Exhibit 10.15
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT is dated and is effective as of the
twelfth (12th) day of May 1997,
BY AND BETWEEN: BIOCHEM THERAPEUTIC INC., a corporation incorporated under
the laws of Canada, with its principal place of business
located at 000 Xxxxxx-Xxxxxxxx Xxxxxxxxx, Xxxxx, Xxxxxx,
Xxxxxx X0X 0X0;
(hereinafter referred to as "BioChem"),
AND: NEOPHARM INCORPORATED, a corporation incorporated under the
laws of the State of Delaware, with a place of business at
000 Xxxx Xxxxxxxx, Xxxxx 000, Xxxx Xxxxxx, Xxxxxxxx, Xxxxxx
Xxxxxx of America, 60045
(hereinafter referred to as "NeoPharm")
RECITALS:
A. NeoPharm holds certain rights to a product currently known as BUdR (the
"Product", as defined herein below) and is conducting a program to
develop the Product for use as a radiosensitizing agent for the
treatment of cancer in humans and as a prognostic marker for breast
cancer;
B. NeoPharm has the Know-How necessary for the development of the Product
and has prepared and filed a New Drug Application ("NDA") with respect
thereto with the proper regulatory authorities in the United States;
C. BioChem has development, sales and marketing expertise in the human
pharmaceutical field;
D. BioChem wishes to obtain and NeoPharm is willing and has the
unrestricted right to grant to BioChem in accordance with the terms and
conditions set forth herein, the exclusive right to commercialize the
Product in Canada (the "Territory");
E. As of the effective date of this Agreement, no patent has been granted
for the Product in any jurisdiction in the Territory or elsewhere in
the world either to NeoPharm or any of its Affiliates;
NOW, THEREFORE, in consideration of the various premises and undertakings set
forth herein, the Parties agree as follows:
ARTICLE I
INTERPRETATION
1.1 DEFINITIONS. Unless otherwise specifically provided herein, or in the
Manufacturing and Supply Agreement attached hereto as Exhibit 5.1, the following
terms shall have the following meanings:
(a) "AFFILIATE" shall mean any Person which is directly or indirectly
controlled by, or controls or is under common control with, another Person,
provided that "control" shall mean ownership of more than fifty percent (50%)
of another Person or the power to direct decisions of another Person,
including, without limitation, the power to direct management and policies of
another Person, whether by reason of ownership or by contract.
(b) "AGREEMENT" shall mean this Collaboration Agreement and all
instruments supplemental hereto or in amendment or confirmation hereof;
"herein", "hereof", "hereto", "hereunder" and similar expressions mean and
refer to this Agreement and not to any particular Article, Section,
Subsection or other subdivision; "Article", "Section", "Subsection" or other
subdivision of this Agreement means and refers to the specified Article,
Section, Subsection or other subdivision of this Agreement.
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(c) "BIOCHEM KNOW-HOW" shall mean all inventions, technical data,
techniques, knowledge and other information, whether or not patented or
patentable, which are owned or controlled by BioChem (excluding that
developed by NeoPharm) during the course of, and in connection with clinical
development or commercialization of the Product for use in the Field in the
Territory pursuant to this Agreement.
(d) "BUDR NDA" shall mean the NDA for the Product; as more fully described
in Exhibit " 1.1 (d)" hereto.
(e) "CALENDAR QUARTER" shall mean any period of three (3) consecutive
months ending on the last day of March, June, September or December, as the
case may be.
(f) "DOLLARS" and "$" shall mean lawful money of the United States, unless
otherwise indicated.
(g) "DUE DILIGENCE" shall mean all reasonable efforts consistent with
prudent business judgment.
(h) "FIELD" shall mean use as a therapeutic, diagnostic and/or prognostic
agent for any disease indication in humans.
(i) "FDA" means the United States Food and Drug Administration or any
successor or replacement entities thereof.
(j) "GOVERNMENTAL BODY" shall mean (i) any domestic or foreign national,
federal, provincial, state, municipal or other government or body, (ii)
any international or multilateral body, (iii) any subdivision,
ministry, department, secretariat, bureau, agency, commission, board,
instrumentality or authority of any of the foregoing governments or
bodies, (iv) any quasi-governmental or private body exercising any
regulatory, expropriation or taxing authority under or for the account
of any of the foregoing governments or bodies, or (v) any domestic,
foreign, international, multilateral, or multinational judicial, quasi
judicial, arbitration or administrative court, grand jury, tribunal,
commission, board or panel.
(k) "HPB" shall mean the Health Protection Branch of Health Canada or any
successor or replacement entities thereof.
(l) "IMPROVEMENTS" shall mean advances in or modifications to the Product,
developed by or on behalf of, acquired by or made available to NeoPharm and/or
BioChem prior to or during the term of this Agreement.
(m) "LAWS" SHALL MEAN:
(i) all constitutions, treaties, laws, statutes, codes, ordinances,
orders, decrees, rules, regulations, and municipal by-laws,
whether domestic, foreign or international;
(ii) all judgments, orders, writs, injunctions, decisions, rulings,
decrees, and awards of any Governmental Body; and
(iii) all policies, practices and guidelines of any Governmental Body;
in each case binding on or affecting the Party or Person referred to in the
context in which such word is used; and "Law" shall mean any one of them.
(n) "MANAGEMENT COMMITTEE" shall mean that entity organized and acting
pursuant to Article III hereof.
(o) "NDA" shall mean any New Drug Application required to be filed with
the FDA, with respect to the Product, including any amendments or supplements
("sNDA") thereto.
(p) "NDS" shall mean any New Drug Submission, required to be filed with
the HPB, with respect to the Product, including any amendments or supplements
("sNDS") thereto.
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(q) "NEOPHARM KNOW-HOW" shall mean all inventions, technical data,
techniques, knowledge and other information, whether or not patented or
patentable, which are owned or controlled by NeoPharm and are useful in the
manufacture, use or sale of the Product, including the BUdR NDA.
(r) "NET SALES" shall mean the aggregate arms' length gross invoiced sales
price charged for sale for commercial use of the Product sold by BioChem and, if
applicable, BioChem's Affiliates and sublicensees, to non-Affiliated third
Persons in the Territory after deduction of the following items, provided and to
the extent that such items were actually incurred and included in the gross
price charged and do not exceed customary amounts in the market in which such
sale occurred:
(i) trade, quantity and cash discounts or rebates;
(ii) credits or allowances for rejection or return of previously
sold goods;
(iii) any tax or charge (other than an income tax) levied on the
sale, transportation or delivery of a product and borne by
the seller thereof; and
(iv) any charge for freight or insurance.
In determining Net Sales, no allowances or deductions shall be made for any
commissions or sales fees. To the extent that BioChem uses a third Person sales
or marketing organization to sell the Product to wholesalers or dispensers of
the Product, Net Sales shall be calculated starting from the aggregate arm's
length gross invoice sales price charged for sale for commercial use to such
wholesaler or such dispenser, less the deductions listed in items (i) to (iv);
it being understood that "Net Sales" shall be calculated on the basis of the
first arm's length sale of each such Product by BioChem, BioChem's Affiliates or
its sublicensees (as the case may be) to a non-Affiliated third Person.
(s) "PARTY" shall mean NeoPharm or BioChem and, when used in the plural,
shall mean NeoPharm and BioChem.
(t) "PERSON" shall mean an individual, corporation, company, cooperative,
partnership, organization or any similar entity.
(u) "PRODUCT" shall mean any and all pharmaceutical products containing the
chemical agent BUdR, as licensed to BioChem by NeoPharm for the Territory
pursuant to Article II hereof; the whole as more fully described in Exhibit 1.1
(u)" hereto.
(v) "TERRITORY" shall mean Canada and its territories and possessions, as
recognized on the effective date hereof.
1.2 EXHIBITS. The following are the exhibits annexed to and incorporated
in this Agreement by reference and deemed to be a part hereof:
Exhibit "1.1(d)" - Table of Contents and Executive Summary of BUdR NDA;
Exhibit "1.1(u)" - Product Description;
Exhibit "3.1" - Initial Nominees for the Management Committee; and
Exhibit "5.1" - Manufacturing and Supply Agreement.
In the event of any conflict between the provisions of any Exhibit to this
Agreement and the main text of the Agreement, the main text shall prevail.
1.3 RECITALS. The recitals are incorporated herein by reference and
deemed to be part hereof
ARTICLE II
LICENCES
2.1 LICENSE TO BIOCHEM.
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(a) NeoPharm hereby grants to BioChem, and BioChem hereby accepts, the
exclusive right and license to seek regulatory approval for the manufacture,
marketing and sale of and, following such approval, to market, sell and have
marketed and sold, the Product in the Territory for use as a radiosensitizing
agent in the treatment of brain tumors and as a prognostic marker for use in
breast cancer (the "Primary Indications"), and, subject to Subsection 2.1(c),
for use in all other indications in the Field. NeoPharm hereby grants BioChem,
and BioChem hereby accepts, the exclusive right and license to use the NeoPharm
Know-How and Improvements in connection with the foregoing. Promptly following
the execution hereof, and continuously thereafter during the term of this
Agreement as the NeoPharm Know-How and Improvements become available, NeoPharm
shall use Due Diligence in furnishing the NeoPharm Know-How and Improvements to
BioChem. Without limiting the generality of the foregoing, NeoPharm shall use
Due Diligence in providing BioChem with copies of and the right to reference all
NeoPharm Know-How at any time during the term hereof BioChem shall have the
right to use such data solely for the purposes contemplated by this Agreement.
(b) Without limiting the generality of Subsection 2.1(a), NeoPharm agrees
to use Due Diligence in providing additional technical and scientific assistance
to BioChem in connection with BioChem's efforts to obtain HPB approval for any
use of the Product in the Field; provided that such assistance shall not result
in NeoPharm having to conduct any additional clinical trials or other activities
or having to make any additional expenditures not provided for by NeoPharm with
respect to research and development of the Product outside the Territory under
the BUdR NDA. NeoPharm shall, concurrently with any submissions regarding
approval of the Product for use and sale in any indications made by NeoPharm,
its Affiliates or licensees to the FDA or similar Governmental Bodies outside
the Territory, unless prohibited from doing so by a written agreement with a
third Person, provide BioChem with a copy of and the right to reference any and
all NeoPharm Know-How contained in such submissions, as well as of additional
NeoPharm Know- How supplied to such Governmental Bodies. Should NeoPharm be
prohibited from providing BioChem with copies of and a right to reference any
NeoPharm Know-How due to a written confidentiality agreement as aforesaid,
NeoPharm shall use its best efforts to obtain BioChem such copies and right to
reference. BioChem shall be entitled to incorporate data contained in any such
NDA or other application for regulatory approval in any documents BioChem is
required to file with the HPB in an attempt to seek approval to commercialize
the Product in the Territory. At the written request of BioChem, NeoPharm shall
provide, shall cause its Affiliates to provide, or shall use its Due Diligence
to obtain from any of its licensees outside the Territory, written notification
to HPB of BioChem's right to reference any such NDA or other application for
regulatory approval in any NDS filed by BioChem with respect to use of the
Product in the Territory. The Parties acknowledge that, in reviewing BioChem's
NDS for the Product, HPB may require additional information to that which is
contained in the BUdR NDA and/or made available to BioChem pursuant to the
forgoing provisions of this Subsection 2.1(b). Should HPB request such
additional information, and NeoPharm is in possession of or has access to such
information, NeoPharm shall, unless prohibited from doing so by a written
agreement with a third Person, provide copies thereof to BioChem for use
hereunder. BioChem shall be required to reimburse NeoPharm for all reasonable
out-of-pocket expenses NeoPharm incurs in providing such additional information
to BioChem.
(c) Except as otherwise specifically provided for herein, BioChem is under
no obligation, but shall have the right, to conduct research and development
activities in respect of the Product in the Territory. BioChem agrees to use its
Due Diligence in preparing and filing an NDS for the use of the Product in the
Primary Indications. Such NDS shall be based on and filed subsequent to the BUdR
NDA filed by NeoPharm or its licensees outside the Territory. Subject to Section
4.3, BioChem shall assume all expenses relating to the preparation and filing of
the NDS. Subject to Section 2.6, BioChem shall be also be entitled, upon advance
written notice to NeoPharm, to prepare and file NDS(s) for the use of the
Product in the Territory in any one (1) or more additional indications in the
Field (the "Additional Indications").
