Exhibit 10.1

 

Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as **. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

 

LICENSE AGREEMENT

 

dated as of April 7th, 2004

 

by and between

 

Unigene Laboratories, Inc.

 

and

 

Novartis Pharma AG

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TABLE OF CONTENTS

 

ARTICLE I DEFINITIONS    1 ARTICLE II LICENSE GRANTS    6

2.1.

   License Grant from Unigene to Novartis    6

2.2.

   Reservation of Rights to the Licensed Technology    6

2.3.

   Novartis Sublicensing Rights    7

2.4.

   Improvement License Grants from Novartis to Unigene to manufacture API    8

2.5.

   Improvement License Grants from Novartis to Unigene to manufacture proteins
or peptides other than API    9

2.6.

   Licensed Technology Facilities    9 ARTICLE III PAYMENTS    9

3.1.

   Initial Fee to Unigene    9

3.2.

   Milestone Payments to Unigene    9

3.3.

   Unigene Licensed Technology Royalties    11 ARTICLE IV TECHNOLOGY TRANSFER   
13

4.1.

   Unigene Know-How and Material Transfer    13

4.2.

   Assistance    13

4.3.

   Technical Support beyond the Technology Transfer Plan    13

4.4.

   Cost of Technology Transfer    14 ARTICLE V SUPPLY AND MANUFACTURE    14

5.1.

   Unigene Supply to Novartis    14

5.2.

   Novartis Supply to Unigene    14

 

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ARTICLE VI INTELLECTUAL PROPERTY    15

6.1.

   Ownership and Inventorship of Sole and Joint Improvements    15

6.2.

   Filing, Prosecution, Maintenance and Enforcement of Patents    15 ARTICLE VII
REPRESENTATIONS, WARRANTIES AND COVENANTS    19

7.1.

   Warranties    19 ARTICLE VIII CONFIDENTIALITY AND EXCHANGE OF INFORMATION   
20

8.1.

   Confidential Information    20

8.2.

   Permitted Disclosures    21

8.3.

   Public Announcements    22

8.4.

   Publications    22

8.5.

   Bankruptcy    23 ARTICLE IX INDEMNIFICATION    23

9.1.

   Indemnification of Novartis    23

9.2.

   Indemnification of Unigene    23

9.3.

   Procedure    24 ARTICLE X DISCLAIMER OF WARRANTIES    24 ARTICLE XI TERM AND
TERMINATION    25

11.1.

   Term    25

11.2.

   Termination for Material Breach    25

11.3.

   Termination for Insolvency; Retention of License    25

11.4.

   General Effect of Termination    26 ARTICLE XII MISCELLANEOUS    27

 

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12.1.

   Governing Law    27

12.2.

   Waiver    28

12.3.

   Assignment    28

12.4.

   Notices    28

12.5.

   Force Majeure    29

12.6.

   Independent Contractors    29

12.7.

   Other Obligations    29

12.8.

   Severability    30

12.9.

   Further Assurances    30

12.10.

   Entire Agreement, Waivers, Etc.    30

12.11.

   Headings, Construction and Interpretations    30

12.12.

   Counterparts    31

 

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This License Agreement (this “Agreement”), dated as of April 7th, 2004 (the
“Effective Date”), is made between Novartis Pharma AG, a Swiss corporation
(“Novartis”) and Unigene Laboratories, Inc., a Delaware corporation (“Unigene”)
(each a “Party” and collectively, the “Parties”).

 

R E C I T A L S

 

WHEREAS, Unigene has developed certain proprietary technology related to the
manufacture of API, Intermediate and Amidating Enzyme;

 

WHEREAS, Unigene is the owner of all right, title and interest in, or otherwise
controls, certain Unigene Patent Rights and Unigene Know-How which relate to the
manufacture of API, Intermediate and Amidating Enzyme;

 

WHEREAS, Unigene desires to grant to Novartis and Novartis desires to obtain, an
exclusive, worldwide license under this Agreement for Novartis and/or its
Affiliates to develop, have developed, manufacture, use, import and export API,
Intermediates and Amidating Enzyme for use in Novartis and Unigene Drug
Products;

 

WHEREAS, Unigene desires to supply, and Novartis desires to be supplied with API
suitable for a ** Clinical Study for the development of Novartis’ Oral Product
according to the terms of the Clinical Supply Agreement attached hereto as
Exhibit A;

 

WHEREAS, the parties shall negotiate in good faith the terms and conditions of a
clinical and a commercial supply agreement to cover the supply of API for
clinical and commercial use in Unigene’s Drug Products (“Product Supply
Agreement” and the “Contract Manufacturing Agreement) as set forth below.

 

NOW, THEREFORE, in consideration of the mutual covenants set forth in this
Agreement, Novartis and Unigene, intending to be legally bound, hereby agree as
follows:

 

ARTICLE I

DEFINITIONS

 

1.1. “Affiliate” means any legal entity (such as a corporation, partnership, or
limited liability company) that Controls, is Controlled by or is under common
Control with a Party to this Agreement. For the purposes of this definition, the
term “Control” means: (i) beneficial ownership of at least fifty percent (50%)
of the voting securities of a corporation or other business organization with
voting securities (or such lesser percentage which is the maximum allowed by a
foreign corporation in a particular jurisdiction); (ii) a fifty percent (50%) or
greater interest in the net assets or profits of a partnership or other business
organization without voting securities; or (iii) the ability to direct the
affairs of any such entity.

 

1.2. “Amidating Enzyme” means a recombinant enzyme used to convert non amidated
peptides or proteins to amidated peptides or proteins.

 

- 1 -

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“API” or “Active Pharmaceutical Ingredient” means recombinant salmon calcitonin
manufactured under or using the Licensed Technology in bulk active ingredient
form.

 

“Calendar Quarter” means a period of three (3) consecutive calendar months
ending on March 31, June 30, September 30 or December 31.

 

“Calendar Year” means a period of twelve (12) consecutive calendar months
beginning on January 1 and ending on December 31.

 

“Clinical Supply Agreement” means that certain clinical supply agreement, dated
as of the date hereof, by and between Novartis and Unigene, which is attached
hereto as Exhibit A.

 

“Commencement of **” means the date **.

 

“Commencement of **” means the date **.

 

“Competing Product” means any product sold by a Third Party that contains API.
Affiliates, sublicensees, Joint Ventures and distributors of Unigene shall not
be considered to be Third Parties.

 

“Confidentiality Agreement” means the Confidentiality and Non-Disclosure
Agreement, dated November 6, 2002, between Novartis AG and Unigene.

 

“Confidential Information” means (i) any proprietary or confidential information
or material in tangible form disclosed hereunder that is marked as
“Confidential” at the time it is delivered to the receiving Party, (ii)
proprietary or confidential information disclosed orally hereunder which is
identified as confidential or proprietary when disclosed and such disclosure of
confidential information is confirmed in writing within forty-five (45) days
thereafter by the disclosing Party.

 

“Contract Manufacturing Agreement” shall have the meaning assigned to it in
Section 5.2.1

 

“Control,” “Controls,” “Controlled,” or “Controlling” means (except with respect
to “Affiliate” as defined in Section 1.1) possession of the ability to grant the
licenses or sublicenses as provided herein without violating the terms of any
license agreement or other arrangement with any Third Party, or any government
regulation or statute.

 

“Effective Date” means the date set forth above.

 

“Field” means the use by oral administration of the API for the prophylactic
and/or therapeutic treatment of any human diseases or disorders, including, but
not limited to, osteoporosis.

 

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“FDA” means, with respect to the United States, the United States Food and Drug
Administration, any successor entity thereto, or any equivalent foreign
regulatory authority(ies) in a particular country of the Territory.

 

“First Commercial Sale” means the first sale of any Novartis Drug Product to a
Third Party by Novartis or its respective Affiliates or permitted sublicensees.

 

“Future Novartis Products” means any and all drug products developed or licensed
by Novartis for use outside the Field during the term of this Agreement, but not
yet developed or licenced upon Effective Date, in any formulation containing or
incorporating API, alone or in combination with any pharmacologically active
ingredient.

 

“Improvements” shall collectively mean Joint Improvements, Novartis
Non-Severable Sole Improvements, Novartis Severable Sole Improvements and
Unigene Sole Improvements, and Non-Severable Joint Improvements.

 

“Intermediate” means API precursors generated during the process of
manufacturing API.

 

“Joint Improvements” means any improvements, inventions, discoveries, processes,
improved cell lines, cell banks, clones, vectors, cassettes, and other
knowledge, whether or not patentable (including patents, patent applications,
divisions, continuations, continuation-in-part, reissues, reexaminations,
extensions or supplemental patent certificates) that are (a) jointly made after
the Effective Date of this Agreement by at least one individual or individuals
under an obligation to assign their rights to such improvements to Unigene
and/or its Affiliate as applicable and at least one individual or individuals
under an obligation to assign their rights to such improvements to Novartis
and/or its Affiliate as applicable and (b) implemented in ** and c) not derived
from ** or from ** or otherwise by Unigene and/or its Affiliate as applicable,
and d) not derived from ** or from ** or otherwise by Novartis and/or its
Affiliate as applicable.

 

“Joint Venture” means any entity, collaboration or association between Unigene
and a Third Party for, inter alia, manufacturing API solely for use in Other
Unigene Products, in which Unigene has a ** or greater direct ownership of the
interest of such entity, collaboration or association and has a significant and
active management role.

 

“Licensed Technology” means the **.

 

“Net Sales” means with respect to the Novartis Drug Products, the gross amount
invoiced by Novartis, its Affiliates, its sublicensees, its co-promoters, its
co-marketers or a joint venture to which Novartis, its Affiliates or
sublicensees are a party,

 

- 3 -

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to unrelated Third Parties on sales of Novartis Drug Product in the Territory
less the following customary and reasonable deductions for the Novartis Drug
Products:

 

Trade, quantity and cash discounts allowed;

**

 

Actual Novartis Drug Product returns and allowances;

**

**

 

“Non-Severable Joint Improvements” means all improvements, inventions,
discoveries, processes, improved cell lines, cell banks, clones, vectors, and
cassettes, and other knowledge, whether or not patentable (including patents,
patent applications, divisions, continuations, continuation-in-part, reissues,
reexaminations, extensions or supplemental patent certificates) that are (a)
derived from **, or from ** as applicable, and implemented in the ** and (b)
made after the **, provided, however, that if such improvement was **, as
applicable, ** shall be deemed to be a **. ** shall be deemed to be a **.

 

“Novartis Non-Severable Sole Improvements” means all improvements, inventions,
discoveries, processes, improved cell lines, cell banks, clones, vectors and
cassettes, and other knowledge, whether or not patentable (including patents,
patent applications, divisions, continuations, continuation-in-part, reissues,
reexaminations, extensions or supplemental patent certificates) that are (a)
derived from ** and (b) made after the ** as applicable.

 

“Novartis’ Oral Product” means the drug product for use in the Field in
development by Novartis upon the Effective Date, in finished pharmaceutical form
suitable for oral administration, containing or incorporating API, alone or in
combination with any pharmacologically active ingredient.

 

“Novartis Drug Products” means (a) the Novartis Oral Product, (b) the Future
Novartis Products and (c) the Other Novartis Products.

 

“Novartis Severable Sole Improvements” means all improvements, inventions,
discoveries, processes, improved cell lines, cell banks, clones, vectors,
cassettes, and other knowledge, whether or not patentable (including patents,
patent applications, divisions, continuations, continuation-in-part, reissues,
reexaminations, extensions or supplemental patent certificates) that are either
(a) derived from ** upon having been made after the ** or (b) derived by any
individual or individuals **.

 

“Other Novartis Products” shall mean any and all drug products developed or
licensed by Novartis for use outside the Field upon the Effective Date, in any
formulation containing or incorporating API, alone or in combination with any
pharmacologically active ingredient.

 

- 4 -

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“Other Unigene Products” shall mean any and all drug products developed or
licensed by Unigene for use outside the Field upon the Effective Date and/or
during the term of this Agreement, in any formulation (in particular but not
limited to nasal and/or injectable), containing or incorporating API, alone or
in combination with any pharmacologically active ingredient.

 

“** Clinical Studies” means the ** clinical study **.

 

“** Clinical Studies” means ** clinical trials **, as prescribed by applicable
FDA regulations.

 

“Process Transfer Information” means the information to be supplied by Unigene
as set forth in Section 4.1.

