EXHIBIT 10.15
LICENSE AGREEMENT made as of the 26th day of June, 1995
between F.H. FAULDING & CO. LIMITED of 160 Greenhill Road, Parkside
in the State of South Australia (hereinafter called "Faulding") and
PUREPAC PHARMACEUTICAL CO. of 200 Elmora Avenue, Elizabeth, New
Jersey, United States of America (hereinafter called "Purepac");
WHEREAS, Faulding is the proprietor of the Technology in
relation to the manufacture and production of the Product;
WHEREAS, Purepac wishes to obtain an exclusive right to
utilize the Technology to complete development of the Product and
to manufacture and sell the Product within the Territory;
WHEREAS, Faulding has agreed to license the Technology to
Purepac on the terms and conditions set forth in this Agreement.
NOW, THEREFORE, IT IS AGREED as follows:
1. For the purposes of this Agreement the following terms
shall have the following meanings:
1.1 "Affiliates" shall mean (a) an entity controlled by
a common parent that owns more than fifty percent of the voting
stock of both such entity and one of the parties to this Agreement
and (b) such parent company.
1.2 "Direct Material Costs" shall mean, with respect to
any calendar quarter, the actual material costs of the manufacture
of the Product, including, without limitation, the costs of
packaging, as determined in accordance with generally accepted U.S.
accounting principles, consistently applied.
1.3 "Enhancements" shall mean any improvements,
enhancements or changes in the Technology in relation to the
Product that are developed by Purepac after the Technology Transfer
Date during the term of this Agreement.
1.4 "Gross Margin" shall mean the Net Sales Price less
the Direct Material Costs.
1.5 "Know-How" shall mean the processes, methods and
procedures for the manufacture and production of the Product and
any improvement or modifications that may be developed by or on
behalf of either Faulding or Purepac during the term of this
Agreement, as set forth in Section 14 hereof.
1.6 "Net Sales Price" shall mean, with respect to any
calendar quarter, the gross income of Purepac from sales of the
Product to independent third parties (not including amounts
received as reimbursement of freight, insurance and other costs or
taxes) invoiced by Purepac during such quarter, less price
discounts, trade returns, trade allowances, chargebacks or rebates
relating to such sales, as calculated using Purepac's standard
accounting procedures, in accordance with U.S. generally accepted
accounting principles, consistently applied. It is understood and
agreed that where the amount of any deduction can not be fairly
determined during the quarter immediately following the quarter in
question, such deduction may be claimed by Purepac with respect to
Net Sales made during a subsequent quarter.
1.7 "Product" shall mean the product set forth on
Schedule 1 hereto.
1.8 "Regulatory Authority" shall mean the United States
Federal Food and Drug Administration and/or any other like
authority whether Federal or State regulating the manufacture,
distribution, marketing and/or sale in the Territory of therapeutic
substances.
1.9 "Technology" shall mean that technology including
technical, scientific, industrial information or knowledge,
confidential information and expertise in relation to the
formulation and composition of the Product, which, as of the
Technology Transfer Date, has been in the possession of Faulding.
1.10 "Technology Transfer Date" shall mean August 31,
1995 or such other date, as mutually agreed to by the parties, on
which Faulding shall transfer the Know-How in Faulding's possession
and the Technology to Purepac.
1.11 "Territory" shall mean the United States of America
and its commonwealth states and territories.
1.12 "U.S." shall mean the United States of America.
2. LICENSE OF TECHNOLOGY
2.1 In consideration of the payment of Technology
licensing fee, set forth in Section 2.2 hereof and the royalty
payments set forth in Section 8 hereof, Faulding hereby licenses
the Technology to Purepac for a period commensurate with the term
of this Agreement, as set forth in Section 15 hereof, to use and
take advantage of the Technology for the purposes of completing the
development of the Product and manufacturing and selling the
Product within the Territory during the term of this Agreement.
Purepac management has been involved in the development of the
Technology and understands that further development of the
Technology is necessary for completion of the Product.
2.2 The parties agree that the Technology licensing fee
shall aggregate $(U.S.)1,834,434 and, as the case may be, has been
paid or shall be payable by Purepac to Faulding in three payments
as follows:
(a) $(U.S.)1,234,434, which Purepac has heretofore paid
Faulding in full;
(b) $(U.S.)350,000, payable on July 31, 1995; and
(c) $(U.S.)250,000, payable thirty (30) days after the
Technology Transfer Date.
