EXCLUSIVE LICENSE AGREEMENT between
Exhibit
10.1
Portions
of this exhibit marked [*]
are
requested to be treated confidentially.
Execution
Copy 3 of 3
between
S.L.A.
Pharma XX,
Xxxxxxxx
0, Xxxxxxxx, XX-0000 Xxxxxxx, Xxxxxxxxxxx
hereinafter
"the
Licensor"
and
Paramount
BioSciences, L.L.C.,
000
Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, XX 00000, Xxxxxx Xxxxxx of
America
hereinafter
"the
Licensee"
relating
to
Anoheal
and Incostop
TABLE
OF CONTENTS
1.
|
Preamble
|
3
|
2.
|
Definitions
|
3
|
3.
|
License
Grant
|
9
|
4.
|
Sublicensing
|
10
|
5.
|
Transfer
of Know-How, Materials, and Contracts
|
10
|
6.
|
Best
Efforts
|
12
|
7.
|
Royalties
|
12
|
8.
|
Milestone
Payments and Other Payments
|
16
|
9.
|
Payment
and Taxes
|
21
|
10.
|
Records
and Reports
|
22
|
11.
|
Licensee
Equity Interest
|
24
|
12.
|
Further
Development
|
25
|
13.
|
Marketing
|
30
|
14.
|
Costs,
Validity, and Prosecution of Patents
|
32
|
15.
|
Trademarks
and Improvements
|
34
|
16.
|
Infringement,
Validity Challenges and Litigation
|
34
|
17.
|
Third
Party Rights
|
38
|
18.
|
Representations
and Warranties
|
39
|
19.
|
Limitation
of Liability
|
45
|
20.
|
Indemnification
|
46
|
21.
|
Product
Liability
|
47
|
22.
|
Force
Majeure
|
48
|
23.
|
Termination
|
48
|
24.
|
Confidentiality
|
51
|
25.
|
Paramount
Guarantee
|
53
|
26.
|
Miscellaneous
|
54
|
27.
|
Governing
Law and Dispute Resolution
|
56
|
List
of Exhibits:
Exhibit
1
|
Licensee
Clinical Development Plan
|
|
Exhibit
2
|
Patents
|
|
Exhibit
3
|
Material
|
|
Exhibit
4
|
Trademarks
|
|
Exhibit
5
|
Licensor
IND(s)
|
|
Exhibit
6
|
Disclosed
Agreements and Opposition
|
|
Termination
Agreement between SLA Pharma AG and Solvay
|
||
Pharmaceuticals,
Inc.
|
||
Assignment
Agreement between Dr. M A Xxxx Xx. X X Xxxxxxxx and Slaco Pharma
AG
|
||
Exhibit
7
|
Form
of Stock Purchase Agreement
|
|
Exhibit
8
|
Material
Agreements
|
|
Exhibit
9
|
Withholding
Tax - Exemption
Certificate
|
2
1. Preamble
The
Licensor owns certain intellectual property rights, including but not limited
to, patent rights, patent applications, trademarks, know-how and regulatory
filings relating to Anoheal and Incostop. The Licensor is in search of a partner
for the manufacture, development and distribution of Anoheal and Incostop in
North America.
The
Licensee has evaluated Anoheal and Incostop under the term sheet between the
parties dated December 8, 2006, and as a result the Licensee would like to
manufacture, develop and exclusively distribute the Licensed Products as defined
hereafter in North America.
Therefore,
both-parties are willing to enter into a license agreement with the following
terms and conditions:
2. Definitions
|
2.1.
|
"Affiliate" shall mean
with respect to either party (i) an entity which owns or controls,
directly or indirectly, a controlling interest in such party, by stock
ownership or otherwise; or (ii) an entity which is wholly-owned by such
party, either directly or indirectly, by stock ownership or
otherwise.
|
|
2.2.
|
"Anoheal" means a
topical formulation of diltiazem or any analogs, prodrugs, metabolites,
salt forms, stereoisomers, racemates and/or derivatives
thereof.
|
|
2.3.
|
"Anoheal API" means
diltiazem or any analogs, prodrugs, metabolites, salt forms,
sterioisomers, racemates and/or derivatives
thereof.
|
|
2.4.
|
"Anoheal Net Sales" shall
mean Net Sales of Licensed Products incorporating Anoheal API as an
API.
|
2.5.
|
"API" means active
pharmaceutical ingredient.
|
3
|
2.6.
|
"Effective Date" shall
mean the date both Licensee and Licensor have signed this
Agreement.
|
|
2.7.
|
"FDA" shall mean the
U.S. Federal Food and Drug Administration and any successor agency
thereof.
|
|
2.8.
|
"Incostop" means a
topical formulation of phenylephrine or any analogs, prodrugs,
metabolites, salt forms, stereoisomers, racemates and/or derivatives
thereof.
|
|
2.9.
|
"Incostop API" means
phenylephrine or any analogs, prodrugs, metabolites, salt forms,
stereoisomers, racemates and/or derivatives
thereof.
|
2.10.
|
"Incostop Net Sales"
shall mean Net Sales of Licensed Products Incorporating Incostop API as an
API.
|
2.11.
|
"IND" shall mean
Investigational New Drug Application to the
FDA.
|
2.12.
|
"Confidential
Information" shall mean any and all information, data or know-how,
whether technical or non-technical, oral or written, related to the
Licensed Products, the Technology or research and development or business
of a party that is disclosed by one party or its Affiliates ("Disclosing
Party") to the other party or its Affiliates ("Receiving Party"), and
which is designated confidential or would otherwise reasonably be
considered as confidential or proprietary to the Disclosing Party,
consistent with industry practices and
standards.
|
2.13.
|
"Licensee" shall mean
Paramount BioSciences, LLC.
|
2.14.
|
"Licensee Clinical Development
Plan" means the plan for the conduct of clinical development of
Licensed Products by or on behalf of Licensee as defined in Exhibit
1.
|
4
2.15.
|
"Licensor" shall mean
S.L.A. Pharma AG.
|
2.16.
|
"Licensor Clinical Development
Plan" means the plan for the conduct of clinical studies of
Licensed Products by or on behalf of Licensor for purposes of seeking
Marketing Authorization in the European Community, as amended from time to
time.
|
2.17.
|
"NDA" shall have the
meaning described in Clause
8.1.1.(c).
|
2.18.
|
"Patents" shall (1) mean
the patents and patent applications listed in Exhibit 2 (2) any United
States, foreign or international patents and/or patent applications owned,
licensed, or otherwise controlled by Licensor, prior to or during the term
of this Agreement, with respect to the Territory that claim (i) Anoheal or
Incostop (ii) the manufacture or use of either of any of the foregoing, or
(iii) any Improvements (provided such improvements are used solely in the
development and/or commercialization of Anoheal, Incostop, or other
Licensed Products), (3) all continuations, continuations in part,
divisionals, provisionals, continued prosecution applications, renewals,
request for continued examinations, reissues, reexaminations, extensions,
supplementary protection certificates, registrations, confirmations, and
improvements of any of the foregoing with respect to the Territory, (4)
any United States, foreign, or international patents issuing from any of
the foregoing in the Territory, and (5) any foreign counterpart of any of
the foregoing in the Territory.
|
2.19.
|
"Know-How" shall mean
all Material and all other technical and medical information and data,
inventions, discoveries and other technology, whether or not patentable,
made or developed by or on behalf of the Licensor, or owned, controlled,
or licensed by Licensor, which relate to Licensed Products, Technology,
Improvements, or the development, manufacture, use, or sale of any of the
same in or for the Territory, and including, but not limited to, all data,
information, and results of (i) Licensor's research and development
(including but not limited to clinical studies) of Licensed Products prior
to and following the Effective Date and (ii) Licensor's performance of the
work described in the Licensor Clinical Development
Plan.
|
5
2.20.
|
"Material" shall mean
the documents and data listed in Exhibit
3.
|
2.21.
|
"Licensed Products"
shall mean any product containing Anoheal or Incostop, the manufacture,
use or sale of which is covered by a Valid Claim of the Patents or which
is manufactured, used or sold by applying the Know How or the Technology
or any Mexican Product.
|
2.22.
|
"Mexican Product" shall
mean any product sold by Licensee or its Affiliates, or by their
sublicensees pursuant to a license granted by Licensee or an Affiliate
thereof, in Mexico that would, if such product had been sold in the United
States on the date of such product's sale in Mexico, be a Licensed
Product.
|
2.23.
|
"Registration Authority"
shall mean the FDA and any equivalent competent regulatory authority in
the other countries of the Territory competent to grant Marketing
Authorization.
|
2.24.
|
"Marketing
Authorization" shall mean such governmental approval (including
pricing approval, where required) for the marketing of a Licensed Product
in a country for human therapeutic, prophylactic, or diagnostic use as is
necessary to enable Licensee, directly or through its respective
Affiliates, sub-licensees or marketing partners to commercially sell and
distribute the Licensed Product in such country for human therapeutic,
prophylactic, or diagnostic use, including but not limited to, in the
United States, final FDA approval of an
NDA.
|
2.25.
|
"Net Sales" shall have
them meaning described in Clause
7.2.
|
6
2.26.
|
"Trademarks" shall mean
the Trademarks listed in Exhibit 4.
|
2.27.
|
"Technology" shall mean
all proprietary information, procedures, methods, prototypes, designs and
technical data owned, controlled, or licensed by Licensor, other than
Know-How, that are necessary or useful in the development or for obtaining
the Marketing Authorization of Licensed Products, or which relate to the
Licensed Products in the Territory.
|
2.28.
|
"Territory" shall mean
the United States of America, Canada and Mexico, including their
territories and protectorates.
|
2.29.
|
"Third Party" shall mean
an entity other than a party to this Agreement and its respective
Affiliates.
|
2.30.
|
"Valid Claim" shall mean
a claim of an issued and unexpired patent or pending patent application
which has not been withdrawn, abandoned, revoked or held unenforceable,
unpatentable, or invalid by a decision of a court or other governmental
agency of competent jurisdiction, unappealable or unappealed within the
time allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or
otherwise.
|
2.31.
|
"Phase III Study" means
a pivotal human clinical trial of a Licensed Product, which trial is
designed to: (a) establish that a Licensed Product is safe and efficacious
for its intended use; (b) define warnings, precautions and adverse
reactions that are associated with the Licensed Product in the dosage
range to be prescribed; (c) support Marketing Authorization of such
Licensed Product; and (d) be generally consistent with the criteria of 21
CFR § 312.21(c) or its foreign
equivalent.
|
7
2.32.
|
"Improvement" means any
modification, enhancement, or improvement of a Licensed Product, or any
inventions, discoveries, improvements (whether patentable or not),
information, and data, owned or controlled by Licensor any time during the
term of this Agreement, which would be useful or necessary in the
manufacture, use, or sale of any Licensed Product in or for the Territory,
or the practice of which would infringe an issued or pending claim within
the Patents.
|
2.33
|
"Field" means the
treatment, prevention, or diagnosis of any disease or
condition.
|
|
2.34
|
"Alternative
Formulation" means any pharmaceutical formulation of Incostop other
than the pharmaceutical formulation of Incostop derived by or on behalf of
SLA as of the Effective Date. The Alternative Formulation shall include
the pharmaceutical formulation of Incostop derived by or on behalf of
Solvay Pharmaceuticals as of the Effective
Date.
|
2.35.
|
"Orphan Indication"
means an indication which, for a particular Licensed Product, would
qualify such Licensed Product for designation by FDA as an orphan drug
(i.e. drug for the treatment of a rare disease or condition) in accordance
with the provisions of 21 C.F.R. §
316.20.
|
2.36.
|
"Licensee Improvement"
means any modification, enhancement, or improvement of a Licensed Product,
or any inventions, discoveries, improvements (whether patentable or not),
information, and data, owned or controlled by Licensee any time during the
term of this Agreement, which would be useful or necessary in the
manufacture, use, or sale of any Licensed Product, or the practice of
which would, if practiced in the Territory, infringe an issued or pending
claim within the Patents.
|
2.37.
|
"Royalty Term" means, on
a country-by-country and Licensed Product-byLicensed Product basis, the
period commencing on the Effective Date and ending on the date of the last
to expire Valid Claim contained in the Patent covering a Licensed Product
in such country.
|
8
3. License
Grant
|
3.1.
|
Subject
to the terms of this Agreement, Licensor hereby grants to Licensee an
exclusive, royalty bearing license, under the Patents, Know-How,
Technology, and Trademarks, in the Field to sell, have sold, develop,
make, have made, use, have used, import, and have imported Licensed
Products in the Territory, and which license shall include but not be
limited to a right of reference to all filings with and submissions to
regulatory or governmental authorities (including Market Authorizations
and INDs) and all data and information contained therein, without
limitation, made by or on behalf of Licensor, or which is under Licensor's
ownership or control. Additionally, Licensor hereby grants to Licensee a
non-exclusive, royalty bearing license, under the Patents, Know-How,
Technology, and Trademarks, in the Field to develop, make, have made, use,
have used, import, and have imported (but not sell or have sold) Licensed
Products outside of the Territory.
|
|
3.2.
|
Notwithstanding
the foregoing, Licensee hereby agrees that Licensor shall have the
transferable right to develop, make, have made, use, have used, and import
(but not sell or have sold) Licensed Products in the Field in the
Territory solely for the purpose of developing and commercializing Anoheal
or Incostop outside of the Territory, with the right to
sublicense.
|
|
3.3.
|
The
Licensor undertakes not to give any other license for the Licensed
Products, Know-How, Trademarks, and the Technology to a Third Party in the
Territory during the term of this
Agreement.
|
|
3.4.
|
Licensee
undertakes not to sell Licensed Products in the Field outside the
Territory.
|
9
|
3.5.
|
Licensee
hereby grants Licensor a license under and right of reference to all data,
information, and results of Licensee's development of Licensed Products,
and all regulatory submissions and or filings made by Licensee with
respect to Licensed Products in the Territory (including INDs and Market
Authorizations), for the sole purpose of seeking and obtaining Marketing
Authorization for Licensed Products outside the
Territory.
|
4. Sublicensing
Licensee
shall have the right to grant non-exclusive and exclusive sublicenses hereunder,
provided that:
|
4.1.
|
Licensee
shall furnish within thirty (30) days of the execution thereof, a true and
complete copy of each sublicense and any changes or additions
thereto;
|
|
4.2.
|
Licensee
shall pay royalties on Net Sales made by sublicensees pursuant to Section
7; and
|
|
4.3.
|
Each
sublicense granted by Licensee shall include provisions which are in all
material respects similar of those of Clauses: 4.1, 4.2, 4.3, 6.1, 10,
13.3, 13.4, 13.6, 15.2, 16.1.1, 17.1, 21.2 and
24.
|
5. Transfer
of Know-How, Materials, and Contracts
|
5.1.
|
The
Material and all other Know-How and Technology have been transmitted to
the Licensee before execution of this Agreement for Licensee's use
pursuant to the terms of this Agreement. Licensee acknowledges that it has
checked the Material and has determined that the documents contained
therein include information which the Licensee believes will be useful for
the development and commercialization of the Licensed
Products.
|
10
|
5.2.
|
Upon
execution of this Agreement and continuing thereafter, Licensor shall
provide at no additional cost, the right to reference (for the purpose of
completing regulatory filings) and a copy of the Materials and of any and
all pre-clinical data, human safety or efficacy data, INDs, if any, (which
shall include, but not be limited to the INDs, whether now existing or
previously submitted, described in Exhibit 5, and of any filings, updates,
material correspondence, or material communications to or from any
applicable Registration Authority with respect thereto, including but not
limited to any IND(s) (collectively, the "Licensor IND(s)"), drug master
files, and other regulatory data, submissions, filings, and correspondence
that is in its possession or that shall otherwise be generated and/or come
into its possession following the execution of this Agreement related to
the development, manufacture, use or sale of any Licensed Products in the
Territory. Licensor shall, at Licensor's cost, take any and all actions
requested by the Licensee to effect the purposes of the foregoing as
promptly as practicable following the execution of this Agreement, which
shall include but not be limited to (i) preparing and filing whatever
filings, requests or applications are required or deemed advisable to be
filed with any Registration Authority, if any, in connection with the
assignment of the Licensor IND(s) and other materials, information, and
data and (ii) taking all reasonable actions necessary to enable the
Licensee to undertake the manufacture, development and commercialization
of Licensed Products under this Agreement. It is however understood that
it is Licensee's responsibility to file for the Marketing Authorization in
the Territory.
|
|
5.3.
|
During
the time that Licensor is the holder of any Licensor IND(s) or other
materials, data, and/or information referred to above, Licensor shall (i)
promptly provide Licensee an advance draft of any proposed responses to
such written notices or inspections and the resolution of any issue raised
by such Registration Authority and (ii) make such reasonable changes to
such proposed response as may be recommended by Licensee, and the Licensee
shall be entitled to attend any and all meetings and participate in
telephone calls with the Registration Authorities, including without
limitation any meeting preparation, meeting co-ordination and preparation
of minutes.
|
11
|
5.4.
|
Licensor
is not a party to any material agreements relating to Licensed Products,
Know-how or the Technology in the Territory, other than those set forth in
Exhibit 6(A).
|
6. Best
Efforts
|
6.1.
|
Licensee
shall use all reasonable commercial efforts at its own cost to bring the
Licensed Products to market in the Territory through a diligent program
for the exploitation of the Patents, Technology, and Know-How in the
Field. Such program shall include the preclinical and clinical development
of Licensed Products, including research and development, manufacturing,
laboratory and clinical testing, registering and marketing of Licensed
Products. Following Marketing Authorization of a Licensed Product in a
particular country, Licensee shall use commercially reasonable efforts to
continue active, diligent marketing efforts for the Licensed Product in
such country throughout the term of the Agreement. Notwithstanding the
foregoing, termination by the Licensee of clinical development or
commercialization of either Incostop or Anoheal will not be a breach of
this Clause 6.1 or any other Clause in this Agreement provided however,
termination by the Licensee of clinical development or commercialization
of both Incostop and Anoheal, subject to Clause 23.2, will be a material
breach of this Clause 6.1 and the Licensor will be able to pursue it
rights according to Clause 23.
|
7. Royalties
|
7.1.
|
During
the Royalty Term (subject to Clause 7.5), in any country where Licensed
Products are sold by the Licensee or its sublicensees, Licensee shall pay
to Licensor the following royalties, as they may be further adjusted
pursuant to this Clause 7 or Clause
16.1.5:
|
12
|
(a)
|
[*]
Percent ([*]%) of the first [*] Dollars ($[*]) of Anoheal Net Sales (as
defined below) in any calendar year;
and
|
|
(b)
|
[*]
Percent ([*]%) of Anoheal Net Sales in excess of [*] Dollars ($[*]) in any
calendar year.
|
|
(c)
|
[*]
Percent ([*]%) of the first [*] Dollars ($[*]) of Incostop Net Sales in
any calendar year; and
|
|
(d)
|
[*]
Percent ([*]%) of Incostop Net Sales for Incostop Net Sales in excess of
[*] Dollars ($[*]) in any calendar
year.
|
Further,
no multiple royalties shall be payable on a Licensed Product because the use,
lease or sale of any Licensed Product is, or shall be, covered by more than one
Valid Claim contained in the Patents.
|
7.2.
|
For
purposes of this Agreement, "Net Sales" shall mean the total gross
receipts for sales of Licensed Products by or on behalf of the Licensee or
any of its Affiliates or sublicensees, less only the sum of the following:
(a) usual trade discounts to customers; (b) sales, tariff duties and/or
use taxes directly imposed and with reference to particular sales; (c)
outbound transportation prepaid or allowed and transportation insurance;
(d) amounts allowed or credited on returns; (e) bad debt deductions
actually written off during the accounting period; (f) wholesaler and
distribution fees (to the extent not exceeding [*]% of the respective Net
Sales); and (g) freight charges and other duties. Components of Net Sales
(and the deductions listed above) shall be determined in the ordinary
course of business in accordance with internationally recognised
accounting principles.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
13
Notwithstanding
anything herein to the contrary, the transfer of a Licensed Product to an
Affiliate, sublicensee, or other Third Party in connection with the research,
development or testing of a Licensed Product or for purposes of resale shall not
be considered a sale of a Licensed Product under this Agreement. Nor shall the
transfer of Licensed Product solely for indigent or similar public support or
compassionate use programs be considered a sale of Licensed Product under this
Agreement.
|
7.3.
|
In
the event that a Licensed Product is sold in the form of a combination
product containing one or more technologies which, if incorporated into a
product by themselves, would not render a product a Licensed Product, the
Net Sales for such combination product shall be calculated by multiplying
the sales price of such combination product by the fraction A/(A+B) where
(i) A is the invoice price of a Licensed Product incorporating solely the
technology which renders such product a Licensed Product, or, if such
Licensed Product is not sold separately, the fair market value of a
Licensed Product incorporating solely such technology, and (ii) B is the
total invoice price of products incorporating solely the other
technologies or, if such products are not sold separately, the fair market
value of such products.
|
|
7.4.
|
Should
a compulsory license be granted by a court of law or regulatory authority
or other government entity with jurisdiction, or be the subject of a
possible grant, to a Third Party under the applicable laws of any country
in the Territory under the rights licensed under this Agreement, the
Licensee shall notify Licensor, including any material information
concerning such compulsory license, and the running royalty rate payable
under Clause 7 for sales of Licensed Products in such country will be
adjusted to equal any lower royalty rate granted to such Third Party for
such country with respect to the sales of such Licensed Products therein
(the "Compulsory Royalty") during such periods such third parties sell or
offer for sale under the compulsory license articles that compete with the
Licensed Products then marketed and sold by the Licensee, its Affiliates,
or sublicensees in that country, provided that such Compulsory Royalty
shall remain subject to further adjustment consistent with this Clause
7.
|
14
|
7.5.
|
If
the Royalty Term covering a particular Licensed Product in any country of
the Territory has expired, Licensee shall still be obligated to pay
royalties under this Clause 7 with respect to sales of such Licensed
Product in such country, provided, however, that the royalty percentage
rate shall be reduced, on a calendar quarter-by-calendar quarter basis, by
the same percentage as the average net selling price of the respective
Licensed Product before expiration is reduced (Example: if the average net
selling price has to be reduced by 25% from 100 to 75, then the royalty
rate for Anoheal Net Sales up to USD 100,000,000 shall be reduced from
[*]% to [*]%). The royalty reduction shall be effective with respect to a
particular Licensed Product in a particular country beginning with the
first day of the calendar quarter following the initial price reduction of
such Licensed Product in such country following the expiration of the
Royalty Term covering such Licensed Product in such country, and
additional such reductions shall apply to each and every price reduction
taking place thereafter (Example: Using the facts from the first example
above, if the average net selling price is further reduced from 75 to 50,
then the royalty rate for Anoheal Net Sales up to USD 100,000,000 would be
reduced to [*]% (50/100 = 50%; 50% x [*]% = [*]%). The Licensor's royalty
shall not be reduced pursuant to any such price reduction until there are
no Valid Claims covering such Licensed Product in the relevant country.