 

“Term” means the term of this Agreement as set forth in Section 11.1.

 

“Territory” means all the countries and territories of the world.

 

“Third Party(ies)” means any party(ies) other than Unigene, Novartis or their
respective Affiliates.

 

“Unigene’s Oral Product” means the drug product in development by Unigene upon
Effective Date for use in the Field, containing or incorporating API, alone or
in combination with any pharmacologically active ingredient.

 

“Unigene Drug Product” means (a) the Unigene Oral Product and (b) the Other
Unigene Products.

 

“Unigene Know How” means all **, ideas, inventions, data, instructions,
processes **, formulas, expert opinions and information, including, without
limitation, biological, chemical, pharmacological, physical and analytical,
clinical, safety, manufacturing and quality control data and information, in
each case, which are necessary or useful for the development, testing, use,
manufacture or sale of ** and which is in the possession of and owned or
Controlled by Unigene and/or its Affiliate as applicable. For avoidance of
doubt, Unigene Know-How shall include all **, but does not include any **. Upon
filing of the corresponding **. Unigene Know-How shall be Confidential
Information of Unigene as defined in Section 1.11 and shall be documented to the
extent reasonable in written and/or electronic form.

 

“Unigene Patent Rights” means: (i) all patents and patent applications in
existence as of the Effective Date or during the Term of this Agreement claiming
generically or specifically the ** that contain a Valid Claim which would be
infringed by making, using, selling, offering for sale, or having made API in
the Territory or by the importation of API into the Territory; and (ii) any
divisions, continuations, continuations-in-part, reissues, reexaminations,
patents of additions, extensions, supplemental patent

 

- 5 -

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certificates, corresponding patents or patent applications in the same or other
countries claiming priority from a patent a patent application in existence as
of the Effective Date, including those in patent applications or patents derived
from Unigene Sole Improvements set forth in Exhibit D that contain a Valid Claim
which would be infringed by **, or other governmental actions which extend the
term of any Valid Claim of the patent applications or patents in clause (i)
above, and any substitutions, confirmations, registrations or revalidations of
any of the foregoing, in each case which is owned or Controlled, in whole or
part, by license, assignment or otherwise by Unigene and/or its Affiliate as
applicable as of the Effective Date. The Unigene Patent Rights are set forth in
Exhibit E.

 

“Unigene Sole Improvements” means all improvements, whether or not severable,
inventions, discoveries, processes, improved cell lines, cell banks, clones,
vectors, cassettes, separations, purifications and other knowledge, whether or
not patentable (including patents, patent applications, divisions,
continuations, continuation-in-part, reissues, reexaminations, extensions or
supplemental patent certificates), derived from Licensed Technology and made
after the Effective Date of this Agreement **.

 

“U.S. Territory” means the United States of America and all of its territories
and possessions, and shall include Puerto Rico.

 

“Valid Claim” means a claim in an unexpired and issued patent or pending patent
application included in Unigene Patent Rights that has not been disclaimed,
revoked or held invalid or unenforceable by a final unappealable decision of a
government agency or court of competent jurisdiction, or unappealed within the
time limit allowed for appeal, or which has not been admitted to be invalid or
unenforceable through reissue, reexamination or disclaimer or otherwise.

 

LICENSE GRANTS

 

License Grant from Unigene to Novartis. Subject to the terms and conditions of
this Agreement, Unigene hereby grants to Novartis and its Affiliates an
exclusive license under the Licensed Technology to develop, manufacture, sell,
use, import and export API, Intermediate and Amidating Enzyme in the Territory
solely for the purpose of

 

developing, having developed, manufacturing, using, selling, having sold
importing and exporting Novartis Drug Products and/or

 

manufacturing and selling API to Unigene for use in Unigene Drug Products, by
Unigene its Affiliates, licensees or distributors.

 

Reservation of Rights to the Licensed Technology.

 

- 6 -

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            Unigene’s Oral Product. Notwithstanding the exclusive license
granted to Novartis in Section 2.1.1, Unigene shall have the right to

 

manufacture API, Amidating Enzyme and Intermediates for use in Unigene’s Oral
Product needed until completion of **;

 

have manufactured API for use in Unigene’s Oral Product for commercial sale
exclusively by Novartis and/or its Affiliates, as per the terms of the Contract
Manufacturing Agreement;

 

have manufactured API for use in Unigene’s Oral Product by a Third Party, **.

 

In the event that the Parties shall not **.

 

            Other Unigene Products. Notwithstanding the exclusive license
granted to Novartis in Section 2.1.1, Unigene shall have the right to

 

develop, manufacture, have manufactured by a Joint Venture, sell, use, import
and export API, Intermediates and Amidating Enzyme to the extent it is used in
Other Unigene Products, it being understood that such Joint Venture shall have
the rights to manufacture API solely for use in Other Unigene Products;

 

have manufactured API for use in Other Unigene Products by Novartis and/or its
Affiliates, as per the terms of the Contract Manufacturing Agreement;

 

have manufactured API for use in Other Unigene Products by a Third Party, **;

 

In the event that the Parties shall **.

 

            **. Each Party and its Affiliates will, upon reasonable request,
provide the other Party with a **.

 

Novartis Sublicensing Rights.

 

            Novartis shall not be permitted to sublicense the manufacture of
API, Amidating Enzyme or Intermediates or provide any Third Party with access to
** included within the Licensed Technology without consent and prior written
approval from Unigene, which approval shall be within Unigene’s sole discretion.

 

Novartis shall have the right to sublicense **, of Novartis Drug Products (but
excluding **) without consent or approval from Unigene.

 

- 7 -

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Improvement License Grants from Novartis to Unigene to manufacture API.

 

            For Novartis Non-Severable Sole Improvements and Non-Severable Joint
Improvements.

 

During the term of the Contract Manufacturing Agreement and/or this Agreement.
During the term of the Contract Manufacturing Agreement and/or this Agreement
Novartis and/or its Affiliate as applicable shall upon implementation of
Novartis Non-Severable Sole Improvements or Non-Severable Joint Improvements in
its manufacture of API, Intermediates or Amidating Enzyme, grant to Unigene, its
Affiliates and/or Joint Ventures a **, to Novartis Non-Severable Sole
Improvements solely to manufacture API, Intermediates or Amidating Enzyme.

 

Upon termination of the Contract Manufacturing Agreement and this Agreement.
After both the Contract Manufacturing Agreement and this Agreement have
terminated any license granted to Unigene under Section 2.4.1.1 above shall be
converted to a **, to Novartis Non-Severable Sole Improvements and Non-Severable
Joint Improvements solely to manufacture and have manufactured API,
Intermediates or Amidating Enzyme.

 

Novartis and its Affiliates shall not at any time license Novartis Non-Severable
Sole Improvements and/or Non-Severable Joint Improvements to any Third Party,
and shall only employ Novartis Non-Severable Sole Improvements and/or
Non-Severable Joint Improvements to manufacture API, Intermediates or Amidating
Enzyme for Novartis Drug Products or for Unigene.

 

For Novartis Severable Sole Improvements.

 

During the term of the Contract Manufacturing Agreement and this Agreement.
During the term of the Contract Manufacturing Agreement and this Agreement
Novartis and/or its Affiliate as applicable shall upon implementation of
Novartis Severable Sole Improvements in its manufacture of API, Intermediates or
Amidating Enzyme, grant to Unigene, its Affiliates **, to Novartis Severable
Sole Improvements solely to manufacture API, Intermediates or Amidating Enzyme,
**.

 

Upon termination of the Contract Manufacturing Agreement and/or the term of this
Agreement. Upon termination of the Contract Manufacturing Agreement and/or the
term of this Agreement the Parties shall negotiate in good faith the terms of a
** solely to manufacture or have manufactured for Unigene, its Affiliates and/or
Joint Ventures API, Intermediates or Amidating Enzyme.

 

Third Party Manufacturing. Unigene shall have the right ** is bound to
confidentiality with respect to any information shared in the implementation of
such ** are bound by the terms and limitations of such licenses as set forth
herein.

 

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Improvement License Grants from Novartis to Unigene to manufacture proteins or
peptides other than API.

 

For Novartis Non-Severable Sole Improvements. Upon **, the Parties shall
negotiate in good faith the terms of an **. The right to ** will also be
negotiated in good faith **.

 

For Novartis Severable Sole Improvements. Upon **, the Parties shall negotiate
in good faith the terms of a **. ** will be negotiated on an ** basis, unless
agreed to the contrary in writing by the Parties. The right to ** will also be
negotiated in good faith on an ** basis.

 

Licensed Technology Facilities. Prior to the commencement thereat, Novartis
shall notify Unigene of each location at which Novartis will utilize the
Licensed Technology, with respect to the manufacture of API, Amidating Enzyme,
Intermediates and/or Novartis Drug Products.

 

PAYMENTS

 

Initial Fee to Unigene. In partial consideration for the license to Licensed
Technology granted to Novartis under Section 2.1 of this Agreement, Novartis
shall pay to Unigene three million five hundred thousand U.S. dollars (U.S. $
3,500,000) within fifteen (15) days following execution of this Agreement, which
amounts shall be non-refundable and not creditable against other amounts due
Unigene under this Agreement.

 

Milestone Payments to Unigene.

 

            Milestone Schedule for Novartis’ **. In partial consideration for
the license to Licensed Technology granted to Novartis under Section 2.1 of this
Agreement, Novartis shall pay Unigene the amounts set forth below following the
first achievement by Novartis its respective Affiliates or permitted
sublicensees, as applicable and as the case may be, of each of the following
milestones with respect to the Novartis’ ** (“Milestones”):

 

    

Milestone

--------------------------------------------------------------------------------

   Amounts

--------------------------------------------------------------------------------

1.    The sixtieth (60th) day after initiation of the technology transfer in
accordance with the Technology Transfer Plan    U.S. $2,000,000 2.    **    U.S.
$** 3.    **    U.S. $** 4.    **    U.S. $** 5.    **    U.S. $**

 

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            For the avoidance of doubt, the parties hereby acknowledge, ** to
determine the Milestones listed in Section 3.2.1 shall only relate to **.

 

Novartis shall provide written notice of achievement of all Milestones other
than Milestone 1 to Unigene within fifteen (15) days after such event. For
Milestone 1, Novartis shall notify Unigene in writing of the initiation of the
Technology Transfer.

 

If Unigene has shipped API in accordance with the Clinical Supply Agreement, **.

 

Upon receipt of an invoice from Unigene specifying the Milestone achieved,
Novartis shall pay such Milestone within forty-five (45) days after receipt of
such invoice.

 

Each such payment shall be made only one time, based upon achievement of a
particular Milestone, regardless of how many times such Milestone is achieved.

 

Each such payment shall be non-refundable and non-creditable to Novartis against
other amounts due to Unigene under this Agreement.

 

Unigene Licensed Technology Royalties.

 

            Royalties on ** and **. In partial consideration of the license and
rights granted under the Licensed Technology hereunder, Novartis shall pay
royalties to Unigene on ** and ** as follows:

 

** of ** up to and including **;

 

** of ** in excess of ** up to and including **;

 

** of ** in excess of ** up to and including **; and

 

** of ** in excess of **;

 

provided that, for purposes of this Section 3.3.1, achievement of the **
thresholds set forth shall be determined by **. The royalty rates so determined
shall **.

 

By way of examples: **.

 

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            Royalties on ** of **. In partial consideration of the license and
rights granted under the Licensed Technology hereunder, Novartis shall pay **
royalties to Unigene on **.

 

            Unigene Licensed Technology Royalties. **.

 

            Royalty Term. In accordance with Section 3.3.1 and 3.3.2 Novartis
shall be obliged to pay royalties until the termination of this Agreement
pursuant to Article 11 as follows:

 

Novartis shall pay royalties as per Section 3.3.1 and 3.3.2 on a ** until **.

 

**. After the occurrence of the **.

 

**. **, during the term of this Agreement, ** it being agreed **.

 

Payment of Royalties. Payment of royalties shall be made forty five (45) days
after the end of each Calendar Quarter on all Net Sales in the preceding quarter
(“Quarterly Payment”). For each quarter, a detailed report shall be delivered to
Unigene forty-five (45) days after quarter end setting forth the total Net Sales
by country in the Territory for the preceding Calendar Quarter. Such report
shall include **. In the event that a ** is met during a Calendar Quarter, **.

