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Exhibit 10.1
MANUFACTURING AGREEMENT
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This Manufacturing Agreement is entered into as of the 1st day of March 2001 and
amends and restates that certain Manufacturing Agreement entered into as of the
10th day of October 1994 by and between European Medical Contract Manufacturing
(hereafter referred to as "EMCM"), Xxxxxxxxxxxxx 00, 0000 XX Xxxxxxxx, Xxx
Xxxxxxxxxxx and Gliatech Medical Inc. (hereafter referred to as "Gliatech"),
00000 Xxxxxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxx 00000, X.X.X.
In consideration of the premises and the mutual promises and covenants set forth
below, EMCM and Gliatech mutually agree as follows.
ARTICLE I
DEFINITIONS
1.1 "Agreement" shall mean this Manufacturing Agreement as amended and
restated with its accompanying Attachments and Schedules.
1.2 "Confidential Information" shall mean the technical information,
know-how, technology, prototypes, information, manuals, ideas, inventions,
improvements, data, files, supplier and customer identities and lists,
accounting records, business and marketing plans, and information and
documentation to which a party has rights relating to this Agreement and all
copies and tangible embodiments thereof (in whatever form or medium) that are
not generally known by the public or which would constitute a trade secret under
the Uniform Trade Secrets Act (including any of the foregoing as may be embodied
in the Technology); provided, however, that any of the foregoing shall not be
considered Confidential Information if it: (i) has entered into the public
domain through no wrongful act or breach of any obligation of confidentiality on
the receiving party's or any third party's part; (ii) was in the lawful
knowledge and possession of, or was independently developed by, the receiving
party prior to the time it was disclosed to, or learned by, the receiving part
as evidenced by written records kept in the ordinary course of business by the
receiving party or by written or other documentary proof of actual use by the
receiving party; (iii) was rightfully received from a third party not in
violation of any contractual, legal or fiduciary obligation by such third party;
or (iv) was approved for release by written authorization by the part having
rights in such information.
1.3 "Device Master Record" shall mean a compilation of records
containing the procedures and specifications for a finished device.
1.4 "Non-Conformance" shall mean any failure to meet Specifications.
1.5 "Product" shall consist of gel, liquid or other approved material
which (i) is manufactured and packaged in a collapsible aluminum tube and/or
syringe or other configuration approved by Gliatech, labeled and packaged with
other components in a unit kit; and (ii) is to be commercially distributed and
sold under the various "ADCON(TM)" names, including, without limitation,
ADCON-L(TM) and ADCON-T/N(TM).
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1.6 "Room Temperature" shall be defined as that combination of
temperature and relative humidity approved in United States Pharmacopeia (USP)
guidelines for room temperature controls.
1.7 "Specifications" shall mean Gliatech and EMCM procedures, approved
by both parties, controls, specifications, acceptance criteria and related
information (including, but not limited to, the Device Master Record) regarding
or affecting the manufacture of the Products, as defined pursuant to Article
3.1(a) hereof.
1.8 "Technology" shall mean the formulae, know-how and other
confidential, technical and proprietary information (including, without
limitation, patents and patent applications) owned by, or licensed to, Gliatech
relating to the manufacture of the Products.
ARTICLE II
LICENSE AND TERM OF THE AGREEMENT
2.1 GRANT OF LICENSE. Gliatech hereby grants to EMCM, subject to the
terms and conditions hereinafter set forth, a non-exclusive license to use the
Technology solely in connection with the manufacture of the Products for sale to
Gliatech. EMCM is not granted any right to sublicense any of the Technology to
others or to use any of the Technology for itself or for any other purpose.
Without limiting the generality of the foregoing, EMCM shall not use any of the
Technology to manufacture the Products outside of or after the termination of
this Agreement or to develop or manufacture any other products.
2.2 TERM OF THE AGREEMENT. Unless sooner terminated as hereinafter
provided, the term of this Agreement shall remain in full force and effect for a
period of three years from the effective date of this Agreement. Thereafter,
this Agreement may be renewed automatically for two terms each for two (2)
years, unless (i) Gliatech provides EMCM with written notice of its intent to
terminate no less than two hundred and seventy (270) days prior to the end of
the original term or any renewal term, or (ii) EMCM provides Gliatech with
written notice of its intent to terminate no less than two hundred-seventy (270)
days prior to the end of the original term or any renewal term.
