"Omitted Information filed separately with SEC-Confidential Treatment Requested
by New Brunswick Scientific Co., Inc." and indicated as [* *]
RESEARCH AND LICENSE AGREEMENT
This License Agreement ("Agreement"), effective as of 28th day of May, 1999
("Effective Date") is by and between Novo Nordisk A/S, a corporation existing
under the laws of Denmark and having a place of business at Novo Alle, DK-2880,
Bagsvaerd, Denmark ("Novo Nordisk"), and DGI BioTechnologies, LLC, a company
having its principal place of business at 40 Talmadge Road, PO Box 424, Edison,
NJ 08818-0424.
WITNESSETH
WHEREAS, DGI is the owner of certain DGI Technology (as hereinafter
defined) and DGI Patent Rights (as hereinafter defined); and
WHEREAS, Novo Nordisk desires to obtain from DGI, and DGI desires to grant
to Novo Nordisk a license to use and sell products in all countries of the world
under such DGI Patent Rights and DGI Technology.
NOW THEREFORE, in consideration of the mutual promises and for the other
good and valuable consideration, the receipt of which is hereby acknowledged,
the Parties agree as follows:
1. DEFINITIONS
The following definitions shall control the construction of each of the
following items wherever they appear in this Agreement.
1.1 "Affiliate" shall mean any company, joint venture partnership, or other
business entity which controls, is controlled by, or is under common control
with DGI or Novo Nordisk, as the case may be. A business entity shall be deemed
to control another business entity if it possesses, directly or indirectly, the
power to order or cause the direction, management and policies of such other
business entity, whether through the ownership of voting securities, by contract
or otherwise.
1.2 "DGI" shall mean DGI BioTechnologies, LLC and/or any Affiliate which is
a party to the arrangements set forth in this Agreement.
1.3 "DGI Patent Rights" shall mean all of DGI's rights possessed at any time
during the Term of this Agreement in and to any patents and patent applications,
including but not limited to DGI patents listed on Appendix A to this Agreement.
Said patents and patent applications shall include but not be limited to
selection patents, patent applications, divisionals, continuations,
continuations-in-part, reissues,
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re-examinations and extensions. Extensions of patents shall include; (a)
extensions under the U.S. Patent Term Restoration Act, (b) extensions of patents
under Japanese Patent Law, (c) Supplementary Protection Certificates for members
of the European Patent Convention and other countries in the European Economic
Area, and (d) similar extensions under any applicable law in the Territory.
1.4 "DGI Technology" shall mean any proprietary know-how owned or controlled
by DGI as of the Effective Date and/or developed, acquired or controlled by DGI
during the Term, including but not limited to technical data, experimental
results, specifications, techniques, inventions, processes, formulas and other
materials, all of which are useful in the development, discovery, production or
use of Licensed Product. DGI Technology shall not include; (a) know-how which
at the time of disclosure is in the public domain, (b) know-how which prior to
the disclosure was in Novo Nordisk's possession, and (c ) know-how developed
independently by Novo Nordisk without any use of any DGI Technology whatsoever.
1.5 "Diogenesis" shall mean DGI's surrogate ligand-based approach to finding
and using site-directed assays to identify drug leads.
1.6 "Field" shall mean a Product useful in treating, preventing or
controlling diabetes by direct or indiret [* *], the
development or discovery of which utilizes DGI Technology and/or is covered
by a DGI Patent Right.
1.7 "First Commercial Sale" shall mean the first sale or other commercial
disposal by Novo Nordisk or its sublicensee, after the Effective Date, of a
Licensed Product for value, in an arm's length transaction, in any country
within the Territory.
1.8 "Improvement" shall mean any modification, alteration, enhancement or
improvement to DGI Patent Rights and/or DGI Technology, which relates to the
Licensed Product(s).
1.9 "IND" shall mean an Investigational New Drug application submitted to
the Food and Drug Administration of the United States, and/or an equivalent
application to the equivalent regulatory body in the European Union and/or
Japan.
1.10 "Licensed Product" shall mean Products within the Field;
(a) the manufacture and/or sale of which are covered by a Valid Claim of DGI
Patent Rights, and/or
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(b) which are developed utilizing DGI Technology.
1.11 "Major Market" shall mean the United States, European Union and/or
Japan.
1.12 "NDA" shall mean a New Drug Application submitted to the Food and Drug
Administration of the United States, and/or an equivalent application to the
equivalent regulatory body in the European Union and/or Japan.
1.13 "Net Sales" shall mean Novo Nordisk's and its sublicensee's (s') gross
proceeds from sales of Licensed Product invoiced to any independent third party
less,
i. any direct or indirect credits and allowances or adjustments, including,
without limitation, credits and allowances on account of price adjustments or on
account of rejection, recall or return of Licensed Product previously sold;
ii. any trade and cash discounts; price reductions or rebates, retroactive
or otherwise, imposed by government authorities; and third party distributor
fees;
iii. any sales, excise, turnover, value added, or similar taxes and any
duties and other governmental charges imposed upon the production, importation,
use or sale of Licensed Product(s);
iv. applicable transportation, importation, insurance and other handling
charges, and
v. the cost of special devices used for administration of Licensed Product.
