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 AND DEVELOPMENT AGREEMENT
THIS LICENSE AND DEVELOPMENT AGREEMENT (this "Agreement") is made and
entered into as of November 26, 2002 (the "Effective Date") by and between
Xxxxxx-Xxxxx Laboratories, Inc., a corporation existing under the laws of the
State of Minnesota and which has offices at 00000 00/xx/ Xxxxxx Xxxxx,
Xxxxxxxxxxx, Xxxxxxxxx 00000 ("USL"), and Unigene Laboratories, Inc., a
corporation existing under the laws of the State of Delaware and which has
offices at 000 Xxxxxx Xxxxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx 00000 ("Unigene").
R E C I T A L S
WHEREAS, Unigene has developed certain proprietary technology for the
manufacture and formulation of salmon calcitonin suitable for nasal
administration;
WHEREAS, Unigene has undertaken testing, animal studies and human
clinical trials for its formulation of salmon calcitonin;
WHEREAS, USL wishes to obtain an exclusive license from Unigene under
Unigene's intellectual property rights to market Unigene's formulation of salmon
calcitonin in the United States;
WHEREAS, the parties intend that Unigene produce the salmon calcitonin
for USL and supply USL with Unigene's formulation of salmon calcitonin in filled
vials, labeled and packaged in bulk;
NOW, THEREFORE, in consideration of the foregoing and the mutual
promises, terms and conditions hereinafter set forth, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties do hereby agree to be legally bound as follows:
ARTICLE 1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
"Act" means the U.S. Food, Drug and Cosmetic Act, as amended, and
regulations promulgated thereunder.
"Affiliate", with respect to any party, shall mean any other Person
that, directly or indirectly, through one or more intermediaries, Controls, is
Controlled By or is Under Common Control With such Person.
"Agreement" shall have the meaning given in the opening paragraph of
this document.
"Agreement Term" shall have the meaning set forth in Section 16.1
below.
"Active Pharmaceutical Ingredient" or "API" shall mean bulk active
salmon calcitonin in lyophilized form ready for appropriate formulation and
filling into Vials.
"Amended Financing Statement" shall have the meaning set forth in
Section 13.1(c)(x) below.
"Annual Volume Cap" shall have the meaning set forth in Section 7.1(b)
below.
"Business Day" shall mean a day, Monday through Friday, on which banks
are open for business in New York, New York.
"Business Plan" shall have the meaning set forth in Section 11.4 below.
"cGMP" shall mean the current Good Manufacturing Practices as set forth
in 21 CFR (S)211, as amended from time to time.
"Confidential Information" shall mean all proprietary and confidential
business information, Technical Information, or data owned by a party and
disclosed by that party to the other party pursuant to this Agreement including,
without limitation, manufacturing, marketing, financial, personnel, scientific
and other business information and plans, and the material terms of this
Agreement, whether in oral, written, graphic or electronic form.
"Control" and, with correlative meanings, the terms "Controlled By" and
"Under Common Control With" shall mean the power to direct or cause the
direction of the management or policies of a Person, whether through the
ownership of voting securities, by contract, resolution, regulation or
otherwise.
"Cost of Goods Sold" shall mean manufacturing costs and expenses
incurred by USL (including labor and materials) in connection with assembling
and finishing Finished Product upon receipt of Vials supplied by Unigene
hereunder ** calculated in accordance with GAAP (as defined in the definition of
"Net Sales" below) **.
"Credit" and "Credits" shall have the meanings set forth in Section 4.3
below.
"Earned Royalty" has the meaning given in Section 4.1 below.
"Effective Date" shall mean the date set forth in the opening paragraph
of this Agreement.
"FDA" shall mean the U.S. Food and Drug Administration.
"Field" shall mean the nasal administration of salmon calcitonin to
human subjects for all indications now or hereafter approved by the FDA.
"Finished Product" shall mean Vials packaged (with the pump and
associated packaging) and labeled for sale to the ultimate consumer.
"First Amendment" shall have the meaning set forth in Section
13.1(c)(x).
"First Commercial Sale" shall mean the first sale of Finished Product
by USL to a Third Party.
"Forecast" shall have the meaning set forth in 7.2(a) below.
"Force Majeure" shall have the meaning set forth in Section 17.14
below.
"Free Samples" shall have the meaning set forth in Section 7.4(c)
below.
"Indemnitor" shall have the meaning set forth in Section 12.1(a) or
12.1(b) below, as applicable.
"Indemnitee" shall have the meaning set forth in Section 12.1(a) or
12.1(b) below, as applicable.
"Infringement Action" shall have the meaning set forth in Section 10.3
below.
"Innovator" shall mean the innovator listed in the Orange Book with
respect to the ** which there is a patent listing in the Orange Book.
"**" shall have the meaning set forth in Section 13.1(c)(x).
"Label", "Labeled", or "Labeling" means all labels and other written,
printed, or graphic matter upon: (i) API, Vials or Finished Product (as the case
may be) or any container or wrapper utilized with API, Vials or Finished Product
(as the case may be) or (ii) any written material accompanying API, Vials or
Finished Product (as the case may be).
"**" shall have the meaning set forth in Section 13.1(c)(x).
"**" shall have the meaning set forth in Section 13.1(c)(x).
"Licensed Patents" shall, subject to Section 2.5.4, mean any United
States patent (including any extension, reissue, reexamination, or the like
relating thereto) or patent application (including any provisional, divisional,
continuation or continuation-in-part and renewal applications) now or hereafter
owned by or licensed to Unigene that claims Product or any use of Product in the
Field, including, without limitation (i) Unigene's United States Patent No. **
issued on **; provided however, that any rights in Licensed Patents covering API
shall be limited to the right to use API in the Product, Vials and Finished
Product.
"Licensed Trademark" shall mean the trademark owned or controlled by
Unigene and designated by Unigene for use with Finished Product pursuant to
Section 11.2.
"Listed Patent" shall mean the patent(s) listed in the Orange Book in
connection with NDA No. ** for a nasal product whose active ingredient is salmon
calcitonin.
"Loss" and "Losses" shall have the meaning set forth in Section 12.1(a)
below.
"Market Year" means each twelve (12) month period following the first
day of the month following the First Commercial Sale, and in each successive
anniversary of that date.
"Milestone" shall have the meaning set forth in Section 3.2 below.
"Milestone Payment" shall have the meaning set forth in Section 3.2
below.
"Monthly Volume Cap" shall have the meaning set forth in Section 7.1(b)
below.
"NDA" shall mean the New Drug Application for the commercial sale of
Finished Product in the United States pursuant to 21 U.S.C. (S)355(b)(2).
"NDA Approval" shall mean final approval by the FDA of the NDA
permitting the commercial sale of Finished Product in the United States, and
such NDA being made effective pursuant to 21 U.S.C. (S)355(c)(3).
"Net Royalties" shall mean the sum of Earned Royalties for a given
Reporting Quarter minus the Transfer Price, minus the Cost of Goods Sold.
"Net Sales" shall mean the gross revenues earned or accrued
(determined in accordance with United States generally accepted accounting
principles consistently applied ("GAAP")) from sales of Finished Product, after
NDA Approval by USL or its Affiliates, to a Third Party; less all of the
following deductions (as applicable):
(a) transportation charges, including insurance, for transporting
Finished Product;
(b) sales and excise taxes and duties and any other governmental
charges imposed upon the production, importation, use or sale of
such Finished Product;
(c) trade, quantity and cash discounts **;
(d) allowances, refunds or credits to customers on account of
rejection or return of Finished Product (including returned,
spoiled, damaged, outdated or defective goods) or on account of
retroactive price reductions affecting Finished Product **;
(e) rebates and charge backs attributable to Finished Product,
including those granted to managed-care entities and government
agencies **;
(f) interest, service, finance, and sales carrying charges paid by
customers for extension of credit on sales **; and
(g) bad debt actually incurred.
Sales among USL and its Affiliates shall be excluded from the computation of Net
Sales unless Finished Product is administered or used by such Affiliate. Free
Samples shall not be included in the calculation of Net Sales and no Royalty
shall be payable with respect to Free Samples.
"Net Sales Shortfall" shall mean the amount by which Targeted Net Sales
exceed actual Net Sales in any Market Year for which Exhibit A provides for a
Targeted Net Sales objective.
"Notice of Second Amendment" shall have the meaning set forth in
Section 13.1(c)(x).
"OOS" shall have the meaning set forth in Paragraph 7 of Exhibit B.
"Orange Book" shall mean a publication of the FDA titled "Approved Drug
Products With Therapeutic Equivalence Evaluations".
"Packaging" means all primary containers, cartons, shipping cases,
inserts or any other like material used in packaging, or accompanying API, Vials
or Finished Product (as the case may be).
"Paragraph 4 Certification" shall mean a certification pursuant to 21
U.S.C. (S)355(b)(2)(A)(iv) that Product does not infringe the Listed Patent(s)
or that the Listed Patent(s) is/are invalid or unenforceable
"**" shall have the meaning set forth in Section 10.3 below.
"Person" shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including,
without limitation, a government or political subdivision, department or agency
of a government.
"Product" shall mean Unigene's proprietary formulation of salmon
calcitonin for nasal administration for all indications now or hereafter
approved by the FDA.
"Projections" shall have the meaning set forth in Section 5.1 below.
"PTO" shall have the meaning set forth in Section 3.1
"** Event" shall have the meaning set forth in Section 5.2(a) below.
"Rejected Vials" shall have the meaning set forth in Paragraph 5.1 of
Exhibit B.
"Reporting Date" shall have the meaning set forth in Section 6.2 below.
"Reporting Quarter" shall have the meaning set forth in Section 6.2
below.
"Restricted Business" shall have the meaning set forth in Section
14.1(a) below.
"Restricted Period" shall have the meaning set forth in Section 14.1(a)
below.
"Royalty" means, collectively and individually, both the Earned
Royalty and the Shortfall Royalty.
"SEC" shall mean the U.S. Securities and Exchange Commission.
"Second Amendment" shall have the meaning set forth in Section
13.1(c)(x).
"Section 9.2 Credit" shall have the meaning set forth in Section 9.2
below.
"Shortfall Royalty" shall have the meaning set forth in Section 5.2
below.
"SOP" and "SOPs" shall mean Unigene's Standard Operating Procedures.
"Specifications" shall mean the specifications which describe testing
methods and acceptance criteria for Vials as specified in the NDA, as such
specifications may be amended from time to time by mutual written agreement of
the parties or as requested or required by the FDA, including without limitation
such amendments to the NDA. The Specifications shall include, without
limitation: (a) the specifications for materials, packaging, components,
labeling, finished product and manufacturing controls for the Vials or API (as
applicable) covered under Unigene's Standard Operating Procedures (the "SOPs"),
Validation Documentation, policies or covered under any other materials
identified and committed to in any applicable regulatory application, and (b)(i)
material and component specifications (including approved suppliers and
distributors; physical, chemical and microbiological specifications, as
appropriate); (ii) Labeling specifications (including approved suppliers and
distributors, physical attributes, art proofs); (iii) sampling requirements (for
physical, chemical, microbiological testing); (iv) manufacturing requirements,
including processing and equipment requirements; (v) in-process control
specifications; (vi) Packaging requirements, including processing and equipment
requirements; (vii) Finished Product release requirements (including testing
methodology, equipment requirements, and release specifications); and (viii)
stability specifications (including testing methodology, equipment requirements
and testing specifications). All Specifications must comply with cGMP
requirements and be consistent with U.S. Pharmacopeia standards, National
Formulary standards and International Committee for Harmonization standards, as
applicable.
"Suspension Event" shall have the meaning set forth in Section 5.2(a)
below.
"Targeted Net Sales" shall mean the Net Sales objective for each Market
Year as provided for each such Market Year on Exhibit A.
"Technical Information" shall mean Unigene's proprietary formulation,
clinical, preclinical, animal and manufacturing information and data, regulatory
filings, unpublished patent applications and other proprietary information, all
of which shall, and does, constitute Unigene's Confidential Information.
"Territory" shall mean the United States of America, its territories
and its possessions.
"Third Party" shall mean any Person other than USL, Unigene or their
respective Affiliates.
"Third Party Infringement" shall have the meaning set forth in Section
10.2 below.
"Transfer Price" shall have the meaning set forth in Section 7.4(a)
below.
"Unit" shall mean one (1) unit of Finished Product.
"Vial" shall mean a labeled container of Product containing ** of
salmon calcitonin.
ARTICLE 2. LICENSE
2.1. License to USL under Licensed Patents.
(a) Subject to the terms and conditions herein, Unigene grants
USL an exclusive license in the Territory under the Licensed Patents to make,
have made, use, sell or offer for sale Finished Product (i) made from Vials
manufactured by, and purchased from, Unigene or its designees or (ii) produced
by USL to the extent provided in Sections 7.3(b) or 2.5 below.
(b) Subject to the terms and conditions herein and to the
extent required for USL to manufacture Product and Vials pursuant to Section 7.3
below, Unigene grants USL a nonexclusive license in the Territory under the
Licensed Patents to make, and use Product and Vials for use in the production of
Finished Product for sale in the Territory.