Notwithstanding anything to the contrary, (i) royalties on Net Sales of
Mexican Products shall be entitled to the royalty reductions described
above upon the expiration of the Royalty Term in the United States and
(ii) any royalties adjusted pursuant to this Clause 7.5 shall remain
subject to further adjustment consistent with this Clause
7.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
15
|
7.6.
|
Notwithstinding
anything to the contrary herein, if the Licensee obtains one or more
licenses under patents or patent applications owned by a Third Party to
avoid infringement thereof by the manufacture, use, or sale of any
Licensed Product, to reasonably avoid infringement-related litigation
regarding a Licensed Product, then the Licensee, with the prior written
approval of the Licensor, may deduct a fair and reasonable share, up to an
amount of [*] percent ([*]%) of any fees, milestones or royalties paid
under such license(s) (even if paid in settlement or judgment of any claim
for infringement) from the payments otherwise due Licensor under this
Agreement; provided, however, that, notwithstanding the foregoing, the
total amount due Licensor under this Agreement in any particular calendar
quarter shall not be reduced by more than [*] percent ([*]%) as a result
of any such deduction, and any amounts not deducted in a calendar quarter
shall be carried forward for deduction in the subsequent calendar
quarter(s), subject to such [*] percent ([*]%) limitation in each
case.
|
|
7.7.
|
Royalties
shall be paid not later than 60 days after the end of each Accounting
Period to the account of Licensor indicated in Clause 9.1
hereafter.
|
8. Milestone
Payments and Other Payments
8.1. Milestone
Payments
8.1.1.
|
During
the Royalty Term, Licensee shall make the following one-time milestone
payments to Licensor:
|
|
a)
|
$0.25
million ($250,000) upon execution of the License Agreement by both
parties, to be payable in two installments of (i) $0.125 million
($125,000) within 30 days of the Effective Date; and (ii) $0.125 million
($125,000) within 6 months of the Effective
Date;
|
b)
|
$0.125
million ($125,000) upon Institutional Review Board ("IRB") approval to
initiate a Phase III Study of a Licensed Product incorporating
Anoheal API as an API under a Licensee sponsored (or sublicensee
sponsored) Investigational New Drug Application (an "IND") approved by the
U.S. Food and Drug Administration
("FDA");
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
16
|
c)
|
$[*]
($[*]) upon [*];
|
|
d)
|
$[*]
($[*]) upon [*];
|
|
e)
|
$0.125
million ($125,000) upon IRB approval to initiate a Phase III Study of a
Licensed Product incorporating Incostop API as an API for the treatment of
an Orphan Indication under a Licensee sponsored (or sublicensee sponsored)
IND approved by the FDA;
|
|
f)
|
$[*]
($[*]) upon [*];
|
|
g)
|
$[*]
($[*]) upon [*];
|
|
h)
|
$[*]
($[*]) upon [*]; and
|
|
i)
|
$[*]
($[*]) upon [*].
|
8.1.2.
|
Milestone
payments under 8.1 above must be paid within 30 (thirty) days of such
events taking place. Notwithstanding anything to the contrary, (i) each
milestone payment indicated above shall only be paid once under this
Agreement, notwithstanding the number of indications or Licensed Products
achieving such milestone, and (ii) the total amount payable under this
Clause 8.1. shall not exceed US$20,500,000 in any event. For the purposes
of this Clause 8, a Current Valid Claim means a claim of an issued and
unexpired patent included in the Patents which has not been withdrawn,
abandoned, revoked or held unenforceable, unpatentable, or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or
otherwise.
|
[*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
17
|
8.1.3.
|
Even
if Licensee is not obligated to remit milestone payments pursuant to 8.1.1
Point c) or 8.1.1 Point d) because, at the time of the achievement of the
applicable milestone, the applicable Licensed Product was not covered by a
Current Valid Claim, the Licensee shall still have an obligation to remit
the applicable payment if and when the applicable Licensed Product becomes
covered by a Current Valid Claim, provided, however, the applicable
Licensed Product becomes covered by a Current Valid Claim prior to the
date that is [*] from the date that the FDA approves the first NDA for
such Licensed Product.
|
8.2.
|
Anoheal
and Incostop Project Costs
|
|
8.2.1.
|
As
a compensation for the Licensor's participation in and management of the
development and commercialization of Anoheal and Incostop as described in
the Licensee Clinical Development Plan (the "Anoheal Project" and the
"Incostop Project" respectively) commencing on the Execution Date, the
Licensee shall make separate payments to Licensor equal to $41,500 per
month for the Anoheal Project (the "Anoheal Project Payment") and $41,500
per month for the Incostop Project (the "Incostop Project Payment").
Payments pursuant to this Clause 8.2.1 shall be due the last day of each
calendar month for the respective calendar month, with the provision that
for the month the NDA is accepted or the project is terminated, the full
payment of $ 41,500 shall be due.
|
[*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
18
|
8.2.2.
|
Licensee's
obligation to make the Anoheal Project Payment shall terminate upon the
earlier of (i) the date Licensee informed Licensor in writing of the
termination of the Anoheal Project and (ii) two years subsequent to the
Effective Date, provided, however subject
to Clause 8.2.4, if the Licensee does not file an NDA with a Licensed
Product incorporating Anoheal API by the date that is [*] subsequent to
the Effective Date (the "Anoheal Recommencement Date"), the Licensee will
recommence the Anoheal Project Payments until such time as an NDA relating
to a Licensed Product incorporating Anoheal API is filed by the Licensee,
its Affiliate or sublicensee.
|
|
8.2.3.
|
Licensee's
obligation to make the Incostop Project Payment shall end at the earlier
of (i) the date Licensee informed Licensor in writing of the termination
of the Incostop Project; and (ii) two years subsequent to the Effective
Date, provided, however,
subject to Clause 8.2.4, if the Licensee does not file an NDA with a
Licensed Product incorporating Incostop by the date that is [*] subsequent
to the Option Expiration Date (the "Incostop Recommencement Date"), the
Licensee will recommence the Incostop Project Payments until such time as
an NDA relating to a Licensed Product incorporating Incostop is filed by
the Licensee, its Affiliate or
sublicensee.
|
8.2.4.
|
If,
prior to the Anoheal or Incostop Recommencement Date (as applicable), the
FDA requires, in writing, that Licensee cease, halt, suspend or delay
initiation of any clinical trial or redesign any clinical trial or
otherwise put the Licensee on clinical hold, for any Licensed Product
relating to the use of Anoheal or Incostop (collectively a "Clinical
Hold"), then Licensee shall have no obligation to remit Anoheal or
Incostop Project Payments (as applicable), until such time as the FDA
authorizes the commencement or continuation of such clinical
studies.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
19
|
8.3.
|
Notwithstanding
anything in this Agreement Licensee may, in its sole discretion at any
time upon written notice to Licensor, discontinue Licensee's conduct of
the Anoheal Project. In the event the Licensee discontinues its
performance of the Anoheal Project during the one-year period after the
Effective Date, Licensee nonetheless shall be required to pay to Licensor
those amounts that otherwise would have been paid to Licensor pursuant to
Clause 8.2.1 for the Anoheal Project for such one (1) year period after
the Effective Date. In the event that the Licensee discontinues the
Anoheal Project on or after the first anniversary of the Effective Date,
then Licensee shall not be required to make any continuing payments to
Licensor relating to the Anoheal Project pursuant to Clause
8.2.
|
8.4.
|
Notwithstanding
anything in this Agreement, Licensee may, in its sole discretion at any
time upon written notice to Licensor, discontinue Licensee's conduct of
the Incostop Project. In the event the Licensee discontinues its
performance of the Incostop Project during the one-year period after the
Effective Date, Licensee nonetheless shall be required to pay to Licensor
those amounts that otherwise would have been paid to Licensor pursuant to
Clause 8.2.1 for the Incostop Project for such one (1) year period after
the Effective Date, unless however,
Licensee terminates the Incostop project prior to the date that is 90 days
subsequent to the Effective Date (the "Option Expiration Date"), in which
case Licensee shall no longer have any obligation to remit payments to the
Licensor pursuant to Clause 8.2.1. Additionally, in the event that the
Licensee discontinues the Incostop Project on or after the first
anniversary of the Effective Date, then Licensee shall not be required to
make any continuing payments to Licensor relating to the Incostop Project,
pursuant to Clause 8.2.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
20
9. Payment
and Taxes
|
9.1.
|
Mode of
Payment: All payments made by Licensee to Licensor under this
Agreement shall be made in the Licensor's currency of choice (or, if
Licensor fails to notify Licensee of Licensor's currency of choice prior
to the first payment coming due, United States Dollars) to [*] or such
other bank and account Licensor may inform Licensee of in writing from
time to time, free of any bank or other charges. For the determination of
the applicable exchange rate from any currency to another, such conversion
shall be made by using the exchange rate prevailing at Citibank, N.A. in
New York, New York (or its successor). For royalty payments, this rate
should be the rate prevailing on the last business day of the calendar
quarter for which the royalties are being paid. For all other payments
this should be the prevailing rate on the earlier of the date when the
payment is actually made or the date when the payment becomes due.
Notwithstanding the foregoing, in each country whether the local currency
is blocked and cannot be removed from the country under such country's
applicable law, royalties accrued with respect to that country shall be
paid to Licensor in such country in local currency by deposit in a local
bank designated by Licensor, unless the parties otherwise agree in
writing.
|
|
9.2.
|
Non-refundable:
Subject to Clause 10.8, all monies paid to Licensor pursuant to this
Agreement are non-refundable and non-creditable against future
royalties.
|
|
9.3.
|
Delayed
Payment: If any payment due under this Agreement is overdue by more
than thirty days, interest from the due date to the date of actual payment
will be charged at [*]% above the Bank of England base rate (or its
successor).
|
9.4.
|
Withholding
Taxes: Licensee shall pay all taxes imposed by any governmental
authority or agency by reason of the transactions contemplated by this
Agreement provided that Licensee shall not be responsible for the payment
of any taxes imposed upon the income of Licensor. If any tax or amount in
respect of tax must be withheld or deducted from any sums payable to
Licensor ("the Withholding Tax"), then Licensee shall withhold or deduct
the Withholding Tax amounts from the sums payable and pay such Withholding
Tax amounts to the relevant tax authorities. The Licensee shall pay to
Licensor the amounts available after such withholding and deduction is
made, which shall be in full satisfaction of its payment liability due at
the time of the payment. Licensee shall use its commercially reasonable
efforts to obtain any exemptions from taxes, including submittal of
appropriate documents, available under the relevant laws and Licensor
agrees that Licensee fulfilled its obligations with respect to the
relevant exempt taxes by providing Licensor with a valid tax exemption
certificate (Form W-8BEN).
|
[*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
21
10. Records
and Reports
10.1.
|
Accounting
Period: An "Accounting Period" shall refer to each of the four three month
periods commencing on January 1, April 1, July 1 and October 1 of each
year, respectively. Royalties on Net Sales shall be calculated for each
Accounting Period not later than 60 days after the end of the respective
Accounting Period.
|
10.2.
|
The
amount of Net Sales in foreign currencies shall be converted into
US-dollars at the exchange rate applicable on the last business day of
each Accounting Period as calculated by using the applicable exchange rate
then prevailing at the Bank of England base rate. (or its
successor).
|
10.3.
|
Licensee
shall keep records and books of account in respect of all Net Sales made
and sold by Licensee and its sublicensees. Licensee shall keep the same
for at least ten (10) years after it pays the Licensor the royalties due
for such Net Sales and requires sublicensees to do the
same.
|
10.4.
|
Licensee
shall report to Licensor in writing quarterly, concurrently with the
payment due pursuant to Clause 7, the Net Sales by country by the Licensee
and each sublicensee.
|
22
10.5.
|
No
more frequently than once per calendar year, Licensor may, at its expense,
designate a suitably qualified independent accountant, reasonably
acceptable to Licensee, to review during ordinary business hours, such
part of Licensee's and its Affiliates' books and accounts as may be
necessary to determine, in respect of any Accounting Period, the accuracy
of any report and/or payment made under this Agreement. Said accountant
shall not disclose to Licensor any information other than that relating to
the accuracy of the reports and payments hereunder. Licensee shall be
provided within 60 days a written statement from the Licensor confirming
the outcome of the accountant's
visit.
|
10.6.
|
If
such independent accountant's report shows any underpayment of royalties
by Licensee, within thirty (30) days after Licensee's receipt of such
report, Licensee shall deliver to Licensor a written response addressing
each item in dispute. As soon as practicable, but not later than 30
business days following the receipt of Licensee's response by Licensor,
the parties shall meet and endeavor to resolve any disputed
item.
|
10.7.
|
In
the event of any underpayment, Licensee shall remit to
Licensor:
|
(a) the
amount of such underpayment; and
(b) if
such underpayment with respect to a particular calendar year exceeds [*] percent
([*]%) of the total royalties owed for the calendar year then being reviewed,
the reasonable, documented fees and expenses of such independent accountant
performing the review. Otherwise, Licensor's accountant's fees and expenses
shall be borne solely by Licensor.
10.8.
|
Any
overpayment of royalties shall be fully creditable against future amounts
payable under this Agreement in any subsequent calendar
quarter.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
23
10.9.
|
Subject
to the procedure described hereafter Licensor herewith authorizes Licensee
to make certain payments as defined hereafter to Solvay Pharmaceuticals
Inc. ("Solvay"), that would be otherwise due from Licensee to Licensor,
under this Agreement, upon written request of Solvay and presentation of a
final and binding judgment of a competent court condemning Licensor to pay
Termination Fees under the Termination Agreement listed in Exhibit 6 ("the
Judgment"). In the event of a payment request by Solvay, Licensee shall
immediately inform Licensor thereof in writing by registered mall. If
Licensor does not provide proof of payment to Solvay to Licensee within 10
days after Licensor received Licensee's notice, Licensee shall be entitled
to remit any monies owed to Solvay under the Termination Agreement and
such amount shall be deducted from any payment due from Licensee to
Licensor under this Agreement. Licensee shall have absolutely no liability
to Licensor for payments made to Solvay and deducted from any amount owed
to Licensor under this Agreement.
|
11. Licensee
Equity Interest
11.1.
|
Sometime
after the Effective Date, Licensee shall form a Delaware Company for the
initial purpose of developing and commercializing the Technologies
("NewCo") and will issue to Licensor, for a nominal consideration not to
exceed $.01 per share, that number of shares of the NewCo's common stock
(the "Common Stock") equal to five percent (5%) of the Licensee's
outstanding Common Stock as of the Effective Date (the "Issued Shares"),
which Common Stock shall be the same series as and shall carry the same
rights and privileges as the common stock issued to the Licensee.
Paramount shall then assign this Agreement to NewCo and Licensor hereby
consents to such assignment, such consent subject to Clause
11.2.
|
11.2.
|
As
a condition to consenting to the assignment by Licensee of this Agreement
to NewCo as provided for in Clause 11.1 above, NewCo shall agree, in
writing and hereby undertakes that as of the tirne of the closing of
NewCo's first equity financing including Third Party investors yielding
total gross proceeds of not less than Five Million Dollars ($5,000,000),
(such financing, the "Financing"), the Issued Shares do not have a fair
market value at least equal to $500,000 (calculated by multiplying the
number of Issued Shares by the price per share paid by Third Party
investors in the Financing), then NewCo shall issue to Licensor that
number of additional shares of Common Stock (the "Subsequently Issued
Shares") so that the number of shares of Common Stock held by Licensor
following such issuance (including the Issued Shares and Subsequently
Issued Shares) have a fair market value equal to $500,000 (based on price
per share paid by such Third Party investors in the Financing). For
purposes of clarification but not limitation, the Financing may include
Paramount as an investor, and amounts invested by Paramount in such
Financing shall be included in the determination of gross proceeds
described above, provided that Third Parties other than Paramount invest
at least $500,000 in such
financing.
|
11.3.
|
It
is understood and agreed that, notwithstanding anything to the contrary in
this Agreement, the Issued Shares and Subsequently Issued Shares (if
applicable and collectively the "Shares") will be non-refundable. The
Shares will not be registered under the Securities Act of 1933, as
amended, and may not be transferred unless and until registered or NewCo
has received an opinion of counsel or other evidence satisfactory to Newco
and its counsel that such registration is not required. The Shares will be
(i) issued pursuant to a subscription agreement, in the form attached
hereto as Exhibit 7, which the parties shall execute simultaneously with
the formation of NewCo.
|
12. Further
Development
12.1.
|
Development
Cost for the European Union
Licensor
shall perform the work described in the Licensor Clinical Development
Plan, on the schedule described therein in accordance with all applicable
laws, rules, regulations, and International Conference on Harmonisation
("ICH") guidelines, including but not limited to Good Clinical Practices
("GCP") and Good Laboratory Practices ("GLP") guidelines, as reasonably
appropriate. Material changes to the Licensor Clinical Development Plan
may only be made upon the approval of the Committee (defined
below).
|
25
12.2.
|
Consideration
to Licensor for EU Clinical
Development
|
Subject
to Clause 12.3, in consideration for the work described In Clause 12.1, Licensee
shall reimburse Licensor for reasonable, documented, direct costs and expenses
of performing such work described in the Licensor Clinical Development Plan
incurred subsequent to the Effective Date and pursuant to the budget established
therein, as they are reasonably incurred, upon presentment of invoices therefore
to Licensee, provided,
however,
that Licensee's total payment obligation under this Agreement with respect to
such costs and expenses shall not in any event exceed (i) US$2,800,000 to be
used by Licensor for the Anoheal Project (the "Maximum Anoheal Amount) and (ii)
US$1,200,000 to be used by the Licensor for the Incostop Project (the "Maximum
Incostop Amount"). It is understood that such costs shall be invoiced to the
Licensee on a monthly basis and shall include the actual costs for the
Licensor's professional services (including proportions of employees
remuneration, travel, office and other related expenses determined in good
faith) incurred by Licensor in connection with the development of Anoheal and
Incostop (as applicable). Invoices for Third Party goods and services may at
Licensor's discretion (i) be paid by Licensor and reimbursed by Licensee or (ii)
be directed to Licensee for direct payment. The Licensee irrevocably undertakes
to settle all invoices issued by or directed for payment by the Licensor within
thirty (30) days of receipt thereof. The Licensee shall remit $50,000 to the
Licensor upon execution of this Agreement for reimbursement of clinical
development costs of Licensor, such amount to be credited toward either the
Maximum Incostop Amount or the Maximum Anoheal Amount at Licensor's discretion.
Licensor shall account for its use of funds provided to it by Licensee pursuant
to this Clause 12.2 separately between the Incostop Project and the Anoheal
Project, such records to be provided to the Licensee quarterly.
26
12.3.
|
Termination
of Expense Payments
|
|
12.3.1.
|
In
the event that the Licensor discontinues the portion of the Licensor
Clinical Development Plan relating to the Anoheal Project arid/or the
Incostop Project, then the Licensee shall have no further payment
obligation with respect to the applicable project other than to pay for
uncancellabie financial commitments made prior to such discontinuance
relating to the applicable discontinued program. Additionally, in the
event that the Licensee discontinues the Licensee Clinical Development
Plan relating to the Incostop Project and/or the Anoheal Project, then the
Licensee's payment obligations pursuant to Clause 12.2 shall terminate
with respect to the corresponding project under the Licensor Clinical
Development Plan, other than to pay for uncancellable financial
commitments made prior to such discontinuance relating to such
discontinued program, and upon such payment, the balance of the Maximum
Incostop Amount (in the case of termination of the Incostop Project) or
the Maximum Anoheal Amount (in the case of termination of the Anoheal
Project) shall be zero.
|
|
12.3.2.
|
Notwithstanding
Clause 12.3.1, IF the Licensee elects to use a Alternative Formulation to
conduct the Incostop Project in the Territory, THEN the Maximum Incostop
Amount shall be reduced to $600,000. Notwithstanding the
foregoing, IF the FDA agrees that positive data and results from a single
United States Phase III Study conducted by Licensee using the Alternative
Formulation will be required for the approval of an NDA relating to a
Licensed Product incorporating Incostop API, THEN the Maximum Incostop
Amount shall be increased back to $1,200,000. IF (i) the Licensee elects
to use a Alternative Formulation to conduet the Incostop Project in the
Territory and (ii) the FDA requires the Licensee .to conduct two United
States Phase III Studies for the approval of an NDA relating to a Licensed
Product incorporating Incostop API, THEN (x) the Maximum Incostop Amount
shall remain $600,000 and (y) Licensee shall reimburse up to $600,000 to
Licensor for its conduct of the Incostop Project outside the Territory
(the "EU Incostop Trial") upon the submission by the Licensee of an NDA to
the FDA relating to a Licensed Product incorporating Incostop and data
generated from the EU Incostop Trial. Finally, IF the Licensor and the
Licensee use the same pharmaceutical formulation of Incostop to conduct
the Incostop Project in their respective territories (that is they both
use the same Alternative Formulation or they both use the same
non-Alternative Formulation), THEN the Maximum Incostop Amount shall be
$1,200,000.
|
27
12.4.
|
Development
Committee
|
|
12.4.1.
|
A
development committee (the "Committee") shall be organized to monitor the
clinical development of the Licensed Products in the Territory and the
European Union. The Committee will consist of independent scientific and
technical thought leaders that are highly regarded by the scientific
community in the field of each Licensed Product and at least one
representative from each of Licensor and the Licensee. The Licensor and
the Licensee will have equal membership on the Committee and all members
of the Committee must be agreed upon in writing by Licensor and Licensee.
