Palatin Technologies Inc 10-K for FY2020
Palatin Technologies Inc (PTN)
10-K
2020-09-25
For: 2020-06-30
View Original
Added on
April 06, 2026
About this 10-K
Palatin Technologies Inc filed this 10-K on September 25, 2020, covering the fiscal year ended June 30, 2020 (FY2020).
Headline figures
Fiscal year ended June 30, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $117.99K
- down 99.8% from $60.3M a year earlier
- Net loss
- $22.43M
- compared with net income of $35.77M a year earlier
- Diluted EPS
- -$0.10
- compared with $0.16 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10 – K
☑
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the
fiscal year ended June 30, 2020
Or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the
transition period from ___________ to __________
Commission
file number: 001-15543
PALATIN TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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95-4078884
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(State
or other jurisdiction of incorporation or
organization)
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(I.R.S.
Employer Identification No.)
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4B Cedar Brook Drive
Cranbury, New Jersey
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08512
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(Address
of principal executive offices)
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(Zip
Code)
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(609) 495-2200
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Trading Symbol
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Name of Each Exchange
on Which Registered
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Common
Stock, par value $.01 per share
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PTN
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NYSE
American
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Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as
defined in Rule 405 of the Securities Act. Yes ☐ No
☑
Indicate
by check mark if the registrant is not required to file reports
pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No
☑
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes ☑ No ☐
Indicate
by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for
such shorter period that the registrant was required to
submit). Yes ☑ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act.
|
Large
accelerated filer
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☐
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Accelerated
filer
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☐
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Non-accelerated
filer
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☑
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Smaller
reporting company
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Emerging
growth company
|
☐
|
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and
attestation to its management’s assessment of the
effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b))
by the registered public accounting firm that prepared or issued
its audit report. ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐ No
☑
State
the aggregate market value of the voting and non-voting common
equity held by non-affiliates, computed by reference to the price
at which the common equity was last sold, or the average bid and
asked price of such common equity, as of the last business day of
the registrant’s most recently completed second fiscal
quarter (December 31, 2019): $176,555,811
Indicate
the number of shares outstanding of each of the registrant’s
classes of common stock, as of the latest practicable date
(September 24, 2020): 229,855,417
PALATIN TECHNOLOGIES, INC.
Table of Contents
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Page
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PART
I
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1
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15
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37
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37
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37
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37
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PART
II
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38
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38
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38
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44
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45
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77
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77
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77
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PART
III
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78
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83
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92
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95
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95
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PART
IV
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96
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99
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i
Special Note Regarding Forward-Looking Statements
In this
Annual Report on Form 10-K (this “Annual Report”)
references to “we,” “our,”
“us,” the “Company” or
“Palatin” means Palatin Technologies, Inc. and its
subsidiary.
Statements
in this Annual Report, as well as oral statements that may be made
by us or by our officers, directors, or employees acting on our
behalf, that are not historical facts constitute
“forward-looking statements,” which are made pursuant
to the safe harbor provisions of Section 21E of the Securities
Exchange Act of 1934 (the “Exchange Act”). The
forward-looking statements in this Annual Report do not constitute
guarantees of future performance. Investors are cautioned that
statements that are not strictly historical facts contained in this
Annual Report, including, without limitation, the following are
forward looking statements:
●
our business,
financial condition, and results of operations may be adversely
affected by global health epidemics, including the novel strain of
coronavirus (“COVID-19”) pandemic, such as, for
example, increase in costs of and delays in conducting human
clinical trials and the performance of our contractors and
suppliers, and reduction in our productivity or the productivity of
our contractors and suppliers;
●
our ability to
successfully commercialize Vyleesi® (the trade name for
bremelanotide) for the treatment of premenopausal women with
hypoactive sexual desire disorder (“HSDD”) in the
United States, which may be adversely affected by delays or
disruptions related to the ongoing COVID-19 pandemic;
●
our ability to
develop the infrastructure to successfully manufacture, through
contract manufacturers, Vyleesi, and to successfully market and
distribute Vyleesi in the United States;
●
our ability to meet
post-marketing requirements of the U.S. Food and Drug
Administration (“FDA”) to conduct two additional
studies and one additional clinical trial for Vyleesi;
●
our expectations
regarding the potential market size and market acceptance for
Vyleesi for HSDD in the United States and elsewhere in the
world;
●
our expectations
regarding performance of our exclusive licensees of Vyleesi for the
treatment of premenopausal women with HSDD, which is a type of
female sexual dysfunction (“FSD”),
including:
o
Shanghai Fosun
Pharmaceutical Industrial Development Co. Ltd.
(“Fosun”), a subsidiary of Shanghai Fosun
Pharmaceutical (Group) Co., Ltd., for the territories of the
People’s Republic of China, Taiwan, Hong Kong S.A.R. and
Macau S.A.R. (collectively, “China”), and
o
Kwangdong
Pharmaceutical Co., Ltd. (“Kwangdong”) for the Republic
of Korea (“Korea”);
●
our expectations
and the ability of our licensees to timely obtain approvals and
successfully commercialize Vyleesi in countries other than the
United States;
●
estimates of our
expenses, future revenue and capital requirements;
●
our ability to
achieve profitability;
●
our ability to
obtain additional financing on terms acceptable to us, or at all,
including unavailability of funds or delays in receiving funds as a
result of the ongoing COVID-19 pandemic;
●
our ability to
advance product candidates into, and successfully complete,
clinical trials;
●
the initiation,
timing, progress and results of future preclinical studies and
clinical trials, and our research and development
programs;
●
the timing or
likelihood of regulatory filings and approvals;
●
and our other
product candidates, if approved for commercial use;
●
our expectations
regarding the clinical efficacy and utility of our melanocortin
agonist product candidates for treatment of inflammatory and
autoimmune related diseases and disorders, including ocular
indications;
●
our ability to
compete with other products and technologies treating the same or
similar indications as our product candidates;
●
the ability of our
third-party collaborators to timely carry out their duties under
their agreements with us;
●
the ability of our
contract manufacturers to perform their manufacturing activities
for us in compliance with applicable regulations;
●
our ability to
recognize the potential value of our licensing arrangements with
third parties;
●
the potential to
achieve revenues from the sale of our product
candidates;
●
our ability to
obtain adequate reimbursement from Medicare, Medicaid, private
insurers and other healthcare payers;
●
our ability to
maintain product liability insurance at a reasonable cost or in
sufficient amounts, if at all;
●
the performance of
our management team, senior staff professionals, and third-party
contractors and consultants;
ii
●
the retention of
key management, employees and third-party contractors;
●
the scope of
protection we are able to establish and maintain for intellectual
property rights covering our product candidates and technology in
the United States and throughout the world;
●
our compliance with
federal and state laws and regulations;
●
the timing and
costs associated with obtaining regulatory approval for our product
candidates, including delays and additional costs related to the
ongoing COVID-19 pandemic;
●
the impact of
fluctuations in foreign exchange rates;
●
the impact of
legislative or regulatory healthcare reforms in the United
States;
●
our ability to
adapt to changes in global economic conditions as well as competing
products and technologies; and
●
our ability to
remain listed on the NYSE American stock exchange.
Such
forward-looking statements involve risks, uncertainties and other
factors that could cause our actual results to be materially
different from historical results or from any results expressed or
implied by such forward-looking statements. Our future operating
results are subject to risks and uncertainties and are dependent
upon many factors, including, without limitation, the risks
identified under the caption “Risk Factors” and
elsewhere in this Annual Report, and any of those made in our other
reports filed with the U.S. Securities and Exchange Commission (the
“SEC”). Except as required by law, we do not intend,
and undertake no obligation, to publicly update forward-looking
statements to reflect events or circumstances after the date of
this document or to reflect the occurrence of unanticipated
events.
Palatin
Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc. Other trademarks referred to in this
report are the property of their respective owners.
iii
PART I
Item 1. Business.
Our Business Overview
Palatin
is a specialized biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin and natriuretic peptide receptor
systems. Our product candidates are targeted, receptor-specific
therapeutics for the treatment of diseases with significant unmet
medical need and commercial potential.
In
January 2020, our North American licensee for Vyleesi®
(bremelanotide injection), AMAG Pharmaceuticals, Inc.
(“AMAG”), announced that it had completed a strategic
review of its product portfolio and business strategy, and was
pursuing options to divest its female health products, including
Vyleesi. On July 27, 2020, Palatin and AMAG announced that they had
mutually terminated the license agreement for Vyleesi effective
July 24, 2020, and that Palatin was assuming responsibility for
manufacturing, marketing and distribution of Vyleesi in the United
States.
Melanocortin Receptor System. The melanocortin receptor
(“MCr”) system is hormone driven, with effects on food
intake, metabolism, sexual function, inflammation and immune system
responses. There are five melanocortin receptors, MC1r through
MC5r. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have significant pharmacological effects.
Our
lead product, Vyleesi, was approved by the FDA on June 21, 2019,
and since July 24, 2020 we have been marketing Vyleesi in the
United States. Prior to July 24, 2020, the product was marketed in
North America by AMAG pursuant to a license agreement which was
terminated on that date. Vyleesi, a melanocortin receptor agonist,
is an “as needed” therapy used in anticipation of
sexual activity and self-administered by premenopausal women with
HSDD in the thigh or abdomen via a single-use subcutaneous
auto-injector. The most common adverse events are nausea, flushing,
injection site reactions, headache and vomiting. Vyleesi is
contraindicated in women with uncontrolled hypertension or known
cardiovascular disease. In addition, the Vyleesi label includes
precautions that it may cause (i) small, transient increases in
blood pressure with a corresponding decrease in heart rate; (ii)
focal hyperpigmentation (darkening of the skin on certain parts of
the body), including the face, gums (gingiva) and breasts; and
(iii) nausea.
Our
current new product development activities focus primarily on
peptides which are agonists at MC1r, and in some instances
additional melanocortin receptors, with potential to treat
inflammatory and autoimmune diseases such as dry eye disease, which
is also known as keratoconjunctivitis sicca, uveitis, diabetic
retinopathy and inflammatory bowel disease. We believe that the
MC1r agonist peptides we are developing have broad
anti-inflammatory effects and appear to utilize mechanisms engaged
by the endogenous melanocortin system in regulation of the immune
system and resolution of inflammatory responses. We are also
developing peptides that are active at more than one melanocortin
receptor, and MC4r peptide and small molecule agonists with
potential utility in obesity and metabolic-related disorders,
including rare disease and orphan indications.
Natriuretic Peptide Receptor System. The natriuretic peptide
receptor (“NPR”) system regulates cardiovascular
functions, and therapeutic agents modulating this system have
potential to treat fibrotic diseases, cardiovascular diseases,
including reducing cardiac hypertrophy and fibrosis, heart failure,
acute asthma, pulmonary diseases and hypertension. We have designed
and are developing potential NPR candidate drugs selective for one
or more different natriuretic peptide receptors, including
natriuretic peptide receptor-A (“NPR-A”), natriuretic
peptide receptor B (“NPR-B”), and natriuretic peptide
receptor C (“NPR-C”).
Our Business Strategy. Key elements of our business strategy
include:
●
Maximizing revenue
from Vyleesi by marketing Vyleesi in the United States, supporting
our existing licensees for China and South Korea, and licensing
Vyleesi for the United States and additional regions;
●
Assembling and
maintaining a team to create, develop and commercialize MCr and NPR
products addressing unmet medical needs;
●
Entering into
strategic alliances and partnerships with pharmaceutical companies
to facilitate the development, manufacture, marketing, sale, and
distribution of product candidates that we are
developing;
●
Partially funding
our product development programs with the cash flow generated from
existing license agreements, as well as any future research,
collaboration or license agreements; and
●
Completing
development and seeking regulatory approval of certain of our other
product candidates.
1
Pipeline Overview
The
following chart illustrates the status of our drug development
programs and Vyleesi, which has been approved by the FDA for the
treatment of premenopausal women with acquired, generalized
HSDD.
Melanocortin Receptor Programs
Vyleesi for HSDD. Vyleesi, the registered trademark for
bremelanotide injection, was approved by the FDA on June 21, 2019
for the treatment of premenopausal women with acquired, generalized
HSDD. AMAG, which had exclusively licensed Vyleesi for North
America, initiated sales and marketing efforts for Vyleesi in the
United States in August 2019, with a national launch in September
2019. In January 2020, AMAG announced that, based on a review of
their business strategy, including an adverse outcome of an FDA
advisory panel review of their lead health product Makena®
(hydroxyprogesterone caproate injection), they made a decision to
divest Vyleesi and another female healthcare product. In July 2020,
Palatin and AMAG entered into a termination agreement, pursuant to
which the license agreement was terminated, Palatin regained all
North America rights for Vyleesi, and AMAG made a $12.0 million
payment to Palatin at closing and will make a $4.3 million payment
to Palatin by March 31, 2021. Palatin has assumed Vyleesi
manufacturing agreements, and AMAG has transferred information,
data and assets related exclusively to Vyleesi, including existing
inventory. AMAG is providing certain transition services to Palatin
for a period to ensure continued patient access to Vyleesi during
the transition period. Palatin will reimburse AMAG for the agreed
upon costs of the transition services.
Vyleesi
faces competition primarily from Addyi® (flibanserin), which
was introduced into the market in October 2015 for the treatment of
HSDD in pre-menopausal women and is marketed by Sprout
Pharmaceuticals, Inc. We are not aware of any company actively
developing another melanocortin receptor agonist drug for the
treatment of HSDD. However, we are aware of several other drugs at
various stages of development, most of which are being developed
for the treatment of HSDD that are to be taken on a chronic,
typically once-daily, basis. There may be other companies
developing new drugs for FSD indications other than HSDD, which may
compete with Vyleesi, some of which may be in clinical trials in
the U.S. or elsewhere. Vyleesi may also compete with products
prescribed “off-label” by healthcare
providers.
Vyleesi
is distributed nationally through specialty pharmacies. Our
marketing strategy focuses on efforts to establish Vyleesi as the
preferred option for women and healthcare providers seeking a
treatment for HSDD, which we implement through media such as
direct-to-consumer marketing in search and social media channels.
We also focus our Vyleesi marketing efforts towards healthcare
professionals, who play a significant role in increasing HSDD and
Vyleesi awareness among their patients. As the potential of Vyleesi
is demonstrated, Palatin will explore licensing marketing and
distribution rights for the United States to a marketing
partner.
In
January 2017, we entered into a license agreement with AMAG,
pursuant to which we granted AMAG an exclusive license in all
countries of North America, with the right to grant sublicenses, to
research, develop and commercialize products containing Vyleesi.
Upon the license agreement becoming effective on February 2, 2017,
AMAG paid us $60.0 million as a one-time initial payment, and has
reimbursed us $25.0 million for direct out-of-pocket expenses
incurred in development and regulatory activities necessary to file
an NDA, less certain expenses directly paid by AMAG. Upon the FDA
acceptance of the Vyleesi NDA filing for HSDD, AMAG paid us a $20.0
million milestone payment less agreed deductions for expenses
incurred by AMAG, and upon FDA approval of Vyleesi, AMAG paid us a
$60.0 million milestone payment.
2
In
early September 2017, we entered into a license agreement with
Fosun for exclusive rights to commercialize Vyleesi in China. We
received an upfront payment of $5.0 million, less required tax
withholding, and when regulatory approval for a Vyleesi product is
obtained in China we will receive a $7.5 million milestone payment.
We may receive up to $92.5 million in sales related milestones and
will receive high-single digit to low double-digit royalties on net
sales in China. In November 2017, we entered into a license
agreement with Kwangdong for exclusive rights to commercialize
Vyleesi in Korea, and received an upfront payment of $0.5 million,
less required tax withholding. Upon the first commercial sale of
Vyleesi in Korea we will receive a $3.0 million milestone payment
and will receive mid-single digit to low double-digit royalties on
all net sales and may receive up to $37.5 million in sales related
milestones.
We
retain worldwide rights for Vyleesi for HSDD and all other
indications outside Korea and China. We are actively seeking
potential partners for marketing and commercialization rights for
Vyleesi for HSDD outside the licensed territories, including
entering into a license agreement for marketing and
commercialization rights for Vyleesi in the United States. However,
we may not be able to enter into suitable agreements with potential
partners on acceptable terms, if at all.
Our Current Product Development Strategy. We are designing
and developing potent and highly selective MC1r agonist peptides
and agonist peptides specific for more than one melanocortin
receptor for treatment of a variety of inflammatory and autoimmune
indications. In animal models our peptides agonists, as well as the
endogenous agonist alpha-MSH, can reduce inflammation and
potentially resolve chronic inflammatory conditions. We believe
that our agonist peptides suppress certain inflammatory cytokines,
and modulate the activities of immune cells, such as monocytes and
T cells, to reduce immune response, and may utilize mechanisms
engaged by the endogenous melanocortin system in regulation of the
immune system and resolution of inflammatory
responses.
We have
conducted preclinical animal studies with MC1r and multiple MCr
peptide drug candidates for selected inflammatory disease and
autoimmune indications. MC1r plays a role in many diseases,
including inflammatory bowel disease and ocular indications such as
uveitis, diabetic retinopathy and dry eye disease. Work with rodent
animal models have demonstrated therapeutic responses that are
statistically significant compared to placebo, and that are equal
to or superior to established positive controls in animal models.
However, success in animal models does not necessarily mean that
any of our drug candidates will be able to successfully treat
diseases in human patients.
PL9643 for Dry Eye Disease and Anti-Inflammatory Ocular
Indications. PL9643, a peptide melanocortin agonist active
at multiple MCrs, including MC1r and MC5r, is our lead clinical
development candidate for anti-inflammatory ocular indications,
including dry eye disease, which is also known as
keratoconjunctivitis sicca. Dry eye disease is a syndrome with
symptoms including irritation, redness, discharge and blurred
vision. It may result from an autoimmune disease such
Sjögren’s syndrome, an ocular lipid or mucin deficiency,
blink disorders, abnormal corneal sensitivity or environmental
factors. It is estimated to affect over 30 million people in the
United States.
We have
developed an aqueous eye drop formulation which will be used in
clinical trials in a single use delivery device. We held a
pre-Investigational New Drug (“IND”) meeting with the
FDA on Phase 2 study design and the overall development program
through Phase 3 registration studies, submitted the IND to the FDA,
and initiated the Phase 2 clinical trial in February 2020. The
Phase 2 study is a multi-center, randomized double-masked and
placebo-controlled study evaluating the efficacy and safety of
PL9643 ophthalmic solution (topical eye drops) compared to placebo
for the treatment of the signs and symptoms of dry eye. The study
completed enrollment in July 2020, with 160 participants enrolled
at three sites in the US. Patients were randomized in a 1:1 ratio
into two arms, PL9643 or placebo, and undergo twelve weeks of
treatment. The two primary endpoints are inferior corneal
fluorescein staining and ocular discomfort, and data is expected as
early as the fourth quarter of calendar year 2020. If results from
the Phase 2 study support advancing to Phase 3, we will initiate a
Phase 3 efficacy study as early as mid-2021.
Systemic PL8177 for COVID-19 Related Indications. We are
developing PL8177 as a potential treatment for patients with
COVID-19, the disease caused by infection with the SARS-CoV-2
virus, and having hypoxemic respiratory failure with or without
acute respiratory distress syndrome. This decision was based on
positive results in preclinical multiple inflammatory disease
models and a lung injury model, which showed the ability of PL8177
to reduce inflammation, protect lung tissue and reduce lung
fibrosis. We are conducting additional preclinical studies to
support the filing of an IND with the FDA for this indication, and
thereafter initiate a Phase 2 study. We are seeking support for the
proposed Phase 2 study from the federal government and other
sources, and if external support is not available we may determine
not to initiate Phase 2 studies.
Oral PL8177 for Inflammatory Bowel Diseases. PL8177, a
selective MC1r agonist peptide, is our lead clinical development
candidate for inflammatory bowel diseases, including ulcerative
colitis. PL8177 is a cyclic peptide comprised of seven amino acids.
We filed an IND application on PL8177 in late 2017 and in 2018
successfully completed subcutaneous dosing of human subjects in a
Phase 1 single and multiple ascending dose clinical safety
study.
3
For
ulcerative colitis and other inflammatory bowel diseases we will
administer PL8177 in an oral formulation designed to deliver PL8177
to the interior wall of the diseased bowel. PL8177 activates MC1r
present on the interior wall of the bowel in ulcerative colitis and
other inflammatory bowel diseases. We believe that delivering
PL8177 directly to MC1r in the bowel wall will maximize treatment
effect while minimizing any systemic or off-target
effects.
A Phase
2 study in ulcerative colitis using the oral, delayed-release,
polymer formulation of PL8177 is scheduled to start in the first
half of calendar year 2021, and may take up to one year to
complete.
Systemic PL8177 for Non-Infectious Uveitis. PL8177 has been
granted orphan drug designation by the FDA for the treatment of
non-infectious intermediate, posterior, pan and chronic anterior
uveitis. Non-infectious uveitis is a group of inflammatory diseases
that produces swelling and destroys eye tissue and can result in
vision loss. A Phase 2 program in non-infectious uveitis using a
systemic delivery formulation of PL8177 is under
development.
Melanocortin Peptides for Diabetic Retinopathy. We are
conducting preclinical studies with melanocortin peptides in
diabetic retinopathy models and are scheduled to complete these
studies by the first half of calendar year 2021. If results support
advancing the program, we would conduct required safety studies and
manufacture drug product under Good Manufacturing Practices
(“GMP”) regulations preparatory to filing an IND and
initiating clinical studies.
Natriuretic Peptide Receptor Programs
Natriuretic Peptide Receptor Systems. The NPR system has
numerous cardiovascular functions, and therapeutic agents
modulating this system may be useful in treatment of cardiovascular
and fibrotic diseases. While the therapeutic potential of
modulating this system is well appreciated, development of
therapeutic agents has been difficult due, in part, to the short
biological half-life of native peptide agonists. We have made
potential NPR candidate drugs that are selective for one or more
different natriuretic peptide receptors, including NPR-A, NPR-B,
and NPR-C.
PL3994 for Mechanism of Action Studies. PL3994 is an NPR-A
agonist and synthetic mimetic of the endogenous neuropeptide
hormone atrial natriuretic peptide (“ANP”). PL3994
activates NPR-A, a receptor known to play a role in cardiovascular
homeostasis. Consistent with being an NPR-A agonist, PL3994
increases plasma cyclic guanosine monophosphate
(“cGMP”) levels, a pharmacological response consistent
with the effects of endogenous natriuretic peptides on
cardiovascular function and smooth muscle relaxation. PL3994 also
decreases activity of the renin-angiotensin-aldosterone system
(“RAAS”), a hormone system that regulates blood
pressure and fluid balance. The RAAS system is frequently
over-activated in heart failure patients, leading to worsening of
cardiovascular function.
In
conjunction with clinicians at a major research institution, PL3994
is entering Phase 2A clinical trial supported by a grant from the
American Heart Association in the fourth quarter of calendar year
2020. We have conducted Phase 1 safety studies with PL3994, with no
serious or severe adverse events. Consistent with the PL3994
mechanism of action, elevations in plasma cGMP levels, increased
diuresis and increased natriuresis were all observed for several
hours after single subcutaneous doses.
Because
of the limited patent term remaining on PL3994, we do not intend to
pursue PL3994 as a pharmaceutical product but are utilizing it to
establish the mechanism of action and pharmaceutical utility of
synthetic mimetics of ANP.
PL5028 for Cardiovascular and Fibrotic Disease. PL5028, a
dual NPR-A and NPR-C agonist we developed, is in preclinical
development for cardiovascular and fibrotic diseases, including
reducing cardiac hypertrophy and fibrosis. We have ongoing academic
collaborations with several institutions with PL5028.
Technologies We Use
We used
a rational drug design approach to discover and develop proprietary
peptide, peptide mimetic and small molecule agonist compounds,
focusing on melanocortin and natriuretic peptide receptor systems.
Computer-aided drug design models of receptors are optimized based
on experimental results obtained with peptides and small molecules
that we develop. With our approach, we believe we are developing an
advanced understanding of the factors which drive
agonism.
We have
developed a series of proprietary technologies used in our drug
development programs. One technology employs novel amino acid
mimetics in place of selected amino acids. These mimetics provide
the receptor-binding functions of conventional amino acids while
providing structural, functional and physiochemical advantages. The
amino acid mimetic technology is employed in PL3994, our compound
in development for treatment of heart failure.
4
Some
compound series have been derived using our proprietary and
patented platform technology, called MIDAS™, or Metal Ion-induced Distinctive Array of Structures. This technology employs
metal ions to fix the three-dimensional configuration of peptides,
forming conformationally rigid molecules that remain folded
specifically in their active state. These MIDAS molecules are
generally simple to synthesize, are chemically and proteolytically
stable, and have the potential to be orally bioavailable. In
addition, MIDAS molecules are information-rich and provide data on
structure-activity relationships that may be used to design small
molecule, non-peptide drugs.
Competition
General. Our products under development will compete on the
basis of quality, performance, cost effectiveness and application
suitability with numerous established products and technologies. We
have many competitors, including pharmaceutical, biopharmaceutical
and biotechnology companies. Furthermore, there are several
well-established products in our target markets that we will have
to compete against. Other companies may also introduce products
using new technologies that may be competitive with our proposed
products. Most of the companies selling or developing competitive
products have financial, technological, manufacturing and
distribution resources significantly greater than ours and may
represent significant competition for us. In addition, approved
products such as Vyleesi may eventually face competition from
generic versions that will sell at significantly reduced prices, be
preferred by managed care and health insurance payers, and be
eligible for automatic pharmacy substitution even when a prescriber
writes a prescription for our product. The timing and extent of
future generic competition is dependent upon both our intellectual
property rights and the FDA regulatory process but cannot be
accurately predicted.
The
pharmaceutical and biotechnology industries are characterized by
extensive research efforts and rapid technological change. Many
biopharmaceutical companies have developed or are working to
develop products similar to ours or that address the same markets.
Such companies may succeed in developing technologies and products
that are more effective or less costly than any of those that we
may develop. Such companies may be more successful than us in
developing, manufacturing and marketing products.
We
cannot guarantee that we will be able to compete successfully in
the future or that developments by others will not render our
proposed products under development or any future product
candidates obsolete or noncompetitive or that our collaborators or
customers will not choose to use competing technologies or
products.
Vyleesi for Treatment of HSDD. There is competition and
financial incentive to develop, market and sell drugs for the
treatment of HSDD and other forms of FSD. Flibanserin, sold under
the trade name Addyi®, is the only drug other than Vyleesi
currently approved in the United States for treatment of HSDD.
Flibanserin, a non-hormonal oral serotonin 5-HT1A agonist, 5-HT2A
antagonist, which requires chronic dosing, was approved by the FDA
on August 18, 2015 for treatment of premenopausal women with HSDD.
The FDA approval, included a risk evaluation and mitigation
strategy (“REMS”) because of the increased risk of
severe hypotension and syncope due to the interaction between
flibanserin and alcohol, and a Boxed Warning to highlight the risks
of severe hypotension and syncope in patients who drink alcohol
during treatment with flibanserin, in those who also use moderate
or strong CYP3A4 inhibitors, and in those who have liver
impairment. The Boxed Warning was modified by FDA in April 2019 to
clarify that there remains a concern about consuming alcohol close
in time to taking flibanserin, but that alcohol does not have to be
avoided completely. Specifically, the Boxed Warning reflects women
should discontinue drinking alcohol at least two hours before
taking flibanserin at bedtime, or to skip the flibanserin dose that
evening. We are aware of several other drugs at various stages of
development, most of which are taken on a chronic, typically
once-daily, basis. There are other companies reported to be
developing new drugs for FSD indications, some of which may be in
clinical trials in the United States or elsewhere. We are not aware
of any other company actively developing a melanocortin receptor
agonist drug for HSDD.
Melanocortin Receptor 1 Agonist Drug Products for Inflammatory and
Autoimmune Diseases. Many inflammatory disease-related
indications are treated using systemic steroids or
immunosuppressant drugs, all of which have side effects that can be
dose limiting. There are a number of approved biological drugs and
other biological drugs under development for treatment of
inflammatory disease-related indications, which typically affect
only one pathway in the inflammatory response. Many of these drugs
address symptoms, but do not resolve the underlying inflammatory or
autoimmune disease process.
Oral PL8177 for Inflammatory Bowel Diseases/Ulcerative
Colitis. FDA-approved drugs used in treatment of ulcerative
colitis include aminosalicylates such as mesalazine and related
drugs, immunosuppressive drugs such as cyclosporine and
azathioprine, corticosteroids such as prednisone and other
steroids, and various biologic drugs, including tumor necrosis
factor inhibitors such as infliximab and adalimumab. There are a
number of drugs in development for ulcerative colitis, including
Janus kinase inhibitors, monoclonal antibodies specific for one or
more immune system cytokine signaling molecules, and additional
classes of immunomodulatory drugs. There are no reported MC1r
agonist drugs in clinical trials for inflammatory bowel diseases,
including ulcerative colitis. If one or more of the competing
products under development are approved and can effectively treat
ulcerative colitis with an acceptable side effect profile, such
products could reduce the market for oral PL8177 for inflammatory
bowel diseases, including ulcerative colitis.
5
Systemic PL8177 for Non-Infectious Uveitis. FDA-approved
drugs used in treatment of non-infectious uveitis include
immunosuppressive medications such as adalimumab, sold under the
brand name Humira® and other brand names, and corticosteroids
such as prednisone and other steroids. There are other products in
development, including tumor necrosis factor inhibitors and
interleukin receptor agonists such as gevokizumab, as well as
formulations of glucocorticoid receptor agonists. There are no
reported MC1r agonist drugs in clinical trials for non-infectious
uveitis. If one or more the competing product candidates under
development is approved and can resolve non-infectious uveitis with
an acceptable side effect profile, it could reduce the market for
systemic PL8177 for this indication.
Systemic PL8177 for Treatment of Patients with COVID-19. On
a global level there are numerous vaccines, anti-viral drugs for
treating COVID-19 and drugs for treating symptoms of COVID-19 in
development, and there is a concerted effort by the federal
government to develop effective therapies. There is also intense
pressure for federal funding, through a number of programs, for
developing effective therapies. If one or more competing product
candidates under development is approved and can resolve COVID-19
and effectively treat symptoms and sequela of COVID-19, it could
reduce the market for systemic PL8177 for treatment of patients
with COVID-19.
PL9643 for Anti-Inflammatory Ocular Indications. PL9643 is
under development for dry eye diseases and may also have utility
for other inflammatory ocular indications. Mild to moderate dry eye
disease and other ocular inflammatory diseases may be treated with
artificial tear eye drops, lubricating tear ointments, hot
compresses or punctual plugs, but more severe disease may be
treated with topical immunosuppressants such as cyclosporine
ophthalmic emulsions, including Restasis® marketed in the
United States by Allergan, Inc., or with drugs inhibiting
inflammatory cell binding, such as lifitegrast, including
Xiidra® marketed in the United States by Shire US Inc. In
addition, there are a number of drugs in clinical development for
treatment of dry eye disease, with over 20 agents reported to be in
or have completed Phase 2 development. Products under development
include tumor necrosis factor agonists, alpha-2 adrenergic receptor
agonist, calcineurin inhibitors and nicotinic receptor agonists,
among others. There are no reported MC1r agonist drugs in clinical
trials for dry eye disease. If one or more of these competing
product candidates is approved and either treats the signs and
symptoms of dry eye disease or reduces the frequency of flares of
dry eye in patients, it could reduce the market for PL9643 for dry
eye disease.
Obesity and Related Indications. There are a number of
FDA-approved drugs and medical devices for the treatment of
obesity, and a large number of products in clinical development by
other companies, including products which target melanocortin
receptors. Rhythm Pharmaceuticals, Inc. is reported to have
completed Phase 3 clinical trials with an MC4r agonist peptide drug
for rare genetic disorders of obesity.
PL5028 for Cardiovascular and Fibrotic Indications. We are
evaluating potential clinical indications for PL5028, and have not
determined a specific indication for initial studies. There are
many approved drugs and drugs in clinical studies for
cardiovascular diseases, including drugs that directly modulate the
NPR system, such as nesiritide (sold under the trade name
Natrecor®), a recombinant NPR-B peptide drug, and a
combination drug comprised of sacubitril and valsartan (sold under
the trade name Entresto®), which inhibits both the angiotensin
II receptor and neprilysin, which is an enzyme that inactivates
endogenous active natriuretic peptides. This combination drug
results in increases of endogenous active ANP levels. In addition,
there are a number of approved drugs and drugs in development for
treatment of cardiovascular and fibrotic diseases through
mechanisms or pathways other than agonism of NPR-A.
Patents and Proprietary Information
Patent Protection. Our success will depend in substantial
part on our ability to obtain, defend and enforce patents, maintain
trade secrets and operate without infringing upon the proprietary
rights of others, both in the United States and abroad. We own a
number of issued United States patents and have pending United
States patent applications, many with issued or pending counterpart
patents in selected foreign countries. We seek patent protection
for our technologies and products in the United States and those
foreign countries where we believe patent protection is
commercially important.
We own
three issued United States patents and a pending patent application
in the United States for methods of treating FSD with Vyleesi, with
related patents issued in Australia, South Africa, the Republic of
Georgia, Austria, Belgium, Denmark, Finland, France, Germany,
Ireland, Israel, Italy, Japan, Mexico, New Zealand, Netherlands,
Norway, Philippines, Poland, Spain, Sweden, Switzerland, Turkey,
Ukraine and the United Kingdom and related patent applications
pending in Brazil, Canada, China, Hong Kong, India, Indonesia,
Korea, Malaysia, and Vietnam. We do not know the full scope of
patent coverage we will obtain, or whether any patents will issue
other than the patents already issued. Issued patents and pending
applications in the United States and elsewhere in the world have a
presumptive term, if a patent is issued, until 2033.
6
We own
two issued United States patents claiming the Vyleesi drug
substance. The issued United States patents have a term until 2020,
and applications have been filed to extend the term of one patent
for a maximum period of five years as compensation for patent term
lost during drug development and the FDA regulatory review process,
pursuant to the Drug Price Competition and Patent Term Restoration
Act of 1984, or the Hatch-Waxman Amendments. An interim extension
for a period of one year from the original expiration date of both
patents of June 28, 2020, was granted in May 2020, but the length
of the final extension which may be granted under the Hatch-Waxman
Amendments has not been determined. In addition, the claims of
issued patents covering Vyleesi may not provide meaningful
protection. Further, third parties may challenge the validity or
scope of any issued patent, and under the Hatch-Waxman Amendments,
potentially receive approval of a competing generic version of our
product or products even before a court rules on the validity or
infringement of our patents.
We own
patents on an alternative class of melanocortin receptor-specific
peptides for treatment of sexual dysfunction and other indications,
including obesity, consisting of two issued patents in the United
States. The presumptive term of the issued patents is until 2029.
We also have patents and pending patent applications for a second
class of alternative melanocortin receptor-specific peptides for
treatment of sexual dysfunction and other indications, including
obesity, consisting of three issued patents in the United States
and issued patents in Australia, Canada, China, France, Germany,
Ireland, Japan, Israel, Korea, New Zealand, Russia, South Africa,
Switzerland and the United Kingdom and pending patent applications
on the same class in Brazil, China, India, and Mexico. The
presumptive term of the issued patents and pending patent
applications is until 2030. Until one or more product candidates
covered by a claim of one of these patents and patent applications
are developed for commercialization, which may never occur, we
cannot evaluate the duration of any potential patent term extension
under the Hatch-Waxman Amendments.
We own
five issued patents in the United States, and issued patents in
Australia, Belgium, Canada, China, France, Germany, Ireland,
Israel, Japan, Korea, Mexico, New Zealand, Russia, South Africa,
Sweden, Switzerland and the United Kingdom claiming highly
selective MC1r agonist peptides, including for treatment of
inflammation-related diseases and disorders and related
indications, and pending patent applications in Australia, Brazil,
and India. The presumptive term of the issued patents and pending
patent applications is until 2030. Until one or more product
candidates covered by a claim of one of these patent applications
are developed for commercialization, which may never occur, we
cannot evaluate the duration of any potential patent term extension
under the Hatch-Waxman Amendments.
We own
two issued United States patents claiming the PL3994 substance and
other natriuretic peptide receptor agonist compounds that we have
developed and an issued United States patent claiming a precursor
molecule to the PL3994 substance, both of which expire in 2027.
Corresponding patents on the PL3994 substance and other natriuretic
peptide receptor agonist compounds were issued in a number of
countries throughout the world, but we do not intend to develop a
PL3994 product for commercialization and will cease maintaining
patents outside the United States. We also own an issued United
States patent claiming use of the PL3994 substance for treatment of
acute asthma and chronic obstructive pulmonary disease, which
expires in 2031. We additionally have 35 issued United States
patents on melanocortin receptor specific peptides and small
molecules, and five issued United States patents on natriuretic
peptide receptor agonist compounds, but we are not actively
developing any product candidate covered by a claim of any of these
patents.
In the
event that a third party has also filed a patent application
relating to an invention we claimed in a patent application, we may
be required to participate in an interference proceeding
adjudicated by the United States Patent and Trademark Office
(“USPTO”) to determine priority of invention. The
possibility of an interference proceeding could result in
substantial uncertainties and cost, even if the eventual outcome is
favorable to us. An adverse outcome could result in the loss of
patent protection for the subject of the interference, subjecting
us to significant liabilities to third parties, the need to obtain
licenses from third parties at undetermined cost, or requiring us
to cease using the technology. Additionally, the claims of our
issued patents may be narrowed or invalidated by administrative
proceedings, such as interference or derivation, inter partes review, post grant review
or reexamination proceedings before the USPTO.
Future Patent Infringement. We do not know for certain that
our commercial activities will not infringe upon patents or patent
applications of third parties, some of which may not even have been
issued. Although we are not aware of any valid United States
patents which are infringed by Vyleesi or our other product
candidates, we cannot exclude the possibility that such patents
might exist or arise in the future. We may be unable to avoid
infringement of any such patents and may have to seek a license,
defend an infringement action, or challenge the validity of such
patents in court. Patent litigation is costly and time consuming.
If such patents are valid and we do not obtain a license under any
such patents, or we are found liable for infringement, we may be
liable for significant monetary damages, may encounter significant
delays in bringing products to market, or may be precluded from
participating in the manufacture, use or sale of products or
methods of treatment covered by such patents.
7
Proprietary Information. We rely on proprietary information,
such as trade secrets and know-how, which is not patented. We have
taken steps to protect our unpatented trade secrets and know-how,
in part with confidentiality and intellectual property agreements
with our employees, consultants and certain contractors. If our
employees, scientific consultants, collaborators or licensees
develop inventions or processes independently that may be
applicable to our product candidates, disputes may arise about the
ownership of proprietary rights to those inventions and processes.
Such inventions and processes will not necessarily become our
property but may remain the property of those persons or their
employers. Protracted and costly litigation could be necessary to
enforce and determine the scope of our proprietary
rights.
If
trade secrets are breached, our recourse will be solely against the
person who caused the secrecy breach. This might not be an adequate
remedy to us because third parties other than the person who causes
the breach will be free to use the information without
accountability to us. This is an inherent limitation of the law of
trade secret protection.
U.S. Governmental Regulation of Pharmaceutical
Products
General
Regulation
by governmental authorities in the United States and other
countries will continue to significantly impact our research,
product development, manufacturing and marketing of any
pharmaceutical products. The nature and the extent to which
regulations apply to us will vary depending on the nature of any
such products. Our potential pharmaceutical products will require
regulatory approval by governmental agencies prior to
commercialization. The products we are developing are subject to
federal regulation in the United States, principally by the FDA
under the Federal Food, Drug, and Cosmetic Act
(“FFDCA”), and by state and local governments, as well
as ministries of health and other authorities in foreign
governments. Such regulations govern or influence, among other
things, the research, development, testing, manufacture, safety and
efficacy requirements, labeling, storage, recordkeeping, licensing,
advertising, promotion, distribution and export of products,
manufacturing and the manufacturing process. In many foreign
countries, such regulations also govern the prices charged for
products under their respective national social security systems
and availability to consumers.
All
drugs intended for human use are subject to rigorous regulation by
the FDA in the United States and similar regulatory bodies in other
countries. The steps ordinarily required by the FDA before an
innovative new drug product may be marketed in the United States
are similar to steps required in most other countries and include,
but are not limited to:
●
completion of
preclinical laboratory tests, preclinical animal testing and
formulation studies;
●
submission to the
FDA of an IND, which must be in effect before clinical trials may
commence;
●
clinical studies to
evaluate safety and efficacy;
●
submission to the
FDA of an NDA that includes preclinical data, clinical trial data
and manufacturing information;
●
payment of
substantial user fees for filing the NDA and other recurring user
fees;
●
FDA review of the
NDA;
●
satisfactory
completion of an FDA pre-approval inspection of the manufacturing
facilities; and
●
FDA approval of the
NDA, including approval of all product labeling.
For new
drug products or for combination products deemed to have a
“drug” primary mode of action, primary review of the
product will be conducted by the appropriate division within the
FDA’s Center for Drug Evaluation and Research
(“CDER”). For combination products, CDER will consult
with the Center for Devices and Radiological Health to ensure that
the device components of the product meet all applicable device
requirements.
The
research, development and approval process requires substantial
time, effort and financial resources, and approvals may not be
granted on a timely or commercially viable basis, if at
all.
Preclinical
testing includes laboratory evaluations to characterize the
product’s composition, impurities, stability, and mechanism
of its pharmacologic effect, as well as animal studies to assess
the potential safety and efficacy of each product. Preclinical
safety tests must be conducted by laboratories that comply with FDA
regulations regarding Good Laboratory Practices and the U.S.
Department of Agriculture’s Animal Welfare Act. Violations of
these laws and regulations can, in some cases, lead to invalidation
of the tests, requiring such tests to be repeated and delaying
approval of the NDA. The results of the preclinical tests, together
with manufacturing information and analytical data, are submitted
to the FDA as part of an IND and are reviewed by the FDA before the
commencement of human clinical trials. Unless the FDA objects to an
IND by placing the study on clinical hold, the IND will go into
effect 30 days following its receipt by the FDA. The FDA may
authorize trials only on specified terms and may suspend ongoing
clinical trials at any time on various grounds, including a finding
that patients are being exposed to unacceptable health risks. If
the FDA places a study on clinical hold, the sponsor must resolve
all of the FDA’s concerns before the study may begin or
continue. The IND application process may become extremely costly
and substantially delay development of products. Similar
restrictive requirements also apply in other countries.
Additionally, positive results of preclinical tests will not
necessarily indicate positive results in clinical
trials.
8
Clinical
trials involve the administration of the investigational product to
humans under the supervision of qualified principal investigators.
Our clinical trials must be conducted in accordance with Good
Clinical Practice regulations under protocols submitted to the FDA
as part of an IND. In addition, each clinical trial is approved and
conducted under the auspices of an institutional review board
(“IRB”) and requires the patients’ informed
consent. An IRB considers, among other things, ethical factors, the
safety of human subjects, and the possibility of liability of the
institutions conducting the trial. The IRB at each institution at
which a clinical trial is being performed may suspend a clinical
trial at any time for a variety of reasons, including a belief that
the test subjects are being exposed to an unacceptable health risk.
As the sponsor, we can also suspend or terminate a clinical trial
at any time.
Clinical
development is typically conducted in three sequential phases,
Phases 1, 2, and 3, involving clinical trials with increasing
numbers of human subjects. These phases may sometimes overlap or be
combined. Phase 1 trials are performed in a small number of healthy
human subjects or subjects with the targeted condition, and involve
testing for safety, dosage tolerance, absorption, distribution,
metabolism and excretion. Phase 2 studies, which may involve up to
hundreds of subjects, seek to identify possible adverse effects and
safety risks, preliminary information related to the efficacy of
the product for specific targeted diseases, dosage tolerance, and
optimal dosage. Finally, Phase 3 trials may involve up to thousands
of individuals often at geographically dispersed clinical trial
sites, and are intended to provide the data demonstrating the
effectiveness and safety required for approval. Prior to commencing
Phase 3 clinical trials many sponsors elect to meet with FDA
officials to discuss the conduct and design of the proposed trial
or trials.
In
addition, federal law requires the listing, on a publicly available
website, of detailed information on clinical trials for
investigational drugs. Some states have similar or supplemental
clinical trial reporting laws.
Success
in early-stage animal studies and clinical trials does not
necessarily assure success in later-stage clinical trials. Data
obtained from animal studies and clinical activities are not always
conclusive and may be subject to alternative interpretations that
could delay, limit or even prevent regulatory
approval.
All
data obtained from the preclinical studies and clinical trials, in
addition to detailed information on the manufacture and composition
of the product, would be submitted in an NDA to the FDA for review
and approval for the manufacture, marketing and commercial
shipments of any of our products. FDA approval of the NDA is
required before commercial marketing or non-investigational
interstate shipment may begin in the United States. The FDA may
also conduct an audit of the clinical trial data used to support
the NDA.
The FDA
may deny or delay approval of an NDA that does not meet applicable
regulatory criteria. For example, the FDA may determine that the
preclinical or clinical data or the manufacturing information does
not adequately establish the safety and efficacy of the drug. The
FDA has substantial discretion in the approval process and may
disagree with an applicant’s interpretation of the data
submitted in its NDA. The FDA can request additional information,
seek clarification regarding information already provided in the
submission or ask that new additional clinical trials be conducted,
all of which can delay approval. Similar types of regulatory
processes will be encountered as efforts are made to market any
drug internationally. We will be required to assure product
performance and manufacturing processes from one country to
another.
Even if
the FDA approves a product, it may limit the approved uses for the
product as described in the product labeling, require that
contraindications, warning statements or precautions be included in
the product labeling, require that additional studies be conducted
following approval as a condition of the approval, impose
restrictions and conditions on product distribution, prescribing or
dispensing in the form of a REMS, or otherwise limit the scope of
any approval or limit labeling. Once it approves an NDA, the FDA
may revoke or suspend the product approval if compliance with
post-market regulatory commitments is not maintained or if problems
occur after the product reaches the marketplace. In addition, the
FDA may require post-marketing studies to monitor the effect of
approved products and may limit further marketing of the product
based on the results of these post-market studies. The FDA and
other government agencies have broad post-market regulatory and
enforcement powers, including the ability to levy civil and
criminal penalties, suspend or delay issuance of approvals, seize
or recall products and revoke approvals.
Pharmaceutical
manufacturers, distributors and their subcontractors are required
to register their facilities with the FDA and state agencies.
Manufacturers are required to list their marketed drugs with the
FDA, are subject to periodic inspection by the FDA’s current
GMP regulations, and the product specifications set forth in the
approved NDA. The GMP requirements for pharmaceutical products are
extensive and compliance with them requires considerable time,
resources and ongoing investment. The regulations require
manufacturers and suppliers of raw materials and components to
establish validated systems and to employ and train qualified
employees to ensure that products meet high standards of safety,
efficacy, stability, sterility (where applicable), purity, and
potency. The requirements apply to all stages of the manufacturing
process, including the synthesis, processing, sterilization,
packaging, labeling, storage and shipment of the drug product. For
all drug products, the regulations require investigation and
correction of any deviations from GMP requirements and impose
documentation requirements upon us and any third-party
manufacturers that we may decide to use. Manufacturing
establishments are subject to mandatory user fees, and to periodic
unannounced inspections by the FDA and state agencies for
compliance with all GMP requirements. The FDA is authorized to
inspect manufacturing facilities without a warrant at reasonable
times and in a reasonable manner.
9
We or
our present or future suppliers may not be able to comply with GMP
and other FDA regulatory requirements. Failure to comply with the
statutory and regulatory requirements subjects the manufacturer
and/or the NDA sponsor or distributor to possible legal or
regulatory action, such as a delay or refusal to approve an NDA,
suspension of manufacturing, seizure or recall of a product, or
civil or criminal prosecution of the company or individual officers
or employees.
Post-Marketing Regulation
Vyleesi
and any other drug products manufactured or distributed by us
pursuant to FDA approvals, as well as the materials and components
used in our products, are subject to pervasive and continuing
regulation by the FDA, including:
●
recordkeeping
requirements;
●
periodic reporting
requirements;
●
GMP requirements
related to all stages of manufacturing, testing, storage,
packaging, labeling and distribution of finished dosage forms of
the product;
●
monitoring and
reporting of adverse experiences with the product; and
●
advertising and
promotional reporting requirements and restrictions.
Adverse
experiences with the product must be reported to the FDA and could
result in the imposition of market restriction through labeling
changes or product removal. Product approvals may be revoked if
compliance with regulatory requirements is not maintained or if
problems concerning safety or effectiveness of the product occur
following approval. The FDA is developing a national electronic
drug safety tracking system known as SENTINEL that may impose
additional safety monitoring burdens, and enhanced FDA enforcement
authority, beyond the extensive requirements already in effect. As
a condition of NDA approval, the FDA may require post-approval
testing and surveillance to monitor a product’s safety or
efficacy. The FDA also may impose other conditions, including
labeling restrictions which can materially impact the potential
market and profitability of a product.
With
respect to post-market product advertising and promotion, the FDA
and other government agencies including the Department of Health
and Human Services and the Department of Justice, and individual
States, impose a number of complex regulations on entities that
advertise and promote pharmaceuticals, including, among others,
standards and restrictions on direct-to-consumer advertising,
off-label promotion, industry-sponsored scientific and educational
activities and promotional activities involving the Internet. The
FDA has very broad enforcement authority under the FFDCA, and
failure to abide by these regulations can result in administrative
and judicial enforcement actions, including the issuance of a
Warning Letter directing correction of deviations from FDA
standards, a requirement that future advertising and promotional
materials be pre-cleared by the FDA, False Claims Act prosecution
based on alleged off-label marketing seeking monetary and other
penalties, including potential exclusion of the drug and/or the
company from participation in government health care programs, and
state and federal civil and criminal investigations and
prosecutions. Foreign regulatory bodies also strictly enforce these
and other regulatory requirements and drug marketing may be
prohibited in whole or in part in other countries.
We, our
collaborators, licensees or third-party contract manufacturers may
not be able to comply with the applicable regulations. After
regulatory approvals are obtained, the subsequent discovery of
previously unknown problems, or the failure to maintain compliance
with existing or new regulatory requirements, may result
in:
●
restrictions on the
marketing or manufacturing of a product;
●
Warning Letters or
Untitled Letters from the FDA asking us, our collaborators or
third-party contractors to take or refrain from taking certain
actions;
●
withdrawal of the
product from the market;
●
the FDA’s
refusal to approve pending applications or supplements to approved
applications;
●
voluntary or
mandatory product recall;
●
fines or
disgorgement of profits or revenue;
●
suspension or
withdrawal of regulatory approvals;
●
refusals to permit
the import or export of products;
●
product seizure;
and
●
injunctions or the
imposition of civil or criminal penalties.
10
We may
also be subject to healthcare laws, regulations and enforcement and
our failure to comply with any such laws, regulations or
enforcement could adversely affect our business, operations and
financial condition. Certain federal and state healthcare laws and
regulations pertaining to fraud and abuse and patients’
rights are and will be applicable to our business. We are subject
to regulation by both the federal government and the states in
which we or our partners conduct our business. The laws and
regulations that may affect our ability to operate
include:
●
the federal
Anti-Kickback Statute, which prohibits, among other things, any
person or entity from knowingly and willfully offering, soliciting,
receiving or providing any remuneration (including any kickback,
bribe or rebate), directly or indirectly, overtly or covertly, in
cash or in kind, to induce either the referral of an individual or
in return for the purchase, lease, or order of any good, facility
item or service, for which payment may be made, in whole or in
part, under federal healthcare programs such as the Medicare and
Medicaid programs;
●
federal civil and
criminal false claims laws and civil monetary penalty laws,
including, for example, the federal civil False Claims Act, which
impose criminal and civil penalties, including civil whistleblower
or qui tam actions, against individuals or entities for, among
other things, knowingly presenting, or causing to be presented, to
the federal government, including the Medicare and Medicaid
programs, claims for payment that are false or fraudulent or making
a false statement to avoid, decrease or conceal an obligation to
pay money to the federal government;
●
the federal Health
Insurance Portability and Accountability Act of 1996
(“HIPAA”), which created new federal criminal statutes
that prohibit knowingly and willfully executing, or attempting to
execute, a scheme to defraud any healthcare benefit program or
obtain, by means of false or fraudulent pretenses, representations
or promises, any of the money or property owned by, or under the
custody or control of, any healthcare benefit program, regardless
of the payer (e.g., public or private), knowingly and willfully
embezzling or stealing from a health care benefit program,
willfully obstructing a criminal investigation of a health care
offense and knowingly and willfully falsifying, concealing or
covering up by any trick or device a material fact or making any
materially false statements in connection with the delivery of, or
payment for, healthcare benefits, items or services relating to
healthcare matters;
●
HIPAA, as amended
by the Health Information Technology for Economic and Clinical
Health Act, and their implementing regulations, which impose
obligations on covered entities, including healthcare providers,
health plans, and healthcare clearinghouses, as well as their
respective business associates that create, receive, maintain or
transmit individually identifiable health information for or on
behalf of a covered entity, with respect to safeguarding the
privacy, security and transmission of individually identifiable
health information;
●
the federal
physician sunshine requirements under the Patient Protection and
Affordable Care Act (“Affordable Care Act”), which
require manufacturers of drugs, devices, biologics and medical
supplies to report annually to the Centers for Medicare &
Medicaid Services information related to payments and other
transfers of value provided to physicians and teaching hospitals,
and ownership and investment interests held by physicians and their
immediate family members; and
●
state law
equivalents of each of the above federal laws, such as
anti-kickback and false claims laws, which may apply to items or
services reimbursed by any third-party payer, including commercial
insurers; state laws that require pharmaceutical companies to
comply with the pharmaceutical industry’s voluntary
compliance guidelines and the applicable compliance guidance
promulgated by the federal government, or otherwise restrict
payments that may be provided to healthcare providers and other
potential referral sources; state laws that require drug
manufacturers to report information related to payments and other
transfers of value to healthcare providers or marketing
expenditures; and state laws governing the privacy and security of
health information in certain circumstances, many of which differ
from each other in significant ways and may not have the same
effect, thus complicating compliance efforts.
Because
of the breadth of these laws and the narrowness of the statutory
exceptions and safe harbors available, it is possible that some of
our business activities could be subject to challenge under one or
more of such laws. In addition, recent health care reform
legislation has strengthened these laws. For example, the
Affordable Care Act, among other things, amended the intent
requirement of the federal Anti-Kickback Statute and certain
criminal healthcare fraud statutes. A person or entity no longer
needs to have actual knowledge of the statute or specific intent to
violate it. In addition, the Affordable Care Act provided that the
government may assert that a claim including items or services
resulting from a violation of the federal Anti-Kickback Statute
constitutes a false or fraudulent claim for purposes of the federal
civil False Claims Act.
Achieving
and sustaining compliance with these laws may prove costly. In
addition, any action against us for violation of these laws, even
if we successfully defend against it, could cause us to incur
significant legal expenses and divert our management’s
attention from the operation of our business. If our operations are
found to be in violation of any of the laws described above or any
other governmental laws or regulations that apply to us, we may be
subject to penalties, including administrative, civil and criminal
penalties, damages, fines, disgorgement, the exclusion from
participation in federal and state healthcare programs, individual
imprisonment or the curtailment or restructuring of our operations,
any of which could adversely affect our ability to operate our
business and our financial results.
11
Generic Competition
Orange Book Listing. In seeking approval for a drug through
an NDA, applicants are required to list with the FDA each patent
whose claims cover the applicant’s product. Upon approval of
a drug, the applicant identifies all patents that claim the
approved product’s active ingredient(s), the drug
product’s approved formulation, or an approved method of use
of the drug. Each of the identified patents are then published in
the FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book. Drugs listed in the
Orange Book can, in turn, be cited by potential generic competitors
in support of approval of an abbreviated new drug application
(“ANDA”). An ANDA provides for marketing of a drug
product that has the same active ingredients in the same strengths
and dosage form as the listed drug and has been shown through
bioequivalence testing, unless such testing is waived by the FDA,
as is the case with some injectable drug products, to be
therapeutically equivalent to the listed drug. Other than
bioequivalence testing, ANDA applicants are not required to
conduct, or submit results of, preclinical or clinical tests to
prove the safety or effectiveness of their drug product. Drugs
approved in this way are commonly referred to as “generic
equivalents” to the listed drug, and can usually be
substituted by pharmacists under prescriptions written for the
original listed drug.
The
ANDA applicant is required to certify to the FDA concerning any
patents listed for the approved product in the FDA’s Orange
Book. Specifically, the applicant must certify either that: (1) the
required patent information has not been filed (a Paragraph I
Certification); (2) the listed patent has expired (a Paragraph II
Certification); (3) the listed patent has not expired, but will
expire on a particular date and the generic approval is being
sought only after patent expiration (a Paragraph III
Certification); or (4) the listed patent is invalid, unenforceable,
or will not be infringed by the proposed generic product (a
Paragraph IV Certification). In certain circumstances, the ANDA
applicant may also elect to submit a “section (viii)”
statement instead of a Paragraph IV Certification, certifying that
its proposed ANDA label does not contain (or carves out) any
language regarding the patented method-of-use rather than certify
to a listed method-of-use patent. If the application contains only
Paragraph I or Paragraph II Certifications, the ANDA may be
approved as soon as FDA completes its review and concludes that all
approval requirements have been met. If the ANDA contains one or
more Paragraph III Certifications, the ANDA cannot not be approved
until each listed patent for which a Paragraph III Certification
was filed have expired.
If the
ANDA applicant has provided a Paragraph IV certification to the
FDA, the applicant must also send notice of the Paragraph IV
certification to the NDA holder and patent owner once the ANDA has
been accepted for filing by the FDA. The patent owner or NDA holder
may then commence a patent infringement lawsuit in response to the
notice of the Paragraph IV certification. The filing of a patent
infringement lawsuit within 45 days of the receipt of a Paragraph
IV certification automatically prevents the FDA from approving the
ANDA until the earlier of 30 months (the “30-month
stay”), expiration of the patent, settlement of the lawsuit
in which the patent owner admits that the patent is invalid or not
infringed by the ANDA product, or a decision in the infringement
case that holds the patent to be invalid or not infringed, or an
order by the court shortening the 30-month stay due to actions by
the patent holder to delay the litigation. In most circumstances,
the NDA holder is only eligible for one 30-month stay against an
ANDA.
If a
patent infringement action is filed against an ANDA applicant, any
settlement of the litigation must be submitted to the Federal Trade
Commission (“FTC”). If the FTC believes the terms or
effects of the settlement are anticompetitive, the FTC may bring an
antitrust enforcement action against the parties. Private parties
may also bring antitrust lawsuits against drug companies based on
such patent litigation settlements.
The
ANDA also will not be approved until any applicable non-patent
regulatory exclusivity listed in the Orange Book for the referenced
product has expired.
Regulatory Exclusivity. Upon NDA approval of a new chemical
entity (“NCE”), which is a drug that contains no active
moiety that has been approved by the FDA in any other NDA, that
drug receives five years of marketing exclusivity during which the
FDA cannot receive for review any ANDA seeking approval of a
generic version of that drug. An ANDA containing a Paragraph IV
Certification may be received by the FDA 4 years after the NCE
drug’s approval, but any 30-month stay that ensues would be
extended so that it expires seven and one half years after the NCE
approval date, subject to early termination by reason of a court
decision or settlement as described above.
Certain
changes to an NDA drug, such as the addition of a new indication to
the package insert, for which new clinical trials, conducted or
sponsored by the applicant are deemed by the FDA to be essential to
the approval of the change, can be eligible for a three-year period
of exclusivity during which the FDA cannot approve an ANDA for a
generic drug that includes the change. An ANDA that contains a
section (viii) statement to a method of use patent may be approved
with labeling that omits the patented use before the use patent
expires. Generic drugs approved with such a labeling carve out may
be substituted by pharmacists for the original branded drug before
the method of use patent expires.
12
Section 505(b)(2) NDAs. Most drug products obtain FDA
marketing approval pursuant to an NDA or an ANDA. A third
alternative is a special type of NDA, commonly referred to as a
505(b)(2) NDA, which enables the applicant to rely, in part, on the
FDA’s previous approval of a similar product, or published
literature, in support of its application.
505(b)(2)
NDAs often provide an alternate path to FDA approval for new or
improved formulations or new uses of previously approved products.
A 505(b)(2) NDA may be used where at least some of the information
required for approval comes from studies not conducted by, or for,
the applicant and for which the applicant has not obtained a right
of reference. If the 505(b)(2) applicant can establish that
reliance on the FDA’s previous approval is scientifically
appropriate, it may eliminate the need to conduct certain
preclinical or clinical studies of the new product. The FDA may
also require companies to perform additional studies or
measurements to support the change from the approved product. The
FDA may then approve the new product candidate for all, or some, of
the label indications for which the referenced product has been
approved, as well as for any new indication or conditions of use
sought by the Section 505(b)(2) applicant.
