties.
GMP shall have the right to audit or cause its representatives to audit the
books and records of NOVA from time to time to determine if the pricing, rates,
margins, and
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overheard rates and other terms and conditions for the Products is consistent
with the representations and warranties and agreements of the parties with
respect to the same. Such audits shall be at the expense of GMP unless it is
determined that there are material differences ((5%) or more), in which case
NOVA shall reimburse GMP for the reasonable costs and expenses incurred in
connection with that audit.
SECTION 6/COST OF REWORK OR SCRAP
NOVA will absorb all costs related to scrap or rework resulting from
manufacturing errors or defects. GMP will be charged all costs related to rework
and scrapping of inventory as a result of design changes initiated by GMP (other
than as a result of the breach of warranties by NOVA) or to scrapping Product
which is within design specifications but found to be unacceptable by GMP.
SECTION 7/MANUFACTURING/ENGINEERING
Following the Commencement of Production, NOVA will provide manufacturing
engineering services which are required: (i) to ensure that the Product conforms
with NOVA's and industry quality standards; and (ii) to support continuing cost
and reliability improvements. NOVA shall manufacture the Product in accordance
with the FDA Quality Systems Regulation ("QSR") and ISO 9000 guidelines. NOVA
shall also provide GMP with documentation necessary to establish and maintain
the Product's compliance with FDA QSR and other FDA regulations.
SECTION 8/PRODUCT CHANGES
NOVA shall maintain the DMR in compliance with QSR requirements and shall make
the DMR accessible to GMP on request. All changes to the DMR will be controlled
by NOVA's ECO procedures and GMP will be on the required approval list.
GMP and NOVA anticipate that during the Term, modifications to the Product
design will occur. NOVA will make no design changes without written
authorization by GMP.
GMP may from time to time request NOVA to incorporate an engineering change into
a Product. Within seven (7) business days of receipt of such request, NOVA will
inform GMP in writing of the earliest possible implementation date for the
proposed engineering change, of any increase or decrease in the price of the
Product as a result of such change, and of any effect on production scheduling
or QA test coverage. If GMP elects to proceed with the change, NOVA will prepare
an ECO for approval. NOVA shall be required to accept and implement all
reasonable engineering changes to the Product.
In support of its ongoing efforts to improve efficiency and reduce the costs of
manufacturing Products, NOVA may from time to time suggest that an engineering
change be made to a Product by delivering an "Engineering Change Proposal" to
GMP. Each Engineering Change Proposal shall be in writing and shall include a
description of the proposed change, a description of any improvements in the
Product or cost reductions which will result from the change, and the effect of
the change, if any, on production scheduling or quality assurance testing. Each
Engineering Change Proposal shall provide
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detail sufficient to permit GMP to evaluate the desirability of such change. GMP
agrees to consider each Engineering Change Proposal it receives from NOVA, but
reserves the right to accept or reject each such Proposal in its sole
discretion.
In the event either GMP or NOVA identifies an engineering change that must be
implemented for reasons of safety (a "Safety Change"), the parties agree to
cooperate so as to effect such Safety Change as soon as possible after
discovery. Once such a Safety Change is discovered, the parties agree that no
affected Product shall be manufactured or shipped until such Safety Change has
been implemented, notwithstanding any delay in scheduled ship dates. The parties
further agree to cooperate in the implementation of such Safety Change on
Product shipped prior to discovery of the hazard. In this regard, NOVA agrees to
manufacture a field change kit or to implement factory retrofitting, as
appropriate. GMP and NOVA shall agree on a case by case basis on appropriate
charges for the implementation of a Safety Change prior to implementation,
provided that NOVA agrees that it shall be responsible for costs and expenses
incurred as a result of its breach of a Product warranty provided by NOVA.
GMP and NOVA agree to review each change and determine if the change directly
impacts material or labor costs. If such a change is due to modification of the
design (other than as a result of faulty design) and impacts cost, the price of
the units will be adjusted.
