Exhibit 10.1(j)
AGREEMENT
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This Agreement is made by and between Roche Molecular Systems, Inc.
("RMS"), having an office at 0000 X.X. Xxxxxxx 000, Xxxxxxxxxx, Xxx Xxxxxx
00000-0000 and Genica Pharmaceuticals Corporation ("Genica"), Worcester,
Massachusetts, hereafter collectively referred to as "The Parties".
BACKGROUND
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A. RMS has the right to grant immunities from suit under certain United
States Patents describing and claiming, inter alia, a gene amplification process
known as the polymerase chain reaction ("PCR") technology.
B. Genica has attained substantial expertise in validating, documenting
and performing sophisticated diagnostic procedures.
C. Genica desires to obtain an immunity from suit from RMS to practice
PCR Technology to perform human in vitro clinical laboratory services, and RMS
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is willing to grant such an immunity, on the terms and subject to the conditions
provided exclusively in this Agreement.
NOW, THEREFORE, for and in consideration of the mutual covenants
contained herein, RMS and Genica agree as follows:
* Material omitted and filed separately with the Securities and Exchange
Commission pursuant to request for confidential treatment under Rule 406.
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1. Definitions
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For the purpose of this Agreement, and solely for that purpose, the
terms set forth hereinafter shall be defined as follows:
1.1. The term "Affiliate" of a designated party to this Agreement shall
mean:
(a) an organization of which fifty percent (50%) or more of the
voting stock is controlled or owned directly or indirectly by
either party to this Agreement;
(b) an organization which directly or indirectly owns or controls
fifty percent (50%) or more of the voting stock of either
party to this Agreement;
(c) an organization, the majority ownership of which is directly
or indirectly common to the majority ownership of either party
to this Agreement; and
(d) an organization under (a), (b), or (c) above in which the
amount of said ownership is less than fifty percent (50%) and
that amount is the maximum amount permitted pursuant to the
law governing the ownership of said organization.
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It is understood and agreed, however, that the term "Affiliate" shall not
include Genentech Inc., a company located at 000 Xxxxx Xxx Xxxxx Xxxxxxxxx,
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, X.X.X. ("Genentech").
1.2. "Assay" shall mean an in vitro diagnostic procedure utilizing PCR
Technology to detect the presence, absence or quantity of a nucleic acid
sequence associated with a specific human disease or condition.
1.3. "Diagnostic Product" shall mean an assemblage of reagents,
including but not limited to reagents packaged in the form of a kit, useful in
performing an Assay.
1.4. "Effective Date" shall mean the date on which the last signatory
to this Agreement signs the Agreement.
1.5. "Licensed Field" shall mean the field of human in vitro
diagnostics solely for the detection of genetic diseases, genetic
pre-disposition to disease, microorganisms associated with infectious diseases,
cancer, or for tissue transplant typing or Parentage.
1.6. "Licensed Services" shall mean the performance of an Assay by
Genica to detect nucleic acid sequences associated with a human disease or
condition within the Licensed Field. Licensed Services include but are not
limited to, any combination of the steps of col-
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lecting a sample for analysis, isolating nucleic acid sequences therein,
amplifying one or more desired sequences, analyzing the amplified material and
reporting the results.
1.7. "Licensed Technology" shall mean the application of PCR
Technology, as that term is defined in Section 1.10, to perform Licensed
Services.
1.8. "Net Service Revenues" shall mean gross invoice price for the
Licensed Services performed by Genica (or the fair market value for any
nonmonetary consideration which Genica agrees to receive in exchange for
Licensed Services), less the following deductions where they are factually
applicable and are not already reflected in the gross invoice price:
(i) discounts allowed and taken, in amounts customary in the
trade (which shall include the difference between the
dollar amount charged by Genica for a Licensed Service and
the Medicare and/or Medicaid Limits of Allowance and/or
reimbursement limitations of a Third Party insurance
program); and
(ii) sales and/or use taxes and/or duties imposed upon and with
specific reference to particular sales; and
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(iii) actual bad debt, up to [ ]%* of gross invoice price for
Licensed Services, which bad debt Genica can prove and
document that it was reasonable and diligent in its efforts
to collect payment.