2.2. License to USL under Technical Information.
(a) Subject to the terms and conditions herein, Unigene grants
USL an exclusive license in the Territory under the Technical Information to
make, have made, use, sell or offer for sale Finished Product (i) made from
Vials manufactured by, and purchased from, Unigene or its designees or (ii)
produced by USL to the extent provided in Sections 7.3(b) or 2.5 below
(b) Subject to the terms and conditions herein and to the
extent required for USL to manufacture Product and Vials pursuant to Section 7.3
below, Unigene grants USL a nonexclusive license in the Territory under the
Technical Information to make, and use Product and Vials for use in the
production of Finished Product for sale in the Territory.
2.3. License to USL under Licensed Trademark. Subject to the terms and
conditions herein, Unigene grants USL an exclusive license in the Territory to
sell Finished Product marked with the Licensed Trademark.
2.4. Private Label Distributors. USL has the right to sell Finished
Product to Third Parties on a private label basis for distribution by the Third
Party of Finished Product under its own private label, subject to the approval
of Unigene which approval will not be unreasonably withheld.
2.5. License for Manufacture of API and Product If Unigene Does Not
Deliver. In order to provide USL the right to make, have made and use Product
and API in the event Unigene does not supply Vials or API as contemplated in
this Agreement, the parties now agree that, subject to and in accordance with
the terms of this Section 2.5, Unigene shall (and by this Section 2.5 does)
grant to USL a limited use right and license to make, have made, import and use
API and the Product for use in the production of Vials and Finished Product for
sale in the Territory, as described below in this Section 2.5.
2.5.1. License to USL under Licensed Patents. Subject to the
terms and conditions of this Section 2.5, Unigene grants USL a nonexclusive
license in the Territory under the Licensed Patents to make, have made and use
Product and/or API for use only in the production of Vials and Finished Product
for sale in the Territory in accordance with, and as contemplated by, this
Agreement.
2.5.2. License to USL under Technical Information. Subject to
the terms and conditions of this Section 2.5, Unigene grants USL a nonexclusive
license in the Territory under the Technical Information to make, have made,
import and use Product and/or API for use only in the production of Vials and
Finished Product for sale in the Territory in accordance with, and as
contemplated by, this Agreement. Unigene shall furnish Technical Information and
technical assistance to enable USL to exercise its rights under this Section
2.5.2.
2.5.3. Limitation on Exercise of License.
(a) USL agrees (i) not to exercise the rights and licenses
granted as of the date of this Agreement, under Sections 2.5.1 and 2.5.2 above
until such time as Unigene does not supply to USL Vials in accordance with the
terms of Section 7.3(a) and in such event to exercise its rights and licenses to
make or have made Product and Vials using API supplied by Unigene provided
Unigene supplies USL's requirements for API (and USL will furnish forecasts and
purchase orders for API in the same manner as contemplated in Section 7.2 for
Vials), and (ii) not to exercise its rights under 2.5.1 and 2.5.2 to make or
have made API until such time as Unigene does not supply to USL its requirements
for API. The exercise of the rights and licenses granted under Sections 2.5.1
and 2.5.2 shall be in addition to any other rights or remedies available under
this Agreement or under law.
(b) If USL has, in accordance with Section 2.5.3(a), commenced
exercise of the rights and licenses granted as of the date of this Agreement
under Sections 2.5.1 and 2.5.2 above, and thereafter Unigene again begins to
supply to USL Product or API (as the case may be) in accordance with the terms
of this Agreement, USL shall then in an orderly manner discontinue exercise of
such rights and licenses and obtain its supply from Unigene, provided
that Unigene shall first do the following (it being understood that the
following may be performed by Unigene or a permitted successor or assignee of
Unigene under this Agreement):
(1) Unigene shall reimburse USL for all reasonable
expenses incurred in preparing to commence and commencing the manufacture,
testing and supply of Product or API (as the case may be) by USL or a Third
Party on behalf of USL under this Section 2.5, including any expenses related to
obtaining regulatory approval for the manufacture and supply of API and Product
under the NDA, and other expenses as required to comply with applicable law and
regulation in connection with such manufacture and supply;
(2) If USL has entered into a contract with a Third
Party in connection with the manufacture (for example a contract manufacturer),
testing, quality assurance or otherwise in connection with the exercise of USL's
rights under Sections 2.5.1 and 2.5.2 above, Unigene shall have assumed any such
contract and obtained the release of USL from any and all obligations thereunder
arising from events occurring from and after the date of Unigene's assumption of
that contract (it being understood that Unigene shall not be liable for
obligations or liabilities under that contract arising from events occurring
before the date of Unigene's assumption of that contract); and
(3) Unigene shall reimburse USL for any and all ** that
USL shall have incurred as a result of Unigene having not supplied Product or
API (as the case may be) in accordance with the terms of this Agreement,
including payment of amounts incurred or paid by USL to obtain a supply (by
exercise of the rights and licenses under this Section 2.5) of Product or API
(including as applicable, USL's cost of manufacture) to the extent it exceeds
the Transfer Price that USL would have paid Unigene for such Product or API
under this Agreement.
2.5.4. Definition of "Licensed Patents" as Used in Section 2.5.
Notwithstanding anything contained in this Agreement to the contrary, as used in
Section 2.5, "Licensed Patents" shall mean any United States patent (including
any extension, reissue, reexamination, or the like relating thereto) or patent
application (including any provisional, divisional, continuation or
continuation-in-part and renewal applications) now or hereafter owned by or
licensed to Unigene that claims Product or a component thereof, any portion of
the production of Product or component thereof, or any use of Product in the
Field, including, without limitation (i) Unigene's United States Patent No. **
issued on **, (ii) Unigene's United States Patent No. ** issued on **, and (iii)
Unigene's United States Patent No. ** issued on **.
ARTICLE 3. SIGNING FEE AND MILESTONE PAYMENTS
3.1. Signing Fee. As consideration and reimbursement to the Licensor
for certain of its costs and expenses associated with in-process research,
development, and testing for the Product and Vials, USL will (a) upon the
execution of this Agreement, pay Unigene a non-refundable fee of THREE MILLION
DOLLARS (U.S. $3,000,000), and pay Unigene certain Milestone Payments subject to
and in accordance with Section 3.2 below. The signing fee shall be paid by USL
to Unigene upon written confirmation to USL (including written confirmation by
fax) of **.
3.2. Milestones. Subject to the Section 9.2 Credit described in
Sections 3.4 and 9.2 below, Upon achievement of certain events (each a
"Milestone"), USL shall pay Unigene the corresponding Milestone amount as set
forth below (each a "Milestone Payment"):
Milestone Description Milestone Payment
--------------------- -----------------
1. ** **
2. ** **
3.3. Milestone Notices. Unigene shall notify USL in writing of the
achievement of each of the foregoing Milestones within ** (**) Business Days
after such achievement.
3.4. Milestone Credits. USL shall be entitled to credit against the
second Milestone Payment equal to the Section 9.2 Credit (as provided in Section
9.2 hereof).
3.5. Milestone Payments. Milestone Payments shall be due and payable
on or before the ** (**) day after delivery to USL of Unigene's notice of the
achievement of the corresponding Milestone.
ARTICLE 4. ROYALTIES
4.1. Royalty. Subject to the credits provided in Section 4.3, USL
shall pay to Unigene, or its designee, on a quarterly basis, an earned royalty
(the "Earned Royalty") equal to (a) ** of Net Sales for so long as (1) the
Finished Product is covered by at least ** of a Licensed Patent that has issued
and is in full force, and (2) **, or (b) ** of Net Sales of Finished Product in
the event that at the time of the sale the circumstances are as described in
either (i) or (ii) as follows: (i) both (A) ** and (B) ** or (ii) both (A) **
and (B) **.
4.2. Royalty Term.
(a) USL's obligation to pay Earned Royalties shall commence
upon the First Commercial Sale and shall continue through **. After the later of
(i) or (ii) above in this Section 4.2(a), (A) USL shall have a fully paid up,
royalty-free right and license under the licenses and rights granted under this
Agreement and (B) Unigene's sole compensation under this Agreement will be **
for Vials or API (as the case may be) supplied by Unigene to USL described in
**, provided that, except as provided in Section 17.1, such licenses and rights
shall terminate at such time as USL (or its permitted assignee) **.
(b) USL shall have an obligation to pay a Shortfall Royalty in
accordance with and subject to Section 5.2 for any Market Year in which USL has
an obligation to pay Earned Royalties ** pursuant to Section 4.1 above. Also as
described in Section 5.2, ** of Net Sales. For any Market Year in which USL has
an obligation to pay Earned Royalties ** during only a portion of the Market
Year, USL's obligation to pay a Shortfall Royalty shall be determined in
accordance with Section 5.2.
4.3. Credits. USL shall be entitled to credit against each payment of
Earned Royalties otherwise due the amount of the following to the extent not yet
taken as a credit under this Section 4.3: ** (each a "Credit" and, collectively,
the "Credits"); provided, however, that in no event shall the aggregate dollar
value of such ** Credit for any Reporting Quarter exceed ** of the Net Royalties
due to Unigene for such Reporting Quarter. Any unapplied ** Credits shall be
applicable to subsequent payments (other than for Transfer Price) due under this
Agreement. In addition, USL shall be entitled to credit against any payment of
Shortfall Royalty the amount of any **, provided, however, that in no event
shall the aggregate dollar value of such ** for any Shortfall Royalty due for a
given Market Year exceed ** of the Shortfall Royalty due to Unigene for such
Market Year.
ARTICLE 5. TARGETED NET SALES
5.1. Projections. USL has provided to Unigene projections by Market
Year for the projected Net Sales of Finished Product, which projections are
attached as Exhibit A (the "Projections"). In the event that **, Unigene and USL
will negotiate in good faith **; provided, however, that if USL and Unigene
cannot reach agreement with respect thereto within ** (**) days of the first
meeting between the parties with respect to such matter, (a) the respective
officers of Unigene and USL with decision making authority with respect to such
matter shall meet face-to-face within ** (**) days after the expiration of the
aforementioned ** (**) day period, and (b) if the respective officers of Unigene
and USL cannot resolve the matter within ** (**) days after their first meeting,
the matter shall be submitted to arbitration pursuant to Section 17.2.
5.2. Targeted Net Sales.
(a) During each Market Year in which USL has an obligation to
pay Earned Royalties **, USL will use commercially reasonable efforts to achieve
Targeted Net Sales, as set forth on Exhibit A, provided that for any Market Year
in which USL has an obligation to pay Earned Royalties ** under Section 4.1(a)
during a portion, but not all, of the Market Year, the Targeted Net Sales shall
be prorated to equal the product of the Targeted Net Sales for that Market Year
multiplied by a fraction, the numerator of which is the number of days during
the applicable Market Year that USL has an obligation to pay Earned Royalties
**, and the denominator of which is the total number of days in that Market
Year. Also, ** to reflect the number of days during the applicable Market Year
that a "Suspension Event" is occurring. The term "Suspension Event" means the
occurrence of any of the following events: (A) Unigene materially ** in
accordance with the terms of this Agreement, (B) the occurrence of an event of
Force Majeure; **. Specifically, the Targeted Net Sales for the applicable
Market Year shall be reduced by an amount equal to ** during which USL has an
obligation to pay Earned Royalties equal to ** of Net Sales.
(b) In addition to Section 5.2(a) above, if a Suspension Event
continues for a period ** or more consecutive days, then in addition to the
proration of the Targeted Net Sales for the applicable Market Year as described
above, ** as, and to the extent, determined pursuant
to the same process described below in Section 5.2(c) utilized when a "Reduction
Event" has occurred.
(c) Upon the occurrence of a "Reduction Event," Unigene and USL
will negotiate in good faith to reduce, if appropriate, the Targeted Net Sales
to reflect such Reduction Event. The term "Reduction Event" means the occurrence
of any of the following events: **. If USL and Unigene cannot reach agreement
with respect thereto within ** (**) days following written notice by one party
to the other of the occurrence of a Reduction Event, (i) the respective officers
of Unigene and USL with decision making authority with respect to such matter
shall meet face-to-face within ** (**) days after the expiration of the
aforementioned ** (**) day period, and (ii) if the respective officers of
Unigene and USL cannot resolve the matter within ** (**) days after their first
meeting, the matter shall be submitted to arbitration pursuant to Section 17.2.
(d) The terms of Section 5.2(a) through (c) shall be in
addition to any other rights or remedies available under this Agreement or
applicable law.
(e) In the event that a Net Sales Shortfall occurs in a given
Market Year, within sixty (60) days after the end of such Market Year, USL shall
pay to Unigene a "Shortfall Royalty" equal to **. The payment of the Shortfall
Royalty shall be accompanied (or preceded) by a written statement setting forth
the itemized calculations used to compute the amount of the Shortfall Royalty.
5.3. Effect of Net Sales Shortfall.
(a) In the event that a Net Sales Shortfall occurs under
Section 5.2 in any ** period commencing after **, Unigene, at its sole option,
may terminate this Agreement for cause pursuant to Section 16.3, provided
Unigene gives notice of termination specifically referencing this Section 5.5
and stating the basis for such termination within ** (**) days following
Unigene's receipt from USL of the report described in Section 5.2(b) following
the end of the ** period. Such termination shall be effective ** (**) days
following USL's receipt of such notice of termination.