The Licensee will have the tie-breaking vote with respect to matters
regarding the Territory, including the approval of the Licensee Clinical
Development Plan and related budget, subject to reasonably considering the
Licensor's reasonable perspective; Licensor will have the tie-breaking
vote with respect to matters relating to the Licensor Clinical Development
Plan and its related budget, subject to reasonably considering the
Licensee's reasonable
perspective.
|
28
|
12.4.2.
|
The
Committee will be responsible for (i) making recommendations relating to
the pre-clinical and clinical development strategy of Licensed Products;
(ii) analysis and assessment of ongoing pre-clinical and clinical
development of each Licensed Product; (iii) proposing recommendations for
other tactical and developmental uses of the Licensed Products; and (iv)
approving any amendments to the Licensor Clinical Development Plan,
Licensee Clinical Development Plan or conduct of clinical activities
concerning Licensed Products in the Territory and the European Community
other than the activities described in the Licensor Clinical Development
Plan or the Licensee Clinical Development Plan. The actions and opinions
of the Committee will be confidential. The Committee will meet at least
two (2) times per year.
|
12.5.
|
Licensor
Development Obligations
|
|
12.5.1.
|
Licensor
shall use all reasonable commercial efforts to complete the clinical
development of the Technology outside of the Territory pursuant to the
Licensor Clinical Development Plan. Any expenses incurred over and above
the Maximum Incostop Amount, as adjusted pursuant to this Clause 12 (for
the development and commercialization of Incostop) and the Maximum Anoheal
Amount (for the development and commercialization of Anoheal) to complete
the Licensor Clinical Development Plan shall be borne solely by the
Licensor, with the provision that any development work not provided for in
the Clinical Development Plan which is performed by the Licensor at
Licensee's request shall be paid by Licensee in addition to the Maximum
Anoheal Amount or the Maxim Incostop Amount (as
applicable).
|
29
13.
|
Marketing
|
|
13.1
|
The
Licensee shall, not later than [*] ([*]) [*] prior to the anticipated
launch of the Licensed Products in each country in the Territory, create a
marketing plan for the commercialization of Licensed Products in that
country and submit such marketing plan to the Licensor for
comment.
|
|
13.2
|
The
marketing plan shall be updated on an annual basis and shall include a
rolling three year sales forecast for each Licensed Product. The annual
updates (including the updated sales forecasts) shall be sent to the
Licensor under the notice requirements of Clause 26.3 within one month of
each anniversary of the receipt of the first marketing plan by the
Licensor.
|
|
13.3
|
The
Licensee shall, following Marketing Authorization of each Licensed
Product, take reasonable efforts consistent with good business practice to
promote the sale of such Licensed Product in the Territory, including any
legally permissible pre-marketing activities, and will keep the Licensor
informed of its marketing activities no less frequently than every twelve
months from first submission to the Licensor of the marketing plan
required under Clause 13.1. Where such approval by any regulatory,
government or non-government authority is a pre-requisite to commercial
launch of Licensed Products for human therapeutic use, the Licensee shall
use commercially reasonable endeavours to seek pricing and reimbursement
approval for the Licensed Products in that country in the Territory, and
to manage any other methods of reimbursement control that may be
reasonably necessary to materially increase the commercial potential of
the Licensed Products in the
Territory.
|
|
13.4
|
The
Licensee shall launch each Licensed Product as quickly as reasonably
practicable in each country in the Territory, but no later than [*] ([*])
months following the grant of a Marketing Authorization for the Licensed
Product by the Registration Authority in that
country.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
30
|
13.5
|
The
Licensee shall, as between the parties, be responsible for the application
and own or control all Marketing Authorizations and other regulatory
submissions or filings in the Territory and act as the national
representative for the Licensed Products-related medical affairs and drug
safety matters in the Territory. The Licensee shall inform the Licensor
regularly, but at least at the end of each calendar quarter on the status
of the application and the progress with regard to the Licensee Clinical
Development Plan in general. The Licensee shall promptly notify Licensor
of the issuance of each Marketing Authorization. Furthermore the Licensee
shall inform the Licensor of any adverse events or other events material
to the development, marketing and/or sale of Licensed Products as soon as
reasonably possible and within the internationally recognised time period
appropriate to the severity of the adverse event. Licensor, or at
Licensor's discretion, Licensor's licensees or sublicensees shall act as
the national representative for the Licensed Products-related medical
affairs and drug safety matters outside the Territory. Licensor
shall report to Licensee any adverse events or other events material to
the development, marketing and/or sale of Licensed Products as soon as
reasonably possible, but in any event no later than within the
internationally recognised time period appropriate to the severity of the
adverse event.
|
|
13.6
|
The
Licensee shall comply with all laws, rules and regulations, and, to the
extent commercially reasonable, pharmaceutical industry trade association
guidelines applicable to the marketing and distribution of the Licensed
Products in the Territory; Licensor shall comply with all laws, rules,
regulations, and, to the extent commercially reasonable, pharmaceutical
industry trade association guidelines applicable to the marketing and
distribution of Licensed Products outside the Territory. For
clarification, this includes, but is not limited to, pharmacovigilance and
drug safety monitoring, product promotion, product quality and product
recall. Each party shall inform the other promptly in writing in the event
it becomes aware of any matter which may reasonably precipitate a product
recall, market withdrawal, or field correction, whether or not required by
law.
|
31
14.
|
Costs,
Validity, and Prosecution of
Patents
|
14.1.
|
Licensor
shall, at Licensee's expense as described in Clause 14.3 below, diligently
file, prepare, prosecute and maintain the Patents and Improvements
developed by Licensor in the Territory, including, but not limited to, the
filing of patent applications, extensions, continuations, continuations in
part, divisionals, reexaminations, or re-issue applications that may be
reasonably required or advisable to advance the purposes of this Agreement
or otherwise to protect the rights and licenses granted hereunder.
Licensor shall control such prosecution and maintenance, at Licensee's
expense, using counsel of its choosing (but approved by Licensee, such
approval not to be unreasonably withheld). Licensor agrees to keep
Licensee reasonably informed with respect to the status and progress of
any such applications, prosecutions and maintenance activities for the
Patents and Improvements developed by Licensor in the Territory and in all
foreign counterparts of said Patents and Improvements outside the
Territory and to consult in good faith with Licensee and take into account
Licensee's reasonable comments and requests with respect thereto prior to
the filing of any such documents. Licensee shall file, prosecute, and
maintain Patents claiming any Improvements developed by Licensee to the
extent commercially reasonable. Both parties agree to provide reasonable
cooperation to each other to facilitate the application and prosecution of
Patents pursuant to this Agreement. Notwithstanding anything to the
contrary, Licensor shall not abandon prosecution of any pending Patent or
maintenance of any issued Patent without first giving Licensee notice at
least sixty (60) days prior to the date on which such patent application
or patent will become abandoned, and shall allow Licensee to assume
prosecution of any such patent application, or maintenance of any such
patent, at Licensee's own expense and with counsel of its choosing,
provided that the claims of any such patent or patent application shall
thereafter not be
considered Valid Claims for purposes of this Agreement, including but not
limited to the determination of payments due
hereunder.
|
32
14.2.
|
Where
reasonably possible and reasonably useful or valuable in the
commercialization of Licensed Products, Licensor shall, at Licensee's
cost, use commercially reasonable efforts to apply for or enable Licensee
to apply for a patent term extension, adjustment or restoration,
supplementary protection certificate, or other form of market exclusivity
conferred by applicable laws, rules, or regulations (collectively, "Patent
Term Extensions") in the relevant country of the Territory. Licensee
shall, to the extent reasonably possible, assist Licensor in pursuing
Patent Term Extensions.
|
14.3.
|
Starting
as of the Effective Date, Licensee shall pay, in connection with the
preparation, filing, and prosecution, issuance and maintenance of the
Patents (including Patent Term Extensions) in the Territory (i) all
reasonable attorney fees for the services performed to obtain the issuance
of the Patents and Patent Term Extensions, (ii) all government fees and
all maintenance fees relating to the Patents and Patent Term Extension, to
the extent such payments become due at or after Effective
Date.
|
14.4.
|
Licensee
shall not contest the ownership of Licensor of the Patents and the
Technology as existing, in either case. If Licensee challenges in a court
of law the validity of the Patents or the ownership of Technology as
existing, in either case, then Licensor shall be entitled to terminate
this Agreement with immediate effect upon written notice to
Licensee.
|
33
15.
|
Trademarks
and Improvements
|
15.1.
|
Licensor
will inform Licensee promptly in writing and in reasonable detail of all
Improvements.
|
15.2.
|
Licensee
shall inform Licensor promptly in writing and in reasonable detail of all
Licensee Improvements and Licensor shall inform Licensee promptly in
writing and in reasonable detail of any Improvements. Licensee hereby
grants Licensor (i) a free non exclusive license outside the Territory
under all Licensee Improvement solely to make, have made, and use products
(but not sell) and (ii) a free exclusive license outside the Territory
under all Licensee Improvements solely to sell products incorporating
Licensee Improvements, provided, however, that in the case of both (i) and
(ii), such products incorporating Licensee Improvements are used solely in
the development and/or commercialization of Anoheal or
Incostop.
|
15.3.
|
Licensee
is entitled without obligation to use in the Territory the Trademarks
listed In Exhibit 4.
|
15.4.
|
Licensee,
its Affillates, and their sublicensees may elect to use or license
additional trademarks for the Licensed Products in the Territory. Such
trademarks shall be registered and paid for by Licensee or its Affiliates,
sublicensees or licensors, and shall remain the sole property of Licensee
or its Affiliates, sublicensees or licensors, as the case may
be.
|
16.
|
Infringement,
Validity Challenges and Litigation
|
16.1.
|
Infringement
and Validity Challenges
|
|
16.1.1.
|
The
Parties to this Agreement shall inform each other promptly of any
potential, actual, alleged, or reasonably suspected infringement of the
Patents (or in the case of patents claiming Licensee Improvements, such
patents), and/or challenge to the validity or enforceability of any claims
of any of the foregoing, and provide each other with any available
evidence of such infringement or
challenge.
|
34
|
16.1.2.
|
During
the term of this Agreement, the Licensee shall have the first right, but
not the obligation, to take (or refrain from taking) appropriate action to
enforce Patents, to defend any declaratory judgments seeking to invalidate
or hold the Patents unenforceable, to control any litigation or other
enforcement action and to enter into, or permit, the settlement of any
such litigation, declaratory judgments or other enforcement action
pertaining to Patents, with respect to any potential, threatened, alleged,
or actual infringement of, or challenge, to the Patents, at its own
expense and with counsel of its choosing, in the Territory. In furtherance
of such right, Licensor hereby agrees that the Licensor may join Licensee
as a party in any such suit (and will join at the Licensee's request),
provided that the Licensee pay all of Licensor's reasonable, documented
out-of-pocket expenses with respect thereto. If, within twelve (12) months
of the written notice above, the Licensee (i) shall have been unsuccessful
in persuading the alleged infringer to desist, (ii) shall not have brought
and shall not be diligently prosecuting an infringement action, or (iii)
has not entered into settlement discussions with respect to such
infringement, or if the Licensee notifies Licensor that it has decided not
to undertake any of the foregoing against any such alleged infringer, then
Licensor shall then have the right to bring suit to enforce such Patents,
at its own expense, provided, however, that, within thirty (30) days after
receipt of notice of Licensor's intent to file such suit, Licensee shall
have the right to jointly prosecute such suit and to fund up to one-half
(1/2) the costs of such suit In exchange for a commensurate share of the
proceeds of such suit. Subject to the effects of the foregoing in the
event the Licensee exercises the aforementioned right, any recovery of
damages or amounts received in settlement pursuant to this Clause 16.1.2
shall be allocated pursuant to Clause 16.1.4
below.
|
35
|
16.1.3.
|
The
party controlling any action, suit, or defense under Clause 16.1.1 (the
"Controlling Party") shall be free to enter into a settlement, consent
judgment, or other voluntary disposition of any such action, provided,
however, that (i) the Controlling Party shall consult with the other party
(the "Secondary Party") prior to entering into any settlement thereof and
(ii) any settlement, consent judgment or other voluntary disposition of
such actions which (1) materially limits the scope, validity, or
enforceability of any patents or, if the Licensee is the Secondary Party,
patents or patent applications owned or controlled by the Licensee, (2)
subjects the Secondary Party to any non-indemnified liability, payment
obligation, or injunction, or (3) admits fault or wrongdoing on the part
of Secondary Party, it then must be approved in writing by Secondary
Party, such approval not to be unreasonably withheld. Secondary Party
shall provide the Controlling Party notice of its approval or denial of
such approval within twenty (20) business days of any request for such
approval by the Controlling Party, provided that in the event Secondary
Party wishes to deny such approval, such notice shall include a written
description of Secondary Party's reasonable objections to the proposed
settlement, consent judgment, or other voluntary disposition and (ii)
Secondary Party shall be deemed to have approved such proposed settlement,
consent, judgment or other voluntary disposition in the event it fails to
provide such notice within such twenty (20) business day
period.
|
36
|
16.1.4.
|
Any
damages, recoveries, or settlement amounts Licensee obtains .as a result
of the matters contemplated by Clause 16.1.2, when Licensee is prosecuting
or defending any action, shall first be applied to payment of each of the
parties' costs related to any actions taken by the parties with respect to
such matters, with the remainder, to the extent attributable to
infringement of the Patents, deemed Anoheal Net Sales or Incostop Net
Sales, as elected by Licensee in its sole discretion for book keeping
purposes, and subject to the applicable royalty obligation under Clause 7
of this Agreement. Any recovery of damages or amounts received in
settlement by Licensor under Clause 16.1.2, when Licensee is prosecuting
or defending any action, shall be applied first in satisfaction of any
unreimbursed expenses and legal fees of each of Licensee and Licensor
relating thereto, with the balance remaining from any such recovery being
allocated as follows: (i) any amounts reasonably attributable to any
intellectual property rights of Licensee (other than those licensed to
Licensee hereunder) being paid to Licensee and (ii) the remaining balance
shall be retained by the Licensor.
|
|
16.1.5.
|
To
the extent there is no recovery of damages or amounts received in
settlement by Licensee, its Affiliates, or Licensor with respect to any
matter contemplated by Clause 16.1.2 above, or such amounts are
insufficient to fully reimburse the Licensee for any amounts incurred by
the Licensee with respect to such matter (including but not limited to
attorneys' fees, out-of-pocket costs, and all amounts paid as judgments,
damages, or in settlement) (such amounts, "Infringement Costs"), the
Licensee may, to the extent not deducted from amounts due under this
Agreement pursuant to Clause 7.6, credit [*] percent ([*]%) of
Infringement Costs (such [*] percent ([*]%), the "Infringement Cost
Credit") against royalties or other amounts thereafter payable to Licensor
under this Agreement. If the Infringement Cost Credit exceeds [*]% of the
amounts payable to Licensor under this Agreement in any calendar quarter
in which the relevant Infringement Costs are incurred, then the amount of
such Infringement Cost Credit in excess of the amounts payable to Licensor
shall be carried over and credited against payments due in future calendar
quarters. In no event shall the deduction of Infringement Cost under this
clause 16.1.5 and the deduction under clause 7.6. added together exceed
[*]% of the total amount due Licensor under this Agreement In any
particular calendar quarter. Notwithstanding the foregoing, If any action
or suit is initially brought by Licensee under this Clause 16 (as opposed
to Licensee defending an action or suit pursuant to this Clause 16.1.5),
then this Clause 16.1.5. shall not
apply.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
37
|
16.1.6.
|
In
any suit or other action contemplated by Clause 16.1.2, the Secondary
Party shall, at the request and expense of the Controlling Party,
cooperate in all respects and, to the extent possible, have its employees
testify when requested and make available relevant records, papers,
information, samples, specimens, and the
like.
|
17.
|
Third
Party Rights
|
17.1.
|
If
either party is charged with the actual or alleged infringement of Third
Party rights based on the exploitation of the Patents, the Technology, or
the use, manufacture, sale, or import of Licensed Products or any other
products incorporating Anoheal API or Incostop API, such party shall
immediately inform the other party about this
allegation.
|
17.2.
|
The
Licensee may, in its sole discretion, modify Licensed Products to avoid
such infringement and/or may settle on terms that it deems advisable in
its sole discretion, provided that any final disposition of the litigation
that will restrict the claims in or admit any invalidity of any Patents
shall not be made without consultation with and approval by Licensor, such
approval not to be unreasonably withheld. Otherwise, the Licensee shall
have the first right, but not the obligation, to defend or settle any such
claim or suit. If the Licensee has not exercised such right to defend or
entered into settlement discussions concerning such alleged infringement
within the sooner of (i) twelve (12) months of the assertion of such a
claim or (ii) thirty (30) days of the filing of such a suit, or if the
Licensee notifies Licensor that it has decided not to undertake such
defense or enter into settlement discussions with respect to its alleged
infringement, then Licensor shall then have the right to defend such
alleged infringement, at its sole expense, provided however that no
settlement affecting Patents will be agreed upon without Licensee's
written consent.
|
38
17.3.
|
If
(i) Licensee by a final judgment is ordered to stop manufacturing, using,
selling, or importing any Licensed Product or (ii) a judgment is rendered
which would reasonably preclude Licensee's manufacture, use, sale, or
import of any particular Licensed Product, and Licensee or Licensor does
not secure sufficient rights under such Third Party patents to continue or
resume such use, manufacture, sale, or import, Licensee shall have no
further obligations under this Agreement to make, use, or sell such
Licensed Product and shall not be in breach of this Agreement with respect
to any failure to make, use, or sell such Licensed Product thereafter, and
Licensor shall not be entitled to terminate this Agreement for any reason
related to Licensee's failure to make, use, or sell such Licensed
Product.
|
17.4.
|
In
any suit to defend any alleged infringement of Third Party intellectual
property rights by the manufacture, use, sale, or import of a Licensed
Product, Licensor shall, at the request and expense of Licensee, cooperate
in all respects and, to the extent possible, have its employees testify
when requested and make available relevant records, papers, information,
samples, specimens, and the like.
|
18.
|
Representations
and Warranties
|
Licensor hereby
represents and warrants that:
39
18.1.
|
It
is not aware of any legal deficiencies of the Patents, Know-How, or
Technology. Licensor assumes no liability for the lack of such unknown
deficiencies.
|
18.2.
|
It
has full authority to grant the licenses provided hereunder and that all
necessary corporate actions have been
taken.
|
18.3.
|
Licensor
owns all right, title, and interest in and to the Patents and the Material
free and clear of all liens, encumbrances or other restrictions or
limitations whatsoever.
|
18.4.
|
The
US and foreign patent applications and patents itemized on Exhibit 2 set
forth all of the patents and patent applications necessary or useful for
practicing the Technology, manufacturing, using or selling Licensed
Products, or manufacturing, using, or selling products incorporating
Anoheal or Incostop in the Field in the Territory, in each case owned or
controlled by Licensor.
|
18.5.
|
Licensor
is not aware of any licenses, options, restrictions, liens, rights of
third parties, disputes, royalty obligations, proceedings or claims
relating to, affecting, or limiting Licensor's rights or the rights of the
Licensee under this Agreement, or which may lead to a claim of
infringement by or invalidity regarding, any part or all of the Patents,
Technology, or Know-how or their use except as disclosed in Exhibit 6
(A).
|
18.6.
|
Licensor
is not aware of any claim, pending or threatened, of infringement,
interference or invalidity regarding any part or all of the Patents,
Technology, or Know-how or their use in the Territory except as disclosed
in Exhibit 6 (B).
|
18.7.
|
The
Licensor is not aware of any inventors of Patents other than those listed
as inventors on applications filed for such
Patents.
|
40
18.8.
|
The
development of the Technology, Patents, and Know-how were not supported in
whole or part by funding or grants by any governmental agency or
philanthropic or charitable
organization.
|
18.9.
|
The
Licensor is a corporation duly organized, validly existing and in good
standing under the laws of Switzerland. The Licensor has the requisite
power and authority to execute and deliver this Agreement and to
consummate the transactions contemplated hereby. The execution and
delivery of this Agreement and the performance and consummation of the
transactions contemplated hereby by the Licensor have been duly authorized
by all necessary action on the part of the Licensor and will not result in
any violation or breach of, constitute (with or without notice or lapse of
time or both) a default under or conflict with/or give rise to a right of
termination, amendment, cancellation or acceleration of any agreement
which is material for the performance of the present
Agreement.
|
18.10.
|
This
Agreement has been duly executed and delivered by the Licensor and,
subject to the due authorization, execution and delivery of this
Agreements by the Licensee, this Agreement constitutes a valid and binding
obligation of the Licensor, enforceable against the Licensor in accordance
with its terms, except as such enforcement may be affected by bankruptcy,
reorganization, insolvency, moratorium or similar laws affecting
creditor's rights generally and except for general principles of
equity.
|
18.11.
|
The
execution and delivery of this Agreement does not, the consummation of the
transactions contemplated hereby and the performance of Licensor's
obligations hereunder will not, (i) conflict with, or result in any
violation or breach of any provision of the organizational documents of
the Licensor, (ii) conflict with or violate any applicable statutes,
judgments, decrees, laws, ordinances, rules, regulations, injunctions and
orders ("Laws") of any Swiss federal, canton, or local government or any
Swiss court, tribunal, administrative agency or commission or other
governmental or regulatory authority, body or agency, including any
self-regulatory organization ("Governmental Authorities") applicable to
the Licensor.
|
41
18.12.