No allowance or deduction shall be made for commissions or collections,
by whatever name known.
It is hereby understood and agreed that, to the extent feasible, the
Licensed Services shall at all times be invoiced, listed and billed by Genica as
a separate item in Genica's invoices, bills and reports to customers. However,
in the event a Licensed Service is offered in combination with another non-PCR
diagnostic assay(s) or together with a nontesting service(s) (e.g., an
interpretive or consultive service) as part of a package (e.g., genetic
counseling) (this combination of a Licensed Service with a nontesting or
interpretive service is hereinafter referred to as a "Combination Service"),
then Net Service Revenues for purposes of determining royalties on a Licensed
Service which is part of a Combination Service shall be determined by
multiplying the gross invoice price, less applicable deductions, for the
Combination Service, by the appropriate fraction in Attachment I hereto. The
fraction specified in Attachment I for a particular Licensed Service shall be
mutually agreed to by The Parties as accurately reflecting the value contributed
by the Licensed Service to the overall value of the package of the Combination
Service as offered by Genica. Attachment I hereto may be modified at any time by
mutual consent of The Parties.
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The Net Service Revenues of the Licensed Services that are performed by
Genica for any person, firm or corporation controlling, controlled by, or under
common control with Genica, or enjoying a special course of dealing with Genica,
shall be determined by reference to the Net Service Revenues which would be
applicable under this Section in an arm's length transaction by Genica to a
Third Party other than such person, firm or corporation.
1.9. "Parentage" shall mean analysis of human genetic material to
ascertain whether two or more individuals are biologically related, but
specifically excludes analysis of forensic evidence for a criminal proceeding.
1.10. "PCR Technology" shall mean polymerase chain reaction technology
covered by United States Patent Nos. B1 4,683,195 and B1 4,683,202 and any
reissue or reexamination patents thereof.
1.11. "Third Party" shall mean a party other than an Affiliate of The
Parties to this Agreement.
2. Grant
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2.1. Upon the terms and subject to the conditions of this Agreement,
RMS hereby grants to Genica, and Genica hereby accepts from RMS, a
royalty-bearing, nonexclusive immunity from suit under PCR Technology solely to
use Licensed Technology to perform Li-
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censed Services within the United States and its possessions and the
Commonwealth of Puerto Rico. The Parties understand and agree that no rights are
hereby granted, expressly or by implication, under U.S. Patent No. 4,965,188
(the `l88 patent). An immunity from suit under the `188 patent may be obtained
by purchase of RMS-manufactured polymerase or by contacting the Director of
Licensing, Roche Molecular Systems, Inc., 0000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX
00000 (510/865-5400).
2.2. The Licensed Technology hereunder may be practiced solely for the
performance of Licensed Services and for no other purpose whatsoever, and no
other right, immunity or license is granted expressly, impliedly or by estoppel.
2.3. Genica expressly agrees that this Agreement is intended to and
does supersede all prior agreements between Genica and the Cetus Corporation,
RMS' predecessor in interest, relating to PCR Technology, including specifically
the agreement dated November 13, 1990.
2.4. Genica expressly acknowledges and agrees that the immunity from
suit pursuant to this Agreement is personal to Genica alone and Genica shall
have no right to sublicense, assign or otherwise transfer or share its rights
under the foregoing immunity from suit and further agrees that Licensed Services
will be performed, offered, marketed and sold only by Genica and Genica shall
not authorize any other party, including Affiliates, to practice the Li
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censed Technology, nor shall it practice the Licensed Technology in conjunction
with any other party.
