Exhibit 10.11 Nutra Pharma Corp.
AGREEMENT FOR RESEARCH SERVICES
THIS AGREEMENT is by and among Nutra Pharma Corp., a California corporation with
principal executive offices located at 0000 XX 00xx Xxx, Xxxxx Xxxxxxx, Xxxxxxx
00000 ("Nutra Pharma") and Eno Research and Development, Inc. ("ERDI"), located
at X.X. Xxx 0000, Xxxxxxxxxxxx, XX 00000.
1. Terms and Duties
Nutra Pharma wishes ERDI to conduct, and ERDI hereby agrees to conduct research
on drug delivery technology ("plantumans") from Portage BioMed for a period of
one (1) year, commencing on the date this agreement is fully executed
("Effective Date") and terminating one year later.
In consideration of the payment provided herein, Nutra Pharma agrees to the
following conditions:
a. Nutra Pharma, through Portage BioMed, shall provide ERDI with a sufficient
number of plantumans for the proposed research ("Samples"). Research will be
performed according to the proposal listed in Appendix A, which is attached
hereto and incorporated herein by reference and which may be modified by mutual
written agreement from time to time. Any amendments to the Study and extent
thereof shall be mutually agreed in writing between the Official Correspondents
to this agreement, as the Study progresses. Such Samples, or any derivative
thereof, should not be used for any other purpose other than Study as stated in
such proposal and are provided without warranty of merchantability or fitness
for any particular purpose.
b. The Study will be performed at an ERDI laboratory or facility contracted by
ERDI. Nutra Pharma warrants that the Samples are not in violation of any third
party agreement or obligation. ERDI represents that the obligations undertaken
by ERDI under this Agreement are not in conflict with any third party agreement
or obligation.
x. XXXX agrees that the samples will not be administered to humans.
d. The term "ERDI" as used herein, shall be deemed to include Investigators and
any agents, employees and technicians ERDI utilizes in the performance of this
Agreement. The obligations and representations ERDI makes hereunder are also
imposed on the agents, employees and technicians of ERDI. ERDI shall advise such
persons of these obligations and representations.
e. Xxx X. Xxxxxxx shall be the Official Correspondent for Nutra Pharma. In the
event that ERDI needs to correspond with other Nutra Pharma personnel, a copy of
such correspondence shall be sent to Nutra Pharma's Official Correspondent at
the address above. In a similar fashion, ERDI's Official Correspondent shall be
Xxxxx X. Xxxxxxx. In the
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event that Nutra Pharma needs to correspond with other ERDI personnel, a copy of
such correspondence shall be sent to ERDI's Official Correspondent at the
address listed above.
f. ERDI shall provide Nutra Pharma with a final written report ("Final Report")
within thirty (30) days of completion of the Study. Nutra Pharma shall keep such
final written report confidential until the earlier of: (i) publication of the
Study by results by ERDI, as described herein; or (ii) five (5) years from the
termination or expiration of this Agreement, unless mutually agreed to in
writing by the Official Correspondents for this Agreement.
2. Compensation
a. For Phase I of this study as outlined in Appendix A, Nutra Pharma agrees to
pay ERDI a sum based on the cost of the Study, up to a maximum of Thirty Two
Thousand Dollars ($32,000.00) for the Study under this Agreement. The full sum
is due upon execution of this contract. Upon receipt of this payment, ERDI will
commence work on Phase I of this Study. Completion of Phase I marks Decision
Point 1 (DP1) for this Study. Should the Study be considered "successful" by
Nutra Pharma (with input from Portage BioMed), the Study will proceed to Phase
II as described in Appendix A. For Phase II of this study as outlined in
Appendix A, Nutra Pharma agrees to pay ERDI a sum based on the cost of the
Study, up to a maximum of Thirty Five Thousand Dollars ($35,000.00) for this
Phase of the Study under this Agreement. The full sum is to be paid before work
on Phase II can commence. This Study is expected to take 5 - 7 weeks to
complete. The actual total payment shall reflect the research completed under
this Agreement. In the event of early termination, costs shall be determined as
per Article 9.
b. As an independent contractor, ERDI shall be responsible for withholding and
payment of any and all income taxes and social security contributions that may
be required.
c. Further compensation, if required, shall be agreed in writing between the
parties.
