Exhibit 10.14
SECOND AMENDMENT TO
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LICENSE AND DEVELOPMENT AGREEMENT
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THIS SECOND AMENDMENT TO LICENSE AND DEVELOPMENT AGREEMENT (this
"Agreement"), effective as of June 22, 2004 (the "Effective Date"), is entered
into by and between NOVADEL PHARMA INC., a Delaware corporation ("NOVADEL"), and
THE VETERINARY COMPANY, INC., a Delaware corporation (the "LICENSEE"). NovaDel
and Licensee each may be referred to herein individually as a "Party," or
collectively as the "Parties."
WHEREAS, NovaDel has certain proprietary rights and intellectual property
(including pursuant to certain patents) with respect to buccal sprays for the
metered delivery of pharmaceutical products (the "Technology"); and
WHEREAS, Licensee desires to obtain from NovaDel, and NovaDel desires to
grant to Licensee, a license to develop and commercialize certain pharmaceutical
products that will be administered to non-human animals using the Technology on
the terms and conditions set forth herein; and
WHEREAS, Licensee and NovaDel entered into a License and Development
Agreement as of October 23, 2003 outlining terms of the foregoing (the "Original
Agreement);
WHEREAS, the Original Agreement was amended as of October 24, 2003 (the
"First Amendment");
WHEREAS, the Licensee and NovaDel wish to amend the Original Agreement, as
amended by the First Amendment, with this Agreement, and the parties hereby
intend that the Original Agreement and the First Amendment shall be, as of the
date hereof, null and void and that this Agreement shall supercede both the
Original Agreement and the First Amendment in their entirety as of the date
hereof;
NOW, THEREFORE, in consideration of the foregoing premises, the mutual
promises and covenants of the Parties contained herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto, intending to be legally bound, do hereby agree
as follows:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall
have the following meanings, unless otherwise specifically provided herein:
1.1 "AFFILIATE" shall mean, with respect to any Entity, any other Entity
that directly or indirectly through one or more intermediaries, controls, is
controlled by or is under common control with such Entity. For purposes of this
Article 1.1 only, "control" and, with correlative meanings, the terms
"controlled by" and "under common control with" shall mean (a) the possession,
directly or indirectly, of the power to direct the management or policies of an
Entity, whether through the ownership of voting securities, by contract or
otherwise, or (b) the ownership, directly or indirectly, of at least fifty
percent (50%) of the voting securities or other ownership interest of an Entity.
1.2 "APPLICABLE LAW" shall mean the applicable laws, rules, regulations,
guidelines and requirements of the Regulatory Authorities in the Territory.
1.3 "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the
development or commercialization of a Licensed Product, efforts and resources
commonly used in the research-based pharmaceutical industry for a product of
similar commercial potential at a similar stage in its lifecycle, taking into
consideration its safety and efficacy, its cost to develop, the competitiveness
of alternative products, its proprietary position, the likelihood of regulatory
approval, its profitability, and all other relevant factors. Commercially
Reasonable Efforts shall be determined on a market-by-market basis for each
Licensed Product without regard to the particular circumstances of a Party,
including any other product opportunities of such Party.
1.4 "CONFIDENTIAL INFORMATION" shall have the meaning set forth in Article
16.
1.5 "CONTROL" shall mean, with respect to any item of Information and
Inventions, Patent or other intellectual property right, possession of the
ability, whether directly or indirectly, and whether by ownership, license or
otherwise, to assign, or grant a license, sublicense or other right to or under,
such item, Patent or right as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party.
1.6 "DESIGNATED COMPOUND" shall mean a separate chemical active ingredient
(collectively, the "Designated Compounds" which are each of the First Designated
Compound, Second Designated Compound, Third Designated Compound, Fourth
Designated Compound and Additional Designated Compounds listed on Exhibit 3 when
such compound(s) are added to Exhibit 3. For clarity, it is acknowledged that a
Designated Compound is not a new formulation, salt or ester of a previously
identified Designated Compound. The "First Designated Compound" shall mean the
compound designated as the "First Designated Compound" on Exhibit 3 when and if
such compound is added to Exhibit 3 in accordance with Article 3. The "Second
Designated Compound" shall mean the compound containing a different active
ingredient than the First Designated Compound designated as the "Second
Designated Compound" on Exhibit 3 when and if such compound is added to Exhibit
3 in accordance with Article 3. The "Third Designated Compound" shall mean the
compound containing a different active ingredient than either the First
Designated Compound or the Second Designated Compound designated as the "Third
Designated Compound " on Exhibit 3 when and if such compound is added to Exhibit
3 in accordance with Article 3. The "Fourth Designated Compound" shall mean the
compound containing a different active ingredient than either the First
Designated Compound, the Second Designated Compound or the Third Designated
Compound designated as the "Fourth Designated Compound " on Exhibit 3 when and
if such compound is added to Exhibit 3 in accordance with Article 3. The
"Additional Designated Compound" shall refer to each Designated Compound Exhibit
3 other than the First Designated Compound, Second Designated Compound, Third
Designated Compound, or Fourth Designated Compound.
1.7 "CANDIDATE COMMITTEE" shall have the meaning set forth in Article
3.2.1.
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1.8 "EFFECTIVE DATE" shall have the meaning set forth in the preamble.
1.9 "ENTITY" shall mean any individual, sole proprietorship, corporation,
limited liability company, association, joint venture, partnership, limited
partnership, limited liability partnership, trust, university, business,
government or political subdivision thereof, including an agency, or any other
organization that possesses independent legal standing.
1.10 "EXPLOIT" shall mean to make, have made, import, use, sell, or offer
for sale, including to research, develop, register, modify, improve,
manufacture, have manufactured, store, have used, export, transport, distribute,
promote, market or have sold or otherwise dispose of a licensed product or
process.
1.11 "EXPLOITATION" shall mean the making, having made, importation, use,
sale, offering for sale of a licensed product or process, including the
research, development, registration, modification, improvement, manufacture,
storage, optimization, import, export, transport, distribution, promotion,
marketing, sale or other disposition of a licensed product or process.
1.12 "FDA" shall mean the United States Food and Drug Administration, or
any successor agency responsible for the evaluation and approval of
pharmaceutical products.
1.13 "FIELD OF USE" shall mean all commercial applications of buccal sprays
for the metered delivery of pharmaceutical materials for the treatment,
prevention, or diagnosis of diseases in non-human animals.
1.14 "FIRST COMMERCIAL SALE" shall mean the first sale of the Licensed
Product in a country under this agreement in an arms' length transaction to an
unaffiliated third party.
1.15 "IMPROVEMENT" shall mean any modification, variation or revision to an
apparatus, method, product or technology, or any discovery, technology, device,
process or formulation related to an apparatus, method, product or technology,
whether or not patented or patentable, including any enhancement in the
manufacture or steps or processes thereof, ingredients, preparation,
presentation, formulation, means of delivery, packaging or dosage of an
apparatus, method, product or technology, any discovery or development of any
new or expanded indications for an apparatus, method, product or technology, or
any discovery or development that improves the stability, safety or efficacy of
an apparatus, method, product or technology and which is necessary or useful to
commercialize the Licensed Process or Licensed product in the Field Improvement
shall not include those Improvements, inventions, conceptions, or reductions to
practice by Licensee that are applicable solely to the veterinary industry, or
which did not rely on Licensed Technology.
1.16 "INADA" shall mean an investigational new animal drug application
filed with the FDA or any equivalent application required by any Regulatory
Authority for approval to commence testing a Licensed Product in animals.
1.17 "INDEMNIFICATION CLAIM NOTICE" shall have the meaning set forth in
Article 10.3.1.
1.18 "INDEMNIFIED PARTY" shall have the meaning set forth in Article
10.3.1.
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1.19 "INFRINGEMENT SUIT" shall have the meaning set forth in Article 6.9.2.
1.20 "INFORMATION AND INVENTIONS" shall mean all technical, scientific and
other know-how and information, trade secrets, knowledge, technology, means,
methods, processes, practices, formulas, instructions, skills, techniques,
procedures, experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses, specifications, data,
results and other material, including pre-clinical and clinical trial results,
manufacturing procedures and test procedures and techniques, (whether or not
confidential, proprietary, patented or patentable) in written, electronic or any
other form now known or hereafter developed, and all Improvements, whether to
the foregoing or otherwise, and other discoveries, developments, inventions, and
other intellectual property (whether or not confidential, proprietary, patented
or patentable) relating to a Licensed Technology, Licensed Product or Licensed
Process.
1.21 "JOINT PATENTS" shall mean the patents and patent applications jointly
invented and/or owned by Licensee and NovaDel that are filed during the Term.
1.22 ."JOINT IMPROVEMENTS" shall be those Improvements (that include Joint
Patents and Joint Technology) that are made and owned together by NovaDel and
Licensee.
1.23 "JOINT TECHNOLOGY" shall be Technology that is made and owned together
by NovaDel and Licensee.
1.24 "LICENSED PROCESS" shall mean the proprietary buccal spray technology
for the delivery of active pharmaceutical compounds through the mucosal membrane
of the mouth or using an aerosol or pump spray device that is under the Control
of NovaDel as of the Effective Date and any Improvements thereto by NovaDel
during the term of this Agreement.
1.25 "LICENSED PRODUCT(S)" shall mean buccal sprays for the metered
delivery of pharmaceutical products within the Field of Use.
1.26 "LICENSED TECHNOLOGY" shall mean the NovaDel Patents and the NovaDel
Know-How and any Drug Master File or its equivalent submitted to a regulatory
agency by NovaDel, collectively, but only with respect to the Exploitation of
Licensed Products within the Field of Use.
1.27 "LICENSED TRADEMARK" shall mean those Trademarks Controlled by NovaDel
as of the execution date and during the term of this agreement which cover
licensed products and such other Trademarks as may be designated by NovaDel in
writing from time to time, and any registrations of the foregoing and pending
applications relating thereto.
1.28 "LICENSEE" shall mean The Veterinary Company, Inc., a Delaware
corporation.
1.29 "MANUFACTURING AGREEMENT" shall mean the Manufacturing and Formulation
Agreement for clinical trial material referred to Article 3.1.
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1.30 MATERIAL IMPROVEMENT shall mean a Joint Patent which was not directly
envisioned or directly foreshadowed by NovaDel Patents as of the date of
execution of this Agreement.
1.31 "MINIMUM FINANCING" shall mean [***].
1.32 "NADA" shall mean any New Animal Drug Application (or an Abbreviated
New Animal Drug Application) filed pursuant to the requirements of the FDA, and
any equivalent application required by any Regulatory Authority for the
marketing, sale or use of the Licensed Products in the Territory.
1.33 "NET SALES" shall mean, for any period, the gross amount invoiced by
Licensee and its Affiliates for the sale of Licensed Product by Licensee or any
of its Affiliates to Third Parties, less deductions for chargebacks, billing
errors, rejected goods, damaged goods and returns. Any of the deductions listed
above that involves a payment by Licensee or its Affiliates shall be taken as a
deduction in the calendar quarter in which the payment is accrued by such
entity. For purposes of determining Net Sales, a Licensed Product shall be
deemed to be sold when invoiced and a "sale" shall not include transfers, uses
or dispositions for promotional, pre-clinical, clinical, regulatory or
governmental purposes. For purposes of calculating Net Sales, sales between or
among Licensee or its Affiliates shall be excluded from the computation of Net
Sales, but sales by Licensee or its Affiliates to Third Parties shall be
included in the computation of Net Sales.
1.34 "NOVADEL" shall have the meaning set forth in the preamble.
1.35 "NOVADEL KNOW-HOW" shall mean all Information and Inventions
Controlled by NovaDel as of the Effective Date or, from time to time, during the
Term that (a) (i) are necessary for the use of the Licensed Process to Exploit
Licensed Products or (ii) relate to Improvements to the Licensed Product, during
the term of this Agreement and (b) are not generally known, but excluding any
Information and Inventions to the extent covered by or claimed by any NovaDel
Patents.
1.36 "NOVADEL PATENTS" shall mean the Patents and patent applications that
NovaDel Controls (a) as of the Effective Date, (b) that are filed during the
Term by NovaDel and describe or claim the Licensed Process or Licensed Product
or its use or manufacture, (c) any Improvements to the Licensed Products or
Licensed Process that are conceived and reduced to practice during the term of
the Agreement or (d) any Patents owned or controlled by NovaDel that the
manufacturing, use, sale, or commercialization of a Licensed Product by the
Licensee or its Sublicensee would infringe upon but for this Agreement
1.37 "PATENTS" shall mean (a) all patents and patent applications; (b) any
substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions,
supplementary protection certificates and the like,
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
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and any provisional applications, of any such patents or patent applications;
and (c) any foreign or international equivalent of any of the foregoing relating
to the Technology.
