Exhibit 10.21
DEVELOPMENT
AND
DISTRIBUTION AGREEMENT
AGREEMENT entered by and between Xxxxxxxx Xxxxxx Research, a
Massachusetts General Partnership ("HTR") and Cell Robotics International, Inc.,
a Colorado corporation ("CRII") executed and deemed effective September 10,
1999.
WHEREAS, HTR and CRII intend that CRII will grant to HTR and HTR will
exploit to the parties' mutual benefit the worldwide right to distribute, market
and sell CRII's In-Vitro Fertilization technology which includes the IVF
Workstation and Zona Laser Treatment System and future improvement;
NOW, THEREFORE, in consideration of the mutual covenants, agreements,
representations and warranties herein contained, the parties hereby agree as
follows:
1. DEFINITIONS
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1.1 The term "IVF Technology" shall be used generally to mean the IVF
Workstation and the Zona Laser Treatment System and future improvements, which
are devices intended for human application, to be utilized by health care
providers in clinical settings, and designed and constructed to incorporate and
exploit the patents, know-how, and engineering technologies of CRII as it
relates to this product. (Exhibit A)
2. GRANT OF DISTRIBUTION RIGHTS AND LICENSE
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2.1 Subject to the terms and conditions stated herein, CRII grants
to HTR an exclusive, worldwide right to distribute, market and sell CRII's IVF
Technology.
2.2 During the term of HTR's rights of exclusivity herein, CRII
shall not market, sell or distribute CRII's IVF Technology products or
substantially similar products to any third party or grant to a third party any
rights with respect to any of the foregoing products in contradiction of any of
the rights granted HTR in this Agreement.
2.3 Subject to HTR's performance of its obligations under this
Agreement, CRII grants to HTR the further right to sublicense or assign any HTR
rights licensed or granted in this Section 2; provided, however, that such
sublicense or assignment shall be solely for the purpose of permitting HTR to
engage the services of sales representatives, dealers and other persons to
assist HTR in its performance under this agreement. Under no circumstances
shall HTR have the right to assign to any third party the exclusive right or
non-exclusive rights granted herein without the express written consent of CRII
which consent shall not be unreasonably withheld.
2.4 CRII and HTR agree that HTR receives no licenses or rights
whatsoever, by implication or otherwise, with respect to any CRII patents,
patent rights, patent applications, trademarks, technology or other intellectual
property except as specifically granted herein; and upon termination of this
Agreement, other than as to inventory in HTR's possession at the time of
termination, HTR shall have no further right to distribute, market or sell
CRII's IVF Technology products.
2.5 CRII shall promptly notify HTR in writing of any new, enhanced,
derivative, or similar products (that are not improvements as defined in section
1.1 of this Agreement and for performing
laser-assisted hatching) it develops or acquires related to laser-assisted
batching devices or material components thereof, and HTR shall have a first
right of refusal to negotiate the exclusive rights to distribute, market and
sell any such products and devises, and to manufacture, market, distribute and
sell any such products and devices according to the terms herein. Upon receipt
of such notification from CRII, HTR shall have a period of 60 days in which HTR
has the exclusive right to negotiate with CRII in mutual good faith an agreement
by which CRII grants the above stated rights on terms generally consistent with
those contained in this Agreement.
3. PRODUCTION AND PURCHASE COMMITMENTS
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3.1 Subject to the various terms, conditions, and timetables provided
in this Section 3, CRII will produce and sell to HTR and HTR will purchase from
CRII all IVF Workstation and Xxxx Xxxxx Treatment System products HTR may
require.
3.2 HTR shall have the right to receive and CRII shall promptly
provide to HTR all communications between CRII and the FDA involving or
affecting the products subject to this agreement.