 

Single Royalty; Non-Royalty Sales. No royalty shall be payable under Section
3.3.1 and 3.3.2 above with respect to sales of the Novartis Drug Products among
Novartis its Affiliates and permitted sublicensees for resale to a Third Party.
In no event shall more than one such royalty be due to Unigene hereunder with
respect to the sale of each Novartis Drug Products.

 

Third Party Fees or Royalties. Novartis shall be fully responsible for the
payment of any additional royalties, license fees, milestones and any and all
other payments due to Third Parties that are required for Novartis, its
Affiliates or licensees to develop, use, market, sell or import **. In such
case, ** shall be responsible for the **.

 

Currencies. Payments under this Agreement shall be made in United States
Dollars. Net Sales for each country shall be converted into United States
Dollars using Novartis’ then current standard exchange rate methodology ** for
converting such local currency to the United States Dollar.

 

Manner of Payments. All sums due to Unigene under this Agreement shall be
payable in United States Dollars by bank wire transfer in immediately available
funds to such bank account as Unigene shall designate. Novartis shall notify
Unigene, in advance, as to the date and amount of any such wire transfer.

 

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For any payment made more than forty-five (45) days from the due date, Novartis
shall pay interest at the ** on the unpaid amount (unless a lower percentage is
required by law).

 

Tax Withholding. Any tax, duty or other levy paid or required to be withheld by
Novartis on account of royalties or other payments payable to Unigene under this
Agreement shall be deducted from the amount of royalties or payments otherwise
due, provided that Novartis shall make such deductions only to the minimum
extent required by the relevant jurisdiction. Novartis shall secure and send to
Unigene proof of payment of any such taxes, duties or other levies withheld and
paid by Novartis for the benefit of Unigene, and cooperate at Unigene’s
reasonable request to ensure that amounts withheld are reduced, creditable (or
otherwise recoverable) to the fullest extent permitted by the relevant
jurisdiction.

 

Financial Records and Audits; Unigene’s Right to Audit. Unigene, at its own
cost, through an independent auditor (who will have executed a confidentiality
agreement with Novartis) reasonably acceptable to Novartis, may inspect and
audit the records of Novartis and its Affiliates (including, without limitation,
**), as may be necessary and for the sole purpose of verifying the accuracy of
all financial and numerical information and calculations provided in the reports
of Novartis relating to the sale of Novartis Drug Product and any royalties due
to Unigene under Section 3.3. Novartis shall, and shall cause its Affiliates
(including, without limitation, **), provide access to such records during
reasonable and regular business hours. Such audits shall not be conducted more
than once in any four (4) consecutive calendar quarters during the period that
Novartis has an obligation to pay Royalties hereunder. The auditors shall report
to Unigene only the amount of Royalty due. Unigene shall provide Novartis with
written notice of its election to inspect and audit the records related to the
royalty due hereunder not less than thirty (30) days prior to the proposed date
of review of such records by Unigene’s auditors. Novartis shall, and shall cause
its Affiliates (including, without limitation, **) to, maintain sufficient
records to permit the inspection and auditing permitted hereunder for three (3)
years after the date of each respective reporting period (or such longer period
as such records are required to be maintained by applicable law, rule,
regulation or similar requirement). Novartis shall, and shall cause each of its
Affiliates (including, without limitation, **) to, prepare its records and
reports according to IAS rules (International Accounting Standards) consistently
applied. Should the auditor find any underpayment of royalties by Novartis,
Novartis shall promptly pay Unigene the amount of such underpayment, plus
interest ** per annum or portion thereof on the amount of any underpayment from
the date payment was due, and shall reimburse Unigene for the cost of the audit
should such underpayment equal or exceed ** of royalties paid in any Calendar
Quarter.

 

Bundling. When a Novartis Drug Product is bundled with one or more other
Novartis Drug Products or one or more other products sold by Novartis which are
not Novartis Drug Products, the selling price for each such Novartis Drug
Product shall be the ** sold to a Third Party in an arm’s length transaction.
However, in

 

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no event shall Novartis be constrained in pricing any Novartis Drug Product and
in no event shall Novartis be required to reveal to Unigene the pricing of any
Novartis Drug Product or any other product sold by Novartis as part of the
bundle.

 

TECHNOLOGY TRANSFER

 

Unigene Know-How and Material Transfer. Upon written notice from Novartis
Unigene shall use its reasonable commercial efforts to promptly transfer, or
cause to be transferred to Novartis and/or its designated Affiliate a copy of
Unigene Know-How reduced to written or electronic form and all Process Transfer
Information that is reasonably required by Novartis and or its Affiliates in
accordance with the Technology Transfer Plan, it being understood that
initiation of the technology transfer and locations as determined in the
Technology Transfer Plan in Exhibit C attached hereto may be adjusted by
Novartis as needed, it being further understood, that provided the Licensed
Technology shall be transferred to Novartis’ Affiliate **, the locations as
determined in Exhibit C shall remain unchanged. Unigene Know-How shall remain
the exclusive property of Unigene and shall be deemed to be Unigene’s
Confidential Information.

 

Assistance. In accordance with the Technology Transfer Plan and upon written
request by Novartis and/or its Affiliates Unigene shall provide the Novartis
Affiliate with technical support with respect to the transfer, implementation
and use of the Unigene Know-How in the manufacture of API, Amidating Enzyme and
Intermediates (the “Technical Support”). The Technical Support as agreed on in
the Technology Transfer Plan will be provided ** in connection with the
provision of the Technical Support. The Technical Support will be provided at
the locations designated in the technology transfer plan, and shall include
access to documents and key personnel necessary to allow Novartis to develop the
expertise to manufacture, and access and visits to the Unigene facilities to
observe the manufacturing; provided, however, that Technical Support provided at
Unigene’s facilities shall not be permitted to interfere with the day-to-day
operations thereof. It is understood, that the Technical Support to be provided
by Unigene ** shall be limited to **, provided that such man days may be
reallocated by Novartis and/or its Affiliates to different tasks of the
Technology Transfer Plan as needed, except as to the designated locations to
provide the Technical Support, which shall remain unchanged. All Technical
Support shall be provided in English. All information provided by Unigene in
carrying out the Technical Support shall be deemed to be Unigene Know-How.

 

Technical Support beyond the Technology Transfer Plan. It is understood that
activities, scale, locations, timing and man days as listed in the Technology
Transfer Plan are best estimates only and may require adaptation as well as
additional activities and additional man days by Unigene. All costs and out
-of-pocket expenses incurred by Unigene for Technical Support requested by
Novartis in addition to the Technical Support agreed on in the Technology
Transfer Plan shall be borne by

 

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Novartis. Such additional Technical Support shall be reimbursed at the rate of
Euro ** per man-day with each man-day equal to at least eight (8) working hours.

 

Cost of Technology Transfer. All other cost of such technology transfer shall be
borne by Novartis. If the parties come to an agreement on the Contract
Manufacturing Agreement as set forth in Section 5.2.2, then all costs of such
technology transfer shall be borne by Novartis, whether or not Novartis
continues to develop Novartis’ Oral Product. Termination of this Agreement shall
not relieve the obligation of Novartis to bear all such costs, provided the
parties have agreed on the Contract Manufacturing Agreement pursuant to Section
5.2.2. below.

 

SUPPLY AND MANUFACTURE

 

Unigene Supply to Novartis. Unigene hereby agrees to manufacture, sell and
deliver API for use in the development of Novartis’ Oral Product pursuant to the
Clinical Supply Agreement attached hereto as Exhibit A, which terms shall be
incorporated herein.

 

Novartis Supply to Unigene.

 

            Clinical and Commercial Supply of API for use in Unigene Drug
Products. Within ** days following Effective Date, which may be extended by
mutual agreement (the “Negotiation Period”) Novartis and Unigene shall negotiate
in good faith toward concluding a clinical supply agreement (“Product Supply
Agreement”) and a commercial supply agreement (the “Contract Manufacturing
Agreement”). Such Product Supply Agreement and Contract Manufacturing Agreement
shall incorporate the principles as set forth in Exhibits B, C and F, provided,
however, that Exhibits B, C and F shall be legally nonbinding to both parties
and are subject to final senior management approval of both parties.

 

In the event that **, shall be appointed by Novartis to be the party to the
Contract Manufacturing Agreement, the Contract Manufacturing Agreement (Exhibit
B), the Product Supply Agreement (Exhibit F) and the Technology Transfer Plan
(Exhibit C) shall be binding on both parties, provided, however, that the
initiation of the Technology Transfer Plan and the Obligated Date in the Product
Supply Agreement shall be adjusted as needed.

 

In the event that no Contract Manufacturing Agreement shall be concluded and
executed within the Negotiation Period despite good faith negotiations, the
license granted to Novartis under Section 2.1 (b) shall terminate.

 

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INTELLECTUAL PROPERTY

 

Ownership and Inventorship of Sole and Joint Improvements.

 

            Ownership. Unigene shall solely own all right, title, and interest
in all Unigene Sole Improvements. Novartis and or its Affiliates shall solely
own all right, title, and interest in all Novartis Non-Severable Sole
Improvements and Novartis Severable Sole Improvements. Each Party shall own an
undivided right, title, and interest, as defined under the applicable U.S. law,
in any Joint Improvements and Non-Severable Joint Improvements, and whether
patentable or not patentable subject to the provisions of this Agreement. Each
Party shall reasonably promptly disclose to the other Party all Improvements
made by it. Each Party shall notify the other Party if it wishes to file a
patent application concerning an Improvement no later than thirty (30) days
before the anticipated date of such filing. If an express grant of rights from
one Party to the other is required in any country to give full force and effect
to this provision, the Parties shall execute any instrument necessary to
accomplish the intent of the foregoing grant.

 

Inventorship. Inventorship and, subject to this Agreement the rights of
ownership, of inventions and other intellectual property rights conceived and/or
reduced to practice in connection with the development activities hereunder
shall be determined in accordance with the laws of the United States. It is
understood that, except as otherwise provided herein, neither Party shall have
any obligation to account to the other for profits, or to obtain any approval of
the other Party to license, assign, mortgage or exploit a Joint Improvement by
reason of joint ownership of any such intellectual property, and may otherwise
undertake all activities a sole owner might undertake with respect to such Joint
Improvement without the consent and without accounting to the other joint owner,
except as otherwise provided in this Agreement or as the Parties may otherwise
agree in writing.

 

Filing, Prosecution, Maintenance and Enforcement of Patents.

 

Licensed Technology. If Unigene elects not to prosecute or maintain such patent
applications or ensuing patents or claims included in Unigene Patent Rights in
any country of the Territory, Unigene shall give Novartis notice thereof within
a reasonable period prior to allowing such patent applications or patents or
such claims encompassed by such patent applications or patents to lapse or
become abandoned or unenforceable, and Novartis shall thereafter have the right,
at its sole expense, to prepare, file, prosecute and maintain such patent
applications and patents or divisional applications related to such claims
encompassed by such patent applications or patents in countries of Novartis’
choice throughout the world. Patents which Novartis has assumed the prosecution
and maintenance of shall no longer be included in the Unigene Patent Rights.

 

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Sole Improvements. Each of Unigene and Novartis (“Filing Party”) shall be
responsible for the reasonable and diligent filing and prosecution of all patent
applications relating to its Sole Improvements under this Agreement, but no
party shall have an obligation to file an application relating to such Sole
Improvement. Each Filing Party shall bear the cost and responsibility for the
filing and prosecution of all such patent applications. The Filing Party shall
provide the other Party with (a) a brief summary of the Sole Invention, and (b)
the main claim at least thirty (30) days before the patent application is
planned to be filed. The other Party may comment and make recommendations about
content and filing strategy, which comments the Filing Party shall take under
consideration. The Filing Party shall also keep the other Party informed of all
material issues relating to the preparation, filing and prosecution of such
patent applications. Neither Party shall file any patent application which shall
lead to the disclosure of the other Party’s Confidential Information unless the
other Party has first agreed in writing to the filing. If Novartis decides not
to continue to prosecute or maintain a patent application or patent in a country
for Novartis Non-Severable Sole Improvements after such patent or patent
application has been published and Unigene wishes to do so, then the Novartis
Non-Severable Sole Improvement and resulting patent applications and patents
shall be assigned to Unigene and such patent applications and patents shall
become part of Unigene Patent Rights and shall no longer be a Novartis
Non-Severable Sole Improvement. Prior to publication, Novartis and/or its
Affiliates will have no obligation to assign such patents or patent applications
to Unigene.

