Ex 10.2
[***] TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 2
LICENSE AGREEMENT
THIS AGREEMENT effective this 29TH day of MAY (month), 1998 (year) by and
between DOV PHARMACEUTICAL, INCORPORATED, a corporation organized and existing
under the laws of the New Jersey, having its registered offices at 0 Xxxxxx
Xxxxx, Xxxxx 0000, Xxxx Xxx, Xxx Xxxxxx 00000, (hereinafter DOV) and AMERICAN
CYANAMID COMPANY, a corporation organized under the laws of the State of Maine,
U.S.A., having its principal place of business at 0 Xxxxxxx Xxxxx, Xxxxxxx, Xxx
Xxxxxx 00000, U.S.A., (hereinafter ACY).
WITNESSETH:
WHEREAS, ACY possesses industrial property rights relating to the chemical
compounds listed in Schedule 1 attached hereto and made a part hereof and to
pharmaceutical products to be processed from the aforesaid compound.
WHEREAS, ACY designates Wyeth-Ayerst Laboratories, an Affiliate of ACY,
with principal offices at 000 X. Xxxxxxxxx Xxxxxx, Xx. Xxxxxx, Xxxxxxxxxxxx
00000, U.S.A., as the correspondent and contact for day-to-day business
regarding the compounds that appear in Schedule 1. All correspondence and
contacts shall be with Wyeth-Ayerst Laboratories.
WHEREAS, DOV is interested to develop as well as manufacture, have
manufactured by, use, and sell pharmaceutical products containing CL 220,075, CL
216,303, CL 285,489, CL 273,547 worldwide under licenses which ACY is willing to
grant.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and agreements set forth herein, the parties hereto agree as follows:
ARTICLE 1.0 DEFINITIONS
1.1 "Effective Date" means the date upon which this License Agreement is
executed by both parties.
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1.2 "Product" means any one, or all, of the compounds listed in Schedule 1, as
elected by DOV pursuant to the Option Agreement of May 22, 1997.
1.3 "Marketed Product" means the pharmaceutical preparation in finished form
containing Product suitable for human administration, whether alone or in
combination with other active ingredients.
1.4 "ACY Patents" means all patents, certificates of invention, and
applications covering the Product. Such ACY Patents are listed in Exhibit
A of this License Agreement.
1.5 "ACY Know-How" means all information, patentable or otherwise, developed,
applied, or acquired by ACY as of the Effective Date of the Option
Agreement relating to the production or development of the Product which
is reasonably useful or necessary to develop or manufacture Product.
1.6 "ACY's Place of Payment" means 000 Xxxx Xxxxxxxxx Xxx., Xx Xxxxxx
Xxxxxxxxxxxx 00000.
1.7 "Affiliate" means with respect to a party, any other business entity which
directly or indirectly controls, is controlled by, or is under common
control with, such party. A business entity or party shall be regarded as
in control of another business entity if it owns, or directly or
indirectly controls, at least fifty percent (50%) of the voting stock or
other ownership interest of the other business entity, or if it directly
or indirectly
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possesses the power to direct or cause the direction of the management and
policies of the other business entity by any means whatsoever.
1.8 "Net Sales" shall mean the gross amount invoiced for the Marketed Product
sold by DOV or its Affiliate or their sublicensee, less:
(i) transportation charges or allowances, if any, included in such
price;
(ii) trade, quantity or cash discounts, service allowances and broker's
or agent's commissions, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account of price
adjustments, returns, bad debts, off-invoice promotional discounts,
rebates, and any all Federal, state or local government rebates
whether in existence now or enacted at any time during the term of
the Agreement (e.g., HCFA or Medicaid rebates), rejections, recalls
or Specialty destruction requested or made by an appropriate
government agency; and
(iv) any tax, excise or governmental charge upon or measured by the sale,
transportation, delivery or use of the Marketed Product; provided
that Net Sales shall in no event be less than [***] % of Gross
Sales.
