1
EXHIBIT 2.2
SUPPLY AGREEMENT
FINAL FINISHED PHARMACEUTICALS
BETWEEN
SB PHARMCO PUERTO RICO INC.
SUBSIDIARY OF
SMITHKLINE XXXXXXX PLC
AND
XXXXX MEDICAL INDUSTRIES, INC.
FOR
TRIOSTAT
[LIOTHYRONINE SODIUM INJECTION (T3)]
2
TABLE OF CONTENTS
SUPPLY AGREEMENT
FINAL FINISHED PHARMACEUTICALS
Page
----
Background 1
Article 1 - Definitions 1
Article 2 - Orders, Pricing, Payment and Conformance 3
2.1 Exclusivity and Requirements
2.2 Forecasts and Orders
2.3 Price; Payment and Shipment
2.4 Acceptance
2.5 Testing; Certificate of Analysis and Conformance
Article 3 - Warranties, Covenants and Indemnification 5
3.1 General Warranty and Indemnification
3.2 Manufacture of the Product
3.3 Regulatory Matters
3.4 Other General Representations
3.5 Complaints and Recalls
3.6 Adverse Experience Reports
3.7 Insurance
Article 4 - Term and Termination 11
Article 5 - Confidentiality 12
Article 6 - Miscellaneous 13
6.1 Corporate Organization and Authority
6.2 Public Announcements
6.3 Force Majeure
6.4 Amendment and Waiver
6.5 Governing Law
6.6 Successors and Assigns
6.7 Nature of Agreement
6.8 Notice
ii
3
6.9 Entire Agreement
6.10 Counterparts
6.11 Survival of Representations
612 Guaranty
EXHIBITS
Exhibit A - Product and Specifications
Exhibit B - Prices
Exhibit C - SB Quality Assurance Requirements
iii
4
SUPPLY AGREEMENT
FINAL FINISHED PHARMACEUTICALS
Triostat(R)
This is a Supply Agreement for Final Finished Pharmaceuticals (as defined
below) ("Agreement") effective as of June 27, 1997, by and between SmithKline
Xxxxxxx Pharmaceuticals, division of SB Pharmco Puerto Rico Inc., a
Commonwealth of Puerto Rico corporation, having a place of business at Xxxx
000XX 9.1 BO Xxxxxxxxxx, Xxxxx, Xxxxxx Xxxx 00000 ("SB"), SmithKline Xxxxxxx
Corporation ("Vendor"), an Affiliate of SB, and Xxxxx Medical Industries, Inc.,
a Delaware corporation having a place of business at 0000 Xxxxx Xxxx, Xx.
Xxxxx, Xxxxxxxx 00000 ("BUYER");
BACKGROUND
A. Vendor and BUYER have entered into an Asset Purchase
Agreement dated June 27, 1997 (the "APA"), pursuant to which
Vendor is, among other things, transferring to BUYER certain
rights to products known as Triostat(R), containing liothyronine
sodium injection (T3) as the sole active ingredient and assets
relating thereto, including the FDA-approved New Drug Application
for Triostat, NDA #20-105;
B. SB has manufactured Triostat for Vendor and has the
appropriate registrations, approvals, facilities and the ability
to continue to manufacture Products pursuant to the NDA;
C. In connection with the APA, BUYER desires to purchase
Triostat from SB in final finished package form as specified in
EXHIBIT A ("Products");
D. SB desires to manufacture and supply Product to BUYER, subject to
the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the
promises herein, the parties, intending to be legally bound, agree as follows:
ARTICLE I - DEFINITIONS
Where used in this Agreement the following words or phrases shall have the
meanings set forth below unless the context otherwise requires:
1.1 Affiliate when used to indicate a relationship with any Person means
any other Person directly or indirectly controlling, controlled by or under
common control with such
1
5
Person. For purposes hereof, the term "controlled" (including the terms
"controlled by" and "under common control with"), as used with respect to any
Person, shall mean the direct or indirect ability or power to direct or cause
the direction of management policies of such Person or otherwise direct the
affairs of such Person, whether through ownership of voting securities or
otherwise.
1.2 Adverse Experiences shall mean the definitions as set forth in Section
3.6.
1.3 Applicable Laws shall mean all applicable foreign, federal, state and
local laws, ordinances, rules and regulations of any kind whatsoever, including
without limitation, the United States Federal Food, Drug and Cosmetic Act.
