Exhibit 10.109
SUBLICENSE AGREEMENT
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This Sublicense Agreement (hereinafter referred to as this
"Agreement"), effective as of April 14, 2004, (the "Effective Date"), is
entered into by and between IGI, Inc. ("IGI"), with its principal place of
business located at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, and Tarpan
Therapeutics, Inc., a corporation duly organized and existing under the
laws of the State of Delaware (the "Company"), with is principal place of
business located at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇.
WHEREAS, IGI has been granted the exclusive license to certain
proprietary rights and intellectual property (including pursuant to certain
patents) to a technology for the clinical uses of PTH 1-34 relating to the
regulation of cell differentiation and proliferation for treatment of skin
disorders (the "Technology"), invented by ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, M.D., PhD,
pursuant to the terms of a License Agreement between and among IGI and
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, M.D., PhD and A&D Bioscience, Inc. dated effective as of
December 24, 2003 (the "Master License Agreement"), a copy of which is
attached hereto as Exhibit A; and
WHEREAS, the Company desires to obtain from IGI, and IGI desires to
grant to the Company, an exclusive, world-wide, royalty bearing sublicense
to develop and commercialize the Technology on the terms and conditions set
forth herein; and
NOW, THEREFORE, in consideration of the foregoing premises, the
mutual promises and covenants of the Parties contained herein, and other
good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereto, intending to be legally bound, do
hereby agree as follows:
ARTICLE 1 - DEFINITIONS
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For the purposes of this Agreement, the following words and phrases
shall have the following meanings:
1.1 The "Company" shall mean Tarpan Therapeutics, Inc., a Delaware
corporation.
1.2 "Affiliate" of any Entity (as defined herein) shall mean
another Entity that directly or indirectly controls, is controlled by, or
is under common control with, such first Entity.
1.2.1 "Control" shall mean direct or indirect control of more
than fifty percent (50%) of the voting securities of an Entity or, if
such Entity does not have outstanding voting securities, more than a
50% ownership interest in such Entity.
1.2.2 "Entity" shall mean any corporation, partnership,
limited liability company, trust, university, sole proprietorship,
government or political subdivision thereof, including an agency, or
any other organization that possesses separate legal existence that
can exercise independent legal standing.
1.3 "PTH Patent Rights" shall mean all claims for the clinical uses
of PTH 1-34 contained in any and U.S. and foreign patents and patent
applications set forth on Schedule 1.3;
1.3.1 All claims for the clinical uses of PTH 1-34 contained
in any other United States and/or foreign, patent applications and/or
patents together with any and all patents issuing thereon, including
continuation, divisionals and re-issue applications and continuation-
in-part applications and any United States or foreign patents granted
upon such applications, based upon inventions or improvements
discovered by the Company, any and all of which shall be deemed added
to Schedule 1.3;
1.3.2 All claims for the clinical uses of PTH 1-34 contained
in any later-filed United States and/or foreign patent applications
based on the patent applications and/or patents listed in Appendix I,
or corresponding thereto, including any continuations, continuations-
in-part, divisional, reissues, reexaminations, or extensions thereof;
1.3.3 All claims for the clinical uses of PTH 1-34 contained
in any United States and/or foreign patents issuing from any of the
foregoing.
1.4 "Know-how" shall mean all tangible information (other than
those contained in the PTH Patent Rights) whether patentable or not (but
which have not been patented) and physical objects related to the
Technology or to the Licensed Product, including but not limited to
formulations, materials, data, drawings and sketches, designs, testing and
test results, regulatory information of a like nature, owned by or licensed
to IGI under the Master License Agreement, which IGI have the right to
disclose and license to the Company in accordance with the terms of the
Master License Agreement.
1.5 "Improvements" means any inventions (whether patentable or
not), information and data that are developed by the Company or as a result
of any research conducted by any Entity (to the extent permitted by law)
during the term of this Agreement, the manufacture use or sale of which
would infringe an issued or pending claim within the PTH Patent Rights.
1.6 "Licensed Product(s)" shall mean:
1.6.1 Any product covered in whole or in part by a valid and
unexpired claim contained in the PTH Patent Rights that is made,
manufactured, distributed, marketed, used, leased or sold anywhere in
the world; and
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1.6.2 Any product that is manufactured anywhere is the world
using a process which is covered in whole or in part by a valid and
unexpired claim contained in the PTH Patent Rights; and
1.6.3 Any product that is used anywhere in the world according
to a method which is covered in whole or in part by a valid and
unexpired claim contained in the PTH Patent Rights.
1.7 "Net Sales" shall mean the total gross receipts for sales of
Licensed Products by or on behalf of the Company or any of its Affiliates
or sublicensees, whether invoiced or not, 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,
which are not charged to, paid for, or otherwise assumed by the customer;
(c) outbound transportation prepaid or allowed and transportation
insurance, which is not charged to, paid for, or otherwise assumed by the
customer; (d) amounts allowed or credited on returns; and (e) packaging and
freight charges, which are not charged to, paid for, or otherwise assumed
by the customer. For purposes of calculating Net Sales: (a) sales between
or among the Company and its Affiliates shall be excluded from the
computation of Net Sales where the Affiliates are not the end-users on the
sale of the Licensed Products; in which case, such sales by the Company to
the Affiliates are so excluded, and it is the gross receipts received by
the Affiliates on the subsequent sales of such License Products by the
Affiliates to Third Parties that shall be included in the computation of
Net Sales; and (b) on sales of Licensed Products by the Company to
Affiliates that are end-users of such Licensed Products, the amount that
would have been received by the Company for the sale of the same Licensed
Products to a third party in an arms length transaction shall be included
as the value of such sales in the computation of Net Sales.
ARTICLE 2 - GRANT
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2.1 IGI hereby grants to the Company and the Company accepts,
subject to the terms and conditions of this Agreement, an exclusive
worldwide sublicense to the PTH Patent Rights, Know-how and Improvements
for all uses, and to make, have made, use, lease and/or sell the Licensed
Products, to the full end of the term for which the PTH Patent Rights are
granted, unless sooner terminated as hereinafter provided.
2.2 IGI has an exclusive worldwide license pursuant to the terms of
the Master License Agreement to the PTH Patent Rights, free and clean of
all liens, charges, encumbrances or other restrictions or limitations of
any kind whatsoever, together with the right to grant sublicenses thereto.