|
No
consent, approval or authorization of, or declaration or filing with, any
Swiss Governmental Authority or other Third Party (a "Consent") is
required on the part of the Licensor in connection with its execution,
delivery, and performance of this Agreement or the consummation of the
transactions contemplated hereby.
|
18.13.
|
Exhibit
8 hereto sets forth a true and complete list of each license, contract or
other agreements (together with certain other agreements and any
amendments to any of the foregoing) to which the Licensor is a party and
which relates to the Licensed Products or the Patents in the Territory,
including but not limited to the clinical trial agreements (collectively,
the "Material Agreements"). True and complete copies of all Material
Agreements have been previously delivered to the Licensee. To the best
knowledge of the Licensor each of the Material Agreements is valid,
binding and in full force and effect, and enforceable by the Licensor, or
has expired, in each case in accordance with its respective terms. No
person or entity (other than the Licensor) that is a party to any Material
Agreement or is otherwise bound thereby is, to the knowledge of the
Licensor, in default or breach thereof and, to the Licensor's knowledge,
no event, condition or act exists that, with the giving of notice or the
lapse of time or both, would give rise to such a default or breach thereof
or a right of cancellation by the Licensor thereunder. The Licensor is not
in default or breach in any material respect of any of the Material
Agreements and, to the knowledge of the Licensor, no event, condition or
act exists that, with the giving of notice or the lapse of time or both,
would give rise to a default or breach by the Licensor thereof or a right
of cancellation thereunder by any other party
thereto.
|
42
18.14.
|
No
written communication has been received by the Licensor, and to the
knowledge of the Licensor no investigation, regulatory enforcement action
(including seizure, injunction, civil penalty or criminal action) or any
related Governmental Authority review is or, in respect of any Licensed
Product was at any time pending or is threatened by any Governmental
Authority with respect to (i) any alleged or actual violation by the
Licensor of any permit, Law or other requirement or any Governmental
Authority relating to the operations conducted by the Licensor with
respect to any Licensed Product or the Technology or (ii) any alleged or
actual failure to have or maintain in effect all permits required in
connection with the operations conducted by the Licensor with respect to
any Licensed Product or the Technology. The Licensor has not received from
the FDA, the U.S. Drug Enforcement Administration ("DEA"), or any similar
state, local, federal, or foreign Governmental Authority any written
notice regarding the approvability or approval of any of the Licensed
Products. No Licensed Product has been withdrawn, suspended or
discontinued by the Licensor as a result of any action by the FDA, the DEA
or any similar state, local, federal, or foreign Governmental Authority,
either within or outside the U.S. (whether voluntarily or otherwise). To
the best knowledge of the Licensor with respect to any Licensed Products,
no officer, employee or agent of the Licensor has made any untrue
statement of a material fact or a fraudulent statement to the FDA, DEA or
any similar state, local, federal, or foreign Governmental
Authority.
|
18.15.
|
The
Licensor is not aware of any suits or actions, administrative, arbitration
or other proceedings, or governmental investigations pending or threatened
against or affecting the Licensor with respect to Licensed Products,
Technology, Know-How, or the Patents other than pending oppositions to
European Patents corresponding to the Patents. No Entity has notified the
Licensor in writing of any material claim against the Licensor alleging
any personal property or economic injury, loss or damage incurred as a
result of or relating to the use of the Technology, Know-How, or any
Licensed Products. The Licensor is not aware of any judgment, order,
Injunction, decree, writ or award against the Licensor that is not
satisfied and remains outstanding with respect to the Technology, Patents,
Know-How, or any Licensed
Product.
|
43
18.16.
|
The
Licensor has not received any notice of infringement of, or conflict with,
any license, patent, copyright, trademark, service xxxx or other
intellectual property right of any Third Party relating to the Territory.
Except as provided herein, the validity or enforceability of any of the
Patents and or the title of the Licensor thereto has not been questioned
in any litigation, governmental inquiry or proceeding to which the
Licensor is a party and, to the knowledge of the Licensor, no such
litigation, governmental inquiry or proceeding is threatened except as
disclosed in Exhibit 6 (B).
|
18.17.
|
To
the knowledge of the Licensor, the Licensor has taken all reasonable
actions necessary or appropriate to preserve the confidentiality of all
trade secrets, proprietary and other confidential information material to
the Licensed Products, Know-how, Technology, and
Patents.
|
18.18.
|
Licensor
is not aware of any Third Party activities which would constitute
misappropriation or infringement of the Patents in the
Territory.
|
18.19.
|
These
are the only representations and warranties given by Licensor to the
exclusion of all others.
|
Licensee hereby
grants and warrants that:
18.20.
|
The
Licensee is a limited liability company duly organized, validly existing
and in good standing under the laws of New York. The Licensee has the
requisite power and authority to execute and deliver this Agreement and to
consummate the transactions contemplated hereby. The execution and
delivery of this Agreement and the performance and consummation of the
transactions contemplated hereby by the Licensee have been duly authorized
by all necessary action on the part of the Licensee. This Agreement has
been duly executed and delivered by the Licensee and, subject to the due
authorization, execution and delivery of this Agreements by the Licensor,
this Agreement constitutes a valid and binding obligation of the Licensor,
enforceable against the Licensee in accordance with its terms, except as
such enforcement may be affected by bankruptcy, reorganization,
insolvency, moratorium or similar laws affecting creditor's rights
generally and except for general principles of
equity.
|
44
18.21.
|
The
execution and delivery of this Agreement does not, the consummation of the
transactions contemplated hereby, and the performance of Licensor's
obligations hereunder will not, (i) conflict with, or result in any
violation or breach of any provision of the organizational documents of
the Licensee, (ii) conflict with or violate any applicable statutes,
judgments, decrees, laws, ordinances, rules, regulations, injunctions and
orders ("Laws") of any government or court, tribunal, administrative
agency or commission or other governmental or regulatory authority, body
or agency, including any self-regulatory organization in the Territory
("Governmental Authorities") applicable to the
Licensee.
|
18.22.
|
No
consent, approval or authorization of, or declaration or filing with, any
Governmental Authority or other Third Party (a "Consent") is required on
the part of the Licensee in connection with its execution, delivery, and
performance of this Agreement or the consummation of the transactions
contemplated hereby, that has not been received or filed by
Licensee.
|
19.
|
Limitation
of Liability
|
NEITHER
PARTY SHALL BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, OR INDIRECT
DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF
LIABILITY, subject to compulsory Swiss law regarding damages caused
intentionally or in a grossly negligent manner.
45
20.
|
Indemnification
|
20.1.
|
Licensee
shall indemnify, hold harmless and defend Licensor and its directors,
officers, employees and agents against any and all losses, expenses, cost
of defense (including without limitation attorney's fees, witness fees,
damages, judgments, fines and amounts paid in settlement) and any amounts
Licensor becomes legally obligated to pay because of any claim or claims
against it to the extent that such claim or claims arise out of the
development, manufacture, sale or use of the Licensed Products by
Licensee, its Affiliates or its sublicensees, except to the extent such
losses, expenses, costs and amounts are due to Licensor's, its
Affiliates', or their sublicensees' (i) development, manufacture, use, or
sale of Licensed Products or other products incorporating Anoheal API or
Incostop API, (ii) negligence or intentional misconduct, (iii) breach of
this Agreement, or (iv) failure to comply with all applicable laws, rules,
and regulations, except to the extent such loss was due to Licensor's
gross negligence, willful misconduct or
fraud.
|
20.2.
|
Licensor
shall indemnify, hold harmless and defend Licensee and its directors,
officers, employees and agents against any and all losses, expenses, cost
of defense (including without limitation attorney's fees, witness fees,
damages, judgments, fines and amounts paid in settlement) and any amounts
Licensee becomes legally obligated to pay because of any claim or claims
against it to the extent that such claim or claims arise out of
Licensor's, its Affiliates', or their sublicensees' (i) development,
manufacture, use or sale of the Licensed Products or other products
incorporating Anoheal API or Incostop API, (ii) negligence or intentional
misconduct, (iii) breach of this Agreement, or (iv) failure to comply with
all applicable laws, rules, and regulations, except to the extent such
loss was due to Licensee's gross negligence, willful misconduct or
fraud.
|
20.3.
|
In
the event that either party intends to seek indemnification for any claim
under Clause 20.1 or 20.2, it shall inform the other party of the claim
promptly after receiving notice of the
claim.
|
46
20.4.
|
In
the case of a claim for which Licensor seeks indemnification under Clause
20.1, Licensor shall permit the Licensee to direct and control the defense
of the claim and shall provide such reasonable assistance as is reasonably
requested by the Licensee (at the Licensee's cost) in the defense of the
claim, provided that nothing in this clause 20.4 shall permit the Licensee
to make any admission on behalf of Licensor, or to settle any claim or
litigation which would impose any financial obligations on Licensor
without the prior written consent of Licensor, such consent not to be
unreasonably withheld or
delayed.
|
In the
case of a claim for which the Licensee seeks indemnification under Clause 20.2,
the Licensee shall permit Licensor to direct and control the defense of the
claim and shall provide such reasonable assistance as is reasonably requested by
Licensor (at Licensor's cost) in the defense of the claim, provided that nothing
in this Clause 20.3 shall permit Licensor to make any admission on behalf of the
Licensee, or to settle any claim or litigation which would impose any financial
obligations on the Licensee, without in either case the prior written consent of
the Licensee, such consent not to be unreasonably withheld or
delayed.
21.
|
Product
Liability
|
21.1.
|
Licensee
agrees that Licensor shall have no liability to Licensee or to any
purchasers or users of Licensed Products made or sold by Licensee for any claims, demands,
losses, costs, or damages suffered by Licensee, or purchasers or users of
such Licensed Products, or any other party, which may result from personal
injury, death, or property damage related to the manufacture, use, or sale
of such Licensed Products, except to the extend such claims, demands,
losses, costs, or damages are a result of Licensor's gross negligence or
willful misconduct.
|
47
21.2.
|
Each
party shall maintain insurance coverage in types and amounts reasonably
sufficient to cover its obligations under Clause 20 and provide evidence
thereof to the other party upon written request. At such time as a party
or its sublicensees, as applicable, begins to sell or distribute Licensed
Products (other than for the purpose of obtaining regulatory approvals),
such party or sublicensee, as applicable, shall at its sole expense,
procure and maintain policies of comprehensive general liability insurance
naming the other party as an additional insured. Such comprehensive
general liability insurance shall provide product liability coverage. Each
party shall provide the other with written evidence of such insurance and
shall inform the other party with notice at least fifteen (15) days prior
to any cancellation, non-renewal or material change in such insurance, to
the extent such party receives advance notice of such matters from its
insurer.
|
22.
|
Force
Majeure
|
Neither
party shall be liable to the other for any inability to perform any obligation
under this Agreement (except monetary obligations of either party) due to,
events beyond its reasonable control, including, but not limited to, fire,
storm, flood, earthquake, explosions, riots, strikes, transportation embargoes
or delays, shortages of materials or machinery, or acts of the
government.
23.
|
Termination
|
23.1.
|
This
Agreement shall come into force upon signing by both parties and shall
continue in force for each country of the Territory for Anoheal and
Incostop, respectively, until the sale of Licensed Products incorporating
Anoheal API or Incostop API, respectively, is terminated, subject to
termination pursuant to this Clause 23. For the avoidance of doubt it is
stated that the Agreement also ends if the sale of products containing
Anoheal or Incostop continues provided such products are not covered by
Valid Claims and do not incorporate or use Technology or Know-How
(including but not limited to clinical studies) as defined in Clauses 2.19
and 2.27 above.
|
48
23.2.
|
The
Licensee shall have the right to terminate the Agreernent, in its entirety
or with respect to its rights and obligations with respect to Licensed
Products incorporating Anoheal or Incostop, respectively, in any country,
on ninety (90) days written notice. Upon termination of either the
Incostop Project or the Anoheal Project pursuant to this Clause 23.2, all
rights to the Patents relating to Incostop Project or the Anoheal Project,
as applicable, shall revert to the Licensor, except to the extent such
rights (i) are needed by Licensee for the development and
commercialization of the unterminated project, if any, and (ii) relating
to Licensee Improvements (except Licensor shall retain rights relating to
Licensee Improvements to be used solely in the development and/or
commercialization of Anoheal or
Incostop).
|
23.3.
|
In
the event either party (the "Insolvent Party") becomes bankrupt or files a
petition in bankruptcy, or if the business of a party shall be placed in
the hands of a receiver, assignee or trustee for the benefit of creditors,
whether by the voluntary act of such party or otherwise, such party shall
provide notice thereof to the other party and the other party may, subject
to the effects of and protections of any applicable bankruptcy-related
laws, rules, or regulations (including but not limited to Section 365(n)
of the United States Bankruptcy Code, which shall apply to the rights
granted Licensee under this Agreement), terminate this Agreement upon
notice to the Insolvent Party given within thirty (60) business days of
the other party's receipt of such
notice.
|
23.4.
|
Upon
any material breach or material default of this Agreement by either party
(the "Breaching Party"), the other party (the "Non-Breaching Party") shall
have the right to terminate this Agreement and the rights, privileges and
license granted hereunder by giving sixty (60) days prior written notice
to the Breaching Party. Upon the expiration of the sixty (60) day period,
if Breaching Party shall have not cured such breach or default, this
Agreement shall, at the option of the Non-Breaching Party, terminate upon
written notice of Non-Breaching Party given within ten (10) business days
of the expiration of such sixty (60) day period. Notwithstanding anything
herein to the contrary, if the nature of the breach is such that
additional time is reasonably needed to cure such breach, and Breaching
Party has commenced with good faith efforts to cure such breach, then
Non-Breaching Party shall provide Breaching Party with reasonably
sufficient additional time in which to cure such breach, provided such
time shall not in any event exceed ninety (90) days. For the avoidance of
doubt, failure of the Licensee to timely remit to the Licensor monies due
under this Agreement shall be deemed a "material breach" of this
Agreement.
|
49
23.5.
|
Upon
the termination of this Agreement pursuant to this Clause 23, Licensee may
notify Licensor of the amount of Licensed Products that Licensee has in
its possession, under its control, or in the process of manufacture and
Licensee may then, notwithstanding anything to the contrary, be entitled
to sell that amount of Licensed Products, but no more, subject to the
royalties provided for in this Agreement. Licensee shall stop using the
Know How and the Technology and the right to make reference to the
Materials or data contained in the Know How, including but not limithd to
clinical studies, shall end.
|
23.6.
|
Sublicenses:
In the event this Agreement is terminated pursuant to Clause 23.2, 23.3,
or 26.4, any sublicense granted by Licensee to the extent concerning the
rights subject to such termination shall remain in effect and be assigned
to Licensor and Licensor shall assume all rights and obligations of
Licensee applicable after termination of this
Agreement.
|
23.7.
|
Upon
termination of this Agreement for any reason, nothing herein shall be
construed to release either party from any obligation that matured prior
to the effective date of such termination, and the following provisions
shall survive such termination: Clauses 2, 10.3, 16 (with respect to
infringement occurring prior to such termination), 17 (with respect to
infringement occurring prior to such termination), 19, 20, 21, 23, 24, 25,
26, and 27.
|
50
23.8.
|
In
the event Licensee terminates the development and sale of either Anoheal
or Incostop then upon written request of the Licensor the Licensee shall
transfer and assign at no cost, any and all pre-clinical data, human
safety data, preliminary efficacy data, INDs and other regulatory data and
filings that are in its possession related to the Licensed Product
affected .by such stop, and shall provide Licensor with the right to
reference with respect to such data and regulatory
filings.
|
23.9.
|
In
the event Licensor terminates the development and marketing efforts for
either Anoheal or Incostop then upon written request of the Licensee the
Licensor shall transfer and assign at no cost, any and all pre-clinical
data, human safety data, preliminary efficacy data, INDs and other
regulatory data and filings that are in its possession related to the
Licensed Product in the European Union affected by such stop, and shall
provide Licensee with the right to reference with respect to such data and
regulatory filings.
|
24.
|
Confidentiality
|
24.1.
|
Each
party agrees to retain in strict confidence and not to disclose to any
other person or entity any Confidential Information of the other party,
whether disclosed prior to or after the date of signature of this
Agreement or of prior secrecy agreements. The parties further agree not to
use any such Confidential Information for any purpose, except pursuant to,
and in order to carry out, the terms and objectives of this
Agreement.
|
24.2.
|
Each
party agrees to undertake all necessary and appropriate precaution to
prevent and restrain the unauthorized disclosure of such Confidential
Information. Each party warrants that each of its employees or
representatives to whom any Confidential Information is revealed shall
previously have been informed of the confidential nature of the
Confidential Information and shall have agreed to be bound by the terms
and conditions substantially similar to this confidentiality
obligation.
|
51
24.3.
|
The
provisions of this section 24 shall not apply to any Confidential
Information disclosed hereunder
which:
|
|
24.3.1.
|
was
known by the receiving party prior to its disclosure to the receiving
party by the other party, as evidenced by the prior written records of the
receiving party, or
|
|
24.3.2.
|
either
before or after the date of disclosure to the receiving party by the other
party is lawfully disclosed to the receiving party without obligation of
confidentiality or limitation on use by an Third Party rightfully in
possession of the Confidential Information,
or
|
|
24.3.3.
|
Confidential
Information that was developed before the Effective Date independently by
the receiving party without use or benefit of the Confidential Information
of the other party, as evidenced by written records;
or
|
|
24.3.4.
|
is
required to be disclosed by the receiving party to comply with applicable
laws, to defend or prosecute litigation or to comply with governmental
laws or regulations, provided that the receiving party provides prior
written notice of such disclosure to the other party and takes reasonable
and lawful actions to avoid and/or minimize the degree of such disclosure,
subject to the reasonable advice and comment of disclosing
party.
|
24.4.
|
The
provisions of this section 24 shall not apply to any Confidential
Information. disclosed hereunder
|
|
24.4.1.
|
to
Solvay Pharmaceuticals, Inc., pursuant to the Termination Agreement listed
in Exhibit 6 A
|
52
|
24.4.2.
|
to
the inventors M.A. Xxxx and X.X. Xxxxxxxx under the Assignment Agreement
listed in Exhibit 6 A.
|
24.5.
|
The
confidentiality obligations of the parties contained in the foregoing
paragraphs of this section 24 shall remain binding on both parties during
the term of this Agreement and for a period of ten (10) years after the
termination of this Agreement, regardless of the cause of such
termination.
|
25.
|
Paramount
Guarantee
|
Until the
closing of the Financing, in consideration of Licensor's execution of and
performance under this Agreement, Paramount hereby agrees (in the event of
assignment of this Agreement to NewCo) to be jointly and severally liable for
all amounts due under Clauses 6, 7, 8, 12, 14.1, and 18 hereof. Paramount's
guarantee obligation under this Clause 25 shall continue in full force and
effect until the Financing, at which time Paramount shall have no further
obligations or liabilities under this Clause 25, regardless of any existing,
uncured nonpayment existing as of the Financing, and Paramount shall be hereby
released by Licensor and NewCo of any liability with respect thereto upon the
closing of the Financing (including any such liability with respect to, any
previously unpaid amounts due Licensor). NewCo shall reimburse Paramount in full
for any amounts incurred or paid by Paramount under this Clause 25 upon request
by Paramount, including but not limited to amounts paid Licensor by Paramount
and any reasonable, documented fees and expenses (including attorneys' fees)
incurred by or on behalf of Paramount with respect to any dispute related to
NewCo's nonpayment of amounts due hereunder.
53
26.
|
Miscellaneous
|
26.1.
|
Affiliates of the
Parties: Each party is responsible that all their Affiliates, to
the extent exercising rights or performing obligations under this
Agreement, comply with the terms of this
Agreement.
|
26.2.
|
No Agency:
Neither party is, nor will be deemed to be, an employee, agent or
representative of the other party for any purpose. Each party is an
independent contractor, not an employee or partner of the other party.
Neither party shall have the authority to speak for, represent or obligate
the other party in any way without prior written authority from the other
party.
|
26.3.
|
Notices: Any
notice or other communication given or made under or in connection with
the matters contemplated by this Agreement shall be delivered or sent by
registered mail, over night courier or facsimile message to the party to
be served at the address or facsimile number appearing hereafter or such
other address as the party may substitute for such purpose by notice given
to the other party.
|
To
Licensor:
Xxxxx
Xxxxxx
S.L.A.
Pharma AG
Xxxxxxxx
0
Xxxxxxx,
Xxxxxxxxxxx
Office:
[*]
Fax:
[*]
to
Licensee:
Xx. Xxx
Xxxxxx
Paramount
BioSciences, L.L.C.
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
54
000
Xxxxxxx Xxxxxx, 00xx
Xxxxx
Xxx Xxxx,
XX 00000, XXX
Office:
[*]
Fax:
[*]
26.4.
|
Entire
Agreement: This Agreement together with its Exhibits constitute the
whole and only Agreement between the Parties relating to the matters
contemplated by this Agreement and supersedes and extinguishes any prior
agreements, undertakings and arrangements of any nature whatsoever whether
or not in writing relating thereto.
|
26.5.
|
Severability:
Should one of the provisions of this Agreement be or become invalid or
unenforceable or should a gap become apparent, the validity of the other
provisions in this Agreement shall remain unaffected. The parties shall
replace the invalid or unenforceable provision or fill the gap with a
valid and enforceable provision, to the extent legally possible and
permissible, which comes as close as possible to what the parties would
have agreed upon at conclusion of this Agreement if the necessity of such
an adjustment had been known to them at that
time.
|
26.6.
|
Modifications:
This Agreement and its Exhibits shall only be amended in writing, provided
that (i) Exhibit 2 shall be automatically amended from time-to-time
without further agreement by the parties as items may be included and
excluded from Patents pursuant to the definition thereof and the terms of
this Agreement and (ii) Exhibit 1 may be amended, and will be amended from
time to time, at the discretion of the
Committee.
|
26.7.
|
No Waiver: The
failure by any Party to this Agreement to enforce at any time or for any
period of time any provision of this Agreement shall not be construed as a
waiver of such provision or of the right of such Party thereafter to
enforce each and every such provision of this
Agreement.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
55
26.8.
|
Assignment:
Neither Party shall assign this Agreement or any rights or obligations
hereunder to any third party without the written consent of the other
Parties hereto, provided that, notwithstanding the foregoing, each Party
may assign this Agreement without the consent of the other party (i) to a
purchaser, merging, or consolidating corporation, or acquirer of all or
substantially all of that party's assets or business (or that portion
thereof to which this Agreement relates) and/or pursuant to any
reorganization of the respective party or (ii) to an Affiliate of the
respective party.
|
26.9.
|
Counterparts:
This Agreement may be executed in counterparts and all counterparts shall
constitute an original, and all counterparts shall together constitute one
and the same instrument.
|
27.
|
Governing
Law and Dispute Resolution
|
27.1.
|
This
Agreement is subject to and governed by the laws of Switzerland without
reference to its principles of conflicts of
law.
|
27.2.
|
All
disputes arising out of or in connection with the present agreement
including disputes on its conclusion, binding effects, amendment and
termination shall be resolved by the ordinary courts of Zurich,
Switzerland, without limiting the right of
recourse.
|
56
For
the Licensor:
|
For
the Licensee:
|
|
S.L.A.
