EXHIBIT 10.15
THIS AGREEMENT is made as of the 15th day of March 1995
BETWEEN: X. X. XXXXXXXX & CO. LIMITED having offices at 000 Xxxxxxxxx Xxxx,
Xxxxxxxx in the State of South Australia 5063 ("Faulding")
AND: PUREPAC PHARMACEUTICAL CO. having offices at 000 Xxxxxx
Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx 00000, Xxxxxx Xxxxxx of America
("Purepac").
Faulding possesses certain technology and expertise related to the Product
described in Schedule 1.
Purepac, a company with expertise in capsule and tablet technology and in the
packaging, promotion and distribution of pharmaceutical products, wishes to
obtain the right to import, distribute, promote and sell the Product within
the Territory.
Faulding has agreed, subject to the terms and conditions of this Agreement to
grant Purepac a non-exclusive license to import, distribute, promote and/or
sell the Product in the Territory and to appoint sub-licensees within the
Territory.
NOW, THEREFORE, in consideration of the mutual covenants as hereinafter
contained, the parties agree as follows:
1. Definitions
As used in this Agreement, the following terms shall have the
following meanings:
"GMP" means good manufacturing practice as required by the regulations of
the United States Federal Food and Drug Administration..
"License Fee" means the fee of US$70,000 for the grant of the
license by Faulding to Purepac under this Agreement, which has been
paid by Purepac.
"Product" means the product of Faulding and any adaptation or
variation or part thereof whatsoever which is listed in Schedule 1
and such other products as may from time to time be added to that
Schedule by mutual agreement between the parties.
"Regulatory Authority" means the United States Federal Food and Drug
Administration and/or any other like authority whether Federal or
State regulating the import, distribution, marketing and/or sale in
the Territory of therapeutic substances.
"Rights" means any copyright, patent, trade xxxx, design (whether
registered or unregistered), logos or any other proprietary or
personal rights and includes without limitation all such rights in
relation to all drawings, flow charts, models, formulae operating
instructions, specifications, lists and compilations of data and
other written materials relating to the Product.
"Sales Year" means each full fiscal year during which commercial
sales of the Product occur in the Territory.
"Territory" means the territories listed in Schedule 2 and any other
territories as may from time to time be added to that Schedule by
mutual agreement between the parties.
"Unit" means each one thousand (1,000) capsules, in the case where
the Product is supplied by Faulding to Purepac in containers each
containing bulk capsules with each capsule containing one hundred
(100) milligrams of doxycycline.
2. Appointment of Distributor
Faulding hereby grants to Purepac, and Purepac hereby accepts, the
right to import in bulk, package, distribute, promote and sell the
Product in the Territory subject to the terms and conditions of this
Agreement.
3. Right to Purchase
Faulding hereby grants to Purepac the right to purchase supplies
from Faulding of the Product for sale within the Territory.
4. Distribution and Sale of Product
4.1 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.
4.2 Purepac shall use reasonable efforts to maintain a reasonable
adequate level of stock of the Product to meet the market demand for
the Product within and throughout the Territory and without limiting
the generality of the foregoing, shall hold sufficient stocks of the
Product in finished form to meet at least three (3) months
requirements of forward budgeted sales in the Territory.
4.3 Purepac shall prepare, at its cost, estimated annual sales of the
Product for discussion with Faulding at least annually.
4.4 Purepac shall submit to Faulding, in a form satisfactory to Faulding
and at Purepac's cost:
(a) bi-annual reports of:
(i) its inventory of the Product; and
(ii) sales of the Product for the month and year to date; and
(b) annual estimates of Purepac s requirements for the
Product, at least three (3) months before the start of
each fiscal year or at such other time as Faulding may
reasonably request.
5. Discounts
Any discount or rebate given by Purepac to any customer will be
borne by Purepac and will not be recoverable from Faulding.
6. Appointments
6.1 Subject to the limitations set forth in clause 6.2 hereof, Purepac
shall have the right to appoint any private label distributor or
unit dose packer to distribute, market, promote and/or sell the
Product within the Territory.