IGI represents that to the best of its knowledge no party is currently in
breach of any provision of the Master License Agreement. To IGI's knowledge
and belief there are no licenses, options, restrictions, liens, rights of
third parties, disputes, royalty obligations, proceedings or claims
relating to, affecting, or limiting its rights or the rights of the Company
under this Agreement with respect to, or which may lead to a claim of
infringement or invalidity regarding, any part or all of the PTH Patent
Rights and their use as
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contemplated in the underlying patent applications as presently drafted. To
the best of IGI's actual knowledge and belief there is no claim, pending or
threatened, of infringement, interference or invalidity regarding, any part
or all of the PTH Patent Rights and their use as contemplated in the
underlying patents and applications as presently drafted.
2.3 IGI has an exclusive worldwide license granted pursuant to the
terms of a License Agreement dated December 14, 1995 between Micro-Pak,
Inc., a wholly owned subsidiary of Novavax Inc., and Igen, Inc., a wholly
owned subsidiary of IGI, (the "Novasome License Agreement"), to certain
proprietary rights and intellectual property (including pursuant to certain
patents) to a lipid vesicle technology for topical dermatologic products
for localized usage at the delivery zone ("the Novasome Technology"). To
the extent the Company or its affiliates or sublicensees wish to utilize
the Novasome Technology for the development or production of any License
Product, IGI expressly agrees to supply and/or manufacture for the Company
or its Affiliates or sublicensees any such Licensed Product utilizing the
Novasome Technology at IGI's cost.
2.3.1 As per the terms of the Novasome License Agreement, IGI
was granted the license rights to the Novasome Technology for a term
of 10 years. In addition, IGI was granted an option ("Option") to
extend the exclusive license rights granted thereunder for an
additional 10 years, which option is exercisable in the last year of
the initial 10 year license period upon the payment of an option fee
of $1,000,000. The initial 10 year license granted to IGI under the
Novasome License Agreement expires on December 13, 2005. IGI
expressly represents and warrants to the Company that it intends to
exercise the Option to extend the Novasome License for an additional
10 year period and has already advised Novavax of such intention. IGI
further represents and warrants to the best of its current ability
based upon its present and future projected business operations that
it shall have available the financial and/or other resources to
satisfy the Option Fee due and payable on December 13, 2005, to
exercise the Option to Extend.
2.3.2 In the event that IGI fails to exercise the Option, then
the royalties described in Section 4.1 of this Agreement shall be
reduced by one-third (1/3).
2.3.3 IGI further represents and warrants that to the best of
its knowledge no party is currently in breach of any provision of the
Novasome License Agreement. To IGI's knowledge and belief there are
no licenses, options, restrictions, liens, rights of third parties,
disputes, royalty obligations, proceedings or claims relating to,
affecting, or limiting its rights or the rights of the Company under
this Agreement with respect to, or which may lead to a claim of
infringement or invalidity regarding, any part or all of the Novasome
Technology.
2.3.4 To the best of IGI's actual knowledge and belief there
is no claim, pending or threatened, of infringement, interference or
invalidity regarding, any part or all of the Novasome Technology.
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2.4 IGI represents and warrants that following the execution of
this Agreement, IGI will negotiate in good faith with the Company to grant
the Company a non-exclusive sublicense to certain rights to use the
Novasome Technology (the "Novasome Sublicense").
2.5 (a) IGI hereby grants to the Company the right to grant
sublicenses to third parties in accordance with the terms contained herein.
Any sublicense shall be expressly subject in all respects to the rights,
duties, obligations, restrictions, exceptions, royalty and other payment
obligations of this Agreement.
(b) The Company shall provide IGI with a full and complete
executed copy of any and all sublicense agreements granted hereunder, as
well as any amendments thereto, within five (5) business days following the
execution thereof. The Company shall also deliver to IGI copies of all
quarterly royalty reports within 10 business days following receipt by the
Company from each such sublicensee as shall be required under the terms of
the sublicense agreement.
(c) Any and all Sublicense Agreements granted by the Company
hereunder shall expressly provide by the terms thereof that in the event of
termination of this Agreement between the Company and IGI, other than
termination pursuant to Articles 7.1 and/or 7.6 hereof, such Sublicenses
Agreements shall survive and shall be automatically assigned by the Company
to IGI without any further action required by the Company, IGI and/or the
sublicensees, thereby becoming a direct Sublicense Agreement between IGI
and the applicable sublicensee. In the event this Agreement is terminated
pursuant to Article 7.1 and/or 7.6 hereof, any and all Sublicense
Agreements granted by the Company hereunder shall automatically terminate
simultaneously therewith by the express terms thereof.
ARTICLE 3 - DUE DILIGENCE
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The Company shall use all reasonable commercial efforts to bring the
Technology to market through a thorough, vigorous and diligent program for
exploitation of the Technology as timely and efficiently as possible. Such
program shall include, without limitation, and the Company shall be
responsible for the cost of, the preclinical and clinical development of
the project, including research and development, manufacturing, laboratory
and clinical testing and trials and marketing of Licensed Products, for
which the Company shall be responsible. The Company will use all
commercially reasonable efforts to treat the first human patient with a
Licensed Product within 18 months following execution of this Agreement.
The Company shall continue active, diligent marketing efforts for the
Technology throughout the term of this Agreement.
Within thirty (30) days of the Effective Date of this Agreement, the
Company and IGI shall establish a development committee (the "Development
Committee"), which shall oversee the development activities performed by
the Company relating to all uses of the Technology. The Development
Committee shall consist of four representatives. Each Party
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shall be entitled to appoint an equal number of representatives with the
requisite experience, credentials, qualifications and seniority to enable
him/her to provide the Parties with oversight, recommendations, and
guidance with respect to the development activities of the Company relating
to the Technology. Each Party shall provide the other Party with written
notice of the initial representatives it proposes for appointment to the
Development Committee accompanied by their respective resumes, CVs or other
statement of professional qualifications for review and written approval by
the other Party. From time to time, each Party on written notice to the
other Party may remove any of its representatives and appoint new
representatives in place thereof, subject to written approval of the other
Party. The Company shall be solely responsible for all costs and expenses
related to the Development Committee. The Development Committee shall meet
monthly or as otherwise agreed to by the Parties. The Company and IGI shall
adopt standing rules governing the Development Committee as shall be
necessary for its work. A quorum of the Development Committee shall exist
whenever there is present at a meeting at least one representative
appointed by each Party. Members of the Development Committee may attend a
meeting either in person or by telephone, video conference or similar means
in which each participant can hear what is said by the other participants.
Representation by proxy shall not be allowed. Neither the Development
Committee nor any member thereof shall have any authority or power to act
on behalf of or to bind the Company and/or IGI solely as a result of their
position and/or in their capacity as a member of the Development Committee.