Pharma AG
|
Paramount
BioSciences, LLC.
|
By:
|
/s/ X.
Xxxxxx
|
By:
|
/s/ Xxx
Xxxxxx
|
|
Name:
|
X. Xxxxxx
|
Name:
|
Xxx
Xxxxxx
|
|
Title:
|
President
|
Title:
|
President
|
|
Date:
|
20/03/07
|
Date:
|
23/03/07
|
57
EXHIBIT
1
LICENSEE
CLINICAL DEVELOPMENT PLAN
Anoheal Development Program
[*]
Incostop Development Plan
[*]
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
EXHIBIT
2
PATENTS
Anoheal
USA-
Application
number 09/355928 - filing (PCT) date 26/02/1998 - pending
Application
number 10/214333 (Publication No. 2004-0028752) - filing (PCT) date 23/02/1998 -
pending
Canada-
Application
number 2281755 - filing (PCT) date 23/02/1998 (published as W098/36733) -
pending
Mexico-
None
Incostop
USA-
Patent
number 6635678 (Application number 09/331163) - filing (PCT) date 23/12/1997 -
granted 21/12/2003
Application
number 10/389773 (Publication No. 2003-0216420) - filing (PCT) date 23/12/1997 -
pending
Canada-
Application
number 2275663 - filing (PCT) date 23/12/1997 (published as W098/27971) -
pending
Mexico-
None
EXHIBIT
3
MATERIAL
ANOHEAL
[*]
INCOSTOP
[*]
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
EXHIBIT
4
TRADEMARKS
Anoheal
USA-
Registration
number 2767016 (Application number 75/634497) - filing date 05/02/1999 -
registration date 23/09/2003 - granted
Canada-
Application
number 890193 - filing date 14/09/1998 - pending to be abandoned (use
requirements) Application number 1302465 - filing date 15/05/2006 -
pending
Mexico-
Registration
number 887847 (Application number 377132) - filing date 28/05/1999 -
registration date 24/06/2005 - granted
Incostop
USA-
Application
number 76/344233 - filing date 22/06/2000 - registration number 2697369 -
registration date 18/03/2003 - granted
Canada-
Application
number 1123564 - filing date 29/11/2001 - pending
Mexico-
Application
number 521828 - filing date 05/12/2001 - pending
EXHIBIT
5
LICENSOR
IND(S)
NONE
EXHIBIT
6 (A)
DISCLOSED
AGREEMENTS
Termination
Agreement between Licensor and Solvay Pharmaceuticals signed 6/20/05 and
4/08/05
M.A.
Xxxx and X.X. Xxxxxxxx under the Assignment Agreement dated March
1997 (See attached.)
EXHIBIT
6 (B)
Anoheal
The
European Patent (EP 0969813 B1) in respect of Anoheal has been Opposed by
Tecnimede Sociedade Tecnico-Medicinal, S.A. The Opposition Division issued a
verbal Decision at the end of a Hearing on January 29, 2007 revoking the Patent.
As usual, no reasons for the Decision were given at that time but those reasons
will be stated in due course in a Written Decision. It is assumed that the
ground is lack of novelty over WO-A-95/06466 (Lubowski). As at February 8, 2007,
neither the Hearing Minutes nor the Written Decision had issued. An Appeal
against the Decision will be filed within a period specified in the Written
Decision but it is unlikely that the Appeal will be heard before
2009.
Incostop
The
European Patent (EP 0946155 B1) in respect of Incostop has been Opposed by
Norgine BV. The Opposition was filed on December 21, 2006 and an extendable
period expiring May 26, 2007 has been allowed for the filing of the Defence. It
is unlikely that the Opposition will be heard before 2009. It is believed that
Norgine’s primary objective is to obtain amendment of the granted claims to
exclude the use of Methoxamine as an active in a topical formulation for the
treatment of fecal incontinence or anal itch.
EXHIBIT 6
(C)
TERMINATION
AGREEMENT
entered
into by and between
1.
|
S.L.A. Pharma AG,
Xxxxxxxx 0, XX-0000 Xxxxxxx, Xxxxxxxxxxx, hereinafter referred to as
"SLA"
|
and
2.
|
Solvay Pharmaceuticals,
Inc., 000 Xxxxxx Xxxx, Xxxxxxxx, Xxxxxxx 00000, XXX, hereinafter
referred to as "SOLVAY"
|
SLA and
SOLVAY being hereinafter referred to as the PARTY(IES).
Preamble
On
December 18,2001, SLA and SOLVAY entered into a license agreement (hereinafter
referred to as the "INITIAL LICENSE AGREEMENT) for Anoheal® (Diltiazem) and
Incostop® (Phenylephrine) (the "PRODUCTS" as defined below) for USA, Canada and
Mexico.
Some time
after, SLA offered to SOLVAY the extension of the license granted under the
INITIAL LICENSE AGREEMENT to the whole world except Japan, North Korea, China
and Taiwan.
SOLVAY
accepted the above proposal and both PARTIES entered on February 19, 2003, into
a Licence Agreement (hereinafter referred to as "LICENCE AGREEMENT") by which
SLA granted SOLVAY an exclusive licence under the SLA Patents for the
development, manufacturing, marketing use and sale of Anoheal® (Diltiazem) and
Incostop® (Phenylephrine) (the "PRODUCTS" as defined below) for the whole world
except Japan, North Korea, China and Taiwan, terminating as a consequence the
INITIAL LICENSE AGREEMENT.
At the
same time, the LICENSE AGREEMENT being subject to the grant of certain
co-marketing rights and manufacturing rights with respect to the PRODUCTS to be
sublicensed to Gebro Pharma GmbH, A-6391 Fieberbrunn, Austria (hereinafter
referred to as “GEBRO”), SOLVAY’s affiliate in Switzerland, Solvay
Pharmaceuticals Marketing & Licensing AG, Xxxxxxxxxxxxxxxx 00, XX-0000
Xxxxxxxxxx 0, Xxxxxxxxxxx, (hereinafter referred to as “SPML”) entered with
GEBRO into a Cooperation Agreement and a Manufacturing and Supply Agreement,
granting GEBRO the aforementioned rights.
SLA is
now interested to have the rights granted to SOLVAY under the LICENCE AGREEMENT
granted back to SLA to enable SLA to develop by itself or through LICENSEE(S) or
ASSIGNEE(S) the PRODUCTS and to register, promote, distribute and sell the
PRODUCTS in the TERRITORY, as SLA deems appropriate.
SOLVAY is
willing to accept the grant-back of the said licence for the PRODUCTS and, as a
consequence, the premature termination of the LICENCE AGREEMENT and assignment
of the Cooperation Agreement and a Manufacturing and Supply Agreement to SLA,
subject to the terms and conditions set forth in this termination agreement
(hereinafter “AGREEMENT”).
Now,
therefore, in consideration of the mutual covenants and agreements hereinafter
set forth and other good and valuable consideration, the receipt and legal
sufficiency of which are mutually acknowledged, the PARTIES hereto agree as
follows:
Preliminary
Conditions
1. In
return for SOLVAY’s consent to the grant-back to SLA of the rights granted under
the LICENSE AGREEMENT and to the premature termination of the LICENSE AGREEMENT,
SLA shall in accordance with the terms of this AGREEMENT pay to SOLVAY certain
termination fees (hereinafter referred to as the “TERMINATION FEES”) based as
follows:
|
a)
|
In
case SLA decides to develop and/or commercialize the PRODUCTS in the
TERRITORY by itself, SLA shall pay to SOLVAY a royalty over the NET SALES
of the PRODUCTS made by SLA in the
TERRITORY.
|
|
b)
|
In
case SLA decides to develop and/or commercialize the PRODUCTS in the
TERRITORY through LICENSEE(S) or ASSIGNEE(S), SLA shall pay to SOLVAY
certain amounts of any up-front and milestone payments, as well as a
certain percentage of the SLA ROYALTIES (as defined below), received by
SLA.
|
2. SLA
shall, at its sale discretion, decide to license, sub-license or assign any or
all of its rights with respect to the PRODUCTS granted back by SOLVAY according
to this AGREEMENT provided that SOLVAY receives a prior notice in writing of the
name(s) and address(es) of any such LICENSEE(S) or ASSIGNEE(S), as the case may
be. Furthermore, notwithstanding such license, sub-license or assignment, SLA
shall remain in any case obliged toward SOLWAY, especially but not limited to
for the payment of any TERMINATION FEES as provided hereunder.
1. Definitions
|
1.1
|
“AFFILIATE”
— shall mean any company or other entity controlling, controlled by or
under common control with a PARTY to this AGREEMENT. For the purposes of
this AGREEMENT “control” shall mean the power to, directly or indirectly,
appoint a majority of the directors, or to otherwise direct or cause the
direction of the management or policies of such company or other entity,
whether through share ownership, by contract or
otherwise;
|
|
1.2
|
"ASSIGNEE(S)"
— shall mean a SLA AFFILIATE or a third party to which SLA has
assigned, transferred or in any way passed over any or all of its rights
or obligations with respect to the PRODUCTS, to develop, promote,
distribute or sell the PRODUCTS in the TERRITORY or part
thereof;
|
1.3
|
"EFFECTIVE
DATE" — shall mean the date of signing of this
AGREEMENT.
|
|
1.4
|
"LICENCEE"
— shall mean a SLA AFFILIATE or a third party to which SLA has granted
rights under license or sublicense as the case may be, to develop,
promote, distribute or sell the PRODUCTS in the TERRITORY or part
thereof;
|
|
1.5
|
"NET
SALES" — shall mean the gross sales of the PRODUCTS invoiced by SLA its
LICENSEE(S) or ASSIGNEE(S) or their marketing partners, as the case may
be, to third parties in arms length transactions, less all excise and
other sales taxes, charges for freight and other duties, all trade,
quantity and cash discounts, all rebates and charge backs, allowances or
credits to customers on account of rejection, withdrawal, recall or return
which are customary in the pharmaceutical industry and which SLA, the
LICENSEE(S) or the ASSIGNEE(S) or the marketing partner, as the case may
be, have to pay or absorb on such
sales.
|
|
1.6
|
“PRODUCTS”
— shall mean the pharmaceutical products currently named Anoheal®
(Diltiazem) cream and Incostop® (phenylephrine)
gel.
|
|
1.7
|
“SLA
ROYALTIES” — shall mean any royalties on sales of the PRODUCTS in the
TERRITORY due to SLA by LICENSEE(S), ASSIGNEE(S) or marketing partners,
based on an agreed percentage (hereinafter referred to as the “ROYALTY
RATE”) of the LICENSEE(S), ASSIGNEE(S) or marketing partners’ NET
SALES.
|
|
1.8
|
“TERRITORY”
— shall mean the whole world except Japan, North Korea, China and
Taiwan.
|
2. Termination
|
2.1
|
As
from the EFFECTIVE DATE, the LICENCE AGREEMENT is terminated prematurely
and replaced by this AGREEMENT.
|
|
2.2
|
SOLVAY
hereby assigns, and SLA herewith accepts being assigned all SPML's right,
title and interest and all of SPML obligations under the Cooperation
Agreement and Manufacturing and Supply Agreement, provided that SOLVAY
shall be responsible to obtain GEBRO's Consent for such assignment in a
agreement letter which will be attached to this
AGREEMENT.
|
3. Grant Back of License
|
3.1.
|
From
the EFFECTIVE DATE, SOLVAY hereby grants back to SLA the exclusive license
formerly granted by SLA to SOLVAY under the LICENSE AGREEMENT with respect
to the PRODUCTS, which grant back SLA hereby
accepts.
|
|
3.2.
|
Other
than expressly stated in this AGREEMENT, SOLVAY retains no rights with
respect to the PRODUCTS.
|
|
3.3
|
As
a consequence hereof and subject to the terms and conditions set forth in
this AGREEMENT, as from the EFFECTIVE DATE SLA shall be responsible for
carrying out, or having carried out by LICENSEE(S) or ASSIGNEE(S), all
activities relating:
|
a)
|
the
PRODUCTS development and clinical
trials;
|
b)
|
the
registration of the PRODUCTS;
|
|
c)
|
the
promotion, distribution and sale of the PRODUCTS in the TERRITORY, as SLA
will deem appropriate.
|
4. Transfer of data
As from
the EFFECTIVE DATE, SOLVAY shall transfer and/or reassign to SLA, as the case
may be
4.1.
|
All
the PRODUCTS development data and clinical trials generated by
SOLVAY
or received from SLA during the LICENSE
AGREEMENT.
|
|
4.2.
|
All
the regulatory documents and files with respect to the PRODUCTS generated
by SOLVAY or received from SLA during the LICENSE
AGREEMENT.
|
4.3
|
All
marketing data generated by SOLVAY during the LICENSE
AGREEMENT.
|
5. Development and Commercialization of the PRODUCTS and
Partnering
|
5.1.
|
SLA
shall keep SOLVAY regularly informed of its discussions and negotiations
regarding the development and/or commercialization of the PRODUCTS in the
TERRITORY through LICENSEE(S) or ASSIGNEE(S), as the case may
be
|
|
5.2.
|
SOLVAY
shall provide to SLA free of charge, at SLA's request, reasonable
technical assistance from its New Business Development Department in SLA's
partnering discussions, provided that such assistance shall be supplied
only to the extent that SOLVAY, in its sole discretion, determines that
(a) it has sufficient resources available to provide such assistance, and
(b) such technical assistance provided by SOLVAY shall be limited in Fall
Time Equivalents and in time to one (1) FTE for up to a maximum of eighty
(80) hours to be taken within eighteen months as from the EFFECTIVE
DATE.
|
6. TERMINATION FEES
|
6.1.
|
In
consideration of the grant back to SLA by SOLVAY of the exclusive rights
to the PRODUCTS and SOLVAY's acceptance of the premature termination of
the LICENSE AGREEMENT, SLA shall pay to SOLVAY certain TERMINATION
FEES.
|
|
6.2.
|
In
case SLA decides to develop and/or commercialize the PRODUCTS in the
TERRITORY by itself, the TERMINATION FEES payable by SLA to SOLVAY shall
be equal to [*] percent ([*]%) of the NET SALES of the PRODUCTS in the
TERRITORY.
|
|
6.3.
|
In
case SLA decides to develop and/or commercialize the PRODUCTS in the
TERRITORY through LICENSEE(S) or ASSIGNEE(S) as the case may be and
subject to clause 6.3.3 below, SLA shall pay to SOLVAY the following
TERMINATION FEES:
|
6.3.1 TERMINATION
FEES on upfront and/or milestone payments:
SLA shall
pay to SOLVAY on any upfront and/or milestone payments received by it the
following TERMINATION FEES:
|
a)
|
On
the [*] USD ($[*]) received by SLA as up-front and/or milestone payments,
SLA shall [*] to SOLVAY;
|
|
b)
|
[*]
percent ([*]%) of the aggregate of up-front and/or milestone payments
received by SLA exceeding [*] USD ($ [*]) and not exceeding [*] USD
($[*]);
|
|
c)
|
[*]
percent ([*]%) of the aggregate of up-front and/or milestone payments
received by SLA exceeding [*] USD
($ [*]).
|
6.3.2 TERMINATION
FEES on SLA ROYALTIES:
SLA shall
pay to SOLVAY the following percentage of SLA ROYALTIES:
|
(i)
|
up
to and including a ROYALTY RATE imposed on the LICENSE(S) or the
ASSIGNEE(S) equal to [*] percent ([*]%), SLA shall pay to SOLVAY [*]
percent ([*]%) of SLA ROYALTIES;
|
|
(ii)
|
as
from a ROYALTY RATE imposed on the LICENSE(S) or the ASSIGNEE(S) exceeding
[*] percent ([*]%), SLA shall pay to SOLVAY [*] percent ([*]%) of SLA
ROYALTIES.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
|
6.3.3
|
Notwithstanding
the above, it is agreed between the PARTIES that in case SLA was to pay
any down payment to GEBRO according to the Cooperation Agreement assigned
to SLA as per this AGREEMENT, the next TERMINATION FEES normally due to
SOLVAY as described under this Clause 6.3 shall not have be paid by SLA to
SOLVAY. The TERMINATIONS will only become due again as from the moment SLA
shall be considered as having received from LICENSEE(S) or ASSIGNEE(S) an
aggregate amount of up-front and/or milestone payments as well as of SLA
ROYALTIES equal to the amount of the down payment paid to
GEBRO.
|
|
6.4.
|
SOLVAY
shall have the .right to require payment of any TERMINATION FEES directly
from SLA's LICENSEE(S) or ASSIGNEE(S) for NET SALES in case of a default
in payment by SLA, and SLA's LICENSEE(S) or ASSIGNEE(S) shall specifically
agree in their agreement with SLA that in the event of such requests it
shall make all TERMINATION FEES payments and furnish reports and documents
directly to SOLVAY.
|
|
6.5.
|
The
TERMINATION FEES according to this Clause 6 shall be paid to SOLVAY as
long as the PRODUCTS are sold by SLA and/or its successors and/or its
LICENSEE(S) or ASSIGNEE(S) and/or their successors in the
TERRITORY.
|
|
6.6.
|
Accounting
and payment of the TERMINATION FEES shall be effectuated on a quarterly
basis in accordance with internationally recognised accounting principles.
SLA shall submit the statement of accounts April, July, October and
January of each year, and pay the TERMINATION FEES for each quarter within
thirty (30) days after the end of the calendar
quarter.
|
|
6.7.
|
The
TERMINATION FEES shall be paid in USD to the bank account indicated by
SOLVAY.
|
|
6.8.
|
SLA
shall always keep up-to-date and correct records of the sales of the
PRODUCTS so that SOLVAY or its accounting expert is able to verify the NET
SALES and the SLA ROYALTIES.
|
|
6.9.
|
SOLVAY
is entitled to have these figures verified by an accounting expert at any
time upon its first request not more than once a year; in such case SLA
shall permit the accounting expert delegated by SOLVAY to inspect its
books and other accounts relating to the PRODUCTS as well as relevant
documents to the extent required for that purpose upon reasonable prior
written notice and during normal business
hours.
|
7. Applicable Law and Jurisdiction
|
7.1.
|
This
Termination Agreement shall in all parts exclusively be construed under,
governed by, interpreted under, and made subject to the laws of
Switzerland.
|
|
7.2.
|
Any
dispute arising out of or in connection with this Termination Agreement
shall be solved amicably. If the PARTIES do not come to a mutual
understanding, then it is hereby agreed that any dispute shall be settled
exclusively by the Commercial Court of
Zürich.
|
8. Miscellaneous
|
8.1.
|
If
any provision thereof is or becomes invalid, the existence of this
AGREEMENT and the validity of the remaining provisions shall not be
effected thereby. The contracting PARTIES shall immediately and by mutual
agreement replace the invalid provisions by a valid provision which is as
consistent as possible with the original intent of the contracting
PARTIES.
|
|
8.2.
|
Any
amendment to and/or modification of this AGREEMENT shall only be valid if
made in writing and signed by both
PARTIES.
|
|
8.3.
|
Neither
this AGREEMENT nor any interest under this AGREEMENT shall be assignable
by either PARTY without the written consent of the other, provided,
however, that either PARTY may assign this AGREEMENT or any part thereof
to any AFFILIATE or to any corporation with which it may merge or
consolidate, or to which it may transfer all or substantially all of its
assets to which this AGREEMENT relates, without obtaining the consent of
the other PARTY.
|
IN
WITNESS WHEREOF the PARTIES hereto have duly executed this AGREEMENT in a
legally binding manner
Solvay
Pharmaceuticals, Inc
|
||
/s/
X. Xxxxxx
|
/s/ Xxxxxx
X. Xxxxxxx
|
|
Xxxxxx
X. Xxxxxxx
|
||
Liestal,
|
President
& CEO
|
|
Solvay
Pharmaceuticals, Inc.
|
||
6/20/05
|
Annex
to the Termination Agreement
between
S.L.A. Pharma AG and Solvay
Pharmaceuticals, Inc.
Assignment and assumption
Agreement
To be
attached.
DATED March
1997
(1) DR
MA XXXX
(2) XX
XX XXXXXXXX
and
(3) SLACO
PHARMA AG
ASSIGNMENT
AGREEMENT
|
||
Xxxxxxxx
Xxxx
Marcol
House
000
Xxxxxx Xxxxxx
Xxxxxx
X0X 0XX
ASSIGNMENT
AGREEMENT
THIS
AGREEMENT is made the day of March
0000
XXXXXXX
Xx
Xxxxxxx X. Xxxx of [*] and Mr Xxxxx K S Xxxxxxxx of [*] (hereinafter
together called "the Assignors")
and
Slaco
Phanna AG, a Swiss company incorporated under the laws of Switzerland having its
principal
office at Xxxxxxxxxxxxxx 00x, 00 Xxxxxxxx, XX-0000 Xxxxxxx, Xxxxxxxxxxx
(hereinafter called
"the Assignee")
WHEREAS
the Assignors have agreed to assign the First Invention and Second Invention to
the Assignee in accordance with the terms and conditions hereinafter
mentioned.