3.3 In addition to purchasing three demo units at cost plus 15%, HTR
will purchase from CRII a minimum of 25 units during Selling Year One (first
twelve month period); 45 units in Selling Year Two (second twelve month period);
and 70 units during Selling Year Three (third twelve month period). CRII will
charge HTR a price per unit equal to 1.7 times CRII's all-in unit production
cost plus freight, FOB Albuquerque. All-in production costs include: material
costs, direct labor and manufacturing overhead (included here as Exhibit
B-1 & B-1). CRII shall establish cost standards for the purpose of determining
interim unit production costing which shall be reconciled quarterly to actual
costs. Unit all-in production costs incurred by CRII shall be subject to
increases or decrease from time to time upon 90 days prior written notice to HTR
to reflect actual increases in costs incurred by CRII for raw material,
component notification of cost increase to HTR shall identify the overall
elements CRII's production costs and those elements subject to increase or
decrease. CRII will at all times keep and maintain complete and accurate books
of accounting containing records of CRII's IVF Technology products all-in costs,
in sufficient detail to enable transfer prices to be computed and verified. CRII
will permit HTR or its representatives to inspect such records upon reasonable
notice to CRII. HTR shall have the option to re-negotiate the terms of this
agreement if CRII's all-in cost rise above 15% of cost in Exhibit A of this
Agreement.
3.4 HTR shall be responsible for procuring, according to CRII's
specifications, and delivering to CRII, at HTR's sole cost and expense, the
computer monitor and surge suppressor.
3.5 Payment terms will be net 30 days following date of shipment.
CRII will maintain a sufficient inventory of IVF Workstation and Zona Laser
Treatment System parts to deliver the specific product within 45 days of the
received order subject to causes beyond CRII's control. HTR will provide CRII
with a quarterly, twelve month rolling forecast of IVF Workstation and Zona
Laser Treatment System units.
3.6 HTR will provide CRII with a twelve month order forecast 90 days
prior to the commencement of Selling Year Two. Following commencement of Selling
Year Two, and on an ongoing basis thereafter, HTR will provide CRII with a
quarterly, twelve month rolling forecast of IVF Workstation and Zona Laser
Treatment System unit orders. CRII will provide all IVF Workstation and Zona
Laser Treatment System within 45 days of the received order subject to causes
beyond CRII's control. CRII will maintain a 30-day inventory of IVF Workstation
and Zona Laser Treatment System units during Selling Year Two as determined by
the average, rolling consumption rate during the preceding 90 day period. The
rolling forecast and shipment schedule processes established in this Section
shall apply to any annual purchase periods following Selling Year Two.
3.7 HTR shall pay for all costs related to FDA clinical trials and
the submission to the PMA, including any resulting FDA inspection, for CRII's
IVF Technology products. HTR shall pay CRII for its Regulatory Affairs Officer
and technical staff to complete the clinical trial, submit the PMA and oversee
the resulting FDA inspection of the technology development files and the
manufacturing process in an amount equal to 1.7 times cost. HTR shall pay at the
same staffing rates for engineering hardware or software upgrades, provided that
such upgrades are agreed upon in writing by HTR and the upgrades are deemed
necessary for marketing and competitive reasons. HTR shall pay for resulting
regulatory submittals.
3.8 HTR shall pay for consulting by CRII research and technical staff
for an agreed upon number of weeks at 75% of a staff person's time at 1.7 times
all-in cost, where all-in costs include salary plus fringe only. HTR shall pay
for travel and other related expenses for in-house training sessions and trade
shows conducted by CRII's product manager and other experts in support of HTR.
3.9 HTR shall use its best efforts to distribute and market CRII's
IVF Technology products in a high quality, technically correct manner and in
such a way as to not detract from the image and reputation of CRII, and to
protect CRII's proprietary rights therein. All marketing of the CRII's IVF
Technology products shall identify CRII, shall use CRII trademarks and names
and shall include appropriate copyright, trademark and proprietary xxxx notices.
Changes to product names shall be subject to mutual agreement in writing.
3.10 HTR shall furnish to each customer CRII's "standard warranty"
covering CRII's IVF Technology products design and materials (attached as
Exhibit C). Such warranty shall contain a statement to the effect that no one is
authorized to make any warranty or representation on behalf of CRII or any other
party other than set forth in the standard warranty and that the customer may
not rely on any other warranty or representation. HTR shall make no
representation regarding the CRII's IVF Technology products except as provided
in product descriptions, user manuals or promotional materials provided by CRII.
HTR warrants that it will make no false or misleading claims or commitments
concerning the performance or capabilities of the IVF Workstation and Zona Laser
Treatment System. HTR agrees to indemnify, defend and hold harmless CRII from
any and all losses incurred by CRII as a result of any false or misleading
claims or commitments by HTR. It is expressly understood that CRII shall have no
obligation or liability whatsoever to any customer or end user of the CRII's IVF
Technology products except for breaches of any express warranty given by CRII
and except as may be provided for by the express terms of this Agreement.
