Exhibit 10.2
THIS AGREEMENT made as of this 25th day of March, 1998 (the "Effective
Date"), by and between Pharmaceutical Resources, Inc., a New Jersey corporation,
with offices at One Ram Ridge Road, Spring Valley, New York, United States of
America, 10977 (hereinafter referred to as "Resources") and Genpharm Inc., an
Ontario corporation, with offices at 85 Advance Road, Etobicoke, Ontario, M8Z
2S6, (hereinafter referred to as "Genpharm").
R E C I T A L S
WHEREAS Genpharm and its Affiliates (as hereafter defined) are engaged in
research, development, manufacture and distribution of pharmaceutical products
and have submitted to the United States Food and Drug Administration abbreviated
new drug applications (and/or have compiled or intend to compile data for
submission of abbreviated new drug applications) for certain of the Products (as
hereafter defined);
AND WHEREAS, as between Genpharm and its Affiliates, Genpharm has the
exclusive right to supply, market and distribute such Products in North America,
which right permits Genpharm to appoint distributors, exclusive or otherwise, in
respect of all or any of the Products for the whole or any part of such
territory;
AND WHEREAS Resources and its Affiliate are engaged in, inter alia,
manufacturing, marketing and distributing generic pharmaceutical products
throughout the Territory (as hereafter defined) and own and operate FDA approved
manufacturing facilities and possess qualified marketing and distribution
systems and organizations to enable it to repackage bulk Products and
effectively promote, market and distribute such Products throughout the
Territory;
AND WHEREAS Genpharm desires to grant to Resources the exclusive right to
purchase, market, promote and distribute the Products in the Territory and
Resources desires to accept and exercise such right, all subject to the terms
and conditions set forth in this agreement;
AND WHEREAS the parties wish to enter into this agreement to set forth
herein the arrangements regarding their respective rights and obligations with
respect to the development, registration, supply and distribution of the
Products for the Territory;
NOW THEREFORE the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATION
1.1 Definitions: Wherever used in this agreement the words and terms,
"Affiliate", "ANDA", "Applicable Percentage", "Approved Listing Fee", "business
day", "CGMP", "Competing Product", "Confidential Information", "Deductible
Listing Fee", "Development Cost", "Excess Reprocurement Costs", "FDA", "Gross
Profits", "Gross Sales", "Manufacturer", "Manufacturing Cost","Marketing Costs",
"Net Sales", "Person", "Plant","Products", "Product Approval", "Product
Information", "Product Manufacturing Requirements", "Recall", "Recall Expenses",
"Repackaging Expenses", "Specifications", "Stock Purchase Agreement",
"Territory", "Third Party Licensor", "Third Party Royalty", "Transfer Price",
"Threshold Amount" and "Unit" shall have the respective meanings set out in
Schedule "A" annexed hereto. In addition, words and expressions parenthetically
defined elsewhere in this agreement shall, throughout this agreement, have the
meanings therein provided. Defined terms shall be used in the singular or in the
plural, as sense shall require.
1.2 Headings: The headings of all Articles and Sections hereof are inserted for
convenience of reference only, are not intended to be full or accurate
descriptions of the contents hereof and shall not be considered part of this
agreement or affect the construction or interpretation of this agreement.
1.3 No Strict Construction: The language used in this agreement shall be deemed
to be the language chosen by the parties hereto to express their mutual intent
and no rule of strict construction against any party shall apply to any term or
condition of this agreement.
ARTICLE 2
EXCLUSIVE APPOINTMENT
2.1 Exclusive Distributor: Subject to the provisions of this agreement and to
the receipt by Genpharm or its Affiliate, as the case may be, of a Product
Approval for such Product, Genpharm hereby appoints Resources as the sole and
exclusive distributor of the Products for the Territory and Resources hereby
accepts such appointment and agrees to act as such sole distributor upon such
terms and conditions. Except for its right to delegate to an Affiliate of
Resources any duty, obligation or right hereunder in relation to a Product in
accordance with the provisions of Section 14.8 below (but only for so long as
such Person remains an Affiliate of Resources), Resources shall not delegate to
any Person any duty or obligation of Resources hereunder in relation to a
Product without the prior written consent of Genpharm (which consent may be
withheld in the sole discretion of Genpharm).
2.2 Additional Products: The parties may, by mutual agreement, add any other
generic pharmaceutical product to or delete a Product from this agreement and,
in such event, the parties shall date and initial such alteration on Schedule
"B" for purposes of identification and thereafter the terms of this agreement
shall govern the products so added and shall terminate in respect of the
products so deleted (except to the extent of continuing obligations following
termination as hereinafter contemplated). The foregoing right to terminate this
agreement as regards a specific Product by mutual agreement is in addition to
and not in substitution or derogation of any right of a party hereunder to
unilaterally terminate this agreement as regards any Product pursuant to Section
3.4 or 3.7 or Article 10 hereof. The foregoing right to add any product by
mutual agreement to Schedule "B" is in addition to and not in substitution or
derogation of the rights and obligations contemplated in Sections 3.4 or 3.10
hereof.
2.3 Nature of Relationship: This agreement does not constitute or create (and
the parties do not intend to create hereby) a joint venture, pooling
arrangement, partnership, or formal business organization of any kind between
and among any of the parties, and the rights and obligations of the parties
shall be only those expressly set forth herein. The relationship hereby
established between Resources and Genpharm is solely that of buyer and seller,
each is an independent contractor engaged in the operation of its own respective
business. Neither party shall be considered to be an agent of the other for any
purpose whatsoever. Each party shall be responsible for providing its own
personnel and workers' compensation, medical coverage or similar benefits, any
life, disability or other insurance protection; and shall be solely responsible
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for the payment of social security benefits, unemployment insurance, pension
benefits, withholding any required amounts for income and other
employment-related taxes and benefits of its own employees, and shall make its
own arrangements for injury, illness or other insurance coverage to protect
itself; its Affiliates, its subcontractors and personnel from any damages, loss
and/or liability arising out of the performance of this agreement. Neither party
has the power or authority to act for, represent, or bind the other (or its
Affiliates) in any manner.
2.4 Territorial and Product Restrictions Applicable to Resources: During the
term of this agreement applicable to a Product neither Resources nor any of its
Affiliates will directly or indirectly sell such Product outside of the
Territory or to any Person in the Territory where it knows or has reason to
believe that such Product will be resold by such Person outside of the
Territory. In the event the foregoing provision is or becomes unenforceable or
is unlawful in the Territory, then it shall be deemed replaced by the most
restrictive provision on marketing or sale of the Product outside of the
Territory as shall be lawful and enforceable in the Territory. If Genpharm
establishes that one of Resources' customers or a customer of any of its
Affiliates is exporting such Product out of the Territory, Resources shall (and
shall cause its Affiliates to) either cease to supply such customer or obtain
(and enforce, if necessary) an undertaking from such customer not to sell the
Product outside of the Territory (unless Resources [or its Affiliate, as the
case may be] is precluded from taking such action under applicable law). In
addition, Resources shall not (and it shall not authorize, permit or suffer any
of its Affiliates to), directly or indirectly, manufacture, purchase, sell or
distribute a Competing Product in the Territory at any time during the term of
this agreement applicable to a Product (including, for greater certainty, prior
to receipt by Genpharm or any of its Affiliate of a Product Approval for such
Product).
2.5 Product Restrictions Applicable to Genpharm: Genpharm agrees that, during
the term of this agreement applicable to a Product, neither it nor any of its
Affiliates shall, directly or indirectly, sell such Product in the Territory or
to any Person outside of the Territory where it knows or has reason to believe
that such Product will be resold by such Person in the Territory. In the event
the foregoing provision is or becomes unenforceable or unlawful in the Territory
it shall be deemed to be replaced by the most restrictive provision on marketing
or sale of the Product in the Territory as shall be lawful or enforceable in the
Territory. If Resources notifies Genpharm that one of its customers (or a
customer of its Affiliate) is marketing the Product in the Territory, Genpharm
shall (and shall cause its Affiliates to) either cease to supply such customer
or obtain (and enforce if necessary) an undertaking from such customer not to
market such Product in the Territory (unless Genpharm [or its Affiliate, as the
case may be] is precluded from taking such action under applicable law).
Genpharm further agrees that, so long as Merck KGaA and its Affiliates hold
collectively at least 33-1/3% of the issued and outstanding shares of Resources'
common stock, neither Genpharm nor any of its Affiliates will sell, market or
distribute in the Territory any generic pharmaceutical product which has the
same active ingredient, same strengths, is in the same dosage form and is for
the same indication as a generic pharmaceutical product currently marketed and
distributed by Resources and its Affiliates in the Territory as described in
Schedule "C" annexed hereto so long as Resources or any of its Affiliates are
actively marketing and selling such Product in the Territory; provided that
where a product identified on Schedule "C" is one in respect of which Genpharm
or any of its Affiliates holds the ANDA approval and is being distributed by
Resources and its Affiliates in the Territory pursuant to an agreement with
Genpharm or any of its Affiliates then Genpharm and its Affiliates shall be free
to sell, market and distribute such product in the Territory at such time as its
agreement with Resources and its Affiliates terminates in respect of such
product or Resources and/or its Affiliates' exclusive right to distribute such
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product by or on behalf of Genpharm and its Affiliates pursuant to such
agreement is terminated in accordance with the provisions thereof.
ARTICLE 3
PRODUCT DEVELOPMENT AND REGISTRATION
3.1 Obligations to Develop and Register Products: Subject to Section 3.4 below,
Genpharm shall, or shall cause its Affiliates to, use commercially reasonable
best efforts to develop the Products for the Territory in such order of priority
as is determined by Genpharm and to submit ANDA's to the FDA to obtain Product
Approvals for such Products as soon as reasonably practicable following
successful development, provided that Genpharm shall have the right, in its
discretion, to alter the priority to be given to development and/or registration
of the Products and nothing herein contained shall constitute a guarantee or
warranty of Genpharm that development of any Product will be commenced or
continued, that a submission for a Product Approval for such Product will be
filed within any specific time period or that a Product Approval for any Product
will be obtained. Notwithstanding the foregoing, Genpharm and its Affiliate may,
at their option, in lieu of independently developing a Product (directly or
through any other Affiliate) obtain a licence of the Product Information of any
Person who is not an Affiliate of Merck KGaA (the "Third Party Licensor") and
submit an ANDA for such Product based upon such licenced Product Information. It
is understood and agreed by Resources that where Genpharm or its Affiliate
licences its Product Information for a Product from a Third Party Licensor it
may be required to pay to the Third Party Licensor a royalty or other
compensation (including, without limitation, profit sharing) for its right to
use such Product Information (the "Third Party Royalty"). Genpharm shall
hereafter advise Resources of its intention or the intention of its Affiliate to
licence any Product Information in relation to a Product for the Territory from
a Third Party Licensor and shall consult with Resources prior to entering into
any agreement with such Third Party Licensor to licence such Product Information
so that Resources shall be fully informed as to the nature and terms of such
relationship.
3.2 Development Responsibility: Subject to Section 3.4 below, it shall be the
responsibility of Genpharm and/or its Affiliates, (i) to complete the
development of the Products in accordance with the applicable requirements of
the FDA, (ii) where such development has been successfully completed, to file an
ANDA for the Product with the FDA and, (iii) where an ANDA for such Product has
been submitted, to use commercially reasonable efforts to ensure that it
receives a Product Approval for such Product from the FDA on the earliest
possible schedule given the FDA process. It is understood and agreed that the
Product Approval granted in respect of a Product will be registered in
Genpharm's name or the name of one of its Affiliates.
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3.3 Status Reporting: Genpharm shall from time to time:
(i) advise Resources in writing of any unforeseen material
problems or delays encountered or additional requirements
imposed upon Genpharm or its Affiliate, as the case may be,
since the date of its last report in connection with the
development and/or registration of a Product (and of which
Resources has not been otherwise advised pursuant to (ii)
below); and
(ii) provide Resources with such information as Resources may
reasonably request in writing from time to time with respect
to the status of the development and/or registration of a
particular Product.
3.4 Right to Terminate Obligations Prior to Product Approval: Notwithstanding
Section 3.1 hereof or any other provision contained in this agreement but
subject to the limitations set forth in the final sentence of this Section,
Genpharm shall have the right, upon written notice to Resources, to immediately
terminate its obligations hereunder to develop, and/or seek a Product Approval
for a Product or Products if, in the reasonable opinion of Genpharm, it is not
commercially reasonable to develop such Product or to seek to obtain or maintain
a Product Approval therefor, including, by way of illustration only and without
limiting the generality of the foregoing, by reason of:
(i) technical factors relating to the development of the Product
including, without limitation, the failure of clinical
trials/bioavailability studies previously conducted by
Genpharm or its Affiliate, as the case may be, in relation to
the Territory or elsewhere or the introduction by the FDA of
new technical requirements, in each case, which materially
increase the cost of developing the Product or of obtaining or
maintaining a Product Approval therefore;
(ii) withdrawal from the market of the branded counterpart of the
Product in the Territory;
(iii) the existence of contra indications relating to the Product
not currently known which may adversely affect the
marketability of such Product;
(iv) the high cost of manufacturing the Product;
(v) the shortage of supply of the active ingredient or other
components essential to the manufacture of such Product;
(vi) the presence or anticipated presence on the market of
Competing Products in the Territory at the time when a Product
Approval for such Product is expected to be obtained or within
a reasonable time period thereafter which may affect the
potential selling price of the Product or Resources' potential
share of the market having regard for the volume required to
obtain reasonable economies of scale for Genpharm or the
Manufacturer;
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(vii) the introduction into the Territory of new branded products
which materially adversely affect or may potentially
materially adversely affect the market for the Product in the
Territory;
(viii) the introduction into the Territory or the anticipated
introduction into the Territory of a product which has the
same active ingredient and is for the same indication as a
Product but which is in a different dosage form and which
materially adversely affects or may materially adversely
affect the market for such Product in the Territory; or
(ix) the institution of any suit, action or other legal proceeding
against Genpharm or its Affiliates, as the case may be, or
against any other Person alleging that the development of the
Product as contemplated by Genpharm or the Affiliate in
question breaches the proprietary rights of any Person which
proceeding, in the reasonable opinion of Genpharm, could delay
the ability of Genpharm or such Affiliate to obtain a Product
Approval for the Product to a point in time where marketing
the Product will no longer be economically feasible and/or the
costs of litigating, even if successful, will materially
adversely affect the potential economic benefit which Genpharm
or its Affiliate may derive through the distribution of the
Product pursuant to this agreement or could result in the
liability of Genpharm or such Affiliate for material damages
or affect their right to develop, manufacture or sell such
Product.
Upon the exercise of such right by Genpharm this agreement, except Sections 3.5
and 3.6 below, shall terminate in respect of the Product in question. Provided
that if Genpharm exercises the rights hereunder to terminate this agreement as
regards more than 10 of the Products to which this agreement applies on the
Effective Date then it shall, upon any further exercise of such right pursuant
to this Section, substitute for the Product in respect of which this agreement
is to be terminated (the "Replaced Product") a generic pharmaceutical product
which in the opinion of Genpharm, acting reasonably, is a commercially
reasonable substitute (the "Substitute Product") for such Replaced Product.
Genpharm shall consult with Resources prior to selecting the Substitute Product
and shall advise Resources in writing of the identity of the Substitute Product
within 30 days of the exercise of its right of termination as regards the
Replaced Product pursuant to this Section, whereupon Schedule "B" hereto shall
be amended by the addition of the Substitute Product, which addition shall be
dated and initialled by Genpharm and Resources for purposes of identification
and thereafter this agreement shall apply to the Substitute Product. Genpharm
acknowledges and agrees that once a clinical trial/bioavailability study has
been successfully completed with respect to a Product Genpharm shall be
obligated to file (or cause its Affiliate to file) an ANDA with the FDA for such
Product unless Resources consents to Genpharm (and its Affiliates) not filing
such an ANDA, which consent of Resources shall not be unreasonably withheld or
unduly delayed.