 

Joint Improvements. In the case of Joint Improvements **, the Parties shall
decide whether or not to secure patent protection and which Party shall bear the
primary responsibility for preparing, filing and prosecuting the Patent
applications resulting there from. Patent-related expenses for Joint
Improvements **. If the Parties cannot agree which Party shall bear the primary
responsibility for preparing, filing, and prosecuting Patent Applications
resulting from a Joint Invention **, then counsel mutually agreeable to the
Parties shall prepare, file and prosecute the patent applications and the
Parties shall ** related thereto. Each Party shall promptly render all necessary
assistance reasonably requested by the other Party in applying for and
prosecuting the patent applications. Neither Party shall file any patent
application on Joint Improvements ** which shall lead to the disclosure of the
other Party’s Confidential Information, unless the other Party has first agreed
in writing to the filing. If a Party responsible for the prosecution or
maintenance of a patent or patent application directed to a Joint Improvement **
elects not to continue prosecution or maintenance of such patent or patent
application, the Party will give the other Party notice of such election within
a reasonable period prior to allowing such patent or patent application to lapse
or become unenforceable, and the other Party will have the right to continue
prosecution or maintenance of such patent or patent application; and if **
decides not to file a patent application for a ** shall be permitted to do so.
If a Party (the “Relinquishing Party”) declines to pay its share of
patent-related expenses for any patent application or patent directed to a Joint
Improvement **, the other Party may assume payment of the Relinquishing Party’s
share of the patent-related expenses, and

 

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the Relinquishing Party will assign title to such patent application or patent
to Party assuming payment.

 

Enforcement of Unigene Patent Rights. Subject to Section 6.2.5 below, in the
event that a Party learns that any Unigene Patent Rights necessary for the
manufacture, use and/or sale of API are infringed or misappropriated by a Third
Party in any country in the Territory, or is subject to a declaratory judgment
action arising from such infringement in such country, such Party shall promptly
notify the other Party hereto. Unigene shall have the initial right (but not the
obligation) to enforce such Unigene Patent Rights by initiating an appropriate
suit or action against such Third Party, or defend any declaratory judgment
action with respect thereto, at its expense, and to use Novartis’ name in
connection therewith; provided that such use without Novartis’ written consent
may only occur where necessary or indispensable for Unigene to bring such suit
or action. Novartis shall have the right to join in any suit or action initiated
by Unigene within 90 days of the bringing of such suit or action by Unigene.
Novartis may retain counsel of its choosing, at Novartis’ sole expense, or
Novartis may utilize the counsel selected and directed by Unigene and share
equally in the costs associated therewith. In the event that Unigene fails to
initiate a suit or action to enforce such Unigene Patent Rights against such a
Third Party in any jurisdiction in the Territory within ninety (90) days after
notification of such infringement, Novartis may initiate such suit or action in
its own name with regard to the applicable Unigene Patent Rights against such
infringement, at the expense of Novartis, and to use Unigene’s name in
connection therewith; provided that such use without Unigene’s written consent
may only occur where necessary or indispensable for Novartis to bring such suit
or action. If Novartis initiates such a suit or action, Unigene will have the
right to join within ninety (90) days of the bringing of such suit or action by
Novartis. Unigene may retain counsel of its choosing, at Unigene’s sole expense,
or Unigene may utilize the counsel selected and directed by Novartis and share
equally in the costs associated therewith. If only one Party is prosecuting a
suit or action, the Party involved in the suit or action (the “Enforcing
Party”), shall keep the other Party hereto reasonably informed of the progress
of any such action. Unigene and/or Novartis shall recover their respective
actual out-of-pocket expenses, or equitable proportions thereof, associated with
any litigation or settlement thereof from any recovery made in a suit or action
to which they were an active Party. Any excess amount recovered shall be
allocated as follows: if the suit is joined by both Parties, the excess amount
recovered is divided equally, and if only one Party brings the suit (the
“Litigating Party”) and is not joined by the other Party, then only the
Litigating Party shall receive the excess amount recovered.

 

Enforcement of Joint Improvement Patent Rights. Notwithstanding anything to the
contrary in Section 6.2.4 above, in the event that any patent that is jointly
owned by Unigene and Novartis under Section 6.1.1 of this Agreement is infringed
or misappropriated by a Third Party, Novartis and Unigene shall discuss whether,
and, if so, how, to enforce such jointly owned patent or defend such jointly
owned patent in an infringement action, declaratory judgment or other
proceeding. In the event only one Party wishes to participate in such
proceeding, it shall have the right

 

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to proceed alone, at its expense, and may retain any recovery; provided,
however, that at the request and expense of the participating Party, the other
Party agrees to cooperate and join in any proceedings in the event that a Third
Party asserts that the coowner of such Joint Improvement patent rights or
Non-Severable Joint Improvement patent rights is necessary or indispensable to
such proceedings. The participating Party shall keep the other Party hereto
reasonably informed of the progress of such proceeding. Damages recovered by a
Party or Parties in an action under this Section 6.2.5 are to be allocated
according to the scheme set out in Section 6.2.4, above.

 

Infringement Claims. If the manufacture, use, or sale of API in the Territory
pursuant to this Agreement results in any claim, suit or proceeding alleging
patent infringement against Unigene or Novartis, or their Affiliates, such Party
shall promptly notify the other Party hereto. If Novartis or its Affiliate is
not named as a Party in such a claim, suit or proceeding, Novartis or its
Affiliate may, at its own expense and through counsel of its own choice, seek
leave to intervene in such claim, suit or proceeding. Unigene agrees not to
oppose such intervention. If Novartis or its Affiliate, and not Unigene, is
named as a Party to such claim, suit or proceeding, Novartis shall have the
right to control the defense and settlement of such claim, suit or proceeding,
at its own expense, using counsel of its own choice. Unigene, however, at its
own expense and through counsel of its own choice, may seek to intervene if the
claim, suit or proceeding relates to the commercialization of the API in the
Field, and in such event, Novartis and its Affiliates agree not to oppose such
intervention. If Novartis or its Affiliate is named as a Party, or if Novartis
or its Affiliate is successful in intervening in actions brought against Unigene
or its Affiliate, and Unigene shall, at any time, tender its defense to Novartis
or its Affiliate, then Novartis shall defend Unigene in such claim, suit or
proceeding, at Novartis’ own expense and through counsel of its own choice, and
Novartis shall control the defense and settlement of any such claim, suit or
proceeding; provided, Novartis shall not enter into any agreement which (i)
extends or purports to exercise Novartis’ rights under Unigene’s Licensed
Technology beyond the rights granted pursuant to this Agreement, (ii) makes any
admission regarding (a) wrongdoing on the part of Unigene, or (b) the
invalidity, unenforceability or absence of infringement of any Unigene Patent
Rights or patent claiming a Joint Invention, without the prior written consent
of Unigene, which consent shall not be unreasonably withheld. The Parties shall
cooperate with each other in connection with any such claim, suit or proceeding
and shall keep each other reasonably informed of all material developments in
connection with any such claim, suit or proceeding.

 

Litigation Activities Update. The Parties shall keep one another informed of the
status of and of their respective activities regarding any litigation or
settlement thereof concerning API, provided however that no settlement or
consent judgment or other voluntary final disposition of any suit defended or
action brought by a Party pursuant to this Article 6 may be entered into without
the written consent of the other Party, which consent shall not be unreasonably
withheld or delayed.

 

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REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Warranties.

 

            Unigene. Unigene warrants and represents to Novartis that:

 

as of the Effective Date, and except as otherwise disclosed to Novartis, it has
full Control of the Licensed Technology to grant the rights and licenses granted
hereunder, and that it otherwise has the full right and authority to enter into
this Agreement;

 

as of the Effective Date, there are no existing or threatened actions, suits or
claims pending against it with respect to the Licensed Technology or its right
to enter into and perform its obligations under this Agreement;

 

as of the Effective Date, to the best of Unigene’s knowledge, there are no
existing intellectual property rights that would be infringed by Novartis’
practice of the Licensed Technology in the Territory or by the developing,
making, use or importation by Novartis of API in the Territory;

 

as of the Effective Date, it has not granted, and will not grant during the Term
of this Agreement, any right, license or interest in or to the Licensed
Technology that is in conflict with the rights or licenses granted under this
Agreement, nor as of the Effective Date, has it encumbered any Unigene Know-How
and/or Unigene Patent Rights, except as set forth on Exhibit G, attached hereto
and incorporated herein;

 

as of the Effective Date, it has no knowledge from which it concludes that the
process by which it manufactures API would infringe patent rights of Third
Parties in the Territory;

 

there is nothing in any Third Party agreement Unigene has entered into as of the
Effective Date, which, in any way, will limit Unigene’s ability to perform all
of the obligations undertaken by Unigene hereunder, and that it will not enter
into any agreement after the Effective Date under which Unigene would incur any
such limitations;

 

it has not intentionally concealed from Novartis the existence of any
pre-clinical or clinical data or information concerning API, or anticipated
components thereof, which suggests that there may exist quality, toxicity,
safety and/or efficacy concerns which may materially impair the utility and/or
safety of API, or anticipated components thereof; and

 

it will perform all of its obligations under any Third Party agreements
necessary to maintain Unigene Patent Rights as set out in Appendix E, and

 

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will maintain such agreements in full force and effect and will not terminate or
amend such agreements without Novartis’ written approval.

 

Novartis. Novartis warrants and represents to Unigene that:

 

as of the Effective Date, it has the full right and authority to enter into this
Agreement;

 

as of the Effective Date, there are no existing or threatened actions, suits or
claims pending against it with respect to its right to enter into and perform
its obligations under this Agreement;

 

as of the Effective Date, it has not granted, and it will not employ or license,
right, title or interest in or to the Novartis Non-Severable Improvements, the
Novartis Severable Sole Improvements and/or Joint Improvements which is in
conflict with the rights or licenses granted to Unigene under this Agreement, or
is inconsistent with this Agreement and

 

there is nothing in any Third Party agreement Novartis has entered into as of
the Effective Date, which, in any way, will limit Novartis’ ability to perform
all of the obligations undertaken by Novartis hereunder, and that it will not
enter into any agreement after the Effective Date under which Novartis would
incur any such limitations.

 

CONFIDENTIALITY AND EXCHANGE OF INFORMATION

 

Confidential Information. Except as expressly provided herein, the Parties agree
that, for the Term of this Agreement and for ten (10) years thereafter, the
receiving Party shall keep completely confidential and shall not publish or
otherwise disclose and shall not use for any purpose except for the purposes
contemplated by this Agreement any Confidential Information furnished to it by
the disclosing Party hereto pursuant to this Agreement, except that to the
extent that it can be established by the receiving Party by competent proof that
such Confidential Information:

 

            was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure;

 

was generally available to the public at the time of its disclosure to the
receiving Party;

 

became generally available to the public after its disclosure and other than
through any act or omission of the receiving Party in breach of this Agreement;

 

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            was independently developed by the receiving Party without reference
to any information or materials disclosed by the disclosing Party; or

 

was subsequently disclosed to the receiving Party by a person other than a Party
without breach of any legal obligation to the disclosing Party.

 

The foregoing obligations shall be in addition to, and not in lieu of, the
obligations of confidentiality set forth in the Confidentiality Agreement.

 

Permitted Disclosures.

 

            Each Party hereto may disclose the other’s Confidential Information
to the extent such disclosure is reasonably necessary in connection with the
conduct of the development activities to be conducted hereunder, prosecuting or
defending litigation, complying with applicable governmental regulations or
otherwise submitting information to tax or other governmental authorities or
conducting clinical trials, provided that if a Party is required to make any
such disclosure of another Party’s Confidential Information, it will give
reasonable advance notice to the latter Party of such disclosure and, will use
its commercially reasonable best efforts to secure confidential treatment of
such information prior to its disclosure (whether through protective orders or
otherwise). In no event shall Novartis, its Affiliate or any Third party include
Unigene Confidential Information in any patent application without written
consent from Unigene, nor disclose such information to any non-governmental
Third Party unless the Third Party has entered into a Confidentiality Agreement
at least as protective as this Article 8. Similarly, in no event shall Unigene,
its Affiliate or any Third Party include Novartis Confidential Information in
any patent application without written consent from Novartis, nor disclose such
information to any non-governmental Third Party unless the Third Party has
entered into a Confidentiality Agreement at least as protective as this Article
8.