Such special devices shall not include conventional devices (e.g. tablets,
standard syringes, suppositories and/or standard transdermal patches).
Deductions i, ii, and iv shall not exceed fifteen percent (15%) of gross sales
of Licensed Product by Novo Nordisk and its sublicensee(s) during any reporting
period.
In the event that the Licensed Product is sold as part of a Combination Product
the Net Sales of the Licensed Product, for the purposes of determining royalty
payments, shall be determined by multiplying the Net Sales of the Combination
Product (as defined in the standard Net Sales definition) by the fraction, A/(A
+ B) where A is the average sale price of the Licensed Product when sold
separately in finished form and
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B is the average sale price of the other product(s) sold separately in finished
form.
In the event that the average sale price of the Licensed Product can be
determined but the average sale price of the other product(s) cannot be
determined, Net Sales for purposes of determining royalty payments shall be
calculated by multiplying the Net Sales of the Combination Products by the
fraction C/(C + D) where C is the selling party's average sales price of the
Licensed Product and D is the difference between the average selling price of
the Combination Product and the average selling price of the Licensed Product.
If the average sale price of the other product(s) can be determined but the
average price of the Licensed Product cannot be determined, Net Sales for
purposes of determining royalty payment shall be calculated by multiplying the
Net Sales of the Combination Products by the following formula: one (1) minus
C/(C + D) where C is the average selling price of the other product(s) and D is
the difference between the average selling price of the Combination Products and
the average selling price of the other product(s). In no event, however, shall
the Net Sales of Licensed Products be less than fifty percent (50%) of the Net
Sales of the Combination Products.
In the event that the average sale price of both the Licensed Product and the
other product(s) in the Combination Product cannot be determined, the Net Sales
of the Licensed Product shall be deemed to be equal to fifty percent (50%) of
the Net Sales of the Combination Product.
The Net Sales price for a Combination Product shall be calculated once each
calendar year and such price shall be used during all applicable royalty
reporting periods for the entire calendar year. When determining the average
sale price of a Licensed Product or product(s), the average sale price shall be
calculated using data arising from the twelve (12) months preceding the
calculation of the Net Sales price for the Combination Product. As used above,
the term "Combination Product" means any pharmaceutical product which comprises
the Licensed Product and other active compounds and/or ingredients.
1.14 "Novo Nordisk" shall mean Novo Nordisk A/S and/or any Affiliate thereof
which is a party to the arrangements set forth in this Agreement.
1.15 "Novo Nordisk Patent Rights" shall mean rights to patent applications
and patents filed by or on behalf of Novo Nordisk pursuant to this Agreement.
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1.16 "Parties" shall mean DGI and Novo Nordisk collectively and the term
"Party" shall mean each of DGI and Novo, Nordisk, individually.
1.17 "Phase II" initiation shall mean initiation of clinical trials to
demonstrate efficacy and short term safety.
1.18 "Phase III" initiation shall mean initiation of clinical trials to
demonstrate efficacy and safety in larger patient groups.
1.19 "PLPc" shall mean Preclinical Lead Profile candidate as defined in the
prevailing Novo Nordisk guidelines for management of Novo Nordisk's Health Care
Discovery projects.
1.20 "Product" shall mean a molecule discovered and/or developed using DGI
Patent Rights and/or DGI Technology.
1.21 [**].
1.22 "Research Plan" shall mean the research program to be carried out by
DGI as described in Section 6.3 and as included as Appendix B to this Agreement.
1.23 "Term" shall mean the last to expire of a DGI or Novo Nordisk Patent
Right containing a Valid Claim, covering the making, using or selling of
Licensed Product or twenty (20) years, whichever is later.
1.24 "Territory" shall mean all countries in the world.
1.25 [* *]
2. GRANT OF LICENSES
2.1 DGI hereby grants to Novo Nordisk, and Novo Nordisk hereby accepts, an
exclusive license within the Field under DGI Patent Rights and DGI Technology,
even as to DGI, including the right to sublicense, to use, produce, have
produced, import, offer to sell, sell and/or co-promote and/or co-market with
one or more third parties, Licensed Products in the Territory subject to Section
2.3. For the purpose of this Agreement, a co-promotor or a co-marketer shall be
considered a sublicensee.
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2.2 DGI hereby grants to Novo Nordisk, and Novo Nordisk hereby accepts, an
exclusive license subject to Section 2.3, even as to DGI, to use and develop
DGI Patent Rights and DGI Technology within the Field.
2.3
(a) DGI shall retain a royalty free right and license to use DGI
Technology, either alone or in combination with others to develop and [*
*} povided however such license shall be limited only to the [* *]
(b) DGI shall keep Novo Nordisk informed of the progress of its [* *]
on a regular basis and particularly if any significant results are observed,
provided it is not precluded from doing so by a commitment to a third party.