(d) NeoPharm hereby grants to BioChem the right to conduct clinical trials
and compassionate drug release programs with respect to the Product in the
Territory should BioChem so desire. Should BioChem elect to exercise either of
these options, NeoPharm will provide BioChem with a reasonable amount of Product
for use as clinical trial materials, at no cost to BioChem. Subject to Section
4.3, the costs of carrying out such clinical trials or compassionate release
programs with respect to the Product in the Territory shall be borne by BioChem.
(e) At any time prior to approval by HPB of the Product for use in the
Territory in the Primary Indications, BioChem shall have the right, at BioChem's
sole option:
(i) upon receipt of prior written approval of NeoPharm of the form
and content of any proposed clinical
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trials (which approval shall not be unreasonably withheld or
delayed), to have additional specific clinical trials relating
to the Product (the "Additional Trials") effected within
NeoPharm's overall clinical development program at sites in
the Territory and NeoPharm shall use Due Diligence in
providing assistance to BioChem in this regard. Subject to
Section 4.3, the costs of carrying out Additional Trials with
respect to the Product in the Territory shall be borne by
BioChem; or
(ii) to discontinue all efforts with respect to seeking regulatory
approval of the Product in the Territory, with the result that
the license granted to BioChem hereunder with respect to use of
the Product in the Territory shall terminate, without any payment
or penalty owed from either Party to the other.
BioChem shall notify NeoPharm in writing, at least thirty (30) days in advance
of exercising its option under this Subsection 2.1(e), of BioChem's intention to
exercise such option, which notice shall identify the option BioChem intends to
exercise.
(f) In the event that NeoPharm and/or NeoPharm's licensees elect not to
pursue or continue pursuing FDA approval for the Product in the Primary
Indications in the United States, NeoPharm shall so advise BioChem in writing,
and BioChem shall, within sixty (60) days of receipt of NeoPharm's notice,
advise NeoPharm whether BioChem will use its Due Diligence to pursue HPB
approval for the sale of the Product in the Territory for use in the Field (in
which case, all licenses granted hereunder shall continue in full force and
effect) or terminate its license with respect to such use of the Product,
without further liability in respect thereof.
2.2 SUBLICENSING. BioChem's license rights hereunder shall include the
right to grant sublicenses within the Territory; provided that the granting of
any such sublicense shall not relieve BioChem of its obligations toward NeoPharm
hereunder; including, without limitation, the obligation of BioChem to make the
Net Sales Payment referred to in Article IV hereof with respect to the first
arm's length sale of each product by BioChem's sublicensee. Prior to granting
any such sublicense, BioChem shall consult with NeoPharm in good faith, and
shall pay due consideration to any concerns NeoPharm may have with respect to
the identity of any proposed sublicensee, it being understood however, that any
final decisions to be taken with respect to the granting of sublicenses
hereunder shall be at the sole discretion of BioChem.
2.3 ADVERSE DRUG REACTION REPORTING.
(a) ADVERSE DRUG REACTIONS. Each Party shall promptly advise the other
Party and provide the other Party with a copy by telecopier or overnight
delivery service addressed to the attention of its Vice President, Clinical and
Regulatory Affairs, of any reports of unexpected side effects, adverse reactions
or injury ("ADR Reports") which have been brought to that Party's attention at
any place within or outside the Territory and which are alleged to have been
caused by the Product. ADR Reports shall include publications in journals or
other media. NeoPharm shall use Due Diligence in monitoring all media for
information on factors adversely or positively affecting the Product and shall
promptly advise BioChem of the existence of same. Serious ADR Reports and
unexpected ADR Reports (according to CIOMS criteria) shall be forwarded without
delay by each Party to the other Party as soon as such reports come to either
Party's attention. Any other ADR Reports shall be reported by each Party to the
other on a quarterly basis. The informing Party may, and is invited to, give in
writing its professional evaluation of such reports, in particular with regard
to suspected causality, either together with such reports or as soon as possible
at a later date. NeoPharm shall report such side effects and adverse reaction or
injury to Governmental Bodies and others outside the Territory as appropriate or
necessary within the time limits required by applicable Laws and BioChem shall
report same to the HPB.
(b) REGULATORY AND OTHER INQUIRIES. Upon being contacted by the HPB or any
other Governmental Body in connection with the Product or any other matter which
might reasonably be expected to affect the rights or obligations of either Party
under this Agreement, the Parties shall immediately notify each other. BioChem
shall respond to all inquiries from Governmental Bodies located in the
Territory, including HPB, and NeoPharm shall provide BioChem with reasonable
assistance in this regard. NeoPharm shall respond to all inquiries from
Governmental Bodies outside the Territory regarding the benefits, side effects
and other characteristics of the Product, which responses shall be provided by
NeoPharm on a timely basis. A copy of all such responses shall be provided to
BioChem by NeoPharm
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promptly following their sending to such Governmental Bodies.
(c) PRODUCT RECALL. In the event that either Party determines that an
event, incident or circumstance has occurred which may result in the need for a
recall or other removal of the Product, or any lot or lots thereof, from the
market, such Party shall advise and consult with the other Party as to the
appropriate measures to be taken.
2.4 PERIODIC REPORTS. NeoPharm shall provide BioChem with periodic reports
on NeoPharm's and NeoPharm's licensees' progress in seeking regulatory approvals
for the Product and of plans for commercializing the Product outside the
Territory. As soon as NeoPharm intends to, or as soon as NeoPharm receives a
notice from NeoPharm's licensee that such licensee intends to commence clinical
trials for the Product outside the Territory, NeoPharm shall provide BioChem
with notice thereof. BioChem shall advise NeoPharm of its decision whether or
not to participate in the clinical trials within ninety (90) days of receiving
such notice.
2.5 COMMERCIALIZATION BY BIOCHEM. BioChem agrees to use Due Diligence to
file an NDS for use of the Product in the Primary Indications in the Territory
and, following receipt of a Notice of Compliance ("NOC") from HPB in relation to
such NDS, to market and sell the Product for such indication in the Territory.
BioChem shall also have the right to pursue regulatory approval to commercialize
the Product for any indication in the Field. Accordingly, BioChem shall:
(a) within six (6) months of receipt from NeoPharm of the completed
BUdR NDA, prepare and file an NDS with respect to the use of the
Product in the Primary Indications;
(b) within three (3) months of receipt of an NOC for the Product in
any indication, introduce the Product for sale for use in such
indication in the Territory;
(c) subject to applicable Laws, use Due Diligence to advertise,
promote the sale of and otherwise employ marketing and sales
techniques reasonably designed to develop a demand for the
Product in the approved indications. Such sale, advertising and
promotional efforts shall be consistent with those undertaken by
other companies similarly situated within the industry for
similar products to treat similar indications. BioChem shall be
entitled to use a third Person marketing or sales agency to carry
out the obligations of BioChem under this Subsection 2.5(c); and
(d) upon the reasonable written request of NeoPharm, furnish NeoPharm
with copies of advertising, sales and promotional materials
relating to the Product;
provided that, in the event of any delay by NeoPharm or any third Person in
supplying Product pursuant to the Manufacturing and Supply Agreement referred to
in Article V hereof, the time periods allotted to BioChem for commercialization
under this Subsection 2.5 shall be extended by the duration of such delay in
supply.
2.6 BIOCHEM KNOW-HOW. BioChem hereby grants NeoPharm a royalty-free
license to use the BioChem Know How in NeoPharm's applications for Governmental
Approvals outside of the Territory during the term hereof NeoPharm shall not be
entitled to sublicense any right granted to it under this Section 2.6 unless the
sublicensee or sublicensees provide their Know-How on the same terms as
described herein. From time to time while this Agreement is in force, BioChem
shall use Due Diligence in providing NeoPharm with the BioChem Know-How.
ARTICLE III
MANAGEMENT COMMITTEE
3.1 CREATION OF THE MANAGEMENT COMMITTEE. The Parties hereby agree to the
creation of a Management Committee made up of three (3) representatives of each
Party to facilitate the collaboration contemplated herein. The initial nominees
are shown on Exhibit "3.1" attached hereto. Each Party may change its
representatives on written notice to the other Party.
3.2 REGULAR MEETINGS. During the term of this Agreement, the Management
Committee shall meet at least twice
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annually. Meetings may be called by either Party on thirty (30) days' notice to
the other and, unless otherwise agreed, occur by telephone conference call. A
designated representative of the Party hosting the meeting shall chair that
meeting and a designated representative of the other Party shall act as
secretary of the meeting.
3.3 RESPONSIBILITIES OF THE MANAGEMENT COMMITTEE. Subject to the
recognition by NeoPharm that BioChem possesses the expertise necessary for the
development, sales and marketing of the Product in the Territory and to the
exclusive rights granted to BioChem hereunder, the Management Committee shall be
the primary vehicle for interaction between the Parties with respect to the
collaboration contemplated herein. Without limiting the foregoing, the
Management Committee shall be responsible for:
(a) reviewing and coordinating any NDS for the Product in the
Territory;
(b) reviewing and commenting on clinical trial publications proposed
to be circulated in the Territory by BioChem with respect to the
Product;
(c) monitoring the progress of development (including preclinical and
clinical trials) outside and in the Territory by NeoPharm or its
licensees (other than BioChem) of the Product; and
(d) reviewing and commenting on any proposed alignment of strategies
and/or commercial activities with respect to the use of the
Product in the Field.
Each Party shall disclose proposed agenda items to the other in writing, at
least fifteen (15) days in advance of each meeting of the Management Committee.
3.4 DECISIONS OF THE MANAGEMENT COMMITTEE. Except as specifically provided
for in this Section 3.4, decisions made by the Management Committee will be by
mutual agreement of the members. If disputes arise regarding matters properly
before the Management Committee, which disputes cannot be resolved by the
members of the Management Committee, the Parties will attempt to resolve those
disputes by direct discussions, in person if appropriate, between the Chief
Executive Officers of BioChem and NeoPharm. Notwithstanding anything to the
contrary herein contained, any disagreements with respect to overall development
and commercialization strategy of Product in the Territory which remain
unresolved after following the aforementioned procedure shall be finally
resolved by BioChem, acting reasonably and in good faith.
ARTICLE IV
CONSIDERATION
4.1 INITIAL PAYMENT. As partial consideration for the rights transferred to
BioChem under Article II, upon signature of this Agreement by the Parties
BioChem will pay to NeoPharm a nonrefundable amount of five hundred thousand
Dollars ($500,000) (the "Initial Payment").
4.2 MILESTONE PAYMENTS. In addition to the other payments to NeoPharm
provided for herein, and subject to fulfillment of preconditions to payment
referred to in this Section 4.2, as partial consideration for the rights granted
by NeoPharm hereunder, BioChem shall make payments to NeoPharm in the amounts
and at the times set forth below:
(a) Subject to Subsection 4.2(c), Two Hundred Fifty Thousand Dollars
($250,000), in the form of a nonrefundable payment made within
thirty (30) days of receipt by NeoPharm (or its licensee) of THE
FIRST (and only the first) notice of acceptance from the FDA of
the Product for further review for use as a radiosensitizing
agent for the treatment of brain cancer in humans.
(b) Subject to Subsection 4.2(c), One Hundred Fifty Thousand Dollars
($150,000), in the form of a nonrefundable payment made within
thirty (30) days of receipt by BioChem of THE FIRST (and only the
first) notice of compliance ("NOC") from the HPB for the Product
for use as a radiosensitizing agent for the treatment of brain
cancer in humans.
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(c) Should BioChem receive an NOC for the Product for use as a
radiosensitizing agent for the treatment of brain cancer in
humans prior to the receipt by NeoPharm (or its licensee) of a
notice of acceptance from the FDA for such indication, the Two
Hundred Fifty Thousand Dollar ($250,000) and One Hundred Fifty
Thousand Dollar ($150,000) payments referred to in subsections
(a) and (b) above shall be combined, in the form of a
nonrefundable payment in the amount of Four Hundred Thousand
Dollars ($400,000), to be made by BioChem to NeoPharm within
thirty (30) days of receipt by BioChem of such NOC. Upon payment
of the amount referred to in this Subsection (c), BioChem shall
have no further obligations to NeoPharm with respect to the
payments referred to in Subsections (a) and (b).
(d) Subject to Subsection 4.2(f), Fifty Thousand Dollars ($50,000),
in the form of a nonrefundable payment made within thirty (30)
days of receipt by NeoPharm (or its licensee) of THE FIRST (and
only the first) notice of acceptance from the FDA for the Product
for use as a prognostic marker in the treatment of breast cancer
in humans.
(e) Subject to Subsection 4.2(f), Fifty Thousand Dollars ($50,000),
in the form of a nonrefundable payment made within thirty (30)
days of receipt by BioChem of THE FIRST (and only the first)
notice of compliance ("NOC") from the HPB for the Product for use
as a prognostic marker in the treatment of breast cancer in
humans.
