Exhibit
99.1
National
Institute on Drug Abuse
Medications
Development Program
STANDARD
AGREEMENT FOR SUBMITTING COMPOUNDS FOR
PRECLINICAL
PHARMACOLOGICAL, PHARMACOKINETIC
AND
TOXICOLOGICAL EVALUATION
THIS
AGREEMENT, made and entered into on the
19
th
day of
October
, 2015, by and between the National Institute
on Drug Abuse (hereinafter referred to as “NIDA”), a component of the National Institutes of Health (NIH); and Cortex
Pharmaceuticals, a corporation having executive offices at _126 Valley Rd. Suite C Glen Rock, NJ 07452, (hereinafter referred
to as “COMPANY”);
WHEREAS,
COMPANY is the owner of
allosteric modulators of the AMPA receptor, called Ampakines
(hereinafter referred to as
“COMPOUNDS”) and certain proprietary information pertaining thereto, which may be useful in the treatment of drug
abuse and drug addiction;
WHEREAS,
NIDA has certain conventional preclinical assays (hereinafter referred to as “CONVENTIONAL TESTS”) which may be useful
in the pharmacological, pharmacokinetic, and toxicological evaluation of compounds which may prove effective in the treatment
of drug abuse and drug addiction.
WHEREAS,
COMPANY wishes to have its proprietary compounds tested by NIDA in CONVENTIONAL TESTS and not administered to humans, and
WHEREAS,
the parties wish to enter into arrangements to be used in the confidential testing of COMPANY compounds by NIDA;
NOW
THEREFORE, the parties agree as follows:
Article
1
. From time to time COMPANY will supply to a facility under contract to NIDA (hereinafter referred to as a “NIDA CONTRACTOR”)
or to a Government laboratory designated by NIDA, the above-mentioned COMPOUNDS and/or other compositions of matter patented or
unpatented, for testing so that NIDA may evaluate the pharmacological, pharmacokinetic, and toxicological properties of such COMPOUNDS
for preclinical evaluation for potential use as medications for the treatment of drug abuse and drug addiction. COMPANY shall
have the right to review all protocols used in testing of COMPOUNDS.
Information
relating to the COMPOUNDS themselves, including their chemical structure or other identifiers, their physical properties, their
biological activity, and the identity of the provider of COMPOUNDS, will be provided to NIDA by COMPANY and appropriately marked
as “Confidential” (hereinafter referred to as “COMPANY CONFIDENTIAL INFORMATION”). Information will be generated
on COMPOUNDS by NIDA CONTRACTORS and/or Government Laboratories using CONVENTIONAL TESTS (hereinafter referred to as “NIDA
DATA”).
Article
2
. In order to facilitate the record keeping and handling of COMPANY CONFIDENTIAL INFORMATION the parties agree as follows:
a.
At the time COMPANY supplies COMPOUNDS pursuant to Article 1, COMPANY shall forward to NIDA’s Division of Pharmacotherapies
and Medical Consequences of Drug Abuse (hereinafter referred to as “DPMCDA”) a data sheet for each COMPOUND giving pertinent
available data as to chemical formula, structure, purity, solubility, melting point, other physical characteristics, stability,
toxicity, and precautions which need to be followed in handling and storing of the COMPOUND. After authorization from DPMCDA,
COMPANY shall ship the COMPOUND(s) directly to the NIDA CONTRACTOR specified by DPMCDA.
b.
DPMCDA will inform COMPANY which COMPOUNDS are new to DPMCDA and which submitted COMPOUNDS duplicate any COMPOUNDS previously
existing in NIDA’s structure-activity database.
c.
COMPANY CONFIDENTIAL INFORMATION will not be disclosed by NIDA unless required by law. Only those FEDERAL GOVERNMENT or NIDA CONTRACTOR
employees with a need to know will have access to COMPANY CONFIDENTIAL INFORMATION.
d.
NIDA shall require that COMPANY CONFIDENTIAL INFORMATION will be retained by NIDA CONTRACTORS, and shall not be released, published,
or disclosed without the written consent of NIDA after consultation with COMPANY.
e.
NIDA shall make no use of the COMPOUNDS and COMPANY CONFIDENTIAL INFORMATION other than for purposes stated in Article 1 without
COMPANY’s written permission.
f.
NIDA shall return to COMPANY and eliminate from the NIDA testing process any COMPOUND that COMPANY may designate prior to commencement
of CONVENTIONAL TESTS.
g.