SECTION 9/WARRANTY
NOVA represents and warrants, for a period of one (1) year from the date of
shipment to GMP, that all Products supplied in connection with this Agreement
(i) shall be new and unused; (ii) shall conform to the Product specifications
and documentation; (iii) shall be free from defects in design, material and
workmanship; and (iv) shall be manufactured and provided by NOVA in accordance
and conformity with good manufacturing practices and in compliance with all
applicable federal, state or municipal statutes, laws, rules and regulations,
including those relating to the environment, food or drugs and occupational
health and safety. This warranty shall not apply if a Product's non-conformity
to the relevant Product specifications and documentation is due to (i)
modifications or changes made by GMP or any third party not approved by NOVA;
(ii) the combination of such Product with other products; or (iii) the use of
such Product in a manner for which it was not designed nor intended. Without
limiting the foregoing, NOVA represents and warrants that it shall comply with
all present and future statutes, laws, ordinances and regulations relating to
the manufacture, assembly and supply of the Products being provided hereunder,
including, without limitation, those enforced by the FDA (including compliance
with FDA QSR). In the event that any Product does not conform as aforesaid,
GMP's sole and exclusive remedy for such defective Product shall be the repair
or replacement (at NOVA's option) of such nonconforming Product within a
reasonable period of time. All costs of repair or replacement of nonconforming
Product during the warranty period shall be borne by NOVA. Any repairs to
Products made by NOVA at GMP's cost to correct or repair out-of-warranty
Products shall be charged and billed to GMP at a labor rate of $125 per hour for
engineers and $70 per hour for technicians, plus
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material and NOVA's current and auditable material overhead costs during the
Initial Term and at NOVA's then-current labor rates during any Renewal Terms.
EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NOVA DISCLAIMS ALL WARRANTIES,
WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE PRODUCT
INCLUDING, WITHOUT LIMITATION, ANY WARRANT OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY LOSS OF THE OTHER PARTY OF
DATA, PROFITS OR USE OF THE PRODUCTS, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL,
PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN CONNECTION
WITH THE MANUFACTURE, USE OR PERFORMANCE OF THE PRODUCT, EVEN IF SUCH PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES.
All Products shall be subjected to quality control inspection and final release
by NOVA in accordance and conformance with NOVA's quality control standards and
system and FDA QSR. NOVA's quality control standards shall be sufficient to
ensure that all Products conform to GMP's Product specifications. At GMP's
request, NOVA shall provide a copy of its standards to GMP and shall in all
respects adhere to such standards. NOVA shall permit GMP to review periodically
NOVA's production and quality control procedures and records and to inspect
NOVA's facilities at reasonable times with a representative of NOVA present in
order to assure satisfaction of the requirements of this Agreement.
SECTION 10/NOTICE
All notices and demands required or permitted to be given or made pursuant to
this Agreement shall be in writing and shall be effective when personally given
or made or when placed in an envelope and deposited in the United States mail
postage prepaid, addressed as follows:
IF TO GMP: IF TO NOVA:
Xxxxxxx Xxxxx, MD Xxxxxxx X. XxXxxx, Ph.D.
Executive Vice President Vice President - Business Development
GMP|Companies, Inc. NOVA Biomedical Corporation
One East Broward Boulevard, Suite 1701 000 Xxxxxxxx Xxxxxx
Xx. Xxxxxxxxxx, Xx 00000 Xxxxxxx, XX 00000
or to such other address as to which either party may notify the other.
SECTION 11/GOVERNING LAW; ARBITRATION
This Agreement shall be governed by, and construed and enforced in accordance
with, and any arbitration hereunder shall apply, the laws of the Commonwealth of
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Massachusetts, without regard to its principles of conflict of laws. If any
dispute, difference or question shall arise at any time after the Effective Date
between the parties in respect of or in connection with this Agreement, then,
the dispute, difference or questions shall be finally settled by arbitration to
be conducted in Boston, Massachusetts, under the commercial arbitration in
English under the rules of the American Arbitration Association by an arbitrator
appointed in accordance with such rules. The arbitration award shall be based on
and accompanied by a written opinion. Judgment upon the reward rendered may be
entered in any court having jurisdiction or application may be made to such
court for a judicial acceptance of the award and an order of enforcement, as the
case may be. Notwithstanding anything contained in this Section to the contrary,
each party shall have the right to institute judicial proceedings against the
other party or anyone acting by, through or under such other party, in order to
enforce the instituting party's rights hereunder through reformation of
contract, specific performance, injunction or similar equitable relief. In the
event of such arbitration the parties agree to continue to perform under the
terms of this Agreement pending the outcome of the arbitration.