THEREFORE
in consideration of the mutual understanding set out below IT IS HEREBY AGREED
AS FOLLOWS:
1
|
In
consideration of the matters set out below the Assignors assign all
world-wide rights to and in:
|
|
1.1
|
patent
application numbers 9626750.5, 9626739.8 and 9703750.1 which applications
relate to compounds for treating anal incontinence by means of a
pharmaceutical composition (hereinafter called "the First
Invention")
|
|
1.2
|
patent
application number 9703309.6 which application relates to a compound which
has an effect on the longitudinal muscle for treating anal disorders
(hereinafter called "the Second
Invention")
|
2
|
The
Assignors will provide the Assignee with all necessary know-how and in
return the Assignee will involve the Assignors in all future development
of the compounds covered by this Agreement and will keep the Assignors
fully informed of the status of all developments including but not limited
to clinical trials. The Assignee shall be responsible for conducting all
relevant clinical and other trials relating to the development of the
First and Second Inventions and will appoint independent centres to
conduct certain of the clinical or other trials. However, before
instructing any independent centre to conduct such trials the Assignee
shall always first offer the Assignors the right to conduct such trial on
commercial terms to be agreed and the Assignors may accept or reject the
offer as they see fit.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
3
|
The
Assignee will be responsible for all filing of patents and all costs that
are incurred and shall at its own cost diligently prosecute to grant all
patent applications made
or to be in respect of the First Invention and the Second Invention. The
Assignee will be responsible for maintaining the validity of the patents
when they issue for the fall terms thereof and will be responsible for the
enforcement of the patents when they issue and the assignee covenants to
use its reasonable endeavours to enforce the patents against
infringers.
|
4
|
The
Assignee shall make all diligent efforts to develop the First Invention
and the Second Invention and will meet all development costs in those
counties where patents are granted or
pending.
|
5
|
The
Assignors receive [*] percent ([*]%) of the Net Sales Value shared equally
in respect of world-wide sales where products comprising the compounds
which form the subject matter of the First or Second Invention are
marketed by the Assignee. This level of royalties shall continue for the
duration of the patent where granted (as extended by any supplementary
protection certificate if obtained in any particular country), or in the
event of a patent application not being granted royalties shall continue
for the life of the products and be reduced by mutual consent if the sales
are adversely affected by competitor
products.
|
6
|
The
Assignee undertakes that it will assign unconditionally to the Assignors
[*] ([*]) percent of any royalty payment shared equally (less all
applicable credits) payable to the Assignee accruing out of the rights and
obligations contained in any licence or assignment agreement(s) between
the Assignee and any other party.
|
7
|
The
Assignee undertakes that it will assign. unconditionally to the Assignors
[*] percent ([*]%) of all up-front and sell-off payments shared equally
which have been negotiated by the Assignee and a third party in respect of
the sale to such third party of all or any of the patents or patent
applications resulting from the First or Second
Invention..
|
8
|
The
Assignee when conducting negotiations with a third party, when any patent
or patent application is proposed to be licensed or assigned to the third
party, shall use its best endeavours to achieve an agreement which ensures
that the same percentage of royalties payable to the Assignors in
accordance with clause 5 above shall continue without
interruption.
|
9
|
MARKETING
|
The
Assignee shall use its reasonable endeavours to market products resulting from
the First or Second Inventions and to ensure that an equivalent provision is
included in any licence or assignment that it proposes to enter into with any
third party.
10
|
PAYMENT
TO THE ASSIGNORS
|
10.1
|
The
Assignee will supply to the Assignors all royalty reports, sales, figures
and other relevant information and will allow the Assignors or their duly
appointed agents to inspect at the Assignee's place of business all
records relating to the sales and transactions of the compounds covered by
the agreements.
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
10.2
|
All
royalty payments payable by any company in respect of net sales of the
compounds in any territory shall be apportioned between Assignee and the
Assignors in accordance with the above and said amounts are paid directly
to the Assignors by electronic fund transfer to the Assignors' accounts
the details of which shall be provided to the Assignee. This shall also
apply to all up-front and sell-off
payments.
|
10.3
|
As
from the date of issue of a product licence in respect of products
containing the compounds disclosed in the First or Second Invention on a
country by country basis, the Assignee shall pay the Assignors a royalty
as specified in this Agreement. Payments shall be made
quarterly in arrears, allowing up to three weeks following the
quarter-end.
|
10.4
|
Royalty
payments shall be paid in pounds sterling and shall be calculated in the
currency in which the sales are made and where conversions of currency are
necessary shall be converted at the rate of exchange at the date when
payment is due. All bank charges and exchange expenses shall be at the
expense of the Assignee.
|
11
|
NOTICES
|
11.1
|
Any
notice to be given hereunder shall be sent by first class mail with
recorded delivery to the other party at the addresses contained herein or
at such other addresses as each party shall have indicated to each other
and shall be deemed to be given two (2) days following the date of
mailing.
|
11.2
|
In
the event that the Assignee proposes to assign, change or licence any or
all of the patents granted or applied for in any country in the world in
respect of the composition, they will negotiate with the third party on an
arms' length basis so as to secure the best commercial terms possible, and
they will promptly notify the Assignors of the terms and conditions of the
proposed transactions and prior to the entering into of any contractual
commitment obtain the Assignors prior approval; such approval not to be
unreasonably withheld save that the Assignee agrees that it will be
reasonable for the Assignors to withhold their approval to any proposed
licence, assignment or other agreement which does not ensure that they
continue to receive the same level of royalties as provided for in clause
5 above unless there are any legal or commercial circumstances applicable
in a particular country or countries to which the proposed agreement
relates which prevent such level of royalty being
achieved.
|
11.3
|
The
Assignors shall be kept informed of all distribution and marketing
arrangements entered into by the
Assignee.
|
12
|
GOVERNING
LAW
|
Disputes
in relation to this Agreement which arise between the Assignors and the assignee
shall be governed by the laws of England and shall be subject to the exclusive
jurisdiction of the English Courts.
13
|
WAIVER
|
A waiver
by one party of a breach by the other party of any terms of this Assignment
shall not prevent the subsequent enforcement of the terms and shall not be
deemed a waiver of any subsequent breach.
14
|
DEFINITIONS
|
The
singular includes the plural and vice-versa where the context so admits or
requires reference to the Assignors and Assignee shall include their respective
employees or agents.
"Territory"
means any country or state in which the First or Second Invention is
sold.
"Net
Sales Value" for the purposes of this Agreement means the price paid by third
parties (including but not limited to distributors or agents) to the Assignee in
respect of any product comprising the First or Second Invention in an arm's
length transaction exclusively for money after deduction of normal (not special
or promotional) trade discounts actually granted and of any credits actually
given by the Assignee for returned or defective goods and excluding or making
proper deductions for any costs of packing, insurance, carriage and freight and
Value Added Tax or other sales tax and applicable governmental levies or subject
in all cases to the same being separately charged on customer invoices. In any
sale or other disposal of any products or part thereof otherwise then in any
arm's length transaction exclusively for money, the fair market price (if
higher) shall be substituted for the Net Sales Value.
15
|
EFFECTIVE
DATE
|
This
Agreement shall be effective from the date of the signed
signature.
IN
WITNESS whereof the parties have caused this Agreement to be signed by
themselves or their duly authorised representatives on the date below
written.
SIGNED by Xx
Xxxxxxx X. Xxxx
|
) |
|
||||||
in the presence of:
|
) |
|
/s/ Xxxxxxx
Xxxx
|
|||||
Xx
Xxxxxxx X Xxxx
|
||||||||
Witness Name
|
: |
X.
Xxxxx
|
||||||
Witness Address
|
: |
[*]
|
||||||
[*]
|
||||||||
Witness Signature
|
: |
/s/ X.
Xxxxx
|
||||||
SIGNED by Xx
Xxxxx X Xxxxxxxx
|
) |
|
||||||
in the presence of:
|
) |
|
/s/ Xxxxx
Xxxxxxxx
|
|||||
Xx
Xxxxx X Xxxxxxxx
|
||||||||
Witness Name
|
: |
X. Xxxxxxx
|
||||||
Witness Address
|
: |
[*]
|
||||||
Witness Signature
|
: |
/s/ X. Xxxxxxx
|
||||||
SIGNED by
|
) |
|
||||||
duly authorized on behalf of
|
) |
/s/ X.
Xxxxxx
|
||||||
SLACO PHARMA AG
|
) |
|
||||||
in the presence of:
|
) |
|
||||||
Witness Name
|
: |
Xxxx
X. Xxxxxxxx
|
||||||
Witness Address
|
: |
[*]
|
||||||
Witness Signature
|
: |
/s/ Xxxx
X. Xxxxxxxx
|
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
EXHIBIT
7
SUBSCRIPTION
AGREEMENT
(SEE
ATTACHED)
EXHIBIT
7
FORM OF STOCK PURCHASE
AGREEMENT
THIS STOCK PURCHASE AGREEMENT ("Agreement") is
entered into as of _____, 2007, by and between the undersigned (the "Purchaser")
and __________, Inc. a
Delaware corporation having a business address at 000 Xxxxxxx Xxxxxx, Xxx Xxxx,
XX 00000 (the "Corporation").
RECITALS
WHEREAS, the Corporation desires to
sell shares of common stock, par value $.001 per share, of the Corporation
(which class of shares is referred to herein as "Common Stock") to
Purchaser, and Purchaser desires to purchase these shares, upon the terms and
conditions herein specified; and
WHEREAS, Purchaser is willing to
subject the Stock (as defined herein) to the restrictions contained
herein.
AGREEMENT
NOW, THEREFORE, in consideration of the
foregoing recitals and of the mutual promises herein contained, the parties
hereby agree as follows:
1.
Issuance and Acquisition of
Stock.
(a) Immediately
after the execution of this Agreement by the parties, the Corporation shall
transfer to the Purchaser, and the Purchaser shall acquire from the Corporation,
the number of shares of Common Stock listed beside the Purchaser's name on the
signature page hereto (the "Stock"), at the
purchase price of $.001 per share, for the total purchase price listed below the
Purchaser's name on the signature page hereto (the "Purchase
Price").
(b) As
soon as reasonably practicable after the execution of this Agreement, the
Corporation shall deliver to the Purchaser a certificate or certificates
evidencing the Stock, registered in the name of the Purchaser and concurrently
therewith the Purchaser shall make payment for the Stock by delivering to the
Seller a check payable to the Corporation in the amount of the Purchase
Price.
2.
Violation Of Transfer
Provisions. The Corporation shall not be required (i) to
transfer on its books any shares of Stock which shall have been sold,
transferred, assigned or pledged in violation of any of the provisions of this
Agreement or (ii) to treat as owner of such shares or to accord the right to
vote as such owner or to pay dividends to any transferee to whom such shares
shall have been so sold, transferred, assigned or pledged.
3. Rights as
Shareholder. Except as otherwise provided herein during the
term of this Agreement, the Purchaser shall exercise all rights and privileges
of a shareholder of the Corporation with respect to the Stock.
4. Representation and
Warranties by the Corporation.
The Corporation represents, warrants
and covenants with the Purchaser as follows:
(a) The
Corporation has all necessary power and capacity to execute and deliver this
Agreement, to perform its obligations hereunder and to consummate the
transaction contemplated hereby. This Agreement has been validly
executed and delivered by the Corporation and constitutes the legal, valid and
binding obligation of the Corporation, enforceable against the Corporation in
accordance with its terms. The execution and delivery of this
Agreement by the Corporation do not and the performance of its obligations under
this Agreement will not conflict with or result in any breach or constitute a
default under any contracts to which the Corporation is a party or by which the
Corporation or any property or asset of the Corporation is bound or
affected.
(b) The
Corporation has good title to the Stock and owns the Stock free and clear of any
security interests, liens, claims, pledges, options, rights of first refusal,
agreements, limitations on voting rights, charges and other encumbrances of any
nature whatsoever (collectively, "Liens") other than restrictions on transfer
imposed under the Securities Act of 1933, as amended (the "Securities
Act"). Upon delivery thereof to the Purchaser, the Purchaser shall
acquire good title to the Stock, free and clear of any Liens other than the
restrictions set forth in this Agreement and under the Securities
Act. The Stock is validly issued, fully paid and
nonassessable. The Corporation is transferring the Stock to the
Purchaser hereunder pursuant to a valid exemption from registration under the
Securities Act.
5. Representations and
Warranties by the Purchaser.
The Purchaser represents, warrants and
covenants with the Corporation as follows:
(a) The
Purchaser has all necessary power and capacity to execute and deliver this
Agreement, to perform its obligations hereunder and to consummate the
transaction contemplated hereby. This Agreement has been validly
executed and delivered by the Purchaser and constitutes the legal, valid and
binding obligation of the Purchaser, enforceable against the Purchaser in
accordance with its terms. The execution and delivery of this
Agreement by the Purchaser do not and the performance of its obligations under
this Agreement will not conflict with or result in any breach or constitute a
default under any contracts to which the Purchaser is a party or by which the
Purchaser or any property or asset of the Purchaser is bound or
affected.
(b) The
Stock will be acquired by the Purchaser for his own account with the Purchaser's
own funds for investment purposes and for the Purchaser's own account, not as a
nominee or agent for any other person, firm or corporation, and not with a view
to the sale or distribution of all or any part thereof, and the Purchaser has no
present intention of selling, granting any participation in, or otherwise
distributing, any or all of the Stock. The Purchaser does not have
any contract, undertaking, agreement or arrangement with any person, firm or
corporation to sell, transfer or grant any participation to any person, firm or
corporation with respect to any or all of the Stock.
(c) The
Purchaser understands that the Stock will not be registered under the Securities
Act of 1933, as amended, (the "Securities Act"), and that the Stock is being
issued and sold to the Purchaser based upon an exemption from registration
predicated in part on the accuracy and completeness of the Purchaser's
representations and warranties appearing herein.
(d) The
Purchaser agrees that in no event will the Purchaser sell, transfer, assign or
pledge all or any part of the Stock or any interest therein, unless and until
(i) the Purchaser shall have furnished the Corporation with an opinion of
counsel satisfactory in form and content to the Corporation to the effect that
(A) such disposition will not require registration of the Stock under the
Securities Act or compliance with applicable state securities laws, or (B)
appropriate action necessary for compliance with the Securities Act and
applicable state securities laws has been taken; (ii) the Corporation shall have
waived, expressly and in writing, its right under clause (i) of this subsection;
and (iii) the proposed transferee of the Stock shall have provided the
Corporation with a written agreement or undertaking by which such transferee
agrees to be bound by all terms, conditions and limitations of this Agreement
applicable to such transferee's transferor as if such transferee were a party
hereto. The requirement of subparagraph (iii) shall not apply to any
transfer (A) pursuant to an offering registered under the Securities Act, (B)
pursuant to Rule 144 under the Securities Act or (C) effected in a market
transaction otherwise exempt from registration under the Securities
Act.
(e) The
Purchaser is able to fend for itself in connection with the transactions
contemplated by this Agreement, has such knowledge and experience in financial
and business matters (including investments in development stage biotechnology
companies) as to be capable of evaluating the merits and risks of its investment
in the Corporation, has the ability to bear the economic risks of its investment
for an indefinite period of time and can afford a complete loss of its
investment and has had the opportunity prior to the Purchaser's purchase of the
Stock to ask questions of and receive answers from representatives of the
Corporation concerning the finances, operations and business of the
Corporation. The Purchaser acknowledges and agrees that (i) it is not
relying upon any statement, promise or assurance of the Corporation or any
investor in the Corporation (or any representative of the Corporation or any
such investor) in arriving at the Purchaser's decision to purchase the Stock,
and has not otherwise been induced to purchase the Stock by the Corporation or
any such investor (or any representative of the Corporation or any such
investor); and that (ii) it has decided to purchase the Stock based upon the
Purchaser's own analysis of the merits and risks of investing in the Corporation
without the intervention or assistance of any other person, firm or
corporation.
(f) The
Purchaser understands and acknowledges that the Purchaser will not be permitted
to sell, transfer, assign or pledge the Stock until it is registered under the
Securities Act or an exemption from the registration and prospectus delivery
requirements of the Securities Act is available to the Purchaser, and that there
is no assurance that such an exemption from registration will ever be available
or that the Purchaser will ever be able to sell any of the
Stock.
(g) All
certificates representing the Stock and, until such time as the Stock is sold in
an offering which is registered under the Securities Act or the Corporation
shall have received an opinion of counsel satisfactory in form and content to
the Corporation that such registration is not required in connection with a
resale (or subsequent resale) of the Stock, all certificates issued in transfer
thereof or substitution therefor, shall, where applicable, have endorsed thereon
the following (or substantially equivalent) legends:
|
(i)
|
THE
SECURITIES REPRESENTED BY THIS CERTIFICATE ARE NOT TRANSFERABLE WITHOUT
THE EXPRESS WRITTEN CONSENT OF __________, INC., (THE "COMPANY") AND HAVE
NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 OR ANY APPLICABLE
STATE SECURITIES OR "BLUE SKY" LAWS, AND MAY NOT BE SOLD, OFFERED FOR
SALE, PLEDGED, OR HYPOTHECATED OR OTHERWISE TRANSFERRED IN THE ABSENCE OF
A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER
SUCH ACT OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH
REGISTRATION IS NOT REQUIRED OR UNLESS SOLD PURSUANT TO RULE 144 OF SUCH
ACT. ANY SUCH TRANSFER MAY ALSO BE SUBJECT TO APPLICABLE STATE
SECURITIES OR "BLUE SKY" LAWS.
|
(ii)
|
Any
legend required to be placed thereon by any applicable state securities
law.
|
(h) The
Corporation shall not be obligated to transfer any of the Stock if counsel for
the Corporation determines that any applicable registration requirement under
the Securities Act or any other applicable requirement of federal or state law
has not been met.
6. General
Provisions.
(a) No
Assignments. The Purchaser shall not transfer, assign or
encumber any of its rights, privileges, duties or obligations under this
Agreement without the prior written consent of the Corporation, and any attempt
to so transfer, assign or encumber shall be void.
(b) Notices. All
notices and other communications which are required or permitted to be given
pursuant to the terms of this Agreement shall be in writing and shall be
sufficiently given (i) if personally delivered, (ii) if sent by telex or
facsimile, provided that "answer-back" confirmation is received by the sender or
(iii) upon receipt, if sent by registered or certified mail, postage paid return
receipt requested in any case addressed as follows:
|
(i)
|
If
to the Corporation:
|
____________________________________ | ||
____________________________________ | ||
____________________________________ |
(ii)
|
If
to the Purchaser, to the address set forth on the signature page of this
Agreement.
|
The
address of a party, for the purposes of this Section 6(b)(ii), may be changed by
giving written notice to the other party of such change in the manner provided
herein for giving notice. Unless and until such written notice is
received, the addresses as provided herein shall be deemed to continue in effect
for all purposes hereunder.
(c) Standoff
Agreement. The Purchaser agrees that, in connection with each
underwritten public offering registered under the Securities Act of shares of
Common Stock or other equity securities of the Corporation by or on behalf of
the Corporation, the Purchaser shall not sell or transfer, or offer to sell or
transfer, any shares of Common Stock or other equity securities of the
Corporation for such period as the managing underwriter of such offering or the
Corporation determines is necessary to effect the underwritten public
offering.
(d) Choice of Law; Consent to
Jurisdiction. This Agreement shall be governed by and
construed in accordance with the internal laws (without giving effect to the
conflicts of law principles) of the State of New York.
(e) Severability. The
parties hereto agree that the terms and provisions in this Agreement are
reasonable and shall be binding and enforceable in accordance with the terms
hereof and, in any event, that the terms and provisions of this Agreement shall
be enforced to the fullest extent permissible under law. In the event
that any term or provision of this Agreement shall for any reason be adjudged to
be unenforceable or invalid, then such unenforceable or invalid term or
provisions shall not affect the enforceability or validity of the remaining
terms and provisions of this Agreement, and the parties hereto hereby agree to
replace such unenforceable or invalid term or provision with an enforceable and
valid arrangement which, in its economic effect, shall be as close as possible
to the unenforceable or invalid term or provision.
(f) Successors. All
references in this Agreement to the Corporation shall include any and all
successors in interest to the Corporation, whether by merger, consolidation,
sale of all or substantially all assets or otherwise, and this Agreement shall
inure to the benefit of the successors and assigns of the Corporation and,
subject to the terms herein set forth, shall be binding upon the Purchaser, its
successors and permitted assigns.
(g) Counterparts. This
Agreement may be executed in two counterparts, each of which shall be deemed an
original, but which together shall constitute one and the same
instrument.
(h) Modification, Amendment and
Waiver. No modification, amendment or waiver of any provision
of this Agreement shall be effective against the Corporation unless the same
shall be in a written instrument signed by an officer of the Corporation on its
behalf and such instrument is approved by its Board of Directors. The
failure at any time to enforce any of the provisions of this Agreement shall in
no way be construed as a waiver of such provisions and shall not affect the
right of either party thereafter to enforce each and every provision hereof in
accordance with its terms.
(i) Further
Assurances. The parties agree to execute such further
instruments and to take such further action as may reasonably be necessary to
carry out the intent of this Agreement.
(j) Integration. This
Agreement constitutes the entire agreement of the parties with respect to the
subject matter hereof.
(k) Headings. The
headings of the Sections and paragraphs of this Agreement have been inserted for
convenience of reference only and do not constitute a part of this
Agreement.
(l) Gender and
Number. As used in this Agreement, the masculine, feminine or
neuter gender, and the singular or plural, shall be deemed to include the others
whenever and wherever the content so requires. Additionally, unless
the context requires otherwise, "or" is not exclusive.