(c) DGI hereby grants to Novo Nordisk, the first right of refusal for an
exclusive license to any [* *] DGI shall not offer a license
under more favorable terms to a third party unless first offered to Novo
Nordisk.
2.4 Any improvements within the Field, made conceived, obtained and/or
controlled by DGI during the Term shall be disclosed to Novo Nordisk without
further financial obligation subject to Section 2.3. Novo Nordisk may use such
DGI improvements in connection with the Licensed Product by Novo Nordisk and/or
its sublicensees in the Territory.
3. LICENSING FEES, MILESTONE FEES AND ROYALTIES
3.1 As compensation to DGI for the licenses granted hereunder and furnished
to Novo Nordisk, Novo Nordisk agrees to pay to DGI the license fees set forth in
Section 3.2, milestone fees set forth in Section 3.3 and royalties set forth in
Section 3.4.
3.2 Novo Nordisk shall pay the following license fees to DGI:
(a) Six Hundred Thousand U.S. Dollars (US $600,000) within ten (10) business
days of signing of this Agreement by both Parties;
(b) Five Hundred Thousand U. S. Dollars (US $500,000) within ten (10)
business days of the signing of this Agreement by both Parties, and
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(c ) Five Hundred Thousand U.S. Dollars (US $500,000) within ten (10)
business days of the one (1) year anniversary of the signing of this Agreement
by both Parties.
3.3 Novo Nordisk shall pay the following milestone fees to DGI:
(a) [* *]:
i. [* .*]
ii. [* .*]
iii. [* *]
iv. [* *]
v. [* *]
vi. [* *]
vii. [* *]
(b) [* *]
i. [* *]
ii. [* *]
iii. [* *]
iv. [* *]
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v. [* *]
vi. [* *]
vii. [* *]
3.4. Novo Nordisk shall pay DGI a royalty based upon its and its
sublicensee's(s') annual Net Sales of Licensed Products in the Territory, for
each year commencing with the First Commercial Sale and terminating
[* *] The royalty shall be payable by Novo
Nordisk on annual Net Sales within the Territory, according to the following
rates:
(a) [* *]
i. [* *]
ii. [* *]; and
iii. [* *].
(b) [* *].
3.5 In the event Novo Nordisk experiences generic competition in excess of
twenty percent (20%), in a country of Novo Nordisk and its sublicensee's(s')
sales of Licensed Product during any calendar quarter, as reflected in IMS data
and/or documented declines in governmental sales, then the rate at which Novo
Nordisk pays royalty in that country, shall be reduced by the same reduction of
market share as the generic competition.
3.6 One-half of the milestone fee payments, set forth in Section 3.3, shall
be credited against the royalty payments under Section 3.4. However, in each
year referred to in Section 3.4, Novo Nordisk shall not deduct
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more than fifty percent (50%) of the royalties due under Section 3.4. Novo
Nordisk shall continue to take a credit against royalty payments until the sum
of the milestone fees has been fully credited.
3.7 Novo Nordisk shall pay only one royalty under Section 3.4 on Net Sales
of Licensed Product, notwithstanding the number of patents within DGI Patent
Rights and/or the nature and/or amount of DGI Technology. Once Novo Nordisk has
made one or more milestone payments for a molecule, such milestone payments
already paid need not be paid for another molecule selected for development in
place of the first mentioned molecule, unless such molecule is to be taken
independently to the market.
3.8 Sales of Licensed Product between Novo Nordisk, its Affiliates and its
sublicensees shall not be subject to any royalty obligation. In such cases, the
royalty shall be calculated upon Novo Nordisk's or its Affiliate's or its
sublicensee's Net Sales to an independent third party.
3.9 (a) If Novo Nordisk grants a sublicense, all of the terms and
conditions of this Agreement shall apply to the sublicensee to the same extent
as they apply to Novo Nordisk for all purposes of this Agreement. Novo Nordisk
assumes responsibility for the performance of all obligations so imposed on such
sublicensee and will itself pay and account to DGI for all royalties due under
this Agreement by reason of the operations of any such sublicensee.
(b) Novo Nordisk may extend to any of its Affiliates the benefit of this
Agreement, but Novo Nordisk shall remain responsible to DGI for all of the
obligations placed upon Novo Nordisk by this Agreement.
4. PAID UP LICENSE
4.1 Novo Nordisk's obligations to pay royalties, under section 3.4 shall
expire on a country-by-country basis upon the later of ten (10) years after the
First Commercial Sale of Licensed Product and expiration of the DGI Patent
Rights.
4.2 Upon the expiration of Novo Nordisk's obligation to pay royalties, Novo
Nordisk shall have a fully paid-up license to use, produce, offer to sell, sell
and/or co-promote and/or co-market with one or more third parties under DGI
Patent Rights and DGI Technology.