1.38 "REGULATORY APPROVAL" shall mean any and all approvals (including
pricing and reimbursement approvals), licenses, registrations or authorizations
of any Regulatory Authority, necessary for the Exploitation of the Licensed
Products in a country in the Territory, including (a) any approval of any
Licensed Product (including any INADAs, NADAs, and supplements or amendments
thereto); (b) pre- and post-approval marketing authorizations for a Licensed
Product (including any prerequisite manufacturing approval or authorization
related thereto); (c) labeling approval for a Licensed Product; and (d)
technical, medical and scientific licenses.
1.39 "REGULATORY AUTHORITY" shall mean any applicable supra-national,
federal, national, regional, state, provincial or local regulatory agencies,
departments, bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the Licensed
Technology or the Licensed Products in the Territory.
1.40 "REGULATORY DOCUMENTATION" shall mean all applications, registrations,
licenses, authorizations and approvals (including all Regulatory Approvals), all
correspondence submitted to or received from Regulatory Authorities (including
minutes and official contact reports relating to any communications with any
Regulatory Authority), all supporting documents and all clinical studies and
tests, relating to any Licensed Products, and all data contained in any of the
foregoing, including all regulatory drug lists, advertising and promotion
documents, adverse event files and complaint files.
1.41 "SUBLICENSEE" shall mean any Third Party to which Licensee grants a
sublicense pursuant to Article 2.
1.42 "SUBLICENSING FEES" shall mean all non-royalty consideration of any
kind, including any fees, milestones or other payments (whether cash or non-cash
(which shall be valued at fair market value)), received by Licensee or any of
its Affiliates from any Sublicensee as a direct or indirect result of the grant
by Licensee or any of its Affiliates to any Sublicensee of a license under, or
the use by any such Sublicensee of, any of the Licensed Technology or Licensed
Trademarks, in excess of the payments to be paid pursuant to Articles 4.4 and
4.5.
1.43 "TECHNOLOGY" shall mean buccal sprays for the metered delivery of
pharmaceutical products.
1.44 "TERM" shall have the meaning set forth in Article 7.
1.45 "TERRITORY" shall mean the entire world.
1.46 "THIRD PARTY" shall mean any Entity other than NovaDel, Licensee and
their respective Affiliates.
1.47 "THIRD PARTY CLAIM" shall have the meaning set forth in Article
10.3.2.
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1.48 "TRADEMARK" shall include any word, name, symbol, color, designation
or device or any combination thereof, including any trademark, trade dress,
brand xxxx, trade name, brand name, logo or business symbol.
1.49 "VALID CLAIM" shall mean, with respect to a particular country, a
claim of a Patent in such country that (a) has not been revoked or held
unenforceable or invalid by a decision of a court or governmental agency of
competent jurisdiction from which no appeal can be taken or has been taken
within the time allowed for appeal, and (b) has not been abandoned, disclaimed,
denied or admitted to be invalid or unenforceable through reissue or disclaimer
or otherwise in such country, and (c) in the case of a patent application claim,
has not been pending for more than seven years.
ARTICLE 2
GRANT OF RIGHTS
2.1 LICENSE GRANTS TO LICENSEE.
2.1.1 Subject to Article 2.3 and the other terms and conditions of
this Agreement, NovaDel hereby grants to Licensee and Licensee accepts, a
non-transferable (except as provided in Article 12), sublicensable (only as
provided in Article 2), royalty-bearing, exclusive right and license under
the Licensed Technology, Improvements, Patents, Joint Technology, Joint
Improvements and Joint Patents within the Field of Use to Exploit Licensed
Products in the Territory, to the full end of the Term for which the
Licensed Technology is licensed, unless sooner terminated as hereinafter
provided. For purposes of clarity, the License granted hereunder shall in no
way be interpreted to preclude NovaDel or any Affiliate, licensee or
sub-licensee of the NovaDel Patents and/or Licensed Technology in
pre-clinical animal testing of a compound ultimately intended for human use.
2.1.2 Subject to Article 2.3 and the other terms and conditions of
this Agreement, NovaDel hereby grants to Licensee and Licensee accepts, a
non-transferable (except as provided in Article 12), sublicensable (only as
provided in Article 2.5), royalty-bearing, non-exclusive right and license
under the Licensed Trademarks for the sole purpose of using such Licensed
Trademarks to market, distribute and sell the Licensed Products licensed
under Article 2.1.1 in the Territory, to the full end of the Term for which
the Licensed Products are licensed, unless sooner terminated as hereinafter
provided.
2.1.3 As partial consideration for the grant of this license, Licensee
shall not enter into an Agreement to sell Licensed Products with a Third
Party, that is a direct competitor of NovaDel, which develops, manufactures
or sells buccal spray to treat animals without the consent of NovaDel for
the term of this agreement.
2.1.4 Neither Party shall take any action against a Third Party,
including but not limited to bringing an infringement proceeding, pertaining
to Joint Patents without the consent of the other Party, which shall not be
unreasonably withheld.
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2.2 RETAINED RIGHTS. NovaDel retains all right, title and interest,
including the right to grant licenses to Third Parties, in and to the Licensed
Technology not specifically granted to the Licensee under this Agreement, other
than those rights Controlled or co-owned by Licensee. Licensee shall have no
rights, express or implied, with respect to the Licensed Technology or the
Licensed Trademarks, except as expressly set forth in Article 2, and Licensee
covenants to NovaDel that none of Licensee, its Affiliates or Sublicensees shall
use the Licensed Technology, directly or indirectly, for any purpose other than
in connection with the development or Exploitation of Licensed Products, or the
Licensed Trademarks, directly or indirectly, for any purpose other than the
Exploitation of Licensed Products hereunder.
2.3 SUBLICENSES. Licensee shall have the right to grant sublicenses under
the grants in Article 2.1 to Third Parties pursuant to a separate written
agreement, subject to the following requirements and conditions:
2.3.1 Within five (5) days after execution or receipt thereof, as
applicable, Licensee shall provide NovaDel with a full and complete copy of
each sublicense granted hereunder and shall deliver copies of all reports
(including relating to royalties and other payments) received by Licensee
from such Sublicensees.
2.3.2 Termination of this Agreement by NovaDel pursuant to Article 8
with respect to Licensee shall not terminate any sublicense granted by
Licensee pursuant to this Article 2.3 with respect to a Sublicensee,
provided that (a) such Sublicensee is not in breach of any provision of this
Agreement; provided however, if Sublicensee is in breach, NovaDel shall give
Licensee written notice of breach and 60 days to cure. In such case, NovaDel
shall assume and perform all obligations of Licensee under the sublicense
agreement.
2.3.3 Licensee shall not grant a Sublicense to Joint Patents outside
of the Field of Use without the consent of NovaDel. Licensee may grant a
sublicense to Joint Patents in the Field.
ARTICLE 3
DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES
3.1 DEVELOPMENT AND COMMERCIALIZATION. Licensee shall have the sole right
and obligation to develop and commercialize the Licensed Products in the
Territory. NovaDel shall perform or cause to be performed, on behalf of
Licensee, certain development activities in accordance with a Manufacturing
Agreement to provide Licensed Product for use in clinical trials. Within thirty
days of the execution of this Agreement, the parties hereto shall execute such
Manufacturing Agreement that is not inconsistent with the terms herein and which
shall govern the manufacture of Licensed Product for clinical trials.. The
Parties within sixty days of the execution of this Agreement shall execute a
Second Manufacturing Agreement for the production of Licensed Product for
commercial purposes. Except as set forth herein and in the Manufacturing
Agreements, Licensee shall be solely responsible for all costs and expenses in
connection with all development and commercialization activities.
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3.2 CANDIDATE COMMITTEE.
3.2.1 FORMATION AND AUTHORITY OF CANDIDATE COMMITTEE. NovaDel and
Licensee shall establish a candidate committee (the "Candidate Committee"),
which shall approve the selection of each product candidate that Licensee
intends to license under this Agreement. Upon approval of each product
candidate, such compound shall be listed on Exhibit 3 to this Agreement as
the Candidate Committee deems appropriate. The Candidate Committee may not
unreasonably withhold consent to the Licensee to add a compound to Exhibit
3. Each Party shall appoint an equal number of representatives with the
requisite experience and seniority to enable them to make decisions on
behalf of the Parties. From time to time, each Party may substitute its
representatives on written notice to the other Party.
3.2.2 PROCEDURAL RULES OF CANDIDATE COMMITTEE. The Candidate Committee
shall meet prior to the commencement of the development of a product
candidate or as otherwise agreed to by the Parties, at the offices of
NovaDel. The Candidate Committee shall adopt such standing rules as shall be
necessary for its work. A quorum of the Candidate Committee shall exist
whenever there is present at a meeting at least one representative appointed
by each Party. Members of the Candidate Committee may attend a meeting
either in person or by telephone, video conference or similar means in which
each participant can hear what is said by the other participants.
Representation by proxy shall not be allowed. The Candidate Committee shall
take action by unanimous consent of NovaDel and Licensee, with each such
Party having a single vote, irrespective of the number of representatives
actually in attendance at a meeting, or by a written resolution signed by
the designated representatives of each of NovaDel and Licensee.
3.2.3 DISPUTE RESOLUTION. If the Candidate Committee cannot, or does
not, reach agreement on an issue, then either Party shall have the right to
refer such issue to the Chief Executive Officers of the Parties who shall
confer on the resolution of the issue in good faith. Any final decision
mutually agreed to by the Chief Executive Officers of the Parties shall be
in writing and shall be conclusive and binding on the Parties. If such
officers are not able to agree on the resolution of an issue within twenty
(20) days after such issue was first referred to them, then Chief Executive
Officer of the Licensee shall have the sole right to choose a product
candidate, and such product candidate shall be added to Exhibit 3 as a
Designated Compound. Full consideration will be given to NovaDel's goodwill
when making this decision for a product candidate under a good faith
dispute.
3.2.4 LIMITATIONS ON AUTHORITY OF CANDIDATE COMMITTEE. Each Party to
this Agreement shall retain the rights, powers, and discretion granted to it
under this Agreement, and no such rights, powers, or discretion shall be
delegated to or vested in the Candidate Committee unless such delegation or
vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing. The Candidate Committee shall not have the
power to amend or modify this Agreement, which may only be amended or
modified as provided in Article 17.4 .
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3.3 Formulation Activities NovaDel shall manufacture and supply Licensee
with Licensed Product for clinical development of the Licensed Product. As such
NovaDel shall present Licensee with a suitable formulation for a Designated
Compound approved by Candidate Committee no later than the targeted timeframes
for formulation of Designated Compound as presented in Exhibit 1. Furthermore,
the cost for development of such Designated Compound shall be determined by the
schedule of expenses presented in Exhibit 2 and the cost of all materials needed
to formulate the Designated Compound which shall include, but not exclusively;
active and inactive ingredients, components, bottles, caps etc. presented below
and. All such reasonable and customary costs shall be paid by [***]. NovaDel
shall formulate designated compounds sequentially while working solely in the
labs located at 00 Xxxxx Xxxxxxx 00, Xxxxxxxxxx, XX and shall formulate no more
than two designated compounds simultaneously when working at new labs at 00
Xxxxxxxxxxxx Xxxx, Xxxxxxxxxx, XX. The first formulation will begin on payment
of the upfront licensing fee as per 4.4.1. The new labs at 00 Xxxxxxxxxxxx Xxxx,
Xxxxxxxxxx, XX will be completed no later than nine months from Effective Date.
3.4 NovaDel shall source the Designated Compound (i.e., active ingredient)
for the manufacture of the clinical trial formulation. Licensee shall have input
and shall be allowed to provide timely recommendations for potential sources of
such active ingredient. NovaDel shall take into consideration the timing and
cost of the material as well as the reliability of the supplier.
3.5 REGULATORY APPROVALS. All INADAs, NADAs and other filings, applications
or requests pursuant to or in connection with the Regulatory Approvals required
to Exploit a Licensed Product shall be made in the name of [***].
