EXHIBIT 10.11
Execution Copy
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LICENSE AGREEMENT
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This License Agreement (this "Agreement") is entered into as of November
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20, 2001 (the "Effective Date"), by and between American BioScience, Inc., a
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California corporation ("ABI") and American Pharmaceutical Partners, Inc., a
California corporation ("APP").
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RECITALS
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A. ABI has developed and owns the rights to the Product, as defined in
Section 1.21 of this Agreement.
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B. APP is in the business of manufacturing, marketing and distributing
pharmaceutical Products in the United States and elsewhere in the world, and has
special expertise in oncolytics.
C. The Parties desire to enter into an agreement for APP to market,
distribute and sell the Product under a license from ABI.
AGREEMENT
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In consideration of the premises, the mutual covenants contained herein,
and other good and valuable consideration, the receipt and sufficiency of which
is acknowledged, the Parties agree as follows:
1. Definitions. As used in this Agreement (in addition to other definitions
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set forth in this Agreement), the following definitions shall apply:
1.1 "ABI Parties means ABI, its Affiliates, permitted assignees and any
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party (if any) licensed or approved by ABI to use, market, distribute, import,
export, sell or offer to sell the Product with the exception of the APP Parties.
1.2 "Action" means any actual or threatened claim, suit, arbitration,
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hearing, inquiry, proceeding, complaint, charge or investigation by or before
any court, government, governmental entity or arbitrator.
1.3 "Affiliate" means any entity controlling, controlled by or under the
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common control of APP or ABI, as the case may be. Such entity will be considered
an Affiliate only for the time during which such control exists. For the purpose
of this Agreement, "control" means having, directly or indirectly, the power to
direct or cause the direction of management and policies of such entity. FOR
PURPOSES OF THIS AGREEMENT, APP WILL NOT BE CONSIDERED AN AFFILIATE OF ABI, AND
ABI WILL NOT BE CONSIDERED AN AFFILIATE OF APP.
1.4 "APP Parties" or "APP Party" means any of APP, its Affiliates and
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its permitted sublicensees and assignees.
1.5 "Chargeable Price" means, with respect to Product manufactured by
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APP, the Standard Costs per unit of Product, and with respect to Product not
manufactured by APP, the
[***] Omitted pursuant to a confidential treatment request. The material has
been filed separately with the Securities and Exchange Commission.
price APP pays for the Product from ABI's designated manufacturer(s) plus the
reasonable costs of quality control and other activities performed by APP that
would be included in Standard Costs if APP were the manufacturer.
1.6 "Chemical Ingredients" means paclitaxel and albumin.
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1.7 "Competitor" means a business entity that markets and sells a
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pharmaceutical Product that includes taxanes as an active pharmaceutical
ingredient.
1.8 "Damages" means any and all losses, liabilities, obligations, costs,
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expenses, damages or judgments of any kind or nature whatsoever including
reasonable attorneys', accountants' and experts' fees, disbursements of counsel
and other costs and expenses incurred in pursuing or defending claims under this
Agreement.
1.9 "FDA" means the United States Food and Drug Administration or any
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other successor agency whose approval is necessary to market the Product in the
United States and any comparable agency in other countries in the Territory
where ABI intends to obtain regulatory approval.
1.10 "GAAP" means generally accepted accounting principles as in effect
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in the United States applied on a basis consistent with past practice.
1.11 "Gross Profits (or Losses)" means Net Sales less: (A) Chargeable
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Price; (B) any fees, costs and expenses incurred by APP in connection with
obtaining and maintaining Regulatory Approval for the Product including, without
limitation, those paid pursuant to Section 13.2; and (C) user fees. Any moneys
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paid to ABI under Sections 8, 9, 10 and 11 of this Agreement will not be
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included in the calculation of Gross Profits (or Losses).
1.12 "Gross Sales Net of Chargebacks" means gross invoiced sales of the
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Product by APP to its customers (or in the case of sales to an Affiliate of APP,
the first sale to a non-affiliated customer) less chargebacks.