3.11 During the term of this Agreement, HTR covenants to and with
CRII, its successors and assigns, that it will not directly or indirectly engage
or become interested financially or otherwise in any business which
manufactures, markets, distributes or sells a laser-based IVF product or any
other laser product that is competitive with the CRII's IVF Technology products;
nor shall HTR directly or indirectly conduct research or development on its own
behalf or on behalf of any third party related to the development of any laser
inventions or products which are substantially the same as or competitive with
the IVF Workstation and Zona Laser Treatment System; nor shall HTR directly or
indirectly engage in the manufacture, marketing or sale of any laser product
which is substantially the same as, similar or competitive to the IVF
Workstation and Zona Laser Treatment System, unless or until CRII conveys non-
exclusive rights to any such products to a third party pursuant to the terms of
Section 2.5, in which case HTR shall be entitled to compete with any products
for which rights have been conveyed.
4. OPTION TO PURCHASE
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4.1 For a period of one year from the date of this document, HTR
shall have the option to purchase the exclusive manufacturing, marketing and
sales rights to CRII's IVF Technology products. Upon exercising the option, HTR
shall pay a $100,000 licensing fee and commence paying a
royalty of 12% of net revenues received by HTR per each CRII product sold. Net
revenues are defined as gross sales price less sales taxes, VAT or other import
taxes and outside commissions to unrelated parties. All royalties shall be paid
quarterly on or before the last day of the moth following the end of a royalty
quarter. Royalties shall be deemed earned upon receipt of customer payment by
HTR.
4.2 Upon exercising the option, HTR shall also commence manufacture of the
products and shall purchase the residual IVF Workstation and Zona Laser
Treatment System parts inventory and manufacturing tools and fixtures from CRII
at cost plus 15%. CRII will transfer copies of the manufacturing drawings,
specifications and assembly instructions and shall utilize CRII software and
engineering capabilities at an agreed upon price per hour or a fee for services
arrangement.
4.3 HTR shall furnish CRII, with each royalty payment, a statement
specifying the total CRII IVF Technology product sales for which royalties have
been earned during the quarter and the corresponding royalties paid. HTR will at
all time keep and maintain complete and accurate books of accounting containing
records of CRII's IVF Technology product sales, computed and verified. HTR will
permit CRII or its representatives to inspect such records upon reasonable
notice to HTR.
5. CRII COVENANTS, REPRESENTATION, AND WARRANTIES
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5.1 CRII has not knowingly withheld from HTR, during the course of
HTR's due diligence investigation of CRII or at any other time, any material
facts relating to CRII IVF Technology Products, CRII's business, operations,
financial condition or prospects. No representation or warranty in this
Agreement or in any certificate, exhibit, schedule, statement or other agreement
instrument or document furnished by CRII under or in connection with this
Agreement contains or will contain to the best of CRII's knowledge any untrue
statement of a material fact or omits to stat any material fact necessary to
make the statements herein or therein not misleading.
5.2 CRII is and will exercise diligent efforts to remain the record
and beneficial owner or exclusive licensee of al right, title and interest in
and to any patents, copyrights, mask works, trademarks, service marks, trade
names, logos, trade secrets, know-how, inventions, designs, processes, computer
programs, technical data and other intellectual property, whether registered or
unregistered, and all registrations and applications for any of the foregoing,
relating to CRII's IVF Technology products, without any conflict with the
industrial or intellectual property rights of others and free and clear of all
liens, security interests, charges, encumbrances, equities and other adverse
claims. The provisions of this Section 5.2 shall not be construed to constitute
a representation or warranty by CRII that the manufacture, distribution and sale
of the IVF Workstation and Zona Laser Treatment System either are or will be
subject to protection under any applicable patent, copyright, trademark or other
laws applicable to intellectual property and unfair competition. CRII expressly
disclaims any such representation or warranty, now or in the future.
5.3 The use, license or sale of the IVF Workstation and Zona Laser
Treatment System products and technologies, as intend herein, to the best of
CRII's knowledge does not infringe, induce or contribute to the infringement of,
violate or otherwise conflict with any patent, trademark, copyright or trade
secret or intellectual property right belonging to any other person in either
the U.S. or any other country.