2.5. For each Combination Service that Genica offers pursuant to this
immunity from suit, Genica agrees that it will notify RMS at least sixty (60)
days before it commercializes said Combination Service. The Parties shall then
agree on the fraction of the value of Combination Services which is attributable
to the Licensed Service component. As to all other Licensed Services offered by
Genica which are not part of a Combination Service, Genica agrees to keep RMS
informed about the availability from Genica of each such Service within a
reasonable time after Genica commences offering the Service.
2.6. RMS hereby grants to Genica the right and Genica accepts and
agrees to credit RMS as the source of PCR Technology rights in Genica's
promotional materials and any other materials intended for distribution to Third
Parties as follows:
"This test is performed pursuant to a license agreement with Roche
Molecular Systems, Inc."
3. Acknowledgment and Agreement on Diagnostic Products
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3.1. Genica acknowledges and agrees that the immunity from suit granted
hereunder is for the performance of Licensed Services only and does not include
any right to make, have made, import, offer or sell any products, including
devices, PCR reagents, kits or
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Diagnostic Products. Genica further acknowledges and agrees that RMS Affiliates
are in the business of providing clinical laboratory testing services and the
commercial sale of diagnostic testing systems and therefore may compete directly
with Genica's business.
4. Royalties, Records and Reports
------------------------------
4.1. Royalties. For the rights and privileges granted under this
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Agreement, Genica shall pay to RMS earned royalties equal to [ ]%*
of Genica's Net Service Revenues for each Assay performed.
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4.2. Genica shall keep full, true and accurate books of account
containing all particulars which may be necessary for the purpose of showing the
amount payable to RMS by way of royalty or by way of any other provision under
this Agreement. Such books and the supporting data shall be open at all
reasonable times, for three (3) years following the end of the calendar year to
which they pertain (and access shall not be denied thereafter, if reasonably
available), to the inspection of RMS or an independent certified public
accountant retained by RMS for the purpose of verifying Genica's royalty
statements or Genica's compliance in other respects with this Agreement. If in
dispute, such records shall be kept until the dispute is settled. The inspection
of records shall be at RMS' sole cost and expense, unless the inspector
concludes that royalties reported by Genica for the period being audited are
understated by [ ]%* or more from actual royalties, in which case the costs and
expenses of such inspection shall be paid by Genica.
4.3. Genica shall within thirty (30) days after the first day of
January, April, July and October of each year deliver to RMS a true and accurate
royalty report. This report shall give such particulars of the business
conducted by Genica during the preceding three (3) calendar months as are
pertinent to an accounting for royalty under this Agreement and shall include at
least the following:
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(a) the number of assays performed in connection with
performance of the Licensed Services and Combination
Services during those three (3) months;
(b) compilation of xxxxxxxx thereon and the allowable
deductions therefrom;
(c) Net Service Revenues and the calculation of total
royalties thereon; and
(d) the calculation of the net royalty payable to RMS.
If no royalties are due it shall be so reported.
The correctness and completeness of each such report shall be attested
to in writing by the responsible financial officer of Genica's organization or
by Genica's external auditor or by the chair or other head of Genica's internal
audit committee.
Simultaneously with the delivery of each such report, Genica shall pay
to RMS the royalty and any other payments due under this Agreement for the
period covered by such report. All payments due RMS hereunder shall be sent
together with the royalty report by the due date to the following address:
Roche Molecular Systems, Inc.
X.X. Xxx 00000
Xxxxxx, X.X. 00000
or to any address that RMS may advise in writing.
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4.4. All amounts payable hereunder by Genica to RMS shall be payable in
United States currency.
4.5. Genica's obligation to pay royalties pursuant to this Agreement
shall terminate upon a final holding of invalidity or unenforceability of all of
the patents identified in Section 1.10, supra, by a court of appellate
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jurisdiction or by a trial court from which no appeal is or can be taken.
4.6. If Genica shall fail to pay any amount specified under this
Agreement after the due date thereof, the amount owed shall bear interest
[ ]%* from the due date until paid, provided, however, that if
this interest rate is held to be unenforceable for any reason, the interest rate
shall be [ ]* at the time the payment is due.