1.13 "IPO" means the closing of the first sale by APP of shares of its
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common stock, par value $0.001 per share, for an aggregate offering price of a
minimum of $50 million in an underwritten public offering registered under the
Securities Act of 1933, as amended.
1.14 "Legal Requirement" means any statute, law, ordinance, rule,
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regulation, permit, order, writ, judgment, injunction, decree or award issued,
enacted or made by any governmental entity or any arbitrator.
1.15 "Manufacturing Agreement" means that certain manufacturing
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agreement entered into between ABI and APP dated the same date as this
Agreement.
1.16 "Manufacturing Recall" means a Recall arising from or relating to
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the Product that, when manufactured by APP, was adulterated, contaminated or was
otherwise caused by APP's failure to comply with the Manufacturing Agreement or
the Specifications as defined in the Manufacturing Agreement.
1.17 "NDA" means one or more of the New Drug Applications that ABI files
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for the Product with the FDA, including any supplements or amendments and
510(k)s, and any foreign equivalents in Canada or Mexico.
1.18 "Net Sales" means Gross Sales Net of Chargebacks less, with respect
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to sales of Product: (A) freight and insurance charges actually paid; (B)
discounts, credits or allowances, if any, given or made because of price
adjustments; (C) actual replacements, returns or rebates (including but not
limited to group purchasing organization fees and rebates and governmental
rebates); (D) reasonable selling and marketing expenses (including pre-launch
expenses and sales force costs); (E) sales, excise and value added taxes if paid
by APP and (F) general and administrative costs incurred with respect to the
Product during a calendar year [***]. The amount of the Net Sales for any period
will be determined in accordance with GAAP on the basis of sales recorded in the
ordinary course on the books of the relevant APP Parties during such period,
less the deductions provided for in this Section 1.18.
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1.19 "Parties" means APP and ABI ("Party" meaning one of the Parties).
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1.20 "Person" means any natural person, corporation, trust, association,
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company, partnership, joint venture, governmental entity or other entity.
1.21 "Product" means ABI-007, a cremaphor-free, nanoparticle paclitaxel
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formulation [***].
1.22 "Product Liability Claim" means any Action by a third party and any
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appeal from any Action asserted by a third party with respect to the Product
alleging product liability, product defect, design, manufacturing, packaging or
labeling defect, failure to warn, or any similar action relating to the
formulation, manufacture, use or safety of the Product.
1.23 "Proprietary Information" means all information relating to the
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Product, the properties, composition or structure of the Product or the
manufacture or processing of the Product or the machines used to manufacture or
process the Product or to a Party's business (including, without limitation,
reagents, computer programs, algorithms, names and expertise of employees and
consultants, know-how, formulas, processes, ideas, inventions, whether
patentable or not, schematics and other technical, business, financial, customer
and Product development plans, forecasts, strategies and information), whether
previously, currently or subsequently disclosed to the other Party. ABI's
Proprietary Information shall include ABI Owned Developments and ABI
Developments. APP's Proprietary Information shall include APP Owned
Developments.
1.24 "Proprietary Rights" means any and all patent rights, copyrights,
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mask work rights, trade secret rights and all other intellectual and industrial
property rights.
1.25 "Regulatory Approval" means the procurement of any registration,
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permit and approval required by applicable government authorities for the
manufacture, importation, marketing, sale or distribution of the Product.
1.26 "Standard Costs" means direct and indirect costs, including without
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limitation the materials, components, raw materials, direct labor and overhead,
attributable to
production, manufacturing, processing, quality control and packaging by APP of
the Product, and shall be fixed year-to-year as set forth hereafter. Except for
the purposes of determining Actual Costs in accordance with Section 10.6(B),
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Standard Costs will not include costs incurred in connection with Bad Batches
(as hereafter defined) of the Product. In addition, Standard Costs will not
include general and administrative costs. The Standard Costs will be updated at
the end of each calendar year for the purpose of determining Chargeable Price
for the succeeding year. Except as otherwise contemplated by this definition or
agreed by the Parties, Standard Costs will be determined in accordance with GAAP
and standard costing principles as currently practiced by APP.