1.4 Damages shall mean any and all costs, losses, claims, liabilities,
fines, penalties, damages and expenses, court costs and reasonable fees and
disbursements of counsel, consultants and expert witnesses incurred by a party
hereto (including interest which may be imposed in connection therewith).
1.5 FDA shall mean the United States Food and Drug Administration or
comparable state or local authority.
1.6 Final Finished Pharmaceutical(s) shall mean the Product(s) packaged in
final form and ready for sale by BUYER to BUYER's ultimate customer.
1.7 cGMP shall mean current good manufacturing practices of the FDA, as
set forth in 21 C.F.R. Parts 210 and 211 and all applicable rules, regulations,
guides and guidances.
1.8 NDA shall mean the New Drug Application Number 20-105 for the Product
filed by Vendor with the FDA and all subsequent submissions thereto.
1.9 Person shall mean a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental authority
or any other entity or organization.
1.10 Price shall mean the prices set forth in EXHIBIT B.
1.11 Product(s) shall mean Triostat in the Final Finished
Pharmaceutical(s) form(s) listed in EXHIBIT A.
1.12 SB Quality Assurance Requirements shall mean the requirements set
forth in EXHIBIT C.
1.13 Specifications shall mean the requirements and standards pertaining
to the Product as set forth in EXHIBIT A.
2
6
1.14 Territory shall mean the United States, its possessions and
territories, including Puerto Rico, and Canada.
ARTICLE 2 - ORDERS, PRICING, PAYMENT AND CONFORMANCE
2.1 Exclusivity and Requirements. SB shall sell Product exclusively to
BUYER for sale in the Territory and shall supply all of BUYER's reasonable
requirements of Product in the Territory. SB covenants and agrees that it will
not manufacture Product for sale or resale in the Territory by any Person other
than BUYER.
2.2 Forecasts and Orders.
(a) Orders and forecasts for Product shall be in full
lot sizes, as defined in EXHIBIT A, or full multiples thereof.
(b) Simultaneously with the execution of this
Agreement for the period remaining in the current calendar
year and then by October lst of each year during the term of
this Agreement, BUYER shall provide SB with a 12 month
forecast to run from January 1st to December 31st of the next
calendar year of BUYER's estimated full lot requirements of
the Product, which forecast will be updated every three (3)
months. The first three (3) months of each rolling 12-month
forecast or updated forecast shall be a binding order against
which SB is authorized to manufacture, and which BUYER is
required to purchase.
(c) SB agrees to deliver the Product in such full lot
quantities and on such delivery dates as are specified in
BUYER's forecast. SB will use reasonable commercial efforts
to meet BUYER's revised forecasts and orders to the extent
different from the most recent forecasted requirements for the
Product for said period.
BUYER will bear the reasonable out-of-pocket costs incurred
by SB in connection with any delay in the shipment of the
Product caused by BUYER's rescheduling of shipping dates.
(d) BUYER is not obligated to buy any specific amount
of Product under this Agreement and shall be obligated to
purchase only those quantities for which it has submitted a
binding order.
(e) BUYER shall, however, upon expiration or termination of this
Agreement be obligated to buy reasonable quantities (based on
BUYER's forecasts) of raw materials and packaging components
in the possession of SB used solely in the manufacture of
Product under this Agreement. Upon
3
7
expiration or termination of this Agreement, SB shall provide
BUYER with a listing of all raw materials and packaging
components in the possession of SB and used by SB solely in
the manufacture of Product together with the costs thereof.
2.3 Price; Payment; Shipment.
(a) The price for the Product ordered is set forth in EXHIBIT B,
F.O.B. SB manufacturing site, freight collect. Risk of loss
in transit shall lie with BUYER. SB may adjust the price
annually to account for any reasonable increase in the direct
cost of labor and materials, with such increase not to exceed
the annual percentage increase in the Consumer Price Index
("CPI"), as published by the U.S. Department of Labor on a
national basis using 1996 as the base year.
(b) BUYER agrees to pay SB for the Product as set forth above, net
thirty (30) days from date of invoice.
(c) SB hereby covenants that it will use reasonable efforts to
assure that all shipments of Product ordered by BUYER pursuant
hereto are shipped timely in accordance with the directions
of BUYER.