2.3 The license of the Technology pursuant to this
Agreement is sole and exclusive for the development, manufacture,
and sale of the Product in the Territory. Faulding agrees that it
will not sell or transfer the Technology or grant any rights to use
or exploit the Technology to any other person or corporation for
the manufacture or distribution in the Territory of the Product or
a product competitive with the Product during the term of this
Agreement, but the parties understand and agree that Faulding has
the right, subject to the limitations set forth in Section 4.3, to
license the Technology outside the Territory for any purpose and
within the Territory for any purpose other than the manufacture and
distribution of a product competitive with the Product.
2.4 Purepac agrees that it will not use or exploit the
Technology for any purpose other than the manufacture and sale of
the Product in the Territory and that it will not manufacture, sell
or attempt to sell the Product outside the Territory either on its
own account or through any third party nor will it sell any Product
to any person or corporation within the Territory where Purepac has
reasonable grounds to believe that such other person or corporation
intends to sell the Product outside the Territory.
2.5 In the event that either (a) Purepac submits a
written request to Faulding to market the Product outside the
Territory or (b) Faulding submits a written request to Purepac to
purchase the Product for sale by Faulding outside the Territory,
the parties agree to negotiate in good faith to determine whether
they can reach an agreement that is commercially acceptable to both
of them.
3. TECHNOLOGY TRANSFER
3.1 Immediately upon execution of this Agreement
Faulding will provide to Purepac details of all work done to date
in relation to development of the Product. Faulding will continue
to carry on formulation work until the Technology Transfer Date and
will provide regular reports on progress with this work to Purepac
and in any event will report not less than twice a month.
3.2 On the Technology Transfer Date, Faulding will
provide to Purepac all Technology and Know-How in its possession as
may be necessary and helpful for Purepac to complete the
development work with respect to the Product and replicate and
scale-up the process for the manufacture of the Product.
3.3 Upon payment of the third installment of the
Technology licensing fee, as set forth in Section 2.2 of this
Agreement, Purepac will be entitled to request Faulding to provide
appropriate scientists and engineers ("Faulding Engineers") on
sites at Purepac's premises to aid Purepac in the completion of the
development work with respect to the Product, the commissioning of
the equipment and the replicating and scaling up of the process of
manufacture of the Product. If requested by Purepac, Faulding,
will send to Purepac's site in the U.S. (a)at Faulding's expense,
a team of not more than two (2) Faulding Engineers from Australia
for a maximum of two visits, together aggregating no more than two
months' duration, and (b) at Purepac's reasonable expense, one
qualified formulator from Australia for one or more visits,
aggregating approximately two years' duration (the exact duration
of which being subject to the on-going negotiation between the
parties).
3.5 At the request of Purepac, but not more than twice
in any calendar year, Purepac personnel will be entitled to visit
Faulding's premises in Australia for technical discussions relating
to the development and scale-up work on the Product PROVIDED,
HOWEVER, that such visits will be at Purepac's sole expense and
will be held at a time reasonably convenient to Faulding.
4. INTELLECTUAL PROPERTY RIGHTS
4.1 Purepac acknowledges and agrees that Faulding is the
owner of the Technology and all industrial and intellectual
property rights of any kind in relation to the Technology including
the right to patents, registered or other designs, copyright,
trademarks or trade names and any other confidential information.
Nothing contained in this Agreement shall be effective to give
Purepac any rights of ownership in and to the Technology and to the
intellectual property owned by Faulding in any area outside the
Territory and the licensing of the Technology under this Agreement
is for the sole purpose of developing, manufacturing and selling
the Product in the Territory.
4.2 Any improvements to the Technology as it applies to
the Product made or discovered by Faulding during the term of this
Agreement shall be made known to Purepac and Purepac shall be
entitled to use and commercially exploit any such improvements
without payment of any further sum PROVIDED HOWEVER, that if such
improvement has the effect of rendering the existing Technology
obsolete (the "Superseding Technology") and the existing
Technology, as such Technology may be improved or enhanced by
Purepac, is effective in relation to the Product at the time of
such Superseding Technology, Faulding shall grant Purepac a right
of first refusal to license the Superseding Technology for the
purposes of manufacturing and selling an improved product within
the Territory on a comparable basis and on comparable terms as
provided in this Agreement and PROVIDED FURTHER, HOWEVER, that if
the existing Technology, as such Technology may be improved or
enhanced by Purepac, is not effective in relation to the Product at
the time of such Superseding Technology, Purepac shall be entitled
to use, enhance and commercially exploit such Superseding
Technology without payment of any further sum.