ARTICLE 4 - ROYALTIES AND OTHER CONSIDERATION
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4.1 During the term of this Agreement, the Company shall pay to IGI
royalties equal to six percent (6%) of annual Net Sales of the Licensed
Products covered by at least one issued and unexpired claim under the PTH
Patent Rights; provided, however, that in any calendar year in which Net
Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company
shall pay IGI royalties equal to nine percent (9%) of any and all Net Sales
greater than Two Hundred Million Dollars ($200,000,000) in such calendar
year. The Company's royalty obligations under this Article 4.1 shall
terminate on a country by country basis with respect to each Licensed
Product upon the expiration date of the last to expire of any patent
included in the PTH Patent Rights covering the sale of such Licensed
Product in such country.
4.2 As provided by and consistent with the terms of Article 1.7, on
sales of Licensed Products by the Company to Affiliates that are end users
of such Licensed Products, the value of Net Sales attributed thereto under
this Article 4 shall be that gross sales amount which would have been
received by the Company from a third party in an arms-length transaction
for the sale of the same such Licensed Products.
4.3 No multiple royalties shall be payable because the use, lease
or sale of any Licensed Product is, or shall be, covered by more than one
valid and unexpired claim contained in the PTH Patent Rights.
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4.4 In the event that a Licensed Product is sold in the form of a
combination package together with companion products that are not
themselves a License Product, the Net Sales for such combination package
upon which the royalty due to IGI is based shall be calculated by
multiplying the total sales price of such combination package by the
fraction A/(A+B), where A is the invoice price of the Licensed Product if
sold separately, and B is the total invoice price of each of the other
companion products included in the combination package if sold separately.
4.5 Royalty payments shall be paid in United States dollars in New
York, New York or at such other place as IGI may reasonably designate
consistent with the laws and regulations controlling in any foreign
country. Any withholding taxes which the Company, its Affiliate or any
sublicensee shall be required by law to withhold on remittance of the
royalty payments shall be deducted from such royalty payment to IGI. The
Company shall furnish IGI with the original copies of all official receipts
for such taxes. If any currency conversion shall be required in connection
with the payment of royalties hereunder, such conversion shall be made by
using the exchange rate prevailing at Citibank, N.A. in New York, New York
on the last business day of the calendar quarterly reporting period to
which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, the royalties
payable by the Company to IGI under this Agreement shall be paid quarterly
on or before sixty (60) days following each fiscal quarter ending March 31,
June 30, September 30 and December 31 of each calendar year. Each such
payment shall be for unpaid royalties which accrued within or prior to the
Company's most recently completed fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense
Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II
clinical trial of a Licensed Product for the treatment of psoriasis
sponsored by or on behalf of the Company or any of its Affiliates or
sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III
clinical trial of a Licensed Product for the treatment of psoriasis
sponsored by or on behalf of the Company or any of its Affiliates or
sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug
Application ("NDA") for a Licensed Product for the treatment of
psoriasis filed by or on behalf of the Company or any of its
Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA
for a Licensed Product for the treatment of psoriasis filed by or on
behalf of the Company or any of its Affiliates or sublicensees;
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4.7.6 $500,000 upon dosing of the first patient in the first
Phase III clinical trial of a Licensed Product for the treatment of
any disease, physical condition, ailment or illness other than
psoriasis that is sponsored by or on behalf of the Company or any of
its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first
NDA for a Licensed Product for the treatment of any disease, physical
condition, ailment or illness other than psoriasis that is filed by
or on behalf of the Company or any of its Affiliates or sublicensees;
and
4.7.8 $2,400,000 upon the final approval by the FDA of the
first NDA for a Licensed Product for the treatment of any disease,
physical condition, ailment or illness other than psoriasis that is
filed by or on behalf of the Company or any of its Affiliates or
sublicensees.
4.8 No payment obligations shall be due with respect to any sale or
sublicense covering any Licensed Product in a country if there are no
issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or
judgment issued by a court of competent jurisdiction to obtain a royalty
bearing license from a third party in order to sell any Licensed Product
hereunder in such jurisdiction, then in such case the Company may deduct
from the royalties otherwise payable hereunder to IGI for the License
Products sold in such jurisdiction up to percent (50%) of the amount of
royalties that the Company actually paid to the third party licensee in
such jurisdiction; provided, however, that in no event shall the aggregate
royalties payable to IGI in any quarterly period on the sales of Licensed
Products in such jurisdiction be reduced by more than fifty per cent (50%)
as a result of any such deduction pursuant to this Article 4.9 and provided
further that any excess deduction remaining as a result of such foregoing
limitation may be carried forward to subsequent periods.
ARTICLE 5 - REPORTS AND RECORDS
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5.1 The Company shall keep full, true and accurate books of account
containing all particulars that may be necessary for the purpose of
evidencing the amounts payable to IGI by way of royalty as aforesaid. Said
books of account shall be kept at the Company's principal place of business
and the supporting data shall be opened up to IGI twice per year upon
reasonable notice to the Company. In addition, for two (2) years following
the end of the calendar year to which they pertain, said books of account
shall be opened up for inspection by IGI's internal accounting staff,
independent accountants, chief financial officer and/or by another
qualified professional designated by IGI, except one to whom the Company
has reasonable objection, for the purpose of verifying the Company's
royalty statements or compliance in other respects with this Agreement. If
an inspection shows an under reporting
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or underpayment of royalties in excess of the greater of $50,000 or two
percent (2%) of royalties payable for the preceding twelve (12) month
period, then the Company shall within ten (10) days reimburse IGI for the
all costs and expenses of the inspection together with payment of the full
amount of the unreported royalties, including any late charges as required
by paragraph 5.4 of this Agreement.
5.2 Commencing with the date upon which the Company or any of its
Affiliates or sublicensees makes its first commercial sale of a Licensed
Product, the Company shall thereafter deliver to IGI within 60 days
following each fiscal quarter ending March 31, June 30, September 30 and
December 31 of each calendar year. complete and accurate reports, giving
such particulars of the business conducted by the Company and its
Affiliates and sublicensees during the preceding quarter under this
Agreement as shall be pertinent to a royalty accounting hereunder. These
shall include at least the following:
5.2.1 List of all Licensed Products used, leased, sold or
distributed by or for the Company or its Affiliates or sublicensees.
5.2.2 Total gross amounts invoiced for all Licensed Products
used, leased, sold or distributed by or for the Company or its
Affiliates or its sublicensees.