1.27 "Technology" means any and all ideas, techniques, inventions,
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methods, data, information, formulae, processes, trade secrets, intellectual
property, know-how, and test results, whether patentable or not, and whether or
not reduced to practice, including Proprietary Rights, owned, controlled or
otherwise in possession of or used by ABI as of the date of this Agreement, or
during the term of this Agreement and necessary or useful to make, have made,
develop, have developed, use, import, market, offer for sale or sell the
Product.
1.28 "Territory" means North America.
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2. License Grant.
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Subject to the terms and conditions set forth in this Agreement:
2.1 ABI grants to APP a license to and under the Technology to use,
market, distribute, import, export, sell and offer to sell the Product in the
Territory subject to Section 9. Any modification or improvement made by or for
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ABI to the Technology during the term of this Agreement must be promptly
disclosed to APP and included in this license without additional charge to APP,
except as provided in Section 9. Subject to any modification under Section 9,
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APP's license is exclusive solely within the Territory, even as against ABI. APP
will have the right to grant sublicenses to third parties as provided in Section
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2.2.
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2.2 APP's right to sublicense will be in accordance with the terms of
the license granted to APP under this Agreement. Any sublicense and the relevant
sublicense agreement will be subject to ABI's review and prior written approval,
which approval shall not be unreasonably withheld or delayed. Despite the
foregoing, in no event will ABI be obligated to consent to the sublicensing of
this Agreement to a Competitor. Even if APP sublicenses the license granted
under this Agreement, APP will remain responsible to ABI for the performance of
its obligations under this Agreement and for any breach of the obligations under
this Agreement whether or not the breach is caused by APP or any sublicensee.
2.3 APP may purchase the Product only from manufacturer(s) designated in
writing by ABI, which manufacturer(s) shall initially be APP under the
Manufacturing Agreement. ABI hereby designates APP as a manufacturer from which
APP may purchase the Product, for as long as the Manufacturing Agreement is in
effect.
2.4 If ABI terminates APP's right to manufacture Product under the
Manufacturing Agreement for any reason other than under Section 12.2 or 12.4 of
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said Agreement, ABI shall arrange for adequate supply of Product to APP for sale
in the Territory for
the duration of APP's license under this Agreement at a price not in excess of
the Chargeable Price applicable to APP manufactured Product in effect at the
time of such termination, as such price would be adjusted from time to time if
APP had been the manufacturer. If ABI terminates the Manufacturing Agreement
under Section 12.2 or 12.4 of said Agreement, but does not terminate this
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Agreement, ABI shall use commercially reasonable best efforts to arrange for
adequate supply of Product to APP for sales in the Territory for the duration of
this License Agreement. In each case, ABI shall provide that the supplier of
Product to APP shall be responsible for the purity and conformance to
Specifications of the Product supplied to APP, and shall indemnify ABI and APP
to the same extent as APP indemnifies ABI under the Manufacturing Agreement.
2.5 Except as otherwise agreed to by the Parties:
(A) APP's license is limited to the Territory, and no APP Party may
directly or indirectly market, distribute, sell or offer to sell the
Product outside the Territory, nor may any APP Party directly or indirectly
market, distribute, sell or offer to sell the Product to anyone that it has
knowledge intends to, or reasonably believes intends to, directly or
indirectly market, distribute, sell or offer to sell the Product to anyone
outside the Territory.
(B) Except as provided in Section 9, (i) no ABI Parties may directly
or indirectly market, distribute, sell or offer to sell the Product inside
the Territory, nor (ii) may ABI or its Affiliates sell the Product to
anyone that it has knowledge intends to, or reasonably believes intends to,
directly or indirectly market, distribute, sell or offer to sell the
Product to anyone inside the Territory.