3. Confidential Matters
a. ERDI shall keep in confidence all information relating to this Agreement
which may be acquired from Nutra Pharma in connection with the Study
("Information"). During the term of this agreement and for five (5) years
thereafter, without prior written consent of Nutra Pharma, neither ERDI nor any
of its agents or employees shall publish, communicate, divulge, disclose, or use
any of such Information acquired from Nutra Pharma which has been designated by
Nutra Pharma as
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proprietary Information. Upon termination or expiration of this Agreement, ERDI
shall deliver all such Information and copies thereof to Nutra Pharma and such
shall remain property of Nutra Pharma, save for one copy to be retained by ERDI
to ensure compliance with the duty of confidentiality.
b. Nothing in this Article 3 and Article 4, below, shall be construed to impose
a confidentiality obligation on ERDI in connection with any information to the
extent such information: (i) is at the time of disclosure already known to ERDI
on a non-confidential basis as clearly demonstrated by ERDI records; (ii) is at
the time of disclosure or subsequently becomes part of the public domain through
no fault or act of omission by ERDI; (iii) is subsequently disclosed to ERDI by
a third party whose receipt and disclosure of such information does not
constitute a violation of any confidentiality obligation; or (iv) is
independently developed by ERDI, as evidenced by its written records.
c. In the event that ERDI is requested by a court of law or regulatory agency to
provide Information, ERDI shall immediately notify Nutra Pharma and reasonably
co-operate with Nutra Pharma's efforts to obtain any and all protections
available for such Information prior to any such requested disclosure.
The obligations imposed on ERDI by this Article 3 and by Article 4, below, shall
survive any termination or expiration of this Agreement and the termination of
ERDI services hereunder.
4. Ownership
a. Nutra Pharma shall be free to use the results of this Study for its own
purposes, subject to any intellectual property rights that ERDI may have.
x. XXXX shall promptly and confidentially disclose to Nutra Pharma all
inventions, developments or discoveries that are made during the course of and
arise from the Study ("Inventions"). Ownership of such Inventions shall reflect
inventorship as determined by U.S. patent law, if patentable, and shall be
determined by mutual consent between the parties if not patentable. Nutra Pharma
shall have, without option fee other than the reimbursement of all patent
expenses for the subject Invention incurred prior to and during the option
period and appertaining license negotiation period, a first option to acquire an
exclusive worldwide royalty-bearing license to ERDI's rights in any Inventions.
Such option shall extend for ninety (90) days from the date of disclosure to
Nutra Pharma. Upon Nutra Pharma's exercise of its option, the parties shall
negotiate a license agreement in good faith.
x. XXXX shall be free to use the results of the Study for publication purposes
without the payment of royalties or other fees. Collaboration
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between ERDI and Nutra Pharma on any publication shall be sufficient to allow
one or more Nutra Pharma representatives authorship on said publication. ERDI
shall submit a copy of any proposed publication resulting from the study to
Nutra Pharma for review at least thirty (30) days prior to submission to a
publisher thereof. If Nutra Pharma determines that the proposed publication
contains subject matter requiring patent protection, then ERDI shall delay
publication for up to an additional sixty (60) days for the filing of patent
applications. Such publication shall not contain any Information provided by
Nutra Pharma without the prior written consent of Nutra Pharma.
d. Any abstracts or seminars pertaining to the results of the Study prior to
publication shall be made by representatives of ERDI after the content of said
abstract or seminar has been approved by Nutra Pharma. Preparation of the
presentation should follow the rules set for publication as described above.
5. Disclaimer
a. Nutra Pharma provides the Samples with the understanding that the Samples are
derived from human cell lines and DNA and as such could be inherently dangerous.
All reasonable and necessary precautions should be taken in the handling of
these Samples. It is Nutra Pharma's understanding that ERDI and its personnel
are skilled in the handling of such Samples. Nutra Pharma assumes no
responsibility or liability for any injury or harm caused by the handling of
such Samples, except for any such liability that may be traced to Nutra Pharma's
gross negligence or intentional malfeasance.
x. XXXX will defend and hold harmless Nutra Pharma, its officers, directors,
employees and agents from any claims for personal injury, death or property
damage arising out of ERDI's negligence or willful misconduct in connection with
the performance of this agreement.
c. Nutra Pharma acknowledges that ERDI may not know the therapeutic use that the
results of any study will be used for and acknowledges that ERDI has no control
over Nutra Pharma's use of such results. Nutra Pharma shall, therefore,
indemnify and hold ERDI, its officers, directors, agents, employees and
affiliates, harmless from any claim, liability, or expense arising directly or
indirectly from ERDI's association with Nutra Pharma as the result of this
Agreement and the Study, including, without limitation, any claim, liability or
expense arising out of the harmful or otherwise unsafe affect of the Study
materials or Nutra Pharma's use of the Study or its use for marketing of any
Study materials.
6. General Relationship
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In all matters relating to this agreement, ERDI acts as an independent
contractor. Neither ERDI nor ERDI employees are employees of Nutra Pharma under
the meaning or application of any federal or state unemployment or insurance
laws or worker's compensation laws, or otherwise. ERDI shall assume all
liabilities or obligations imposed by any one or more of such laws with respect
to the negligence or willful misconduct of ERDI employees in their performance
of this Agreement. ERDI shall not have any authority to assume or create any
obligation, express or implied, on behalf of Nutra Pharma and ERDI shall have no
authority to represent itself as an agent, employee, or in any other capacity of
Nutra Pharma. Nutra Pharma shall not, without prior written permission of ERDI,
use in advertising, publicity or otherwise, the name, symbol, logo or other
image of ERDI or ERDI's employees or agents.