To the
extent that the Section 505(b)(2) applicant is relying on studies
conducted for an already approved product, the applicant is
required to certify to the FDA concerning any patents listed for
the approved product in the Orange Book to the same extent that an
ANDA applicant would. As a result, approval of a 505(b)(2) NDA can
be stalled until all the listed patents claiming the referenced
product have expired, until any non-patent exclusivity, such as
exclusivity for obtaining approval of a new chemical entity, listed
in the Orange Book for the referenced product has expired, and, in
the case of a Paragraph IV certification and subsequent patent
infringement suit, until the expiration of any 30-month stay,
subject to early termination of the stay as described
above.
Changing Legal and Regulatory Landscape
Periodically,
legislation is introduced in the U.S. Congress that could change
the statutory and regulatory provisions governing the approval,
manufacturing and marketing of our drugs. In addition, the FFDCA,
FDA regulations and guidance are often revised or reinterpreted by
the FDA or the courts in ways that may significantly affect our
business and products. We cannot predict whether or when
legislation or court decisions impacting our business will be
enacted or issued, what FDA regulations, guidance or
interpretations may change, or what the impact of such changes, if
any, may be in the future.
Third-Party Reimbursements
Successful
sales of our proposed products in the United States and other
countries depend, in large part, on the availability of adequate
reimbursement from third-party payers such as governmental
entities, managed care organizations, health maintenance
organizations (“HMOs”), and private insurance plans.
Reimbursement by a third-party payer depends on a number of
factors, including the payer’s determination that the product
has been approved by the FDA for the indication for which the claim
is being made, that it is neither experimental nor investigational,
and that the use of the product is safe and efficacious, medically
necessary, appropriate for the specific patient and cost
effective.
Since
reimbursement by one payer does not guarantee reimbursement by
another, we or our licensees may be required to seek approval from
each payer individually. Seeking such approvals is a time-consuming
and costly process. Third-party payers routinely limit the products
that they will cover and the amount of money that they will pay
and, in many instances, are exerting significant pressure on
medical suppliers to lower their prices.
Payers
frequently employ a tiered system in reimbursing end users for
pharmaceutical products, with tier designation affecting copay or
deductible amounts. Vyleesi is classified as a Tier 3 drug by at
least two insurers, and will likely be classified as a Tier 3 drug
by additional insurers. Thus reimbursement will be limited for
Vyleesi for treatment of premenopausal women with HSDD.
Flibanserin, sold under the trade name Addyi, is similarly
classified as a Tier 3 drug. Less than full reimbursement by
governmental and other third-party payers may adversely affect the
market acceptance of Vyleesi. Further, healthcare reimbursement
systems vary from country to country, and third-party reimbursement
might not be made available for Vyleesi for HSDD under other
reimbursement systems.
Manufacturing and Marketing
To be
successful, our proposed products will need to be manufactured in
commercial quantities under GMP prescribed by the FDA and at
acceptable costs. We do not have the facilities to manufacture any
of our proposed products under GMP. We intend to rely on
collaborators, licensees or contract manufacturers for the
commercial manufacture of our proposed products.
13
Vyleesi
is manufactured using contract manufacturing companies. Pursuant to
the termination of the license agreement with AMAG, we have assumed
contracts relating to manufacturing, and intend to manufacture
Vyleesi for sales in the United States and to our licensees
throughout the world.
Our
PL3994 product candidate is a peptide mimetic molecule,
incorporating a proprietary amino acid mimetic structure and amino
acids. We have had a contract manufacturer make the active
pharmaceutical ingredient in quantities sufficient for Phase 1 and
Phase 2.
Our
MC1r and MCr agonist product candidates are synthetic peptides. We
have had a contract manufacturer make both the PL8177 and PL9643
peptides in suitable scale for toxicity studies and under GMP for
clinical trial use. The PL8177 drug product for uveitis has been
manufactured for clinical trial use, and manufacturing process
development is ongoing for an oral formulation of PL8177
preparatory to manufacturing oral PL8177 drug product for clinical
trial use. While the production process for making peptide active
pharmaceutical ingredient involves well-established technology,
there are few manufacturers capable of scaling up to commercial
quantities under GMP at acceptable costs. Additionally, scaling up
to commercial quantities may involve production, purification,
formulation and other problems not present in the scale of
manufacturing done to date. Manufacturing drug product, such as the
oral formulation of PL8177, similarly may involve production,
formulation and other problems not present in manufacturing at
laboratory scale.
The
failure of any manufacturer or supplier to comply with FDA
regulations, including GMP or medical device quality systems
regulations (“QSR”), or to supply the device component
or drug substance and services as agreed, would force us or our
licensees to seek alternative sources of supply and could interfere
with our and our licensees’ ability to deliver product on a
timely and cost-effective basis or at all. Establishing
relationships with new manufacturers or suppliers, any of whom must
be FDA-approved, is a time-consuming and costly
process.
Product Liability and Insurance
Our
business may be affected by potential product liability risks that
are inherent in the testing, manufacturing, marketing and use of
our proposed products. We have liability insurance providing $10
million coverage in the aggregate as to certain product liability
and commercialization risks and certain clinical trial
risks.
Employees
As of
September 24, 2020, we employed 20 people full time, of whom 14 are
engaged in research and development activities and five are engaged
in administration and management, and did not have any part-time
employees. While we have been successful in attracting skilled and
experienced scientific personnel, competition for personnel in our
industry is intense. None of our employees are covered by a
collective bargaining agreement. All of our employees have executed
confidentiality and intellectual property agreements. We consider
relations with our employees to be good.
We rely
on contractors and scientific consultants to work on specific
research and development programs. We also rely on independent
organizations, advisors and consultants to provide services,
including aspects of manufacturing, testing, preclinical
evaluation, clinical management, regulatory strategy and market
research. Our independent advisors, contractors and consultants
sign agreements that provide for confidentiality of our proprietary
information and that we have the rights to any intellectual
property developed while working for us.
Corporate Information
We were
incorporated under the laws of the State of Delaware on November
21, 1986 and commenced operations in the biopharmaceutical area in
1996. Our corporate offices are located at 4B Cedar Brook Drive,
Cranbury, New Jersey 08512 and our telephone number is (609)
495-2200. We maintain an Internet site at www.palatin.com, where among other
things, we make available free of charge on and through this
website our Forms 3, 4 and 5, annual reports on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K, and
amendments to those reports filed or furnished pursuant to Section
13(a) or 15(d) and Section 16 of the Exchange Act as soon as
reasonably practicable after we electronically file such material
with, or furnish it to, the SEC. Our website and the information
contained in it or connected to it are not incorporated into this
Annual Report. The reference to our website is an inactive textual
reference only.
The SEC
maintains an Internet site that contains reports, proxy and
information statements, and other information regarding issuers
that file electronically with the SEC (www.sec.gov).
14
Item 1A. Risk Factors.
Risks Related to Our Financial Results and Need for
Financing
We have a history of substantial net losses, including a net loss
of $22.4 million for the year ended June 30, 2020, and while we had
net income for the years ended June 30, 2019 and 2018, we expect to
incur substantial net losses over the next few years, and we may
never achieve or maintain profitability.
As of
June 30, 2020, we had an accumulated deficit of $318.2 million. We
had a net loss of $22.4 million for the year ended June 30, 2020,
compared to $35.8 million of net income for the year ended June 30,
2019, and $24.7 million of net income for the year ended June 30,
2018. We may not sustain profitability in future years, depending
on numerous factors, including profitability of Vyleesi, whether
and when development and sales milestones are met, whether and when
we enter into license agreements for any of our products under
development, regulatory actions by the FDA and other regulatory
bodies, the performance of our licensees, and market acceptance of
our products.
We
expect to incur significant expenses as we continue our development
of MC1r, MCr and natriuretic peptide receptor products. These
expenses, among other things, have had and will continue to have an
adverse effect on our stockholders’ equity, total assets and
working capital.
Until
we commenced selling Vyleesi in July 2020 upon termination of our
license agreement with AMAG, since 2005 we have not had any
products available for commercial sale and have not received any
revenues from the sale of our product candidates. Because of
termination of the license agreement with AMAG relating to Vyleesi,
we cannot accurately forecast sales of Vyleesi. However, we
anticipate a net loss from Vyleesi sales for at least the year
ending June 30, 2021. For the foreseeable future, we will have to
fund our operations and capital expenditures from license, royalty
and contract revenue under license agreements, existing cash
balances and outside sources of financing, which may not be
available on acceptable terms, if at all. We will not have product
revenue from our products in development unless and until we
receive approval from the FDA or other equivalent regulatory
authorities outside the United States, and to date the only
approved product is Vyleesi in the United States. We have devoted
substantially all of our efforts to research and development,
including preclinical and clinical trials. Because of the numerous
risks associated with developing drugs, we are unable to predict
the extent of future losses, whether or when any of our product
candidates will become commercially available, or when we will
become profitable, if at all.
We will need additional funding, including funding to complete
clinical trials for our product candidates other than Vyleesi,
which may not be available on acceptable terms, if at
all.
We
intend to focus future efforts on our MC1r product candidates and
secondarily on our natriuretic peptide product candidates. As of
June 30, 2020, we had cash and cash equivalents of $82.9 million,
with current liabilities of $3.9 million. We believe we have
sufficient existing capital resources to fund our planned
operations through at least September 2021. We will need additional
funding to complete development activities and required clinical
trials for our MC1r product candidates and, if those clinical
trials are successful (which we cannot predict), to complete
submission of required regulatory applications to the
FDA.
We
cannot predict product sales for Vyleesi for HSDD in the United
States, so we may not have significant recurring revenue and may
need to depend on financing or partnering to sustain our
operations. We may raise additional funds through public or private
equity or debt financings, collaborative arrangements on our
product candidates, or other sources. However, such financing
arrangements may not be available on acceptable terms, or at all.
To obtain additional funding, we may need to enter into
arrangements that require us to develop only certain of our product
candidates or relinquish rights to certain technologies, product
candidates and/or potential markets.
If we
are unable to raise sufficient additional funds when needed, we may
be required to curtail operations significantly, cease clinical
trials and decrease staffing levels. We may seek to license, sell
or otherwise dispose of our product candidates, technologies and
contractual rights on the best possible terms available. Even if we
are able to license, sell or otherwise dispose of our product
candidates, technologies and contractual rights, it is likely to be
on unfavorable terms and for less value than if we had the
financial resources to develop or otherwise advance our product
candidates, technologies and contractual rights
ourselves.
Our
future capital requirements depend on many factors,
including:
●
our ability to
develop and maintain manufacturing, marketing and distribution
capability for sales of Vyleesi in the United States, including our
ability to enter into agreements with one or more third parties to
conduct activities relating to the commercialization of
Vyleesi;
●
our ability to
enter into one or more licensing or similar agreements for Vyleesi
outside of Korea and China;
●
the timing of
obtaining regulatory approvals for Vyleesi for HSDD in markets
outside the United States;
●
the expense and
timing of obtaining regulatory approvals for our other product
candidates;
●
the number and
characteristics of any additional product candidates we develop or
acquire;
15
●
the scope,
progress, results and costs of researching and developing our
future product candidates, and conducting preclinical and clinical
trials;
●
the cost of
commercialization activities if any future product candidates are
approved for sale, including marketing, sales and distribution
costs;
●
the cost of
manufacturing any future product candidates and any products we
successfully commercialize;
●
our ability to
establish and maintain strategic collaborations, licensing or other
arrangements and the terms and timing of such
arrangements;
●
the degree and rate
of market acceptance of any future approved products;
●
the emergence,
approval, availability, perceived advantages, relative cost,
relative safety and relative efficacy of alternative and competing
products or treatments;
●
any product
liability or other lawsuits related to our products;
●
the expenses needed
to attract and retain skilled personnel;
●
the costs involved
in preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims, including litigation costs and the outcome
of such litigation; and
●
the timing, receipt
and amount of sales of, or royalties on, future approved products,
if any.
We have a limited operating history upon which to base an
investment decision.
Our
operations are primarily focused on acquiring, developing and
securing our proprietary technology, conducting preclinical and
clinical studies and formulating and manufacturing, through
contract manufacturers, our principal product candidates on a
small-scale basis. These operations provide a limited basis for
stockholders to assess our ability to commercialize our product
candidates.
While
we have completed Phase 3 clinical trials on Vyleesi for HSDD in
premenopausal women, filed an NDA on Vyleesi for HSDD with the FDA,
and received approval on Vyleesi from the FDA, we have not yet
demonstrated our ability to perform the functions necessary for the
successful commercialization of any of our current product
candidates. The successful commercialization of our product
candidates will require us to perform a variety of functions,
including:
●
continuing to
conduct preclinical development and clinical trials;
●
participating in
regulatory approval processes;
●
formulating and
manufacturing products, or having third parties formulate and
manufacture products;
●
post-approval
monitoring and surveillance of our products;
●
conducting sales
and marketing activities, either alone or with a partner;
and
●
obtaining
additional capital.
If we
are unable to obtain regulatory approval of any of our product
candidates, to successfully commercialize any products for which we
receive regulatory approval or to obtain additional capital, we may
not be able to recover our investment in our development
efforts.
The
clinical and commercial success of our product candidates will
depend on a number of factors, including the
following:
●
the ability to
raise additional capital on acceptable terms, or at
all;
●
timely completion
of our clinical trials, which may be significantly slower or cost
more than we currently anticipate and will depend substantially
upon the performance of third-party contractors;
●
whether we are
required by the FDA or similar foreign regulatory agencies to
conduct additional clinical trials beyond those planned to support
the approval and commercialization of our product candidates or any
future product candidates;
●
acceptance of our
proposed indications and primary endpoint assessments relating to
the proposed indications of our product candidates by the FDA and
similar foreign regulatory authorities;
●
our ability to
demonstrate to the satisfaction of the FDA and similar foreign
regulatory authorities, the safety and efficacy of our product
candidates or any future product candidates;
16
●
the prevalence,
duration and severity of potential side effects experienced with
our product candidates or future approved products, if
any;
●
the timely receipt
of necessary marketing approvals from the FDA and similar foreign
regulatory authorities;
●
achieving and
maintaining, and, where applicable, ensuring that our third-party
contractors achieve and maintain, compliance with our contractual
obligations and with all regulatory requirements applicable to our
product candidates or any future product candidates or approved
products, if any;
●
the ability of
third parties with whom we contract to manufacture clinical trial
and commercial supplies of our product candidates or any future
product candidates, remain in good standing with regulatory
agencies and develop, validate and maintain commercially viable
manufacturing processes that are compliant with the FDA’s
current GMP regulations;
●
a continued
acceptable safety profile and efficacy during clinical development
and following approval of our product candidates or any future
product candidates;
●
our ability to
successfully commercialize our product candidates or any future
product candidates in the United States and internationally, if
approved for marketing, sale and distribution in such countries and
territories, whether alone or in collaboration with
others;
●
acceptance by
physicians and patients of the benefits, safety and efficacy of our
product candidates or any future product candidates, if approved,
including relative to alternative and competing
treatments;
●
our and our
partners’ ability to establish and enforce intellectual
property rights in and to our product candidates or any future
product candidates;
●
our and our
partners’ ability to avoid third-party patent interference or
intellectual property infringement claims; and
●
our ability to
develop, in-license or acquire additional product candidates or
commercial-stage products that we believe can be successfully
developed and commercialized.
If we
do not achieve one or more of these factors, many of which are
beyond our control, in a timely manner or at all, we could
experience significant delays or an inability to obtain regulatory
approvals or commercialize our product candidates. Even if
regulatory approvals are obtained, we may never be able to
successfully commercialize any of our product candidates.
Accordingly, we cannot assure you that we will be able to generate
sufficient revenue through the sale of our product candidates or
any future product candidates to continue our
business.
Raising additional capital may cause dilution to existing
shareholders, restrict our operations or require us to relinquish
rights.
We may
seek the additional capital necessary to fund our operations
through public or private equity offerings, collaboration
agreements, debt financings or licensing arrangements. To the
extent that we raise additional capital through the sale of equity
or convertible debt securities, existing shareholders’
ownership interests will be diluted and the terms may include
liquidation or other preferences that adversely affect their rights
as a shareholder. Debt financing, if available, may involve
agreements that include covenants limiting or restricting our
ability to take specific actions such as incurring additional debt,
making capital expenditures or declaring dividends. If we raise
additional funds through collaborations and licensing arrangements
with third parties, we may have to relinquish valuable rights to
our technologies or product candidates or grant licenses on terms
that are not favorable to us.
Risks Related to Our Business, Strategy and Industry
We are substantially dependent on the commercial success of Vyleesi
for HSDD, but we and our licensees may never successfully
commercialize Vyleesi for HSDD or obtain approvals in countries
other than the United States.
To
date, we have invested most of our efforts and financial resources
in the research and development of Vyleesi for HSDD, which was
approved by the FDA in June 2019. Since July 24, 2020, the
effective date of the termination of our license agreement with
AMAG for
Vyleesi, we have been
responsible for manufacturing, marketing and distribution of
Vyleesi in the United States. We licensed all rights to
commercialize Vyleesi in China to Fosun and in Korea to Kwangdong.
We have not yet received regulatory approval to commercialize
Vyleesi in China or Korea, and regulatory approval in these
countries cannot be assured.
17
Our
near-term prospects, including our ability to finance our company
and generate revenue, will depend heavily on the successful
commercialization of Vyleesi for HSDD, as well as any future
product candidates. The clinical and commercial success of Vyleesi
and our product candidates will depend on a number of factors,
including the following:
●
timely completion
of, or need to conduct additional clinical trials and studies, for
our product candidates, which may be significantly slower or cost
more than we currently anticipate and will depend substantially
upon the accurate and satisfactory performance of third-party
contractors;
●
the ability to
demonstrate to the satisfaction of the FDA the safety and efficacy
of future product candidates through clinical trials;
●
whether we or our
licensees are required by the FDA or other similar foreign
regulatory agencies to conduct additional clinical trials to
support the approval of Vyleesi and future product
candidates;
●
our ability to
successful manufacture Vyleesi for worldwide markets;
●
our success and the
success of our licensees in educating physicians and patients about
the benefits, administration and use of Vyleesi for
HSDD;
●
the prevalence and
severity of adverse events experienced with Vyleesi for HSDD or any
future product candidates or approved products;
●
the adequacy and
regulatory compliance of the autoinjector device, supplied by an
unaffiliated third party, used as part of the Vyleesi combination
product;
●
the timely receipt
of necessary marketing approvals from the FDA and similar foreign
regulatory authorities;
●
our ability to
raise additional capital on acceptable terms to achieve our
goals;
●
achieving and
maintaining compliance with all regulatory requirements applicable
to Vyleesi for HSDD or any future product candidates or approved
products;
●
the availability,
perceived advantages, relative cost, relative safety and relative
efficacy of alternative and competing treatments;
●
the effectiveness
of our own or our future potential strategic collaborators’
marketing, sales and distribution strategy and
operations;
●
the ability to
manufacture clinical trial supplies of any future product
candidates and to develop, validate and maintain a commercially
viable manufacturing process that is compliant with current
GMP;
●
our ability to
successfully commercialize Vyleesi for HSDD in the United
States;
●
our ability to
successfully commercialize any future product candidates, if
approved for marketing and sale, whether alone or in collaboration
with others;
●
our ability to
enforce our intellectual property rights in and to Vyleesi for HSDD
or any future product candidates;
●
our ability to
avoid third-party patent interference or intellectual property
infringement claims;
●
acceptance of
Vyleesi for HSDD or any future product candidates, if approved, as
safe and effective by patients and the medical community;
and
●
a continued
acceptable safety profile and efficacy of Vyleesi for HSDD or any
future product candidates following approval.
If we
fail to satisfy any one of these prerequisites to our commercial
success, many of which are beyond our control, in a timely manner
or at all, we could experience significant delays or an inability
to successfully commercialize our product candidates. Accordingly,
we cannot assure you that we will be able to generate sufficient
revenue through direct sales of Vyleesi for HSDD in the United
States and the license agreements with Fosun and Kwangdong, or
through the sale of any future product candidate, to continue our
business. In addition to preventing us from executing our current
business plan, any delays in our clinical trials, or inability to
successfully commercialize our products could impair our reputation
in the industry and the investment community and could hinder our
ability to fulfill our existing contractual commitments. As a
result, our share price would likely decline significantly, and we
would have difficulty raising necessary capital for future
projects.
18
Production and supply of Vyleesi depend on contract manufacturers
over whom we do not have any control, and there may not be adequate
supplies of Vyleesi.
We do
not have the facilities to manufacture the Vyleesi active drug
ingredient or the autoinjector pen component of the Vyleesi
combination product, or to fill, assemble and package the Vyleesi
combination product. We have contracts with third parties to make
the Vyleesi combination product. The contract manufacturers must
perform these manufacturing activities in a manner that complies
with FDA regulations. Our ability to control third-party compliance
with FDA requirements is limited to contractual remedies and rights
of inspection. The manufacturers of approved products and their
manufacturing facilities will be subject to ongoing review and
periodic inspections by the FDA and other authorities where
applicable, and must comply with regulatory requirements, including
FDA regulations concerning GMP. Failure of third-party
manufacturers to comply with GMP, medical device quality system
regulations, or other FDA requirements may result in enforcement
action by the FDA. Failure to conduct their activities in
compliance with FDA regulations could delay or negatively impact
our ability to market Vyleesi. Establishing relationships with new
suppliers, who must be FDA-approved, is a time-consuming and costly
process. If we are not able to obtain adequate supplies of Vyleesi,
it will be difficult for us to market and commercialize Vyleesi and
compete effectively.
The effect of COVID-19 and other possible pandemics and
outbreaks could result in material adverse effects on our clinical
trials, business, financial condition and results of
operations.
We have
active and planned clinical trial sites in the United States and
planned clinical trial sites in Europe, and our licensees have
planned clinical trial sites in Asia-Pacific countries. As the
COVID-19 pandemic continues to spread around the globe, we will
likely experience disruptions that could severely impact our
planned clinical trials, including potential Phase 3 clinical
trials with PL9643 in the United States for dry eye disease, a
planned Phase 2 clinical trial with PL8177 for ulcerative colitis,
a planned Phase 2 clinical trial with PL3994, an NPR-A agonist, in
heart failure patients in collaboration with two major academic
medical centers, and clinical trials planned to be conducted in the
People’s Republic of China and the Republic of Korea by our
licensees for Vyleesi, Fosun and Kwangdong.
It is
possible that the COVID-19 pandemic may delay enrollment in our
clinical trials due to prioritization of medical and hospital
resources toward the outbreak, and some patients may be unwilling
to enroll in our trials or be unable to comply with clinical trial
protocols if quarantines impede patient movement or interrupt
healthcare services, which would delay our ability to conduct
clinical trials or release clinical trial results.
The
spread of COVID-19 may also result in the inability of our
suppliers to deliver clinical drug supplies on a timely basis or at
all. In addition, medical centers and hospitals may reduce staffing
and reduce or postpone certain treatments in response to the spread
of an infectious disease. Such events may result in a period of
business disruption, and in reduced operations, or doctors and
medical providers may be unwilling to participate in our clinical
trials.
The
COVID-19 pandemic and measures to prevent the spread of COVID-19
subject us to various risks and uncertainties that could materially
adversely affect our clinical trials, business, financial condition
and results of operation, including the following:
●
our ability to
recruit subjects for clinical trials and studies for our product
candidates and to timely complete clinical trials and other
studies;
●
our ability to
successfully market Vyleesi, given significant limitations in
person-to-person marketing and contacts, including limitations in
educating physicians and other health care professionals about the
benefits, administration and use of Vyleesi for HSDD;
●
adverse impacts on
our ability to manufacture and distribute Vyleesi, including due to
the negative impact of COVID-19 on air travel, as well as temporary
disruptions, restrictions or closures of facilities of our
suppliers and contract manufacturers in the Vyleesi manufacturing
chain;
●
adverse impacts of
COVID-19 on our ability to successful manufacture product
candidates for clinical trials and to successfully manufacture
Vyleesi for the United States market and clinical trials elsewhere
in the world;
●
adverse impacts on
our operations resulting from remote working
arrangements;
●
limitations in
employee resources that would otherwise be focused on the conduct
of our clinical trials, including because of sickness of employees
or their families, delays or difficulties in conducting site visits
and other required travel, and the desire of employees to avoid
contact with large groups of people;
●
the inability of
global suppliers of raw materials or components used in the
manufacture of our products, or contract manufacturers of our
products, to supply and/or transport those raw materials,
components and products to us in a timely and cost effective manner
due to shutdowns, interruptions or delays, limiting and precluding
the production of our finished products, impacting our ability to
supply customers, reducing our sales, increasing our costs of goods
sold, and reducing our absorption of overhead;
19
●
the illiquidity or
insolvency of our suppliers, vendors and customers, or their
inability to pay our invoices in full or in a timely manner, due to
the reduction in their revenues caused by the cancellation or delay
of procedures and other factors, which could potentially reduce our
cash flow and our liquidity;
●
delays in our
ability, and the ability of our development partners, to conduct,
enroll and complete clinical development programs;
●
the instability to
worldwide economies, financial markets, social institutions, labor
markets and the healthcare systems as a result of the COVID-19
pandemic, which could result in an economic downturn that could
adversely impact our business, results of operations and financial
condition, as well as that of our investors, suppliers, customers
or other business partners;
●
changes in customer
behavior and preferences for Vyleesi, as customers may experience
financial difficulties or may delay or reduce their spending in
light of COVID-19; and
●
a recurrence of the
COVID-19 pandemic after social distancing and other similar
measures have been relaxed.
Most of
our employees have transitioned to remote working arrangements, and
we have not determined how long these arrangements will last. While
remote working has not had a significant adverse impact on our
financial results or our operations to date, there can be no
assurance that these arrangements will not ultimately result in
lower work efficiency and productivity, which in turn may adversely
affect our business. Certain employees, such as laboratory
personnel, cannot work remotely, and COVID-19 may adversely affect
our ability to conduct research and preclinical studies, and
undertake other activities related to development of potential
products. In addition, COVID-19 has resulted in industry events and
business travel being suspended, cancelled or significantly
curtailed, which may negatively impact our ability to identify and
form relationships with potential development and marketing
partners.
The
extent to which the global COVID-19 pandemic impacts our business
will depend on future developments, which are highly uncertain and
cannot be predicted, including new information that may emerge
concerning the severity of COVID-19 and the actions to contain or
treat its impact, among others. The COVID-19 pandemic has adversely
affected economies and financial markets worldwide, resulting in an
economic downturn that could impact our business, financial
condition and results of operations, including our ability to
obtain additional funding, if needed.
Our product candidates other than Vyleesi, including PL9643 for dry
eye disease and PL8177 for the treatment of COVID-19, are still in
the early stages of development and remain subject to clinical
testing and regulatory approval. If we are unable to successfully
develop and test our product candidates, we will not be
successful.
Our
product candidates, including PL9643 for dry eye disease and PL8177
for the treatment of COVID-19, are at various stages of research
and development, will require regulatory approval, and may never be
successfully developed or commercialized. Our product candidates
will require significant further research, development and testing
before we can seek regulatory approval to market and sell them. We
must demonstrate that our product candidates are safe and effective
for use in patients in order to receive regulatory approval for
commercial sale. Preclinical studies in animals, using various
doses and formulations, must be performed before we can begin human
clinical trials. Even if we obtain favorable results in the
preclinical studies, the results in humans may be different.
Numerous small-scale human clinical trials may be necessary to
obtain initial data on a product candidate’s safety and
efficacy in humans before advancing to large scale human clinical
trials. We face the risk that the results of our trials in later
phases of clinical trials may be inconsistent with those obtained
in earlier phases. Adverse or inconclusive results could delay the
progress of our development programs and may prevent us from filing
for regulatory approval of our product candidates. Additional
factors that could inhibit the successful development of our
product candidates include:
●
lack of
effectiveness of any product candidate during clinical trials or
the failure of our product candidates to meet specified
endpoints;
●
failure to design
appropriate clinical trial protocols;
●
uncertainty
regarding proper dosing;
●
for injectable
products, inability to develop or obtain a supplier for a suitable
autoinjector device that meets the FDA’s medical device
requirements;
●
insufficient data
to support regulatory approval;
●
inability or
unwillingness of medical investigators to follow our clinical
protocols;
●
inability to add a
sufficient number of clinical trial sites; or
●
the availability of
sufficient capital to sustain operations and clinical
trials.
20
You
should evaluate us in light of these uncertainties, difficulties
and expenses commonly experienced by early stage biopharmaceutical
companies, as well as unanticipated problems and additional costs
relating to:
●
product approval or
clearance;
●
regulatory
compliance;
●
good manufacturing
practices;
●
intellectual
property rights;
●
product
introduction; and
●
marketing and
competition.
If clinical trials for our product candidates are prolonged or
delayed, we may be unable to commercialize our product candidates
on a timely basis, which would require us to incur additional costs
and delay our receipt of any revenue from potential product
sales.
We may
be unable to commercialize our product candidates on a timely basis
due to unexpected delays in our human clinical trials. Potential
delaying events include:
●
discovery of
serious or unexpected toxicities or side effects experienced by
study participants or other safety issues;
●
slower than
expected rates of subject recruitment and enrollment rates in
clinical trials resulting from numerous factors, including the
prevalence of other companies’ clinical trials for their
product candidates for the same indication, or clinical trials for
indications for which patients do not as commonly seek
treatment;
●
difficulty in
retaining subjects who have initiated a clinical trial but may
withdraw at any time due to adverse side effects from the therapy,
insufficient efficacy, fatigue with the clinical trial process or
for any other reason;
●
difficulty in
obtaining IRB approval for studies to be conducted at each
site;
●
delays in
manufacturing or obtaining, or inability to manufacture or obtain,
sufficient quantities of materials for use in clinical
trials;
●
inadequacy of or
changes in our manufacturing process or the product formulation or
method of delivery;
●
changes in
applicable laws, regulations and regulatory policies;
●
delays or failure
in reaching agreement on acceptable terms in clinical trial
contracts or protocols with prospective contract research
organizations (“CROs”), clinical trial sites and other
third-party contractors;
●
failure of our CROs
or other third-party contractors to comply with contractual and
regulatory requirements or to perform their services in a timely or
acceptable manner;
●
failure by us, our
employees, our CROs or their employees or any partner with which we
may collaborate or their employees to comply with applicable FDA or
other regulatory requirements relating to the conduct of clinical
trials or the handling, storage, security and recordkeeping for
drug, medical device and biologic products;
●
delays in the
scheduling and performance by the FDA of required inspections of
us, our CROs, our suppliers, or our clinical trial sites, and
violations of law or regulations discovered in the course of FDA
inspections;
●
scheduling
conflicts with participating clinicians and clinical institutions;
or
●
difficulty in
maintaining contact with subjects during or after treatment, which
may result in incomplete data.
Any of
these events or other delaying events, individually or in the
aggregate, could delay the commercialization of our product
candidates and have a material adverse effect on our business,
results of operations and financial condition.
In light of the COVID-19 pandemic, it is possible that one or more
government entities may take actions that directly or indirectly
have the effect of abrogating some of our rights or opportunities.
If we were to develop a treatment for COVID-19, the economic value
of such a therapeutic treatment to us could be
limited.
Various
government entities, including the U.S. government, are offering
incentives, grants and contracts to encourage additional investment
by commercial organizations into preventative and therapeutic
agents against coronavirus, which may have the effect of increasing
the number of competitors and/or providing advantages to known
competitors. Accordingly, there can be no assurance that we will be
able to successfully establish a competitive market share for our
COVID-19 therapeutic treatment, if any.
21
We may not be able to secure and maintain relationships with
research institutions and other organizations to conduct our
clinical trials.
We rely
on research institutions and other organizations to conduct our
clinical trials, and we therefore have limited control over the
timing and cost of clinical trials and our ability to recruit
subjects. If we are unable to reach agreements with suitable
research institutions or organizations on acceptable terms, or if
any such agreement is terminated, we may be unable to quickly
replace the research institution or organization with another
qualified institution or organization on acceptable terms. We may
not be able to secure and maintain suitable research institutions
or organizations to conduct our clinical trials.
Even if our product candidates receive regulatory approval, they
may never achieve market acceptance, in which case our business,
financial condition and results of operation will be materially
adversely affected.
Regulatory
approval for the marketing and sale of any of our product
candidates does not assure the product’s commercial success.
Any approved product will compete with other products manufactured
and marketed by major pharmaceutical and other biotechnology
companies. If any of our product candidates are approved by the FDA
and do not achieve adequate market acceptance, our business,
financial condition and results of operations will be materially
adversely affected. The degree of market acceptance of any such
product will depend on a number of factors, including:
●
perceptions by
members of the healthcare community, including physicians, about
the safety and effectiveness of any such product;
●
cost-effectiveness
relative to competing products and technologies;
●
availability of
reimbursement for our products from third-party payers such as
health insurers, HMOs and government programs such as Medicare and
Medicaid; and
●
advantages over
alternative treatment methods.
There
is one other FDA approved product for treatment of HSDD,
flibanserin, which is sold under the trade name Addyi®, and
started marketing in October 2015. Because flibanserin was not
consistently marketed since October 2015, and ownership of the
product has changed, the actual market size and market dynamics for
HSDD are unknown. While we believe that an on-demand drug for HSDD
has competitive advantages compared to chronic or daily use drugs,
we may not be able to realize this perceived advantage in the
market. Vyleesi is administered by subcutaneous injection. While
the single-use, disposable autoinjector pen format is designed to
maximize market acceptability, Vyleesi as a subcutaneous injectable
drug for HSDD may never achieve significant market acceptance. In
addition, we believe reimbursement of Vyleesi from third-party
payers such as health insurers, HMOs or other third-party payers of
healthcare costs will be similar to reimbursement for flibanserin
and erectile dysfunction (“ED”) drugs, and that the
ultimate user may pay a substantial part of the cost of Vyleesi for
HSDD. If the market opportunity for Vyleesi is smaller than we
anticipate, it may also be difficult for us to find marketing
partners and, as a result, we may be unable to generate revenue and
business from Vyleesi. If Vyleesi for HSDD does not achieve
adequate market acceptance at an acceptable price point, our
business, financial condition and results of operations will be
materially adversely affected.
Even if our product candidates receive regulatory approval in the
United States, we may never receive approval or commercialize our
products outside of the United States.
In
order to market any products outside of the United States, we must
establish and comply with numerous and varying regulatory
requirements of other countries regarding safety and efficacy.
Approval procedures vary among countries and can involve additional
product testing and additional administrative review periods. The
time required to obtain approval in other countries might differ
from that required to obtain FDA approval. The regulatory approval
process in other countries may include all of the risks detailed
above regarding FDA approval in the United States as well as other
risks. Regulatory approval in one country does not ensure
regulatory approval in another, but a failure or delay in obtaining
regulatory approval in one country may have a negative effect on
the regulatory process in others. Failure to obtain regulatory
approval in other countries or any delay or setbacks in obtaining
such approval would impair our ability to develop foreign markets
for our product candidates and may have a material adverse effect
on our results of operations and financial condition.
22
If side effects emerge that can be linked to Vyleesi or any of our
product candidates (either while they are in development or after
they are approved and on the market), we may be required to perform
lengthy additional clinical trials, change the labeling of any such
products, or withdraw such products from the market, any of which
would hinder or preclude our ability to generate
revenues.
If we
identify side effects or other problems occur in future clinical
trials, we may be required to terminate or delay clinical
development of the product candidate. Furthermore, even if any of
our product candidates receive marketing approval, as greater
numbers of patients use a drug following its approval, if the
incidence of side effects increases or if other problems are
observed after approval that were not seen or anticipated during
pre-approval clinical trials, or if the incidence of side effects
increase or other problems are observed with Vyleesi, a number of
potentially significant negative consequences could result,
including:
●
regulatory
authorities may withdraw their approval of the
product;
●
we may be required
to reformulate such products or change the way the product is
manufactured;
●
we may become the
target of lawsuits, including class action suits; and
●
our reputation in
the marketplace may suffer resulting in a significant drop in the
sales of such products.
Any of
these events could substantially increase the costs and expenses of
developing, commercializing and marketing any such product
candidates or could harm or prevent sales of any approved
products.
We may not be able to keep up with the rapid technological change
in the biotechnology and pharmaceutical industries, which could
make any future approved products obsolete and reduce our
revenue.
Biotechnology
and related pharmaceutical technologies have undergone and continue
to be subject to rapid and significant change. Our future will
depend in large part on our ability to maintain a competitive
position with respect to these technologies. Our competitors may
render our technologies obsolete by advances in existing
technological approaches or the development of new or different
approaches, potentially eliminating the advantages in our drug
discovery process that we believe we derive from our research
approach and proprietary technologies. In addition, any future
products that we develop, including our clinical product
candidates, may become obsolete before we recover expenses incurred
in developing those products, which may require that we raise
additional funds to continue our operations.
Competing products and technologies may make our proposed products
noncompetitive.
Flibanserin,
a daily-use oral drug sold under the trade name Addyi®, has
been approved by the FDA for HSDD in premenopausal women. There are
other products reported as being developed for HSDD and other FSD
indications, including oral combination drugs, some of which
incorporate testosterone, antidepressants or PDE-5 inhibitors.
There is competition to develop drugs for treatment of HSDD and FSD
in both premenopausal and postmenopausal patients. Our Vyleesi drug
product is administered by subcutaneous injection, and an on-demand
drug product for the same indication which utilizes another route
of administration, such as a conventional oral drug product, may
make subcutaneous Vyleesi noncompetitive.
There
are a number of products approved for use in treating inflammatory
diseases and indications, and other products are being developed,
including products in clinical trials. The dry eye disease and
ocular inflammatory disease markets are highly competitive, with a
number of marketed products and products reported to be in late
stage clinical trials. Similarly, the inflammatory bowel disease
and ulcerative colitis markets are highly competitive, with a
number of marketed products and products reported to be in late
stage clinical trials.
There
are several products approved for use in treatment of obesity and
related indications, and a number of other products being developed
for treatment of obesity, including products in clinical trials.
There is intense competition to develop drugs for treatment of
obesity and related indications.
In
general, the biopharmaceutical industry is highly competitive. We
are likely to encounter significant competition with respect to
Vyleesi, MC1r product candidates, MCr product candidates and NPR
product candidates. Most of our competitors have substantially
greater financial and technological resources than we do. Many of
them also have significantly greater experience in research and
development, marketing, distribution and sales than we do.
Accordingly, our competitors may succeed in developing, marketing,
distributing and selling products and underlying technologies more
rapidly than we can. These competitive products or technologies may
be more effective and useful or less costly than Vyleesi or our
MC1r product candidates, MCr product candidates and NPR product
candidates. In addition, academic institutions, hospitals,
governmental agencies and other public and private research
organizations are also conducting research and may develop
competing products or technologies on their own or through
strategic alliances or collaborative arrangements.
23
We rely on third parties over whom we have no control to conduct
preclinical studies, clinical trials and other research for our
product candidates and their failure to timely perform their
obligations could significantly harm our product
development.
We have
limited research and development staff. We rely on third parties
and independent contractors, such as researchers at CROs and
universities, in certain areas that are particularly relevant to
our research and product development plans. We engage such
researchers to conduct our preclinical studies, clinical trials and
associated tests. These outside contractors are not our employees
and may terminate their engagements with us at any time. In
addition, we have limited control over the resources that these
contractors devote to our programs, and they may not assign as
great a priority to our programs or pursue them as diligently as we
would if we were undertaking such programs ourselves. There is also
competition for these relationships, and we may not be able to
maintain our relationships with our contractors on acceptable
terms. If our third-party contractors do not carry out their duties
under their agreements with us, fail to meet expected deadlines or
fail to comply with appropriate standards for preclinical or
clinical research, our ability to develop our product candidates
and obtain regulatory approval on a timely basis, if at all, may be
materially adversely affected.
Production and supply of our product candidates depend on contract
manufacturers over whom we have no control, with the risk that we
may not have adequate supplies of our product candidates or
products.
We do
not have the facilities to manufacture our early stage potential
products such as PL8177, PL9643, PL3994 and other natriuretic
peptide and melanocortin receptor agonist compounds for use in
preclinical studies and clinical trials. Contract manufacturers
must perform these manufacturing activities in a manner that
complies with FDA regulations. Our ability to control third-party
compliance with FDA requirements is limited to contractual remedies
and rights of inspection. The manufacturers of our potential
products and their manufacturing facilities will be subject to
continual review and periodic inspections by the FDA and other
authorities where applicable, and must comply with ongoing
regulatory requirements, including FDA regulations concerning GMP.
Failure of third-party manufacturers to comply with GMP, medical
device QSR, or other FDA requirements may result in enforcement
action by the FDA. Failure to conduct their activities in
compliance with FDA regulations could delay our development
programs or negatively impact our ability to receive FDA approval
of our potential products. Establishing relationships with new
suppliers, who must be FDA-approved, is a time-consuming and costly
process.
If we are unable to establish sales and marketing capabilities
within our organization or enter into and maintain agreements with
third parties to market and sell Vyleesi and our product
candidates, we may be unable to generate product
revenue.
We do
not currently have any experience in sales, marketing and
distribution of pharmaceutical products. We are currently working
to establish sales and marketing capabilities for Vyleesi in the
United States, including through establishing agreements with third
parties to market and sell Vyleesi. We may not be able to enter
into suitable agreements on acceptable terms, if at all, with third
parties to market and sell Vyleesi. Engaging a third party to
perform these services could impede sales of Vyleesi. If we are
unable to establish adequate sales, marketing and distribution
capabilities for Vyleesi, whether independently or with third
parties, we may not be able to generate sufficient product revenue
to support Vyleesi-associated costs and expenses, and our business
would suffer. In addition, if we enter into arrangements with third
parties to perform sales, marketing and distribution services, we
will be dependent on the performance of third parties over whom we
have limited control.
If any
of our products candidates are approved by the FDA or other
regulatory authorities, we must enter into agreements with third
parties to market these product candidates or develop marketing,
distribution and selling capacity and expertise, which will be
costly and time consuming, or enter into agreements with other
companies to provide these capabilities. We may not be able to
enter into suitable agreements on acceptable terms, if at all.
Engaging a third party to perform these services could delay the
commercialization of any of our product candidates, if approved for
commercial sale. If we are unable to establish adequate sales,
marketing and distribution capabilities, whether independently or
with third parties, we may not be able to generate product revenue
and our business would suffer. In addition, if we enter into
arrangements with third parties to perform sales, marketing and
distribution services, our product revenues are likely to be lower
than if we could market and sell any products that we develop
ourselves.
We need to hire additional employees in order to commercialize
Vyleesi and our product candidates in the future. Any inability to
manage future growth could harm our ability to commercialize
Vyleesi and ultimately our product candidates, increase our costs
and adversely impact our ability to compete
effectively.
In
order to commercialize Vyleesi and ultimately our product
candidates, we will need to hire experienced sales and marketing
personnel to sell and market those product candidates we decide to
commercialize, and we will need to expand the number of our
managerial, operational, financial and other employees to support
commercialization. Competition exists for qualified personnel in
the biopharmaceutical field.
24
Future
growth will impose significant added responsibilities on members of
management, including the need to identify, recruit, maintain and
integrate additional employees. Our future financial performance
and our ability to commercialize our product candidates and to
compete effectively will depend, in part, on our ability to manage
any future growth effectively.
Our ability to achieve revenues from the sale of our products will
depend, in part, on our ability to obtain adequate reimbursement
from Medicare, Medicaid, private insurers and other healthcare
payers.
Our
ability to successfully commercialize our products, including
Vyleesi and our products in development, will depend, in
significant part, on the extent to which we or our marketing
partners can obtain reimbursement for our products and also
reimbursement at appropriate levels for the cost of our products.
Obtaining reimbursement from governmental payers, insurance
companies, HMOs and other third-party payers of healthcare costs is
a time-consuming and expensive process. There is no guarantee that
our products will ultimately be reimbursed. There is significant
uncertainty concerning third-party reimbursement for the use of any
pharmaceutical product incorporating new technology and third-party
reimbursement might not be available for our proposed products once
approved, or if obtained, might not be adequate.
There
is significant uncertainty concerning the extent and scope of
third-party reimbursement for products treating HSDD and other
forms of FSD. We believe that Vyleesi for HSDD will be classified
as a Tier 3 drug, as was flibanserin, so that reimbursement will be
limited for Vyleesi for treatment of premenopausal women with HSDD.
Third-party payers are increasingly challenging the prices charged
for diagnostic and therapeutic products and related services.
Reimbursement from governmental payers is subject to statutory and
regulatory changes, retroactive rate adjustments, administrative
rulings and other policy changes, all of which could materially
decrease the range of products for which we are reimbursed or the
rates of reimbursement by government payers. In addition, recent
legislation reforming the healthcare system may result in lower
prices or the actual inability of prospective customers to purchase
our products. The cost containment measures that healthcare payers
and providers are instituting and the effect of any healthcare
reform could materially and adversely affect our ability to operate
profitably. Furthermore, even if reimbursement is available, it may
not be available at the volume and price levels sufficient for us
to realize a positive return on our investment, which would have a
material adverse effect on our business, financial condition and
results of operations.
Even if we receive regulatory approval for our products in Europe,
we may not be able to secure adequate pricing and reimbursement in
Europe for us or any strategic partner to achieve
profitability.
Even if
one or more of our products are approved in Europe, we may be
unable to obtain appropriate pricing and reimbursement for such
products. In most European markets, demand levels for healthcare in
general and for pharmaceuticals in particular are principally
regulated by national governments. Therefore, pricing and
reimbursement for our products will have to be negotiated on a
“Member State by Member State” basis according to
national rules, as there does not exist a centralized European
process. As each Member State has its own national rules governing
pricing control and reimbursement policy for pharmaceuticals, there
are likely to be uncertainties attaching to the review process, and
the level of reimbursement that national governments are prepared
to accept. In the current economic environment, governments and
private payers or insurers are increasingly looking to contain
healthcare costs, including costs on drug therapies. If we are
unable to obtain adequate pricing and reimbursement for our
products in Europe, we or a potential strategic partner or
collaborator may not be able to cover the costs necessary to
manufacture, market and sell the product, limiting or preventing
our ability to achieve profitability.
We may incur substantial liabilities and may be required to limit
commercialization of our products in response to product liability
lawsuits.
The
testing and marketing of medical products entails an inherent risk
of product liability. If we cannot successfully defend ourselves
against product liability claims, we may incur substantial
liabilities or be required to limit commercialization of our
products or cease clinical trials. Our inability to obtain
sufficient product liability insurance at an acceptable cost to
protect against potential product liability claims could prevent or
inhibit the commercialization of pharmaceutical products we
develop, alone or with corporate collaborators. We currently carry
$10 million liability insurance in the aggregate as to certain
product liability and commercialization risks and certain clinical
trial risks. We, or any corporate collaborators, may not in the
future be able to obtain insurance at a reasonable cost or in
sufficient amounts, if at all. Even if our agreements with any
future corporate collaborators entitle us to indemnification
against losses, such indemnification may not be available or
adequate should any claim arise.
25
Our internal computer systems, or those of our third-party
contractors or consultants, may fail or suffer security breaches,
which could result in a material disruption of our product
development programs.
In the
ordinary course of our business, we collect, store and transmit
confidential information. Despite the implementation of security
measures, our internal computer systems and those of our
third-party contractors and consultants are vulnerable to damage
from computer viruses, unauthorized access, natural disasters,
terrorism, war and telecommunication and electrical failures. We
rely on industry accepted measures and technology to secure
confidential and proprietary information maintained on our computer
systems. However, these measures and technology may not adequately
prevent security breaches. While we do not believe that we have
experienced any such system failure, accident, or security breach
to date, if such an event were to occur and cause interruptions in
our operations, it could result in a loss of clinical trial data
for our product candidates that could result in delays in our
regulatory approval efforts and significantly increase our costs to
recover or reproduce the data. Cyberattacks are increasing in their
frequency, sophistication and intensity. Cyberattacks could include
the deployment of harmful malware, denial-of-service attacks,
social engineering and other means to affect service reliability
and threaten the confidentiality, integrity and availability of
information. Significant disruptions of our information technology
systems or security breaches could adversely affect our business
operations and/or result in the loss, misappropriation, and/or
unauthorized access, use or disclosure of, or the prevention of
access to, confidential information (including trade secrets or
other intellectual property, proprietary business information and
personal information), and could result in financial, legal,
business and reputational harm to us. To the extent that any
disruption or security breach results in a loss of or damage to our
data or applications or other data or applications relating to our
technology, intellectual property, research and development or
product candidates, or inappropriate disclosure of confidential or
proprietary information, we could incur liabilities and the further
development of our product candidates could be
delayed.
We may be subject to claims that our employees, consultants or
independent contractors have wrongfully used or disclosed
confidential information of third parties or that our employees
have wrongfully used or disclosed alleged trade secrets of their
former employers.
We may
in the future employ individuals who were previously employed at
universities or other biotechnology or pharmaceutical companies,
including our competitors or potential competitors. Although we try
to ensure that our employees, consultants and independent
contractors do not use the proprietary information or know-how of
others in their work for us, we may be subject to claims that we or
our employees, consultants or independent contractors have
inadvertently or otherwise used or disclosed intellectual property,
including trade secrets or other proprietary information, of any of
our employee’s former employer or other third parties.
Litigation may be necessary to defend against these claims. If we
fail in defending any such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights or
personnel, which could adversely impact our business. Even if we
are successful in defending against such claims, litigation could
result in substantial costs and be a distraction to management and
other employees.
We may be subject, directly or indirectly, to federal and state
healthcare fraud and abuse laws, false claims laws, and health
information privacy and security laws. If we are unable to comply,
or have not fully complied, with such laws, we could face
substantial penalties.
If we
begin commercializing any of our products in the United States, our
operations may be directly, or indirectly through our customers,
subject to various federal and state fraud and abuse laws,
including, without limitation, the federal Anti-Kickback Statute,
the federal False Claims Act, and physician sunshine laws and
regulations. These laws may impact, among other things, our
proposed sales, marketing, and education programs. In addition, we
may be subject to patient privacy regulation by both the federal
government and the states in which we conduct our business. The
laws that may affect our ability to operate include:
●
the federal
Anti-Kickback Statute, which prohibits, among other things, persons
or entities from soliciting, receiving, offering or providing
remuneration, directly or indirectly, in return for or to induce
either the referral of an individual for, or the purchase order or
recommendation of, any item or services for which payment may be
made under a federal health care program such as the Medicare and
Medicaid programs;
●
federal civil and
criminal false claims laws and civil monetary penalty laws, which
prohibit, among other things, individuals or entities from
knowingly presenting, or causing to be presented, claims for
payment from Medicare, Medicaid, or other third-party payors that
are false or fraudulent;
●
HIPAA, which
created new federal criminal statutes that prohibit executing a
scheme to defraud any healthcare benefit program and making false
statements relating to healthcare matters;
●
HIPAA, as amended
by the Health Information Technology and Clinical Health Act, and
its implementing regulations, which imposes certain requirements
relating to the privacy, security, and transmission of individually
identifiable health information;
26
●
The federal
physician sunshine requirements under the Affordable Care Act,
which require manufacturers of drugs, devices, biologics, and
medical supplies to report annually to the U.S. Department of
Health and Human Services information related to payments and other
transfers of value to physicians, other healthcare providers, and
teaching hospitals, and ownership and investment interests held by
physicians and other healthcare providers and their immediate
family members and applicable group purchasing organizations;
and
●
state law
equivalents of each of the above federal laws, such as
anti-kickback and false claims laws that may apply to items or
services reimbursed by any third-party payor, including commercial
insurers, state laws that require pharmaceutical companies to
comply with the pharmaceutical industry’s voluntary
compliance guidelines and the relevant compliance guidance
promulgated by the federal government, or otherwise restrict
payments that may be made to healthcare providers and other
potential referral sources; state laws that require drug
manufacturers to report information related to payments and other
transfers of value to physicians and other healthcare providers or
marketing expenditures; and state laws governing the privacy and
security of health information in certain circumstances, many of
which differ from each other in significant ways and may not have
the same effect, thus complicating compliance efforts.
Because
of the breadth of these laws and the narrowness of the statutory
exceptions and safe harbors available, it is possible that some of
our business activities could be subject to challenge under one or
more of such laws. In addition, recent health care reform
legislation has strengthened these laws. For example, the
Affordable Care Act, among other things, amends the intent
requirement of the federal anti-kickback and criminal healthcare
fraud statutes. A person or entity no longer needs to have actual
knowledge of this statute or specific intent to violate it.
Moreover, the Affordable Care Act provides that the government may
assert that a claim including items or services resulting from a
violation of the federal anti-kickback statute constitutes a false
or fraudulent claim for purposes of the False Claims
Act.
If our
operations are found to be in violation of any of the laws
described above or any other governmental regulations that apply to
us, we may be subject to penalties, including civil and criminal
penalties, damages, fines, exclusion from participation in
government health care programs, such as Medicare and Medicaid,
imprisonment, and the curtailment or restructuring of our
operations, any of which could adversely affect our ability to
operate our business and our results of operations.
We are highly dependent on our management team, senior staff
professionals and third-party contractors and consultants, and the
loss of their services could materially adversely affect our
business.
We rely
on our relatively small management team and staff as well as
various contractors and consultants to provide critical services.
Our ability to execute our clinical programs for Vyleesi, PL8177,
PL9643, PL3994 and our other preclinical programs for MC1r and MC4r
peptide or small molecule drug candidates and natriuretic peptide
drug candidates depends on our continued retention and motivation
of our management and senior staff professionals, including
executive officers and senior members of product development and
management, including commercialization, who possess significant
technical expertise and experience and oversee our development and
commercialization programs. If we lose the services of existing key
personnel, our development programs could be adversely affected if
suitable replacement personnel are not recruited quickly. Our
success also depends on our ability to develop and maintain
relationships with contractors, consultants and scientific
advisors.
There
is competition for qualified personnel, contractors and consultants
in the pharmaceutical industry, which makes it difficult to attract
and retain the qualified personnel, contractors and consultants
necessary for the development and growth of our business. Our
failure to attract and retain such personnel, contractors and
consultants could have a material adverse effect on our business,
results of operations and financial condition.
Existing coverage for Vyleesi for the treatment of HSDD is
classified as a Tier 3 drug by third-party payers, so that demand
for Vyleesi will be tied to discretionary spending levels of our
targeted patient population and particularly affected by
unfavorable economic conditions.
The
market for HSDD may be particularly vulnerable to unfavorable
economic conditions. We expect Vyleesi for the treatment of HSDD to
have significant copay or deductible requirements and to be only
partially reimbursed by third-party payers and, as a result, demand
for this product may be tied to discretionary spending levels of
our targeted patient population. The recent global financial crisis
caused extreme volatility and disruptions in the capital and credit
markets. A severe or prolonged economic downturn could result in a
variety of risks to our business, including weakened demand for
Vyleesi for HSDD or any future product candidates, if approved, and
our ability to raise additional capital when needed on acceptable
terms, if at all. This is particularly true in Europe, which is
undergoing a continued severe economic crisis. A weak or declining
economy could also strain our suppliers, possibly resulting in
supply disruption, or cause our customers to delay making payments
for our services. Any of the foregoing could harm our business and
we cannot anticipate all of the ways in which future economic
climates and financial market conditions could adversely impact our
business.
27
Risks Related to Government Regulation
Both before and after marketing approval, our product candidates
are subject to ongoing regulatory requirements and, if we fail to
comply with these continuing requirements, we could be subject to a
variety of sanctions and the sale of any approved commercial
products could be suspended.
Both
before and after regulatory approval to market a particular product
candidate, the manufacturing, labeling, packaging, adverse event
reporting, storage, advertising and promotion and record keeping
related to the product candidates are subject to extensive
regulatory requirements. If we fail to comply with the regulatory
requirements of the FDA and other applicable U.S. and foreign
regulatory authorities, we could be subject to administrative or
judicially imposed sanctions, including:
●
restrictions on the
products or manufacturing process;
●
warning
letters;
●
civil or criminal
penalties;
●
fines;
●
injunctions;
●
imposition of a
Corporate Integrity Agreement requiring heightened monitoring of
our compliance functions, overseen by outside monitors, and
enhanced reporting requirements to, and oversight by, the FDA and
other government agencies;
●
product seizures or
detentions and related publicity requirements;
●
suspension or
withdrawal of regulatory approvals;
●
regulators or IRBs
may not authorize us or any potential future collaborators to
commence a clinical trial or conduct a clinical trial at a
prospective trial site;
●
total or partial
suspension of production; and
●
refusal to approve
pending applications for marketing approval of new product
candidates.
Changes
in the regulatory approval policy during the development period,
changes in or the enactment of additional regulations or statutes,
or changes in the regulatory review for each submitted product
application may cause delays in the approval or rejection of an
application. Even if the FDA approves a product candidate, the
approval may impose significant restrictions on the indicated uses,
conditions for use, labeling, advertising, promotion, marketing
and/or production of such product, and may impose ongoing
requirements for post-approval studies, including additional
research and development and clinical trials. The approval may also
impose REMS on a product if the FDA believes there is a reason to
monitor the safety of the drug in the marketplace. REMS may include
requirements for additional training for health care professionals,
safety communication efforts and limits on channels of
distribution, among other things. The sponsor would be required to
evaluate and monitor the various REMS activities and adjust them if
need be. The FDA also may impose various civil or criminal
sanctions for failure to comply with regulatory requirements,
including withdrawal of product approval.
Furthermore,
the approval procedure and the time required to obtain approval
varies among countries and can involve additional testing beyond
that required by the FDA. Approval by one regulatory authority does
not ensure approval by regulatory authorities in other
jurisdictions. The FDA has substantial discretion in the approval
process and may refuse to accept any application or may decide that
our data are insufficient for approval and require additional
preclinical, clinical or other studies.
In
addition, varying interpretations of the data obtained for
preclinical and clinical testing could delay, limit or prevent
regulatory approval of a product candidate. Even if we submit an
application to the FDA for marketing approval of a product
candidate, it may not result in marketing approval from the
FDA.
We do
not expect to receive regulatory approval for the commercial sale
of any of our product candidates that are in development in the
near future, if at all. The inability to obtain FDA approval or
approval from comparable authorities in other countries for our
product candidates would prevent us or any potential future
collaborators from commercializing these product candidates in the
United States or other countries.
28
The regulatory approval process is lengthy, expensive and
uncertain, and may prevent us from obtaining the approvals that we
require.
Government
authorities in the United States and other countries extensively
regulate the advertising, labeling, storage, record-keeping,
safety, efficacy, research, development, testing, manufacture,
promotion, marketing and distribution of drug products. Drugs are
subject to rigorous regulation in the United States by the FDA and
similar regulatory bodies in other countries. The steps ordinarily
required by the FDA before a new drug may be marketed in the United
States include:
●
completion of
non-clinical tests including preclinical laboratory and formulation
studies and animal testing and toxicology;
●
submission to the
FDA of an IND application, which must become effective before
clinical trials may begin, and which may be placed on
“clinical hold” by the FDA, meaning the trial may not
commence, or must be suspended or terminated prior to
completion;
●
performance of
adequate and well-controlled Phase 1, 2 and 3 human clinical trials
to establish the safety and efficacy of the drug for each proposed
indication, and potentially post-approval or Phase 4 studies to
further define the drug’s efficacy and safety, generally or
in specific patient populations;
●
submission to the
FDA of an NDA that must be accompanied by a substantial “user
fee” payment;
●
FDA review and
approval of the NDA before any commercial marketing or sale;
and
●
compliance with
post-approval commitments and requirements.
Satisfaction
of FDA pre-market approval requirements for new drugs typically
takes a number of years and the actual time required for approval
may vary substantially based upon the type, complexity and novelty
of the product or disease to be treated by the drug. The results of
product development, preclinical studies and clinical trials are
submitted to the FDA as part of an NDA. The NDA also must contain
extensive manufacturing information, demonstrating compliance with
applicable GMP requirements. Once the submission has been accepted
for filing, the FDA generally has twelve months to review the
application and respond to the applicant. Such response may be an
approval, or may be a “complete response letter”
outlining additional data or steps that must be completed prior to
further FDA review of the NDA. The review process is often
significantly extended by FDA requests for additional information
or clarification. Success in early stage clinical trials does not
assure success in later stage clinical trials. Data obtained from
clinical trials is not always conclusive and may be susceptible to
varying interpretations that could delay, limit or prevent
regulatory approval. The FDA may refer the NDA to an advisory
committee for review, evaluation and recommendation as to whether
the application should be approved, but the FDA is not bound by the
recommendation of the advisory committee. The FDA may deny or delay
approval of applications that do not meet applicable regulatory
criteria or if the FDA determines that the clinical data do not
adequately establish the safety and efficacy of the drug.
Therefore, our proposed products could take a significantly longer
time than we expect or may never gain approval. If regulatory
approval is delayed or never obtained, our business, financial
condition and results of operations would be materially adversely
affected.
Some of
our products or product candidates may be used in combination with
a drug delivery device, such as an injector or other delivery
system. Vyleesi is considered a drug-device combination product
because of its injection delivery device. Medical products
containing a combination of new drugs, biological products or
medical devices are regulated as “combination products”
in the United States. A combination product generally is defined as
a product comprised of components from two or more regulatory
categories (e.g., drug/device, device/biologic, drug/biologic).