5. REMITTANCES AND AUDITS
5.1 Novo Nordisk shall make all payments to DGI under this Agreement,
according to its terms. If any payments made by Novo Nordisk under
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this Agreement is subject to withholding tax, such withholding tax shall be
borne by DGI and shall be deducted from the payments made by Novo Nordisk. As
long as DGI provides Novo Nordisk with all the necessary documentation (i.e.,
special Danish Tax Form, IRS Form 1001, and relevant equivalents), Novo Nordisk
shall, with respect to applicable laws support DGI in its efforts of minimizing
the withholding taxes. In the event that Novo Nordisk does deduct or withhold
any such taxes, as soon as practical, Novo Nordisk shall submit to DGI proper
documentation confirming Novo Nordisk's payment of any such taxes for DGI's
account.
5.2 All royalty payments under this Agreement shall be due and payable
within sixty (60) days after the last day of each calendar quarter, beginning
with the calendar quarter in which the First Commercial Sale occurred.
5.3 Novo Nordisk shall, within (60) days after the last day of each calendar
quarter, beginning with the quarter in which the First Commercial Sale occurred,
provide DGI a written statement, showing all Net Sales by country in the
Territory. In case no royalty is due for any such period, Novo Nordisk shall so
report.
5.4 All payments of royalties shall be made in United States Dollars and
such payments shall be made via wire transfer to one or more bank accounts to be
designated in writing, prior to the First Commercial Sale, by DGI to Novo
Nordisk. In the event that any Net Sale is made in a foreign currency, the
amount of such Net Sale shall be converted to United States dollars at the
exchange rate set forth in the Wall Street Journal (Eastern Edition). This
conversion shall be made using an average quarterly exchange rate determined as
the average of the exchange rates set forth in the Wall Street Journal (Eastern
Edition) published during the applicable reporting calendar quarter, if
available, and otherwise using rates as announced by the central bank of the
subject country of the Territory.
5.5 For the Term and for two (2) years thereafter, Novo Nordisk shall keep,
and shall cause its sublicensee(s) selling Licensed Product in the Territory to
keep, complete and accurate records of Net Sales of Licensed Product. Records
shall be kept in sufficient detail to enable the determination of royalties due,
under Section 3.4 hereof.
5.6 During the Term and for two (2) years thereafter, Novo Nordisk shall
give access to a nationally-recognized independent certified public accountant
("DGI Accountant"), appointed and paid by DGI, to which/whom Novo Nordisk has no
reasonable objection, to such
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records of Novo Nordisk as described in Section 5.5, within two (2) years of the
royalty period to which the records apply, in order to permit the DGI Accountant
to verify the accuracy of any royalty payments made or payable under this
Agreement. Such access shall be granted no more than once in any calendar year,
at DGI's request, during regular business hours and with ten (10) business-days'
notice. The DGI Accountant shall be under a confidentiality obligation to Novo
Nordisk to disclose to DGI, in such Accountant's report, only the amount and
accuracy of royalty payments made or payable under this Agreement. In the event
the amount payable under this Agreement is more than that actually paid to DGI
by Novo Nordisk (except for amounts not yet due on Net Sales for the
immediately-past calendar quarter), Novo Nordisk shall pay such difference to
DGI within thirty (30) days of such DGI Accountant's report.
5.7 If in any country, the transfer of royalties provided for herein is
prohibited by law or regulation, Novo Nordisk shall remit the royalty in local
currency to an interest bearing account in the name of DGI with banks or other
financial institutions located in such country as designated by DGI.
6. DEVELOPMENT AND REGISTRATON
6.1 [* *] Novo Nordisk shall conduct,
at its expense, any pre-clinical and clinical trials necessary to receive and
maintain registrations to sell any Licensed Products(s) in the Territory.
6.2 Novo Nordisk shall obtain and maintain, at its sole cost and expense,
all permits, licenses, authorizations and registrations for any country,
sovereignty, state, country, parish, municipality, or other local governmental
entity in the Territory which are necessary for Novo Nordisk to import,
distribute and sell Licensed Product.
6.3 DGI shall allocate the equivalent of one full time employee to conduct
further research on behalf of Novo Nordisk. Such research shall commence upon
both Parties mutually agreeing upon the research to
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be conducted, as outlined in the Research Program in Appendix B of this
Agreement. Such research shall be performed at a cost of One Hundred Eighty
Five Thousand U.S. Dollars (US $185,000). Such payment shall be made to DGI on
a quarterly basis. During the Research Program; (i) an exchange of information
shall occur on an ad hoc basis between scientists, and (ii) at the conclusion of
the Research Program, DGI shall submit a report to Novo Nordisk stating all
results of the Research Program. Upon the completion of said research, the
Parties shall mutually decide whether further work is necessary.
6.4
(a) A Steering Committee shall be established. Novo Nordisk and DGI
shall each appoint their members (one, maximum two) to the Steering Committee.