(f) Should BioChem receive an NOC for the Product for use as a
prognostic marker in the treatment of breast cancer in humans
prior to the receipt by NeoPharm (or its licensee) of a notice of
acceptance from the FDA for such indication, the Fifty Thousand
Dollar ($50,000) payments referred to in subsections (d) and (e)
above shall be combined, in the form of a nonrefundable payment
in the amount of One Hundred Thousand Dollars ($100,000), to be
made by BioChem to NeoPharm within thirty (30) days of receipt by
BioChem of such NOC. Upon payment of the amount referred to in
this Subsection (f), BioChem shall have no further obligations to
NeoPharm with respect to the payments referred to in Subsections
(d) and (e).
IT BEING UNDERSTOOD BETWEEN THE PARTIES THAT THE MAXIMUM AMOUNT POTENTIALLY
PAYABLE BY BIOCHEM TO NEOPHARM AS MILESTONE PAYMENTS FOR THE PRODUCT USE IN THE
ALL INDICATIONS IS FIVE HUNDRED THOUSAND DOLLARS ($500,000).
4.3 BUDR CLINICAL TRIALS. Subject to Subsection 2.1(b), NeoPharm will
provide BioChem with all data and results from ongoing clinical trials carried
out with respect to the Product. In addition, on terms and subject to conditions
(including the preparation of a draft budget) to be agreed upon between the
Parties acting reasonably and in good faith and submitted to the Management
Committee for review and approval, BioChem shall be permitted to participate in
any ongoing NeoPharm clinical trial program with respect to the Product. BioChem
shall be entitled to deduct fifty percent (50%) of its costs associated with
such participation against Net Sales payments made by BioChem to NeoPharm under
Section 4.4 hereof
4.4 NET SALES PAYMENT. Subject to Section 4.5, as further consideration
for the rights granted by NeoPharm hereunder, BioChem shall pay to NeoPharm a
portion of the Net Sales of the Product in the Territory (the "Net Sales
Payment"), to be calculated as follows:
(a) Except as otherwise provided for in Subsections 4.4(b) to (d),
BioChem shall pay to NeoPharm, within thirty (30) days following
each Calendar Quarter, an amount equivalent to thirty-five
percent (35%) of Net Sales of the Product in the Territory for
the Calendar Quarter.
(b) Notwithstanding the reference to thirty-five percent (35%) in
Subsection 4.4(a), BioChem shall pay to NeoPharm an amount
equivalent to twenty-five percent (25%) of Net Sales in excess of
Nine Million Canadian dollars (CDN$ 9,000,000) in any given
calendar year.
(c) Notwithstanding the reference to thirty-five percent (35%) in
Subsection 4.4(a), in the event that a
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generic version of the Product is sold in the Territory, the
Net Sales Payment shall be decreased to twenty-five percent
(25%) for Net Sales following the date of entry of the generic
product on the market.
(d) Notwithstanding anything to the contrary herein contained, after
the fifteenth (15th) anniversary date of the first commercial
sale of the Product in the Territory, the Net Sales Payment shall
be decreased to fifteen percent (15%).
4.5 LIMITATIONS ON NET SALES PAYMENT. NOTWITHSTANDIng anything to the
contrary herein contained, the Net Sales Payment otherwise payable by BioChem to
NeoPharm hereunder shall be adjusted as follows:
(a) Should competition for the Product by another product (the "New
Entry Product") which is commercialized, directly or indirectly
by NeoPharm and/or any of its sublicensees in the Territory for
the same indications as the Product cause a reduction in Net
Sales of the Product in the Territory by BioChem, BioChem's
Affiliates or BioChem's sublicensees of twenty percent (20%) or
more from the previous calendar year, then the Net Sales Payment
rate otherwise payable hereunder shall automatically be reduced
by the same percentage as the percentage decrease in Net Sales;
provided that the Parties shall first consult in good faith with
respect to matters which may effect the Net Sales of the Product
in the Territory. Notwithstanding anything to the contrary herein
contained, any final decisions to be taken with respect to the
commercialization of the Product in the Territory shall be at the
sole discretion of BioChem. In no event shall the provisions of
this Subsection 4.5(a) alone operate to reduce the Net Sales
Payment rate otherwise payable with respect to Net Sales of the
Product by more than twenty-five percent (25%);
(b) If the effect on Net Sales of the Product caused by the New Entry
Product in the Territory ceases to exist and the Net Sales of the
Product are restored to the levels which existed immediately
prior to arrival of the New Entry Product on the market in the
Territory, then the Net Sales Payment rate adjustment which
resulted from the application of paragraph (a) shall cease to
apply with respect to the Product, on a going-forward basis;
(c) If NeoPharm is in default of its obligation to supply or procure
supply of the Product under the Manufacturing and Supply
Agreement referred to in Article V hereof, such that BioChem
incurs costs and/or expenses to locate a replacement source of
supply of the Product to BioChem, BioChem may set-off the costs
and expenses of locating such replacement source against Net
Sales Payments due hereunder; and
(d) The effects of all Net Sales Payments rate adjustments hereunder
shall be cumulative. Accordingly, notwithstanding the occurrence
of any one (1) event which results in a reduction or limitation
of Net Sales Payments with respect to the Product, the Net Sales
of the Product shall remain subject to all other Net Sales
Payments rate adjustments set forth in this Agreement.
4.6 MODE OF PAYMENT. All Net Sales Payments to NeoPharm hereunder shall be
made by deposit of a cheque in Canadian dollars made payable to NeoPharm in the
requisite Canadian dollar amount to such bank account as NeoPharm may from time
to time designate by written notice to BioChem. Payments shall be free and clear
of any fees and charges (other than applicable taxes which BioChem is required
to pay or withhold with respect to Net Sales Payments or to pay with respect to
all other payments to be made to NeoPharm under this Agreement).
4.7 RECORDS RETENTION. (5) years after each sale of the Product, BioChem
shall keep (and shall assure that its relevant Affiliates and sublicensees
shall keep) records of such sales in sufficient detail to confirm the accuracy
of the Net Sales calculations hereunder, provided that, in the event BioChem is
required by applicable Law to keep such records for a period of longer than five
(5) years, such longer period shall apply. At the request of NeoPharm, BioChem
shall (and shall assure that BioChem's relevant Affiliates and sublicensees
shall) permit an independent certified or chartered accountant appointed by
NeoPharm (which accountant shall be acceptable to BioChem, acting reasonably),
at reasonable times and upon reasonable notice, to examine these records solely
to the extent necessary to verify such
9
calculations. Such investigation shall be at the expense of NeoPharm unless it
reveals an error on the part of BioChem resulting in NeoPharm having received
less than ninety-five percent (95%) of the Net Sales Payments due to NeoPharm on
BioChem's sales of the Product occurring at any time during the time period
covered by such investigation, in which event BioChem shall pay the reasonable
costs of such investigation. Any such investigation occurring within six (6)
months of a previous investigation shall be at the expense of NeoPharm unless it
reveals an error on the part of BioChem resulting in NeoPharm having received
less than ninety-six percent (96%) of the Net Sales Payments due to NeoPharm on
BioChem's sales of the Product occurring at any time during the time period
covered by such investigation, in which event BioChem shall pay the reasonable
costs of such investigation. Net Sales Payments covering a particular time
period shall not be subject to investigation more than once hereunder.
4.8 NO NON-MONETARY CONSIDERATION FOR SALES. Without the prior written
consent of NeoPharm, BioChem and its Affiliates and agents shall not accept or
solicit any non-monetary consideration for the sale of the Product other than as
would be reflected in Net Sales.
4.9 TAXES. Any tax which BioChem is required to pay or withhold with
respect to royalty payments and to pay with respect to all other payments to be
made to NeoPharm hereunder shall be deducted from the amount otherwise due,
provided that, in regard to any such deduction, BioChem and/or its Affiliates
shall give NeoPharm such assistance as may reasonably be necessary to enable or
assist NeoPharm to claim exemption therefrom or a reduction thereof and shall,
upon request, provide documentation from time to time so as to confirm the
payment by BioChem of such tax to the appropriate Governmental Body.
ARTICLE V
MANUFACTURE AND SUPPLY
5.1 PRODUCT SUPPLY. NeoPharm shall manufacture for and supply or ensure the
manufacture of and supply to BioChem, BioChem's Affiliates and BioChem's
sublicensees of all of their requirements of the Product pursuant to the terms
and conditions of the Manufacturing and Supply Agreement attached hereto as
Exhibit "5.1 ". BioChem desires a secure source of long-term supply of Product
for use in the Territory and NeoPharm wishes to provide BioChem with such a
source of supply and NeoPharm shall use its best efforts to enter into one or
more contracts with material suppliers and contract manufacturers as required in
order to assure the availability of Product for commercialization by BioChem in
the Territory on terms and conditions set forth in the Manufacturing and Supply
Agreement. NeoPharm shall provide a progress report to BioChem on an ongoing
basis of the state of negotiations with such contract manufacturers and
suppliers. NeoPharm agrees to be subject to the penalty provided for in Article
II of Exhibit 5.1 hereto in the event a secure source of supply is not assured
according to the terms of said Article II.
ARTICLE VI
TRADEMARKS
6.1 TRADE MARKS. NeoPharm shall apply in the Territory for the
registration, and, to the extent available, BioChem shall use on all Product
sold in the Territory, trade marks currently in use or substantially similar to
those being used on the same or similar products incorporating the chemical
agent BUdR being sold by NeoPharm, its Affiliates, licensees outside the
Territory. In the event of a third Person action alleging trade xxxx
infringement, the Parties may agree to adopt another trade xxxx for use with the
Product. BioChem shall be consulted by NeoPharm with respect to NeoPharm's
choice of trade xxxx counsel for the Territory and shall also be consulted with
respect to and kept informed of all matters relating to the preparation, filing,
prosecution and maintenance of trade marks for use with the Product in the
Territory. NeoPharm shall afford due consideration to BioChem's comments and
concerns with respect to trade xxxx matters relating to use of the Product in
the Territory.
ARTICLE VII
CONFIDENTIALITY: ETC.
7.1 CONFIDENTIALITY; NON-DISCLOSURE; RESTRICTED USE. Except to the extent
expressly authorized by this Agreement or otherwise agreed in writing, the
Parties agree that the receiving Party shall keep confidential, shall not
publish or otherwise disclose and shall not use directly or indirectly for any
purpose, any information furnished to the
10
receiving Party by the other Party pursuant to this Agreement. The foregoing
obligations shall not apply to any information which the receiving Party can
establish by competent proof:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving
Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act
or omission of the receiving Party in breach of this Agreement;
or
(d) was subsequently disclosed to the receiving Party, other than
under an obligation of confidentiality, by a third Person who had
no obligation to the disclosing Party not to disclose such
information to others;
(e) was independently developed by the receiving Party or its
Affiliates;
The obligations of confidentiality, non-disclosure and non-use hereunder shall
continue until the relevant information falls within the exceptions provided for
in paragraphs (a) to (e) above. Each Party may disclose the other Party's
confidential information to the extent such disclosure is reasonably necessary
in filing or prosecuting patent applications, prosecuting or defending
litigation, complying with applicable Laws, making a permitted sublicense of or
otherwise entering into business relationship with respect to, or exercising,
its rights hereunder, or in conducting clinical trials; provided, however, that
prior to making any such disclosure the Party intending to do so will give
reasonable advance notice to the other Party of such disclosure requirement and
will use its best efforts to secure confidential treatment of such information
prior to its disclosure.
7.2 INFORMATION STORAGE. Without limiting the generality of Section 7.1,
each Party shall retain all the other Party's information in a secure place,
separate from any other information, data, reports, or other documents not
relating hereto, with access to such information limited to those persons who
have a "need to know" such information, for the purposes of carrying out the
retaining Party's obligations under this Agreement.
7.3 RETURN OF INFORMATION. Subject to Article IX, upon termination of this
Agreement, the receiving Party shall promptly return all of the disclosing
Party's information, including all reproductions and copies thereof and shall
immediately delete all references thereto stored electronically, provided that
the receiving Party shall be entitled to retain one copy of the information for
its legal counsel for the purposes of determining its rights and obligations
undo this Article VII.