3.5 Licence of Product Information to Resources:
(a) If Genpharm exercises its right pursuant to Section 3.4 for any reason
(other than pursuant to Paragraphs 3.4 (iii) or (ix) above) to
terminate this agreement in respect of a Product, Resources shall have
the right for a period of 20 business days following receipt by it of
the notice contemplated in Section 3.4 hereof to require Genpharm to
grant (or cause the applicable Affiliate to grant) to Resources an
exclusive licence upon the terms herein contemplated to use the Product
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Information to obtain a Product Approval for such Product in the
Territory and to market and sell such Product in the Territory, the
right of Resources hereunder to be exercised by notice in writing to
Genpharm (which notice, to be effective, shall reference this Section,
shall specify the Product to be licenced and shall be received by
Genpharm within such 20 business day period). The rights of Resources
and the obligations of Genpharm pursuant to this Subsection (a) shall
not apply to any Products in respect of which Genpharm (or the
applicable Affiliate, as the case may be) licenses Product Information
from a Third Party Licensor if the agreement with such Third Party
Licensor prohibits Genpharm (or such Affiliate) from so licensing such
Product Information to Resources (whether absolutely or without the
consent of the Third Party Licensor, which consent Genpharm (or such
Affiliate) has been unable to obtain notwithstanding its use of
reasonable commercial efforts to obtain such consent).
(b) Following the proper exercise by Resources of its rights pursuant to
Subsection (a) above, Resources and Genpharm (on its own behalf or on
behalf of its applicable Affiliate, as the case may be) shall negotiate
in good faith the provisions of an exclusive licence agreement in
relation to such Product Information and the Product, which agreement
shall be executed and delivered by the licensor and Resources within 60
days of the receipt by Genpharm of the notice contemplated in
Subsection (a) above or within 15 days of the final determination of
the provisions of such licence agreement as contemplated in Subsection
(c) below. Such agreement shall be prepared initially by Genpharm and
shall be submitted by Genpharm to Resources within 30 days of its
receipt of such notice. Such agreement shall provide that:
(i) Resources shall not have the right to sublicence any Product
Information or to authorize any other Person to use Product
Information for any purpose (other than to a Person who is
then and who continues thereafter to be an Affiliate of
Resources and who agrees to be bound by the provisions of the
licence agreement);
(ii) all information, tests and studies not contained in the
Product Information and which are required by Resources to
obtain a Product Approval for such Product shall be developed
and conducted by Resources and/or its Affiliate at their sole
cost and expense;
(iii) the licensor will answer Resources' reasonable inquiries
concerning such Product Information so as to enable Resources
to obtain a Product Approval for the Product in question but
it shall not be required to compile or develop information
which is not already available to or possessed by it;
(iv) Resources will not use the Product Information licenced to it
pursuant hereto to obtain a regulatory licence or approval to
market the Product outside of the Territory nor will it sell
such Product outside of the Territory or to any Person in the
Territory where Resources knows or has reason to believe such
Person will resell the same outside of the Territory (and the
agreement will contain restrictions similar to those contained
in Section 2.4 hereof);
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(v) Resources will pay to the licensor (and to Genpharm, where
Genpharm is not the licensor, in the proportions directed by
Genpharm) an aggregate royalty equal to [****] of the Gross
Profits derived from Net Sales of the licensed Product made by
or on behalf of Resources or its Affiliates in the Territory
(determined in the manner contemplated in this agreement with
the proviso that Resources or its Affiliates manufacturing
cost of such product calculated in the manner contemplated in
the definition "Manufacturing Cost" herein contemplated shall
be treated as the Transfer Price hereunder), provided that no
royalty shall be payable on Gross Profits earned from Net
Sales of the licensed Product until such Gross Profits exceed
an amount equal to the reasonable Development Costs incurred
by Resources and its Affiliates to develop such Product and to
obtain the Product Approval for such Product.
(c) Such agreement shall also contain such other terms and provisions
customarily included in license agreements for product information as
Genpharm and Resources may mutually agree upon and in the event of a
dispute between such parties as to the inclusion of any provision in
such agreement or the manner of expressing any concept, such dispute
shall be resolved through arbitration to be conducted in accordance
with the provisions of Article 13 hereof.
3.6 Withdrawal from Market: If Genpharm terminates this agreement with respect
to a Product pursuant to Section 3.4 hereof and Resources does not exercise its
rights pursuant to Section 3.5 in respect of such Product then neither Genpharm
nor its Affiliate will seek a Product Approval for such Product for a period of
18 months from the date upon which this agreement terminates in respect of such
Product without offering Resources the right to reinstate this agreement as
regards such Product.
3.7 Election of Resources:
(a) At least 90 days prior to Genpharm commencing to manufacture the
validation batches of the Product required to obtain the Product
Approval for such Product, Genpharm shall notify Resources in writing
of its estimated Transfer Price of such Product (it being acknowledged
and agreed by Resources that Genpharm shall have no obligation to
manufacture or cause its Affiliates to manufacture the validation
batches until such time as Resources has waived in writing its rights
with respect to such Product pursuant to Subsection (b) below and
submitted to Genpharm [or such right has expired and Resources is
deemed to have submitted to Genpharm pursuant to Subsection (b) below]
a purchase order for the Product to be so manufactured in such
validation batches).
(b) Notwithstanding the provisions of 2.1 hereof, within 30 days of the
receipt by Resources of the notice contemplated in Subsection (a)
above, Resources shall have the right, to be exercised by written
notice to Genpharm, to immediately terminate its obligations to
distribute such Product hereunder if, in the reasonable opinion of
Resources:
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(i) it is not commercially reasonable to sell and distribute such
Product by reason of those factors, events or circumstances
contemplated in clauses 3.4 (ii), (iii), (vii) or (viii); or
(ii) the Gross Profit which may be earned by Resources and its
Affiliates pursuant to this agreement from the distribution of
such Product will be less than [****] of Gross Sales having
regard to the estimated Transfer Price of the Product and
taking into account the presence or anticipated presence in
the market of Competing Products at the time when the Product
Approval for such Product is expected to be obtained by
Genpharm or its Affiliate or within a reasonable time period
thereafter which may affect the potential selling price of the
Product or Resources' potential share of the market;
Upon the exercise of such right by Resources, this agreement, except
Subsection (c) below, shall terminate in respect of the Product in
question. In the event that Resources does not exercise such right of
termination within the time and in the manner hereinbefore
contemplated, Resources shall be deemed to have placed a purchase order
with Genpharm for the products manufactured as part of the validation
batches, which products shall be made available to Resources for pickup
as contemplated in Section 5.3 hereof as soon as possible following
receipt by Genpharm or its Affiliates of the Product Approval
therefore.
(c) If Resources exercises the right pursuant to Subsection (b) above to
terminate this agreement in respect of a Product and within 30 days of
Genpharm or its Affiliate receiving a Product Approval for such Product
Genpharm, despite reasonable commercial efforts in that regard, remains
unable to engage any other Person reasonably acceptable to Genpharm to
exclusively distribute such Product in the Territory on its behalf upon
terms and provisions at least as favourable to Genpharm as those
contained herein, Resources shall pay to Genpharm [****] of the
reasonable Development Costs incurred by Genpharm and its Affiliates to
develop the Product and to obtain a Product Approval for such Product.
In addition, Resources shall not, and shall not authorize, permit or
suffer any of its Affiliates to sell, market or distribute a Competing
Product in the Territory for a period of 3 years from the date upon
which Resources shall have elected to terminate this agreement in
respect of such Product.
3.8 Representation and Warranties re Status:
(a) Resources represents and warrants to Genpharm that neither it nor any
of its Affiliates is prohibited by any law, rules or regulation or by
any order, directive or policy from selling any of the Products
(assuming that the Product Approvals have been obtained) or other
pharmaceutical products within the Territory and that neither Resources
nor any of its Affiliates is a Person who is listed by a United States
federal agency as debarred, suspended, proposed for debarment or
otherwise ineligible for federal programs in the United States or other
jurisdictions within the Territory (an "Ineligible Person").
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(b) Genpharm represents and warrants to Resources that neither it nor any
of its Affiliates who have or are developing a Product for the
Territory or who is or will be a Manufacturer thereof is currently
prohibited by any law, rule or regulation or by any order, directive or
policy from selling the Products within the Territory (on the
assumption that it holds whatever licenses are required for a foreign
corporation to carry on business generally within such jurisdiction and
holds Product Approvals for such Products) and that neither Genpharm
nor any such Affiliate is an Ineligible Person.
3.9 Expenses of Patent Challenges: Resources shall pay to Genpharm, within 30
days of the receipt of an invoice therefor (which invoice shall be accompanied
with a copy of the third party invoice evidencing the expense in question),
[****] of the legal fees and disbursements and other reasonable expenses
actually incurred by Genpharm and its Affiliates to investigate and defend the
claim of any Person (hereafter referred to as a "Claim") that the Product as
developed by Genpharm (and/or its Affiliates) infringes any patent or other
proprietary right of such Person enforceable in the Territory (such legal fees,
disbursements and other expenses incurred by Genpharm and its Affiliates to
investigate and defend a Claim being herein referred to as the "Patent Defence
Expenses"). If the Patent Defence Expenses incurred by Genpharm and its
Affiliates in respect of a Product exceeds [****] then, at any time thereafter,
Resources shall have the right terminate its obligation to fund [****] of any
future Patent Defence Expenses incurred by Genpharm and its Affiliates with
respect to such Product by notice in writing to Genpharm (a "Notice"), which
Notice shall be effective upon its receipt by Genpharm and shall terminate the
obligation of Resources to fund any Patent Defence Expenses incurred by Genpharm
and its Affiliates with respect to such Product after the date upon which such
Notice is received by Genpharm but, for greater certainty, Resources shall
remain liable to Genpharm for [****] of the Patent Defence Expenses incurred by
Genpharm and its Affiliates to and including the date upon which such Notice is
so received by Genpharm. Termination by Resources hereunder of its obligation to
fund Patent Defence Expenses incurred by Genpharm and its Affiliates in respect
of one or more Products shall not affect the obligation of Resources to fund
Patent Defence Expenses incurred by Genpharm and its Affiliates with respect to
other Products (subject to Resources' rights to terminate its obligations to
fund such expenses with respect to any other Product or Products in accordance
with the provisions hereof). The obligation of Resources to fund Patent Defence
Expenses incurred in respect of a Product shall terminate upon termination of
this agreement in respect of such Product provided that Resources shall remain
liable to Genpharm for the Patent Defence Expenses relating to such Product
incurred prior to such date of termination (to the extent it is otherwise liable
therefor), which liability shall survive the termination of this agreement. Upon
a written request of Resources Genpharm will authorize the lawyer or other
representative of Genpharm or its applicable Affiliate engaged in the defense or
investigation of such Claim to discuss with and disclose to Resources possible
future Patent Defense Expenses to be incurred in the investigation or defense of
the Claim.
3.10 Right of First Refusal - Development: Resources acknowledges and agrees on
its own behalf and on behalf of its Affiliates that they shall not commence to
develop any generic pharmaceutical product for the Territory not under active
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development by Resources or any of its Affiliates on the Effective Date without
first offering to Genpharm, by notice in writing (which notice shall specify in
respect of such product, its dosage form, indications and strengths) the right
to develop such product (either itself or through one of its Affiliates) as an
additional product to which this agreement shall apply. Genpharm shall, within
45 days of the receipt of such notice, notify Resources whether or not it wishes
to add such product to this agreement (and, in the absence of any such reply,
Genpharm shall be deemed to have declined such offer). If Genpharm declines or
is deemed to have declined such offer Resources and Genpharm (and their
respective Affiliates) shall each be free to develop such product for the
Territory free of any rights of the other. Subject to the final sentence of this
Section, if Genpharm accepts such offer within the time and in the manner herein
provided such product shall be added to Schedule "B" hereto as a product to be
developed for the Territory by Genpharm and/or its Affiliate (which addition
shall be dated and initialled by the parties for purposes of identification) and
thereafter the terms of this agreement shall govern such product. Provided that
from and after the date, if ever, upon which Merck KGaA and its Affiliates hold
collectively less than 33-1/3% of the issued and outstanding shares of
Resources' common stock, Resources shall have no further obligation pursuant to
this section to offer to Genpharm the first right to develop products which
Resources and its Affiliates proposes to develop as herein contemplated. Where
Resources' proposes to develop such product and obtain an ANDA approval therefor
from the FDA based upon a licence of Product Information from a third party then
any exercise by Genpharm of its right pursuant to this Section to have such
product added to this agreement shall be null and void (and such product shall
not be added to this agreement with each such party being free to develop such
product independently as hereinbefore contemplated) if Resources, within 60 days
of the exercise by Genpharm of such right hereunder, can provide reasonable
evidence that Genpharm and its Affiliates do not have the ability to develop and
have such product available to market within a reasonably comparative time frame
to that within which Resources could reasonably develop and have such product
available to market based upon the third party's licenced information.
ARTICLE 4
MANUFACTURE AND SUPPLY OF PRODUCT
4.1 Exclusive Supplier: Subject to receipt by Genpharm or its Affiliate of a
Product Approval for a Product Genpharm shall use commercially reasonable
efforts to manufacture (or cause to be manufactured) and supply to Resources, in
accordance with the terms and conditions set forth herein and in a timely
fashion, reasonable quantities of such Product. Resources shall order from
Genpharm all of its and its Affiliate's requirements of the Product for the
Territory in accordance with the terms and conditions set forth herein.
4.2 Manufacturing Responsibilities: Each Product supplied by Genpharm hereunder
shall be manufactured (which shall include, without limitation, all testing,
bulk packaging and labelling) in an FDA approved facility and in accordance with
the following (collectively, the "Product Manufacturing Requirements"), (i) the
Specifications for the Product, (ii) applicable cGMP and good laboratory
practices and (iii) all other applicable rules, regulations and requirements of
the FDA relative to the manufacture of such Product.
4.3 Storage of Products Pending Shipment: The finished bulk Product to be made
available to Resources hereunder shall be stored by Genpharm and/or the
Manufacturer, pending shipment, in accordance with the Specifications for such
Product and applicable cGMP.
11
4.4 Quality Control and Assurances and Release Documentation: Genpharm shall or,
shall cause the Manufacturer to, perform all in-process quality control tests
and quality assurance reviews on the Product as required by the Product
Manufacturing Requirements and shall, or shall cause the Manufacturer to,
certify in writing that each batch of the Product delivered to Resources was
manufactured in strict conformity with the Product Manufacturing Requirements
and the other terms of this agreement.
4.5 Product Warranty: Genpharm warrants that all Product supplied by it to
Resources pursuant to this agreement shall be manufactured, packaged, tested,
stored and handled in accordance with the Product Manufacturing Requirements and
that at the time of the delivery of such Product to the carrier at Genpharm's or
the Manufacturer's Plant, as the case may be, such Product: (i) will not be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act ("Act"), as amended, or within the meaning of any applicable state
or municipal law in which the definitions of adulteration and misbranding are
substantially the same as those contained in the Act, as such Act and such laws
are constituted and effective at the time of delivery and (ii) will not be an
article which may not, under the provisions of Sections 404 and 505 of such Act,
be introduced into interstate commerce. NEITHER GENPHARM NOR THE MANUFACTURER
MAKES ANY REPRESENTATION THAT THE PRODUCT IS USEFUL FOR THE INTENDED PURPOSE OR
THAT IT IS FREE FROM INHERENT SIDE EFFECTS EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT.