However, each Party may bring as many representatives of its organization to a
meeting of the Steering Committee as it chooses.
(b) The Steering Committee shall be responsible for the following:
i. overseeing execution of the Research Plan to be performed referred to in
Section 6.3 of this Agreement;
ii. review and report all DGI Technology being transferred to Novo Nordisk;
iii. review and comment on all patent applications to be filed by either
Party which are related to the Field;
iv. perform such other duties as the Parties mutually agree upon; and
v. determining which new technologies, know-how, inventions identified by
each Party, will become part of Appendix C of this Agreement.
(c) The Steering Committee shall make decisions by making a resolution, such
resolution being passed unanimously. All decisions, resolutions and matters
discussed at the Steering Committee shall be stated in minutes approved by both
Parties. Should the Steering Committee not be able to make a unanimous
decision, the matter shall be referred to the Corporate Vice President of Health
Care Discovery at Novo Nordisk and to the President of DGI.
(d) The Steering Committee shall determine all matters of a procedural
nature for the conduct of its meetings, including but
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not limited to, place, frequency and form. The first meeting ofthe Steering
Committee shall take place no later than thirty (30) days after the execution
date of this Agreement.
7. TECHNICAL INFORMATION AND KNOW-HOW
During the Term, DGI shall disclose and furnish to Novo Nordisk all DGI
Technology developed with the use of the [* *] and controlled by DGI
during the Term subject to Section 2.3.
8. MARKETING AND PROMOTION
Novo Nordisk shall employ resources in developing, registering, promoting,
marketing and selling Licensed Products in the Territory that are consistent
with its activities with respect to its other products of similar commercial
potential and product profile, and it shall be solely responsible for developing
and implementing a marketing plan for the Licensed Products. All costs and
expenses in connection with the marketing, advertising and promoting of Licensed
Products in the Territory shall be borne by Novo Nordisk.
9. PATENTS
9.1 DGI Patent Rights shall be maintained and prosecuted by DGI. The
Parties shall mutually agree on patent counsel [* *]. The fees and
expenses including, without limitation, filing, prosecution and maintenance fees
and the fees and expenses of such patent counsel shall be paid by [* *]. Any
additional countries which [* *] filing, shall be approved by both Parties.
[* .*]
9.2 At least every six months and prior to filing of any DGI Patent Rights,
DGI shall provide to Novo Nordisk an update on the status and progress of the
filing, prosecution and maintenance of all patents and patent applications
within DGI Patent Rights. DGI agrees to provide copies of all documents
received from the relevant patent offices in relation to all DGI Patent Rights
and further agrees to provide Novo
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Nordisk with advance copies of any papers to be filed in a patent office
relating to DGI Patent Rights with sufficient time for Novo Nordisk to provide
its comments to DGI before the filing of said papers.
9.3 Novo Nordisk shall have the right to file patents based upon DGI Patent
Rights, DGI Technology and/or the Licensed Product resulting from Novo Nordisk's
research and development. Such patents shall be known as Novo Nordisk Patent
Rights which are to be maintained, prosecuted and paid for by Novo Nordisk.
9.4 Without limiting the forgoing, each Party will have all rights of a
joint owner under any joint patents or other inventions made jointly by both
Parties ("Joint Patent Rights"). DGI agrees that Novo Nordisk shall be granted
an exclusive license, even as to DGI, including the right to sublicense, to use
Joint Patent Rights within the Field. The use of Joint Patent Rights outside
the Field shall be mutually agreed by both Parties. Inventorship shall be
determined according to US law. Joint Patent Rights shall be maintained,
prosecuted and paid for by Novo Nordisk.
9.5 Except as otherwise explicitly licensed as provided herein each Party
will, as between it and the other Party hereto, retain ownership of its own
inventions, copyrights, trade secrets, patent rights and other technology.
9.6 All trademark and service mark rights and all goodwill associated with
any trademarks and service marks used by Novo Nordisk and its Affiliates and
sublicensees in connection with Licensed Products shall belong solely to Novo
Nordisk.
9.7 The Parties shall furnish to the other Party copies of any proposed
publication and/or presentation of results relating to the Field in advance of
the submission of such proposed publication and/or presentation to a journal,
editor or other third party. The receiving Party shall have two (2) months
after receipt of said copies to object to such proposed presentation and/or
proposed publication because there is patentable subject matter or other
confidential information which needs protection. In the event, that the
receiving Party objects, the other Party shall refrain from making such
publication and/or presentation for a maximum of six (6) months from date of
receipt of such objection. In no event, shall either Party be allowed to
publish and/or present the peptide sequences and motifs and the other Parties'
confidential or proprietary information without prior written approval.
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10. INFRINGEMENT OF DGI PATENT RIGHTS
10.1 Each Party shall advise the other promptly upon becoming aware of any
infringement by a third party of DGI Patent Rights.