6.2 The appointment of any private label distributor or unit dose packer
under clause 6.1 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 private label distributor or
unit dose packer appointed pursuant to clause 6.1 and hereby
indemnifies Faulding against any and all loss, liability, damage,
claims, cost and expense arising from or in connection with such
private label distributor's or unit dose packer's acts, deeds or
omissions.
7. Advertising and Promotion
Purepac shall ensure, at its cost, that all packaging and labelling
used for the Product meets all the requirements under the applicable
laws, rules and regulations in the Territory.
8. Supply of Information to Purepac
Faulding shall place at Purepac's disposal its entire know-how:
(a) concerning the chemical, pharmacological, toxicological and clinical
data of the Product;
(b) the technical data concerning methods, formulae, and standards
to be employed by Purepac in the packaging of the Product; and
(c) any special precautions or handling instructions with respect
to the Product in order to prevent injury or damage arising
from improper handling thereof.
9. Packaging
(a) Purepac agrees that it will prepare and pack the Product in
accordance with any applicable law or regulation in the
Territory relating to the preparation and packaging of the
Product.
(b) Faulding agrees that it will ship the Product under appropriate
storage conditions and will package the Product for shipment
according to the laws and regulations of the United States and
Australia, as applicable and with all necessary export
clearances obtained.
10. Rights of Faulding
Purepac acknowledges and accepts that any and all Rights in, or in
relation to, the Product and/or the processes, designs and
techniques for its manufacture are owned or controlled by Faulding
in and throughout the Territory and agrees not to alter, remove,
disguise, tamper or conceal in any way whatsoever any of the Rights
on or in relation to the Product and not to sell any of the Product
separate from any of the information that may be specifically
provided by Faulding for sale with the Product. Labels or notices
attached to the Product in its packaged form by Purepac shall
provide that the Product is manufactured by Faulding in Australia.
11. Quality Control
11.1 Faulding agrees to maintain adequate and appropriate quality control
in,respect of its manufacture and packaging in bulk of the Product
and to provide Purepac for each lot of Product shipped to Purepac a
certified analysis ensuring and warranting that each such lot meets
the specification set forth in clause 11.2 hereof. Purepac shall
have the right to inspect Faulding's quality control procedures and
records during normal business hours upon prior reasonable written
notice to Faulding.
11.2 Faulding shall submit to Purepac an appropriate specification in
respect of the Product for each lot shipped to Purepac. Purepac
shall have twenty five (25) days after receipt of supplies of the
Product manufactured and sold to Purepac pursuant to this Agreement
to inspect such Product to determine if it conforms to the
applicable specification.
11.3 Faulding agrees to manufacture the Product in accordance with the
regulations of the Regulatory Authority and in conformance with GMP.
Faulding acknowledges and agrees that, as the approved site of
manufacture of the Product, it may be required to undergo
preapproval and other periodic inspections by the Regulatory
Authority.
11.4 Purepac shall give Faulding written notice of any non-conformance
within four (4) weeks after receipt of the Product and Faulding
agrees that in order to maintain Purepac's ability to supply the
Product, such rejected goods shall be replaced by Faulding within
four (4) weeks of Faulding's receipt of Purepac's notice of
rejection. Thereafter, Faulding and Purepac will mutually agree
upon an independent laboratory that will examine the Product in
dispute to determine if it conforms to the applicable specification.
Both parties agree to abide by the opinion of the independent
laboratory. The party in error shall pay the independent
laboratory's fees and all transportation, shipping and insurance
costs and other fees incident to the shipping of the replacement
Product.
12. Condition of Products
12.1 Subject to clause 12.2 and to packaging of the Product, Purepac
shall offer for sale and sell the Product in the same condition as
it is delivered by Faulding. Purepac shall not sell any Product
which has been damaged or is otherwise defective.
12.2 Purepac shall provide suitable storage and handling facilities for
the Product to ensure it can be offered for sale and sold in the
same condition as it is delivered by Faulding.