EXHIBIT
8
MATERIAL
AGREEMENTS
NONE
OTHER THAN DISCLOSED AGREEMENTS
EXHIBIT
9
WITHOLDING
TAX - EXEMPTION CERTIFICATE
(SEE
ATTACHED)
[*]
[*] Confidential
treatment requested; certain information omitted and filed separately with the
SEC.
AMENDMENT
NO. 1 TO EXCLUSIVE LICENSE AGREEMENT
AMENDMENT NO. 1 TO EXCLUSIVE LICENSE
AGREEMENT, dated July 24, 2008 (this “Amendment”), between
S.L.A. PARMA AG (the
“Licensor”),
and VENTRUS BIOSCIENCES,
INC., as assignee of Paramount Biosciences, LLC (the “Licensee”).
WHEREAS, the Licensor and the
Licensee have entered into that certain Exclusive License Agreement, dated as of
March 23, 2007 (the “License
Agreement”);
WHEREAS, the parties hereto
desire to amend the License Agreement as set forth herein.
NOW, THEREFORE, in
consideration of the foregoing and for other consideration the sufficiency and
receipt of which is hereby acknowledged by the parties, it is hereby agreed by
and between the parties as follows:
1. Capitalized
Terms. Terms used herein but not otherwise defined shall have the meaning
ascribed thereto in the License Agreement.
2. Amendments.
(a) “Maximum
Anoheal Amount”, as defined in Section 12.2 of the License Agreement, shall be
increased to US$4,000,000, to be used by Licensor for the Anoheal Project, and
all references to Maximum Anoheal Amount in such License Agreement shall be
deemed a reference to this increased amount. Notwithstanding anything
to the contrary contained in the License Agreement, the Maximum Anoheal Amount
shall be paid in advance in accordance with the schedule set forth on Annex I hereto, so
that on each Specified Date set forth therein Licensor shall have available to
it no less than the Threshold Amount set forth on Annex I.
(b) Notwithstanding
anything contained in Sections 8.2.2 of the License Agreement to the contrary,
Licensee’s obligation to make the “Anoheal Project Payment” shall terminate upon
the earlier of (i) the date Licensee informed Licensor in writing of the
termination of the Anoheal Project and (ii) such time as an NDA relating to a
Licensed Product incorporating Anoheal API is filed by the License, its
Affiliate or sublicensee.
(c) Notwithstanding
anything contained in Sections 8.2.3 of the License Agreement to the contrary,
Licensee’s obligation to make the “Incostop Project Payment” shall terminate
upon the earlier of (i) the date Licensee informed Licensor in writing of the
termination of the Incostop Project and (ii) such time as an NDA relating to a
Licensed Product incorporating InCostop API is filed by the Licensee, its
Affiliate or sublicensee.
(d) For
the avoidance of doubt it is stated that the due dates for Anoheal Project
Payments and the Incostop Project Payments as defined in Section 8.2.1 of the
License Agreement are not affected by the payment schedule in Annex I but shall
continue to be due at the end of each calendar month.
(e) The
Licensee shall reimburse the Licensor the costs of the sponsored research fellow
in Australia. Such salary costs will be invoiced quarterly to the Licensee at a
rate of £10,000 per quarter for the next eighteen (18) months. Such amounts
shall be paid by Licensee in addition to the Maximum Anoheal
Amount.
(f) Notwithstanding
anything contained in Section 23.4 of the License Agreement to the contrary, the
cure period for purposes of a material breach or material default of the License
Agreement relating in its entirety to failure to pay to the Licensor the amounts
set forth in accordance with the schedule on Annex
I hereto or the Anoheal Project Payments or the Incostop
Project Payments, on each date specified, shall be twenty one (21) days from the
date the notice of termination is received by the non-breaching or
non-defaulting party. For the avoidance of doubt, no other cure period set forth
in Section 23.4 of the License Agreement shall apply with respect to a material
breach or material default by the Licensee with respect to the payments set
forth on Annex
I hereto, the Anoheal Project Payments and the Incostop Project Payments.
Notwithstanding anything contained in Section 23.4 of the License Agreement to
the contrary the License Agreement shall end without further notice upon
expiration of the 21 day cure period, if such material breach or material
default has not otherwise been cured. Upon termination of the Projects pursuant
to this clause, all rights to the Patents relating to Incostop Project and the
Anoheal Project shall revert to the Licensor.
3. Counterparts.
This Amendment may be executed in any number of separate counterparts, each of
which shall be an original and all of which taken together shall constitute one
and the same instrument. Facsimile counterpart signatures to this Amendment
shall be acceptable and binding.
4. Applicable
Law. This Amendment shall be governed by and construed in accordance with
the laws of Switzerland without regard to principles of conflicts of
law.
5. Dispute
Resolution. All disputes arising out of or in connection with this
Amendment shall be resolved by the ordinary courts of Zurich, Switzerland,
without limiting the right of recourse.
6. No Other
Amendments. Except as expressly set forth herein, the License Agreement
remains in full force and effect in accordance with its terms and nothing
contained herein shall be deemed to be a waiver, amendment, modification or
other change of any term, condition or provision of the License
Agreement.
7. Effectiveness.
This Amendment shall become effective immediately upon the date
hereof.
2
8. References
to the License Agreement. From and after the date hereof, all
references in the License Agreement and any other documents to the License
Agreement shall be deemed to be references to the License Agreement after giving
effect to this Amendment.
* * * *
*
3
IN WITNESS WHEREOF, the
parties hereto have executed this Amendment No. 1 to Exclusive License Agreement
as of the date first written above.
SLA
PHARMA AG
|
VENTRUS
BIOSCIENCES, INC.
|
|||||
By:
|
/s/ Xxxxxx Syz
28-7-2008
|
By:
|
/s/ Xxxxxx Xxxxxxx
|
|||
Name:
Xxxxxx Syz
|
Name: Xxxxxx
Xxxxxxx
|
|||||
Title:
Director
|
Title:
President & CEO
|
4
ANNEX I
Specified Date
|
Nature of Payment
|
Threshold Amount
|
||||
November 30, 2008
|
Cost
of Anoheal development from June 2008 to October 2008
|
$ | 300,000 | |||
November 30, 2008
|
First
upfront installment to SLA
|
$ | 1,000,000 | |||
April 30, 2009
|
Second
upfront installment to SLA
|
$ | 800,000 | |||
October 30, 2009
|
Third
upfront installment to SLA
|
$ | 700,000 | |||
April 30, 2010
|
Final
upfront installment to SLA
|
Balance
of $4,000,000
|
PARAMOUNT
BIOSCIENCES, LLC
000
Xxxxxxx Xxxxxx
00xx
Xxxxx
Xxx
Xxxx, XX 00000
October
27, 2008
|
SLA
Pharma AG
Xxxxxxxx
0
Xxxxxxx,
Xxxxxxxxxxx
Attn:
Xxxxx Xxxxxx
Dear
Xxxxx:
Reference
is hereby made to the Exclusive License Agreement, dated as of March 23, 2007,
as amended on July 24, 2008 (the “License Agreement”),
between SLA Pharma AG (“SLA”) and Ventrus
Biosciences Inc. (“Ventrus”), as
assignee of Paramount Biosciences, LLC (“Paramount”). Paramount
shall make a payment (the “Payment”) in an
amount equal to USD$100,000 to SLA on behalf of Ventrus on the date hereof, in
partial satisfaction of the $250,000 presently owed by Ventrus to SLA that has
been guaranteed by Xxxxxxx X. Xxxxxxxxx, M.D. At such time as (i) no
cash payments are past due under the License Agreement, and (ii) Ventrus has
paid SLA an amount of cash exceeding what is then owed under the License
Agreement by at least USD$100,000, SLA shall promptly remit to Paramount an
amount equal to USD$100,000.
* * * *
*
If the
foregoing correctly sets forth your understanding of our agreement with respect
to the matters addressed above, please indicate your acceptance and approval
below.
PARAMOUNT
BIOSCIENCES, LLC
|
|||
By:
|
/s/
|
Xxxxxxx X. Xxxxxxxxx
|
|
Name: Xxxxxxx
X. Xxxxxxxxx, MD
|
|||
Title: Sole
Member
|
|||
VENTRUS
BIOSCIENCES, INC.
|
|||
By:
|
/s/
|
Xxxxxx Xxxxxxx
|
|
Name: Xxxxxx
Xxxxxxx
|
|||
Title: President
& CEO
|
AGREED
AND ACKNOWLEDGED:
SLA
PHARMA AG
By:
|
/s/ X. Xxxxxx
|
|
Name: X.
Xxxxxx
|
||
Title: President
|
||
29/10/08
|
2
AMENDMENT
NO. 2 TO EXCLUSIVE LICENSE AGREEMENT
AMENDMENT NO. 2 TO EXCLUSIVE LICENSE
AGREEMENT, dated November 20, 2008 (this “Amendment”), between
S.L.A. PARMA AG (the
“Licensor”),
and VENTRUS BIOSCIENCES,
INC., (the “Licensee”) as
assignee of Paramount Biosciences, LLC (“Paramount”).
WHEREAS, the Licensor and the
Licensee have entered into that certain Exclusive License Agreement, dated as of
March 23, 2007, as amended by Amendment No. 1 to Exclusive License Agreement
dated as of July 24, 2008 (as amended to date, the “License
Agreement”);
WHEREAS, the parties hereto
desire to further amend the License Agreement as set forth herein.
NOW, THEREFORE, in
consideration of the foregoing and for other consideration the sufficiency and
receipt of which is hereby acknowledged by the parties, it is hereby agreed by
and between the parties as follows:
1. Capitalized
Terms. Terms used herein but not otherwise defined shall have the meaning
ascribed thereto in the License Agreement.
2. Amendments.
(a) Notwithstanding
anything to the contrary contained in the License Agreement, the Maximum Anoheal
Amount shall be paid in advance in accordance with the schedule set forth on
Annex I hereto,
so that on each Specified Date set forth therein Licensor shall have available
to it no less than the Threshold Amount set forth on Annex I.
(b) As
of October 31, 2008 Licensee owes to Licensor the amounts set forth on Annex
II. Notwithstanding anything contained in Section 8.2 of the License
Agreement to the contrary, Licensee’s obligation to make the Anoheal Project
Payment and the Incostop Project Payment from the date hereof through December
31, 2008 (such period, the “Forbearance Period”)
shall be suspended, and such amounts shall instead accrue and be payable in full
at the end of the Forbearance Period.
(c) Notwithstanding
anything contained in Section 23.4 of the License Agreement and section 2 (f) of
Amendment No. 1 to the Exclusive License Agreement to the contrary, the cure
period for purposes of a material breach or material default of the License
Agreement relating in its entirety to failure to pay to the Licensor any amounts
due under the License Agreement, shall be twenty one (21) days from the date the
notice of termination is received by the non-breaching or non-defaulting
party. For the avoidance of doubt, no other cure period set forth in
Section 23.4 of the License Agreement shall apply with respect to a material
breach or material default by the Licensee with respect to any payments due to
the Licensor. Notwithstanding anything contained in Section 23.4 of
the License Agreement to the contrary the License Agreement shall end without
further notice upon expiration of the 21 day cure period, if such material
breach or material default has not otherwise been cured, subject to clause 2 (d)
hereafter. Upon termination of the Projects pursuant to this clause,
all rights to the Patents relating to Incostop Project and the Anoheal Project
shall revert to the Licensor.
(d) In
the event Licensor does not receive new funds in the amount of at least USD $1
(one) million on or before December 31, 2008 (the “Funds”), payment of all
monies due under the License Agreement shall be suspended until the earlier of
(i) the date Licensee receives the Funds and (ii) February 28, 2009 (“the
Extended Forbearance Period”), subject to clause 2 (e) hereafter.
(e) Notwithstanding
anything to the contrary in section 2 (d) above Licensee shall make the payments
set forth in Annex III in accordance with the schedule set forth therein, so
that on each Specified Date set forth therein Licensor shall have available to
it no less than the Threshold Amount set forth in Annex
III.
(f)
Notwithstanding anything contained in
Section 2 (e) above, Licensor shall be entitled to terminate the License
Agreement without notice and with immediate effect, if any of the payments set
forth in Annex III is not available to him on the Specified Date.
For so
long as Licensee complies with the payment terms and conditions of this
Amendment, then Licensee shall not be entitled to terminate this License
Agreement for non-payment pursuant to Section 23.4 thereof.
3. Counterparts.
This Amendment may be executed in any number of separate counterparts, each of
which shall be an original and all of which taken together shall constitute one
and the same instrument. Facsimile counterpart signatures to this Amendment
shall be acceptable and binding.
4. Applicable
Law. This Amendment shall be governed by and construed in accordance with
the laws of Switzerland without regard to principles of conflicts of
law.
5. Dispute
Resolution. All disputes arising out of or in connection with this
Amendment shall be resolved by the ordinary courts of Zurich, Switzerland,
without limiting the right of recourse.
6. No Other
Amendments. Except as expressly set forth herein, the License Agreement
remains in full force and effect in accordance with its terms and nothing
contained herein shall be deemed to be a waiver, amendment, modification or
other change of any term, condition or provision of the License
Agreement.
7. Effectiveness.
This Amendment shall become effective immediately upon the date
hereof.
2
8. References
to the License Agreement. From and after the date hereof, all references
in the License Agreement and any other documents to the License Agreement shall
be deemed to be references to the License Agreement after giving effect to this
Amendment.
* * * *
*
3
IN WITNESS WHEREOF, the
parties hereto have executed this Amendment No. 2 to Exclusive License Agreement
as of the date first written above.
SLA
PHARMA AG
|
VENTRUS
BIOSCIENCES, INC.
|
|||
By:
|
/s/ Xxxxx Xxxxxx
|
By:
|
/s/ Xxxxxx Xxxxxxx
|
|
Name: Xxxxx
Xxxxxx
|
Name: Xxxxxx
Xxxxxxx
|
|||
Title:
PRESIDENT
|
Title: President
&
CEO
|
PARAMOUNT
BIOSCIENCES, LLC
|
|||
By:
|
/s/ Xxxxxxx X. Xxxxxxxxx
|
||
Name: Xxxxxxx
X. Xxxxxxxxx, MD
|
|||
Title: Sole
Member
|
|||
Legal
Approved
|
|||
Initial:
|
MRD
|
||
Date:
|
4
ANNEX I
Specified
Date
|
Nature
of Payment
|
Threshold
Amount
|
||||
December
31, 2008
|
In
account of cost of Anoheal development from June 2008 to December
2008
|
$ | 300,000 | |||
December
31, 2008
|
First
upfront installment to SLA
|
$ | 1,000,000 | |||
April
30, 2009
|
Second
upfront installment to SLA
|
$ | 800,000 | |||
October
30, 2009
|
Third
upfront installment to SLA
|
$ | 700,000 | |||
April
30, 2010
|
Final
upfront installment to SLA
|
Balance
of $4,000,000
|
ANNEX
II
Annex
II
S.L.A. Pharma AG
|
Invoices to Ventrus Schedule
Outstanding
|
as of
01/10/08
|
|||||||||||||||||
Invoice
Date
|
Invoice
No.
|
Invoice
Type
|
Period
|
Invoice
Amount
|
Date
Received
|
Amount
Received
|
Balance
Due
|
||||||||||||
2/29/2008
|
12A
|
DR
|
February ‘08
|
166,863.00 | |||||||||||||||
3/1/2008
|
13B
|
MF
|
March ‘08
|
88,000.00 | |||||||||||||||
3/31/2008
|
13A
|
DR
|
March ‘08
|
91,593.00 | |||||||||||||||
3/31/2008
|
4D
|
PR
|
March
‘08
|
10,695.00 | |||||||||||||||
3/31/2008
|
1E
|
OS
|
March
‘08
|
9,430.00 | |||||||||||||||
4/30/2008
|
14B
|
MF
|
April
‘08
|
53,000.00 | |||||||||||||||
4/30/2008
|
14A
|
DR
|
April
‘08
|
111,566.00 | |||||||||||||||
5/31/2008
|
16B
|
MF
|
May
‘08
|
83,000.00 | |||||||||||||||
5/31/2008
|
15A
|
DR
|
May
‘08
|
116,987.00 |
8/20/2008
|
249,863.00 | *) | ||||||||||||
6/26/2008
|
16B
|
MF
|
June
‘08
|
83,000.00 |
7/11/2008
|
100,000.00 | *) | ||||||||||||
6/30/2008
|
6D
|
PR
|
June
‘08
|
36,760.00 |
7/22/2008
|
160,000.00 | *) | ||||||||||||
7/31/2008
|
17B
|
MF
|
July
‘08
|
83,000.00 | |||||||||||||||
8/31/2008
|
00X
|
XXX
|
August
‘08
|
83,000.00 | |||||||||||||||
9/20/2008
|
00X
|
XXX
|
September
‘08
|
83,000.00 | |||||||||||||||
9/20/2008
|
6D
|
PR
|
September
‘08
|
21,802.00 | |||||||||||||||
9/30/2008
|
2E
|
OS
|
September
‘08
|
16,169.00 |
10/29/2008
|
100,000.00 | *) | ||||||||||||
10/31/2008
|
20B
|
IJP
|
October
‘08
|
83,000.00 | |||||||||||||||
2,245,885.00 | 899,065.00 | $ | 880,122.00 | ||||||||||||||||
Invoice
Type and _____ reference
|
*
from Paramount
|
||||||||||||||||||
MF Management
Fee (ref 0.2)
|
|||||||||||||||||||
DR
Development recharge (ref 12.2)
|
|||||||||||||||||||
PR
Patent recharge (ref 14.1 / 14.3)
|
|||||||||||||||||||
OS
Outside scope (ref 12.5.1)
|
2
ANNEX
III
Specified
Date
|
Nature
of Payment
|
Threshold
Amount
|
||||
January
1, 2009
|
in
account of management fees and patent costs June to December
2008
|
$ | 100,000 | |||
February
1, 2009
|
in
account of management fees and patent costs June to December
2008
|
$ | 100,000 |
PARAMOUNT
BIOSCIENCES, LLC
000
Xxxxxxx Xxxxxx
00xx
Xxxxx
Xxx Xxxx,
XX 00000
November
20, 2008
SLA
Pharma AG
Xxxxxxxx
0
Xxxxxxx,
Xxxxxxxxxxx
Attn:
Xxxxx Xxxxxx
Dear
Xxxxx:
Reference
is hereby made to the Exclusive License Agreement, dated as of March 23, 2007,
as amended on July 24, 2008 (the “License Agreement”),
between SLA Pharma AG (“SLA”) and Ventrus
Biosciences, Inc. (“Ventrus”), as
assignee of Paramount Biosciences, LLC (“Paramount”). Paramount
shall make a payment (the “Payment”) in an
amount equal to USD$150,000 to SLA on behalf of Ventrus on the date hereof, in
full satisfaction of the amounts presently owed by Ventrus to SLA that have been
guaranteed by Xxxxxxx X. Xxxxxxxxx, M.D. At such time as (i) no cash
payments are past due or have been suspended under the License Agreement, and
(ii) Ventrus has paid SLA an amount of cash exceeding what is then owed under
the License Agreement by at least USD$250,000, SLA shall promptly remit to
Paramount an amount equal to USD$150,000.
* * * * *
If the
foregoing correctly sets forth your understanding of our agreement with respect
to the matters addressed above, please indicate your acceptance and approval
below.
LEGAL
APPROVAL
|
PARAMOUNT BIOSCIENCES, LLC | ||||
By:
|
/s/ Xxxxxxx X. Xxxxxxxxx,
MD
|
||||
Initial:
|
MHD
|
Name:
Xxxxxxx X. Xxxxxxxxx, MD
|
|||
Date:
|
Title:
Sole Member
|
||||
VENTRUS
BIOSCIENCES, INC.
|
|||||
By:
|
/s/ Xxxxxx Xxxxxxx
|
||||
Name: Xxxxxx
Xxxxxxx
|
|||||
Title:
President &
CEO
|
AGREED
AND ACKNOWLEDGED:
|
|
SLA
PHARMA AG
|
|
By:
|
/s/ X. Xxxxxx
|
Name: X.
Xxxxxx
|
|
Title:
President
|
PARAMOUNT
BIOSCIENCES, LLC
0000
X Xxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx
Xxxxxxx, XX 00000
January
22, 2009
SLA
Pharma AG
Xxxxxxxx
0
Xxxxxxx,
Xxxxxxxxxxx
Attn:
Xxxxx Xxxxxx
Dear
Xxxxx:
Reference
is hereby made to the Exclusive License Agreement, dated as of March 23, 2007,
between SLA Pharma AG (“SLA”) and Ventrus
Biosciences, Inc. (“Ventrus”), as
assignee of Paramount Biosciences, LLC (“Paramount”), as
amended by Amendment No. 1 to Exclusive License Agreement, between SLA, Ventrus,
and Paramount, dated as of July 24, 2008, Amendment No. 2 to Exclusive License
Agreement, between SLA, Ventrus, and Paramount, dated as of November 20, 2008,
the letter agreement between Paramount, Ventrus, and SLA, dated as of October
27, 2008, and the letter agreement between Paramount, Ventrus, and SLA dated as
of November 20, 2008 (taken together, including all amendments and alterations
to date, the “License
Agreement”). To the extent this letter agreement is in
conflict with any provision of the License Agreement, such provision of the
License Agreement is hereby superseded and replaced in all respects by the
content of this Letter Agreement.
Ventrus
shall make a payment to SLA in the amount set forth in Exhibit A hereto
immediately upon its receipt of this document countersigned by SLA, in full
satisfaction of all accrued expenses to date under the License Agreement (the
“2008 Balance
Payment”). In addition, Ventrus will make a payment to SLA at
that time in the amount set forth in Exhibit A hereto in
full satisfaction of any other Incostop and Anoheal Project payments due to SLA
by Ventrus by February 15, 2009 under the License Agreement (the “Outstanding Project
Payment”). Finally, any other payments to SLA that may be
required no later than February 28, 2009 under the License Agreement shall
instead become due no later than May 31, 2009.