5.2.3 Total amount of deductions applicable in computed "Net
Sales" as defined in Paragraph 1.7 on gross amounts invoiced for
Licensed Products used, disturbed, leased, or sold by or for the
Company or its Affiliates or its sublicensees.
5.2.4 Total royalties due from Net Sales of Licensed Products
by or for the Company or its Affiliates or its sublicensees.
5.2.5 Names and addresses of all sublicensees and Affiliates
of the Company.
5.2.6 On an annual basis, the year-end financial statements
for each of the Company and its Affiliates and sublicensees.
5.3 With each such quarterly report submitted, the Company shall
pay to IGI the royalties due and payable under this Agreement. In the event
no royalties shall be due under the terms hereof, the Company shall inform
IGI in writing.
5.4 Amounts which are not paid when due and which are not the
subject of a bona fide dispute shall accrue interest from the due date
until paid, at a rate equal to the then prevailing prime rate of Citibank,
N.A., plus two percent (2%).
5.5 The Company agrees to forward to IGI a copy of any and all
reports, which are in substance similar to the reports required by this
Article 5, received from any sublicensee and other documents received from
any sublicensee as IGI may reasonably request, as may be pertinent to an
accounting of royalties. The Company agrees that with respect to
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any and all Sublicense Agreements granted by the Company hereunder, the
Sublicense Agreement executed by the Company and any such third party with
respect thereto shall expressly include substantially similar reporting
provision requirements for the sublicensee as set forth in this Article 5.
5.6 Subject to the confidentiality obligations described in Article
15, IGI agrees to hold in confidence each report delivered by the Company
pursuant to this Article 5 until the termination of this Agreement, except
for disclosure as is necessary for IGI's financial reporting and audit
requirements and such other disclosure by IGI as may be required by law,
including without limitation any disclosure required for compliance with
the laws, rules, and regulations of the Securities and Exchange Commission
("SEC"), the American Stock Exchange ("AMEX") or any other regulatory body
governing publicly traded companies to which IGI is currently or may be in
the future be subject. Notwithstanding the foregoing, IGI may disclose any
such information required to be disclosed pursuant to any judicial,
administrative or governmental request, subpoena, requirement or order,
provided that IGI take reasonable steps to provide the Company with the
opportunity to contest such request, subpoena, requirement or order.
5.7 In accordance with the terms of this Agreement, any and all
quarterly royalty payments due and owing to IGI from the Company pursuant
to Article 4 for fiscal quarters ending March 31, June 30, September 30 and
December 31 of each of calendar year, and the corresponding royalty
accounting reports pertinent thereto required under this Article 5, shall
be made and delivered to by the Company to IGI within sixty (60) days after
the end of each such fiscal quarter.. However, pursuant to securities laws,
rules, and regulations, IGI is required to file its quarterly financial
reports on SEC Form 10-Q within 45 days of the end of each fiscal quarter,
and, as such, cannot report therein royalty revenues earned for that
quarter but for which payment thereof was not received within 45 days of
the end of such quarter. As a result, since IGI will not receive payment
for the royalties earned during each fiscal quarter until sixty (60) days
after the end thereof, IGI shall be required to report the quarterly
royalty payments received under this Agreement not in the quarter for which
they were earned but in the subsequent quarter payment was received. In
view thereof, the Parties expressly acknowledge and agree that each report
delivered by the Company pursuant to this Article 5 shall contain material
nonpublic information relating to and having potential affect on the
financial results to be reported by IGI for the subsequent quarter that
payment was receive. The Parties further expressly acknowledge and agree
that such information constitutes "inside information" subject to the
nondisclosure requirements and other restrictions and obligations imposed
under applicable securities laws, rules and regulations. Based upon the
foregoing, and subject to the confidentiality obligations described in
Article 15, the Company agrees to hold in confidence each report and any
and all information contained therein, in whole or part, delivered by the
Company to IGI pursuant to this Article 5 until such time that the such
information has been reported by IGI's filing of its SEC Form 10-Q for the
quarter in which the royalty payment was received by IGI.. Notwithstanding
the foregoing, the Company may disclose any such information required to be
disclosed pursuant to any judicial, administrative or governmental
subpoena, compulsory legal requirement or order, provided that the Company
take reasonable
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steps to provide IGI with adequate time and opportunity to contest such
subpoena, compulsory legal requirement or order.
ARTICLE 6 - PATENT PROSECUTION AND MAINTENANCE
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6.1 The Company shall diligently prosecute and maintain the
intellectual property included in the PTH Patent Rights and Improvements
including, but not limited to, the filing of patent applications which may
be required or desirable. The Company agrees to keep IGI reasonably well
informed with respect to the status and progress of any such applications,
prosecutions and maintenance activities including and to consult in good
faith with IGI and take into account IGI's comments and requests with
respect thereto. Both Parties agree to provide reasonable cooperation to
each other to facilitate the application and prosecution of patents
pursuant to this Agreement.
6.2 The Company may, in its discretion, elect to abandon any patent
applications or issued patent comprising the PTH Patent Rights, in which
case the Company shall have no further royalty obligation to IGI in respect
of any Licensed Products the manufacture, use or sale of which is covered
by an issued claim of such abandoned PTH Patent Rights. Prior to any such
abandonment, the Company shall give IGI at least sixty (60) days notice and
a reasonable opportunity to take over prosecution of such PTH Patent
Rights. In such event, IGI shall have the right, but not the obligation, to
commence or continue such prosecution and to maintain any such PTH Patent
Rights under its own control and at its expense and the Company shall then
have no royalty or other obligation to IGI in respect of any Licensed
Products, the manufacture, use or sale of which is covered by an issued
claim of such PTH Patent Rights. The Company agrees to cooperate in such
activities including execution of any assignments or other documents
necessary to enable IGI to obtain and retain sole ownership and control of
such PTH Patent Rights.
ARTICLE 7 - TERMINATION
-----------------------
7.1 If the Company shall become bankrupt, or shall file a petition
in bankruptcy under Chapter 7, 11 and/or 13, or if the business of the
Company shall be placed in the hands of a receiver or trustee for the
benefit of creditors, whether by the voluntary act of the Company or
otherwise, this Agreement shall automatically terminate. Furthermore,
consistent with the express terms of Article 2.4(c) of this Agreement, any
and all Sublicense Agreements granted by the Company hereunder shall by its
express terms likewise terminate simultaneous with any of the foregoing
events.