12.3 Purepac shall forthwith inform Faulding by written notice, of any
damaged or otherwise defective Product alleged to have been
delivered by Faulding and shall upon the request of Faulding return
the damaged or defective Product to Faulding forthwith and the
reasonable cost of return of such Product shall be borne by Faulding
and Faulding shall replace such damaged or defective Product free of
charge depending upon Faulding's availability of stocks of the
Product and provided that Faulding concludes that such damage or
defects have not been caused by Purepac. If Purepac disagrees with
Faulding's determination that such damage or defects have been
caused by Purepac, then the Product shall be submitted to an
independent laboratory, the costs of which shall be paid by the
party against whom the discrepancy is resolved.
12.4 In the event that Purepac determines that a Product should be
recalled for any reason, prior to taking any action, it shall give
written notice to Faulding specifying its reasons for the necessity
of a recall (the "Recall Notice"). If Faulding agrees with the
determination made by Purepac as stated in the Recall Notice,
Purepac shall handle the administration of the recall and Faulding
agrees to replace all Product recalled within one hundred twenty
(120) days from the date of the Recall Notice and to reimburse
Purepac for all reasonable out-of-pocket expenses relating to such
recall. If, within ten (10) days from the date of the Recall Notice,
the parties have been unable to reach an agreement concerning the
necessity of a recall, the parties agree to submit the Product to an
independent laboratory for an independent evaluation (the "Report"),
the cost of which shall be paid by the party against whom the
discrepancy is resolved. In the event that the discrepancy is
resolved against Faulding, Purepac shall handle the administration
of the recall and Faulding shall replace all Product recalled within
one hundred twenty (120) days from the date of the Report and shall
reimburse Purepac for all reasonable out-of-pocket expenses relating
to such recall. In the event that the discrepancy is resolved in
favor of Faulding and Purepac elects to recall the Product
notwithstanding the Report, Faulding shall have no obligation to
Purepac with respect to replacement of Product or reimbursement of
expenses.
13. No Sales Outside the Territory
To the extent permitted by the prevailing laws in the Territory,
Purepac undertakes and agrees that it will not sell any of the
Product directly or indirectly outside the Territory nor export any
of the Product out of the Territory nor fill any orders for the
Product knowing that such orders are intended for sale outside the
Territory.
14. Payments by Purepac
14.1 Purepac hereby agrees that it will bear all reasonable costs of
clinical trials and stability trials in respect of the Product which
are required to obtain registration and/or approval to market the
Product in the Territory during the term of this Agreement whether
those trials are conducted by it or by Faulding and whether or not
they have commenced on the date of execution of this Agreement.
14.2 The price per Unit of the Product purchased by Purepac shall be
$(U.S.)148.65, which price the parties shall review on an annual
basis or more frequently, if requested in writing by either party.
Any amounts due and payable shall be paid in full by Purepac to
Faulding within either sixty (60) days from the date of dispatch of
the Product or thirty (30) days from receipt of Product at Purepac's
premises, whichever is earlier.
14.3 Purepac shall during the continuance of this Agreement and any
extension thereof and thereafter for a period of twelve (12) months
after the date of the transactions to which they relate keep at its
principal office true and particular accounts and records of all
sales of the Product. 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 clause 14.3.
14.4 Purepac shall not be entitled to a discount or rebate from Faulding
on surcharges noted in the invoices such as packing, freight,
insurance, government charges, taxes and duties.
14.5 Property in the Product supplied by Faulding to Purepac under this
Agreement will only pass to Purepac at such time as the Products
have been paid for in full, provided always that all risk in and to
the Product shall pass to Purepac upon delivery to it of the Product.
15. Delivery
All deliveries of Product by Faulding to Purepac will be FOB ex
Faulding's factory at Salisbury, South Australia or such other place
or places as may be mutually agreed by the parties. The delivery of
Product may be in whole or in part of the accepted order. Purepac
shall be responsible for the payment of all freight and insurance
charges and all fees, taxes, excises, duties, and any other charges
which may be assessed against Product ordered from Faulding.