1.9 "Territory" means all countries of the world.
1.10 "Scheduled Payments" means those lump sums payable at the time of the
achievement of specific developmental activities during the development
period through actual commercial introduction of a Product following
regulatory approval.
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material has been separately filed with the Securities and Exchange
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1.11 As used in this License Agreement, the singular includes the plural and
the plural includes the singular, wherever appropriate by fact or by
context.
ARTICLE 2.0 LICENSE GRANT
2.1 As of the Effective Date of this License Agreement, ACY hereby grants DOV
an exclusive license under ACY Patents .and ACY Know-How to make, have
made, use, and/or sell Marketed Product in the Territory.
2.2 Subject to ACY's right of first refusal provided for in Article 4.0, and
the provisions in Article 5.0, DOV shall have the right to grant
sublicenses under the License provided for in Article 2.1.
ARTICLE 3.0 DEVELOPMENTAL ACTIVITIES
3.1 While this Agreement is in effect, DOV shall use reasonable efforts to
develop and commercialize the Product, either through itself or through a
third party commercial partner. Such activities include negotiating the
terms of a sublicense agreement with a third party.
3.2 DOV may disclose unpublished ACY Patents and ACY Know-How to a third
party, bound under an obligation of confidentiality which is substantially
the same as the obligation provided for in Article 7 of this License
Agreement, to the extent
4
necessary to negotiate a sublicense, and thereafter to develop and
commercialize the Product.
3.3 On a quarterly basis, DOV shall provide ACY with a written report
outlining its developmental activities during that quarter.
ARTICLE 4.0 ACY RIGHT OF FIRST REFUSAL
4.1 Prior to its entering into a sublicense agreement with a third party with
respect to Product, DOV shall present, in writing, to ACY the BONA FIDE
proposed terms and conditions of said sublicense agreement. Following
receipt by ACY of said terms and conditions, ACY shall have sixty (60)
days to notify DOV if it intends to enter into a development agreement
with DOV, the terms of which would exceed those proposed by a third party
by [***] % relative to Scheduled Payments and royalties. So as to permit
ACY to reach such decision, DOV shall provide to ACY all relevant data and
information regarding Product available to DOV, simultaneously with its
providing to ACY the terms and conditions offered by the said third party.
4.2 Upon ACY's providing DOV with notification of its intent to enter into an
agreement with DOV pursuant to Article 4.1, the parties will promptly
negotiate said agreement embodying ACY's offer under Article 4.1 and this
License Agreement shall terminate upon the effective date of said
agreement, solely with regard to the Product(s) elected by ACY under
Article 4.1 and contained in said agreement.
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material has been separately filed with the Securities and Exchange
Commission.
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4.3 If ACY does not notify DOV of its intention to enter into an agreement
with DOV pursuant to Articles 4.1 and 4.2, hereinabove, within the agreed
upon period, DOV shall be free to enter into a sublicense agreement with
the third party under the terms presented to ACY, or better.
4.4 In the event that DOV files a New Drug Application (NDA) in the USA, or a
foreign equivalent thereof in Europe or Japan, but has not yet entered
into a license agreement with a third party for Product, DOV shall provide
ACY with a copy of the NDA ( or the foreign equivalent thereof as filed
together with its English translation) for evaluation by ACY. If ACY shall
express an interest in marketing the Product, then the parties shall enter
into good faith negotiations relating to the possibility of ACY's
obtaining marketing rights to the Product.
ARTICLE 5.0 SUBLICENSE AGREEMENTS
5.1 If DOV grants a sublicense to a third party with regard to Product under
this Agreement, such sublicense agreement shall provide for DOV to receive
Scheduled Payments and royalty payments based on Net Sales of Marketed
Product.