 

Notwithstanding anything in this Agreement or in any other agreement to the
contrary, each Party to this Agreement (and each employee, representative, or
other agent of each Party) may (but is not required to) disclose to any and all
persons, without limitation of any kind, the tax treatment and tax structure of
the transaction contemplated by this Agreement and the other agreements and
instruments to be executed in connection herewith, as of the earlier of (a) the
date of public announcement of discussions relating to the transactions
contemplated by this Agreement, (b) the date of public announcement of such
transactions, or (c) the date of the execution of the Agreement to enter into
such transactions; provided, however, that such disclosure shall be prohibited
to the extent required to comply with any applicable federal or state securities
laws; and provided further that the confidentiality provisions of this Agreement
and the other agreements and instruments relating to the transactions between
the Parties shall continue to apply to information that is irrelevant to
understanding the tax treatment or tax structure of the transactions
contemplated hereby and thereby (including, without limitation, the names and
other identifying details

 

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of any Party to this Agreement). The preceding sentences are intended to cause
the transaction contemplated herein to be treated as not having been offered
under conditions of confidentiality for purposes of Section 1.6011-4(b)(3) (or
any successor provision) of the Internal Revenue Code (the “Code”) and shall be
construed in a manner consistent with such purpose. Each Party recognizes that
the privilege each has with respect to the confidentiality of the transaction
contemplated by this Agreement or the confidentiality of a communication
relating to such transaction, including a confidential communication with its
attorney or with a federally authorized tax practitioner under Section 7252 of
the Code, is not intended to be waived by the foregoing.

 

Novartis and its Affiliates hereby agree to be parties to the Confidentiality
Agreement described in Section 1.10 as of its effective date.

 

Public Announcements. No public announcement or other disclosure to Third
Parties concerning the existence of, terms, or subject matter of this Agreement
shall be made, either directly or indirectly, by any Party to this Agreement,
except as may be legally required or as may be required for recording purposes,
without first obtaining the approval of the other Party and agreement upon the
nature and text of such announcement or disclosure. The Party desiring to make
any such public announcement or other disclosure (including, without limitation,
those which are legally required or may be required for recording purposes)
shall inform the other Party of the proposed announcement or disclosure in
reasonably sufficient time prior to public release, which shall be at least
three (3) business days prior to release of such proposed announcement or
disclosure, and shall provide the other Party with a written copy thereof, in
order to allow such other Party to comment upon such announcement or disclosure.
Each Party agrees that it shall cooperate fully with the other with respect to
all disclosures regarding this Agreement to the Securities Exchange Commission
and any other governmental or regulatory agencies, including, without
limitation, requests for confidential treatment of proprietary information of
either Party included in any such disclosure. Notwithstanding the foregoing,
Novartis hereby agrees that Unigene shall be entitled to issue a press release
in the form attached hereto as Exhibit H without the need for further approval
by Novartis.

 

Publications. Neither Party shall submit for written or oral publication any
manuscript, abstract or the like which includes data or other information
containing the other Party’s Confidential Information without first obtaining
the prior written consent of the other Party, which consent shall not be
unreasonably withheld, and shall be promptly given or refused. In no event shall
either party be required to approve publication of its Know-How or other
Confidential Information. Nothing herein shall be construed to prevent Novartis
from disclosing on a need to know basis any information received from Unigene
hereunder to an Affiliate, Third Party distributor, research or clinical
contractor of Novartis, provided, such recipient shall be bound by
confidentiality obligations as set out herein with respect to Confidential
Information. Nothing herein shall be construed to prevent Unigene from
disclosing any information on a need to

 

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know basis received from Novartis or its Affiliate to a Third Party distributor,
research or clinical contractor, licensee or potential licensee of Unigene
provided such recipient shall be bound by confidentiality provisions set out
herein with respect to Confidential Information.

 

Bankruptcy. All Confidential Information disclosed by one Party to the other
shall remain the intellectual property of the disclosing Party. In the event
that a court or other legal or administrative tribunal, directly or through an
appointed master, trustee or receiver, assumes partial or complete control over
the assets of a Party to this Agreement based on the insolvency or bankruptcy of
such Party, the bankrupt or insolvent Party shall promptly notify the court or
other tribunal (i) that Confidential Information received from the other Party
under this Agreement remains the property of the other Party, and (ii) of the
confidentiality obligations under this Agreement. In addition, the bankrupt or
insolvent Party shall, to the extent permitted by law, take all steps necessary
or desirable to maintain the confidentiality of the other Party’s Confidential
Information and to ensure that the court, other tribunal or appointee maintains
such information in confidence in accordance with the terms of this Agreement.

 

INDEMNIFICATION

 

Indemnification of Novartis. Unigene shall indemnify and hold harmless Novartis
and its respective Affiliates, directors, officers, employees, agents and
counsel, and the successors and assigns of the foregoing (the “Novartis
Indemnitees”), from and against any and all liabilities, damages, losses, costs
or expenses (including reasonable attorneys’ and professional fees and other
expenses of litigation and/or arbitration) resulting from a claim, suit or
proceeding brought by a Third Party against a Novartis Indemnitee, to the extent
arising from or occurring as a result of (a) Unigene’s material breach of this
Agreement, or (b) the research, development, commercialization and/or marketing
of any Unigene Drug Products by Unigene, its Affiliates, designees, sublicensees
and Joint Ventures, except, in each case, to the extent caused by the negligence
or willful misconduct of Novartis (including their respective Affiliates and
sublicensees) or to the extent that Novartis is obligated to indemnify Unigene
under Section 9.2 below or pursuant to the Clinical Supply Agreement or Contract
Manufacturing Agreement. It is understood that the foregoing indemnity does not
include any lost profits or consequential damages.

 

Indemnification of Unigene. Novartis shall indemnify and hold harmless Unigene
and its Affiliates and their respective directors, officers, employees, agents
and counsel and the successors and assigns of the foregoing (the “Unigene
Indemnitees”), from and against any and all liabilities, damages, costs or
expenses (including reasonable attorneys’ and professional fees and other
expenses of litigation and/or arbitration) brought by a Third Party against a
Unigene Indemnitee, arising from or occurring as a result of: (a) the conduct of
clinical trials and development activities

 

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related to API, Amidating Enzyme, Intermediates and/or Novartis Drug Products by
either Novartis or its Affiliates or sublicensees, (b) the research,
development, manufacture, marketing and/or commercialization of any Novartis
Drug Product by Novartis or its Affiliates or sublicensees (including without
limitation, Novartis Drug Product liability claims, (c) the use of the Licensed
Technology by Novartis or its Affiliates or sublicensees except as is expressly
authorized pursuant to this Agreement, or (d) any material breach of this
Agreement by Novartis except, in each case, to the extent caused by the
negligence or willful misconduct of Unigene, its Affiliates, designees,
sublicensees and Joint Ventures or to the extent that Unigene is obligated to
indemnify Novartis under Section 9.1. It is understood that the foregoing
indemnity does not include any lost profits or consequential damages.

 

Procedure. A Party (the “Indemnitee”) that intends to claim indemnification
under this Article 9 shall promptly notify the other Party (the “Indemnitor”) in
writing of any loss, claim, damage, liability or action in respect of which the
Indemnitee or any of its Affiliates, sublicensees or their directors, officers,
employees, agents or counsel intend to claim such indemnification, and the
Indemnitor shall have the right to participate in, and, to the extent the
Indemnitor so desires, to assume the defense thereof with counsel mutually
satisfactory to the Parties. The indemnity agreement in this Article 9 shall not
apply to amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is made without the consent of the Indemnitor, which
consent shall not be withheld unreasonably. The failure to deliver written
notice to the Indemnitor within a reasonable time after the commencement of any
such action, if prejudicial to its ability to defend such action, shall relieve
such Indemnitor of any liability to the Indemnitee under this Article 9. At the
Indemnitor’s request, the Indemnitee under this Article 9, and its employees and
agents, shall cooperate fully with the Indemnitor and its legal representatives
in the investigation and defense of any action, claim or liability covered by
this indemnification and provide full information with respect thereto.

 

DISCLAIMER OF WARRANTIES

 

THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. UNIGENE AND
NOVARTIS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR
IMPLIED, WITH RESPECT TO THE LICENSED TECHNOLOGY, EACH OF THEIR RESEARCH,
DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT
LIMITATION, WHETHER THE UNIGENE AND/OR THE NOVARTIS DRUG PRODUCTS CAN BE
SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY,
RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS,
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE UNIGENE
AND/OR THE NOVARTIS DRUG PRODUCTS. EXCEPT AS EXPRESSLY PROVIDED IN THIS
AGREEMENT, IN NO EVENT SHALL EITHER UNIGENE OR NOVARTIS BE LIABLE TO THE OTHER
FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES UNDER OR
INCIDENTAL TO THIS AGREEMENT, ITS PERFORMANCE OR THE NEGOTIATIONS LEADING UP TO
ITS ENTRY, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, LOSS OF OR DAMAGE TO
GOODWILL OR TO

 

- 24 -

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ANY OTHER EXPECTATION BENEFIT, OR LIABILITY TO THIRD PARTIES, EXCEPT AS PROVIDED
FOR IN ARTICLE IX.

 

TERM AND TERMINATION

 

Term. This License Agreement shall be effective as of the Effective Date. Unless
this License Agreement is otherwise terminated earlier pursuant to provisions of
this Article 11, this License Agreement shall continue in full force and effect
until date which first occurs of (a) the date Novartis and its Affiliates cease
to manufacture API for use in Novartis Drug Products and in Unigene Drug
Products or (b) the date Novartis and/or its Affiliates decide not to
manufacture API.

 

Termination for Material Breach. Either Party may terminate this License
Agreement in the event the other Party and/or its Affiliates and/or its Joint
Ventures have materially breached or defaulted in the performance of any of its
obligations hereunder, and if such default is not corrected within sixty (60)
days after receiving written notice from the other Party with respect to such
default, such other Party shall have the right to terminate this Agreement by
giving written notice to the Party in default, provided the notice of
termination is given within one (1) year of when the Party giving notice knew or
should have known of the default and prior to correction of the default;
provided that the time period for providing such notice of termination shall be
extended for so long as the Parties are engaged in good faith negotiations to
resolve the situation. Notwithstanding the above, in the case of a failure of
Novartis to pay any Royalty, and/or Milestone, and/or upfront payment due
hereunder, the period for cure of any such failure to pay following written
notice from Unigene thereof shall be thirty (30) days and, unless payment is
made by Novartis within such period or unless Novartis has notified Unigene that
a good faith dispute exists regarding Novartis’ failure to pay, the termination
shall become effective at the end of such thirty (30) day period.

 

Termination for Insolvency; Retention of License. If voluntary or involuntary
proceedings by or against a Party are instituted in bankruptcy under any
insolvency law, or a receiver or custodian is appointed for such Party, or
proceedings are instituted by or against such Party for corporate reorganization
or the dissolution of such Party, which proceedings, if involuntary, shall not
have been dismissed within sixty (60) days after the date of filing, or if such
Party makes an assignment for the benefit of creditors, or substantially all of
the assets of such Party are seized or attached and not released within sixty
(60) days thereafter, the other Party may immediately terminate this Agreement
effective upon notice of such proceeding. Notwithstanding the bankruptcy of a
Party, or the impairment of performance by a Party of its obligations under this
Agreement as a result of bankruptcy or insolvency of such Party, and subject to
such Party’s rights to terminate this Agreement for reasons other than
bankruptcy or insolvency as expressly provided in this Agreement, the other
Party shall be entitled to retain the licenses under the terms and conditions
granted herein.

 

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General Effect of Termination.

 

            Accrued Obligations. Termination of this Agreement for any reason
shall not release any Party hereto from any liability which, at the time of such
termination, has already accrued to the other Party or which is attributable to
a period prior to such termination, nor preclude either Party from pursuing any
rights and remedies it may have hereunder or at law or in equity which accrued
or are based upon any event occurring prior to such termination.