ARTICLE 5
PRODUCTION FORECASTS, ORDERS AND DELIVERIES
5.1 Forecasts and Commitments: To assist Genpharm to schedule production of the
Products, Resources shall provide to Genpharm (or as it directs) for each
Product to be manufactured and supplied to Resources hereunder, quarterly (at
least 45 days in advance of the commencement of the first calendar month
forecasted thereunder), a 12 month rolling forecast of Resources' estimated
requirements of the Product, which forecast shall represent a commitment of
Resources to purchase the quantity of Product projected for the first month
thereunder and a commitment, subject to a 20% variance, to purchase the quantity
of Product forecasted for the second and third months forecasted thereunder.
Subject to the foregoing, all forecasts are estimates only and Resources shall
only be bound to purchase the Product pursuant to purchase orders submitted, or
deemed hereunder to be submitted, by it to Genpharm (or to such person as
Genpharm may direct). All purchase orders for a Product shall specify the
delivery date therefor, which delivery date shall be no sooner than 16 weeks
following the receipt of such order by Genpharm or such other period of time as
Genpharm shall specify in writing to Resources within a reasonable period of
time following receipt by Genpharm or the Manufacturer of the Product Approval
for such Product. Resources shall deliver the first such forecast within a
reasonable period of time following receipt of such Product Approval by Genpharm
or the Manufacturer and shall deliver the updated and extended forecasts every 3
months thereafter.
5.2 Purchase Orders: All orders for Product shall be placed using Resources'
standard form of purchase order and shall be invoiced using Genpharm's standard
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form of invoice. All purchase orders submitted by Resources shall contemplate
the purchase of Product in minimum batch sizes as contemplated in the applicable
Product Approval or multiples thereof (unless Genpharm agrees in writing to
smaller quantities [either generally or in respect of any particular purchase
order]) and shall specify, amongst other things, the required delivery date. In
the event of any conflict between the terms of any purchase order and the terms
of any invoice related thereto, the terms of the purchase order shall govern. In
the event of any conflict between the terms of any purchase order and the terms
of this agreement, the terms of this agreement shall govern (unless the parties
shall have mutually agreed to the contrary in writing in respect of a particular
instance).
5.3 Delivery of Product:
(a) Products shall be made available to Resources for pickup in bulk
containers (where applicable) at Genpharm's or the Manufacturer's
Plant, as the case may be. Resources shall arrange for shipping and/or
transportation of the Products from such Plant to Resources' Spring
Valley, New York facility and pay all shipping and related costs,
including insurance, and any customs duties and other taxes imposed on
the importation of the Product into the Territory. Genpharm shall (or
shall cause the Manufacturer to) promptly notify Resources by fax that
any order (or part thereof) is available for pick-up at its or at such
Manufacturer's Plant (this notice shall hereafter be referred to as the
"Availability Notice"). Resources shall use reasonable commercial
efforts to pick up the Products that are the subject of an Availability
Notice within 10 business days of receipt of the Availability Notice;
provided that, if such pickup has not occurred on or prior to the
expiry of such 10 day period, Resources shall, for purposes of its
payment obligations to Genpharm pursuant to Sections 6.1 and 6.2 below,
be deemed to have picked up the Products which are the subject of the
Availability Notice on the last business day of such 10 day period. If
the Products in question have not been picked up by or on behalf of
Resources within 20 business days of an Availability Notice, Genpharm
may, but shall not be obligated to, cause the Products to be delivered
to Resources' Spring Valley, New York, facility at Resources' sole cost
and expense and risk of loss and title to the Products shall pass to
Resources upon pickup of the Products at Genpharm's or such
Manufacturer's Plant, as the case may be, in the same manner as if the
pickup had been effected by Resources itself, provided that Genpharm
shall provide for the Products to be insured during transit in a
commercially reasonable manner at Resources' sole cost and expense.
(b) Genpharm shall, or shall cause the Manufacturer to, supply to Resources
all documentation necessary to export such Product from the
jurisdiction where its Plant is located and all documentation required
by Resources to import such Product into the Territory to the extent
that same is available to Genpharm (or such Manufacturer) or is
reasonably capable of being generated by it.
(c) Risk of loss and title to the Products shall pass to Resources upon
pickup of the Product by, on behalf of, or for the account of Resources
at Genpharm's or such Manufacturer's Plant as aforesaid.
(d) Products supplied by Genpharm hereunder shall have a minimum shelf life
of 20 months which shall run from the date that the Availability Notice
in respect of such Product is received by Resources.
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5.4 Cancellation of Order: Notwithstanding anything herein contained, if an
Availability Notice in respect of any Product subject to a purchase order has
not been given within 60 days following the required delivery date hereunder
Resources shall be entitled to cancel such order (or portion thereof in respect
of which no Availability Notice has so been given) by notice in writing to
Genpharm.
5.5 Documentation to Accompany Deliveries: All deliveries of Product by or on
behalf of Genpharm shall be accompanied by all documentation required under
applicable law to import the Product into, and for Resources to offer the
Product for sale in, the Territory including, without limitation, any quality
assurance or quality control audit results and/or certifications that the
Product Approval for the Product have been audited to ensure that any Product
supplied hereunder has been manufactured in conformity with cGMP and applicable
FDA regulations.
5.6 Assistance With Export & Import Laws: Resources and Genpharm shall provide
such commercially reasonable assistance as the other may request relative to the
exportation or importation of Products not expressly provided in this agreement.
ARTICLE 6
PAYMENTS, REPORTS AND AUDIT
6.1 Purchase Price:
(a) The purchase price payable by Resources for Product supplied to it by
or on behalf of Genpharm shall be the aggregate of (i) the Transfer
Price of such Product and (ii) the additional consideration to be paid
to Genpharm pursuant to Section 6.3 hereof in respect of Net Sales of
such Product.
(b) In addition to such purchase price Resources shall pay all applicable
sales tax, use tax, consumption tax, goods and services tax, value
added tax or similar tax, imposts or duties levied upon the sale of the
Product by Genpharm to Resources whether that tax, impost or duty is
levied under the laws of the jurisdiction where the Manufacturer's
Plant is located or the jurisdiction where Resources or Genpharm is
located (or of any state, province, territory or other political
subdivision thereof) and whether it is currently in force or comes into
force after the Effective Date of this agreement.
(c) The Transfer Price shall be invoiced and all payments hereunder shall
be made in U.S. dollars. Any costs or expenses which are to be paid by
Resources hereunder or which were incurred by Genpharm (or a
Manufacturer, as the case may be) in a currency other than U.S. dollars
shall be converted into its U.S. dollar equivalent in accordance with
the usual procedures therefore used by Genpharm or the applicable
Manufacturer in determining its Manufacturing Costs.
6.2 Invoicing and Payment: Genpharm shall invoice Resources for the Transfer
Price of the Product at the time such product is picked up or is deemed to be
picked up by or on behalf of Resources as contemplated in Section 5.3 hereof or
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within a reasonable period of time thereafter. The Transfer Price shall be due
and payable within 45 days following the date of such invoice. Each shipment of
Product to Resources shall constitute a separate sale, obligating Resources to
pay the purchase price therefor, whether such shipment be in whole or only
partial fulfilment of any order.
6.3 Additional Consideration:
(a) As additional consideration for the Products Resources shall pay to
Genpharm the Applicable Percentage of the Gross Profits arising out of
Net Sales in the Territory by Resources or its Affiliates of Product
supplied by or on behalf of Genpharm pursuant hereto, which additional
consideration shall be paid to Genpharm as part of the purchase price
for the Product sold and shall not be treated as a royalty or similar
payment.
(b) The payment to Genpharm of its share of Gross Profits shall be made in
U.S dollars. For the purposes of determining Gross Profits, any
delivery costs or other expenses incurred by Resources which are
relevant to the calculation of Gross Profits and which are payable or
were paid in a currency other than U.S. Dollars shall be converted into
their U.S. dollar equivalent based upon the rate of exchange between
the currency in question and U.S. dollars as reported in the Wall
Street Journal on the 2nd business day preceding the day on which any
such payment on account of Gross Profits is due.
6.4 Payment of Additional Consideration and Accompanying Documentation:
Genpharm's share of Gross Profits shall be paid by Resources to Genpharm
quarterly, within 30 days following the end of each calendar quarter (being the
last day of March, June, August and December in each year) with respect to Net
Sales made by Resources or its Affiliates of such Products during such calendar
quarter. Each such payment shall be accompanied by the following in respect of
each Product supplied by or on behalf of Genpharm:
(a) a sales summary reasonably satisfactory to Genpharm showing all sales
of such Product by Units (sku's) and dollars made by Resources and its
Affiliates during the quarter in question;
(b) a detailed statement showing all returns, adjustments, credits, rebates
and other debits and credits relevant to the calculation of Net Sales
of such Product for the quarter in question together with copies of all
documentation to support allowable deductions used in computing Net
Sales during such quarter;
(c) a detailed statement showing Repackaging Expenses, Recall Expenses and
Excess Reprocurement Costs incurred by Resources and its Affiliates and
duties and taxes recovered by Resources and its Affiliates which are
relevant to the calculation of Gross Profits for the quarter in
question;
(d) a certificate signed by the Chief Financial Officer of Resources
certifying that, to the best of his knowledge, information and belief,
after reasonable investigation, the foregoing statements contemplated
in (a), (b) and (c) above are true and correct and do not omit any
material information required to be provided pursuant to this Section;
and
(e) a summary of the calculation of the Gross Profits payable to Genpharm
on such date.
15
For purposes of this agreement a sale shall be considered to have been made at
the time the Product is shipped by Resources' or its Affiliate's to its
customer. For purposes of computing Net Sales, all sales and other transactions
between Resources and its Affiliates shall be disregarded.
6.5 Additional Information: Resources shall provide to Genpharm and shall cause
its Affiliates to provide to Genpharm, promptly following a request therefor,
such additional information concerning any sales of a specific Product
(including, without limitation, in respect of any sale, the date of the
shipment, the name of the customer, the number of Units of the Product (by sku,
if requested) sold to such customer and the invoice price charged by Resources
or its Affiliates), chargebacks, credits, returns, adjustments and other credits
and debits relevant to the calculation of Net Sales and Gross Profits in respect
of a Product including information relating to Repackaging Expenses, Recall
Expenses and Excess Reprocurement Costs incurred in or applicable to any period
in respect of such Product, as Genpharm may reasonably request. Genpharm shall,
or shall cause the applicable Manufacturer to, provide to Resources, promptly
following a request therefor, such additional information concerning the
calculation of the Transfer Price of Products previously supplied to Resources
hereunder as Resources may reasonably request.
6.6 Interest: All payments to be made to Genpharm under this agreement shall
bear interest from and after the Applicable Day (as that term is defined below)
until paid at the annualized rate equal to the daily (as at the close of
business on each such day) prime rate as quoted from time to time by Citibank
N.A., New York, New York plus 5%, compounded daily. For purposes of this Section
the term "Applicable Day" shall mean:
(i) where the payment is on account of the Transfer Price of a
Product which has not been made on its due date and Resources
has not on 2 or more occasions during the same calendar year
failed to pay a Transfer Price to Genpharm on its due date, 30
days after the due date therefore;
(ii) in any other case, the due date therefore.
6.7 Maintenance of Records: Each of Genpharm and Resources agrees that it shall
keep (and shall cause its Affiliates to keep) complete and accurate books and
records of account containing all information required for the computation and
verification of all amounts on which payments hereunder are based and shall,
upon reasonable written notice from the other, make such records available for
examination by such other party or, at the requesting party's expense, supply
copies of such records to such other party.
6.8 Examination of Records: Each of Genpharm and Resources shall have the right,
upon reasonable written notice to the other, to designate an independent
certified public or chartered accountant (except one to whom the other has a
reasonable objection) to have access during ordinary working hours to such
records as may be necessary to audit the correctness of any invoice, report or
payment made under this agreement. Genpharm and Resources shall provide and
shall cause its Affiliates to provide to the accountant engaged by the other
full and complete access to their pertinent books and records. In the event that
any accountant shall have questions which are not in his judgment answered by
such books and records, the accountant shall have the right to confer with
representatives of the Person whose books and records are under review including
its Chief Financial Officer. If any audit under this Section 6.8 shall reveal a
16
discrepancy by more than 3% of any amount payable hereunder or $10,000.00 US,
whichever is greater, the costs and expenses relating to such
investigation/audit shall be borne by the party creating such discrepancy.
Genpharm and Resources shall each have the right to audit such books and records
of the other pursuant to this Section 6.8 no more often than twice in any
contract year (as hereinafter defined) unless in any of the prior 3 contract
years such investigation revealed a discrepancy by more than 3% or $10,000.00
US, as aforesaid, in which case Genpharm or Resources shall have the right to
audit such books and records of the other 3 times in such contract year. For the
purposes hereof, a contract year shall be a period of 12 months commencing on
the Effective Date of this agreement or on an anniversary thereof. Any Person
whose books and records are to be audited in accordance with the foregoing may,
as a condition to providing any accountant access to its books and records,
require such accountant to execute a reasonable confidentiality agreement.
6.9 Survival of Obligation: The obligation to make the payments and to provide
the reports contemplated in this Article 6 and the rights of Resources and
Genpharm to conduct audits or investigations pursuant to Section 6.8 hereof
shall survive the termination or expiration of this agreement or thereafter and
shall apply to all Products supplied to Resources by or on behalf of Genpharm
pursuant hereto prior to the effective date of the termination or expiration of
this agreement or thereafter notwithstanding that such Product may have been
resold by Resources or its Affiliates to its customers after the termination or
expiration of this agreement. For greater certainty, the parties acknowledge and
agree that Resources shall pay to Genpharm the Applicable Percentage of the
Gross Profit derived from Net Sale of all Products supplied by or on behalf of
Genpharm to Resources pursuant to this agreement irrespective of whether such
Product is resold by Resources or its Affiliate prior to or subsequent to the
termination or expiration of this agreement.
ARTICLE 7
REPACKAGING AND DISTRIBUTION
7.1 Resources' Repackaging Responsibilities:
(a) Resources shall repackage and relabel the Product into finished
labelled Units for sale in the Territory in an FDA approved facility
and shall be solely responsible for the contents of the labels and
artwork on all Units of finished labelled Product sold or otherwise
released by Resources (except for information contained in such labels
which are also contained on the labels of the bulk Product supplied by
or on behalf of Genpharm to Resources pursuant hereto). In repackaging
and relabelling the Product Resources shall comply with (i) the
Specifications for such Product, (ii) applicable FDA cGMP and (iii) all
other applicable rules, regulations and requirements of the FDA and any
other applicable governmental or regulatory bodies, agencies and
officials in the Territory relative to repackaging and labelling of the
Product for sale in the Territory. All labels and all artwork concepts
on all packaging material used by Resources in connection with
relabelling and packaging of a Product shall be subject to the prior
reasonable approval of Genpharm, provided that the approval by Genpharm
17
of any label or artwork concept shall not relieve or otherwise affect
Resources' obligations or responsibilities hereunder in relation to
relabelling and packaging of the Product or arising out of the use of
such labels or packaging material or the release of Product in the
Territory so labelled and packaged (or impose any obligation or
responsibility on Genpharm in connection with such labels or packaging
material or their use or release, as aforesaid, except as expressly
contemplated above with respect to the contents of information
contained on the labels which was provided by or on behalf of
Genpharm).
(b) Genpharm shall, or shall cause the Manufacturer to, supply to Resources
all information and data relating to a Product which it is obligated to
provide to Resources and its Affiliates as a repackager and relabeller
of such Product pursuant to applicable laws. Genpharm shall, or shall
cause the Manufacturer to, deliver to Resources, upon reasonable
request of Resources, a copy of all correspondence which it receives
from or forwards to the FDA or other regulatory authority with respect
to a Product following receipt of its Product Approval therefor
provided that such correspondence does not contain Confidential
Information of Genpharm or such Manufacturer which it desires to
maintain confidential and which it is not obligated by law to disclose
to Resources.