(b) In the event of a ** in any Market Year, USL may give
written notice at any time of its ** in good faith the **. Upon such notice from
USL, Unigene and USL shall (within thirty (30) days) enter into good faith
negotiations for a period of ** (**) days, commencing on the date of Unigene's
written notice, regarding **, or give written notice that it does not wish to do
so. If, in response to any such notice from USL **, Unigene gives written notice
that it does not wish to enter into negotiations as described above, or if the
parties enter into such negotiations but are unable to reach agreement as to any
**, USL may ** upon written notice to Unigene, and such ** shall be effective **
(**) days following Unigene's receipt of such notice of **. Absent the written
agreement of the parties to the contrary, nothing in this Section 5.3(a) shall
limit, or affect Unigene's rights under Section 5.3(a).
ARTICLE 6. STATEMENTS AND REMITTANCES
6.1. Records. USL will maintain all books and records reasonably
necessary to completely and accurately determine the amount of Royalties due to
Unigene under this Agreement. USL will maintain such books and records for at
least ** (**) months after the end of the Market Year to which those records
relate.
6.2. Contents of Net Sales Reports; Payment of Royalties. Within
forty-five (45) days after the last day of USL's manufacturing month (determined
in the ordinary course or USL's business practice) for each February, May,
August, and November during the period when USL has an obligation to pay Earned
Royalties under this Agreement (the "Reporting Date"), USL shall deliver to
Unigene a detailed written report describing, for the three (3) month period
ending respectively on the last such day of USL's manufacturing month for such
February, May, August , or November (the "Reporting Quarter"): (a) the number
and full description of the Units manufactured and sold by USL and its
Affiliates; (b) the gross sales and Net Sales for each such Unit and sufficient
information to show the deductions from gross sales used to calculate Net Sales;
(c) any Credits, itemized by type, applied against Earned Royalties; (d) the
number of Free Samples (as defined below) distributed; and (e) the total Earned
Royalties due to Unigene. Each such report shall be accompanied by full payment
to Unigene of the Royalties (net of any applicable Credits) or other payments
then due and payable under this Agreement.
6.3. Payments.
(a) All payments required to be paid to Unigene under this
Agreement shall be made in U.S. DOLLARS by means of ACH wire transfer provided
that Unigene maintains authorization permitting such wire transfer by USL into
Unigene's account. If Unigene does not maintain such authorization, after
Unigene gives USL notice thereof, USL will pay by check.
(b) Whenever any payment hereunder shall be stated to be due on
a day which is not a Business Day, such payment shall be made on the immediately
succeeding Business Day.
(c) Payments hereunder shall be considered to be made as of the
date on which such payment is received by Unigene.
(d) In the event that USL is late by more than ** (**) days in
paying any amount owed to Unigene under this Agreement, such late payment shall
bear interest at the bank reference rate of TCF Bank Minnesota from the date the
payment should have been made to Unigene.
6.4. Unigene's Right to Audit. Upon thirty (30) days prior written
notice to USL, USL shall permit an independent certified public accounting firm
of nationally recognized standing selected by Unigene and reasonably acceptable
to USL, at Unigene's expense, to have access during normal business hours to
examine books and records of USL described in Section 6.1 hereof as may be
reasonably necessary to verify the accuracy of the reports described in
Section 6.2 hereof. The examination shall be limited to USL's books and records
for any year ending not more than ** (**) months prior to the date of such
request, unless any such audit establishes that the Royalties actually paid for
any Market Year subject to the audit were actually less than ** percent (**%) of
the Royalties due for such Market Year, in which event the audit may extend to
include records ending not more than ** (**) months prior to the date of such
initial request. An examination under this Section 6.4 shall not occur more than
once in any Market Year, and any period shall be subject to audit under this
Section 6.4 only once during the term of this Agreement. USL may designate
competitively sensitive information, which such accountant may not disclose to
Unigene, provided, however, that such designation shall not impair the
accountant's ability to examine the relevant books and records or to report the
accountant's conclusions to Unigene. The accounting firm shall disclose to
Unigene only whether the reports described in Section 6.2 hereof are correct or
incorrect and the specific details concerning any discrepancies. Any such
accounting firm shall sign a confidentiality agreement, in a form and substance
reasonably acceptable to USL, as to any of USL's confidential information which
they are provided or to which they have access while conducting any audit
pursuant to this Section 6.4. Unigene shall pay all costs of conducting audits
pursuant to this Section 6.4; provided, however, that USL shall reimburse
Unigene in full for such reasonable costs whenever the accounting reveals that,
with respect to any audited period (but in no event a period of less than a
Market Year), the aggregate Royalties actually paid to Unigene were less than **
percent (**%) of the total of Royalties due to Unigene hereunder. Should such an
audit identify an underpayment of aggregate Royalties, USL shall immediately
remit such underpayment amount to Unigene plus interest at the bank reference
rate of TCF Bank Minnesota from the date the payment should have been made.
Should such an audit identify any overpayment of aggregate Royalties, Unigene
shall immediately remit such overpayment amount to USL, **.
ARTICLE 7. PRODUCTION, TESTING, FORECASTING
7.1. Production.
(a) Except as provided in Sections 7.3 and 2.5, Unigene shall
produce API for Product, formulate Product, fill, label and bulk package the
Vials with Product for supply to USL, and USL shall obtain Product in Vials from
Unigene. Unigene shall collect such data on production, maintain such records,
retain such retention and reserve samples of all raw materials and in-process
production steps, and take such other steps as required to comply with cGMP.
Subject to the confidentiality provisions set forth in ARTICLE 15 hereof,
Unigene and USL shall both share such data, information or samples with one
another as required to maintain the NDA. Unigene will have, during the period it
is to supply Vials or API to USL under this Agreement, the requisite experience,
knowledge and expertise, suitable facility and qualified personnel, as well as
the legal right, to perform its obligations under this Agreement in a sound,
safe, lawful and workmanlike manner. In addition, Unigene will perform in
accordance with the terms of Exhibit B attached hereto. USL has the requisite
experience, knowledge and expertise, suitable facility and qualified personnel,
as well as the legal right to perform its obligations under this Agreement in a
sound, safe, lawful and workmanlike manner.
(b) Unigene shall supply all of USL's requirements for Vials as
stated in USL's purchase orders as described below, provided, however, that
Unigene shall not be obligated to accept purchase orders for more than ** Vials
per Market Year (the "Annual Volume Cap") or purchase orders for the delivery of
more than ** Vials in any calendar month (the "Monthly Volume Cap").
(c) USL shall purchase the pumps to be included in Finished
Product from a Third Party, and provide appropriate samples to Unigene at no
cost. Unigene shall, thereafter, test and release the pumps from such sample.
7.2. Forecasting; Purchase Orders.
(a) USL will deliver to Unigene, within seven (7) days after
the beginning of each USL manufacturing quarter, its forecast for Vials for the
succeeding twelve (12) manufacturing month period (the "Forecast"), provided
that the first Forecast will be provided approximately six (6) months prior to
the anticipated date of commercial launch of the Finished Product. The Forecast
will be updated each manufacturing quarter on a rolling twelve (12) month basis.
Unigene will use the Forecast for planning purposes only. For any given quarter,
Unigene may purchase raw materials and components (for Vials or API, as
applicable) on the basis of USL's most recent Forecast for Vials or API (as
applicable) for the second manufacturing quarter covered by that Forecast given
in accordance with this Section 7.2(a). If USL does not submit purchase orders
for that manufacturing quarter in a volume equaling or exceeding such Forecast
for that quarter, USL will reimburse Unigene for the cost of those raw materials
and components that Unigene cannot use thereafter for the manufacture of Product
or Vials or otherwise for equivalent value.
(b) Vials will be ordered by USL by the issuance of separate,
pre-numbered binding purchase orders. Unigene will supply USL with its estimated
batch yield of Vials to assist USL in ordering batch lot quantities. USL's
purchase orders will designate the desired quantities of the Vials, delivery
dates and destinations and will be submitted at least ** (**) days prior to the
shipment date specified. Subject to the terms of Section 7.1(b) above, Unigene
will fill and ship all orders of Vials in accordance with USL's purchase orders
provided that if such orders exceed the Forecast for such period by more than **
percent (**%), Unigene shall not be required to fill and ship such excess
amount, but shall use commercially reasonable efforts to do so. If any USL
purchase order is not submitted at least ** (**) days prior to the requested
delivery dates, Unigene will still use commercially reasonable efforts to meet
USL's requested delivery dates. Unigene shall not produce Vials more than **
(**) days prior to the shipment date of such Vials; provided, however, in the
event that the FDA approves the Product for ** (**) month expiration dating,
Unigene shall not produce Vials more than ** (**) days, rather than the
aforementioned ** days, prior to the shipment date of such Vials.
(c) All sales of Vials by Unigene to USL will be subject to the
provisions of this Agreement and will not be subject to the terms and conditions
contained in any purchase order of USL or confirmation of Unigene, except
insofar as any such purchase order or confirmation establishes (i) the quantity
of Vials to be sold; (ii) the shipment dates for those
Vials; and (iii) the destinations to which those Vials are to be shipped. In the
event of any conflict between the terms of this Agreement and the terms of any
purchase order, invoice or similar document, the terms of this Agreement shall
prevail.
7.3. Alternative Source for Vials.
(a) Unigene must be able to supply Vials sufficient to meet the
Monthly Volume Cap and the Annual Volume Cap. In order to do so, Unigene shall
have the right to designate and (at Unigene's expense) qualify a Third Party to
supply Vials; **.
(b) In addition, if USL anticipates that it will require a
quantity of Vials in excess of the Monthly Volume Cap and/or the Annual Volume
Cap, USL shall give Unigene reasonable notice thereof. USL and Unigene shall
thereafter promptly meet and work together in good faith to identify a
reasonable means of increasing capacity for supply in a mutually beneficial,
commercially reasonable manner, with the objective of having excess capacity
available in the time period reasonably requested by USL. Alternatives for doing
so may include Unigene increasing its capacity, qualifying a Third Party to
supply Vials, qualifying USL to supply Vials (in which case USL may manufacture
Product and Vials under the license and right granted in Sections 2.1(b) and
2.2(b) above and Unigene shall supply all of USL's requirements for API for use
in the manufacture of such Product and Vials (and USL will furnish forecasts and
purchase orders for API in the same manner as contemplated in Section 7.2 for
Vials)), or some combination thereof, with the objective of achieving such extra
capacity in the reasonable time frame on commercially reasonable terms. USL and
Unigene shall agree in good faith upon a commercially reasonable manner to
proceed with a view of time frame, cost and other commercially reasonable
considerations. All costs and expenses incurred in connection with Unigene
increasing its capacity, qualifying a Third Party to supply Vials, qualifying
USL to supply Vials, or some combination thereof, pursuant to this Section
7.3(b), shall be borne ** by USL and ** by Unigene. Notwithstanding anything in
this Section 7.3(b) to the contrary, upon USL giving notice that it will require
a quantity of Vials in excess of the Monthly Volume Cap and/or the Annual Volume
Cap, Unigene and USL will within ** (**) days of such notice meet to commence
good faith discussions and negotiations to decide among the three alternatives
taking into account commercially reasonable considerations as discussed in this
Section 7.3(b); provided, however, that if USL and Unigene cannot reach
agreement with respect thereto within ** (**) days following USL's written
notice, (i) the respective officers of Unigene and USL with decision making
authority with respect to such matter shall meet face-to-face within ** (**)
days after the expiration of the aforementioned ** (**) day period, and (ii) if
the respective officers of Unigene and USL cannot resolve the matter within **
(**) days after their first meeting, the matter shall be submitted to
arbitration pursuant to Section 17.2.
7.4. Transfer Price.
(a) The "Transfer Price" shall initially be ** per Vial (plus
transportation charges, including insurance). If it becomes clear that by reason
of costs outside Unigene's control that Unigene's ** percent (**%) shall exceed
the ** (plus transportation charges, including insurance) by ** percent (**%) or
more, Unigene shall deliver USL written notice of
the same (including an explanation of the cause of the increase to Unigene's **)
at least thirty (30) days before the end of the relevant Reporting Quarter,
along with a revised Transfer Price calculated to achieve a price equal to
Unigene's ** percent (**%) based on prices available at the time of the notice,
provided that in no event shall the Transfer Price change more than once
annually. Notwithstanding the foregoing, at such time as USL's obligation for
the payment of Earned Royalties expires under Section 4.2(a), the applicable
Transfer Price shall be increased to an amount equal to Unigene's ** percent
(**%). In the event USL commences manufacture of Product and Vials pursuant to
Section 7.3 or Section 2.5, the Transfer Price for API supplied by Unigene to
USL hereunder shall equal Unigene's ** percent (**%) until such time as USL's
obligation for the payment of Earned Royalties expires under Section 4.2(a), and
thereafter the applicable Transfer Price for API shall be increased to an amount
equal to Unigene's ** percent (**%), subject to the terms of Section 14.1(b)
below.