7.2 Should the Company fail to make any royalty payments, milestone
payments and/or any other payments to IGI which are due in accordance with
the terms of this Agreement and which are not the subject of a bona fide
dispute between IGI and the Company, IGI shall have the right to terminate
this Agreement upon 60 days written notice of termination unless the
Company shall pay to IGI, within the 60-day period, all such amounts due
and
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owing. Upon the expiration of the 60-day period, if the Company shall not
have paid all such amounts due and owing, the rights, privileges and
license granted hereunder shall, at the option of IGI, immediately
terminate.
7.3 Upon any material breach or default of this Agreement by the
Company, other than as set forth in Articles 7.1 and 7.2 hereinabove, IGI
shall have the right to terminate this Agreement and the rights, privileges
and sublicense granted hereunder upon giving sixty (60) days written notice
to the Company. Such grounds for termination include, but shall not be
limited to, IGI's reasonable determination that the Company is not using
its commercially reasonable efforts to keep Licensed Products reasonably
available to the public after commercial use commences unless such failure
is through no fault of the Company. Such termination shall become effective
immediately unless the Company shall have cured any such breach or default
prior to the expiration of the sixty (60) day period referred to above.
7.4 Following the date that is 18 months from the Effective Date of
this Agreement, the Company shall have the right to terminate this
Agreement in whole or as to any portion of the PTH Patent Rights by giving
ninety (90) days written notice thereof to IGI.
7.5 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 or the obligations
under Articles 5, 8, 9, 10, 15 and 16. The Company, and/or its it
Affiliates and/or any sublicensees thereof may, however, after the
effective date of such termination and continuing for a period not to
exceed six (6) months thereafter, sell all completed Licensed Products and
any Licensed Products still in the process of manufacture but more than 50%
completed at the time of such termination, and sell the same, provided that
the Company shall pay or cause to be paid to IGI the royalties thereon as
required by Article 4 of this Agreement and shall submit the reports
required by Article 5 hereof on the sales of such Licensed Products. Any
and all License Products that are not sold by the Company or it Affiliates
or sublicensees within such six (6) month period shall be destroyed with
validating certification of destruction at the sole cost and expense of the
Company or its Affiliates or sublicensees, as the case may be.
7.6 If not terminated sooner under the express terms of this
Article 7, this Agreement shall terminate on the earlier of (a) twenty (20)
years, (b) the last to expire patent contained in the Patents Rights
sublicensed to the Company hereunder, or (c) the termination or expiration
of the Master License Agreement.
7.7 Any and all Sublicense Agreements granted by the Company
hereunder shall expressly provide by the terms thereof that in the event of
termination of this Agreement between the Company and IGI, other than
termination pursuant to Articles 7.1 and/or 7.6 hereof, such Sublicenses
Agreements shall survive and shall be automatically assigned by the Company
to IGI without any further action required by the Company, IGI and/or the
sublicensees, thereby becoming a direct Sublicense Agreement between IGI
and the applicable sublicense. In the event this Agreement is terminated
pursuant to Articles 7.1 and/or 7.6 hereof,
12
any and all Sublicense Agreements granted by the Company hereunder shall
automatically terminate simultaneously therewith.
ARTICLE 8 - ARBITRATION
-----------------------
8.1 Any dispute arising from or relating to this Agreement shall be
submitted for adjudication to the American Arbitration Association ("AAA")
located in New York, New York. Unless otherwise mutually agreed by the
Parties in writing, the arbitration shall be before a tribunal of three AAA
arbitrators under the AAA rules and procedures governing commercial
arbitration, as hereby or subsequently amended and/or supplemented by
mutual agreement of the Parties. IGI and the Company shall each select one
arbitrator to serve on the panel from the list of approved arbitrators
provided by the AAA, and the third arbitrator shall be selected by mutual
agreement of the first two arbitrators from the list of approved
arbitrators provided by the AAA. The Parties further expressly acknowledge
and agree that the Federal Rules of Civil Procedure and the Federal Rules
of Evidence shall govern the arbitration proceedings. Within sixty (60)
days of the completion of the arbitration hearings and all post arbitration
proceedings, the arbitrators shall provide the Parties with its written
decision specifically setting for the disposition of each claim at issue
and the legal, factual and evidentiary basis thereof. No punitive damages
can be sought or claimed by either Party in the arbitration, and the
arbitrators shall have no authority to and shall be expressly prohibited
from awarding any punitive damages against or in favor of either Party on
any claim at issue in the arbitration.
8.2 In the event any dispute arising from or relating to this
Agreement is submitted to the AAA for adjudication, and in conjunction
therewith there arises a claim, dispute, defense or controversy concerning
the validity, enforceability, or infringement of any patent contained in
the PTH Patent Rights sublicensed hereunder ("Patent Claims"), the
arbitration shall be immediately stayed until such time that the Patent
Claims are fully and finally adjudicated by a court having competent
jurisdiction thereof. Thereafter, the arbitration shall resume with full
binding effect and application being given to the judicial resolution of
the Patent Claims in adjudicating the claims at issue in the arbitration.
8.3 The costs and expenses of such arbitration under Article 8.1,
including without limitation attorneys' fees, expert fees and arbitrators'
fees, shall be borne by the Parties proportionate to the finding of fault
as to each Party as determined by the Arbitrators' written decision.
Judgment on the arbitration award may be entered to the extent permitted by
law by any court of competent jurisdiction.
13
ARTICLE 9 - INFRINGEMENT AND OTHER ACTIONS
------------------------------------------
9.1 The Company and IGI shall promptly provide written notice, to
the other party, of any alleged infringement by a third party of the PTH
Patent Rights and provide such other Party with any available evidence of
such infringement.
9.2 During the term of this Agreement, the Company shall have the
right, but not the obligation, to prosecute and/or defend, at its own
expense and utilizing counsel of its choice, any infringement of, and/or
challenge to, the PTH Patent Rights. In furtherance of such right, IGI
hereby agree that the Company may join IGI as a party in any such suit,
without expense to IGI. No settlement, consent judgment or other voluntary
final disposition of any such suit which would adversely affect the rights
of IGI may be entered into without the consent of IGI, which consent shall
not be unreasonably withheld. The Company shall indemnify and hold IGI
harmless against any costs, expenses or liability that may be found or
assessed against IGI in any such suit other than resulting from IGI'
negligence or willful misconduct.