Each component of a combination product is subject to the
requirements established by the FDA for that type of component,
whether a new drug, biologic or device. In order to facilitate
pre-market review of combination products, the FDA designates one
of its centers to have primary jurisdiction for the pre-market
review and regulation of the overall product based upon a
determination by the FDA of the primary mode of action of the
combination product. The determination whether a product is a
combination product or two separate products is made by the FDA on
a case-by-case basis. Our product candidates intended for use with
such devices, or expanded indications that we may seek for our
products used with such devices, may not be approved or may be
substantially delayed in receiving approval if the devices do not
gain and/or maintain their own regulatory approvals or clearances.
Where approval of the drug product and device is sought under a
single application, the increased complexity of the review process
may delay approval. In addition, because these drug delivery
devices are provided by single source unaffiliated third-party
companies, we are dependent on the sustained cooperation and effort
of those third-party companies both to supply the devices, maintain
their own regulatory compliance, and, in some cases, to conduct the
studies required for approval or other regulatory clearance of the
devices. We are also dependent on those third-party companies
continuing to maintain such approvals or clearances once they have
been received. Failure of third-party companies to supply the
devices, to successfully complete studies on the devices in a
timely manner, or to obtain or maintain required approvals or
clearances of the devices, and maintain compliance with all
regulatory requirements, could result in increased development
costs, delays in or failure to obtain regulatory approval and
delays in product candidates reaching the market or in gaining
approval or clearance for expanded labels for new
indications.
29
Upon
approval, a product candidate may be marketed only in those dosage
forms and for those indications approved by the FDA. Once approved,
the FDA may withdraw the product approval if compliance with
regulatory requirements is not maintained or if problems occur
after the product reaches the marketplace. In addition, the FDA may
require post-marketing studies, referred to as Phase 4 studies, to
monitor the approved products in a specific subset of patients or a
larger number of patients than were required for product approval
and may limit further marketing of the product based on the results
of these post-market studies. The FDA has broad post-market
regulatory and enforcement powers, including the ability to seek
injunctions, levy fines and civil penalties, criminal prosecution,
withdraw approvals and seize products or request
recalls.
If
regulatory approval of any of our product candidates is granted, it
will be limited to certain disease states or conditions, patient
populations, duration or frequency of use, and will be subject to
other conditions as set forth in the FDA-approved labeling. Adverse
experiences with the product must be reported to the FDA and could
result in the imposition of market restriction through labeling
changes or in product removal. Product approvals may be withdrawn
if compliance with regulatory requirements is not maintained or if
problems concerning safety or efficacy of the product occur
following approval.
Outside
the United States, our ability to market our product candidates
will also depend on receiving marketing authorizations from the
appropriate regulatory authorities. The foreign regulatory approval
process generally includes all of the risks associated with FDA
approval described above. The requirements governing the conduct of
clinical trials and marketing authorization vary widely from
country to country. At present, foreign marketing authorizations
are applied for at a national level, although within the European
Community (“EC”), registration procedures are available
to companies wishing to market a product to more than one EC member
state. If the regulatory authority is satisfied that adequate
evidence of safety, quality and efficiency has been presented, a
marketing authorization will be granted. If we do not obtain, or
experience difficulties in obtaining, such marketing
authorizations, our business, financial condition and results of
operations may be materially adversely affected.
The FDA has required that two postmarketing studies and a clinical
trial be conducted on Vyleesi.
In its
approval of Vyleesi, under the FFDCA the FDA imposed certain
postmarketing requirements, consisting of two studies, one a
prospective, registry-base, observational cohort study that
compares obstetrical, maternal, fetal/neonatal, and infant outcomes
in women exposed to Vyleesi during pregnancy to an internal,
unexposed cohort of pregnant women, and the other a retrospective
cohort study using electronic claims data that compares maternal,
fetal/neonatal, and infant outcomes in women exposed to Vyleesi
during pregnancy to an internal, unexposed cohort of pregnant
women, and one clinical trial in lactating women who have received
Vyleesi to assess potential adverse effects in the breastfed infant
and measure bremelanotide concentrations in breast milk using a
validated assay. We are evaluating requirements, timelines and
costs for these studies and the clinical trial. We do not know the
outcomes of the studies or the clinical trials, and do not know
whether the outcomes would adversely affect approvals of
Vyleesi.
Legislative or regulatory healthcare reforms in the United States
may make it more difficult and costly for us to obtain regulatory
clearance or approval of any future product candidates and to
produce, market and distribute our products after clearance or
approval is obtained.
From
time to time, legislation is drafted and introduced in Congress,
and court decisions are issued, that could significantly change the
statutory provisions governing the regulatory clearance or
approval, manufacture and marketing of regulated products or the
reimbursement thereof. In addition, FDA regulations and guidance
are often revised or reinterpreted by the FDA in ways that may
significantly affect our business and our products. Any new
regulations or revisions or reinterpretations of existing
regulations may impose additional costs or lengthen review times of
Vyleesi for HSDD or any future product candidates. We cannot
determine what effect changes in regulations, statutes, court
decisions, legal interpretation or policies, when and if
promulgated, enacted, issued or adopted may have on our business in
the future. Such changes could, among other things:
●
require changes to
manufacturing methods;
●
require recall,
replacement or discontinuance of one or more of our
products;
●
require additional
recordkeeping;
●
limit or restrict
our ability to engage in certain types of marketing or promotional
activities;
●
alter or eliminate
the scope or terms of any currently available regulatory
exclusivities; and
●
restrict or
eliminate our ability to settle any patent litigation we may bring
against potential generic competitors.
30
Each of
these would likely entail substantial time and cost and could
materially harm our business and our financial results. In
addition, delays in receipt of or failure to receive regulatory
clearances or approvals for any future products would harm our
business, financial condition and results of
operations.
Changes in healthcare policy could adversely affect our
business.
U.S.
and foreign governments continue to propose and pass legislation
designed to reduce the cost of healthcare. For example, the
Medicare Prescription Drug Improvement and Modernization Act of
2003 (“MMA”), expanded Medicare coverage for drugs
purchased by Medicare beneficiaries and introduced new
reimbursement methodologies. In addition, this law provided
authority for limiting the number of drugs that will be covered in
any therapeutic class. Until our products are approved and drug
plan formulary listing decisions are made, we do not know what
impact the MMA and similar laws will have on the availability of
coverage for and the price that we receive for any approved
products. Moreover, while the MMA applies only to drug benefits for
Medicare beneficiaries, private payers often follow Medicare
policies in setting their own reimbursement policies, and any
reduction in reimbursement that results from the MMA may result in
similar reductions by private payers.
The
Affordable Care Act, as amended by the Health Care and Education
Affordability Reconciliation Act (together the “ACA”),
was adopted in 2010. This law has resulted in an increase in the
number of people who are covered by both public and private
insurance and has changed the way health care is financed by both
government health program and private insurers, with significant
impacts on the pharmaceutical industry. The ACA contains a number
of provisions that may impact our business and operations in ways
that may negatively affect our potential revenues in the future.
For example, the ACA imposes a non-deductible excise tax on
pharmaceutical manufacturers or importers that sell branded
prescription drugs to U.S. government programs that we believe will
increase the cost of any products that we develop. In addition, as
part of the ACA’s provisions closing a funding gap that
currently exists in the Medicare Part D prescription drug program
(commonly known as the “donut hole”), we will be
required to provide a 50% discount on any branded prescription
drugs that we develop sold to beneficiaries who fall within the
donut hole. We cannot predict all of the specific effects the ACA
or any future healthcare reform legislation will have on our
business, but they could have a material adverse effect on our
business and financial condition.
Some of
the provisions of the ACA have yet to be fully implemented, while
certain provisions have been subject to judicial and Congressional
challenges, as well as efforts by the Trump administration to
repeal or replace certain aspects of the ACA. Since January 2017,
President Trump has signed two executive orders and other
directives designed to delay, circumvent, or loosen certain
requirements mandated by the ACA. Concurrently, Congress has
considered legislation that would repeal or repeal and replace all
or part of the ACA. While Congress has not passed repeal
legislation, the Tax Cuts and Jobs Act (the “2017 Tax
Act”) includes a provision repealing, effective January 1,
2019, the tax-based shared responsibility payment imposed by the
ACA on certain individuals who fail to maintain qualifying health
coverage for all or part of a year that is commonly referred to as
the “individual mandate”. Congress may consider other
legislation to repeal or replace elements of the ACA. Because of
the continued uncertainty about the implementation of the ACA,
including the potential for further legal challenges or repeal of
the ACA, we cannot quantify or predict with any certainty the
likely impact of the ACA or its repeal on our business, prospects,
financial condition or results of operations.
The
availability of government reimbursement for prescription drugs
will be impacted by the Budget Control Act of 2011, which was
signed into law on August 2, 2011. This law is expected to result
in federal spending cuts totaling between $1.2 trillion and $1.5
trillion over the next decade, over half of which will include cuts
in Medicare and other health-related spending.
Risks Related to Our Intellectual Property
If we fail to adequately protect or enforce our intellectual
property rights or secure rights to patents of others, the value of
our intellectual property rights would diminish.
Our
success, competitive position and future revenues will depend in
part on our ability and the abilities of our licensors to obtain
and maintain patent protection for our products, methods, processes
and other technologies, to preserve our trade secrets, to prevent
third parties from infringing on our proprietary rights and to
operate without infringing the proprietary rights of third parties.
We cannot predict:
●
the degree and
range of protection any patents will afford us against competitors,
including whether third parties will find ways to invalidate or
otherwise circumvent our patents;
●
if and when patents
will be issued;
●
whether or not
others will obtain patents claiming aspects similar to those
covered by our patents and patent applications; and
●
whether we will
need to initiate litigation or administrative proceedings, which
may be costly whether we win or lose.
31
If our
products, methods, processes and other technologies infringe the
proprietary rights of other parties we could incur substantial
costs and we may have to:
●
obtain licenses,
which may not be available on commercially reasonable terms, if at
all;
●
redesign our
products or processes to avoid infringement;
●
stop using the
subject matter claimed in the patents held by others;
●
pay damages;
or
●
defend litigation
or administrative proceedings, which may be costly whether we win
or lose, and which could result in a substantial diversion of our
management resources.
We may become involved in lawsuits to protect or enforce our
patents or other intellectual property or the patents of our
licensors, which could be expensive and time
consuming.
Competitors
may infringe our intellectual property, including our patents or
the patents of our licensors. As a result, we may be required to
file infringement claims to stop third-party infringement or
unauthorized use. This can be expensive, particularly for a company
of our size, and time-consuming. In addition, in an infringement
proceeding, a court may decide that a patent of ours is not valid
or is unenforceable, or may refuse to stop the other party from
using the technology at issue on the grounds that our patent claims
do not cover its technology or that the factors necessary to grant
an injunction against an infringer are not satisfied.
An
adverse determination of any litigation or other proceedings could
put one or more of our patents at risk of being invalidated or
interpreted narrowly and could put our patent applications at risk
of not issuing.
Interference,
derivation or other proceedings brought at the USPTO may be
necessary to determine the priority or patentability of inventions
with respect to our patent applications or those of our licensors
or collaborators. Litigation or USPTO proceedings brought by us may
fail or may be invoked against us by third parties. Even if we are
successful, domestic or foreign litigation or USPTO or foreign
patent office proceedings may result in substantial costs and
distraction to our management. We may not be able, alone or with
our licensors or collaborators, to prevent misappropriation of our
proprietary rights, particularly in countries where the laws may
not protect such rights as fully as in the United
States.
Furthermore,
because of the substantial amount of discovery required in
connection with intellectual property litigation or other
proceedings, there is a risk that some of our confidential
information could be compromised by disclosure during this type of
litigation or proceedings. In addition, during the course of this
kind of litigation or proceedings, there could be public
announcements of the results of hearings, motions or other interim
proceedings or developments or public access to related documents.
If investors perceive these results to be negative, the market
price for our common stock could be significantly
harmed.
If we infringe or are alleged to infringe intellectual property
rights of third parties, our business could be harmed.
Our
research, development and commercialization activities may infringe
or otherwise violate or be claimed to infringe or otherwise violate
patents owned or controlled by other parties. There may also be
patent applications that have been filed but not published that,
when issued as patents, could be asserted against us. These third
parties could bring claims against us that would cause us to incur
substantial expenses and, if successful against us, could cause us
to pay substantial damages. Further, if a patent infringement suit
were brought against us, we could be forced to stop or delay
research, development, manufacturing or sales of the product or
product candidate that is the subject of the suit.
As a
result of patent infringement claims, or to avoid potential claims,
we may choose or be required to seek licenses from third parties.
These licenses may not be available on acceptable terms, or at all.
Even if we are able to obtain a license, the license would likely
obligate us to pay license fees or royalties or both, and the
rights granted to us might be nonexclusive, which could result in
our competitors gaining access to the same intellectual property.
Ultimately, we could be prevented from commercializing a product,
or be forced to cease some aspect of our business operations, if,
as a result of actual or threatened patent infringement claims, we
are unable to enter into licenses on acceptable terms, if at
all.
There
has been substantial litigation and other proceedings regarding
patent and other intellectual property rights in the pharmaceutical
industry. In addition to infringement claims against us, we may
become a party to other patent litigation and other proceedings,
including interference, derivation or post-grant proceedings
declared or granted by the USPTO and similar proceedings in foreign
countries, regarding intellectual property rights with respect to
our current or future products. The cost to us of any patent
litigation or other proceeding, even if resolved in our favor,
could be substantial. Some of our competitors may be able to
sustain the costs of such litigation or proceedings more
effectively than we can because of their substantially greater
financial resources. Patent litigation and other proceedings may
also absorb significant management time. Uncertainties resulting
from the initiation and continuation of patent litigation or other
proceedings could impair our ability to compete in the marketplace.
The occurrence of any of the foregoing could have a material
adverse effect on our business, financial condition or results of
operations.
32
Our patent applications and the enforcement or defense of our
issued patents may be impacted by the application of or changes in
U.S. and foreign standards.
The
standards that the USPTO and foreign patent offices use to grant
patents are not always applied predictably or uniformly and can
change. Consequently, our pending patent applications may not be
allowed and, if allowed, may not contain the type and extent of
patent claims that will be adequate to conduct our business as
planned. Additionally, any issued patents we currently own or
obtain in the future may have a shorter patent term than expected
or may not contain claims that will permit us to stop competitors
from using our technology or similar technology or from copying our
product candidates. Similarly, the standards that courts use to
interpret patents are not always applied predictably or uniformly
and may evolve, particularly as new technologies develop. In
addition, changes to patent laws in the United States or other
countries may be applied retroactively to affect the validation
enforceability, or term of our patent. For example, the U.S.
Supreme Court has recently modified some legal standards applied by
the USPTO in examination of U.S. patent applications, which may
decrease the likelihood that we will be able to obtain patents and
may increase the likelihood of challenges to patents we obtain or
license. In addition, changes to the U.S. patent system have come
into force under the Leahy-Smith America Invents Act, or the
Leahy-Smith Act, which was signed into law in September 2011. The
Leahy-Smith Act included significant changes to U.S. patent law.
These include provisions that affect the way patent applications
are prosecuted and also affect patent litigation. Under the
Leahy-Smith Act, the United States transitioned in March 2013 to a
“first to file” system in which the first inventor to
file a patent application will be entitled to the patent. Third
parties are allowed to submit prior art before the issuance of a
patent by the USPTO, and may become involved in opposition,
derivation, reexamination, inter
partes review or interference proceedings challenging our
patent rights or the patent rights of others. An adverse
determination in any such submission, proceeding or litigation
could reduce the scope of, or invalidate, our patent rights, which
could adversely affect our competitive position.
While
we cannot predict with certainty the impact the Leahy-Smith Act or
any potential future changes to the U.S. or foreign patent systems
will have on the operation of our business, the Leahy-Smith Act and
such future changes could increase the uncertainties and costs
surrounding the prosecution of our patent applications and the
enforcement or defense of our issued patents, all of which could
have a material adverse effect on our business, results of
operations, financial condition and cash flows and future
prospects.
We may not be able to protect our intellectual property rights
throughout the world.
Filing,
prosecuting and defending patents on product candidates in all
countries throughout the world would be prohibitively expensive,
and our intellectual property rights in some countries outside the
United States can be less extensive than those in the United
States. In addition, the laws of some foreign countries do not
protect intellectual property rights to the same extent as federal
and state laws in the United States and in some cases may even
force us to grant a compulsory license to competitors or other
third parties. Consequently, we may not be able to prevent third
parties from practicing our inventions in all countries outside the
United States, or from selling or importing products made using our
inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have
not obtained patent protection to develop their own products and
further, may export otherwise infringing products to territories
where we have patent protection, but enforcement is not as strong
as that in the United States. These products may compete with our
products and our patents or other intellectual property rights may
not be effective or sufficient to prevent them from
competing.
Many
companies have encountered significant problems in protecting and
defending intellectual property rights in foreign jurisdictions.
The legal systems of certain countries, particularly certain
developing countries, do not favor the enforcement of patents and
other intellectual property protection, particularly those relating
to biopharmaceuticals, which could make it difficult for us to stop
the infringement of our patents or marketing of competing products
in violation of our proprietary rights generally. Proceedings to
enforce our patent rights in foreign jurisdictions could result in
substantial costs and divert our efforts and attention from other
aspects of our business, could put our patents at risk of being
invalidated or interpreted narrowly and our patent applications at
risk of not issuing and could provoke third parties to assert
claims against us. We may not prevail in any lawsuits that we
initiate and the damages or other remedies awarded, if any, may not
be commercially meaningful. Accordingly, our efforts to enforce our
intellectual property rights around the world may be inadequate to
obtain a significant commercial advantage from the intellectual
property that we develop or license.
In
addition, our ability to protect and enforce our intellectual
property rights may be adversely affected by unforeseen changes in
domestic and foreign intellectual property laws.
33
If we are unable to keep our trade secrets confidential, our
technologies and other proprietary information may be used by
others to compete against us.
In
addition to our reliance on patents, we attempt to protect our
proprietary technologies and processes by relying on trade secret
laws and agreements with our employees and other persons who have
access to our proprietary information. These agreements and
arrangements may not provide meaningful protection for our
proprietary technologies and processes in the event of unauthorized
use or disclosure of such information, and may not provide an
adequate remedy in the event of unauthorized disclosure of
confidential information. In addition, our competitors may
independently develop substantially equivalent technologies and
processes or gain access to our trade secrets or technology, either
of which could materially and adversely affect our competitive
position.
Risks Related to the Ownership of Our Common Stock
Our stock price is volatile and may fluctuate in a way that is
disproportionate to our operating performance and we expect it to
remain volatile, which could limit investors’ ability to sell
stock at a profit.
The
volatile price of our stock makes it difficult for investors to
predict the value of their investment, to sell shares at a profit
at any given time or to plan purchases and sales in advance. A
variety of factors may affect the market price of our common stock.
These include, but are not limited to:
●
publicity regarding
actual or potential clinical results relating to products under
development by our competitors or us;
●
delay or failure in
initiating, completing or analyzing preclinical or clinical trials
or unsatisfactory designs or results of these trials;
●
interim decisions
by regulatory agencies, including the FDA, as to clinical trial
designs, acceptable safety profiles and the benefit/risk ratio of
products under development;
●
achievement or
rejection of regulatory approvals by our competitors or by
us;
●
announcements of
technological innovations or new commercial products by our
competitors or by us;
●
developments
concerning proprietary rights, including patents;
●
developments
concerning our collaborations;
●
regulatory
developments in the United States and foreign
countries;
●
economic or other
crises and other external factors;
●
period-to-period
fluctuations in our revenue and other results of
operations;
●
changes in the
structure of healthcare payment systems or other actions that
affect the effective reimbursement rates for treatment regimens
containing our products;
●
changes in
financial estimates and recommendations by securities analysts
following our business or our industry;
●
sales of our common
stock, or the perception that such sales could occur;
and
●
the other factors
described in this “Risk Factors” section.
We will
not be able to control many of these factors, and we believe that
period-to-period comparisons of our financial results will not
necessarily be indicative of our future performance. If our
revenues, if any, in any particular period do not meet
expectations, we may not be able to adjust our expenditures in that
period, which could cause our operating results to suffer further.
If our operating results in any future period fall below the
expectations of securities analysts or investors, our stock price
may fall by a significant amount.
For the
12-month period ended June 30, 2020, the price of our stock has
been volatile, ranging from a high of $1.21 per share to a low of
$0.36 per share. In addition, the stock market in general, and the
market for biotechnology companies in particular, has experienced
extreme price and volume fluctuations that may have been unrelated
or disproportionate to the operating performance of individual
companies. These broad market and industry factors may seriously
harm the market price of our common stock, regardless of our
operating performance.
As a public company in the United States, we are subject to the
Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”). We can
provide no assurance that we will, at all times, in the future be
able to report that our internal controls over financial reporting
are effective.
Companies
that file reports with the SEC, including us, are subject to the
requirements of Section 404 of Sarbanes-Oxley. Section 404 requires
management to establish and maintain a system of internal control
over financial reporting, and annual reports on Form 10-K filed
under the Exchange Act must contain a report on the effectiveness
of our internal control over financial reporting. Ensuring that we
have adequate internal financial and accounting controls and
procedures in place to produce accurate financial statements on a
timely basis is a costly and time-consuming effort that needs to be
re-evaluated frequently. Failure on our part to have effective
internal financial and accounting controls would cause our
financial reporting to be unreliable, could have a material adverse
effect on our business, operating results, and financial condition,
and could cause the trading price of our common stock to fall
dramatically.
34
If securities or industry analysts do not publish research or
publish unfavorable research about our business, our stock price
and trading volume could decline.
As a
smaller company, it may be difficult for us to attract or retain
the interest of equity research analysts. A lack of research
coverage may adversely affect the liquidity of and market price of
our common stock. We do not have any control of the equity research
analysts or the content and opinions included in their reports. The
price of our stock could decline if one or more equity research
analysts downgrade our stock or issue other unfavorable commentary
or research. If one or more equity research analysts ceases
coverage of us, or fails to publish reports on us regularly, demand
for our stock could decrease, which in turn could cause our stock
price or trading volume to decline.
Holders of our preferred stock may have interests different from
our common stockholders.
We are
permitted under our certificate of incorporation to issue up to
10,000,000 shares of preferred stock. We can issue shares of our
preferred stock in one or more series and can set the terms of the
preferred stock without seeking any further approval from our
common stockholders. 4,030 shares of our Series A Preferred Stock
remain outstanding as of September 24, 2020. Each share of Series A
Preferred Stock is convertible at any time, at the option of the
holder, and such conversion could dilute the value of our common
stock to current stockholders and could adversely affect the market
price of our common stock. The conversion price decreases if we
sell common stock (or equivalents) for a price per share less than
the conversion price or less than the market price of the common
stock and is also subject to adjustment upon the occurrence of a
merger, reorganization, consolidation, reclassification, stock
dividend or stock split which results in an increase or decrease in
the number of shares of common stock outstanding. Upon (i)
liquidation, dissolution or winding up of the Company, whether
voluntary or involuntary, (ii) sale or other disposition of all or
substantially all of the assets of the Company, or (iii) any
consolidation, merger, combination, reorganization or other
transaction in which the Company is not the surviving entity or in
which the shares of common stock constituting in excess of 50% of
the voting power of the Company are exchanged for or changed into
other stock or securities, cash and/or any other property, after
payment or provision for payment of the debts and other liabilities
of the Company, the holders of Series A Preferred Stock will be
entitled to receive, pro rata and in preference to the holders of
any other capital stock, an amount per share equal to $100 plus
accrued but unpaid dividends, if any. Any preferred stock that we
issue may rank ahead of our common stock in terms of dividend
priority or liquidation premiums and may have greater voting rights
than our common stock.
Because we do not anticipate paying any cash dividends on our
common stock in the foreseeable future, capital appreciation, if
any, will be your sole source of gains.
We do
not anticipate paying any cash dividends in the foreseeable future
and intend to retain future earnings, if any, for the development
and expansion of our business. Our outstanding Series A Preferred
Stock, consisting of 4,030 shares on September 24, 2020, provides
that we may not pay a dividend or make any distribution to holders
of any class of stock unless we first pay a special dividend or
distribution of $100 per share to the holders of the Series A
Preferred Stock. In addition, the terms of existing or future
agreements may limit our ability to pay dividends. As a result,
capital appreciation, if any, of our common stock will be your sole
source of gain for the foreseeable future.
Anti-takeover provisions of Delaware law and our charter documents
may make potential acquisitions more difficult and could result in
the entrenchment of management.
We are
incorporated in Delaware. Anti-takeover provisions of Delaware law
and our charter documents may make a change in control or efforts
to remove management more difficult. Also, under Delaware law, our
board of directors may adopt additional anti-takeover measures.
Under Section 203 of the Delaware General Corporation Law, a
corporation may not engage in a business combination with an
“interested stockholder” for a period of three years
after the date of the transaction in which the person first becomes
an “interested stockholder,” unless the business
combination is approved in a prescribed manner.
We are
authorized to issue up to 300,000,000 shares of common stock. To
the extent that we sell or otherwise issue authorized but currently
unissued shares, this could have the effect of making it more
difficult for a third party to acquire a majority of our
outstanding voting stock.
Our
charter authorizes us to issue up to 10,000,000 shares of preferred
stock and to determine the terms of those shares of stock without
any further action by our stockholders. If we exercise this right,
it could be more difficult for a third party to acquire a majority
of our outstanding voting stock.
In
addition, our equity incentive plans generally permit us to
accelerate the vesting of options and other stock rights granted
under these plans in the event of a change of control. If we
accelerate the vesting of options or other stock rights, this
action could make an acquisition more costly.
The
application of these provisions could have the effect of delaying
or preventing a change of control, which could adversely affect the
market price of our common stock.
35
We are a smaller reporting company and the reduced disclosure
requirements applicable to smaller reporting companies may make our
common stock less attractive to investors.
We are
currently a “smaller reporting company” as defined in
the Exchange Act. Smaller reporting companies are able to provide
simplified executive compensation disclosures in their filings, and
have certain other decreased disclosure obligations in their SEC
filings. We cannot predict whether investors will find our common
stock less attractive because of our reliance on the smaller
reporting company exemption. If some investors find our common
stock less attractive as a result, there may be a less active
trading market for our common stock and our stock price may be more
volatile.
As of September 24, 2020, there were 44,970,962 shares of common
stock underlying outstanding convertible preferred stock, options,
restricted stock units and warrants. Stockholders may experience
dilution from the conversion of preferred stock, exercise of
outstanding options and warrants and vesting and delivery of
restricted stock units.
As of
September 24, 2020, holders of our outstanding dilutive securities
had the right to acquire the following amounts of underlying common
stock:
●
66,059 shares
issuable on the conversion of our immediately convertible Series A
Convertible Preferred Stock, subject to adjustment, for no further
consideration;
●
20,042,950 shares
issuable upon the exercise of stock options at a weighted-average
exercise price of $0.79 per share;
●
5,778,105 shares
issuable under restricted stock units which vest on dates between
December 12, 2020 and June 16, 2024, subject to the fulfillment of
service or performance conditions;
●
6,444,353 shares of
common stock which have vested under restricted stock unit
agreements, but are subject to provisions to delay delivery;
and
●
12,639,495 shares
issuable upon the exercise of warrants at a weighted-average
exercise price of $0.74 per share.
If the
holders convert, exercise or receive these securities, or similar
dilutive securities we may issue in the future, stockholders may
experience dilution in the net book value of their common stock. In
addition, the sale or availability for sale of the underlying
shares in the marketplace could depress our stock price. We have
registered or agreed to register for resale substantially all of
the underlying shares listed above. Holders of registered
underlying shares could resell the shares immediately upon
issuance, which could result in significant downward pressure on
our stock price.
Our failure to meet the continued listing requirements of the NYSE
American could result in a de-listing of our common
stock.
Our
common shares are listed on the NYSE American, a national
securities exchange, under the symbol “PTN”. Although
we currently meet the NYSE American’s listing standards,
which generally mandate that we meet certain requirements relating
to stockholders’ equity, market capitalization, aggregate
market value of publicly held shares and distribution requirements,
we cannot assure you that we will be able to continue to meet the
NYSE American’s listing requirements. If we fail to satisfy
the continued listing requirements of the NYSE American, such as
the corporate governance requirements or the minimum closing bid
price requirement, the NYSE American may take steps to de-list our
common stock. If the NYSE American delists our securities for
trading on its exchange, we could face significant material adverse
consequences, including:
●
a limited
availability of market quotations for our securities;
●
reduced liquidity
with respect to our securities;
●
a determination
that our shares of common stock are “penny stock” which
will require brokers trading in our shares of common stock to
adhere to more stringent rules, possibly resulting in a reduced
level of trading activity in the secondary trading market for our
shares of common stock;
●
a limited amount of
news and analyst coverage for our company; and
●
a decreased ability
to issue additional securities or obtain additional financing in
the future.
Such a
de-listing would likely have a negative effect on the price of our
common stock and would impair your ability to sell or purchase our
common stock when you wish to do so. In the event of a de-listing,
we may take actions to restore our compliance with the NYSE
American’s listing requirements, but we can provide no
assurance that any such action taken by us would allow our common
stock to become listed again, stabilize the market price or improve
the liquidity of our common stock, prevent our common stock from
dropping below the NYSE American minimum bid price requirement or
prevent future non-compliance with the NYSE American’s
listing requirements.
36
The
National Securities Markets Improvement Act of 1996, which is a
federal statute, prevents or preempts the states from regulating
the sale of certain securities, which are referred to as
“covered securities.” Our common shares are considered
to be covered securities because they are listed on the NYSE
American. Although the states are preempted from regulating the
sale of our securities, the federal statute does allow the states
to investigate companies if there is a suspicion of fraud, and, if
there is a finding of fraudulent activity, then the states can
regulate or bar the sale of covered securities in a particular
case. Further, if we were no longer listed on the NYSE American,
our common stock would not be covered securities and we would be
subject to regulation in each state in which we offer our
securities.
Item 1B. Unresolved Staff
Comments
None.
Item 2. Properties
Our
corporate offices are located at 4B Cedar Brook Drive, Cedar Brook
Corporate Center, Cranbury, NJ 08512, where we lease approximately
10,000 square feet of office space under a lease that expires in
June 2025. We also lease approximately 1,700 square feet of
laboratory space in the Township of South Brunswick, NJ, and have
signed an amendment to expand the lease to approximately 3,600
square feet of laboratory space in the fourth quarter of calendar
year 2020 and extend the lease until October 2023. We believe our
present facilities are adequate for our current needs. We do not
own any real property.
Item 3. Legal Proceedings
We are
involved, from time to time, in various claims and legal
proceedings arising in the ordinary course of our business. We are
not currently a party to any claim or legal
proceeding.
Item 4. Mine Safety Disclosures
Not
applicable.
37
PART II
Item 5. Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities.
Our
common stock has been listed on NYSE American under the symbol
“PTN” since December 21, 1999. It previously traded on
The Nasdaq SmallCap Market under the symbol
“PLTN.”
On
September 23, 2020 we had approximately 106 record holders of
common stock and the closing sales price of our common stock as
reported on the NYSE American was $0.49 per share. The aggregate
market value of the common and non-voting common equity held by
non-affiliates on such date, computed by reference to the closing
sales price of our common stock on that date, was
$111,043,160.
Issuer purchases of equity securities. In certain instances
we provide our employees with the option to withhold shares to
satisfy tax withholding amounts due from the employees upon the
vesting of restricted stock units and stock options in connection
with our 2011 Stock Incentive Plan. The following 6,696 shares were
withheld during the quarter ended June 30, 2020 at the direction of
the employees as permitted under the 2011 Stock Incentive Plan in
order to pay the minimum amount of tax liability owed by the
employee from the vesting of those units and options:
|
Fiscal Month
Period
|
Total Number of
Shares Purchased (1)
|
Weighted Average
Price per Share
|
Total Number of
Shares Purchased as Part of Publicly Announced Plans or
Programs
|
Maximum Number
of Shares that May Yet be Purchased Under Announced Plans or
Programs
|
|
April 1, 2020
through April 30, 2020
|
6,696
|
$0.44
|
-
|
-
|
|
May 1, 2020 through
May 31, 2020
|
-
|
-
|
-
|
-
|
|
June 1, 2020
through June 30, 2020
|
-
|
-
|
-
|
-
|
|
Total
|
6,696
|
$0.44
|
-
|
-
|
(1)
Consists solely of 6,696 shares that were withheld to satisfy tax
withholding amounts due from employees upon the vesting of
previously issued restricted stock units and options.
Dividends and dividend policy. We have never declared or
paid any dividends. We currently intend to retain earnings, if any,
for use in our business. We do not anticipate paying dividends in
the foreseeable future.
Dividend restrictions. Our outstanding Series A Preferred
Stock, consisting of 4,030 shares on September 23, 2020, provides
that we may not pay a dividend or make any distribution to holders
of any class of stock unless we first pay a special dividend or
distribution of $100 per share to the holders of the Series A
Preferred Stock.
Equity compensation plan information. Reference is
made to the information contained in the Equity Compensation Plan
table contained in Item 11 of this Annual Report.
Item 6. Selected Financial
Data.
Not
Applicable.
Item 7. Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction
with the consolidated financial statements and notes to the
consolidated financial statements filed as part of this Annual
Report.
38
Forward-Looking Statements
The
following discussion and analysis contains forward-looking
statements within the meaning of the federal securities laws. You
are urged to carefully review our description and examples of
forward-looking statements included earlier in this Annual Report
immediately prior to Part I, under the heading
“Forward-Looking Statements.” Forward-looking
statements are subject to risk that could cause actual results to
differ materially from those expressed in the forward-looking
statements. You are urged to carefully review the disclosures we
make concerning risks and other factors that may affect our
business and operating results, including those made in Part I,
Item 1A of this Annual Report, and any of those made in our other
reports filed with the SEC. You are cautioned not to place undue
reliance on the forward-looking statements included herein, which
speak only as of the date of this document. We do not intend, and
undertake no obligation, to publish revised forward-looking
statements to reflect events or circumstances after the date of
this document or to reflect the occurrence of unanticipated
events.
Critical Accounting Policies and Estimates
Our
significant accounting policies are described in Note 2 to the
consolidated financial statements included in this Annual Report.
We believe that our accounting policies and estimates relating to
revenue recognition, accrued expenses and stock-based compensation
are the most critical.
Revenue Recognition
In May 2014, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update
(“ASU”) No. 2014-09, Revenue from Contracts with
Customers (“ASC Topic
606”), which, along with amendments from 2015 and 2016
requires an entity to recognize the amount of revenue to which it
expects to be entitled for the transfer of promised goods or
services to customers. ASC Topic 606 replaced most existing revenue
recognition guidance in U.S. GAAP when it became
effective.
On July 1, 2018, we adopted ASC Topic 606 using the modified
retrospective approach, a practical expedient permitted under ASC
Topic 606, and applied this approach only to contracts that were
not completed as of July 1, 2018. We calculated a one-time
cumulative transition adjustment of $500,000, which was recorded on
July 1, 2018 to the opening balance of accumulated deficit related
to our license agreement with Kwangdong (the “Kwangdong
License Agreement”) because we determined a significant
revenue reversal would not occur in a future period. The one-time
adjustment consisted of the recognition of $500,000 of deferred
revenue.
Revenue Recognition for Periods Prior to July 1, 2018
We have
generated revenue solely through license and collaboration
agreements. Prior to July 1, 2018, we recognized revenue in
accordance with FASB Accounting Standards Codification
(“ASC”) Topic 605-25, Revenue Recognition for Arrangements with
Multiple Elements, which addressed the determination of
whether an arrangement involving multiple deliverables contained
more than one unit of accounting. A delivered item within an
arrangement was considered a separate unit of accounting only if
both of the following criteria were met:
●
the delivered item
had value to the customer on a stand-alone basis; and
●
if the arrangement
included a general right of return relative to the delivered item,
delivery or performance of the undelivered item was considered
probable and substantially in control of the vendor.
Under
FASB ASC Topic 605-25, if both of the criteria above were not met,
then separate accounting for the individual deliverables was not
appropriate.
We
determined that it was appropriate to recognize such revenue
specifically related to the up-front payment the Company received
using the input-based proportional method during the period of
Palatin’s development obligations as defined in the license
agreement with AMAG (the “AMAG License Agreement”).
Refer to Note 4 of the accompanying consolidated financial
statements for additional information.
Under
the license agreement with Fosun for exclusive rights to
commercialize Vyleesi in the China (the “Fosun License
Agreement”), as discussed in Note 5 of the accompanying
consolidated financial statements, we received consideration in the
form of an upfront license fee payment and determined that it was
appropriate to recognize such consideration as revenue in the first
quarter of the fiscal year ended June 30, 2018 (“fiscal
2018”), which was the quarter in which the license was
granted, since the license had stand-alone value and the upfront
payment we received was non-refundable.
Under
the Kwangdong License Agreement, as discussed in Note 6 of the
accompanying consolidated financial statements, we received
consideration in the form of an upfront license fee payment in
fiscal 2018 and determined that it was appropriate to record such
consideration as deferred revenue because the upfront payment we
received is subject to certain refund provisions.
39
Revenue
resulting from the achievement of development milestones was
recorded in accordance with the accounting guidance for the
milestone method of revenue recognition. Amounts received prior to
satisfying the revenue recognition criteria were recorded as
deferred revenue on our consolidated balance sheet.
Revenue Recognition for Periods Commencing July 1,
2018
For
licenses of intellectual property, we assess, at contract
inception, whether the intellectual property is distinct from other
performance obligations identified in the arrangement. If the
licensing of intellectual property is determined to be distinct,
revenue is recognized for nonrefundable, upfront license fees when
the license is transferred to the customer and the customer can use
and benefit from the license. If the licensing of intellectual
property is determined not to be distinct, then the license will be
bundled with other promises in the arrangement into one performance
obligation. We need to determine if the bundled performance
obligation is satisfied over time or at a point in time. If we
conclude that the nonrefundable, upfront license fees will be
recognized over time, we will need to assess the appropriate method
of measuring proportional performance.
Regulatory
milestone payments are excluded from the transaction price due to
the inability to estimate the probability of reversal. Revenue
relating to achievement of these milestones is recognized in the
period in which the milestone is achieved.
Sales-based
royalty and milestone payments resulting from customer contracts
solely or predominately for the license of intellectual property
will only be recognized upon occurrence of the underlying sale or
achievement of the sales milestone in the future and such
sales-based royalties and milestone payments will be recognized in
the same period earned.
We recognize revenue for reimbursements of research and development
costs under collaboration agreements as the services are performed.
We record these reimbursements as revenue and not as a reduction of
research and development expenses as we are the principal in the
research and development activities based upon our control of such
activities, which is considered part of our ordinary
activities.
Development milestone payments are generally due 30 business days
after the milestone is achieved. Sales milestone payments are
generally due 45 business days after the calendar year in which the
sales milestone is achieved. Royalty payments are generally due on
a quarterly basis 20 business days after being
invoiced.
Accrued Expenses
Third
parties perform a significant portion of the Company’s
development activities. The Company reviews the activities
performed under all contracts each quarter and accrues expenses and
the amount of any reimbursement to be received from its
collaborators based upon the estimated amount of work completed.
Estimating the value or stage of completion of certain services
requires judgment based on available information. If the Company
does not identify services performed for it but not billed by the
service-provider, or if it underestimates or overestimates the
value of services performed as of a given date, reported expenses
will be understated or overstated.
Stock-Based Compensation
We
expense the fair value of stock options and other equity awards
granted. Compensation costs for stock-based awards with time-based
vesting are determined using the quoted market price of our common
stock on the date of grant or for stock options, the value
determined utilizing the Black-Scholes option pricing model, and
are recognized on a straight-line basis, while awards containing a
market condition are valued using multifactor Monte Carlo
simulations. Compensation costs for awards containing a performance
condition are determined using the quoted price of our common stock
on the date of grant or for stock options, the value is determined
utilizing the Black Scholes option pricing model, and are
recognized based on the probability of achievement of the
performance condition over the service period. The Black-Scholes
option pricing model requires us to make estimates of expected
volatility and interest rates, which we estimate based on prior
experience and public sources of information. The expected term of
the option used is based upon the simplified method, which
represents the average of the vesting and contractual term.
Compensation expense is not adjusted for subsequent changes in the
estimates used to calculate fair value or for actual experience.
Forfeitures are recognized as they occur. As the amount and timing
of compensation expense to be recorded in future periods may be
affected by the achievement of performance conditions and employee
terminations, stock-based compensation may vary significantly
period to period.
See
Note 3 to the consolidated financial statements included in this
Annual Report for a description of recent accounting pronouncements
that affect us.
40
Results of Operations
Year Ended June 30, 2020 Compared to the Year Ended June 30,
2019:
Revenue – For the fiscal year ended June 30, 2020
(“fiscal 2020”), we recognized $117,989 in revenue
pursuant to our license agreement with AMAG compared to $60,300,476
in revenue for the fiscal year ended June 30, 2019 (“fiscal
2019”).
On
January 8, 2017, we entered into the AMAG License Agreement which
provided for $60,000,000 as a one-time initial payment. Pursuant to
the terms of and subject to the conditions in the AMAG License
Agreement, AMAG reimbursed us $25,000,000, less certain expenses
directly paid by AMAG for direct out-of-pocket expenses we incurred
following the effective date of the AMAG License Agreement in
connection with development and regulatory activities necessary to
file an NDA for Vyleesi for HSDD in the United States, less certain
other expenses directly paid or to be paid by AMAG. We recognized
$117,989 and $300,476 for fiscal 2020 and fiscal 2019,
respectively, as license and contract revenue which included
additional billings for AMAG-related Vyleesi costs.
In
addition, pursuant to the terms of and subject to the conditions in
the AMAG License Agreement, we were eligible to receive up to
$80,000,000 from AMAG in specified regulatory milestone payments
upon achievement of certain regulatory milestones. On June 21,
2019, the FDA granted approval of Vyleesi for use in the United
States, which triggered a $60,000,000 milestone payment to Palatin.
As a result, we recognized $60,000,000 in revenue related to
regulatory milestones in fiscal 2019.
Due to
the early commercial stage of Vyleesi and the sales and marketing
strategy of AMAG, including no charge for the first Vyleesi
prescription, AMAG has not generated positive net sales through
June 30, 2020, which resulted in no royalties to Palatin during
this period. On January 9, 2020, AMAG announced plans to divest
Vyleesi.
On July 27, 2020, Palatin and AMAG announced that they had mutually
terminated the license agreement for Vyleesi effective July 24,
2020. Under the terms of the
termination agreement, the Company regained all North American
development and commercialization rights for Vyleesi. AMAG made a
$12.0 million payment to the Company at closing and will make a
$4.3 million payment to the Company on March 31, 2021. The Company
assumed all Vyleesi manufacturing agreements, and AMAG will
transfer information, data, and assets related exclusively to
Vyleesi, including, but not limited to, existing inventory. AMAG is
providing certain transitional services to the Company for a period
of time to ensure continued patient access to Vyleesi during the
transition back to the Company. The Company will reimburse AMAG for
the costs of the transition services.
Research and Development – Total research and
development expenses, including general research and development
spending, were $13,959,379 for fiscal 2020 compared to $14,857,059
for fiscal 2019. The decrease is a result of lower compensation
cost in fiscal 2020 along with lower spending on our Vyleesi
program offset by an increase in spending on our other melanocortin
receptor programs.
Research
and development expenses related to our Vyleesi, PL3994, PL8177,
MC1r, MC4r and other preclinical projects were $10,187,786 and
$10,129,640 in fiscal 2020 and fiscal 2019, respectively. The
increase in spending for fiscal 2020 as compared to fiscal 2019 is
a result of increased spending primarily on our melanocortin
receptor programs offset by a decrease in spending on our Vyleesi
program. The amount of such spending and the nature of future
development activities are dependent on a number of factors,
including primarily the availability of funds to support future
development activities, success of our clinical trials and
preclinical and discovery programs, and our ability to progress
compounds in addition to Vyleesi, PL8177 and PL3994 into human
clinical trials.
The
amounts of project spending above exclude general research and
development spending, which was $3,771,611 and $4,727,455 in fiscal
2020 and fiscal 2019, respectively. The decrease in general
research and development spending is primarily attributable to
lower compensation cost in fiscal 2020.
Cumulative
spending from inception to June 30, 2020 was approximately
$311,400,000 on our Vyleesi program and approximately $154,700,000
on all our other programs (which include PL8177, PL9643, other
melanocortin receptor agonists, NPR programs and terminated
programs). Due to various risk factors described herein under
“Risk Factors,” including the difficulty in currently
estimating the costs and timing of future Phase 1 clinical trials
and larger-scale Phase 2 and Phase 3 clinical trials for any
product under development, we cannot predict with reasonable
certainty when, if ever, a program will advance to the next stage
of development or be successfully completed, or when, if ever,
related net cash inflows will be generated.
General and Administrative – General and
administrative expenses, which consist mainly of compensation and
related costs, were $9,765,372 for fiscal 2020 compared to
$9,699,061 for fiscal 2019. The increase in general and
administrative expenses is primarily attributable the final payment
made in connection with the Greenhill agreement and professional
fees related to the Vyleesi divestiture offset by a decrease in
compensation costs.
41
Other Income (Expense) – Total other income (expense),
net was $1,180,757 and $28,707 for fiscal 2020 and fiscal 2019,
respectively. For fiscal 2020, we recognized $1,200,898 of
investment income offset by $20,141 of interest expense. For fiscal
2019, we recognized $446,268 of investment income offset by
$417,561 of interest expense primarily related to our venture debt.
The increase in investment income is a result of Company’s
increased cash position. The decrease in interest expense relates
to our paying down of the venture debt.
Income Taxes – For fiscal 2020 and fiscal 2019, the
Company recorded no income tax benefit or expense as a result of
the generation of and utilization of net operating losses that were
subject to a full valuation allowance.
Year Ended June 30, 2019 Compared to the Year Ended June 30,
2018:
Revenue – For fiscal 2019, we recognized $60,300,476
in revenue pursuant to our license agreement with AMAG compared to
$67,134,758 in revenue for fiscal 2018 pursuant to our license
agreements with AMAG and Fosun.
On
January 8, 2017, we entered into the AMAG License Agreement which
provided for $60,000,000 as a one-time initial payment. Pursuant to
the terms of and subject to the conditions in the AMAG License
Agreement, AMAG reimbursed us $25,000,000, less certain expenses
directly paid by AMAG for direct out-of-pocket expenses we incurred
following the effective date of the AMAG License Agreement in
connection with development and regulatory activities necessary to
file an NDA for Vyleesi for HSDD in the United States, less certain
other expenses directly paid or to be paid by AMAG. We recognized
$300,476 and $42,134,758 for fiscal 2019 and fiscal 2018,
respectively, as license and contract revenue which included
additional billings for AMAG-related Vyleesi costs of $300,476 and
$1,151,243 in fiscal 2019 and fiscal 2018,
respectively.
In
addition, pursuant to the terms of and subject to the conditions in
the AMAG License Agreement, we were eligible to receive up to
$80,000,000 from AMAG in specified regulatory milestone payments
upon achievement of certain regulatory milestones. On June 4, 2018,
the FDA accepted the Vyleesi NDA for filing, which triggered a
$20,000,000 milestone payment to Palatin from AMAG, that was
recognized in revenue in fiscal 2018. On June 21, 2019, the FDA
granted approval of Vyleesi for use in the United States, which
triggered a $60,000,000 milestone payment to Palatin. As a result,
we recognized $60,000,000 in revenue related to regulatory
milestones in fiscal 2019.
On
September 6, 2017, we entered into the Fosun License Agreement,
which provided for $5,000,000 as a one-time non-refundable upfront
payment, which was recorded as revenue during the year ended June
30, 2018. Pursuant to the Fosun License Agreement, $500,000 was
withheld in accordance with tax withholding requirements in the
Chinese Territories and was recorded as an expense during the year
ended June 30, 2018.
Research and Development – Total research and
development expenses, including general research and development
spending, were $14,857,095 for fiscal 2019 compared to $32,566,217
for fiscal 2018. Fiscal 2019 costs primarily relate to our MC4r and
other preclinical programs along with an additional Phase 1 study
for Vyleesi.
Fiscal 2018 costs primarily relate to our Vyleesi Phase 3 clinical
trial program and ancillary studies necessary to file an NDA for
Vyleesi for HSDD.
Research
and development expenses related to our Vyleesi, PL3994, PL8177,
MC1r, MC4r and other preclinical projects were $10,129,640 and
$27,449,494 in fiscal 2019 and fiscal 2018, respectively. Spending
to date was primarily related to our Vyleesi for the treatment of
HSDD program. The decrease in research and development expenses is
mainly attributable to the conclusion of Phase 3 clinical trial and
development of Vyleesi for HSDD. The amount of such spending and
the nature of future development activities are dependent on a
number of factors, including primarily the availability of funds to
support future development activities, success of our clinical
trials and preclinical and discovery programs, and our ability to
progress compounds in addition to Vyleesi, PL8177 and PL3994 into
human clinical trials.
The
amounts of project spending above exclude general research and
development spending, which was $4,727,455 and $5,116,723 in fiscal
2019 and fiscal 2018, respectively. The decrease in general
research and development spending is primarily attributable to
lower stock-based compensation in fiscal 2019.
Cumulative
spending from inception to June 30, 2019 was approximately
$310,200,000 on our Vyleesi program and approximately $142,000,000
on all our other programs (which include PL8177, PL9643, other
melanocortin receptor agonists, NPR programs and terminated
programs). Due to various risk factors described herein under
“Risk Factors,” including the difficulty in currently
estimating the costs and timing of future Phase 1 clinical trials
and larger-scale Phase 2 and Phase 3 clinical trials for any
product under development, we cannot predict with reasonable
certainty when, if ever, a program will advance to the next stage
of development or be successfully completed, or when, if ever,
related net cash inflows will be generated.
42
General and Administrative – General and
administrative expenses, which consist mainly of compensation and
related costs, were $9,699,061 for fiscal 2019 compared to
$8,641,976 for fiscal 2018. The increase in general and
administrative expenses is primarily attributable to an increase in
compensation expense.
Other Income (Expense) – Total other income, net was
$28,707 for fiscal 2019 and total other expenses, net was
$1,141,351 for fiscal 2018. For fiscal 2019, we recognized $446,268
of investment income offset by $417,561 of interest expense
primarily related to our venture debt. For fiscal 2018, we
recognized $1,452,014 of interest expense primarily related to our
venture debt, offset by $310,663 of investment income. The decrease
in interest expense relates to our paying down of the venture
debt.
Income Taxes – For fiscal 2019, the Company recorded
no income tax expense as a result of the utilization of net
operating losses that were subject to a full valuation
allowance.
Effects of Inflation
We do
not believe that inflation has had a material impact on our
business, revenues or operating results during the periods
presented.
Liquidity and Capital Resources
Since
inception, we have generally incurred net operating losses,
primarily related to spending on our research and development
programs. We have financed our net operating losses primarily
through debt and equity financings and amounts received under
collaborative agreements.
Our
product candidates are at various stages of development and will
require significant further research, development and testing and
some may never be successfully developed or commercialized. We may
experience uncertainties, delays, difficulties and expenses
commonly experienced by early stage biopharmaceutical companies,
which may include unanticipated problems and additional costs
relating to:
●
the development and
testing of products in animals and humans;
●
product approval or
clearance;
●
regulatory
compliance;
●
GMP
compliance;
●
intellectual
property rights;
●
product
introduction;
●
marketing, sales
and competition; and
●
obtaining
sufficient capital.
Failure
to enter into or successfully perform under collaboration
agreements and obtain timely regulatory approval for our product
candidates and indications would impact our ability to generate
revenues and could make it more difficult to attract investment
capital for funding our operations. Any of these possibilities
could materially and adversely affect our operations and require us
to curtail or cease certain programs.
In
addition, the COVID-19 pandemic may negatively impact our
operations, including possible effects on our financial condition,
ability to access the capital markets on attractive terms or at
all, liquidity, operations, suppliers, industry, and workforce. We
will continue to evaluate the impact that these events could have
on the operations, financial position, and the results of
operations and cash flows during fiscal year 2021 and
beyond.
During
fiscal 2020, net cash provided by operating activities was
$41,326,415 compared to net cash used in operating activities of
$21,782,841 in fiscal 2019 and net cash provided by operating
activities of $1,703,103 in fiscal 2018. The difference in cash
provided by operations in fiscal 2020 compared with cash used in
operations in fiscal 2019 and compared with cash provided by
operating activities in fiscal 2018 was primarily related to the
timing of the receipt of payments related to revenue recorded for
the AMAG License Agreement, including for the FDA’s approval
of Vyleesi.
During
fiscal 2020, net cash used in investing activities consisted of
$62,880 compared to $36,139 during fiscal 2019, which consisted of
the acquisition of equipment. During fiscal 2018, net cash provided
by investing activities was $227,549, which consisted of $250,000
of proceeds from maturity of investments offset by $22,451 used for
the acquisition of equipment.
During
fiscal 2020 net cash used in financing activities was $1,921,687
which consisted of payment on notes payable obligations of
$832,851, repurchase and cancellation of outstanding warrants of
$2,547,466 and payment of withholding taxes related to restricted
stock units of $122,868 offset by net proceeds from the sale of
common stock of $1,581,498 in our “at-the-market”
offering program. During fiscal 2019, net cash provided by
financing activities was $27,329,231 which consisted of proceeds
from the sale of common stock of $33,136,060 and proceeds from the
exercise of common stock warrants of $808,934 offset by payment of
withholding taxes related to restricted stock units and stock
options of $115,763 and payment of debt obligations of $6,500,000.
During fiscal 2018, net cash used in financing activities was
$4,130,805, which consisted of payments of capital lease
obligations of $14,324, payment of withholding taxes related to
restricted stock units of $45,165, and payment of debt obligations
of $8,000,000, offset by proceeds from the exercise of stock
options, and common stock warrants of $2,670,910 and sale of common
stock of $1,257,774.
43
We have
incurred cumulative negative cash flows from operations since our
inception, and have expended, and expect to continue to expend in
the future, substantial funds to develop the capability to market
and distribute Vyleesi in the United States and to complete our
planned product development efforts. Continued operations are
dependent upon our ability to generate future income from sales of
Vyleesi in the United States and from existing licenses, including
royalties and milestones, to complete equity or debt financing
activities and enter into additional licensing or collaboration
arrangements. As of June 30, 2020, our cash and cash equivalents
were $82,852,270 with current liabilities of
$3,927,553.
We
intend to utilize existing capital resources for general corporate
purposes and working capital, including establishing marketing and
distribution capabilities for
Vyleesi in the United States and preclinical and clinical
development of our MC1r and MC4r peptide programs and natriuretic
peptide program, and development of other portfolio
products.
We
believe that our cash and cash equivalents as of June 30, 2020 will
be sufficient to fund our current operating plans through at least
September 2021. We will need additional funding to complete
required clinical trials for our other product candidates and
development programs and, if those clinical trials are successful
(which we cannot predict), to complete submission of required
regulatory applications to the FDA.
We had
a net loss for fiscal 2020 of $22,426,023. We may not attain
profitability in future years, which is dependent on numerous
factors, including whether and when development and sales
milestones are met, regulatory actions by the FDA and other
regulatory bodies, the performance of our licensees, and market
acceptance of our products.
We
expect to incur significant expenses as we continue to develop
marketing and distribution capability for Vyleesi in the United
States and continue to develop our MC1r and natriuretic peptide
product candidates. These expenses, among other things, have had
and will continue to have an adverse effect on our
stockholders’ equity, total assets, and working
capital.
Off-Balance Sheet Arrangements
None.
Contractual Obligations
We have
entered into various contractual obligations and commercial
commitments. The following table summarizes our most significant
contractual obligations as of June 30, 2020:
|
|
Payments due by
Period
|
||||
|
|
Total
|
Less than 1
Year
|
1 - 3
Years
|
3 - 5
Years
|
More than 5
Years
|
|
|
|
|
|
|
|
|
Operating
leases
|
$1,434,330
|
$355,164
|
$556,818
|
$522,348
|
$-
|
Item 7A. Quantitative and Qualitative
Disclosures About Market Risk.
Not
applicable.
44
Item 8. Financial Statements and
Supplementary Data.
Table of Contents
Consolidated Financial Statements
The
following consolidated financial statements are filed as part of
this Annual Report:
|
|
Page
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
46
|
|
|
|
|
Consolidated
Balance Sheets
|
47
|
|
|
|
|
Consolidated
Statements of Operations
|
48
|
|
|
|
|
Consolidated
Statements of Comprehensive (Loss) Income
|
49
|
|
|
|
|
Consolidated
Statements of Stockholders’ Equity (Deficiency)
|
50
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
51
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
52
|
45
Report of Independent Registered Public Accounting
Firm
To the
Stockholders and Board of Directors
Palatin
Technologies, Inc.:
Opinion on the Consolidated Financial Statements
We have
audited the accompanying consolidated balance sheets of Palatin
Technologies, Inc. and subsidiary (the Company) as of June 30, 2020
and 2019, the related consolidated statements of operations,
comprehensive (loss) income, stockholders’ equity
(deficiency), and cash flows for each of the years in the
three-year period ended June 30, 2020, and the related notes
(collectively, the consolidated financial statements). In our
opinion, the consolidated financial statements present fairly, in
all material respects, the financial position of the Company as of
June 30, 2020 and 2019, and the results of its operations and its
cash flows for each of the years in the three-year period ended
June 30, 2020, in conformity with U.S. generally accepted
accounting principles.
Changes in Accounting Principle
As discussed in Note 2 to the consolidated financial statements,
the Company has changed its method of accounting for revenue as of
July 1, 2018 due to the adoption of Accounting Standards Update
(ASU) No. 2014-09, Revenue from Contracts with
Customers.
Also as
discussed in Note 3 to the consolidated financial statements, the
Company has changed its method of accounting for leases as of July
1, 2019 due to the adoption of ASU No. 2016-02, Leases.
Basis for Opinion
These
consolidated financial statements are the responsibility of the
Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due
to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting. As part of our audits, we are required to obtain an
understanding of internal control over financial reporting but not
for the purpose of expressing an opinion on the effectiveness of
the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of
material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a
test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation
of the consolidated financial statements. We believe that our
audits provide a reasonable basis for our opinion.
/s/
KPMG LLP
We have
served as the Company’s auditor since 2002.