(b) After the Transfer Price increases to Unigene's **, Unigene
shall, upon written request from USL from time to time, but not more than once
in any Market Year, promptly furnish to USL written documentation maintained by
Unigene in the ordinary course evidencing the cost of **. Upon thirty (30) days
prior written notice to Unigene, Unigene shall permit an independent certified
public accounting firm of nationally recognized standing selected by USL and
reasonably acceptable to Unigene, at USL's expense, to have access during normal
business hours to examine books and records of Unigene hereof as may be
reasonably necessary to verify the accuracy of the Transfer Price for any period
after USL's obligation for the payment of Earned Royalties expires under Section
4.2(a), and written documentation evidencing the cost of manufacture described
in this Section7.4(b). The examination shall be limited to Unigene's books and
records for any year ending not more than ** (**) months prior to the date of
such request, unless any such audit establishes that the Transfer Price actually
paid for any Market Year subject to the audit were actually more than ** percent
(**%) of the Royalties due for such Market Year after USL's obligation for the
payment of Earned Royalties expires under Section 4.2(a), in which event the
audit may extend to include records ending not more than ** (**) months prior to
the date of such initial request. An examination under this Section 7.4(b) shall
not occur more than **, and any period shall be subject to audit under this
Section 7.4(b) only once during the term of this Agreement. Unigene may
designate competitively sensitive information, which such accountant may not
disclose to USL, provided, however, that such designation shall not impair the
accountant's ability to examine the relevant books and records or to report the
accountant's conclusions to USL. The accounting firm shall disclose to USL only
whether the Transfer Price paid for the period subject to the audit are correct
or incorrect and the specific details concerning any discrepancies. Any such
accounting firm shall sign a confidentiality agreement, in a form and substance
reasonably acceptable to Unigene, as to any of Unigene's confidential
information which they are provided or to which they have access while
conducting any audit pursuant to this Section 7.4(b). USL shall pay all costs of
conducting audits pursuant to this Section 7.4(b); provided, however, that
Unigene shall reimburse USL in full for such reasonable costs whenever the
accounting reveals that, with respect to any audited period (but in no event a
period of less than a Market Year), the aggregate Transfer Price actually paid
by USL was more than ** (**%) of the total Transfer Price due to Unigene for the
applicable period hereunder. Should such an audit identify an overpayment of
Transfer Price for
any period after USL's obligation for the payment of Earned Royalties expires
under Section 4.2(a), Unigene shall immediately remit such overpayment amount to
USL plus interest at the bank reference rate of TCF Bank Minnesota from the date
the overpayment was made. Should such an audit identify any underpayment of
Transfer Price for any period after USL's obligation for the payment of Earned
Royalties expires under Section 4.2(a), USL shall immediately remit such
underpayment amount to Unigene, plus interest at the bank reference rate of TCF
Bank Minnesota from the date the payment should have been made.
(c) For each Vial or API (as the case may be) shipped to USL,
USL shall pay to Unigene the Transfer Price, which shall be due and payable
within thirty (30) days after the last to occur of (i) delivery to USL's
facility of the applicable shipment of Vials or API (as the case may be); and
(ii) the delivery to USL of the invoice relating to the applicable shipment of
Vials or API (as the case may be).
(d) For each Reporting Quarter, the aggregate amount of any
accumulated Transfer Price paid to Unigene, except for such amounts paid on
Vials or API (as the case may be) used in samples distributed for no cost or a
nominal cost ("Free Samples"), shall be creditable against Earned Royalties
pursuant to Section 4.3.
7.5. Shipment and Risk of Loss. Unigene will ship all Vials or API (as
the case may be) to USL, F.O.B. point of delivery (USL's loading dock). The risk
of loss of or damage to any Vials or API (as the case may be) ordered by USL and
shipped by Unigene will pass to USL upon Unigene's delivery to USL, F.O.B. point
of delivery (USL's loading dock). Unigene will pay the cost of all freight and
insurance for each shipment.
ARTICLE 8. REGULATORY APPROVAL
8.1. NDA Approval and **. Unigene shall file and pursue the application
for NDA Approval. When NDA Approval is granted, **. Following NDA Approval,
Unigene shall cooperate in, and take all commercially reasonable actions
necessary for, **, including without limitation all actions set forth in the
regulations of the FDA relating to such ** (currently codified at **). USL shall
reimburse Unigene for Unigene's payment to the FDA of **; provided that if, the
facility covered by ** to be reimbursed by USL, is being used by Unigene to
produce product or materials other than those used for the production and supply
of Vials to USL hereunder, USL's obligation to reimburse Unigene for the ** will
be prorated on the basis of the number of products produced at the facility for
commercial sale. **, subject to the limitations set forth in this ARTICLE 8, **.
8.2. ** upon Termination. Upon termination of this Agreement for any
reason, USL shall promptly **. Upon the occurrence of an event requiring USL **
shall cooperate in, and take all actions necessary for, **, including without
limitation all actions set forth in the regulations of the FDA relating to such
** (currently codified at **). ** shall bear the cost and expense of such **,
provided that ** shall bear the cost and expense of such ** in the event of any
termination under Section 5.3, or termination by Unigene under Section 16.3.
8.3. Prohibition on Technical Information **. Except in connection with
a permitted assignment of this Agreement by USL as provided in Section 17.1
below, USL shall not assign, transfer or allow any Third Party to reference the
Technical Information ** for any purpose, it being understood and agreed that
this prohibition shall not apply in the case of an assignment of this Agreement
by USL permitted in Section 17.1. USL shall not employ or reference the
Technical Information ** for any purpose other than for the sale of Finished
Product in the Territory.
8.4. Permitted Uses of the Technical Information **. Unigene shall be
free to reference and use (a) ** the Technical Information for any purpose
outside the Territory, (b) Technical Information for any purpose outside the
Field within the Territory, and (c) **.
8.5. Adverse Drug Reaction. Each party shall promptly inform the other
party of any adverse reaction related to API, Product, Vials or Finished
Product.
ARTICLE 9. **
9.1. **
9.2. **
ARTICLE 10. INTELLECTUAL PROPERTY RIGHTS
10.1. Patent Prosecution and Maintenance. Unigene shall be responsible
in its sole discretion for taking all necessary actions to file, prosecute, and
maintain Licensed Patents, including the following:
(a) Filing applications for patents, reexaminations and
reissues;
(b) Prosecuting all patent applications and applications for
reexaminations and reissue, and responding to opposition or any other form of
action for invalidity or revocation (other than litigation described in Section
10.2 or 10.3, for which the responsibility shall be borne as described in those
sections); and
(c) Maintaining in force any patents by duly filing all
necessary papers and paying any fees required by the patent legislation of the
particular country in which such patents were granted.
Unigene shall consult with USL regarding, and shall consider in good faith USL's
proposals and recommendations with respect to, patent applications and
applications for reexaminations and reissue under the Licensed Patents. Unigene
shall keep USL advised of the status of patent applications and applications for
reexaminations and reissue and the patents in the Licensed Patents by making
available to USL copies of all patent applications and applications for
reexaminations and reissue, office actions, amendments, copies of issued patents
and copies of notices from the patent office.
10.2. Patent Enforcement. If either Unigene or USL learns of an
infringement or threatened infringement of a Licensed Patent or of a
misappropriation of Technical Information by a Third Party in the Field (any of
the foregoing, a "Third Party Infringement"), such party shall promptly, and in
any event within ** days, notify the other party of such Third Party
Infringement. Unigene shall have the right to bring an action to remedy such
Third Party Infringement in the Field **. In the event that USL does not join in
an action brought by Unigene in connection with a Third Party Infringement,
Unigene shall bear the entire cost of such action **. In the event that Unigene
elects not to pursue a Third Party Infringement, USL ** may bring an action to
remedy such Third Party Infringement **. Notwithstanding anything set forth in
this Section 10.2 to the contrary, if necessary, each party agrees to be
included as a named party in any Third Party Infringement action.
10.3. Infringement of Third Party Rights. Other than as provided in
Section 9.1, if the manufacture, sale or use of Product, Vials or Finished
Product pursuant to this Agreement results in any claim, suit or proceeding
alleging patent infringement against Unigene or USL (any of the foregoing, an
"Infringement Action"), such party shall promptly notify the other party hereto
of such Infringement Action. ** will assume the defense ** through counsel of
its own choice, and in such event **. If USL is named as a party ** through
counsel of its own choice **. Notwithstanding anything set forth in this
Agreement to the contrary, ** shall not, under any circumstances (without the
prior written consent of **, which consent shall not be unreasonably withheld),
enter into any agreement which (a) extends or purports to exercise **; or (b)
makes any admission regarding (i) wrongdoing on the part of **; or (ii) the
invalidity, unenforceability or absence of infringement **. The parties shall
cooperate with each other in connection with any such Infringement Action and
shall keep each other reasonably informed of all material developments in
connection with any such Infringement Action. ** shall bear all cost and expense
in defending any Infringement Action ** (including, without limitation, any
money damages award (including without limitation any award or settlement
providing for continuing royalties payable to a third party) and reasonable
attorney's fees and expenses) incurred by ** in connection with such
Infringement Action **; provided, further, however, that the ** shall not
include any cost or expense (including, without limitation, any money damages
award (including without limitation any award or settlement providing for
continuing royalties payable to a third party) and reasonable attorney's fees
and expenses) of USL to the extent attributable to USL's modification or
innovation of Product **.
ARTICLE 11. MARKETING
11.1. Grant of Marketing and Promotion Rights. Subject to the terms and
conditions of this Agreement, Unigene hereby grants to USL the right to market
Finished Product within the Territory.
11.2. Trademarks.
(a) Finished Product shall be marketed and distributed under the
Fortical(R) or Forcaltonin(R) trademarks, which are owned by, and registered
and maintained by Unigene. Unigene shall determine which such trademark shall be
used and such trademark shall become
the "Licensed Trademark". Unigene hereby grants to USL an exclusive,
non-transferable license to use the Licensed Trademark in the Territory solely
in connection with the marketing and distribution of Finished Product under this
Agreement. All rights not expressly granted in the Licensed Trademark are
reserved by Unigene, and USL acknowledges that nothing in this Agreement shall
give it any right, title or interest in or to any Unigene trademarks other than
the license to the Licensed Trademark granted herein.
(b) Notwithstanding Section 11.2(a) above, if the FDA rejects
the Fortical(R) and Forcaltonin(R) trademarks for use with Finished Product,
USL, at its cost and expense, shall develop, own, register and maintain a
different trademark for use with the Finished Product.
(c) In the event that, pursuant to Section 11.2(b) above, USL
is the owner of the trademark used in connection with the sale of Finished
Product, upon termination of this Agreement for any reason other than
termination due to the insolvency or other event described in Section 16.3(a) on
the part of Unigene, or due to Unigene's breach under Section 16.3(b), USL shall
assign such trademark to Unigene and Unigene ** for any product sold by Unigene
or any licensee bearing such trademark. Unigene shall be obligated to make such
** in the same manner as set forth in Article ** (without reference to any "**"
since there are no ** applicable to Unigene's ** obligation under this Section
11.2), and similarly Unigene shall maintain records and USL shall be entitled to
** in the same manner as set forth in Article **.
11.3. Marketing Obligations.
(a) Subject to Section 11.3(a) and subject to availability of
Vials to be supplied by Unigene, including quantities for commercial launch,
following NDA Approval, USL shall, at its own expense, use its commercially
reasonable efforts to market and sell the Finished Product within the Territory
commensurate with those efforts used by USL to commercialize its own branded
products of similar nature, value and status. Upon reasonable request from
Unigene, USL will furnish to Unigene, on a confidential basis, subject to the
terms of Section 15 of this Agreement, information regarding those efforts used
by USL to commercialize its own branded products of similar nature, value and
status.
(b) USL shall prepare copy for Finished Product packaging and
Finished Product inserts in the appropriate languages and provide to Unigene
such copy for submission by Unigene to FDA. USL will, prior to NDA Approval,
submit its launch promotional materials to Unigene for submission by Unigene to
the FDA on a timely basis in accordance with applicable law and regulation. **,
USL will be responsible for ** on a timely basis in accordance with applicable
law and regulation.
(c) Notwithstanding anything contained in this Agreement to the
contrary, the parties understand and agree that USL shall not commence shipment
of commercial launch quantities of the Finished Product for sale in the United
States **, unless Unigene and USL otherwise first agree in writing that USL
shall commence such shipment of commercial launch quantities of the Finished
Product prior to such **.
11.4. Marketing Plans. USL shall furnish to Unigene, on a confidential
basis, a draft launch plan (which includes launch promotional materials
referenced in Section 11.3(b) above) for Finished Product as soon as is
commercially reasonable, taking into account any **, and the impact of those
events on planning and activities in anticipation of commercial launch of the
Finished Product. The parties shall meet annually, on or about the anniversary
of the First Commercial Sale, to discuss, on a confidential basis, USL's annual
marketing and sales plan for Finished Product. Unigene shall provide to USL
consultation in connection with USL's marketing and sales efforts, including
feedback regarding USL's marketing and sales plans, for Finished Product as
reasonably requested from time to time by USL.
ARTICLE 12. INDEMNITY
12.1. General Indemnification.
(a) Unigene (for purposes of this Section 12.1(a),
"Indemnitor") shall, at its own expense, defend, indemnify, and forever hold
harmless USL and its respective officers, directors, agents and employees (for
purposes of this Section 12.1(a), each an "Indemnitee"), from and against any
and all losses, liabilities, claims, costs, damages and expenses (including,
without limitation, fines, forfeitures, reasonable attorneys' fees,
disbursements and administrative or court costs) (individually "Loss," and
collectively "Losses") that arise from any claim of a Third Party arising out of
a breach of any representation, warranty or agreement of Unigene in this
Agreement, Unigene's willful misconduct or negligence, or an Infringement Action
that alleges that the API or its production violates the Third Party's
intellectual property rights. Notwithstanding the foregoing provisions of this
Section 12.1(a), in no event will an Indemnitee be entitled to indemnification
under this Section 12.1(a) with respect to any and all Losses to the extent that
they arise from an Indemnitee's (including any Affiliates of an Indemnitee)
negligence or willful misconduct. The indemnification provisions of this Section
12.1(a) shall not apply to any matters covered by the indemnification and
reimbursement provisions set forth in Sections 9.1, 9.2 or 10.3 hereof, except
to the extent that a Loss is due to a breach by Unigene of any representations
and warranties set forth in Section 13.1(c)(v) or (vii) in which event USL shall
be entitled to indemnification to the full extent provided in this Section
12.1(a).