9.3 In the event that a claim or suit is asserted or brought
against the Company alleging that the manufacture or sale of any Licensed
Product by the Company, an Affiliate of the Company, or any sublicensee, or
the use of such Licensed Product by any customer of any of the foregoing,
infringes proprietary rights of a third party, the Company shall give
written notice thereof to IGI. The Company may, in its sole discretion,
modify such Licensed Product to avoid such infringement and/or may settle
on terms that it deems advisable in its sole discretion, subject to
paragraph 9.2. Otherwise, the Company shall have the right, but not the
obligation, to defend any such claim or suit. In the event the Company
elects not to defend such suit, IGI shall have the right, but not the
obligation to do so at its sole expense.
9.4 Any recovery of damages by the Company, in any such suit, shall
be applied first in satisfaction of any unreimbursed expenses and legal
fees of the Company relating to the suit and then to IGI for any royalties
credited in accordance with paragraph 9.4. The balance remaining from any
such recovery shall be treated as Net Sales and shared in accordance with
Paragraph 4.1 hereof.
9.5 The Company may credit up to fifty percent (50%) of any
litigation costs incurred by the Company in any country pursuant to this
Article 9 and up to 50% of all amounts paid in judgment or settlement of
litigation within this Article 9 scope of against royalties thereafter
payable to IGI hereunder for such country and apply the same toward one-
half of its actual, reasonable out-of-pocket litigation costs. If one-half
of such litigation costs in such country exceeds 50% of royalties payable
to IGI in any year in which such costs are incurred than the amount of such
costs, expenses and amounts paid in judgment or settlement, in excess of
such 50% of the royalties payable shall be carried over and credited
against royalty payments in future years for such country.
9.6 If within six (6) months after receiving notice of any alleged
infringement, the Company shall have been unsuccessful in persuading the
alleged infringer to
14
desist, or shall not have brought and shall not be diligently prosecuting
an infringement action, or if the Company shall notify IGI, at any time
prior thereto, of its intention not to bring suit against the alleged
infringer, then, and in those events only, IGI shall have the right, but
not the obligation, to prosecute, at its own expense and utilizing counsel
of its choice, any infringement of the PTH Patent Rights, and IGI may, for
such purposes, join the Company as a party plaintiff. The total cost of any
such infringement action commenced solely by IGI shall be borne by IGI and
IGI shall keep any recovery or damages for infringement or otherwise
derived therefrom and such shall not be applicable to any royalty
obligation of the Company.
9.7 In any suit to enforce and/or defend the PTH Patent Rights
pursuant to this Agreement, the party not in control of such suit 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.
ARTICLE 10 - LIMITATION OF LIABILITY, INDEMNITY
-----------------------------------------------
10.1 IGI DOES NOT MAKE, AND EXPRESSLY DISCLAIMS ANY WARRANTIES,
EXPRESSED OR IMPLIED, ORAL OR WRITTEN, AS TO ANY MATTER WHATSOEVER,
INCLUDING MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
10.2 The Company agrees to defend, indemnify and hold IGI harmless
from and against all liability, demands, damages, including without
limitation, expenses or losses including death, personal injury, illness or
property damage arising directly or indirectly: (a) out of use by the
Company or its Affiliates or sublicenses of the PTH Patent Rights, Know-
how, Improvements, License Products or other information licensed under
this Agreement, or (b) out of any use, sale or other disposition by the
Company or its Affiliates of sublicensees of Licensed Products, in each
case which are not the direct and proximate result of IGI's gross
negligence or willful misconduct. The Company agrees that any and all
sublicense agreement entered into relating to a Licensed Product shall
contain an express covenant by such sublicense providing for the same
defense and indemnity of IGI as provided in this Article.
ARTICLE 11 - ASSIGNMENT
-----------------------
This Agreement and the rights and duties appertaining hereto may not
be assigned by either Party without first obtaining the written consent of
the other which consent shall not be unreasonably withheld. Any such
purported assignment, without the written consent of the other Party, shall
be null and of no effect. Notwithstanding the foregoing, the Company may
assign this Agreement to a purchaser, merging or consolidating corporation,
or acquirer of substantially all of the Company's assets and/or pursuant to
any reorganization qualifying under section 368 of the Internal Revenue
Code of 1986 as amended, as may be in effect at such time.
15
ARTICLE 12 - PAYMENT OF FEES AND EXPENSES
-----------------------------------------
Each of the Company and IGI shall be responsible for their own
expenses relating to the preparation and consummation of this Agreement and
the agreements and transactions contemplated hereby.
ARTICLE 13 - USE OF NAMES AND PUBLICATION
-----------------------------------------
13.1 Nothing contained in this Agreement shall be construed as
granting any right to the Company or its Affiliates or sublicensees to use
in advertising, marketing, publicity, or other promotional activities any
name, trade name, trademark, or other designation of IGI or any of its
units (including contraction, abbreviation or simulation of any of the
foregoing) without the prior written consent of IGI; provided, however,
that IGI acknowledges and agrees that the Company may use the names of IGI
in various documents used by the Company for capital raising and financing
without such prior written consent where the use of such names may be
required by law.
13.2 Nothing herein shall be deemed to establish a relationship of
principal and agent between IGI and the Company, nor any of their agents or
employees for any purpose whatsoever. This Agreement shall not be construed
as creating a partnership between IGI and the Company, or as creating any
other form of legal association or arrangement which would impose liability
upon one Party for the act or failure to act of the other Party.
13.3 In the event that IGI desires to publish or disclose, by
written, oral or other presentation, Know-How, PTH Patent Rights, or any
material information related thereto then IGI shall notify the Company in
writing by facsimile where confirmed by the receiving Party, and/or by
certified or registered mail (return receipt requested) of their intention
at least thirty (30) days prior to any speech, lecture or other oral
presentation and at least thirty (30) days before any written or other
publication or disclosure. IGI shall include with such notice a description
of any proposed oral presentation or, in any proposed written or other
disclosure, a current draft of such proposed disclosure or abstract. The
Company may request that IGI, no later than ten (10) days following the
receipt of such notice, to delay such presentation, publication or
disclosure in order to enable the Company to file, or have filed on their
behalf, a patent application, copyright or other appropriate form of
intellectual property protection related to the information to be
disclosed. Upon receipt of such request to delay such presentation,
publication or disclosure, IGI shall arrange for a delay of such
presentation, publication or disclosure until such time as the Company has
filed, or had filed on its behalf, such patent application, copyright or
other appropriate form of intellectual property protection in form and in
substance reasonably satisfactory to the Company, but in no case shall the
delay be for a period of more than thirty (30) days. If IGI does not
receive any such request from the Company to delay such presentation,
publication or disclosure, IGI may submit such material for presentation,
publication or other form of disclosure.
