SECOND AMENDMENT 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.
EXHIBIT
10.7
SECOND
AMENDMENT TO
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 supersede 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
1.1 "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.
2
1.7 "CANDIDATE
COMMITTEE" shall have the meaning set forth in Article 3.2.1.
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.
3
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.
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.
4
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.
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.
5
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, 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.
6
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.
7
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.
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.
8
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.
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.
9
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 Licensee or its designee, unless
Applicable Law requires that a Regulatory Approval be solely or jointly in
the
name of NovaDel or its Affiliates, in which case NovaDel hereby assigns and
shall cause its Affiliates to assign, as applicable, such Regulatory Approval
to
Licensee to the extent permitted by Applicable Law; provided,
however,
that
NovaDel shall have a perpetual, irrevocable, worldwide right to use and
reference the Regulatory Documentation with respect to the Licensed Products
and
any data included or referenced therein for all purposes in connection with
the
treatment of humans, unless such use would violate the exclusive rights granted
to Licensee under this Agreement.
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 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.
10
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 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.
11
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 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.
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.
12
3.11.5 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:
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.
13
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.
4.4 LICENSE
FEES.
4.4.1 Licensee
shall pay to NovaDel $1,500,000.00 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 $250,000.00 upon completion of the Company's first
financing in excess of $10,000,000.
4.4.3 Licensee
shall pay NovaDel $50,000.00 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;
14
(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.
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;
15
(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.
(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
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.
16
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
17
5.3 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.
5.4 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:
5.4.1 All
Licensed Products used, leased or sold, by or for Licensee or its
Affiliates.
5.4.2 Total
amounts invoiced for Licensed Products used, leased or sold, by or for Licensee
or its Affiliates.
5.4.3 Deductions
applicable in computed "Net Sales" as defined in Article 1.33.
5.4.4 Total
milestone payments due based on achievement of milestones.
5.4.5 Total
Sublicense Fees owed by License from its Sublicensees.
5.4.6 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.
5.4.7 Names
and
addresses of all Sublicensees and Affiliates of Licensee.
5.5 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.
5.6 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.
5.7 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.
18
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, 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.
19
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.
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.
20
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.
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.
21
6.9 POTENTIAL
THIRD PARTY RIGHTS.
6.9.1 THIRD-PARTY
LICENSES. If (a) in the opinion of Licensee, 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 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.
22
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 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.
23
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 December 15, 2004, 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.
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.
24
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.
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.
25
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 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.
26
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 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.
27
(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 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.
28
(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 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.
29
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 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.
30
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 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 INARTICLES 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.
31
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 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.
32
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:
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
33
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 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;
34
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 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;
35
16.4.3 REQUIRED
BY REGULATORY AUTHORITY. Made by such Party to he 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.
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.
36
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 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.
37
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
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.
IN
WITNESS WHEREOF,
the
duly authorized officers of the Parties have executed this Agreement as of
the
dates set forth below their respective signatures.
THE
VETERINARY COMPANY
|
|||||
By:
|
/s/
Xxxx Xxxxxxxx
|
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
|
38
EXHIBIT
1
MANUFACTURING
AGREEMENT
FORMULATION
DEVELOPMENT TIMING FOR PROOF
OF
CONCEPT STAGE
Activity
|
Estimated
Time
|
|
A
|
Formulation
|
5
weeks
|
Pre-formulation
Study
Formulation
Pilot
Stability
Report
Batches
for Method
development
support
|
||
B
|
Methods
Development
Analytical
methods
Other
methods (spray
Characterization)
Report
on method
Development
|
8
weeks
|
C.
|
Manufacturing
|
3
to 5 weeks
|
Raw
materials and excipients
Testing
and releasing in-
coming
raw materials and
packaging
components
Manufacturing
of batches for
stability
study & PK clinical
trial
|
||
D.
|
Sampling
and testing stability
samples/every
month (AC) –
3
month (CRT)
|
14
week (at least 4
weeks
needed prior
to
PK study plus 2
weeks
for analysis)
|
TOTAL
|
22
- 24 weeks*
|
*Assumptions
1. |
Active
ingredients, inactive ingredients and components are readily available
from suppliers. Any delay to the expected date of receipt of ingredients
and/or components may result in a further delay due availability
of
NovaDel resources and equipment.
|
2. |
If
a product fails stability testing or we do not achieve successful
results
in the PK clinical study, an assessment will be conducted and the
reformation process will start at point
A.
|
39
EXHIBIT
2
NovaDel
Pharma Inc.
Project
Employee Costs
May
2004
Employee
Level/Function
|
$
Per Hour
|
|||
Vice
President Pharmaceutical Development
|
$
|
[***
|
]
|
|
Director,
Analytical
|
$
|
[***
|
]
|
|
Senior
Scientist, Analytical
|
$
|
[***
|
]
|
|
Manager,
Analytical
|
$
|
[***
|
]
|
|
Director,
Regulatory Affairs & Quality Assurance
|
$
|
[***
|
]
|
|
Director,
Project Management
|
$
|
[***
|
]
|
|
Director,
Manufacturing
|
$
|
[***
|
]
|
|
Manager,
Manufacturing
|
$
|
[***
|
]
|
|
Manager,
Clinical
|
$
|
[***
|
]
|
Note:
1. |
Hourly
rates are subject to change based on raises, promotions,
etc.
|
2. |
Rates
above include allocations for senior management and administrative
support
|
3. |
Temporary
help is billed, at cost, to
Licensee.
|
40
Intentionally
Blank
41
EXHIBIT
3
DESIGNATED
COMPOUNDS
--------------------
42