The foregoing restrictions on use and disclosure of COMPANY CONFIDENTIAL INFORMATION hereunder shall not apply to any information
which was in NIDA’s possession or control prior to the date of COMPANY’s disclosure or to any information which is
in the public domain through no improper act on the part of NIDA, its employees or contractors, or which is available without
restriction from any source, including COMPANY.
Article
3
. COMPANY, in voluntarily supplying COMPOUNDS hereunder, is entitled to protection for the research and development work
it has done and for any COMPANY CONFIDENTIAL INFORMATION, while NIDA has the responsibility to facilitate the development of medications
for the treatment of drug abuse and drug addiction. Accordingly, the parties agree as follows:
a.
NIDA agrees that all preexisting rights in those COMPOUNDS in which COMPANY has a proprietary interest shall remain in COMPANY.
Inasmuch as this Agreement concerns only the evaluation of COMPANY’s COMPOUNDS in CONVENTIONAL TESTS, NIDA recognizes that
the mere performance of said CONVENTIONAL TESTS
and
nothing
more
does not constitute invention.
b.
Contracts between NIDA and NIDA CONTRACTORS carrying out CONVENTIONAL TESTS on submitted COMPOUNDS, will contain terms to implement
the provisions of this Agreement relating to NIDA CONTRACTORS and to safeguard the rights of COMPANY under this Agreement.
c.
NIDA shall be informed in writing whenever COMPANY desires to include NIDA DATA in any publication, and appropriate credit shall
be given to the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA.
Article
4
. As soon as NIDA DATA is reported to NIDA, NIDA agrees to provide this information to COMPANY. If a COMPOUND is found to
exhibit properties that suggest its potential for safe use in the treatment of drug abuse and drug addiction, NIDA will advise
COMPANY to that effect.
Article
5
. It is understood that COMPANY shall not be liable to the Government for any claims or damages which may result from the
testing of COMPOUNDS while in NIDA’s or the NIDA CONTRACTORS’ custody, except if claims or damages are the result
of negligence on the part of COMPANY.
Article
6
. In performing the CONVENTIONAL TESTS hereunder, NIDA and NIDA CONTRACTORS shall function independently and not as employees
or agents of COMPANY.
Article
7
. The construction, validity, performance, and effect of this Agreement shall be governed by Federal law, as applied by the
Federal Courts in the District of Columbia.
Article
8
. This Agreement shall become effective upon the date hereinabove set forth.
SIGNATURES
ON NEXT PAGE
Acceptance
of the foregoing terms and conditions shall be indicated in duplicate by signatures below of the authorized representatives of
each party.
COMPANY
:
Cortex Pharmaceuticals
|
/s/
Richard Purcell
|
|
Date:
10/19/15
|
|
Name
(Type or Print):
Richard Purcell
|
|
|
|
Title:
Senior Vice President
|
|
|
COMPANY
Department: Research & Development
COMPANY
Name: RespireRx Pharmaceuticals
COMPANY
Address: 126 Valley Rd, Suite C, Glen Rock, NJ 08542
NATIONAL
INSTITUTE ON DRUG ABUSE
:
|
/s/
Nora D. Volkow
|
|
Date:
10/21/2015
|
Nora D.
Volkow, M.D.
Director,
National
Institute on Drug Abuse
Neuroscience
Center, Room 4123
6001 Executive
Boulevard, MSC 9551
Bethesda,
Maryland 20892-9551
Exhibit 99.2
RespireRx
Pharmaceuticals Inc. Announces New Research Program with the National Institute of Drug Abuse
RespireRx
Expands Research Initiatives Involving Treatments for Drugs of Abuse
Glen
Rock, N.J., January 19, 2016/Globe Newswire - RespireRx Pharmaceuticals Inc. (OTC: RSPI) (“RespireRx” or the “Company”)
announces that the Company has reached agreement with the Medications Development Program of the National Institute of Drug Abuse
(“NIDA”) for NIDA to conduct research on RespireRx compounds CX717 and CX1739. Pursuant to this program, NIDA will
evaluate the Company’s proprietary ampakine compounds in a series of preclinical pharmacologic, pharmacokinetic and toxicologic
protocols to determine their potential effectiveness for the treatment of drug abuse and addiction. Initial studies will focus
on cocaine and methamphetamine addiction and abuse and be contracted to outside testing facilities and/or government laboratories,
with all costs to be paid by NIDA. RespireRx will provide NIDA with supplies of CX1739 and CX717 and will work with the NIDA staff
to refine the protocols and dosing parameters for these animal models of addiction. RespireRx will retain all intellectual property,
proprietary and commercialization rights to these compounds.
