EXHIBIT 10.14
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CONSULTING AGREEMENT
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THIS CONSULTING AGREEMENT entered into as of the 1st day of November, 1996,
by and between LASERSIGHT TECHNOLOGIES, INC., a Delaware corporation, with its
principal place of business at 00000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxxx, XX 00000
(the "Company") and XXXXXXXX X. XXXXXXXX, Ph.D., whose address is 000 Xxxx Xxxx
Xxxxx, Xxxxxx, XX 00000 ("Consultant").
Background of agreement
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Consultant is an expert in regulatory and clinical affairs with respect to
submission of medical device documents to the U.S. Food and Drug Administration
("FDA") and competent authorities and IRB's for review and approval.
The Company desires to engage the services of Consultant to assist the
Company with the preparation and prosecution of applications for approval of its
surgical lasers by the FDA or other regulatory authorities, and Consultant
desires to provide such services on the terms set forth in this Agreement.
Terms of agreement
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In consideration of the mutual promises and covenants contained herein, the
parties agree as follows:
1. Consulting Services. The Company hereby engages the Consultant to serve
as its internal director of regulatory affairs with the following duties:
(a) Consultant shall have responsibility and oversight of the Company's
regulatory and clinical development projects, subject, in all cases, to
final approval of all actions by the President of the Company.
(b) Consultant shall prepare in a timely and effective manner all Company
submissions to the FDA, serve as the Company's principal liaison to the
FDA, monitor all of the Company's clinical trials for adherence to
appropriate regulatory protocols, and assure proper conduct of such
clinical trials pursuant to the applicable laws and regulations of the
United States, Canada, and other foreign nations in which the Company is
planning to sell or license its technologies. Consultant shall obtain the
approval of the President of the Company prior to submission of any
protocol.
(c) Once PMA approvals are obtained, Consultant shall take measures
necessary to ensure that all post-marketing surveillance requirements are
being met by the sales and marketing arms of the Company including
assurance of the compliance of advertising claims and collection of any
follow-up data required by FDA.
(d) Consultant shall insure proper IRB approvals are obtained, oversee the
proper development, completion, and signing of informed consent documents
by all clinical trial participants, and assure that the Company's clinical
trials and research meet the Declaration of Helsinki ethical requirements.
(e) Consultant shall oversee the Company's internal and clinical inspection
procedures and activities to insure their compliance with all requirements
of applicable U.S. and foreign regulatory agencies.
(f) Consultant shall assure the proper creation and maintenance of
appropriate files and record-keeping for clinical investigators under
agreement to the Company to insure compliance with all applicable U.S. and
foreign regulatory requirements and the availability of useful and
effective data for such submissions.
(g) Consultant shall serve as a Company liaison with applicable regulatory
authorities for the purpose of presenting and interpreting statistical data
obtained by the Company in its clinical trials, subject, in all cases, to
the prior review and approval by the President of the Company or his
designee of the information and conclusions to be presented by Consultant
from such data.
(h) Consultant shall serve as an interface for the Company with HIMA
regulatory and FDA groups and shall attend meetings and conferences the
Company deems appropriate.
(i) Consultant shall perform such other services as the Company reasonably
requests consistent with her experience and the general scope of this
Agreement.
2. Compensation. As compensation for the Consultant's services herein to
the Company, the Consultant shall receive the following:
(a) The Company shall pay to the Consultant a monthly fee of $5,500 on or
about the first day of each month for services rendered by Consultant
during the immediately preceding month against Consultant's invoice to the
Company.
(b) The Company shall provide Consultant a monthly housing allowance of
$1,000.
(c) In addition to the cash compensation described above, the Consultant
shall be entitled to receive options to purchase shares of the Company's
common stock at the times and in the manner as described below. Each time a
protocol is submitted and accepted by the FDA for a new IDE study,
Consultant shall be issued an option to purchase shares of the Company's
common stock, as follows: An option to purchase 5,000 shares shall be
issued to Consultant at the time of submission of the protocol ("FDA
Submission Options") and an additional option to purchase 5,000 shares
shall be issued to Consultant at the time of FDA approval of said protocol
("FDA Approval Options"). These options shall be for a term of five (5)
years from the date of issuance, subject to the approval of the Company's
Stock Option Committee, granting the Consultant the right to purchase
shares of the Company's common stock at a purchase price equal to 100% of
the fair market value of the shares of the Company's Common Stock as more
fully set forth in and in accordance with the terms of one or more of the
Company's stock option plans. The Company's Stock Option Committee shall
have sole discretion to determine from which of the Company's stock option
plans these options will be granted to Consultant. Consultant shall
develop, implement, and maintain a system for providing advance
notification to the Company's Stock Option Committee and Chief Financial
Officer of each FDA submission and anticipated FDA approval.
(d) The Company shall reimburse Consultant for all reasonable and necessary
expenses in connection with Consultant's travel on Company-related
business. Consultant shall provide documentation required by the Company to
support each claim for expense reimbursement and shall seek advance
approval of the President of the Company for travel expenses or other
significant expenses.
(e) Each invoice from Consultant shall set forth all fees, allowances, and
expenses payable by the Company for the month in question. The invoice
shall be accompanied by a detailed report from Consultant in a form
approved by the Company on the specific duties completed by her during the
month for which payment is sought. Company shall have no obligation to pay
any amounts to Consultant until such time that Company has received
Consultant's invoice and report for an applicable month.