ARTICLE 6.0 PAYMENTS
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6.1 Within thirty (30) days after the Effective Date of the License Agreement,
DOV shall pay ACY the fee as indicated below in this paragraph 6.1 for
exercising its Option rights with regard to each Product. Such fee shall
be non-refundable and non-creditable against any other payments due ACY
pursuant to this Agreement:
Bicifadine, CL 220,075 [***]
CL 216,303 [***]
CL 285,489 [***]
CL 273,547 [***]
6.2 If DOV enters into a sublicense agreement with a third party before the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth in
paragraph 6.4 of this Agreement, pay ACY during the term of this Agreement
35% of all remuneration, excluding all adequately documented future
research and development payments, whether tangible or intangible,
including all Scheduled Payments within 30 days of receipt by DOV from
such sublicensee and one-third of all other royalties and profits, whether
tangible or intangible, within 30 days of receipt by DOV derived from the
final sale to the trade of Marketed Product by DOV or its sublicensee, as
the case may be.
6.3 If DOV enters into a sublicense agreement with a third party after the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth in
paragraph 6.4 of this Agreement, pay ACY during the term of this Agreement
25% of all remuneration, whether tangible or intangible,
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material has been separately filed with the Securities and Exchange
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including Scheduled Payments within 30 days of receipt by DOV from such
sublicensee, and 25% of all other royalties and profits, whether tangible
or intangible, within 30 days of receipt by DOV derived from the final
sale to the trade of Marketed Product by DOV or its sublicensee, as the
case may be.
6.4 Notwithstanding any other provision of this Agreement, ACY shall in no
event receive Scheduled Payments and once the Product has been
commercialized, royalties on sales of Marketed Product to the trade by DOV
or its third-party sublicense with respect to each Product listed in
Schedule 1 less than the amount below indicated in this paragraph. The
Scheduled Payments due ACY for each of the Schedule 1 compounds shall be
paid pursuant to the 30-day period specified in paragraphs 6.2 and 6.3 if
received by DOV from third parties; but in the event that DOV achieves the
filing of an NDA, or its equivalent in the United States, Europe, or Japan
for a Product without assistance of a third party, DOV shall remit to ACY
the aggregate minimum Scheduled Payments set forth below no later than 30
days following the achievement of such Regulatory filing.
Aggregate Minimum Scheduled Minimum Royalty Due ACY
Payment for each Product due ACY on Net Sales
-------------------------------- -----------------------
Bicifadine, CL 220,075 $5.0 Million 4.5%
CL 216,303 $2.5 Million 2.5%
CL 285,489 $2.5 Million 2.5%
CL 273,547 $2.5 Million 2.5%
Provided however if marketing exclusivity in any country of the Territory
is lost to DOV or its sublicensee prior to the expiration of this
Agreement in such country, the parties shall meet to discuss whether any
modification to these terms is appropriate.
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6.5 DOV shall keep and shall obligate its sublicensees to keep accurate and
complete records of all sales of Product and Marketed Product in
accordance with generally accepted accounting principles and practices. In
any agreement between DOV and a third party, DOV shall obligate such third
party to allow routine audits by ACY of such third party records relating
to Products and Marketed Products. ACY may conduct, at its own expense, at
reasonable times during normal business hours, through an accountant
designated by ACY and acceptable to DOV (and its sublicensees as
appropriate), an audit of the accounts contemplated above, as well as any
supporting instruments and documents, and may make copies of and extracts
from such records for the sole purpose of ascertaining or verifying the
correctness of the amounts remitted by DOV hereunder. Results in the form
of a report of such audit, which can be requested at any time during the
term of the Agreement and up to five (5) years following its termination
or expiration, but not more than one time per calendar year, shall be made
available by ACY to DOV. Should such audit reveal any discrepancies
between reports made by DOV or its sublicensees and the audit exceeding 5%
(five percent) in favor of DOV, then DOV shall pay in full the costs of
such audit requested by ACY; otherwise, ACY shall bear the costs in full
for the audit of the records of DOV, its Affiliates, or its sublicensees.