2.3 TERMINATION FOR BREACH. Non-compliance with, or any breach of, the
terms and conditions of this Agreement shall be considered grounds for
termination (hereafter referred to as "violative termination"). Violative
termination must be communicated by one party in writing to the party believed
to be in violation of the terms of this Agreement. That party shall then have
sixty (60) days from the date of receipt of the notice of violative termination
to correct the violation in question. Failure to correct the violation to the
satisfaction of the notifying party shall effectively terminate this Agreement.
2.4 EFFECT OF TERMINATION. In the event of termination for any reason,
unless otherwise agreed to in writing by the parties, the parties shall have the
rights and obligations set forth in this Section 2.4.
(a) FIRM ORDERS. Gliatech shall have the right, but not the
obligation, to continue to issue to EMCM firm orders for Products for three
quarters from the date of
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termination. EMCM shall be responsible for promptly filling these orders. In
case of violative termination Gliatech shall have the right and the obligation
to continue to issue to EMCM firm orders for products for three quarters from
date of termination, and EMCM shall have the right and the obligation to
manufacture firm orders for products for three quarters from date of
termination, unless both parties mutually agree to renounce from such rights and
obligations.
(b) RETURN OF MATERIALS. EMCM shall be responsible for the return,
in good order, of all existing materials and supplies provided by Gliatech, as
well as all Gliatech purchased equipment and all tangible embodiments of
Gliatech's Confidential Information and Technology, and all copies thereof
received or generated by EMCM. Gliatech will reimburse EMCM for reasonable cost
associated with the return of materials, or, in the discretion of Gliatech,
allow EMCM to purchase certain materials.
(c) TECHNOLOGY. EMCM shall have no further right and license to
use the Technology. Notwithstanding the foregoing, EMCM shall be permitted to
use the Technology solely to fulfill its obligations pursuant to Article 2.4(a)
hereof.
ARTICLE III
MANUFACTURE AND ACCEPTANCE OF PRODUCT
3.1 MANUFACTURE OF PRODUCT. EMCM agrees to produce the Products in
accordance with all Specifications and within EMCM facilities.
(a) PROCEDURES AND SPECIFICATIONS. The Specifications currently in
effect as of the date of the signing of this Agreement are defined in the Device
Master Record. These Specifications may change from time to time. In the event
that Gliatech intends to change the Specifications, Gliatech will notify EMCM in
writing of any such change in the Specifications. Both Gliatech and EMCM must
approve any changes to the Specifications.
(b) ENVIRONMENTAL CONTROLS. EMCM agrees that all Products shall be
produced in its controlled, clean room suites in accordance with the
Specifications. In addition, EMCM agrees that during the time of manufacture of
the Products, no product, supplies, and, after notification to Gliatech,
production equipment; provided that such equipment shall not adversely affect
the production of the Products other than that required for the Products shall
be present in the clean room suite.
(c) WAREHOUSING. EMCM agrees to store and maintain raw materials
and unpackaged Products in excess of the current production order, but not to
exceed the requirements of one calendar quarter's forecast (as per Article 3.2
hereof) in their warehouse. EMCM will store raw materials and unpackaged
Products in accordance with the requirements of the Specifications and have
adequate security (as approved in writing by Gliatech) so as to restrict access
to raw materials and Products only to appropriate personnel.
(d) INVENTORY. Gliatech shall supply EMCM with requirements for
labels, packaging materials, primary unit containers, accessories, salts and
buffers, and critical raw materials. All of these items will be inspected and
approved by Gliatech before shipment to EMCM. EMCM will inspect these items upon
arrival at its facility for damage or to
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specifications we mutually agree upon. EMCM will supply all Water for Injection
(as defined in EP and USP), which is certified to be in compliance with both
current European Pharmacopeia ("EP") and United States Pharmacopeia ("USP")
regulations. EMCM shall provide to Gliatech, upon Gliatech's request, all
documentation regarding such certification.