2.4 Acceptance. Within thirty (30) days after receipt of any Product and
the COA (as defined below) provided for such Product, BUYER shall perform such
samplings and tests as it deems appropriate, if any, using validated test
methods described in the NDA to determine whether the Product meets the
Specifications. If BUYER wishes to reject any shipment, BUYER shall within
such thirty (30) days' time, inform SB in writing of its refusal to accept the
lot(s), and the reasons therefor. Any Product not rejected within such thirty
(30) day period shall be deemed accepted. In the event that BUYER rejects any
shipment, SB, upon confirmation of the reasons for rejection, shall use
reasonable efforts to replace the rejected Product within the shortest possible
time with Product which meets the Specifications and SB shall deliver such
replacement Product, at its sole cost and expense, to BUYER. If so requested
by BUYER, rather than replacing the noncomplying Product, SB shall credit the
account of BUYER for all such rejected Product. In addition, SB shall, at its
sole cost and expense, arrange for all such noncomplying Product to be picked
up promptly and destroyed in accordance with all Applicable Laws. BUYER shall
have no responsibility to SB for the purchase price of noncomplying Product.
If SB and BUYER do not agree on the rejection of Product, then either party may
refer the matter for final analysis to a specialized laboratory of national
reputation reasonably acceptable to both parties for the purpose of determining
whether the Product meets Specifications. Any determination by such laboratory
shall be binding upon both parties. SB shall retain "batch retention samples"
of all Products manufactured by SB as required by all Applicable Laws. SB
shall furnish BUYER with a sample of the "batch retention samples" on request.
4
8
2.5 Testing; Certificate of Analysis and Conformance - SB shall provide a
Certificate of Analysis and Conformance ("COA") to BUYER with each shipment of
Product.
ARTICLE 3 - WARRANTIES, COVENANTS AND INDEMNIFICATION
3.1 General Warranty and Indemnification.
(a) SB represents and warrants that (i) the Product is and will
be manufactured in accordance with the NDA, the
Specifications, and with cGMPs, (ii) at the time of delivery
of the Product to BUYER, the Product will (A) be free from
defects in materials and workmanship, (B) not be adulterated
or misbranded within the meaning of the U.S. Federal Food,
Drug, and Cosmetic Act (the "Act"), (C) not be an article
which may not, under the Act, be introduced into interstate
commerce, and (D) be in compliance with all Applicable Laws,
(iii) upon delivery of any Product pursuant hereto, good title
to such Product shall be conveyed to BUYER free and clear of
any and all claims, liens and encumbrances of any kind, and
(iv) unless otherwise mutually agreed upon by the parties, any
and all Product delivered to BUYER shall have a shelf life of
at least twenty (20) months from the date of delivery, unless
the date of delivery has been delayed due to acts of BUYER.
EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, SB MAKES NO
EXPRESS OR IMPLIED WARRANTY AS TO THE MERCHANTABILITY OF THE
PRODUCT, OR AS TO ITS FITNESS FOR A PARTICULAR PURPOSE AND
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. After the
expiration of the initial term, as defined in Section 4.1
below, BUYER shall not be entitled to incidental, indirect or
consequential damages, including damages from loss of profits,
loss of use or loss of goodwill as a result of any breach of
warranty by SB.
(b) In the event that any Product is quarantined or recalled, or
is subject to stop-sale action, whether voluntary or by
governmental action, it is agreed and understood that any
expenses, including reasonable fees of any experts or
attorneys that may be utilized by either party, government
fines or penalties, related to such recall, quarantine or
stop-sale, shall be borne by BUYER unless it is determined
that SB has breached its obligations or warranties under this
Agreement and such breach is the basis upon which said recall,
quarantine or stop-sale was initiated. Said determination may
be made by mutual agreement of the parties following
examination and review of all records pertinent to the
manufacture of the Product subject to such recall.
5
9
(c) SB and Vendor jointly and severally covenant and agree to
defend, indemnify and hold BUYER and its Affiliates,
directors, employees and agents harmless from and against any
and all Damages to the extent arising out of or with respect
to (i) the fault or negligence of SB; or (ii) any
misrepresentation or breach of warranty of SB contained in
this Agreement or in any exhibit or schedule hereto, or in any
other statement, certificate or document furnished or to be
furnished to BUYER pursuant hereto or in connection with the
transactions contemplated hereby; or (iii) any breach of a
covenant or obligation of SB contained in this Agreement.