5. Performance of Licensed Services
--------------------------------
5.1. The Parties agree that quality assurance is of utmost importance
in the performance of Licensed Services. To that end, Genica agrees that it
will:
(a) participate in at least one independent proficiency
testing program for each Licensed Service when such
program(s) becomes available; and
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(b) comply with all Medicare, Medicaid and/or CLIA standards for
diagnostic testing as well as all other applicable federal,
state and local regulations applicable to human diagnostic
testing.
6. Technology Notification
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6.1. With respect to any invention, improvement or discovery
(hereinafter referred to as "Discoveries" in this Article) of Genica made after
entering into this Agreement, resulting from work conducted under this Agreement
and being applicable to PCR, if Genica decides to license that Discovery to
Third Parties, then Genica agrees to provide to RMS, unless not possible due to
Genica's previous commitments to Third Parties relating to said Discoveries, a
reasonable opportunity to negotiate a license to use said Discoveries in
PCR-based diagnostic products and services. Such Discoveries include, but are
not limited to, improvements of the PCR process or in the performance of Assays,
modifications to or new methods of performing the Assays, including the
automation of the PCR process or of the Assays.
6.2. Any agreement reached between The Parties as a result of Genica
notification to RMS of a Discovery pursuant to Section 6.1 hereto shall be upon
terms and conditions negotiated in good faith by The Parties.
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7. Diligence
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Genica shall exercise reasonable diligence in developing, testing,
validating, documenting, promoting and selling the Licensed Services. In the
course of such diligence, Genica shall take appropriate steps including, upon
reasonable written request of RMS, furnishing RMS with representative copies of
all promotional material relating to the Licensed Services.
8. Term and Termination
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8.1. The immunity from suit granted to Genica herein shall commence on
the Effective Date and terminate on the date of expiration of the last to expire
of the patents included within the PCR Technology, which patent contains at
least one claim covering the performance of Licensed Services.
8.2. If in the course of performing and offering Licensed Services,
Genica fails to comply with the quality assurance provisions of Article 5,
Genica shall so notify RMS and RMS shall notify Genica to correct the defects.
Genica shall have thirty (30) days from receipt of such notice to cure all
defects of which it is notified. If Genica does not cure all such defects within
the designated thirty (30) days, RMS may then in its sole discretion terminate
this Agreement in its entirety, or any portion thereof immediately. For the
purposes of this Section and this Agreement, Genica's failure to provide an
accurate and correct test result when participating in an independent
proficiency testing program pursuant to Section 5.1 (a),
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on two consecutive evaluations, shall automatically be deemed a failure to
comply with Article 5 and shall be a material breach of this Agreement.
8.3. Notwithstanding any other Section of this Agreement, Genica may
terminate this Agreement for any reason on thirty (30) days' written notice to
RMS.
8.4. The decision of a Court or Administrative body finding RMS liable
or culpable due to Genica's performance of Licensed Services shall give RMS the
right to terminate this Agreement immediately upon notification to RMS of said
decision.
8.5. The immunity granted hereunder to Genica shall automatically
terminate upon (i) an adjudication of Genica as bankrupt or insolvent, or
Genica's admission in writing of its inability to pay its obligations as they
mature; or (ii) an assignment by Genica for the benefit of creditors; or (iii)
Genica's applying for or consenting to the appointment of a receiver, trustee or
similar officer for any substantial part of its property; or such receiver,
trustee or similar officer's appointment without the application or consent of
Genica, if such appointment shall continue undischarged for a period of ninety
(90) days; or (iv) Genica's instituting (by petition, application, answer,
consent or otherwise) any bankruptcy, insolvency arrangement, or similar
proceeding relating to Genica under the laws of any jurisdiction; or (v) the
institution of any such proceeding (by petition, application or otherwise)
against Genica, if such proceeding shall remain undismissed for a period of
ninety (90) days or the issuance or levy of any
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judgment, writ, warrant of attachment or execution or similar process against a
substantial part of the property of Genica, if such judgment, writ, or similar
process shall not be released, vacated or fully bonded within ninety (90) days
after its issue or levy; or (vi) loss of Genica's federal or state licenses
permits or accreditation necessary for operation of Genica as a health care
institution.