(e) EQUIPMENT.
(1) Gliatech shall purchase, or reimburse EMCM for purchasing
all equipment it considers to be exclusive to the production of the Products,
including certain analytical and sterilizing equipment. EMCM shall be
responsible for the ongoing validation, calibration and maintenance of all
equipment (as specified in the Device Master Record) used in the manufacturing
of the Products. All purchases of equipment will be authorized by Gliatech in
advance of purchase. Gliatech will reimburse EMCM for such authorized equipment
upon the presentation and inspection of EMCM's invoice for such purchases. Title
to all such equipment shall be in the name of Gliatech.
(2) All equipment used in the manufacture of Products and that
directly contacts the Products will be used exclusively for the manufacture of
Products.
(f) EMCM will produce Products in accordance with specifications
and appropriate regulations. There will be sufficient personnel with the
necessary education, background, training and experience to assure that
production and quality control/assurance activities are performed correctly.
Training shall be in compliance with established Quality System Regulation
("QSR") guidelines and other such standards as Gliatech may require. EMCM will
be required to provide the equivalent of a full-time Quality Control Manager
responsible for timely day-to-day operations (with a proportionate amount of
time focused on Gliatech Products), as well as the maintenance of the EMCM
Quality System, including the inspection, testing, documentation, release, and
compliance activities. Additionally, EMCM will provide a full-time Material
Coordinator, as defined in Attachment III, who will coordinate the scheduling
and execution of materials and activities for EMCM and Gliatech, exclusively.
Gliatech will reimburse EMCM on a monthly basis for the
salaries, benefits, and miscellaneous expenses associated with these positions.
Candidates for each position will be jointly agreed upon for hire by both
Gliatech and EMCM. The salaries of these employees shall be set by Gliatech.
(g) REPORTING. EMCM shall maintain a system of document control
that maintains compliance with QSR and other applicable regulations and release
Product in accordance with procedures outlined in Attachment II. EMCM shall
maintain a system of change notification for all controls, policies and
specifications which may impact the manufacture of the Products. This
notification shall be inclusive of all contracted services, specifically those
which relate to calibration, validation and environmental controls. The
notification of changes by EMCM must be approved by Gliatech's quality assurance
and manufacturing personnel before implementation.
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(1) EMCM shall provide investigation reports and corrective
action plans for all aspects of the production and analytical processes falling
outside of expected or historically derived outcomes as specified and defined in
the Device Master Record.
(2) Gliatech, in its sole discretion, shall determine the
disposition of non-conforming material, processes and Product. All finished
Product satisfying the acceptance criteria of the Specifications will be
accepted by Gliatech.
(3) EMCM shall forward to Gliatech copies of all original
records pertaining to production, and shall keep the originals for their own
records, but make them available to Gliatech for a period of 6 years.
Thereafter, these documents will be released to Gliatech.
(h) Gliatech-provided material. Title to all materials provided by
Gliatech pursuant to this Agreement (including, but not limited to, equipment
purchased by, or on behalf of, Gliatech, all raw materials, and all labeling and
packaging materials) shall remain in the name of Gliatech at all times. All such
materials and equipment shall be labeled clearly as "Property of Gliatech" and,
where possible, shall be stored separately.
3.2 QUALITY. EMCM will maintain a Quality System as defined in, and in
accordance with, the appropriate ISO 9000 and EN46000 series guidelines and the
U.S. FDA's current Quality System Regulation requirements as set forth in 21 CFR
Part 820 as currently in effect as of the date hereof, as verified by Gliatech
personnel, and subject to periodic Gliatech audit. In the event that these
regulations are modified, amended or otherwise updated, EMCM will modify, amend
or otherwise update and maintain a Quality System in accordance therewith;
provided, however, that Gliatech consents to any such modification, amendment or
other update to such Quality System.
3.3 QUANTITY; FORECASTS. With respect to each Product, Gliatech will
issue to EMCM firm orders for a period of one full calendar quarter, and provide
forecasts covering a period of one additional quarter. One month prior to the
beginning of the forecast quarter, Gliatech will issue to EMCM firm orders for
that forecast period, and a forecast for the next calendar quarter. Attachment I
is the firm order for the calendar quarter ended March 31, 2001 and contains the
forecast for the quarters and years of 2001 and 2002.