ARTICLE VIII
INDEMNIFICATION
8.1 INDEMNIFICATION BY NEOPHARM. NeoPharm shall defend, indemnify and hold
harmless, BioChem and BioChem's Affiliates, directors, officers, employees,
shareholders and agents (individually, a "BioChem Indemnified Party", and
collectively, the "BioChem Indemnified Parties"), from and against any and all
liabilities, losses, damages, fines, costs, claims, actions and expenses
incurred by the BioChem Indemnified Parties (including the reasonable fees,
costs and expenses of attorneys and other professional and court costs), based
on any civil, criminal, statutory, regulatory or other claims of liability
(referred to collectively as "Liabilities"), asserted at any time arising out of
or involving a breach or misstatement by NeoPharm of its representations,
warranties, covenants or obligations under this Agreement (including under the
Exhibits hereto).
8.2 GOVERNMENT RESTRICTIONS. Subject to Section 8.1, NeoPharm will not be
liable for any damages on account of any restrictions imposed by any
Governmental Body in the Territory on the use, sale or distribution of the
Product. NeoPharm will not be responsible for any recall, confiscation or other
restriction on the use or sale of the Product by any Governmental Body in the
Territory for any reason other than the negligent acts or omissions of NeoPharm,
its
11
Affiliates, Contract Manufacturers or agents.
8.3 INDEMNIFICATION BY BIOCHEM. BioChem shall defend, indemnify and hold
harmless, NeoPharm and NeoPharm's Affiliates, directors, officers, employees,
shareholders and agents (individually, a "NeoPharm Indemnified Party", and
collectively, the "NeoPharm Indemnified Parties"), from and against any and all
liabilities, losses, damages, fines, costs, claims, actions and expenses
incurred by the NeoPharm Indemnified Parties (including the reasonable fees,
costs and expenses of attorneys and other professional and court costs), based
on any civil, criminal, statutory, regulatory or other claims of liability
(referred to collectively as "Liabilities"), asserted at any time arising out of
or involving (i) a breach or misstatement by BioChem of its representations,
warranties, covenants or obligations under this Agreement (including under the
Exhibits hereto), (ii) the development, use, manufacture, promotion, sale or
other disposition, of any other products which incorporate the Product (herein
"Other Product") by BioChem; or (iii) BioChem's use of any NeoPharm Know-How or
Improvements in Other Products. Without limiting the foregoing, BioChem will
defend, indemnify and hold harmless the NeoPharm Indemnified Parties, from and
against any Liabilities resulting from:
8.3.1 Any product liability claim or other claim of any kind related to
the use by a third Person of any Other Product that was manufactured,
sold or otherwise disposed of by BioChem;
8.3.2 Clinical trials or studies conducted by or on behalf of BioChem
and any of its Affiliates, sublicensees, or assignees to whom NeoPharm
and its Affiliates, sublicensees, Contract Manufacturers or assignees
supplies CTM, including, without limitation, any claim by or on behalf
of a human subject of any such clinical trial or study, and any claim
or deviation, authorized or unauthorized, from the protocols of any
such clinical trial or study and any claim resulting from, or arising
out of, the manufacture or quality by a third Person of any substance,
other than the CTM, administered in any clinical trial or study,
provided, however, that BioChem will not be obligated to indemnify and
hold harmless NeoPharm with respect to claims resulting solely from, or
arising solely out of NeoPharm's negligent or intentional acts or
omissions with respect to the manufacture or quality of the CTM
supplied by NeoPharm and its Affiliates, sublicensees, Contract
Manufacturers or sublicensees.
8.4 EXCEPTIONS. No indemnification shall be made to a BioChem Indemnified
Party or NeoPharm Indemnified Party to the extent any Liabilities arise out of,
result from or involve (i) the breach or misstatement by such Person of its
representations, warranties or obligations under this Agreement or the Exhibits
hereto or (ii) the negligence or willful misconduct of such Person.
Notwithstanding anything to the contrary herein contained, neither Party shall
be liable hereunder to defend, indemnify or hold harmless, any Person for any
claim for indirect, special or consequential damages of any kind.
8.5 INDEMNIFICATION PROCEDURES. A Party (the "indemnitee") which intends to
claim indemnification under this Article VIII shall promptly notify the other
Party (the "indemnitor") in writing of the Liability with respect to which the
claim of indemnification relates. The indemnitee shall permit, and shall cause
its employees and agents to permit, the indemnitor, at its discretion, to settle
any such Liability, the defense and settlement of which shall be under the
complete control of the indemnitor; provided, however, that such settlement
shall not adversely affect the indemnitee's rights hereunder or impose any
obligations on the indemnitee in addition to those set forth herein in order for
it to exercise those rights. No such Liability shall be settled without the
prior written consent of the indemnitor, and the indemnitor shall not be
responsible for any legal fees or other costs incurred other than as provided
herein. The indemnitee, its employees and agents shall co-operate fully with the
indemnitor and its legal representatives in the investigation and defense of any
Liability covered by this indemnification. The indemnitee shall have the right,
but not the obligation, to be represented by counsel of its own selection and
expense.
ARTICLE IX
TERM; TERMINATION
9.1 TERM OF AGREEMENT. This Agreement shall commence as of the date first
above written and shall continue in force until terminated in accordance with
the provisions of this Article IX.
9.2 RETENTION OF LICENSE. Subject to Sections 9.4 and 9.6, upon the
expiration or termination of this Agreement
12
for any reason other than (a) termination by NeoPharm under Section 9.3
following a default by BioChem, (b) termination on notice by BioChem under
Section 9.4 or (c) termination by NeoPharm under Section 9.5 (i.e. bankruptcy,
insolvency, etc. of BioChem), BioChem shall retain a paid-up, royalty-free,
exclusive license (with the right to sublicense) to the NeoPharm Know-How and
Improvements to continue to use, sell and have manufactured and sold, the
Product in the Territory, without any further consideration whatsoever being
payable by BioChem to NeoPharm. Subject to Sections 9.4 and 9.6, upon the
expiration or termination of this Agreement for any reason other than (a)
termination by BioChem under Section 9.3 following a default by NeoPharm, or (b)
termination by BioChem under Section 9.5 (i.e. bankruptcy, insolvency, etc. of
NeoPharm), NeoPharm shall retain a paid-up, royalty-free, nonexclusive license
(with the right to sublicense) to use the BioChem Know-How in NeoPharm's
applications for Governmental Approvals outside of the Territory, without any
further consideration whatsoever being payable by NeoPharm to BioChem.
9.3 TERMINATION ON DEFAULT.
(a) Failure by a Party to comply with its material obligations
contained herein shall entitle the Party not in default to give
to the Party in default notice specifying the nature of the
default and requiring it to make good such default. If such
default is not cured within ninety (90) days after the receipt of
such notice (which period shall be decreased to thirty (30) days
for defaults relating to the payment of sums of money due
hereunder), or diligent steps taken to cure if by its nature such
default could not be cured in ninety (90) days (or thirty (30)
days for defaults relating to the payment of sums of money due
hereunder), the Party not in default shall be entitled, without
prejudice to any of its other rights conferred on it by this
Agreement, and in addition to any other remedies available to it
by Law, to terminate this Agreement.
(b) Failure by a Party to comply with its material obligations
contained in the Manufacturing and Supply Agreement shall entitle
the Party not in default to give to the Party in default notice
specifying the nature of the default and requiring it to make
good such default. If such default is not cured within the cure
period provided for in the Manufacturing and Supply Agreement or
diligent steps taken to cure if by its nature such default could
not be cured in such period, the Party not in default shall be
entitled, without prejudice to any of its other rights conferred
on it by this Agreement or the Manufacturing and Supply
Agreement, and in addition to any other remedies available to it
by Law, to terminate this Agreement.
(c) Any right to terminate arising under Subsections 9.3(a) or (b)
shall be stayed if, during the relevant cure period, the Party
alleged to have been in default shall:
(i) have initiated arbitration in accordance with Section 10.10
below, with respect to the alleged default; and
(ii) be diligently and in good faith cooperating in the prompt
resolution of such arbitration proceedings.
(d) The right of a Party to terminate this Agreement shall not be
affected in any way by its waiver or failure to take action with
respect to any prior default.
9.4 TERMINATION ON NOTICE BY BIOCHEM. Upon one hundred eighty (180) days
notice delivered to NeoPharm at any time following the first (1st) anniversary
of the effective date of this Agreement, BioChem may terminate its participation
in the commercialization program that is the basis of the Agreement. In such
event, all rights granted to BioChem under the Agreement will terminate and
BioChem will make any payments then due or owing or which may become due during
the one hundred eighty (180) day notice period. Subject to Section 9.6, upon
delivery of the notice by BioChem, NeoPharm will have access to the regulatory
filings of BioChem relating to the Product in order that NeoPharm may continue
the commercialization of the Product in a timely manner within the Territory.
9.5 TERMINATION ON BANKRUPTCY: INSOLVENCY; ETC. Either Party may, in
addition to the other remedies available
13
to it at Law, terminate this Agreement by written notice to the other Party, if
the other Party shall have become bankrupt or insolvent, or shall have made an
assignment for the benefit of its creditors, or shall have sought protection or
relief under any bankruptcy, insolvency reorganization or other similar statute,
or there shall have been appointed a trustee or receiver of the other Party. In
the event of termination of this Agreement by BioChem pursuant to and in
accordance with this Section 9.5 (i.e. upon bankruptcy, insolvency etc. of
NeoPharm), BioChem shall retain a paid-up, royalty-free, exclusive license (with
the right to sublicense) to the NeoPharm Know-How and Improvements to continue
to use, sell and have manufactured and sold, the Product in the Territory.
Subject to Section 9.6, in the event of termination of this Agreement by
NeoPharm pursuant to and in accordance with this Section 9.5 (i.e. upon
bankruptcy, insolvency etc. of BioChem), NeoPharm shall retain a paid-up,
royalty-free, non-exclusive license (with the right to sublicense) to use the
BioChem Know-How in NeoPharm's applications for Governmental Approvals outside
of the Territory.
9.6 BIOCHEM KNOW-HOW: SPECIAL PROVISIONS.
(a) The license granted to NeoPharm pursuant to Section 2.6 hereof
shall terminate immediately upon termination of this Agreement by
BioChem pursuant to, and in accordance with, the terms of Section
9.3 and/or Section 9.5.
(b) In the event of termination of this Agreement for any reason
other than by BioChem pursuant to, and in accordance with, the
terms of Section 9.3 and/or Section 9.5, BioChem shall, at
NeoPharm's sole option, but subject to the Parties' agreement as
to the amount payable to BioChem by NeoPharm as provided below,
upon written request of NeoPharm, (i) provide NeoPharm with a
copy of all written data and information then in BioChem's
possession relating to the development of the Product by BioChem
up to that time; and (ii) to the extent permitted by Law,
transfer any NOC or other evidence of HPB approval of the Product
to NeoPharm; provided that any such requests shall be made within
one (1) year following the date as of which the Agreement
terminates.
(c) In consideration of the transfer of such development data and of
the transfer of the NOC or other evidence of HPB approval
referred to in Subsection 9.6(b), NeoPharm agrees to pay BioChem,
promptly upon occurrence of such transfers, the following:
(i) if termination of this Agreement occurs prior to BioChem's
submission of an NDS for the Product, an amount equal to one
hundred percent (100%) of BioChem's, BioChem's Affiliates'
and BioChem's sublicensees' fully absorbed, allocable costs
and expenses in connection with the development of the
Product;
(ii) if termination of this Agreement occurs after to BioChem's
submission of an NDS for the Product but before an NOC is
obtained therefore, an amount equal to one hundred percent
(100%) of BioChem's, BioChem's Affiliates' and BioChem's
sublicensees' fully absorbed, allocable costs and expenses
in connection with the development of the Product; and
(iii) if termination of this Agreement occurs after an NOC has
been obtained for the Product, an amount to be mutually
agreed upon between the Parties with respect to the Product,
which amount shall at least reflect the costs and expenses
incurred by BioChem, BioChem's Affiliates and BioChem's
sublicensees in connection with the development,
commercialization and marketing of the Product.
(d) Notwithstanding anything to the contrary herein contained,
NeoPharm shall not be required to pay BioChem the amounts
described in Subsection 9.6(c) in respect of any transfer of
data, NOC or other evidence of HPB approval, following
termination by NeoPharm under (i) Section 9.3 (default by
BioChem), or (ii) Section 9.5 (bankruptcy, insolvency, etc.
of BioChem).
9.7 RETURN OF KNOW-HOW. Subject to the licenses granted under this Article
IX which are expressly stated to survive termination of this Agreement, upon
termination hereof, each Party shall return other Party, and shall thereafter
14
cease making use of , all of such other Party's Know-How.