(b) USL (for purposes of this Section 12.1(b), "Indemnitor")
shall, at its own expense, defend, indemnify, and forever hold harmless Unigene
and its respective officers, directors, agents and employees (for purposes of
this Section 12.1(b), each an "Indemnitee"), from and against any and all Losses
that arise from any claim of a Third Party arising out of a breach of any
representation, warranty or agreement of USL in this Agreement or USL's willful
misconduct or negligence. Notwithstanding the foregoing provisions of this
Section 12.1(b), in no event will an Indemnitee be entitled to indemnification
under this Section 12.1(b) with respect to any and all Losses to the extent that
they arise from an Indemnitee's (including any Affiliates of an Indemnitee)
negligence or willful misconduct.
12.2. Supplemental Indemnification.
(a) Unigene agrees to indemnify and hold USL harmless against
any and all Losses due to Third Party actions, claims, damages, injuries,
losses, costs and expenses (including reasonable attorney's fees and
disbursements) arising from or claimed to arise from the **, or from manufacture
of Product or Vials by Unigene to the extent that such Product (including
without limitation the API, included in such Product) or Vials did not meet
Specifications. Notwithstanding the foregoing provisions of this Section
12.2(a), in no event will an Indemnitee be entitled to indemnification under
this Section 12.2(a) with respect to any and all Losses to the extent that they
arise from an Indemnitee's (including any Affiliates of an Indemnitee)
negligence or willful misconduct. The indemnification provisions of this Section
12.2(a) shall not apply to any matters covered by the indemnification and
reimbursement provisions set forth in Sections 9.1, 9.2 or 10.3 hereof, except
to the extent that a Loss is due to a breach by Unigene of any representations
and warranties set forth in Section 13.1(c)(v) or (vii) in which event USL shall
be entitled to indemnification to the full extent provided in this Section
12.1(a). In the event USL commences production of some or all of its
requirements for Vials, pursuant to Section 7.3 or Section 2.5, references in
this 12.2(a) to Product or Vials supplied by Unigene hereunder shall, as
applicable, be deemed changed to reference instead API supplied by Unigene
hereunder.
(b) USL agrees to indemnify and hold Unigene harmless against
any and all Losses due to Third Party actions, claims, damages, injuries,
losses, costs and expenses (including reasonable attorney's fees and
disbursements) arising from or claimed to arise from the manufacture of Vials
(but only in the event and to the extent that USL manufactures Vials), assembly,
outer packaging, labeling, transportation of Finished Product from USL's
facility, sale, performance or use of Finished Product by USL. Notwithstanding
the foregoing provisions of this Section 12.2(b), in no event will an Indemnitee
be entitled to indemnification under this Section 12.2(b) with respect to any
and all losses, liabilities, claims, costs, damages and expenses (including,
without limitation, fines, forfeitures, reasonable attorneys' fees,
disbursements and administrative or court costs) to the extent that they arise
from an Indemnitee's (including any Affiliates of an Indemnitee) negligence or
willful misconduct.
12.3. 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.
12.4. Insurance. From and after NDA Approval, each party will at all
times thereafter during the term of this Agreement, maintain in full force and
effect, for the benefit of itself and each other, comprehensive general
liability insurance which (i) is sufficient to protect against the risks
associated with its ongoing business, including the risks which might possibly
arise in connection with the transactions contemplated by this Agreement and in
any event, will maintain product liability insurance in an amount not less than
** for each occurrence and in the aggregate; and (ii) that cannot be terminated
or canceled without giving the other party thirty (30) days prior written
notice. Each party's product liability insurance policy will name the other
party as an additional insured. Upon request of the other party, each party
shall furnish the other with a certificate of insurance evidencing that such
insurance coverage is in force.
12.5. Finished Product Recalls. In the event (i) the FDA issues a
request, directive or order that any Finished Product be recalled; or (ii) a
court of competent jurisdiction orders such a recall; or (iii) Unigene
reasonably determines, after consultation with USL, that any Finished Product
should be recalled because API, Product or Vials do not conform to
Specifications; or (iv) USL, after consultation with Unigene, reasonably
determines that any Finished Product should be recalled for any reason, the
parties will take all appropriate corrective actions reasonably requested by the
other party or by the FDA. To the extent that any such recall results because
API, Product or Vials (in each case made by or on behalf of Unigene) do not
conform to Specifications, Unigene will be responsible for all of the expenses
of the recall. In all other cases, USL will be responsible for all of the
expenses of the recall. For the purposes of this Agreement, the expenses of the
recall will include, without limitation, all expenses for notification of
customers and the destruction or return of the recalled Finished Product, as
well as all reasonable out-of-pocket costs incurred by Unigene and USL in
connection with any corrective action taken by Unigene and USL. USL will conduct
the recall process. USL and Unigene will fully cooperate with the other party to
assist in the recall process as reasonably necessary to complete the process.
ARTICLE 13. REPRESENTATIONS, WARRANTIES, DISCLAIMERS
13.1. Representations And Warranties.
(a) Each party represents and warrants to the other that:
(i) As of the date of this Agreement, it is duly
organized and validly existing under the laws of
its state of incorporation or formation, and has
full corporate or partnership power and authority
to enter into this Agreement and to carry out the
provisions hereof.
(ii) As of the date of this Agreement, it is duly
authorized to execute and deliver this Agreement
and is (and will continue to be) duly authorized to
perform its obligations hereunder, and the Person
or
Persons executing this Agreement on its behalf has
been duly authorized to do so by all requisite
corporate or partnership action.
(iii) This Agreement is legally binding upon it,
enforceable in accordance with its terms, subject
to applicable bankruptcy or other laws affecting
creditors' rights generally and to general
principles of equity. The execution, delivery and
performance of this Agreement by it does not
conflict with any agreement, instrument or
understanding, oral or written, to which it is a
party or by which it may be bound, nor violate any
material law or regulation of any court,
governmental body or administrative or other agency
having jurisdiction over it.
(iv) It has not, and shall not during the Agreement
Term, grant any right to any Third Party which
would conflict with the rights granted to the other
party hereunder. There are no outstanding
assignments, grants, licenses, encumbrances,
obligations, or agreements, either written or
implied, inconsistent with the terms of this
Agreement, except in the case of Unigene as
expressly stated below in Section 13.1(c)(x). It
has (or shall have at the time performance is due)
maintained and shall maintain and keep in full
force and effect all agreements (including license
agreements) and filings (including patent filings)
necessary to perform its obligations hereunder.
(b) USL represents, warrants and covenants to Unigene that:
(i) As of the date of this Agreement, to USL's actual
knowledge, there is no action, suit or inquiry or
investigation instituted by or before any court or
governmental agency which questions or threatens
the validity of this Agreement.
(ii) USL agrees that, during the term of this Agreement,
USL shall comply with and assure compliance with
all laws and regulations applicable to its
manufacture of Vials (but only in the event and to
the extent that USL manufactures Vials), assembly,
packaging, outer labeling, maintenance of
government registration, transportation,
performance, sale or use of Finished Product.
(iii) During the term of this Agreement, USL shall only
market Finished Product.
(iv) To the extent that, during the term of this
Agreement, USL conducts manufacturing, packaging,
labeling or similar activities in conjunction with
Vials or Finished Product, all such activities will
conform to and be performed in accordance with
their applicable Specifications. To the extent
that, during the term of this Agreement, USL
conducts manufacturing, packaging, labeling or
similar activities, USL warrants that all
manufacturing, packaging, labeling and similar
activities conducted by USL shall be conducted in
an FDA Registered Facility under cGMP.
(v) As of the date of this Agreement, USL has no actual
knowledge of any adverse test results regarding
Vials or Finished Product that would render Vials
or Finished Product, or application thereof (now
existing or anticipated) unsuitable or unsafe, and
USL agrees promptly to disclose any such actual
knowledge as USL shall obtain during the term of
this Agreement.
(vi) USL agrees, during the term of this Agreement,
promptly to disclose all pertinent, material
correspondence received from the U.S. Patent and
Trademark Office and FDA which relates to the
Licensed Patents, Vials, Finished Product or the
NDA.
(c) Unigene represents and warrants to USL that:
(i) Except as previously disclosed by or on behalf of
Unigene to USL in writing, as of the date of this
Agreement, to Unigene's actual knowledge, there is
no action, suit, inquiry, investigation or any
threat thereof, that was instituted, or was
threatened to be instituted, by or before any court
or governmental agency which questions or threatens
the validity, priority, enforceability or ownership
of any Licensed Patent or the validity of this
Agreement.
(ii) Unigene agrees that, during the term of this
Agreement, Unigene shall comply with and assure
compliance with all laws and regulations applicable
to its manufacture, packaging, labeling, government
registration, transportation, performance or use of
API, Product and Vials.
(iii) All Product and Vials (as the case may be) sold by
Unigene to USL pursuant to this Agreement will,
during the term of this Agreement, conform to and
be performed in accordance with their applicable
Specifications. Unigene warrants that, during the
term of this Agreement, Product and Vials (as the
case may be) delivered by Unigene to USL shall be
manufactured in an FDA Registered Facility under
cGMP.
(iv) Unigene has not received any written notification
of, and as of the date of this Agreement, has no
actual knowledge that there is now pending or that
there have been any FDA regulatory orders to
restrict or limit the use of API, Product, Vials or
Finished Product, and Unigene agrees, during the
term of this Agreement, promptly to disclose any
such actual knowledge as Unigene shall obtain
during the term of this Agreement. Except as
previously disclosed to USL in writing, Unigene has
no actual knowledge of any adverse test results
regarding API, Product, Vials or Finished Product
that would render API, Product, Vials or Finished
Product, or application thereof (now existing or
anticipated) unsuitable or unsafe, and Unigene
agrees, during the term of this Agreement, promptly
to disclose any such actual knowledge as Unigene
shall obtain during the term of this Agreement.
(v) To Unigene's actual knowledge, as of the date of
this Agreement, the development and reduction to
practice of the Licensed Patents as related to API,
Product, Vials or Finished Product have not
constituted or involved the misappropriation of
trade secrets of any Third Party that would
reasonably be expected to materially impair
Unigene's rights under the Licensed Patents, and
Unigene agrees, during the term of this Agreement,
promptly to disclose any such actual knowledge as
Unigene shall obtain during the term of this
Agreement.
(vi) To Unigene's actual knowledge, as of the date of
this Agreement, no Third Party is using or
infringing information or processes covered by the
Licensed Patents as they relate to API, Product,
Vials or Finished Product.
(vii) Except as previously disclosed to USL in writing,
to Unigene's actual knowledge, as of the date of
this Agreement, there is no outstanding written
order, judgment, decree or stipulation regarding
API, Product, Vials or Finished Product or
restricting their respective uses, or use of the
Technical Information or the Licensed Patents as
contemplated by this Agreement, and, to Unigene's
actual knowledge, there is no legal, governmental
or regulatory proceeding pending or threatened
against Unigene that materially impairs the
Licensed Patents or the use or sale of API, API,
Product, Vials or Finished Product, and Unigene
agrees, during the term of this Agreement, promptly
to disclose any such actual knowledge as Unigene
shall obtain during the term of this Agreement.
(viii) To Unigene's actual knowledge, as of the date of
this Agreement, Unigene has made available to USL
all pertinent, material correspondence received
from the U.S. Patent and Trademark Office and FDA
which relates to the Licensed Patents, API,
Product, Vials, Finished Product or the NDA, and
Unigene agrees, during the term of this Agreement,
promptly to disclose any such knowledge as Unigene
shall obtain during the term of this Agreement.
(ix) Unigene has disclosed to USL any material third
party patents which Unigene has considered as being
of possible relevance to the manufacture, use or
sale of the Product, Vials and the Finished
Product.
(x) **.
13.2. Disclaimer of Warranties, Etc. THE REPRESENTATIONS, WARRANTIES,
COVENANTS AND CONDITIONS OF THE PARTIES SET FORTH IN THIS AGREEMENT ARE
EXCLUSIVE AND IN LIEU OF ALL OTHER REPRESENTATIONS, WARRANTIES, COVENANTS AND
CONDITIONS, WHETHER WRITTEN, ORAL, EXPRESS OR IMPLIED BY STATUTE OR OTHERWISE.
EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH
RESPECT THERETO.