8.6. RMS shall have the right to terminate this Agreement by written
notice to Genica upon any change in the ownership or control of Genica or of its
assets. Termination under this Section shall be effective immediately upon
receipt by Genica of RMS' notice of termination. For such purposes, a "change in
ownership or control" shall mean that [ ]%* of the voting stock of Genica become
subject to the control of a person or entity, or any related group of persons or
entities acting in concert, which person(s) or entity(ies) did not control such
proportion of voting stock as of the effective date of the Agreement.
Analogously, RMS shall have the right to terminate this Agreement upon any
transfer or sale of [ ]%* of the assets of Genica to another party.
8.7. Breach. Upon any breach of or default of a material term under
this Agreement by Genica, RMS may terminate this Agreement upon thirty (30)
days' written notice to Genica. Said notice shall become effective at the end of
the thirty-day (30) period, unless during said period Genica fully cures such
breach or default and notifies RMS of such a cure.
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8.8. Upon termination of this Agreement as provided herein, all
immunities and rights granted to Genica hereunder shall revert to or be retained
by RMS. To the extent RMS has licensed technology or know-how of Genica pursuant
to Article 6 hereto, those licenses shall remain in force according to their
terms.
8.9. Genica's obligations to report to RMS and to pay royalties to RMS
as to the Licensed Services performed under the Agreement prior to termination
or expiration of the Agreement shall survive such termination or expiration.
9. Confidentiality-Publicity
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9.1. Except as otherwise specifically provided in Section 2.6, Genica
agrees to obtain RMS' approval before distributing any written information,
including but not limited to promotional and sales materials, to Third Parties
which contains references to RMS or this Agreement. RMS' approval shall not be
unreasonably withheld or delayed and, in any event, RMS' decision shall be
rendered within three (3) weeks of receipt of the written information. Once
approved, such materials, or abstracts of such materials, which do not
materially alter the context of the material originally approved may be
reprinted during the term of the Agreement without further approval by RMS
unless RMS has notified Genica in writing of its decision to withdraw permission
for such use.
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9.2. Each Party agrees that any financial, legal or business
information or any technical information disclosed to it (the "Receiving Party")
by the other (the "Disclosing Party") in connection with this Agreement shall be
considered confidential and proprietary and the Receiving Party shall not
disclose same to any Third Party and shall hold it in confidence for a period of
five (5) years and will not use it other than as permitted under this Agreement
provided, however, that any information, know-how or data which is orally
disclosed to the Receiving Party shall not be considered confidential and
proprietary unless such oral disclosure is reduced to writing and given to the
Receiving Party in written form within thirty (30) days after oral disclosure
thereof. Such confidential and proprietary information shall include, without
limitation, marketing and sales information, commercialization plans and
strategies, research and development work plans, and technical information such
as patent applications, inventions, trade secrets, systems, methods, apparatus,
designs, tangible material, organisms and products and derivatives thereof.
9.3. The above obligations of confidentiality shall not be applicable
to the extent:
(a) such information is general public knowledge or, after
disclosure hereunder, becomes general or public knowledge
through no fault of the Receiving Party; or
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(b) such information can be shown by the Receiving Party by its
written records to have been in its possession prior to
receipt thereof hereunder; or
(c) such information is received by the Receiving Party from
any Third Party for use or disclosure by the Receiving
Party without any obligation to the Disclosing Party
provided, however, that information received by the
Receiving Party from any Third Party funded by the
Disclosing Party (e.g. consultants, subcontractors, etc.)
shall not be released from confidentiality under this
exception; or
(d) the disclosure of such information is reasonably needed for
use in connection with performing, offering and selling
Licensed Services; or
(e) the disclosure of such information is required or desirable
to comply with or fulfill governmental requirements,
submissions to governmental bodies, or the securing of
regulatory approvals.