9.8 ACCRUED RIGHTS; SURVIVING OBLIGATIONS..
(a) Termination, relinquishment or expiration of this Agreement
for any reason shall be without prejudice to any rights
which shall b have accrued to the benefit of a Party prior
to such termination, relinquishment or expiration. Further,
any such termination, relinquishment or expiration shall not
relieve a Party from obligations which are expressly
indicated to survive termination, relinquishment or
expiration.
(b) Without limiting the foregoing, the provisions of Section
4.6, Article VII, Article VIII, Article IX, Section 10.3 and
Section 10.10 of this Agreement shall survive the expiration
or termination of this Agreement.
ARTICLE X
MISCELLANEOUS PROVISIONS
10.1 RELATIONSHIP OF THE PARTIES. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency or employer-employee
relationship between Parties and/or any of their respective Affiliates or
employees. Neither Party shall incur any debts or make any commitments for the
other.
10.2 ASSIGNMENTS. Except as expressly provided herein, neither this Agreement
nor any interest hereunder shall be assignable, nor any other obligation
delegable, by a Party without the prior written consent of the other; provided,
however, that a Party may assign this Agreement to any Affiliate of it or to any
successor by law or by sale of substantially all of its assets to which this
Agreement relates provided that he assigning Party shall guarantee and remain
liable and responsible for the performance and observance of all its duties and
obligations hereunder. This Agreement shall be binding upon the successors and
permitted assigns of the Parties including assignees of any rights with respect
to the Product, NeoPharm Know-How, BioChem Know-How or Improvements. Any
assignment not in accordance with this Section 10.2 shall be void. Nothing in
this Section 10.2 shall restrict BioChem's right to sublicense under Article II
hereof.
10.3 REPRESENTATIONS AND WARRANTIES. NeoPharm and BioChem each represents and
warrants to the other that:
(a) it is free to enter into this Agreement;
(b) its execution, delivery and performance of this Agreement do
not and will not violate or conflict with any provision of
Law or any other agreement to which it is a party and n o
consents, approval or authorizations, registrations or
filings are required in connection with the execution,
delivery, performance, validity or enforceability of this
Agreement, except as have been obtained or made or set forth
hemin;
(c) (in respect of NeoPharm only) to the best of NeoPharm's
knowledge, after due inquiry, there is no outstanding claim
or allegation that the Product, NeoPharm Know-How and/or
Improvements infringe upon any rights of a third Person nor
any potential claim or allegation that the Product, NeoPharm
Know-How and/or Improvements infringe upon the rights of a
third Person;
(d) (in respect of NeoPharm only) to the best of NeoPharm's
knowledge, after due inquiry, NeoPharm has informed BioChem
about all information in NeoPharm's possession or of which
NeoPharm otherwise has knowledge concerning side effects,
injury, toxicity or sensitivity reactions and incidents (in
each case provided same are material), associated with all
uses, studies, investigations or tests involving the Product
(animal or human) throughout the world, whether or not
determined to be attributable to the Product;
(e) it is a corporation duly organized and validly existing
under the Laws of the jurisdiction indicated
15
above and, by virtue of such jurisdiction's Laws, is in good
standing as a domestic corporation of such jurisdiction;
(f) it is qualified to do business in all jurisdiction in which
such qualification is necessary in order to perform its
obligations hereunder;
(g) the execution, delivery and performance by it of this
Agreement have been duly authorized by all requisite
corporate action and each such document, when signed, will
constitute its legal, valid and binding obligation,
enforceable according to its terms and condition.
10.4 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver
such further instruments and to do all such other acts as may be reasonably
necessary or reasonably appropriate in order to carry out the purposes and
intent of this Agreement.
10.5 NO TRADE XXXX RIGHTS. Except Party as otherwise specifically provided
for herein (including in the Exhibits hereto), no right, express or implied, is
granted hereby to a Party to use in any manner the name or any other trade name
or trade xxxx of the other Party.
10.6 PUBLIC ANNOUNCEMENTS. If either Party wishes to make a public disclosure
concerning this Agreement or the terms hereof, the other Party shall be provided
with an advance copy of the proposed disclosure and shall have three (3)
business days within which to approve or disapprove thereof unless the law
requires immediate disclosure in which case the Party will endeavor to give
notice thereof as soon as possible to the other Party. Approval shall not be
unreasonably withheld by either Party. Absent approval, no public disclosure
concerning this Agreement or the terms hereof shall be made by either Party,
except to the extent required to Law.
10.7 ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement (including
the Exhibits hereto), together with the Confidentiality and Non-Disclosure
Agreement signed by the Parties on May 12, 1997, constitutes and
contains the entire understanding and agreement of the Parties and cancels and
supersedes any and all prior negotiations, correspondence, understandings and
agreements between the Parties, whether oral or written, respecting the subject
matter hereof, including, without limitation, the letter agreement between
Parties dated February 10, 1997. No waiver, modification or amendment of any
provision of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
10.8 APPLICABLE LAW. This Agreement shall be governed by and interpreted in
accordance with the Laws of the State of New York and shall be treated in all
respects as a New York contract.
10.9 NOTICES AND DELIVERIES. Any notice, request, delivery, approval or
consent required or permitted to be given under this Agreement shall be in
writing and shall be deemed to have been sufficiently given if delivered
personally, transmitted by telecopier (confirmation of receipt by confirmed
facsimile transmission being deemed receipt of communication sent by telecopy)
or five (5) days after it was sent, by registered letter (or its equivalent) to
the party to which it is directed as its address shown below or such other
address as such Party shall have last given by notice delivered in accordance
herewith to the other Party:
(a) If to BioChem, addressed to:
BIOCHEM THERAPEUTIC INC.
000 Xxxxxx, Xxxxxxxx Xxxxxxxxx
Xxxxx, Xxxxxx, Xxxxxx
X0X 0X0
Attention: Mr. Xxxxxxx Xxxx
Telecopier: (000) 000-0000;
with a copy to:
16
BIOCHEM PHARMA, INC.
at the same address
Attention: Xx. Xxxxxxx Xxxxxxx, VP, Legal Affiairs and
Corporate Secretary
Telecopier: (000) 000-0000
(b) If to NeoPharm, addressed to:
NEOPHARM INCORPORATED
000 Xxxx Xxxxxxxx
Xxxxx 000
Xxxx Xxxxxx, Xxxxxxxx, XXX 00000
Attention: Xx. Xxxxxxxx X. Xxxx, PH.D., Vice President,
Corporate
Telecopier: (000) 000-0000
with a copy to:
XXXXX, XXXXXX, XXXXXX & XXXXXXXXXX, P.C.
22nd Floor, IBM Plaza
000 Xxxxx Xxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxx XXX 00000-0000
Attention: Xxxxxxxxxxx X. Xxxxxxx, Esq.
Telecopier: (000) 000-0000
10.10 DISPUTES.
(a) The Parties shall mutually consult in good faith in an attempt to
settle amicably in the spirit of cooperation any and all disputes
arising out of or in connection with this Agreement or questions
regarding the interpretation of the provisions hereof.
(b) Subject to Section 3.4, each dispute arising out of or in
connection with this Agreement or question regarding the
interpretation hereof which cannot be settled amicably within
sixty (60) days from the date of notification of either Party to
the other of such dispute or question, which notice shall specify
the details of such dispute or question, shall be finally settled
by binding arbitration, conducted, in English, in accordance with
the Commercial Arbitration Rules of the American Arbitration
Association, by one (1) arbitrator appointed in accordance with
such Rules. If the Parties cannot agree on the arbitrator to be
so appointed, each Party shall be entitled to appoint one (1)
arbitrator, and the two (2) arbitrators so appointed shall agree
upon a third. The arbitrator(s) shall have the technical
expertise required to understand and arbitrate the dispute. The
arbitration carried out hereunder shall apply to the exclusion of
regular legal means, provided that the rights of the Parties in
urgent situations in which time is of the essence to obtain
proper remedies in court of Law shall remain unimpaired.
(c) Any arbitration referred to herein shall be held in Lake Forest,
Illinois if initiated by BioChem an din Montreal, Quebec, if
initiated by Neo Pharm.
(d) The costs of any arbitration hereunder, including administrative
and arbitrator(s) fees, shall be shared equally by the Parties,
but each Party shall bear its own costs and attorneys' and
witness' fees, provided however, that the prevailing Party, if
determined by the arbitrator(s), shall be entitled to an award
against the other Party in the amount of the prevailing Party's
costs (including arbitration costs) and reasonable attorneys' and
witness' fees.
(e) There shall be no appeal from the decision or findings of the
arbitrator(s), which shall be final and binding upon the Parties
and may be entered in any court having proper jurisdiction.
17
10.11 NO THIRD PARTY BENEFICIARIES. Except as specifically provided in this
Agreement, no Person not a Party to this Agreement, including any employee of
any Party to this Agreement, shall have or acquire any rights by reason of this
Agreement, nor shall any Party hereto have any obligations or liabilities to
such other Person solely by reason of this Agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized officers as of the day and year first above
written, each copy of wich shall for all purposes be deemed to be an original.
NEOPHARM INCORPORATED
witness /s/ Xxxxx Xxxxx /s/ Xxxxxxxx X. Xxxx
-------------------- ------------------------------------------
per: Xx. Xxxxxxxx X. Xxxx, Ph.D., Vice President,
Corporate Development
witness
--------------------
BIOCHEM THERAPEUTIC INC.
witness
-------------------- /s/ Xxxxxxx Xxxx
-------------------------------------------
per: Xxxxxxx Xxxx, President
/s/ Xxxxx Xxxxxx
-------------------------------------------
per: Xx. Xxxxx Xxxxxx, Vice-President,
witness /s/ Lucy Ameuol Business Development
--------------------
18
EXHIBIT 1(d)
TO THE
COLLABORATION AGREEMENT
DATED MAY 12, 1997
BETWEEN
BIOCHEM THERAPEUTIC INC. ("BIOCHEM") AND NEOPHARM INCORPORATED ("NEOPHARM")
TABLE OF CONTENTS OF BUDR NDA
19
EXHIBIT 1(u)
TO THE
COLLABORATION AGREEMENT
DATED MAY 12, 1997
BETWEEN
BIOCHEM THERAPEUTIC INC. ("BIOCHEM") AND NEOPHARM INCORPORATED ("NEOPHARM")
PRODUCT DESCRIPTION
20
EXHIBIT 3.1
TO THE
COLLABORATION AGREEMENT
DATED MAY 12, 1997
BETWEEN
BIOCHEM THERAPEUTIC INC. ("BIOCHEM") AND NEOPHARM INCORPORATED ("NEOPHARM")
INITIAL NOMINEES FOR THE MANAGEMENT COMMITTEE
BIOCHEM: XXXXXXX XXXX; XXXXXX XXXXXX; AND XXXXXXXX XXXXXXX
NEOPHARM: XX. XXXXXXXX X. XXXX; XX. XXXXXXX XXXXXX; AND XX. XXXXXXX X. XXXXXX
21
EXHIBIT 5.1
TO THE
COLLABORATION AGREEMENT
DATED MAY 12, 1997
BETWEEN
BIOCHEM THERAPEUTIC INC. ("BIOCHEM") AND NEOPHARM INCORPORATED ("NEOPHARM")
MANUFACTURING AND SUPPLY AGREEMENT
[see Attached]
22
MANUFACTURING AND SUPPLY AGREEMENT
This MANUFACTURING and SUPPLY AGREEMENT is dated and effective as of the 12th
day of May 1997;
BY AND BETWEEN: BIOCHEM THERAPEUTIC INC., a corporation
incorporated under the laws of Canada, with its
principal place of business located at 000
Xxxxxx-Xxxxxxxx Xxxxxxxxx, Xxxxx, Xxxxxx, Xxxxxx, X0X
0X0:
(hereinafter referred to as "BioChem"),
AND: NEOPHARM INCORPORATED, a corporation incorporated
under the laws of the State of Delaware, with a place
of business at 000 Xxxx Xxxxxxxx, Xxxxx 000, Xxxx
Xxxxxx, Xxxxxxxx, Xxxxxx Xxxxxx of America, 60045
(hereinafter referred to as "NeoPharm")
RECITALS:
A. NeoPharm manufactures and supplies Product (as defined in the
Collaboration Agreement of even date herewith between the
Parties (the "Collaboration Agreement"));
B. BioChem has been granted certain rights from NeoPharm under
the Collaboration Agreement to the Product for use as a
radiosensitizing agent for the treatment of cancer in humans
and as a prognostic marker for breast cancer;
C. BioChem wishes to purchase from NeoPharm and NeoPharm wishes
to manufacture for and supply to BioChem, the Product on the
terms and subject to the conditions set forth in this
Agreement;
NOW, THEREFORE, in consideration of the various premises and undertakings set
forth herein, the Parties agree as follows:
ARTICLE I
INTERPRETATION
1.1 Unless otherwise specifically provided herein, the following terms shall
have the following meanings:
(a) "AGREEMENT" shall mean this Manufacturing and Supply Agreement and all
instruments supplemental hereto or in amendment or confirmation hereof;
"herein", "hereof", "hereto", "hereunder"
and similar expressions mean and refer to this Agreement and not to any
particular Article, Section, Subsection or other subdivision; "Article",
"Section", "Subsection" or other subdivision of this Agreement means and refers
to the specified Article, Section, Subsection or other subdivision of this
Agreement.