4.3 Faulding acknowledges and agrees that Purepac is the
owner of all Enhancements to the Technology, as applied to the
Product, and all industrial and intellectual property rights of any
kind in relation to such Enhancements, including the right to
patents, registered or other designs, copyright and any other
confidential information. Nothing contained in this Agreement
shall be effective to give Faulding any rights of ownership in and
to the Enhancements and to the intellectual property rights owned
by Purepac. In the event that Faulding shall desire to register
any product which in any way utilizes any Enhancement anywhere,
within or outside the Territory, the parties agree to negotiate in
good faith to determine the mutually acceptable and commercially
reasonable consideration that Faulding shall pay to Purepac for the
right to use such Enhancement.
4.4 The parties agree that all Know-How shall be jointly
owned by them and that each of them may freely use the Know-How,
whether it has been developed by either party or jointly by both
parties. Any improvement to the Know-How as it applies to the
Product made or discovered by either party during the term of this
Agreement shall be made known to the other party, upon written
request by the other party, and the other party shall be entitled
to use and commercially exploit any such improvement without
payment of any sum to the other party.
5. FAULDING EXPENSES AFTER THE TECHNOLOGY TRANSFER DATE
5.1 Purepac shall only reimburse Faulding for such
reasonable costs incurred by Faulding in connection with the
Technology after the transfer of the Technology to Purepac on the
Technology Transfer Date that Purepac has preapproved in writing.
5.2 If for any reason after the Technology Transfer Date,
Purepac requests Faulding either to (a) perform any services with
respect to the Product or (b) manufacture any batches of the
Product, and Faulding performs such services, Purepac shall
reimburse Faulding for the costs of all such services as follows:
(i) Within seven (7) days after the end each month,
Faulding will submit to Purepac the commercially
reasonable costs incurred by Faulding pursuant to
the provisions of this Section 5.3(a "Monthly
Statement");
(ii) Subject to the provisions of the following
sentence, Purepac shall pay to Faulding the amount
due as reflected in each Monthly Statement within
thirty (30) days after its receipt of such
Statement. Within 10 days after its receipt of the
Final Cost Statement, Purepac may initiate a review
of Faulding's costs, as reflected in the Statement,
by written notice to Faulding. Within 10 days of
Faulding's receipt of such notice, the parties will
meet and negotiate in good faith to resolve any
differences between them.
6. REGULATORY APPROVALS; ADVERSE REPORTS.
6.1 Subject to the provisions of Section 15.3 of this
Agreement, Purepac hereby agrees, at its own expense, to:
6.1.1 complete the development work with respect to
the Product;
6.1.2 carry out all work necessary for the
registration of the Product in the Territory, including scale-up
and definitive pharmacokinetic and stability studies;
6.1.3 seek all necessary approvals and/or
registrations from the appropriate Regulatory Authority in the
Territory to permit the conduct of clinical trials using the
Product and/or the manufacture, distribution, marketing and sale of
the Product in the Territory; and
6.1.4 comply with the reporting compliance
requirements of the Regulatory Authority in the Territory during
the term of this Agreement.
6.2 Faulding hereby agrees that it will, when and as
requested by Purepac, assist Purepac, at Purepac's commercially
reasonable cost, in preparing the ANDA, including, without
limitation providing assistance to Purepac with regard to any
Product/development reports required by the FDA. Purepac will
reimburse Faulding for the costs of such services in the same
manner and during the same time frame as set forth in Section 5.2
of this Agreement.
6.3 Faulding and Purepac recognize and agree that
Purepac, during the term of this Agreement, shall hold title to the
ANDA and to all clinical data developed by Purepac for registration
of the Product in the Territory. Purepac agrees, however, that it
shall not transfer or assign the ANDA to any third party without
the prior consent of Faulding. In the event that Faulding shall
elect to include any of the aforementioned clinical data in an
application by Faulding to register the Product anywhere outside
the Territory, the parties agree to negotiate in good faith to
determine the mutually acceptable and commercially reasonable
consideration that Faulding shall pay to Purepac for the right to
use such clinical data.