3.6 REGULATORY RECORDS. NovaDel and Licensee each shall maintain, or cause
to be maintained, records of its respective Development Activities in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes, which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of its respective
Development Activities, and which shall be retained by such Party for at least
five (5) years after the termination of this Agreement, or for such longer
period as may be required by Applicable Law. Each Party shall have the right,
during normal business hours and upon reasonable notice, to inspect and copy any
such records.
3.7 DEVELOPMENT AND USE OF TRADEMARKS. Licensee shall have the sole right
to determine the Trademarks to be used with respect to the Exploitation of the
Licensed Products on a worldwide basis, provided that the product labeling and
promotional materials disclose that the Licensed Products are delivered using
the Licensed Process and include the Licensed Trademarks.
3.8 DILIGENCE OBLIGATIONS. Licensee shall use Commercially Reasonable
Efforts to (a) develop and commercialize the Licensed Products in the Territory
in accordance with the terms and conditions of this Agreement; (b) obtain
Regulatory Approval(s) with respect to each Licensed Product in the Territory;
and (c) thereafter diligently and aggressively Exploit
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
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each Licensed Product in the Territory to maximize sales. Licensee shall ensure
that any Sublicense be terminable at the option of the Licensee in the event
that a Sublicensee fails to maintain active, diligent marketing efforts for
Licensed Product. NovaDel shall use Commercially Reasonable Efforts to formulate
and manufacture the Licensed Products requested by Licensee in accordance with
the terms and conditions of this Agreement.
3.9 BREACH OF DILIGENCE OBLIGATIONS.
3.9.1 NOTIFICATION AND MEETING. If at any time NovaDel has a
reasonable basis to believe that Licensee is in breach of its obligations
under Article 3.8 with respect to a country in the Territory, NovaDel shall
notify Licensee thereof, specifying the basis for its belief, and the
Parties shall meet within ten (10) days after such notice to discuss in good
faith NovaDel's concerns and Licensee's activities with respect to the
Licensed Products in such country.
3.9.2 If at any time Licensee has a reasonable basis to believe that
NovaDel is in breach of its formulation or manufacturing obligations under
Article 3, Licensee shall provide NovaDel written notice thereof, specifying
the basis for its belief, and the Parties shall meet within ten business
days (10) days after such notice to discuss in good faith Licensee's
concerns and NovaDel's activities with respect to such formulation or
manufacturing activities. If the breach is due solely to a technical or
scientific difficulty or to a situation that is not within the control of
NovaDel, the Parties shall cooperate to address and overcome such
difficulty, and Licensee shall agree to a reasonable extension to overcome
such sole technical or scientific difficulty.
3.10 RIGHT OF TERMINATION WITH RESPECT TO A LICENSED PRODUCT. If after good
faith discussions pursuant to Article 3.9, Licensee does not take reasonable
steps designed to rectify the breach of its obligations under Article 3.8 in
such country within sixty (60) days of meeting with NovaDel pursuant to Article
3.9.1 or, if such failure cannot be rectified within such sixty (60)-day period,
if Licensee does not commence actions to rectify such failure within such period
and thereafter diligently pursue such actions, the license grants to Licensee
under Article 2.1 with respect to such Licensed Product in such country shall
terminate. Upon the termination of Licensee's rights with respect to a Licensed
Product pursuant to the immediately preceding sentence, if NovaDel chooses,
Licensee (a) shall, and shall cause its Affiliates and Sublicensees to, promptly
disclose to NovaDel, in whatever form NovaDel may request, all Regulatory
Documentation in the possession or Control of Licensee, its Affiliates or
Sublicensees that relate to the Exploitation of such Licensed Product in such
country; provided that [***], (b) Licensee shall, and will hereby, grant, and
shall cause its Affiliates and Sublicensees to grant, to NovaDel, (i) in the
case of a Joint Patent that is not a Material Improvement, an exclusive,
transferable, sublicensable license to all of Licensee's respective rights,
titles and interests in and to any and all Joint Patents in the Field of Use in
the country at no additional cost; and in the case of a Joint Patent that is a
Material Improvement, an exclusive, transferable, fully sublicenseable license
in the Field of Use in that country under the same royalty and sublicense terms
and costs as Licensee is required to pay for NovaDel Patents under this
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
11
Agreement. ; and (ii) other Information in the possession or Control of
Licensee, its Affiliates or Sublicensees, in each case that relate to the
Exploitation of such Licensed Product in such country (the "Product-Related
Assets") and that solely relate to such country; provided that NovaDel reimburse
Licensee for the cost of such Information and as long as the transfer of
Information does not, in Licensee's reasonable opinion, place Licensee at a
competitive disadvantage in that or another country and solely to the extent
that the Product-Related Assets relate to such country and may be licensed or
transferred under the terms set out herein without a legal impediment.
3.11 MANUFACTURING.
3.11.1 Subject to Article 3, at Licensee's expense, NovaDel shall
manufacture and supply Licensee with Licensed Product for clinical
development of the Licensed Product not later than the timeframe given in
Exhibit 1 pursuant to the clinical trial Manufacturing Agreement. The
Manufacturing Agreement will include the following terms: (i) NovaDel shall
present Licensee with a suitable formulation for a Designated Compound that
delivers the target dosage(s) within the timeframe designated in Exhibit 1;
and (ii) the cost of the clinical supplies to Licensee shall [***], and
further provided that NovaDel shall return such capital, equipment upgrade
or additional components to Licensee at the termination or expiration of
this Agreement unless the parties agree that NovaDel shall retain such
capital equipment or equipment upgrades on terms to be agreed between the
parties.
3.11.2 Following receipt of Regulatory Approval, NovaDel shall
manufacture and supply Licensee with projected and approved needs for
Licensed Product in the United States pursuant to the Second Manufacturing
Agreement on commercially reasonable terms, which is intended to be [***]
over the reasonable and competitive cost of manufacturing.
3.11.3 The Manufacturing Agreements will provide among other things
that in the event that Licensee enters into a Sublicense for a Licensed
Product and such Sublicensee desires to obtain rights to manufacture such
Licensed Product, then NovaDel will not unreasonably withhold its consent to
transfer the manufacturing rights to such Sublicensee, provided that
measures are incorporated into the sublicensing agreement to continue to
safeguard the confidentiality of NovaDel Know-how and technology with
respect to the Licensed Product.
3.11.4 It is the intent of the Parties that NovaDel manufacture and
supply Licensee with 100% of its needs for Licensed Product in the United
States pursuant to the terms of the Manufacturing Agreement. Licensee shall
provide NovaDel with projections of Licensees commercial need and
commercially reasonable time to prepare and manufacture the commercial
product. Notwithstanding anything herein to the contrary, in the event that
NovaDel is unable or unwilling to provide clinical or commercial supply of
Licensed Product within a reasonable period of time upon commercially
reasonable terms, then Licensee shall be entitled to use an alternate
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
12
manufacturing source.. NovaDel shall promptly establish a contingency
manufacturing plan so that in the event that NovaDel cannot or does not
want to manufacture the Licensed Product in a commercially timely manner.
NovaDel shall advise Licensee of the identity of the contingency
manufacturer and provide confirmation of the ability and willingness of
that manufacturer to act as the contingency manufacturing source. In such
event, Licensee shall use commercially reasonable efforts to ensure that
any such alternate manufacturing source agree (a) to maintain in strictest
confidence all information Controlled by NovaDel relating to the
manufacture of the Licensed Product and the Licensed Technology
3.11.5 NovaDel will promptly notify Licensee of its inability to
manufacture and supply Licensed Product according to agreed commercial
projections by the Parties. Such notification shall be within a reasonable
time period so that Product and Technology transfer may occur to an
alternative manufacturing facility without significant disruption to
commercial supply.
3.11.6 COMPLIANCE WITH APPLICABLE LAW. Both NovaDel and Licensee shall
perform, or cause to be performed, any and all of its activities with
respect to the Licensed Products in good scientific manner and in compliance
in all material respects with all Applicable Law. NovaDel agrees that, at
all times during the performance of the Development Activities, it will act
in accordance with good manufacturing practices and all applicable laws,
rules and regulations.
ARTICLE 4
ROYALTIES AND OTHER CONSIDERATION
4.1 EQUITY. Simultaneously with the execution of this Agreement, Licensee
shall issue to NovaDel 592,500 shares of its common stock, par value $0.001 per
share (the "Common Stock") representing 15% of the outstanding shares of Common
Stock of the Company as of October 23, 2003. NovaDel represents that it is
acquiring the Common Stock for investment purposes only, for an indefinite
period of time, for its own account, not as a nominee or agent for any other
Entity, and not with a view to the sale or distribution of all or any part
thereof, and NovaDel has no present intention of selling, granting any
participation in, or otherwise distributing, any or all of the Common Stock.
NovaDel does not have any contract, undertaking, agreement or arrangement with
any Entity to sell, transfer or grant participation to such person, firm or
corporation, with respect to any or all of the Common Stock.
4.2 ROYALTIES. As partial consideration for the rights, privileges and
licenses granted hereunder and the activities performed by NovaDel under the
Manufacturing Agreements, Licensee shall make the following payments to NovaDel:
13
4.2.1 Licensee shall pay to NovaDel royalties in an amount equal to
[***] percent ([***]) of worldwide aggregate Net Sales by Licensee or any
Affiliate of Licensee of each Licensed Product during each calendar year.
4.2.2 Licensee shall pay to NovaDel (1) [***] percent ([***]) of all
royalties received by Licensee or its Affiliate from sales by any
Sublicensee of Licensed Product unless Licensee is strictly passive with
regard to the development and commercialization activities of such
Sublicensee relating to the Licensed Product sublicensed, in which case
Licensee shall pay NovaDel [***] percent ([***])of all royalties received by
Licensee or its Affiliate from sales by any Sublicensee of Licensed Product.
For the purpose of Article 4, Licensee is deemed passive if the Sublicense
occurs within six months of the date of this Agreement, or if Licensee has
not filed any Regulatory Documentation with an appropriate regulatory agency
prior to entering into the Sublicense.
4.2.3 Licensee shall pay to NovaDel [***] percent ([***]) of all
Sublicensing Fees other than fees received by Licensee under 4.2.2 unless
Licensee is strictly passive with regard to the development and
commercialization activities of such Sublicensee relating to the Licensed
Product sublicensed, in which case Licensee shall pay NovaDel [***] percent
([***]) of all Sublicense Fees received by Licensee or its Affiliate from
sales by any Sublicensee of Licensed Product.
4.2.4 ROYALTY TERM. Licensee's royalty obligations under Article 4.2
shall terminate, on a country-by-country basis, with respect to each
Licensed Product on the expiration date in such country of the last to
expire of any issued NovaDel Patent that includes at least one Valid Claim
covering the sale of such Licensed Product in such country. Upon termination
of the royalty obligations under this Article 4.2 in a country, the license
grants to Licensee in Article 2.1 shall be reduced in accordance with terms
respect to such Licensed Product in Article 4.6.
4.3 ROYALTY PAYMENTS. Royalties under Article 4.2.1 and sublicensing
royalties under 4.2.2 shall be payable to NovaDel on a quarterly basis, within
forty-five (45) days after the end of each calendar quarter; provided, however,
at the end of a calendar year Licensee shall determine the actual amounts owed
to NovaDel under Article 4.2.2 and any additional amounts owed to NovaDel for
the first three calendar quarters of such calendar year shall be paid with the
royalty payment for the last calendar quarter of such calendar year, and
provided further in the event that Licensee's payments for such calendar
quarters exceed the actual royalties owed for such calendar quarters, Licensee
shall have the right to offset such excess payments against the royalty payment
for the last calendar quarter of such calendar year. Only one royalty payment
will be due on Net Sales of a given Licensed Product even though the
manufacture, sale or use of such Licensed Product may be covered by more than
one intellectual property right in a country.
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
14
4.4 LICENSEE FEES.
4.4.1 Licensee shall pay to NovaDel [***] as an upfront licensing fee,
payable within 10 Business Days of the first date on which the Licensee has
received the Minimum Financing.
4.4.2 Licensee shall pay to NovaDel [***] upon completion of the
Company's first financing in excess of [***].
4.4.3 Licensee shall pay NovaDel [***] promptly upon designation by
the Candidate Committee of the First Designated Compound.
4.4.4 Licensee shall pay NovaDel [***] promptly upon designation by
the Candidate Committee of the Second Designated Compound.