2.6 So long as APP has made all milestone payments required under
Section 9, the license to APP shall convey the exclusive right to market and
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sell the Product in the Territory. If APP fails to make a milestone payment
required by Section 9, then the license to APP shall be limited to those
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oncology indications for which milestone payments have been made under Section
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9, and ABI may, in its discretion, market or license the Product in the
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Territory, for those indications for which APP did not make milestone payments.
Neither Party will be responsible to the other Party for the distribution or
sale of the Product other than by itself or its Affiliates for indications other
than those as to which it holds express rights under this Agreement, at the time
of the distribution or sale.
2.7 Except as expressly provided in Section 14, nothing in this Section
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2 or otherwise in this Agreement will confer any right to use in advertising,
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publicity or other promotional activities any name, trademark or trade name of
ABI.
3. Transfer of Technology; Improvements. ABI will convey and disclose in
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tangible form to APP, as soon as reasonably practicable after the Effective Date
and throughout the term of this Agreement, all Technology. Each Party agrees to
as soon as reasonably practicable disclose in tangible form to the other Party
all modifications and improvements made to the Technology during the term of
this Agreement. APP will immediately transfer to ABI all right, title and
interest in and to any process, product, composition, or product-by-process, or
any improvements thereto, including inventions ("Developments"), made by the APP
Parties using
ABI's processes or outputs ("Processes") (collectively, the "ABI Owned
Developments"). From and after their development, the ABI Owned Developments
will be included within the scope of the license granted to APP under this
Agreement. APP will own any Developments made by APP or its assignees using any
process or output other than the Processes, provided such Developments are
developed solely by APP or its assignees without any input from ABI or any of
its employees, including Xxxxxxx Soon-Shiong. Any Developments that are
developed solely by APP without using any Processes are referred to as the "APP
Owned Developments." APP may take whatever steps it deems necessary to protect
its rights in the APP Owned Developments. APP further grants to ABI, subject to
Section 17.2, a perpetual, royalty-free license to use all of the APP Owned
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Developments that are used or needed by APP in the manufacture or
commercialization of the Product.
4. Marketing. Subject to Section 9, APP will use reasonable commercial
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efforts to market, distribute and sell the Product under the license granted
under this Agreement. Those efforts will include marketing, distributing and
selling the Product on its own merits and not in a manner instead intended to
promote other Products. Any advertising of the Product by the APP Parties must
be free from unwarranted statements and all advertising and promotional
materials will be subject to the review and comment of ABI. APP will continue to
promote the sale of the Product in the Territory during the term of this
Agreement, and will maintain the types of facilities, places of business,
approvals, employees (or third party representatives) that are necessary to do
so.
5. Representation and Warranties of the Parties. Each Party represents to
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the other Party that as of the date of this Agreement:
5.1 The Party (A) is a corporation duly organized, validly existing and
in good standing under the laws of its jurisdiction of incorporation and (B) has
full power and authority to execute and deliver this Agreement and to perform
its obligations under this Agreement;
5.2 This Agreement constitutes the valid and legally binding obligation
of the Party and is enforceable against the Party in accordance with its terms;
5.3 Except as limited in Section 6, the execution and delivery of this
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Agreement and the performance of its obligations under this Agreement by the
Party will not cause the Party to violate or contravene (A) the Party's articles
of incorporation or bylaws, (B) any instrument, agreement or understanding by
which the Party or any of its Affiliates is bound or affected, or (C) any Legal
Requirement by which the Party or its properties or assets is bound or affected;
and
5.4 The Party is not required to obtain a consent, approval or license
from any Person to execute, deliver and perform this Agreement (except for
Regulatory Approvals contemplated under this Agreement), and except for the
consent approvals or licenses that have been duly obtained by the Party.