7.2 Resources' Obligation re Marketing: Resources shall use reasonable best
commercial efforts (utilizing its marketing, distribution and management systems
and those of its Affiliate) to develop a market for the Products in the
Territory and to actively and continuously promote the sale of the Products in
the Territory, such efforts shall be not less than those used by Resources and
its Affiliates to promote the sale of other products which they market.
Resources shall be solely responsible for advertising and promotion of the
Product and shall comply with all applicable laws, rules and regulations in that
regard including, without limitation, applicable FDA regulations and guidelines.
7.3 Pricing: Resources shall have sole discretion in setting the price for the
sale of the Products in the Territory, provided that it shall not discount the
price of any Product to enhance the sale of Resources' or any of its Affiliates'
Other Products (as that term is defined below) or use any Product as a loss
leader or incentive to procure the sale of Resources' or any of its Affiliates'
Other Products (including, without limitation, through tied or bundled sales).
Rebate and other discount programs (excluding any pricing programs where the
price of the Product is discounted to enhance the sale of Resources' or any of
its Affiliates' Other Products or where a Product is used as such loss leader or
incentive or to procure the sale of Resources' or its Affiliates' Other
Products) generally available to Resources' or its Affiliates' customers in
connection with the purchase of pharmaceutical products shall not be prohibited
by this Section. Any discounts to a price below what is reasonably necessary to
secure sales of any Product or discounts that are used to secure sale of Other
Products of Resources' or its Affiliate's (through bundled sales or otherwise)
will be fully absorbed by Resources out of its share of Gross Profits in
relation to the Product or will be charged to those Other Products of Resources
18
or its Affiliates that are in the product bundles, as the case may be, and will
not directly or indirectly reduce Genpharm's share of Gross Profits hereunder.
For purposes of this Section 7.3, the term "Other Products" shall mean
pharmaceutical products sold, marketed and distributed by Resources or its
Affiliates other than the Products.
7.4 Storage and Handling by Resources: Resources shall ensure that all Products
made available to it by or on behalf of Genpharm pursuant to this agreement are
transported, received, handled, stored and delivered in accordance with the
Specifications for the Product applicable thereto and applicable cGMP and other
FDA requirements (and the requirements of all other applicable governmental or
regulatory bodies, agencies or affiliates in the Territory) so that such
Products do not become adulterated or otherwise cease to meet their
Specifications as a result of any acts or omissions of Resources, its
Affiliates, and their respective agents, employees, transporters or those for
whom Resources or its Affiliates are responsible.
7.5 Release of Product By Resources: Resources shall conduct or cause to be
conducted such quality control tests as it deems necessary or as are required by
law (including any rules, regulations and requirements of the FDA and the
requirements of all other applicable governmental or regulatory body, agency or
officials in the Territory) prior to sale or other release of a Product in the
Territory.
7.6 Credit Risks: Resources shall assume sole responsibility for all credit
risks and collections of receivables in respect of Products sold by it or its
Affiliates in the Territory and in respect of all dealings between Resources or
its Affiliates and its customers and any third parties from whom Resources
and/or its Affiliates sources any goods and services required by it in
connection with repackaging, labelling, transporting, storing, promoting,
marketing, selling or delivering the Product.
7.7 Repackaging and Marketing Expenses: For greater certainty, Resources
acknowledges and agrees that it shall be solely responsible for all costs and
expenses incurred by it or its Affiliates in connection with relabelling,
packaging, promoting, marketing and selling the Products in the Territory (or
otherwise performing its obligations hereunder) without any right to recover
same directly or indirectly from Genpharm (save and except for partial recovery
of permitted listing fees and other similar payments contemplated in Paragraph
(iv) of the definition "Net Sales" and Repackaging Expenses through the
calculation and sharing of Gross Profits hereunder).
ARTICLE 8
PRODUCT REJECTIONS AND RETURNS
8.1 Product Rejection:
(a) Within 35 days from the date of receipt of each delivery of Product
Resources shall inspect the Product (Resources hereby acknowledging
19
that its failure to inspect shall not release it from the obligations
it would otherwise have had it conducted an inspection as herein
contemplated, or provide it with additional rights). Resources shall
advise Genpharm in writing (a "Rejection Notice") if a shipment of
Product is not in conformity with Genpharm's obligations hereunder or
is otherwise defective, provided, however, that Resources' failure to
advise Genpharm in a timely manner that a shipment of Product does not
conform shall not prejudice Resources' right to reject or return the
Product if the defect or other non-conforming condition which justifies
rejection or return could not have been detected by Resources'
inspection in accordance with cGMP standards. If Resources delivers a
Rejection Notice in respect of all or any part of a shipment of
Product, then Genpharm and Resources shall have 60 days from the date
of Genpharm's receipt of such notice to resolve any dispute regarding
whether all or any part of such shipment of Product fails to conform
with the Product Specifications or is otherwise defective. Disputes
between such parties as to whether all or any part of a shipment
rejected by Resources conforms with Product Specifications not resolved
in the 60 day period shall be resolved by an independent testing
laboratory or a consultant ( if not a laboratory analysis issue), the
cost of which shall be paid by the party least successful in such
dispute.
(b) In the event any Product is appropriately rejected by Resources (being
Product which does not satisfy the Product warranty contemplated in
Section 4.5 as a result of any act by or omission of Genpharm or the
Manufacturer), Genpharm shall replace such Products with conforming
goods within 16 weeks or, if requested by Resources, provide a credit
to Resources for the Transfer Price previously paid by Resources to
Genpharm on account of the Product in question, and for all
transportation and insurance costs, duties, taxes and fees paid or
payable by Resources to import and deliver the Product in question from
Genpharm's or the Manufacturer's Plant, as the case may be, to
Resources' facility in Spring Valley, New York. The credit shall be
provided immediately following the expiry of the period during which
Genpharm may dispute a Rejection Notice as contemplated in Subsection
(a) above (unless the Rejection Notice is disputed by Genpharm, in
which event such credit shall only be given upon resolution of the
dispute). Replacement Products shall be delivered to Resources at no
cost to Resources if Resources has already paid for the rejected
Products and not received a credit therefor, as aforesaid.
(c) For purposes of Section 10.2 hereof, once a Product is rejected by
Resources, Resources' obligation to pay for such Product shall be
suspended until such time as it is determined:
(i) by the independent laboratory or consultant that the Product
should not have been rejected by Resources; or
(ii) by the parties or by any arbitration conducted pursuant hereto
or by a final order of a court of competent jurisdiction
(which is not subject to further appeal) that no act by or
omission of Genpharm or the Manufacturer was the cause of the
problem.
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8.2 Products Returns:
(a) Notwithstanding the provisions of Section 8.1 hereof, Genpharm shall
accept the return of any Product which is returned to Resources by its
customers because of defects (including failure to meet the Product's
Specifications) which are due to any act or omission of Genpharm. In
the event of such an accepted return, Genpharm shall provide a credit
to Resources for the Transfer Price paid by Resources to Genpharm for
the returned Product and all transportation and insurance costs and
custom duties, taxes and fees paid by Resources upon the importation
and delivery of such Product from Genpharm's or the Manufacturer's
Plant, as the case may be, to Resources' facility in Spring Valley, New
York (or an allowance on account thereof) or, at Resources' request,
shall make available to Resources, without charge, replacement Product
within a period of 16 weeks. At Resources' option, and with the consent
of Genpharm, which shall not be unreasonably withheld, Resources may
destroy any Product returned to it.
(b) Any return of Product accepted by Resources from its customers in the
ordinary course of business, including without limitation, Product
returned as defective due to acts or omissions attributable to
Resources, its Affiliates or their respective agents or employees,
shall be treated as returns for the purpose of calculating Net Sales so
that when Resources next calculates the share of Gross Profits payable
to Genpharm in respect of the Product in question, it shall not include
(if the sale of the returned Product was not previously included in a
prior reporting period) or it shall deduct from Net Sales (if
previously included in respect of a prior reporting period), as the
case may be, an amount equal to the Gross Profit attributable to
returned Product, it being the intention of Genpharm and Resources that
no share of Gross Profit shall be paid or payable to Genpharm in
respect of the sale of a returned Product.
(c) In the event any Product is returned to Genpharm by its customers
because the Product is alleged to be defective and Resources believes
that such defect is due to an act or omission of Genpharm or the
Manufacturer, Resources shall notify Genpharm within a reasonable
period of any such return and shall provide or make available to
Genpharm (or, at Genpharm's direction, the Manufacturer) such samples
(if available) and other information concerning the returned Product
available to Resources or its Affiliate so as to allow Genpharm (or
such Manufacturer) to test and evaluate the allegedly defective
Product. Resources shall retain a sufficient number of samples of the
allegedly defective Product so that additional samples are available at
a later date should additional testing be required by an independent
testing laboratory or consultant as contemplated in Subsection (d)
below, or by Resources or by Genpharm (or such Manufacturer) for their
own purposes. If not enough samples exist to be so divided, then
Resources and Genpharm shall confer and reach agreement as to the
handling of any available samples.
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(d) Genpharm shall complete its review and evaluation of the returned
Products (or cause the Manufacturer to complete such review and
evaluation) within 20 business days of receiving the returned Products
from Resources or such longer period of time as may be reasonable in
the circumstances to enable Genpharm (or such Manufacturer) to conduct
or cause to be conducted such tests, studies or investigations (and to
receive the results therefrom) as may be required to confirm or dispute
the existence of the problem or to identify the cause or source
thereof. If Genpharm asserts that the returned Product satisfies the
Product Manufacturing Requirements or that the defect is not due to any
act or omission of Genpharm or the Manufacturer, representative samples
of the Product shall be submitted to a mutually acceptable independent
testing laboratory or consultant (if not a laboratory analysis issue)
for analysis or review, the costs of which shall be paid by the party
against whom the discrepancy is resolved. If it is determined by the
independent laboratory or consultant that the returned Product does not
satisfy the Product warranty contemplated in Section 4.5 and that such
failure is due to any act by or omission of Genpharm or the
Manufacturer, then the replacement Product in respect of the returned
Product shall be delivered to Resources without charge or appropriate
credit (or allowance) shall be given therefor as contemplated in
Subsection 8.2(a) hereof.
8.3 Exclusive Remedy: Subject to Section 9.1 and 9.2 hereof and to its rights,
if any, to recover expenses associated with a Recall as herein contemplated,
Resources hereby acknowledges and agrees (on its own behalf or on behalf of its
Affiliates) that the sole remedy for Genpharm's failure to supply Product in
accordance with the provisions of this agreement (unless such failure is wilful
or due to gross negligence of Genpharm or the Manufacturer, if applicable) shall
be to require Genpharm to replace the Product that does not meet such Product's
warranty hereunder with conforming goods within the time periods hereinbefore
contemplated or to provide Resources with a credit in the amount contemplated in
this Article and that Genpharm (and its Affiliates) shall not be liable to
Resources for consequential or incidental damages including, without limitation,
loss of profits or prospective profits of any kind (and that neither Resources
nor any of its Affiliates shall have any rights or recourse whatsoever against
the Manufacturer, all of which rights and recourses, if any, are herein waived
and released); provided that in the event that Genpharm fails to supply Product
(or replacement Product) to Resources in accordance with its obligations
hereunder and, as a result of such failure, a customer of Resources or its
Affiliate is entitled to cancel an order for such Product from Resources or its
Affiliate and to source a Competing Product from an alternate source (being a
Person other than Resources or any of its Affiliates) and to require Resources
or its Affiliate to pay to such customer the reasonable excess reprocurement
costs incurred by such customer, then Genpharm's responsibility shall be limited
to reimbursing Resources for the Applicable Percentage of such excess
reprocurement costs actually paid or credited by Resources or its Affiliate to
its customer (such costs being the difference between the landed cost to such
customer of such Competing Product over and above the sale price of the Product
in question from Resources to such customer [the "Excess Reprocurement Costs"]).
22
8.4 Return Policy: Other than Product which have been appropriately rejected by
Resources pursuant to Section 8.1 above or returned Product as contemplated in
Subsection 8.2(a) above Resources shall not have the right to return to Genpharm
any Product purchased by it without Genpharm's prior written consent.
8.5 Survival of Provisions: The provisions of this Article 8 shall survive the
termination or expiration of this agreement.
ARTICLE 9
DAMAGES, INDEMNIFICATION AND INSURANCE
9.1 Limitation re Claims: Subject to the limitations set forth in this Section
9.1, Resources and Genpharm covenant and agree to indemnify, save harmless and
compensate the other (and its Affiliates, for whose benefit such other party
shall hold the benefit of this provision in trust) from, against or for, as the
case may be, any and all claims, demands, actions, causes of action, suits,
proceedings, judgements, damages, expenses (including reasonable attorney's fees
and expenses), losses, fines, penalties and other similar assessments, as the
case may be, (the "Damages") relating to or arising out of a breach by Genpharm
or Resources, as the case may be, of any of the representations, warranties,
covenants or agreements herein; provided that, except where the breach arises
out of the representation or warranty being intentionally false or inaccurate or
constitutes a wilful material breach by Genpharm or Resources of its duties or
obligations hereunder or an act or omission constituting gross negligence, the
claim of the aggrieved party for Damages arising out of the breach shall be
limited to claiming the amounts owing or payable to it in accordance with the
provisions of this agreement and any out of pocket costs and expenses (including
amounts paid or payable by it to third parties, other than Excess Reprocurement
Costs [except to the extent contemplated in Section 8.3 hereof]) which it has
incurred and the aggrieved party shall not be entitled to recover from the
defaulting or breaching party any lost profits or consequential or punitive
damages, including loss or damage to its goodwill or reputation.
9.2 Third Party Claims: In the event that the sale or other release in the
Territory by Resources or its Affiliates of any Product supplied by or on behalf
of Genpharm to Resources pursuant to this agreement results in a third party
claim:
(a) to the extent that the Damages awarded or incurred relate to or arise
out of the manufacturing, testing, bulk packaging, labelling (if
applicable), storage or handling of a Product by Genpharm or a
Manufacturer or any other act by or omission of Genpharm, a
Manufacturer or any other Persons for whose acts or omissions they are
responsible at law Genpharm shall be responsible therefor and shall
defend, indemnify and hold harmless Resources and its Affiliate from
and against all such Damages; and
23
(b) to the extent that the Damages awarded or incurred relate to or arise
out of transporting, receiving, manufacturing (if applicable),
repackaging, labelling (if applicable), testing, storage, handling,
use, marketing, distribution, sale or delivery of a Product by
Resources or its Affiliates or any other act by or omission of
Resources, any of its Affiliate or any other Person for whose acts or
omissions they or any one or more of them is responsible at law,
Resources shall be responsible therefor and shall defend, indemnify and
hold harmless Genpharm and its Affiliates from and against all such
Damages;
Upon the assertion of any third party claim against Genpharm or Resources (or
their respective Affiliates) that may give rise to right of indemnification
under this agreement, the Person claiming a right to indemnification (the
"Indemnified Party") shall give prompt notice to the Person alleged to have the
duty to indemnify (the "Indemnifying Party") of the existence of such claim
(provided that the failure to give such notice in timely fashion shall not
release the Indemnifying Party of its obligations of indemnification hereunder
except to the extent that the Indemnifying Party has been prejudiced thereby)
and shall give the Indemnifying Party reasonable opportunity to control, defend
and/or settle such claim at its own expense and with counsel of its own
selection; provided, however, that the Indemnified Party shall, at all times,
have the right to fully participate in such defense at its own expense with
separate counsel and, provided that both parties to the extent that they are not
contractually or legally excluded therefrom, or otherwise prejudiced in a legal
position by so doing, shall co-operate with each other and with their respective
insurers in relation to the defense of such third party claim. The Indemnifying
Party shall consult with the Indemnified Party with respect to settlement of any
claim. The Indemnifying Party shall have the right to settle any claim without
the consent of the Indemnified Party, provided that the Indemnified Party is
unconditionally released from such claim and it is not otherwise prejudiced by
the terms of settlement. In the event the Indemnifying Party elects to defend
such claim, the Indemnified Party may not settle such claim without the prior
written consent of the Indemnifying Party. If the Indemnifying Party shall,
within a reasonable time after such notice has been given, fail to defend,
compromise or settle such claim, (or thereafter fails to diligently defend such
claim) then the Indemnified Party shall have the right to defend, compromise or
settle such claim without prejudice to its rights of indemnification hereunder.