Philadelphia,
Pennsylvania
September
25, 2020
46
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
|
|
June
30,
2020
|
June
30,
2019
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$82,852,270
|
$43,510,422
|
|
Accounts
receivable
|
-
|
60,265,970
|
|
Prepaid expenses
and other current assets
|
738,216
|
637,289
|
|
Total current
assets
|
83,590,486
|
104,413,681
|
|
|
|
|
|
Property and
equipment, net
|
140,216
|
141,539
|
|
Right-of-use
assets
|
1,266,132
|
-
|
|
Other
assets
|
56,916
|
179,916
|
|
Total
assets
|
$85,053,750
|
$104,735,136
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$715,672
|
$504,787
|
|
Accrued
expenses
|
2,899,097
|
2,848,692
|
|
Notes payable, net
of discount
|
-
|
332,896
|
|
Short-term
operating lease liabilities
|
312,784
|
-
|
|
Other current
liabilities
|
-
|
499,517
|
|
Total current
liabilities
|
3,927,553
|
4,185,892
|
|
|
|
|
|
Long-term operating
lease liabilities
|
953,348
|
-
|
|
Total
liabilities
|
4,880,901
|
4,185,892
|
|
|
|
|
|
Commitments and
contingencies (Note 13)
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued
and outstanding designated as follows:
|
|
|
|
Series A
Convertible: authorized 264,000 shares: issued and outstanding
4,030 shares as of June 30, 2020 and June 30, 2019
|
40
|
40
|
|
Common stock of
$0.01 par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 229,258,400 shares as of June 30, 2020 and 226,815,363
shares as of June 30, 2019
|
2,292,584
|
2,268,154
|
|
Additional paid-in
capital
|
396,079,127
|
394,053,929
|
|
Accumulated
deficit
|
(318,198,902)
|
(295,772,879)
|
|
Total
stockholders’ equity
|
80,172,849
|
100,549,244
|
|
Total liabilities
and stockholders’ equity
|
$85,053,750
|
$104,735,136
|
The
accompanying notes are an integral part of these consolidated
financial statements
47
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
License and
contract
|
$117,989
|
$60,300,476
|
$67,134,758
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research and
development
|
13,959,397
|
14,857,095
|
32,566,217
|
|
General and
administrative
|
9,765,372
|
9,699,061
|
8,641,976
|
|
Total operating
expenses
|
23,724,769
|
24,556,156
|
41,208,193
|
|
|
|
|
|
|
(Loss) income from
operations
|
(23,606,780)
|
35,744,320
|
25,926,565
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
Investment
income
|
1,200,898
|
446,268
|
310,663
|
|
Interest
expense
|
(20,141)
|
(417,561)
|
(1,452,014)
|
|
Total other income
(expense), net
|
1,180,757
|
28,707
|
(1,141,351)
|
|
|
|
|
|
|
(Loss) income
before income taxes
|
(22,426,023)
|
35,773,027
|
24,785,214
|
|
Income tax
expense
|
-
|
-
|
(82,500)
|
|
NET LOSS
(INCOME)
|
$(22,426,023)
|
$35,773,027
|
$24,702,714
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss)
income per common share
|
$(0.10)
|
$0.17
|
$0.12
|
|
|
|
|
|
|
Diluted net (loss)
income per common share
|
$(0.10)
|
$0.16
|
$0.12
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic net
(loss) income per common share
|
234,684,776
|
207,670,607
|
198,101,060
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing diluted net
(loss) income per common share
|
234,684,776
|
217,133,374
|
207,007,558
|
The
accompanying notes are an integral part of these consolidated
financial statements
48
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Comprehensive (Loss) Income
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
|
|
|
|
|
Net (loss)
income
|
$(22,426,023)
|
$35,773,027
|
$24,702,714
|
|
|
|
|
|
|
Other comprehensive
income:
|
|
|
|
|
Unrealized gain on
available-for-sale investments
|
-
|
-
|
590
|
|
|
|
|
|
|
Total comprehensive
(loss) income
|
$(22,426,023)
|
$35,773,027
|
$24,703,304
|
The
accompanying notes are an integral part of these consolidated
financial statements
49
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Stockholders’ Equity
(Deficiency)
|
|
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
|
Accumulated
Other Comprehensive (Loss)
|
Accumulated
|
|
||
|
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Income
|
Deficit
|
Total
|
|
Balance, June 30,
2017
|
4,030
|
$40
|
160,515,361
|
$1,605,153
|
$349,974,538
|
$(590)
|
$(356,743,785)
|
$(5,164,644)
|
|
Cumulative effect
of accounting change
|
-
|
-
|
-
|
-
|
4,835
|
-
|
(4,835)
|
-
|
|
Stock-based
compensation
|
-
|
-
|
795,041
|
7,951
|
3,510,400
|
-
|
-
|
3,518,351
|
|
Sale of common
stock , net of costs
|
-
|
-
|
1,283,754
|
12,838
|
1,244,936
|
-
|
-
|
1,257,774
|
|
Withholding taxes
related to restricted stock units
|
-
|
-
|
(27,465)
|
(275)
|
(20,511)
|
-
|
-
|
(20,786)
|
|
Warrant
exercises
|
-
|
-
|
37,778,614
|
377,786
|
2,133,243
|
-
|
-
|
2,511,029
|
|
Option
exercises
|
-
|
-
|
208,900
|
2,089
|
157,792
|
-
|
-
|
159,881
|
|
Unrealized gains on
investments
|
-
|
-
|
-
|
-
|
-
|
590
|
-
|
590
|
|
Net
income
|
-
|
-
|
-
|
-
|
-
|
-
|
24,702,714
|
24,702,714
|
|
Balance, June 30,
2018
|
4,030
|
40
|
200,554,205
|
2,005,542
|
357,005,233
|
-
|
(332,045,906)
|
26,964,909
|
|
Cumulative effect
of accounting change
|
-
|
-
|
-
|
-
|
-
|
-
|
500,000
|
500,000
|
|
Stock-based
compensation
|
-
|
-
|
327,692
|
3,277
|
3,478,800
|
-
|
-
|
3,482,077
|
|
Sale of common
stock , net of costs
|
-
|
-
|
24,785,814
|
247,858
|
32,888,202
|
-
|
-
|
33,136,060
|
|
Withholding taxes
related to restricted stock units
|
-
|
-
|
(67,038)
|
(670)
|
(65,322)
|
-
|
-
|
(65,992)
|
|
Withholding taxes
related to stock options
|
-
|
-
|
(37,994)
|
(380)
|
(49,391)
|
-
|
-
|
(49,771)
|
|
Warrant
exercises
|
-
|
-
|
1,115,333
|
11,153
|
797,781
|
-
|
-
|
808,934
|
|
Option
exercises
|
-
|
-
|
137,351
|
1,374
|
(1,374)
|
-
|
-
|
-
|
|
Net
income
|
-
|
-
|
-
|
-
|
-
|
-
|
35,773,027
|
35,773,027
|
|
Balance, June 30,
2019
|
4,030
|
40
|
226,815,363
|
2,268,154
|
394,053,929
|
-
|
(295,772,879)
|
100,549,244
|
|
Stock-based
compensation
|
-
|
-
|
614,117
|
6,141
|
3,132,323
|
-
|
-
|
3,138,464
|
|
Sale of common
stock , net of costs
|
-
|
-
|
1,895,934
|
18,959
|
1,562,539
|
-
|
-
|
1,581,498
|
|
Withholding taxes
related to restricted stock units
|
-
|
-
|
(93,875)
|
(939)
|
(121,929)
|
-
|
-
|
(122,868)
|
|
Warrant
repurchases
|
-
|
-
|
-
|
-
|
(2,547,466)
|
-
|
-
|
(2,547,466)
|
|
Warrant
Exercises
|
-
|
-
|
26,861
|
269
|
(269)
|
-
|
-
|
-
|
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(22,426,023)
|
(22,426,023)
|
|
Balance June 30,
2020
|
4,030
|
$40
|
229,258,400
|
$2,292,584
|
$396,079,127
|
$-
|
$(318,198,902)
|
$80,172,849
|
The
accompanying notes are an integral part of these consolidated
financial statements
50
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Cash Flows
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
|
Net
(loss) Income
|
$(22,426,023)
|
$35,773,027
|
$24,702,714
|
|
Adjustments
to reconcile net (loss) income to net cash
|
|
|
|
|
provided
by (used in) operating activities:
|
|
|
|
|
Depreciation and
amortization
|
64,203
|
58,635
|
56,569
|
|
Non-cash interest
expense
|
438
|
51,234
|
175,493
|
|
Decrease in
right-of-use asset
|
298,558
|
-
|
-
|
|
Stock-based
compensation
|
3,138,464
|
3,482,077
|
3,518,351
|
|
Deferred income tax
benefit
|
-
|
-
|
(500,000)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
Accounts
receivable
|
60,265,970
|
(60,265,970)
|
15,116,822
|
|
Prepaid expenses
and other assets
|
22,073
|
35,399
|
715,533
|
|
Accounts
payable
|
210,885
|
(1,718,906)
|
672,326
|
|
Accrued
expenses
|
50,405
|
745,671
|
(8,393,698)
|
|
Deferred
revenue
|
-
|
-
|
(34,550,572)
|
|
Operating lease
liabilities
|
(298,558)
|
-
|
-
|
|
Other
liabilities
|
-
|
55,992
|
189,565
|
|
Net cash provided
by (used in) operating activities
|
41,326,415
|
(21,782,841)
|
1,703,103
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
Proceeds from
matured investments
|
-
|
-
|
250,000
|
|
Purchases of
property and equipment
|
(62,880)
|
(36,139)
|
(22,451)
|
|
Net cash (used in)
provided by investing activities
|
(62,880)
|
(36,139)
|
227,549
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
|
Payment on capital
lease obligations
|
-
|
-
|
(14,324)
|
|
Payment of
withholding taxes related to restricted
|
|
|
|
|
stock
units
|
(122,868)
|
(115,763)
|
(45,165)
|
|
Payment on notes
payable obligations
|
(832,851)
|
(6,500,000)
|
(8,000,000)
|
|
Proceeds from the
exercise of stock options
|
-
|
-
|
159,881
|
|
Proceeds from
exercise of common stock warrants
|
-
|
808,934
|
2,511,029
|
|
Warrant
repurchases
|
(2,547,466)
|
-
|
-
|
|
Proceeds from the
sale of common stock,
|
|
|
|
|
net of
costs
|
1,581,498
|
33,136,060
|
1,257,774
|
|
Net cash (used in)
provided by financing activities
|
(1,921,687)
|
27,329,231
|
(4,130,805)
|
|
|
|
|
|
|
NET INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
39,341,848
|
5,510,251
|
(2,200,153)
|
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS, beginning of year
|
43,510,422
|
38,000,171
|
40,200,324
|
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS, end of year
|
$82,852,270
|
$43,510,422
|
$38,000,171
|
|
|
|
|
|
|
SUPPLEMENTAL CASH
FLOW INFORMATION:
|
|
|
|
|
Cash paid for
interest
|
$19,222
|
$354,456
|
$1,084,158
|
|
Cash paid for
income taxes
|
-
|
-
|
500,000
|
The
accompanying notes are an integral part of these consolidated
financial statements
51
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
(1)
ORGANIZATION
Nature of Business - Palatin Technologies, Inc.
(“Palatin” or the “Company”) is a
specialized biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin and natriuretic peptide receptor systems. The
Company’s product candidates are targeted, receptor-specific
therapeutics for the treatment of diseases with significant unmet
medical need and commercial potential.
Melanocortin Receptor System. The melanocortin receptor
(“MCr”) system is hormone driven, with effects on food
intake, metabolism, sexual function, inflammation and immune system
responses. There are five melanocortin receptors, MC1r through
MC5r. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have significant pharmacological effects.
The
Company’s lead product, Vyleesi®, was approved by the
U.S. Food and Drug Administration (“FDA”) in June 2019
and was being marketed in North America by AMAG Pharmaceuticals,
Inc. (“AMAG”) for the treatment of hypoactive sexual
desire disorder (“HSDD”) in premenopausal women
pursuant to a license agreement between them for Vyleesi for North
America, which was entered into on January 8, 2017 (the “AMAG
License Agreement”). As disclosed in Note 4, AMAG announced
its plan in January 2020 to divest Vyleesi and another product. As
disclosed in Note 17, subsequent to fiscal year end AMAG and the
Company entered into an agreement to terminate the AMAG License
Agreement.
The
Company’s new product development activities focus primarily
on MC1r agonists, with potential to treat inflammatory and
autoimmune diseases such as dry eye disease, which is also known as
keratoconjunctivitis sicca, uveitis, diabetic retinopathy and
inflammatory bowel disease. The Company believes that the MC1r
agonist peptides in development have broad anti-inflammatory
effects and appear to utilize mechanisms engaged by the endogenous
melanocortin system in regulation of the immune system and
resolution of inflammatory responses. The Company is also
developing peptides that are active at more than one melanocortin
receptor, and MC4r peptide and small molecule agonists with
potential utility in obesity and metabolic-related disorders,
including rare disease and orphan indications.
Natriuretic Peptide Receptor System. The natriuretic peptide
receptor (“NPR”) system regulates cardiovascular
functions, and therapeutic agents modulating this system have
potential to treat cardiovascular and fibrotic diseases. The
Company has designed and is developing potential NPR candidate
drugs selective for one or more different natriuretic peptide
receptors, including natriuretic peptide receptor-A
(“NPR-A”), natriuretic peptide receptor B
(“NPR-B”), and natriuretic peptide receptor C
(“NPR-C”).
Business Risks and Liquidity – Since inception, the
Company has incurred negative cash flows from operations, and has
expended, and expects to continue to expend, substantial funds to
develop the capability to market and distribute Vyleesi in the
United States and complete its planned product development efforts.
As shown in the accompanying consolidated financial statements, the
Company had an accumulated deficit as of June 30, 2020 of
$318,198,902 and a net loss for the year ended June 30, 2020 of
$22,426,023, and the Company anticipates incurring significant
expenses in the future as a result of spending on developing
marketing and distribution capabilities for Vyleesi in the United
States and spending on its development programs and will require
substantial additional financing or revenues to continue to fund
its planned developmental activities. To achieve sustained
profitability, if ever, the Company, alone or with others, must
successfully develop and commercialize its technologies and
proposed products, conduct successful preclinical studies and
clinical trials, obtain required regulatory approvals and
successfully manufacture and market such technologies and proposed
products. The time required to reach sustained profitability is
highly uncertain, and the Company may never be able to achieve
profitability on a sustained basis, if at all.
As of
June 30, 2020, the Company’s cash and cash equivalents were
$82,852,270 and current liabilities were $3,927,553. Management
intends to utilize existing capital resources for general corporate
purposes and working capital, including establishing marketing and
distribution capabilities for Vyleesi in the United States and
preclinical and clinical development of the Company’s MC1r
and MC4r peptide programs and natriuretic peptide program, and
development of other portfolio products.
52
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Management
believes that the Company's cash and cash equivalents as of June
30, 2020 will be sufficient to fund our current operating plans
through at least September 2021. The Company will need additional
funding to complete required clinical trials for its other product
candidates and, assuming those clinical trials are successful, as
to which there can be no assurance, to complete submission of
required applications to the FDA. If the Company is unable to
obtain approval or otherwise advance in the FDA approval process,
the Company’s ability to sustain its operations could be
materially adversely affected.
The
Company may seek the additional capital necessary to fund its
operations through public or private equity offerings,
collaboration agreements, debt financings or licensing
arrangements. Additional capital that is required by the Company
may not be available on reasonable terms, or at all.
In
March 2020, the World Health Organization declared COVID-19, a
disease caused by a novel strain of coronavirus, a pandemic. The
Company has taken steps to ensure the safety and well-being of its
employees and clinical trial patients to comply with guidance from
federal, state and local authorities, while working to ensure the
sustainability of its business operations as this unprecedented
situation continues to evolve. In mid-March, the Company
transitioned to a company-wide work from home policy.
Business-critical activities continue to be subject to heightened
precautions to ensure safety of employees. The Company continues to
assess its policies, business continuity plans and employee
support.
The
Company continues to evaluate the impact of COVID-19 on the
healthcare system and work with contract research organizations
supporting its clinical, research, and development programs to
mitigate risk to patients and its business and community partners,
taking into account regulatory, institutional, and government
guidance and policies.
The
Company receives a royalty on sales of Vyleesi by our licensees. We
have licensed third parties to sell Vyleesi in China and Korea. The
COVID-19 coronavirus could adversely impact the time required to
obtain regulatory approvals to sell Vyleesi in China and Korea,
which would delay when the Company receives royalty income from
sales in those countries.
The
Company cannot be certain what the overall impact of the COVID-19
pandemic will be on its business and it has the potential to
materially adversely affect its business, financial condition and
results of operations and cashflows during fiscal 2021 and
beyond.
Concentrations – Concentrations in the Company’s
assets and operations subject it to certain related risks.
Financial instruments that subject the Company to concentrations of
credit risk primarily consist of cash and cash equivalents. The
Company’s cash and cash equivalents are primarily invested in
one money market account sponsored by a large financial
institution. For the year ended June 30, 2020, the Company reported
$117,989 in revenue, solely related to the AMAG License Agreement
(Note 4). For the years ended June 30, 2019 and 2018, the Company
reported $60,300,476, and $62,134,758, respectively, in license and
contract revenue related to the AMAG License Agreement. In
addition, for the year ended June 30, 2018, the Company reported
$5,000,000 in license revenue related to a license agreement with
Fosun.
(2)
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation – The consolidated
financial statements include the accounts of the Company and its
wholly-owned inactive subsidiary. All intercompany accounts and
transactions have been eliminated in consolidation.
Use of Estimates – The preparation of consolidated
financial statements in conformity with accounting principles
generally accepted in the United States of America (“U.S.
GAAP”) requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
consolidated financial statements and the reported amounts of
revenues and expenses during the reporting period. Actual results
could differ from those estimates.
53
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Cash and Cash Equivalents – Cash and cash equivalents
include cash on hand, cash in banks and all highly liquid
investments with a purchased maturity of less than three months.
Cash equivalents consist of $82,406,697 and $43,381,556 in a money
market account at June 30, 2020 and 2019,
respectively.
Fair Value of Financial Instruments – The
Company’s financial instruments consist primarily of cash
equivalents, accounts receivable and accounts payable. Management
believes that the carrying values of cash equivalents, accounts
receivable and accounts payable are representative of their
respective fair values based on the short-term nature of these
instruments.
Credit Risk – Financial instruments which potentially
subject the Company to concentrations of credit risk consist
principally of cash and cash equivalents. Total cash and cash
equivalent balances have exceeded balances insured by the Federal
Depository Insurance Company (“FDIC”).
Property and Equipment – Property and equipment
consists of office and laboratory equipment, office furniture and
leasehold improvements and includes assets acquired under capital
leases. Property and equipment are recorded at cost. Depreciation
is recognized using the straight-line method over the estimated
useful lives of the related assets, generally five years for
laboratory and computer equipment, seven years for office furniture
and equipment and the lesser of the term of the lease or the useful
life for leasehold improvements. Amortization of assets acquired
under capital leases is included in depreciation expense.
Maintenance and repairs are expensed as incurred while expenditures
that extend the useful life of an asset are
capitalized.
Impairment of Long-Lived Assets – The Company reviews
its long-lived assets for impairment whenever events or changes in
circumstances indicate that the carrying amount of the assets may
not be fully recoverable. To determine recoverability of a
long-lived asset, management evaluates whether the estimated future
undiscounted net cash flows from the asset are less than its
carrying amount. If impairment is indicated, the long-lived asset
would be written down to fair value. Fair value is determined by an
evaluation of available price information at which assets could be
bought or sold, including quoted market prices, if available, or
the present value of the estimated future cash flows based on
reasonable and supportable assumptions.
Revenue Recognition – In
May 2014, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update
(“ASU”) No. 2014-09, Revenue from Contracts with
Customers (“ASC Topic
606”), which, along with amendments from 2015 and 2016
requires an entity to recognize the amount of revenue to which it
expects to be entitled for the transfer of promised goods or
services to customers. ASC Topic 606 replaced most existing revenue
recognition guidance in U.S. GAAP when it became
effective.
On July 1, 2018, the Company adopted ASC Topic 606 using the
modified retrospective approach, a practical expedient permitted
under ASC Topic 606, and applied this approach only to contracts
that were not completed as of July 1, 2018. The Company calculated
a one-time cumulative transition adjustment of $500,000 which was
recorded on July 1, 2018 to the opening balance of accumulated
deficit related to the license agreement with Kwangdong
Pharmaceutical Co., Ltd. (“Kwangdong”) to market
Vyleesi in the Republic of Korea (the “Kwangdong License
Agreement”), as the Company determined a significant revenue
reversal would not occur in a future period. The one-time
adjustment consisted of the recognition of $500,000 of deferred
revenue.
Revenue Recognition for Periods Prior to July 1, 2018
The
Company has generated revenue solely through license and
collaboration agreements. Prior to July 1, 2018, the Company
recognized revenue in accordance with FASB Accounting Standards
Codifications (“ASC”) Topic 605-25, Revenue Recognition for Arrangements with
Multiple Elements, which addressed the determination of
whether an arrangement involving multiple deliverables contained
more than one unit of accounting. A delivered item within an
arrangement was considered a separate unit of accounting only if
both of the following criteria were met:
●
the delivered item
had value to the customer on a stand-alone basis; and
●
if the arrangement
included a general right of return relative to the delivered item,
delivery or performance of the undelivered item was considered
probable and substantially in control of the vendor.
54
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Under
FASB ASC Topic 605-25, if both of the criteria above were not met,
then separate accounting for the individual deliverables was not
appropriate.
The
Company determined that it was appropriate to recognize such
revenue using the input-based proportional method during the period
of the Company’s development obligations as defined in the
AMAG License Agreement. Refer to Note 4 for additional
information.
Under
the Fosun License Agreement (Note 5), the Company received
consideration in the form of an upfront license fee payment and
determined that it was appropriate to recognize such consideration
as revenue in the first quarter of fiscal 2018, which was the
quarter in which the license was granted, since the license had
stand-alone value and the upfront payment received by the Company
was non-refundable.
Under
the Kwangdong License Agreement (Note 6), the Company received
consideration in the form of an upfront license fee payment and
determined that it was appropriate to record such consideration as
deferred revenue because the upfront payment received by the
Company is subject to certain refund provisions.
Revenue
resulting from the achievement of development milestones was
recorded in accordance with the accounting guidance for the
milestone method of revenue recognition. Amounts received prior to
satisfying the revenue recognition criteria were recorded as
deferred revenue on the Company’s consolidated balance
sheet.
Revenue Recognition for Periods Commencing July 1,
2018
For
licenses of intellectual property, the Company assesses, at
contract inception, whether the intellectual property is distinct
from other performance obligations identified in the arrangement.
If the licensing of intellectual property is determined to be
distinct, revenue is recognized for nonrefundable, upfront license
fees when the license is transferred to the customer and the
customer can use and benefit from the license. If the licensing of
intellectual property is determined not to be distinct, then the
license will be bundled with other promises in the arrangement into
one performance obligation. The Company needs to determine if the
bundled performance obligation is satisfied over time or at a point
in time. If the Company concludes that the nonrefundable, upfront
license fees will be recognized over time, the Company will need to
assess the appropriate method of measuring proportional
performance.
Regulatory
milestone payments are excluded from the transaction price due to
the inability to estimate the probability of reversal. Revenue
relating to achievement of these milestones is recognized in the
period in which the milestone is achieved.
Sales-based
royalty and milestone payments resulting from customer contracts
solely or predominately for the license of intellectual property
will only be recognized upon occurrence of the underlying sale or
achievement of the sales milestone in the future and such
sales-based royalties and milestone payments will be recognized in
the same period earned.
The Company recognizes revenue for reimbursements of research and
development costs under collaboration agreements as the services
are performed. The Company records these reimbursements as revenue
and not as a reduction of research and development expenses as the
Company is the principal in the research and development activities
based upon its control of such activities, which is considered part
of its ordinary activities.
Development milestone payments are generally due 30 business days
after the milestone is achieved. Sales milestone payments are
generally due 45 business days after the calendar year in which the
sales milestone is achieved. Royalty payments are generally due on
a quarterly basis 20 business days after being
invoiced.
The cumulative effect of applying ASC Topic 606 to the
Company’s consolidated balance sheet was as
follows:
|
|
Balance at
June 30,
2018
|
Net Adjustment
|
Balance at
July 1,
2018
|
|
Deferred
revenue
|
$500,000
|
$(500,000)
|
$-
|
|
Accumulated
deficit
|
(332,045,906)
|
500,000
|
(331,545,906)
|
55
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
ASC Topic 606 did not have an impact on the Company’s
consolidated statements of operations or cash flows.
Research and Development Costs – The costs of research
and development activities are charged to expense as incurred,
including the cost of equipment for which there is no alternative
future use.
Accrued Expenses – Third parties perform a significant
portion of the Company’s development activities. The Company
reviews the activities performed under all contracts each quarter
and accrues expenses and the amount of any reimbursement to be
received from its collaborators based upon the estimated amount of
work completed. Estimating the value or stage of completion of
certain services requires judgment based on available information.
If the Company does not identify services performed for it but not
billed by the service-provider, or if it underestimates or
overestimates the value of services performed as of a given date,
reported expenses will be understated or overstated.
Stock-Based Compensation – The Company charges to
expense the fair value of stock options and other equity awards
granted. Compensation costs for stock-based awards with time-based
vesting are determined using the quoted market price of the
Company’s common stock on the date of grant or for stock
options, the value determined utilizing the Black-Scholes option
pricing model, and are recognized on a straight-line basis, while
awards containing a market condition are valued using multifactor
Monte Carlo simulations. Compensation costs for awards containing a
performance condition are determined using the quoted price of the
Company’s common stock on the date of grant or for stock
options, the value is determined utilizing the Black Scholes option
pricing model, and are recognized based on the probability of
achievement of the performance condition over the service period.
Forfeitures are recognized as they occur.
Income Taxes – The Company and its subsidiary file
consolidated federal and separate-company state income tax returns.
Income taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the
financial statement carrying amounts of assets and liabilities and
their respective tax basis and operating loss and tax credit
carryforwards. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences or operating loss and
tax credit carryforwards are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in
tax rates is recognized in the period that includes the enactment
date. The Company has recorded and continues to maintain a full
valuation allowance against its deferred tax assets based on the
history of losses incurred.
On
March 27, 2020, the President of the United States signed into law
the Coronavirus Aid, Relief, and Economic Security Act (the
“CARES Act”), which provides emergency economic
assistance for American workers, families and businesses affected
by the COVID-19 pandemic. The economic relief package includes
government loan enhancement programs and various tax provisions to
help improve liquidity for American businesses. Based on
management’s evaluation of the CARES Act tax provisions,
there is no material impact to the Company for the year ended June
30, 2020. Management will continue monitor any effects that may
arise from the CAREs Act.
Net (Loss) Income per Common Share - Basic and diluted
(loss) income per common share (“EPS”) are calculated
in accordance with the provisions of FASB ASC Topic 260,
Earnings per Share, which
includes guidance pertaining to the warrants issued in connection
with the Company’s July 3, 2012, December 23, 2014, and July
2, 2015 private placement offerings and the August 4, 2016
underwritten offering, that were exercisable for nominal
consideration and, therefore, to the extent not yet exercised were
considered in the computation of basic and diluted net (loss)
income per common share. As of November 21, 2017, all warrants
exercisable for nominal value had been converted into common
stock.
56
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
The
following table is a reconciliation of net (loss) income and the
shares used in calculating basic and diluted net (loss) income per
common share for the years ended June 30, 2020, 2019 and
2018:
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
|
|
|
|
|
Net (loss)
income
|
$(22,426,023)
|
$35,773,027
|
$24,702,714
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
Weighted average
common shares - Basic
|
234,684,776
|
207,670,607
|
198,101,060
|
|
|
|
|
|
|
Effect of dilutive
shares:
|
|
|
|
|
Common stock
equivalents arising from stock options,
|
|
|
|
|
warrants and
conversion of preferred stock
|
-
|
7,142,309
|
6,752,604
|
|
Restriced stock
units
|
-
|
2,320,458
|
2,153,874
|
|
Weighted average
common shares - Diluted
|
234,684,776
|
217,133,374
|
207,007,538
|
|
|
|
|
|
|
Net (loss) income
per common share:
|
|
|
|
|
Basic
|
$(0.10)
|
$0.17
|
$0.12
|
|
Diluted
|
$(0.10)
|
$0.16
|
$0.12
|
For the
year ended June 30, 2020, no additional common shares were added to
the computation of diluted EPS because to do so would have been
anti-dilutive. The potential number of common shares excluded from
diluted EPS during the year ended June 30, 2020 was
40,890,091.
As of
June 30, 2019 and 2018 common shares issuable upon conversion of
Series A Convertible Preferred Stock, the exercise of outstanding
options and warrants, excluding outstanding warrants exercisable
for nominal consideration, and the vesting of restricted stock
units amounted in an aggregate of 6,130,876 and 5,197,592,
respectively, being excluded from the weighted average number of
common shares outstanding used in computing diluted net income per
common share because they were anti-dilutive during the period or
the minimum performance requirements or market conditions had not
been met.
Included
in the weighted average common shares used in computing basic and
diluted net (loss) income per common share are 7,127,362,
6,138,166, and 3,140,499 vested restricted stock units that had not
been issued as of June 30, 2020, 2019 and 2018, respectively, due
to a provision in the restricted stock unit agreements to delay
delivery.
(3)
NEW
AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS
In August 2020, the FASB issued ASU No. 2020-06,
Debt (Topic 470) and Derivatives and Hedging (Topic 815):
Accounting for Convertible Instruments and Contracts in an
Entity’s Own Equity. The amendments in this
update address issues identified as a result of the complexity
associated with applying GAAP for certain financial instruments
with characteristics of liabilities and equity. The guidance is
effective for public entities for fiscal years beginning after
December 15, 2021, and for interim periods within those fiscal
years, with early adoption permitted. The guidance is applicable to
the Company beginning July 1, 2022. The Company is currently
evaluating the potential effects of this guidance on its
consolidated financial statements.
57
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
In December 2019, the FASB issued ASU No. 2019-12,
Income
Taxes (Topic 740): Simplifying the Accounting for Income
Taxes. The amendments in this
update simplify the accounting for income taxes by removing certain
exceptions to the general principles in Topic 740. The amendments
also improve consistent application and simplify U.S. GAAP for
other areas of Topic 740 by clarifying and amending existing
guidance. The guidance is effective for public entities for fiscal
years beginning after December 15, 2020, and for interim periods
within those fiscal years, with early adoption permitted. The
guidance is applicable to the Company beginning July 1, 2021. The
Company is currently evaluating the potential effects of this
guidance on its consolidated financial
statements.
In November 2018, the FASB issued ASU No. 2018-18,
Collaborative
Arrangements (Topic 808): Clarifying the Interaction between Topic
808 and Topic 606. This
update provides clarification on the interaction between Revenue
Recognition (Topic 606) and Collaborative Arrangements (Topic 808),
including the alignment of unit of account guidance between the two
topics. The guidance is
effective for public entities for fiscal years beginning after
December 15, 2019, and for interim periods within those fiscal
years, with early adoption permitted. The guidance is
applicable to the Company beginning July 1, 2020. The adoption of
ASU No. 2018-18 is not expected to have a material impact on the
Company’s consolidated financial
statements.
In May
2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718):
Scope of Modification Accounting, which clarifies when to
account for a change to the terms or conditions of a share-based
payment award as a modification. Under the new guidance,
modification accounting is required only if the fair value, the
vesting conditions, or the classification of the award (as equity
or liability) changes as a result of the change in terms or
conditions. It is effective prospectively for the annual period
ending June 30, 2019 and interim periods within that annual period.
Early adoption is permitted. The Company adopted this guidance
during the year ended June 30, 2019. The adoption of this standard
did not have a material impact on the Company’s consolidated
financial statements.
In June
2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses:
Measurement of Credit Losses on Financial Instruments, which
requires measurement and recognition of expected credit losses for
financial assets held at the reporting date based on historical
experience, current conditions, and reasonable and supportable
forecasts. This is different from the current guidance as this will
require immediate recognition of estimated credit losses expected
to occur over the remaining life of many financial assets. The new
guidance will be effective for the Company on July 1, 2023 with
early adoption permitted. The adoption of this standard is not
expected to have a material impact on the Company’s
consolidated financial statements.
On July
1, 2019, the Company adopted the requirements of ASU No.2016-02,
Leases (“Topic
842”). The objective of this ASU, along with several related
ASUs issued subsequently, is to increase transparency and
comparability between organizations that enter into lease
agreements. For lessees, the key difference of the new standard
from the previous guidance (“Topic 840”) is the
recognition of a right-of-use (“ROU”) asset and lease
liability on the balance sheet. The most significant change is the
requirement to recognize ROU assets and lease liabilities for
leases classified as operating leases. The standard requires
disclosures to meet the objective of enabling users of financial
statements to assess the amount, timing, and uncertainty of cash
flows arising from leases. As part of the transition to the new
standard, the Company elected to measure and recognize leases that
existed at July 1, 2019 using a modified retrospective approach,
including the option to not restate comparative periods. For leases
existing at the effective date, the Company elected the package of
three transition practical expedients and therefore did not
reassess whether an arrangement is or contains a lease, did not
reassess lease classification, and did not reassess what qualifies
as an initial direct cost. Additionally, the Company elected, as
practical expedients, not separating lease and non-lease components
for all of its leases and the short-term lease recognition
exemption for all of its leases that qualify. The Company did not
elect the use of the hindsight practical expedient. The adoption of
Topic 842 resulted in the recognition of an operating ROU asset and
operating lease liability of $225,134 as of July 1, 2019. The
adoption did not have a material impact on the consolidated
statements of operations, stockholder’s equity and cash flows
for year ended June 30, 2020.
58
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
At
lease inception, the Company determines whether an arrangement is
or contains a lease. Operating leases are included in operating
lease ROU assets, current operating lease liabilities, and
noncurrent operating lease liabilities in the consolidated
financial statements. ROU assets represent the Company’s
right to use leased assets over the term of the lease. Lease
liabilities represent the Company’s contractual obligation to
make lease payments over the lease term. For operating leases, ROU
assets and lease liabilities are recognized at the commencement
date. The lease liability is measured as the present value of the
lease payments over the lease term. The Company uses the rate
implicit in the lease if it is determinable. When the rate implicit
in the lease is not determinable, the Company uses an estimate
based on a hypothetical rate provided by a third party as the
Company currently does not have issued debt. Operating ROU assets
are calculated as the present value of the remaining lease payments
plus unamortized initial direct costs plus any prepayments less any
unamortized lease incentives received. Lease terms may include
renewal or extension options to the extent they are reasonably
certain to be exercised. The assessment of whether renewal or
extension options are reasonably certain to be exercised is made at
lease commencement. Factors considered in determining whether an
option is reasonably certain of exercise include, but are not
limited to, the value of any leasehold improvements, the value of
renewal rates compared to market rates, and the presence of factors
that would cause incremental costs to the Company if the option
were not exercised. Lease expense is recognized on a straight-line
basis over the lease term. The Company has elected not to recognize
an ROU asset and obligation for leases with an initial term of
twelve months or less. The expense associated with short term
leases is included in general and administrative expense in the
statement of operations. To the extent a lease arrangement includes
both lease and non-lease components, the Company has elected to
account for the components as a single lease
component.
In
January 2016, the FASB issued ASU No. 2016-01, Financial Instruments: Recognition and
Measurement of Financial Assets and Financial Liabilities.
The new guidance relates to the recognition and measurement of
financial assets and liabilities. The new guidance makes targeted
improvements to GAAP impacting equity investments (other than those
accounted for under the equity method or consolidated), financial
liabilities accounted for under the fair value election, and
presentation and disclosure requirements for financial instruments,
among other changes. The Company adopted this guidance during the
year ended June 30, 2019. The adoption of this standard did not
have a material impact on the Company’s consolidated
financial statements.
(4)
AGREEMENT
WITH AMAG
On
January 8, 2017, the Company entered into the AMAG License
Agreement pursuant to which the Company granted AMAG (i) an
exclusive license in all countries of North America (the
“Territory”), with the right to grant sub-licenses, to
research, develop and commercialize products containing Vyleesi
(each a “Product”, and collectively,
“Products”), (ii) a non-exclusive license in the
Territory, with the right to grant sub-licenses, to manufacture the
Products, and (iii) a non-exclusive license in all countries
outside the Territory, with the right to grant sub-licenses, to
research, develop and manufacture (but not commercialize) the
Products.
Following
the satisfaction of certain conditions to closing, the AMAG License
Agreement became effective on February 2, 2017, and AMAG paid the
Company $60,000,000 as a one-time initial payment. Under the AMAG
License Agreement, AMAG was required to reimburse the Company up to
an aggregate amount of $25,000,000 for reasonable, documented,
direct out-of-pocket expenses incurred by the Company following
February 2, 2017, in connection with development and regulatory
activities necessary to file a New Drug Application
(“NDA”) for Vyleesi for HSDD in the United
States.
The
Company determined there was no stand-alone value for the license,
and that the license and the reimbursable direct out-of-pocket
expenses, pursuant to the terms of the AMAG License Agreement,
represented a combined unit of accounting which totaled
$85,000,000. The Company recognized revenue of the combined unit of
accounting over the arrangement using the input-based proportional
method as the Company completed its development obligations. For
the years ended June 30, 2020, 2019, and 2018, license and contract
revenue included additional billings for AMAG related Vyleesi costs
of $117,989, $1,151,243, and $707,342 respectively.
On June
4, 2018, the FDA accepted the Vyleesi NDA for filing. The
FDA’s acceptance triggered a $20,000,000 milestone payment to
the Company from AMAG. As a result, the Company recognized
$20,000,000 in revenue related to regulatory milestones in fiscal
2018. On June 21, 2019, the FDA granted approval of Vyleesi for use
in the United States. The FDA’s approval triggered a
$60,000,000 milestone payment to the Company from AMAG. As a
result, the Company recognized $60,000,000 in revenue related to
regulatory milestones in fiscal 2019. In addition , pursuant to the
terms and subject to the conditions in the AMAG License Agreement,
the Company was eligible to receive from AMAG certain sales
milestone payments and royalties on net sales of the products. As
of June 30, 2019, no revenue was recognized related to these
payments and royalties.
59
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
The
Company engaged Greenhill & Co. LLC (“Greenhill”)
as the Company’s sole financial advisor in connection with a
potential transaction with respect to Vyleesi. Under the
engagement agreement with Greenhill, the Company was obligated to
pay Greenhill a fee equal to 2% of all proceeds and consideration,
as defined, paid or to be paid to the Company by AMAG in connection
with the AMAG License Agreement, subject to a minimum fee of
$2,500,000. The minimum fee of $2,500,000, less a credit of $50,000
for an advisory fee previously paid by the Company, was paid to
Greenhill and recorded as an expense upon the closing of the
licensing transaction. This amount was credited toward amounts that
were to become due to Greenhill, provided that the aggregate fee
payable to Greenhill would not be less than 2% of all proceeds and
consideration, as defined, paid or to be paid to the Company by
AMAG in connection with the AMAG License Agreement. On November 21,
2019, the Company and Greenhill mutually agreed to terminate the
engagement agreement. As a result, the Company made a final payment
to Greenhill of $625,000, which was recorded in general and
administrative expenses during the year ended June 30, 2020. The
Company has no future payment obligations to
Greenhill.
Pursuant
to the AMAG License Agreement, the Company assigned to AMAG the
Company’s manufacturing and supply agreements with Catalent
Belgium S.A. to perform fill, finish and packaging of
Vyleesi.
On
January 9, 2020, AMAG announced plans to divest Vyleesi and
Intrarosa® (prasterone), both women’s healthcare
products. While AMAG indicated that it has received preliminary
expressions of interest to acquire or sublicense rights to these
products, there were no public disclosures of any potential
licensees of AMAG’s rights to Vyleesi in North America. After
FDA approval of Vyleesi in June 2019, AMAG launched Vyleesi
nationally in September 2019 through select specialty pharmacies
with its maternal and women’s health sales
force.
As disclosed in Note 17, effective July 24, 2020, the Company and AMAG
entered into an agreement to mutually terminate the AMAG License
Agreement.
(5)
AGREEMENT
WITH FOSUN:
On
September 6, 2017, the Company entered into a license agreement
with Fosun (“Fosun License Agreement”) for exclusive
rights to commercialize Vyleesi in China. Under the terms of the
agreement, the Company received $4,500,000 in October 2017, which
consisted of an upfront payment of $5,000,000 less $500,000 that
was withheld in accordance with tax withholding requirements in
China and recorded as an expense during the year ended June 30,
2018. The Company will receive a $7,500,000 milestone payment when
regulatory approval in China is obtained, provided that a
commercial supply agreement for Vyleesi has been entered into. The
Company has the potential to receive up to $92,500,000 in
additional sales related milestone payments and high single-digit
to low double-digit royalties on net sales in the licensed
territory. All development, regulatory, sales, marketing, and
commercial activities and associated costs in the licensed
territory will be the sole responsibility of Fosun.
(6)
AGREEMENT
WITH KWANGDONG:
On
November 21, 2017, the Company entered into the Kwangdong License
Agreement for exclusive rights to commercialize Vyleesi in Korea.
Under the terms of the agreement, the Company received $417,500 in
December 2017, consisting of an upfront payment of $500,000, less
$82,500, which was withheld in accordance with tax withholding
requirements in Korea and recorded as an expense during the year
ended June 30, 2018. Based upon certain refund provisions, the
upfront payment was recorded as non-current deferred revenue at
June 30, 2018. On July 1, 2018, in
conjunction with the adoption of ASC Topic 606, a one-time
transition adjustment of $500,000 was recorded to the opening
balance of accumulated deficit as the Company determined a
significant revenue reversal would not occur in a future
period. The Company will receive a $3,000,000 milestone
payment based on the first commercial sale in Korea. The Company
has the potential to receive up to $37,500,000 in additional sales
related milestone payments and mid-single-digit to low double-digit
royalties on net sales in the licensed territory. All development,
regulatory, sales, marketing, and commercial activities and
associated costs in the licensed territory will be the sole
responsibility of Kwangdong.
60
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
(7)
PREPAID
EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other
current assets consist of the following:
|
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
|
Clinical /
regulatory costs
|
$43,625
|
$61,798
|
|
Insurance
premiums
|
84,741
|
87,937
|
|
Other
|
609,850
|
487,554
|
|
|
$738,216
|
$637,289
|
(8)
FAIR
VALUE MEASUREMENTS
The
fair value of cash equivalents is classified using a hierarchy
prioritized based on inputs. Level 1 inputs are quoted prices
(unadjusted) in active markets for identical assets or liabilities.
Level 2 inputs are quoted prices for similar assets and liabilities
in active markets or inputs that are observable for the asset or
liability, either directly or indirectly through market
corroboration, for substantially the full term of the financial
instrument. Level 3 inputs are unobservable inputs based on
management’s own assumptions used to measure assets and
liabilities at fair value. A financial asset’s or
liability’s classification within the hierarchy is determined
based on the lowest level input that is significant to the fair
value measurement.
The
following table provides the assets carried at fair
value:
|
|
Carrying
Value
|
Quoted prices in
active markets (Level 1)
|
Other
quoted/observable inputs (Level 2)
|
Significant
unobservable inputs (Level 3)
|
|
June 30,
2020:
|
|
|
|
|
|
Money Market
Account
|
$82,406,697
|
$82,406,697
|
$-
|
$-
|
|
June 30,
2019:
|
|
|
|
|
|
Money Market
Account
|
$43,381,556
|
$43,831,556
|
$-
|
$-
|
(9)
LEASES
The
Company has operating leases for office and laboratory space, which
expire on June 30, 2025 and June 30, 2021, respectively. The
Company also has operating leases for copier equipment that expire
October 15, 2021 and phone equipment that expires on June 30,
2023.
61
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
The
components of lease expense are as follows:
|
Lease
cost
|
Year
ended
June
30,
2020
|
|
Operating lease
cost
|
$209,226
|
|
Variable lease
cost
|
71,297
|
|
Short-term lease
cost
|
18,120
|
|
Total lease
cost
|
$298,643
|
Supplemental
balance sheet information related to leases was as
follows:
|
|
June
30,
2020
|
|
Operating lease ROU
asset
|
$1,266,132
|
|
|
|
|
Short-term
operating lease liabilities
|
$312,784
|
|
Long-term operating
lease liabilities
|
953,348
|
|
|
$1,266,132
|
Supplemental
lease term and discount rate information related to leases was as
follows:
|
Weighted-average
remaining lease term (years)
|
4.6
|
|
Weighted-average
discount rate
|
5.51%
|
Supplemental
cash flow information related to leases was as
follows:
|
|
Year
ended
June
30,
2020
|
|
Cash paid for the
amounts included in the measurement of lease
liabilities:
|
|
|
Operating
cash flows for operating leases
|
$318,244
|
|
Supplemental
non-cash information on lease liabilities arisng from obtaining
right-of-use assets:
|
|
|
Right-of-use
assets obtained in exchange for new lease obligation
|
$1,339,556
|
62
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
The
following table summarizes the maturity of the Company’s
operating lease liability as of June 30, 2020:
|
Year Ending June
30
|
|
|
2021
|
$355,164
|
|
2022
|
277,062
|
|
2023
|
279,756
|
|
2024
|
257,316
|
|
2025
|
265,032
|
|
Less imputed
interest
|
(168,198)
|
|
Total
|
$1,266,132
|
As of
June 30, 2019, the Company had $225,120 in future lease payments
for the year ending June 30, 2020 under ASC Topic 840. For the
years ended June 30, 2019 and 2018, rent expense was $285,453 and
$292,411, respectively.
(10)
PROPERTY
AND EQUIPMENT, NET
Property
and equipment, net, consists of the following:
|
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
|
Office
equipment
|
$1,193,162
|
$1,193,162
|
|
Laboratory
equipment
|
648,673
|
585,795
|
|
Leasehold
improvements
|
751,226
|
751,226
|
|
|
2,593,061
|
2,530,183
|
|
Less: Accumulated
depreciation and amortization
|
(2,452,845)
|
(2,388,644)
|
|
|
$140,216
|
$141,539
|
63
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
(11)
ACCRUED
EXPENSES
Accrued
expenses consist of the
following:
|
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
|
Clinical /
regulatory costs
|
$1,722,729
|
$943,721
|
|
Other research
related expenses
|
586,185
|
1,361,414
|
|
Professional
services
|
217,662
|
317,500
|
|
Other
|
372,521
|
226,057
|
|
|
$2,899,097
|
$2,848,692
|
(12)
NOTES PAYABLE:
Notes
payable consist of the following:
|
|
June
30,
|
|
|
2019
|
|
Notes payable under
venture loan
|
$333,333
|
|
Unamortized related
debt discount
|
(295)
|
|
Unamortized debt
issuance costs
|
(142)
|
|
Notes
payable
|
$332,896
|
On
December 23, 2014, the Company closed on a $10,000,000 venture loan
which was led by Horizon Technology Finance Corporation
(“Horizon”). The debt facility was a four-year senior
secured term loan that bore interest at a floating coupon rate of
one-month LIBOR (floor of 0.50%) plus 8.50%, and provided for
interest-only payments for the first eighteen months followed by
monthly payments of principal of $333,333 plus accrued interest
through January 1, 2019. The lenders also received five-year
immediately exercisable Series D 2014 warrants to purchase 666,666
shares of common stock exercisable at an exercise price of $0.75
per share. The Company recorded a debt discount of $267,820 equal
to the fair value of these warrants at issuance, which was
amortized to interest expense over the term of the related debt.
This debt discount was offset against the note payable balance and
included in additional paid-in capital on the Company’s
balance sheet. In addition, a final incremental payment of $500,000
was due on January 1, 2019, or upon early repayment of the loan.
This final incremental payment was accreted to interest expense
over the term of the related debt and included in other liabilities
on the consolidated balance sheet. The Company incurred $209,367 of
costs in connection with the loan. These costs were capitalized as
deferred financing costs and were offset against the note payable
balance. These debt issuance costs were amortized to interest
expense over the term of the related debt. During the three months
ended December 31, 2018, the loan matured, and on December 31,
2018, the Company made the final incremental payment of
$500,000.
64
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
On July
2, 2015, the Company closed on a $10,000,000 venture loan led by
Horizon. The debt facility was a four-year senior secured term loan
that bore interest at a floating coupon rate of one-month LIBOR
(floor of 0.50%) plus 8.50% and provided for interest-only payments
for the first eighteen months followed by monthly payments of
principal of $333,333 plus accrued interest through August 1, 2019.
The lenders also received five-year immediately exercisable Series
G warrants to purchase 549,450 shares of the Company’s common
stock exercisable at an exercise price of $0.91 per share. The
Company recorded a debt discount of $305,196 equal to the fair
value of these warrants at issuance, which were amortized to
interest expense over the term of the related debt. This debt
discount was offset against the note payable balance and was
included in additional paid-in capital on the Company’s
balance sheet. In addition, a final incremental payment of $500,000
was due on August 1, 2019. This final incremental payment was
accreted to interest expense over the term of the related debt and
was included in other current liabilities on the consolidated
balance sheet as of June 30, 2019. The Company incurred $146,115 of
costs in connection with the loan agreement. These costs were
capitalized as deferred financing costs and were offset against the
note payable balance. These debt issuance costs were amortized to
interest expense over the term of the related debt. During the year
ended June 30, 2020, the loan matured, and on July 31, 2019, the
Company made the final incremental payment of
$500,000.
(13)
COMMITMENTS
AND CONTINGENCIES
Employment Agreements – The Company has employment
agreements with two executive officers which provide a stated
annual compensation amount, subject to annual increases, and annual
bonus compensation in an amount to be approved by the
Company’s Board of Directors. Each agreement allows the
Company or the employee to terminate the agreement in certain
circumstances. In some circumstances, early termination by the
Company may result in severance pay to the employee for a period of
18 to 24 months at the salary then in effect, continuation of
health insurance premiums over the severance period and immediate
vesting of all stock options and restricted stock units.
Termination following a change in control will result in a lump sum
payment of one and one-half to two times the salary then in effect
and immediate vesting of all stock options and restricted stock
units.
Employee Retirement Savings Plan – The Company
maintains a defined contribution 401(k) plan for the benefit of its
employees. The Company currently matches a portion of employee
contributions to the plan. For the years ended June 30, 2020, 2019,
and 2018 Company contributions were $116,807, $170,643, and
$166,962, respectively.
Contingencies – The Company accounts for litigation
losses in accordance with ASC 450-20, Loss Contingencies. Under ASC 450-20,
loss contingency provisions are recorded for probable losses when
management is able to reasonably estimate the loss. Any outcome
upon settlement that deviates from the Company’s best
estimate may result in additional expense or in a reduction in
expense in a future accounting period. The Company records legal
expenses associated with such contingencies as
incurred.
The
Company is involved, from time to time, in various claims and legal
proceedings arising in the ordinary course of its business. The
Company is not currently a party to any such claims or proceedings
that, if decided adversely to it, would either individually or in
the aggregate have a material adverse effect on its business,
financial condition or results of operations.
(14)
STOCKHOLDERS’
EQUITY (DEFICIENCY)
Series A Convertible Preferred Stock – As of June
30, 2020, 4,030 shares of Series A Convertible Preferred Stock were
outstanding. Each share of Series A Convertible Preferred Stock is
convertible at any time, at the option of the holder, into the
number of shares of common stock equal to $100 divided by the
Series A Conversion Price. As of June 30, 2020, the Series A
Conversion Price was $6.10, so each share of Series A Convertible
Preferred Stock is currently convertible into approximately 16.4
shares of common stock. The Series A Conversion Price is subject to
adjustment, under certain circumstances, upon the sale or issuance
of common stock for consideration per share less than either (i)
the Series A Conversion Price in effect on the date of such sale or
issuance, or (ii) the market price of the common stock as of the
date of such sale or issuance. The Series A Conversion Price is
also subject to adjustment upon the occurrence of a merger,
reorganization, consolidation, reclassification, stock dividend or
stock split which will result in an increase or decrease in the
number of shares of common stock outstanding. Shares of Series A
Convertible Preferred Stock have a preference in liquidation,
including certain merger transactions, of $100 per share, or
$403,000 in the aggregate as of June 30, 2020. Additionally, the
Company may not pay a dividend or make any distribution to holders
of any class of stock unless the Company first pays a special
dividend or distribution of $100 per share to holders of the Series
A Convertible Preferred Stock.
65
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Financing Transactions – On June 21, 2019 and April 20, 2018, the Company
entered into equity distribution agreements with Canaccord Genuity
LLC (“Canaccord”) (the “2019 Equity Distribution
Agreement” and the “2018 Equity Distribution
Agreement”, respectively), pursuant to which the Company may,
from time to time, sell shares of the Company’s common
stock at market prices by
methods deemed to be an “at-the-market offering” as
defined in Rule 415 promulgated under the Securities Act of 1933,
as amended. The 2018 Equity Distribution Agreement and related
prospectus was limited to sales of up to an aggregate maximum $25.0
million of shares of the Company’s common stock, and the 2019
Equity Distribution Agreement and related prospectus is limited to
sales of up to an aggregate maximum $40.0 million of shares of the
Company’s common stock. The Company pays Canaccord 3.0% of
the gross proceeds as a commission.
Proceeds raised under the 2019 Equity Distribution Agreement are as
follows:
|
|
Year Ended June
30, 2020
|
Year Ended June
30, 2019
|
Cumulative from
inception
|
|||
|
|
Shares
|
Proceeds
|
Shares
|
Proceeds
|
Shares
|
Proceeds
|
|
Gross
proceeds
|
1,895,934
|
$1,723,195
|
7,564,575
|
10,607,047
|
9,460,509
|
$12,330,242
|
|
Fees
|
-
|
(51,697)
|
-
|
(318,211)
|
-
|
(369,908)
|
|
Expenses
|
-
|
(90,000)
|
-
|
|
-
|
(90,000)
|
|
Net
proceeds
|
1,895,934
|
$1,581,498
|
7,564,575
|
$10,288,836
|
9,460,509
|
$11,870,334
|
Proceeds raised under the 2018 Equity Distribution are as
follows:
|
|
Year Ended June
30, 2019
|
Year Ended June
30, 2018
|
Cumulative from
inception
|
|||
|
|
Shares
|
Proceeds
|
Shares
|
Proceeds
|
Shares
|
Proceeds
|
|
Gross
proceeds
|
17,221,239
|
23,553,838
|
1,283,754
|
1,446,159
|
18,504,993
|
$24,999,997
|
|
Fees
|
-
|
(706,615)
|
-
|
(43,385)
|
-
|
(750,000)
|
|
Expenses
|
-
|
-
|
-
|
(145,000)
|
-
|
(145,000)
|
|
Net
proceeds
|
17,221,239
|
$22,847,223
|
1,283,754
|
$1,257,774
|
18,504,993
|
$24,104,997
|
As of June 30, 2019, the 2018 Equity Distribution agreement is
completed.
Stock Purchase Warrants – On September 13, 2019, the
Company’s Board of Directors approved a plan to offer to
purchase and terminate certain outstanding common stock purchase
warrants through privately negotiated transactions. The purchase
and termination program has no time limit and may be suspended for
periods or discontinued at any time.
66
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
During
the year ended June 30, 2020, the Company entered into several
warrant termination agreements to repurchase and cancel the
following previously issued Series F, Series H, and Series J
warrants for the following aggregate buyback prices:
|
|
Year Ended June
30, 2020
|
|
|
|
Warrants
|
Buyback
price
|
|
Series F
Warrants
|
297,352
|
$62,712
|
|
Series H
Warrants
|
1,466,432
|
577,373
|
|
Series J
Warrants
|
4,774,889
|
1,907,381
|
|
|
6,538,673
|
$2,547,466
|
During
the year ended June 30, 2020, the Company issued 26,861 shares of
common stock upon the cashless exercise provisions of 666,666
Series D warrants at an exercise price of $0.75 per
share.
As of
June 30, 2020, the Company had outstanding warrants exercisable for
shares of common stock as follows:
|
|
Shares of
Common
|
Exercise Price
per
|
Latest
Termination
|
|
Descripton
|
Stock
|
Share
|
Date
|
|
Series F
warrants*
|
1,894,429
|
$0.91
|
July 2,
2020**
|
|
Series G
warrants
|
549,450
|
0.91
|
July 2,
2020**
|
|
Series H warrants
*
|
7,974,881
|
0.70
|
August 4,
2021
|
|
Financial services
warrants
|
25,000
|
0.70
|
August 4,
2021
|
|
Series J
warrants*
|
4,639,614
|
0.80
|
December 6,
2021
|
|
|
15,083,374
|
|
|
*
Subject to a limitation on their exercise if the holder and its
affiliates would beneficially own 9.99% of the total number of the
Company's shares of common stock following such
exercise.
**
Expired unexercised on July 2, 2020.
During
the year ended June 30, 2019, the Company received $225,600 and
issued 282,000 shares of common stock pursuant to the exercise of
warrants at an exercise price of $0.80 per share. The Company also
received $583,334 and issued 833,333 shares of common stock
pursuant to the exercise of warrants at an exercise price of $0.70
per share.
67
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
During
the year ended June 30, 2018, the Company received $2,396,646 and
$114,383, respectively, and issued 2,995,807 shares of common stock
pursuant to the exercise of warrants at an exercise price of $0.80
per share and issued 11,438,356 shares of common stock pursuant to
the exercise of warrants at an exercise price of $0.01 per share.
The Company also issued 23,344,451 shares of common stock pursuant
to the cashless exercise provisions of warrants at an exercise
price of $0.01 per share. As of June 30, 2018, there were no
warrants outstanding at an exercise price of $0.01 per
share.
Stock Plan – The Company’s 2011 Stock Incentive
Plan was approved by the Company’s stockholders at the annual
meeting of stockholders held in May 2011 and amended at the annual
meeting of stockholders held on June 8, 2017, June 26, 2018, and
again at the annual meeting of stockholders held on June 25, 2020.
The 2011 Stock Incentive Plan, as amended, provides for incentive
and nonqualified stock option grants, restricted stock unit awards
and other stock-based awards to employees, non-employee directors
and consultants for up to 42,500,000 shares of common stock. The
2011 Stock Incentive Plan is administered under the direction of
the Board of Directors, which may specify grant terms and
recipients. Options granted by the Company generally expire ten
years from the date of grant and generally vest over three to four
years. The Company’s former 2005 Stock Plan was terminated
and replaced by the 2011 Stock Incentive Plan, and shares of common
stock that were available for grant under the 2005 Stock Plan
became available for grant under the 2011 Stock Incentive Plan. No
new awards can be granted under the 2005 Stock Plan, but awards
granted under the 2005 Stock Plan remain outstanding in accordance
with their terms. As of June 30, 2020, 5,552,149 shares were
available for grant under the 2011 Stock Incentive
Plan.
The
Company has outstanding options that were granted under the 2005
Stock Plan. The Company expects to settle option exercises under
any of its plans with authorized but currently unissued
shares.
68
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
The
following table summarizes option activity and related information
for the years ended June 30, 2020, 2019, and 2018:
|
|
Number of
Shares
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining Term in Years
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
Outstanding - June
30, 2017
|
8,927,132
|
$0.76
|
7.5
|
-
|
|
|
|
|
|
|
|
Granted
|
4,182,550
|
0.90
|
|
|
|
Forfeited
|
(39,500)
|
1.70
|
|
|
|
Exercised
|
(208,900)
|
0.77
|
|
|
|
Expired
|
(85,820)
|
6.95
|
|
|
|
|
|
|
|
|
|
Outstanding - June
30, 2018
|
12,775,462
|
0.76
|
7.7
|
|
|
|
|
|
|
|
|
Granted
|
2,340,200
|
1.34
|
|
|
|
Forfeited
|
(280,362)
|
0.62
|
|
|
|
Exercised
|
(270,500)
|
0.64
|
|
|
|
Expired
|
(129,150)
|
1.77
|
|
|
|
Outstanding - June
30, 2019
|
14,435,650
|
0.85
|
7.3
|
|
|
|
|
|
|
|
|
Granted
|
5,779,850
|
0.58
|
|
|
|
Forfeited
|
(235,950)
|
0.86
|
|
|
|
Exercised
|
-
|
-
|
|
|
|
Expired
|
(77,100)
|
2.72
|
|
|
|
|
|
|
|
|
|
Outstanding - June
30, 2020
|
19,902,450
|
$0.76
|
7.4
|
$380,514
|
|
|
|
|
|
|
|
Exercisable at June
30, 2020
|
10,366,100
|
$0.79
|
5.8
|
$299,137
|
|
|
|
|
|
|
|
Expected to vest at
June 30, 2020
|
9,536,350
|
$0.74
|
9.2
|
$81,377
|
Stock
options granted to the Company’s executive officers and
employees generally vest over a 48-month period, while stock
options granted to its non-employee directors vest over a 12-month
period.
69
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Included
in the options outstanding above are 1,075,000 and 117,500
performance-based options granted in December 2017 to executive
officers and employees, respectively, which vest during a
performance period ending on December 31, 2020, if and upon either
i) as to 100% of the target number of shares upon achievement of a
closing price for the Company’s common stock equal to or
greater than $1.50 per share for 20 consecutive trading days, which
is considered a market condition; or ii) as to thirty percent (30%)
of the target number of shares, upon the acceptance for filing by
the FDA of an NDA for Vyleesi for HSDD in premenopausal women
during the performance period, which is considered a performance
condition; iii) as to fifty percent (50%) of the target number of
shares, upon the approval by the FDA of an NDA for Vyleesi for HSDD
in premenopausal women during the performance period, which is also
considered a performance condition; iv) as to twenty percent (20%)
of the target number of shares, upon entry into a licensing
agreement during the performance period for the commercialization
of Vyleesi for FSD in at least two of the following geographic
areas (a) four or more countries in Europe, (b) Japan, (c) two or
more countries in Central and/or South America, (d) two or more
countries in Asia, excluding Japan and China, and (e) Australia,
which is also considered a performance condition. The fair value of
these options was $602,760. The Company amortized the fair value
over the derived service period of 1.1 years or upon the attainment
of the performance condition. Pursuant to the FDA acceptance of the
NDA filing of Vyleesi, 30% of the target number of options vested
in June 2018 and 50% of the target number of options vested in June
2019 upon FDA approval of Vyleesi.
For the
years ended June 30, 2020, 2019 and 2018, the fair value of option
grants was estimated at the grant date using the Black-Scholes
model or a multi-factor Monte Carlo simulation. The Company’s
weighted average assumptions for the years ended June 30, 2020,
2019, and 2018 were as follows:
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
|
|
|
|
|
Risk-free interest
rate
|
0.5%
|
1.9%
|
1.8%
|
|
Volatility
factor
|
67.1%
|
69.3%
|
52.6%
|
|
Dividend
yield
|
0%
|
0%
|
0%
|
|
Expected option
life (years)
|
6.1
|
6.1
|
6.0
|
|
Weighted average
grant date fair value
|
$0.33
|
$0.85
|
$0.58
|
Expected
volatilities are based on the Company’s historical
volatility. The expected term of options is based upon the
simplified method, which represents the average of the vesting term
and the contractual term. The risk-free interest rate is based on
U.S. Treasury yields for securities with terms approximating the
expected term of the option.