6.4 Purepac agrees that upon the expiration of, or
termination of the Agreement for any reason other than a default by
Faulding, Purepac will grant Faulding, or Faulding's nominee, for
the ninety (90) day period after such expiration or termination
(the "Election Period"), a right of first refusal to an assignment
by Purepac of the ANDA as follows:
(a) The right of first refusal may be exercisable by
Faulding by delivery of a written offer (the "Faulding
Assignment Offer") to Purepac, which Faulding Assignment
Offer shall contain all of the material terms of
Faulding's proposed offer. Within ten (10) days after
Purepac's receipt of the Assignment Offer, Purepac shall
either deliver a written acceptance of the Offer to
Faulding or meet with Faulding to negotiate in good faith
mutually acceptable and commercially reasonable terms
upon which to transfer the ANDA.
(b) If the parties shall fail to reach an agreement, or
if Purepac otherwise, during the Election Period,
receives any bona fide offer from an unaffiliated third
party to have the ANDA assigned to such third party (the
"Third Party Assignment Offer"), Purepac shall notify
Faulding in writing of any such Assignment Offer at least
thirty (30) days prior to the intended closing date
thereof, which notice (the "Third Party Assignment
Notice") shall contain all the material terms of the
Third Party Assignment Offer and Faulding may, within
fifteen (15) business days after its receipt of the Third
Party Assignment Notice exercise its right of first
refusal by delivery of a written notice to Purepac.
(c) If Faulding shall fail to elect to enter into the
transaction described in the Third Party Assignment
Notice, or then Purepac shall, during the remainder of
the Election Period be free to consummate the Third Party
Assignment Offer on the terms and conditions, including
price, specified in such Notice.
(d) Upon assignment of the ANDA to Faulding or
Faulding's nominee, Purepac shall promptly deliver to
Faulding, or to Faulding's nominee, any documents in its
possession relating to the ANDA and the registration of
the Product in the Territory and shall execute all such
documents as the Regulatory Authority may require or as
Faulding may deem appropriate to ensure any such
assignment is effected.
6.5 Purepac agrees that it will, in accordance with the
laws and regulations of the Territory as such laws and regulations,
may from time to time be amended, notify Faulding promptly (a) of
any serious and unexpected adverse reactions reported to it or to
any sub-licensee of Purepac resulting from the use of the Product
and provide to Faulding copies of all other adverse action reports
received by it or any sub-licensee of Purepac and (b) of any
complaints from third parties involving the Product.
6.6 Purepac agrees to maintain adequate quality control
in respect of its manufacture, packaging, labelling and storage of
the Product and to ensure that all manufacture of and packaging and
labelling used for the Product meets all the requirements under the
applicable laws, rules and regulations in the Territory.
6.7 In the event that Faulding, subject to the
provisions of Section 4 of this Agreement, uses the Technology,
either within or without the Territory, in the manufacture of any
other product, Faulding agrees that it will, in accordance with the
laws and regulations of the Territory as such laws and regulations,
may from time to time be amended, notify Purepac promptly (a) of
any serious and unexpected adverse reactions reported to it or to
any sub-licensee of Faulding resulting from such use of the
Technology in any product and provide to Purepac copies of all
other adverse action reports received by it or any sub-licensee of
Faulding and (b) of any complaints from third parties involving
such other product.
7. DISTRIBUTION AND SALE OF PRODUCT; APPOINTMENTS
7.1 Upon registration of the Product, Purepac shall use
reasonable efforts, at its expense, to promote, distribute and sell
the Product in and throughout the Territory in order to obtain the
optimum market potential for the Product within and throughout the
Territory.
7.2 Subject to the limitations set forth in Section 7.3
hereof, Purepac shall have the right to appoint any agent or sub-
licensee to market, distribute, promote and/or sell the Product
within the Territory.
7.3 The appointment of any agent or sub-licensee under
Section 7.2 shall be on such terms and conditions as Purepac may
reasonably require in writing provided such terms and conditions
are not inconsistent with the terms and conditions of this
Agreement. Purepac agrees that it shall, at all times, be solely
responsible for the acts, deeds or omissions of any agent or sub-
licensee appointed pursuant to Section 7.2 and hereby indemnifies
Faulding against any and all loss, liability, damage, claims, cost
and expense arising from or in connection with such agent's or sub-
licensee's acts, deeds or omissions.
8. ROYALTY PAYMENTS
8.1 Purepac shall pay to Faulding throughout the term of
this Agreement a royalty at the rate of 8.2% of the Gross Margin of
all Product sold in the Territory by Purepac and its agents and
sub-licensees.