SECTION 12/LIABILITY INSURANCE
NOVA will obtain and keep in force during the Term, comprehensive liability
insurance covering each occurrence of bodily injury (including death) and
property damage in the amount not less that $______________________combined in a
single limit including:
1. Product and completed operations liability.
2. Blanket contractual liability.
3. Blanket broad form property damage.
SECTION 13/TERMINATION
Either party may terminate this Agreement by written notice to the other party
following the occurrence of any of the following events:
(a) if the other party ceases doing business as a going concern, becomes
insolvent, or makes an assignment for the benefit of creditors; or
(b) if the other party files a petition for reorganization or bankruptcy
under the United States Bankruptcy Code or any other similar law of any
other jurisdiction, or if any petition for reorganization or bankruptcy
under such Code or under any other similar law of any other
jurisdiction is filed against the other party and is not dismissed or
vacated within 30 days thereafter; or
(c) if the other party is in breach of any material terms or provisions of
this Agreement and has failed to cure such breach within 30 days after
receipt of written notice thereof from the party alleging the breach. A
material breach includes, without limitation, the failure of NOVA to
timely deliver Products meeting the Specifications, time being of the
essence.
GMP may terminate this Agreement if it decides to cease the marketing and sale
of the Product by giving NOVA at least 180 days notice. In the alternative, GMP
may elect to
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move the exclusive manufacturing rights for the Product to a third party or
in-house by giving NOVA written notice of such election at least 120 days prior
to the effective date and, if applicable, paying NOVA a termination fee equal to
(i) the projected profit on the projected number of units of the Product which
the parties agree NOVA would have produced over the remaining portion of the
Initial Term (assuming no breach of this Agreement) or (ii) if the parties
cannot agree on the projected number of units, the projected profit on the
actual number of units of the Product produced by the third party or in-house
over the remaining portion of the Initial Term and payable monthly in arrears.
NOVA agrees to cooperate in the orderly transition of the manufacturing rights
following the termination or expiration of this Agreement, including, without
limitation, the transfer of intellectual property as provided in Section 4.
Upon any termination or expiration of this Agreement, NOVA will sell and
transfer to GMP, free and clear of all liens and encumbrances, all of NOVA's
inventory and work-in-process of Products and all of NOVA's capital equipment
relating to the manufacture of the Product. The purchase price for such
inventory, work-in-process and capital equipment shall be NOVA's cost including
manufacturing overhead or, in the case of the capital equipment, the net book
value.
In the case of any termination or expiration of this Agreement by either party,
it is expressly agreed that no termination indemnity or payment of any kind
shall be due from one party to the other hereunder for loss of goodwill or
profit expectations or otherwise.
SECTION 14/TERMS OF PAYMENT
GMP shall pay NOVA for the full amount of each invoice within 30 days of the
invoice date. Payment shall not constitute acceptance of non-conforming
Products. Payment shall be made in United States Dollars.
SECTION 15/INDEMNIFICATIONS
a) GMP hereby agrees to indemnify, defend and hold harmless NOVA, its
affiliates, directors, officers, employees and agents, from and against all
claims, liabilities, losses or expenses (including reasonable attorney's fees)
("Losses") arising out of or in connection with GMP's use, commercialization,
marketing, distribution or sale of any Product, including, but not limited to,
any actual or alleged injury, damage, death or other consequence occurring to
any person as a result, directly or indirectly, of the possession or use of any
Product, whether claimed by reason of breach of warranty, negligence, product
defect or otherwise, and regardless of the form in which any such claim is made.
Notwithstanding the foregoing, the foregoing indemnity shall not apply to the
extent that any such Losses are due to (1) the failure of a Product manufactured
by NOVA to meet the warranty provided in Section 9 above (without regard to the
one year limitation) or (2) the gross negligence or willful misconduct of NOVA
or its affiliates, directors, officers, employees and agents.