6.6 Royalty payments shall be due within the shorter period of thirty (30)
days following receipt thereof by DOV or sixty (60) days of the end of
each calendar quarter on Net Sales made in that quarter and shall be paid
at ACY's Place of Payment. Royalties shall accrue in the currency of the
country in which the sale of Marketed Product is made,
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and if different from U. S. dollars shall be converted into such currency
using the exchange rate appearing in the WALL STREET JOURNAL applicable
for the last day of the calendar quarter during which the royalties
accrued.
6.7 All taxes, assessments, fees and charges, if any, levied under income tax
laws or regulations with respect to payments due ACY hereunder shall be
for the account of ACY and if required by law to be withheld and paid to
the applicable jurisdiction, will be deducted by DOV from such payments
due to ACY. Receipts for all such deducted taxes, assessments, fees and
charges paid by DOV to the taxing authorities will be secured by DOV and
sent to ACY.
6.8 In case of any delay in payment by DOV to ACY not occasioned by force
majeure, interest at the rate of 1% (one percent) per month, assessed from
the thirty-first day after the due date of the said payment, shall be due
ACY without any special notice.
ARTICLE 7.0 CONFIDENTIALITY
7.1 If during the performance of this Agreement, one party hereto wishes to
disclose information to another which it considers confidential, and if
the receiving party is willing to accept such information, then such
information may not be subsequently disclosed by the receiving party to a
third party, other than as provided in this Agreement, without the written
permission of the disclosing party. The parties to this Agreement agree to
hold in confidence all information and all knowledge, know-how, practices,
10
process, or other information disclosed or submitted in writing or in
other tangible form which is considered to be confidential for a period of
five (5) years from the date of such disclosure, except:
(a) information, which at the time of disclosure, is in the public
domain;
(b) information, which after disclosure, is published or otherwise
becomes part of the public domain through no fault of the receiving
party;
(c) information which was in the possession of the receiving party at
the time of disclosure;
(d) information which is developed by or on behalf of the receiving
party independently of any disclosure to them by the disclosing
party hereunder; or
(e) information which is provided to the receiving party by a third
party with the right to so provide.
ARTICLE 8.0 ADVERSE EXPERIENCE
8.1 DOV shall keep (and DOV shall cause its sublicensees to keep under terms
and conditions equal to those set forth in this Article 8) ACY during the
term of this
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Agreement, promptly and fully informed of all pharmaceutical,
toxicological and clinical findings relating to adverse experience of the
Product and Marketed Product.
8.2 DOV undertakes to notify ACY promptly with written confirmation by
immediate telecopy of any information concerning any serious adverse event
as defined by C.I.O.M.S. or the F.D.A. or by the Ministry of Health &
Welfare in Japan, as applicable, reasonably associated with clinical
studies or attributed to the use or application of the Product and
Marketed Product. In any event the above notification shall be made within
two working days after DOV should first learn or be advised of all
relevant information with respect to such adverse event.
8.3 DOV shall also forward regularly (and usually every six months unless the
parties agree on another period) to ACY any information on all other
adverse effects or any difficulty associated with the clinical use,
studies, investigations, tests and prescription of the Product.
8.4 DOV shall provide upon request the information on patient exposure:
estimated patient-days of exposure.
8.5 DOV shall inform ACY without delay, of any governmental action,
correspondence or reports to or from governmental authorities which may
affect the situation of the Product and furnish ACY with copies of any
relevant documents relating thereto.
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ARTICLE 9.0 REPRESENTATIONS AND WARRANTIES
9.1 ACY hereby represents and warrants that it has the right to xxxxx XXX the
license under Article 2 of this Agreement, and that ACY is not aware of
any lawsuit, opposition or action of any kind questioning or contesting
the validity of the Patents. Notwithstanding the foregoing, ACY makes no
other warranties, expressed or implied, and ACY does not warrant, nor does
it entitle any agent, officer, employee or representative of ACY to
warrant validity, enforceability, efficacy, merchantability, fitness for a
particular purpose or otherwise with respect to any Product, Marketed
Product or ACY Patent as the case may be.