(d) BUYER agrees to defend, indemnify and hold SB and its
Affiliates, directors, employees and agents harmless from and
against any Damages to the extent arising out of or with
respect to (i) fault or negligence of BUYER; or (ii) any
misrepresentation or breach of warranty of BUYER contained in
this Agreement; or (iii) any breach of a covenant or
obligation of BUYER contained in this Agreement.
(e) No party against whom a claim of indemnity is made under this
Agreement shall be liable unless the party making such claim
shall (i) notify the indemnifying party of such claim in a
timely manner upon becoming aware of the existence or
threatened existence of any such claim giving rise to or which
may give rise to a claim of indemnity, and (ii) cooperate in
the defense of such claim.
3.2 Manufacture of the Product.
(a) For and during the term of this Agreement, SB shall
manufacture, package, label, test, prepare for shipment and
ship Product to BUYER at the times and in the quantities set
forth by BUYER. SB shall manufacture Product at its facility
in Cidra, Puerto Rico and will deliver the Product to BUYER at
all times in full compliance with the NDA, all Applicable
Laws, the Specifications, cGMPs and SB Quality Control
Requirements. SB shall maintain all records as are necessary
and appropriate to demonstrate compliance with cGMPs. In
addition, SB shall retain a copy of the NDA at its facility
for reference purposes. SB shall promptly notify BUYER of any
and all problems with respect to any batches of Product
manufactured by SB, which have or could reasonably be expected
to have adverse regulatory compliance and/or reporting
consequences concerning Product.
(b) The Product shall be labeled, prepared and packed by SB for
shipment in full compliance with the approved NDA, all
Applicable Laws, and in accordance with the provisions of this
Agreement. All Products shall be
6
10
stored and shipped by SB in such a manner (whether by
refrigeration or otherwise) as shall be necessary to maintain
and insure the integrity and stability of the Product. To the
extent permitted by the NDA and all Applicable Laws, BUYER's
name shall be shown (in a format reasonably acceptable to
BUYER) on the label as the distributor of the Product. Lot
numbers shall be affixed by SB on the containers for the
Product and on each shipping card in accordance with
Applicable Laws and SB's customary practice.
(c) BUYER shall use its best efforts to transfer manufacture of
the Product to its own facility, or that of a third party, and
to obtain regulatory approval of the transfer within two (2)
years after the effective date of this Agreement. Upon
BUYER's request, SB agrees to reasonably cooperate with BUYER
to transfer the technology and know-how to manufacture the
Product to BUYER or a third party selected by BUYER. SB shall
provide reasonable assistance with respect to the transfer of
the NDA to BUYER's facility or to such other facility as BUYER
may request, including without limitation, corresponding with
the FDA as may be reasonably requested by BUYER.
BUYER will perform, at its own expense, all studies required
by FDA in connection therewith and shall prepare, or have
prepared, a supplemental NDA and/or a drug master file seeking
authorization for the transfer and shall diligently seek
approval of such authorization.
(d) BUYER shall have the right, on reasonable advance
notice and during normal business hours once per year during
the term of this Agreement, or more than once per year in the
event that BUYER reasonably believes that SB is not in
substantial compliance with the provisions of this Agreement,
to inspect and audit SB's facilities and operations to confirm
compliance with the covenants contained in this Agreement.
(e) SB shall provide all active and inactive raw
materials, components, packaging, inserts, containers,
labeling, release testing, quality control, equipment, labor,
and other necessary services and materials, as part of the
price for Product.
3.3 Regulatory Matters
(a) As soon as the NDA has been transferred to BUYER,
BUYER shall file all required reports and maintain the NDA in
good standing during the term of this Agreement. SB shall,
within all time limits required by Applicable Laws, furnish
BUYER with all information and reports in its
7
11
possession which may be required in order to enable BUYER to
maintain the NDA as herein set forth.
(b) SB shall maintain all regulatory and governmental permits,
licenses and approvals that may be necessary to manufacture
and ship the Product to BUYER.
(c) During the term of this Agreement, SB will be responsible for
any reporting of matters regarding the manufacture of Product
to the FDA in accordance with pertinent laws and regulations.
SB shall furnish copies of such reports to BUYER. SB shall
also advise BUYER of any occurrences or information which
arise out of SB's manufacturing activities which have or could
reasonably be expected to have adverse regulatory compliance
and/or reporting consequences concerning Product.