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b) NOVA hereby agrees to indemnify, defend and hold harmless GMP, its
affiliates, directors, officers employees and agents, from and against all
Losses arising out of or in connection with the failure of a Product
manufactured by NOVA to meet the warranty provided in Section 9 (without regard
to the one-year limitation), including, but not limited to, any actual or
alleged injury, damage, death or other consequence occurring to any person as a
result, directly or indirectly, of such failure, regardless of the form in which
any such claim is made. Notwithstanding the foregoing, the foregoing indemnity
shall not apply to the extent that any such Losses are due to the gross
negligence or willful misconduct of GMP or its affiliates, directors, officers,
employees and agents.
c) GMP hereby agrees to indemnify, defend and hold harmless NOVA, its
affiliates, directors, officers, employees and agents, from and against all
Losses arising out of, or in connection with, any claim by a third party that
the manufacture, use, or sale of a Product infringes any intellectual property
right claimed by such third party, except to the extent NOVA indemnifies GMP
under Subsection (d) of this Section 15. Indemnification and defense shall
proceed as provided under Section 15(f).
d) NOVA hereby agrees to indemnify, defend and hold harmless GMP, its
affiliates, directors, officers, employees and agents, from and against all
Losses arising out of or in connection with, any claim by a third party that the
manufacture of a Product infringes any intellectual property right claimed by
such third party and relating to use of NOVA technology in the manufacturing
processes in order to manufacture such Product. Indemnification and defense
shall proceed as provided under Section 15(f).
e) In the event that either party becomes aware of the possible infringement or
other misuse by a third party of intellectual property rights of GMP or NOVA
incorporated into the Products, such party will promptly notify the other party.
If such infringement or misuse is related to the Products, the owner of the
right infringed or misused shall promptly act to terminate the infringement or
misuse. For purposes of clarification, GMP shall be the owner with respect to
GMP technology and NOVA shall be the owner with respect to NOVA technology.
f) If either GMP or NOVA becomes aware of an infringement allegation which might
give rise to a right or obligation of indemnification and defense under Section
15 (c) or Section 15 (d), or becomes aware of possible infringement or misuse of
intellectual property rights which might give rise to a right or obligation
under Section 15 (e), such party shall promptly notify the other. The party in
the role of indemnitor shall control, bear the full expense of, and retain all
proceeds of, the defense against or settlement of such allegation, unless the
indemnified party subsequently agrees otherwise. The indemnitee shall cooperate
in such action if reasonably requested by the indemnitor. In no event shall the
indemnitor settle or otherwise terminate any allegation, or allow any
infringement or misuse to be terminated, in a manner which might abrogate any
obligations, rights or licenses between GMP and NOVA granted or which might be
granted under this Agreement. Any settlement of any such claims that imposes any
liability or limitation on the indemnified party shall not be entered into
without the prior
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written consent of the indemnified party. The indemnitee may, in its own
discretion, be represented in the defense or settlement of any such allegation
by counsel of its own choosing at its sole expense.
g) In the event a claim is based partially on an indemnified claim described in
Sections 15(a), (b), (c) or (d) above and partially on a non-indemnified claim,
or is based partially on a claim indemnified by GMP pursuant to Section 15(a) or
15(c) above and partially on a claim indemnified by NOVA pursuant to Section
15(b) or (d) above, any payments and reasonable attorney fees incurred in
connection with such claims are to be apportioned between the parties in
accordance with the degree of cause attributable to each party.
SECTION 16/PRODUCT RECALL
In the event that GMP or NOVA recalls or takes any corrective action with
respect to any of the Products, sold or distributed by GMP because the Products
are believed to violate any provision of applicable law, NOVA shall bear all
costs and expenses of any recall or corrective action related to matters covered
by NOVA's warranty including, without limitation, expenses or obligations to
third parties, the cost of notifying customers and costs associated with the
shipment of recalled Product from customers to GMP or NOVA. Similarly, GMP shall
bear all costs and expenses of any recall related to the incorporation of GMP
technology into the Products.
Both parties shall maintain complete and accurate records, for such periods as
may be required by applicable law, of all the Products manufactured or sold by
it. The parties will cooperate fully with each other in effecting any recall of,
or corrective action with respect to, the Products, including communications
with any purchasers or users.
SECTION 17/DISCLOSURE OF INFORMATION
Since each party to this Agreement has executed a non-disclosure agreement
(dated March 29, 2000) and will continue to have access to confidential
information of the other relating, for example, to manufacture of products,
marketing strategies, sales information, product plans, and the like, each party
agrees to hold in confidence, all information concerning and related to the
Products and their manufacture disclosed to the other through the Term and for a
period of five (5) years after termination of this Agreement, except as provided
below. Each party further agrees, for the same duration, to take all reasonable
steps to ensure that such information does not pass negligently, or otherwise,
into the hands of those unauthorized by the disclosure to receive it and that
such information is not used for any purposes other than those set out in this
Agreement, even if said Agreement is terminated by either party. Each party will
only use confidential information of the other party for the purpose of
fulfilling its respective obligations under this Agreement or as otherwise
permitted under this Agreement.