9.2 DOV hereby represents and warrants that the minimum financial criterion
established according to the Option Agreement of May 22, 1997, has been
met.
9.3 DOV is fully cognizant of Good Laboratory Practices ("GLP") and Good
Manufacturing Practices ("GMP") and shall manufacture or have manufactured
Product and Marketed Product in a manner which fully complies with GLP and
GMP.
ARTICLE 10.0 INDEMNIFICATION, LIABILITY AND INSURANCE
10.1 DOV shall at all times during the term of this Agreement, and thereafter,
indemnify, defend and hold ACY and all its Affiliates and their respective
directors, officers, partners, employees, servants and agents harmless
from and against any and all claims
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and expenses, including without limitation legal expenses, court costs,
and reasonable attorney's fees, arising out of or relating to the death of
or actual or alleged injury to any person(s) or damage to third parties
property, and from and against any other claim, proceeding, demand,
expense, cost and liability of any kind whatsoever (collectively
"liabilities") resulting from, arising out of or related to Product or
Marketed Product.
10.2 DOV shall take all necessary steps, at its own costs, and shall so
obligate its sublicensee to properly maintain insurance policies to cover
all liabilities to any third party which might be incurred, directly or
indirectly as a result of its participation in the performance of the
Agreement.
10.3 DOV shall maintain (and shall cause its sublicensee to maintain) product
liability, insurance which may include funded self-insurance reserves with
respect to the development, manufacture and sale of Products and Marketed
Products in such amount as customarily in the industry. DOV (and its
sublicensee) shall maintain such insurance for so long as it continues to
develop, manufacture or sell any Products and Marketed Products and
thereafter for so long as required to cover such manufacture or sales.
DOV (and its sublicensee) will name ACY as an additional insured on its
insurance policy. Upon execution of this Agreement, DOV will supply ACY
with evidence of such coverage, and undertakes to communicate to ACY
during the term of this Agreement, any modifications to such coverages.
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ARTICLE 11.0 USE OF NAMES/ TRADEMARKS/PUBLICITY
11.1 Neither party will use the name of the other party in any advertising or
other form of publicity without the written permission of the other.
11.2 By virtue of this License Agreement, DOV shall not acquire any right to
use trademarks, tradedress or other indicia of origin belonging to ACY, or
any of its Affiliates.
11.3 The timing and content of any press release or other public communications
relating to this Agreement and the transactions contemplated herein will,
except as otherwise required by law, be determined jointly by ACY and DOV.
ARTICLE 12.0 PATENT INFRINGEMENTS
12.1 In case any actions, claims, demands, suits or other legal proceedings are
brought or threatened to be brought against DOV by a third party for
infringement of such third party's patent(s) relating to Product PER SE,
by virtue of DOV's manufacture, use, sale or offer for sale of the Product
or Marketed Product hereunder, DOV shall notify ACY forthwith of the
threat or existence of such actions with sufficient evidence thereof, to
enable the parties to prepare an appropriate defense strategy. The parties
shall consult together as to the action to be taken and as to how the
defense will be handled. DOV shall be responsible for all defense costs.
15
DOV undertakes not to make any admission of liability to a claimant or
plaintiff or his or her legal representative or insurer and not to sign
any agreement in respect of such proceedings without ACY's previous
written consent not to be unreasonably withheld.
When DOV, because of the settlement with ACY's consent of the claimed
infringement, or a final unappealable or non-appealed judgment of a court
of competent jurisdiction, isrequired to make payments to one or more
third parties to obtain a license without which the marketing of the
Marketed Product could not be made in a given country, DOV may deduct such
payments from the royalty payments due to ACY hereunder, provided however
that in no event shall the royalty rate be reduced by more than [***] of
that which would otherwise be due ACY.