For the
years ended June 30, 2020, 2019, and 2018, the Company recorded
stock-based compensation related to stock options of $1,372,931,
$1,116,350, and $1,131,895, respectively. As of June 30, 2020,
there was $3,958,195 of unrecognized compensation cost related to
unvested options, which is expected to be recognized over a
weighted-average period of 3.1 years.
During
fiscal 2019, the terms of certain options were modified to
accelerate vesting and extend the date to exercise the options. As
a result, the Company recorded additional stock-based compensation
of $111,499.
In
connection with the cashless exercise of stock options during the
year ended June 30, 2019, the Company withheld 37,994 shares with
aggregate value of $49,771 in satisfaction of minimum tax
withholding obligations.
70
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
Restricted Stock Units – The following table
summarizes restricted stock award activity for the years ended June
30, 2020, 2019 and 2018:
|
|
Year Ended June
30,
|
||
|
|
2020
|
2019
|
2018
|
|
Outstanding at
beginning of year
|
10,327,833
|
9,323,876
|
5,209,617
|
|
Granted
|
3,397,950
|
1,517,450
|
4,914,550
|
|
Forfeited
|
(123,438)
|
(182,351)
|
(5,250)
|
|
Vested
|
(636,775)
|
(331,142)
|
(795,041)
|
|
Outstanding at end
of year
|
12,965,570
|
10,327,833
|
9,323,876
|
For the
years ended June 30, 2020, 2019 and 2018 the Company recorded
stock-based compensation related to restricted stock units of
$1,765,533, $2,143,640, and $2,386,456, respectively.
During
fiscal 2019, the terms of certain restricted stock units were
modified to accelerate vesting. As a result, the Company recorded
additional stock-based compensation of $110,589.
Included
in outstanding restricted stock units in the table above are
7,127,362 vested shares that have not been issued as of June 30,
2020 due to a provision in the restricted stock unit agreements to
delay delivery.
Time-based
restricted stock units granted to the Company’s executive
officers, employees and non-employee directors generally vest over
48 months, 48 months, and 12 months, respectively.
In June
2020, the Company granted 1,203,500 performance-based restricted
stock units to its executive officers and 113,484 performance-based
restricted stock units to other employees which vest during a
performance period ending June 24, 2024. The performance-based
restricted stock units vest on performance criteria relating to
advancement of MC1r programs, including initiation of clinical
trials and licensing of Vyleesi in additional countries or
regions.
In June
2019, the Company granted 438,000 performance-based restricted
stock units to its executive officers and 182,725 performance-based
restricted stock units to other employees which vest during a
performance period ending June 24, 2023. The performance-based
restricted stock units vest on performance criteria relating to
advancement of MC1r programs, including initiation of clinical
trials and licensing of Vyleesi in additional countries or
regions.
In
December 2017, the Company granted 1,075,000 performance-based
restricted stock units to its executive officers and 670,000
performance-based restricted stock units to other employees which
vest during a performance period, ending on December 31, 2020, if
and upon either i) as to 100% of the target number of shares upon
achievement of a closing price for the Company’s common stock
equal to or greater than $1.50 per share for 20 consecutive trading
days, which is considered a market condition; or ii) as to thirty
percent (30%) of the target number of shares, upon the acceptance
for filing by the FDA of an NDA for Vyleesi for HSDD in
premenopausal women during the performance period, which is
considered a performance condition; iii) as to fifty percent (50%)
of the target number of shares, upon the approval by the FDA of an
NDA for Vyleesi for HSDD in premenopausal women during the
performance period, which is also considered a performance
condition; iv) as to twenty percent (20%) of the target number of
shares, upon entry into a licensing agreement during the
performance period for the commercialization of Vyleesi for FSD in
at least two of the following geographic areas (a) four or more
countries in Europe, (b) Japan, (c) two or more countries in
Central and/or South America, (d) two or more countries in Asia,
excluding Japan and China, and (e) Australia, which is also
considered a performance condition. The fair value of these awards
was $913,750 and $569,500, respectively. The Company amortized the
fair value over the derived service period of 1.1 years or upon the
attainment of the performance condition. Pursuant to the FDA
acceptance of the NDA filing for Vyleesi, 30% of the target number
of shares vested in June 2018. Pursuant to the FDA approval of
Vyleesi, 50% of the target number of shares vested in June
2019.
71
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
In
connection with the vesting of restricted share units during the
years ended June 30, 2020, 2019, and 2018, the Company withheld
93,875, 67,038 and 27,465 shares, respectively, with aggregate
values of $122,868, $65,992, and $20,786 respectively, in
satisfaction of minimum tax withholding obligations.
(15)
INCOME
TAXES
For
fiscal 2020 and 2019, the Company recorded no income tax expense as
a result of, respectively, an operating loss and the utilization of
net operating losses that were subject to a full valuation
allowance.
For
fiscal 2018, the Company recorded income tax expense of $82,500,
which consisted of $500,000 that was withheld in accordance with
tax withholding requirements in China related to the Fosun License
Agreement (Note 5) and $82,500, which was withheld in accordance
with tax withholding requirements in Korea related to the Kwangdong
License Agreement (Note 6). Any potential credit to be received by
the Company on its United States tax returns is offset by the
Company’s valuation allowance. The total income tax expense
of $582,500 was offset by an income tax benefit of $500,000, which
resulted from the Tax Cuts and Jobs Act (the “2017 Tax
Act”), under which Alternative Minimum
Tax (“AMT”)
credits became refundable, and therefore a $500,000 benefit related
to the release of a valuation allowance against an AMT credit was
recorded during the quarter ended December 2017. The
Company’s June 30, 2017 tax return was filed during the
quarter ended March 31, 2018 and the Company did not incur an AMT
liability. As a result, the Company had an income tax receivable of
$500,000 from estimated fiscal 2018 AMT that can be refunded in the
future. As of June 30, 2019, based upon the filing of the
Company’s June 30, 2018 tax returns, the Company had a
current income tax receivable of $377,000 and a long-term income
tax receivable of $123,000. As of June 30, 2020, the Company has a
current income tax receivable of $500,000.
Deferred
tax assets and liabilities are determined based on the estimated
future tax effect of differences between the financial statement
and tax reporting basis of assets and liabilities, as well as for,
net operating loss carryforwards and research and development
credit carryforwards, given the provisions of existing tax
laws.
As of
June 30, 2020, the Company had state net operating loss
carryforwards of approximately $100,000,000, which will expire, if
not utilized, between 2034 and 2040, federal net operating loss
carryforwards of approximately $82,400,000 and federal research and
development credits of approximately $6,400,000, which expire, if
not utilized, between 2035 and 2040, and foreign tax credits of
$582,500, which expire, if not utilized, in 2028.
In
assessing the realizability of deferred tax assets, the Company
considers whether it is more likely than not that some portion or
all of the deferred tax assets will not be realized. The ultimate
realization of deferred tax assets is dependent upon the generation
of future taxable income and the application of loss limitation
provisions related to ownership changes. The Company assesses the
available positive and negative evidence to estimate if sufficient
future taxable income will be generated to use the existing
deferred tax assets. The Company also considers the scheduled
reversal of deferred tax liabilities (including the impact of
available carryback and carryforward periods), projected future
taxable income, and tax-planning strategies in making this
assessment. Based on a history of losses incurred, the Company has
recognized a full valuation allowance against its net deferred tax
assets during the years ended June 30, 2020, 2019, and
2018.
A
sustained period of profitability in the Company’s operations
is required before it would change its judgment regarding the need
for a full valuation allowance against its net deferred tax assets.
Accordingly, although the Company was profitable in fiscal 2018 and
fiscal 2019 based in part on revenue recorded upon the achievement
of certain regulatory milestones, the Company continues to record a
full valuation allowance against the net deferred tax
assets.
Improvement
in the Company’s operating results, however, could lead to a
reversal of all or some portion of the valuation allowance. Until
such time, the use of net operating loss carryforwards and tax
credits to offset profits, if any, will reduce the overall level of
deferred tax assets subject to valuation allowance.
The Tax
Reform Act of 1986 (the “Act”) provides for limitation
on the use of the Company’s net operating loss and research
and development tax credit carryforwards following certain
ownership changes (as defined by the Act) that could limit the
Company’s ability to utilize these carryforwards. Since its
inception, the Company has completed several financings and sales
of common stock which has resulted in multiple ownership changes
defined by Section 382 of the Act. Accordingly, the Company’s
ability to utilize the aforementioned carryforwards are subject to
limitation under Section 382.
72
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
If the
Company undergoes a future ownership change or as it completes its
Section 382 limitation assessments, any unutilized carryforwards
that were not previously subject to a Section 382 limitation may
become subject to limitation which may result in a significant
limitation and loss of net operating loss carryforwards and
research and development credits.
Additionally,
U.S. tax laws limit the time during which these carryforwards may
be applied against future taxes; therefore, the Company may not be
able to take full advantage of these carryforwards for federal
income tax purposes. Accordingly, a portion of the carryforwards
may expire unutilized.
The
Company’s net deferred tax assets are as
follows:
|
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
|
Net operating loss
carryforwards
|
$24,321,000
|
$18,724,000
|
|
Research and
development and AMT tax credits
|
6,443,000
|
6,207,000
|
|
Foreign tax
credits
|
583,000
|
583,000
|
|
Basis differences
in fixed assets and other
|
1,076,000
|
1,072,000
|
|
|
32,423,000
|
26,586,000
|
|
Valuation
allowance
|
(32,423,000)
|
(26,586,000)
|
|
Net deferred tax
assets
|
$-
|
$-
|
The
Company recognizes interest expense and penalties on uncertain
income tax positions as a component of interest expense. No
interest expense or penalties were recorded for uncertain income
tax matters in fiscal 2020, 2019 or 2018. As of June 30, 2020 and
2019, the Company had no liabilities for uncertain income tax
matters.
73
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
(16)
CONSOLIDATED
QUARTERLY FINANCIAL DATA - UNAUDITED
The
following tables provide quarterly data for the years ended June
30, 2020 and 2019.
|
|
Three Months Ended
|
|||
|
|
June
30,
|
March
31,
|
December
31,
|
September
30,
|
|
|
2020
|
2020
|
2019
|
2019
|
|
|
(amounts in
thousands, except per share data)
|
|||
|
Revenues
|
$-
|
$-
|
$21
|
$97
|
|
Operating
expenses
|
7,390
|
5,713
|
5,662
|
4,960
|
|
Other income,
net
|
91
|
331
|
397
|
362
|
|
Loss before income
taxes
|
(7,299)
|
(5,382)
|
(5,244)
|
(4,501)
|
|
Income
taxes
|
-
|
-
|
-
|
-
|
|
Net
loss
|
$(7,299)
|
$(5,382)
|
$(5,244)
|
$(4,501)
|
|
Basic net loss per
common share*
|
$(0.03)
|
$(0.02)
|
$(0.02)
|
$(0.02)
|
|
Diluted net loss
per common share*
|
$(0.03)
|
$(0.02)
|
$(0.02)
|
$(0.02)
|
|
Weighted average
number of
|
|
|
|
|
|
common shares
outstanding
|
|
|
|
|
|
used in computing
basic net
|
|
|
|
|
|
loss per common
share
|
235,394,831
|
235,322,087
|
234,923,592
|
233,113,241
|
|
Weighted average
number of
|
|
|
|
|
|
common shares
outstanding
|
|
|
|
|
|
used in computing
diluted net
|
|
|
|
|
|
income loss per
common share
|
235,394,831
|
235,322,087
|
234,923,592
|
233,113,241
|
* Sum
of quarters does not equal annual total due to
rounding.
|
|
Three Months Ended
|
|||
|
|
June
30,
|
March
31,
|
December
31,
|
September
30,
|
|
|
2019
|
2019
|
2018
|
2018
|
|
|
(amounts in
thousands, except per share data)
|
|||
|
Revenues
|
$60,265
|
$-
|
$-
|
$35
|
|
Operating
expenses
|
8,080
|
5,763
|
5,050
|
5,663
|
|
Other
income(expense), net
|
39
|
36
|
8
|
(54)
|
|
Income (loss)
before income taxes
|
52,224
|
(5,727)
|
(5,042)
|
(5,682)
|
|
Income
taxes
|
-
|
-
|
-
|
-
|
|
Net income
(loss)
|
$52,224
|
$(5,727)
|
$(5,042)
|
$(5,682)
|
|
Basic net income
(loss) per common share
|
$0.25
|
$(0.03)
|
$(0.02)
|
$(0.03)
|
|
Diluted net income
(loss) per common share
|
$0.23
|
$(0.03)
|
$(0.02)
|
$(0.03)
|
|
Weighted average
number of
|
|
|
|
|
|
common shares
outstanding
|
|
|
|
|
|
used in computing
basic net
|
|
|
|
|
|
income (loss) per
common share
|
212,253,194
|
207,016,304
|
206,487,984
|
205,009,278
|
|
Weighted average
number of
|
|
|
|
|
|
common shares
outstanding
|
|
|
|
|
|
used in computing
diluted net
|
|
|
|
|
|
income (loss) per
common share
|
228,526,106
|
207,016,304
|
206,487,984
|
205,009,278
|
74
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
(17) SUBSEQUENT EVENTS
Effective July 24, 2020, the Company entered into
a termination agreement (the “Termination Agreement”)
with AMAG terminating the AMAG License Agreement. Under the terms of the Termination Agreement, the
Company has regained all North American development and
commercialization rights for Vyleesi. AMAG made a $12.0 million
payment to the Company at closing of the Termination Agreement and
will make a $4.3 million payment to the Company on March 31, 2021.
The Company will assume all Vyleesi manufacturing agreements, and
AMAG will transfer all information, data, and assets related
exclusively to Vyleesi, including, but not limited to, existing
inventory.
Under the Termination Agreement, AMAG will provide certain
transitional services to the Company for a period of time to ensure
continued patient access to Vyleesi during the transition back to
the Company. The Company will reimburse AMAG for the agreed upon
costs of the transition services.
Pursuant to the Termination Agreement, the Company will assume
Vyleesi manufacturing contracts with Catalent Belgium S.A.
(“Catalent”), a subsidiary of Catalent Pharma
Solutions, Inc., to manufacture drug product and prefilled syringes
and assemble prefilled syringes into an auto-injector device (the
“Catalent Agreement”), Ypsomed AG
(“Ypsomed”), to manufacture the auto-injector device
(the “Ypsomed Agreement”), and Lonza Ltd.
(“Lonza”), to manufacture the active pharmaceutical
ingredient peptide (the “Lonza
Agreement”).
The Company originally entered into the Catalent Agreement on June
20, 2016, and subsequently assigned the Catalent Agreement to AMAG
pursuant to the AMAG License Agreement. Upon the Company and AMAG
entering into the Termination Agreement, the Catalent Agreement was
assigned to the Company. The initial term of the Catalent Agreement
is through August 21, 2024, unless earlier terminated in accordance
with the terms of the Catalent Agreement. The Catalent Agreement
may be terminated immediately by either party if the other party
files a petition in bankruptcy, enters into an agreement with its
creditors or takes similar action, or if the other party materially
breaches any of the provisions of the Catalent Agreement and such
breach is not cured within the period outlined in the Catalent
Agreement. The Company may terminate the Catalent Agreement if
Catalent fails to supply products in accordance with the Catalent
Agreement, or if the Company provides notice and pays a termination
penalty. There are specified minimum purchase requirements under
the Catalent Agreement, and under specified circumstances,
termination fees may be payable upon termination of the Catalent
Agreement by the Company.
AMAG entered into the Lonza Agreement on June 1, 2018, and upon the
Company and AMAG entering into the Termination Agreement, the Lonza
Agreement was assigned to the Company. The term of the Lonza
Agreement is through December 31, 2022. The Lonza Agreement may be
terminated if the other party materially breaches any provisions of
the Lonza Agreement and such breach is not cured within the period
outlined in the Lonza Agreement, by the Company if the Company is
required to withdraw the defined product from the market, or by
either party, if the other party becomes insolvent, is dissolved,
files a petition in bankruptcy or takes similar action. There are
specified minimum purchase requirements under the Lonza Agreement,
and under specified circumstances, termination fees may be payable
upon termination of the Lonza Agreement by the
Company.
AMAG entered into the Ypsomed Agreement on December 20, 2018, and
upon the Company and AMAG entering into the Termination Agreement,
the Ypsomed Agreement was assigned to Company. The initial term of
the Ypsomed Agreement is through December 31, 2025, with automatic
renewal for successive one-year periods unless either party
terminates the Ypsomed Agreement by ten months’ written
notice prior to the expiration of the Ypsomed Agreement or any
automatic renewal period. The Ypsomed Agreement may be terminated
if the other party materially breaches any provisions of the
Ypsomed Agreement and such breach is not cured within the period
outlined in the Ypsomed Agreement, by the Company if the Company is
required to withdraw the defined product from the market, or by
either party, if there is a change of control of the other party or
the other party becomes insolvent, is dissolved, files a petition
in bankruptcy or takes similar action. There are specified minimum
purchase requirements under the Ypsomed Agreement, and under
specified circumstances, termination fees may be payable upon
termination of the Lonza Agreement by the Company.
75
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Notes to Consolidated Financial Statements
As part
of the Termination Agreement, the Company assumed certain supply
agreements with manufacturers and suppliers, including the Catalent
Agreement, Lonza Agreement and Ypsomed Agreement. The Company is
required to make certain payments for the manufacture and supply of
Vyleesi. The following table summarizes the contractual obligations
under the Catalent Agreement, Lonza Agreement and Ypsomed Agreement
at July 24, 2020:
|
|
Total
|
Less than 1
Year
|
1 - 3
Years
|
4 - 5
Years
|
|
Inventory purchase
commitments
|
$24,319,542
|
$5,189,542
|
$17,158,000
|
$1,972,000
|
76
Item 9. Changes in and Disagreements with
Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and
Procedures.
Our
management carried out an evaluation, with the participation of our
Chief Executive Officer and our Chief Financial Officer, of the
effectiveness of our disclosure controls and procedures (as defined
in Rules 13a-15(e) or 15d-15(e) of the Exchange Act) as of the end
of the period covered by this report. Based upon this evaluation,
our Chief Executive Officer and our Chief Financial Officer
concluded that, as of June 30, 2020, our disclosure controls and
procedures were effective.
A
control system, no matter how well designed and operated, cannot
provide absolute assurance that the objectives of the control
system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any,
within a company have been detected.
Management’s Report on Internal Control Over Financial
Reporting
Management
is responsible for establishing and maintaining adequate internal
control over financial reporting as defined in Rule 13a-15(f) or
15d-15(f) of the Exchange Act. Our internal control system was
designed to provide reasonable assurance to management and the
board of directors regarding the preparation and fair presentation
of published financial statements.
All
internal control systems, no matter how well designed, have
inherent limitations. Therefore, even those systems determined to
be effective can provide only reasonable assurance with respect to
financial statement preparation and presentation.
There
was no change in our internal control over financial reporting
during the fourth quarter of the period covered by this Annual
Report that has materially affected, or is reasonably likely to
materially affect, our internal control over financial
reporting.
Management
assessed the effectiveness of our internal control over financial
reporting as of June 30, 2020. In making this assessment, it used
the criteria set forth by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO) in Internal Control-Integrated Framework as
adopted in 2013. Based on its assessment, management
believes that, as of June 30, 2020, our internal control over
financial reporting is effective based on those
criteria.
Item 9B. Other
Information.
None.
77
PART III
Item 10. Directors, Executive Officers and
Corporate Governance.
Identification of Directors
The
following table sets forth the names, ages, positions and committee
memberships of our current directors. All directors hold office
until the next annual meeting of stockholders or until their
successors have been elected and qualified. All current directors
were elected at our annual stockholders’ meeting on June 25,
2020.
|
Name
|
|
Age
|
|
Position with Palatin
|
|
Carl
Spana, Ph.D.
|
|
58
|
|
Chief
Executive Officer, President and a Director
|
|
John
K.A. Prendergast, Ph.D. (3)
|
|
66
|
|
Director, Chairman
of the Board of Directors
|
|
Robert
K. deVeer, Jr. (1) (2)
|
|
74
|
|
Director
|
|
J.
Stanley Hull (1) (2)
|
|
68
|
|
Director
|
|
Alan W.
Dunton, M.D. (1) (2)
|
|
66
|
|
Director
|
|
Angela
Rossetti (1) (3)
|
|
67
|
|
Director
|
|
Arlene
M. Morris (2) (3)
|
|
68
|
|
Director
|
|
Anthony
M. Manning, Ph.D. (3)
|
|
58
|
|
Director
|
(1)
Member of the audit committee.
(2)
Member of the compensation committee.
(3)
Member of the nominating and corporate governance
committee.
CARL
SPANA, Ph.D., co-founder of Palatin, has been our Chief Executive
Officer and President since June 14, 2000. He has been a director
of Palatin since June 1996 and has been a director of our
wholly-owned subsidiary, RhoMed Incorporated, since July 1995. From
June 1996 through June 14, 2000, Dr. Spana served as an executive
vice president and our chief technical officer. From June 1993 to
June 1996, Dr. Spana was vice president of Paramount Capital
Investments, LLC, a biotechnology and biopharmaceutical merchant
banking firm, and of The Castle Group Ltd., a medical venture
capital firm. Through his work at Paramount Capital Investments and
The Castle Group, Dr. Spana co-founded and acquired several private
biotechnology firms. From July 1991 to June 1993, Dr. Spana was a
Research Associate at Bristol-Myers Squibb, a publicly-held
pharmaceutical company, where he was involved in scientific
research in the field of immunology. Dr. Spana received his Ph.D.
in molecular biology from The Johns Hopkins University and his B.S.
in biochemistry from Rutgers University.
Dr.
Spana’s qualifications for our board include his scientific
expertise, leadership experience, business judgment and industry
knowledge. As a senior executive of Palatin for over twenty years,
he provides in-depth knowledge of our company, our drug products
under development and the competitive and corporate partnering
landscape.
JOHN
K.A. PRENDERGAST, Ph.D., co-founder of Palatin, has served as the
non-executive Chairman of the board since June 14, 2000, and as a
director since August 1996. While Mr. Prendergast has served as a
member of the board, he does not, and has not, served in a
management or operational role with the company. Dr. Prendergast
has been president and sole stockholder of Summercloud Bay, Inc.,
an independent consulting firm providing services to the
biotechnology industry, since 1993. Dr. Prendergast is lead
director of Heat Biologics, Inc., a publicly traded clinical stage
immunotherapy company, and a director and non-executive chairman of
Recce Pharmaceuticals Ltd., a publicly traded Australian
pharmaceutical company developing antibiotic drugs. He was
previously a member of the board of the life science companies AVAX
Technologies, Inc., Avigen, Inc. and MediciNova, Inc. From October
1991 through December 1997, Dr. Prendergast was a managing director
of The Castle Group Ltd., a medical venture capital firm. Dr.
Prendergast received his M.Sc. and Ph.D. from the University of New
South Wales, Sydney, Australia and a C.S.S. in administration and
management from Harvard University.
78
Dr.
Prendergast brings a historical perspective to our board coupled
with extensive industry experience in corporate development and
finance in the life sciences field. His prior service on other
publicly traded company boards provides experience relevant to good
corporate governance practices.
ROBERT
K. deVEER, Jr. has been a director of Palatin since November 1998.
Since January 1997, Mr. deVeer has been the president of deVeer
Capital LLC, a private investment company. He was a director of
Solutia Inc., a publicly-held chemical-based materials company,
until its merger with Eastman Chemical Company in July 2012. From
1995 until his retirement in 1996, Mr. deVeer served as Managing
Director, Head of Industrial Group, at New York-based Lehman
Brothers. From 1973 to 1995, he held increasingly responsible
positions at New York-based CS First Boston, including Head of
Project Finance, Head of Industrials and Head of Natural Resources.
He was a managing director, member of the investment banking
committee and a trustee of the First Boston Foundation. He received
a B.A. in economics from Yale University and an M.B.A. in finance
from Stanford Graduate School of Business.
Mr.
deVeer has extensive experience in investment banking and corporate
finance, including the financing of life sciences companies, and
serves as the audit committee’s financial
expert.
J.
STANLEY HULL has been a director of Palatin since September 2005.
Mr. Hull has over three decades of experience in the field of
sales, marketing and drug development. Mr. Hull joined
GlaxoSmithKline, a research-based pharmaceutical company, in
October 1987 and retired as Senior Vice President, Pharmaceuticals
– North America in May 2010. Mr. Hull was responsible for all
commercial activities including sales, marketing, sales training
and office operations. Previously Mr. Hull served in the R&D
organization of Glaxo Wellcome as Vice President and Worldwide
Director of Therapeutic Development and Product Strategy –
Neurology and Psychiatry. Prior to his service in the R&D
organization he was Vice President of Marketing – Infectious
Diseases and Gastroenterology for Glaxo Wellcome-U.S. Mr. Hull
started his career in the pharmaceutical industry with SmithKline
and French Laboratories in 1978. Mr. Hull received his B.S. in
business administration from the University of North Carolina at
Greensboro.
Mr.
Hull has extensive experience in commercial operations, development
and marketing of pharmaceutical drugs and corporate alliances
between pharmaceutical companies and biotechnology
companies.
ALAN
W. DUNTON, M.D., has been a director of Palatin since June 2011. He
founded Danerius, LLC, a biotechnology consulting company, in 2006.
From November 2015 through March 2018 he was senior vice president
of research, development and regulatory affairs for Purdue Pharma
L.P., with responsibilities for overall research strategy and
development programs. From January 2007 to March 2009, Dr. Dunton
served as president and chief executive officer of Panacos
Pharmaceuticals Inc. and he served as a managing director of
Panacos from March 2009 to January 2011. Dr. Dunton is currently a
member of the board of directors of the publicly traded companies
Recce Pharmaceuticals Ltd (ASX: RCE), Regeneus Ltd (ASX: RGS),
CorMedix Inc. (NYSE: CRMD) and Oragenics, Inc. (NYSE: OGEN). He
previously served on the board of directors of the publicly traded
companies Targacept, Inc., EpiCept Corporation (as Non-Executive
Chairman), Adams Respiratory Therapeutics, Inc. (acquired by
Reckitt Benckiser Group plc), MediciNova, Inc. and Panacos
Pharmaceuticals, Inc. Dr. Dunton has served as a director or
executive officer of various pharmaceutical companies, and from
1994 to 2001, Dr. Dunton was a senior executive in various
capacities in the Pharmaceuticals Group of Johnson & Johnson,
including president and managing director of the Janssen Research
Foundation, the primary global R&D organization for Johnson
& Johnson. Dr. Dunton received his M.D. degree from New York
University School of Medicine, where he completed his residency in
internal medicine. He also was a Fellow in Clinical Pharmacology at
the New York Hospital/Cornell University Medical
Center.
Dr.
Dunton has extensive drug development, regulatory and clinical
research experience, having played a key role in the development of
more than 20 products to regulatory approval, and also has
extensive experience as an executive and officer for both large
pharmaceutical companies and smaller biotechnology and
biopharmaceutical companies.
ANGELA
ROSSETTI has been a director of Palatin since June 2013. Ms.
Rossetti consults with pharmaceutical companies, including
consultation on rare disease indications and pharmaceutical
utilization in low- and middle-income markets. From June 2015
through July 2017, she served as Executive Vice President of Cell
Machines, Inc., an early stage biopharmaceutical company developing
novel protein therapies. Previously, Ms. Rossetti served in
pharmaceutical marketing, communications and financial roles,
including as Vice President at Pfizer Inc., where she led a global
commercial medicine team for smoking cessation, and as an Assistant
Vice President at Wyeth, managing a global hemophilia business.
Previously, she was President of Ogilvy Healthworld, an advertising
business in the pharmaceutical and biotechnology sectors, and
served on the Biotech and Pharmaceutical Advisory Board of Danske
Capital for six years. Ms. Rossetti graduated from a joint program
of the Albert Einstein College of Medicine and Benjamin N. Cardozo
School of Law with an M.S.in Bioethics in 2014, has an M.B.A. in
Finance from Columbia University Graduate School of Business and a
B.A. in Biology from the University of Pennsylvania, and is an
adjunct Assistant Professor at New York Medical
College.
79
Ms.
Rossetti has extensive experience in worldwide development and
marketing of specialty pharmaceuticals, including prefilled syringe
products, in communications and development of commercialization
plans and in pharmaceutical and biotechnology finance.
ARLENE
M. MORRIS has been a director of Palatin since June 2015. Since May
2015 she has served as the chief executive officer of Willow
Advisors, LLC. From April 2012 until May 2015 she was President and
Chief Executive Officer of Syndax Pharmaceuticals, Inc., a
privately held biopharmaceutical company focused on the development
and commercialization of an epigenetic therapy for
treatment-resistant cancers, and was a member of the board of
directors from May 2011 until May 2015. From 2003 to January 2011,
Ms. Morris served as the President, Chief Executive Officer and a
member of the board of directors of Affymax, Inc., a publicly
traded biotechnology company. Ms. Morris has also held various
management and executive positions at Clearview Projects, Inc., a
corporate advisory firm, Coulter Pharmaceutical, Inc., a publicly
traded pharmaceutical company, Scios Inc., a publicly traded
biopharmaceutical company, and Johnson & Johnson, a publicly
traded healthcare company. She is currently a member of the board
of directors of Viveve Medical, Inc., a publicly traded female
healthcare medical device company, miRagen Therapeutics, Inc., a
publicly traded microRNA therapeutics company, and Unum
Therapeutics Inc., a publicly traded solid tumor cancer therapy
company, and was a director of Neovacs SA, a publicly traded French
company, Biodel Inc., a publicly traded specialty pharmaceutical
company, from 2015 until its merger with Albireo Limited in 2016,
and Dimension Therapeutics, Inc., a publicly traded gene therapy
company, until its acquisition by Ultragenyx Pharmaceutical Inc. in
2017. Ms. Morris received a B.A. in Biology and Chemistry from
Carlow College.
Ms.
Morris has extensive experience in the biotechnology industry,
including prior leadership positions, senior management and board
service, and experience as chief executive officer of companies
with product candidates in phase 3 clinical trials.
ANTHONY
M. MANNING, Ph.D., has been a director of Palatin since September
2017. Since 2013, Dr. Manning has been senior vice president of
research, and since 2018 chief scientific officer, at Momenta
Pharmaceuticals, Inc., a publicly traded biopharmaceutical company
developing innovative therapeutics for rare immune-related
diseases. From 2011 to 2013, he was senior vice president of
research and development at Aileron Therapeutics, Inc., a publicly
traded biopharmaceutical company developing stapled peptide
therapeutics for cancers and other diseases. From 2007 to 2011, he
was vice president and head of inflammation and autoimmune diseases
research at Biogen, Inc., a publicly traded biopharmaceutical
company developing medicines for neurological and neurodegenerative
conditions. From 2002 to 2007, he was vice president and global
therapy area head for Inflammation, Autoimmunity and
Transplantation Research at Roche Pharmaceuticals, the
pharmaceutical division of Roche Holding AG, and from 2000 to 2002
he was vice president of Pharmacia, a global pharmaceutical company
acquired by Pfizer in 2002. Dr. Manning received his Ph.D., M.Sc.
and B.Sc. from the University of Otago, Dunedin, New
Zealand.
Dr.
Manning has extensive experience in translational research and
development of new pharmaceutical products, and in pharmaceutical
and biotechnology research, development and business
strategy.
The Board and Its Committees
Committees and meetings. The board has an audit committee, a
compensation committee and a nominating and corporate governance
committee. During fiscal 2020, the board met six times, the audit
committee met four times, the compensation committee met two times
and the nominating and corporate governance committee met two
times. Each director attended at least 75% of the total number of
meetings of the board and committees of the board on which he
served. The independent directors meet in executive sessions at
least annually, following the annual board meeting. We do not have
a policy requiring our directors to attend stockholder meetings.
With the exception of Drs. Prendergast and Spana, the directors did
not attend the annual meeting of stockholders held on June 25,
2020.
Audit committee. The audit committee reviews the engagement
of the independent registered public accounting firm and reviews
the independence of the independent registered public accounting
firm. The audit committee also reviews the audit and non-audit fees
of the independent registered public accounting firm and the
adequacy of our internal control procedures. The audit committee is
currently composed of four independent directors, Mr. deVeer
(chair), and Dr. Dunton, Ms. Rossetti and Mr. Hull. The board has
determined that the members of the audit committee are independent,
as defined in the listing standards of the NYSE American, and
satisfy the requirements of the NYSE American as to financial
literacy and expertise. The board has determined that at least one
member of the committee, Mr. deVeer, is the audit committee
financial expert as defined by Item 407 of Regulation S-K. The
responsibilities of the audit committee are set forth in a written
charter adopted by the board and updated as of October 1, 2013, a
copy of which is available on our web site at
www.palatin.com.
80
Compensation committee. The compensation committee reviews
and recommends to the board on an annual basis employment
agreements and compensation for our officers, directors and some
employees, and administers our 2011 Plan and the options still
outstanding which were granted under previous stock option plans.
The compensation committee is composed of Dr. Dunton (chair), Ms.
Morris and Messrs. deVeer and Hull. The board has determined that
the members of the compensation committee are independent, as
defined in the listing standards of the NYSE American. Our Chief
Executive Officer aids the compensation committee by providing
annual recommendations regarding the compensation of all executive
officers, other than himself. Our Chief Financial Officer supports
the committee in its work by gathering, analyzing and presenting
data on our compensation arrangements and compensation in the
marketplace.
The
responsibilities of the compensation committee are set forth in a
written charter adopted by the board effective October 1, 2013, a
copy of which is available on our web site at www.palatin.com. The
committee administers our 2011 Plan, under which it has delegated
to an officer its authority to grant stock options to employees and
to a single-member committee of the board its authority to grant
restricted stock units to officers and to grant options and
restricted stock units to our consultants, but in either instance
not to grant options or restricted stock units to themselves, any
member of the board or officer, or any person subject to Section 16
of the Exchange Act.
Nominating and corporate governance committee. The
nominating and corporate governance committee assists the board in
recommending nominees for directors, and in determining the
composition of committees. It also reviews, assesses and makes
recommendations to the board concerning policies and guidelines for
corporate governance, including relationships of the board, the
stockholders and management in determining our direction and
performance. The responsibilities of the nominating and corporate
governance committee are set forth in a written charter adopted by
the board and updated as of October 1, 2013, a copy of which is
available on our web site at www.palatin.com. The nominating and
corporate governance committee is composed of Dr. Prendergast
(chair), Mss. Rossetti and Morris and Dr. Manning, each of whom
meets the independence requirements established by the NYSE
American.
Duration of Office. Unless a director resigns, all directors
hold office until the next annual meeting of stockholders or until
their successors have been elected and qualified. Directors serve
as members of committees as the board determines from time to
time.
Communicating With Directors
Generally,
stockholders or other interested parties who have questions or
concerns should contact Stephen T. Wills, Secretary, Palatin
Technologies, Inc., 4B Cedar Brook Drive, Cranbury, NJ 08512.
However, any stockholder or other interest party who wishes to
address questions regarding our business directly to the board of
directors, or any individual director, including the Chairman or
non-management directors as a group, can direct questions to the
board members or a director by regular mail to the Secretary at the
address above or by e-mail at boardofdirectors@palatin.com.
Stockholders or other interested parties may also submit their
concerns anonymously or confidentially by postal mail.
Communications
are distributed to the board, or to any individual directors as
appropriate, depending on the facts and circumstances outlined in
the communication, unless the Secretary determines that the
communication is unrelated to the duties and responsibilities of
the board, such as product inquiries, resumes, advertisements or
other promotional material. Communications that are unduly hostile,
threatening, illegal or similarly unsuitable will also not be
distributed to the board or any director. All communications
excluded from distribution will be retained and made available to
any non-management director upon request.
Board Role in Risk Oversight
Our
board, as part of its overall responsibility to oversee the
management of our business, considers risks generally when
reviewing our strategic plan, financial results, business
development activities, legal and regulatory matters. The board
satisfies this responsibility through regular reports directly from
our officers responsible for oversight of particular risks. The
board’s risk management oversight also includes full and open
communications with management to review the adequacy and
functionality of the risk management processes used by management.
The board’s role in risk oversight has no effect on the
board’s leadership structure. In addition, committees of the
board assist in its risk oversight responsibility,
including:
81
●
The audit committee
assists the board in its oversight of the integrity of the
financial reporting and our compliance with applicable legal and
regulatory requirements. It also oversees our internal controls and
compliance activities and meets privately with representatives from
our independent registered public accounting firm.
●
The compensation
committee assists the board in its oversight of risk relating to
compensation policies and practices. The compensation committee
annually reviews our compensation policies, programs and
procedures, including the incentives they create and mitigating
factors that may reduce the likelihood of excessive risk taking, to
determine whether they present a significant risk to our
company.
Board Leadership Structure
Since
2000, the roles of chairman of the board and chief executive
officer have been held by separate persons. John K.A. Prendergast,
Ph.D., a non-employee director, has served as Chairman of the board
since June 2000. Carl Spana, Ph.D., has been our Chief Executive
Officer and President since June 2000. Generally, the chairman is
responsible for advising the chief executive officer, assisting in
long-term strategic planning, and presiding over meetings of the
board, and the chief executive officer, together with our chief
financial officer and chief operating officer, is responsible for
leading our day-to-day performance and operations. While we do not
have a written policy with respect to separation of the roles of
chairman of the board and chief executive officer, the board
believes that the existing leadership structure, with the
separation of these roles, provides several important advantages,
including: enhancing the accountability of the chief executive
officer to the board; strengthening the board’s independence
from management; assisting the board in reaching consensus on
particular strategies and policies; and facilitating robust
director, board, and executive officer evaluation
processes.
Code of Corporate Conduct and Ethics
We have
adopted a code of corporate conduct and ethics, updated as of March
11, 2016, that applies to all of our directors, officers and
employees, including our Chief Executive Officer and Chief
Financial Officer. You can view the code of corporate conduct and
ethics at our website, www.palatin.com. We will disclose any
amendments to, or waivers from, provisions of the code of corporate
conduct and ethics that apply to our directors, principal executive
and financial officers in a current report on Form 8-K, unless the
rules of the NYSE American permit website posting of any such
amendments or waivers.
Executive Officers
Executive
officers are appointed by the board and serve at the discretion of
the board. Each officer holds his position until his successor is
appointed and qualified. The current executive officers hold office
under employment agreements.
|
Name
|
|
Age
|
|
Position with
Palatin
|
|
Carl
Spana, Ph.D.
|
|
58
|
|
Chief
Executive Officer, President and Director
|
|
Stephen
T. Wills, MST, CPA
|
|
63
|
|
Chief
Financial Officer, Chief Operating Officer, Executive Vice
President, Secretary and Treasurer
|
Additional
information about Dr. Spana is included above under the heading
“Identification of Directors.”
STEPHEN
T. WILLS, CPA, MST, currently serves as the Chief Financial Officer
(since 1997), Chief Operating Officer (since 2011), Treasurer and
Secretary of Palatin. Mr. Wills has served on the board of
directors of MediWound Ltd. (Nasdaq: MDWD), a biopharmaceutical
company focused on treatment in the fields of severe burns, chronic
and other hard to heal wounds, since April 2017, and as Chairman
since January 2018, and also has served on the board of directors
of Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune
therapeutics company, since March 2019 (audit and finance committee
member), and of Amryt Pharma, a biopharmaceutical company focused
on developing and delivering treatments to help improve the lives
of patients with rare and orphan diseases, since September 2019
(chairman of audit committee and member of the finance committee).
Mr. Wills also serves on the board of trustees and executive
committee of The Hun School of Princeton, a college preparatory day
and boarding school, since 2013, and as its Chairman since June
2018. Mr. Wills served on the board of directors of Caliper
Corporation, a psychological assessment and talent development
company, since March 2016, and as Chairman from December 2016 to
December 2019, when Caliper was acquired by PSI. Mr. Wills served
as Executive Chairman and Interim Principal Executive Officer of
Derma Sciences, Inc., a provider of advanced wound care products,
from December 2015 to February 2017, when Derma Sciences was
acquired by Integra Lifesciences (Nasdaq: IART). Previously, Mr.
Wills served on the board of directors of Derma Sciences as the
lead director and chairman of the audit committee from June 2000 to
December 2015. Mr. Wills served as the Chief Financial Officer of
Derma Sciences from 1997 to 2000. Mr. Wills served as the President
and Chief Operating Officer of Wills, Owens & Baker, P.C., a
public accounting firm, from 1991 to 2000. Mr. Wills, a certified
public accountant, earned his Bachelor of Science in accounting
from West Chester University, and a Master of Science in taxation
from Temple University.
82
Section 16(A) Beneficial Ownership Reporting
Compliance
The
rules of the SEC require us to disclose failures to file or late
filings of reports of stock ownership and changes in stock
ownership required to be filed by our directors, officers and
holders of more than 10% of our common stock. To the best of our
knowledge, all of the filings for our directors, officers and
holders of more than 10% of our common stock were made on a timely
basis in fiscal 2020.
Item 11. Executive
Compensation.
Fiscal 2020 Summary Compensation Table
The
following table summarizes the compensation earned by or paid to
our principal executive officer and our principal financial
officer, who constitute all of our executive officers, for fiscal
2020 and fiscal 2019. We have no defined benefit or actuarial
pension plan, and no deferred compensation plan.
|
Name and Principal Position
|
Fiscal
Year
|
Salary
($)
|
Stock
awards (1) ($)
|
Option
awards (1) ($)
|
Nonequity incentive plan compensation (2) ($)
|
All
other
compensation
(3) ($)
|
Total
($)
|
|
Carl Spana,
Ph.D.,
|
2020
|
600,000
|
712,443
|
712,559
|
252,000
|
15,615
|
2,292,617
|
|
Chief
Executive Officer and President
|
2019
|
505,400
|
616,668
|
632,225
|
506,000
|
14,118
|
2,274,411
|
|
Stephen T. Wills, MST, CPA, Chief
Financial Officer,
|
2020
|
550,000
|
613,814
|
613,805
|
231,000
|
16,207
|
2,024,826
|
|
Chief
Operating Officer and Executive Vice President
|
2019
|
461,700
|
527,826
|
542,151
|
462,000
|
14,085
|
2,007,762
|
(1)
Amounts in these
columns represent the aggregate grant date fair value for stock
awards and option awards computed using either the Black-Scholes
model or a multifactor Monte Carlo simulation. The aggregate grant
date fair value of the performance-based stock options and
performance-based restricted stock units granted in fiscal 2020,
assuming that the highest level of performance would be achieved,
was as follows: for Dr. Spana, $337,500 for performance-based stock
options and $337,500 for performance-based restricted stock units;
and for Mr. Wills, $290,750 for performance-based stock options and
$290,750 for performance-based restricted stock units. The
aggregate grant date fair value of the performance-based restricted
stock units granted in fiscal 2019, assuming that the highest level
of performance would be achieved, was $300,428 for Dr. Spana and
$257,146 for Mr. Wills. There were no performance-based stock
options granted in fiscal 2019. For a description of the
assumptions we used to calculate these amounts, see Note 14 to the
consolidated financial statements included in this Annual
Report.
(2)
Annual incentive
amounts.
(3)
Consists of
matching contributions to 401(k) plan.
Base Salary
The
salary for each named executive officer is based, among other
factors, upon job responsibilities, level of experience, individual
performance, comparisons to the salaries of executives in similar
positions obtained from market surveys, and internal comparisons.
The compensation committee considers changes in the base salaries
of our named executive officers annually. In fiscal 2020, the
compensation committee approved increases in base salaries to
$600,000 for Dr. Spana and $550,000 for Mr. Wills in connection
with entering into new employment agreements with each
officer.
83
Annual Incentive Program
We
provide annual incentive opportunities to our named executive
officers to promote the achievement of annual performance
objectives. Each year, the compensation committee establishes the
target annual incentive opportunity for each named executive
officer, which is based on a percentage of his base salary. For
fiscal 2020, the target annual incentive opportunity for each named
executive officer equaled 60% of his annual base salary, up from
50% of base salary for fiscal 2019.
The
2020 annual incentive bonus for the named executive officers was
determined based on corporate performance and individual
achievements and performance, as warranted. In determining the
annual incentive bonus opportunity for executives, the
executive’s annual base salary is multiplied by the target
bonus percentage. The resulting amount is then multiplied by the
corporate performance percentage approved by the compensation
committee, which is dependent on the achievement of corporate
performance goals, and also potentially adjusted upwards or
downwards for individual executives based on their individual
contribution toward the corporate results during the relevant year.
The corporate objectives are established so that target attainment
is not assured. Instead, our executives are required to demonstrate
significant effort, dedication, and achievement to attain payment
for performance at target or above.
The
following table briefly describes each category of corporate
objectives, the relative weighting of each objective, and the
related achievement level:
|
Corporate Objectives Related to:
|
Weight
|
Achievement Level
|
Discretionary Adjustments*
|
Total Weighted Achievement
|
|
Vyleesi
(bremelanotide) FSD Program
|
20%
|
0%
|
0%
|
0%
|
|
Anti-Inflammatory
Programs
|
15%
|
0%
|
0%
|
0%
|
|
Ocular
Programs
|
45%
|
77%
|
15%
|
40%
|
|
Other
Corporate
|
20%
|
100%
|
50%
|
30%
|
|
Total
Payout
|
70%
|
|||
*Discretionary
adjustments for ocular programs were primarily related to program
advances for PL9643 for dry eye disease, including management of
clinical trial enrollment during the COVID-19 pandemic;
discretionary adjustments for other corporate were primarily
related to management of AMAG’s announced divestiture of
Vyleesi and management of corporate operations in the light of the
COVID-19 pandemic.
For
fiscal 2020, the compensation committee determined that our named
executive officers achieved 70% of their target objectives. As a
result, each named executive officer received a payout under the
2020 annual incentive program equal to 70% of his target annual
incentive opportunity, or $252,000 for Dr. Spana and $231,000 for
Mr. Wills (subject to rounding conventions).
Long-Term Incentive Program
The
total direct compensation levels for our named executive officers
are heavily weighted to long-term incentive opportunities. This
structure is intended to align executives’ interests with
those of our stockholders, enhance our retention incentives and
focus our executives on delivering sustainable performance over the
longer-term.
The
design of this program has evolved over the past several years to
reflect core performance metrics and an incentive structure the
compensation committee believes is necessary to drive our long-term
success and that reflects feedback received from investors during
our stockholder engagement process.
Each
year, the compensation committee establishes the target long-term
incentive opportunity for each named executive officer, which is
based on a percentage of his base salary. For fiscal 2020, the
target long-term incentive opportunity for each named executive
officer equaled 250% of base salary for Dr. Spana and 235% of base
salary for Mr. Wills.
On June
24, 2019, as part of our 2020 long-term incentive program, we
granted 236,000 time-based restricted stock units and 236,000
performance-based restricted stock units to Dr. Spana, and 202,000
time-based restricted stock units and 202,000 performance-based
restricted stock units to Mr. Wills. The time-based restricted
stock units vest as to 25% of the number of shares granted at each
anniversary of the date of grant. The performance-based restricted
stock units vest on performance criteria relating to advancement of
MC1r programs, including initiation of clinical trials and
licensing of Vyleesi in additional countries or
regions.
84
On June
24, 2019, we also granted 744,000 stock options to Dr. Spana and
638,000 stock options to Mr. Wills, which vest as to 25% of the
number of shares granted on each anniversary of the date of grant.
The options have an exercise price of $1.34, the fair market value
of the common stock on the business day immediately preceding the
date of grant, and they expire on June 24, 2029.
On June
16, 2020, as part of our 2021 long-term incentive program, we
granted 646,500 time-based restricted stock units and 646,500
performance-based restricted stock units to Dr. Spana, and 557,000
time-based restricted stock units and 557,000 performance-based
restricted stock units to Mr. Wills. The time-based restricted
stock units vest as to 25% of the number of shares granted at each
anniversary of the date of grant. The performance-based restricted
stock units vest on performance criteria relating to advancement of
MC1r programs, including initiation of clinical trials, and
licensing of Vyleesi in additional countries or
regions.
On June
16, 2020, we also granted 1,071,500 time-based options and
1,071,500 performance-based options to Dr. Spana, and 923,000
time-based options and 923,000 performance-based options to Mr.
Wills, a portion of which were contingent on increasing the shares
reserved for grant under the 2011 Stock Incentive Plan, which was
approved by the stockholders at a meeting on June 25, 2020. The
time-based options vest as to 25% of the number of shares granted
at each anniversary of the date of grant. The performance-based
options vest on performance criteria relating to advancement of
MC1r programs, including initiation of clinical trials, and
licensing of Vyleesi in additional countries or regions. The
options have an exercise price of $0.58, the fair market value of
the common stock on the business day immediately preceding the date
of grant, and they expire on June 16, 2030.
Employment Agreements
Effective
July 1, 2019, we entered into employment agreements with Dr. Spana
and Mr. Wills which continue through June 30, 2022 unless
terminated earlier. Under these agreements, which replaced
substantially similar agreements that expired on June 30, 2019, Dr.
Spana is serving as Chief Executive Officer and President at a base
salary of $600,000 per year and Mr. Wills is serving as Chief
Financial Officer and Chief Operating Officer at a base salary of
$550,000 per year. Each agreement also provides
for:
●
annual
discretionary bonus compensation, in an amount to be decided by the
compensation committee and approved by the board, based on
achievement of yearly performance objectives;
and
●
participation in
all benefit programs that we establish, to the extent the
executive’s position, tenure, salary, age, health and other
qualifications make him eligible to participate.
Each
agreement allows us or the executive to terminate the agreement
upon written notice, and contains other provisions for termination
by us for “cause,” or by the employee for “good
reason” or due to a “change in control” (as these
terms are defined in the employment agreements and set forth
below). Early termination may, in some circumstances, result in
severance pay at the salary then in effect, plus continuation of
medical and dental benefits then in effect for a period of two
years. In addition, the agreements provide that options and
restricted stock units granted to these officers accelerate upon
termination of employment except for voluntary resignation by the
officer or termination for cause. In the event of retirement,
termination by the officer for good reason, or termination by us
other than for “cause”, options may be exercised until
the earlier of twenty-four months following termination or
expiration of the option term. Arrangements with our named
executive officers in connection with a termination following a
change in control are described below. Each agreement includes
non-competition, non-solicitation and confidentiality
covenants.
Other Compensation Practices and Policies
At
our last annual meeting of stockholders on June 25, 2020, our
non-binding stockholder advisory vote to approve the compensation
of our named executive officers (commonly known as a
“Say-on-Pay” vote) was supported by approximately 60%
of the votes cast for or against advisory approval. We continue to
evaluate our executive compensation program and solicit input from
our largest investors. Following is a summary of our current
compensation practices and policies.
85
●
Retain an Independent Compensation
Advisor. The compensation committee engaged Korn Ferry
Hay Group (“Hay Group”), a nationally-recognized global
human resources consulting firm, as its independent compensation
advisor in May 2019. Hay Group principally provided analysis,
advice and recommendations on named executive officer and
non-employee director compensation. The compensation committee
intends to conduct an independent compensation advisor review at
least every other fiscal year, with the most recent review by our
independent compensation advisor made for awards in June 2019 for
the fiscal year ending June 30, 2020. Our compensation peer group
for awards made in June 2019 is as follows, which was designed to
reflect the industry and sector in which Palatin competes, as well
as companies comparable to Palatin in terms of company life cycle,
phase of development of potential products, market capitalization
and talent market:
|
AcelRx
Pharmaceuticals, Inc.
|
MEI
Pharma, Inc.
|
|
Ardelyx,
Inc.
|
Protagonist
Therapeutics, Inc.
|
|
ArQule,
Inc.
|
Rigel
Pharmaceuticals, Inc.
|
|
Calithera
Biosciences, Inc.
|
Savara Inc.
|
|
Savara
Inc.
|
Stemline Therapeutics, Inc.
|
|
ChemoCentryx,
Inc.
|
Syndax Pharmaceuticals, Inc.
|
|
Cytokinetics,
Inc.
|
Verastem,
Inc.
|
|
Sutro
Biopharma, Inc.
|
|
|
Geron
Corporation
|
|
|
ImmunoGen,
Inc.
|
|
|
Verastem,
Inc.
|
|
|
La
Jolla Pharmaceutical
|
|
We
anticipate engaging an independent compensation advisor for a
review for awards to be made in June 2021 for the fiscal year
ending June 30, 2022, including utilization of a compensation peer
group.
●
Compensation at Risk. Our
executive compensation program is designed so that a significant
portion of compensation is “at risk” based on our
performance, as well as short-term cash and long-term equity
incentives to align the interests of our executive officers and
stockholders. Long-term equity incentives will be no less than base
salaries, with at least half of long-term equity incentives being
performance-based.
●
Use a Pay-for-Performance
Philosophy. The compensation committee employs a
mixture of compensation elements designed to balance short-term
goals with longer-term performance. Our executive compensation
program includes these principal elements:
o
Base salary, which
targets the comparable position median salary for our peer
group;
o
An annual incentive
compensation opportunity, with a target bonus payout, effective for
fiscal 2020, of no less than 60% of base salary, depending on
performance; and,
o
A long-term
incentive program consisting of stock option and restricted stock
unit awards. In fiscal 2020, approximately 50% of all long-term
incentive awards were allocated to time-based stock options and
performance-based restricted share units, with performance-based
restricted share units comprising 50% of issued restricted share
units.
●
Maintain a Stock Ownership
Policy. We have adopted a stock ownership policy that
requires our named executive officers, as well as our board
members, to maintain a minimum ownership level of our common stock.
As of June 30, 2020, the most recent “Determination
Date” under the stock ownership policy, all current named
executive officers and board members meet the target ownership
levels of shares with a value equal to at least five times the
annual base salary of named executive officers and at least two
times the annual retainer for board members. Our stock ownership
policy is on our website at
www.palatin.com/about/corporate-governance/. In addition, certain
time-based and performance-based restricted stock unit awards
contain deferred delivery provisions providing for delivery of the
common stock after the grantee’s separation from service or a
defined changed in control.
86
●
Maintain a Clawback Policy. We
have adopted a clawback policy allowing Palatin to recover related
compensation should the board determine that compensation paid to
named executive officers resulted from material noncompliance with
financial reporting requirements under federal securities law. Our
clawback policy is on our website at
www.palatin.com/about/corporate-governance/.
●
Maintain an Independent Compensation
Committee. The compensation committee consists entirely
of independent directors.
●
Annual Executive Compensation
Review. The compensation committee conducts an annual
review and approval of our compensation strategy, utilizing an
independent compensation advisor at least every other year. This
review, including a peer group review, is intended to ensure that
our compensation programs appropriately reward corporate growth
without encouraging excessive or inappropriate
risk-taking.
●
“Double Trigger” Feature for
Acceleration of CEO and CFO/COO Equity Awards. Under
employment agreements with our named executive officers,
outstanding equity awards granted to our named executive officers
provide that, upon a change in control of Palatin, the vesting of
such awards will accelerate only in the event of a subsequent
involuntary termination of employment (a
“double-trigger” provision).
●
No Excise Tax Gross-Ups. Prior to
July 1, 2019, our employment agreements for the named executive
officers provided that they were entitled to a tax gross-up for any
golden parachute excise tax imposed on payments received in
connection with a change in control. Most investors disfavor this
type of tax gross-up benefit. In response to stockholder feedback,
effective with new employment agreements for our named executive
officers commencing July 1, 2019, we removed all golden parachute
excise tax gross-up provisions. As a result, the Company no longer
provides tax gross-ups for named executive officers or any other
employees in the event they are subject to golden parachute excise
taxes on payments received in connection with a change in
control.
●
No Stock Option Re-pricing. Our
2011 Stock Incentive Plan does not permit options to purchase
shares of our common stock to be repriced to a lower exercise or
strike price without the approval of our stockholders.
●
No Dividends or Dividend Equivalents Payable
on Unvested or Undelivered Equity Awards. Under our
restricted share unit agreements, we do not pay dividends or
dividend equivalents on unvested RSU awards or vested RSU awards
subject to delayed delivery.
●
No Executive Retirement Plans. We
do not offer pension arrangements or retirement plans or
arrangements to our executive officers that are different from or
in addition to those offered to our other employees.
●
No Special Welfare or Health
Benefits. Our executive officers participate in
broad-based Company-sponsored health and welfare benefit programs
on the same basis as our other full-time, salaried
employees.
87
Outstanding Equity Awards at 2020 Fiscal Year-End
The
following table summarizes all of the outstanding equity-based
awards granted to our named executive officers as of June 30, 2020,
the end of our fiscal year.
|
|
|
Option awards (1)
|
Stock awards (2)
|
|||||||
|
Name
|
Option or
stock
award
grant
date
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Equity incentive plan award: number of securities underlying
unexercised unearned options (#)
|
Option
exercise
price
($)
|
Option
expiration
date
|
Number of shares or units of stock that have not
vested
(#)
|
Market value of shares or units of stock that have not
vested
($) (3)
|
Equity incentive plan awards: number of unearned shares, unit or
other rights that have not vested (#)
|
Equity incentive plan awards: market or payout value of unearned
shares, units or other rights that have not vested ($)
|
|
Carl
Spana
|
06/22/11
|
300,000
|
-
|
-
|
1.00
|
06/22/21
|
|
|
|
|
|
|
07/17/12
|
150,000
|
-
|
-
|
0.72
|
07/17/22
|
|
|
|
|
|
|
06/27/13
|
275,000
|
-
|
-
|
0.62
|
06/27/23
|
|
|
|
|
|
|
06/25/14
|
175,000
|
-
|
-
|
1.02
|
06/25/24
|
|
|
|
|
|
|
06/11/15
|
300,000
|
-
|
-
|
1.08
|
06/11/25
|
|
|
|
|
|
09/07/16
|
354,500
|
77,500
|
-
|
0.68
|
09/07/26
|
|
|
|
|
|
|
06/20/17
|
703,500
|
234,500
|
-
|
0.37
|
06/20/27
|
|
|
|
|
|
|
12/12/17
|
312,500
|
312,500
|
-
|
0.85
|
12/12/27
|
|
|
|
|
|
|
12/12/17
|
500,000
|
-
|
125,000
|
0.85
|
12/12/27
|
|
|
|
|
|
|
06/26/18
|
266,500
|
266,500
|
-
|
1.00
|
06/26/28
|
|
|
|
|
|
|
06/24/19
|
186,000
|
558,000
|
-
|
1.34
|
06/24/29
|
|
|
|
|
|
|
06/16/20
|
-
|
1,071,500
|
-
|
0.58
|
06/16/30
|
|
|
|
|
|
|
06/16/20
|
-
|
-
|
1,071,500
|
0.58
|
06/16/30
|
|
|
|
|
|
|
12/12/17
|
|
|
|
|
|
312,500
|
159,375
|
125,000
|
63,750
|
|
|
06/24/19
|
|
|
|
|
|
177,000
|
90,270
|
185,850
|
94,784
|
|
|
06/16/20
|
|
|
|
|
|
646,500
|
329,715
|
646,500
|
329,715
|
|
|
Total
Stock Awards
|
|
|
|
1,136,000
|
579,360
|
957,350
|
488,249
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephen T.
Wills
|
06/22/11
|
250,000
|
-
|
-
|
1.00
|
06/22/21
|
|
|
|
|
|
07/17/12
|
135,000
|
-
|
-
|
0.72
|
07/17/22
|
|
|
|
|
|
|
06/27/13
|
250,000
|
-
|
-
|
0.62
|
06/27/23
|
|
|
|
|
|
|
06/25/14
|
150,000
|
-
|
-
|
1.02
|
06/25/24
|
|
|
|
|
|
|
06/11/15
|
270,000
|
-
|
-
|
1.08
|
06/11/25
|
|
|
|
|
|
|
09/07/16
|
324,750
|
71,250
|
-
|
0.68
|
09/07/26
|
|
|
|
|
|
|
06/20/17
|
644,250
|
214,750
|
-
|
0.37
|
06/20/27
|
|
|
|
|
|
|
12/12/17
|
287,500
|
287,500
|
-
|
0.85
|
12/12/27
|
|
|
|
|
|
|
12/12/17
|
372,500
|
-
|
95,000
|
0.85
|
12/12/27
|
|
|
|
|
|
|
06/26/18
|
227,000
|
227,000
|
-
|
1.00
|
06/26/18
|
|
|
|
|
|
|
06/24/19
|
159,500
|
478,500
|
-
|
1.34
|
06/24/29
|
|
|
|
|
|
|
06/16/20
|
-
|
923,000
|
-
|
0.58
|
06/16/30
|
|
|
|
|
|
|
06/16/20
|
-
|
-
|
923,000
|
0.58
|
06/16/30
|
|
|
|
|
|
|
12/12/17
|
|
|
|
|
|
287,500
|
146,625
|
95,000
|
48,450
|
|
|
06/24/19
|
|
|
|
|
|
151,500
|
77,265
|
159,075
|
81,128
|
|
|
06/16/20
|
|
|
|
|
|
557,000
|
284,070
|
557,000
|
284,070
|
|
|
Total
Stock Awards
|
|
|
|
996,000
|
507,960
|
811,075
|
413,648
|
|||
(1)
Stock option
vesting schedules: all options granted on or before September 6,
2016 have fully vested. Options granted after September 6, 2016
vest over four years with 1/4 of the shares vesting per year
starting on the first anniversary of the grant date, provided that
the named executive officer remains an employee. See
“Termination and Change-In-Control Arrangements” below,
except for performance-based options granted on June 16, 2020,
which vest according to the terms of the grant described above, and
December 12, 2017, which vested as to thirty percent on June 26,
2018, upon ratification by the Board of the compensation
committee’s determination that the FDA had accepted for
filing an NDA for Vyleesi for HSDD, and fifty percent on June 24,
2019, upon the compensation committee’s determination that
FDA had approved the NDA for Vyleesi for HSDD. The remaining 20%
will vest, if at all, during the performance period ending December
31, 2020 upon entry into one or more licensing agreements for the
commercialization of Vyleesi in selected countries, which is
considered a performance condition or upon achievement of a closing
price for Palatin common stock equal to or greater than $1.50 per
share for 20 consecutive trading days, which is considered a market
condition, provided that in no event will the aggregate granted
exceed the number of performance-based stock units awarded to Dr.