ARTICLE 14. NONCOMPETITION
14.1. Covenant Not to Compete.
(a) During the period commencing on the Effective Date and
continuing until ** after the expiration of USL's obligation to pay Earned
Royalties (the "Restricted Period"), USL, other than pursuant to this Agreement,
shall not, and shall cause its Affiliates to not, engage in the Territory in
developing, manufacturing, marketing, or selling ** without the prior written
consent of Unigene. Also, if USL decides to develop, market or sell a ** product
other than a ** product (after reasonable inquiry and due diligence by USL
regarding the market and product) in the Territory, and Unigene is developing
such a product and has the authority and right to grant to USL exclusive rights
in that product in the Territory similar to the rights granted hereunder, then
before USL begins to develop, market or sell any other such ** product USL will
give Unigene written notice of its interest, and the parties shall enter into
good faith discussions regarding the grant of rights by Unigene to USL in
Unigene's such other ** product. USL shall be free to pursue such other **
product without restriction if: (1) Unigene does not give USL written notice of
its interest in entering into such good faith discussions within ** (**) days
following the date of USL's written notice of interest; (2) the parties do not
sign a terms
sheet outlining basic financial terms regarding a proposed transaction within **
(**) days following the date of USL's written notice of interest; or (3) the
parties do not sign a definitive agreement regarding the grant of rights by
Unigene to USL in such other ** product within ** (**) days following the date
of USL's written notice of interest. Notwithstanding the foregoing provisions of
this Section 14.1(a), the restrictive covenants of USL contained in this ARTICLE
14 shall expire and be of no further force or effect in the event of that USL
terminates this Agreement for cause pursuant to Section 16.3(b) or USL
terminates this Agreement pursuant to Section 17.1(c).
(b) During the Restricted Period, Unigene, other than pursuant
to this Agreement, shall not, and shall cause its Affiliates to not, engage in
the Territory in developing, manufacturing, marketing or selling a ** product
for use in the Field and in the Territory without the prior written consent of
USL; provided, however, the foregoing shall not restrict Unigene's ability to
develop, manufacture, market, use or sell API to Third Parties, provided,
further, that after USL's obligation to pay Earned Royalties ends, Unigene shall
** (1) those reflected in the computation of **, (2) the price and terms on
which Unigene ** for supply to USL hereunder, or (3) the price and terms on
which Unigene ** for the production of Product and Vials, in the event that USL
commences production of some or all of the Product and Vials for Finished
Products pursuant to Section 7.3(b) or Section 2.5. Notwithstanding the
foregoing provisions of this Section 14.1(b), the restrictive covenants of
Unigene contained in this ARTICLE 14 shall expire and be of no further force or
effect in the event of that Unigene terminates this Agreement for cause pursuant
to Section 16.3(b) or USL terminates this Agreement pursuant to Section 17.1(c).
(c) If either party violates its respective covenant not to
compete under Sections 14.1(a) and 14.1(b), the Restricted Period of that
party's covenant not to compete shall be deemed increased by the number of days
during which such party violated its covenant not to compete.
(d) Each party acknowledges that, in consideration of the
mutual promises and covenants set forth herein, both the length of time and the
geographic scope of the restrictions set forth in this ARTICLE 14 are considered
by it to be reasonable given the nature of Product and are necessary to the
protection of the other party's rights hereunder.
ARTICLE 15. CONFIDENTIALITY; PUBLICATION
15.1. Confidentiality. The receiving party shall not transfer any
samples or disclose any Confidential Information of the disclosing party to any
Third Party other than in confidence to those of the receiving party's own
employees and attorneys to whom disclosure is necessary, on a "need to know"
basis, to carry out the receiving party's rights and obligations hereunder. The
receiving party shall not make any other use (commercial or otherwise) of the
Confidential Information except as contemplated under this Agreement without the
prior written consent of the disclosing party. At all times the receiving party
shall protect the disclosing party's Confidential Information with at least the
same degree of care it uses to protect its own Confidential Information, such
care to be of the type and degree of care that would be used by a
reasonable and prudent business person. The obligations of confidentiality and
restrictions on the use of Confidential Information contained herein shall
continue in force for a period five (5) years following any termination of this
Agreement.
15.2. Exceptions. Confidential Information shall not include any
information which the receiving party can prove falls into any of the following
categories:
(a) information that is now known or becomes known to the
public through no fault of receiving party;
(b) information that, at the time of disclosure by the
disclosing party, was already known to the receiving party;
(c) information that is or was disclosed to the receiving
party, free of any obligation of confidentiality, by a Third Party who has the
right to disclose the same;
(d) information that is independently developed by receiving
party employees without access to the disclosing party's Confidential
Information, as demonstrated by competent proof; or
(e) as required to be disclosed by judicial authorities,
provided that the receiving party promptly informs the disclosing party in
writing of such obligation and affords the disclosing party the opportunity to
oppose such order.
15.3. Ownership of Confidential Information. Except as expressly
provided herein to the contrary, Confidential Information is, and will remain,
the property of the disclosing party, and the receiving party has no claim of
ownership to the Confidential Information of the disclosing party. At the
written request of the disclosing party, the receiving party agrees to return to
the disclosing party any Confidential Information furnished by the disclosing
party containing any Confidential Information (regardless of form or author),
and all copies thereof; provided, however, that the receiving party may retain a
copy of Confidential Information received from the disclosing party for solely
for legal archival purposes. In the event the receiving party has included
Confidential Information of the other party in any of its own internally
prepared documents, the receiving party shall not be obligated to deliver those
internal documents to the disclosing party, but the receiving party shall
collect and segregate all such internal documents from its other flies and shall
certify in writing to the disclosing party that such internal documents: (a)
have been collected and segregated; (b) will not be duplicated; and (c) will be
maintained confidential in accordance with this Agreement or have been
destroyed.
15.4. Terms of Agreement. The parties agree that this Agreement and the
terms hereof shall be considered Confidential Information of both parties.
Notwithstanding the foregoing, either party may disclose such terms as are
required to be disclosed under strictures of confidentiality to bona fide
potential investors or lenders, or as otherwise required pursuant to applicable
law.
15.5. Authorized Disclosure. Each party may disclose Confidential
Information belonging to the other party solely to the extent such disclosure is
reasonably necessary in the following instances:
(a) filing or prosecuting patents relating to the Agreement;
(b) FDA, SEC and other required governmental or regulatory
filings;
(c) prosecuting or defending litigation;
(d) complying with applicable court orders or governmental
regulations;
(e) conducting pre-clinical or clinical trials;
Notwithstanding the foregoing, in the event a party is required to make a
disclosure of the other party's Confidential Information pursuant to this
Section 15.5, it shall give reasonable advance notice to the other party of such
disclosure and use efforts to secure confidential treatment of such information
at least as diligent as such party would use to protect its own confidential
information, but in no event less than reasonable efforts. In any event, the
parties agree to take all reasonable action to avoid disclosure of Confidential
Information hereunder. The parties shall consult with each other on the
provisions of this Agreement to be redacted in any filings made by the parties
with the SEC or as otherwise required by law.
15.6. Prior Confidentiality Agreements. Unigene and USL agree that the
confidentiality provisions set forth in this ARTICLE 15 shall govern all
disclosures of Confidential Information prior to the Effective Date and that any
prior agreements relating by the same (including, without limitation, the Mutual
Confidentiality Agreement, dated as of July 1, 2002, by and between USL and
Unigene) are superseded by this Agreement.
ARTICLE 16. TERM
16.1. Agreement Term. The term of this Agreement shall commence on the
Effective Date and continue through the expiration of USL's obligation to pay
Royalties under Article 4, and continue thereafter **, it being understood and
agreed that after expiration of USL's obligation to pay Royalties under Article
4, USL shall have a fully paid up, royalty-free right and license under the
licenses and rights granted under this Agreement, unless earlier terminated
pursuant to this ARTICLE 16 or extended upon terms mutually agreeable to both
parties.
16.2. Termination by Mutual Agreement. The parties may at any time
terminate this Agreement by written agreement executed by both Unigene and USL.
16.3. Termination for Cause. Each party shall have the right to
terminate this Agreement immediately upon delivery to the other of written
notice upon the occurrence of any of the following:
(a) Upon or after the insolvency, dissolution or winding up of
the other party (other than a dissolution or winding up for the purpose of
reconstruction or amalgamation); or
(b) Upon or after the breach of any material provision of this
Agreement by the other party if the breaching party has not cured such breach
within the sixty (60) day period following written notice of such breach by the
non-breaching party. The notice described in the immediately preceding sentence
shall state the nature of the breach in reasonable detail and that the
terminating party views such alleged breach as a basis for terminating this
Agreement under this Section 16.3(b). Notwithstanding the foregoing, if the
breach cannot reasonably be cured within sixty (60) days through no fault or
delay on the part of the breaching party, the breaching party shall not be in
breach of this Agreement if said party promptly (i) notifies the non-breaching
party of delay and its cause; and (ii) commences to cure the breach and
diligently and in good faith continues to cure the breach; provided, however,
that in no event shall the breaching party's cure period be extended for more
than an additional ** (**) days.
(c) This Agreement may be terminated as provided in Sections
5.3(a) and (b), and 17.1(c).
(d) Notwithstanding anything contained in the Agreement to the
contrary, if there is a dispute between the parties as to whether the alleged
material breach occurred or whether it has been cured, and either party, prior
to the expiration of the applicable cure period, initiates arbitration under
Section 17.2 to resolve that dispute, the applicable cure period will be deemed
extended for a period of forty-five (45) days after the entry of final judgment
by a court of competent jurisdiction on an arbitration award determining (as
applicable) that the breach specifically alleged in the Notice of Cure in fact
occurred, is material and has not been cured.
16.4. Accrued Rights, Surviving Obligations.
(a) Expiration or termination of this Agreement shall not
affect any rights or obligations of either party accruing prior to such
expiration or termination. Certain rights shall survive termination as set forth
below. The provisions of this Section 16.4, together with Sections 8.2, 13.2,
14.1, 16.5, 17.2, 17.3, 17.4 and 17.6 and ARTICLES 3, 4, 6, 9, 12 and 15, and
any other provision which by its terms is intended to survive the termination of
this Agreement, shall survive the expiration or termination of this Agreement.
(b) Promptly after termination of this Agreement each party
shall return or dispose of any material, technology or know-how of the other in
the accordance with the instructions of the other, except for such material or
information that is (i) required to be retained by applicable law; (ii)
reasonably necessary to effect any licenses that remain in force pursuant to
this ARTICLE 16; or (iii) retained solely for legal archival purposes (for
purposes of this clause (iii), in each case, limited to one copy or specimen).
(c) In the event this Agreement is terminated for any reason
after commencement of commercial sales of Finished Product by USL and/or its
Affiliates, USL and its Affiliates shall have the right to continue to complete
assembly of Finished Product, and to
sell all inventory of Finished Product so produced and also any Finished Product
on hand as of the date of termination subject to the applicable terms of this
Agreement, including, but not limited to, Earned Royalty obligations.
16.5. Bankruptcy Provisions. All rights (including any marketing and
distribution rights) granted under or pursuant to the Agreement by Unigene to
USL 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(35A) of the U.S. Bankruptcy Code. The Parties agree
that USL, as licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the U.S. Bankruptcy Code,
subject to performance by USL of its preexisting obligations under the
Agreement. The Parties further agree that, in the event of the ** of a
bankruptcy proceeding by or against Unigene under the U.S. Bankruptcy Code, USL
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 USL (a) upon any such ** of a bankruptcy proceeding upon
written request therefor by USL, 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 therefor by USL.
ARTICLE 17. MISCELLANEOUS
17.1. Assignments.
(a) Except as provided in this Section 17.1, this Agreement may
not be assigned or transferred by either party without the prior written consent
of the other, which consent will not be unreasonably withheld.
(b) Subject to Section 17.1(c) and Section 17.1(d), any party
may assign its rights hereunder to an Affiliate or, subject to the terms of this
Section 17.1, to a purchaser in connection with a merger or consolidation of
such party, or a sale of all or substantially all of the assets or business of
that party to which the Product relates (in each case, outside of a bankruptcy
proceeding in which USL is the bankrupt party).
(c) If USL is the assignor and the assignee is ** another party
engaged in the business of marketing or selling a ** product, such assignment of
this Agreement by USL shall be subject to the prior written approval of Unigene.
USL shall give prior written notice of the anticipated assignment to such a
party, and within ** (**) days after Unigene's receipt of USL's notice, Unigene
shall give USL written notice whether it approves or does not approve of such an
assignment. If Unigene fails to give written notice under the preceding sentence
within the specified time frame, Unigene shall be deemed to have approved of
such assignment. If Unigene does not approve of such an assignment, USL may
terminate this Agreement effective on the date specified in such notice of
termination.
(d) If USL is the assignor and the assignee is engaged in the
business of marketing or selling a ** product that is not a ** product, then USL
shall give prior written notice of the anticipated assignment to such a party,
and within ** (**) days after Unigene's receipt of USL's notice, Unigene shall
notify USL either (1) that Unigene elects to permit ** the assignment of this
Agreement to such assignee, or alternatively (2) that Unigene elects, at the
time of the assignment of this Agreement to such assignee, **, and
contemporaneously to grant such assignee all rights, and deliver such documents
and do such things, **, as reasonably required to permit USL to provide the
assignee all rights to commercialize the Finished Product as provided to USL
under this Agreement (it being the intention of the parties that such ** shall
not present an impediment in any respect to the assignee's ability to
commercialize the Finished Product or otherwise to exercise the rights under
this Agreement). If Unigene fails to give written notice of its election under
the preceding sentence within the specified time frame, Unigene shall be deemed
to have elected to permit the ** to such assignee.
(e) Any assignment of this Agreement by either Unigene or USL
shall not release the assigning party hereto from its duties and obligations
under this Agreement, and in the event of any such assignment of this Agreement
the assignee must agree in writing to be bound by the terms and conditions of
this Agreement. Any purported assignment, delegation, sale, transfer or other
disposition in violation of this Section 17.1 shall be null and void. This
Agreement shall be binding upon, and inure to the benefit of, Unigene and USL
and their respective successors and assigns, to the extent such assignments are
in accordance with this Section 17.1.