7. Non-Assignability
In view of the specific nature of the Study to be performed by ERDI hereunder,
ERDI shall not have the right to assign or transfer any of its obligations,
rights or benefits hereunder without the prior written consent of Nutra Pharma.
However, Nutra Pharma may assign this Agreement to an Affiliate or to a
purchaser of all or substantially all of the business to which it pertains.
"Affiliate" shall mean any company directly or indirectly controlled or under
common control with Nutra Pharma. For this purpose, the terms "controlling",
"controlled", and "control" shall mean ownership, directly or indirectly, of at
least fifty percent (50%) or the maximum percentage allowed by law in the given
country, of the voting stock or general partnership interests of such
corporation, partnership or other entity.
8. Superseding Effect
This Agreement supersedes all prior oral or written agreements, if any, between
the parties relating to matters subject to this Agreement, and constitutes the
entire agreement between the parties. This Agreement may not be amended or
supplemented except by a writing signed by each of the parties.
9. Termination
Both parties reserve the right to cancel this Agreement for any reason upon
thirty (30) days prior written notice to the other party. If this Agreement is
so terminated, Nutra Pharma shall be liable only for payment for services
performed, costs incurred or irrevocably obligated and travel approved and
undertaken prior to the effective date of termination; provided, however, that
ERDI shall not be liable to return to Nutra Pharma any amount received prior to
the effective date of termination. Upon such termination, ERDI shall provide a
summary of all Study
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results to the date of termination to Nutra Pharma, and copies of the original
data as requested by Nutra Pharma.
10. Force Majeure
Either party shall be excused from performing its obligations with respect to
this Agreement if its performance is delayed or prevented by any cause beyond
such party's control, including, but not limited to, acts of God, fire,
explosion, weather, disease, war, insurrection, civil strife, riots, government
action, or power failure. Performance shall be excused only to the extent of and
during the reasonable continuance of such disability. Any deadline or time for
performance that falls due during or subsequent to the occurrence of any of the
disabilities referred to herein shall be automatically extended for a period of
time equal to the period of such disability. ERDI will immediately notify Nutra
Pharma if, by reason of any of the disabilities referred to herein, ERDI is
unable to meet any deadline or time for performance.
11. Applicable Law
The law of the State of North Carolina shall govern any controversy or claim
arising out of or relating to this Agreement. The parties agree that any action
or proceeding arising out of or related to this Agreement shall be brought only
in the state or federal courts located in North Carolina. The parties hereby
consent to such venue and to the jurisdiction of such courts over the subject
matter of such proceedings and themselves.
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IN WITNESS WHEREOF the parties hereto executed this Agreement below.
NUTRA PHARMA CORPORATION
By: /s/ Xxx X. Xxxxxxx
Name: Xxx X. Xxxxxxx
Title: President, CEO
Date: November 24, 2004
ENO RESEARCH & DEVELOPMENT INCORPORATED
By: /s/Xxxxx X. Xxxxxxx
Name: Xxxxx X. Xxxxxxx
Title: President, Chief Scientific Officer
Date: November 24, 2004
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Appendix A
Phase I of 4 Step Characterization Process as presented to Portage BioMed
1. Characterization of "Plantumans"
A novel cell such as this must be characterized.
* Scanning electron, light and fluorescence microscopy for
cellular composition and structure.
* Differential centrifugation to separate organelles
* Cytogenetics to determine genetic composition (human vs plant
chromosomes in the "plantuman")
2. Measure "Plantumans" drug absorption / release kinetics
Use 5-class chemotherapeutic screen: 5-FU (DNA antimetabolite), Taxol
(microtubule agent), CPT-11 (TopoI inhibitor), Adriamycin (TopoII
inhibitor) and Cytoxan (alkylator)
* Measure chemo uptake into "plantumans" over time by HPLC,
UV-Vis, fluorometery
* Measure chemo retention over time in buffer and plasma by
HPLC, UV-Vis, fluorometery
* Measure viability over time as a function of "plantuman"
exposure to chemo by MTS, calcein, trypan.
3. Evaluate selectivity of "plantumans" for cancer cells
Using ERDI's proprietary Tumor Specificity Assay to evaluate effect
of empty and loaded "plantumans" on normal and tumor cells at the same
time in multiple cancer lines
Prostate
Breast
Neuro
Ovarian
Lung
Epithelial
Phase II
4. Mouse Study
10 mice per group, endpoint is time for tumor to grow to five-times
initial volume or 5 weeks, whichever comes first
Option 1: 5 Groups - Untreated Control, Vehicle control, "plantumans"
+ vehicle, vehicle + drug, "plantumans" + vehicle + drug
Option 2: 7 Groups - Add second concentration of drug to demonstrate
dose dependence of system.
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