8.2 Royalty payments required by Section 8.1 shall be
made by Purepac within 45 days after the close of each calendar
quarter in U.S. dollars by wire transfer to the account specified
by Faulding from time to time. Purepac may withhold from such
payments any withholding required under U.S. law and shall submit
to Faulding documents evidencing such tax withholding, if any. At
the same time as making any royalty payment, Purepac shall submit
to Faulding a statement setting forth the sales of Product, the
invoiced amount of such sales, the calculation of direct material
costs and gross margin and the amount of any other payments
received in relation to sales of such Product.
8.3 Purepac, during the term of this Agreement and any
extension hereof and thereafter for a period of two years after, as
the case may be,
(a)the last expiration date of any Product manufactured
pursuant to this Agreement; or
(b)an expiration of this Agreement caused by the recall of the
Product in the Territory
shall keep at its principal office true and particular accounts and
records of all sales, the calculation of direct material costs and
gross margin of Product by Purepac and its agents and sub-licensees.
Faulding or its duly authorized representatives after
giving reasonable notice shall have the right during ordinary
business hours to inspect and audit the accounts and records
referred to in this Section 8.3.
9. WARRANTY
9.1 Faulding represents and warrants to Purepac that it:
(a) has the corporate authority to enter into this Agreement
and to perform its obligations hereunder;
(b) is not aware of any legal, contractual or other
restriction, limitation or condition which might affect adversely
its ability to perform hereunder;
(c) is the owner of the Technology free and clear of any
liens or encumbrances of third parties and has sufficient right,
title and interest in the Technology to grant the license to
Purepac granted hereunder;
(d) to the best of its knowledge as of the date of this
Agreement, the Technology, as known as of the date hereof, does not
infringe any valid published U.S. patent; and
(e) upon the transfer of the Technology to Purepac, as
contemplated by Section 3 of this Agreement (i) it will be the
owner of the Technology free and clear of any liens or encumbrances
of third parties and (ii) to the best of its knowledge as of the
date of this Agreement, it will have sufficient right, title and
interest in the Technology to grant the license to Purepac granted
hereunder.
9.2 Purepac represents and warrants to Faulding that it:
(a) has the corporate authority to enter into this Agreement
and to perform its obligations hereunder; and
(b) is not aware of any legal contractual or other
restriction, limitation or condition which might affect adversely
its ability to perform hereunder.
10. CONFIDENTIALITY
10.1 Purepac agrees with Faulding that it will not
disclose to any person or corporation any confidential information
of Faulding that it may acquire at any time during the term of this
Agreement, including, without limitation the Technology and Know-How
and any Enhancements without the prior written consent of
Faulding and that Purepac will use all reasonable efforts to
prevent unauthorized publication or disclosure by any person of
such Technology and Know-How, including, without limitation,
requiring its employees, consultants, sub-licensees and agents to
enter into similar confidentiality agreements in relation to the
Technology and such other confidential information.
10.2 Faulding agrees with Purepac that it will not
disclose to any person or corporation any confidential information
of Purepac that it may acquire at any time during the term of this
Agreement, including, without limitation the Know-How and any
Enhancements, without the prior written consent of Purepac and that
Faulding will use all reasonable efforts to prevent unauthorized
publication or disclosure by any person of such confidential
information, including requiring its employees, consultants and
agents to enter into similar confidentiality agreements in relation
to the Technology and such other confidential information.
10.3 The obligations undertaken by each party under this
Section 10 shall continue in force for a period of five (5) years
following the termination or expiration of this Agreement.
10.4 The obligations contained in this Section 10 do not
apply to any information:
(a) which was at the time of receipt by a party in the public
domain or generally known in the pharmaceutical manufacturing
industry otherwise than by breach of a party's duty of
confidentiality;
(b) which a party can establish to have been known to it at
the time of receipt from the other party and not to have been
acquired directly or indirectly from the other party and
(c) acquired by a party from a third party otherwise than in
breach of an obligation of confidence to the other party.
(d) required by law to be provided to governmental agencies
but only for the purpose of providing it to such governmental
agencies; and
(e) disclosed to an Affiliate of either party for purposes
consistent with this Agreement.