Spana and Mr. Wills.
(2)
Time-based stock
award vesting schedule: restricted stock units granted on December
12, 2017, as to 625,000 shares for Dr. Spana and 575,000 shares for
Mr. Wills, which vest in equal amounts over a four year period,
provided that the named executive officer remains an employee;
restricted stock units granted on June 24, 2019 as to 236,000
shares for Dr. Spana and 202,000 shares for Mr. Wills and
restricted stock units granted on June 16, 2020 as to 646,500
shares for Dr. Spana and 557,000 shares for Mr. Wills, which vest
in equal amounts over a four year period, provided that the named
executive officer remains an employee. Both time-based and
performance-based restricted stock unit awards prior to fiscal 2019
contain deferred delivery provisions providing for delivery of the
common stock after the grantee’s separation from service or a
defined change in control. See “Stock Options and Restricted
Stock Unit Awards” above and “Termination and
Change-In-Control Arrangements” below.
(3)
Calculated by
multiplying the number of restricted stock units by $0.51, the
closing market price of our common stock on June 30, 2020, the last
trading day of our most recently completed fiscal
year.
88
Termination
and Change-In-Control Arrangements
The
employment agreements, stock option agreements and restricted stock
unit agreements with Dr. Spana and Mr. Wills contain the following
provisions concerning severance compensation and the vesting of
stock options and restricted stock units upon termination of
employment or upon a change in control. The executive’s
entitlement to severance, payment of health benefits and
accelerated vesting of options is contingent on the executive
executing a general release of claims against us.
Termination Without Severance
Compensation. Regardless of
whether there has been a change in control, if we terminate
employment for cause or the executive terminates employment without
good reason (as those terms are defined in the employment agreement
and set forth below), then the executive will receive only his
accrued salary and vacation benefits through the date of
termination. He may also elect to receive medical and dental
benefits pursuant to COBRA for up to two years, but must remit the
cost of coverage to us. Under the terms of our outstanding options
and restricted stock units, all unvested options and restricted
stock units would terminate immediately, and vested options would
be exercisable for three months after
termination.
Severance Compensation After
Death or Disability. In
the event of the executive’s death or disability, we will
provide lump sum severance pay equal to 24 months of base pay, as
well as the opportunity for COBRA benefits as described above under
“Termination Without Severance
Compensation.”
Severance Compensation Without
a Change in Control. If we
terminate or fail to extend the employment agreement without cause,
or the executive terminates employment with good reason, then the
executive will receive as severance pay his salary then in effect,
paid in a lump sum, plus medical and dental benefits at our
expense, for a period of two years after the termination date. In
addition, upon such event all unvested options would immediately
vest and be exercisable for two years after the termination date
or, if earlier, the expiration of the option term, and all unvested
restricted stock units would accelerate and become fully
vested.
Severance Compensation After a
Change in Control. If, within
one year after a change in control, we terminate employment or the
executive terminates employment with good reason, then the
executive will receive as severance pay 200% of his salary then in
effect, paid in a lump sum, plus medical and dental benefits at our
expense, for a period of two years after the termination date. We
would also reimburse the executive for up to $25,000 in fees and
expenses during the six months following termination, for locating
employment. All unvested options would immediately vest and be
exercisable for two years after the termination date or, if
earlier, the expiration of the option term. All unvested restricted
stock units would vest upon a change in control, without regard to
whether the executive’s employment is
terminated.
Option and Restricted Stock Unit Vesting Upon a Change in
Control. Pursuant to the
employment agreements, options and restricted stock units granted
under the 2011 Stock Incentive Plan vest upon termination of the
employee within twelve months following a change in control. If any
options granted under the 2005 Stock Plan are to be terminated in
connection with a change in control, those options will vest in
full immediately before the change in control.
Definitions. Under the
employment agreements, a “change in control,”
“cause” and “good reason” are defined as
follows:
A “change in control” occurs
when:
(a)
any person or entity acquires more than 50% of the
voting power of our outstanding securities;
(b)
the individuals who, during any twelve-month
period, constitute our board of directors cease to constitute at
least a majority of the board of directors;
(c)
the consummation of a merger or consolidation;
or
(d)
we
sell substantially all our assets.
The term
“cause” means:
(a)
the occurrence of (i) the
executive’s material breach of, or habitual neglect or
failure to perform the material duties which he is required to
perform under, the terms of his employment agreement; (ii) the
executive’s material failure to follow the reasonable
directives or policies established by or at the direction of our
board of directors; or (iii) the executive’s engaging in
conduct that is materially detrimental to our interests such that
we sustain a material loss or injury as a result thereof, provided
that the breach or failure of performance is not cured, to the
extent cure is possible, within ten days of the delivery to the
executive of written notice thereof;
89
(b)
the willful breach by the executive of his
obligations to us with respect to confidentiality, invention and
non-disclosure, non-competition or non-solicitation;
or
(c)
the conviction of the executive of, or the entry
of a pleading of guilty or nolo contendere by the executive to, any
crime involving moral turpitude or any felony.
The
term “good reason” means the occurrence of any of the
following, with our failure to cure such circumstances within 30
days of the delivery to us of written notice by the executive of
such circumstances:
(a)
any material adverse change in the
executive’s duties, authority or responsibilities, which
causes the executive’s position with us to become of
significantly less responsibility, or assignment of duties and
responsibilities inconsistent with the executive’s
position;
(b)
a material reduction in the executive’s
salary;
(c)
our failure to continue in effect any material
compensation or benefit plan in which the executive participates,
unless an equitable arrangement has been made with respect to such
plan, or our failure to continue the executive’s
participation therein (or in a substitute or alternative plan) on a
basis not materially less favorable, both in terms of the amount of
benefits provided and the level of the executive’s
participation relative to other participants;
(d)
our failure to continue to provide the executive
with benefits substantially similar to those enjoyed by the
executive under any of our health and welfare insurance, retirement
and other fringe-benefit plans, the taking of any action by us
which would directly or indirectly materially reduce any of such
benefits, or our failure to provide the executive with the number
of paid vacation days to which he is entitled;
or
(e)
the
relocation of the executive to a location which is a material
distance from Cranbury, New Jersey.
Director Compensation
The
following table sets forth the compensation we paid to all
directors during fiscal 2020, except for Dr. Spana, whose
compensation is set forth above in the Summary Compensation Table
and related disclosure. Dr. Spana did not receive any separate
compensation for his services as a director.
|
Name
|
Fees earned or
paid in cash ($)
|
Stock awards ($)
(1) (2)
|
Option
awards
($) (1)
(2)
|
Total
($)
|
|
John K.A.
Prendergast, Ph.D.
|
97,500
|
57,400
|
57,400
|
212,300
|
|
Robert K. deVeer,
Jr.
|
66,250
|
42,300
|
42,400
|
150,950
|
|
J. Stanley
Hull
|
57,500
|
42,300
|
42,400
|
142,200
|
|
Alan W. Dunton,
M.D.
|
66,250
|
42,300
|
42,400
|
150,950
|
|
Angela
Rossetti
|
53,750
|
42,300
|
42,400
|
138,450
|
|
Arlene
Morris
|
53,750
|
42,300
|
42,400
|
138,450
|
|
Anthony Manning,
Ph.D.
|
48,750
|
42,300
|
42,400
|
133,450
|
(1)
The aggregate
number of shares underlying option awards and stock awards
outstanding at June 30, 2020 for each director was:
|
|
Option
awards
|
Stock
awards
|
|
Dr.
Prendergast
|
808,250
|
259,000
|
|
Mr.
deVeer
|
365,500
|
153,000
|
|
Mr.
Hull
|
362,000
|
153,000
|
|
Dr.
Dunton
|
314,000
|
143,000
|
|
Ms.
Rossetti
|
266,500
|
133,000
|
|
Ms.
Morris
|
221,500
|
123,000
|
|
Dr.
Manning
|
149,000
|
115,000
|
(2)
Amounts in these
columns represent the aggregate grant date fair value for stock
awards and option awards. For a description of the assumptions we
used to calculate these amounts, see Note 14 to the consolidated
financial statements included in this Annual Report. Amounts in
this column include options granted on June 16, 2020 for our
current fiscal year ending June 30, 2021.
90
Our director compensation program is designed to enhance our
ability to attract and retain highly qualified directors and to
align their interests with the long-term interests of our
stockholders. The program includes an equity component, which is
designed to align the interests of non-employee directors and
stockholders, and a cash component, which is designed to compensate
non-employee directors for their service on the board. Directors
who are employees of the Company receive no additional compensation
for their service on the board.
The compensation committee annually reviews compensation paid to
our non-employee directors and makes recommendations for
adjustments, as appropriate, to the full board. As part of this
annual review, the compensation committee considers the significant
time commitment and skill level required by each non-employee
director in serving on the board and its various committees. The
compensation committee seeks to maintain a market competitive
director compensation program and, with the assistance of its
independent compensation consultant, Hay Group, benchmarks our
director compensation program against the peer group we use to
evaluate our executive compensation program.
Non-Employee Directors’ Equity Grants. Our
non-employee directors receive an annual equity grant at the board
meeting closest to the beginning of each fiscal year, or such other
date as may be determined by the board.
On June
16, 2020, the Chairman of the board received 99,000 restricted
stock units which vest on June 16, 2021 and an option to purchase
172,000 shares of common stock, and each other serving non-employee
director received 73,000 restricted stock units which vest on June
16, 2021 and an option to purchase 127,000 shares of common stock.
All of the options have an exercise price of $0.58 per share, the
closing price of our common stock on the business day immediately
preceding the date of grant, vest in twelve monthly installments
beginning July 31, 2020, expire ten years from the date of grant
and provide for accelerated vesting in the event of involuntary
termination as a director following a change in control, with
exercise permitted following accelerated vesting for up to the
earlier of one year after termination or the expiration date of the
option.
On June
24, 2019, the Chairman of the board received 84,000 restricted
stock units which vested on June 24, 2020, and an option to
purchase 70,000 shares of common stock, and each other serving
non-employee director received 32,000 restricted stock units which
vested on June 24, 2020, and an option to purchase 52,000 shares of
common stock. All of the options have an exercise price of $1.34
per share, the closing price of our common stock on the business
day immediately preceding the date of grant, vested in twelve
monthly installments beginning on July 31, 2019, expire ten years
from the date of grant and provide for accelerated vesting in the
event of involuntarily termination as a director following a change
in control, with exercise permitted following accelerated vesting
for up to the earlier of one year after termination or the
expiration date of the option.
Non-Employee Directors’ Cash Compensation. Dr.
Prendergast serves as Chairman of the board and for fiscal 2020
received an annual retainer of $87,500, payable quarterly. Other
non-employee directors received an annual base retainer of $40,000,
payable on a quarterly basis. The chairperson of the audit
committee received an additional annual retainer of $17,500, the
chairperson of the compensation committee received an additional
annual retainer of $17,500 and the chairperson of the corporate
governance committee received an additional annual retainer of
$10,000. Members of the foregoing committees, other than the
non-employee Chairman, received an additional retainer of one-half
the retainer payable to the committee chairperson. For the fiscal
year ending June 30, 2021, Dr. Prendergast serves as Chairman of
the board and will received an annual retainer of $87,500, payable
quarterly. Other non-employee directors will receive an annual base
retainer of $40,000, payable on a quarterly basis. The chairperson
of the audit committee will receive an additional annual retainer
of $17,500, the chairperson of the compensation committee will
receive an additional annual retainer of $17,500 and the
chairperson of the corporate governance committee will receive an
additional annual retainer of $10,000. Members of the foregoing
committees, other than the non-employee Chairman, receive an
additional retainer of one-half the retainer payable to the
committee chairperson.
The
board also formed a program development committee, charged with
reviewing new product opportunities and product development
strategy. The chairperson of the program development committee
receives $3,500 per day of service, and members of the committee
receive $2,500 per day of service.
Non-Employee Directors’ Expenses. Non-employee
directors are reimbursed for expenses incurred in performing their
duties as directors, including attending all meetings of the board
and any committees on which they serve.
Employee Directors. Employee directors are not separately
compensated for services as directors but are reimbursed for
expenses incurred in performing their duties as directors,
including attending all meetings of the board and any committees on
which they serve.
91
Item 12. Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder
Matters.
Securities Authorized for Issuance Under Equity Compensation
Plans. The table below provides information on our equity
compensation plans as of June 30, 2020:
|
Equity
Compensation Plan Information
as
of June 30, 2020
|
|||
|
Plan
category
|
Number of
securities to be issued upon exercise of outstanding options,
warrants and rights
|
Weighted-average
exercise price of outstanding options, warrants and
rights
|
Number of
securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
|
|
|
(a)
|
(b)
|
(c)
|
|
Equity compensation
plans approved by security holders
|
32,592,020(1)
|
$0.76(2)
|
5,552,149
|
|
Equity compensation
plans not approved by security holders
|
25,000(3)
|
$0.70
|
-
|
|
Total
|
32,617,020
|
|
5,552,149
|
(1)
Includes 19,888,450
options and 12,965,570restricted stock units granted under our 2011
Stock Incentive Plan and 14,000 options granted under our 2005
Stock Plan. Our 2005 Stock Plan has terminated, but termination
does not affect awards that are currently outstanding under this
plan. The shares subject to outstanding awards under the 2005 Stock
Plan, if forfeited prior to exercise, will become available for
issuance under the 2011 Stock Incentive Plan.
(2)
The amount in
column (a) for equity compensation plans approved by security
holders includes 12,689,570 shares reserved for issuance on vesting
of outstanding restricted stock units, granted under our 2011 Stock
Incentive Plan, which vest on various dates through June 16, 2024,
subject to the fulfillment of service, market conditions, or
performance conditions. Because no exercise price is required for
issuance of shares on vesting of the restricted stock units, the
weighted-average exercise price in column (b) does not take the
restricted stock units into account.
(3)
Consists of two
warrants to purchase 12,500 shares at $0.70 per share issued in
connection with a contract for financial advisory
services.
Beneficial Ownership Tables. The tables below show the
beneficial stock ownership and voting power, as of September 24,
2020, of:
●
each director, each
of the named executive officers, and all current directors and
officers as a group; and
●
all persons who, to
our knowledge, beneficially own more than five percent of the
common stock or Series A preferred stock.
“Beneficial
ownership” here means direct or indirect voting or investment
power over outstanding stock and stock which a person has the right
to acquire now or within 60 days after September 24, 2020. See the
footnotes for more detailed explanations of the holdings. Except as
noted, to our knowledge, the persons named in the tables
beneficially own and have sole voting and investment power over all
shares listed.
The
common stock has one vote per share and the Series A preferred
stock has approximately 16 votes per share of Series A preferred
stock. Voting power is calculated on the basis of the aggregate of
common stock and Series A preferred stock outstanding as of
September 24, 2020, on which date 229,855,417 shares of
common stock and 4,030 shares of Series A preferred stock,
convertible into 66,059 shares of common stock, were
outstanding.
92
Under
our Insider Trading and Securities Law Compliance Policy directors
and officers may not engage in hedging, monetization or pledging
transactions of our securities. None of the shares of our
management and directors shown on the table below are
pledged.
The
address for all members of our management and directors is c/o
Palatin Technologies, Inc., 4B Cedar Brook Drive, Cranbury, NJ
08512. Addresses of other beneficial owners are in the
table.
MANAGEMENT:
|
Class
|
Name of beneficial owner
|
Amount and nature of beneficial ownership
|
Percent of class
|
Percent of total voting power
|
|
Common
|
Carl Spana,
Ph.D.
|
7,187,368(1)
|
3.0%
|
*
|
|
Common
|
Stephen T.
Wills
|
6,380,047(2)
|
2.7%
|
*
|
|
Common
|
John K.A.
Prendergast, Ph.D.
|
1,202,349(3)
|
*
|
*
|
|
Common
|
Robert K. deVeer,
Jr.
|
697,472(4)
|
*
|
*
|
|
Common
|
J. Stanley
Hull
|
650,132(5)
|
*
|
*
|
|
Common
|
Alan W. Dunton,
M.D.
|
610,684(6)
|
*
|
*
|
|
Common
|
Angela
Rossetti
|
535,332(7)
|
*
|
*
|
|
Common
|
Arlene M.
Morris
|
477,332(8)
|
*
|
*
|
|
Common
|
Anthony M. Manning,
Ph.D.
|
256,332(9)
|
*
|
*
|
|
|
|
|
|
|
|
|
All current
directors and executive officers as a group (nine
persons)
|
17,997,048(10)
|
7.4%
|
1.4%
|
*Less
than one percent.
(1)
Includes 3,600,500
shares of common stock underlying outstanding options and 2,703,500
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(2)
Includes 3,141,750
shares of common stock underlying outstanding options and 2,376,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(3)
Includes 667,582
shares of common stock underlying outstanding options and 140,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(4)
Includes 386,332
shares of common stock underlying outstanding options and 70,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(5)
Includes 386,332
shares of common stock underlying outstanding options and 70,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(6)
Includes 346,332
shares of common stock underlying outstanding options and 60,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(7)
Includes 298,832
shares of common stock underlying outstanding options and 50,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(8)
Consists of 253,832
shares of common stock underlying outstanding options and 40,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(9)
Consists of 159,332
shares of common stock underlying outstanding options and 10,000
shares of common stock underlying restricted stock units, all of
which shares of common stock underlying restricted stock units have
vested but not been delivered under deferred delivery provisions
providing for delivery after the grantee’s separation from
service or a defined change in control, but does not include shares
of common stock underlying outstanding options or restricted stock
unit awards that have not vested and will not vest within 60
days.
(10)
Includes 14,760,324
shares of common stock underlying outstanding options and
restricted stock units.
93
MORE THAN 5% BENEFICIAL OWNERS:
|
Class
|
Name and address of beneficial owner
|
Amount and nature of beneficial ownership (1)
|
Percent of class Percent of total voting power
|
|
Series A
Preferred
|
Steven N.
Ostrovsky
43 Nikki
Ct.
Morganville, NJ
07751
|
500
|
12.4%*
|
|
Series A
Preferred
|
Thomas L. Cassidy
IRA Rollover
38 Canaan
Close
New Canaan, CT
06840
|
500
|
12.4%*
|
|
Series A
Preferred
|
Jonathan E.
Rothschild
300 Mercer St.,
#28F
New York, NY
10003
|
500
|
12.4%*
|
|
Series A
Preferred
|
Arthur J.
Nagle
19 Garden
Avenue
Bronxville, NY
10708
|
250
|
6.2%*
|
|
Series A
Preferred
|
Thomas P. and Mary
E. Heiser, JTWROS
10 Ridge
Road
Hopkinton, MA
01748
|
250
|
6.2%*
|
|
Series A
Preferred
|
Carl F.
Schwartz
31 West 87th
St.
New York, NY
10016
|
250
|
6.2%*
|
|
Series A
Preferred
|
Michael J.
Wrubel
3650 N. 36 Avenue,
#39
Hollywood, FL
33021
|
250
|
6.2%*
|
|
Series A
Preferred
|
Myron M.
Teitelbaum, M.D.
175 Burton
Lane
Lawrence, NY
11559
|
250
|
6.2%*
|
|
Series A
Preferred
|
Laura Gold
Galleries Ltd. Profit Sharing Trust Park South Gallery at Carnegie
Hall
154 West 57th
Street, Suite 114
New York, NY
10019
|
250
|
6.2%*
|
|
Series A
Preferred
|
Laura
Gold
180 W. 58th
Street
New York, NY
10019
|
250
|
6.2%*
|
|
Series A
Preferred
|
Nadji T.
Richmond
20 E. Wedgewood
Glen
The Woodlands, TX
77381
|
230
|
5.7%*
|
*Less
than one percent.
(1)
Unless otherwise indicated by footnote, all share amounts represent
outstanding shares of the class indicated, and all beneficial
owners listed have, to our knowledge, sole voting and dispositive
power over the shares listed.
94
Item 13. Certain Relationships and Related
Transactions, and Director Independence.
The
board of directors has determined that all the directors except for
Dr. Spana (our Chief Executive Officer and President) are
independent directors, as defined in the listing standards of the
NYSE American.
As a
condition of employment, we require all employees to disclose in
writing actual or potential conflicts of interest, including
related party transactions. Our code of corporate conduct and
ethics, which applies to employees, officers and directors,
requires that the audit committee review and approve related party
transactions. Since July 1, 2015, there have been no
transactions or proposed transactions in which we were or are to be
a participant, in which any related person had or will have a
direct or indirect material interest.
Item 14. Principal Accounting Fees and
Services.
KPMG
LLP (“KPMG”), served as our independent registered
public accounting firm for fiscal 2020 and fiscal
2019.
Audit Fees. For fiscal 2020, fees for professional services
rendered for the audit of our annual consolidated financial
statements, review of our consolidated financial statements in our
Forms 10-Q, and services provided in connection with comfort
letters were $329,000. For fiscal 2019, fees for professional
services rendered for the audit of our annual consolidated
financial statements, the audit of internal control over financial
reporting as of June 30, 2019, review of our consolidated financial
statements in our Forms 10-Q, and services provided in connection
with regulatory filings and comfort letters were
$504,000.
Audit-Related Fees. For fiscal 2020 and fiscal 2019, KPMG
did not perform or bill us for any audit-related
services.
Tax Fees. For fiscal 2020, KPMG billed us $23,600 for
professional services rendered for tax compliance services. For
fiscal 2019, KPMG billed us a total of $37,000 for professional
services rendered for tax compliance and consulting
services.
All Other Fees. KPMG did not perform or bill us for any
services other than those described above for fiscal 2020 and
fiscal 2019.
Policy on Audit Committee Pre-Approval of Audit and Permissible
Non-Audit Services of Independent Auditors. Consistent with
SEC policies regarding auditor independence, the audit committee
has responsibility for appointing, setting compensation for and
overseeing the work of the independent registered public accounting
firm. In recognition of this responsibility, the audit committee
has established a policy to pre-approve all audit and permissible
non-audit services provided by the independent registered public
accounting firm.
The
audit committee pre-approves fees for each category of service. The
fees are budgeted and the audit committee requires the independent
registered public accounting firm and management to report actual
fees versus the budget periodically throughout the year by category
of service. During the year, circumstances may arise when it may
become necessary to engage the independent registered public
accounting firm for additional services not contemplated in the
original pre-approval. In those instances, the audit committee
requires specific pre-approval before engaging the independent
registered public accounting firm.
The
audit committee may delegate pre-approval authority to one or more
of its members. The member to whom such authority is delegated must
report, for informational purposes only, any pre-approval decisions
to the audit committee at its next scheduled meeting.
95
PART IV
Item 15. Exhibits, Financial Statement
Schedules.
(a) Documents filed as part of the
report:
1.
Financial
statements: The following consolidated financial statements are
filed as a part of this report under Item 8 – Financial
Statements and Supplementary Data:
—
Report of Independent Registered Public Accounting
Firm
—
Consolidated Balance Sheets
—
Consolidated Statements of Operations
—
Consolidated Statements of Comprehensive (Loss) Income
—
Consolidated Statements of Stockholders’ Equity
(Deficiency)
—
Consolidated Statements of Cash Flows
—
Notes to Consolidated Financial Statements
2.
Financial statement
schedules: None.
3.
List of
Exhibits
The
following exhibits are incorporated by reference or filed as part
of this report:
|
Exhibit
Number
|
Description
|
Filed
Herewith
|
Form
|
Filing
Date
|
SEC
File No.
|
|
Equity
Distribution Agreement, dated April 20, 2018, by and between
Palatin Technologies, Inc. and Canaccord Genuity LLC
|
|
8-K
|
April
20, 2018
|
001-15543
|
|
|
Equity
Distribution Agreement, dated June 21, 2019, by and between Palatin
Technologies, Inc. and Canaccord Genuity LLC
|
|
8-K
|
June
21, 2019
|
001-15543
|
|
|
Restated
Certificate of Incorporation of Palatin Technologies, Inc., as
amended.
|
|
10-K
|
September
27, 2013
|
001-15543
|
|
|
Bylaws
of Palatin Technologies, Inc.
|
|
10-Q
|
February
8, 2008
|
001-15543
|
|
|
Form
of Series A 2012 Warrant.
|
|
8-K
|
July
6, 2012
|
001-15543
|
|
|
Form
of Series B 2012 Warrant.
|
|
8-K
|
July
6, 2012
|
001-15543
|
|
|
Form of Series C
2014 Common Stock Purchase Warrant.
|
|
8-K
|
December
30,
2014
|
001-15543
|
|
|
Form of Series D
2014 Common Stock Purchase Warrant.
|
|
8-K
|
December
30,
2014
|
001-15543
|
|
|
Form of Series E
2015 Common Stock Purchase Warrant.
|
|
8-K
|
July 7,
2015
|
001-15543
|
|
|
Form of Series F
2015 Common Stock Purchase Warrant.
|
|
8-K
|
July 7,
2015
|
001-15543
|
|
|
Form of Series G
2015 Common Stock Purchase Warrant.
|
|
8-K
|
July 7,
2015
|
001-15543
|
|
|
Form of Series H
2016 Common Stock Purchase Warrant.
|
|
8-K
|
August 2,
2016
|
001-15543
|
|
|
Form of Series I
2016 Common Stock Purchase Warrant.
|
|
8-K
|
August 2,
2016
|
001-15543
|
|
|
Form of Series J
2016 Common Stock Purchase Warrant.
|
|
8-K
|
December 1,
2016
|
001-15543
|
|
|
|
Form of warrant
issued to PSL Business Development Consulting and SARL Avisius in
connection with a contract for financial advisory
services.
|
|
10-Q
|
February 10,
2017
|
001-15543
|
96
|
Description of
Securities
|
|
10-K
|
September 12,
2019
|
001-15543
|
|
|
10.1†
|
1996
Stock Option Plan, as amended.
|
|
10-K
|
September
28, 2009
|
001-15543
|
|
10.2†
|
Form
of Option Certificate (Incentive Option) Under the 2005 Stock
Plan.
|
|
8-K
|
September
21, 2011
|
001-15543
|
|
10.3†
|
Form
of Incentive Stock Option Under the 2005 Stock Plan.
|
|
8-K
|
September
21, 2011
|
001-15543
|
|
10.4†
|
Form
of Opinion Certificate (Non-Qualified Opinion) Under the 2005 Stock
Plan.
|
|
8-K
|
September
21, 2011
|
001-15543
|
|
10.5†
|
Form
of Non-Qualified Stock Option Agreement Under the 2005 Stock
Plan.
|
|
8-K
|
September
21, 2011
|
001-15543
|
|
10.6†
|
2007
Change in Control Severance Plan.
|
|
10-Q
|
February
8, 2008
|
001-15543
|
|
10.7†
|
2005
Stock Plan, as amended.
|
|
10-Q
|
May
15, 2009
|
001-15543
|
|
10.8†
|
Form
of Executive Officer Option Certificate.
|
|
10-Q
|
May
14, 2008
|
001-15543
|
|
10.9†
|
Form
of Amended Restricted Stock Unit Agreement.
|
|
10-Q
|
May
14, 2008
|
001-15543
|
|
Form
of Amended Option Certificate (Incentive Option) Under the 2005
Stock Plan.
|
|
10-Q
|
May
14, 2008
|
001-15543
|
|
|
2011
Stock Incentive Plan, as amended.
|
|
8-K
|
June
27, 2018
|
001-15543
|
|
|
Form
of Restricted Share Unit Agreement Under the 2011 Stock Incentive
Plan.
|
|
10-Q
|
May
13, 2011
|
001-15543
|
|
|
Form
of Nonqualified Stock Option Agreement under the 2011 Stock
Incentive Plan.
|
|
10-Q
|
May
13, 2011
|
001-15543
|
|
|
Form
of Incentive Stock Option Agreement under the 2011 Stock Incentive
Plan.
|
|
10-Q
|
May
13, 2011
|
001-15543
|
|
|
Form
of Restricted Share Unit Agreement under the 2011 Stock Incentive
Plan.
|
|
8-K
|
December
11, 2015
|
001-15543
|
97
|
Form
of Performance-Based Restricted Share Unit Agreement under the 2011
Stock Incentive Plan.
|
|
8-K
|
December
11, 2015
|
001-15543
|
|
|
Form
of Restricted Share Unit Agreement for Non-Employee Directors under
the 2011 Stock Incentive Plan.
|
|
8-K
|
December
11, 2015
|
001-15543
|
|
|
Amended
form of Restricted Share Unit Agreement under the 2011 Stock
Incentive Plan.
|
|
10-Q
|
February
12, 2016
|
001-15543
|
|
|
Amended
form of Performance-Based Restricted Share Unit Agreement under the
2011 Stock Incentive Plan.
|
|
10-Q
|
February
12, 2016
|
001-15543
|
|
|
Amended
form of Restricted Share Unit Agreement for Non-Employee Directors
under the 2011 Stock Incentive Plan.
|
|
10-Q
|
February
12, 2016
|
001-15543
|
|
|
Form
of Indenture.
|
|
S-3
|
August
17, 2018
|
333-226905
|
|
|
Amended
and Restated Venture Loan and Security Agreement, dated July 2,
2015, by and between Palatin Technologies, Inc. and Horizon
Technology Finance Corporation, Fortress Credit Co LLC, Horizon
Credit II LLC and Fortress Credit Opportunities V CLO
Limited.
|
|
8-K
|
July 7,
2015
|
001-15543
|
|
|
10.23††
|
Commercial
Supply Agreement dated June 20, 2016, by and between Catalent
Belgium S.A. and Palatin Technologies, Inc.
|
|
10-K
|
September
19, 2016
|
001-15543
|
|
10.24††
|
Manufacturing
Preparation and Services Agreement dated June 20, 2016, by and
between Catalent Belgium S.A. and Palatin Technologies,
Inc.
|
|
10-K
|
September
19, 2016
|
001-15543
|
|
10.25††
|
License
Agreement, dated January 8, 2017, by and between AMAG
Pharmaceuticals, Inc. and Palatin Technologies, Inc.
|
|
10-Q
|
February
10, 2017
|
001-15543
|
|
10.26††
|
License
Agreement, dated September 6, 2017, by and between Shanghai Fosun
Pharmaceutical Industrial Development Co., Ltd. and Palatin
Technologies, Inc.
|
|
10-Q
|
November
13, 2017
|
001-15543
|
|
|
Employment
Agreement, effective as of July 1, 2019, between Carl Spana and
Palatin Technologies, Inc.
|
|
8-K
|
June
26, 2019
|
001-15543
|
98
|
Employment
Agreement, effective as of July 1, 2019, between Stephen T. Wills
and Palatin Technologies, Inc.
|
|
8-K
|
June
26, 2019
|
001-15543
|
|
|
Termination
Agreement between Palatin Technologies, Inc. And AMAG
Pharmaceuticals, Inc., dated July 24, 2020.
|
|
8-K
|
July 27, 2020
|
001-15543
|
|
|
10.30†††
|
Manufacturing Services Agreement, dated as of June 1, 2019, by and
between Palatin Technologies, Inc. (as assignee from AMAG
Pharmaceuticals, Inc.) and Lonza Ltd.
|
X
|
|
|
|
|
10.31†††
|
Supply Agreement, dated as of December 20, 2018, by and between
Palatin Technologies, Inc. (as assignee from AMAG Pharmaceuticals,
Inc.) and Ypsomed AG.
|
X
|
|
|
|
|
Subsidiary
of Palatin Technologies, Inc.
|
X
|
|
|
|
|
|
Consent
of KPMG LLP.
|
X
|
|
|
|
|
|
Certification
of Chief Executive Officer.
|
X
|
|
|
|
|
|
Certification
of Chief Financial Officer.
|
X
|
|
|
|
|
|
Certification
of principal executive officer pursuant to U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
X
|
|
|
|
|
|
Certification
of principal financial officer pursuant to U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
X
|
|
|
|
|
|
101.INS
|
XBRL
Instance Document.
|
X
|
|
|
|
|
101.SCH
|
XBRL
Taxonomy Extension Schema Document.
|
X
|
|
|
|
|
101.CAL
|
XBRL
Taxonomy Extension Calculation Linkbase Document.
|
X
|
|
|
|
|
101.LAB
|
XBRL
Taxonomy Extension Label Linkbase Document.
|
X
|
|
|
|
|
101.PRE
|
XBRL
Taxonomy Extension Presentation Linkbase Document.
|
X
|
|
|
|
|
101.DEF
|
XBRL
Taxonomy Extension Definition Linkbase Document.
|
X
|
|
|
|
† Management contract or compensatory plan or
arrangement.
††
Confidential treatment granted as to certain portions of the
exhibit, which portions are omitted and filed separately with the
SEC.
†††
Portions of the exhibit are omitted pursuant to Regulation S-K Item
601(b)(10). Palatin agrees to furnish to the U.S. Securities and
Exchange Commission a copy of any omitted schedule and/or exhibit
upon request. The confidential portions of this exhibit were
omitted by means of marking such portions with asterisks because
the identified confidential portions (i) are not material and (ii)
would be competitively harmful if publicly disclosed.
Item 16. Form 10-K Summary.
None.
99
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
|
|
PALATIN
TECHNOLOGIES, INC.
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Carl
Spana
|
|
|
|
|
Carl Spana,
Ph.D.
|
|
|
|
|
President and Chief
Executive Officer
(principal
executive officer)
|
|
Date:
September 25, 2020
Pursuant
to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of
the registrant and in the capacities and on the dates
indicated.
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
/s/
Carl Spana
|
|
President,
Chief Executive Officer and Director
|
|
September
25, 2020
|
|
Carl
Spana
|
|
(principal
executive officer)
|
|
|
|
|
|
|
|
|
|
/s/
Stephen T. Wills
|
|
Executive
Vice President, Chief Financial Officer
|
|
September
25, 2020
|
|
Stephen
T. Wills
|
|
and
Chief Operating Officer (principal financial and accounting
officer)
|
|
|
|
|
|
|
|
|
|
/s/
John K. A. Prendergast
|
|
Chairman
and Director
|
|
September
25, 2020
|
|
John K.
A. Prendergast
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Robert K. deVeer, Jr,
|
|
Director
|
|
September
25, 2020
|
|
Robert
K. deVeer, Jr.
|
|
|
|
|
|
|
|
|
|
|
|
/s/ J.
Stanley Hull
|
|
Director
|
|
September
25, 2020
|
|
J.
Stanley Hull
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Alan W. Dunton
|
|
Director
|
|
September
25, 2020
|
|
Alan W.
Dunton
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Angela Rossetti
|
|
Director
|
|
September
25, 2020
|
|
Angela
Rossetti
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Arlene M. Morris
|
|
Director
|
|
September
25, 2020
|
|
Arlene
M. Morris
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Anthony M. Manning
|
|
Director
|
|
September
25, 2020
|
|
Anthony
M. Manning
|
|
|
|
|
100
Exhibit 10.30
Portions of this Exhibit have been redacted because they are both
(i) not material and (ii) would be competitively harmful if
publicly disclosed. Information that was omitted has been noted in
this document with a placeholder identified by the mark
“[***]”.
Manufacturing Services Agreement
(the
“Agreement”)
by and
between
Lonza Ltd
Münchensteinerstrasse
38
CH-4002
Basel
Switzerland
-
hereinafter “Lonza” -
and
AMAG Pharmaceuticals, Inc.
1100
Winter St, Waltham,
MA
02451
-
hereinafter “Customer” –
Effective
as of 1 June, 2018 (the “Effective Date”)
1
Table of Contents
1 Definitions
and Interpretation
2 Commitments
and Performance of Services
3 Project
Management / Steering
Committee
4 Quality
5 Insurance
6 Forecasting,
Ordering and Cancellation
7 Delivery
and Acceptance
8 Price
and Payment
9 Intellectual
Property
10 Warranties
11 Indemnification
and Liability
12 Confidentiality
13 Term
and Termination
14 Force
Majeure
15 Miscellaneous
Appendix
A
Appendix
B
Appendix
C
Appendix
D
Appendix
E
2
Recitals
WHEREAS,
Customer is engaged in the development and research of certain
products and requires assistance in the development and manufacture
of product;
WHEREAS,
Lonza and its Affiliates have expertise in the evaluation,
development and manufacture of products;
WHEREAS,
Lonza and Palatin Technologies, Inc. (“Palatin”)
entered into a Service Agreement dated as of November 11, 2015, as
amended on January 19, 2016 and November 11, 2017 (the
“Palatin Service Agreement”);
WHEREAS,
pursuant to a License Agreement entered into as of January 8, 2017,
by and between Customer and Palatin (the “Palatin License
Agreement”), Palatin was obligated to assign to Customer
agreements that relate to the manufacture or supply of the Product,
as defined herein, including specifically the Palatin Service
Agreement;
WHEREAS,
on December 27, 2017, Palatin assigned to Customer the Palatin
Service Agreement;
WHEREAS,
Customer wishes to engage Lonza for Services relating to the
manufacture of the Product as described in this Agreement;
and
WHEREAS,
Lonza, or its Affiliate, is prepared to perform such Services for
Customer on the terms and subject to the conditions set out
herein.
NOW,
THEREFORE, in consideration of the mutual promises contained
herein, and for other good and valuable consideration, the parties
intending to be legally bound, agree as follows:
1Definitions and Interpretation
|
|
|
|
“Affiliate”
|
means
any company, partnership or other entity which directly or
indirectly Controls, is Controlled by or is under common Control
with the relevant Party. “Control” means the ownership
of more than fifty percent (50%) of the issued share capital or the
power to direct or cause the direction of the general management
and policies of the relevant Party.
|
|
|
|
|
“Agreement”
|
means
this agreement incorporating all Appendices, as amended from time
to time by written agreement of the Parties.
|
|
|
|
|
“Applicable
Laws”
|
means
all relevant federal, state and local laws, statutes, rules, and
regulations in the Territory which are applicable to a
Party’s activities hereunder, including, without limitation,
the applicable regulations and guidelines of any Governmental
Authority and all applicable cGMP together with amendments
thereto.
|
3
|
|
|
|
“Approval”
|
means
the first marketing approval by the FDA or EMA of Product from the
Facility for commercial supply.
|
|
|
|
|
“Background
Intellectual Property”
|
means
any Intellectual Property either (i) owned or controlled by a Party
prior to the Effective Date or (ii) developed or acquired by a
Party (a) independently from the performance of the Services
hereunder during the Term of this Agreement and (b) that does not
claim or otherwise expressly incorporate the other Party’s
Intellectual Property.
|
|
|
|
|
“Batch”
|
means
the Product derived from a single run of the Manufacturing Process,
yielding approximately
[***] of Product.
|
|
|
|
|
"Batch
Price"
|
means
the Price of each Batch.
|
|
|
|
|
“Binding
Forecast”
|
has the
meaning given in Section 6.1.
|
|
|
|
|
“Campaign”
|
means a
series of cGMP Batches manufactured consecutively.
|
|
|
|
|
“Cancellation
Fee”
|
has the
meaning given in Section 6.7.
|
|
|
|
|
“Capacity
Reservation”
|
has the
meaning given in Section 6.5.
|
|
|
|
|
“Certificate
of Analysis”
|
means a
document prepared by Lonza listing tests performed by Lonza or
approved External Laboratories, the Specifications and test
results.
|
|
|
|
|
“cGMP”
|
means
those laws and regulations applicable in the Territory, relating to
the manufacture of medicinal products for human use, including,
without limitation, current good manufacturing practices as
specified in the ICH guidelines, including without limitation, ICH
Q7A “ICH Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients”, US Federal Food Drug and
Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the
Guide to Good Manufacturing Practices for Medicinal Products as
promulgated under European Directive 91/356/EEC, each as may be
amended from time to time. For the avoidance of doubt,
Lonza’s operational quality standards are defined in internal
cGMP policy documents.
|
|
|
|
|
“cGMP
Batches”
|
means
any Batches which are required under the Project Plan to be
manufactured in accordance with cGMP.
|
4
|
|
|
|
“Change”
|
means
any change to the Services, Specifications, pricing or Scope of
Work incorporated into a written amendment to the Agreement in
accordance with clause 15.2 or effected in accordance with the
Quality Agreement.
|
|
|
|
|
“Change
Order”
|
means a
document in the format provided in Appendix E provided by Lonza to Customer
outlining a proposed adjustment (increase or decrease) to the Price
and the reasons for such adjustment, such document to be reviewed
and signed by both parties to enable such adjustment to take
effect.
|
|
|
|
|
“Commencement
Date”
|
means
the date of commencement of manufacturing activities for a Campaign
or Batch hereunder.
|
|
|
|
|
“Confidential
Information”
|
means
Customer Information and Lonza Information, as the context
requires.
|
|
|
|
|
“Customer
Indemnitees”
|
has the
meaning given in Section 11.1.
|
|
|
|
|
“Customer
Information”
|
means
all information that is proprietary to Customer or any Affiliate of
Customer and that is maintained in confidence by Customer or any
Affiliate of Customer and that is disclosed by Customer or any
Affiliate of Customer to Lonza under or in connection with this
Agreement, including without limitation, the Manufacturing Process,
any and all Customer know-how and trade secrets, and any materials
supplied by Customer to Lonza in accordance with this
Agreement.
|
|
|
|
|
“Delivery
Date”
|
means
the delivery date of a Batch as set forth in a Purchase Order and
confirmed by Lonza in accordance with Section 6.3.
|
|
|
|
|
“Disclosing
Party”
|
has the
meaning given in Section 12.1.
|
|
|
|
|
“EMA”
|
means
the European Medicines Agency, or any successor agency
thereto.
|
|
|
|
|
“External
Laboratories”
|
means
any Third Party instructed by Lonza, with Customer’s prior
consent, which is to conduct activities required to complete the
Services.
|
|
|
|
|
“Facility”
|
means
Lonza’s manufacturing facilities in
[***] or such
other Lonza facility as may be agreed upon by the
Parties.
|
|
|
|
|
“Failure
to Supply”
|
has the
meaning given in Section 7.4.1.
|
5
|
|
|
|
“FDA”
|
means
the United States Food and Drug Administration, or any successor
agency thereto.
|
|
|
|
|
“Forecast”
|
has the
meaning given in Section 6.1.
|
|
|
|
|
“Governmental
Authority”
|
means
any Regulatory Authority and any national, multi-national,
regional, state or local regulatory agency, department, bureau, or
other governmental entity in the Territory.
|
|
|
|
|
“Intellectual
Property”
|
means
(i) inventions (whether or not patentable), patents, trade secrets,
copyrights, trademarks, trade names and domain names, rights in
designs, rights in computer software, database rights, rights in
confidential information (including know-how) and any other
intellectual property rights, in each case whether registered or
unregistered, and (ii) all applications (or rights to apply) for,
and renewals or extensions of, any of the rights described in the
foregoing clause (i) in each case, which exist now or which come to
exist in the future, anywhere in the world.
|
|
|
|
|
“LOI”
|
has the
meaning given in Section 2.4.
|
|
|
|
|
“LOI
Batch”
|
has the
meaning given in Section 2.4.
|
|
|
|
|
“Lonza
Indemnitees”
|
has the
meaning given in Section11.2.
|
|
|
|
|
“Lonza
Information”
|
means
all information that is proprietary to Lonza or any Affiliate of
Lonza and that is maintained in confidence by Lonza or any
Affiliate of Lonza and that is disclosed by Lonza or any Affiliate
of Lonza to Customer under or in connection with this Agreement,
including without limitation, any and all Lonza know-how and trade
secrets.
|
|
|
|
|
“Lonza
Manufacturing-related IP”
|
has the
meaning given in Section 9.7.
|
|
|
|
|
“Lonza
Release”
|
has the
meaning given in Section 7.1.
|
|
|
|
|
“Manufacturing
Process”
|
means
the production process provided by Customer for the manufacture of Product, as
such process may be improved or modified from time to time by
agreement of the Parties in writing.
|
|
|
|
|
“Master
Batch Record”
|
means
the document, proposed by Lonza and approved by Customer, which
defines the manufacturing methods, test methods and other
procedures, directions and controls associated with the manufacture
and testing of Product.
|
|
|
|
|
“Minimum
Quantity”
|
has the
meaning given in Section 6.4.
|
6
|
|
|
|
“Minimum
Quantity Penalty”
|
has the
meaning given in Section 6.4.
|
|
|
|
|
“Necessary
Consumables”
|
has the
meaning given in Section 2.8.
|
|
|
|
|
“New
Customer Intellectual Property”
|
has the
meaning given in Section 9.2.
|
|
|
|
|
"New
General Application Intellectual Property”
|
has the
meaning given in Section 9.3.
|
|
|
|
|
“Party”
|
means
each of Lonza and Customer and, together, the
“Parties”.
|
|
|
|
|
“Price”
|
means
the price for the Services and Products as set out in Appendix
A.
|
|
|
|
|
“Process
Validation Batch”
|
means a
Batch that is produced with the intent to show reproducibility of
the Manufacturing Process and is required to complete process
validation studies.
|
|
|
|
|
“Product”
|
means
the proprietary molecule identified by Customer as PI-001
(Bremelanotide), to be manufactured using the Manufacturing Process
by Lonza for Customer as specified in the Project
Plan.
|
|
|
|
|
“Project
Plan”
|
means
the plan(s) describing the Services to be performed by Lonza under
this Agreement, including any update and amendment of the Project
Plan to which the Parties may agree from time to time. The initial
Project Plan is attached hereto as Appendix B.
|
|
|
|
|
“Purchase
Order”
|
has the
meaning set forth in Section 6.2.
|
|
|
|
|
“Quality
Agreement”
|
means
the quality agreement, attached hereto as Appendix C, setting out the
responsibilities of the Parties in relation to quality as required
for compliance with the Manufacturing Process, Specifications and
cGMP.
|
|
|
|
|
“Raw
Materials”
|
means
all general ingredients, solvents, amino acids, and other
components of the Product required to perform the Manufacturing
Process or Services set forth in the bill of materials detailing
the same (excluding
[***], which is defined as “Specialty Material”
herein).
|
|
|
|
|
“Receiving
Party”
|
has the
meaning given in Section 12.1.
|
|
|
|
|
“Specialty
Material”
|
means
[***].
|
|
|
|
|
"Specialty
Material Fee"
|
means a
procurement and handling fee of
[***] of the acquisition cost of Specialty Material
by
|
7
Lonza
that is charged to the Customer in accordance with Section 2.9. In
the event that Specialty Material will be used less than
[***] times,
the handling fee for the next purchase of Specialty Materials shall
be reduced to
[***].
|
|
|
|
“Regulatory
Authority”
|
means
the FDA, EMA and any other similar regulatory authorities in the
Territory.
|
|
|
|
|
“Release
for Delivery”
|
has the
meaning given in Clause 7.1.
|
|
|
|
|
“Services”
|
means
all or any part of the services to be performed by Lonza under this
Agreement (including, without limitation, process and analytical
method transfer, process development, process optimization,
validation, clinical and commercial manufacturing, as well as
quality control and quality assurance activities), particulars of
which are set out in a Project Plan and the Quality
Agreement.
|
|
|
|
|
“Specifications”
|
means
the specifications of the Product as specified in Appendix D, which may be amended from
time to time in accordance with this Agreement.
|
|
|
|
|
“Term”
|
has the
meaning given in Section 13.1.
|
|
|
|
|
“Territory”
|
means
the United States, European Union and such other countries as may
be agreed upon by the Parties.
|
|
|
|
|
“Third
Party”
|
means
any party other than Customer, Lonza and their respective
Affiliates.
|
|
|
|
|
“Up-Front
Payment”
|
has the
meaning set forth in Appendix
A.
|
In this
Agreement references to the Parties are to the Parties to this
Agreement, headings are used for convenience only and do not affect
its interpretation, references to a statutory provision include
references to the statutory provision as modified or re-enacted or
both from time to time and to any subordinate legislation made
under the statutory provision, references to the singular include
the plural and vice versa, and references to the word
“including” are to be construed without
limitation.
2 Commitments
and Performance of Services
|
|
|
|
2.1
|
Performance of Services. Lonza shall itself and through its
Affiliates, diligently carry out the Services as provided in the
Project Plan. Lonza shall retain appropriately qualified and
trained personnel with the requisite knowledge and experience to
perform the Services in accordance with this Agreement. Lonza may
subcontract or delegate any of its rights or obligations under this
Agreement to an External Laboratory to perform the Services only
with prior written consent from Customer; provided, that any
External Laboratories shall be subject to the same obligations and
other provisions contained in this Agreement or any applicable
Project Plan. In the event that Customer requests
|
8
Lonza
to outsource certain services to an External Laboratory appointed
by Customer, Lonza shall not be responsible for analytical lab
services performed by External Laboratories.
|
|
|
|
2.2
|
cGMP
Batch(es). Lonza will, in accordance with the terms of this
Agreement and Quality Agreement, manufacture at the Facility and
deliver to Customer, cGMP Batches that comply with the
Manufacturing Process, cGMP and the Specifications, together with a
Certificate of Analysis and all other documentation as set forth in
the Quality Agreement. Prior to commencement of cGMP manufacturing
in 2018, Lonza shall review the process assumptions. In the event
that there is a material difference in the process assumptions as
compared with the process results demonstrated during previous
manufacturing campaigns, the Parties shall meet to discuss in good
faith to resolve the matter.
|
|
|
|
|
2.2.1
|
Notwithstanding
anything herein to the contrary or in the Quality Agreement, except
as otherwise agreed to by Customer in writing or as may be required
to comply with Applicable Laws (including cGMPs), Lonza shall not
amend, change, or supplement any of the following without
Customer’s prior written consent: (1) the Specifications; (2)
the specifications for or the source of Raw Materials or Specialty
Materials that have regulatory impact; (3) the equipment and
machinery, other than in-kind replacements, used in the manufacture
of Product that have a direct impact on the quality of the Product;
(4) the test methods used in connection with manufacturing Product
that have regulatory impact; or (5) the Manufacturing
Process.
|
|
|
|
|
2.2.2
|
In the
event that Lonza is required to change any of the foregoing in
order to comply with a change in an Applicable Law (including
cGMPs) or such change is otherwise agreed to by Customer in
writing, Lonza shall: (i) immediately notify Customer of such
change and use commercially reasonable efforts to implement such
change as soon as reasonably practicable; (ii) be responsible for
ensuring that all Product manufactured following such change meets
the Specifications; and (iii) provide Customer with all information
with respect to the manufacture of the Product in connection with
such change needed to amend any regulatory filings maintained with
respect to the Product.
[***].
|
|
|
|
|
2.2.3
|
In the
event that Customer desires to propose a discretionary change
(i.e., changes which are not required by cGMPs or other Applicable
Laws) under Section 2.2.1 during the Term, the Parties shall
discuss such discretionary changes and any manufacturing issues
identified by either Party in connection with implementing such
change. In all cases, such discretionary changes shall be made in
accordance with any change control procedures in the Quality
Agreement to the extent applicable.
[***].
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2.2.4
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In the
event that Lonza desires to propose a discretionary change (i.e.,
changes which are not required by cGMPs or other Applicable Laws)
under Section 2.2.1 during the Term, the Parties shall discuss such
discretionary changes and any manufacturing issues identified by
either Party in connection with implementing such change. In all
cases, such discretionary changes shall be made in accordance with
any change control procedures in the Quality Agreement to the
extent applicable.
[***].
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2.2.5
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Lonza
acknowledges that any such change(s) under this Section 2.2 shall,
in each case, comply with cGMP, this Agreement and the Quality
Agreement. Any
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9
such
amended Specifications shall be reflected in and attached hereto as
an amended and restated Appendix
D.
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2.3
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Process Validation Batches. Customer may request Lonza to
manufacture and deliver Process Validation Batches as mutually
agreed by Parties sufficient to document the operability and
reproducibility of the Manufacturing Process and permit the Parties
to complete and file the necessary regulatory documents. Any and
all validation effort shall be additional and outside the scope of
this Project Plan. No Validation effort is currently anticipated as
part of the current Project Plan.
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2.3.1
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Upon
request of Customer, Lonza and Customer shall further discuss and
agree to a process validation plan identifying the validation
requirements of the Manufacturing Process. Any and all process
validation activities are not considered as part of the Project
Plan and are excluded from the Prices within this Agreement. Any
such future Process Validation or Process Validation Batches shall
be approved by the Customer in advance and shall be paid for by the
Customer at a Price to be determined in a separate Project
Plan.
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2.4
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Letter of Intent. The Parties entered into a Letter of
Intent dated
[***] (the “LOI”)
[***] (the “LOI
[***]”). In accordance with Sections 6(c) and 11 of
the LOI, the terms covenants and conditions of this Agreement
govern the supply of the LOI
[***] and such LOI
[***] is deemed to be Product manufactured by Lonza and
supplied to AMAG under this Agreement. In the event of a conflict
between this Agreement and the LOI, this Agreement shall
control.
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2.5
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Regulatory Support Activities. Any regulatory support
documentation (including, without limitation, documentation related
to pre-Approval inspection and provision of any data and
information (in English) relating to Lonza’s performance
under this Agreement) required and agreed to by Customer to support
and maintain the Approval of the Product from the Facility shall be
performed and supported by Lonza as reasonably requested by
Customer.
[***]. If required, additional regulatory support activities
shall be approved by the Customer in advance,
[***] at a price set out in a separate Project
Plan.
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2.6
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Commercial manufacturing and supply. Customer shall purchase
Product from Lonza during the Term at the Price outlined in
Attachment A. Lonza shall
manufacture all Product as ordered and accepted per Section 6,
under this Agreement at the Facility and pursuant to the terms
hereof and the Quality Agreement. Manufacturing of Product may not
be relocated from the Facility without Customer’s prior
written consent.
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2.7
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Supply of Customer Information. Customer shall supply to
Lonza all Customer Information and other information or materials
that may be reasonably required by Lonza to perform the Services.
Lonza shall not be responsible for any delays arising out of
Customer’s failure to provide such Customer Information or
other information or materials reasonably required to perform the
Services to Lonza.
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2.8
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Raw Materials. Lonza shall procure all required Raw
Materials as well as consumables necessary to perform the Services
(the “Necessary
Consumables”). In order to fulfil its obligations
under this Agreement, Lonza may purchase and hold a minimum of
[***] extra Batch’s requirements of Raw Materials to
serve as safety stock.
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2.9
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Specialty Material and Specialty Material Fee. Specialty
Material is not considered part of the Raw Materials and shall be
ordered and invoiced separately from Raw Materials. Specialty
Material shall be ordered and stocked by Lonza only upon reasonable
notice
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10
to and
approval by Customer, such notice not to be unreasonably withheld.
The Specialty Material Fee is intended compensate Lonza for the
procurement and handling of the Specialty Material, any development
or validation efforts Lonza performs in order to prepare, use,
clean and/or store Specialty Material (including any
experimentation to determine the number of times Specialty Material
may be reused), and Lonza’s preparation, use, cleaning and/or
storage of Specialty Material. Lonza shall submit an invoice to
Customer, together with sufficient substantiating documentation,
for the cost of Specialty Material and the associated Specialty
Material Fee. Customer shall pay invoices under this Section in
accordance with Section 8.
3 Project
Management / Steering Committee
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3.1
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Project Plan. With respect to the Services to be governed by
this Agreement, a Project Plan shall be added by agreement in a
writing signed by the Parties and appended to Appendix B. The
Project Plan shall include a description of the Services to be
provided and such other information as is necessary for performance
of the Services. In the event of a conflict between the terms of a
Project Plan and this Agreement, the terms of this Agreement will
govern unless the terms of the Project Plan expressly override the
terms of the Agreement set forth herein.
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3.2
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Project Management. Each party will appoint a project
manager who will be the party responsible for overseeing the
Project Plan.
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3.3
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Steering Committee. Each Party shall name a mutually agreed
upon equal number of representatives for the Steering Committee,
which shall meet twice per calendar year, or as otherwise mutually
agreed by the Parties. In the event that a Steering Committee
dispute cannot be resolved, such dispute shall be escalated to a
senior executive of each of Customer and Lonza.
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The
primary function of the Steering Committee is to ensure the ongoing
communication between the Parties and discuss and resolve any
issues arising under this Agreement. In addition to the primary
function described above, the Steering Committee shall also take on
the following responsibilities:
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3.3.1
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discuss
and seek resolution of issues around management of the
Services;
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3.3.2
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agree
and monitor deadlines and milestones for the Services;
and
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3.3.3
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discuss
and recommend any changes to the Services (although such changes
will not take effect until they have been incorporated into a
written amendment to the Project Plan which has been signed by the
Parties).
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3.4
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Person in Plant. In addition to the inspection and audit
rights set forth in Section 4.2 and the Quality Agreement, Customer
shall be permitted to have, at no additional cost,
[***] at the
Facility as reasonably requested by Customer,
[***] the Manufacturing Process for the purpose of
observing, reporting on, and consulting as to the performance of
the Services. Such
[***] shall be subject to and agree to abide by
confidentiality obligations of this Agreement and Lonza’s
customary practices and operating procedures regarding persons in
plant, and such
[***] agrees to comply with all instructions of
Lonza’s employees at the Facility.
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4 Quality
11
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4.1
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Responsibility
for quality assurance and quality control of Product shall be
allocated between Customer and Lonza as set forth in the Quality
Agreement. If there is a conflict between the terms and conditions
of this Agreement and the Quality Agreement, the terms and
conditions of this Agreement shall prevail except on quality
matters where the Quality Agreement shall prevail. Lonza and
Customer commit to enter into the Quality Agreement in a timely
manner, but in no event later than the commencement of cGMP
manufacturing.
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4.2
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Inspections
by Regulatory Authorities and audits shall be in accordance with
the Quality Agreement.
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5 Insurance
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5.1
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Each
Party shall, during the Term and for
[***] years
after delivery of the last Product manufactured or Services
provided under this Agreement, obtain and maintain
[***] from a qualified insurance company, comprehensive
general liability insurance including, but not limited to product
liability coverage in the amount of at least
[***] per claim. Each Party shall provide the respective
other Party with a copy of the certificate of such insurance upon
reasonable request.
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6 Forecasting,
Ordering and Cancellation
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6.1
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Forecast and Binding Forecast. No later than the first (1st)
day of each calendar quarter, Customer shall supply Lonza with a
written forecast showing Customer’s good faith estimated
quarterly requirements for Batches for the following
[***] period (the “Forecast”). No later than
[***] following Lonza’s receipt of a Forecast, Lonza
shall provide written notice to Customer of whether it has (as of
the date of receipt of the Forecast) capacity available to
manufacture the number of Batches forecasted therein and shall
provide Customer with an estimated production schedule showing the
estimated Commencement Date and delivery date of each Batch. In the
event Customer disputes all or a portion of such production
schedule provided by Lonza, the Parties agree to negotiate in good
faith the disputed portion(s) of such production schedule. Upon
agreement between the Parties regarding the production schedule set
forth in the Forecast, the first
[***] of such Forecast shall be binding on both Parties (the
“Binding
Forecast”). For the sake of clarity, such Binding
Forecast shall include at least the Minimum Quantity as set forth
in Section 6.4. If the Binding Forecast exceeds the Capacity
Reservation as set forth in Section 6.5, Lonza will use
commercially reasonable efforts to include such excess Batch(es) in
its production schedule.
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6.2
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Purchase Order. Customer shall provide Lonza with a binding
purchase order in writing (the “Purchase Order”) a minimum of
[***] prior to the scheduled Commencement Date of each Batch
consistent with the Binding Forecast under Section
6.1.
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6.3
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Purchase Order Confirmation. Lonza shall confirm the
delivery date as set out in each Purchase Order within
[***] business days of receipt from Customer of the relevant
Purchase Order (the “Delivery
Date”). Upon confirmation, each Purchase Order will be
regarded by the Parties as a binding commitment by Lonza to
manufacture and to deliver to Customer the Batch according to the
requirements set out in such Purchase Order. Lonza will make
commercially reasonable efforts to effect delivery as close as
possible to the Delivery Date set forth in the Purchase Order
confirmation, provided that in no event shall actual delivery be
greater than
[***] before or after such Delivery Date.
[***]. Any additional or inconsistent terms or conditions of
any Purchase Order, acknowledgement or similar standardized form
given or received pursuant to this
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12
Section
shall have no effect and such additional or inconsistent terms or
conditions are hereby rejected.