6. Representation and Warranties of ABI. ABI represents and warrants to APP
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that as of the date of this Agreement:
6.1 ABI owns and has the unrestricted and enforceable right to use,
develop and commercialize the Technology and the Product in the Territory, and
may enter into this Agreement. To ABI's knowledge, all prior art was disclosed
in the course of the prosecution of the patents included in the Technology that
ABI was aware would cause such patents to be invalid or unenforceable. Subject
to the immediately preceding sentence, ABI makes no representation as to the
validity or enforceability of any patent relating to the Product.
6.2 ABI has not previously assigned, licensed, sublicensed, encumbered
or otherwise transferred to any third party any of the Technology or the Product
in the Territory;
6.3 To ABI's knowledge, there are no Actions that are pending or, to the
knowledge of ABI, threatened, that challenge the rights of ABI or its licensees
to develop, use or commercialize the Technology or the Product;
6.4 To ABI's knowledge, ABI has provided APP with all material
information with respect to its clinical trials for the Product;
6.5 To ABI's knowledge, ABI has not used in any capacity the services of
any person debarred under Section 3.6 of the Federal Food, Drug and Cosmetic Act
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in connection with the NDA filed for Product;
6.6 No royalties are due to third parties by APP for sales of the
Product;
6.7 ABI has taken, and will continue to take, reasonable security
measures to protect the secrecy, confidentiality and value of the Technology;
and
6.8 To ABI's knowledge, ABI's activities to date relating to the
Technology and the Product have not been, and the planned and proposed
development, use and commercialization of the Technology and the Product will
not be in violation or contravention of the patent, intellectual property, trade
secret or other rights of any third party. Neither ABI, its Affiliates or
employees nor, to ABI's knowledge, ABI's agents, advisors or consultants, has
received any written or oral communication (A) alleging that it has violated, or
by use, development or commercialization of the Technology or Product would
violate, the patent, intellectual property, trade secret or other rights of any
third party or (B) that otherwise challenges ABI's rights with respect to the
Technology or the Product.
6.9 EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 6.1 - 6.8, ABI (A)
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SPECIFICALLY DISCLAIMS ALL WARRANTIES OF ANY KIND REGARDING THE PRODUCT OR THE
TECHNOLOGY, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, (B) MAKES NO REPRESENTATION REGARDING THE SUITABILITY OF THE
PRODUCT OR ANY OF THE TECHNOLOGY FOR ANY THIRD PARTY'S REQUIREMENTS, AND (C)
MAKES NO REPRESENTATION AS TO WHETHER OR NOT THE TECHNOLOGY INFRINGES ON THE
PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
7. APP Representations and Warranties.
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7.1 APP represents and warrants to ABI that, as of the date of this
Agreement, none of the executive officers of APP has any knowledge that any of
ABI's representations and warranties are inaccurate. For purposes of this
Section 7.1, the knowledge of Xxxxxxx Soon-Shiong shall be imputed to ABI rather
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than to APP.
7.2 APP acknowledges and agrees that none of APP or its Affiliates has
or claims to have ownership or license rights to the Technology or Product
except as set forth in this Agreement. APP agrees that neither ABI nor any third
party has promised, offered or conveyed to APP any interest in the Technology or
Product except as set forth in this Agreement and the Manufacturing Agreement.
8. Up-Front Payment; IPO.
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8.1 APP shall pay to ABI:
(A) $15 million on a date designated by ABI to APP on at least two
(2) days written notice, which payment date shall not be earlier than 30
days nor later than 45 days following the execution of this Agreement;
(B) $10 million upon the earlier of (1) January 15, 2002 or (2) 30
days following APP's IPO; and
(C) $35 million upon the earlier of (1) January 15, 2003 or (2) 30
days following APP's IPO.