(d) SB shall be responsible for handling and responding to any
FDA or other governmental agency inspections with respect to
the manufacture of the Product during the term of this
Agreement. SB shall provide to BUYER any information
reasonably requested by BUYER and all information requested by
any governmental agency in connection with any governmental
inspection related to the Product.
(e) Except as otherwise provided herein, SB will obtain the
advance written consent of BUYER for changes relating to the
manufacturing process of the Product or relating to any of the
materials, functions, or controls of the Product.
3.4 Other General Representations. (a) SB and Vendor represent and
warrant that: (i) each of SB and Vendor has the corporate power to enter into
this Agreement and to carry out its obligations hereunder, (ii) the execution
and delivery of this Agreement and the performance of SB's and Vendor's
obligations hereunder have been duly authorized by all necessary corporate
action by the Board of Directors of SB and Vendor, and no other corporate
proceedings on the part of SB or Vendor are necessary to authorize such
execution, delivery and performance, (iii) this Agreement has been duly
executed by SB and by Vendor and constitutes the valid and binding obligation
of SB and Vendor enforceable against them in accordance with its terms, and
(iv) the execution of this Agreement and consummation of the transactions
contemplated hereby will not result in the violation of, or conflict with, any
of the terms and provisions of the articles of incorporation or by-laws of SB
or Vendor or of any law or regulation or any applicable order of any court,
arbitrator or governmental authority having jurisdiction over SB, Vendor, the
Products or SB's ability to manufacture Products for BUYER, or of any indenture
or other agreement, written or oral, to which SB or Vendor may be a party.
8
12
(b) BUYER represents and warrants that (i) BUYER has the corporate
power to enter into this Agreement and to carry out its obligations hereunder,
(ii) the execution and delivery of this Agreement and the performance of
BUYER'S obligations hereunder have been duly authorized by all necessary
corporate action by the Board of Directors of BUYER, and no other corporate
proceedings on the part of BUYER are necessary to authorize such execution,
delivery and performance, (iii) this Agreement has been duly executed by BUYER
and constitutes the valid and binding obligation of BUYER enforceable against
it in accordance with its terms, and (iv) the execution of this Agreement and
consummation of the transactions contemplated hereby will not result in the
violation of, or conflict with, any of the terms and provisions of the articles
of incorporation or by-laws of BUYER or of any law or regulation or any
applicable order of any court, arbitrator or governmental authority having
jurisdiction over BUYER.
3.5 Complaints and Recalls.
(a) Product Complaints - Product complaint reports concerning
manufacture of Product received by BUYER will be faxed (and
followed immediately by mailing the same by overnight courier,
postage prepaid) within 2 business days to:
SmithKline Xxxxxxx Pharmaceuticals
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Vice President Quality Assurance
Telephone No.: (000) 000-0000
Fax: (000) 000-0000
Product complaint reports received by SB will be faxed (and
followed immediately by mailing the same by overnight courier,
postage prepaid) within 2 business days to:
Xxxxx Medical Industries, Inc.
0000 Xxxxx Xxxx
X.X. Xxx 00000
Xx. Xxxxx, XX 00000
Attn: G. Xxxxxx Xxxxx
Telephone No.: (000) 000-0000
Fax: (000) 000-0000
9
13
with a copy to:
Xxxxxx X. Chod, Esq.
Xxxxxxxxxxxx, Xxxxxx & Xxxx, P.C.
00 Xxxxx Xxxxxxxx
0000 Xxxxxxxxx Xxxxxxxx
Xx. Xxxxx, Xxxxxxxx 00000
Telephone No.: (000) 000-0000
Fax No.: (000) 000-0000
(b) SB will promptly investigate all complaints
associated with the manufacture of Product and provide a
written summary to BUYER. BUYER will investigate all other
Product complaints associated with the Product and provide a
written summary to SB. BUYER also will provide a written
response on each complaint to each complaint with a copy to
SB.
(c) Recalls - In the event SB should be required to
initiate a recall, field alert, product withdrawal or field
correction pursuant to any Product provided under this
Agreement, SB shall immediately notify BUYER in writing. In
the event that BUYER believes that a recall, field alert,
product withdrawal, or field correction is necessary for
Product provided under this Agreement, BUYER shall so notify
SB. SB will be responsible for all costs and expenses
associated with any recall field alert, product withdrawal or
field correction arising from SB's negligence or failure to
abide by the provisions of this Agreement.