 

Return of Materials. Upon any termination of this Agreement except as for
termination by Novartis according to Section 11.2, Novartis shall promptly
return to Unigene all of Unigene’s Confidential Information in Novartis’
possession or control (except for one copy of Confidential Information which is
to be retained in the confidential files of Novartis for record purposes only).
Upon any termination of this Agreement, Unigene shall promptly return to
Novartis all of Novartis’ Confidential Information in Unigene’s possession or
control (except for one copy of Confidential Information which is to be retained
in the confidential files of Unigene for record purposes only).

 

Stock on Hand. In the event that this Agreement is terminated for any reason,
other than upon the occurrence of a material breach by Novartis pursuant to
Section 11.2, after commencement of commercial sales of Novartis Drug Products
by Novartis and/or its Affiliates and sublicensees, Novartis and its Affiliates
and sublicensees shall have the right to sell (as to Novartis Drug Product only)
or otherwise dispose of the stock of any Novartis Drug Products then on hand for
up to six (6) months after the date of termination, subject to Article 3 and the
other applicable terms of this Agreement, including, but not limited to, royalty
obligations. If Unigene terminates this Agreement pursuant to Section11.2,
Novartis and its Affiliates and sublicensees shall immediately cease all sales
of Novartis Drug Products.

 

Termination of Licenses for material breach by Novartis. Subject to Section
11.4.3, upon termination of this Agreement by Unigene due to an uncured material
breach by Novartis pursuant to Section 11.2, the licenses granted to Novartis
under this Agreement shall terminate.

 

Material Breach by Unigene. In the event of disclosure of Licensed Technology in
violation of this Agreement and/or the Contract Manufacturing Agreement by
Unigene to a Third Party so as to enable a Third Party to manufacture API for
commercial purposes, and at the sole option of Novartis all provisions of this
Agreement shall remain in full force and effect with the exception of Sections
** which shall terminate with immediate effect, provided Novartis does not
terminate the Agreement as per Section 11.2. In all other events of a material
breach by Unigene, and provided Novartis, in its sole discretion, does not
terminate the Agreement as per Section 11.2, all provisions of this Agreement
shall remain in full force and effect, with

 

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the exception that the **, and Sections **, provided Novartis does not terminate
the Agreement accordance with Section 11.2.

 

Bankruptcy Provisions. All rights to the Licensed Technology granted to Novartis
under Article 2 hereof are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101(52) of the U.S. Bankruptcy Code. The
Parties agree that Novartis, as licensee of such rights, shall retain and may
fully exercise all of its rights and elections under the U.S. Bankruptcy Code,
subject to performance by Novartis of its obligations under this Agreement. The
Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against Unigene under the U.S. Bankruptcy Code, Novartis shall
be entitled to a complete duplicate of (or complete access to, as appropriate)
any such intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession, shall be promptly
delivered to Novartis (a) upon any such commencement of a bankruptcy proceeding
upon written request therefore by Novartis, unless Unigene elects to continue to
perform all of its obligations under this Agreement, or (b) if not delivered
under (a) above, upon the rejection of this Agreement by or on behalf of Unigene
upon written request therefore by Novartis, provided, however, that upon
Unigene’s (or its successor’s) written notification to Novartis that Unigene is
again willing and able to perform all of its obligations under this Agreement,
Novartis shall promptly return all such tangible materials to Unigene.

 

Survival. Articles 2.4.1.2, 2.4.1.3, 2.4.2.2, 2.4.3 (survives the License
Agreement as long as the Contract Manufacturing Agreement is in effect) 3.7,
3.8, 3.9, 3.10, 6.2.2, 6.2.3, 6.2.5, 6.2.6,8, 9, 10,11, 12.1, 12.3, 12.4, 12.6,
12.9, 12.10, 12.11, shall survive the expiration or termination of this
Agreement for any reason. In addition, any other provision required to interpret
and enforce the Parties’ rights and obligations under this Agreement shall also
survive, but only to the extent required for the observation and performance of
the aforementioned surviving portions of this Agreement.

 

MISCELLANEOUS

 

Governing Law. This Agreement shall be deemed to have been made in the State of
New Jersey, U.S.A., and its form, execution, validity, construction and effect
shall be determined in accordance with, and any dispute arising from the
performance or breach hereof shall be governed by and construed in accordance
with, the laws of the State of New Jersey, without reference to conflicts of
laws principles. Each of the Parties irrevocably submits to the exclusive
jurisdiction of the state and federal courts situated in the State of New Jersey
for purposes of any suit, action or other proceeding arising out of this
Agreement or any transaction contemplated hereby and agrees not to commence any
action, suit or proceeding relating hereto except in such courts. NO PARTY
HERETO SHALL CHALLENGE OR CONTEST THE

 

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SUBJECT MATTER OR PERSONAL JURISDICTION OF ANY SUCH COURT OR ITS VENUE OR ASSERT
THE DEFENSE OF “FORUM NONCONVENIENS”.

 

Waiver. Neither Party may waive or release any of its rights or interests in
this Agreement except in writing. 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. No waiver by either
Party of any condition or term in any one or more instances shall be construed
as a further or continuing waiver of such condition or term or of another
condition or term.

 

Assignment. This Agreement shall not be assignable by either Party to any Third
Party without the written consent of the other Party hereto; except either party
may assign this Agreement, without such consent, to (i) an Affiliate or (ii) an
entity that acquires all or substantially all of the capital stock, business or
assets of the Party to which this Agreement pertains, (whether by merger,
reorganization, acquisition, sale, or otherwise) and agrees in writing to be
bound by the terms and conditions of this Agreement. The terms and conditions of
this Agreement shall be binding on and inure to the benefit of the permitted
successors and assigns of the Parties.

 

Notices. Any notices, requests and other communications hereunder shall be in
writing and shall be personally delivered or sent by international express
delivery service, registered or certified air mail, return receipt requested,
postage prepaid, or by facsimile (confirmed by prepaid registered or certified
air mail letter or by international express delivery mail) (e.g., FedEx)), and
shall be deemed to have been properly served to the addressee upon receipt of
such written communication, to the following addresses of the Parties, or such
other address as may be specified in writing to the other:

 

If to Novartis:

  

Novartis Pharma AG

      Lichtstrasse 35

      4002 Basel, Switzerland

      Attention: Herve Girsault

      Telephone: +41 61 324 68 77

      Telecopy: +41 61 324 23 22

with copies to:

   General Counsel

 

All notices properly delivered to Novartis as provided in this Section 12.4
shall satisfy all of Unigene’s notification obligations hereunder.

 

If to Unigene:

  

Unigene Laboratories, Inc.

      110 Little Falls Road

      Fairfield, NJ 07004

      Attention: President

      Telephone: 973-882-0860

      Telecopy: 973-227-6088

 

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with copies to:

  

Dechert LLP

      Princeton Pike Corporate Center

      P.O. Box 5218

      Princeton, New Jersey 08543-5218

    

      For deliveries:

      Dechert LLP

      Princeton Pike Corporate Center

      997 Lenox Drive

      Building 3, Suite 210

      Lawrenceville, New Jersey 08648

    

      Attention:

      Telephone:

      Telecopy:

  

James Marino, Esq.

609-620-3214

609-620-3259

 

Any Party may change the address to which notices, requests, demands, claims,
and other communications hereunder are to be delivered by giving the other
Parties notice in the manner herein set forth.

 

Force Majeure. Neither Party shall be liable to the other for failure or delay
in the performance of any of its obligations under this Agreement for the time
and to the extent such failure or delay is caused by earthquake, riot, civil
commotion, terrorism, war, hostilities between nations, governmental law, order
or regulation, embargo, action by the government or any agency thereof, act of
God, storm, fire, accident, labor dispute or strike, sabotage, explosion or
other similar or different contingencies, in each case, beyond the reasonable
control of the respective Party. The Party affected by force majeure shall
provide the other Party with full particulars thereof as soon as it becomes
aware of the same (including its best estimate of the likely extent and duration
of the interference with its activities), and will use its commercially
reasonable efforts to overcome the difficulties created thereby and to resume
performance of its obligations as soon as practicable. If the performance of any
obligation under this Agreement is delayed owing to a force majeure for any
continuous period of more than six (6) months, the Parties hereto shall consult
with respect to an equitable solution including, without limitation, the
possible termination of this Agreement.

 

Independent Contractors. Nothing contained in this Agreement is intended
implicitly, or is to be construed, to constitute Novartis or Unigene as partners
or joint venturers in the legal sense. No Party hereto shall have any express or
implied right or authority to assume or create any obligations on behalf of or
in the name of any other Party or to bind any other Party to any contract,
agreement or undertaking with any Third Party.

 

Other Obligations. Except as expressly provided in this Agreement or as
separately agreed upon in writing between Unigene and Novartis, each Party shall
bear its own costs incurred in connection with the implementation of the
obligations under this Agreement.

 

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Severability. If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law. In the event that the terms and conditions of this Agreement are
materially altered as a result of the above, the Parties will renegotiate the
terms and conditions of this Agreement to resolve any inequities.

 

Further Assurances. At any time or from time to time on and after the date of
this Agreement, either Party shall at the request of the other Party (i) deliver
to the requesting Party such records, data or other documents consistent with
the provisions of this Agreement, (ii) execute, and deliver or cause to be
delivered, all such consents, documents or further instruments of assignment,
transfer or license, and (iii) take or cause to be taken all such actions, as
the requesting Party may reasonably deem necessary or desirable in order for the
requesting Party to obtain the full benefits of this Agreement and the
transactions contemplated hereby.

 

Entire Agreement, Waivers, Etc. This Agreement, including all its Exhibits,
together with the Confidentiality Agreement constitutes the entire agreement,
both written or oral, with respect to the subject matter hereof, and supersedes
and terminates all prior or contemporaneous understandings or agreements,
whether written or oral, between the Parties with respect to such subject matter
hereof. In the event of any conflicts among the Agreements, this Agreement shall
govern. No terms or provisions of this Agreement shall be varied or modified by
any prior or subsequent statement, conduct or act of either of the Parties,
except that the Parties may amend this Agreement by written instruments
specifically referring to and executed in the same manner as this Agreement.

 

Headings, Construction and Interpretations. The headings used in this Agreement
have been inserted for convenience of reference only and do not define or limit
the provisions hereof. The Parties have participated jointly in the negotiation
and drafting of this Agreement. In the event an ambiguity or question of intent
or interpretation arises, this Agreement shall be construed as if drafted
jointly by the Parties and no presumption or burden of proof shall arise
favoring or disfavoring any Party by virtue of the authorship of any of the
provisions of this Agreement. Whenever the words “include”, “includes” or
“including” are used in this Agreement, they shall be deemed to be followed by
the words “without limitation”. The words “hereof”, “herein” and “hereunder” and
words of similar import when used in this Agreement shall refer to this
Agreement as a whole and not to any particular provision of this Agreement. All
terms defined in this Agreement shall have the defined meanings when used in any
certificate or other document made or delivered pursuant hereto unless otherwise
defined therein. The definitions contained in this Agreement are applicable to
the singular as well as the plural forms of such terms and to the masculine as
well as to the feminine and neuter genders of such term.

 

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Counterparts. This Agreement may be executed in any number of counterparts, each
of which shall be deemed an original and all of which together shall constitute
one and the same instrument even if both Parties have not executed the same
counterpart.

 

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IN WITNESS WHEREOF, the Parties hereto have caused this License Agreement to be
duly executed by their authorized representatives as of the Effective Date.

 

UNIGENE LABORATORIES, INC.

     

NOVARTIS PHARMA AG

By:   /S/    WARREN P. LEVY               By:   /S/    HERVE GIRSAULT        
Name:   Warren P. Levy       Name:   Herve Girsault Title:   President and Chief
Executive Officer       Title:   Head, Global Partnering Date:  

4/7/04

      Date:  

4/7/04

            By:   /S/    BETTINA EGLI                     Name:   Bettina Egli  
          Title:   Legal Counsel             Date:  

4/7/04

 

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EXHIBIT A

 

CLINICAL SUPPLY AGREEMENT

 

THIS CLINICAL SUPPLY AGREEMENT (this “Agreement”) is entered into as of April
7th, 2004 (the “Effective Date”), by and between Novartis Pharma AG, a Swiss
corporation (“Novartis”), and Unigene Laboratories, Inc., a Delaware corporation
(“Unigene”) (each a “Party” and collectively, the “Parties”). All terms not
otherwise defined herein shall have their respective meaning as set forth in the
License Agreement and the Contract Manufacturing Agreement (as defined below).