16
13.4 At any time after the Effective Date of this Agreement, either
Party shall, at its sole cost and expense, be permitted to publicly
announce, advertise, feature and/or otherwise market the business
relationship between the Parties created under this Agreement in and
through such print and other media vehicles as selected by the Parties.
Each Party shall provide the other for its prior review and approval, at
least seven (7) days prior to the proposed release date, with the form and
substance of any and all such proposed announcements, advertising and/or
features under this Article 13.4, which approval shall not be unreasonably
withheld by such Party.
ARTICLE 14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
-------------------------------------------------------
Any payment, notice or other communication required or permitted to
be given pursuant to this Agreement shall be in writing and sent by
certified first class mail, postage prepaid, by hand delivery or by
facsimile if confirmed in writing, in each case effective upon receipt, at
the addresses below or as otherwise designated by written notice given to
the other Party in accordance with the terms of this Article 14:
In the case of IGI:
▇▇▇▇▇ ▇▇▇▇▇▇▇
Chairman & CEO
IGI, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Tel: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
With a copy of all such notices and communications, excluding
payments to:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇ & Associates, P.C.
1776 On the Green
▇▇ ▇▇▇▇ ▇▇▇▇▇ - ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Tel: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
In the case of the Company:
Tarpan Therapeutics, Inc.
17
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: President
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
15. CONFIDENTIALITY
-------------------
15.1 Any proprietary or confidential information relating to the
Technology (including but not limited to Know-how and patent prosecution
documents relating to PTH Patent Rights) collectively constitute the
"Confidential Information." The Company and IGI agree that they will not
use the Confidential Information for any purpose unrelated to this
Agreement and will hold it in confidence during the term of this Agreement
and for a period of five (5) years after the termination or expiration date
of this Agreement. The Company shall exercise with respect to such the
Confidential Information the same degree of care as the Company exercises
with respect to its own confidential or proprietary information of a
similar nature, and shall not disclose it or permit its disclosure to any
third party (except to those of its employees, consultants, or agents who
are bound by the same obligation of confidentiality as the Company is bound
by pursuant to this Agreement). However, such undertaking of
confidentiality by the Company shall not apply to any information or data
which:
15.1.1 The Company receives at any time from a third-party
lawfully in possession of same and having the right to disclose same.
15.1.2 Is, as of the date of this Agreement, in the public
domain, or subsequently enters the public domain through no fault of
the Company.
15.1.3 Is independently developed by the Company as
demonstrated by written evidence without reference to information
disclosed to the Company by IGI.
15.1.4 Is disclosed pursuant to the prior written approval of
IGI.
15.1.5 Is required to be disclosed pursuant to law or legal
process (including, without limitation, to a governmental authority)
provided, in the case of disclosure pursuant to legal process,
reasonable notice of the impending disclosure is provided to IGI and
IGI has agreed to such disclosure in writing or has exhausted its
right to contest such disclosure.
ARTICLE 16 - MISCELLANEOUS PROVISIONS
-------------------------------------
16.1 This Agreement shall be construed, governed, interpreted,
enforced and applied in accordance with the laws of the State of New
Jersey, without regard to principles of conflicts of laws. Further, it is
expressly agreed by the Parties hereto that any and all claims
18
and/or disputes between the Parties subject to arbitration under Article
8.1 hereof shall be governed, adjudicated, decided and/or otherwise
resolved by the laws of the State of New Jersey.
16.2 If this Agreement or any associated transaction is required by
the law of any nation to be either approved or registered with any
governmental agency, the Company shall assume all legal obligations to do
so and the costs in connection therewith.
16.3 The Company shall observe all applicable United States and
foreign laws with respect to the transfer of Licensed Products and related
technical data to foreign countries, including, without limitation, the
International Traffic in Arms Regulations (ITAR) and the Export
Administration Regulations.
16.4 The Parties hereto acknowledge that this Agreement, including
the Schedules, Exhibits and documents incorporated by reference, sets forth
the entire agreement and understanding of the Parties hereto as to the
subject matter hereof, and shall not be subject to any change of
modification except by the execution of a written instrument subscribed to
by the Parties hereto.
16.5 The provisions of this Agreement are severable, and in the
event that any provision of this Agreement shall be determined to be
invalid or unenforceable under any controlling body of law, such invalidity
or unenforceability shall not in any way affect the validity or
enforceability of the remaining provisions hereof.
16.6 The failure of either Party to assert a right hereunder or to
insist upon compliance with any term or condition of this Agreement shall
not constitute a waiver of that right or excuse a similar subsequent
failure to perform any such term or condition by the other Party.
16.7 The headings of the several articles are inserted for
convenience of reference only and are not intended to be a part of or to
affect the meaning or interpretation of this Agreement.
16.8 This Agreement will not be binding upon the Parties until it
has been signed below on behalf of each Party, in which event, it shall be
effective as of the date recited on page one.
16.9 This Agreement embodies the entire understanding of the Parties
and shall supersede all previous communications, representations or
understandings, either oral or written, between the Parties relating to the
subject matter hereof.
16.10 Each Party hereto shall be excused from any breach of this
Agreement which is proximately caused by governmental regulation, act of
war, strike, act of God or other similar circumstance normally deemed
outside the control of the Parties.
19
16.11 The Company represents and warrants that the execution,
delivery and performance of this Agreement by the Company has been duly
authorized by the Company with all requisite corporate action. IGI
represents and warrants that the execution, delivery and performance of
this Agreement by IGI has been duly authorized with all requisite corporate
action.
16.12 This Agreement may be executed in one or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
16.13 This Agreement is the product of negotiations between the
Parties and shall be construed neutrally, without regard to the identity of
the Party who drew it.
16.14 (A) All references in this Agreement to the plural shall also
mean the singular and to the singular shall also mean the plural unless the
context otherwise requires. The words "hereof", "herein", "hereunder",
"this Agreement", "the Agreement" and words of similar import when used in
this Agreement shall refer to this Agreement as a whole and not any
particular provision of this Agreement unless the context otherwise
requires. The word "including" when used in this Agreement shall mean
"including, without limitation". "And" and "or" as used in this Agreement
shall be interpreted conjunctively and shall not be interpreted
disjunctively to exclude any information otherwise within the scope
thereof.; (B) Any reference in this Agreement to any corporate and/or other
business entity shall include and extend to the benefit of such corporate
and/or other business entities' predecessors, successors, subsidiaries,
affiliates, assigns and/or any and all of their respective past and present
agents, attorneys, representatives, officers, directors, employees,
representatives, independent contractors, accountants and shareholders, as
if same were named individually herein.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
20
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement,
in triplicate by proper persons thereunto duly authorized.