8.2 Despite the provisions of the relevant instruments, ABI is required
to repay APP any amounts owing under the Demand Promissory Note dated July 24,
2001 and as amended and restated in October, 2001, and the Letter Agreement
dated October 21, 1999, no later than the earlier of (A) the five year
anniversary of the execution of this Agreement, and (B) the payment of $75
million by APP to ABI under Section 10. Notwithstanding the foregoing, APP shall
be allowed to take as a credit against the payments of Section 8.1(C) in excess
of $25 million, any amounts above $22 million advanced to ABI by APP. Promptly
after the execution of this Agreement, ABI and APP will enter into an agreement
to secure ABI's obligation under this Section 8.2.
9. Milestone Payments.
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9.1 In addition to the payments provided for in Section 8, Section 10
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and Section 11, upon notice to APP from ABI of the achievement of the following
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milestones, and within 30 days of that notice (subject to the provisions of
Sections 9.4 and 9.5), APP is required to make the following respective one-time
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payments:
(A) $10 million upon notification that the FDA has accepted for
filing ABI's NDA for the Product for a breast cancer indication;
(B) $15 million upon FDA approval of the NDA for the Product for a
breast cancer indication;
(C) $7.5 million upon the first publication in a United States
top-tier peer- reviewed journal associated with a professional association
of the Product's positive final Phase II results of lung cancer clinical
trials;
(D) $5 million upon notification that the FDA has accepted for
filing ABI's NDA for the Product for a lung cancer indication;
(E) $5 million upon FDA approval of the NDA for the Product for a
lung cancer indication;
(F) $7.5 million upon the first publication in a United States
top-tier peer-reviewed journal associated with a professional association
of the Product's positive final Phase II results of ovarian cancer clinical
trials;
(G) $5 million upon notification that the FDA has accepted for
filing ABI's NDA for the Product for an ovarian cancer indication;
(H) $5 million upon FDA approval of the NDA for the Product for an
ovarian cancer indication;
(I) $7.5 million upon the first publication in a United States
top-tier peer- reviewed journal associated with a professional association
of the Product's positive final Phase II results of prostate cancer
clinical trials;
(J) $5 million payments upon the first publication with respect to
each other indication established for study by the Steering Committee (as
defined in Section 12.3) in a United States top-tier peer-reviewed journal
associated with a professional association of the Product's positive final
Phase II results of clinical trials;
(K) $10 million upon FDA approval of the NDA for the Product for a
prostate cancer indication; and
(L) $10 million upon FDA approval of the NDA for each other
indication established for study by the Steering Committee.
9.2 With respect to any publication milestones, if the Parties do not
reasonably agree that prescribers are entitled to be reimbursed for the
applicable indications as a consequence of the publication, the respective
payment will be reduced to $5 million.
9.3 No milestone payment with respect to lung, ovarian or prostrate
cancers, or other cancer indications will be due and payable prior to Regulatory
Approval of the NDA for a breast cancer indication.
9.4 In the event one or more of the milestone payments under Section 9.1
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(A) - (H) are due before APP has an IPO, and ABI at that time owns or controls
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at least fifty percent
(50%) of APP's capital stock, APP shall be allowed to pay such milestone
payment(s) plus interest at a rate of 8% per year on the unpaid amount from the
due date until paid, rather than within 30 days of notice as stated in Section
9.1, by paying ABI seventy-five percent (75%) of the Gross Profits until the
earlier of (i) the date on which the payments of additional 25% of Gross Profits
has been equal to the amount of such deferred milestone payments and (ii) APP's
IPO, at which time APP shall pay all amounts that remain due and owing within 30
days. In the event one or more of the milestone payments under Section 9.1(A) -
(H) are due before APP has an IPO, and ABI at that time owns or controls less
than fifty percent (50%) of APP's capital stock, and APP fails to make the
milestone payment when due, APP shall have no right to use, market, distribute,
import, export, sell or offer to sell the Product for such indication. Any
marketing or distribution of Product for such indication by APP after such
failure to make a milestone payment will be a breach of this Agreement by APP.
From and after APP's failure to make such milestone payment, ABI will have the
right to use the Technology for the relevant indication in any manner it deems
appropriate, including use within the Territory.