12.2 DOV shall promptly inform ACY of any suspected infringement of any of ACY
Patents by a third party and provide ACY with any available evidence of
such suspected infringement.
ACY shall have the right but not the obligation to institute any claim,
suit or proceeding against an infringer or a presumed infringer to protect
and defend ACY Patents. ACY shall control the prosecution of any such suit
or claim, including without limitation the choice of counsel and shall
settle or dispose of any such suit or claim. DOV shall provide ACY with
all reasonable assistance (other than financial) required to institute and
maintain such proceedings. In the event ACY so elects, ACY shall bear the
entire costs of such prosecution and shall be entitled to retain after
deducting the costs and expenses
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borne by ACY in prosecuting the claim of infringement, 90% (ninety
percent) of the amount of any recovery, court award or settlement.
DOV shall not institute any negotiations or legal proceedings with respect
to any such infringement without prior written consent of ACY, but shall
have the right to institute infringement proceedings against a third party
in the event that ACY would elect not to do so. In such event, DOV shall
bear the entire costs and expenses of such proceedings. ACY shall provide
DOV with all reasonable assistance (other than financial) required to
institute and maintain such proceedings. In such event, DOV shall be
entitled to retain 90% ( ninety percent) of the proceeds of any such
recovery, after first deducting the costs and expenses borne by DOV in
initiating and maintaining such infringement action.
ARTICLE 13.0 DURATION AND TERMINATION
13.1 This Agreement shall be binding on the parties as of the day of its
execution but shall have no force or effect until either the parties
determine that notification under Title II of the Xxxx-Xxxxx-Xxxxxx
Antitrust Improvements Act of 1976, 15 U.S.C. 18a, and the regulations
promulgated thereunder, 16 C.F.R 801.1 et seq., is not required or if the
parties determine that such notification is required, the waiting period
shall have expired or been terminated. If a notification filing is
required, the parties will, at their own expense, prepare and make all
appropriate filings. The parties shall cooperate in the antitrust
clearance process and hereby agree to furnish promptly to the FTC and the
Antitrust Division of the Department of Justice such additional
information reasonably
17
requested by them in connection with such filings. In the event that the
waiting period has not expired or been terminated within six (6) months
after the date of signature of this agreement by both parties, the parties
shall revert to their status before signing and this agreement shall be of
no force and effect, except for Articles 7, 10, and 11 which shall survive
pursuant to their terms. Thereafter, the Agreement shall continue in full
force and effect in each country of the Territory until the later of
expiration of the ACY Patents in such country or a period of ten (10)
years following the launch of each such Product or Marketed Product by DOV
or its sublicensee(s) in each country of the Territory.
13.2 Upon expiration of this Agreement with respect to each country of the
Territory, DOV shall be deemed to have a fully-paid, royalty-free license
with the right to make or have made, use or sell Product and Marketed
Product as well as to freely utilize all data generated hereunder or
received from ACY by DOV without DOV's having further obligation to ACY,
except for maintaining confidentiality as required by Article 7.1 of this
Agreement.
13.3 DOV shall be free to terminate this entire Agreement and surrender and
return to ACY all rights acquired by DOV hereunder in its own discretion
at any time upon 90 days' prior written notice at which time all license
rights granted hereunder shall come to an end.
13.4 In the event that a party hereto shall be presumed by the other to have
breached any material condition herein contained, the complaining party
shall be required to provide a formal written notice of such presumed
breach, requesting rectification within a sixty-day
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period from the date of receipt of such notice. The party presumed to be
in breach of the Agreement shall either submit a commercially reasonable
plan for rectification within 45 days of receipt of notice (if the breach
cannot be rectified within the sixty-day period), or take appropriate
steps to remedy the breach if capable of remedy within such period. If
within the said sixty-day period neither the aforesaid plan shall have
been submitted, nor the breach cured, the party alleging breach shall then
be entitled to terminate this Agreement, thereby surrendering all rights
granted hereunder, by written notice to the other party, such termination
having immediate effect.