16. Purchase Orders and Forecasts
Purepac shall place written purchase orders with Faulding, receipt
of which shall be promptly acknowledged by Faulding in writing, for
the quantities and the delivery dates of Product which it desires to
purchase under this Agreement. In no event, however, will any such
purchase order specify a delivery date of less than ninety (90) days
from the receipt of the purchase order by Faulding. Faulding shall
confirm to Purepac each purchase order within ten (10) days after
its receipt thereof. On or before the effective date of this
Agreement, and every three (3) months thereafter during the term of
this Agreement, Purepac shall provide Faulding with a forecast of
Product to be ordered for delivery during each quarter for the
succeeding five (5) quarters. Such forecast shall not be a binding
obligation on either party. However, Purepac shall use all
reasonable efforts to make each forecast as accurate as possible,
particularly forecasts for the next two (2) quarters. Faulding
shall not be required to supply during any quarter more than one
hundred and ten per cent (110%) of the forecasted amounts so
furnished for that period but will use all reasonable efforts to
supply the full amount ordered.
17. Warranties, Indemnities and Insurance
17.1 Except as otherwise expressly provided in this Agreement, Faulding
shall not be bound by or subject to any condition, warranty,
obligation or liability of any kind whatsoever in connection with
this Agreement, whether such condition, warranty, obligation or
liability is implied or imposed by virtue of any applicable statute,
statutory rule or regulation or the general law and whether arising
out of negligence on the part of Faulding, its servants or agents or
otherwise howsoever and Purepac shall indemnify and keep indemnified
Faulding against all and any such actions, demands, obligations and
liabilities.
17.2 Purepac agrees to indemnify Faulding against and hold Faulding
harmless from any and all loss, liability, damage, claim cost and
expense (including without limitation, reasonable attorney's fees)
arising from or in connection with the packaging, storage, use, sale
and/or shipping of the Product by Purepac or any Sub-Licensee,
private label distributor or unit dose packer of Purepac and any
claims, express, implied or statutory, made by Purepac or any Sub-
Licensee, private label distributor or unit dose packer of Purepac
as to the efficacy or safety of the Product including, without
limitation, claims made by reference to the labelling or packaging
of the Product; provided however that Purepac shall not be required
to indemnify Faulding with respect to any loss, liability, damage,
claim, cost or expense which results solely from Faulding's breach
of its warranties hereunder, or from information about the Product
supplied by Faulding to Purepac or contained in regulatory filings
within the Territory prepared by Faulding in respect of the Product.
17.3 Faulding agrees to indemnify Purepac against and hold Purepac
harmless from any and all loss (except consequential loss, such as,
for example, loss of business or of profits), liability, damage,
claim, cost and expense (including, without limitation, reasonable
attorney's fees) arising from or in connection with:
(a) the manufacture of the Product by Faulding;
(b) any side effects caused by the active ingredient in the
Product, notwithstanding the fact that the Product meets, or
does not meet, the specification set forth in clause 11.2
hereof;
(c) the breach by Faulding of its warranties hereunder; and
(d) any claims, express, implied or statutory, made by Faulding as
to the efficacy or safety of the Product, or the use to be made
by any purchaser of the Product including, without limitation,
claims made by reference to the labelling or packaging of the
Product approved by Faulding.
17.4 Faulding warrants that:
(a) it has the corporate authority to enter into this Agreement and
to perform its obligations hereunder;
(b) all Product delivered to Purepac pursuant to this Agreement
will meet the specification at the time of delivery by Faulding
to Purepac and throughout its stated shelf-life, provided such
Product has been stored according to Faulding's instructions,
but only so long as it remains in the possession of Purepac;
(c) all Product manufactured and delivered to Purepac pursuant to
this Agreement will be manufactured in a plant which meets the
requirements of the Regulatory Authority in the Territory and
in accordance with Faulding's approved regulatory filings in
the Territory and GMP and will be free and clear of all
security interests, liens and other encumbrances of any kind;
(d) all Product delivered to Purepac pursuant to this Agreement
will have a shelf-life of at least eighteen (18) months,
provided that each order placed by Purepac for such Product
clearly specifies a minimum eighteen (18) months shelf life,
and provided further that such Product has been stored
according to Faulding's instructions; and
(e) Faulding will not deliver adulterated or misbranded Product to
Purepac pursuant to this Agreement.