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6.4
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Minimum Quantity. Customer undertakes to purchase from Lonza
a minimum of
[***] per calendar year during the Term of the Agreement
(“Minimum
Quantity”). For the purposes of this section, a Batch
is considered “purchased” as of the Commencement Date
in the Purchase Order confirmed by Lonza in accordance with Section
6.3. If Customer fails to purchase the Minimum Quantities in any
calendar year, Lonza shall submit an invoice to Customer in January
of the next calendar year and Customer shall pay the
[***] ("Minimum Quantity
Penalty"), within
[***] after receipt of such invoice.
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6.5
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Capacity Reservation.
Lonza shall reserve capacity to manufacture the Minimum Quantity
agreed between the Parties plus
[***] per applicable calendar year during the Term of the
Agreement, starting in 2019 (“Capacity
Reservation”).
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6.6
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First Commercial Batch. Lonza agrees to manufacture
[***]. This commercial
[***] will be manufactured in accordance with the
Specifications. The Parties agreed upon the pricing of
[***] in the Letter of Intent entered into as
[***].
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6.7
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Cancellation Fee. Customer may cancel a Purchase Order upon
written notice to Lonza, subject to the payment of a cancellation
fee equal to
[***] with supplier, of each such Batch cancelled under the
Purchase Order (the "Cancellation
Fee"). Any Up-Front Payment paid by Customer to Lonza in
accordance with Appendix A
shall be deducted from such Cancellation Fee; provided, however, to
the extent that such Up-Front Payment was used by Lonza to purchase
Raw Materials in reliance on such cancelled Purchase Order, (i) the
cost of such Raw Materials, as substantiated by sufficient
documentation, shall not be deducted from the Cancellation Fee, and
(ii) such Raw Materials shall be used by Lonza in the preparation
of a subsequent Batch (and the cost of such Raw Materials shall be
deducted from the Batch Price for such subsequent Batch) or
otherwise disposed of at Customer’s direction. Any
Cancellation Fee shall be payable in accordance with Section 8
herein. For the purpose of calculating whether Customer has
purchased the Minimum Quantity in accordance with Section 6.4, any
Batch in a Purchase Order that is cancelled under this Section 6.7
and for which the applicable Cancellation Fee has been paid by
Customer will be considered a Batch “purchased” as of
the Commencement Date in such cancelled Purchase
Order.
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6.8
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Rescheduling. Lonza shall have the right to reschedule a
Commencement Date of any Batch or Campaign once upon
[***] prior written notice to Customer, provided that the
resulting rescheduled Delivery Date is targeted not to exceed
[***] later than the confirmed Delivery Date and for the
purpose of calculating whether Customer has purchased the Minimum
Quantity in accordance with Section 6.4, such rescheduled Batch
will be considered “purchased” as of the original
Commencement Date in the confirmed Purchase Order. If the Customer
requests to change the Commencement Date, Lonza will make all
reasonable attempts to accommodate the request; provided, however,
in the event that this change would impact other projects scheduled
for occupancy in the designated suite or suites, manufacture of the
Customer’s Batch or Campaign may be delayed until an adequate
time period is available in the Facility schedule. Parties shall
discuss in good faith the impact such rescheduling request has. Any
delay requested by Customer of more than
[***] shall be considered a cancellation of the Purchase
Order and shall be subject to the Cancellation Fee set forth in
Section 6.7.
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13
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6.9
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Product
Quantities. A Batch of
[***] of Product (the “Target Quantity”), up to
a maximum of
[***] above or below, will be invoiced according to the
Batch Price as set forth in Appendix A.
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In case
of quantities below
[***] of the Target Quantity), Lonza shall invoice and
Customer shall pay (i) the Batch Price minus (ii) the Batch Price
multiplied by the number of kilograms produced less than
[***] divided by the Target Quantity. For example: In case
the quantity is
[***]))).
In case
of quantities above
[***] of the Target Quantity) Lonza shall invoice and
Customer shall pay (i) the Batch Price plus (ii) the Batch Price
multiplied by the number of kilograms produced in excess of
[***] divided by the Target Quantity. For example: In case
the quantity is
[***]))).
The
Purchase Order shall be fulfilled if at least
[***] of the Target Quantity is delivered. In the event that
[***] or less
of the Target Quantity for any Batch is delivered, (a) the Parties
will negotiate in good faith the scheduling of the manufacture of a
subsequent Batch, and Lonza will use its best efforts to prioritize
the scheduling of such subsequent Batch so as to minimize
disruption of Customer’s supply of Product, and (b) at
Customer’s discretion, such subsequent Batch shall be
considered a Batch “purchased” in the next calendar
year for purposes of calculating whether Company has purchased the
Minimum Quantity in accordance with Section 6.4.
7 Delivery
and Acceptance
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7.1
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Delivery. Lonza shall deliver to Customer all documentation
as set forth in the Quality Agreement and as is reasonably required
to meet all applicable regulatory requirements of the Governmental
Authorities, including without limitation Master Batch Records,
Certificates of Analysis, deviations, and Batch records in
accordance with the Quality Agreement (the “Lonza Release”). After the Lonza
Release,
[***] in accordance with Appendix A and Section 8. Customer shall
be responsible for reviewing such documentation and for final
release for delivery of the Product to Customer within
[***] after Lonza Release in accordance with the Quality
Agreement, and upon approval of such documentation by Customer,
Lonza shall deliver the Product
[***] on a date mutually agreed to by the Parties in
accordance with Section 7.2 (the “Release for Delivery”) and title
and risk of loss shall transfer to Customer
[***].
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7.2
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Storage. Customer shall arrange for shipment and take
delivery of such Batch from the Facility, at
[***] expense, within
[***] after Lonza Release or
[***]. Lonza shall provide storage in accordance with the
requirements set forth in the Quality Agreement on a bill and hold
basis for such Batch(es) at
[***] for up to
[***]; provided that any additional storage beyond
[***]. In addition to Section 8.2, below,
[***] shall be responsible for all value added tax (VAT) and
any other applicable taxes, levies, import, duties and fees of
whatever nature imposed as a result of any storage. Notwithstanding
anything to the contrary contained in this Agreement, in no event
shall Lonza be required to store any Batch for more than
[***] after Release for Delivery. Within
[***] following a written request from Lonza, Customer shall
provide Lonza with a letter in form satisfactory to Lonza
confirming the bill and hold status of each stored
Batch.
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7.3
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Acceptance/Rejection
of Product.
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7.3.1
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Promptly
following Lonza Release of a Batch, Customer shall inspect such
Batch and shall have the right to test such Batch to determine
compliance with the
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14
Product
Specifications. Customer shall notify Lonza in writing of any
rejection of a Batch based on any claim that it fails to meet
Specifications within
[***] of Release for Delivery, after which time all
unrejected Batches shall be deemed accepted. Customer shall inform
Lonza in writing in case of concealed or latent defects (i.e. not
discovered by routine quality control means), promptly upon
discovery of such defects but no later than
[***] after delivery of the Product.
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7.3.2
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In the
event that Lonza believes that a Batch has been incorrectly
rejected, Lonza may require that Customer provide to it Batch
samples for testing. Lonza may retain and test the samples of such
Batch. In the event of a discrepancy between Customer’s and
Lonza’s test results such that Lonza’s test results
fall within relevant Specifications, or there exists a dispute
between the Parties over the extent to which such failure is
attributable to a given Party, the Parties shall cause an
independent laboratory promptly to review records, test data and
perform comparative tests and analyses on samples of the Product
that allegedly fails to conform to Specifications. Such independent
laboratory shall be mutually agreed upon by the Parties. The
independent laboratory’s results shall be in writing and
shall be final and binding save for manifest error. Unless
otherwise agreed to by the Parties in writing, the costs associated
with such testing and review shall be borne by the Party against
whom the independent laboratory rules.
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7.3.3
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Lonza
shall Reprocess or Rework any Batch, as defined in the Quality
Agreement, or, if Reprocessing or Reworking is not possible,
replace any Batch that fails to conform with the Specifications (a
“Failed Batch”).
In the event that such failure of the Failed Batch is determined by
the Parties or the independent laboratory in accordance with
Section 7.3.2 to be attributable to the Manufacturing Process
supplied to Lonza by Customer (“AMAG Failed Batch”), then such
Reprocessing, Reworking or replacement will be at
[***] cost, including the cost of Raw Materials and
Necessary Consumables, according to a schedule mutually agreed to
by the Parties, which shall in any event be as promptly as
practicable.
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In the
event that it is determined by the Parties or the independent
laboratory in accordance with Section 7.3.2 that such failure of
the Failed Batch is not attributable to the Manufacturing Process
supplied to Lonza by Customer (“Lonza Failed Batch”), then such
Reprocessing, Reworking or replacement will be at
[***] cost, including the cost of Raw Materials and
Necessary Consumables, and according to a schedule mutually agreed
to by the Parties, which shall in any event be as promptly as
practicable. If Lonza is or will be unable to (i) Reprocess or
Rework such Lonza Failed Batch and deliver the resulting Product
within
[***] of the Delivery Date, or (ii) replace such Lonza
Failed Batch and deliver the resulting Product within
[***] of the Delivery Date, then in either case Lonza shall
instead, at Customer’s discretion, refund the Batch Price of
the Lonza Failed Batch to Customer. In the event that
[***] or more consecutive Lonza Failed Batches occur during
the Term, Customer may, at its discretion, terminate this
Agreement.
Regardless of the
remedy elected by Customer under this Section 7.3.3, for the
purpose of calculating whether Customer has purchased the Minimum
Quantity in accordance with Section 6.4, a Failed Batch shall be
considered a Batch “purchased” on the Commencement Date
of such Batch as specified in the Purchase Order.
15
Except
for Lonza’s indemnification obligations set forth in Section
11.1, Customer acknowledges and agrees that its sole remedy with
respect to a Lonza Failed Batch is as set forth in this Section,
and in furtherance thereof, Customer hereby waives all other
remedies at law or in equity regarding the foregoing
claims.
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7.4
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Failure to Supply
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7.4.1
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If
Lonza is or will be unable, for any reason (not including an event
of Force Majeure under Section 14 hereof) to supply a Batch in
accordance with the quantity and/or on the Delivery Date specified
in a Purchase Order confirmed by Lonza in accordance with Section
6.3 or as rescheduled in accordance with Section 6.8
(“Failure to
Supply”), Lonza shall immediately upon discovery
notify Customer in writing of such circumstance. Within
[***] of discovery of such Failure to Supply, Lonza shall
notify Customer of the cause of such failure and shall propose a
plan of remediation.
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7.4.2
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If
Lonza is unable to remedy the Failure to Supply within
[***] after the Delivery Date specified in the Purchase
Order confirmed by Lonza in accordance with Section 6.3, then
Customer may, at its discretion, cancel such Purchase Order,
provided that in the event of such a cancellation, (i) the
Cancellation Fee set forth in Section 6.7 shall not apply to such
canceled Purchase Order, (ii) the Batch set forth in such canceled
Purchase Order shall be considered a Batch “purchased”
on the Commencement Date of such Batch as specified in the Purchase
Order for purposes of calculating whether Company has purchased the
Minimum Quantity in accordance with Section 6.4, and (iii) any
Up-Front Payment paid by Customer to Lonza according to
Appendix A shall be, at
Customer’s discretion, fully refunded to Customer or applied
to the Batch Price for a subsequent Batch.
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7.4.3
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Lonza
shall promptly notify Customer when Lonza can resume supply of
Product in accordance with this Agreement and provide Customer with
a date for Delivery of the Product in accordance with
Customer’s needs.
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7.4.4
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In the
event that
[***] or more consecutive Supply Failures occur during the
Term, Customer may, at its discretion, terminate this
Agreement.
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8 Price
and Payment
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8.1
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Pricing
for the Services provided by Lonza are set out in, and based on the
assumptions and information set out in Appendix A.
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8.2
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Unless
otherwise indicated in writing by Lonza, all Prices and charges are
exclusive of value added tax (VAT) and of any other applicable
taxes, levies, import, duties and fees of whatever nature imposed
by or under the authority of any government or public authority and
all such charges applicable to the Services shall be paid by
Customer.
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8.3
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All
invoices are strictly net of any deduction and payment must be made
within
[***] of date of receipt of invoice. Customer will inform
Lonza in writing if it disputes any invoice or amounts specified
therein within
[***] of its receipt thereof.
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8.4
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Any
payments due hereunder which are not made within
[***] after the due date of such payments shall be subject
to default interest at the lesser of (i) rate of
[***] per month or (ii) the
[***], such interest to accrue on a day to day basis until
full payment, provided that if any portion of an invoice is
disputed by Customer on justified grounds,
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16
Customer
shall pay the undisputed amounts in accordance with the terms
above, and the Parties shall use good faith efforts to resolve
differences or discrepancies with regard to any disputed amount as
soon as practicable.
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8.5
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Price adjustments. Not more than once per calendar year,
Lonza may adjust the Batch Price in accordance with
[***] increase for the previous calendar year, such increase
not to exceed
[***] in any calendar year, provided that Lonza provides
Customer with sufficient documentation to substantiate such
proposed increase. The new Batch Price reflecting any such
adjustment shall be effective for any Batch for which the
Commencement Date is on or after the date of Lonza’s notice
to Customer of the Price adjustment. In the event of an adjustment
to the Batch Price under this Section 8.5, Lonza will submit a
Change Order to the pricing to substantiate the change at least
[***] prior to the proposed change, to be signed by both
Parties.
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8.6
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Capital Equipment. Any capital equipment required for the
performance of the Services shall be acquired on terms to be agreed
by the Parties prior to commencement of the relevant
Services.
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9 Intellectual
Property
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9.1
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Except
as expressly otherwise provided herein, neither Party will, as a
result of this Agreement, acquire any right, title, or interest in
any Background Intellectual Property of the other Party, including
any improvements made thereto during the Services under this
Agreement.
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9.2
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Subject
to Section 9.3, Customer shall own all right, title, and interest
in and to
[***] (collectively, the “New Customer Intellectual
Property”). For avoidance of doubt, New Customer
Intellectual Property shall include
[***].
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9.3
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Subject
to Section 9.2, and subject to the license granted in Section 9.5,
Lonza shall own all right, title and interest in
[***] (“New General
Application Intellectual Property”). For avoidance of
doubt, New General Application Intellectual Property shall include
[***].
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9.4
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Lonza
agrees to assign and hereby assigns to Customer all of its right,
title and interest in any New Customer Intellectual Property. Lonza
shall execute, and shall require its personnel as well as its
Affiliates, External Laboratories or other contractors or agents
and their personnel involved in the performance of the Services to
execute, any documents reasonably required to confirm
Customer’s ownership of the New Customer Intellectual
Property, and any documents required to apply for, maintain and
enforce any patent or other right in the New Customer Intellectual
Property. Customer agrees to assign and hereby assigns to Lonza all
of its right, title and interest in any New General Application
Intellectual Property. Customer shall execute, and shall require
its personnel as well as its Affiliates, or other contractors or
agents and their personnel involved in the performance of the
Services to execute, any documents reasonably required to confirm
Lonza’s ownership of the New General Application Intellectual
Property, and any documents required to apply for, maintain and
enforce any patent or other right in the New General Application
Intellectual Property.
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9.5
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Subject
to the terms and conditions set forth herein (including the payment
of the Price as required above), Lonza hereby grants to Customer a
non-exclusive, world-wide, fully paid-up, irrevocable, transferable
license, including the right to grant sublicenses, under the Lonza
Background Intellectual Property and the New General Application
Intellectual
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17
Property
to use, offer for sale, sell, export and import the Product
manufactured under this Agreement.
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9.6
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Subject
to the terms and conditions set forth herein, Customer hereby
grants Lonza the non-exclusive right to use the Customer
Information, Customer Background Intellectual Property and New
Customer Intellectual Property during the Term solely for the
purpose of fulfilling its obligations under this
Agreement.
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9.7
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Customer
has the right to transfer the Manufacturing Process to itself and
any Third Party. Lonza shall provide reasonably necessary documents
to complete such technology transfer and
[***] (based on a full-time employee rate for such support)
and expenses that are substantiated by sufficient documentation. If
any Lonza Confidential Information, Lonza Background Intellectual
Property, or New General Application Intellectual Property is
useful in manufacturing the Product (“Lonza Manufacturing-related IP”),
the Parties shall negotiate in good faith the terms and conditions
of a
[***] license under such Lonza Manufacturing-related IP for
the manufacture of the Product, provided, additionally, that any
such license shall be
[***].
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10 Representations
and Warranties
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10.1
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Lonza
represents and warrants that:
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10.1.1
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the
Services shall be performed in accordance with all Applicable
Laws;
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10.1.2
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except
with respect to any development services and preparation batches as
needed, the manufacture of Product shall be performed in accordance
with cGMP and the Quality Agreement and will, at the date of
delivery, meet the Specifications at the date of delivery and not
be adulterated or misbranded within the meaning of the U.S. Federal
Food, Drug and Cosmetic Act, or any similar Applicable
Laws;
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10.1.3
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it or
its Affiliate holds, and shall maintain during the Term, all
necessary permits, approvals, consents and licenses to enable it to
perform the Services at the Facility in accordance with Applicable
Laws, the Quality Agreement and this Agreement;
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10.1.4
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it is
under no contractual or other obligation or restriction that is
inconsistent with its execution or performance of this Agreement,
and it will not enter into any agreement, either written or oral,
that would conflict with its responsibilities under this
Agreement;
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10.1.5
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at the
Effective Date of this Agreement and to the best of its knowledge,
the performance and provision of Services will not infringe or
misappropriate any patent, trade secret or other proprietary or
Intellectual Property rights of any Third Party;
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10.1.6
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it will
promptly notify Customer in writing if it becomes aware of a claim
from a Third Party that its performance of the Services or the use,
offer for sale, sale, import or export by the Customer of the
Product manufactured under this Agreement infringes any
Intellectual Property or other rights of any Third
Party;
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10.1.7
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as of
the Effective Date of this Agreement and to the best of its
knowledge, any Third Party property that is either (i) used in
Lonza’s performance of the Services or (ii) incorporated into
the Services or the Product manufactured under this
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18
Agreement
or (iii) subject to a sub-license from Lonza to Customer under the
terms of this Agreement is under a valid license, with the right to
sublicense, from the Third Party;
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10.1.8
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Lonza,
its employees, affiliates, contractors, and agents used to perform
Services under this Agreement, and any of their respective officers
or directors, as applicable: (i) have not been debarred and are not
subject to a pending debarment, (ii) are not disqualified and are
not subject to a pending disqualification proceeding by any
government or regulatory agency from performing the Services, and
(iii) have not been convicted of a crime for which a person can be
debarred under Section 335(a) or 335(b) of the Federal Food, Drug,
and Cosmetic Act or under any analogous law or regulation under
Applicable Laws, and are not subject to any such pending action
upon execution of this Agreement; and Lonza will notify Customer
immediately if Lonza, its employees, affiliates, contractors, and
agents, or any person used to perform Services under this
Agreement, or any of their respective officers or directors, as
applicable, is subject to the foregoing, or if any action, suit,
claim, investigation, or proceeding relating to the foregoing is
pending, or to the best of Lonza’s knowledge, is threatened;
and
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10.1.9
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it has
the necessary corporate authorizations to enter into and perform
this Agreement.
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10.2
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Customer
warrants that:
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10.2.1
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at the
Effective Date of this Agreement and to the best of its knowledge,
Lonza’s use of the Customer Information and Customer
Intellectual Property in connection with the performance of the
Services shall not infringe any Third Party Intellectual Property
rights;
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10.2.2
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Customer
will promptly notify Lonza in writing if it becomes aware of a
claim from a Third Party that Customer Information and Customer
Intellectual Property or that the use by Lonza thereof for the
provision of the Services infringes any Intellectual Property or
other rights of any Third Party;
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10.2.3
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Customer
has the necessary corporate authorizations to enter into this
Agreement;
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10.2.4
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Customer,
its employees, affiliates, contractors, and agents used to perform
Services under this Agreement, and any of their respective officers
or directors, as applicable: (i) have not been debarred and are not
subject to a pending debarment, (ii) are not disqualified and are
not subject to a pending disqualification proceeding by any
government or regulatory agency from performing the Services, and
(iii) have not been convicted of a crime for which a person can be
debarred under Section 335(a) or 335(b) of the Federal Food, Drug,
and Cosmetic Act or under any analogous law or regulation under
Applicable Laws, and are not subject to any such pending action
upon execution of this Agreement upon execution of this Agreement;
and Customer will notify Lonza immediately if Lonza, its employees,
affiliates, contractors, and agents, or any person used to perform
Services under this Agreement, or any of their respective officers
or directors, as applicable, is subject to the foregoing, or if any
action, suit, claim, investigation, or proceeding relating to the
foregoing is pending, or to the best of Customer’s knowledge,
is threatened.
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19
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10.3
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The
Parties hereby acknowledge that Customer is publicly traded on the
NASDAQ National Market System under the symbol "AMAG".
Further, each party is aware and will advise its employees,
consultants and representatives who are informed of matters that
are the subject of this Agreement, of the restrictions imposed by
certain federal and state securities laws on the purchase or sale
of securities by any person who has received or had access to
material, nonpublic information concerning a company and on the
communication of such information to any other person when it is
reasonably foreseeable that such person is likely to purchase
or sell such securities in reliance on such
information.
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10.4
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DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS
AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND ALL OTHER
WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED,
INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
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11 Indemnification
and Liability
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11.1
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Indemnification by Lonza. Lonza shall indemnify the
Customer, its Affiliates, and their respective officers, employees
and agents (“Customer
Indemnitees”) for any loss, damage, costs and expenses
(including reasonable attorney fees) that Customer Indemnitees may
suffer as a result of any Third Party claim arising directly out of
(i) any material breach of the warranties given by Lonza in this
Agreement, or (ii) Lonza’s or Lonza’s
Indemnitees’ negligence or intentional misconduct in
performing any obligations under this Agreement, or (iii) any
claims alleging that the Services (excluding use by Lonza of
Customer Information and Customer Background Intellectual Property)
infringe any Intellectual Property rights of a Third Party except,
in each case, to the extent that such claims resulted from the
negligence, intentional misconduct or breach of this Agreement by
any Customer Indemnitees.
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11.2
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Indemnification by Customer. Customer shall indemnify Lonza,
its Affiliates, and their respective officers, employees and agents
(“Lonza
Indemnitees”) from and against any loss, damage, costs
and expenses (including reasonable attorney fees) that Lonza
Indemnitees may suffer as a result of any Third Party claim arising
directly out of (i) any material breach of the warranties
given by Customer in this Agreement, or (ii) any claims alleging
that Lonza’s use of the Customer Intellectual Property or
Customer Information in the performance of Services infringes any
Intellectual Property rights of Third Parties, or (iii)
Customer’s or Customer’s Indemnitees’ negligence
or intentional misconduct in performing any obligations under this
Agreement, or (iv) the manufacture (except pursuant to this
Agreement), use, sale, or distribution of any Product, including
any claims of product liability; except, in each case, to the
extent that such claims (A) resulted from the negligence,
intentional misconduct or breach of this Agreement by any Lonza
Indemnitees, or (B) resulted in any loss, damage, costs and
expenses (including reasonable attorney fees) for which Lonza is
liable pursuant to Clause 11.1 above.
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11.3
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Indemnification Procedure. If the Party to be indemnified
intends to claim indemnification under this Clause 11, it shall
promptly notify the indemnifying Party in writing of such claim.
The indemnitor shall have the right to control the defense and
settlement thereof; provided, however, that any indemnitee shall
have the right to retain its own counsel at its own expense. The
indemnitee, its employees and agents, shall reasonably cooperate
with the indemnitor in the investigation of any liability covered
by this Clause 11. The failure to deliver prompt written notice to
the indemnitor of any claim, to the extent prejudicial to its
ability to defend such claim, shall relieve the indemnitor of its
obligation
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20
to the
indemnitee under this Clause 11 to the extent so prejudiced. The
indemnitor shall not settle or compromise any claim in any manner
that could have an adverse effect upon any indemnitee without such
indemnitee’s consent, which shall not be unreasonably
withheld or delayed. The indemnitor shall not make any
admission of liability in respect of any claim without the prior
written consent of the indemnitee(s).
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11.4
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DISCLAIMER OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL
EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR
[***] ARISING FROM OR RELATED TO THIS AGREEMENT, EXCEPT TO
THE EXTENT RESULTING FROM FRAUD, NEGLIGENCE OR INTENTIONAL
MISCONDUCT, OR A BREACH OF SECTION 12.
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11.5
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LIMITATION OF LIABILITY. LONZA’S LIABILITY FOR DAMAGES
UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED,
[***] UNDER THIS AGREEMENT IN THE
[***] (OR IN THE CASE OF RELATED CAUSES OF ACTION,
[***]), EXCEPT TO THE EXTENT RESULTING FROM INDEMNIFIABLE
THIRD PARTY CLAIM UNDER CLAUSE 11.1 (i) OR (ii) ABOVE,
LONZA’S FRAUD,
NEGLIGENCE OR INTENTIONAL MISCONDUCT, OR A BREACH OF SECTION
12.
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12 Confidentiality
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12.1
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Except
as expressly permitted otherwise herein, the Party receiving
Confidential Information (the “Receiving Party”) agrees to
strictly keep secret any and all Confidential Information received
during the Term from or on behalf of the other Party (the
“Disclosing
Party”) using at least the same level of measures as
it uses to protect its own Confidential Information, but in any
case at least commercially reasonable and customary efforts.
Confidential Information shall include information disclosed in any
form including but not limited to in writing, orally, graphically
or in electronic or other form to the Receiving Party, observed by
the Receiving Party or its employees, agents, consultants, or
representatives, or otherwise learned by the Receiving Party under
this Agreement, which the Receiving Party knows or reasonably
should know is confidential or proprietary.
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12.2
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Notwithstanding
the foregoing, Receiving Party may disclose to any courts and/or
other authorities Confidential Information which is required to be
disclosed pursuant to applicable governmental or administrative or
public law, rule, regulation or order. In such case the Receiving
Party will, to the extent legally permitted, (i) inform the other
Party promptly in writing, (ii) cooperate with the Disclosing Party
to secure confidential treatment for such Confidential Information,
and (iii) seek to minimize the extent of Confidential Information
which is required to be disclosed to the courts and/or
authorities.
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12.3
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The
obligation to maintain confidentiality under this Agreement does
not apply to Confidential Information, which:
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12.3.1
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at the
time of disclosure was publicly available; or
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12.3.2
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is or
becomes publicly available other than as a result of a breach of
this Agreement by the Receiving Party; or
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12.3.3
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as the
Receiving Party can establish by contemporaneous written records,
was rightfully in its possession at the time of disclosure by the
Disclosing Party and had not been received from or on behalf of
Disclosing Party; or
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21
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12.3.4
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is
supplied to a Party by a Third Party which was not in breach of an
obligation of confidentiality to Disclosing Party or any other
party, as evidenced by contemporaneous written records;
or
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12.3.5
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is
developed by the Receiving Party independently from and without use
of the Confidential Information, as evidenced by contemporaneous
written records.
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12.4
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The
Receiving Party will use Confidential Information only for the
purposes of this Agreement and will not make any use of the
Confidential Information for its own separate benefit or the
benefit of any Third Party including, without limitation, with
respect to research or product development or any reverse
engineering or similar testing. The Receiving Party agrees to
return or destroy promptly (and certify such destruction) on
Disclosing Party’s request all written or tangible
Confidential Information of the Disclosing Party, except that one
copy of such Confidential Information may be kept by the Receiving
Party in its confidential files for record keeping purposes
only.
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12.5
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Each
Party will restrict the disclosure of Confidential Information to
such officers, employees, consultants and representatives of itself
and its Affiliates who have been informed of the confidential
nature of the Confidential Information and who have a need to know
such Confidential Information for the purpose of this Agreement.
Prior to disclosure to such persons, the Receiving Party shall bind
its and its Affiliates’ officers, employees, consultants and
representatives to confidentiality and non-use obligations no less
stringent than those set forth herein. The Receiving Party shall
notify the Disclosing Party as promptly as practicable of any
unauthorized use or disclosure of the Confidential
Information.
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12.6
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The
Receiving Party shall be fully liable for any and all breaches of
the confidentiality obligations in this Clause 13 by any of its
Affiliates or the officers, employees, consultants and
representatives of itself or its Affiliates.
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12.7
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Each
Party hereto expressly agrees that any breach or threatened breach
of the undertakings of confidentiality provided under this Clause
12 by a Party may cause irreparable harm to the other Party and
that money damages may not provide a sufficient remedy to the
non-breaching Party for any breach or threatened breach. In the
event of any breach and/or threatened breach, then, in addition to
all other remedies available at law or in equity, the non-breaching
Party shall be entitled to seek injunctive relief.
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12.8
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The
confidentiality and non-use obligations imposed by this Agreement
shall expire with respect to any particular item of a Disclosing
Party's Confidential Information on the
[***] anniversary of the date of disclosure of such
Confidential Information (and in the case of trade secrets, until
such time as such trade secrets are no longer accorded trade secret
status under
[***] law).
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13 Term
and Termination
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13.1
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Term. This Agreement shall commence on the Effective Date
and shall be in effect until
[***] (the "Term”). In order to avoid
interruptions in the supply of Product to Customer, at least
[***] prior
to the expiration of
the Term, the Parties shall meet (in person or telephonically) to
discuss whether or not to extend the Term of this Agreement or to
agree in good faith on a new agreement, which may include revisions
to the following terms:
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22
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13.1.1
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an
annual minimum supply quantity (kilograms or Batches) Customer
undertakes to purchase from Lonza;
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13.1.2
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a
minimum % of Customer's annual demand that Customer undertakes to
purchase from Lonza; and
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13.1.3
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the
option for Lonza to produce the Product in a dedicated
manufacturing asset.
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13.2
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Termination. This Agreement may be terminated as
follows:
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13.2.1
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by
either Party if the other Party breaches a material provision of
this Agreement and fails to cure such breach within
[***] for non-payment) following written notification of
such breach from the non-breaching party to the breaching party;
provided, however, that such
[***] (or
[***] for non-payment) period may be extended only if
mutually agreed to by the Parties if the identified breach is
incapable of cure within
[***] (or
[***] for non-payment) and if the breaching Party promptly
provides a plan and timeline to cure the breach, promptly commences
efforts to cure the breach and diligently prosecutes such
cure;
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13.2.2
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by
Customer, if the Product does not receive FDA approval and if
Customer notifies Lonza in writing, within
[***] that it wishes to terminate the Agreement for that
reason;
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13.2.3
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by
Customer, if Customer is required to withdraw the Product from the
market for regulatory or health and safety reasons, on
[***] prior written notice to Lonza;
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13.2.4
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by
either Party, immediately, if the other Party becomes insolvent, is
dissolved or liquidated, makes a general assignment for the benefit
of its creditors, or files or has filed against it, a petition in
bankruptcy or has a receiver appointed for a substantial part of
its assets, provided that, in the case of an involuntary
proceeding, such other Party may not terminate this Agreement if
the petition is dismissed within
[***] of filing; or
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13.2.5
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by
Customer pursuant to Section 7.3.3, 7.4.4 or 14.
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13.3
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Consequences of
Termination.
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13.3.1
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In the
event of termination hereunder by Lonza under Section 13.2.1, or
13.2.4 Lonza shall submit to Customer an invoice, together with
sufficient substantiating documentation, for (i) any applicable
[***] and (ii) any applicable
[***]. Customer shall pay such invoice in accordance with
Section 8. At Customer’s direction, with regard to any
[***].
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13.3.2
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In the
event of termination hereunder by Customer under Clause 13.2.2, or
13.2.3, (i) any Purchase Order(s) issued prior to the termination
date that have not been fulfilled will be cancelled and such
cancelled Purchase Orders shall not be subject to the Cancellation
Fee set forth in Section 6.7, and (ii) Lonza shall submit to
Customer an invoice, together with sufficient substantiating
documentation, for (a) the
[***], and (b)
[***] as set
forth in Section 6.4, if applicable. Customer shall pay such
invoice in accordance with Section 8. At Customer’s
direction, with regard to any
[***].
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23
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13.3.3
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In the
event of termination hereunder by Customer under Clause 13.2.1,
13.2.4 or 13.2.5, (i) any Purchase Order(s) issued prior to the
termination date that have not been fulfilled will be cancelled and
such cancelled Purchase Orders shall not be subject to the
Cancellation Fee set forth in Section 6.8, (ii) any
[***], and (iii)
[***]. In such event, Customer shall compensate Lonza only
for
[***].
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13.3.4
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In the
event of termination by either Party, each Party agrees to return
or destroy the other Party’s Confidential Information in
accordance with Clause 12.4.
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13.4
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Survival. Sections 2.5, 4, 5, 8, 9, 10, 11, 12, 13.3, 13.4,
15.1, 15.3, 15.4, 15.5 and 15.6 shall survive the termination or
expiration of this Agreement.
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14 Force
Majeure
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14.1
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If
either Party is prevented or delayed in the performance of any of
its obligations under the Agreement by Force Majeure and gives
written notice thereof to the other Party specifying the matters
constituting Force Majeure together with such evidence as the
affected Party reasonably can give and specifying the period for
which it is estimated that such prevention or delay will continue,
the affected Party shall be excused from the performance or the
punctual performance of such obligations as the case may be from
the date of such notice for so long as such cause of prevention or
delay shall continue, provided that such Party is obligated to
mitigate damages and to use best efforts to resume the fulfilment
of its contractual obligations as soon as reasonably possible.
Provided that, if such Force Majeure persists for a period of
[***] or more, the Party not affected by such force majeure
may terminate this Agreement by delivering written notice to the
affected Party, with immediate effect.
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14.2
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“Force
Majeure” shall be deemed to include any reason or cause
beyond a Party’s reasonable control affecting the performance
by the Party of its obligations under the Agreement, including, but
not limited to, acts of God, strike, lockouts, labor troubles,
restrictive governmental orders or decrees, riots, insurrection,
war, or terrorists acts.
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14.3
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Force
Majeure affecting services or production at Lonza’s
Affiliates shall be regarded as an event of Force
Majeure.
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15 Miscellaneous
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15.1
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Severability. If any provision hereof is or becomes at any
time illegal, invalid or unenforceable in any respect, neither the
legality, validity nor enforceability of the remaining provisions
hereof shall in any way be affected or impaired thereby. The
Parties hereto undertake to substitute any illegal, invalid or
unenforceable provision by a provision which is as far as possible
commercially equivalent considering the legal interests and the
Purpose. Any provision of this Agreement held invalid or
unenforceable only in part or degree will remain in full force and
effect to the extent not held invalid or
unenforceable.
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15.2
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Amendments/Assignment. Modifications and/or amendments of
this Agreement must be in writing and signed by the Parties. Lonza
may instruct one or more of its Affiliates to perform any of
Lonza’s obligations contained in this Agreement only with
prior written consent from Customer, but Lonza shall remain fully
responsible in respect of those obligations. Subject thereto,
neither Party may assign its interest under this Agreement without
the prior written consent of the other Party, such consent not to
be unreasonably withheld, conditioned or delayed, provided, however
that (a) either Party may assign
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24
this
Agreement to (i) any Affiliate of such Party or (ii) any third
party in connection with the sale or transfer (by whatever method,
including merger, consolidation, acquisition or other form of
business combination) of all or substantially all of the assets of
the business related to the Facility or providing the Services in
the case of Lonza, or all or substantially all of the assets
related to the Product in the case of Customer, and (b) Lonza shall be entitled to sell,
assign and/or transfer its trade receivables resulting from this
Agreement without the consent of the Customer. For purposes of this
Clause 15.2, the terms “assign” and
“assignment” shall include, without limitation
(i) the sale or transfer or other assignment of all or
substantially all of the assets of the Party or the line of
business or Product to which this Agreement relates, and (ii) a
merger, consolidation, acquisition or other form of business
combination. Any purported assignment without a required consent
shall be void. No assignment shall relieve any Party of
responsibility for the performance of any obligation that accrued
prior to the effective date of such assignment.
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15.3
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Notice. All
notices must be written and sent to the address of the Party first
set forth above. All notices must be given (a) by personal
delivery, with receipt acknowledged, (b) by facsimile or electronic
mail, (c) by prepaid certified or registered mail, return receipt
requested, or (d) by prepaid recognized next business day delivery
service. Notices will be effective upon receipt or at a later date
stated in the notice.
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15.4
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Public Disclosures. It is understood that each Party may
desire or be required to issue press releases or disclosures to the
SEC or other applicable agency relating to this Agreement or
activities hereunder. The Parties shall consult with each other
reasonably and in good faith with respect to text and timing of
such press releases and disclosures prior to the issuance thereof,
provided that (i) neither Party may unreasonably withhold,
condition or delay consent to such press releases or such
disclosures to the SEC or other applicable agency, and (ii) either
Party may issue such press releases or make such disclosures to the
SEC or other applicable agency as it determines, based on advice of
counsel, are reasonably necessary to comply with laws or
regulations or for appropriate market disclosure. Each Party shall
provide the other Party with advance notice of legally required
disclosures to the extent practicable. The Parties will consult
with each other on the provisions of this Agreement to be redacted
in any filings made by a Party with the SEC or as otherwise
required by applicable laws or regulations, provided that each
Party may make any such filing it reasonably determines necessary
under such applicable laws and regulations. After any initial press
releases related to this Agreement, either Party may disclose,
without the other Party’s consent, the existence of this
Agreement, the identity of the other Party, and the terms of the
Agreement which have already been publicly disclosed in accordance
herewith. Notwithstanding the foregoing, Lonza shall not use the
name of Customer, its Affiliates, or the names of their employees
or representatives in any advertising materials without prior
written consent of Customer, and Customer shall not use the name of
Lonza, its Affiliates, or the names of their employees or
representatives in any advertising materials without prior written
consent of Lonza.
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15.5
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Authorized Disclosures. Customer may disclose the terms of
this Agreement to any actual or potential acquiror or licensee to
the Product, provided that: (i) such disclosure is solely for the
purpose of such Third Party evaluating such acquisition or license
opportunity with Customer; (ii) Customer redacts the financial
terms of this Agreement (but Customer shall have the right to
disclose the Batch Prices to any bona fide potential or actual
acquirer or licensee who would bear and/or share the Batch Prices
for the Product). Any party to whom such disclosure is made shall
be under written obligations of confidentiality and non-use at
least as stringent as those herein.
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25
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15.6
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Governing Law/Jurisdiction. This Agreement is governed in
all respects by the laws of
[***]. The Parties agree to submit to the jurisdiction of
the courts of
[***].
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15.7
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Entire Agreement. This Agreement and its Appendices contain
the entire agreement between the Parties as to the subject matter
hereof and supersedes all prior and contemporaneous agreements with
respect to the subject matter hereof. This Agreement may be
executed in any number of counterparts, each of which shall be
deemed to be an original, and all of which together shall
constitute one and the same document. Each party acknowledges that
an original signature or a copy thereof transmitted by facsimile or
by .pdf shall constitute an original signature for purposes of this
Agreement.
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IN WITNESS WHEREOF, each of the Parties
hereto has caused this Manufacturing Services Agreement to be
executed by its duly authorized representative effective as of the
date written above.
LONZA LTD
By:
/s/ Bart A. M. Van
Aarnhem
Name
Bart A. M. Van Aarnhem
Title
Senior Legal Counsel
By:
/s/ Cordula
Altekruger
Name
Cordula Altekruger
Title
Senior Legal Counsel
AMAG
PHARMACEUTICALS, INC
By:
/s/ William K.
Heiden
Name
William K. Heiden
Title
CEO
26
APPENDIX A
Product Pricing
Parties
agree that the Batch Price shall be:
Product Volume Price
per Batch ([***])
[***] Batches
per
Campaign [***] per
Batch
Additional Batches:
[***] (or more) per
Campaign [***]
per Batch
Payment
terms:
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●
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Lonza
shall invoice and Customer shall pay
[***] of the Batch Price upon confirmation of the binding
Purchase Order in accordance with Section 6.3, for facility
reservation, Raw Materials procurement, manufacturing and
preparation (the “Up-Front
Payment”).
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●
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Lonza
shall invoice and Customer shall pay
[***] of the Batch Price upon delivery of the
Batch.
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●
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Invoicing
and payment shall be in accordance with Section 8.
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[***], as defined in this
Agreement.
[***] as
defined in Section 1. Lonza will submit an invoice to Customer for
the Specialty Material and Specialty Material Fee in accordance
with Section 2.9, and Customer will pay such invoice in accordance
with Section 8.
Additional Work Scope:
Any
additional project needs that are not specifically called out
within this Agreement or the Quality Agreement shall be invoiced
and billed under a separate work order.
27
APPENDIX
B
Project Plan
28
APPENDIX C
Quality Agreement
[Attached]
29
APPENDIX D
Specifications
[Attached]
30
APPENDIX E
Change Order
Change Order – [insert
number]
Dated:
[insert
date]
This is
a Change Order of the purposes of Manufacturing Services Agreement
between Lonza Ltd. and
AMAG Pharmaceuticals, Inc. dated
_________________[insert
date] (the “Agreement”).
Terms
used but not defined in this Change Order shall have the meaning
given to them in the Agreement.
Effective
Date: Day, Month, Year
End
Date: Day, Month, Year
Current
Price:
[***]
Revised
Price:
[***]
New
Total Cost (if applicable):
[***]
The
following reasons have caused the Price to change (increase or
decrease):
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1.
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EXECUTED as an AGREEMENT
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Signed
by
LONZA LTD.
___________________________
Signature
___________________________
Name
___________________________
Title
___________________________
Date
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Signed
for and on behalf of
AMAG PHARMACEUTICALS, INC.
___________________________
Signature
___________________________
Name
___________________________
Title
___________________________
Date
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31
Exhibit 10.31
Portions of this Exhibit have been redacted because they are both
(i) not material and (ii) would be competitively harmful if
publicly disclosed. Information that was omitted has been noted in
this document with a placeholder identified by the mark
“[***]”.
SUPPLY AGREEMENT
effective
as of 20 December 2018 ("Effective
Date")
between
AMAG Pharmaceuticals, Inc., 1100 Winter Street, Waltham, MA
02451, USA
-
"AMAG" -
and
Ypsomed AG, Brunnmattstrasse 6, CH-3401 Burgdorf,
Switzerland
-
"Ypsomed"
–
For Autoinjectors for the Administration of
Bremelanotide
Preamble
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a)
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Palatin
Technologies, Inc., 4-B Cedar Brook Drive, Cranbury, New Jersey
08512, USA (“Palatin”) developed a subcutaneous
injection formulation of Bremelanotide (as defined below) for use
in female sexual dysfunction;
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b)
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Palatin
licensed to AMAG the rights to develop and commercialize
Bremelanotide in North America and to manufacture Bremelanotide
worldwide;
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c)
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AMAG,
Palatin and Ypsomed have entered into a three way Confidentiality
and Non-Use Agreement, effective as of 6 March 2017 (hereinafter
“Confidentiality
Agreement”), and, under such Confidentiality
Agreement, have discussed the potential use of a customized version
of the YpsoMate (as defined below) for the injection of
Bremelanotide;
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d)
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Palatin
and Ypsomed entered into an agreement, dated as of 8 June 2012,
with respect to the variant specific customization of the YpsoMate
for the administration of pre-filled Bremelanotide syringes
(“Customization
Proposal”);
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e)
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Palatin
and Ypsomed entered into an agreement, dated as of 30 January 2015,
with respect to an industrialization project for the initializing
of the commercial supply of the customized autoinjectors
(“Industrialization
Proposal”);
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f)
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AMAG
and Ypsomed entered into Terms and Conditions dated 14 June 2017
governing the purchase of Component Sets (as defined therein)
pursuant to AMAG purchase order numbers 71635 and 71636 (the
“Terms and
Conditions”) and it is intended that the terms and
conditions of this Agreement will govern the supply of such
Component Sets to AMAG; and
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g)
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AMAG
and Ypsomed now wish to agree on the terms and conditions of the
commercial supply of the Components (as defined hereunder) used to
assemble the customized YpsoMate injection
device.
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Now,
therefore, in consideration of the above, AMAG and Ypsomed agree as
follows:
1. Definitions
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"Affiliate"
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shall
mean any corporation or other entity that directly or indirectly
controls, is controlled by, or is under common control with AMAG or
Ypsomed, as applicable. For the purpose of this Agreement,
"control" shall mean the direct or indirect ownership of fifty
percent (50%) or more of the outstanding shares or other voting
rights of the subject entity for the election of
directors.
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"Agreement"
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shall
mean this Supply Agreement, together with all Appendices, as
amended or modified from time to time in accordance with the terms
hereof.
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“Annual Minimum Quantity”
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shall
have the meaning set forth in Appendix 3.
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"Appendix", "Appendices"
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shall
mean the addenda, exhibits, schedules and/or supplements to this
Agreement, as amended or modified from time to time in accordance
with the terms hereof.
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"Applicable Laws"
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as of
the Effective Date, Applicable Laws shall mean applicable statutes,
laws and regulations of the United States, the European Union,
Switzerland, Canada, Mexico, China, and South Korea relevant to the
services under this Agreement and the manufacture of the Components
in the Territory, and shall include, without limitation, cGMP; FDA
21 CFR Part 820; European Council Directive 93/42/EEC; ISO
13485:2003; ISO 14971:2007 and any additional, successor or
replacement statutes, laws and regulations thereto, which come into
effect during the Term of this Agreement. The statutes, laws and
regulations of additional countries or jurisdictions in the
Territory may be added to the Applicable Laws upon mutual agreement
of the Parties in accordance with Section 4.9.
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"Authority"
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shall
mean the Food and Drug Administration (“FDA”) (or any
successor agency thereto) in the United States, the European
Medicines Agency EMA (or any successor agency thereto) in Europe,
Health Canada in Canada, and/or the applicable equivalent
regulatory agency or entity, governmental or non-governmental,
having the responsibility, jurisdiction and authority for the grant
of Authorizations in Mexico, China, South Korea, and any other
country or jurisdiction in the Territory as mutually agreed to by
the Parties in accordance with Section 4.9.
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"Authorizations"
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shall
mean the authorizations for the manufacture, labeling, packaging,
importation, promotion, marketing, offer to sell, sale,
distribution and use of the Bremelanotide Devices in the Territory,
and any amendments or modifications thereto.
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“Binding Forecast”
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shall
have the meaning set forth in Section 7.2.
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"Bremelanotide"
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shall
mean Palatin’s injectable drug substance licensed to AMAG in
which the active pharmaceutical ingredient is the peptide
Ac-Nle-cyclo(-Asp-His-D-Phe-Arg-Trp-Lys)-OH.
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"Bremelanotide Device"
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shall
mean the customized YpsoMate for the injection of Bremelanotide
consisting of the Components, a syringe containing Bremelanotide
and accessories, if any, as such Bremelanotide Device is further
defined in the Specifications.
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“Price Change Order”
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shall
mean a document in the format provided in Appendix 5 provided by Ypsomed to AMAG
outlining a proposed adjustment (increase or decrease) to the
Purchase Price and the reasons for such adjustment, such document
to be reviewed and signed by both parties to enable such adjustment
to take effect.
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"cGMP"
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shall
mean the current Good Manufacturing Practice requirements related
to the methods used in, and the facilities and controls used for,
developing, customizing, manufacturing, testing, processing,
packaging, labeling, storing, installing, and servicing of the
Components as specified in the Medical Device Directive 93/42/EEC
and ISO 13485, as amended or modified from time to
time.
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"Components"
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shall
mean the individual parts and subassemblies of Ypsomed’s
customized YpsoMate, as they are described in the Specifications.
For the avoidance of doubt, Components shall not include the
syringe containing Bremelanotide.
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"Component Set"
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shall
mean a complete set of all Components for use by AMAG or its
designee to assemble of one Bremelanotide Device.
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"Delivery"
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shall
have the meaning set forth in Section 8.1.
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“Delivery Date”
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shall
have the meaning set forth in Section 7.4.
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"Hidden Defect"
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shall
mean any Component's failure (i) to have been manufactured in
accordance with this Agreement, including, without limitation, cGMP
in effect at the time of manufacture, or (ii) to conform in all
material respects to the Specifications in effect at the time of
manufacture, to the exclusion of any failure which was or could
have been identified through commercially reasonable and adequate
inspection and testing based on mutually agreed inspection criteria
as set out in the Specifications and according to Section
9.1.
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“Initial Inspection”
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shall
have the meaning set forth in Section 9.1.
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"Initial Term"
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shall
have the meaning set out in Section 21.1.
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"Intellectual Property Rights"
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shall
mean any and all rights in or to inventions, discoveries, know-how,
trade secrets, trade names, confidential information (including
know-how), domain names, works of authorship reduced to a tangible
medium of expression, including, without limitation, technical data
and software, industrial and other design rights, patents,
trademarks, copyrights, database rights, and any other intellectual
property, in each case, whether registered or unregistered or
patentable or not, including rights to applications or
registrations for any of the foregoing.
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"Party", "Parties"
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shall
mean AMAG and/or Ypsomed, as applicable.
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“Pricing Tier”
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shall
have the meaning set forth in Appendix 3.
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“Purchase Order”
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shall
have the meaning set forth in Section 7.3.
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"Purchase Price"
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shall
mean the prices per Component Set according to the price list as
set out in Appendix
3.
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"Quality Agreement"
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shall
mean the quality agreement set out in Appendix 2, as amended or modified from
time to time in accordance with the terms hereof.
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“Rolling Forecast”
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shall
have the meaning set forth in Section 7.2.
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"Subsequent Term"
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shall
have the meaning set out in Section 21.1.
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"Specifications"
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shall
mean the specifications for the Components and Component Sets, as
well as certain requirements regarding the assembly of the
Bremelanotide Device, all as further described in Appendix 1, as amended from time to
time in accordance with the terms hereof.
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"Territory"
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shall -
for the purpose of this Agreement - include the countries
enumerated in the definition of Applicable Laws and Authority
hereinabove; provided however that Ypsomed acknowledges that AMAG
has the right to use, register, and market the Bremelanotide Device
worldwide. Accordingly, statutes, laws and regulations of
additional countries or jurisdictions may be added to the
Applicable Laws and the respective further countries will be
included to the definition of Territory pursuant to Section
4.9.
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" YpsoMate"
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shall
mean the technical platform of a two-step disposable autoinjector
developed by Ypsomed for use with various drug substances contained
in a syringe.
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2.
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Appendices
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2.1
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The
following Appendices are incorporated into this Agreement by this
reference:
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No.
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Appendix
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Subject/Content (inter alia)
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1
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Specifications
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Specifications
for Component and Component Sets
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2
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Quality
Agreement
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Quality
Agreement for Component Sets: change control, complaint handling,
audits, regulatory issues
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3
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Commercial
Terms
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Pre-commercial
supply & capacity reservation, forecast and ordering procedure,
Purchase Prices, minimum purchase quantities
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4
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Price
Change Order
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Form to
be used in the event of a change to the Purchase Price based on the
template format set out in Appendix 4.
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2.2
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Order of Precedence. The following interpretation rule shall
apply: (a) any amendments or modifications to this Agreement or the
Appendices shall prevail over this Agreement or the Appendices
themselves, (b) this Agreement shall prevail over the Appendices,
except with respect to matters relating to the quality of the
Components, the Quality Agreement shall prevail over this
Agreement, and (c) this Agreement shall prevail over the Terms and
Conditions.
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3. Amendments and/or
Modifications
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3.1
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Either
Party may at any time recommend an amendment and/or modification to
this Agreement or the Appendices, including the Specifications.
Amendments and/or modifications to this Agreement or the Appendices
shall only be effective upon a signed written agreement between the
Parties. The Appendices shall be subject to version control to
document any changes made to them. Amendments and/or modifications
to the Specifications shall be made in accordance with the change
control provisions of the Quality Agreement.
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3.2
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Neither
Party shall unreasonably withhold, condition or delay its consent
to any amendments and/or modifications recommended in good faith by
the other Party in relation to compliance with changes in
Applicable Laws, including, without limitation, cGMP, or changes in
the regulatory environment. In the event Ypsomed modifies the
YpsoMate and determines in good faith that corresponding
modifications to any Component is necessary or beneficial, then
AMAG shall approve such modifications,
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provided
that such modifications are made in accordance with the change
control provisions of the Quality Agreement. Notwithstanding the
foregoing, with respect to each proposed amendment and/or
modification to the Agreement or the Appendices, the Parties shall
discuss in good faith the cost and time implications associated
therewith. The requirements and the procedure for change control
are set out in the Quality Agreement.
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3.3
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In the
event that the Parties agree to change the Specifications in
accordance with the change control provisions of the Quality
Agreement, Ypsomed shall: (x) use commercially reasonable efforts
to implement such change as soon as reasonably practicable; (y) be
responsible for ensuring that all Components manufactured following
such change meets the Specifications as amended; and (z) provide
AMAG with all information and reasonable assistance with respect to
the manufacture of the Components in connection with such change
needed to amend any regulatory filings maintained with respect to
the Bremelanotide Device. To the extent such change is a result of
a change in Applicable Law or a discretionary change requested by
[***], AMAG shall
[***] of implementing the changes, otherwise, Ypsomed shall
[***].
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3.4
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The
Specifications are not physically attached to this Agreement, since
they are kept in the Design History File (DHF) which is maintained
at Ypsomed's premises. Ypsomed shall provide AMAG with a copy of
the Specifications.
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4. Commercial Supply
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4.1
|
Ypsomed
shall manufacture the Component Sets in accordance with the terms
of this Agreement and the Specifications attached as Appendix
1.
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4.2
|
Subject
to the terms of this Agreement, AMAG shall purchase Component Sets
from Ypsomed and Ypsomed shall supply AMAG with Component
Sets.
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4.3
|
In the
event AMAG decides during the Term of this Agreement to develop
(directly or indirectly) a new injection device for the
administration of Bremelanotide, AMAG shall give Ypsomed notice
thereof prior to issuing an invitation to tender or commencing
negotiations with any third party in respect of developing such
injection device. If, within
[***] after AMAG gives such notice to Ypsomed, Ypsomed
requests, in writing, an opportunity to submit a proposal with
respect to the development, customization, manufacture and supply
of such injection device, AMAG shall provide Ypsomed with the
desired specifications on a confidential basis and negotiate in
good faith with Ypsomed regarding any such proposal by Ypsomed. For
the avoidance of doubt, AMAG shall be free to engage in parallel
good faith negotiations, and to enter into a definitive agreement,
with any third party with respect to the development,
customization, manufacture and supply of the new injection
device.
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4.4
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Ypsomed
retains all rights to promotion, import, advertisement,
distribution, offering for sale and sale in the Territory of the
YpsoMate and/or
customized variations thereof as well as other disposable injection
systems, other than the Component Sets being supplied to AMAG
pursuant to this agreement, to itself, its customers or
distributors.
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4.5
|
The
commercial terms for the supply of Component Sets are set out in
Appendix 3.
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4.6
|
[***] at the Purchase Price set out in Appendix 3. The Purchase Price is firm
until
[***]. Thereafter, the Purchase Price is subject to
adjustments, however no more than on
[***] basis, to reflect increases or decreases in raw
material prices and other related cost influencing factors that are
not under Ypsomed’s control; provided, however, that
notwithstanding the foregoing, the percentage increase or decrease
in
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the
Purchase Price shall not exceed the lesser of (i) the percentage
increase in the
[***] since the then-current Purchase Price was established
and (ii)
[***]. In the event of a proposed adjustment to the Purchase
Price under this Section 4.6, Ypsomed will in good faith submit a
Price Change Order to AMAG to substantiate the adjustment, and such
adjustment shall not take effect until the Price Change Order is
signed by both Parties.
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4.7
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Throughout
the Term, Ypsomed agrees to use its commercially reasonable efforts
to identify and target all potential areas of cost improvement.
[***]. In the event of a proposed adjustment to the Purchase
Price under this Section 4.7, Ypsomed will in good faith submit a
Price Change Order to AMAG to substantiate the adjustment, and such
adjustment shall not take effect until the Price Change Order is
signed by both Parties.
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4.8
|
Beginning
in
[***], AMAG shall purchase at least the Minimum Annual
Quantity of Component Sets in each remaining calendar year during
the Initial Term as set out in Appendix 3. For the purpose of
determining whether AMAG is in compliance with this Section 4.8, a
Component Set is considered “purchased” as of the
agreed Delivery Date in the respective Purchase Order, provided
however that such ordered Component Sets will have been duly paid
by AMAG (during such calendar year or, as applicable, at a later
stage in accordance with the terms of this Agreement). If AMAG does
not purchase the Annual Minimum Quantity in a calendar year in
accordance with this Section 4.8, AMAG shall pay Ypsomed at the end
of such calendar year, upon receipt of an invoice and reasonable
supporting documentation in accordance with Section 6, an amount
equal to (a) the difference between (i) the Annual Minimum
Quantity for such calendar year and (ii) the aggregate number
of Component Sets purchased by AMAG (or its Affiliates or
licensees) during such calendar year (such amount, the
“Shortfall”),
multiplied by
[***] of the Unit Price per Component Set as set forth in
Appendix 3 (the
“Shortfall
Fee”). In the event that AMAG disputes the amount of
the Shortfall Fee due under this Section 4.8, AMAG shall provide
Ypsomed with written notice of such dispute within
[***] of receipt of such invoice. If no written notice is
provided by AMAG within
[***] of receipt of such invoice AMAG shall be deemed to
have given its approval to the Shortfall Fee.
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4.9
|
The
Parties - each for its obligations under this Agreement - shall
comply with all Applicable Laws. The Parties acknowledge that AMAG
has the right to market, sell and distribute the Bremelanotide
Device in further countries than those enumerated in the definition
of Applicable Laws and Authority in Section 1 subject to and in
accordance with the terms of this Agreement. Accordingly, AMAG has
the right to reasonably request Ypsomed to comply with any
applicable laws other than the Applicable Laws as such laws are
identified and deviate from the Applicable Laws and their
requirements communicated in writing by AMAG to Ypsomed and to
adjust the term Territory under Section 1 accordingly. In the event
of any additional, successor or replacement applicable laws
affecting Ypsomed's performance under this Agreement (including,
without limitation, in respect of costs, timelines, facilities,
equipment, processes, materials or systems), Ypsomed shall have the
right to request and the Parties shall negotiate in good faith an
amendment and/or modification pursuant to Section 3. For
clarity, in the event that any additional, successor or replacement
applicable laws that AMAG wishes Ypsomed to comply with, does not
affect Ypsomed's performance under this Agreement, such additional
applicable laws shall become automatically part of the Applicable
Laws without any need for an amendment and/or modification pursuant
to Section 3.
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4.10
|
The
Parties agree that the terms and conditions of this Agreement will
govern the manufacture and supply of Component Sets pursuant to
AMAG purchase order numbers 71635 and 71636, and such Component
Sets are deemed to be Component Sets manufactured by Ypsomed and
supplied to AMAG under this Agreement. In the event of a conflict
between this Agreement and the Terms and Conditions, this Agreement
shall control.
|
5. Engagement of Subcontractors and
Designees, Final Assembly & Packaging
|
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5.1
|
Ypsomed
shall be entitled to engage subcontractors in accordance with the
Quality Agreement, including (i) such subcontractors involved in
the development and manufacture of the YpsoMate platform
(“YpsoMate
Subcontractor”), and (ii) such other subcontractors
which are solely and specifically involved in the manufacture of
Component Sets under this Agreement, not being YpsoMate
Subcontractors (“Specific
Subcontractor”). The engagement of a Specific
Subcontractor by Ypsomed requires AMAG’s prior written
approval, such approval not to be unreasonably withheld,
conditioned or delayed. Ypsomed shall not be relieved from its
obligations hereunder and assumes full liability for the
performance and all acts and/or omissions of its subcontractors as
if they were its own performance and acts and/or omissions. Ypsomed
shall ensure that each subcontractor is aware of and bound by the
applicable provisions of this Agreement.
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5.2
|
Ypsomed
shall deliver the Component Sets in bulk packaging as set out in
the Specifications (Appendix
1). AMAG shall be responsible for the final assembly and
packaging of the Bremelanotide Device. AMAG shall be entitled to
engage designees for final assembly and/or packaging of the
Bremelanotide Device, provided that AMAG shall not be relieved from
its obligations hereunder and that it assumes full liability for
the performance and all acts and/or omissions of its designees as
if they were its own performance and acts and/or
omissions.
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5.3
|
The
Parties agree that Ypsomed and its subcontractors, and AMAG and its
designees, as applicable, may need to discuss aspects of this
Agreement with each other, (e.g., in respect of AMAG’s
designee's final assembly of the Component Set into the
Bremelanotide Device). For such purpose, Ypsomed and its
subcontractors, as applicable, on the one hand, and AMAG and its
designees, as applicable, on the other hand, may directly disclose
to, and receive from, each other confidential information of the
other Party. Each Party shall ensure that its designees or its
subcontractors, as applicable, are bound by appropriate
confidentiality obligations no less stringent than the
confidentiality obligations set out in this Agreement.
|
6. Payment
|
|
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|
6.1
|
All
costs and prices invoiced under this Agreement are specified in
[***]. All payments due to Ypsomed by AMAG under this
Agreement are expressed as net amounts and AMAG shall be liable to
pay any applicable sales taxes, value added taxes and
duties.