4.4.5 Licensee shall pay NovaDel [***] promptly upon designation by
the Candidate Committee of the Third Designated Compound.
4.4.6 Licensee shall pay NovaDel [***] promptly upon designation by
the Candidate Committee of the Fourth Designated Compound.
4.4.7 Licensee shall pay NovaDel [***] promptly upon designation by
the Candidate Committee of each Additional Designated Compound.
4.5 MILESTONE PAYMENTS. Licensee shall also pay to NovaDel the following
Milestone Payments:
4.5.1 (a) [***] within five Business Days from the date on which the
Licensee's first filed NADA is accepted for review by the FDA for the first
Licensed Product containing the First Designated Compound;
(b) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the first Licensed Product containing
the First Designated Compound within the European Union is accepted for
review by the appropriate Regulatory Authority
(c) [***] promptly upon the date on which the Licensee's first filed
NADA for the first Licensed Product containing the First Designated
Compound is approved by the FDA;
(d) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the first Licensed Product containing
the First Designated Compound in any country within the European Union is
approved by the appropriate Regulatory Authority.
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
15
4.5.2 (a) [***] within five Business Days from the date on which the
Licensee's first filed NADA is accepted for review by the FDA for the
Licensed Product containing the Second Designated Compound;
(b) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Second Designated Compound within the European Union is accepted for
review by the appropriate Regulatory Authority
(c) [***] promptly upon the date on which the Licensee's first filed
NADA for the Licensed Product containing the Second Designated Compound is
approved by the FDA;
(d) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Second Designated Compound in any country within the European Union is
approved by the appropriate Regulatory Authority.
4.5.3 (a) [***] within five Business Days from the date on which the
Licensee's first filed NADA is accepted for review by the FDA for the
Licensed Product containing the Third Designated Compound;
(b) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Third Designated Compound within the European Union is accepted for review
by the appropriate Regulatory Authority
(c) [***] promptly upon the date on which the Licensee's first filed
NADA for the Licensed Product containing the Third Designated Compound is
approved by the FDA;
(d) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Third Designated Compound in any country within the European Union is
approved by the appropriate Regulatory Authority; and
4.5.4 (a) [***] within five Business Days from the date on which the
Licensee's first filed NADA is accepted for review by the FDA for the first
Licensed Product containing the Fourth Designated Compound;
(b) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Fourth Designated Compound within the European Union is accepted for
review by the appropriate Regulatory Authority
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
16
(c) [***] promptly upon the date on which the Licensee's first filed
NADA for the Licensed Product containing the Fourth Designated Compound is
approved by the FDA;
(d) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the Licensed Product containing the
Fourth Designated Compound in any country within the European Union is
approved by the appropriate Regulatory Authority; and
4.5.5 (a) [***] within five Business Days from the date on which the
Licensee's first filed NADA is accepted for review by the FDA for the
Licensed Product containing each Additional Designated Compound;
(b) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the first Licensed Product containing
each Additional Designated Compound within the European Union is accepted
for review by the appropriate Regulatory Authority
(c) [***] promptly upon the date on which the Licensee's first filed
NADA for the Licensed Product containing each Additional Designated
Compound is approved by the FDA;
(d) [***] promptly upon the date on which the Licensee's first filed
European Marketing Application for the first Licensed Product containing
each Additional Designated Compound in any country within the European
Union is accepted for review by the appropriate Regulatory Authority; and
4.6 REDUCTION OF PAYMENTS. In the event that, or from and after the date on
which, (a) no Valid Claim of a NovaDel Patent covering a Licensed Product exists
in a country and (b) no regulatory exclusivity with respect to such Licensed
Product exists in such country (whether as a result of expiration of the
exclusivity period or otherwise), (i) the milestone payments set forth in
Article 4.5 with respect to such Licensed Product, if any, and (ii) the royalty
rate payable to NovaDel by Licensee under Article 4.2 with respect to sales of
such Licensed Product in such country, each shall be reduced by [***] percent
([***]).
4.7 MODE OF PAYMENT. All payments to NovaDel under this Agreement shall be
paid in United States Dollars to a bank account in the United States as NovaDel
may reasonably designate. Any withholding taxes which Licensee, its Affiliates
or any Sublicensee shall be required by applicable law to withhold on remittance
of the payments shall be deducted from such payment to NovaDel and remitted to
the appropriate Regulatory Authority. Licensee shall furnish NovaDel with the
original copies of all official receipts for such taxes. If any currency
conversion shall be required in connection with the payments hereunder, such
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
17
conversion shall be made by using the average of the exchange rates prevailing
at Citibank, N.A. in New York, New York on the first business day of each month
in the reporting period to which such payments relate.
4.8 NON-REFUNDABLE, NON-CREDITABLE. The amounts paid or payable under this
Article 4 shall be non-refundable and non-creditable against any other amounts
due NovaDel under this Agreement.
ARTICLE 5
REPORTS AND RECORDS
5.1 RECORD RETENTION. Licensee shall maintain (and shall ensure that its
Affiliates and Sublicensees shall maintain) complete and accurate books, records
and accounts that fairly reflect their respective Net Sales, Other Income and
any milestones payable with respect to Licensed Products in sufficient detail to
confirm the accuracy of any payments required hereunder and in accordance with
GAAP, which books, records and accounts shall be retained by Licensee until the
later of (a) three (3) years after the end of the period to which such books,
records and accounts pertain, and (b) the expiration of the applicable tax
statute of limitations (or any extensions thereof), or for such longer period as
may be required by Applicable Law.
5.2 AUDIT. NovaDel shall have the right to have an independent certified
public accounting firm of nationally recognized standing, reasonably acceptable
to Licensee, to have access during normal business hours, and upon reasonable
prior written notice, to such of the records of Licensee (and its Affiliates and
Sublicensees) as may be reasonably necessary to verify the accuracy of such Net
Sales, Milestone Payments or Sublicense Fees for any calendar quarter ending not
more than thirty-six (36) months prior to the date of such request; provided,
however, that NovaDel shall not have the right to conduct more than one such
audit in any twelve (12)-month period. The accounting firm shall disclose to
each Party whether such Net Sales, Other Income or milestone payments are
correct or incorrect and the specific details concerning any discrepancies.
NovaDel shall bear the cost of such audit unless the audit reveals an
under-reporting or underpayment in excess of the greater of one hundred thousand
dollars ($150,000) or two percent (2%) of royalties, Milestone Payments or
Sublicense Fees payable for such period, in which case Licensee shall bear the
cost of the audit, rectify such underpayment and pay NovaDel applicable interest
as required by Article 5.5. All payments required under this Article 5.2 shall
be due within thirty (30) days of the date NovaDel provides Licensee notice of
the payment due. The results of such accounting firm shall be final, absent
manifest error.
5.3 REPORTS. Within thirty (30) days of the end of each quarter of each
calendar year, Licensee shall deliver to NovaDel complete and accurate reports,
giving such particulars of the business conducted by Licensee during the
preceding quarter under this Agreement as shall be pertinent to an accounting
for royalties, milestone payments and Other Income hereunder. These shall
include at least the following:
5.3.1 All Licensed Products used, leased or sold, by or for Licensee
or its Affiliates.
18
5.3.2 Total amounts invoiced for Licensed Products used, leased or
sold, by or for Licensee or its Affiliates.
5.3.3 Deductions applicable in computed "Net Sales" as defined in
Article 1.33.
5.3.4 Total milestone payments due based on achievement of milestones.
5.3.5 Total Sublicense Fees owed by License from its Sublicensees.
5.3.6 Total royalties due based on Net Sales by or for Licensee or its
Affiliates and Sublicensing Fees owed by its Sublicensees, including any
adjustments pursuant to Article 4.3.
5.3.7 Names and addresses of all Sublicensees and Affiliates of
Licensee.
5.4 FINANCIAL STATEMENTS. Within one hundred twenty (120) days of the end
of each fiscal year of Licensee, Licensee shall provide NovaDel with a copy of
Licensee's audited financial statements for such year to NovaDel.
5.5 INTEREST. Amounts which are not paid when due and which are not the
subject of a bona fide dispute shall accrue interest from the due date until
paid, at a rate equal to the then prevailing prime rate of Citibank, N.A., plus
four percent (4%), but in no event exceeding the amount permitted by applicable
law.
5.6 CONFIDENTIALITY. Each report received by NovaDel shall be treated by
NovaDel as if it were "Confidential Information" subject to the terms of Article
16.
ARTICLE 6
PATENT AND TRADEMARK
PROSECUTION AND MAINTENANCE
6.1 OWNERSHIP OF INFORMATION AND INVENTIONS. Subject to Article 6.2 and the
license grants under Article 2, as between the Parties, each Party shall own and
retain all right, title and interest in and to any and all Information and
Inventions that are conceived, discovered, developed or otherwise made by or on
behalf of such Party (or its Affiliates or its Sublicensees (other than the
other Party and its Affiliates)), whether or not patented or patentable, and any
and all Patent and other intellectual property rights with respect thereto.
Subject to the license grants to Licensee under Article 2, as between the
Parties, NovaDel shall own and retain all right, title and interest in and to
all Licensed Technology other than Joint Technology, Joint Improvements and
Joint Patents, which shall be owned jointly by NovaDel and Licensee.
6.2 OWNERSHIP OF THE LICENSED PROCESS. Subject to the license grants to
Licensee under Article 2 and other than Joint Technology, Joint Improvements and
Joint Patents, as between the Parties, NovaDel shall own and retain all right,
19
title and interest in and to the Licensed Process, including any and all
Information and Inventions with respect to the Licensed Process (including any
Improvements thereto) that are conceived, discovered, developed or otherwise
made, by or on behalf of NovaDel, its Affiliates or Sublicensees, whether or not
patented or patentable, and any and all Patent and other intellectual property
rights with respect thereto. Licensee acknowledges and agrees that the licenses
granted to it pursuant to Article 2.1 permit Licensee to use the Licensed
Process solely for the Exploitation of Licensed Products as provided in this
Agreement.
6.3 OWNERSHIP OF JOINT TECHNOLOGY, JOINT IMPROVEMENTS AND JOINT PATENTS
Subject to Article 6.2 and the license grants under Article 2, NovaDel and
Licensee shall co-own any and all (a) Information and Inventions, conceived,
discovered, developed or otherwise made, jointly by or on behalf of NovaDel (or
its Affiliates or its sublicensees), on the one hand, and Licensee (or its
Affiliates or Sublicensees), on the other hand, in connection with the work
conducted under or in connection with this Agreement, whether or not patented or
patentable. NovaDel shall have the responsibility to file, prosecute and
maintain all Patents derived from Joint Technology if the Joint Technology can
be adapted to both human and veterinary uses, and Licensee shall have the
responsibility to file, prosecute and maintain all Patents on Joint Technology
directed exclusively to veterinary uses. Each Party shall keep the other
reasonably informed about the status of the Joint Patents according to Article
6.6 and shall prosecute such Joint Patents with the goal of maximizing the value
for both parties. Neither party shall enter into litigation on a Joint Patent
without the consent and participation of the other, as further defined in
Articles 6.7 and 6.8, unless required by law or court order.
6.4 ALLOCATION OF OWNERSHIP INTEREST IN JOINT TECHNOLOGY, JOINT
IMPROVEMENTS AND JOINT PATENTS. NOVADEL SHALL OWN THE EXCLUSIVE INTEREST IN
HUMAN APPLICATIONS AND LICENSEE SHALL OWN THE EXCLUSIVE INTEREST IN NON-HUMAN
APPLICATIONS OF JOINT TECHNOLOGY, JOINT IMPROVEMENTS, AND JOINT PATENTS.