ARTICLE IV
NOTIFICATION AND INSPECTION
4.1 REGULATORY. EMCM shall notify Gliatech within 10 days of all
inspections by N.V. KEMA in the Netherlands, a member of the European Network
for Quality System Assessment and Certification or U.S. FDA or any other
applicable regulatory authorities, either performed or scheduled at EMCM. EMCM
shall allow Gliatech to participate in the investigation or inspection with
respect to Gliatech Products. Except for proprietary customer-specific
information, EMCM shall provide Gliatech the full results of the inspection, and
any responses thereto that relate to the Products shall only be submitted by
EMCM after consultation with, and agreements by, Gliatech.
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4.2 RECORD KEEPING. EMCM shall keep correct and complete records and
books covering the manufacture of the Products and other documents relating to
this Agreement. In addition, EMCM will maintain any other documentation relating
to safety regulation obligations, including, without limitation, adverse event
reports. EMCM agrees to permit Gliatech, at Gliatech's expense and reasonable
request and during ordinary business hours, to have access to, and make copies
of, such records, books and all other documents and materials in the possession
and under the control of EMCM relating to or pertaining to the subject matter of
this Agreement EMCM's internal audit reports will not be accessible to Gliatech.
4.3 DELIVERY, TITLE AND RISK OF LOSS. Title to all Products shall be in
the name of Gliatech at all times. Risk of loss shall be upon EMCM until
Products have satisfied the acceptance criteria of the Specifications except in
the event that agreed upon testing procedures would not have detected a failure
to satisfy the acceptance criteria of the Specifications. Upon acceptance of the
Product, risk of loss shall pass to Gliatech, who shall designate a carrier to
ship such accepted Product to a location specified by Gliatech. All expenses
incurred in connection with such shipping shall be borne by Gliatech. Gliatech
will have the right to utilize EMCM's name and/or address in conjunction with
any labeling or reporting requirements.
4.4 REGULATORY INSPECTION AND REVISION OF SPECIFICATIONS. Following
inspections by applicable regulatory authorities, including, without limitation,
the U.S. FDA, EMCM shall do such actions or cause such actions to be done that
are necessary, advisable or appropriate so that EMCM remains in good standing
with any such regulatory authorities. Prior to undertaking any action pursuant
to this Section 4.4, EMCM shall notify Gliatech of the inspection and disclose
to Gliatech the regulatory authorities' findings and related results of such
inspection (the "Findings"). EMCM shall also provide full disclosure to Gliatech
with respect to any action undertaken or proposed to be undertaken pursuant to
this Section 4.4 prior to acting. In addition, if the Findings of the regulatory
authority suggest, recommend or otherwise indicate a change in the manufacturing
processes and practices of EMCM, including, without limitation, a modification
of the Specifications no such modification can be made without the prior written
consent of Gliatech.
4.5 CONFIDENTIALITY. Each party acknowledges that in the course of its
performance under this Agreement it will have access to the other party's
Confidential Information. All Confidential Information of a party disclosed
under this Agreement shall remain the exclusive property of that party. Each
party agrees (i) to take all reasonable measures necessary to protect the
confidential nature of all Confidential Information (both its and the other
party's); (ii) except as provided in this Agreement or as required by law or
court order, not to disclose to third parties or copy any Confidential
Information of the other party or allow any third party access to the
Confidential Information of the other party without first obtaining that party's
written consent; and, (iii) not to use any of the Confidential Information
except for the purposes set forth herein.