17.2. Governing Law. This Agreement shall be governed by the
substantive laws of the State of New York (without regard to the principles
regarding conflicts of law). All disputes arising out of or relating to this
Agreement (including any questions of fraud or questions concerning the validity
or enforceability of this Agreement) shall, unless earlier resolved by mutual
agreement, be finally settled by arbitration to be held in Chicago, Illinois
pursuant to the then existing Commercial Rules of the American Arbitration
Association. The arbitration panel shall consist of three arbitrators. Each
party shall appoint one arbitrator within thirty (30) days from the date of
filing any demand for arbitration and the third arbitrator (as well as any other
vacancies on the panel) shall be appointed by the American Arbitration
Association. The arbitration hearing will take place and the award will be made
within ninety (90) days of the filing of any demand for arbitration. Any
determination as to the arbitrability of an issue or dispute shall be made by
the arbitrators. Judgment upon the award of a majority of the arbitrators shall
be binding upon the parties hereto and may be entered in any court having
jurisdiction. Specific performance and injunctive relief may be ordered by the
award. The parties shall each pay their respective costs and attorney fees. The
fees and costs to be paid to the AAA for the arbitration shall be allocated
between Unigene and USL so that (a) the party initiating arbitration (the
"Initiating Party") shall pay a portion of the arbitration fees and costs to be
paid to the AAA proportionate to the aggregate amount of the disputed items
submitted to arbitration that are decided against the Initiating Party relative
to the total amount of all disputed items submitted to arbitration, and (b) the
non-Initiating Party shall pay the balance. In the event that a dollar value
cannot be assigned to a matter taken to arbitration, the arbitration expenses
shall be allocated between Unigene and USL in accordance with the decision of
the arbitration panel that reflects the relative fault of the parties. As the
sole exception to arbitration, each party shall have the right to obtain
injunctive relief from any court having jurisdiction so as to preserve that
party's rights for resolution in any pending or imminent arbitration
proceedings, but no such injunction shall prohibit or postpone such arbitration
proceedings and the injunctions may be modified or vacated as a result of the
arbitration award.
17.3. Equitable Relief. Each party acknowledges and agrees that,
notwithstanding anything to the contrary contained herein, any breach by such
party or its Affiliates of ARTICLE 8, 14 or 15 hereof shall cause irreparable
harm to the other party and that the other party's remedies at law for any such
breach or threat of breach shall be inadequate, and that the other party shall
be entitled to an injunction or injunctions to prevent such breaches and to
enforce specifically such terms and provisions, in addition to any other remedy
to which the other party may be entitled at law.
17.4. Public Announcements. Except as permitted under this Section
17.4 or as otherwise agreed to by the parties, neither party shall issue a press
release or public statement regarding the existence of this Agreement or the
terms thereof without the prior written consent of the other, which consent
shall not be unreasonably withheld. Nothing herein shall prohibit any
disclosures by either party required by law, regulation or stock exchange rule,
but in such event such party shall seek confidential treatment of the terms of
this Agreement to the extent feasible, and nothing shall prohibit disclosure to
the parties' stockholders or to potential investors or lenders provided that
such potential investors or lenders have agreed in writing to keep confidential
the disclosed information on terms not less restrictive than those contained in
this Agreement. Further, Unigene shall be entitled to disclose to its
stockholders only the existence of this Agreement, the amount of the Signing
Fee, the sum of the Signing Fee and Milestone Payments (assuming the milestones
are met, and without specifying the Milestones or specific Milestone Payments),
and that Unigene is entitled to receive a transfer price on the Vials and API
(as applicable) and royalties on sales but without disclosing the amount of such
Transfer Price, Royalties or the royalty percentage.
17.5. Non-Waiver. A waiver of any breach of any provision of this
Agreement shall not be construed as a continuing waiver of other breaches of the
same or other provisions of this Agreement.
17.6. Disclaimer of Agency. Nothing herein contained shall be deemed
to create a joint venture, employer-employee, agency or partnership relationship
between the parties hereto. Neither party shall have any power to enter into any
contracts or commitments in the name of, or on behalf of, the other party, or to
bind the other party in any respect whatsoever.
17.7. 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
parties hereto:
If to Unigene: Unigene Laboratories, Inc.
000 Xxxxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: President
Telephone: 000-000-0000
Telecopy: 000-000-0000
with a required copy to: Dechert
Princeton Pike Corporate Center
000 Xxxxx Xxxxx
Xxxxxxxx 0, Xxxxx 000
Xxxxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: Xxxxx Xxxxx, Esq.
Telephone: 000-000-0000
Telecopy: 000-000-0000
if to USL Xxxxxx-Xxxxx Laboratories, Inc.
00000 00xx Xxxxxx Xxxxx
Xxxxxxxxxxx, Xxxxxxxxx 00000
Attention: President and COO
Telephone: 000-000-0000
Telecopy: 000-000-0000
with a required copy to: Xxxxxxxxx & Xxxxxx P.L.L.P.
0000 XXX Xxxxxx
Xxxxxxxxxxx, XX 00000
Attention: Xxxx X. Xxxxx, Esq.
Telephone: 000-000-0000
Telecopy: 000-000-0000
17.8. Entirety of Agreement. This Agreement embodies the entire
understanding between the parties relating to the subject matter hereof, whether
written or oral, and there are no prior representations, warranties or
agreements between the parties not contained in this Agreement.
17.9. Severability. If any provision of this Agreement is declared
invalid or unenforceable by a court having competent jurisdiction, it is
mutually agreed that this Agreement shall endure except for the part declared
invalid or unenforceable by order of such court. The parties shall consult and
use their best efforts to agree upon a valid and enforceable provision which
shall be a reasonable substitute for such invalid or unenforceable provision in
light of the
intent of this Agreement. In the event that no such agreement can be reached,
the parties shall request that the court reform the provision.
17.10. Amendments and Modifications. Any amendment or modification of
any provision of this Agreement must be in writing, dated and signed by both
parties hereto.
17.11. Compliance with Applicable Laws. Each of Unigene and USL
covenants and agrees that all of its activities under or pursuant to this
Agreement shall comply with all applicable laws, rules and regulations.
17.12. Headings. Any headings contained herein are for directory
purposes only, do not constitute a part of this Agreement, and shall not be
employed in interpreting this Agreement.
17.13. Counterparts. This Agreement may be executed in any number of
counterparts and each such counterpart shall be deemed to be an original.
17.14. Force Majeure. Each party shall be excused for any failure or
delay in performing any of its obligations under this Agreement, if such failure
or delay is caused by Force Majeure, provided that such party shall (a) promptly
notify the other party in writing of the occurrence or circumstance upon which
it intends to rely to excuse its performance; (b) immediately resume performance
after the cause of delay is removed; and (c) use all commercially reasonable
efforts to minimize the duration of such delay. In the event of a Force Majeure
affecting Unigene's performance, Unigene will allocate materials, personnel and
resources equitably and not give any preference to any particular customers
including to Unigene itself. For purposes of this Agreement, "Force Majeure"
shall mean any act of God, accident (other than arising out of the asserting
party's negligence), explosion (other than arising out of the asserting party's
negligence), fire (other than arising out of the asserting party's negligence),
storm, earthquake, flood, drought, riot, embargo, civil commotion, war, act of
war or terrorism, act or order of any governmental authority, inability to
obtain or delay in the delivery of raw materials, parts or completed merchandise
by the supplier thereof, or any other circumstances or event beyond the
reasonable control of the party relying upon such circumstance or event.
17.15. No Rights or Licenses by Implication. No rights or licenses with
respect to Product or any intellectual property rights or technology of either
party are granted or deemed granted hereunder or in connection herewith, other
than those rights expressly granted in this Agreement.
[REST OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the parties hereto have signed this Agreement.
XXXXXX XXXXX LABORATORIES, INC.
By: ______________________________
Name: ______________________________
Title: ______________________________
UNIGENE LABORATORIES, INC.
By: ______________________________
Name: ______________________________
Title: ______________________________
EXHIBIT A - PROJECTIONS AND TARGETED NET SALES
--------------------------------------------------------------------------------
MARKET ** PROJECTIONS of Net Sales TARGETED NET SALES
--------- ------------------------ ------------------
--------------------------------------------------------------------------------
** ** **
--------------------------------------------------------------------------------
** ** **
--------------------------------------------------------------------------------
** ** **
--------------------------------------------------------------------------------
** ** **
--------------------------------------------------------------------------------
** and each Market ** ** **
thereafter
--------------------------------------------------------------------------------
**
EXHIBIT B - MANUFACTURING PROCEDURES
1. Specifications. Unigene shall, at its expense, manufacture (or have
manufactured) API, Product and Vials in accordance with the Specifications and
cGMP, and the applicable NDA.
2. Quality Assurance Investigations. ** for any API, Product or Vials found
not to conform with the Specifications. Unigene ** communicate to USL any
quality issues or failures of audits of the FDA that affect USL's ability to
obtain, promote or sell Finished Product. Unigene ** USL with copies of all
investigation reports relating to API, Product or Vials **.
3. Access to Facilities. USL will ** to the facilities of Unigene (or its
contract manufacturer, as the case may be) at mutually agreeable times for the
sole purpose of auditing compliance with cGMP and for overall compliance with
the Act. Absent unusual circumstances, such audits will be limited to ** audit
** and will be conducted by a reasonable number of employees of USL who are
subject to the same requirements of confidentiality as USL. The parties will
cooperate in scheduling and conducting such audits so as not to unreasonably
interfere with Unigene's day-to-day operations, it being understood that Unigene
will need to make personnel and facilities available in the conduct of such
audits.
4. Labeling, Packaging and Promotional Materials. **.
5. Rejected Vials.
5.1. Within ** (**) days of receipt of Vials, USL will either accept or reject
such Vials. **. In the event of rejection, USL's notice to Unigene will specify
in reasonable detail how the Vials lot failed to conform to the Specifications.
Unigene will have an opportunity to investigate and reevaluate any such Vials.
All Vials will be submitted to inspection and evaluation in accordance with
Unigene's SOPs to determine whether or not they meet the Specifications. As to
any Vials which do not comply with the Specifications and are rejected by USL
("Rejected Vials"), Unigene must ** that Rejected Vials promptly, but in all
events within ** (**) days of USL's notice of rejection. Unigene will make
arrangements with USL for the return or disposal of all Rejected Vials, at **
expense.
5.2 **.
5.3 In the event USL commences production of some or all of its requirements
for Vials, pursuant to Section 7.3 or Section 2.5 of the Agreement, references
in this Section 5 of Exhibit, to Rejected Vials shall be deemed changed to
reference instead Rejected API.
6. Product Documentation.
6.1. Unigene will maintain adequate and accurate books and records, including
but not limited to, manufacturing records and lot traceability records, with
respect to each lot of Vials. These records will be retained by Unigene for a
period after completion of the applicable lot of Vials equal to the later of (a)
** (**) months or (b) ** after the expiration date of the applicable lot of
Vials.
6.2. Unigene will test each shipment of Vials before delivery to USL, and will
provide to USL a Certificate of Analysis which sets forth the items tested,
specifications and test results for each lot delivered, all in a manner which
complies with the NDA, the Act and other applicable laws and regulatory
requirements. The appropriate Certificate of Analysis will accompany each
shipment of Vials shipped to USL.
6.3. Unigene agrees that its quality assurance function shall, within ** (**)
Business Days following the manufacture of each batch, review the manufacturing
records for all steps in the manufacture of such batch. Upon discovery of any
deviation from cGMP or from any warranty hereunder Unigene shall conduct
promptly an appropriate investigation to determine the cause of such deviation
and take appropriate action at its expense to avoid recurrence. Unigene shall
provide a copy of any such investigation report to USL.
6.4. **.
6.5. Unigene will promptly notify USL of, and provide USL with copies of, any
correspondence and/or other documentation received or prepared by Unigene in
connection with (1) receipt of any warning letter or other regulatory
correspondence from the FDA or any other regulatory authority in connection with
the manufacture, packaging and storage of Vials; (2) any recall of Vials.
7. Stability Testing and Validation. Unigene must perform its standard
stability test program as committed to in the NDA for Vials and as defined in
Unigene's SOPs and the applicable FDA guidelines. Unigene will provide USL with
a copy of its stability report, as it becomes available, for any Product.
Unigene will, within ** (**) Business Days, after an Out Of Specification
("OOS") result in the stability testing for any Product, and prior to re-testing
for stability, notify USL of those results.
8. Validation Work or Additional Testing. Unigene will undertake all
validation work as may be required by the NDA, cGMP, the Act or other applicable
law, Unigene's SOPs, or as otherwise agreed upon by the parties.
9. FDA Inspection. Unigene must advise USL promptly if Unigene receives
notification that an authorized agent of the FDA or other governmental agency
intends to visit the manufacturing facility, if that visit is related directly
to API, Product or Vials.
10. Changes to Specifications. Neither Unigene, nor any subcontractor of
Unigene, may make any changes to Specifications, testing methods, manufacturing
process, or equipment without prior written approval from USL (which shall not
be unreasonably withheld), including without limitation any changes in the
quality, method of manufacture, or materials used in the manufacture of the
Product or Vials.