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6.2
|
With
respect to each undisputed invoice under this Agreement, AMAG shall
make payments to Ypsomed under this Agreement in immediately
available funds to the bank account designated by Ypsomed from time
to time, within
[***] after the date of the invoice.
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6.3
|
Any
payments due hereunder which are not made within
[***] after
the due date of such payments shall be subject to default interest
of
[***] per
[***] period on the unpaid amount until paid in full.
Notwithstanding any right to terminate this Agreement
|
for
AMAG's material breach as set out in Section 21.2, if any payment
due hereunder is not made within
[***] after the date on which such payment is due, Ypsomed
shall provide written notice to AMAG, and AMAG shall use
commercially reasonable efforts to remedy such failure. If any
portion of an invoice is disputed by AMAG on justified grounds,
AMAG shall pay the undisputed amounts in accordance with the terms
above, and the Parties shall use good faith efforts to resolve
differences or discrepancies with regard to any disputed amount as
soon as practicable.
7. Forecasts and Purchase
Orders
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7.1
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On the
Effective Date and before January 1 of each year thereafter, AMAG
shall provide Ypsomed with a written forecast for
[***] of AMAG’s estimated requirements for Component
Sets (the "Long Range
Forecast"). Such Long Range Forecasts shall only be used for
capacity planning and determination purposes as set out
herein.
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7.2
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On the
Effective Date and on or before of each January 1, April 1, July 1
and October 1 during the Term, AMAG shall provide Ypsomed with a
written
[***] rolling forecast of AMAG’s estimated
requirements for Component Sets (the "Rolling Forecast"). Such Rolling
Forecasts shall include binding and non-binding periods,
[***] (the “Binding
Forecast”). The non-binding portion of each Rolling
Forecast shall only be used for capacity planning and determination
purposes as set out herein. In its Rolling Forecast, AMAG shall, to
the extent practicable, level out potential variations in the
forecasted amounts for consecutive quarters (in any case for at
least the first
[***] covered by the Rolling Forecast) to enable continuous
manufacture and resource planning at Ypsomed.
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7.3
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On or
before each January 1, April 1, July 1 and October 1 during the
Term, AMAG shall submit to Ypsomed a purchase order specifying the
number of Component Sets and the requested delivery date(s) for the
second quarter thereafter in accordance with the Binding Forecast
(“Purchase
Order”), and in each case no later than
[***] prior to the requested delivery date(s) specified in
the Purchase Order.
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7.3
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In the
event of any conflict between a Purchase Order submitted by AMAG
and this Agreement, this Agreement shall prevail, unless Ypsomed
expressly approves such conflict or accepts such Purchase Order in
writing.
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7.4
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Ypsomed
shall acknowledge and confirm each Purchase Order in writing within
[***] of receipt, provided that AMAG has submitted the
Purchase Order in accordance with the terms of this Agreement.
However, (a) in no event shall Ypsomed be required to supply
quantities of Component Sets in excess of the Applicable Capacity
unless otherwise agreed by the Parties, and (b) if the quantity of
ordered Component Sets in a Purchase Order exceeds the quantity set
out in the Rolling Forecast by more than
[***] for the
respective quarter, the Parties will agree on the delivery date for
such excess quantities on a case-by-case basis. If Ypsomed is
unable to deliver all of the Component Sets by the requested date
of Delivery in the Purchase Order, Ypsomed shall so notify AMAG
within
[***] of receipt of the Purchase Order, and the Parties
shall negotiate in good faith an alternate date of Delivery as
close to the requested date of Delivery as is commercially
reasonable, provided that in no event shall such alternate date be
more than
[***] after the requested date of Delivery in the Purchase
Order. Upon confirmation by Ypsomed, each Purchase Order will be
regarded by the Parties as a binding commitment by Ypsomed to
manufacture and Deliver to AMAG the relevant number of Component
Sets on the delivery date (such agreed upon delivery date being the
“Delivery
Date”).
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8. Delivery
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8.1
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Ypsomed
shall deliver the number of Component Sets set out in the relevant
Purchase Order by the Delivery Date (“Delivery”), provided that
over-delivery or under-delivery of up to
[***] of the ordered amount shall be allowed. Component Sets
shall be delivered to AMAG FCA Ypsomed's manufacturing facility
indicated in the Quality Agreement (Incoterms 2010) and title shall
pass upon Delivery at such facility.
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8.2
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Ypsomed
shall notify AMAG of any expected delay in Delivery and will make
commercially reasonable efforts to effect Delivery as quickly as
possible. The Parties shall, if requested by AMAG, renegotiate the
date(s) of Delivery of all placed Purchase Orders following a
delayed Delivery. Ypsomed may, upon AMAG’s prior written
consent, make partial deliveries to maintain continuous supply. In
case Ypsomed anticipates that it may not be able or is unable to
Deliver all Components Sets by more than
[***] after the Delivery Date set forth in a Purchase Order,
Ypsomed shall notify AMAG in writing immediately and provide an
explanation thereof. Ypsomed shall discuss with AMAG potential
remedies and propose as soon as reasonably possible a mitigation
plan to AMAG’s reasonable satisfaction, which will include
concrete measures in line with Ypsomed’s business continuity
plan, such as the introduction or increase of shift work, an
internal second source option, or safety stock provisions; as well
as any other measures in order to provide a fast and secure
recovery of the supply of Component Sets. Notwithstanding the
foregoing, if Ypsomed is or will be unable for any reason to
deliver all Component Sets within
[***] of the Delivery Date in the respective Purchase Order,
then AMAG may, at its sole discretion, (i) cancel such Purchase
Order without penalty to AMAG and the number of Component Sets in
such cancelled Purchase Order shall be counted toward the Annual
Minimum Quantity for the calendar year in which the cancelled
Purchase Order was submitted, or (ii) accept Delivery of the
Component Sets on a delivery date mutually agreed to by the
Parties.
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8.3
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Ypsomed
will convey good title to the Component Sets to AMAG on the date of
Delivery, free and clear of any lien or encumbrance.
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9. Inspection, Notification of
Defects
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9.1
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Upon
receipt of a lot of Component Sets and all release documentation at
AMAG or its designee’s premises, AMAG or its designee acting
on behalf of AMAG shall carry out commercially reasonable and
adequate inspection and testing of the lot of Component Sets based
on mutually agreed inspection criteria as set out in the
Specifications (the “Initial
Inspection”). If any Component Sets fail Initial
Inspection, then AMAG shall notify Ypsomed within
[***] after the arrival of such Component Sets at AMAG's or
its designee’s premises (such notice, a “Failure Notice”). If AMAG does not
so notify Ypsomed, then such Component Sets shall be deemed
accepted by AMAG. In the event AMAG rejects any Component Sets
under this Section 9.1, AMAG shall identify such Component Sets and
their date of Delivery and provide Ypsomed with a report (including
photos if applicable) on the nature of the alleged defect. AMAG
shall hold any such Component Sets for inspection by Ypsomed or,
upon Ypsomed’s written request and at
[***] sole cost, shall return such Component Sets to
Ypsomed, whereas
[***] shall reimburse the cost of returning such Component
Sets to Ypsomed in the event the respective Component Sets are
determined not to have failed Initial Inspection.
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9.2
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If at
any time within a period of
[***] after Delivery of a Component Set to AMAG or its
designee AMAG discovers an alleged Hidden Defect, AMAG shall notify
Ypsomed within
[***] after the discovery of such Hidden Defect. AMAG shall
identify the relevant Component Sets and their date of Delivery and
provide Ypsomed with a report (including photos if applicable)
describing the nature of the alleged Hidden Defect. AMAG shall hold
any such Component Set for inspection by Ypsomed or, upon
Ypsomed’s written request and at
[***] sole cost, shall return such Component Sets to
Ypsomed, whereas
[***] shall reimburse the cost of returning such Component
Sets to Ypsomed in the event the respective Component Sets are
determined to comply with the product warranty set out in Section
11.1. Except to the extent AMAG provides the notice of an alleged
Hidden Defect to Ypsomed in accordance with this Section 9.2, the
Delivered Component Sets shall be deemed to be accepted by
AMAG.
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10. Remedy and Liability for
Defects
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10.1
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In the
event one or more Component Sets fails Initial Inspection under
Section 9.1, has a Hidden Defect under Section 9.2, or is
determined not to comply with the product warranty set out in
Section 11.1, provided that AMAG provided proper notice to Ypsomed
within the agreed time period under Section 9.1 or Section 9.2, as
applicable, and subject to Section 11.2, as applicable, Ypsomed
shall, upon the Parties good faith decision, either (a)
[***] or, (b)
[***]. In either case,
[***] shall reimburse
[***] for any applicable delivery charges. AMAG shall not
request an
[***] as set
out under option (a) above, if the amount of defective Components
is
[***] as set forth in Appendix 4.
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10.2
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In the
event the Parties are unable to agree as to whether or not a
Component Set fails Initial Inspection under Section 9.1, has a
Hidden Defect under Section 9.2, or complies with the product
warranty set out in Section 11.1, the Parties shall select an
independent laboratory which shall test such Component Set lot or
Component Sets to determine
whether such Component Set(s) fails Initial Inspection under
Section 9.1, has a Hidden Defect under Section 9.2, or complies
with the product warranty set out in Section 11.1. The findings of
such laboratory shall be binding.
[***] upon such laboratory testing shall pay the costs
invoiced by such laboratory. During any period that the Parties are
in dispute regarding the conformity of the Component Sets, Ypsomed
shall, if requested by AMAG, replace such quantity of Component
Sets. If the laboratory determines the Component Set(s) fail
Initial Inspection under Section 9.1, has a Hidden Defect under
Section 9.2, or does not comply with the product warranty set out
in Section 11.1, then AMAG shall be entitled to the remedies set
out in Section 10.1. If the laboratory determines the Component
Set(s) passes Initial Inspection under Section 9.1, does not have a
Hidden Defect under Section 9.2, or complies with the product
warranty set out in Section 11.1, then AMAG shall pay for both the
original shipment of Component Sets and the replacement shipment of
Component Sets following such determination.
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11. Representations and Warranties by
Ypsomed
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11.1
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Product Warranty. Subject to Section 11.2, Ypsomed hereby
represents and warrants to AMAG that the Component Sets delivered
by Ypsomed to AMAG hereunder (a) will have been manufactured in
accordance with this Agreement, the Quality Agreement and
Applicable Laws, including, without limitation, cGMP in effect at
the time of manufacture, (b) will, as of the date of Delivery,
conform to the Specifications in effect at the time of manufacture,
and (c) will not be adulterated
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within
the meaning of the U.S. Federal Food, Drug and Cosmetic Act, or any
other law in the Territory.
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11.2
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Warranty Limitation. The warranty under Section 11.1 and
AMAG’s remedies under Section 10 shall not apply to, and
shall be void in respect to (a) Components that have been modified
or altered in any manner by anyone other than Ypsomed or its
Affiliates or designees or authorized by Ypsomed, except that
activities carried out by AMAG or its designees in the final
assembly of a Component Set into a Bremelanotide Device in
accordance with the applicable specification, including the
Specifications, shall not be considered modified or altered under
this Section 11.2(a), or (b) defects caused by anyone other than
Ypsomed or its Affiliates or designees or authorized by Ypsomed
(i) by the use or operation of the Component Sets in an
application or environment other than that intended or recommended
for the Component Sets and/or the Bremelanotide Devices (as further
detailed in the Specifications or other separate documents such as
the Bremelanotide Device IFU); ii) by accident, negligence,
misuse or other causes other than the uses covered by this
Agreement; or (iii) by packaging, transport, warehousing,
storage or handling of the Component Sets, in any manner
inconsistent with this Agreement, including, without limitation,
the Specifications. Ypsomed expressly excludes any liability for
instructions for use for the Component Sets or Bremelanotide
Devices respectively.
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11.
3
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Authority & Approvals. Ypsomed represent and warrants
that (a) it has full power and authority, and has taken all
necessary actions and has obtained all necessary statutory
authorizations, licenses and approvals required, to execute and
perform this Agreement; and (b) its entry into this Agreement and
its performance of its obligations under this Agreement do not, and
will not, breach any agreements (to which it is party) with any
third party.
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11.4
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Regulatory Violations. Ypsomed represents and warrants that
it and its employees, agents, officers and directors have not been
debarred, disqualified or convicted of a crime for which one can be
debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or
(b), or any equivalent foreign or local law, rule or regulation. In
the event that Ypsomed or any of its employees, agents, officers
and directors becomes so debarred, disqualified or convicted,
Ypsomed agrees to notify AMAG thereof immediately, and AMAG shall
have the right to terminate this Agreement pursuant to Section
21.2. Ypsomed further represents and warrants that it has not and
shall not knowingly use or employ in any capacity related to any
activities under this Agreement any individual, corporation,
partnership, or association which has been debarred, disqualified
or convicted of a crime for which one can be debarred under Article
306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent
foreign or local law, rule or regulation. In the event that Ypsomed
becomes aware of or receives notice of the debarment,
disqualification or conviction of any such individual, corporation,
partnership, or association providing services to it which relate
to any activities under this Agreement, Ypsomed agrees to notify
AMAG immediately thereof, and AMAG shall have the right to
terminate this Agreement pursuant to Section 21.2.
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12. Representations and Warranties by
AMAG
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12.1
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AMAG
warrants that, following Delivery to AMAG or its designee, all
Component Sets shall be transported, warehoused, stored, processed,
handled and marketed by AMAG or its designees in accordance with
this Agreement, including the Specifications, and all Applicable
Laws. AMAG further warrants that it will not knowingly put on the
market any Component Sets or Bremelanotide Device with known
defects nor shall AMAG knowingly put on the market any Component
Sets or
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Bremelanotide
Device except subject to and in accordance with the applicable
specifications, including the Specifications and
Authorizations.
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12.2
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AMAG
warrants that all advertising and promotional materials as well as
user manuals and other information, instructions and directions of
use relating to safety and risk issues, use, transport, handling,
and storage of the Bremelanotide Device shall comply with the
applicable specifications, and all applicable laws, rules, and
regulations in the Territory.12.3 AMAG
warrants that it will not market, offer to sell or sell any
Bremelanotide Device in any country unless and until it has all the
necessary Authorizations from the relevant regulatory agency in
such country that are required to market, offer to sell and sell
the Bremelanotide Device. Ypsomed will support AMAG in obtaining
such Authorizations in accordance with Section 14 and as set out in
the Quality Agreement.
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12.4
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Authority & Approvals. AMAG represent and warrants that
(a) it has full power and authority, and has taken all necessary
actions and has obtained all necessary statutory authorizations,
licenses and approvals required, to execute and perform this
Agreement; and (b) its entry into this Agreement and its
performance of its obligations under this Agreement do not, and
will not, breach any agreements (to which it is party) with any
third party.
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12.5
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Regulatory Violations. AMAG represents and warrants that is
has not been debarred under Article 306 of the FDCA, 21 U.S.C.
§335a(a) or (b), or any equivalent foreign or local law, rule
or regulation. In the event that AMAG becomes debarred, AMAG agrees
to notify Ypsomed thereof immediately, and Ypsomed shall have the
right to terminate this Agreement pursuant to Section 21.2. AMAG
further represents and warrants that it has not and shall not
knowingly use or employ in any capacity related to any activities
under this Agreement any individual, corporation, partnership, or
association which has been debarred under Article 306 of the FDCA,
21 U.S.C. §335a(a) or (b), or any equivalent foreign or local
law, rule or regulation. In the event that Ypsomed becomes aware of
or receives notice of the debarment of any such individual,
corporation, partnership, or association providing services to it
which relate to any activities under this Agreement, AMAG agrees to
notify the Ypsomed immediately thereof, and Ypsomed shall have the
right to terminate this Agreement pursuant to Section
21.2.
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13. Quality Management System
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13.1
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On or
about the date hereof the Parties shall enter into a Quality
Agreement covering the Components and Component Sets. The Parties
shall review the Quality Agreement and shall modify same from time
to time as detailed in the Quality Agreement as necessary through a
written amendment to the Quality Agreement signed by an authorized
representative on behalf of each of the Parties. The Parties shall
perform the quality control and quality assurance testing specified
in this Section 13, the Quality Agreement, the Specifications and Applicable
Laws.
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13.2
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Ypsomed
shall (i) maintain a quality management system, (ii) manufacture
the Component Sets and (iii) generate and maintain the compilation
of records of the manufacturing, testing, processing, packaging,
labeling, and storage of the Component Sets in accordance with the
Quality Agreement. Reference is made to Section 24.7 for the
language of such records.
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13.3
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Ypsomed
will participate in and support AMAG in all required actions in
respect of AMAG’s medical device vigilance systems,
including, without limitation, support in
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respect
of initial reporting and corrective action, as set out in the
Quality Agreement or required by Applicable Law.
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13.4
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In
accordance with the Quality Agreement, Ypsomed shall allow AMAG
(and, if requested by AMAG, its notified body) to audit
Ypsomed’s manufacturing facilities in order to assure
compliance with this Agreement and the Quality
Agreement.
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13.5
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Unless
otherwise indicated,
[***] incurred in respect of Audits pursuant to Section
13.4. All information obtained by AMAG in any Audit (including,
without limitation, the findings and results related thereto but
excluding all Confidential Information of AMAG) shall be deemed to
be Ypsomed’s Confidential Information that may not be shared
with any third parties, except as otherwise permitted under this
Agreement (which permitted uses include, for clarity, use in
regulatory filings for Authorizations, provided however that AMAG
shall not be authorized to list patents of Ypsomed in the FDA
publication entitled Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book) without the prior written
consent of Ypsomed) or unless compulsory under Applicable
Law.
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14. Authorizations
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14.1
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AMAG
shall obtain and maintain all Authorizations for the Bremelanotide
Device and shall be the sole owner of such Authorizations in the
Territory. The costs for such applications and Authorizations shall
be borne by
[***]. Subject to Section 14.3, as between the Parties, AMAG
shall be responsible for all communications with Authorities
regarding such Authorizations.
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14.2
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For the
purposes of Sections 14.3 and 14.4, AMAG shall use reasonable
efforts to notify Ypsomed in a timely manner about its application
schedule for Authorizations and any updates thereto. AMAG shall use
reasonable efforts to regularly inform Ypsomed about the expected
times for obtaining the Authorizations and notify Ypsomed in
writing about any Authorizations obtained.
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14.3
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Ypsomed
shall use reasonable efforts to provide AMAG or, at AMAG's request,
Authorities in the Territory with any data and information (in
English) relating to Ypsomed's performance under this Agreement,
which is necessary to apply for and/or maintain Authorizations in
the Territory.
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14.4
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Ypsomed
agrees to cooperate with any inspection of Ypsomed's facilities by
Authorities, including any regulatory inspection required for AMAG
to apply for and/or maintain Authorizations, in accordance with the
Quality Agreement.
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14.5
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Any
provision in this Agreement, including, without limitation, in the
Quality Agreement, giving AMAG the right to access, control, check
or receive documents from Ypsomed or to visit or audit
Ypsomed’s premises, shall be interpreted as covering all
documents and information relevant to the Components but excluding
trade, operating and/or business secrets of Ypsomed and/or its
subcontractors. If documents or information containing such trade,
operating and business secrets are required for (i) AMAG's
certification by an Authority, (ii) applying for and/or maintaining
Authorizations in the Territory, (iii) risk evaluation by an
Authority or (iv) market surveillance by an Authority, the document
or information will be disclosed only to the relevant Authority.
Ypsomed shall inform AMAG of any information directly submitted to
Authorities, and Ypsomed shall be responsible for any updates and
annual reports required by such Authorities in respect of such
information.
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14.6
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[***] shall
[***] in respect of Ypsomed's activities of providing data
and information as set out in Section 14.3, Section 14.4 and
Section 14.5, provided such costs are administrative costs of
Ypsomed. To the extent such costs relate to the Authorizations and
are not administrative costs (e.g., costs for the undertaking of
further technical studies, tests or experiments, costs for
translation of or costs for compiling additional documents),
[***] shall pay the respective costs, provided
[***] supplies reasonable documentation substantiating such
costs, except as otherwise agreed upon in writing. For one (1)
regulatory inspection related to the Authorizations every
[***] pursuant to Section 14.4,
[***] shall bear its own costs.
[***] shall pay the reasonable costs incurred by
[***] for regulatory inspections in excess of one (1) every
[***] related to the Authorizations, provided
[***] supplies reasonable documentation substantiating such
costs, except if such inspection is for-cause.
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15. Patient Complaints and
Recalls
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15.1
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The
process for resolving complaints, adverse events, and inquiries
related to the Bremelanotide Device shall be in accordance with the
Quality Agreement. As between the Parties, AMAG shall have the sole
responsibility for resolving patient questions or complaints
related to the Bremelanotide Device. Ypsomed shall refer any
patient questions and complaints (including safety and efficacy
inquiries, quality complaints and adverse event reports) that it
receives concerning the Bremelanotide Device to AMAG (together with
all available evidence and other information relating thereto) in
accordance with the Quality Agreement. Ypsomed shall not take any
further action in connection with any such patient questions or
complaints without the consent of AMAG, but shall cooperate in the
investigation and closure of any such questions or complaints at
the request of AMAG. Such assistance shall include follow-up
investigations, including testing according to Ypsomed’s SOP
and complaint handling proceedings. In addition, Ypsomed shall
provide AMAG with all information to enable AMAG to respond
properly to patient questions or complaints relating to the
Components Sets as provided in the Quality Agreement.
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15.2
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As
between the Parties, AMAG shall have the sole responsibility as to
whether to institute a recall or withdrawal of Bremelanotide
Devices (whether required by an Authority or instituted by AMAG for
any reason). Ypsomed shall support AMAG as set out in the Quality
Agreement. If AMAG plans a recall or withdrawal of the
Bremelanotide Device, AMAG shall notify Ypsomed promptly of the
details regarding such recall or withdrawal, including, without
limitation, providing copies of all relevant documentation
concerning such recall or withdrawal. As far as the Components are
concerned, Ypsomed shall cooperate with AMAG in any such recall and
AMAG shall reasonably consider Ypsomed’s input in respect to
the Components. Ypsomed shall provide such information in respect
of Ypsomed's performance under this Agreement as AMAG reasonably
requests or which is necessary according to Applicable Laws. All
regulatory contacts that are made and all activities concerning
such recall will be initiated and coordinated by AMAG with
Ypsomed’s involvement and assistance, as such involvement and
assistance is reasonably requested by AMAG. .
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15.3
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Ypsomed
shall indemnify AMAG and bear the expense and costs, including
replacements costs but not including loss of profit, resulting from
a recall or withdrawal of Bremelanotide Device to the extent caused
by a failure of the Components to comply with the product warranty
set out in Section 11.1.
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16. Intellectual Property
Rights
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16.1
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Any and
all Intellectual Property Rights in existence prior to the
Effective Date or developed during the period of this Agreement but
otherwise than in the course of performance of obligations under
this Agreement shall, as between the Parties, remain the sole and
exclusive property of the Party that brings such rights to this
Agreement.
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16.2
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Ypsomed
shall be the sole and exclusive owner of
[***] (“New Ypsomed Intellectual Property
Rights”). AMAG agrees to assign and hereby assigns all of its
rights, including all patent rights, to such New Ypsomed
Intellectual Property Rights to Ypsomed, and such New Ypsomed
Intellectual Property Rights shall be included in the license in
Section 16.4. Ypsomed shall be solely entitled to legally protect
any such New Ypsomed Intellectual Property Rights and shall bear
all related costs.
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16.3
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AMAG
shall be the sole and exclusive owner of
[***] (“New AMAG Intellectual Property Rights”).
Ypsomed agrees to assign and hereby assigns all of its rights,
including all patent rights, to such New AMAG Intellectual Property
Rights to AMAG. AMAG shall be solely entitled to legally protect
any such New AMAG Intellectual Property Rights and shall bear all
related costs.
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16.4
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Ypsomed
grants to AMAG a royalty-free, fully paid-up, irrevocable (during
the term of this Agreement), sublicensable and non-exclusive
license in respect of the Ypsomed Intellectual Property Rights and
New Ypsomed Intellectual Property Rights to the extent required for
AMAG to final assemble and pack, use, sell, offer for sale,
distribute, import and export the Components, Component Sets and
Bremelanotide Device. This limited license shall only survive an
expiration or termination of this Agreement to the extent that a
permitted use set out hereunder outlasts the expiration or
termination of this Agreements. For the avoidance of doubt, the
license shall survive expiration or termination of this Agreement
with respect to any and all Component Sets ordered or purchased as
of the date of expiration or termination until such time as the
resulting Bremelanotide Devices have been sold or have expired. The
license shall not include the right to manufacture or have
manufactured the Components.
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16.5
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Each
Party shall cooperate with the other in completing any patent
applications or obtaining any other patent rights relating to
Intellectual Property Rights created or developed under this
Agreement, including executing and delivering any instrument
required to assign or transfer such Intellectual Property Rights to
the other Party in accordance with Sections 16.2 or
16.3.
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16.6
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Ypsomed
has established a continuous standard patent surveillance in the
EU, USA and Switzerland concerning the YpsoMate. Under this
Agreement Ypsomed shall continue to undertake its continuous
standard patent surveillance concerning the YpsoMate.
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In the
event that Ypsomed becomes aware of any third party patent rights
(granted patents) that may reasonably adversely impact AMAG’s
use of the Components in accordance with this Agreement, Ypsomed
shall notify AMAG thereof in writing without delay.
Ypsomed
represents and warrants that
[***] it has
not received any claims from a third party that the YpsoMate or the
performance of the activities under this Agreement infringe or
misappropriate the rights of any third party Intellectual Property
Rights and according to Ypsomed’s assessment (of infringement
and validity) and good faith belief,
[***], the use of the Components and Component Sets
in accordance with
this Agreement does not infringe or misappropriate any valid and
enforceable issued third party patent. If Ypsomed becomes aware of
any third party claims of patent infringement or misappropriation
(e.g., by receiving a cease and desist letter) after the Effective
Date, Ypsomed shall promptly notify AMAG thereof in
writing.
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16.7
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If
either Party becomes aware of any claim or action by a third party
claiming that the YpsoMate or the Component Sets infringes or
misappropriates a third party patent (in particular upon receipt of
a corresponding letter from such third party) (each a "Third Party Action"), such Party shall
promptly inform the other Party of such Third Party
Action.
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16.8
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The
defense against a Third Party Action shall be ruled as
follows:
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a)
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If the
Third Party Action is directed against Ypsomed for alleged
infringement of a third party patent by the YpsoMate, Ypsomed shall
defend at its sole cost the Third Party Action directed against the
YpsoMate through counsel of its choice. Ypsomed shall reasonably
update and inform AMAG on its defense strategy and the status of
any Third Party Action under this Section 16.8(a).
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b)
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If the
Third Party Action is
[***] then AMAG shall have the right to defend such Third
Party Action
[***]. The Party defending such Third Party Action shall
have the sole and exclusive right to select counsel for such Third
Party Action. The non-controlling Party shall have a reasonable
opportunity for meaningful participation in decision-making and
formulation of defense strategy. The Parties shall reasonably
cooperate with each other in all such actions or proceedings. In
the event that AMAG is enjoined from selling the Bremelanotide
Device as a result of such Third Party Action,
[***].
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c)
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For
Third Party Actions under Section 16.8 (b), the Party conducting
the defense to such Third Party Action shall (i) take all
reasonable steps to prevent judgment by fault or by default being
granted in favor of the third party; (ii) ensure that the other
Party is given the right to conduct proper consultations with the
third party in relation to the claim or potential claim; (iii) if
appropriate and practicable, allow the other party to join in the
defense (including, without limitation, settlement, litigation or
appeal) of any claim; and (iv) not, without the prior written
consent of the other Party, settle or compromise any claim or
consent to the entry of any judgment that imposes any liability or
obligation upon such Party.
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16.9
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In the
event it is established that the Components infringe a third party
patent or if the Parties agree to settle any claim or consent to
the entry of any judgment that prevents Ypsomed to continue to
manufacture and supply the Components to AMAG, the Parties shall
mutually agree on the strategy to be followed which may contain one
of the following actions: (i) Ypsomed at its own cost shall
redesign the Components to avoid the infringement, or (ii) Ypsomed
at its own cost shall procure to obtain a license from such third
party,
[***]. If the Parties cannot agree on either of such
actions, or if such actions are not possible or successful, the
Parties agree to discuss in good faith alternative solutions,
whereas in case such alternative solutions are not possible or
successful, the Parties agree to consensually terminate this
Agreement.
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16.10
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If any
Ypsomed Intellectual Property Right licensed to AMAG under this
Agreement is infringed and/or misappropriated by a third party (the
“Infringed Intellectual
Property”) the Party first having knowledge of such
infringement/misappropriation shall promptly notify the other Party
in writing.
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17. Disclaimer
Except
as expressly set out in this Agreement, neither Party makes any
warranties in respect of its activities under this Agreement,
express or implied, including, without limitation, any implied
warranty of merchantability or fitness for a particular
purpose.
18. Indemnity and Insurance
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18.1
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Ypsomed
agrees to indemnify, defend and hold harmless AMAG, its Affiliates
and its and their respective officers, directors, employees,
subcontractors, and agents (collectively, the “AMAG Indemnitees”) against any and
all losses, damages, liabilities or expenses (including reasonable
attorney’s fees and other costs of defense) (collectively,
“Losses”) in
connection with any and all actions, suits, claims or demands that
are brought or instituted against any AMAG Indemnitee by any third
party to the extent they arise out of (a) any breach of
Ypsomed’s representations, warranties or obligations set out
in this Agreement, including but not limited to the ones set out in
Sections 11, 16.6 and 16.7, (b) any Ypsomed Indemnitees’
gross negligence or willful misconduct in performing obligations
under this Agreement, (c) a recall or withdrawal of Bremelanotide
Device in accordance with Section 15.3, or (d)
[***] except, in each case, to the extent that such Losses
result from an action for which AMAG has an obligation to indemnify
Ypsomed under Section 18.2(a), (b) or (c).
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[***].
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18.2
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AMAG
agrees to indemnify, defend and hold harmless Ypsomed, its
Affiliates and its and their respective officers, directors,
employees, subcontractors, and agents (collectively, the
“Ypsomed
Indemnitees”) against any and all Losses in connection
with any and all actions, suits, claims or demands that are brought
or instituted against any Ypsomed Indemnitee by any third party to
the extent they arise out of (a) the use of the Component Sets, (b)
any breach of AMAG’s representations, warranties or
obligations set out in this Agreement, (c) any AMAG
Indemnitee’s gross negligence or willful misconduct in
performing obligations under this Agreement, or (d) any claim
alleging that the manufacture, use, offer for sale, sale, import or
export of Bremelanotide infringes any Intellectual Property Rights
of a third party, except, in each case, to the extent that such
Losses result from an action for which Ypsomed has an obligation to
indemnify AMAG under Section 18.1(a), (b) or (c).
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18.3
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Each
Party agrees that if it is notified by a third party of any claim
or potential claim that may give rise to a right of indemnification
pursuant to Section 18.1 or Section 18.2, it shall
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a)
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forthwith
inform the other Party of such claim or potential
claim;
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b)
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take
all reasonable steps to prevent judgment by fault or by default
being granted in favor of the third party;
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c)
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ensure
that the other Party is given the right to conduct proper
consultations with the third party in relation to the claim or
potential claim;
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d)
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if
appropriate, allow the other party to join in the defense
(including, without limitation, settlement, litigation or appeal)
of any claim; and
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e)
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not,
without the prior written consent of the other Party, settle or
compromise any claim, or consent to the entry of any judgment that
imposes any liability or obligation upon such Party.
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18.4
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Both
Parties shall obtain and maintain for the duration of this
Agreement and a period of
[***] thereafter
comprehensive liability insurance and other insurance all in
amounts and with coverage as required by the jurisdictions in which
they operate or as necessary to cover their obligations pursuant to
this Agreement. Each Party shall, within
[***] of any request from the other Party, provide a copy or
extract of its certificate of insurance to the other Party
evidencing compliance with this Section.
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19. Limitation of Liability
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19.1
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To the
extent permitted by the applicable law, neither Party shall be
liable to the other Party or to any third party, under this
Agreement, in contract, tort (including negligence) or otherwise
howsoever, and whatever the cause thereof, for lost profits,
goodwill, the cost of procurement of substitute goods, the cost of
Bremelanotide or for any consequential or indirect damages,
provided, however that
such limitation shall not apply with respect to any claim arising
from (a) the gross negligence or willful misconduct of either
Party, or (b) a breach of the confidentiality provisions of Section
20. This limitation shall apply even where a Party has been
advised of the possibility of such damage and notwithstanding the
failure of the essential purpose of any limited remedy stated
herein.
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19.2
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To the
extent permitted by applicable laws and subject to the provisions
of this Section 19.2, either Party’s liability under this
Agreement in any calendar year shall be limited to the greater of
(a)
[***]) and (b) the total charges paid by AMAG to Ypsomed
under this Agreement during the
[***] period preceding the event that gave rise to the
liability, provided, however that Ypsomed’s liability over
such calendar year shall in any event be limited to
[***]. Such limitation shall not apply with respect to any
claim arising from (a) the gross negligence or willful misconduct
of either Party, or (b) a breach of the confidentiality provisions
of Section 20.
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It is
hereby clarified that
[***] own costs for defending a Third Party Action pursuant
to Section 16.8 (a) or 16.8 (b)
[***], shall not be considered as "liability" for the
purpose of calculating
[***] liability limit pursuant to this Section
19.2.
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19.3
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Each
Party shall be obliged to mitigate damages.
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20. Confidentiality
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20.1
|
It is
understood between the Parties that the existing secrecy
undertakings as stipulated in the Confidentiality Agreement have
been and shall remain in force with respect to information
exchanged thereunder.
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20.2
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For
purposes of this Agreement, “Confidential Information” includes
all information furnished by or on behalf of a Party (the
“Disclosing
Party”), its Affiliates or any of its or their
respective Representatives (as defined below), to the other Party
(the “Receiving
Party”), its Affiliates or any of its or their
respective Representatives, in respect of this Agreement or any
performance hereunder, whether furnished before, on or after the
Effective Date and furnished in any form, including written,
verbal, visual, electronic or in any other media or manner and
information acquired by observation or otherwise during any site
visit at the other Party’s facility. Confidential Information
includes all proprietary technologies, know-how, trade secrets,
discoveries, ideas, processes, formulas, samples, compounds,
extracts, inventions and any other intellectual property (whether
or not patented), analyses and compilations,
business, technical and financial information and other materials
prepared by either Party, their respective Affiliates, or any of
its or their respective representatives, containing or based in
whole or in part on any information furnished by the Discloser, its
Affiliates or any of its or their respective Representatives.
Confidential Information also includes the existence of this
Agreement and its terms.
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20.3
|
The
Receiving Party shall maintain all Confidential Information in
trust and confidence and shall not disclose or divulge or use any
Confidential Information for any purpose other than the performance
of its obligations under this Agreement without the prior written
consent of the Disclosing Party.
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20.4
|
The
Receiving Party may disclose Confidential Information to its
officers, directors, employees, agents, independent, consultants,
attorneys or accountants (collectively “Representatives”) only on a need
to know basis; provided that (a) such Representatives are bound by
written agreements to maintain in confidence and not use the
Confidential Information under terms at least as restrictive as the
terms of this Agreement, and (b) the Receiving Party shall be
liable for any breach by its Representatives of any obligations
hereunder.
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20.5
|
The
foregoing obligations of confidentiality shall not apply to
Confidential Information that the Receiving Party can prove by
competent written proof:
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a)
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was
known to the Receiving Party prior to its receipt from the
Disclosing Party, or
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b)
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is
publicly available prior to receipt from the Disclosing Party or
subsequently becomes publicly available through no fault of the
Receiving Party, or
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c)
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is
obtained by the Receiving Party from a third party who is not under
an obligation of confidentiality and has a lawful right to make
such disclosures, or
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d)
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is
independently developed by or for the Receiving Party without use
of the Disclosing Party’s confidential
information.
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20.6
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The
Receiving Party may make disclosures required by an order of a
governmental agency, legislative body or court of competent
jurisdiction, provided that the Receiving Party: (i) provides the
Disclosing Party with immediate written notice of such requirement,
(ii) cooperates with the Disclosing Party at the Disclosing
Party’s expense in connection with the Disclosing
Party’s reasonable and lawful actions to obtain confidential
treatment for such Confidential Information, and (iii) limits such
disclosure of Confidential Information to the fullest extent
permitted under applicable law.
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20.7
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The
confidentiality and non-use obligations imposed by this Agreement
shall expire with respect to any particular item of a Disclosing
Party's Confidential Information on the
[***] anniversary of the date of disclosure of such
Confidential Information.
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21. Term and Termination
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21.1
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The
term of this Agreement shall commence on the Effective Date and,
unless terminated under Sections 21.2 through 21.6, this Agreement
shall continue in full force and effect until
[***] ("Initial
Term"). This Agreement shall be automatically renewed for
successive
[***] year
periods (each a "Subsequent
Term" and, with the Initial Term, the “Term”) unless either Party
terminates this Agreement by
[***] written
notice to the other Party prior to the expiration of the Initial
Term or any Subsequent
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Term,
as applicable.
[***] before expiration of this Agreement, the Parties shall
undertake to facilitate the phase out and wind down of the
supply.
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21.2
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This
Agreement may be terminated by either Party effective upon
[***] written notice to the other Party in the event of
material breach of this Agreement by the other Party, provided it
has previously given written notice of such material breach and the
breaching Party has failed to remedy such breach within
[***] of
receipt of such notice.
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21.3
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This
Agreement may be terminated by either Party effective immediately
upon written notice to the other Party (i) upon the institution by
or against the other Party of insolvency, receivership or
bankruptcy proceedings or any other proceedings for the settlement
of the other Party’s debts, unless such other Party timely
contests such proceedings, (ii) upon the other Party’s
making an arrangement for the benefit of creditors, or
(iii) upon the other Party’s dissolution or cessation of
business.
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21.4
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This
Agreement may be terminated by either Party effective upon
[***] written notice to the other Party in the event of a
change of control of the other Party if such controlling party is a
competitor of the terminating Party. For the purposes of this
Section 21.4, the term “control” shall have the same
meaning as set out in Section 1 in respect of
Affiliates.
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21.5
|
This
Agreement may be terminated by AMAG if the Bremelanotide Device
does not receive FDA approval, provided AMAG notifies Ypsomed in
writing with
[***] notice
that it wishes to terminate the Agreement.
|
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21.6
|
This
Agreement may be terminated by AMAG if AMAG is required to withdraw
the Bremelanotide Device from the market for regulatory or health
and safety reasons, provided AMAG notifies Ypsomed in writing with
[***] notice that is wishes to terminate the
Agreement.
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22. Effects of Termination or
Expiration
|
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22.1
|
Upon
termination by Ypsomed or receipt of notice of termination from
AMAG, Ypsomed will as soon as reasonably practicable cease
performance of the applicable activities in respect to the
Component Sets and will take reasonable steps to mitigate the
out-of-pocket expenses incurred in connection
therewith.
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22.2
|
Each
Party shall return all documents and materials in its possession
which contain confidential information of the other Party within
[***] after termination or expiration of this Agreement,
except for copies of information that may be routinely and
automatically stored in the Party’s computer backup and
electronic communications systems. The receiving Party may retain
one copy of documents and materials which contain the disclosing
Party's confidential information for the purpose of verifying the
receiving Party's compliance with its obligations under this
Agreement or as required by Applicable Laws, but for no other
purpose whatsoever.
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22.3
|
Sections
1, 2, 4.4, 6, 9, 10, 11, 12, 13.2(iii), 13.3, 14.3, 14.4, 14.5,
14.6, 15, 16, 17, 18, 19, 20, 22, 24.1, 24.2, 24.4, 24.5, 24.6,
24.7, 25 and 26 shall survive termination or expiration of this
Agreement.
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22.4
|
In the
event of termination of this Agreement by Ypsomed according to
Section 21.2, 21.3 or 21.4,
[***] shall (i)
[***].
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22.5
|
In the
event of termination of this Agreement by AMAG according to 21.5 or
21.6,
[***] shall (i)
[***].
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22.6
|
In the
event of termination of this Agreement by
[***] according to Sections 16.9, 21.2, 21.3 or 21.4,
[***].
|
23. Force Majeure
Neither
Party shall lose any rights hereunder or be liable to the other
Party for damages or losses (except for payment obligations) on
account of failure of performance by the defaulting Party if the
failure is occasioned by war, strike, acts of terrorism, fire, acts
of god, earthquake, flood, lockout, embargo, governmental acts or
orders or restrictions or any other similar reason where failure to
perform is beyond the reasonable control of and could not
reasonably have been expected to occur by the defaulting Party and
such Party has exerted all reasonable efforts to avoid or remedy
such force majeure. Failure to obtain, or revocation of, one or
more Authorizations shall not be considered an event of force
majeure.
24. Miscellaneous
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24.1
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Entire Agreement. This Agreement, including its Appendices,
together with the Confidentiality Agreement, set forth the entire
agreement and understanding of the Parties in respect of the
subject matter hereof, and supersedes all prior discussions,
agreements and writings relating thereto.
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24.2
|
Independent Contractors. The relationship of the Parties
hereto is that of independent contractors. The Parties are not
deemed to be agents or partners nor are they engaged in a joint
venture for any purpose as a result of this Agreement or the
transactions contemplated herein.
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24.3
|
Assignment. Except as otherwise expressly provided herein,
the Parties agree that their rights and obligations under this
Agreement shall not be delegated, transferred or assigned to a
third party without the prior written consent of the other Party;
provided either Party may assign this Agreement or parts thereof to
its Affiliates, without the other Party's consent. Subject to
Section 21.4, either Party may assign this Agreement in its
entirety, without the other Party’s consent, to a successor
to substantially all of the business or assets of the assigning
Party. This Agreement shall be binding upon and inure to the
benefit of the Parties and their successors and permitted
assigns.
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24.4
|
Severability, Waiver. In the event that any provisions of
this Agreement are determined to be invalid or unenforceable by a
court of competent jurisdiction, the remainder of this Agreement
shall remain in full force and effect without said provision. The
Parties shall in good faith negotiate a substitute clause for any
provision declared invalid or unenforceable, which shall most
nearly approximate the intent of the Parties in entering this
Agreement, or will leave the provision unreplaced by mutual
consent. Any provision of this Agreement held invalid or
unenforceable only in part or degree will remain in full force and
effect to the extent not held invalid or unenforceable. The failure
of a Party to enforce any provision of this Agreement shall not be
construed to be a waiver of the right of such Party to thereafter
enforce that provision or any other provision or
right.
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24.5
|
Notices. Any required notices hereunder shall be given in
writing and sent by (a) facsimile or electronic mail
transmission (receipt verified), (b) recognized overnight courier,
freight prepaid, specifying next-day delivery, with written
verification of receipt
|
or (c)
priority mail, postage prepaid, with written verification of
receipt, in each case, to the address of the applicable Party
below, or to such other address as such Party may substitute by
written notice.
If to
AMAG:
AMAG
Pharmaceuticals, Inc.
1100
Winter Street
Waltham,
MA 02451
USA
Attention:
VP, Technical Operations
Fax:
with a
copy to:
Attention:
General Counsel
Fax:
If to
Ypsomed:
Ypsomed
AG
Brunnmattstrasse
6
CH-3401
Burgdorf
Switzerland
Attention:
General Counsel
Fax:
+41 (34) 424 41 55
With a
copy to:
Attention:
Product and Account Manager AMAG
Either
Party may change its address for communications by a notice to the
other Party in accordance with the terms of this Section
24.5.
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24.6
|
No Use of Name. Neither AMAG nor Ypsomed shall be permitted
to use the name of the other Party in any publicity, advertising or
public announcement concerning this Agreement or the subject matter
hereof without the prior express written consent of the other Party
except to the extent required by law. As soon as the Bremelanotide
Device is in the market, Ypsomed shall be allowed to mention AMAG
in its clients list and to show the Component Set (assembled with a
syringe of placebo) in trade fairs, exhibitions and
publications.
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24.7
|
English Language. This Agreement has been prepared in the
English language and the English language shall control its
interpretation. All notices required or permitted to be given
hereunder, and all written or other communications between the
Parties regarding this Agreement or pursuant to this Agreement,
shall be in the English language, unless otherwise stated herein.
AMAG acknowledges that parts of the technical and quality
documentation for the Component Sets and the documentation of
Ypsomed's business activities are in the German
language.
|
25. Arbitration and Governing
Law
|
|
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25.1
|
Disputes. The Parties will try to settle their differences
amicably between themselves. If any claim, dispute, or controversy
of whatever nature arising out of or relating to this Agreement,
including the performance or alleged nonperformance of a Party of
its obligations under this Agreement arises between the Parties
(each a “Dispute”), a Party will, before
initiating any proceedings pursuant to Section 6(c), notify the
other Party in writing of such Dispute. If the Parties are unable
to resolve the Dispute within
[***] of receipt of the written notice by the other Party,
such dispute will be referred to an executive officer of AMAG and
an executive officer of Ypsomed, or their designees, who will meet
in person at least once and use their good faith efforts to resolve
the Dispute within
[***] after such referral.
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25.2
|
Arbitration. If a Dispute is not resolved as provided in
Section 25.1, whether before or after expiration or termination of
these Terms and Conditions, the Parties hereby agree that such
Dispute will be resolved by final and binding arbitration conducted
in accordance with the
[***]. The arbitration will be held in
[***]. The governing law of this Agreement will govern any
such proceedings. The arbitration will be conducted by a panel of
three (3) arbitrators with significant experience in the
pharmaceutical manufacturing industry, unless otherwise agreed by
the Parties, appointed in accordance with applicable
[***]. Any arbitration herewith will be conducted in the
English language to the maximum extent possible. The arbitrators
will be instructed not to award any punitive or special damages and
will render a written decision no later than
[***] following the selection of the arbitrators, including
a basis for any damages awarded and a statement of how the damages
were calculated. Any award will be promptly paid in U.S. dollars
free of any tax, deduction or offset. Each Party agrees to abide by
the award rendered in any arbitration conducted pursuant to this
Section 6. With respect to money damages, nothing contained herein
will be construed to permit the arbitrator or any court or any
other forum to award punitive or exemplary damages. By entering
into this agreement to arbitrate, the Parties expressly waive any
claim for punitive or exemplary damages. Each Party will pay its
legal fees and costs related to the arbitration (including witness
and expert fees). Judgment on the award so rendered will be final
and may be entered in any court having jurisdiction
thereof.
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25.3
|
Governing
Law. This Agreement and any dispute arising therefrom shall be
governed by and construed in accordance with the laws of
[***], regardless of the conflict of laws principles of that
or any other jurisdiction. The UN Convention on Contracts for the
International Sale of Goods is not applicable to this
Agreement.
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25.4
|
Nothing
in this Section 25 will preclude either Party from seeking
equitable relief or interim or provisional relief from a court of
competent jurisdiction, including a temporary restraining order,
preliminary injunction, specific performance or other interim
equitable relief, concerning a Dispute either prior to or during
any arbitration if necessary to protect the interests of such Party
or to preserve the status quo pending the arbitration
proceeding.
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26.
|
Securities Laws. The parties hereby acknowledge that AMAG is
publicly traded on the NASDAQ National Market System under the
symbol "AMAG" and Ypsomed is publicly traded on the Swiss
Performance Index (SPI) of SIX Swiss Exchange. Further, each
party is aware and will advise its Representatives who are informed
of matters that are the subject of this Agreement, of the
restrictions imposed by certain applicable securities laws on the
purchase or sale of securities by any person who has received or
had access material, nonpublic information concerning a company and
on the communication of such information to any other person when
it is reasonably
foreseeable that such person is likely to purchase or sell such
securities in reliance on such information.
|
In
witness whereof, AMAG and Ypsomed have executed this Agreement in
two originals, one for each Party, by their respective duly
authorized representatives.
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AMAG
Pharmaceuticals, Inc.
|
Ypsomed
AG
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|||
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Date:
|
December
21, 2018
|
|
Date:
|
January
25, 2019
|
|
By:
|
/s/
William K. Heiden
|
|
By:
|
/s/
Ulrike Bauer
|
|
Print
Name:
|
William
K. Heiden
|
|
Print
Name:
|
Ulrike
Bauer
|
|
Title:
|
President
and CEO
|
|
Title:
|
SVP
Marketing and Sales Delivery Systems
|
|
|
|
|
By:
|
/s/
Frank Mengis
|
|
|
|
|
Print
Name:
|
Frank
Mengis
|
|
|
|
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Title:
|
COO
|
Appendix
1
Specifications
for Components
The
Specifications for the Components are kept in the Design History
File (DHF), which is maintained at Ypsomed's premises.
Appendix
2
Quality
Agreement
Separate
Document.
Appendix
3
Commercial
Terms
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1.
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Applicable
Capacity & Contribution
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1.1
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Ypsomed
will invest in the entire production infrastructure required to
produce the Components, including high-cavity tooling and fully
automatic assembly equipment.
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Pursuant
to the terms of the Industrialization Proposal,
[***] partially financed the manufacturing capacity build-up
through upfront payments as set out in the Industrialization
Proposal.
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1.2
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AMAG
and Ypsomed will determine the required manufacturing capacity that
Ypsomed will reserve for AMAG based on AMAG’s Long Range
Forecast delivered by AMAG to Ypsomed in accordance with Section
7.1 of the Supply Agreement. It is agreed between the Parties that
the applicable manufacturing capacity per calendar year
(“Applicable
Capacity”) will be determined in accordance with this
Section 1.2. The initial Applicable Capacity is
[***] Component Sets. The Applicable Capacity may be
adjusted, from time to time upon either Party’s written
request, based on the Long Range Forecast. In the event AMAG
requests an increase in the Applicable Capacity that requires
Ypsomed to invest in additional production infrastructure, such
change shall be possible provided AMAG notifies Ypsomed at least
[***] prior
to such requested increase. In the event AMAG or Ypsomed in good
faith requests a decrease in the Applicable Capacity, such change
shall be possible provided that the Party requesting such decrease
notifies the other Party at least
[***] prior to such requested decrease. Each change of the
Applicable Capacity shall be agreed upon by the Parties in good
faith. In the event AMAG’s capacity demand according to the
Long Range Forecast exceeds
[***] Component
Sets per calendar year, the parties shall negotiate in good faith
the terms upon which Ypsomed will expand its manufacturing capacity
to accommodate AMAG’s increased capacity demand. In the event
AMAG’s capacity demand according to the Long Range Forecast
exceeds
[***] Component Sets per calendar year (i.e., a commitment
for Applicable Capacity above
[***] but not
more than
[***] Component Sets) AMAG shall pay Ypsomed a capacity
contribution fee of
[***]) as follows upon receipt of an invoice from
Ypsomed:
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Payment Milestones (Contribution for Applicable Capacity
from [***] to [***] Component
Sets)
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Amount in [***]
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[***] prior
to the planned change of Applicable Capacity (i.e. date of request
for additional capacity above
[***] Component Sets per calendar year)
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[***]
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[***] prior
to the planned change of Applicable Capacity (i.e.
[***] after
date of request for additional capacity above
[***] Component
Sets per calendar year)
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[***]
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[***] prior
to the planned change of Applicable Capacity (i.e.
[***] after
date of request for additional capacity above
[***] Component Sets per calendar year)
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[***]
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Total
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[***]
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2.
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Minimum
Purchase Quantity
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In
accordance with Section 4.8 of the Supply Agreement, beginning in
2019 AMAG shall purchase at least the Annual Minimum Quantity of
Component Sets in each calendar year during the Term as
set forth below. For the purpose of determining whether AMAG is in
compliance with Section 4.8 of the Agreement, a Component Set is
considered “purchased” as of the agreed Delivery Date
in the respective Purchase Order, provided however that such
ordered Component Sets will have been duly purchased and paid by
AMAG (during such calendar year or, as applicable, at a later stage
in accordance with the terms of this Agreement).
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Units
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Minimum
Purchase Quantity
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Per
Purchase Order
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[***] (the “Minimum Batch Size”)
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Initial
Term
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[***] Component Sets per each calendar year during the
Initial Term beginning in
[***] (the “Annual Minimum
Quantity”)
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Subsequent
Term(s)
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The
Annual Minimum Quantity for the Subsequent Term(s) shall be
determined and mutually agreed upon by the Parties prior to the end
of the Initial Term or of each Subsequent Term, as applicable. If
the Parties cannot agree on the Annual Minimum Quantity for a
Subsequent Term prior to beginning of such Subsequent Term, AMAG
shall be obligated to purchase, in each calendar year during the
Subsequent Term, no less than the Annual Minimum Quantity for the
last full calendar year
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3.
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Purchase
Price
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The
invoiced Purchase Price for Component Sets applied to all invoices
during a calendar year will be determined based on number of
Component Sets for the respective calendar year as set forth in the
Binding Forecast and as determined according to the following
Pricing Tiers:
Pricing Tiers
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Annual Quantity of Component Sets
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Unit Price per Component Set in
[***]
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[***]
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[***]
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[***]
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[***]
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|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
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The
Purchase Price includes the costs for bulk packaging (bulk
packaging as set out in Appendix
2).
The
effective Unit Price per Component Set shall be determined based on
the total number of Component Sets ordered by AMAG for the
respective calendar year accordance with Section 7.3, provided
however that such ordered Component Sets will have been duly
purchased and paid by AMAG (during such calendar year or, as
applicable, at a later stage in accordance with the terms of this
Agreement).
Accordingly,
within
[***] after the end of each calendar year during the Term,
Ypsomed shall calculate the total amount of ordered Component Sets
duly purchased and paid by AMAG and shall perform a
“True-Up”
reconciliation and shall provide AMAG with a written report of such
reconciliation. If the True-Up report shows that a difference in
the number of Component Sets purchased by AMAG compared to the
pricing tier serving as basis for the invoiced Purchase Price in
such calendar year results in either an underpayment or an
overpayment between
the Parties, the Party owing payment to the other Party shall pay
the amount of the difference to the other Party within
[***] of the
date of delivery of such True-Up report.
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4.
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Invoicing
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Ypsomed
shall submit an invoice to AMAG upon each Delivery of Component
Sets. The term of payment is
[***] from
the date of invoice.
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5.
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Delivery
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5.1
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Ypsomed
shall deliver the Component Sets in accordance with Section 8 of
the Agreement and the shipping procedures set out in the
Specifications.
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5.2
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All
Component Sets shall be delivered to AMAG FCA Ypsomed's
manufacturing facility (Incoterms 2010).
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Appendix 4
Price Change Order
Price Change Order – [insert
number]
Dated:
[insert
date]
This is
a Price Change Order of the purposes of Supply Agreement between
Ypsomed AG and AMAG Pharmaceuticals, Inc. dated
_________________[insert
date] (the “Agreement”).
Terms
used but not defined in this Price Change Order shall have the
meaning given to them in the Agreement.
Effective
Date: Day, Month, Year
End
Date: Day, Month, Year
Current
Purchase Price: $
Revised
Purchase Price: $
New
Total Cost (if applicable): $
The
following reasons have caused the Purchase Price to change
(increase or decrease):
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1.
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EXECUTED as an AGREEMENT
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Signed
by
YPSOMED AG
___________________________
Signature
___________________________
Name
___________________________
Title
___________________________
Date
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Signed
for and on behalf of
AMAG PHARMACEUTICALS, INC.
___________________________
Signature
___________________________
Name
___________________________
Title
___________________________
Date
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EXHIBIT
21
SUBSIDIARIES
OF THE REGISTRANT
|
Name of
Subsidiary
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State
of Incorporation
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Name
Under Which
Subsidiary
Does Business
|
|
RhoMed
Incorporated
|
New
Mexico
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RhoMed
Incorporated
|
Exhibit 23
Consent of Independent Registered Public Accounting
Firm
The
Board of Directors
Palatin
Technologies, Inc.:
We
consent to the incorporation by reference in the registration
statements (Nos. 333-33569, 333-56605, 333-64951, 333-72873,
333-84421, 333-52024, 333-54918, 333-74990, 333-100469, 333-101764,
333-104370, 333-112908, 333-128585, 333-132369, 333-140648,
333-146392, 333-174251, 333-183837, 333-185113, 333-201821,
333-206003, 333-206047 and 333-226905) on Form S-3 and in the
registration statements (Nos. 333-57079, 333-83876, 333-128854,
333-149093, 333-163158, 333-174257, 333-191467, 333-206009,
333-214618, 333-221554 and 333-227354) on Form S-8 of Palatin
Technologies, Inc. of our report dated September 25, 2020,
with respect to the consolidated balance sheets of Palatin
Technologies, Inc. and subsidiary as of June 30, 2020 and 2019, the
related consolidated statements of operations, comprehensive (loss)
income, stockholders’ equity (deficiency), and cash flows for
each of the years in the three-year period ended June 30, 2020, and
the related notes (collectively, the consolidated financial
statements), which report appears in the June 30, 2020 annual
report on Form 10-K of Palatin Technologies, Inc. Our report on the
consolidated financial statements refers to changes in accounting
for revenue and leases.
/s/
KPMG LLP
Philadelphia,
Pennsylvania
September
25, 2020
EXHIBIT
31.1
Certification
of Chief Executive Officer
I, Carl
Spana, certify that:
1.
I have reviewed
this Annual Report on Form 10-K of Palatin Technologies,
Inc.;
2.
Based on my
knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period
covered by this report;
3.
Based on my
knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in
this report;
4.
The registrant's
other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such
disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiary, is made known to us by
others within those entities, particularly during the period in
which this report is being prepared;
(b)
Designed such
internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles;
(c)
Evaluated the
effectiveness of the registrant's disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this
report any change in the registrant's internal control over
financial reporting that occurred during the registrant's most
recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, the registrant's internal
control over financial reporting; and
5.
The registrant's
other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to
the registrant's auditors and the audit committee of the
registrant's board of directors:
(a)
All significant
deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably
likely to adversely affect the registrant's ability to record,
process, summarize and report financial information;
and
(b)
Any fraud, whether
or not material, that involves management or other employees who
have a significant role in the registrant's internal control over
financial reporting.
Date:
September 25, 2020
|
/s/
Carl Spana
|
|
Carl
Spana, President and Chief Executive Officer
|
EXHIBIT
31.2
Certification
of Chief Financial Officer
I,
Stephen T. Wills, certify that:
1.
I have reviewed
this Annual Report on Form 10-K of Palatin Technologies,
Inc.;
2.
Based on my
knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period
covered by this report;
3.
Based on my
knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in
this report;
4.
The registrant's
other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such
disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiary, is made known to us by
others within those entities, particularly during the period in
which this report is being prepared;
(b)
Designed such
internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles;
(c)
Evaluated the
effectiveness of the registrant's disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this
report any change in the registrant's internal control over
financial reporting that occurred during the registrant's most
recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, the registrant's internal
control over financial reporting; and
5.
The registrant's
other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to
the registrant's auditors and the audit committee of the
registrant's board of directors:
(a)
All significant
deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably
likely to adversely affect the registrant's ability to record,
process, summarize and report financial information;
and
(b)
Any fraud, whether
or not material, that involves management or other employees who
have a significant role in the registrant's internal control over
financial reporting.
Date:
September 25, 2020
|
/s/
Stephen T. Wills
|
|
Stephen
T. Wills, Executive Vice President, Chief
Financial
Officer and Chief Operating Officer
|
EXHIBIT
32.1
Certification
of Principal Executive Officer
Pursuant
to 18 U.S.C. Section 1350
As
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
I, Carl
Spana, President and Chief Executive Officer of Palatin
Technologies, Inc., hereby certify, to my knowledge, that the
Annual Report on Form 10-K for the year ended June 30, 2020 of
Palatin Technologies, Inc. (the “Form 10-K”) fully
complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 and the information contained in
the Form 10-K fairly presents, in all material respects, the
financial condition and results of operations of Palatin
Technologies, Inc.
Dated:
September 25, 2020
|
/s/
Carl Spana
|
|
Carl
Spana, President and Chief Executive Officer
(Principal
Executive Officer)
|
EXHIBIT
32.2
Certification
of Principal Financial Officer
Pursuant
to 18 U.S.C. Section 1350
As
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
I,
Stephen T. Wills, Executive Vice President, Chief Financial Officer
and Chief Operating Officer of Palatin Technologies, Inc., hereby
certify, to my knowledge, that the Annual Report on Form 10-K for
the year ended June 30, 2020 of Palatin Technologies, Inc. (the
“Form 10-K”) fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
the information contained in the Form 10-K fairly presents, in all
material respects, the financial condition and results of
operations of Palatin Technologies, Inc.
Dated:
September 25, 2020
|
/s/
Stephen T. Wills
|
|
Stephen
T. Wills, Executive Vice President, Chief
Financial
Officer and Chief Operating Officer
(Principal
Financial Officer)
|