4.6 INDEMNIFICATION. Each party agrees to and shall indemnify and hold
the other party harmless from any and all claims, demands, suits, actions,
proceedings, costs, damages, expenses (including, without limitation,
consequential damages), or other disputes arising out of the party's breach of
or non-compliance with its obligations hereunder; provided, however, that no
party shall be indemnified hereunder if any breach of or non-compliance of its
obligations hereunder result from or are caused by that party's gross negligence
or willful misconduct. This
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indemnity provision shall be in addition to any liability which the party may
otherwise have. Promptly after receipt by an indemnified party under this
Section 4.6 of notice of the commencement of any action, such indemnified party
will, if a claim in respect thereof is to be made against the indemnifying party
under this Section 4.6, notify the indemnifying party in writing or the
commencement thereof; but the failure so to notify the indemnifying party (i)
will not relieve it from liability hereunder unless and to the extent it did not
otherwise learn of such action and such failure results in the forfeiture by the
indemnifying party of substantial rights and defenses and (ii) will not, in any
event, relieve the indemnifying party from any obligations to any indemnified
party other than the indemnification obligation provided above. The indemnifying
party shall be entitled to appoint counsel of the indemnifying party's choice at
the indemnifying party's expense to represent the indemnified party in any
action for which indemnification is sought (in which case the indemnifying party
shall not thereafter be responsible for the fees and expenses of any separate
counsel retained by the indemnified party or parties except as set forth below);
PROVIDED, HOWEVER, that such counsel shall be satisfactory to the indemnified
party. Notwithstanding the indemnifying party's election to appoint counsel to
represent the indemnified party in an action, the indemnified party shall have
the right to employ separate counsel (including local counsel), and the
indemnifying party shall bear the reasonable fees, costs and expenses of such
separate counsel if (i) the use of counsel chosen by the indemnifying party to
represent the indemnified party would present such counsel with a conflict of
interest, (ii) the actual or potential defendants in, or targets of, any such
action include both the indemnified party and the indemnifying party and the
indemnified party shall have reasonably concluded that there may be legal
defenses available to it, which are different from or additional to those
available to the indemnifying party, (iii) the indemnifying party shall not have
employed counsel satisfactory to the indemnified party to represent the
indemnified party within a reasonable time after notice of the institution of
such action or (iv) the indemnifying party shall authorize the indemnified party
to employ separate counsel at the expense of the indemnifying party. An
indemnifying party will not, without the prior written consent of the
indemnified parties, settle or compromise or consent to the entry of any
judgment with respect to any pending or threatened claim, action, suit or
proceeding in respect of which indemnification or contribution may be sought
hereunder (whether or not the indemnified parties are actual or potential
parties to such claim or action) unless such settlement, compromise or consent
includes an unconditional release of each indemnified party from all liability
arising out of such claim, action, suit or proceeding.
4.7 AUTHORIZED REPRESENTATIVE. EMCM shall act as Gliatech's Authorized
Representative within the territories that comply with the Medical Device
Directives ("MDD"). EMCM shall be responsible to act as a liaison between
Gliatech and the applicable European Union's regulatory authority.
As Gliatech's "Authorized Representative" EMCM is responsible
for reporting any information brought to the attention of EMCM, which could be
considered relevant to device vigilance reporting (e.g., complaints) activities,
as such activities are defined in the European Commission publication,
Guidelines on Medical Devices Vigilance System, MEDDEV 2. 12/1 March 1998 - rev.
3. EMCM must report such information to Gliatech within 24 hours of EMCM's
becoming aware of such information. EMCM is not responsible for device vigilance
reporting and Gliatech assumes all device vigilance reporting responsibilities.
EMCM agrees to
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notify Gliatech of all potentially reportable events and to provide all
information relating to device vigilance reporting.
In addition, EMCM will inform Gliatech of any information to
which they become aware, that could be considered relevant for purposes of post
market surveillance activities (e.g., verbal and written comments from end
users, etc.). EMCM is not responsible for post market surveillance activities
and Gliatech assumes all post market surveillance responsibilities; provided
that EMCM properly notifies Gliatech of all relevant information relating to
post market surveillance.
EMCM shall maintain a file containing the full index of the
ADCON-L technical dossier, as required by the MDD, which will contain a
reference to the location of the details of the dossier.
4.8 COMPLAINTS. EMCM and Gliatech shall be responsible for notifying
each other of any complaints received pertaining to manufacture of the Products.
EMCM shall be responsible to maintain a file of complaints pertaining to the
Products, and to ensure a proper training of manufacturing personnel in response
to any Product complaint. Gliatech shall be responsible to provide EMCM with a
summary of any manufacturing complaints which it receives, as well as a copy of
Gliatech's response.