13.5 This Agreement may be terminated at once by ACY giving notice to DOV if
DOV is insolvent or has committed an act of bankruptcy or an order is made
or resolution passed for the winding up of either party.
13.6 In the event this Agreement is terminated prior to its full term pursuant
to paragraph 13.3 by DOV or pursuant to paragraphs 13.4 or 13.5 by XXX,
XXX shall within 30 days of such event transfer to ACY all information,
data and know-how of any kind relating to Product and shall authorize the
transfer of all governmental approvals for the Product to ACY, in addition
to DOV's right derived from all License Agreements between DOV and its
third party partners relative to Product and Marketed Product.
ARTICLE 14.0 REPORTS AND NOTICES
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14.1 DOV shall provide ACY an annual report summarizing the stage of
development relating to the Product. Such report shall be provided within
thirty (30) days of each anniversary of the signing of this Agreement.
14.2 DOV shall notify ACY in writing within 15 days after achieving an event
which would require that a Milestone Payment would be payable by a third
party to DOV, or by DOV to ACY, with respect to a product.
14.3 Not later than sixty (60) days following the end of each quarter, DOV will
provide ACY with a report summarizing the Net Sales of Marketed Product in
each country in the Territory made by DOV or a third party sublicensee of
DOV. Such reporting shall begin following the first sale of Marketed
Product in the Territory.
14.4 Any notices or reports required or permitted to be given under this
Agreement shall be sent by certified or registered mail, or by an
equivalent service which provides verification of delivery, return receipt
requested to the respective party at the address stated below or such
address as to which the parties are subsequently appropriately notified:
If to ACY: Wyeth-Ayerst Laboratories
000 X. Xxxxxxxxx Xxx.
Xx. Xxxxxx, XX 00000
Attn: Senior Vice President Global Business Development
If to DOV: DOV Pharmaceutical, Incorporated
Suite 1500
20
000 Xxxxx Xxxxx
Xxxx Xxx, XX 00000
Attn: President
ARTICLE 15.0 ASSIGNMENT
15.1 This Agreement shall be binding upon and inure to the benefit of the
parties hereto and the successors to substantially the entire business and
assets of the respective parties hereto. Notwithstanding the foregoing,
any party may void this Agreement if the Agreement is assigned for the
benefit of a creditor. This Agreement shall not be assignable by either
party, except to an Affiliate, without the prior written consent of the
other party; any other attempted assignment is void.
ARTICLE 16.0 APPLICABLE LAW
16.1 This Agreement shall be governed by and construed according to the laws of
the State of New Jersey, USA.
ARTICLE 17.0 FORCE MAJEURE
17.1 None of the parties shall be responsible for failure or delay in the
performance of any of its obligations hereunder due to Force Majeure.
Force Majeure shall mean any circumstance which, due to an event or a
legal position beyond the party's reasonable control, shall render
impossible the fulfillment of any of the party's obligations hereunder,
such as, but not limited to, acts of God, acts, regulations, or laws of
any
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government, war, civil commotion, destruction of facilities or materials
by fires, earthquakes, or storms, labor disturbances, shortages of public
utilities, common carriers, or raw materials, or any other cause, or
causes of similar effects, except, however, any economic occurrence.
During any such case of Force Majeure, this License Agreement shall not be
terminated, but only suspended and the party so affected shall continue to
perform its obligations as soon as such case of Force Majeure is removed
or alleviated.
ARTICLE 18.0 MISCELLANEOUS
18.1 This Agreement and the Schedules hereto constitute the full understanding
and entire Agreement between the parties and supersede any and all prior
oral or written understandings and agreements with respect to the subject
matter hereof. This Agreement shall not be effective until duly signed by
officers of both ACY and DOV. No terms, conditions, understandings or
Agreements purporting to modify, amend or vary this Agreement shall be
binding unless made in writing and signed by the parties hereto. It is
mutually agreed that no party has relied upon any representations or
statements of any third party except as stated herein.