(b) "CGMP" shall mean U.S. Current Good Manufacturing Practices, as established
from time to time by the FDA.
(c) "COLLABORATION AGREEMENT" shall mean the agreement entered into of even date
between the Parties, to which this Agreement forms EXHIBIT "5.1".
(d) "CONTRACT MANUFACTURER" shall mean any Person designated now or hereafter
under Section 2.4 hereof to manufacture Product.
(e) "DELIVERY DATE" shall mean a date for which delivery of Product to BioChem
by NeoPharm is requested by BioChem in a purchase order and confirmed by
NeoPharm pursuant to Article V hereof.
(f) "DOLLARS" AND "$" shall mean lawful money of the United States of America,
unless otherwise indicated.
(g) "FDA" shall mean the United States Food and Drug Administration, or any
successor or replacement entity thereto.
(b) "GAAP" shall mean United States generally accepted accounting practices,
consistently applied.
(I) "MANUFACTURING COSTS" shall mean NeoPharm's manufacturing costs for Product,
which shall consist of (i) to the extent Product is manufactured by NeoPharm,
NeoPharm's fully-allocated manufacturing cost (including overhead, as determined
and allocated in accordance with customary accounting practices of NeoPharm),
but excluding costs for excess manufacturing capacity not reasonably related to
projected demand for Product, the whole as computed using standard accounting
procedures of NeoPharm, applied on a consistent basis in accordance with GAAP,
and (ii) to the extent Product is manufactured by a third Person on behalf of
NeoPharm, reasonable amounts actually paid to the third person for such Product,
which shall, in any event, be no more than which would be paid to an independent
third Person in an arm's length transaction; in each case, supported by
appropriate documentation.
(j) "SPECIFICATIONS" shall mean, collectively, the procedures, requirements,
standards and other information relating to Product set forth in EXHIBIT "6.1"
hereto, as the same may be amended from time to time in accordance with Section
6.2 hereof.
1.2 All other capitalized terms herein shall have the meaning ascribed thereto
in the Collaboration Agreement, as the case may be.
1.3 The following are the exhibits annexed to and incorporated in this Agreement
by reference and deemed to be a part hereof:
EXHIBIT "4.4" - BioChem Standard Purchase Order Form;
EXHIBIT "6.1" - Specifications; and
EXHIBIT "9.1" - Trade Xxxx License.
In the event of any conflict between the provisions of any exhibit to this
Agreement and the main text of the Agreement, the main text shall prevail.
1.4 The recitals are incorporated herein by reference and deemed to be part
hereof.
ARTICLE II
SUPPLY
2.1 NeoPharm hereby agrees to manufacture for and supply to BioChem, and BioChem
hereby agrees to obtain from NeoPharm, BioChem's total requirements of Product
for:
(a) use in seeking HPB approval to commercialize the Product in
the Territory, including the carrying out of preclinical or
clinical trials for the purpose of obtaining or maintaining
such approval ("Clinical Trial Material" or "CTM"); and
(b) following receipt of HPB approval of the Product, sale in the
Territory ("Commercial Material").
2.2 Notwithstanding the foregoing, NeoPharm shall not supply, and BioChem shall
not be obligated to obtain from NeoPharm, Product, unless and until NeoPharm or
NeoPharm's Contract Manufacturer, as the case may be, shall have complied with
all Laws governing the manufacturing and supply of products such as the Product.
2.3 BioChem desires a secure source of long-term supply of Product and NeoPharm
has agreed to arrange such secure source of long-term supply, NeoPharmn agrees
to use its best efforts to enter into one or more contracts with material
suppliers and contract manufacturers as required in order to assure the
availability of Product for BioChem's requirements as stipulated in this
Agreement. NeoPharm shall provide a progress report to BioChem on an ongoing
basis of the state of negotiations with such contract manufacturers and
suppliers.
2.4 NeoPharm agrees to assure BioChem, pursuant to the terms of this Agreement,
of the adequate supply of Product throughout the term of this Agreement
2.5 In the event that NeoPharm is unable, despite having used its best efforts,
to secure such manufacture and supply of Product within a period of one hundred
eighty (180) days from the date of this Agreement, then NeoPharm shall be
subject to and agrees to pay a penalty for each day beyond said one hundred
eighty (180) days of: (i) for the first thirty (30) days beyond one hundred
eighty (180) days, one thousand dollars ($1,000) per day; (ii) for each day
beyond thirty (30) days but less than sixty-one (61) days, two thousand dollars
($2,000) per day; (iii) for each day beyond sixty (60) and less than ninety-one
(91) days, three thousand dollars ($3,000) per day; (iv) for each day beyond
ninety (90) days and less than one hundred twenty-one (121) days, five thousand
dollars ($5 000) per
day; and (v) for each day beyond one hundred twenty (120) days, seven thousand
dollars ($7,000) per day until the execution of the Contract Manufacturer supply
agreement; provided, however, that in no event shall the aggregate amount of the
penalty payable hereunder exceed the sum of five hundred thousand dollars
($500,000).
2.6 Should the penalty provision provided for in Section 2.5 hereof be found
invalid or unenforceable for any reason whatsoever, NeoPharm agrees that the
total amounts accrued and which otherwise have been owing pursuant to such
penalty provision shall represent a debt owing by NeoPharm to BioChem which
BioChem may offset against any amount owed or owing by BioChem to NeoPharm at
any time.
2.7 In addition, during the term of this Agreement, in the event that NeoPharm
enters into further manufacturing and supply agreements with Contract
Manufacturers and/or material suppliers of Product, NeoPharm shall use its best
efforts to include BioChem as a third party beneficiary of same on terms as
favorable as those offered to NeoPharm in respect of Product.
2.8 NeoPharm agrees, during the term of this Agreement, not to manufacture for,
distribute, sell or otherwise provide, directly or indirectly, any Product to
any Person other than BioChem, anywhere in the Territory. To the extent not
inconsistent with applicable Laws, NeoPharm further agrees not to manufacture
for, distribute, sell or otherwise provide any Product to any Person as
aforesaid, where NeoPharm or BioChem has reasonable grounds to believe that such
Person may, directly or indirectly, sell or cause to be sold in the Territory,
such Product; provided that, should NeoPharm exercise its right hereunder to
supply Product to BioChem through a Contract Manufacturer, NeoPharm shall use
its best efforts to ensure that such Contract Manufacturer shall agree in
writing to terms substantially similar to those contained in this Section 2.8.
2.9 Subject to Section 2.8, throughout this Agreement, all references to
"NeoPharm" that relate to its rights and duties as a manufacturer or supplier of
Product shall be deemed to include any Contract Manufacturer designated by
NeoPharm to manufacture Product for supply to BioChem hereunder provided,
however, that any such Contract Manufacturer has complied with all relevant
Governmental Bodies as well as all applicable Laws and provided further, that,
notwithstanding any such designation, NeoPharm shall remain liable along with
any such Contract Manufacturer, to BioChem under this Agreement for any breach
by such Contract Manufacturer of its obligations hereunder.
ARTICLE
PRICE
3.1 The Parties hereby acknowledge and agree that all Product to be supplied to
BioChem by NeoPharm hereunder shall be supplied at no charge to BioChem, the
consideration for such supply being included in the Net Sales Payment to be made
under the Collaboration Agreement.
ARTICLE IV
FORECASTS: ORDERING
4.1 In order to permit NeoPharm to regularly supply BioChem with Commercial
Material for sale in the Territory, at least four (4) months prior to the first
expected date of delivery of such Commercial Material, BioChem shall provide
NeoPharm with a non-binding forecast of BioChem's estimated
requirements of Commercial Material for the twelve (12) month period following
said expected date of delivery. Such twelve (12) month forecast shall be updated
on a monthly basis.
4.2 A firm, binding purchase order shall be provided by BioChem to NeoPharm with
respect to Products to be supplied hereunder other than in accordance with
Section 4.3, at least four (4) months prior to the scheduled delivery date of
such Products. NeoPharm shall promptly acknowledge the acceptance of such orders
by pro forma invoice or similar written instrument, and shall advise BioChem of
the anticipated shipment date of the quantity of Products so ordered. Upon
acceptance by NeoPharm, each such order shall become firm and binding on the
Parties, and, except as specifically provided for herein, may not be modified
without the prior written approval of the Parties. If BioChem requires
quantities of Products exceeding those mentioned in the relevant forecast
referred to in Section 4.1 by more than fifteen percent (15%), NeoPharm shall
use reasonable efforts to supply same within the aforementioned four (4) month
period, unless NeoPharm has informed BioChem in writing within thirty (30) days
of receipt of BioChem's purchase order of NeoPharm's inability to supply the
quantities referred to in such order. If NeoPharm so informs BioChem, the
Parties shall, without delay and in good faith, negotiate a delivery plan for
the excess amounts set out in such order.
4.3 BioChem shall order a sufficient quantity of Product in the form of CTM from
NeoPharm, for use in seeking HPB approval of the Product and for use in
accordance with the terms of the Collaboration Agreement. The first such order
for CTM shall be placed within one hundred and twenty (120) days following the
date of execution hereof. Subsequent orders shall be placed by BioChem at least
ninety (90) in advance of the required delivery date for such CTM, as stated on
BioChem's purchase order.
4.4 All orders for Product to be purchased hereunder shall be placed on
BioChem's standard purchase order form, a copy of which is attached hereto as
EXHIBIT "4.4". Such purchase order shall specify an anticipated delivery date,
which, once confirmed as acceptable by NeoPharm by pro forma invoice or other
similar written instrument, shall be binding on the Parties (the "Delivery
Date"). In the event of any inconsistency between this Agreement and the terms
of any such purchase order, the terms of this Agreement shall prevail. BioChem
shall have the right, without prejudice to any other rights it may have under
Law, to cancel any orders placed hereunder which have not been filled within
twenty (20) days following the Delivery Date applicable to such order.
4.5 Notwithstanding anything to the contrary herein contained, after receipt by
BioChem of an NOC for the Product in the Territory, should a Net Sales Payment
not be made under the Collaboration Agreement with respect to a particular
shipment of Product within six (6) months of delivery of such Product to BioChem
hereunder, NeoPharm shall invoice BioChem for, and BioChem agrees to advance to
NeoPharm within ten ( 10) days following receipt of such invoice, an amount
equal to the Manufacturing Cost of such Product. Any amounts advanced by BioChem
to NeoPharm under this Section 4.5 shall be deducted, on a Dollar for Dollar
basis, from Net Sales Payments subsequently made with respect to such Product
under Section 4.4 of the Collaboration Agreement.
ARTICLE V
SHIPMENTS
5.1 Delivery of Product to be supplied by NeoPharm to BioChem hereunder shall be
made FOB (per Incoterms, ICC Ed. 1990) NeoPharm's plant in Lake Forest,
Illinois, or such Contract Manufacturer's plant as agreed in writing between the
Parties. BioChem shall arrange for insurance
for all Product supplied hereunder, covering the journey from NeoPharm's
shipping dock in Lake Forest, Illinois (or from any Contract Manufacturer's
shipping dock, as the case may be), until acceptance by BioChem in Quebec, which
insurance shall be at the sole expense of BioChem. All shipments shall be made
pursuant to written instructions received by NeoPharm from BioChem. NeoPharm
shall provide shipping documentation in accordance with that requested in
BioChem's purchase order, as well as a certificate of analysis and such other
documentation relating to the Product as BioChem may request in writing from
time to time, for each production lot included in a- shipment.
5.2 NeoPharm shall package Product for shipment hereunder in accordance with
NeoPharm's current (as at the date of shipment) standard practices and in
accordance with the Specifications and all applicable Laws.
5.3 Product shipped by NeoPharm hereunder shall have a remaining shelf-life as
of the date of such shipment equal to at least three-quarters (3/4) of the total
approved shelf-life of such Product, as listed in the Specifications. NeoPharm
shall fill each purchase order placed by BioChem hereunder from the same batch
of Product.