3.6 Adverse Experience Reports. BUYER and SB shall, upon execution of
this Agreement, apprise the other party of the standard operating procedures
for the investigation and reporting of adverse experiences regarding its
products. The parties shall then promptly develop and agree upon procedures
for the reporting to each other adverse experiences concerning the Product.
The parties shall immediately implement such agreed procedures and shall
provide each other on a regular basis with any appropriate information which
enables the other party to meet its regulatory obligations in the territories
in which it is commercializing or developing Product or which is relevant to
the safe use of the Product. The agreed procedures will be reviewed jointly on
a regular basis or when there is a change in regulations governing adverse
experience reporting. For purposes of this section, "adverse experience(s)"
shall mean any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not
necessarily have to have a causal relationship with this treatment.
3.7 Insurance. During the term of this Agreement, SB and BUYER shall
maintain their own respective comprehensive general liability, property damage
insurance, and product
10
14
liability insurance with respect to the Product, in such amounts (not less than
$10,000,000) and with such scope of coverage as are adequate to cover the
obligations under this Agreement and as are appropriate for companies of like
size, taking into account the scope of activities contemplated herein. BUYER
and SB shall, at the request of the other, provide the other with proof of such
insurance.
ARTICLE 4 - TERM AND TERMINATION
4.1 This Agreement shall have an initial term of two (2) years commencing
on the date first set forth above, unless earlier terminated as provided in
this Agreement. If, at the end of the initial term, BUYER has not received
approval to manufacture the Product at its own facility, or at a third party
facility, the term may be extended by BUYER for up to one additional year.
Buyer shall use its best efforts to transfer manufacture of the Product to its
own facility or to that of a third party within two (2) years after the
effective date of this Agreement.
4.2 Subject to the provisions of Section 4.4 hereof, either party may
terminate this Agreement by giving ninety (90) days written notice to the other
party if the other party is in material breach of any term of this Agreement
and fails to cure that breach within such ninety (90) day period.
4.3 This Agreement may be terminated upon thirty (30) days' prior written
notice by either party at any time during this Agreement if the other party
shall file in any court pursuant to any statute of any government in any
country a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the party or of
its assets; or if any other party proposes a written agreement of composition
for extension of its debts; or if the other party shall be served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within sixty (60) days after filing thereof; or
if the other party shall be a party to any dissolution or liquidation, or if
the other party shall make a general assignment for the benefit of its
creditors; or if the other party is subject to any final order of debarment
which can be reasonably expected to have a material adverse effect on the sales
of the Product.
4.4 (a) Notwithstanding anything in this Agreement to the contrary, in
the event that any dispute or alleged default arises with respect to this
Agreement, then prior to any termination of this Agreement, the institution of
litigation between the parties, or SB ceasing to manufacture and supply Product
to BUYER the parties shall mediate such dispute pursuant to the provisions of
paragraph (b) of this Section 4.4. Pending the outcome of any such mediation,
the provisions of this Agreement shall continue in full force and effect and
the parties shall continue to perform their obligations hereunder.
11
15
(b) (i) A dispute shall be submitted to mediation by written notice to
the other party. In the mediation process, the parties will
try to resolve their differences voluntarily with the aid of
an impartial mediator, who will attempt to facilitate
negotiations. The mediator will be selected by agreement of
the parties. If the parties cannot agree on a mediator, a
mediator will be designated by the American Arbitration
Association ("AAA") at the request of a party. Any mediator
so designated must be acceptable to both parties.
(ii) The mediation will be conducted as specified by the mediator
and agreed upon by the parties. The parties agree to discuss
their differences in good faith and to attempt, with the
assistance of the mediator, to reach an amicable resolution of
the dispute.
(iii) The mediation will be treated as a settlement discussion and
therefore will be confidential. The mediator may not testify
for either party in any later proceeding relating to the
dispute. No recording or transcript shall be made of the
mediation proceedings.
(iv) Each party will bear its own costs in the mediation. The fees
and expenses of the mediator will be shared equally by the
parties.
4.5 Upon expiration or termination, SB will deliver and BUYER shall
promptly pay SB for all inventory of Products, raw materials, components and
works in progress as set forth in Section 2.2(e) of this Agreement. SB shall
also deliver to BUYER, copies of all records relating to the NDA and to the
manufacture of Product that have not already been provided pursuant to the
Asset Purchase Agreement. Notwithstanding the foregoing, all binding orders
for Product (in accordance with forecasts) which are received by SB prior to
the expiration of this Agreement shall be filled by SB in a timely manner in
accordance with the provisions of this Agreement.