4.9 NOTIFICATION. Any official notification as required by this
Agreement shall be addressed to:
Dr. X.X. de Vries, Director
European Medical Contract Manufacturing
Xxxxxxxxxxxxx 00
0000 XX Xxxxxxxx
Xxx Xxxxxxxxxxx
Phone: (00) 000-000000
Fax: (00) 000-000000
Xxxxxx X. Xxxxxx
Gliatech Medical Inc.
00000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxx 00000
Phone: (000) 000-0000
Fax: (000)000-0000
Each of the parties shall be responsible for notifying the other of any changes
this information.
4.10 INSPECTION. Gliatech shall have the right to normally inspect
EMCM's facilities and documentation relating to this Agreement at any time
during normal business hours.
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ARTICLE V
MATERIAL RESPONSIBILITY AND REJECTION OF PRODUCT IN CASE OF NON-CONFORMITY
5.1 MATERIALS LOSSES. Gliatech shall maintain ownership of all
materials provided to EMCM as outlined in Article 3.1(h) hereof. Gliatech shall
be responsible to provide EMCM with adequate material to manufacture the
Products. Any losses in excess of normal expectations shall be the
responsibility of EMCM.
(a) EMCM shall reimburse Gliatech for losses in excess of these
agreed upon, acceptable levels at Gliatech's cost for the item. Such cost
records shall be made available to Gliatech on request by EMCM.
5.2 REJECTION FOR NON-CONFORMANCE. Gliatech may reject any Product
which does not comply with the Specifications. Such materials shall be
determined to have been produced outside of the Specifications, and EMCM shall
be responsible for such losses and will reimburse Gliatech for the costs of such
losses.
(a) EMCM shall have the right to challenge the replacement of
materials for such rejected Product within thirty (30) days after such
rejection. In the event of such a challenge, representatives of Gliatech and
EMCM will jointly produce an identical quantity of Product, utilizing, when
possible, identical materials. This production will occur within EMCM's
facilities within thirty (30) days of Gliatech's receipt of EMCM's challenge of
non-conformance, which shall be provided in writing.
(1) Should the Product not meet such acceptance criteria set
forth in the Specifications, the original Product will be determined to have
been produced outside of the Specifications. EMCM shall replace all
Gliatech-provided materials related to such rejected Product and shall
immediately schedule production to replace the rejected Product.
(2) Should the product not meet specifications due to the
failure of Gliatech equipment or processes, through no fault or negligence of
EMCM, EMCM will not be responsible for such rejected product.
(3) Should the Product meet such acceptance criteria, EMCM
shall be determined to be in compliance with the Specifications and shall not be
accountable for the material loss.
(b) Gliatech shall have the right to withhold payment of accepted
Products until EMCM makes financial restitution for the rejected Product and all
Gliatech-provided materials related thereto.
ARTICLE VI
PRICE AND PAYMENT
6.1 PRICE. Gliatech agrees to pay EMCM the price for each Product
satisfying the acceptance criteria as detailed in Schedule B, attached hereto.
The price shall be based on a per unit cost.
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(a) The price shall remain in effect for the initial term of the
contract. EMCM may increase the price on an annual basis to reflect the increase
in labor costs, not to exceed yearly increases in accordance with the Consumer
Price Index as published in the Wall Street Journal U.S. City Average, all Urban
Workers Cleveland in December of each year ("CPI"). The price increase shall not
exceed documented cost increases at the end of each contract period, and EMCM
shall notify Gliatech in writing one month prior to the expiration date of any
such increase. If no notice is received by that time, the existing price shall
remain in effect in the event of any renewal.
(b) Gliatech shall have the right to challenge any price increase
based on the increase in the costs of labor. Upon demand, EMCM shall provide to
Gliatech documentation costs.
6.2 METHOD OF PAYMENT. All payments due under this Agreement shall be
paid in U.S. dollars within thirty (30) days from the receipt of the applicable
undisputed invoice.