10.2 Novo Nordisk shall at Novo Nordisk's sole discretion, but including
discussion with DGI, take such legal action as is required to restrain such
infringement. DGI shall cooperate fully with Novo Nordisk, at Novo Nordisk's
request, in Novo Nordisk's effort to restrain such infringement. DGI may be
represented by counsel of its own selection at its own expense in any suit or
proceeding brought to restrain such infringement but Novo Nordisk shall have the
right to control the suit or proceeding. Any recovery obtained by Novo Nordisk
as a result of such suit or proceeding whether by judgment, award, decree or
settlement shall be first used to reimburse Novo Nordisk for its costs and
expenses pursuing such suit or proceeding, and the remaining balance shall be
split in the following manner: [* *].
10.3 If Novo Nordisk elects not to initiate an infringement action within
sixty (60) days of the mutual agreement of the Parties as to the existence of
infringement of DGI Patent Rights, DGI shall have the right, in its sole
discretion, to institute such action, at DGI's own expense. In such event, Novo
Nordisk shall fully cooperate with DGI. Any recovery received by DGI as a result
of such suit or proceeding whether by judgment, award, decree or settlement
shall first be used to reimburse DGI for it's costs and expenses pursuing such
suit or proceeding, and the remaining balance shall be [* *].
11. WARRANTIES AND REPRESENTATIONS
11.1 DGI warrants and represents that it owns all rights, title and interest
in and to the DGI Patent Rights and DGI Technology, exclusively licensed
hereunder to Novo Nordisk for the Territory, and that it has the full right and
authority to license the rights granted to Novo Nordisk hereunder. DGI further
warrants and represents that, to the best of its knowledge, each patent within
DGI Patent Rights is valid and enforceable, and that each patent resulting from
a patent application therein shall be valid and enforceable.
11.2 Each party hereby represents, warrants and further covenants to the
other that:
(a) It has full authority to enter this Agreement in accordance with the
terms of this Agreement;
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(b)This Agreement is not in conflict with any other agreements to which it
is party or by which it may be bound;
(c) This Agreement when executed shall become the legal valid and binding
obligation of it, enforceable against it, in accordance with its terms, except
as enforceability may be limited by bankruptcy, insolvency, reorganization or
other similar laws relating to the rights of creditors generally; and
(d) It shall negotiate in good faith the execution of such other documents
or agreements as may be necessary or desirable for the implementation of this
Agreement and the effective execution of the transactions contemplated hereby.
12. INDEMNIFICATION
12.1 Each Party shall defend, indemnify and hold the other Party and its
shareholders, directors, officers, employees and agents harmless from and
against any and all claims, judgments, causes of action, costs, awards, expenses
(including attorneys' fees and (other) expenses of litigation), arising out of
the indemnifying Party's activities under this Agreement, including, as
applicable, the manufacture, importation, use, promotion, marketing and/or sale
of Licensed Product, unless such liability results from a breach of the
indemnified Party's negligence or willful misrepresentations or other misconduct
or a breach of the indemnified Party's warranties set forth in Section 11.
12.2 One Party shall promptly notify the other Party of any claims or suits
for which said one Party may assert indemnification from said other Party
hereunder and said one Party shall permit said other Party, or its insurer, at
said other Party's expense, to assume or participate in the defense of any such
claims or suits and said one Party shall cooperate with said other Party or its
insurer in such defense when reasonably requested to do so. No settlement or
compromise shall be binding on a Party hereto without its prior written consent.
13. CONFIDENTIALITY AND NON-DISCLOSURE
13.1 During the Term, DGI and Novo Nordisk may receive or have access to
information that is confidential and proprietary to the other Party (as to
either party, its "Information"), the maintenance of the secrecy and
confidentiality of which is acknowledged by each Party to be important. For the
purpose of this Section, "Recipient" refers to the Party receiving the
Information from Discloser and "Discloser" refers to the Party disclosing the
Information to Recipient. Information includes proprietary and confidential
matters concerning certain know-how,
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by New Brunswick Scientific Co., Inc." and indicated as [* *]
data and/or other matters related to the Discloser's current and/or proposed
product(s), including but not limited to research, products, clinical data,
insulin receptor, developments, inventions, processes, technology, security
controls, marketing, finances and pricing. Confidential Information shall not
include information which: (i) is known to the Recipient or is independently
generated by or for Recipient without benefit of the Discloser's Confidential
Information; (ii) is disclosed to the Recipient, without restriction, by an
independent third party having a legal right to make such disclosure; (iii) is
or becomes part of the public domain through no breach of this Agreement by
Recipient; or (iv) the Recipient is required to disclose to relevant authorities
in connection with its development or commercialization of a PLPc or Licensed
Product pursuant to this Agreement.