3. Term. The term of this Agreement shall be two (2) years from the
effective date set forth above unless sooner terminated as set forth below. This
Agreement shall be automatically renewed for successive one (1) year terms at
the end of the initial term and any renewal term unless either party provides
the other notice of its intention not to renew this Agreement at least sixty
(60) days prior to the expiration of the initial term or any renewal term of
this Agreement. Either party may terminate this Agreement immediately upon
notice to the other in the event of the material breach or default by the other
party of any material term or condition of this Agreement.
4. Independent Contractor. The Consultant shall have no authority to
represent the Company as, and is not, an agent, partner, or employee of the
Company. The Consultant shall obtain specific authority or approval from the
President of the Company for each instance in which Consultant will submit
information to, or appear before, any regulatory or governmental authority on
behalf of the Company. The Consultant in all respects shall be deemed an
independent contractor with respect to the performance by the Consultant of her
obligations hereunder and shall be solely responsible for any and all taxes on
any compensation payable hereunder.
5. Confidentiality and Nondisclosure. The Consultant acknowledges that, to
the best of her knowledge, the Company is the sole and exclusive owner of all
rights and remedies in and to the Laser Harmonic(TM) System, the Tunable
SoliMed(TM) System, the Compak 200 Mini-Excimer, LaserScan 2000 System, and the
proprietary and technological information concerning same, and all products or
information derived, or to be derived, from Consultant's assistance. In the
event that any trade secret or proprietary information owned by the Company or
provided to the Company by Consultant becomes the subject of a patent
application under the laws of the United States or any other country, Consultant
agrees and understands that the Company shall have all rights and remedies
relating thereto.
The Consultant acknowledges that, during the term of this Agreement, she will
have access to, or become aware of, trade secret information owned and possessed
by the Company or its subsidiaries. Consultant agrees to hold in confidence all
such trade secret information disclosed to her or developed by her in connection
with this Agreement. The Consultant shall not, at any time during this Agreement
or subsequent thereto, disclose or use any trade secret or proprietary
information, or engage in or refrain from any action where such action or
inaction may result: (a) in the unauthorized disclosure of any or all of the
trade secrets to any person or entity; or (b) in the infringement of any or all
such rights.
Consultant hereby agrees that she is a "consultant-for-hire," as defined in the
United States regarding copyrights. All products of this Agreement shall be
deemed "works made for hire," as defined by the laws of the United States
regarding copyrights.
Consultant shall promptly disclose to the Company, in writing, if requested, any
and all inventions, discoveries, or improvements conceived of or made by
Consultant as a result of Consultant's services provided hereunder or relating
to the proprietary rights or trade secrets of the Company or its subsidiaries.
Consultant shall assign, and hereby agrees to assign, all of her interest to the
Company in and to any such matters described in the preceding sentence. This
obligation shall continue beyond the term of this Agreement with respect to
inventions, discoveries, and improvements conceived of or made by the Consultant
during the period of this Consulting Agreement and shall be binding upon the
Consultant's assigns, executors, administrators, or legal representatives.
6. Independent Contractor. Both the Company and the Consultant agree that
the Consultant will act as an independent contractor in performing her duties
under this Agreement. Accordingly, the Consultant shall be responsible for
payment of all taxes, including federal, state, and local taxes arising out of
Consultant's activities in accordance with this contract, including by way of
illustration but not limitation, federal and state income tax, social security
tax, unemployment tax, and other business taxes. Additionally, Consultant shall
have no authority, either expressed or implied, to act or represent that she is
acting on behalf of the Company, except in those instances where the Company has
given her prior written consent and approval.
7. Assignment. This Agreement may be assigned by the Company to any
subsidiary or affiliated company or successor to its business but may not be
assigned by the Consultant.
8. Applicable Law and Binding Effect. This Agreement shall be governed by
and construed in accordance the laws of the State of Florida and shall inure to
the benefit of and be binding upon the respective heirs, personal
representatives, successors, and assigns or the parties hereto. Jurisdiction
shall vest in the applicable federal and state courts residing in Orange County,
Florida. Venue for any proceeding shall be in Orange County, Florida.
9. Multiple Copies or Counterparts of Agreement. The original and one or
more copies of this Agreement may be executed by one or more of the parties
hereto. In such event, all of such executed copies shall have the same force and
effect as the executed original, and all of such counterparts, taken together,
shall have the effect of a fully executed original.
10. Legal Fees. In the event any litigation or arbitration arises out of or
in connection with this Agreement, the prevailing party in such litigation or
arbitration shall receive from the other party all of its court costs and legal
expenses, including reasonable attorneys' fees, incurred in any such litigation
or arbitration, including those associated with appellate and post-judgment
collections proceedings.
11. Waiver or Modification No waiver or modification of this Agreement or
of any covenant, condition, or limitation herein contained shall be valid unless
in writing and duly executed by the party to be charged therewith. Furthermore,
no evidence of any waiver or modification shall be offered or received in
evidence in any proceeding, arbitration, or litigation between the parties
arising out of or affecting this Agreement or the rights or obligations of any
party hereunder, unless such waiver or modification is in writing and duly
executed as aforesaid. The provisions of this paragraph may not be waived except
as herein set forth.
12. Entire Agreement. This Agreement constitutes the entire agreement of
the parties hereto with respect to the subject matter of this Agreement and
supersedes any and all previous agreements between the parties with respect to
such subject matter, whether written or oral.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement the day
and year first above written.
"COMPANY"
LASERSIGHT TECHNOLOGIES, INC.
/s/ Xxxxxxx X. Xxxx
By:--------------------------------
Xxxxxxx X. Xxxx, President
"CONSULTANT"
/s/ Xxxxxxxx X. Xxxxxxxx
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XXXXXXXX X. XXXXXXXX, Ph.D.