ARTICLE 5 - CONFIDENTIALITY
5.1 SB shall use the same efforts to maintain the confidentiality of any
proprietary or confidential information regarding the manufacture or sale of
the Products as SB uses with respect to its own prescription pharmaceutical
products; provided, however, that any such confidential or proprietary
information (a) may be used by SB in performing its obligations under this
Agreement, (b) may be shared, subject to execution of a confidentiality
agreement, with potential third party manufacturers of the Products which are
approved in writing by BUYER, and (c) may be disclosed, subject to execution of
a confidentiality agreement, with potential purchasers of rights outside the
Territory to product lines for which liothyronine sodium injection (T3) is an
active ingredient; provided that no information specific to Purchaser shall be
disclosed in such context.
12
16
5.2 SB's obligations hereunder shall not apply to information which: (i)
is already in the public domain at the time of disclosure; (ii) becomes part of
the public domain through no action or omission of SB after disclosure to the
receiving party; (iii) has been or is disclosed to SB in good faith by a third
party who was or is not, at the time of disclosure, under any obligation of
confidence to BUYER at the time the third party disclosed such information; or
(iv) is required to be disclosed by law.
5.3 This Article 5 shall survive expiration or termination of this
Agreement for a period of ten (10) years.
ARTICLE 6 - MISCELLANEOUS
6.1 Corporate Organization and Authority. Each party represents and
warrants that it is a company duly organized, validly existing, and in good
standing under the laws of the jurisdiction wherein it is organized, and that
it has all necessary power and authorization to assume the obligations under
this Agreement, and to discharge them pursuant to the terms hereof.
6.2 Public Announcements. The parties hereto agree that no disclosure or
public announcement with respect to this Agreement or any of the transactions
contemplated by this Agreement shall be made by any party hereto without the
prior written consent of the other parties hereto provided, however, that
nothing herein contained shall restrict SB or BUYER from making any public
announcement of the transactions contemplated by this Agreement to the extent
that it, in its sole discretion reasonably exercised, is of the view that such
announcement is required or deemed advisable in order to (i) meet its
obligations under the securities laws or stock exchange requirements in the
United Kingdom or the United States of America or (ii) maintain consistency
with respect to prior disclosures; provided further that prior to making such
announcement, the party making it shall provide particulars thereof in writing
to the other parties. Notwithstanding the foregoing, BUYER may disclose this
Agreement and the transactions contemplated hereby, to the extent reasonably
necessary, in connection with any registration of the Product with any state,
Federal or other governmental agency. With respect to an announcement under
item (ii) above, no such announcement shall be made by a party without the
written consent of the other party, which said consent shall not be
unreasonably withheld; provided, however, if no response is received from the
other party within two (2) days after notice of the announcement is given by
the first party, then the other party shall be deemed to have consented to such
announcement.
6.3 Force Majeure. Neither party shall be liable to the other if, and to
the extent, that the performance or delay in performance of any of its
obligations under this Agreement is prevented, restricted, delayed or
interfered with due to circumstances beyond the reasonable control of such
party, including, but not limited to, government legislation, fires, floods,
explosions, epidemics, accidents, acts of God, wars, riots, strikes, lockouts
or other concerted acts of workers and/or acts of government. The party
claiming an event of force majeure shall promptly notify the other party in
writing, and provide full particulars of the cause or event and
13
17
the date of first occurrence thereof, as soon as possible after the event and
also keep the other party informed of any further developments. The party so
affected shall use its best efforts to remove the cause of nonperformance, and
both the parties shall resume performance hereunder with the utmost dispatch
when such cause is removed unless this Agreement is previously expired or
terminated under Article 4 hereof.
6.4 Amendment and Waiver. This Agreement may be amended only by a writing
which specifically states that such an amendment is its purpose and which is
signed by both parties. No course of dealing between the parties or failure by
either party to exercise any right or remedy hereunder shall constitute an
amendment to this Agreement or a waiver of any other right or remedy or the
later exercise of any right or remedy.
6.5 Governing Law. This Agreement shall be governed by and construed in
accordance with the substantive law of the Commonwealth of Pennsylvania without
regard to its rules for conflicts of law.