5.4 The IVF Workstation and Zona Laser Treatment System products
shall be (i) manufactured in accordance with the required standards and
specifications, (ii) substantially free from all material defects in design,
workmanship and materials and (iii) manufactured in accordance with all
applicable federal, state, laws, rules, or regulations including, but not
limited to, FDA requirements.
5.5 The execution and delivery by CRII of this Agreement and any
other documents contemplated hereby, and the performance by CRII of any of its
obligations herein will not conflict with, result in a breach or violation of
the terms or conditions of, or constitute a default under any contract or
agreement of CRII, its Articles of Incorporation or By-laws, or any order,
judgment, statute, rule or regulation to which CRII is subject.
5.6 The execution, delivery, and performance of this Agreement
have been duly authorized and approved by the board of directors of CRII and
this Agreement constitutes a valid and binding agreement of CRII in accordance
with its terms.
6. HTR COVENANTS, REPRESENTATIONS, AND WARRANTIES
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6.1 HTR has not knowingly withheld from CRII, during the course of
CRII's due diligence investigation of HTR or at any other time, any material
facts relating to HTR's business, operations, financial condition or prospects.
No representation or warranty in this Agreement or in any certificate, exhibit,
schedule, statement or other agreement, instrument or document furnished by HTR
under or in connection with this Agreement contains or will contain any untrue
statement of a material fact or omits to state any material fact necessary to
make the statements herein or therein not misleading.
6.2 HTR has the ability to distribute, market and sell the IVF
Workstation and Zona Laser Treatment System worldwide and will diligently pursue
same.
6.3 The execution and delivery by HTR of this Agreement and any
other documents contemplated hereby, and the performance by HTR of any of its
obligations herein will not conflict with, result in a breach or violation of
the terms or conditions of, or constitute a default under any contract or
agreement of HTR, its Articles of Incorporation or By-laws, or any order,
judgment, statute, rule or regulation to which HTR is subject.
6.4 The execution, delivery, and performance of this Agreement
have been duly authorized and approved by the board of directors of HTR and this
Agreement constitutes a valid and binding agreement of HTR in accordance with
its terms.
7. INDEMNIFICATION
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7.1 CRII indemnifies and holds HTR harmless from and against any
and all liabilities, losses, damages, claims, deficiencies, costs and expenses
(including, without limitation, reasonable attorney fees and other costs and
expenses) incident to any suit, action or proceeding arising out of or resulting
from:
(a) Notwithstanding the terms of Section 5.2 and 5.3, any action,
proceeding, or claim involving an express or implied allegation that the
parties' exploitation of any of the rights granted or licensed by CRII to HTR
herein constitutes infringement of intellectual property rights belonging to
another person;
(b) Any claim arising from the existence, operation or use of the IVF
Workstation and Zona Laser Treatment System, based upon alleged defects in
design, material, or workmanship.
(c) The breach or inaccuracy of any warranty or representation by
CRII herein;
(d) Any breach or failure to perform by CRII of any material term,
covenant, or condition herein;
(e) Any act or omission of CRII, its officers, employees, or agents
in the performance of its obligations or conduct of its business whether under
this Agreement or otherwise; or
(f) Any costs and expenses of an FDA recall including, without
limitation, shipping expenses and purchaser notification.
7.2 HTR indemnifies and holds CRII harmless from and against any and all
liabilities, losses, damages, claims, deficiencies, costs and expenses
(including, without limitation, reasonable attorney fees and other costs and
expenses) incident to any suit, action or proceeding arising out of or resulting
from:
(a) The breach or inaccuracy of any warranty or representation by HTR
herein;
(b) Any breach or failure to perform by HTR of any material term,
covenant, or condition herein;
(c) Any act or omission of HTR, its officers, employees, or agents in the
performance of its obligations or conduct of its business whether under this
Agreement or otherwise; or
(d) Any claim arising from the existence, operation or use of the IVF
Workstation and Zona Laser Treatment System based upon defects in workmanship,
if and only if HTR exercises its rights under Section 4.1 and the above
equipment was manufactured by HTR.