9.4. With the exception of Section 2.6, each party shall, to the extent
reasonably practicable, maintain the confidentiality of the provisions of this
Agreement and shall refrain from making any public announcement or disclosure of
the terms of this Agreement without the prior consent of the other party, except
to the extent a party concludes in good faith that
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such disclosure is required under applicable law or regulations, in which case
the other party shall be notified in advance.
10. Compliance
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In exercising any and all rights and in performing its obligations
hereunder, Genica shall comply fully with any and all applicable laws,
regulations and ordinances and shall obtain and keep in effect licenses, permits
and other governmental approvals, whether at the federal, state or local levels,
necessary or appropriate to carry on its activities hereunder. Genica further
agrees to refrain from any activities that would have an adverse effect on the
business reputation of RMS. RMS will advise Genica of any such activities and
Genica will have thirty (30) days to correct such activity.
11. Assignment
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This Agreement shall not be assigned by Genica (including without
limitation any purported assignment or transfer that would arise from a sale or
transfer of Genica's business). RMS may assign all or any part of its rights and
obligations under this Agreement at any time without the consent of Genica.
Genica agrees to execute such further acknowledgments or other instruments as
RMS may reasonably request in connection with such assignment.
12. Negation of Warranties and Indemnity
------------------------------------
12.1. Nothing in this Agreement shall be construed as:
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(a) a warranty or representation by RMS as to the validity
or scope of any Licensed Technology;
(b) a warranty or representation that the practice of the
Licensed Technology is or will be free from
infringement of patents of Third Parties;
(c) an obligation to bring or prosecute actions or suits
against Third Parties for infringement;
(d) except as expressly set forth herein, conferring the
right to use in advertising, publicity or otherwise any
trademark, trade name, or names, or any contraction,
abbreviation, simulation or adaptation thereof, of RMS;
(e) conferring by implication, estoppel or otherwise any
license, right or immunity under any patents or patent
applications of RMS other than those specified in PCR
Technology, regardless of whether such patents and
patent applications are dominant or subordinate to
those in PCR Technology;
(f) an obligation to furnish any know-how not provided in
PCR Technology; or
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(g) creating any agency, partnership, joint venture or
similar relationship between RMS and Genica.
12.2. RMS MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
12.3. Genica acknowledges that the technology licensed hereby is newly
developed, and agrees to take all reasonable precautions to prevent death,
personal injury, illness and property damage from the use of such technology.
Genica shall assume full responsibility for its use of the Licensed Technology
and shall defend, indemnify and hold RMS harmless from and against all
liability, demands, damages, expenses (including attorneys' fees) and losses for
death, personal injury, illness, property damage or any other injury or damage,
including any damages or expenses arising in connection with state or federal
regulatory action (collectively "Damages"), resulting from the use by Genica,
including its officers, directors, agents and employees, of the Licensed
Technology except, and to the extent that such Damages are caused by the
negligence or willful misconduct of RMS.
13. General
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13.1. This Agreement constitutes the entire agreement between The
Parties as to the subject matter hereof, and all prior negotiations,
representations, agreements and understandings are merged into, extinguished by
and completely expressed by it. This Agreement may
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be modified or amended only by a writing executed by authorized officers of each
of The Parties.
13.2. Any notice required or permitted to be given by this Agreement
shall be given by postpaid, first class, registered or certified mail, or by
courier or facsimile, properly addressed to the other party at the respective
address as shown below:
If to RMS:
Roche Molecular Systems, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attn: Corporate Secretary
with a copy to:
Roche Molecular Systems, Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attn: Licensing Manager
If to Genica:
Genica Pharmaceuticals Corporation
Two Biotech Park
000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxxx X. Xxxxxxxx
President
Either party may change its address by providing notice to the other party.