This obligation of confidentiality and nonuse shall not apply to information
which:
a) was known to the receiving party at the time of such disclosure;
b) was in the public domain at the time of disclosure or thereafter enters
into the public
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domain through no fault of the receiving party;
c) becomes known to the receiving party from a source not under obligation
of confidentiality to the disclosing party or is independently
developed by a person(s) employed by or for the receiving party and
having no knowledge of the confidential information; or
d) is disclosed by the receiving party as required by law, court order or
government regulation, after giving the disclosing party written notice
of such disclosure and after providing the disclosing party with
reasonable assistance in its efforts to prevent or limit such
disclosure.
For purposes of this Section 17, information developed by NOVA arising out of or
in connection with this Agreement shall be deemed to be confidential information
belonging to GMP or Nova as provided by this Agreement or the Development
Agreement, and subject to the use and disclosure restrictions set forth in the
first paragraph of this Section.
Each party shall be liable for the disclosure or use of non-confidential
information only to the extent provided by applicable patent or copyright laws.
All obligations of confidentiality and nondisclosure set forth in this Agreement
shall survive the termination or expiration of this Agreement.
SECTION 18/COMPLIANCE WITH LAW
NOVA represents that it is, and will remain, in compliance with all applicable
federal, state and local laws, regulations and orders. NOVA agrees to execute on
request by GMP and to remain in compliance with the terms of GMP's contractor
certification which requires compliance with certain laws, regulations and
executive orders.
SECTION 19/MISCELLANEOUS:
STATUS OF PARTIES: The relationship of the parties under this Agreement shall be
and at all times remain one of independent contractors. Neither party is an
employee, agent or legal representative of the other party or shall have any
authority to assume or create obligations on the other party's behalf.
BINDING EFFECT; ASSIGNMENT: This Agreement shall be binding upon and inure to
the benefit of the parties and their successors and permitted assigns. NOVA
reserves the right to assign this Agreement to one of its affiliates or a
purchaser of all or substantially all of its assets. GMP reserves the right to
assign this Agreement in connection with its assignment of interests in the
technology licensed to GMP by Xx. Xxxx Xxxxxxx.
ENTIRE AGREEMENT: This Agreement and the referenced confidential disclosure
agreement (Section 17) constitute the entire agreement between NOVA and GMP
relating to the subject matter hereof and shall not be amended, altered, or
changed except by a written agreement signed by the parties hereto.
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WAIVERS: No delay or omission on the part of either party to this Agreement in
requiring performance by the other party hereunder, or in exercising any right
hereunder, shall operate as a waiver of any provision hereof or of any right or
rights hereunder, and the waiver or omission or delay in requiring performance
or exercising any right hereunder on one occasion shall not be construed as a
bar to or waiver of such performance or right, or of any right or remedy under
this Agreement, on any future occasion.
FORCE MAJEURE: NOVA shall not be liable, in any respect, for failure to ship,
for any supplier's failure to ship or for delays in transportation nor GMP for
failure to receive Products where such failure or delay shall have been due,
wholly or in part, to the elements, acts of God, acts of civil or military
authority, fires, floods, epidemics, quarantine restrictions, war, riots,
accidents to machinery, or any other like or different events beyond the control
of the party whose performance is interfered with. In any such case, prompt
written notice shall be given by the affected party to the other of the
existence of such cause and of readiness to resume performance. It is understood
that neither party shall be required to settle a labor dispute against its will.
Notwithstanding the foregoing, if any such delay continues for a period in
excess of three (3) months, the other party shall have the immediate right to
terminate this Agreement, without liability to either party.
INVENTIONS: NOVA shall promptly disclose to GMP all data, materials,
information, enhancement, developments, and improvements ("Inventions") relating
to the Products generated or produced by NOVA or any of its employees or agents
in connection with or as a result of manufacturing the Products (except as is
provided in the final sentence of this paragraph). Title to all Inventions shall
be in GMP (except as is provided in the final sentence of this paragraph). NOVA
hereby assigns and agrees to assign to GMP the entire right, title and interest
in each such Invention, agrees to obtain an assignment thereof from each
employee or agent involved, and agrees to furnish and execute all such documents
and provide such further assistance (at GMP's expense) as GMP may reasonably
require in order to perfect and maintain GMP's rights in Invention.