Notwithstanding the foregoing, in the event of any dispute with respect to
indemnity hereunder, each party shall be entitled to participate in the defence
of such claim and to join and implead the other in any such action.
9.3 Insurance: Each of Resources and Genpharm shall (and shall cause their
respective Affiliates, as required, to) during the term of this agreement and
for a period of not less than 36 months following the termination of this
agreement, carry or be subject to coverage under (as a named insured) product
liability insurance (including blanket contractual liability) in an amount of
not less than $10 Million U.S. combined single limit, which insurance will be
written on an occurrence policy form with an insurance carrier reasonably
acceptable to the other party. Each of Genpharm and Resources shall, at the
request of the other, provide evidence to such requesting party of compliance
with its insurance obligations (and those of its Affiliate) under this Section
and evidence of renewals of any such policy, from time to time.
24
9.4 Survival: The provisions of this Article 9 shall survive termination or
expiration of this agreement.
ARTICLE 10
TERM AND TERMINATION
10.1 Term: The initial term of this agreement shall commence on the Effective
Date and, for each particular Product, shall terminate on the 10th anniversary
of the date upon which Genpharm or its Affiliate receives the Product Approval
for such Product, unless earlier terminated in accordance with the provisions of
this agreement. Thereafter, this agreement shall, in respect of such Product,
automatically renew from year to year unless Resources or Genpharm gives written
notice of termination to the other at least 180 days prior to the expiration of
the initial term or any renewal term, as the case may be, subject to earlier
termination as provided in this agreement.
10.2 Payment and Reporting Defaults: Genpharm may, by notice in writing to
Resources, terminate this agreement or, at its option, terminate this agreement
in respect of the particular Product or Products to which the default herein
contemplated relates, if Resources fails to pay to Genpharm any amount payable
by it to Genpharm hereunder as and when the same shall have become due and
payable or shall have failed to deliver (or caused to be delivered, as the case
may be), in timely fashion, the reports or information contemplated in Sections
6.4 or 6.5 hereof, and in either case, such breach shall have continued
unremedied for a period of 15 business days after written notice of such breach
has been given by Genpharm to Resources; provided that Resources shall not have
the right to such 15 business day grace period within which to cure such default
and Genpharm shall have the immediate right to terminate the agreement for such
breach if Resources shall have previously breached Section 6.4 or 6.5, or failed
to remit any sums of at least $100,000.00 to Genpharm when due, in the
aggregate, three times in the 12 month period immediately preceding the default
in question In the event that Resources has been given notice pursuant to this
Section 10.2 and it disputes the alleged breach, the dispute shall be submitted
to arbitration pursuant to Article 13 below and this agreement shall continue in
full force until such time as the arbitrator renders his decision. Termination
of this agreement pursuant hereto shall be without prejudice to any other right
or remedy which Genpharm may have against Resources arising out of the breach in
question including the right to obtain compensation for its damages (provided
that such right shall be subject to the limitations set forth in Section 9.1
hereof).
10.3 Material Breach: Subject to the provisions of Section 10.2 above, Genpharm
or Resources may, by notice in writing to the other, terminate this agreement
or, at its option, terminate this agreement in respect only of those Products to
which the default in question relates, if such other party shall have breached
any of its material duties or obligations under this agreement and such default
continues unremedied for a period of 60 days following receipt of notice of such
default (or, if such default is capable of being remedied but is not reasonably
capable of being remedied within such 60 day period, such longer period of time
25
as is reasonable in the circumstances, not exceeding 90 days in the aggregate,
provided that the defaulting party has, within such 60 day period, commenced and
thereafter actively and diligently pursues the remedying of such default). In
the event that a party has been given notice pursuant to this Section 10.3 and
such party disputes the alleged breach, the dispute shall be submitted to
arbitration pursuant to Article 13 hereof and this agreement shall continue in
full force until such time as the arbitrator renders his decision. The
arbitrator shall determine whether or not there has been a breach and/or whether
or not the same has been remedied within the required cure period. Termination
of this agreement pursuant hereto shall be without prejudice to any other right
or remedy the party terminating this agreement may have against the defaulting
party arising out of the breach in question including the right to obtain
compensation for its damages (provided that such right shall be subject to the
limitations set forth in Section 9.1 hereof).
10.4 Events of Default: Genpharm shall have the right to terminate this
agreement upon written notice to Resources in the event that any one or more of
the following events shall become applicable to Resources or any of its
Affiliates to whom any material duty or obligations of Resources hereunder has
been delegated or assigned and Resources may terminate this agreement in the
event that any one or more of the following events shall become applicable to
Genpharm or, at its option, may terminate this agreement in respect only to
those Products which are being manufactured by a Manufacturer (other than
Genpharm) if any of the following events shall become applicable to a
Manufacturer (Resources, its Affiliate, Genpharm or the Manufacturer affected by
such event being referred to as the "Party"):
(i) an order is made or a resolution or other action of such Party
is taken for the dissolution, liquidation, winding up or other
termination of its corporate existence;
(ii) the Party commits a voluntary act of bankruptcy, becomes
insolvent, makes an assignment for the benefit of its
creditors or proposes to its creditors a reorganization,
arrangement, composition or readjustment of its debts or
obligations or otherwise proposes to take advantage of or
shelter under any statute in force in the United States or in
the governing jurisdiction of such Party for the protection of
debtors;
(iii) if any proceeding is commenced with respect to a compromise or
arrangement, or to have such Party declared bankrupt or to
have a receiver appointed in respect of such Party or a
substantial portion of its property and such proceeding is not
fully stayed or dismissed within 30 days after such
commencement;
(iv) a receiver or a receiver and manager of any of the assets of
such Party is appointed and such receiver or receiver and
manager is not removed within 30 days of such appointment; or
26
(v) such Party ceases or takes steps to cease to carry on its
business.
10.5 Ineligible Person: Genpharm or Resources may terminate this agreement in
respect of a Product upon 30 days prior written notice to the other party if
such party (otherwise than by reason of a breach of its obligations hereunder in
respect of such Product) is legally prohibited from performing its obligations
hereunder or becomes (or, in case of Resources, its Affiliates become and in the
case of Genpharm, a Manufacturer thereof becomes) an Ineligible Person in
respect of such Product (and, where the party purporting to terminate this
agreement is also the party prohibited from performing or it or its Affiliate as
hereinbefore contemplated is the Ineligible Person, it [or such Affiliate, as
the case may be], has made diligent best efforts to remove the prohibition or
its status as an Ineligible Person) and such prohibition or status as an
Ineligible Person has continued uninterrupted for a period of 120 days.
10.6 Force Majeure: Either party may terminate this agreement with respect to a
particular Product materially affected by an event of Force Majeure in
accordance with the provisions of Section 14.2 hereof (but this agreement shall
continue in respect of the other Products which remain subject to this agreement
and which are not effected by such Force Majeure event).
10.7 Price Erosion: Either Genpharm or Resources may terminate this agreement in
respect of a particular Product (the "Specific Product") on 120 days prior
written notice to the other party if, in any calendar year, the Gross Profits
derived from Net Sale of such Specific Product is less than 20% of the Gross
Sales of the Specific Product during such period.
10.8 Minimum Threshold Sales: If, with respect to a Product:
(i) in the first 12 month period (such period being herein
referred to as the "Period") commencing on the date (the
"Commencement Date") which is the 2nd business days
immediately following the date upon which the first
Availability Notice (as contemplated in Subsection 5.3(a)
hereof) is given to Resources hereunder in respect of such
Product, the aggregate Net Sales of such Product for such
Period is less than the Threshold Amount applicable thereto;
or
(ii) in any subsequent 12 month period (a "Subsequent Period")
commencing on the anniversary of the Commencement Date the
aggregate number of Units of such Product sold (excluding, for
greater certainty, free goods) by Resources and its Affiliates
in such Subsequent Period (and included in the Net Sales of
such Product for such Subsequent Period) is, without
reasonable justification (having regard to such factors as, by
way of illustration only but without limitation, the Market
Factors [as defined below]) less than 70% of the Units of such
Product sold (excluding, for greater certainty, free goods) by
Resources and its Affiliates during the Period;
and the shortfall in sales cannot be attributable primarily to the fault of
Genpharm, then Genpharm shall have the right to terminate this agreement in
27
respect of such Product upon 90 days prior written notice to Resources.
For purposes of this Section, the term "Market Factor" means:
(A) the introduction into the Territory of a Competing Product or
additional Competing Products during that or a preceding
Subsequent Period which had a material adverse effect on the
market share of Resources and any other manufacturers and
distributors who were at the time of such introduction
marketing Competing Products in the Territory;
(B) a significant price erosion relating to the Product and
Competing Products as a result of market forces resulting in a
decision by Resources, acting reasonably, not to seek
additional and less profitable sales of such Product merely to
increase Unit sales of such Product at the expense of Gross
Profit;
(C) the introduction into the Territory of new branded products
which materially adversely affected the market for such
Product and Competing Products, if any, in the Territory
during that or a preceding Subsequent Period;
(D) the introduction into the Territory of a product which has the
same active ingredient and is for the same indication as such
Product but which is in a different dosage form and which
materially adversely affected the market for such Product and
Competing Products, if any, in the Territory in that or a
preceding Subsequent Period;
(E) Force Majeure (as defined in Section 14.2 hereof).
10.9 Closing Share Purchase: If the closing pursuant to the Stock Purchase
Agreement has not occurred on or before July 15, 1998, or if prior to July 15,
1998, the Stock Purchase Agreement is terminated in accordance with the
provisions of Section 13.11 thereof, Genpharm may deliver a notice in writing to
Resources on or before July 31, 1998 and thereupon this agreement shall
immediately terminate in respect of those Products for which Product Approvals
have not been received by Genpharm or its Affiliate on or before July 15, 1998
or the date upon which the Stock Purchase Agreement is terminated, whichever is
earlier, and shall terminate in respect of all other Products on the first
anniversary of the Execution Date (without further notice or formality).
10.10 Non-Compete Obligation of Resources: If Genpharm terminates this agreement
(or terminates this agreement in respect of a particular Product or Products
only) pursuant to Section 10.2, 10.3 or 10.8 hereof or if Resources terminates
this agreement pursuant to Section 10.7 hereof, Resources shall not (and shall
not authorize, cause, permit or suffer any of its Affiliates to) directly or
indirectly, manufacture, purchase, sell or distribute in the Territory any
Competing Products to any Product(s) as to which this agreement has been so
terminated for a period of 24 months following the effective date of such
termination.
28
10.11 Non-Compete Obligation of Genpharm: If Resources terminates this agreement
(or terminates this agreement in respect of a particular Product or Products
only) pursuant to Section 10.3 hereof or if Genpharm terminates this agreement
pursuant to Section 10.7 hereof, Genpharm shall not (and shall not authorize,
cause, permit or suffer any of its Affiliates to) directly or indirectly, sell
or distribute such Product(s) in the Territory for a period of 24 months
following the effective date of such termination.
10.12 Purchase of Materials and Stock: Upon termination of this agreement by
Resources (or termination of this agreement by Resources in respect of certain
Products only) pursuant to Sections 10.3 or 10.5 (as a result of Genpharm or a
Manufacturer becoming an Ineligible Person or being legally prohibited from
performing its obligations hereunder), Genpharm shall, at the request of
Resources, repurchase all such Products in respect of which this agreement has
so terminated which were supplied by it or on its behalf and which are then in
the possession, custody or control of Resources and available for sale (and
which have not been adulterated or damaged since they were picked up by the
carrier at Genpharm's or a Manufacturer's Plant for delivery to Resources and
which remain qualified for sale in the Territory) and all packaging material in
the possession, custody or control of Resources which were specifically acquired
by Resources for the Products in question and which cannot be used by Resources
or its Affiliates for any other products sold by any of them, at the landed cost
to Resources of such Products and materials (determined in accordance with
generally accepted accounting principles), which purchase price shall be paid
within 30 days following delivery of such products and materials by Resources to
the carrier for delivery to Genpharm. Genpharm shall also pay all transportation
costs associated with shipping or transporting the repurchased Product or
materials to Genpharm or to such other place as Genpharm may require.
10.13 Survival: Any cause of action for breach of contract shall survive the
termination or expiration of this agreement. The termination or expiration of
this agreement shall not affect any right or obligation of Genpharm or Resources
existing prior to the effective date of termination or expiration and which is
by expressed hereunder to survive termination. Termination or expiration of this
agreement shall not affect any right, duty or obligation arising pursuant to
Section 11.3, 11.4, 11.5, 11.6 or 11.7 hereof or Articles 6, 8, 9 or 12 hereof
(which shall survive termination).
ARTICLE 11
REGULATORY MATTERS AND ACCESS TO FACILITIES
11.1 Access to Genpharm's and Manufacturer's Facilities: Resources shall have
the right, upon reasonable advance written notice to Genpharm to inspect each
Plant where a Product is being manufactured or stored to monitor compliance by
Genpharm and the Manufacturer with the Product Manufacturing Requirements and to
otherwise confirm that the Product is being manufactured, and that Genpharm is
operating, in compliance with the provisions of this agreement in all material
29
respects. Genpharm shall have the right to have its representatives and/or those
of its Affiliate present throughout such inspections. Resources shall promptly
notify Genpharm of any non-compliance at such Plant determined through an
inspection herein contemplated and upon receipt of such notice, Genpharm shall,
or shall cause the applicable Manufacturer to promptly and diligently rectify
any non-compliance and implement appropriate procedures with a view to avoiding
repetition of such non-compliance prior to commencing or continuing to
manufacture the Product(s) in question. Genpharm shall, or shall cause each
Manufacturer to, promptly notify Resources, in writing, of any circumstances
relating to its Plant that may affect the quality of the Product being
manufactured thereat.
11.2 Access to Resources' Storage Facilities: Genpharm shall have the right
(through its own representatives and/or by representatives of a Manufacturer),
upon reasonable advance notice to Resources, to inspect Resources' and its
Affiliate's manufacturing and warehouse facilities which are used to receive,
repackage, label, store or handle any Product to ensure compliance with the
provisions of this agreement including, without limitation, that the Products
are being received, repackaged, labelled, stored and handled in accordance with
the Specifications for the Product relating thereto and applicable laws and
regulations (including FDA cGMP guidelines) and to otherwise ensure that the
Products do not become adulterated or otherwise cease to meet their
Specifications as a result of any acts by or omissions of Resources, its
Affiliates and their respective agents, employees or those for whom they are at
law responsible. Resources shall have the right to have its representatives or
those of its Affiliate present throughout such inspection. Genpharm shall
promptly notify Resources of any non-compliance determined through an inspection
herein contemplated and, upon receipt of such notice, Resources shall promptly
and diligently rectify or cause the rectification of any non-compliance and
implement or cause the implementation of appropriate procedures with a view to
avoiding repetition of such non-compliance. Resources shall promptly notify
Genpharm, in writing, of any circumstances relating to its facilities or those
of its Affiliates where any of the Products are received, repackaged, labelled,
stored or handled that may affect the quality of any Product.