18.2 The invalidity or unenforceability of an Article or any part of an Article
of this Agreement in any jurisdiction shall not cause the invalidity of
the whole Agreement as to such jurisdiction, and shall not affect the
validity or enforceability of such Article or such part of an Article in
any other jurisdiction. The parties shall replace any Article or part of
an Article found invalid or unenforceable by alternative provisions which
shall be as
22
similar as possible in their conditions with regard to their spirit and
commercial effect. If this Agreement in any jurisdiction is found to be
invalid or unenforceable, the parties shall replace it by an alternative
Agreement which shall be as similar as possible in its conditions with
regard to its spirit and commercial effect.
18.3 The failure of either party on any occasion to require the performance by
the other of any provision hereof shall in no manner affect the right of
such party to enforce the same on a subsequent occasion. The waiver by
either party of any breach of any provision hereof shall at no time be
construed to be a waiver of any succeeding breach of that or any other
provision or a waiver of the provision itself.
18.4 This Agreement shall not constitute either party as the joint venturer,
legal representative or agent of the other party for any purpose
whatsoever. Neither party shall have any right or authority to assume or
create any obligation or responsibility for or on behalf of the other
party or to otherwise bind the other party.
18.5 The parties recognize that this is a master Agreement covering a number of
countries. If for any country in the Territory it becomes necessary to
execute a separate instrument for such country in order to satisfy local
regulatory requirements, the parties agree to execute such further
instrument, which shall to the extent permitted by the laws of the country
conform to the terms and conditions of this Agreement.
23
18.6 This Agreement and the Schedules and Exhibits hereto are originally
prepared and signed in the English language. If any translation into any
other language is legally required for purposes of governmental filings,
the parties shall arrange for such translation, and the costs thereof
shall be borne by the party legally required to make such filing. In the
event of any question or dispute as to the meaning or interpretation of
any term, condition or provision of this Agreement, or any Schedule or
Exhibit hereto, the English language version shall in all events govern
for all purposes whatsoever.
18.7 Termination of this Agreement for any reason, or expiration of this
Agreement, will not affect: (i) obligations, including the payment of any
Scheduled Payments or royalties which have accrued as of the date of
termination or expiration, and (ii) rights and obligations which, from the
context thereof, are intended to survive termination or expiration of this
Agreement.
18.8 This Agreement is executed simultaneously in counterparts, each of which
shall be deemed an original, but all of which shall constitute but one and
the same instrument.
XXX XXX
/S/ Xxxxxxx Xxxxxxx /s/ Xxxxxx Xxxxx
------------------------------ ----------------------------------------
NAME: Xxxxxxx Xxxxxxx NAME: Xxxxxx Xxxxx
------------------------ ----------------------------------
TITLE: Vice President TITLE: CEO
----------------------- ---------------------------------
DATE: 5/29/98 DATE: 5/18/98
------------------------ ----------------------------------
24
SCHEDULE I
BICIFADINE, CL 220,075
CL 216,303
CL 285,489
CL 273,547
25
EXHIBIT A
ACY PATENTS
BICIFADINE
UNITED STATES
U.S. 4,196,120 - expires 4/1/97
U.S. 4,231,935 - expires 11/4/97
U.S. 4,435,419 - expires 7/1/01
USSN 08/122,856 - pending
USSN 08/414,180 - pending
CL 216,303
UNITED STATES
U.S. 4,196,120 - expires 4/1/97
U.S. 4,231,935 - expires 11/4/97
U.S. 4,435,419 - expires 7/1/01
USSN 08/122,856 - pending
USSN 08/414,180 - pending
CL 273,547
UNITED STATES
U.S. 4,521,422 - expires 6/23/03
26