7.3 CRII and HTR mutually shall have the right to institute action against
third persons alleging infringement of any patent or patent rights incorporated
in the IVF Workstation and Zona Laser Treatment System products. Any action so
instituted by the parties shall name both parties as plaintiffs or claimants and
the parties shall contribute and participate equally in the expense of the suite
and distribution of any damages recovered. In the event the parties do not
mutually agree to institute any such action, either party may institute action
in its name only and the instituting party shall bear the expense of litigation
and shall be entitled to retain all damages recovered in such action. Any
commencement of action solely by HTR alleging infringement of patents or patent
rights conveyed to HTR herein shall not cause a waiver or forfeiture of any
other claim or remedy HTR may have against CRII under CRII's representations,
warranties, covenants, or obligations herein.
8. INSURANCE
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8.1 CRII agrees to keep in force throughout the duration of this
Agreement Directors & Officers and General Commercial Liability, including
product liability coverage, insurance coverage in the following amounts:
Directors and Officers insurance of $2,000,000, and General Commercial Liability
insurance of $2,000,000, with a $10,000,000 umbrella. CRII's Product Liability
policy shall name HTR as an additional insured. CRII will provide HTR with
current certificates of insurance evidencing such coverages. CRII will provide
HTR with at least 30 days written notice of any cancellation, non-renewal or
amendment of such policies.
8.2 HTR agrees to keep in force throughout the duration of this
Agreement Product Liability and Property Damage insurance coverage in amounts
equivalent to coverages maintained by CRII. HTR's Product Liability policy shall
name CRII as an additional insured. HTR shall provide CRII with current
certificates of insurance evidencing such coverage's on or before this Agreement
is executed. HTR will provide CRII with at least 60 days written notice of any
cancellation, non-renewal or amendment of such policies.
9. TERM & TERMINATION
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9.1 This Agreement shall have an initial term of three years
following the effective date and, unless either party provides the other written
notice of intent not to renew at least ninety days prior to the last day of the
initial or any renewal term, this Agreement shall automatically renew for two
successive one year terms. In the event that HTR exercises its rights under
section 4.1 of this Agreement, the royalty payments will continue throughout the
life of the technology (as described in
section 1.1) so long as the technology is being sold by HTR.
9.2 Except as provided for in Section 11.3, either party shall
have the right to terminate this Agreement in the event of any of the following:
(a) A party breaches the Agreement and does not cure such breach
within 60 days after notice from the non-breaching party specifying the nature
of such breach.
(b) The dissolution, insolvency, bankruptcy or appointment of a
trustee or receiver for a party, whether voluntary or involuntary and bankruptcy
is not dismissed within 60 days.
9.3 In addition to the other provisions of this Agreement, in the
event HTR shall fail to purchase the minimum number of IVF Workstation and Zona
Laser Treatment System units required under Section 3.3, and such failure shall
continue after 60 days' written notice, CRII shall have the right, at its sole
election, to either (i) terminate this Agreement or (ii) modify the rights
granted to HTR under this Agreement from exclusive to non-exclusive. CRII's
failure to reasonably meet minimum production volumes, product quality standards
and timely shipping requirements, subject to causes beyond CRII's control and
after 60 days written notice, shall be grounds for HTR to either (i) terminate
the Agreement pursuant to this Section 9.3 or (ii) exercise the provisions of
Section 4.1 of this Agreement. In the event this Agreement is terminated
pursuant to this Section 9.3, then HTR may sell, and in which case CRII shall
purchase, at fair market value within 60 days following termination, all
manufacturing equipment, devices, materials, inventory, processes, know-how, and
any other property owned by HTR and applied to the production of IVF
Workstations and Zona Laser Treatment Systems.
9.4 Termination of this Agreement for any reason shall not relieve a
party of any obligation owing at the time of the termination.
10. CONFIDENTIALITY
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10.1 The parties acknowledge that the transactions herein will require
the exchange of information which is or may be confidential or proprietary. As
used herein, the term "Confidential Information" shall mean (i) proprietary
information of any of the parties; (ii) information marked or designated by any
of the parties as confidential; (iii) information, whether or not in written
form and whether or not designated as confidential, which is known to a party as
being treated as confidential by the other party; and (iv) information provided
to any party by third parties which any party is obligated to keep as
confidential. Confidential Information includes, but is not limited to,
discoveries, ideas, designs, specifications, drawings, techniques, models, data,
programs, documentation, processes, know-how, customer lists, marketing plans,
and financial and technical information. Confidential Information shall not
include any information of a party now or hereafter voluntarily disseminated by
that party to the public, or which otherwise becomes part of the public domain
through lawful means.