6.5 OWNERSHIP OF LICENSED TRADEMARKS. Subject to the license grants under
Article 2, as between the Parties, NovaDel shall own and retain all right, title
and interest in and to the Licensed Trademarks. NovaDel hereby acknowledges and
affirms (a) that to the best of its knowledge, the Licensed Trademarks and the
registrations thereof are valid and (b) that NovaDel or its Affiliates, as the
case may be, are the owners of all right and title to and interest in the
Licensed Trademarks and the registrations thereof, including any form or
embodiment thereof, and the goodwill now and hereafter associated with the
Licensed Trademarks. Licensee (on its own behalf and on behalf of its
Affiliates) expressly disclaims any right or title to or interest in the
Licensed Trademarks and the registrations thereof, except for the license
granted in Article 2.1.2. Licensee hereby agrees and undertakes that it will
not, and it will cause its Affiliates not to, contest or dispute the validity
of, or the rights of NovaDel and its Affiliates, as the case may be, in and to,
the Licensed Trademarks, or any part thereof, or the registrations thereof, nor
knowingly impair or endanger the validity of any of the foregoing. Licensee
acknowledges that all use of the Licensed Trademarks by or on behalf of Licensee
or its Affiliates shall inure to the benefit of NovaDel and its Affiliates. Upon
termination of the license granted in Article 2.1.2, Licensee and its Affiliates
shall not be entitled to any compensation for any increase in the value of the
Licensed Trademarks or for any goodwill associated therewith. If so requested,
Licensee shall, and shall cause its Affiliates to, assist NovaDel and its
Affiliates to safeguard their full right, title and interest in and to the
Licensed Trademarks and the registrations thereof.
20
6.6 UNITED STATES LAW. The determination of whether Information and
Inventions are conceived, discovered, developed or otherwise made by a Party for
the purpose of allocating proprietary rights (including Patent, copyright or
other intellectual property rights) therein, shall, for purposes of this
Agreement, be made in accordance with applicable United States law.
6.7 PROSECUTION OF PATENTS AND TRADEMARKS.
6.7.1 PROSECUTION OF NOVADEL PATENTS AND TRADEMARKS. NovaDel shall
have the sole right, at its cost and expense, to obtain, prosecute and
maintain throughout the world the NovaDel Patents and Licensed Trademarks.
Licensee shall, and shall cause its Affiliates and Sublicensees, as
applicable, to, cooperate fully with NovaDel in the preparation, filing,
prosecution, and maintenance of NovaDel's Patents. Such cooperation includes
(a) promptly executing all papers and instruments and requiring employees to
execute such papers and instruments as reasonable and appropriate so as to
enable NovaDel to file, prosecute, and maintain its Patents in any country;
and (b) promptly informing NovaDel of matters that may affect the
preparation, filing, prosecution, or maintenance of any such Patents.
NovaDel shall provide Licensee with drafts of all patent applications and
other material submissions to and correspondence with any patent authorities
to the extent such applications or submissions relate to the Licensed
Technology, in sufficient time, but in any event not less than ten (10) days
prior to the date a reply is required by the relevant patent authorities, to
allow for review and comment by Licensee. In addition, NovaDel shall provide
Licensee with an opportunity to consult with NovaDel regarding the filing
and contents of any such application, submission or correspondence. If
Licensee provides to NovaDel comments with respect to any such application,
submission or correspondence, to the extent such comments relate to any
Licensed Technology, NovaDel agrees to reasonably consider such comments, it
being understood that NovaDel retains the right to determine whether to
comply with or incorporate such comments, if at all. If NovaDel elects not
to pursue the filing, prosecution or maintenance of a NovaDel Patent in a
particular country, or to take any other action with respect to a NovaDel
Patent in a particular country that is necessary or useful to establish or
preserve rights with respect to the Licensed Products or Processes, then
NovaDel shall so notify Licensee promptly in writing and in good time to
enable Licensee to meet any deadlines by which an action must be taken to
establish or preserve any such rights in such NovaDel Patent in such
country. Upon receipt of any such notice by NovaDel or if, at any time,
NovaDel fails to initiate any such action within thirty (30) days after a
request by Licensee that it do so (and thereafter diligently pursue such
action), Licensee shall have the right, but not the obligation, to pursue
the filing or registration, or support the continued prosecution or
maintenance, of such NovaDel Patent at its expense in such country. If
Licensee elects to pursue such filing or registration, as the case may be,
or continue such support, NovaDel shall assign such NovaDel Patent to
Licensee at no additional consideration.
6.7.2 PROSECUTION OF JOINT PATENTS The party having the responsibility
to file, prosecute and maintain Joint Patents under Article 6.3 shall comply
with the procedure set out in Article 6.6.1, and the other Party shall
cooperate as set out in Article 6.6.1.
21
6.8 ENFORCEMENT OF PATENTS AND TRADEMARKS.
6.8.1 INFRINGEMENT OF NOVADEL OR JOINT TECHNOLOGY AND TRADEMARKS. If
either Party determines that any Technology or Trademark of NovaDel or any
Joint Technology is being infringed by a Third Party's activities and that
such infringement could affect the exercise by the Parties of their
respective rights and obligations under this Agreement, it shall promptly
notify such other Party in writing and provide such other Party with any
evidence of such infringement that is reasonably available. Promptly after
the receipt of such written notice, the Parties shall meet and discuss in
good faith the removal of such infringement. NovaDel shall consider in good
faith any comments from Licensee and shall keep Licensee reasonably informed
of any steps taken to stop such infringement. NovaDel shall have the first
right, but not the obligation, to stop such infringement at its sole cost
and expense; provided, however, that Licensee shall reimburse NovaDel for
[***] incurred by NovaDel with respect to actions taken to stop the
infringement of Joint Patents or NovaDel Patents to the extent that such
infringement would be a Licensed Product if sold by Licensee. In the event
that NovaDel fails within ninety (90) days following notice of such
infringement, or earlier notifies Licensee in writing of its intent not, to
take commercially appropriate steps to remove any infringement of any
NovaDel Patent or Licensed Trademark that is likely to have a material
adverse effect on the sale of a Licensed Product, Licensee shall have the
right to do so at Licensee's expense; provided, however, that if NovaDel has
commenced negotiations with an alleged infringer for discontinuance of such
infringement within such ninety (90) day period, NovaDel shall have an
additional ninety (90) days to conclude its negotiations before Licensee may
bring suit for such infringement, and provided further that Licensee shall
not enter into any settlement or compromise with respect to any NovaDel
Patent or Licensed Trademark without NovaDel's prior consent, which consent
shall not be unreasonably withheld, and further provided that NovaDel shall
not enter into a settlement or compromise of such infringement without
Licensee's consent, which shall not be unreasonably withheld. Each Party
shall provide reasonable assistance to the other Party, including providing
access to relevant documents and other evidence, making its employees
available at reasonable business hours, and joining the action to the extent
necessary to allow the enforcing Party to maintain the action. Any amounts
recovered by a Party pursuant to this Article, whether by settlement or
judgment, shall be used to reimburse the Parties for their reasonable costs
and expenses in making such recovery (which amounts shall be allocated pro
rata if insufficient to cover the totality of such expenses), with any
remainder being retained by the Party that brought the enforcement action;
provided, however, that to the extent that any award is attributable to the
loss of sales of Licensed Products, such amount shall be paid to Licensee
and shall be treated as Net Sales on which royalties shall be due under
Article 4.
6.9 POTENTIAL THIRD PARTY RIGHTS.
6.9.1 THIRD-PARTY LICENSES. If (a) in the opinion of Licensee,
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
22
Licensee, or any of its Affiliates or Sublicensees, cannot Exploit a
Licensed Product in a country in the Territory without infringing one or
more Patents that have issued to a Third Party in such country, or (b) as
a result of any claim made against a Party, or any of its Affiliates or
Sublicensees, alleging that the Exploitation of a Licensed Product
infringes or misappropriates any Patent or any other intellectual property
right of a Third Party in a country in the Territory, a suit is brought in
a court of competent jurisdiction, Licensee shall have the first right,
but not the obligation to negotiate and to obtain a license from such
Third Party as necessary for the Exploitation of any Licensed Products
hereunder in such country. Licensee shall be solely responsible for [***]
percent ([***]) of all royalty and other obligations with respect to the
Exploitation of Licensed Products; provided, however, that Licensee shall
have the right to credit [***] percent ([***]) of any royalties and other
payments paid by Licensee, its Affiliates or Sublicensees under such
license with respect to such country against the royalty payments or other
payments to be paid by Licensee to NovaDel with respect to the sale of the
Licensed Product(s) in that country ; provided, however, that no royalty
or other payment when due, regardless of the amount or number of credits
available to Licensee in accordance with this Agreement, shall be reduced
by more than [***] percent ([***]) of the amounts otherwise owed in any
calendar quarter. Credits not exhausted in any calendar quarter may be
carried into future calendar quarters. Licensee agrees not to make
statements against the interest of NovaDel or Joint Patents or reach
written conclusions regarding the validity or enforceability of NovaDel or
Joint Patents in any settlement agreement without the consent of NovaDel.
. NovaDel agrees not to make statements against the interest of NovaDel or
Joint Patents or reach written conclusions regarding the validity or
enforceability of NovaDel or Joint Patents in any settlement agreement
without the consent of Licensee.
6.9.2 THIRD PARTY LITIGATION. In the event that a Third Party
institutes a Patent, Trademark or other infringement suit (including any
suit alleging the invalidity or unenforceability of the Patents of a Party
or its Affiliates, or claiming confusion, deception or dilution of a
Trademark) against either Party or its respective Affiliates, licensees or
Sublicensees during the Term, alleging use of the Licensed Technology,
Licensed Trademarks or any other activities hereunder, infringes one or more
Patent, Trademark or other intellectual property rights held by such Third
Party (an "Infringement Suit"), the Parties shall cooperate with one another
in defending such suit. If NovaDel is named as a party to the litigation,
and NovaDel determines that issues raised in the litigation adversely impact
NovaDel Patents or Joint Patents, NovaDel shall have the right, not he
obligation, to control that aspect of the litigation. Licensee shall
cooperate with NovaDel in the defense of that aspect of the litigation. If
NovaDel is not named as a party to the litigation and is not added as a
party to the litigation, however, NovaDel determines that issues raised in
the litigation adversely impact NovaDel Patents or Joint Patents, NovaDel
shall have the right to consult with Licensee in the presentation of the
defense. Licensee shall bear [***] percent ([***]) of its own costs and
expenses associated with any such Infringement Suit to the extent that it
relates to
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
23
the Exploitation of any Licensed Product, and NovaDel shall bear [***]
percent ([***]) of its own costs of cooperation and participation. If
Licensee elects not to defend the Third Party Litigation, and NovaDel is
named as a party to the litigation, NovaDel shall have the right, but not
the responsibility, to do so at its own expense. In such case, Licensee
shall bear [***] percent ([***]) of its own costs of cooperation and
participation.
6.9.3 RETAINED RIGHTS. Nothing in this Article 6.8 shall prevent
Licensee, at its own expense, from obtaining any license or other rights
from Third Parties it deems appropriate in order to permit the full and
unhindered exercise of its rights under this Agreement.
ARTICLE 7
TERM OF THE AGREEMENT
7.1 TERM. Unless otherwise terminated pursuant to Article 8, this Agreement
shall enter into effect on the Effective Date and shall remain in full force and
effect on a country-by-country basis until the later of (a) the expiration date
of the last to expire of any issued NovaDel Patent that includes at least one
Valid Claim and (b) the twentieth (20th) anniversary of the Effective Date.
After such termination, Licensee shall have the full right to exploit the
Licensed Products and Licensed Processes without any further payments or
responsibility to NovaDel.
ARTICLE 8
TERMINATION
8.1 TERMINATION UPON INSOLVENCY. If Licensee shall become bankrupt, or
shall file a petition in bankruptcy or insolvency or for reorganization or for
an arrangement or for the appointment of a receiver or trustee or of its assets,
or if an involuntary petition for any of the foregoing shall be filed with
respect to Licensee and not dismissed within sixty (60) days, or if the business
of Licensee shall be placed in the hands of a receiver, assignee or trustee for
the benefit of creditors, whether by the voluntary act of Licensee or otherwise,
this Agreement shall automatically terminate.
8.2 TERMINATION FOR PAYMENT DEFAULT. Should Licensee fail to make payment
to NovaDel of royalties or other amounts due in accordance with the terms of
this Agreement in a country, NovaDel shall have the right to terminate this
Agreement in that country within sixty (60) days after giving written notice of
termination unless Licensee shall pay to NovaDel, within the 60-day period, all
such amounts due and payable. Upon the expiration of the 60-day period, if
Licensee shall not have paid all such amounts due and payable, the rights,
privileges and licenses granted hereunder shall, at the option of NovaDel,
immediately terminate. In the event a payment is the subject of a bona fide
dispute between NovaDel and Licensee that
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
24
is being pursued by a Party pursuant to the dispute resolution mechanism in
Article 9, then Licensee shall make such payment into an interest bearing escrow
account, and shall provide NovaDel with written notice that such payment is
being made into escrow subject to the outcome of such pending dispute resolution
procedure. In the event such dispute is finally and conclusively resolved in
favor of NovaDel, Licensee shall release such payment to NovaDel with any
accrued interest.