11. INDEMNITY
11.1 Faulding agrees to indemnify, defend and hold
harmless Purepac, its Affiliates and subsidiaries and their
respective employees against any and all claims, losses (except
consequential losses, such as, for example, the loss of business or
of profits), damages and liabilities, including reasonable
attorney's fees, incurred by any of them arising out of any breach
of any obligation by Faulding hereunder or any representation or
warranty by Faulding hereunder or any act or omission of Faulding
in connection with its contract obligations hereunder.
11.2 Purepac agrees to indemnify, defend and hold
harmless Faulding, its Affiliates and subsidiaries and their
employees against any and all claims, losses(except consequential
losses, such as, for example, the loss of business or of profits),
damages and liabilities, including reasonable attorney's fees,
incurred by any of them arising out of any breach of any obligation
by Purepac hereunder, any representation or warranty by Purepac
hereunder, or any act or omission of Purepac in connection with its
contract obligations hereunder.
11.3
(a) If Purepac or any of its Affiliates or subsidiaries or
Faulding or any of its Affiliates or subsidiaries (in each case an
"Indemnified Party") receives any written claim which it believes
is the subject of indemnity hereunder by Faulding or Purepac, as
the case may be, (in each case as "Indemnifying Party"), the
Indemnified Party shall, as soon as reasonably practicable after
forming such belief, give notice thereof to the Indemnifying Party,
including full particulars of such claim to the extent known to the
Indemnified Party; provided, that the failure to give timely notice
to the Indemnifying Party as contemplated hereby shall not release
the Indemnifying Party from any liability to the Indemnified party
other than pursuant to this Section 11. The Indemnifying Party
shall have the right, by prompt notice to the Indemnified Party, to
assume the defense of such claim with counsel reasonably
satisfactory to the Indemnified Party, and at the cost of the
Indemnifying Party. If the Indemnifying Party does not so assume
the defense of such claim or, having done so, does not diligently
pursue such defense, the Indemnified Party may assume such defense,
with counsel of its choice, but for the account of the Indemnifying
Party. If the Indemnifying Party so assumes such defense, the
Indemnified Party may participate therein through counsel of its
choice, but the cost of such counsel shall be for the account of
the Indemnified Party.
(b) The party not assuming the defense of any such claim
shall render all reasonable assistance to the party assuming such
defense, and all out-of-pocket costs of such assistance shall be
for the account of the Indemnifying Party.
(c) No such claims shall be settled other than by the party
defending the same, and then only with the consent of the other
party, which shall not be unreasonably withheld; provided, that the
Indemnified Party shall have no obligation to consent to any
settlement of any such claim which imposes on the Indemnified Party
any liability or obligation which cannot be assumed and performed
in full by the Indemnifying party.
11.4 Faulding shall have no liability hereunder for any
claim which, if true, would constitute a breach of the warranties
contained in Sections 9.1(c), (d) and (e) hereof (hereinafter an
"Infringement Claim") based on Purepac's manufacture or
distribution of the Product, as the case may be, after Purepac
receives a notice from Faulding that Purepac should cease such
manufacture or distribution due to an Infringement Claim.
12. TAXATION ISSUES
12.1 Each of the parties is aware that the commercial
arrangements of this Agreement may be subject to transfer pricing
reviews by the relevant taxation authorities in the Territory and
Australia. As a result, this Agreement may be subject to internal
reviews by either or both parties and to audits by the relevant
taxation authorities. If as a result of such reviews or audits, it
becomes necessary or advisable for either party (the "Affected
Party")to change any commercial arrangements of this Agreement,
including, without limitation, making retroactive adjustments, the
other party, within thirty (30) days after written notification by
the Affected Party, which notification shall explain in reasonable
detail the reason for the proposed change, shall meet with the
Affected Party and each of the parties agrees to negotiate in good
faith, and to use its best efforts to reach agreement with respect
to, any modifications to the commercial terms of this Agreement.
In the event that the parties, despite their best efforts, cannot
reach agreement with respect to any material change, which in the
opinion of either party is necessary or advisable for the reasons
set forth in this Section 12.1, either party, upon written notice
to the other party, may terminate this Agreement. The provisions
of Section 15.4 of this Agreement shall apply upon any termination
of the Agreement pursuant to this Section 12.1.
12.2 Each of the parties agrees to provide reasonable
assistance, at the Affected Party's reasonable cost, if the
Affected Party is subject to a taxation audit that reviews any
commercial arrangement of this Agreement.