TARPAN THERAPEUTICS, INC. IGI, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D., Ph.D. By: ▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------- -------------
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D., Ph.D. Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: President Title: Chairman & CEO
Date: 4/14/04 Date: 4/19/04
------- -------
21
EXHIBIT A
---------
22
SCHEDULE 1.3
------------
1. United States Patent Applications USSN #[], filed on [] and USSN #[]
(CIP of []) filed on [], both entitled "[]".
23
Exhibit 10.109
SUBLICENSE AGREEMENT
This Sublicense Agreement (hereinafter referred to as this
"Agreement"), effective as of May 4, 2004, (the "Effective Date"), is
entered into by and between IGI, Inc. ("IGI"), with its principal place of
business located at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, and Tarpan
Therapeutics, Inc., a corporation duly organized and existing under the
laws of the State of Delaware (the "Company"), with is principal place of
business located at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇.
WHEREAS, IGI and Tarpan have previously entered into a Sublicense
Agreement dated April 19, 2004 (the "Sublicense Agreement") relating to the
development of a technology for the clinical uses of PTH 1-34 relating to
the regulation of cell differentiation and proliferation for treatment of
skin disorders (the "PTH 1-34 Technology"), which contemplates the use of
the Novasome Technology (as defined below); and
WHEREAS, IGI has been granted the exclusive license to certain
proprietary rights and intellectual property (including pursuant to certain
patents) to a lipid vesicle technology for topical dermatologic products
for localized usage at the delivery zone (the "Novasome Technology")
pursuant to a License Agreement between Micro-Pak,, Inc., a wholly owned
subsidiary of Novavax Inc., and Igen, Inc., a wholly owned subsidiary of
IGI, dated December 14, 1995 (the "Novasome License Agreement), a copy of
which is attached hereto as Exhibit A;
WHEREAS, the Company and IGI agree that the Novasome Technology is
critical to the successful commercial development of the PTH 1-34
Technology; and
WHEREAS, in furthering the intent of the parties under the Sublicense
Agreement and in the interest of facilitating the development of the PTH 1-
34 Technology, the Company desires to obtain from IGI, and IGI desires to
grant to the Company the non-exclusive, world-wide right to use the
Novasome Technology under the terms and agreement that MicroPak has with
Igen solely for use in the development, commercialization and sale of PTH
1-34 Technology on the terms and conditions set forth herein.
NOW, THEREFORE, it is hereby agreed that:
Capitalized terms used herein, but not otherwise defined shall have
the meanings ascribed to such terms in the Sublicense Agreement.
1. Definitions.
------------
(a) "Novasome Patent Rights" shall mean all United States and
foreign patents and patent applications granted to IGI under the Novasome
License Agreement and which are attached as Appendix A hereto in the Field
of Use (as defined below).
(b) "Field of Use" shall mean the use of the Novasome Patent Rights
solely in connection with the distribution, marketing, use, or sale of a
Licensed Product incorporating the PTH 1-34 Technology.
2. Grant of Sublicense.
--------------------
(a) IGI hereby grants to the Company and the Company accepts,
subject to the terms and conditions of this Agreement, a non-exclusive,
worldwide non-royalty bearing sublicense to use the Novasome Patent Rights
solely in the Field of Use, to the full end of the term for which the
Novasome Patent Rights are granted, unless sooner terminated as hereinafter
provided.
(b) IGI will use all commercially reasonable efforts to maintain
the Novasome License and shall not take any action that would impair the
rights of the Company to use the Novasome Patent Rights in the Field of
Use.
(c) As per the terms of the Novasome License Agreement, IGI was
granted a license to the Novasome Technology for a term of 10 years, as
well as an option to extend the exclusive license rights granted therunder,
exercisable in the last year of the initial 10 years license period, upon
payment of an option fee of One Million Dollars ($1,000,000) ("Option to
Extend"). The initial 10 year license granted to IGI under the Novasome
License Agreement expires on December 13, 2005. IGI expressly represents
and warrants that it intends to exercise the Option to Extend and has
already advised Novavax of such intention IGI further represents and
warrants to the best of its current ability based upon its present and
future projected business operations that it shall have available the
financial and/or other resources to satisfy the Option Fee due and payable
on December 13, 2005, to exercise the Option to Extend.
3. Representations and Warranties. IGI represents that to its best
knowledge, it is not currently in breach, nor has it received notice from
Novavax that it is in breach, of any provision of the Novasome License
Agreement. To IGI's knowledge and belief there are no licenses, options,
restrictions, liens, rights of third parties, disputes, royalty
obligations, proceedings or claims relating to, affecting, or limiting its
rights or the rights of the Company under this Agreement with respect to,
or which may lead to a claim of infringement or invalidity regarding, any
part or all of the Novasome Patent Rights and their use as contemplated in
the underlying patent applications as presently drafted.
4. Term and Termination. This Agreement shall continue in force
and effect during the term of the Novasome License Agreement, including any
period of
2
time granted pursuant to the exercise of the Option to Extend and shall
terminate only upon the earlier to occur of (a) the expiration or
termination of the Novasome License Agreement, and (b) the expiration or
termination of the Sublicense Agreement.
5. Miscellaneous. Those Articles relating to Confidentiality,
Limitation of Liability, Assignment, Arbitration, Use of Names and Notice
contained in the Sublicense Agreement shall apply to this Agreement mutatis
mutandi.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement
by proper persons thereunto duly authorized.
TARPAN THERAPEUTICS, INC. IGI, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D., Ph.D. By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------- -----------------
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D., Ph.D. Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: President Title: Chairman & CEO
Date: 5/4/04 Date: 5/4/04
------ ------
▇
▇▇▇▇▇▇▇▇ ▇
▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇ Patent Number 5,527,772, Issued on June 18, 1996
entitled "Regulation of Cell Proliferation and Differentiation Using
Peptides"
2. United States Patent Number 5,840,690, Issued on Nov. 24, 1998
entitled, Regulation of Cell Proliferation and Differentiation Using
Peptides"
3. United States Patent Number 6,066,618, Issued on May 23, 2000
entitled "Regulation of Cell Proliferation and differentiation Using
peptides"
4. European Patent Specification PCT/US88/03649 published May 29, 1996
entitled "Regulation of Cell Proliferation and differentiation Using
Peptides"
5. United States Patent Application filed August 2002, entitled
"Regulation of Cell Proliferation and Differentiation using Topically
Applied Peptides"
4