8.3 TERMINATION FOR MATERIAL BREACH. Upon any material breach or default of
this Agreement by either Party, other than as set forth in Article 8.1 or 8.2
above, the other Party shall have the right to terminate this Agreement and the
rights, privileges and licenses granted hereunder upon giving thirty (60) days
written notice to the breaching Party. Such termination shall become effective
upon the expiration of such thirty (60)-day period unless the breaching Party
shall have cured any such breach or default prior to the expiration of such
thirty (60) day period. If the purported breaching party disputes that a breach
has occurred, the dispute shall be settled according to the procedure of Article
9 and the license agreement shall stay in effect during the dispute resolution
process.
8.4 TERMINATION BY THE LICENSEE. The Licensee shall have the right at any
time to terminate this Agreement in whole or as to any Licensed Product by
giving ninety (90) days notice thereof in writing to NovaDel, provided that
Licensee satisfy any outstanding obligations to NovaDel.
8.5 EFFECT ON JOINT PATENTS OF BREACH OR VOLUNTARY TERMINATION. If Licensee
breaches this Agreement which results in termination or Licensee voluntarily
terminates this Agreement, NovaDel shall have the right on written notice to
prohibit Licensee and its Affiliates from further commercialization of a
Licensed Product in a Joint Patent prior to the 20th anniversary of the
Effective Date of this Agreement. If NovaDel breaches this Agreement which
results in termination or NovaDel voluntarily terminates this Agreement,
Licensee shall have the right on written notice to prohibit NovaDel and its
Affiliates from commercialization of a Licensed Product in a Joint Patent prior
to the 20th anniversary of the Effective Date of this Agreement.
8.6 FAILURE TO OBTAIN FINANCING. Notwithstanding anything to the contrary
herein, should Licensee fail to obtain the Minimum Financing by [***], NovaDel
shall have the right, which right shall continue until such time as Licensee
obtains the Minimum Financing, but not the obligation, to immediately terminate
this Agreement upon written notice to Licensee.
8.7 SURVIVAL. Any expiration or termination of this Agreement shall not
affect the rights and obligations of the Parties accrued prior to such
expiration or termination. Without limiting the foregoing, Articles 5, 9, 10,
11, 14, 15 and 16 and Articles 8.5, 8.7, 8.8, 8.9, 17.1 and 17.7 shall survive
the termination or expiration of this Agreement for any reason. Further, all
obligations under Section 6 to cooperate on Joint Patents shall survive the
termination of this Agreement, including being named as a Party to a lawsuit at
the request of the other joint owner,at a minimum nominally participating in any
legal proceeding to protect, defend or assert that Joint Patent right, and
cooperating in the prosecution of the Joint Patents as necessary.
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
25
8.8 WORK-IN-PROGRESS. Licensee and/or any Sublicensee thereof may, after
the effective date of a termination and continuing for a period not to exceed
six (6) months thereafter, sell all completed Licensed Products, and any
Licensed Products in the process of manufacture at the time of such termination,
and sell the same, provided that Licensee shall pay or cause to be paid to
NovaDel the royalties thereon as required by Article 4 of this Agreement and
shall submit the reports required by Article 5 hereof on the sales of Licensed
Products.
8.9 RETURN OF INFORMATION; ASSIGNMENT AND LICENSE.
8.9.1 Upon the termination of Licensee's rights with respect to a
Licensed Product prior to the natural expiration date of this Agreement in a
country, at NovaDel's choice, Licensee (a) shall, and shall cause its
Affiliates and Sublicensees to, promptly disclose to NovaDel, in whatever
form NovaDel may request, all Regulatory Documentation in the possession or
Control of Licensee, its Affiliates or Sublicensees that relate to the
Exploitation of such Licensed Product in such country; provided that NovaDel
reimburses Licensee for the cost of such submissions and Regulatory
Documentation, including the cost of clinical trials and data and document
assembly, (b) shall, and will hereby, grant, and shall cause its Affiliates
and Sublicensees to grant, to NovaDel, (i) in the case of a Joint Patent
that is not a Material Improvement, an exclusive, transferable,
sublicensable license to all of Licensee's respective rights, titles and
interests in and to any and all Joint Patents in the Field of Use in the
country at no additional cost; and in the case of a Joint Patent that is a
Material Improvement, an exclusive, transferable, fully sublicenseable
license in the Field of Use in that country under the same royalty and
sublicense terms and costs as Licensee is required to pay for NovaDel
Patents under this Agreement; and (ii) other Information in the possession
or Control of Licensee, its Affiliates or Sublicensees, in each case that
relate to the Exploitation of such Licensed Product in such country (the
"Product-Related Assets") and that solely relate to such country; provided
that NovaDel reimburse Licensee for the cost of such Information and as long
as the transfer of Information does not, in Licensee's reasonable opinion,
place Licensee at a competitive disadvantage in that or another country and
(c) to the extent that the Product-Related Assets do not solely relate to
such country or may not be licensed or transferred under the terms set out
herein due to a legal impediment, NovaDel and Licensee shall use best
efforts to agree on an alternative plan that would substantially accomplish
the rights and obligations described herein.
8.9.2 Notwithstanding anything contained in Article 8.9 , in the event
that any sublicense granted by Licensee survives pursuant to Article 2.3.2,
the Sublicensee may retain (a) the information and materials identified in
Article 8.6.1 that are rightfully in its possession and (b)
Agreement-Related Assets, in each case until the termination of such
sublicense, whereupon such Sublicensee shall return such materials to
NovaDel.
8.10 CUMULATIVE REMEDIES. The rights and remedies set forth in this Article
8 are cumulative and in addition to any other rights that may be available to
the Parties.
26
8.11 NON-REFUNDABILITY OF MILESTONES AND DEVELOPMENT COSTS. Any and all
Milestone Payments made to NovaDel by Licensee under Article 4.5 of this
Agreement shall be non-refundable in the event of termination of this Agreement
by either party under any of the provisions of Article 8.
ARTICLE 9
ARBITRATION
9.1 PROCEDURES. Any dispute other than a dispute pertaining to the validity
or enforceability of a patent arising from or relating to this Agreement shall
be determined before a tribunal of three arbitrators in New York, New York in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association (the "AAA"). One arbitrator shall be selected by NovaDel, one
arbitrator shall be selected by Licensee and the third arbitrator shall be
selected by mutual agreement of the first two arbitrators or by the AAA, if the
arbitrators appointed by the Parties are unable to select a third arbitrator
within fifteen (15) days of their selection. This Agreement shall stay in effect
during the arbitration proceeding, and all rights and responsibilities of the
Parties shall be honored and complied with during this dispute resolution
period. The decision of the arbitration board shall be binding on both parties
and nonappealable.
9.2 ARBITRATION SHALL BE HANDLED WITH DISPATCH The arbitration proceeding
shall be conducted in a manner that assure that it will be concluded within six
months after the selection of the three arbitrators. The time period for
arbitration may be extended by the agreement of both parties.
9.3 PATENT DISPUTES. Any claim, dispute, or controversy concerning the
validity, enforceability, or infringement of any Patent (including NovaDel or
Joint Patents) shall be resolved in any court having jurisdiction thereof. In
the event that, in any arbitration proceeding, any issue shall arise concerning
the validity, enforceability, or infringement of any Patent contained in the
Patents licensed hereunder, the arbitrators shall, to the extent possible,
resolve all issues other than validity, enforceability, and infringement; in any
event, the arbitrators shall not delay the arbitration proceeding for the
purpose of obtaining or permitting either Party to obtain judicial resolution of
such issues, unless an order staying the arbitration proceeding shall be entered
by a court of competent jurisdiction. Neither Party shall raise any issue
concerning the validity, enforceability, or infringement of any patent contained
in the Patents in any proceeding to enforce any arbitration award hereunder, or
in any proceeding otherwise arising out of any such arbitration award.
9.4 COSTS. The costs of such arbitration shall be borne proportionate to
the finding of fault as determined by the arbitration panel. Judgment on the
arbitration award may be entered by any court of competent jurisdiction.
ARTICLE 10
INDEMNIFICATION AND INSURANCE
10.1 INDEMNIFICATION OF NOVADEL. Licensee shall defend, indemnify and hold
NovaDel, its Affiliates, and their respective directors, officers, employees and
agents harmless from and against all liability, demands, damages, including
27
expenses or losses including death, personal injury, illness or property damage
(collectively, "Losses") arising directly or indirectly out of any: (a) breach
of this Agreement by Licensee, its Affiliates, Sublicensees or permitted assigns
or transferees; (b) actual or asserted violations of Applicable Law by Licensee,
its Affiliates, Sublicensees or permitted assignees or transferees; (c) use by
Licensee, its Affiliates, Sublicensees or permitted assignees or transferees of
the Licensed Technology, unless the loss at is a result or partial result of the
conduct of NovaDel, including in the manufacture of the Licensed Product or
production of adulterated Licensed Product; (d) Exploitation of the Licensed
Products by Licensee, its Affiliates, Sublicensees or permitted assignees or
transferees, , unless the loss at is a result or partial result of the conduct
of NovaDel, including in the manufacture of the Licensed Product and except for
those Losses for which NovaDel has an obligation to indemnify Licensee and its
Affiliates pursuant to Article 10.2, as to which Losses each Party shall
indemnify the other to the extent of their respective liability for the Losses.
10.2 INDEMNIFICATION OF LICENSEE. NovaDel shall defend, indemnify and hold
Licensee, its Affiliates, and their respective directors, officers, employees
and agents harmless from and against all Losses arising directly or indirectly
out of any: (a) breach of this Agreement by NovaDel or its Affiliates; (b)
conduct of NovaDel, including in the manufacture of the Licensed Product or
production of adulterated Licensed Product; (b) actual or asserted violations of
Applicable Law by NovaDel or its Affiliates, except for those Losses for which
Licensee has an obligation to indemnify NovaDel and its Affiliates pursuant to
Article 10.1, as to which Losses each Party shall indemnify the other to the
extent of their respective liability for the Losses.
10.3 INDEMNIFICATION PROCEDURE.
10.3.1 NOTICE OF CLAIM. The indemnified Party shall give the
indemnifying Party prompt written notice (an "Indemnification Claim Notice")
of any Losses or discovery of fact upon which such indemnified Party intends
to base a request for indemnification under Article 10.1 or Article 10.2,
but in no event shall the indemnifying Party be liable for any Losses that
result from any delay in providing such notice. Each Indemnification Claim
Notice must contain a description of the claim and the nature and amount of
such Loss (to the extent that the nature and amount of such Loss is known at
such time). The indemnified Party shall furnish promptly to the indemnifying
Party copies of all papers and official documents received in respect of any
Losses. All indemnification claims in respect of a Party, its Affiliates or
their respective directors, officers, employees and agents shall be made
solely by such Party to this Agreement (the "Indemnified Party").
10.3.2 THIRD PARTY CLAIMS. The obligations of an indemnifying Party
under this Article 11 with respect to Losses arising from claims of any
Third Party that are subject to indemnification as provided for in Articles
10.1 or 10.2 (a "Third Party Claim") shall be governed by and be contingent
upon the following additional terms and conditions:
(a) CONTROL OF DEFENSE. At its option, the indemnifying Party may
assume the defense of any Third Party Claim by giving written notice to
the Indemnified Party within thirty (30) days after the indemnifying
28
Party's receipt of an Indemnification Claim Notice. The assumption of the
defense of a Third Party Claim by the indemnifying Party shall not be
construed as an acknowledgment that the indemnifying Party is liable to
indemnify any indemnified Party in respect of the Third Party Claim, nor
shall it constitute a waiver by the indemnifying Party of any defenses it
may assert against any indemnified Party's claim for indemnification. Upon
assuming the defense of a Third Party Claim, the indemnifying Party may
appoint as lead counsel in the defense of the Third Party Claim any legal
counsel selected by the indemnifying Party. In the event the indemnifying
Party assumes the defense of a Third Party Claim, the Indemnified Party
shall immediately deliver to the indemnifying Party all original notices
and documents (including court papers) received by any indemnified Party
in connection with the Third Party Claim. Should the indemnifying Party
assume the defense of a Third Party Claim, the indemnifying Party shall
not be liable to the Indemnified Party or any other indemnified Party for
any legal expenses subsequently incurred by such indemnified Party in
connection with the analysis, defense or settlement of the Third Party
Claim. In the event that it is ultimately determined that the indemnifying
Party is not obligated to indemnify, defend or hold harmless an
Indemnified Party from and against the Third Party Claim, the Indemnified
Party shall reimburse the indemnifying Party for any and all costs and
expenses (including attorneys' fees and costs of suit) and any Losses
incurred by the indemnifying Party in its defense of the Third Party Claim
with respect to such Indemnified Party.