17.5 Faulding warrants that it is the owner of the Rights free and clear
of any liens or encumbrances of third parties and has sufficient
right, title and interest in the Rights to grant the license to
Purepac granted hereunder;
17.6 Purepac warrants that: it has the corporate authority to enter into
this Agreement and to perform its obligations hereunder.
17.7
(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 17. 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.
18. Regulatory Approval
18.1 Purepac hereby agrees that it will, when and as required by and at
the cost and in the name of Faulding, seek all necessary approvals
and/or registrations from the appropriate Regulatory Authority in
the Territory to enable the conduct of pharmokinetic and stability
trials using the Product and/or the import, distribution, marketing
and sale of the Product in the Territory during the term of this
Agreement.
18.2 In the event that any applicable law or regulation in the Territory
prevents the grant of such approvals and/or registrations of the
Product in the name of Faulding, Purepac will secure such approvals
and/or registrations in its own name and at the expense of Faulding
on the express understanding that Faulding shall remain the
beneficial owner thereof and that such approvals and/or
registrations shall be held in trust for the beneficial owner and
shall be assigned to Faulding by Purepac at no charge to Faulding or
to Faulding's nominee as soon as such assignment is possible but in
no event later than the date of expiration or termination of this
Agreement. If upon expiration or termination of this Agreement no
such assignment may legally be made, such approvals and/or
registrations shall forthwith be surrendered for cancellation on the
request of Faulding. Upon Faulding's request, Purepac shall
promptly deliver to Faulding, or to Faulding's nominee, any
documents in its possession relating to such approval and/or
registrations and shall execute all such documents as Faulding may
deem appropriate to ensure any such assignment or cancellation is
effected.
18.3 Faulding hereby agrees that it will:
(a) notify Purepac promptly of any serious and unexpected adverse
reactions reported to Faulding resulting from the use of any
of the Product and on a regular basis notify Purepac of all
other reports of adverse reactions;
(b) advise Purepac of any and all changes in manufacture and
quality control information provided to the Regulatory
Authorities in the Territory before such changes are made;
(c) retain a representative sample from each batch of the Product
produced by Faulding and retain a portion of each such sample
for twelve (12) months past the expiration date stated thereon,
for use in the event a later analysis becomes necessary; and
(d) perform all stability testing of the Product for required
filing for approval to market or for registration in the
Territory.
18.4 Purepac agrees that it will:
(a) notify Faulding promptly 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;
(b) notify Faulding promptly of any complaints from third parties
involving the Product; and
(c) provide all necessary assistance to Faulding in complying with
the reporting compliance requirements of the Regulatory
Authorities.
19. Term
Subject to clause 24, the term of this Agreement shall be three (3)
years from the date of execution of this Agreement and thereafter
shall be automatically renewed for successive periods of two (2)
years unless either party shall give six (6) months prior written
notice to the other party of its intention not to renew this
Agreement.
20. Termination
The obligation of the parties set forth in 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 material 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 be 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 or are compulsory acquired by any other person.
21. Confidential Information
21.1 All confidential information communicated by Faulding or its
employees, servants or agents to or obtained by Purepac or its
employees, servants, sub-licensees, private label distributors, unit
dose packers or agents (collectively, "Agents") and all other
information and other materials supplied to or received by Purepac
or its Agents from Faulding or its Agents on a confidential basis
shall be kept confidential by Purepac unless the confidential
information or such information or materials or part of it is in the
public domain other than by breach of this Agreement by Purepac or
its Agents, whereupon to the extent that it is public, this
obligation of confidentiality shall cease.
21.2 The obligation of confidence imposed in clause 21.1 shall continue
in force for a period of ten (10) years following the termination or
expiration of this Agreement.