Upon the
payment of the amounts in the described in the preceding paragraph, all accrued
but unpaid Anoheal Project Payments and the Incostop Project Payments (each as
defined the License Agreement) shall be have been paid in full to SLA as of the
date hereof, and Ventrus shall continue to pay to SLA the Anoheal Project
Payments and Incostop Project Payments until May 31, 2009, on a monthly basis as
set forth in Exhibit
A hereto (the “Remaining Project
Payments”). Thereafter, no additional Anoheal Project Payments
or Incostop Project Payments shall accrue or be payable, and such ongoing or
further payments as may be called for in the License Agreement shall be of no
further force or effect, in the event that Ventrus chooses to return licenses to
these products to SLA or to contribute these licenses to a possible joint
venture to be formed among SLA and Ventrus, as described in the succeeding
paragraph with the provision that Ventrus shall remain obliged to fulfil all
payment obligations due but no fulfilled at the time of the return or
contribution of the license unless the parties agree otherwise.
Finally,
Ventrus and SLA shall discuss the terms and feasibility of a possible
United-States-based joint venture to develop and/or commercialize the Patents,
Know-How, Technology, Trademarks, and/or Licensed Products (each as defined in
the License Agreement).
Except as
specified herein, the License Agreement in full force and in good standing among
Ventrus, Paramount, and SLA.
* * * *
*
If the
foregoing correctly sets forth your understanding of our agreement with respect
to the matters addressed above, please indicate your acceptance and approval
below.
PARAMOUNT
BIOSCIENCES, LLC
|
||
By:
|
/s/ Xxxxxxx X. Xxxxxxxxx
|
|
Name: Xxxxxxx
X. Xxxxxxxxx, MD
|
||
Title: Sole
Member
|
||
VENTRUS
BIOSCIENCES, INC.
|
||
By:
|
/s/ Xxxxxx Xxxxxxx
|
|
Name: Xxxxxx
Xxxxxxx
|
||
Title: President
& CEO
|
AGREED
AND ACKNOWLEDGED:
|
|||
SLA
PHARMA AG
|
|||
By:
|
/s/ X. Xxxxxx
|
||
Name: X.
Xxxxxx
|
|||
Title: President
|
2
EXHIBIT
A
Payment
|
Amount
|
Due
Date
|
|||
2008
Balance Payment
|
$ | 612,056 |
upon
signing
|
||
Outstanding
Project Payment
|
$ | 100,000 |
upon
signing
|
||
Remaining
Project Payment
|
$ | 66,000 |
February
28, 2009
|
||
Remaining
Project Payment
|
$ | 83,000 |
March
31, 2009
|
||
Remaining
Project Payment
|
$ | 83,000 |
April
30, 2009
|
||
Remaining
Project Payment
|
$ | 83,000 |
May
31,
2009
|
AMENDMENT
NO. 3 TO EXCLUSIVE LICENSE AGREEMENT
AMENDMENT NO. 3 TO EXCLUSIVE LICENSE
AGREEMENT, dated June 1, 2009 (this “Amendment”), between
S.L.A. PARMA AG (the
“Licensor”),
and VENTRUS BIOSCIENCES,
INC. (the “Licensee”), as
assignee of Paramount Biosciences, LLC (“Paramount”).
WHEREAS, the Licensor and the
Licensee have entered into that certain Exclusive License Agreement, dated as of
March 23, 2007, as amended by Amendment No. 1 to Exclusive License Agreement
dated as of July 24, 2008, Amendment No. 2 to Exclusive License Agreement dated
as of November 20, 2008, and as supplemented by those certain sideletters dated
as of October 27, 2008, November 20, 2008 and January 22, 2009 (as amended,
restated, supplemented or otherwise modified to date, the “License
Agreement”);
WHEREAS, the parties hereto
desire to further amend the License Agreement as set forth herein.
NOW, THEREFORE, in
consideration of the foregoing and for other consideration the sufficiency and
receipt of which is hereby acknowledged by the parties, it is hereby agreed by
and between the parties as follows:
1. Capitalized
Terms. Terms used herein but not otherwise defined shall have the meaning
ascribed thereto in the License Agreement.
2. Amendments.
(a) Notwithstanding
anything to the contrary contained in the License Agreement, the Licensee shall
pay to the. Licensor US$198,201 on the date hereof, receipt of which the
Licensor hereby acknowledges, and the Licensor hereby rescinds that certain
termination letter, dated May 11, 2008, which was previously delivered to
Licensee, and the Licensor hereby confirms and acknowledges that, subject to
Licensor’s and Licensee’s continuing performance pursuant to the terms and
conditions under this Agreement, the License Agreement shall be in good standing
and remain in full force and effect.
(b) Commencing
July 1, 2009, and continuing until December 1, 2009 or the earlier termination
of the License Agreement, Licensee shall pay Licensor $75,000 per month, in
account of the cost of Anoheal development from June 2008 onward.
(c) Notwithstanding
anything to the contrary contained in the License Agreement, all Incostop and
Anoheal Project payments shall accrue during the term of the License Agreement,
and, subject to paragraph 2 (f) below, be payable promptly after the Licensee or
Paramount BioSciences, L.L.C. consummates a financing (or series of related
financings) resulting in net proceeds to it of at least US$10 million (the
“Qualified Financing”).
(d) Notwithstanding
anything to the contrary contained in the License Agreement, the balance of the
Maximum Anoheal Amount shall be paid quarterly (commencing for the quarter ended
September 30, 2009), and Licensor shall make payments in account of the cost of
Anoheal development from June 2008 onward, in accordance with Schedule A attached
hereto. Consequently payments on account of Anoheal Development Costs shall be
executed as described in Schedule B. The payment due for the quarterly period
ended September 30, 2009 may, at the option of the Licensee, be deferred by
written notice until December 31, 2009, solely in the event that the Licensee
has not consummated a Qualified Financing by September 30, 2009.
(e) Notwithstanding
anything contained in Section 23.4 of the License Agreement and section 2 (f) of
Amendment No. 1 to the Exclusive License Agreement to the contrary, the cure
period for purposes of a material breach or material default of the License
Agreement relating in its entirety to failure to pay to the Licensor any amounts
due under the License Agreement (including but not limited to non-payment of
moneys due pursuant to this Amendment), shall be three (3) business days from
the date the notice of termination is received by the non-breaching or
non-defaulting party. For the avoidance of doubt, no other cure period set forth
in Section 23.4 of the License Agreement shall apply with respect to a material
breach or material default by the Licensee with respect to any payments due to
the Licensor. Notwithstanding anything contained in Section 23.4 of the License
Agreement to the contrary the License Agreement shall end without further notice
upon expiration of the 3-day cure period, if such material breach or material
default has not otherwise been cured. Upon termination of the Projects pursuant
to this clause, all rights to the Patents relating to Incostop Project and the
Anoheal Project shall revert to the Licensor.
(f)
For so long as Licensee complies with the payment
terms and conditions
of this Amendment, then Licensee shall not be entitled to terminate this License
Agreement for non-payment Licensor shall, however, be entitled to terminate the
License Agreement without notice and with immediate effect, if the Licensee has
not consummated a Qualified Financing by December 31, 2009. Furthermore, on or
after September 30, 2009, Licensor shall be entitled to terminate this License
Agreement with one month’s notice in the event a third party wishes to enter
into a license agreement relating to Anoheal and Incostop and has entered into a
binding agreement with Licensor to that end. The termination shall however not
become effective if within the notice period Licensee pays all moneys invoiced
and unpaid as of such notice and all unpaid Management Fees through the end of
2009.
3. Counterparts.
This Amendment may be executed in any number of separate counterparts, each of
which shall be an original and all of which taken together shall constitute one
and the same instrument. Facsimile counterpart signatures to this
Amendment shall be acceptable and binding.
4. Applicable
Law. This Amendment shall be governed by and construed in accordance with
the laws of Switzerland without regard to principles of conflicts of
law.
2
5. Dispute
Resolution. All disputes arising out of or in connection with this
Amendment shall be resolved by the ordinary courts of Zurich, Switzerland,
without limiting the right of recourse.
6. No Other
Amendments. Except as expressly set forth herein, the License Agreement
remains in full force and effect in accordance with its terms and nothing
contained herein shall be deemed to be a waiver, amendment, modification or
other change of any term, condition or provision of the License
Agreement.
7. Effectiveness.
This Amendment shall become effective immediately upon the date
hereof.
8. References
to the License Agreement. From and after the date hereof, all references
in the License Agreement and any other documents to the License Agreement shall
be deemed to be references to the License Agreement after giving effect to this
Amendment.
* * * *
*
3
IN WITNESS WHEREOF, the
parties hereto have executed this Amendment No. 3 to Exclusive License Agreement
as of the date first written above.
SLA
PHARMA AG
|
VENTRUS
BIOSCIENCES, INC.
|
|||
By:
|
/s/ X. Xxxxxx
|
By:
|
/s/ Xxxxxx Xxxxxxx
|
|
Name: X.
XXXXXX
|
Name: Xxxxxx
Xxxxxxx
|
|||
Title:
PRESIDENT
|
Title: President
& CEO
|
|||
PARAMOUNT
BIOSCIENCES, LLC
|
||||
By:
|
/s/ Xxxxxxx X. Xxxxxxxxx
|
|||
Name: Xxxxxxx
X. Xxxxxxxxx, MD
|
||||
Title:
Sole
Member
|
4
Schedule
A
Quarterly Period Ending
|
Payments on Account
|
|||
September
30, 2009
|
$ | 775,000 | ||
December
31, 2009
|
$ | 775,000 | ||
March
31, 2010
|
$ | 800,000 |
Schedule
B
Date
|
Payments
|
|||
July
1, 2009 / immediately
|
$ | 75,000 | ||
August
1, 2009
|
$ | 75,000 | ||
September
1, 2009
|
$ | 75,000 | ||
September
30, 2009
|
$ | 775,000 | ||
October
1, 2009
|
$ | 75,000 | ||
November
1, 2009
|
$ | 75,000 | ||
December
1, 2009
|
$ | 75,000 | ||
December
31, 2009
|
$ | 775,000 | ||
March
31, 2010
|
$ | 800,000 | ||
Total
|
$ | 2,800,000 | ||
Already
paid on account of Maximum Anoheal
|
$ | 1,200,000 | ||
Maximum
Anoheal Amount
|
$ | 4,000,000 |
AMENDMENT
NO. 4 TO EXCLUSIVE LICENSE AGREEMENT
AMENDMENT NO. 4 TO EXCLUSIVE LICENSE
AGREEMENT, dated December 18, 2009 (this “Amendment”), between
S.L.A. PHARMA AG (the
“Licensor”) and
VENTRUS BIOSCIENCES,
INC. (the “Licensee”), as
assignee of Paramount Biosciences, LLC (“Paramount”).
WHEREAS, the Licensor and the
Licensee have entered into that certain Exclusive License Agreement, dated as of
March 23, 2007, as amended by Amendment No. 1 to Exclusive License Agreement
dated as of July 24, 2008, Amendment No. 2 to Exclusive License Agreement dated
as of November 20, 2008 and Amendment No. 3 to Exclusive License Agreement dated
as of June 1, 2009, and as supplemented by those certain sideletters dated as of
October 27, 2008, November 20, 2008, and January 22, 2009 (as amended, restated,
supplemented or otherwise modified to date the “License Agreement”);
WHEREAS, the parties hereto
desire to further amend the License Agreement as set forth herein.
NOW, THEREFORE, in
consideration of the foregoing and for other consideration the sufficiency and
receipt of which is hereby acknowledged by the parties, it is hereby agreed by
and between the parties as follows:
1. Capitalized
Terms. Terms used herein but not otherwise defined shall have the meaning
ascribed thereto in the License Agreement.
2. Amendments.
(a) Notwithstanding
anything to the contrary contained in the License Agreement, the Licensee shall
pay to the Licensor US$723,846 for recharge of patent costs (article 14.1. of
the License Agreement) and Anoheal and Incostop Project Payments (article 8.2.
of the License Agreement) as shown in Schedule A in two
equal installments on December 31, 2009 and January 31, 2010. Given Licensee’s
continuing performance pursuant to the terms and conditions under this
Agreement, the License Agreement shall be in good standing and remain in full
force and effect.
(b) Commencing
January 31, 2010, and continuing until June 30, 2010 or the earlier termination
of the License Agreement, Licensee’s obligation to make the Incostop and Anoheal
Project Payments shall be suspended for half of the amount due and Licensee
shall pay Licensor $41,500 per month only, in account of the cost of Incostop
and Anoheal Project payments. Commencing July 2010 Incostop and Anoheal Project
payments shall revert to $83,000 per month payable on the last day of each
month.
(c) The
amounts suspended pursuant to paragraph 2 b) above shall be payable promptly
after the earlier of (i) June 30, 2010 and (ii) Licensee consummating a
financing (or series of related financings) resulting in net proceeds to it of
at least US$10 million (the “Qualified Financing”).
(d) Notwithstanding
anything to the contrary contained in the License Agreement, Licensee shall pay
the balance of the Maximum Anoheal Amount (recharge of development costs
pursuant to article 12.2. of the License Agreement) from January 2010 onward, in
accordance with Schedule B attached
hereto. In accordance therewith, Licensor shall use commercially reasonable
efforts using the January 31, 2010 Schedule B payment to initiate a Phase 3
trial of diltiazem cream (VEN 307) for the relief of pain associated with anal
fissures in Europe by the end of the second quarter of 2010, based on a clinical
development program to be agreed upon by the Licensor and Licensee. The
Licensors commitment to continue the Phase 3 study shall cease in the event of
non payment by the Licensee in accordance with Schedule B.
(e) Notwithstanding
anything contained in Section 23.4 of the License Agreement and section 2 (f) of
Amendment No. 1 to the Exclusive License Agreement to the contrary, the cure
period for purposes of a material breach or material default of the License
Agreement relating in its entirety to failure to pay to the Licensor any amounts
due under the License Agreement (including but not limited to non-payment of
moneys due pursuant to this Amendment), shall be three (3) business days from
the date the notice of termination is received by the breaching or defaulting
party. For the avoidance of doubt, no other cure period set forth in Section
23.4 of the License Agreement shall apply with respect to a material breach or
material default by the Licensee with respect to any payments due to the
Licensor. Notwithstanding anything contained in Section 23.4 of the License
Agreement to the contrary the License Agreement shall end without further notice
upon expiration of the 3-day cure period, if such material breach or material
default has not otherwise been cured. Upon termination of the Projects pursuant
to this clause, all rights to the Patents relating to Incostop Project and the
Anoheal Project shall revert to the Licensor.
(f)
For so long as Licensee complies with the payment
terms and conditions of this Amendment, then Licensor shall not be entitled to
terminate this License Agreement for non-payment. Licensor shall,
however, be entitled to terminate the License Agreement without notice and with
immediate effect, if the Licensee has not consummated a Qualified Financing by
September 30, 2010. Furthermore, Licensor shall be entitled to terminate this
License Agreement with one month’s notice in the event a third party wishes to
enter into a license agreement relating to Anoheal and Incostop and has entered
into a binding agreement with Licensor to that end. The termination shall
however not become effective if within the one month notice period Licensee pays
all moneys invoiced and unpaid as of such notice and the balance of the Maximum
Anoheal Amount.
(g) As
a condition to consenting to the amendments to the License Agreement contained
herein, Licensee shall issue to Licensor 25,000 shares of common stock, par
value $0.001 per share. Such shares of common stock shall be issued pursuant to
a stock purchase agreement substantially in the form previously executed by the
parties in connection with the prior issuance of shares by Licensee to Licensor.
It is understood that Article 11.2. of the License Agreement shall be applicable
mutatis mutandis to the shares issued pursuant to this Amendment No
4.
2
3. Counterparts.
This Amendment may be executed in any number of separate counterparts, each of
which shall be an original and all of which taken together shall constitute one
and the same instrument. Facsimile counterpart signatures to this Amendment
shall be acceptable and binding.
4. Applicable
Law. This Amendment shall he governed by and construed in accordance with
the laws of Switzerland without regard to principles of conflicts of
law.
5. Dispute
Resolution. All disputes arising out of or in connection with this
Amendment shall be resolved by the ordinary courts of Zurich, Switzerland,
without limiting the right of recourse.
6. No Other
Amendments. Except as expressly set forth herein, the License Agreement
remains in full force and effect in accordance with its terms and nothing
contained herein shall be deemed to be a waiver, amendment, modification or
other change of any term, condition or provision of the License
Agreement.
7. Effectiveness.
This Amendment shall become effective immediately upon the date
hereof.
8. References
to the License Agreement. From and after the date hereof, all references
in the License Agreement and any other documents to the License Agreement shall
be deemed to be references to the License Agreement after giving effect to this
Amendment.
* * * *
*
3
IN WITNESS WHEREOF, the
parties hereto have executed this Amendment No. 4 to Exclusive License Agreement
as of the date first written above.
By:
|
/s/ X. Xxxxxx
|
By:
|
/s/ Xxxxxx Xxxxxxx
|
|
Name: X.
Xxxxxx
|
Name: President
|
|||
Title:
PRESIDENT
|
Title: Xxxxxx
Xxxxxxx
|
|||
PARAMOUNT
BIOSCIENCES, LLC
|
||||
By:
|
/s/ Xxxxxxx X. Xxxxxxxxx
|
|||
Name: Xxxxxxx
X. Xxxxxxxxx, MD
|
||||
Title: Sole
Member
|
4
Schedule
A
Invoice Description
|
Payments
|
|||
May
31, 2009 – Invoice 27B Project
payment
|
$ | 83,000 | ||
Jun
30, 2009 – Invoice 9D Patent
recharge
|
$ | 32,664 | ||
Nov
30, 2009 – Invoice 10D Patent
recharge
|
$ | 27,182 | ||
Jun
2009 to Dec 2009 – Invoice 28B Project
payments
|
$ | 581,000 | ||
Total
|
$ | 723,846 |
Schedule
B
Date
|
Payments
|
|||
January
31, 2010
|
$ | 350,000 | ||
June
30, 2010
|
$ | 600,000 | ||
October
31, 2010
|
$ | 600,000 | ||
February
28, 2011
|
$ | 800,000 | ||
Total
|
$ | 2,350,000 | ||
Already
paid on account of Maximum Anoheal Amount
|
$ | 1,650,000 | ||
Maximum
Anoheal Amount
|
$ | 4,000,000 |
AMENDMENT
NO. 5 TO EXCLUSIVE LICENSE AGREEMENT
AMENDMENT NO. 5 TO EXCLUSIVE LICENSE
AGREEMENT, dated June 24, 2010 (this “Amendment”), between
S.L.A. PHARMA AG (the
“Licensor”) and
VENTRUS BIOSCIENCES,
INC. (the “Licensee”), as
assignee of Paramount Biosciences, LLC (“Paramount”).
WHEREAS, the Licensor and the
Licensee have entered into that certain Exclusive License Agreement, dated as of
March 23, 2007, as amended by Amendment No. 1 to Exclusive License Agreement
dated as of July 24, 2008, Amendment No. 2 to Exclusive License Agreement dated
as of November 20, 2008, Amendment No. 3 to Exclusive License Agreement dated as
of June 1, 2009, and Amendment No. 4 to Exclusive License Agreement dated as of
December 18, 2009 and as supplemented by those certain sideletters dated as of
October 27, 2008, November 20, 2008, and January 22, 2009 (as amended, restated,
supplemented or otherwise modified to date the “License Agreement”);
WHEREAS, the parties hereto
desire to further amend the License Agreement as set forth herein.
NOW, THEREFORE, in
consideration of the foregoing and for other consideration the sufficiency and
receipt of which is hereby acknowledged by the parties, it is hereby agreed by
and between the parties as follows:
1. Capitalized
Terms. Terms used herein but not otherwise defined shall have the meaning
ascribed thereto in the License Agreement.
2. Amendments.
(a) Given
Licensee’s continuing performance pursuant to the terms and conditions under
this Agreement, the License Agreement shall be in good standing and remain in
full force and effect.
(b) Commencing
January 31, 2010, and continuing until September 30, 2010 or the earlier
termination of the License Agreement, Licensee’s obligation to make the Incostop
and Anoheal Project Payments shall be suspended for half of the amount due and
Licensee shall pay Licensor $41,500 per month only, in account of the cost of
Incostop and Anoheal Project payments. Commencing October 2010 Incostop and
Anoheal Project payments shall revert to $83,000 per month payable on the last
day of each month.
(c) The
amounts suspended pursuant to paragraph 2 (b) above shall be payable promptly
after the earlier of (i) September 30, 2010 and (ii) Licensee consummating a
financing (or series of related financings) resulting in net proceeds to it of
at least US$10 million (the “Qualified Financing”).
3. Counterparts.
This Amendment may be executed in any number of separate counterparts, each of
which shall be an original and all of which taken together shall constitute one
and the same instrument. Facsimile counterpart signatures to this Amendment
shall be acceptable and binding.
4. Applicable
Law. This Amendment shall he governed by and construed in accordance with
the laws of Switzerland without regard to principles of conflicts of
law.
5. Dispute
Resolution. All disputes arising out of or in connection with this
Amendment shall be resolved by the ordinary courts of Zurich, Switzerland,
without limiting the right of recourse.
6. No Other
Amendments. Except as expressly set forth herein, the License Agreement
remains in full force and effect in accordance with its terms and nothing
contained herein shall be deemed to be a waiver, amendment, modification or
other change of any term, condition or provision of the License
Agreement.
7. Effectiveness.
This Amendment shall become effective immediately upon the date
hereof.
8. References
to the License Agreement. From and after the date hereof, all references
in the License Agreement and any other documents to the License Agreement shall
be deemed to be references to the License Agreement after giving effect to this
Amendment.
* * * *
*
2
IN WITNESS WHEREOF, the
parties hereto have executed this Amendment No. 5 to Exclusive License Agreement
as of the date first written above.
By:
|
/s/ X. Xxxxxx
|
By:
|
/s/ Xxxxxxx
Xxxxxxx
|
|
Name: X.
Xxxxxx
|
Name: Xxxxxxx Xxxxxxxx, MD
|
|||
Title:
PRESIDENT
|
Title: Chief Executive
Officer
|
3