6.6 Successors and Assigns. The provisions of this Agreement shall be
binding upon and inure to the benefit of the parties hereto and their
respective successors and assigns; provided, however, that no party may assign,
delegate or otherwise transfer any of its rights or obligations under this
Agreement without first receiving the prior written consent of the other party
hereto which consent shall not be unreasonably withheld, except that either
party may assign and delegate its rights and duties hereunder without obtaining
such consent (i) any Affiliate or subsidiary of such party, or (ii) to any
party or entity which acquires substantially all of the business or assets of
such party if such party guarantees the performance of the acquiring party and
the acquiring party expressly assumes the assigning party's obligations
hereunder. No assignment of this Agreement or of any rights or obligations
hereunder shall relieve the assigning party of any of its obligations or
liability hereunder.
6.7 Nature of Agreement. In operating under the Agreement, each party
shall act independently and this Agreement shall not be construed as creating
any partnership, joint venture or incorporated business entity. Neither party
shall have any authority to incur any liability or obligation whatsoever on
behalf of the other.
6.8 Notice. Any notice, direction or other instrument required or
permitted to be given to SB hereunder shall be in writing and may be given by
delivering the same or sending the same by telecommunication (and followed
immediately by mailing the same by certified or registered U.S. first class
mail, return receipt requested, postage prepaid) addressed to SB as follows:
To: SmithKline Xxxxxxx Pharmaceuticals
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Senior VP Worldwide Business Development
14
18
Telephone No.: 000-000-0000
Fax: (000)-000-0000
Copy to: SmithKline Xxxxxxx Corporation
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: General Counsel, U.S.
Telephone No.: (000) 000-0000
Fax: (000) 000-0000
Any notice, direction or other instrument required or permitted to be
given to BUYER hereunder shall be in writing and may be given by delivering the
same or sending the same by telecommunication (and followed immediately by
mailing the same by certified or registered U.S. first class mail, return
receipt requested, postage prepaid) addressed to BUYER as follows:
To: Xxxxx Medical Industries, Inc.
0000 Xxxxx Xxxx
X.X. Xxx 00000
Xx. Xxxxx, XX 00000
Attn: Xxxxxxx X. Xxxxxxxxx
Telephone No.: (000) 000-0000
Fax: (000) 000-0000
Copy to: Xxxxxxxxxxxx, Xxxxxx & Xxxx, P.C.
00 X. Xxxxxxxx, Xxxxx 0000
Xx. Xxxxx, XX 00000
Attn: Xxxxxx X. Chod
Telephone No.: (000) 000-0000
Fax: (000) 000-0000
Any such notice, direction or other instrument, if delivered, shall be
deemed to have been given on the date on which it was delivered and if
transmitted by telecommunication shall be deemed to have been given at the
opening of business in the office of the addressee on the Business Day next
following the transmission thereof.
Any party hereto may change its address for service from time to time by
notice given to the other parties hereto in accordance with the foregoing.
6.9 Entire Agreement. This Agreement and the agreements and documents
referred to herein constitute the entire agreement between the parties
pertaining to the subject matter hereof, and supersede, on the effective date
hereof, all prior and contemporaneous agreements, representations and
understandings of the parties in connection herewith. No agent of either
15
19
party is authorized to make any representation, promise, or warranty not
contained in this Agreement.
6.10 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute a single instrument.
6.11 Survival of Representations. Each of the representations and
warranties made in this Agreement shall survive the execution hereof and the
closing of the transactions contemplated hereby.
6.12 Guaranty. In consideration of BUYER entering into the APA and
performing its obligations thereunder and hereunder, Vendor hereby guarantees
payment and performance of all liabilities, obligations and commitments of SB
under this Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK; SIGNATURE PAGE FOLLOWS]
16
20
IN WITNESS WHEREOF, the parties hereto have affixed hereunto their
authorized signature as follows:
XXXXX MEDICAL INDUSTRIES, INC. SB PHARMCO PUERTO RICO INC.
DIVISION OF SMITHKLINE XXXXXXX PLC
By:______________________________ By:_______________________________
(signature) (signature)
Name:____________________________ Name: Xxxxxx X. Xxxxxx
Title: Secretary
Title:___________________________
SMITHKLINE XXXXXXX CORPORATION
By:_______________________________
(signature)
Name:_____________________________
Title:____________________________
17