11.3 Detention of Technical Records and Samples: Each of Genpharm and Resources
shall keep, or cause its Affiliates to keep, as required, such samples and such
records (or copies thereof) in respect of the Products being manufactured,
supplied or distributed by it as are required by the applicable Product
Manufacturing Requirements and/or applicable law for such period of time as may
be required thereunder. Resources shall permit and shall cause its Affiliates to
permit Genpharm and the Manufacturers to have access to such samples and
original records as are required to be maintained by Resources at all reasonable
times upon prior reasonable notice and shall, upon written request, promptly
provide Genpharm (or any Manufacturer, as directed by Genpharm) with a copy of
all such records.
11.4 Co-operation re Product Safety: Genpharm and Resources shall promptly
advise the other of any safety or toxicity problem of which such party or its
30
Affiliate becomes aware regarding a Product being manufactured, supplied or
distributed by it, intermediates or other ingredients or processes used in the
manufacture such Product.
11.5 FDA Correspondence: Following receipt of a Product Approval for a Product
Genpharm and Resources shall provide the other (and Genpharm shall cause each
Manufacturer to provide Resources) with a copy of any correspondence or notices
received by such party from the FDA relating to or referring to such Product
within 10 days of receipt and a copy of any response to any such correspondence
or notices with 10 days of making a response.
11.6 Customer Complaints:
(a) Resources shall notify Genpharm and each Manufacturer, as applicable:
(i) of any customer complaints or alleged adverse drug experiences
("ADE") relating to a Product promptly following their receipt
by Resources or any of its Affiliates (but in any event within
5 days of receipt thereof, except in the case of a Serious ADE
[as defined below] in which event Resources shall notify
Genpharm and the Manufacturer of same within 24 hours, which
latter notification shall be by telephone with a facsimile
confirmation immediately following; or
(ii) of any FDA complaints or complaints of any other governmental
or regulatory body, agency or official in the Territory within
48 hours, except on weekends and holidays.
For purposes of this agreement "Serious ADE" shall mean an adverse
event which gives rise to one or more of the following: death, threat
to life, new or prolonged in-patient hospitalization, permanent or
significant disability or incapacitation, overdose, cancer or
congenital abnormality or serious laboratory abnormality which is
thought by the reporting physician to be serious or associated with
relevant clinical signs or symptoms. Genpharm shall, or shall cause the
applicable Manufacturer to, notify Resources in the manner and within
the time periods hereinbefore contemplated of any ADE or FDA complaint
(or of the complaint of any governmental body, agency or official in
the Territory) relating to such Product in respect of the Territory
following their receipt by Genpharm or such Manufacturer.
(b) Genpharm shall be responsible for filing or causing the Manufacturer to
file any necessary complaint report required by the FDA in accordance
with applicable FDA regulations.
(c) To enable Genpharm or the Manufacturer to respond to any requirements
of the FDA in connection with a complaint or ADE, Resources agrees to
investigate and respond in writing to any complaint or ADE forwarded to
it by or a Manufacturer promptly and, in no event, later than 30 days
after receipt of the ADE or complaint from Genpharm or a Manufacturer.
In addition, Resources shall provide Genpharm and the applicable
Manufacturer with a copy of any correspondence, reports, or other
31
documents relating to a complaint or ADE received by Resources or its
Affiliate relating to the Product promptly of the receipt thereof and
shall also provide to Genpharm (and such Manufacturer) Resources'
response thereto within a reasonable period following generation of
such document by Resources. Upon the request of Genpharm, Resources
shall use reasonable commercial efforts to retrieve and shall cause its
Affiliates to use reasonable commercial efforts to retrieve such
samples of the Product which are the object of a complaint or ADE to
enable Genpharm and/or the applicable Manufacturer to conduct such
tests, studies and investigations as it determines to be necessary to
respond to such ADE or complaint or to take appropriate corrective
action.
11.7 Recalls:
(a) In the event that Genpharm or a Manufacturer shall be required (or
shall voluntarily decide) to initiate a recall, product withdrawal or
field correction of any Product (a "Recall"), whether or not such
Recall has been requested or ordered by the FDA (or any other
governmental body, agency or official having jurisdiction in the
Territory) or by a court, Genpharm shall, or shall cause the applicable
Manufacturer to, notify Resources and Resources shall fully co-operate
and shall cause its Affiliates to fully co-operate with Genpharm (and
such Manufacturer) in notifying their customers to return all such
Product and shall follow any other instructions provided by Genpharm
(or such Manufacturer).
(b) In the event that Resources believes that a Recall may be necessary
and/or appropriate, prior to taking any action Resources shall
immediately notify Genpharm and the applicable Manufacturer and
Genpharm and Resources shall co-operate and cause their respective
Affiliates to co-operate with each other (and the other's Affiliate) in
determining the necessity and nature of the action to be taken.
(c) With respect to any Recall, Genpharm or the Manufacturer shall make all
contacts with the FDA and shall be responsible for co-ordinating all of
the necessary activities in connection with such Recall and Resources
(and its Affiliates) and Genpharm (and its Affiliate) shall each
co-operate with the other (and with the other's Affiliate) in recalling
the affected Product.
(d) In the event that it is determined by agreement of the parties or by
arbitration as herein contemplated that a Recall results solely from
any cause or event arising from the manufacture, labelling, storage,
handling, or packaging of the Product by Genpharm or a Manufacturer or
other cause or event attributable to Genpharm or a Manufacturer,
Genpharm shall be responsible for all expenses of such Recall. In the
event that it is determined by agreement of the parties or by
arbitration as herein contemplated that a Recall results solely from
any cause or event arising from the transportation, manufacturing (if
applicable), repackaging, labelling, storage, handling, marketing or
distribution of the Product by Resources or any of its Affiliates or
other cause or event attributable to Resources or any of its
Affiliates, Resources shall be responsible for all expenses of such
Recall. If:
32
(i) within 60 days of the initiation of a Recall, the parties are
unable to agree that the cause of such Recall was solely the
responsibility of Resources or its Affiliates or Genpharm or a
Manufacturer as hereinbefore contemplated; or
(ii) an arbitrator pursuant to an arbitration initiated by one of
the parties in respect of such Recall within the 60 day period
contemplated in (i) above, determines that the cause of such
Recall was not solely the responsibility of Resources or its
Affiliates or of Genpharm or a Manufacturer as hereinbefore
contemplated;
then Resources shall initially pay or reimburse Genpharm and its
Affiliates, as the case may be, for the expenses of the Recall but
shall be entitled to recover from Genpharm the Applicable Percentage of
the expenses so incurred through deductions to and sharing of Gross
Profits.
(e) For purposes of this agreement, Recall expenses shall include, but not
be limited to, the expenses of notification and destruction or return
of the recalled Product, as the case may be, and Resources' (and its
Affiliates') and Genpharm's and its Affiliates' reasonable
out-of-pocket costs in connection with such Recall including but not
limited to reasonable attorney's fees and expenses and credits and
recall expenses claimed and paid to customers (the "Recall Expenses").
Each of the parties shall use, and shall cause its Affiliates to use,
its reasonable best efforts to minimize the Recall Expenses which it
incurs and shall provide to the other, upon request, reasonable
evidence of the out-of-pocket expenses being claimed by it. The direct
out-of-pocket costs and expenses of the Recall contemplated above shall
not include the gross amount invoiced by Resources or its Affiliates to
the customers on the sale of the Product recalled, which amount shall
be dealt with in accordance with the provisions of Sections 8.2 and
shall also not include any Excess Reprocurement Costs (within the
meaning of Section 8.3 hereof), which costs shall be paid by Resources
(subject to its right to partially recover same through deduction from
Gross Profits).
(f) All Product recalled pursuant to this Section 11.7 shall be treated as
Product returned to Resources by its customers and the provisions of
Section 8.2 shall apply thereto.
(g) All communications relating to a Recall shall be held in confidence and
shall be subject to the terms of Article 12 hereof.
ARTICLE 12
CONFIDENTIALITY
12.1 Confidential Nature of Agreement: Each of the parties hereto agrees that,
without the prior written consent of the other, or except as may be required by
33
law or court order, the existence and terms of this agreement shall remain
confidential and shall not be disclosed to any Person other than employees and
professional advisers of such party or its Affiliate who reasonably require
knowledge of the existence or terms of this agreement and who are bound to such
party or its Affiliate by a like obligation of confidentiality. Such employees
and advisors will be advised of the nature and existence of the confidentiality
undertakings of this agreement and of the applicability of such undertakings to
them and will agree to be bound hereby.
12.2 Duty of Confidentiality: Each of Genpharm and Resources agrees to hold in
trust and confidence (and to cause its Affiliates to hold in trust and
confidence) for the benefit of the other party (and its Affiliates) all
Confidential Information of such other party and its Affiliates and each further
agree to safeguard, and to cause its Affiliates to safeguard, the Confidential
Information of the other (or its Affiliates) to the same extent that it does
with its own confidential information and to limit and control copies, extracts
and reproductions made of such Confidential Information. Neither party will,
without the express written consent of the other, directly or indirectly, use
(or authorize, permit or suffer any of its Affiliates to use) any Confidential
Information of the other party or of its Affiliates for any purpose other than
to implement the provisions of this agreement or in regulatory proceedings or in
litigation. Neither party will disclose Confidential Information to any Person,
other than its employees or other representatives or those of its Affiliates who
have a need to know to fulfill the provisions and intent of this agreement
(where such provisions and intent cannot properly be fulfilled without such
disclosure) and who have been informed of the confidential nature of the
information and have agreed to be bound by the terms hereof. Each of Genpharm
and Resources shall use its best efforts to prevent unauthorized use or
disclosure of the Confidential Information of the other or its Affiliates and
shall use protective measures no less stringent than those used by it in its own
business to protect its own confidential information, including segregating such
information at all times from the confidential material of others so as to
prevent any commingling.
12.3 Compulsory Disclosures: In the event that either Genpharm or Resources (or
any of their respective Affiliates) shall be legally compelled or required by a
court of competent jurisdiction to disclose all or any part of the Confidential
Information of the other (or its Affiliates), it shall provide prompt notice to
the other so that such other party (or its Affiliates) may determine whether or
not to seek a protective order or any other appropriate remedy. If a protective
order or other appropriate remedy is not obtained before such disclosure is
required, the party required to make disclosure will disclose only those
portions of the Confidential Information in question which it is advised by
written opinion of counsel (which opinion shall be addressed to such party and
to the other party), it is legally required to disclose and will exercise its
best efforts to obtain reliable assurances that confidential treatment will be
accorded such Confidential Information.
12.4 Return of Confidential Information: Upon termination of this agreement each
of Genpharm and Resources shall immediately return to the other all material
containing or reflecting or referring to any Confidential Information of the
other party or its Affiliates (including all notes, summaries, analysis or other
documents prepared or derived therefrom) and all copies thereof in any form
whatsoever under the power or control of such party or its Affiliates, except
that one copy may be retained for legal archival purposes, and such party shall
34
delete such Confidential Information from all retrieval systems and data bases
or destroy same as directed by the other party and furnish to the other party,
if requested, a certificate of a senior officer of such party certifying such
return, deletion and/or destruction. Where this agreement is terminated in
respect of a particular Product or Products only then the foregoing obligations
shall thereupon apply to Confirmation Information relating to such Product or
Products.
12.5 Survival: The obligations of confidentiality contained herein shall survive
the termination of this agreement.
ARTICLE 13
ARBITRATION
13.1 Arbitration: Any controversy or claim arising out of, or relating to, this
agreement or the breach thereof shall be referred for decision forthwith to a
senior executive of each party not involved in the dispute. If no agreement is
reached within 30 days of the request by one party to the other to refer the
same to such senior executive, then such controversy or claim shall be settled
by arbitration in accordance with the Commercial Arbitration Rules of the
American Arbitration Association, such arbitration to be held in New York, New
York on an expedited basis. Judgement upon the award rendered by the
Arbitrator(s) may be entered in any court having jurisdiction thereof.
ARTICLE 14
GENERAL CONTRACT TERMS AND CONDITIONS
14.1 Notice: Subject to the express provisions of this agreement, any notice
required or permitted to be given under this agreement shall be sufficiently
given if in writing and delivered by facsimile (with confirmation of
transmittal) or overnight courier (with confirmation of delivery), as well as by
prepaid registered mail (with return receipt requested) or hand delivery to the
appropriate party at the address set forth below, or at such other address or to
the attention of such other individual as such party may from time to time
specify for that purpose in a notice similarly given:
To Genpharm at:
85 Advance Road,
Etobicoke, Ontario,
M8Z 2A6.
Attention: Chief Financial Officer
Fax Number: (416) 236-2940
35
To Resources at:
One Ram Ridge Road,
Spring Valley, New York,
U.S.A. 10977.
Attention: Chief Financial Officer
Fax Number: (914) 425-7922
Any such notice shall be effective (i) if sent by mail, as aforesaid, 5 business
days after mailing, (ii) if sent by facsimile, as aforesaid, when sent (with
confirmation of receipt), and (iii) if sent by courier or hand delivered, as
aforesaid, when received, provided that if any such notice shall have been sent
by mail and if on the date of mailing thereof or during the period prior to the
expiry of the 5th business day following the date of mailing there shall be a
general postal disruption (whether as a result of rotating strikes or otherwise)
in the country or territory where the sender or the intended recipient is
situated then such notice shall not become effective until the 5th business day
following the date of resumption of normal mail service.
Where Resources is authorized or required to notify or otherwise communicate
with a Manufacturer other than Genpharm it shall notify or otherwise communicate
with such Manufacturer in the foregoing manner (and the provisions hereof shall
apply mutatis mutandis) at the address or facsimile number (and to the attention
of such individual) as Genpharm shall notify Resources from time to time in
accordance with the foregoing notice provisions or at such other address or
facsimile number or the attention of such other individual as such Manufacturer
may specify in a notice similarly given, provided that a copy of each such
notice or other communication shall be forwarded to Genpharm at its address for
notice hereunder.
14.2 Force Majeure: Neither party shall be considered to be in default in
respect of any obligation hereunder if failure of performance shall be due to
Force Majeure (as hereinafter defined). If either party is affected by a Force
Majeure event such party shall, within 20 days of its occurrence, give notice to
the other party stating the nature of the event, its anticipated duration and
any action being taken to avoid or minimize its effect. The suspension of
performance shall be of no greater scope and no longer duration than is required
by such Force Majeure and the non-performing party shall use commercially
reasonable efforts to remedy its inability to perform. The obligation to pay
money in a timely manner is absolute and shall not be subject to the Force
Majeure provisions, except to the extent payment is prohibited by governmental
rule or regulations other than rules or regulations incident to bankruptcy or
insolvency proceedings of a party. Force Majeure shall mean an unforeseeable or
unavoidable cause beyond the control and without the fault or negligence of a
36
party or its Affiliate including, but not limited to, explosion, flood, war
(whether declared or otherwise), accident, labour strike or other labour
disturbance, inability to obtain materials or services, sabotage, acts of God,
newly enacted legislation, newly issued orders or decrees of any Court and any
binding act or order of any governmental agency. Notwithstanding anything in
this Section, the party to whom performance is owned but to whom it is not
rendered because of an event of Force Majeure as contemplated in this Section
shall, after the passage of 120 days, have the option to terminate this
agreement in respect of the Product affected by such event on 30 days prior
written notice to the other party hereto. For greater certainty, Force Majeure
in relation to Genpharm's obligation to supply Product hereunder to Resources
shall include the inability to obtain the required Product from the Manufacturer
thereof as a result of events or circumstances relating to such Manufacturer
which would otherwise be an Event of Force Majeure had it occurred in relation
to Genpharm.
14.3 Governing Law and Consent to Jurisdiction:
(a) This agreement shall be deemed to have been made under, and shall be
governed by, the laws of the State of New York without giving effect to
New York's choice of law provisions.