(b) RIGHT TO PARTICIPATE IN DEFENSE. Without limiting Article
10.3.2(a), any Indemnified Party shall be entitled to participate in, but
not control, the defense of such Third Party Claim and to employ counsel
of its choice for such purpose; provided, however, that such employment
shall be at the Indemnified Party's own expense unless (i) the employment
thereof has been specifically authorized by the indemnifying Party in
writing or (ii) the indemnifying Party has failed to assume the defense
and employ counsel in accordance with Article 10.3.2(a) (in which case the
Indemnified Party shall control the defense).
(c) SETTLEMENT. With respect to any Losses relating solely to the
payment of money damages in connection with a Third Party Claim and that
will not result in the Indemnified Party's becoming subject to injunctive
or other relief or otherwise adversely affect the business of the
Indemnified Party in any manner, and as to which the indemnifying Party
shall have acknowledged in writing the obligation to indemnify the
Indemnified Party hereunder, the indemnifying Party shall have the sole
right to consent to the entry of any judgment, enter into any settlement
or otherwise dispose of such Loss, on such terms as the indemnifying
Party, in its sole discretion, shall deem appropriate. With respect to all
other Losses in connection with Third Party Claims, where the indemnifying
Party has assumed the defense of the Third Party Claim in accordance with
Article 10.3.2(a), the indemnifying Party shall have authority to consent
to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss provided it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld or
delayed). The indemnifying Party shall not be liable for any settlement or
29
other disposition of a Loss by an indemnified Party that is reached
without the written consent of the indemnifying Party. Regardless of
whether the indemnifying Party chooses to defend or prosecute any Third
Party Claim, no indemnified Party shall admit any liability with respect
to, or settle, compromise or discharge, any Third Party Claim without the
prior written consent of the indemnifying Party.
(d) COOPERATION. Regardless of whether the indemnifying Party chooses
to defend or prosecute any Third Party Claim, the Indemnified Party shall,
and shall cause each other indemnified Party to, cooperate in the defense
or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested
in connection therewith. Such cooperation shall include access during
normal business hours afforded to indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are
reasonably relevant to such Third Party Claim, and making indemnified
Parties and other employees and agents available on a mutually convenient
basis to provide additional information and explanation of any material
provided hereunder, and the indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in
connection therewith.
(e) EXPENSES. Except as provided above, the costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified
Party in connection with any claim shall be reimbursed on a calendar
quarter basis by the indemnifying Party, without prejudice to the
indemnifying Party's right to contest the Indemnified Party's right to
indemnification and subject to refund in the event the indemnifying Party
is ultimately held not to be obligated to indemnify the Indemnified Party.
10.4 INSURANCE. Licensee shall have and maintain such type and amounts of
liability insurance covering the manufacture, supply, use and sale of the
Licensed Products as is normal and customary in the pharmaceutical industry
generally for parties similarly situated, and shall upon request provide NovaDel
with a copy of its policies of insurance in that regard, along with any
amendments and revisions thereto. NovaDel shall maintain such type and amounts
of liability insurance covering the manufacture, supply, use and sale of the
Licensed Products as is normal and customary in the pharmaceutical industry for
a manufacturer of products.
ARTICLE 11
REPRESENTATIONS AND WARRANTIES;
LIMITATION OF LIABILITY
11.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party hereby
represents and warrants to the other Party as of the Effective Date as follows:
11.1.1 DULY ORGANIZED. Such Party is a corporation duly organized,
validly existing and in good standing under the laws of the state in which
it is incorporated, and has full corporate power and
30
authority and the legal right to own and operate its property and assets
and to carry on its business as it is now being conducted and as is
contemplated to be conducted by this Agreement.
11.1.2 CORPORATE AUTHORITY. Such Party (a) has the power and authority
and the legal right to enter into this Agreement and perform its obligations
hereunder, and (b) has taken all necessary action on its part required to
authorize the execution and delivery of this Agreement and the performance
of its obligations hereunder. The Agreement has been duly executed and
delivered on behalf of such Party and is enforceable against it in
accordance with its terms, subject to the effects of bankruptcy, insolvency
or other laws of general application affecting the enforcement of creditor
rights and judicial principles affecting the availability of specific
performance and general principles of equity, whether enforceability is
considered in a proceeding at law or in equity.
11.1.3 LITIGATION. Such Party is not aware of any pending or
threatened litigation (and has not received any communication) that alleges
that such Party's activities related to this Agreement have violated, or
that by conducting the activities as contemplated herein such Party would
violate, any of the intellectual property rights of any other Person.
11.1.4 CONSENTS, APPROVALS, ETC. All necessary consents, approvals and
authorizations of all regulatory and governmental authorities and other
Persons required to be obtained by such Party in connection with the
execution and delivery of this Agreement and the performance of its
obligations hereunder have been obtained.
11.1.5 CONFLICTS. The execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (a) do not conflict with
or violate any requirement of applicable law or regulation or any provision
of the articles of incorporation, bylaws, or any similar constitutive
document of such Party, as applicable, in any material way, and (b) do not
conflict with, violate, or breach or constitute a default or require any
consent under, any contractual obligation or court or administrative order
by which such Party is bound.
11.1.6 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF NOVADEL. NovaDel
represents and warrants to Licensee that, to its Knowledge, as of the
Effective Date, NovaDel is the owner or (sub)licensee (with the right to
grant sublicenses to Licensee as contemplated under this Agreement) of the
NovaDel Patents, and has all right, title, and interest in and to the
NovaDel Patents, including exclusive, absolute, irrevocable right, title and
interest thereto, free and clear of all liens, charges, encumbrances or
other restrictions or limitations of any kind whatsoever and to the
NovaDel's knowledge and belief there are no licenses, options, restrictions,
liens, rights of third parties, disputes, royalty obligations, proceedings
or claims relating to, affecting, or limiting its rights or the rights of
the Licensee under this Agreement with respect to, or which may lead to a
claim of infringement or invalidity regarding, any part or all of the
Licensed Technology and their use as contemplated in the underlying patent
applications as presently
31
drafted. The NovaDel Patents have not, as of the Effective Date, been held
by a court of competent jurisdiction to be invalid or unenforceable, in
whole or in part.
11.1.7 To NovaDel's knowledge and belief there is no claim, pending or
threatened, of infringement, interference or invalidity regarding, any part
or all of the Licensed Technology and their use as contemplated in the
underlying patent applications as presently drafted.
11.2 ADDITIONAL COVENANTS OF LICENSEE. Licensee on behalf of itself and its
Affiliates agrees and covenants to the extent permitted by applicable law,
never, in any country, region or jurisdiction in the Territory, to institute or
prosecute any claim, action or suit at law or in equity seeking to have any
claim in a NovaDel Patent declared invalid or unenforceable; provided, however,
that nothing contained herein shall prohibit Licensee and its Affiliates and
Sublicensees from either (a) asserting any and all defenses available to it,
including assertions relating to the validity or enforceability of the NovaDel
Patents, in any suit or proceeding brought against them alleging the
infringement of any of the NovaDel Patents or breach of contract, or (b)
asserting any and all defenses, evidence and arguments, including lack of
patentability of the subject matter of a count or claim and lack of support for
a count or claim, in any interference involving a patent or patent application
owned by Licensee or its Affiliates or Sublicensees and a patent or patent
application included within the definition of the NovaDel Patents. In its
agreements with each of its Sublicensees, Licensee shall include provisions
requiring a covenant, materially identical to that Licensee is making in this
Article 11.2, on the part of the Sublicensee, and shall provide that NovaDel
shall have march-in right to seek termination of such agreement in the event the
Sublicensee breaches the covenant. NovaDel's right to seek termination of such
agreement with the Sublicensee shall be subject to notice, cure and dispute
resolutions provisions materially identical to the provision set forth in
Articles 8 and 9. Licensee and its Affiliates will take all reasonable action
(including signing required documents) and offer full cooperation to allow
NovaDel to exercise the march-in rights provided herein, to the extent permitted
by law.
11.3 NovaDel on behalf of itself and its Affiliates agrees and covenants to
the extent permitted by applicable law, never, in any country, region or
jurisdiction in the Territory, to institute or prosecute any claim, action or
suit at law or in equity seeking to have any claim in a Licensee Patent declared
invalid or unenforceable; provided, however, that nothing contained herein shall
prohibit NovaDel and its Affiliates and Sublicensees from either (a) asserting
any and all defenses available to it, including assertions relating to the
validity or enforceability of the Licensee Patents, in any suit or proceeding
brought against them alleging the infringement of any of the Licensee Patents or
breach of contract, or (b) asserting any and all defenses, evidence and
arguments, including lack of patentability of the subject matter of a count or
claim and lack of support for a count or claim, in any interference involving a
patent or patent application owned by NovaDel or its Affiliates or Sublicensees
and a patent or patent application included within the definition of the
Licensee Patents. In its agreements with each of its Sublicensees, NovaDel shall
include provisions requiring a covenant, materially identical to that NovaDel is
making in this Article, on the part of the Sublicensee, and shall provide that
Licensee shall have march-in right to seek termination of such agreement in the
event the Sublicensee breaches the covenant. Licensee's right to seek
termination of such agreement with the Sublicensee shall be subject to notice,
cure and dispute resolutions provisions materially identical to the provision
set forth in Articles 8 and 9. NovaDel and its Affiliates will take all
32
reasonable action (including signing required documents) and offer full
cooperation to allow Licensee to exercise the march-in rights provided herein,
to the extent permitted by law.
11.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
ARTICLES 11.1 AND 11.2, NOVADEL MAKES NO REPRESENTATIONS AND GRANTS NO
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, UNDER THIS AGREEMENT, AND NOVADEL SPECIFICALLY DISCLAIMS
ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR
PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE
NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES UNDER THIS
AGREEMENT.
11.5 LIMITATION OF LIABILITY. NONE OF NOVADEL OR ANY OF ITS AFFILIATES
SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES
(INCLUDING FOR LOST PROFITS), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT,
STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (A) THE USE OF THE LICENSED
TECHNOLOGY OR LICENSED TRADEMARKS OR (B) ANY BREACH OF OR FAILURE TO PERFORM ANY
OF THE PROVISIONS OF THIS AGREEMENT.
ARTICLE 12
ASSIGNMENT
This Agreement and the rights and duties appertaining hereto may not be
assigned by either Party without first obtaining the written consent of the
other which consent shall not be unreasonably withheld. Any such purported
assignment, without the prior written consent of the other Party, shall be null
and of no effect. Notwithstanding the foregoing, Licensee may assign this
Agreement to a purchaser, merging or consolidating corporation, or acquirer of
substantially all of Licensee's assets or business or pursuant to any
reorganization qualifying under Article 368 of the Internal Revenue Code of
1986, as amended, as may be in effect at such time.
ARTICLE 13
PAYMENT OF FEES AND EXPENSES
Each of Licensee and NovaDel shall be responsible for their own expenses
relating to the negotiation, execution and performance of this Agreement.
ARTICLE 14
USE OF NAMES AND PUBLICATION
14.1 USE OF NAME. Nothing contained in this Agreement shall be construed as
granting any right to Licensee, its Affiliates or Sublicensees to use in
advertising, publicity, or other promotional activities any Trademark of NovaDel
or any of its units (including contraction, abbreviation or simulation of any of
33
the foregoing) without the prior, written consent of NovaDel; provided, however,
that NovaDel acknowledges and agrees that Licensee may use the names of NovaDel
in various documents used by Licensee for capital raising and financing without
such prior written consent to the limited extent that such use may be required
by law, and provided further that all such uses shall be factually accurate and
not misleading.
14.2 RELATIONSHIP OF THE PARTIES. Nothing herein shall be deemed to
establish a relationship of principal and agent between NovaDel and Licensee,
nor any of their agents or employees for any purpose whatsoever. This Agreement
shall not be construed as creating a partnership between NovaDel and Licensee,
or as creating any other form of legal association or arrangement which would
impose liability upon one Party for the act or failure to act of the other
Party.