13.2 During the Term and for five (5) years thereafter, Recipient (i) shall
not, without the Discloser's prior written consent, disclose, use or permit to
be used the other Party's Information in any manner except as expressly
authorized by this Agreement (ii) shall treat such Information with at least the
same degree of care that it treats its own confidential information, but in no
event with less than a reasonable degree of care, and (iii) shall use its
reasonable best efforts to prevent disclosure of Information to unauthorized
parties. Recipient shall ensure that only its employees, authorized agents, or
subcontractors or vendors who need to know the other Party's Information will
receive such Information from Discloser and that such persons shall be bound to
Recipient to the extent that Recipient can honor its obligations under the
provisions of this Section 13. Upon demand, or upon the termination of this
Agreement, the Parties shall comply with each other's instructions regarding the
disposition or return of each other's Information in its possession or control.
13.3 Unless otherwise required by law, neither Party shall use the name,
trademark or logo of the other Party in any marketing, advertisement or other
publication, shall not make any public statement relating to the other Party,
and will not release or disclose any information concerning the terms and
conditions of this Agreement to any third party, without the prior written
consent of the other Party, or as required to register, promote or sell Licensed
Product.
14. COMPLIANCE WITH LAWS
Each Party hereto agrees that it shall comply with all applicable international,
country and local laws, ordinances and codes in performing its obligations
hereunder, including the procurement of sublicenses, permits, certificates,
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by New Brunswick Scientific Co., Inc." and indicated as [* *]
registrations and any other requirements necessary to comply with this
Agreement. If at any time during the Term, a Party is informed, or information
comes to its attention, that it is or may be in violation of any law, ordinance,
regulation or code with respect to its activities hereunder, that Party shall
immediately take all appropriate steps to attempt to remedy such violation and
comply with such law, regulation, ordinance or code in all respects. Further,
each Party shall establish and maintain all proper records required by any law
or code of practice applicable to it from time to time.
15. NOTICES
15.1 Any notice required to be given pursuant to this Agreement shall be
made in writing and shall be deemed to have been duly given if delivered by a
recognized commercial courier service with receipt acknowledged, telefaxed with
receipt acknowledged (and with a confirmation copy sent by registered mail,
return receipt requested), or mailed by registered or certified mail, return
receipt requested, postage prepaid, as follows:
If to Novo Nordisk Novo Nordisk A/S
Novo Alle
2880 Bagsvaerd
Denmark
Attention: Corporate Vice President of
Health Care
Fax: 011-45-4442-7280
With copy to: Novo Nordisk A/S
Novo Alle
2880 Bagsvaerd
Denmark
Attention: Legal Department
General Counsel
Fax: 011-45-4498-0670
If to DGI DGI BioTechnologies, LLC
40 Talmadge Road
P.O. Box 424
Edison, NJ 08818
Attention: Dr. Arthur J. Blume, President
Fax: 732-287-1486
With copy to: Gibbons, Del Deo, Dolan,
Griffinger & Vecchione
One River Front Plaza
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"Omitted Information filed separately with SEC-Confidential Treatment Requested
by New Brunswick Scientific Co., Inc." and indicated as [* *]
Newark, NJ 07102
Attention: Bernard S. Leon, Esq.
Fax: 973-639-6461
16. GOVERNING LAW
This Agreement shall be deemed to be a contract made under and construed in
accordance with the laws of the State of New York, without regard to its
conflicts of laws principles. The Parties agree that all disputes will be
adjudicated in Federal Court with both Parties agreeing to waive trial by jury.
17. DISPUTE RESOLUTION
17.1 In the event of any dispute or disagreement between the Parties with
respect to the interpretation of any provision of this Agreement or with respect
to the performance by DGI or by Novo Nordisk of its duties hereunder, each of
the Parties shall appoint a designated employee to meet for the purpose of
endeavoring to resolve such dispute or to negotiate for an adjustment to such
provision.
17.2 In the event, an amicable resolution is not possible the Parties will
mutually agree to non-binding mediation.
17.3 Formal proceedings in Federal Court may only commence after the Parties
have made a good faith attempt to resolve their dispute during a non-binding
mediation proceeding.
18. TERM
This Agreement shall become effective as of the Effective Date and shall
continue through the Term, unless sooner terminated as provided in this
Agreement.
19. TERMINATION
19.1 This Agreement may be terminated with the written approval of both
Parties or upon default as provided in Section 19.2 of this Agreement. In the
event such termination occurs prior to the payment of the license fees in
Section 3.2 of this Agreement, Novo Nordisk will be required to make payment of
such license fees to DGI on the notice of such termination.
19.2 If either Party at any time materially defaults (i) in making the
payment of any money due hereunder, or (ii) in fulfilling any of the other
obligations or conditions hereunder, the other Party may in its sole discretion
waive the default; if not electing to waive the default, the
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other Party shall notify the defaulting Party in writing of the default and
allow the defaulting Party ninety (90) days from such notification to initiate
reasonable steps to cure such default. Notwithstanding this section 19.2, if
the defaulting Party disputes the existence, nature or extent of any default set
forth above, the Parties shall use good faith efforts to resolve the dispute
pursuant to Article 17. This Agreement shall continue until a final decision is
reached pursuant to Article 17.