5.4 In the event of a lost or damaged shipment of Product hereunder, NeoPharm
shall use best efforts to replace said shipment within sixty (60) days of
notification of such loss or damage by BioChem.
ARTICLE VII
SPECIFICATIONS; OUALI 1Y CONTROL: RECORDS
6.1 Product supplied by NeoPharm to BioChem hereunder shall be manufactured,
labeled, stored and shipped by or on behalf of NeoPharm in compliance with all
applicable Laws and in accordance with the Specifications set forth in the
document attached hereto as EXHIBIT "6.1"; provided that BioChem shall be
responsible for supplying NeoPharm with artwork and sample materials for
finished labeling of the Product appropriate for use in the Territory. The
Parties hereby agree that NeoPharm shall be responsible for ensuring that
finished labels correspond to the artwork and samples provided by BioChem
hereunder, and that such labels shall be properly affixed to the Product, and
that BioChem shall be responsible for the content of the artwork and sample
materials. Without limiting the generality of the foregoing, NeoPharm shall
obtain and maintain all licenses, permits and registrations necessary to
manufacture and supply Product hereunder.
6.2 Neither Party may supplement or amend the Specifications without the other
Party's prior written approval, which approval shall not be unreasonably
withheld or delayed; provided, however, that the Specifications shall be amended
or supplemented if required by the FDA or any other Governmental Body. Unless
otherwise specifically required by Law, all such changes shall be approved in
writing at least sixty (60) days prior to their implementation.
6.3 NeoPharm shall be responsible for performing all quality control tests and
assays on raw and packaging materials used in preparing and shipping the
Product, as well as on the Product, all in a manner consistent with the
Specifications and with NeoPharm's internal quality control procedures.
NeoPharm shall retain records pertaining to such testing and shall, upon written
request from BioChem, provide BioChem with copies of such records. Without
limiting the generality of the foregoing, NeoPharm shall prepare and maintain
batch records and file samples, properly stored, from each lot or batch of
Product supplied to BioChem hereunder. Upon termination of this Agreement for
any reason other than a default on the part of BioChem, NeoPharm shall transfer
the originals or certified true copies of the originals of such batch records
and file samples to BioChem.
6.4 NeoPharm shall make available to BioChem all records pertaining to complaint
investigations and/or inspections by Governmental Bodies relating to any site
where Product is manufactured or packaged for shipment, including a record of
any actions taken by or on behalf of NeoPharm in response to such investigations
and/or inspections. Each Party agrees to promptly (i.e. within two (2) business
days of being notified of such complaints or inquiries, or sooner as provided by
Law) inform the other Party of any complaints or inquiries that raise
potentially serious quality, health or safety concerns regarding the Product.
6.5 Each Party shall keep complete and accurate records pertaining to the
manufacture and supply of Product for at least five (5) years, or for such
longer period if and as required by Law. Each Party shall make such records
available to the other Party, for such lawful purpose as the other Party may
reasonably request in writing.
6.6 BioChem shall have the right, upon reasonable notice to NeoPharm, during
normal business hours, no more frequently than reasonably necessary and under
appropriate confidentiality agreements, to send authorized representatives to
manufacturing facilities where Product is manufactured, to audit any
manufacturing and testing operations that BioChem deems reasonably appropriate
to confimn that production of each batch of Product is in compliance with cGMP.
Upon request, NeoPharm agrees to notify BioChem of the next scheduled production
run of Product. NeoPharm agrees to co-operate with BioChem's authorized
representatives in their conduct of such audits. Nothing in this Section 6.6
shall limit or detract from NeoPharm's obligation to manufacture and supply
Product in compliance with all applicable Laws and in accordance with the
Specifications.
ARTICLE VII
NONCONFORMING PRODUCT
7.1 BioChem shall inspect each shipment of Product received hereunder as soon as
practicable following receipt thereof. BioChem shall be deemed to have accepted
delivery of the Product in good order and condition, unless BioChem has notified
NeoPharm in writing of any short delivery or nonconformity in respect of a
shipment of Product within thirty (30) days following receipt of same.
Notwithstanding the foregoing, in the case of any nonconformity which is not
readily apparent or discoverable upon reasonable inspection within such thirty
(30) day period, any claim of nonconformity with respect thereto shall not be
deemed waived and delivery of the Product shall not be deemed to have been
accepted if BioChem notifies NeoPharm as soon as practicable, but no later than
fifteen (15) days, following the date on which BioChem learns of such
nonconformity.
7.2 Any claim of nonconformity hereunder shall be accompanied by a report of
analysis of the allegedly nonconforming Product, which report shall be prepared
by or on behalf of BioChem. If,
after analyzing a sample of such Product, NeoPharm confirms BioChem's claim of
nonconformity, NeoPharm shall, at BioChem's election, replace the nonconforming
Product with conforming Product at NeoPharm's expense or refund the entire
purchase price therefore to BioChem. Pursuant to written directions from
NeoPharm, BioChem shall either return the nonconforming Product to NeoPharm, or
destroy same, in each case, at NeoPharm's expense. If NeoPharm's analysis does
not confirm BioChem's claim of nonconformity, the Parties shall commence good
faith discussions with a view to resolving the issue. In the event the issue
cannot be resolved within thirty (30) days following the start of such
discussions, a sample of the Product in dispute shall be submitted to an
independent laboratory, mutually accepted by the Parties, for testing. The
results of such testing shall be binding upon the Parties. The Party whose
assertion as to the Product in question was not borne out by the results of the
testing by the independent laboratory shall bear all costs relating to such
testing.
7.3 Notwithstanding anything to the contrary contained in this Article VII,
NeoPharm's warranties and indemnification obligations hereunder shall survive
the failure by BioChem to reject any shipment of Product.
ARTICLE VIII
CONFIDENTIALITY: ETC.
8.1 CONFDENTIALITV: NON-DISCLOSURE: RESTRICTED USE. The Parties agree that the
provisions of Article VII of the Collaboration Agreement shall apply, MUTATIS
MUTANDIS, to any information furnished by one Party to the other Party pursuant
to this Agreement.
ARTICLE IX
TRADE MARKS
9.1 NeoPharm shall apply in the Territory for the registration, and, to the
extent available, BioChem shall use on all Product sold in the Territory, trade
marks currently in use or substantially similar to those being used on the same
or similar products incorporating the chemical agent BUdR being sold by
NeoPhartn, its Affiliates, or licensees outside the Territory. In the event of a
third Person action alleging trade xxxx infringement, the Parties may agree to
adopt another trade xxxx for use with the Product. BioChem shall be consulted by
NeoPharm with respect to NeoPharm's choice of trade xxxx counsel for the
Territory and shall also be consulted with respect to and kept informed of all
matters relating to the preparation, filing, prosecution and maintenance of
trade marks for use with the Product in the Territory. NeoPharm shall afford due
consideration to BioChem's comments and concerns with respect to trade xxxx
matters relating to use of the Product in the Territory, provided that NeoPharm
shall have the ultimate authority and responsibility for decisions relating to
such matters. In exercising such authority with respect to the choice of trade
xxxx counsel throughout the Territory, NeoPharm undertakes to consider any
BioChem concerns with respect to actual or perceived conflicts of interest
BioChem may have with such counsel. BioChem shall have the right to use any one
(l) or more trade marks of its choosing in conjunction with its sale of the
Product in the Territory, provided such trade xxxx(s) is (are) not confusingly
similar with the NeoPharm Trade Marks. As between the Parties, NeoPharm, acting
reasonably and in good faith, shall have the ultimate authority for determining
what constitutes a confusingly similar xxxx.
The Parties agree to be bound by the terms and conditions contained in the Trade
xxxx License Agreement attached hereto as Exhibit 9. l with respect to BioChem s
use of the NeoPharm Trade Marks.
ARTICLE X
WARRANTIES
10.1 NeoPharm hereby covenants, represents and warrants to BioChem, and
acknowledges that BioChem has relied on such covenants, representations and
warranties in entering this Agreement, as follows:
(a) On the date of shipment, all Product supplied hereunder shall
be manufactured, stored and shipped by NeoPharm in accordance
with the Specifications and in conformance with all applicable
Laws;
(b) NeoPharm shall have good and marketable title to all Product
supplied hereunder, which title shall pass to BioChem free and
clear of any lien, encumbrance or other conflicting interest
of any kind;
(c) NeoPharm has provided BioChem with true and complete copies of
any current agreements relating to the Product that NeoPharm
has with Contract Manufacturers. All such agreements are in
full force and effect, with no breach thereunder by any party
thereto, and no event, failure or condition has occurred
which, with the passage of time and/or the giving of notice,
would result in a default or breach by either party thereto or
permit the termination, modification or acceleration of any
obligations or rights thereunder; and
(d) To the best of NeoPharm's knowledge after due inquiry,
NeoPharm has informed BioChem about all information in
NeoPharm's possession or control concerning side effects,
injury, toxicity or sensitivity reactions and incidents
associated with all uses, studies, investigations or tests
involving the Product (animal or human) throughout the world,
whether or not determined to be attributable to the Product.
10.2 . EXCEPT AS SPECIFICALLY PROVIDED FOR IN SECTION 10.1 AND SUBJECT TO
ARTICLE XI, NEOPHARM MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED
(i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE; OR (iii) EXCEPT AS SPECIFICALLY PROVIDED FOR IN SECTION 10.1, THAT
BioChem's USE OF THE PRODUCT OR NeoPharm's Know-How OR Improvements WILL NOT
INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER PROPRIETARY OR PROPERTY
RIGHTS OF OTHERS. EXCEPT AS SPECIFICALLY PROVIDED FOR IN SECTION 10.1 AND
SUBJECT TO ARTICLE XI, NeoPharm WILL NOT BE LIABLE TO BioChem, BioChem's
SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM
BioChem's USE OF THE Product OR THE NeoPharm Know-How OR Improvements, ANY CLAIM
ARISING FROM THE MANUFACTURE, USE OR SALE OF OTHER PRODUCTS (i.e. OTHER THAN THE
Products) CONTAINING COMMERCIAL MATERIALS SUPPLIED PURSUANT TO THIS AGREEMENT;
OR ANY CLAIM FOR LOSS OF PROFITS, FOR LOSS OR INTERRUPTION OF BUSINESS OR FOR
INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES OF ANY KIND. BioChem ACCEPTS ALL RISK AND RESPONSIBILITY FOR DETERMINING
THE MANNER IN WHICH BioChem WILL USE THE COMMERCIAL MATERIALS IN OTHER PRODUCTS,
IF ANY, AND NeoPharm AND ITS Affiliates MAKE NO WARRANTIES OR REPRESENTATIONS
CONCERNING, AND ASSUME NO RESPONSIBILITY FOR, THE PERFORMANCE OF ANY OTHER
PRODUCT (i.e. OTHER THAN THE Product) INTO WHICH THE COMMERCIAL MATERIALS MAY BE
INCORPORATED.
ARTICLE XI
INDEMNIFICATION
11.1 INDEMNIFICATION BVNEOPHARM. NeoPharm shall defend, indemnify and hold
harmless, BioChem and BioChem's Affiliates, directors, officers, employees,
shareholders and agents (individually, a "BioChem Indemnified Party", and
collectively, the "BioChem Indemnified Parties"), from and against any and all
liabilities, losses, damages, fines, costs, claims, actions and expenses
incurred by the BioChem Indemnified Parties (including the reasonable fees,
costs and expenses of attorneys and other professional and court costs), based
on any civil, criminal, statutory, regulatory or other claims of liability
(referred to collectively as "Liabilities"), asserted at any time arising out of
or involving a breach or misstatement by NeoPharm of its representations,
warranties, covenants or obligations under this Agreement (including under the
Exhibits hereto).
11.2 GOVERNMENT RESTRICTIONS. Subject to Section ll.l, NeoPharm will not be
liable for any damages on account of any restrictions imposed by any
Governmental Body in the Territory on the use, sale or distribution of the
Product. NeoPharm will not be responsible for any recall, confiscation or other
restriction on the use or sale of the Product by any Governmental Body in the
Territory for any reason other than the negligent acts or omissions of NeoPharm,
its Affiliates, Contract Manufacturers or agents.