ARTICLE VII
EXCLUSIVITY OF THE AGREEMENT
7.1 ENTIRE AGREEMENT. This Agreement, with accompanying Attachments and
Schedules, represents the entire agreement between Gliatech and EMCM. This
Agreement supersedes any verbal or written prior agreement and can be modified
only in writing by the consent and agreement of both parties.
7.2 NO WAIVER. None of the terms of this Agreement shall be deemed to
be waived or amended by either party unless such a waiver or amendment
specifically references this Agreement and is in writing signed by the party to
be bound.
7.3 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
inure to the benefit of the parties, their successors and assigns. This
Agreement shall not be assignable by EMCM without the prior written consent of
Gliatech.
7.4 NO STRICT CONSTRUCTION. The language used in this Agreement shall
be deemed to be the language chosen by both parties hereto to express their
mutual intent and no rule of strict construction against either party shall
apply to any term or condition of this Agreement.
7.5 COMPLIANCE WITH LAWS. Each party shall comply with all applicable
laws, regulations and orders including, but not limited to, import regulations.
The parties shall cooperate with each other to comply with all such measures and
shall promptly inform the other party of any suspected noncompliance.
7.6 SEVERABILITY. Should any provision of this Agreement be held
illegal, invalid or unenforceable by any court or regulatory agency of competent
jurisdiction, such provision shall be modified by such court or regulatory
agency in compliance with the law and, as modified, enforced. All other terms
and conditions of this Agreement shall remain in full force and effect and shall
be construed in accordance with the modified provision, and as if such illegal,
invalid or unenforceable provision had not been contained herein.
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7.7 RELATIONSHIP OF THE PARTIES. Nothing herein shall be construed to
create any relationship of employer and employee, agent and principal,
partnership or joint venture between the parties. Each party is an independent
contractor. Neither party shall assume, either directly or indirectly, any
liability of or for the other party. Neither party shall have the authority to
bind or obligate the other party and neither party shall represent that it has
such authority.
7.8 CHOICE OF LAW. This Agreement and all disputes arising hereunder
shall be governed by, and interpreted in accordance with, the internal laws (and
not the laws of conflicts) of the State of Ohio. Any dispute, controversy or
claim arising out of or relating to the validity, construction, enforceability
or performance of this Agreement, including disputes relating to alleged breach
or to termination of this Agreement, shall be settled by binding Alternative
Dispute Resolution ("ADR"), and shall be conducted by single arbitrator
("Arbitrator"). The Arbitrator shall be selected from the CPR National Panel of
Distinguished Neutrals of the CPR Institute for Dispute Resolution or its
successor organization.
7.9 CONSENT TO JURISDICTION. In the event of any dispute arising
between the parties in connection with this Agreement or any clause or the
construction thereof, or the rights, duties or liabilities or either party, the
following shall apply. If Gliatech elects to bring any equitable or legal
proceeding against EMCM, such proceeding shall be brought in a court having
jurisdiction over EMCM in The Netherlands. If EMCM elects to bring any equitable
or legal proceeding against Gliatech, such proceeding shall be brought in a
court having jurisdiction over Gliatech in Ohio, U.S.A. Each party hereto hereby
irrevocably submits to the jurisdiction of such courts, irrevocably consents to
the service of process by registered mail or personal service and hereby
irrevocably waives, to the fullest extent permitted by law, any objection which
it may have or hereafter have as to personal jurisdiction and venue of any such
action or proceeding brought in such court has been brought in an inconvenient
forum.
7.10 SURVIVAL OF PROVISIONS. Articles 2.4, 4.5, 4.6, 4.7, 4.8, 7.8, 7.9
and 7.10 hereof shall survive the termination of this Agreement for any reason.
7.11 COUNTERPARTS. This Agreement may be executed in counterparts, any
one of which need not contain the signatures of more than one party, but both of
which, taken together, shall constitute one and the same agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement to be
effective as of the date first above written.
European Medical Contract Manufacturing
By: /s/ X.X. de Vries
-------------------------------------
Title: President
---------------------------------
Gliatech Medical Inc.
By: /s/ Xxxxxx X. Xxxxxx
------------------------------------
Title: Chief Operating Officer
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