14.3 PUBLICATIONS. In the event that either Party desires to publish or
disclose, by written, oral or other presentation, Licensed Technology or any
material information related thereto, then that Party shall notify the other
Party in writing of its intention at least sixty (60) days prior to any speech,
lecture or other oral presentation and at least sixty (60) days before any
written or other publication or disclosure. The disclosing Party shall include
with such notice a description of any proposed oral presentation or, with
respect to any proposed written or other disclosure, a current draft of such
proposed disclosure or abstract. The non-disclosing Party may request that the
disclosing party, no later than thirty (30) days following the receipt of such
notice, delay such presentation, publication or disclosure in order to enable
the filing of a patent application, copyright or other appropriate form of
intellectual property protection related to the information to be disclosed.
Upon receipt of such request to delay such presentation, publication or
disclosure, the disclosing Party shall arrange for a delay of such presentation,
publication or disclosure until such time as the appropriate Party has filed, or
had filed on its behalf, such patent application, copyright or other appropriate
form of intellectual property protection in form and in substance reasonably
satisfactory to both Parties. If the disclosing Party does not receive any such
request to delay such presentation, publication or disclosure, the disclosing
Party may submit such material for presentation, publication or other form of
disclosure. Notwithstanding the foregoing, in no event shall the disclosing
Party have any right to publish or disclose the Licensed Process in the Field or
any information or data related thereto without the prior written consent of the
other Party, which consent the non-disclosing Party may not unreasonably
withhold.
ARTICLE 15
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
All notices or other communications that are required or permitted
hereunder shall be in writing and delivered personally, sent by telecopier (and
promptly confirmed by personal delivery, registered or certified mail or
overnight courier as provided herein), sent by nationally-recognized overnight
courier or sent by registered or certified mail, postage prepaid, return receipt
requested, addressed as follows:
34
If to NovaDel to:
NovaDel Pharma, Inc.
00 Xxxxxxxxxxxx Xx., Xxxxx 000
Xxxxxxxxxx,, XX 00000
Attention: President
000.000.0000 (fax)
with a copy (not constituting notice) to:
Xxxxx Day
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
TEL: 0.000.000.0000
FAX: 0.000.000.0000
If to Licensee to:
The Veterinary Company, Inc.
The Veterinary Company, Inc.
000 Xxxxxxxxx Xx., Xxxxxxxxx, XX 00000-0000
Attention: President
Tel: 000-000-0000
with a copy(not constituting notice) to:
King & Spalding
000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxx 00000-0000
Attn: Xxxxxx X. Xxxxxxx, Esq.
Tel: 000-000-0000
Fax: 000-000-0000
or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such
communication shall be deemed to have been given (a) when delivered, if
personally delivered or sent by telecopier on a business day, (b) on the
business day after dispatch, if sent by nationally-recognized overnight courier,
and (c) on the third business day following the date of mailing, if sent by
mail. It is understood and agreed that this Article 16 is not intended to govern
the day-to-day business communications necessary between the Parties in
performing their duties, in due course, under the terms of this Agreement.
ARTICLE 16
CONFIDENTIALITY
16.1 DEFINITION. "Confidential Information" of a Party shall mean all
information and know-how and any tangible embodiments thereof provided by or on
behalf of such Party to the other Party either in connection with the
35
discussions and negotiations pertaining to, or in the course of performing, this
Agreement, including the terms of this Agreement; data; knowledge; practices;
processes; ideas; research plans; engineering designs and drawings; research
data; manufacturing processes and techniques; scientific, manufacturing,
marketing and business plans; and financial and personnel matters relating to
the disclosing Party or to its present or future products, sales, suppliers,
customers, employees, investors or business. For purposes of this Agreement,
notwithstanding the Party that disclosed such information or know-how, all
NovaDel Know-How and all Information and Inventions with respect to the Licensed
Process shall be Confidential Information of NovaDel.
16.2 EXCLUSIONS. Notwithstanding the foregoing, information or know-how of
a Party shall not be deemed Confidential Information with respect to a receiving
Party for purposes of this Agreement if such information or know-how:
16.2.1 was already known to the receiving Party or its Affiliates,
other than under an obligation of confidentiality or non-use, at the time of
disclosure to such receiving Party;
16.2.2 was generally available or known to parties reasonably skilled
in the field to which such information or know-how pertains, or was
otherwise part of the public domain, at the time of its disclosure to such
receiving Party;
16.2.3 became generally available or known to parties reasonably
skilled in the field to which such information or know-how pertains, or
otherwise became part of the public domain, after its disclosure to such
receiving Party through no fault of a Party other than the Party that
Controls such information and know-how;
16.2.4 was disclosed to such receiving Party or its Affiliates, other
than under an obligation of confidentiality or non-use, by a Third Party who
had no obligation to the Party that Controls such information and know-how
not to disclose such information or know-how to others; or
16.2.5 was independently discovered or developed by such receiving
Party or its Affiliates, as evidenced by their written records, without the
use of Confidential Information belonging to the Party that Controls such
information and know-how, except with respect to the NovaDel Know-How with
respect to the Licensed Process, which shall be and remain Confidential
Information of NovaDel.
Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of a Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of such Party. Further, any combination of
Confidential Information shall not be considered in the public domain or in the
possession of a Party merely because individual elements of such Confidential
Information are in the public domain or in the possession of such Party unless
the combination and its principles are in the public domain or in the possession
of such Party.
16.3 DISCLOSURE AND USE RESTRICTION. Except as expressly provided herein,
the Parties agree that, for the Term and for five (5) years thereafter, each
Party and its Affiliates and sublicensees shall keep completely confidential and
36
shall not publish or otherwise disclose and shall not use for any purpose except
for the purposes contemplated by this Agreement any Confidential Information of
the other Party, its Affiliates or Sublicensees.
16.4 AUTHORIZED DISCLOSURE. Each Party may disclose Confidential
Information of the other Party to the extent that such disclosure is:
16.4.1 REQUIRED BY GOVERNMENTAL ORDER. Made in response to a valid
order of a court of competent jurisdiction or other supra-national, federal,
national, regional, state, provincial or local governmental or regulatory
body of competent jurisdiction; provided, however, that such Party shall
first have given notice to such other Party and given such other Party a
reasonable opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information and documents that are the
subject of such order be held in confidence by such court or agency or, if
disclosed, be used only for the purposes for which the order was issued; and
provided further that if a disclosure order is not quashed or a protective
order is not obtained, the Confidential Information disclosed in response to
such court or governmental order shall be limited to that information which
is legally required to be disclosed in response to such court or
governmental order;
16.4.2 REQUIRED BY LAW. Otherwise required by law; provided, however,
that the disclosing Party shall (a) provide the other Party with reasonable
advance notice of and an opportunity to comment on any such required
disclosure, (b) if requested by such other Party, seek confidential
treatment with respect to any such disclosure to the extent available, and
(c) use good faith efforts to incorporate the comments of such other Party
in any such disclosure or request for confidential treatment;
16.4.3 REQUIRED BY REGULATORY AUTHORITY. Made by such Party to the
Regulatory Authorities as required in connection with any filing,
application or request for Regulatory Approval; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information; or
16.4.4 REQUIRED BY AGREEMENT. Made by such Party, in connection with
the performance of this Agreement, to Affiliates, Sublicensees, research
parties, employees, consultants, representatives or agents, each of whom
prior to disclosure must be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Article 17.
16.5 PRESS RELEASES. Press releases or other similar public communication
by either Party relating to this Agreement, shall be approved in advance by the
other Party, which approval shall not be unreasonably withheld or delayed,
except for those communications required by Applicable Law (which shall be
provided to the other Party as soon as practicable after the release or
communication thereof), disclosures of information for which consent has
previously been obtained, and information of a similar nature to that which has
been previously disclosed publicly with respect to this Agreement, each of which
shall not require advance approval.
37
ARTICLE 17
MISCELLANEOUS PROVISIONS
17.1 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, excluding any conflicts or
choice of law rule or principle that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another jurisdiction.
17.2 REGISTRATION. If this Agreement or any associated transaction is
required by the law of any nation to be either approved or registered with any
governmental agency, Licensee shall assume all legal obligations to do so and
the costs in connection therewith.
17.3 TRADE REGULATIONS. Licensee shall observe all applicable United States
and foreign laws with respect to the transfer of Licensed Products and related
technical data to foreign countries, including the International Traffic in Arms
Regulations (ITAR) and the Export Administration Regulations.
17.4 ENTIRE AGREEMENT. The Parties hereto acknowledge that this Agreement,
including the Appendices and documents incorporated by reference set forth the
entire agreement and understanding of the Parties hereto as to the subject
matter hereof, and shall not be subject to any change of modification except by
the execution of a written instrument subscribed to by the Parties hereto. This
Agreement shall supersede all previous communications, representations or
understandings, either oral or written, between the Parties relating to the
subject matter hereof.
17.5 SEVERABILITY. If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of either Party under this Agreement will not be
materially and adversely affected thereby, (a) such provision shall be fully
severable, (b) this Agreement shall be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(c) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom, and (d) in lieu of such illegal, invalid
or unenforceable provision, there shall be added automatically as a part of this
Agreement a legal, valid and enforceable provision as similar in terms to such
illegal, invalid or unenforceable provision as may be possible and reasonably
acceptable to the Parties herein. To the fullest extent permitted by applicable
law, each Party hereby waives any provision of law that would render any
provision prohibited or unenforceable in any respect.
17.6 WAIVER. The failure of either Party to assert a right hereunder or to
insist upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other Party.
17.7 FORCE MAJEURE. Neither Party shall be held liable or responsible to
the other Party or be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the non-performing Party, including fires, floods, earthquakes,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), acts of terrorism, insurrections, riots, civil commotion,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions or
38
delays in acting by any governmental authority. The non-performing Party shall
notify the other Party of such force majeure within ten (10) days after such
occurrence by giving written notice to the other Party stating the nature of the
event, its anticipated duration, and any action being taken to avoid or minimize
its effect. The suspension of performance shall be of no greater scope and no
longer duration than is necessary and the non-performing Party shall use
commercially reasonable efforts to remedy its inability to perform; provided,
however, that in the event the suspension of performance continues for
one-hundred and eighty (180) days after the date of the occurrence, and such
failure to perform would constitute a material breach of this Agreement in the
absence of such force majeure, the non-performing Party may terminate this
Agreement pursuant by written notice to the other Party.
17.8 CONSTRUCTION. Except where the context otherwise requires, wherever
used, the singular shall include the plural, the plural the singular, the use of
any gender shall be applicable to all genders and the word "or" is used in the
inclusive sense (and/or). The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement. The term "including" as used herein shall mean including, without
limiting the generality of any description preceding such term. The language of
this Agreement shall be deemed to be the language mutually chosen by the Parties
and no rule of strict construction shall be applied against either Party hereto.
17.9 FURTHER ASSURANCE. Each Party shall duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes, or to better assure and confirm unto
such other Party its rights and remedies under this Agreement.
17.10 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
17.11 BINDING. This Agreement shall not be binding upon the Parties until
it has been signed below on behalf of each Party, in which event, it shall be
effective as of the Effective Date.
39
IN WITNESS WHEREOF, the duly authorized officers of the Parties have
executed this Agreement as of the dates set forth below their respective
signatures.
NOVADEL PHARMACEUTICAL THE VETERINARY COMPANY
CORPORATION
By: /s/ Xxxx Xxxxxxxx, MD By: /s/ Xxxxxx Xxxxxxxx
-------------------------- --------------------------
Name: Xxxx Xxxxxxxx, M.D. Name: Xxxxxx Xxxxxxxx
Title: President and CEO Title: CEO and President
Date: June 22, 2004 Date: June 22, 2004
40
EXHIBIT 1
---------
MANUFACTURING AGREEMENT
FORMULATION DEVELOPMENT TIMING FOR PROOF
OF CONCEPT STAGE
[***]
--------------------------------------------------------------------------------
INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
41
EXHIBIT 2
---------
NovaDel Pharma Inc.
-------------------
Project Employee Costs
----------------------
[***]
-----
Information marked by [***] has been omitted pursuant to a request for
confidential treatment. The omitted portion has been separately filed with the
Securities and Exchange Commission.
42
EXHIBIT 3
DESIGNATED COMPOUNDS
--------------------
43