(b) Subject to Article 13, in connection with any action commenced
hereunder, each of the undersigned consents to the jurisdiction of the
state and federal courts located in New York City. Genpharm hereby
appoints Coudert Brothers, 1114 Avenue of the Americas, New York, New
York, 10036, (or any successor firm or to such other address as they or
Genpharm may designate in writing) and Resources hereby appoints
Hertzog, Calamari & Gleason, 100 Park Avenue, New York, New York,
l0017, (or any successor firm or to such other address as they or
Resources may designate in writing), as their respective agents upon
whom service of process may be made with the same force and effect as
if service shall have been made personally upon them.
14.4 Entire Agreement: This agreement contains the entire agreement and
understanding of the parties with respect to its subject matter and supersedes
all negotiations, prior discussions and any agreements relating to the Products.
This agreement may not be amended or modified except by a written instrument
signed by the parties.
14.5 Waiver: Any waiver of, or consent to depart from, the requirements of any
provision of this agreement shall be effective only if it is in writing and
signed by the party giving it, and only in the specific instance and for the
specific purpose for which it has been given. No failure on the part of any
party to exercise, and no delay in exercising, any right under this agreement
shall operate as a waiver of such right. No single or partial exercise of any
such right shall preclude any other or further exercise of such right or the
exercise of any other right.
37
14.6 Counterparts: This agreement may be executed in identical duplicate copies
exchanged by facsimile transmission. The parties agree to execute two identical
original copies of the agreement after exchanging signed facsimile versions.
Each identical counterpart shall be deemed an original, but all of which
together shall constitute one and the same instrument.
14.7 Severability of Provisions: If, for any reason whatsoever, any term,
covenant or provision of this agreement or the application thereof to any party
or circumstance or in any jurisdiction is to any extent held or rendered
invalid, unenforceable or illegal, then such term, covenant or condition (a) is
deemed to be independent of the remainder of this agreement and to be severable
and divisible therefrom and its validity, unenforceability or illegality shall
not affect, impair or invalidate the remaining provisions hereof; and (b)
continue to be applicable and enforceable to the fullest extent permitted by law
in every other jurisdiction and against any party and circumstances other than
those as to which or in respect of which it has been held or rendered
unenforceable or illegal. To the extent permitted by applicable law, Genpharm
and Resources hereby waive any provision of law which renders any provision of
this agreement prohibited or unenforceable in any respect. Should any provision
of this agreement be so held to be unenforceable, such provision, if permitted
by law, shall be considered to have been superseded by a legally permissible and
enforceable clause which corresponds most closely to the intent of the parties
as evidenced by the provision held to be unenforceable.
14.8 Assignment: Neither this agreement nor rights of a party hereunder may be
assigned nor may the performance of any duties hereunder be delegated by
Resources or by Genpharm without the prior written consent of the other party.
Notwithstanding the foregoing, Genpharm and Resources may delegate from time to
time some of their respective duties hereunder to any of their respective
Affiliates and, in addition, Genpharm and/or its Affiliate may subcontract the
manufacturing of a Product, in whole or in part, to any other Person (whether or
not an Affiliate), provided that (i) such subcontracting is done in compliance
with all applicable requirements of the FDA); (ii) prior to any such delegation,
the delegating party gives written notice thereof to the other party hereto
(indicating the duties being so delegated and the duration of such delegation)
and (iii) no such delegation or subcontracting shall relieve Genpharm or
Resources, as the case may be, of any of its obligations hereunder. Subject to
the foregoing this agreement shall be binding upon and enure to the benefit of
the parties and their respective successors and permitted assigns.
14.9 Non Contravention: Each party represents and warrants that the execution,
delivery and performance of this agreement by it will not contravene any other
contract or agreement to which it is a party or by which it is bound.
38
14.10 Compliance: Where, in accordance with the provisions of this agreement,
the Affiliate of a party is required to do or omit to do or use reasonable
commercial (or other) efforts to do or refrain from doing any act or thing such
party shall use reasonable best commercial efforts to cause its Affiliates to
comply.
IN WITNESS WHEREOF, each of the parties hereto has caused this
Agreement to be executed by its duly authorized officer as of the date first
above written.
GENPHARM INC. PHARMACEUTICAL RESOURCES, INC.
By: /s/Ian Jacobson By: /s/Kenneth I. Sawyer
------------------------------- -----------------------------------
Name: Ian Jacobson Name: Kenneth I. Sawyer
Title: Executive Vice President Title: President
By: /s/H. Koziarski
-------------------------------
Name: H. Koziarski
Title: Chief Financial Officer
39
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
SCHEDULE "A"
DEFINITIONS
"Affiliate" means, subject to the limitations set forth in (A) and (B) below,
any Person which, directly or indirectly, controls, is controlled by or is under
common control with such Person. For purposes of this definition, the term
"control" (as used in the terms "controls", "controlled by" and "under common
control") means either (i) holding 50% or more of the voting securities of such
Person or, (ii) in the case of a Person that has no outstanding voting
securities, having the right to 50% or more of the profits of such Person or
having the right in the event of dissolution to 50% or more of the net assets of
such Person or, (iii) the power to direct or cause the direction of the
management and policies of such Person, whether pursuant to the ownership of
voting securities, by contract or otherwise; provided, however, that (A) Merck
KGaA and its Affiliates shall be deemed not to be Affiliates of Genpharm unless
such Person is Merck Generics Group B.V. or a subsidiary of Merck Generics Group
B.V. so that by way of illustration only and without limiting the generality of
the foregoing, Dey Laboratories, Inc. will not be an Affiliate of Genpharm and
(B) any Person who (but for the exceptions contemplated herein in (A)) is an
Affiliate of Merck KGaA on the Effective Date or at any time thereafter and that
but for the completion of the transaction contemplated by the Stock Purchase
Agreement or the exercise of any rights granted pursuant thereto or in
connection with the completion of such transaction would not be an Affiliate of
Resources, such Person shall be deemed not to be an Affiliate of Resources so
that, for greater certainty, but without limitation, Genpharm and any of its
Affiliates shall not be Affiliates of Resources or any of Resources' Affiliates
and vice versa;
"ANDA" means the abbreviated new drug application heretofore or hereafter filed
by Genpharm or any of its Affiliates with the FDA for or in respect of a
Product;
"Applicable Percentage" means:
(i) subject to (iii) below, in the case of a Product which is
developed and registered by Genpharm or its Affiliates based
on Product Information provided by a Third Party Licensor,
that percentage which will result in Genpharm receiving the
aggregate of an amount equal to the Third Party Royalty to be
paid to the Third Party Licensor (or as it has directed) by
Genpharm and/or its Affiliates in respect of such Products
sold in the Territory and [****] of the balance of the Gross
Profits;
(ii) subject to (iii) below, in the case of any other Product,
[****]; and
40
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(iii) where Resources has exercised its right pursuant to Section
3.9 hereto to terminate its obligation to fund any further
Patent Defence Expenses (as defined in such Section) in
respect of a Product (in this definition referred to as the
"Specific Product") such percentage which will result in
Genpharm receiving the aggregate of (A) an amount equal to the
Third Party Royalty to be paid to the Third Party Licensor (or
as it has directed) by Genpharm and/or its Affiliates in
respect of sales of the Specific Product in the Territory by
Resources and its Affiliates and (B) the same proportion of
the balance of such Gross Profits (after deducting from Gross
Profits the amount contemplated in (A) above) that the Patent
Defense Expenses incurred by Genpharm and its Affiliates in
respect of such Specific Product to the extent that the same
have not been recovered and are not recoverable from Resources
pursuant to Section 3.9 hereof is to the total Patent Defense
Expenses incurred by Genpharm and its Affiliates in respect of
such Specific Product.
"Approved Listing Fee" means, in respect of a Product, listing fees and other
similar up-front payments paid by Resources and its Affiliates to unrelated
third party customers in consideration for such customers agreeing to buy the
Product to the exclusion of other Competing Products for a specified period of
time, where:
(i) the agreement pursuant to which such payment is to be made has
been entered into in compliance with the policy relating to
listing fees and other similar up-front payments previously
approved by Genpharm, or the proposed agreement has been
approved in writing by Genpharm;
(ii) the agreement pursuant to which such payment is to be made has
been entered into exclusively to enhance the sale of such
Product and is not entered into to directly or indirectly
enhance the sale of Resources or any of its Affiliates Other
Products (within the meaning of Section 7.3 hereof) or as an
incentive for such customer to purchase any Other Products of
Resources or its Affiliates;
(iii) the amount to be paid pursuant to such agreement to such
customer plus the amount previously paid to such customer
and/or Affiliates of such customer in respect of such Product
pursuant to any other similar agreement is less than the sum
of [****], or such greater amount as Genpharm may approve in
writing, which approval shall not be unreasonably withheld or
unduly delayed (and Genpharm shall be deemed to have approved
a request for an increased amount to be paid to a customer
unless Genpharm notifies Resources within 12 business hours
(being hours between 9:00 a.m. and 5:00 p.m., Toronto time, on
a business day) of the receipt by Genpharm of a written
41
request for such increased fee or payment that it does not
consent to such increased amount; and
(iv) not more than 2 unrelated third party customers of Resources
and its Affiliates have already been paid (or are entitled to
receive from Resources or its Affiliates) a listing fee or
other similar upfront payment from Resources or its Affiliates
in respect of such Product, unless Genpharm consents to
increase the number of customers to whom listing fees or
similar upfront payments may be made in accordance with the
foregoing, which consent shall not be unreasonably withheld or
unduly delayed [and Genpharm shall be deemed to have approved
a request to the payment of a listing fee or other similar
upfront payment to a specified customer where such payment
would otherwise be in breach of this paragraph (iv) unless
Genpharm notifies Resources within 12 business hours (being
hours between 9:00 a.m. and 5:00 p.m., Toronto time, on a
business day) of the receipt by Genpharm of a written request
for such a payment to such specified customer that it does not
so consent];
"business day" means a day other than a Saturday, a Sunday or a day which is a
statutory holiday in the Province of Ontario, Canada or the State of New York,
United States of America;
"cGMP" means the current Good Manufacturing Practices of the FDA (as in effect
from time to time);
"Competing Product" means, with respect to a particular Product, a generic
pharmaceutical product which is in the same dosage form, has the same active
ingredient, the same strength and is for the same indication as such Product but
which is manufactured and supplied by or purchased or acquired from any Person
other than Genpharm or its Affiliates;
"Confidential Information" shall mean information disclosed to or obtained by
one party from another party (including information obtained by one party as a
result of access to the facilities of the other party) either prior to or during
the term of this agreement which is non-public, confidential or proprietary in
nature (including, without limitation, trade secrets, financial data, product
information, manufacturing methods, market research data, marketing plans,
identity of customers, or product information [including the nature and source
of raw materials, product formulation and methods of producing, testing and
packaging]) and which relates to the disclosing party's past, present or future
research, development or business activities Confidential Information shall not,
however, include information that a party can demonstrate by written evidence:
(i) is in the public domain (provided that information in the
public domain has not and does not come into the public domain
as a result of a breach by a party hereto (or any of its
Affiliates) of its obligations of confidentiality contained
herein;
(ii) is known by the receiving party prior to disclosure by the
other party; or
42
(iii) which has been developed by the receiving party independent of
any disclosure by the other party;
(iv) is subsequently, lawfully and in good faith obtained by the
receiving party on a non-confidential basis from a third party
as shown by documentation sufficient to establish the third
party as the source of the information, provided that such
third party was not under an obligation to treat such
information in a confidential manner and had a lawful right to
make such disclosure;
"Deductible Listing Fee" means, in relation to a Product in respect of a period
for which Net Sales is being calculated hereunder, the aggregate of those
amounts, each of which is the portion of an Approved Listing Fee paid by
Resources or its Affiliates in such period or in any prior period amortized, on
a monthly basis, over the period of the agreement pursuant to which such
Approved Listing Fee is paid, applicable to such period;
"Development Cost" means, in relation to a Product, the out-of-pocket costs and
expenses (excluding overhead) incurred in connection with the research and
development of such Product for the Territory (which shall include the
formulation of such Product, preliminary batch work, analytical development,
stability testing and the validation thereof, all comparative work against the
branded counterpart of such Product in the Territory and the clinical
trials/bioavailability studies) and to obtain a Product Approval for such
Product;
"FDA" shall mean the United States Food and Drug Administration (or whatever
such agency might be called from time to time), or any successor agency having
regulatory jurisdiction over the manufacture, distribution and sale of drugs in
the United States.
"Gross Profits" means, for a Product in respect of any period, Resources' Net
Sales of such Product in such period less the aggregate of the following:
(a) the landed cost to Resources of such Product sold in such period by
Resources and/or its Affiliate to unrelated third party customers,
determined in accordance with generally accepted accounting principles
consistently applied, to include, without duplication, the Transfer
Price of such Product to Resources, import duties and taxes paid or
payable by Resources in respect of purchase or importation of such
Product and delivery charges (including insurance) incurred by
Resources for the delivery of the Product from the Plant to Resources'
Spring Valley, New York, facility;
(b) Recall Expenses incurred in such period in respect of such Product;
(c) Excess Reprocurement Costs incurred in such period in respect of
such Product; and
43
(d) Repackaging Expenses incurred by Resources applicable to the quantity
of Product sold in such period determined in accordance with generally
accepted accounting principles, consistently applied;
For greater certainty, where Product sold by Resources or its Affiliates in a
period (the "Resale") had previously been sold by Resources or its Affiliates to
an unrelated third party customer in that period or any prior period and
returned to Resources or its Affiliates by such customer in such period or a
prior period and an amount on account of the landed cost of such Product as
contemplated in (a) above has been deducted in calculating Gross Profits in
respect of the prior sale for such period or a prior period then the amount to
be deducted under Paragraph (a) above in respect of the Resale shall be deemed
to be nil.
It is understood and agreed that where Product purchased by Resources has been
returned to Genpharm or otherwise disposed of (in a manner approved of by
Genpharm) entitling Resources to claim a reduction, refund, remission or other
recovery of the import duties or taxes paid or payable by Resources in respect
of the purchase or importation of such Product then Resources shall promptly
claim such reduction, refund, remission or other recovery of such duties and
taxes (and shall promptly file and submit all required documentation to the
applicable fiscal authority therefore) and the Gross Profit for the period in
which the reduction, refund, remission or other recovery of such duties and
taxes is recognized by Resources (or its Affiliates) in accordance with
generally accepted accounting principles shall be increased by the amount of the
recognized reduction, refund, remission or other recovery of such duties and
taxes.
The deduction under (b) and (c) are limited to Recall Expenses or Excess
Reprocurement Costs actually incurred in such period and shall not include any
amount accrued, provided or reserved for estimated or potential deductions.
Excess Reprocurement Costs and Recall Expenses (to the extent they represent
amounts payable to unrelated third party customers) shall be considered to be
actually incurred only when the payment is made or credit is issued to such
customer by Resources or its Affiliates.