10.2 Each party hereby acknowledges that each party's Confidential
Information is and shall continue to be the exclusive property of such party,
whether or not disclosed or entrusted under this Agreement. Each party agrees to
exercise the highest degree of care in safeguarding the Confidential Information
of the other party against loss, theft, or other inadvertent disclosure, and
agrees generally to take all steps necessary to ensure the maintenance of
confidentiality.
10.3 Upon termination of this Agreement, or as otherwise reasonably
requested, each party agrees to deliver promptly to the owning party all
Confidential Information of the owning party, in all forms and copies, that may
be in the non-owning party's possession or under its control.
10.4 Each party acknowledges that any disclosure of Confidential
Information in violation
of this Agreement will cause irreparable harm to the owning party. If a party
fails to abide by the requirements of this Section 10, the other party will be
entitled to specific performance immediate issuance of a temporary restraining
order or preliminary injunction, and to judgment for any damages caused by such
breach, as well as expenses and reasonable attorneys fees incurred in
enforcement of these rights, in addition to and not to the exclusion of nay
other remedies provided in equity or at law.
10.5 The terms of this Section 10, and the rights and obligations
created herein, shall survive the termination of this Agreement for any reason.
11. MISCELLANEOUS
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11.1 This agreement shall be binding upon and inure to the benefit of
the parties and their legal representatives, successors, and assigns. Subject to
Section 2.3, this Agreement and the various rights and obligations herein may
not be assigned without the mutual written consent of the parties.
11.2 Any notices permitted or required under this Agreement shall be
deemed given upon the date of personal delivery, 24 hours after deposit with an
overnight express delivery service, or 72 hours after deposit in the United
States mail, postage fully prepaid, addressed to the respective party:
If to HTR:
Xxxxxxxx Xxxxxx Research
000 Xxxxxxxx Xxxxxx, Xxxxx 000X
Xxxxxxx, XX 00000-0000
Attn: President
With copy to:
Xxxxxxx X. Xxxx, Esquire
Ardiff & Xxxxx
One Corporate Place - 3/rd/ Floor
00 Xxxxxxxxx Xxxx
Xxxxxxx, XX 00000
If to CRII:
Cell Robotics International, Inc.
0000 Xxxxxxxxx Xxxxxxx, XX
Xxxxxxxxxxx, XX 00000
Attn: President
With copy to:
Xxxxxxxx X. Xxxxxx, Esq.
Xxxxxx & Xxxxxxx, LLC
0000 Xxxx Xxxxxx
Xxxxxxx, XX 00000
or at any other address as any party may, from time to time, designate by notice
given in compliance with this Section.
11.3 This Agreement shall be governed by and construed in accordance
with the laws of the State of Colorado without regard to its choice of law
provisions.
11.4 This Agreement contains the entire understanding between the
parties with respect to the subject matter herein and supercedes any prior
understandings and agreements among them regarding the same.
11.5 In the event of any action by a party under this Agreement to
enforce any of its terms, it is agreed that the prevailing party shall be
entitled to recovery its costs and reasonable attorneys fees in bringing or
defending such action.
11.6 This Agreement or any section hereof shall not be construed
against a party due to the fact that the Agreement or any section was drafted by
that party.
11.7 If any provision of this Agreement or application of a
provisions held to be invalid or unenforceable, the remainder of this Agreement
and the enforceability thereof shall not be affected by such determination.
11.8 Any failure or delay be a party to enforce this Agreement or an
right herein shall not constitute in any instance a waiver of such right or
ability to obtain a permitted remedy.
11.9 This Agreement may not be amended or supplemented except by a
written instrument signed by the parties. Any action by a party contrary to or
in modification of the terms of this Agreement shall not create a new agreement
among the parties unless specifically consented to in writing by the non-acting
party.
Agreed and Accepted by:
XXXXXXXX XXXXXX RESEARCH CELL ROBOTICS INTERNATIONAL, INC.
/s/ Xxx X. Xxxxxxxx /s/ Xxxxxx X. Xxxxxxxx, Ph.D.
_________________________ _________________________________
By: Xxx X. Xxxxxxxx By: Xxxxxx X. Xxxxxxxx, Ph.D.
President and CEO President and CEO