Notwithstanding anything contained in this Agreement to the contrary, title to
all data, materials, information, enhancements, developments, and improvements
relating to the manufacturing process for the Products not developed for GMP
under this Agreement or the Development Agreement shall be in NOVA. GMP shall
have the worldwide, non-exclusive, royalty free, perpetual right to use all such
NOVA intellectual property in connection with the manufacture and testing of the
Products and improvements and enhancements thereon. Upon the expiration or
termination of this Agreement and the payment of any sums due NOVA, NOVA shall
cooperate with, and assist in, the orderly and efficient transfer of the
manufacturing process for the Product. GMP agrees to reimburse NOVA for time and
material costs incurred in connection with such activities at the then current
rates.
INDEPENDENT CONTRACTOR:
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(a) GMP, its employees and agents, are not and shall not act or
purport to act as employees, agents, or representatives of NOVA, but
they are, and shall act as, independent contractors, maintaining full
responsibility and complete control over all of their employees and
operations. GMP shall have no authority to represent or bind NOVA in
any way.
(b) NOVA, its employees and agents, are not and shall not act or
purport to act as employees, agents, or representatives of GMP, but
they are, and shall act as, independent contractors, maintaining full
responsibility and complete control over all of their employees and
operations. NOVA shall have no authority to represent or bind GMP in
any way.
Nothing contained herein shall be deemed to create a partnership, joint venture,
or relationship of principal and agent between the parties hereto or between
NOVA and GMP.
SPECIFIC PERFORMANCE: The parties to this Agreement recognize that any breach of
their respective obligations under this Agreement could result in irreparable
injury to the other party. Each party shall, therefore, be entitled, without
restricting such party from other legal and equitable remedies, to injunctive
and other equitable relief to prevent or restrain the breach of this Agreement,
including, without limitation, the return and delivery of property immediately
upon any termination of this Agreement as provided herein.
HIRING OF OTHER PARTY'S EMPLOYEES AND OFFICERS:
(a) Each party agrees not to hire any of the other party's
employees or officers, without the prior and written agreement of the
other party, even if the request for hiring is initiated by the staff
member her/himself.
(b) This mutual non-hiring covenant is valid until the first
anniversary of the termination or expiration of this Agreement, as the
case may be.
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IN WITNESS WHEREOF, authorized representatives of the parties have executed this
Agreement.
GMP|THROMBOFLEX, INC.
By:
---------------------------------------
Xxxx Xxxxxxx, M.D.
President and Chief Executive Officer
On this ____ day of _____, 200_
NOVA BIOMEDICAL CORPORATION
By:
---------------------------------------
Xxxx X. Xxxxxxx
Chief Operating Officer
On this _____ day of _________, 200_
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ATTACHMENT 1
PRODUCT DESCRIPTION
TO BE DETERMINED
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ATTACHMENT 2
GMP/NOVA
NOVA PRICING METHODOLOGY
VOLUME AND MARGIN TO BE DETERMINED UPON COMPLETION OF THE
PRODUCT DEVELOPMENT
PRICING METHOD
NOVA will use the following equation to price Thromboflex for GMP
STANDARD COST CALCULATION Price depends on volume:
-------------------------- ------------------------
EXAMPLE ONLY Units per year Margin
-------------- ------
IF Actual Material Cost
Plus
Material overhead rate (Currently 11.5%) [Not to
Plus exceed
Labor cost (hours x $12.75/hr) 40% and
Plus not to be
Labor overhead rate (Currently 325%) less than
Equals 20%]
Total Standard Cost =
NOTE: Labor and material overhead rates are updated annually in April and are
auditable
EXAMPLE FORMULA
Example
--------
Cost ($)
--------
Material Cost (key item)
Current material overhead ( __%)
Labor cost ( ___ hours @ $__/hr)
Current labor overhead ( ___%)
Standard Cost
NOTE: Actual cost will fluctuate based on the actual labor and material
costs
Units per year Margin Transfer Price if
Materials Cost
is $_____
Note: Example assumes constant materials cost. In higher quantities, the cost of
materials should come down.
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