 

1. GENERAL SCOPE OF AGREEMENT

 

In connection with that certain License Agreement, dated as of the date hereof,
by and between Novartis and Unigene (the “License Agreement”), and that certain
Contract Manufacturing Agreement between ** GmbH and Unigene, Unigene hereby
agrees to manufacture, sell and deliver to Novartis the quantities of material
described in the Task Order attached hereto as Exhibit A (the “Product”), and in
conformity with the terms of the Task Order and the Quality Assurance Agreement
entered into by Unigene and Novartis as of the date hereof attached hereto as
Exhibit B (the Task Order and the Quality Assurance Agreement are referred to
collectively herein as the “Quality Requirements”).

 

2. TERM OF AGREEMENT

 

Unless sooner terminated pursuant to Paragraph 12, this Agreement shall commence
on the date set forth above and shall continue in force until the Termination
Date as defined herein. The Termination Date shall be the date on which Novartis
accepts the final shipment of Product to be delivered pursuant to Paragraph 3C
of this Agreement.

 

3. ACCEPTANCE AND PAYMENT

 

  A. Acceptance

 

  (1) Product delivered pursuant to this Agreement shall be subject to
inspection at Novartis’ facilities for compliance with the Quality Requirements.

 

  (2) Within forty-five (45) days after the applicable shipment of the Product
is received by Novartis at the specified Novartis location, and Unigene has
provided the documentation required by the Task Order, Novartis may analyze the
shipment of the Product If Novartis determines that any shipment of Product, in
whole or in part, fails to conform to the Quality Requirements, Novartis shall
so inform Unigene in writing describing the reason for such rejection in detail
and providing copies of all written materials upon which such rejection is
based.

 

  B. Consequences of Rejection

 

If Unigene receives a complaint under Paragraph 3(A), the following procedures
shall apply:

 

A-1

--------------------------------------------------------------------------------

  (a) If the alleged defect concerns the quantity or quality of the API
delivered and Unigene accepts the details submitted by Novartis as to the API’s
noncompliance, Unigene shall supply to Novartis (at Unigene’s cost, including
the cost of raw materials and components related thereto) the replacement
quantity of the API that was allegedly missing or defective from the original
batch.

 

  (b) If the alleged defect concerns the quantity or quality of the API
delivered and Unigene does not accept the details submitted by Novartis, then
within thirty (30) days from the date on which the details of Novartis’
complaint are received by Unigene, Unigene will appoint an independent
scientific and technical expert acceptable to Novartis to review Novartis’
details supporting its complaint of noncompliance. Novartis shall not
unreasonably refuse to accept the appointment of the independent scientific and
technical expert identified by Unigene. The findings of the expert shall be
final and conclusively binding on the parties as to whether the API complies
with the Quality Requirements. If the analysis of the expert does not confirm
Novartis’ complaint, Novartis shall pay for any replacement quantities delivered
by Unigene. If the expert holds that the API does not meet the Quality
Requirements, all the fees and costs of the expert and the independent
laboratory appointed by the expert to analyze the API shall be paid by Unigene,
and Novartis shall have no obligation to pay for such replacement quantities of
API and Unigene shall be responsible for all costs associated therewith
(including the cost of raw materials, components and shipment related thereto).
If the expert rejects Novartis’ complaint, all such fees and costs of the
laboratory and the expert will be paid by Novartis, Novartis shall pay for any
replacement quantities delivered by Unigene in addition to the original
quantities delivered, and Novartis shall be considered to have finally and
completely accepted such batch of the API.

 

  C. Except as otherwise provided in Paragraph 3B(b), Novartis shall pay for
Product accepted by it within forty-five (45) days after receipt by Novartis of
an invoice from Unigene unless in dispute. All sums due to Unigene shall be
payable in United States Dollars by bank wire transfer in immediately available
funds to such bank account as Unigene shall designate. The Product will be
shipped, at Novartis’ cost, from Unigene FCA Boonton, New Jersey INCOTERMS 2000
in accordance with Novartis’ shipping instructions as provided in writing to
Unigene. In addition, Unigene shall use Novartis’ designated carrier and shall
ship the Product to the address designated on the Task Order. Risk of loss in
transit from Novartis’ designated carrier shall lie with Novartis. Unigene shall
cooperate with Novartis’ designated carrier and provide all required carrier
documentation for the shipment of Product. Novartis shall be responsible only
for those taxes imposed on a purchaser by operation of law.

 

  D.

Novartis has the right to purchase from Unigene a total of ** of Product (the
“Total Amount”) by ** (the “Obligated Date”) at a price of U.S. ** per ** (the
“Obligated Price”). The Total Amount comprises the sum of the “Obligated Amount”
(** of Product) and the “Additional Amount” (** of Product). Upon the Effective
Date, Novartis shall pay to Unigene a non-refundable payment of U.S. $2,100,000
for the order of the Product equal to the sum of (i) U.S. **, and (ii) U.S. **
The total of two million one hundred thousand dollars (U.S. $2,100,000) shall be
paid by Novartis to Unigene within ** days of the Effective Date. The payment in
Paragraph 3D(i) is

 

A-2

--------------------------------------------------------------------------------

 

payment in full for the Obligated Amount to be delivered in accordance with the
Task Order. The payment in Paragraph 3D(ii) is the down payment for the
Additional Amount to be delivered in accordance with the Task Order. Novartis
shall inform Unigene in writing on or before ** whether it wishes Unigene to
prepare and deliver the Additional Amount in accordance with the Task Order.
Unigene shall credit the U.S.** down payment in Paragraph 3D(ii) at $U.S. ** of
Product on a ** for each shipment invoiced to Novartis of Product which is part
of the Additional Amount, and Novartis shall pay the remainder of U.S.** of
Additional Amount. For example, if Unigene ships ** of Additional Product, the
aggregate purchase price will be ** of which will be credited against the down
payment (paid in accordance with Paragraph 3D (ii) and ** which will be due in
accordance with Paragraph 3C. If after Novartis has provided notice on or before
** that it wishes to purchase the Additional Amount, Novartis fails to purchase
all or part of the Additional Amount by the Obligated Date, then Novartis shall
pay Unigene the difference between (i) the Additional Amount multiplied by the
Obligated Price, and (ii) the amount actually paid to Unigene by Novartis for
the portion of Additional Amount purchased pursuant to this Agreement.

 

  E. Novartis may employ Product supplied by Unigene under this Agreement in
connection with ** clinical trials.

 

4. COMMUNICATIONS

 

In the Task Order, the Parties shall identify individuals who shall serve as the
Parties’ representatives as to technical and administrative matters. Except in
case of emergency, all communications between Novartis and Unigene shall be made
through these representatives. Any written communication required or deemed
necessary hereunder shall be deemed to have been properly served or sent if
delivered in person, sent by a recognized overnight delivery service, or
deposited in the United States mail, postage prepaid, for mailing by registered
or certified mail, and addressed to these representatives. Unigene shall
immediately inform Novartis of any occurrence that creates material uncertainty
as to Unigene’s ability to comply fully with any aspect of the Task Order.
Without limiting Unigene’s obligations pursuant to this Paragraph, the Parties’
technical representatives shall establish a regular schedule of conferences to
facilitate such communications.

 

5. INTELLECTUAL PROPERTY

 

Intellectual property matter shall be governed by Article 6 of the License
Agreement.

 

6. CONFIDENTIALITY AND EXCHANGE OF INFORMATION

 

Confidentiality and the Exchange of Confidential Information shall be governed
by Article 8 of the License Agreement.

 

7. PUBLICITY

 

Except as otherwise permitted by Section 8.3 of the License Agreement, neither
Party shall disclose either the fact or terms of this Agreement without the
prior written consent of the other Party except as required by law.

 

Neither Party will use, or authorize others to use, the name, symbols, or marks
of the other

 

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Party in any advertising or publicity material or make any form of
representation or statement with regard to this Agreement or any Task Order
issued hereunder which would constitute an express or implied endorsement by the
other Party of any commercial product or service without that other Party’s
prior written approval.

 

8. DOCUMENTATION, INSPECTIONS AND AUDITING

 

Unigene will document all aspects of its procedures as described in the Task
Order and Quality Assurance Agreement and will deliver to Novartis (or, where
applicable, make available to Novartis for inspection during mutually agreeable
times during normal business hours) in a timely manner all of the documentation
described in the Task Order. In addition, to the extent that such requests do
not include Unigene proprietary or trade secret information and do not conflict
with other contractual or legal obligations of Unigene, Unigene will cooperate
in good faith to provide any additional documentation that Novartis may
reasonably require to determine whether to accept or reject the Product. If
Unigene declines to provide any additional documentation in its possession and
requested by Novartis, then Novartis may, in its sole discretion, reject the
Product. During the term of this Agreement and for three (3) years thereafter
(or for such longer period as may be required by law, regulation, or other
administrative requirement), Unigene will maintain all books, records and other
documents (including but not limited to the documents referred to in Paragraph
8A) relating to the performance of this Agreement or required to be kept by law
or permit.

 

9. INDEMNIFICATION

 

  A. Unigene agrees to indemnify, defend and hold Novartis and its subsidiaries
and affiliates (including all officers, directors, employees, contractors and
agents of the foregoing) harmless from and against any and all third party
claims, demands, causes of action, damages, liabilities, losses, costs and
expenses, including attorneys’ fees (collectively, the “Claims”), arising out of
the negligence or willful misconduct of Unigene in the performance of
obligations under this Agreement (including, but not limited to, the performance
of Unigene’s employees, subcontractors or agents); or from the breach by Unigene
of its warranties, except to the extent that such Claims were caused by the
negligence or willful misconduct of Novartis. Unigene further agrees to
indemnify, defend and hold Novartis and its subsidiaries and affiliates
(including all officers, directors, employees, contractors and agents of the
foregoing) harmless from and against any and all Claims arising out of the
actual or alleged infringements of any patents, trademarks, copyrights or other
third party intellectual property rights arising from the manufacture of the
Product by Unigene.**.

 

  B.

Novartis agrees to indemnify, defend and hold Unigene and its subsidiaries and
affiliates (including all officers, directors, employees, contractors and agents
of the foregoing) harmless from and against any and all Claims, arising out of
the negligence or willful misconduct of Novartis in the performance of its
obligations under this Agreement (including, but not limited to, the performance
of Novartis’ employees, subcontractors or agents); or from the administration or
use of the Product by Novartis, except to the extent that such Claims were
caused by the negligence or willful misconduct of Unigene in the performance of
its obligations

 

A-4

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under this Agreement (including, but not limited to, the performance of
Unigene’s employees, subcontractors or agents); or from the breach by Unigene of
its warranties.

 

  C. The Party seeking indemnification (“Indemnitee”) will notify promptly the
Party from which indemnification is sought (“Indemnitor”) of any complaint,
claim or injury relating to any loss subject to indemnification hereunder.
Indemnitor shall have the right to select defense counsel and to direct and
control the defense or settlement of any such liability, claim, action or suit.
Indemnitee shall cooperate fully with Indemnitor and its legal representatives
in the investigation and defense relating to any loss subject to indemnification
hereunder.

 

  D. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, UNIGENE MAKES NO WARRANTIES
AS TO THE PRODUCT, AND SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES, INCLUDING
AS TO THE MERCHANTABILITY OF THE PRODUCT OR ITS FITNESS FOR A PARTICULAR PURPOSE
OR THAT THE USE OF THE PRODUCT WILL NOT INFRINGE ANY PATENT OR PROPRIETARY
RIGHTS HELD BY A THIRD PARTY.

 

10. INSURANCE

 

  A. Unigene agrees that it shall maintain liability insurance in the amount of
** for a period of five (5) years following termination of this Agreement.

 

  B. Upon execution of this Agreement, Unigene will provide Novartis with
evidence of Unigene’s insurance. Unigene will name Novartis as an additional
insured party under Unigene’s insurance policy. Unigene will not change or
cancel Unigene’s insurance program and will make all premium payments needed to
keep such insurance in force. In the event that Unigene becomes aware of any
changes to its insurance program, Unigene will promptly notify Novartis in
writing of such changes.