21.3 Purepac shall take all reasonable steps to eliminate the risk of
unauthorized disclosure of confidential information by obtaining
from all of its Agents who may be granted access to any confidential
information appropriate nondisclosure agreements.
22. 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 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.
23. Entire Agreement
This Agreement constitutes the entire agreement 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.
24. Variations to Agreement
Any modification, alteration, change or variation of any term or
condition of this Agreement shall be only made in writing, executed
by both parties.
25. Severability
The provisions of this Agreement shall be deemed to be severable and
any invalidity of any provision of this Agreement shall not affect
the validity of the remaining provisions of this Agreement.
26. Relationship of Parties
Nothing contained in this Agreement shall be construed so as to
operate or to place any party in the relationship of employee or
agent or joint venturer or legal representative of any other party
and it is hereby expressly agreed and acknowledged that each of the
parties is an independent contracting party which does not have the
authority or power for or on behalf of the other party to enter into
any contract, to incur debts, to accept money, to assume any
obligations or to make any warranties or representations whatsoever.
27. Waiver
The failure of either of the parties to insist upon a strict
performance of any of the terms and provisions herein shall not be
deemed a waiver of any subsequent breach or default in the terms or
provisions of this Agreement.
28. Notices
Any notice or other communication provided for or permitted in this
Agreement shall be in writing and shall be sent by certified or
registered airmail with postage prepaid, by hand delivery, or by
facsimile transmission to the parties as follows:
TO FAULDING:
The Company Secretary
X. X. XXXXXXXX & CO. LIMITED
000 Xxxxxxxxx Xxxx
Xxxxxxxx Xxxxx Xxxxxxxxx 0000
Telephone No: (00) 000 0000
Facsimile No: (00) 000 0000
TO PUREPAC:
The President
PUREPAC PHARMACEUTICAL CO.
000 Xxxxxx Xxxxxx
Xxxxxxxxx Xxx Xxxxxx 00000 XXX
Telephone No: (000) 000-0000
Facsimile No: (000) 000-0000
or such other address or person as either party may specify by
notice in writing to the other. Any notice or other communication
under this clause shall be deemed to have been duly given or made:
(a) ten (10) days after being deposited in the mail with postage
prepaid;
(b) when delivered by hand; or
(c) if sent by facsimile transmission, upon confirmation of
successful transmission of the facsimile to the recipient
generated by the sender's facsimile machine.
29. Force Majeure
Neither party shall be responsible or liable to the other party for,
nor shall this Agreement be terminated as a result of, any failure
to perform any of its obligations hereunder (with the exception of
payment of monies due and owing), if such failure results from
circumstances beyond the control of such party, including, without
limitation, requisition by any government authority or the effect
of any statute, ordinance or governmental order or regulation, wars,
strikes, lockouts, riots, epidemic, disease, act of god, civil
commotion, fire, earthquake, storm, failure of public utilities,
common carriers or any other circumstances, whether or not similar
to the above causes. In the event such force majeure continues for
a period of more than one hundred and eighty (180) days, the party
not the victim of the force majeure may terminate this Agreement on
thirty (30) days written notice to the other party.
30. Governing Law
This Agreement shall be construed with and in accordance with and
governed by the laws of the State of New Jersey, United States of
America and its form, execution, validity, construction and effect
shall be determined in accordance with the laws of the State of New
Jersey.
31. Execution of All Necessary Additional Documents
Each party agrees that it will forthwith upon the request of the
other party execute and deliver all such instruments and agreements
and will take all such other actions as the other party may
reasonably request from time to time in order to effectuate the
provision and purposes of this Agreement.
32. 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 as
of the date first above written.
PUREPAC PHARMACEUTICAL CO.
By: /s/
--------------------------
X. X. XXXXXXXX & CO. LIMITED
By: /s/
--------------------------
SCHEDULE 1
The Product
Generic version of Faulding's doryx product which is licensed in the United
States to Xxxxxx-Xxxxxxx Company.
SCHEDULE 0
Xxx Xxxxxxxxx
Xxx Xxxxxx Xxxxxx of America and its commonwealth states.