11.3 INDEMNIFICATION BV BIOCHEM. BioChem shall defend, indemnify and hold
harmless, NeoPharm and NeoPharm's Affiliates, directors, officers, employees,
shareholders and agents (individually, a "NeoPharm Indemnified Party", and
collectively, the "NeoPharm Indemnified Parties"), from and against any and all
liabilities, losses, damages, fines, costs, claims, actions and expenses
incurred by the NeoPharm Indemnified Parties (including the reasonable fees,
costs and expenses of attorneys and other professional and court costs), based
on any civil, criminal, statutory, regulatory or other claims of liability
(referred to collectively as "Liabilities"), asserted at any time arising out of
or involving (i) a breach or misstatement by BioChem of its representations,
warranties, covenants or obligations under this Agreement (including under the
Exhibits hereto), (ii) the development, use, manufacture, promotion, sale or
other disposition, of any other products which incorporate the Product (herein
"Other Product") by BioChem; or (iii) BioChem's use of any NeoPharm Know-How or
Improvements in Other Products. Without limiting the foregoing, BioChem will
defend, indemnify and hold harmless the NeoPharm Indemnified Parties, from and
against any Liabilities resulting from:
11.3.1 Any product liability claim or other claim of any kind related to the use
by a third person of any Other Product that was manufactu red , sold or
otherwise disposed of by Bio Chem.
11.3.2 Clinical trials or studies conducted by or on behalf of BioChem and any
of its Affiliates, sublicensees, or assignees to whom NeoPharm and its
Affiliates, sublicensees, Contract Manufacturers or assignees supplies CTM,
including, without limitation, any claim by or on behalf of a human subject of
any such clinical trial or study, and any claim or deviation, authorized or
unauthorized, from the protocols of any such clinical trial or study and any
claim resulting from, or arising out of, the manufacture or quality by a third
Person of any substance, other than the CTM, administered in any clinical trial
or study; provided, however, that BioChem will not be obligated to indemnify and
hold harmless NeoPharm with respect to claims resulting solely from, or arising
solely out of NeoPharm's negligent or intentional acts or omissions with respect
to the manufacture or quality of the CTM supplied by NeoPharm and its
Affiliates, sublicensees, Contract Manufacturers or sublicensees.
11.4 EXCEPTIONS. No indemnification shall be made to a BioChem Indemnified Party
or NeoPharm Indemnified Party to the extent any Liabilities arise out of, result
from or involve (i) the breach or misstatement by such Person of its
representations, warranties or obligations under this Agreement or the Exhibits
hereto or (ii) the negligence or willful misconduct of such Person.
Notwithstanding anything to the contrary herein contained, neither Party shall
be liable hereunder to defend, indemnify or hold harmless, any Person for any
claim for indirect, special or consequential damages of any kind.
11.5 INDEMNIFICATION PROCEDURES. A Party (the "indemnitee") which intends to
claim indemnification under this Article XI shall promptly notify the other
Party (the "indemnitor") in writing of the Liability with respect to which the
claim of indemnification relates. The indemnitee shall permit, and shall cause
its employees and agents to permit, the indemnitor, at its discretion, to settle
any such Liability, the defense and settlement of which shall be under the
complete control of the indemnitor; provided, however, that such settlement
shall not adversely affect the indemnitee's rights hereunder or impose any
obligations on the indemnitee in addition to those set forth herein in order for
it to exercise those rights. No such Liability shall be settled without the
prior written consent of the indemnitor, and the indemnitor shall not be
responsible for any legal fees or other costs incurred other than as provided
herein. The indemnitee, its employees and agents shall cooperate fully with the
indemnitor and its legal representatives in the investigation and defense of any
Liability covered by this indemnification. The indemnitee shall have the right,
but not the obligation, to be represented by counsel of its own selection and
expense.
ARTICLE XII
INSURANCE
12.1 INSURANCE. Prior to the date of manufacture of any Product for sale to the
public by BioChem hereunder, NeoPharm shall have and maintain such type and
amounts of liability insurance covering the manufacturing, supply, use and sale
of products such as the Product as is normal and customary in the pharmaceutical
industry generally for persons similarly situated, which shall, in any event,
provide for a minimum coverage amount of Three Million Dollars for any one
occurrence; and NeoPharm will provide BioChem with a copy of its policies of
insurance in that regard. NeoPharm shall not be entitled to amend or replace any
such insurance without the prior written consent of BioChem, which consent shall
not be unreasonably withheld or delayed.
ARTICLE XIII
TERM: TERMINATION
13.1 TERM. This Agreement shall commence as of the date first above written and,
unless earlier terminated in accordance herewith, shall remain in effect for the
period during which the Collaboration Agreement shall remain in effect.
13.2 TERMINATION FOR DEFAULT.
(a) Failure by a Party to comply with any of the material
obligations contained herein or in the Collaboration Agreement
shall entitle the Party not in default to give to the Party in
default notice specifying the nature of the default and
requiring it to make good such default. If such default is not
cured within sixty (60) days after the receipt of such notice,
or, if applicable, within the cure period provided for in the
Collaboration Agreement, or diligent steps taken to cure if by
its nature such default could not be cured in sixty (60) days
or in the cure period provided for in the Collaboration
Agreement, as the case may be, the Party not in default shall
be entitled, without prejudice to any of its other rights
conferred on it by this Agreement or the Collaboration
Agreement, and in addition to any other remedies available to
it by Law or in equity, to terminate this Agreement.
(b) Any right to terminate arising under Subsection 13.2(a) shall
be stayed if, during the relevant cure period, the Party
alleged to have been in default shall:
(i) have initiated arbitration in accordance with Section l 5.8,
below, with respect to the alleged default; and
(ii) be diligently and in good faith co-operating in the prompt
resolution of such arbitration.
13.3 BANKRUNTCV; INSOLVENCY; ETC. Either Party may, in addition to the other
remedies available to it at Law, terminate this Agreement by written notice to
the other Party, if the other Party shall have become bankrupt or insolvent, or
shall have made an assignment for the benefit of its creditors, or shall have
sought protection or relief under any bankruptcy, insolvency, reorganization or
other similar statute, or there shall have been appointed a trustee or receiver
of the other Party.
13.4 ACCRUED RIGHTS. SURVIVING OBLIGATIONS.
(a) Termination, relinquishment or expiration of this Agreement
for any reason shall be without prejudice to any rights which
shall have accrued to the benefit of a Party prior to such
termination, relinquishment or expiration. Further, any such
termination, relinquishment or expiration, shall not relieve a
Party from obligations which are expressly indicated to
survive termination, relinquishment or expiration of this
Agreement.
(b) Without limiting the generality of Subsection 13.4 (a), the
provisions of Sections 6.3, 6.5 and 6.6 and of Articles IX,
XI, XII and XIII of this Agreement shall survive the
expiration or termination of this Agreement.
13.5 Notwithstanding anything to the contrary herein contained, BioChem may
terminate this Agreement at any time by written notice to NeoPharm, in the event
BioChem is unable to obtain FDA and HPB approval of NeoPharm or a Contract
Manufacturer as the manufacturer and supplier of Product provided, however, that
from the time it is determined that FDA or HPB approval (as the case may be)
will not be obtained, NeoPharm shall have six (6) months to address any concerns
raised by
FDA and HPB, so as to enable BioChem to obtain such approval.
13.6 The right of either Party to terminate this Agreement shall not be affected
in any way by the failure of such Party to take any action with respect to any
prior circumstance or default which mavhave given rise to a right to terminate.
ARTICLE XIV
FORCE MAJEURE
14.1 Neither Party shall be liable to the other for failure or delay in the
performance of any of its obligations under this Agreement for the time and to
the extent such failure or delay is caused by riots, civil commotions, wars,
hostilities between nations, Laws, embargoes, actions by any Government Body,
acts of God, storms, fires, accidents, labor disputes or strikes, sabotage,
explosions or other similar or different contingencies, in each case, beyond the
reasonable control of the respective Parties. The Party affected by Force
Majeure shall provide the other Party with full particulars thereof as soon as
it becomes aware of the same (including its best estimate of the likely extent
and duration of the interference with its activities), and will use its best
endeavors to overcome the difficulties created thereby and to resume performance
of its obligations as soon as practicable. If the performance of any obligation
under this Agreement is delayed owing to a Force Majeure for any continuous
period of more than six (6) months, the parties shall consult with respect to an
equitable solution, including the possible termination hereof.
14.2 In the event a cause described in Section 14.1 restricts NeoPharm from
supplying Product, in whole or in part, to BioChem, NeoPharm shall treat and
supply BioChem in the same equitable manner as all of NeoPharm's other major
customers.
ARTICLE XV
MISCELLANEOUS PROVISIONS
15.1 RELATIONSHIP OF THE PARTIES. Nothing in this Agreement is intended or shall
be deemed to constitute a partnership, agency or employer-employee relationship
between the Parties and/or any of their respective Affiliates or employees.
Neither Party shall incur any debts or make any commitments for the other. Both
Parties are independent contractors under this Agreement. Neither Party shall
have any express or implied right or authority to assume or create any
obligations on behalf of or in the name of the other Party or to bind the other
Party to any other contract, agreement, or undertaking with any third Person.
15.2 ASSIGNMENTS. Except as expressly provided herein, neither this Agreement
nor any interest hereunder shall be assignable, nor any other obligation
delegable, by a Party without the prior written consent of the other; provided,
however, that a Party may assign this Agreement to any Affiliate of it or to any
successor by Law or by sale of all or substantially all of its assets, provided
that the assigning Party shall guarantee and remain liable and responsible for
the performance and observance of all the assigning Party's duties and
obligations hereunder. Nothing in this Section 15.2 shall be construed to
restrict BioChem 's right to sublicense referred to in Article II of the
Collaboration Agreement. This Agreement shall be binding upon the successors and
permitted assigns of the Parties including assignees of any rights respect to
the Product. Any assignment not in accordance with this Section 15.2 shall be
void.
15.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver such
further instruments and to do all such other acts as may be reasonably necessary
or reasonably appropriate in order to carry out the purposes and intent of this
Agreement.
15.4 NO TRADE XXXX RIGHTS. Except as otherwise specifically provided for herein,
no right, express or implied, is granted hereby to a Party to use in any manner
the name or any other trade name or trade xxxx of the other Party.
15.5 PUBLIC ANNOUNCEMENTS. If either Party wishes to make a public disclosure
concerning this Agreement or the terms hereof, the other Party shall be provided
with an advance copy of the proposed disclosure and shall have three (3)
business days within which to approve or disapprove thereof unless the Law
requires immediate disclosure in which case the Party will endeavor to give
notice thereof as soon as possible to the other Party. Approval shall not be
unreasonably withheld by either Party. Absent approval, no public disclosure
concerning this Agreement or the terms hereof shall be made by either Party,
except to the extent required by Law.
15.6 ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement (including the
Exhibits hereto) constitutes and contains the entire understanding and agreement
of the Parties and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements between the Parties, whether oral
or written, respecting the subject matter hereof, including, without limitation,
the letter agreement between the Parties dated February 10, 1997. No waiver,
modification or amendment of any provision of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
Party.
15.7 APPLICABLE LAW. This Agreement shall be governed by and interpreted in
accordance with the Laws of the State of New York, and shall be treated in all
respects as a New York contract. The Parties hereby expressly agree that the
provisions of the United Nations Convention on the International Sale of Goods
shall not apply to this Agreement.
15.8 NOTICES AND DELIVERIES. Any notice, request, delivery, approval or consent
required or permitted to be given under this Agreement shall be in writing and
shall be deemed to have been sufficiently given if delivered in accordance with
Section 10.9 of the Collaboration Agreement.
15.9 DISPUTES. Subject to Section 7.2 hereof, any dispute arising out of or in
connection with this Agreement shall be handled in accordance with Section 10.10
of the Collaboration Agreement.
15.10 NO THIRD PARTV BENEFICIARIES. Except as specifically provided in this
Agreement, no Person not a Party to this Agreement, including any employee of
any Party to this Agreement, shall have or acquire any rights by reason of this
Agreement, nor shall any Party hereto have any obligations or liabilities to
such other Person solely by reason of this Agreement.
15.11 STATUTE OF LIMITATIONS. Should either Party allege that the other Party is
in breach of its obligations under this Agreement' the nonbreachingParty must
bring any action it may have against the other Party with respect to such
alleged breach within two (2) years from the date on which the nonbreaching
Party first became aware of the alleged breach.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized officers as of the day and year first above
written, each copy Of which shall for all purposes be deemed to be an original.
NEOPHARM INCORPORATED
Witness
----------------------
Witness By: /S/ Maherdra X. Xxxx
---------------------- --------------------------------
per: Xx. Xxxxxxxx X. Xxxx, Ph.D., Vice
President, Corporate Development
BIOCHEM THERAPEUTIC INC.
/S/Xxxxxxx Xxxx
------------------------------------
witness per: Xxxxxxx Xxxx, President
----------------------
/S/.XXXXX XXXXXX
------------------------------------
witness per: Xx. Xxxxx Xxxxxx, Vice-President,
---------------------- Business Development