"Gross Sales" means, in respect of sale of Units of the Product by Resources and
its Affiliates in the Territory, the gross invoice price charged by Resources
and its Affiliates to unrelated third party customers less freight, postage and
insurance related to the delivery of the Product to such customer to the extent
that such amount is charged to such customer and shown separately on such
invoice and has been included in the gross invoice price and less sales taxes
and other governmental charges imposed upon the sale of such Product by
Resources or its Affiliates to such customer (to the extent that such amounts
have been included in gross invoice price);
"Manufacturer" means, in respect of a Product, the Affiliate of Genpharm in
whose name the Product Approval for such Product is registered;
44
"Manufacturing Cost" shall mean the cost to Genpharm or the Manufacturer to
manufacture (including quality control and testing) and package the Product
including, without limitation, the landed cost of raw materials and packaging
materials, component costs, energy, labor (salary and benefits) and reasonable
overhead charges (not to exceed 20% of the Manufacturing Cost) relating to the
manufacture of the Product, and other direct and allocable indirect costs to
manufacture such Product, including but not limited to manufacturing charges for
material adjustments, for off grade or defective material, handling losses,
physical adjustments, salvage and depreciation but specifically excluding costs
incurred in research, development, design, marketing, promotion, administration
or obtaining the Product Approval, determined in accordance with methods
currently employed by Genpharm or such Manufacturer in the manufacture of all
products produced in the facility or facilities in which Product is
manufactured. If, in the sole discretion of Genpharm or the Manufacturer, all or
any portion of the manufacturing or packaging of the Product is subcontracted by
such Manufacturer to a third party (or to any Affiliate of Resources) the
Manufacturing Costs shall include the amount paid to such third party (or
Resources' Affiliate). The Manufacturing Cost of the Product shall be
established on the date that the Product Approval for such Product is acquired
by Genpharm or the Manufacturer and on the first day of each calendar quarter
thereafter, which amount shall be used to determine the Transfer Price of
Product manufactured by Genpharm or the Manufacturer for Resources during the
period until the next Manufacturing Cost determination date. The parties further
acknowledge and agree that where, during a period between Manufacturing Cost
determination dates, the variable costs incurred by Genpharm or the Manufacturer
to manufacture the Product (and which are included in the Manufacturing Cost)
have, in the aggregate, increased or decreased by more than 5%, a pro rata
adjustment will be made to the Manufacturing Cost of Products manufactured
during such period as agreed upon by Genpharm and Resources or, failing
agreement, as determined by arbitration pursuant to Article 13 of this
agreement. In determining changes in Manufacturing Cost due to changes in the
variable costs incurred by Genpharm or Manufacturer for raw materials and
components including active ingredient, such materials shall be used and costed
on a first in, first out basis in accordance with generally accepted accounting
principles, consistently applied. Within 30 days of the receipt of a Product
Approval for such Product, and within 30 days of each Manufacturing Cost
determination date, Genpharm shall deliver or cause to be delivered to Resources
a statement showing the calculation of the Manufacturing Cost applicable to such
period, which statement shall be accompanied by a certificate signed by the
Chief Financial Officer of Genpharm or, at Genpharm's option, the Manufacturer
of such Product certifying that, to the best of his knowledge, information and
belief, after reasonable investigation, such statement is true and correct in
all material respects;
"Net Sales" means, in respect of a Product for a period, the gross amount
invoiced by Resources and its Affiliates in such period to unrelated third party
customers on account of the sale of such Product (excluding amounts for freight,
postage, insurance, sales tax and other governmental charges imposed upon such
sale which are included in the gross amount invoiced and shown separately on
such invoice) plus any other form of revenue (other than interest accruing from
or paid by such customers on account of outstanding overdue invoices) or expense
reimbursement or recovery recognized by Resources or its Affiliates in such
45
period in accordance with generally accepted accounting principles as a result
of commercial arrangements relating to such Product less, without duplication:
(i) credits issued or payments made by Resources and its
Affiliates to unrelated third party customers for or on
account of, without duplication, bona fide rebates granted and
customary trade discounts (other than prompt payment
discounts) actually allowed by Resources or its Affiliates to
such customers in the ordinary course of business (except
rebates or discounts granted wholly or partially in
consideration of such customer's agreement to purchase any
service or any product other than the Product unless such
rebates or discounts are across-the-board rebates or discounts
applied uniformly to the Product and other products or
services as part of an overall program of rebates or discounts
established by Resources covering substantially all of its
products), shelf stock adjustments, chargebacks, returned
Product, rejection of damaged Product and billing and shipping
errors related to the Product;
(ii) out-of-pocket costs for freight, postage and insurance
incurred by Resources or its Affiliates in the period to
deliver the Product to unrelated third party customers to the
extent that such amount is not charged to such customer;
(iii) payments made by Resources and its Affiliates for
administrative fees, reimbursements or similar payments to or
for Medicaid or any other government programs, hospitals,
health maintenance organizations, insurance carriers, or other
similar arm's length entity or entities in connection with the
purchase or utilization of the Product;
(iv) Deductible Listing Fees paid by Resources or its Affiliates
which are applicable to the period.
It is understood and agreed that:
(a) deductions under (i), (ii), (iii) and (iv) above from the gross amount
invoiced or other revenue recognized shall not include any amounts
which would be categorized as packaging, relabelling, selling,
promotion, marketing or general or administrative expenses in
accordance with generally accepted accounting principles;
(b) deductions under (i), (iii) and (iv) above from the gross amount
invoiced or other revenue recognized are for actual credits issued or
payments made by Resources and its Affiliates and do not include
amounts accrued, provided or reserved for estimated or potential
deductions;
(c) the deduction under (i) above from the gross amount invoiced or other
revenue recognized shall not include any Recall Expenses or Excess
Reprocurement Costs credited or paid to such customer or any amount
paid or credited to the customer on returned or rejected
46
Product to the extent of the Transfer Price of the Product returned or
rejected (which amounts shall be dealt with in accordance with the
provisions of Sections 8.2 or 8.3 hereof or the definition of "Gross
Profit");
(d) no amount shall be deducted under (i), (ii), (iii), (iv) above or
otherwise from the gross amount invoiced or other revenue recognized on
account of or as an allowance for a bad debt or doubtful account in
relation to Product sold by Resources or its Affiliates;
(e) no amount shall be deducted under (i), (ii), (iii), (iv) or otherwise
from the gross amount invoiced or other revenue recognized where
Resources has the right to recover the amount paid or credited to a
customer or other Person from Genpharm pursuant to this agreement and,
if any amount previously claimed as such deduction in calculating Net
Sales in one period is subsequently recovered or becomes recoverable
from Genpharm in another period the amount so recovered shall be added
to the Net Sales in the period in which it is recovered or becomes
recoverable from Genpharm, it being the intention of the parties hereto
that Resources shall not have the right to recover the same expense
directly from Genpharm and again through the calculation of Gross
Profits hereunder;
(f) no credit or payment to an unrelated third party customer shall be
deducted under (i) from the gross amount invoiced or other revenue
recognized where such credit or payment is an attempt to directly or
indirectly circumvent the restrictions or limitations contained herein
as to the nature or quantum of the items which may be deducted
hereunder in calculating Net Sales nor shall Resources or its
Affiliates reduce the selling price at which the Product is sold to an
unrelated third party customer with a view to circumventing such
restrictions or limitations; and
(g) in respect of transfers of Product by Resources to its Affiliates (or
between Affiliates) for resale, the price at which such products are
resold by such Affiliate to third parties (other than other Affiliates)
shall be included in Gross Profits and the transfer price between
Resources and its Affiliates or between such Affiliates will be
disregarded.
"Person" shall be broadly interpreted and shall include an individual,
partnership, joint venture, association, corporation, company and any other form
of business organization, government, regulatory or governmental agency,
commission, department and instrumentality;
"Plant" means the manufacturing facility and/or warehouse used by Genpharm or
any other Manufacturer to manufacture or store a Product which is to be supplied
to Resources pursuant hereto;
"Product" means the generic pharmaceutical products contemplated in Schedule "B"
annexed hereto which are to be developed and manufactured by or on behalf of
Genpharm or a Manufacturer and supplied by or on behalf of Genpharm to Resources
pursuant hereto;
47
"Product Approval" means, with respect to a Product, the final and unconditional
approval of an ANDA by the FDA enabling Genpharm or the Manufacturer to sell
such Product in the Territory;
"Product Information" means, in respect of any Product, all technical
information and data relating to such Product, including the chemistry,
manufacture, use, formulation and regulatory approval thereof, heretofore or
hereafter during the term of this agreement produced or received by, or known to
Genpharm or its applicable Affiliate including, without limiting the generality
of the foregoing:
(a) where an ANDA approval letter has been issued, a copy of the ANDA as
approved and all communication, documents and information relevant to
the ANDA submission received from or forwarded to the FDA in connection
therewith, including without limitation, any responses to deficiency
letters issued by the FDA;
(b) if an ANDA submission has been made but no approval letter has been
received, the submission to the FDA and all communication,
documentation and information received from or forwarded to the FDA in
connection therewith including any responses to deficiency letters
issued by the FDA; and
(c) if no ANDA submission has been made, all data compiled heretofore or
hereafter compiled for submission including, all studies and all
communications, documents and information received from or forwarded to
the FDA.
Any reference herein to Product Information of a Third Party Licensor or other
Person shall have a corresponding meaning, as applicable.
"Product Manufacturing Requirements" shall have the meaning attributed thereto
in Section 4.2 hereof;
"Recall" shall have the meaning attributable thereto in Section 11.7 hereof;
"Recall Expenses" shall have the meaning attributable thereto in Section 11.7
hereof;
"Repackaging Expenses" means the cost to Resources or its Affiliates to package
the Product including, without limitation, the landed cost of packaging
materials and labour (salaries and benefits) and reasonable overhead charges
(not to exceed 20% of the Repackaging Expenses) relating to repackaging and
labelling of the Product into finished labelled Units, determined in accordance
with generally accepted accounting principles, consistently applied. The
Repackaging Expenses of a Product shall be determined on the date that the
Product Approval for such Product is acquired by Genpharm or the Manufacturer
and on the first day of each calendar quarter thereafter, which amount shall be
used to determine the Repackaging Expenses of Products packaged into final
labelled Units by Resources or its Affiliates during the period until the next
Repackaging Expense determination date. The parties further acknowledge and
agree that where, during a period between Repackaging Expense determination
48
dates, the variable costs incurred by Resources or an Affiliate to repackage and
label a Product (and which are included in the Repackaging Expenses) have, in
the aggregate, increased or decreased by more than 5%, a pro rata adjustment
will be made to the Repackaging Expenses of Products packaged into final
labelled Units during such period as agreed to by Genpharm and Resources or,
failing agreement, as determined by arbitration pursuant to Article 13 of this
agreement. In determining changes in Repackaging Expenses due to changes in the
variable costs incurred by Resources or its Affiliates for packaging material or
other supplies, such materials and supplies shall be used and costed on a first
in, first out basis in accordance with generally accepted accounting principles,
consistently applied;
"Specifications" means the terms and conditions applicable to a Product as
described in the Product Approval covering such Product, as the same may be
supplemented from time to time;
"Stock Purchase Agreement" means the Stock Purchase Agreement between
Pharmaceutical Resources, Inc. and Lipha Americas, Inc. dated as of the 25th day
of March, 1998 relating to the purchase by Lipha Americas, Inc., an Affiliate of
Merck KGaA, of certain shares of the common stock of Pharmaceutical Resources,
Inc.;
"Territory" means the 50 states of the United States of America, plus the
District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands,
Guam, Samoa and any other territory which, on the Effective Date is a United
States government protectorate wherein an ANDA approved by the FDA is required
to sell the Product in such territory.
"Third Party Licensor" shall have the meaning attributed thereto in Section 3.1
hereof;
"Third Party Royalty" shall have the meaning attributed thereto in Section 3.1
hereof;
"Transfer Price" means the Manufacturing Cost of the Product supplied by or on
behalf of Genpharm to Resources pursuant hereto;
"Threshold Amount" means in respect of the Period, the following percentage of
the generic market for the Product (measured in dollars) based upon unit sales
as determined through IMS reported sales for such Period:
49
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(i) if, on the date the Period (as that term is defined in Section
10.8 hereof) commences, there are not more than [****] other
Competing Products being distributed in the Territory, [****];
or
(ii) if, on the date the Period commences, there are more than
[****] but less than [****] Competing Products being
distributed in the Territory, [****]; or
(iii) on the date the Period commences, there are more than [****]
Competing Products being distributed in the Territory, [****];
"Unit" means an individual packaged finished Product;
50
SCHEDULE "B"
PRODUCTS
40 generic pharmaceutical products in solid dosage form (capsules and tablets of
the same molecule to be treated as different products but varying strengths of
the same molecule to be treated as one product) which are, on the Effective
Date, under development for the Territory for or on behalf of Genpharm as
separately agreed to by Genpharm and Resources
51
SCHEDULE "C"
RESOURCES' CURRENT PRODUCTS
ALLOPURINOL 100 MGedact.wpd HALOPERIDOL 0.5 MG
ALLOPURINOL 300 MG HALOPERIDOL 1.0 MG
HALOPERIDOL 2.0 MG
ALPRAZOLAM 0.25 MG HALOPERIDOL 5.0 MG
ALPRAZOLAM 0.5 MG HALOPERIDOL 10.0 MG
ALPRAZOLAM 1.0 MG
HYDRALAZINE/HCTZ 25MG/25MG (HYDRA-ZIDE)
ANILORIDE 5MG HYDRALAZINE/HCTZ 50MG/50MG (HYDRA-ZIDE)
HYDRALAZINE/HCTZ 100MG/50MG (HYDRA-ZIDE)
ATENOLOL 50MG
ATENOLOL 100MG IBUPROPEN 200MG
IBUPROPEN 400MG
BENZTROPINE MESYLATE 0.5MG IBUPROPEN 600MG
BENZTROPINE MESYLATE 1MG IBUPROPEN 800MG
BENZTROPINE MESYLATE 2MG
IMIPRAMINE HCI 10MG
CAPTOPRIL 12.5MG IMIPRAMINE HCI 25MG
CAPTOPRIL 25.5MG IMIPRAMINE HCI50MG
CAPTOPRIL 50.5MG
CAPTOPRIL 100MG ISOSORBIDE DINITR. 5MG ORAL
ISOSORBIDE DINITR. 10MG ORAL
CARISOPRODOL & ASPRIN 200/325MG ISOSORBIDE DINITR. 20MG ORAL
ISOSORBIDE DINITR. 30MG ORAL
DEXAMETHASONE 0.25MG
DEXAMETHASONE 0.50MG MECLIZINE 12.5MG
52
DEXAMETHASONE 0.75MG MECLIZINE 25.0MG
DEXAMETHASONE 1.50MG
DEXAMETHASONE 4.0MG MEGESTROL ACETATE 20MG
DEXAMETHASONE 6.0MG MEGESTROL ACETATE 40MG
DOXEPIN 10MG METHOCARBAMOL & ASPIRIN 400/325MG
DOXEPIN 25MG
DOXEPIN 50MG METOPROLOL TARTRATE 50MG
DOXEPIN 75MG METOPROLOL TARTRATE 100MG
DOXEPIN 100MG
DOXEPIN 150MG MINOXIDIL 2.5MG
MINOXIDIL 10.0MG
FLUPHENAZINE HCI 1.0MG
FLUPHENAZINE HCI 2.5MG NICOTINE PATCH 7MG
FLUPHENAZINE HCI 5.0MG NICOTINE PATCH 14MG
FLUPHENAZINE HCI 10.0MG NICOTINE PATCH 21MG
FLURAZEPAM 15MG NYSTATIN ORAL TABS 500,000 UNITS
FLURAZEPAM 30MG
PINDOLOL 5MG
GLIPIZIDE 5MG PINDOLOL 10MG
GLIPIZIDE 10MG
PIROXICAM 10MG
PIROXICAM 20MG
53
SILVER SULFADIAZINE 1% 25GM TUBE
SILVER SULFADIAZINE 1% 50GM JAR
SILVER SULFADIAZINE 1% 50GM TUBE
SILVER SULFADIAZINE 1% 85GM TUBE
SILVER SULFADIAZINE 1% 300GM JAR
SILVER SULFADIAZINE 1% 1000GM JAR
SILVER SULFADIAZINE AF 1% 50GM JAR
SILVER SULFADIAZINE AF 1% 400GM JAR
SILVER SULFADIAZINE AF 1% 1000GM JAR
TEMAZEPAM 15MG
TEMAZEPAM 30MG
TRIAZOLAM 0.125MG
TRIAZOLAM 0.25MG
ZORPRIN (ASPIRIN) 800MG (BRAND)
54