Unless otherwise specified herein, any notice given in accordance with the
foregoing shall be deemed given
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within four (4) full business days after the day of mailing, or one full day
after the date of delivery to the courier, or the date of facsimile
transmission, as the case will be.
13.3. Governing Law and Venue. This Agreement and its effect are
-----------------------
subject to and shall be construed and enforced in accordance with the law of the
State of New Jersey, U.S.A., except as to any issue which by the law of New
Jersey depends upon the validity, scope or enforceability of any patent within
the Licensed Technology, which issue shall be determined in accordance with the
applicable patent laws of the United States. The Parties agree that the
exclusive jurisdiction and venue for any dispute or controversy arising from
this Agreement shall be in the United States District Court for the District of
New Jersey if federal jurisdiction exists, and if no federal jurisdiction
exists, then in the Superior Court of New Jersey.
13.4. Arbitration. Notwithstanding the provisions of Section 13.3
-----------
above, any dispute concerning solely the determination of facts such as, but not
limited to, (i) the value of a Combination Service and a Licensed Service
pursuant to Section 1.8; (ii) a determination of royalty rate payments owed
pursuant to Section 4.1; (iii) compliance with quality assurance pursuant to
Article 5; or (iv) good faith compliance with Article 6; and which dispute does
not involve a question of law, shall be settled by final and binding arbitration
at a mutually convenient location in the State of New Jersey pursuant to the
commercial arbitration rules of the American Arbitration Association, in
accordance with the following procedural process:
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(a) The arbitration tribunal shall consist of three
arbitrators. Each party shall nominate in the request
for arbitration and the answer thereto one arbitrator
and the two arbitrators so named will then jointly
appoint the third arbitrator as chairman of the
arbitration tribunal.
(b) The decision of the arbitration tribunal shall be
final and judgment upon such decision may be entered
in any competent court for juridical acceptance of
such an award and order of enforcement. Each party
hereby submits itself to the jurisdiction of the
courts of the place of arbitration, but only for the
entry of judgment with respect to the decision of the
arbitrators hereunder.
13.5. Nothing in this Agreement shall be construed so as to require the
commission of any act contrary to law, and wherever there is any conflict
between any provision of this Agreement or concerning the legal right of The
Parties to enter into this contract and any statute, law, ordinance or treaty,
the latter shall prevail, but in such event the affected provisions of the
Agreement shall be curtailed and limited only to the extent necessary to bring
it within the applicable legal requirements.
13.6. If any provision of this Agreement is held to be unenforceable
for any reason, it shall be adjusted rather than voided, if possible, in order
to achieve the intent of the parties to
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the extent possible. In any event, all other provisions of this Agreement shall
be deemed valid and enforceable to the full extent possible.
IN WITNESS WHEREOF, The Parties hereto have set their hands and seals
and duly executed this Agreement on the date(s) indicated below, to be effective
on Effective Date as defined herein.
ROCHE MOLECULAR SYSTEMS, INC. GENICA PHARMACEUTICALS
CORPORATION
By: /s/ Xxxxx Xxxxxxx By: /s/ Xxxxxx X. Xxxxxxxx
-------------------------------------- ------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxx X. Xxxxxxxx
Title: President Title: President
Date: 6/14/94 Date: 6/22/94
------------------------------------ ---------------------
Exhibit 10.1(j)
ATTACHMENT I
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COMBINATION SERVICES
--------------------
Percent of Net Service
Revenues for Combination
Services which is Attributable
Licensed Services to Licensed Services
-----------------
Apo E [ ]%*
Fragile X [ ]%*
Amyloidosis [ ]%*
CSA-1 (Spinocerebellar Ataxia Type I) [ ]%*
Muscular Dystrophy $[ ]*
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November 30, 1999
Xxxxxxx X. Boss, Ph.D.
Vice President, Research and Development
ATHENA DIAGNOSTICS, INC.