19.3 Either Party may terminate this Agreement by written notice to the
other Party in the event the other Party:
(a) become insolvent or bankrupt;
(b) make an assignment for the benefit of its creditors;
(c) appoint a trustee or receiver for itself for all or a substantial part
of its property;
(d) have any case of proceeding commenced or other action taken by or
against itself in bankruptcy that is not dismissed within sixty (60) days of
filing; or
(e) seeks reorganization, liquidation, dissolution, a winding-up
arrangement, composition or readjustment of its debts or other relief under any
bankruptcy, insolvency, reorganization or other similar act or law or any
jurisdiction, now or hereafter in effect.
19.4 Upon any termination of this Agreement, other than the expiration of
the Term, if Novo Nordisk terminates in accordance with Section 19.3 or DGI is
considered to be the defaulting Party pursuant to Articles 17 and 19,
[* *] and DGI shall reconvey to Novo Nordisk all Novo Nordisk's
confidential and proprietary information. In the event, Novo Nordisk is
considered to be the defaulting Party pursuant to Article 17 and 19[*
*] In addition, DGI and Novo Nordisk shall negotiate in good
faith a license for Novo Nordisk's Patent Rights, confidential and proprietary
information within the Field.
20. ASSIGNMENT
20.1 DGI shall notify Novo Nordisk with thirty (30) days prior written
notice, in the event of a sale, assignment or transfer of its rights, title and
interest in, to and under this Agreement to any parent, subsidiary,
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"Omitted Information filed separately with SEC-Confidential Treatment Requested
by New Brunswick Scientific Co., Inc." and indicated as [* *]
affiliate or controlled corporation of corporations not within its current
structure or to any successor by consolidation, merger or the corporate action
or to a corporation or other business entity to which it may sell all or a
percentage of it's assets.
20.2 In addition, all Novo Nordisk Information shall be returned to Novo
Nordisk prior to such assignment. The assignee shall have no access to or
rights in any Novo Nordisk Information and/or Novo Nordisk Patent Rights. It is
expressly understood and agreed, that any assignee of any rights hereunder shall
remain bound by the obligations hereof.
20.3 Neither Party may assign this Agreement except to a party acquiring all
or substantially all of the assigning Party's business to which this Agreement
relates without the prior written consent of the other Party, which consent
shall not be unreasonably withheld. Notwithstanding this Section 20.3, Novo
Nordisk may assign this Agreement without receiving prior written consent of
DGI, to any of its Affiliates. Notwithstanding Section 20.1 and this Section
20.3, DGI shall not assign, sell and/or transfer in whole or in part this
Agreement to Eli Lilly Co., Pfizer and Hoechst and/or their affiliates or
divisions, without the prior written consent of Novo Nordisk.
21. SUCCESSORS
This Agreement binds the heirs, executors, administrators, successors and
assigns of the respective parties with respect to all covenants herein, and
cannot be changed except by written agreement signed by both Parties.
22. SEVERABILITY
Any provision of this agreement which is prohibited, unenforceable or not
authorized in any jurisdiction shall, as to such jurisdiction, be ineffective to
extent of such prohibition, unenforceability or non-authorization without
invalidating the remaining provisions hereof or affecting the validity
enforceability or legality of such provision in any other jurisdiction.
23. FORCE MAJEURE
Neither of the Parties hereto shall be liable in any manner for failure or delay
in fulfillment of all or part of this Agreement, directly owing to acts of God,
governmental orders or restrictions, war, war-like conditions, revolution, riot,
looting, strike, lockout, fire, flood or other causes or circumstances beyond
the Parties' control.
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by New Brunswick Scientific Co., Inc." and indicated as [* *]
24. ARTICLE HEADINGS AND SECTION REFERENCES
The Article headings contained herein are for reference only and shall not be
considered a part of this Agreement, nor shall they in any way affect the
interpretation thereof. Unless otherwise specified herein, all references in
this Agreement to sections are to Sections of this Agreement.
24. COMPLETE AGREEMENT
This Agreement supersedes any and all agreements, contracts or negotiations
relating to the Licensed Product in the Territory. This Agreement is entire in
itself and cannot be changed or terminated orally. No modifications of this
Agreement shall be binding unless signed by the Party against whom it is sought
to be enforced. This Agreement, together with the appendices shall be the
entire agreement and express the complete, exclusive and final understanding of
the Parties with respect to subject written approval herein and shall not be
altered, amended or modified except in a writing incorporated hereto, and signed
by the Parties.
IN WITNESS WHEREOF, Novo Nordisk and DGI have caused this Agreement to be
executed by their duly authorized officers.
NOVO NORDISK A/S DGI BIOTECHNOLOGIES, LLC.
BY:_____________________ BY:_____________________
MADS KROGSGAARD THOMSEN
TITLE: CORPORATE VICE PRESIDENT TITLE:____________________
OF HEALTH CARE DISCOVERY
DATE:___________________ DATE:____________________
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