13. NOTICES
Notices provided under this Agreement to be given or served by
either party on the other shall be given in writing and served
personally or by prepaid registered airmail or by express mail or
by means of facsimile to the following respective addresses or to
such other addresses as the parties may hereafter advise each other
in writing. It being agreed and understood by the parties that any
such notice shall be deemed given and served on the dates
transmitted by facsimile or a date ten (10) days after the date of
airmail by post or express mail.
To: Faulding
The Company Secretary
F.H. Faulding & Co. Limited
160 Greenhill Road
PARKSIDE South Australia 5063
Facsimile +618 373 3120
To: Purepac
President
Purepac Pharmaceutical Co.
200 Elmora Avenue
Elizabeth, New Jersey 07207
United States of America
Facsimile +1 908 527-0649.
14. ASSIGNMENT
Neither party to this Agreement shall assign any rights
hereunder to third parties other than the right of payment of
monies accrued without the prior written consent of the other
party; provided, however, that the restriction contained herein
shall in no way limit the rights to sublicense granted to Purepac
under Section 7 of this Agreement or the rights of either party to
make assignments to Affiliates. This Agreement shall be binding
upon any permitted assignee or successor of either party.
15. TERM AND TERMINATION
15.1 This Agreement shall be for a term of ten (10) years
commencing as of the date of this Agreement and thereafter shall be
automatically renewed for successive periods of five (5) years
unless either party shall give six (6) months prior written notice
to the other party of its intention not to renew this Agreement.
15.2 This Agreement may be terminated by notice in
writing by either party if the other party shall default in the
performance of any of its obligations under this Agreement and such
default shall continue for a period of not less than ninety (90)
days after written notice specifying such default shall have been
given; by either party if the other party makes an arrangement with
its creditors or goes into receivership or liquidation (other than
voluntary liquidation for the purpose of internal reorganization),
or if a receiver or a receiver and manager is appointed in respect
of the whole or part of the property or business of the party in
default or by either party if a major part of the assets or all of
the assets of the other party are disposed of to or compulsorily
acquired by any other person.
15.3 This Agreement may be terminated at any time by
Purepac by notice in writing to Faulding if Purepac determines, in
its sole judgement, that the development, manufacture or sale of
the Product has ceased to be commercially viable and relevant to
the business objectives of Purepac.
15.4 Upon the latter of:
(a) the termination or expiration of this Agreement, or
(b) with respect to any records or other data that must be
retained for a period of time in accordance with, and as set
forth in, the regulations of the Regulatory Authority (the
"Retention Period"), the expiration of the Retention Period,
Purepac shall promptly deliver to Faulding all information with
respect to the Technology in Purepac's possession and Faulding
shall promptly deliver to Purepac all information with respect to
any Enhancements and the parties shall as soon as conveniently
possible reconcile all accounts.
16. FORCE MAJEURE
Neither party shall be liable or be guilty of any breach of
any provision of this Agreement for failure or delay in its part to
perform any obligation where such failure or delay has been
occasioned by any act of God, war, riot, fire, explosion, flood,
sabotage, accident or breakdown of machinery, unavailability of
fuel, labor, containers or transportation facilities, accidents of
navigation or breakdown or damage of vessels or other conveyancers
for air land or sea, other impediments or hindrances to
transportation, government intervention, strikes or other labor
disturbances or any other cause beyond the control of the parties.
17. NON WAIVER
Any party's failure to exercise or enforce any right conferred
upon it under this Agreement shall not be deemed to be a waiver of
any such right or operate to bar the exercise or performance
thereof at any time or times thereafter nor shall any party's
waiver of any right under this Agreement at any given time
including rights to any payment be deemed a waiver for any other
time.
18. GOVERNING LAW
This Agreement shall be deemed to be a contract made under and
shall be governed by and construed in accordance with the laws of
the State of New York.
19. ENTIRE AGREEMENT
This Agreement incorporates the entire understanding of the
parties and revokes and supersedes any and all agreements,
contracts, understandings or arrangements that might have existed
heretofore between the parties regarding the subject matter hereof.
20. HEADINGS
The headings used in this Agreement are intended for guidance
only and shall not be considered part of this written understanding
between the parties hereto.
IN WITNESS WHEREOF, this Agreement has been executed by the
parties on the date first above written.
PUREPAC PHARMACEUTICAL CO.
By: /s/
------------------------
F.H. FAULDING & CO. LIMITED
By: /s/
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SCHEDULE 1
A once daily ketoprofen product that will be the rated A/B
substitutable for Oruvail 200 by the United States Food and Drug
Administration.