Four Biotech Park - 000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Re: Agreement Effective June 22, 1994 between Roche Molecular Systems, Inc.
("RMS") and Athena Diagnostics, Inc. ("ADI") for use of the Polymerase
Chain Reaction (PCR) Technology in Human Diagnostic Services ("the
Agreement")
Dear Dr. Boss:
Pursuant to RMS's review of the descriptions provided with Xx. Xxxxxxxxx'x
letter of November 11, 1999 on the following two tests offered by Athena, the
tests are approved as a Combination Services with royalty-bearing fractions of [
]%*. This royalty-bearing fraction is in recognition of the component of genetic
counseling as a part of the billed price.
Combination Service Royalty Bearing %
Spinocerebellar ataxia Type 12 (SCA 12) [ ]*
Dentatorubro-pallidoluysian atrophy (DRPLA) [ ]*
Charcot-Xxxxx-Tooth disease (EGR 2) [ ]*
Charcot-Xxxxx-Tooth disease (PMP 22) [ ]*
Cerebral autosomal dominant arteriopathy,
sub-cortical infarcts and leukoencephalopathy (CADASIL) [ ]*
Enclosed is a revised Attachment I to the referenced Agreement effective January
1, 2000 including these tests as Combination Services and which supersedes the
previous Attachments I. Please acknowledge ADI's acceptance of the new
Attachment I by having an authorized representative of ADI execute both copies
of this letter, each of which, once executed, shall con-
-29-
stitute an original. Please forward one of the executed duplicate originals to
the attention of Xxxxx Xxxxxxx, Licensing Specialist, at the above address and
retain the other.
Regards, Agreed and Accepted
ROCHE MOLECULAR SYSTEMS, INC. ATHENA DIAGNOSTICS, INC.
/s/ Xxxxxx Xxxxx By: /s/ Xxxxxx Xxxxxxxx
-----------------------------
(authorized signature)
Xxxxxx Xxxxx, Ph.D. Name: Xxxxxx Xxxxxxxx
----------------------------
Vice President, R&D Title: President
----------------------------
Enclosure Date: 12/21/99
----------------------------
Apprv'd as To Form
LAW DEPT
By: /s/
------------------------
ATTACHMENT I
COMBINATION SERVICES
--------------------
Percent of Net Service
Revenues for Combination
Services which is Attributable
Licensed Services to Licensed Services
----------------- --------------------
Amyloidosis [ ]*
Apo E [ ]*
Cerebral autosomal dominant arteriopathy, sub-cortical infarcts and
leukoencephalopathy (CADASIL) [ ]*
Charcot-Xxxxx-Tooth Disease (EGR 2) [ ]*
Charcot-Xxxxx-Tooth Disease (PMP 22) [ ]*
CMT1B [ ]*
CMTX (not CMT1A) [ ]*
Dentatorubro-pallidoluysian atrophy (DRPLA) [ ]*
Dystonia [ ]*
Factor V Leiden [ ]*
Fragile X [ ]*
Friedrech's Ataxia [ ]*
Huntington's Disease [ ]*
Xxxxxxx'x Disease [ ]*
Xxxxxxx-Xxxxxx Disease [ ]*
Mitochondrial DNA (not KSS/CPEO) [ ]*
Muscular Dystrophy $[ ]
Myotonic Dystrophy [ ]*
Oculopharyngeal Muscular Dystrophy [ ]*
Presenilin 1 [ ]*
Spinal Muscular Atrophy [ ]*
Spinocerebellar Ataxia Type 1 (SCA 1) [ ]*
Spinocerebellar Ataxia Type 2 (SCA 2) [ ]*
Spinocerebellar Ataxia Type 6 (SCA 6) [ ]*
Spinocerebellar Ataxia Type 7 (SCA 7) [ ]*
Spinocerebellar Ataxia Type 8 (SCA 8) [ ]*
Spinocerebellar Ataxia Type 12 (SCA 12) [ ]*