 

11. FORCE MAJEURE

 

Neither Party shall be liable to the other for any failure to deliver or receive
Product or for any delay in delivery or receipt of Product when such failure or
delay shall be caused (directly or indirectly) by fire; flood; accident;
explosion; equipment or machinery breakdown; sabotage; strike or any labor
disturbance (regardless of the reasonableness of the demands of labor); civil
commotion; riot; invasion; war; act of terrorism; any act, restraint,
requisition, regulation or direction of any governmental authority (whether or
not valid); shortage of labor, fuel, power or raw materials; inability to obtain
supplies; inability to obtain or delays of transportation facilities; any Act of
God; or any other event beyond the reasonable control of the Party whose
performance is affected (each, an “Event of Force Majeure”). The Party whose
performance is so affected shall provide prompt written notice to the other,
shall indicate the estimated duration of such Event of Force Majeure, and shall
use all commercially reasonable efforts to mitigate the effects of such Event of
Force Majeure.

 

A-5

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If, by reason of any such Event of Force Majeure, Unigene is excused from
performance, then, to the extent Product are not delivered to Novartis in the
quantities or at the times required hereunder, Novartis may purchase a
replacement product from other sources without liability or obligation to
Unigene. In the event Novartis purchases a replacement product from another
source, then Novartis may, to the full extent of such purchases, reduce its
quantity purchase commitment, if any, hereunder. All such quantities of
replacement product so purchased by Novartis shall be considered Product
purchased from Unigene for purposes of calculating discounts based on volume
allowed under this Agreement, if any. During any period of shortage due to any
of said Events of Force Majeure, Unigene shall allocate its supply of Product
fairly and equitably among its customers, including Novartis. In addition,
Novartis may, at its option, extend the Term of this Agreement to permit partial
or total delivery of Product not delivered because of any such Event of Force
Majeure. If such Event of Force Majeure continues for more than sixty (60) days,
Novartis has the option, at any time thereafter during which the Event of Force
Majeure is continuing, to terminate this Agreement without liability to Unigene,
except to pay for Product already accepted.

 

12. TERMINATION

 

  A. This Agreement and the Task Order issued hereunder may be terminated by
Novartis with or without cause upon thirty (30) days written notice to Unigene;
provided, however, that, if Novartis terminates this Agreement without cause,
together with the delivery of such written notice, Novartis shall deliver to
Unigene a termination payment**; provided further, however, that if Novartis
terminates this Agreement with cause, within thirty (30) days after such written
notice, Novartis shall deliver to Unigene a termination payment for costs
incurred by Unigene for any fulfillment of Unigene’s obligations under this
Agreement through the date of such written notice, . Upon receipt of such
written notice, Unigene shall cease all activities under this Agreement related
to the manufacture and delivery of the Product, except as to the delivery of
Product already accepted and paid for.

 

  B. In the event that (a) either Party becomes insolvent or is unable to pay
its debts as they become due, or a petition in bankruptcy or for reorganization
is filed by or against them, or a receiver is appointed of the whole or any
substantial portion of its property; or (b) either Party is in material breach
of its obligations hereunder, which breach remains uncured for sixty (60)
business days following receipt of written notice from the other specifying the
breach, then the other Party shall have the right to terminate this Agreement
with immediate effect, and without prejudice to its other rights or remedies, by
written notice of such election.

 

  C.

This Agreement and the Task Order may be terminated by either party for a
material breach upon sixty (60) days prior written notice, during which period
the other party shall have the opportunity to cure such breach. Notwithstanding
the above, in the case of a failure of Novartis to pay any payment due
hereunder, the period for cure of any such failure to pay following written
notice from Unigene thereof shall be thirty (30) days and, unless payment is
made by Novartis within such period or unless Novartis has notified Unigene that
a good faith dispute exists regarding Novartis’

 

A-6

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failure to pay, the termination shall become effective at the end of such thirty
(30) day period.

 

13. CONFORMANCE WITH LAW AND ACCEPTED PRACTICE; WARRANTIES

 

  A. Unigene shall perform this Agreement: (i) in a professional manner; and
(ii) in conformance with that level of care and skill ordinarily exercised in
similar circumstances by other manufacturers of products that are the same as or
similar to the Product. Unigene warrants that all Product furnished hereunder
has been manufactured, prepared for shipment and delivered to Novartis’
commercial carrier in accordance with all applicable federal, state and local
laws, rules, regulations, orders, ordinances and guidelines and good industry
practice. Unigene has and will maintain all licenses, permits, and similar
authorizations required for the manufacturing, processing and packaging of the
Product.

 

  B. Unigene warrants that all Product supplied hereunder: (i) is owned by
Unigene free of any lien, claim or encumbrance; (ii) conforms fully to every
specification set forth in the Task Order; (iii) conforms fully to every
specification set forth in the Quality Assurance Agreement; (iv) to Unigene’s
knowledge and belief, is free from contamination and any latent or patent
defects in design, materials or workmanship; (v) does not, to Unigene’s
knowledge and belief, infringe any patent, any other intellectual property right
or any other proprietary right of any third party for which Unigene does not
have a license; and (vi) is, to Unigene’s knowledge and belief, suitable for use
in humans; (vii) **; (viii) **. Without limiting the generality of the
foregoing, Unigene acknowledges and understands that Novartis may use the
Product, in Novartis’ sole discretion, as the active pharmaceutical ingredient
in clinical (human) trials, and Novartis acknowledges and understands that
Unigene: (1) has not received any governmental approval in the United States for
the use of the Product in humans; and (2) has no knowledge of any further
formulation of the Product by Novartis, nor of the protocol that Novartis may
utilize for human administration of the Product.

 

14. SUBCONTRACTORS

 

Unigene shall not subcontract any of this Agreement without the prior written
approval of Novartis. Any such approval shall not relieve Unigene of its
obligations under this Agreement.

 

15. APPLICABLE LAW

 

This Agreement shall be construed by and enforced in accordance with the laws of
the State of New Jersey without regard to principles of conflicts of laws. Any
lawsuit which may arise with respect to this Agreement shall be brought only in
a court of competent jurisdiction located in the State of New Jersey.

 

A-7

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16. INDEPENDENT CONTRACTOR

 

  A. In the performance of this Agreement, Unigene shall be deemed to be and
shall be an independent contractor and, as such, neither the Unigene nor its
employees shall be entitled to any benefits applicable to employees of Novartis.

 

  B. Neither Party is authorized or empowered to act as agent for the other for
any purpose and shall not on behalf of the other enter into any contract,
warranty or representation as to any matter. Neither Party shall be bound by the
acts or conduct of the other.

 

17. ENTIRE AGREEMENT

 

This Agreement, together with the Task Order (annexed hereto as Exhibit A), the
Quality Assurance Agreement (annexed hereto as Exhibit B), the License Agreement
including all its Exhibits represent the entire understanding between the
Parties with respect to the subject matter hereof and merge and supercede all
prior and contemporaneous agreements or understandings, oral or written with
respect thereto. None of the Agreements referenced in this Paragraph shall be
modified except by a writing signed by the Parties to the particular Agreement
to be modified specifying that it is a modification to the particular Agreement
to be modified

 

18. SEVERABILITY

 

The invalidity or unenforceability of any term or provision of this Agreement
shall not affect the validity or enforceability of any other term or provision
hereof.

 

19. ASSIGNMENT

 

This Agreement shall not be assignable by either Party to any third party
without the written consent of the other Party hereto; provided, however, that
either party may assign this Agreement, without such consent, to (i) an
affiliate; or (ii) an entity that acquires all or substantially all of the
capital stock, business or assets of Unigene to which this Agreement pertains,
(whether by merger, reorganization, acquisition, sale, or otherwise) and agrees
in writing to be bound by the terms and conditions of this Agreement. The terms
and conditions of this Agreement shall be binding on and inure to the benefit of
the permitted successors and assigns of the Parties.

 

20. WAIVER

 

The failure of a Party to insist upon strict adherence to any term of this
Agreement on any occasion shall not be considered a waiver or deprive that Party
of the right to insist upon strict adherence to that term or any other term of
this Agreement. Any waiver must be in writing and signed by the Party making the
waiver.

 

21. DEBARMENT CERTIFICATION

 

Unigene hereby represents and warrants that neither Unigene nor any person
employed by Unigene in connection with any work to be performed for or on behalf
of Novartis has been debarred under Section 306(a) or (b) of the Federal Food,
Drug and Cosmetic Act, and that no debarred person will in the future be
employed by the Unigene in connection with any work to be performed for or on
behalf of Novartis. If at any time after execution of this Agreement, the
Unigene becomes aware that the Unigene or any person employed by the Unigene in
connection with any work to be performed for or on behalf of Novartis shall
become or shall be in the process of being debarred, the Unigene hereby agrees
to so notify Novartis at once.

 

A-8

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22. SURVIVAL

 

The provisions of Paragraphs 5, 6, 7, 8B, 9, 10, 15, 18, 19 and 20 and this
Paragraph 22 shall survive the expiration or termination of this Agreement as
well as all payment obligations pending at the time of expiration or
termination, if any.

 

A-9

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their respective duly authorized representatives as of the day and year first
above written.

 

NOVARTIS PHARMA AG

/S/    HERVE GIRSAULT        

Name:   Herve Girsault Title:   Head, Global Partnering

 

/S/    BETTINA EGLI         Name:   Bettina Egli Title:   Legal Counsel

 

UNIGENE LABORATORIES, INC. /S/    WARREN P. LEVY             Warren P. Levy    
President and Chief Executive Officer

 

A-10

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EXHIBIT A

TASK ORDER

 

1. Product: recombinant calcitonin **

 

2. Quantity of Product: a total of **, to be supplied as follows:

 

  ** (Obligated Amount)

 

  ** (Obligated Amount)

 

  ** (Obligated Amount)

 

  ** (Additional Amount)

 

  ** (Additional Amount)

 

  ** (Additional Amount)

 

3. To be delivered to:

 

Robert Gallagher

 

One Health Plaza

 

East Hanover, NJ 07936

 

4. Product Specifications: as attached hereto in Schedule 1

 

5. Price: **

 

6. Supplier Procedure Documentation:

 

Unigene will provide the following documents and/or information to Novartis, it
being understood that any and all data to be provided in accordance with this
Task Order shall be in compliance with Section 2.2.4 (Right of Reference) of the
License Agreement:

 

  A. **

 

  B. **

 

  C. **

 

  D. **

 

  E. **

 

  F. **

 

  G. **

 

A - 1

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  H. **

 

  I. **

 

  J. **

 

  K. **

 

  L. **

 

  M. **

 

  N. **

 

  O. **

 

7. Contacts:

 

If to Novartis for Technical Matters:    If to Supplier for Technical Matters:
Simon Bateman, Ph.D/    Paul Shields, Ph.D. Director, Technical Research and
Development    Director, Plant Operations Novartis Pharmaceuticals Corporation
   Unigene Laboratories, Inc. One Health Plaza    83 Fulton St. East Hanover,
New Jersey 07936    Boonton, New Jersey 07005 If to Novartis for Administrative
Matters:    If to Supplier for Administrative Matters: Robert Wager    James P.
Gilligan, Ph.D, MSIB      Vice President of Product Development Novartis
Pharmaceuticals Corporation    Unigene Laboratories, Inc. One Health Plaza   
110 Little Falls Road East Hanover, New Jersey 07936    Fairfield, New Jersey
07004

 

A - 2

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SCHEDULE 1

PRODUCT SPECIFICATIONS

 

**

 

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EXHIBIT B

 

CONTRACT MANUFACTURING AGREEMENT

 

--------------------------------------------------------------------------------

EXHIBIT C **

 

**

 

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EXHIBIT D

 

UNIGENE SOLE IMPROVEMENTS

 

CONFIDENTIAL

 

1)

      **   **

2)

      **   **

3)

      **   **

 

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EXHIBIT E

 

**

 

 

Invention

--------------------------------------------------------------------------------

   Country

--------------------------------------------------------------------------------

    Status

--------------------------------------------------------------------------------

   

Application/

Patent #

--------------------------------------------------------------------------------

   

Application/

Issued

--------------------------------------------------------------------------------

    Expiration date

--------------------------------------------------------------------------------

    Number of
Patents

--------------------------------------------------------------------------------

 

**

         * *   * *   * *   * *   * *     

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

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**

   * *   * *   * *   * *   * *   * *

**

   * *   * *   * *   * *   * *   * *

 

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EXHIBIT F

 

PRODUCT SUPPLY AGREEMENT

 

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EXHIBIT G

 

PATENT SECURITY AGREEMENTS

 

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EXHIBIT H

 

UNIGENE PRESS RELEASE