11. Changes Requested by USL. If USL at any time requests a change to Product
or Vials and Unigene agrees such change is reasonable, that change will be
incorporated within the master batch record and/or Specifications via a written
Change Request form, reviewed and agreed upon by both Unigene and USL at USL's
expense.
12. Changes Required by Regulatory Authorities. In the event the FDA requires a
change **, Unigene may make such change, and shall then notify USL and such
change will become a part of the Specifications. After the NDA **, any change
required by any regulatory authority with respect to the Product or Vials will
be made effective ** via a change request form prior to such incorporation. At
the time of that incorporation, any such change will become part of the
Specifications. If Unigene is required by any regulatory authority to perform
validation studies for purposes of validating new manufacturing process or
cleaning procedures or new materials and product assay procedures with respect
to the Product or Vials in order to continue to engage in the manufacture of
that Product or Vials for USL, those studies must be conducted in accordance
with this Agreement and at Unigene's expense.
13. Waste Disposal. Unigene shall dispose of all wastes in accordance with all
applicable laws, rules and regulations.
14. Information for USL **. Without limiting the generality of the foregoing,
** with the following information in a timely manner for** : **.
15. Change of Terminology. In the event USL commences production of some or all
of its requirements for Vials, pursuant to Section 7.3 or Section 2.5 of the
Agreement, references in this Exhibit B, to Product or Vials shall, as
applicable, be deemed changed to reference instead API.
EXHIBIT C - ** AND FIRST AMENDMENT
**
EXHIBIT D - SECOND AMENDMENT
**
EXHIBIT E - ** LETTER TO USL
Xxxxxx-Xxxxx Laboratories, Inc.
00000 00xx Xxxxxx Xxxxx
Xxxxxxxxxxx, XX 00000
Ladies and Gentlemen:
Unigene Laboratories, Inc., a Delaware corporation ("Unigene") entered into
that certain **. Section 6 of the ** provides that Unigene **, including without
limitation, any ** that is inconsistent with ** without ** .
Unigene desires to enter into a license agreement, substantially in the
form attached (the "License Agreement") with Xxxxxx-Xxxxx Laboratories, Inc.
("USL"), under which Unigene grants a license to USL in relation to certain
Licensed Patents (as defined in the License Agreement). The ** being licensed to
USL under the License Agreement constitute a portion of the ** described in the
** Agreement.
For good and valuable consideration, the receipt and sufficiency are hereby
acknowledged, the undersigned, ** Party hereby:
**.
Sincerely,
**
EXHIBIT F
Form PTO-1595 RECORDATION FORM COVER SHEET U.S. DEPARTMENT OF COMMERCE
(Rev. 03/01) PATENTS ONLY U.S. Patent and Trademark Office
OMB No. 0651-0027 (exp. 5/31/2002)
Tab settings
To the Honorable Commissioner of Patents and Trademarks: Please record the
attached original documents or copy thereof.
1. Name of conveying party(ies): 2. Name and address of receiving party(ies)
Unigene Laboratories, Inc. Name: **
Internal Address:_____________________________________
Additional name(s) of conveying party(ies) attached? [ ] Yes [X] No ______________________________________________________
______________________________________________________
3. Nature of conveyance:
[ ] Assignment [ ] Merger Street Address: **
[X] Security Agreement [ ] Change of Name
______________________________________________________
[ ] Other_______________________________________________________
City: ** State: ** Zip: **
Execution Date: November 26, 2002 Additional name(s) & address(es) attached? [ ] Yes [X] No
4. Application number(s) or patent number(s):
If this document is being filed together with a new application, the execution date of the application is: _________
A. Patent Application No.(s) B. Patent No.(s)
** **
Additional numbers attached? [X] Yes [ ] No
5. Name and address of party to whom correspondence concerning 6. Total number of applications and patents involved: [13]
document should be mailed:
Name: ** 7. Total fee (37 CFR 3.41)..................$ 520.00
Internal Address: ** [ ] Enclosed
________________________________________________________________ [X] Authorized to be charged to deposit account
________________________________________________________________ 8. Deposit account number:
Street Address: **
**
**
City: ** State: ** Zip: ** (Attach duplicate copy of this page if paying by deposit
account)
DO NOT USE THIS SPACE
9. Statement and signature.
To the best of my knowledge and belief, the foregoing information is true and
correct and any attached copy is a true copy of the original document.
Xxxxx Xxxxx /s/ Xxxxx Xxxxx November 26, 2002
---------------------------- --------------- -------------------
Name of Person Signing Signature Date
Total number of pages including cover sheet, attachments, and documents: [ ]
Mail documents to be recorded with required cover sheet information to:
Commissioner of Patents & Trademarks, Box Assignments
Washington, D.C. 20231
EXHIBIT G
CSC THE UNITED STATES CORPORATION COMPANY
FILING PREPARATION - LISTING OF UNANSWERED QUESTIONS
Project ID: 181242
Project Type: UCC3
Project Description: Unigene Laboratories
Project Reference: 322875
You have provided answers for all questions presented; no unanswered questions
remain.
JURISDICTION LIST
STATE ID JURISDICTION
DE Secretary of State
NJ Department of Treasury/Commercial Recording
Page No: 1
[GRAPHIC APPEARS HERE]
UCC FINANCING STATEMENT AMENDMENT
FOLLOW INSTRUCTIONS (front and back) CAREFULLY
A. NAME & PHONE OF CONTACT AT FILER [optional]
B. SEND ACKNOWLEDGMENT TO: (Name and Address)
Corporation Service Company
Suite 100, 0000 Xxxxxxx Xxxx Xxxxx
Xxxxxxxxxx, XX 00000
THE ABOVE SPACE IS FOR FILING OFFICE USE ONLY
1a. INITIAL FINANCING STATEMENT FILE # 1b. This FINANCING STATEMENT AMENDMENT is
1099704 09/12/2001 to be filed [for record] (or recorded) in the
[ ] REAL ESTATE RECORDS.
2. [ ] TERMINATION: Effectiveness of the Financing Statement identified above
is terminated with respect to security interest(s) of the Secured Party
authorizing this Termination Statement.
3. [ ] CONTINUATION: Effectiveness of the Financing Statement identified above
with respect to security interest(s) of the Secured Party authorizing
this Continuation Statement is continued for the additional period
provided by applicable law.
4. [ ] ASSIGNMENT (full or partial): Give name of assignee in item 7a or 7b
and address of assignee in item 7c; and also give name of assignor in
item 9.
5. AMENDMENT (PARTY INFORMATION): This Amendment affects [ ] Debtor or
[ ] Secured Party of record. Check only one of these two boxes.
Also check one of the following three boxes and provide appropriate
information items in 6 and/or 7.
[ ] CHANGE name and/or address: Give current [ ] DELETE name: Give record name to [ ] ADD name: Complete item 7a or 7b,
record name in item 6a or 6b; also give be deleted in item 6a or 6b. and also item 7c; also complete
new name (if name change) in item 7a or 7b items 7d-7g (if applicable).
and/or new address (if address change) in
item 7c.
6. CURRENT RECORD INFORMATION:
6a. ORGANIZATION'S NAME:
OR
6b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
7. CHANGED (NEW) OR ADDED INFORMATION:
7a. ORGANIZATION'S NAME
OR
7b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
7c. MAILING ADDRESS CITY STATE POSTAL CODE COUNTRY
7d. TAX ID #: SSN OR EIN ADD'L INFO RE 7e. TYPE OF 7f. JURISDICTION OF 7g. ORGANIZATIONAL
ORGANIZATION ORGANIZATION ORGANIZATION ID #, if any
DEBTOR [ ] NONE
8. AMENDMENT (COLLATERAL CHANGE): check only one box.
Describe collateral [ ] deleted or [X] added, or give entire [ ] restated
collateral description, or describe collateral [ ] assigned.
**
9. NAME OF ** PARTY OF RECORD AUTHORIZING THIS AMENDMENT (name of assignor, if
this is an Assignment). If this is an Amendment authorized by a Debtor which
adds collateral or adds the authorizing Debtor, or if this is a Termination
authorized by a Debtor, check here [X] and enter name of DEBTOR authorizing
this Amendment.
9a. ORGANIZATION'S NAME
Unigene Laboratories, Inc.
OR
9b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
10. OPTIONAL FILER REFERENCE DATA CSC ID: 181242 DE-Secretary of State
ACKNOWLEDGMENT COPY -- NATIONAL UCC FINANCING STATEMENT AMENDMENT (FORM UCC3)
(REV. 07/29/98)
UCC FINANCING STATEMENT AMENDMENT ADDENDUM
FOLLOW INSTRUCTIONS (front and back) CAREFULLY
11. INITIAL FINANCING STATEMENT FILE # (same as item 1a on Amendment form)
1099704 09/12/2001
12. NAME OF PARTY AUTHORIZING THIS AMENDMENT (same as item 9 on Amendment form)
12a. ORGANIZATION'S NAME
Unigene Laboratories, Inc.
OR
12b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME, SUFFIX
13. Use this space for additional information
THE ABOVE SPACE IS FOR FILING OFFICE USE ONLY
** Parties
**
FILING OFFICE COPY -- NATIONAL UCC FINANCING STATEMENT AMENDMENT ADDENDUM (FORM
UCC3Ad)(REV. 07/29/98)
[GRAPHIC APPEARS HERE]
UCC FINANCING STATEMENT AMENDMENT
FOLLOW INSTRUCTIONS (front and back) CAREFULLY
A. NAME & PHONE OF CONTACT AT FILER [optional]
B. SEND ACKNOWLEDGMENT TO: (Name and Address)
Corporation Service Company
Suite 100, 0000 Xxxxxxx Xxxx Xxxxx
Xxxxxxxxxx, XX 00000
THE ABOVE SPACE IS FOR FILING OFFICE USE ONLY
1a. INITIAL FINANCING STATEMENT FILE # 1b. This FINANCING STATEMENT AMENDMENT is
01922681 08/17/1999 to be filed [for record] (or recorded) in the
[ ] REAL ESTATE RECORDS.
2. [ ] TERMINATION: Effectiveness of the Financing Statement identified above
is terminated with respect to security interest(s) of the Secured Party
authorizing this Termination Statement.
3. [ ] CONTINUATION: Effectiveness of the Financing Statement identified above
with respect to security interest(s) of the Secured Party authorizing
this Continuation Statement is continued for the additional period
provided by applicable law.
4. [ ] ASSIGNMENT (full or partial): Give name of assignee in item 7a or 7b
and address of assignee in item 7c; and also give name of assignor in
item 9.
5. AMENDMENT (PARTY INFORMATION): This Amendment affects [ ] Debtor or [ ]
Secured Party of record. Check only one of these two boxes.
Also check one of the following three boxes and provide appropriate
information in items 6 and/or 7.
[ ] CHANGE name and/or address: Give current [ ] DELETE name: Give record name to [ ] ADD name: Complete item 7a or 7b,
record name in item 6a or 6b; also give be deleted in item 6a or 6b. and also item 7c; also complete
new name (if name change) in item 7a or 7b items 7d-7g (if applicable).
and/or new address (if address change) in
item 7c.
6. CURRENT RECORD INFORMATION:
6a. ORGANIZATION'S NAME:
OR
6b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
7. CHANGED (NEW) OR ADDED INFORMATION:
7a. ORGANIZATION'S NAME
OR
7b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
7c. MAILING ADDRESS CITY STATE POSTAL CODE COUNTRY
7d. TAX ID #: SSN OR EIN ADD'L INFO RE 7e. TYPE OF 7f. JURISDICTION OF 7g. ORGANIZATIONAL
ORGANIZATION ORGANIZATION ORGANIZATION ID #, if any
DEBTOR [ ] NONE
8. AMENDMENT (COLLATERAL CHANGE): check only one box.
Describe collateral [ ] deleted or [X] added, or give entire [ ] restated
collateral description, or describe collateral [ ] assigned.
**
9. NAME OF ** PARTY OF RECORD AUTHORIZING THIS AMENDMENT (name of assignor,
if this is an Assignment). If this is an Amendment authorized by a Debtor
which adds collateral or adds the authorizing Debtor, or if this is a
Termination authorized by a Debtor, check here [X] and enter name of DEBTOR
authorizing this Amendment.
9a. ORGANIZATION'S NAME
Unigene Laboratories, Inc.
OR
9b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX
10. OPTIONAL FILER REFERENCE DATA Debtor(s) Unigene Laboratories, Inc.
CSC ID:181242 NJ-Department of Treasury/Commercial Recording
ACKNOWLEDGMENT COPY -- NATIONAL UCC FINANCING STATEMENT AMENDMENT (FORM UCC3)
(REV. 07/29/98)
UCC FINANCING STATEMENT AMENDMENT ADDENDUM
FOLLOW INSTRUCTIONS (front and back) CAREFULLY
11. INITIAL FINANCING STATEMENT FILE # (same as item 1a on Amendment form)
01922681 08/17/1999
12. NAME OF PARTY AUTHORIZING THIS AMENDMENT (same as item 9 on Amendment form)
12a. ORGANIZATION'S NAME
Unigene Laboratories, Inc.
OR
12b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME, SUFFIX
13. Use this space for additional information
THE ABOVE SPACE IS FOR FILING OFFICE USE ONLY
** Parties
**
FILING OFFICE COPY -- NATIONAL UCC FINANCING STATEMENT AMENDMENT ADDENDUM (FORM
UCC3Ad)(REV. 07/29/98)