The
Company’s participation in the Medications Development Program follows the completion of a National Institutes of Health
Small Business Innovation Research (“SBIR”) contract with NIDA to evaluate the ability of CX1942, another ampakine
compound, to antagonize the respiratory depression induced by the opiate fentanyl.
“In
keeping with our strategic focus on developing drugs for respiratory indications, the Company is seeking to realize the full value
of its compounds by working with development partners to fund the non-respiratory uses of its compounds,” said Dr. Arnold
Lippa, Executive Chairman and Chief Scientific Officer of RespireRx.
Richard
Purcell, Senior Vice President, Research and Development, for RespireRx, added, “Through non-dilutive grants and partnerships
with government agencies like NIDA, the Company is able to advance the development of its ampakine compounds for unmet clinical
needs, not only in the field of respiratory disorders, but also in the related fields of addiction and other central nervous system
disorders.”
About
RespireRx Pharmaceuticals Inc.
RespireRx
Pharmaceuticals Inc.
is a leader in the development of drugs for respiratory disorders, with a focus on sleep apneas and
drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent applications for certain
families of chemical compounds that claim the chemical structures and their use in the treatment of a variety of disorders, as
well as claims for novel uses of known drugs.
RespireRx
Pharmaceuticals Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452
www.respirerx.com
RespireRx’s
pharmaceutical candidates in development are derived from two platforms, as described below.
The
first platform is the class of compounds known as cannabinoids, in particular, dronabinol. Under a license agreement with the
University of Illinois, the Company has rights to patents claiming the use of cannabinoids for the treatment of sleep-related
breathing disorders. In a double-blind, placebo-controlled, dose-ascending Phase 2A clinical study conducted by the Company, dronabinol
produced a statistically significant reduction in the Apnea-Hypopnea Index, the primary therapeutic end-point, and was observed
to be safe and well-tolerated in a group of patients with Obstructive Sleep Apnea (“OSA”). The University of Illinois
and three other centers currently are investigating dronabinol in a potentially pivotal, six week, double-blind, placebo-controlled
Phase 2B clinical trial in 120 patients with OSA. This study, which the University of Illinois has indicated it expects to be
completed during the second quarter of 2016, is fully funded by the National Heart, Lung and Blood Institute of the National Institutes
of Health. The Company is not managing or funding this ongoing clinical trial.
The
second platform of medicines being developed by RespireRx is a class of proprietary compounds known as ampakines, which act to
enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral
and injectable form, are being developed by the Company for the treatment of a variety of breathing disorders. In clinical studies,
select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced
by opiates, without altering their analgesic effects. In animal models of orphan disorders, such as Pompé Disease, spinal
cord damage and perinatal respiratory distress, it has been demonstrated that certain ampakines improve breathing function. The
Company’s compounds belong to a new class of ampakines that do not display the undesirable side effects previously reported
in animal models of earlier generations.
Additional
information about the Company and the matters discussed herein can be obtained on the Company’s web-site at
www.RespireRx.com
or in the Company’s filings with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov
.
Special
Note Regarding Forward-Looking Statements
: Certain statements included or incorporated by reference in this news release,
including information as to the future financial or operating performance of the Company and its drug development programs, constitute
forward-looking statements. The words “believe,” “expect,” “anticipate,” “contemplate,”
“target,” “plan,” “intend,” “continue,” “budget,” “estimate,”
“may,” “schedule” and similar expressions identify forward-looking statements. Forward-looking statements
include, among other things, statements regarding future plans, targets, estimates and assumptions. Forward-looking statements
are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company, are inherently
subject to significant business, economic and competitive uncertainties and contingencies. Many factors could cause the Company’s
actual results to differ materially from those expressed or implied in any forward-looking statements made by, or on behalf of,
the Company. Due to these various risks and uncertainties, actual events may differ materially from current expectations. Investors
are cautioned that forward-looking statements are not guarantees of future performance and, accordingly, investors are cautioned
not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. Forward-looking statements are
made as of the date of this news release and the Company disclaims any intent or obligation to update publicly such forward-looking
statements, whether as a result of new information, future events or results or otherwise.
Company
Contact:
Jeff
Margolis
Vice-President,
Treasurer and Secretary
Telephone:
(917) 834-7206
E-mail:
jmargolis@respirerx.com
RespireRx
Pharmaceuticals Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452
www.respirerx.com