9.5 APP may decline to make the milestone payments set forth in
subsections (I), (J), (K) and (L) of Section 9.1 if, and only if, at the time
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that the milestone is met and notice is provided by ABI to APP, Net Sales of the
Product by APP do not, in the aggregate, equal or exceed $250 million (the
"Milestone Minimum").
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(A) If, upon 30 days notice from ABI that it has achieved a
milestone set forth in subsections (I), (J), (K) or (L) of Section 9.1, APP
has achieved the Milestone Minimum, then APP is required to pay to ABI the
milestone payment provided for in the relevant subsection.
(B) If, upon 30 days notice from ABI that it has achieved a
milestone set forth in subsections (I), (J), (K) or (L) of Section 9.1, APP
has not achieved the Milestone Minimum, then upon notice from ABI, APP is
required to pay to ABI the milestone payment provided for in subsections
(I), (J), (K) or (L) of Section 9.1 or indicate in writing that it is
declining to make the payment. APP's failure to make a certain milestone
payment in subsections (I), (J), (K) or (L) of Section 9.1, or to indicate
that it is declining to make such a payment if the Milestone Minimum has
not been achieved, will be deemed a declination by APP to make such
milestone payment.
(C) Following APP's declination or deemed declination to make a
milestone payment, upon each declination or deemed declination, the
relevant indication for which the milestone set forth in subsections (I),
(J), (K) or (L) was achieved will no longer be included within the license
grant to APP and APP will have no further right to use, market, distribute,
import, export, sell and offer to sell the Product for such indication. Any
marketing or distribution of Product for such indication by APP after its
declination or deemed declination to make the milestone payment will be a
breach of this Agreement by APP. From and after the declination or deemed
declination by APP, ABI will have the right to use the Technology for the
relevant indication in any manner it deems appropriate.
9.6 Once a milestone payment has been made under this Section 9 for a
particular indication (e.g., breast cancer), no additional payment shall be due
for label expansion or improvements within such indication.
10. Share of Gross Profit or Loss.
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10.1 APP will pay to ABI:
(A) Except as set forth in Sections 9.4 and 9.5 and Section
10.1(B), [50% of the Gross Profits on sales of the Product in the Territory
by the APP Parties. For purposes hereof, Gross Profits on sales of the
Product by APP's permitted sublicensees in the United States is the greater
of actual Gross Profits of the sublicensees or the Gross Profits that APP
would have earned based upon its recent prior results if it had sold the
Product itself in the United States rather than through a permitted
licensee.
(B) 50% of the consideration received by APP from any sublicensees
in Canada and Mexico, in consideration for the grant of sublicenses of
Technology, as permitted in Section 2.2 herein. As used in this Section
10.1(B), consideration shall include amounts received from such sublicenses
for the sale of Product to them by APP or its Affiliates, less the Actual
Cost of such Product (as defined in Section 10.6).
10.2 Except as provided in Section 16, APP's obligation to pay a
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percentage of the Gross Profits or consideration received by the APP Parties
will cease on a country-by-country basis within the Territory, after expiration,
in each respective country, of the last to expire of all patents listed on
Exhibit A, as such Exhibit A may be amended from time to time by mutual
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agreement of the Parties. Despite the foregoing, such obligation shall not cease
in the event the APP Parties sell the Product in such a country using the ABI
Brand Names.
10.3 APP must make the payments due under this Section 10 within 45 days
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following the end of, and with respect to sales of the Product by the APP
Parties during, each calendar quarter. If any payment due under Section 10 is
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not made when due, interest will accrue at the rate of 8% per year on the unpaid
amount from the due date until the date of the payment.
10.4 If there is a Gross Loss in any calendar quarter, no payment is
required for that quarter, and the amount of the Gross Loss will be carried
forward and reduce the amount of Gross Profits for the next calendar quarter
(and, as necessary, carried forward to successive quarters until the full amount
of Gross Loss has been offset by subsequent Gross Profit). Pre-launch selling
and marketing expenses of APP under this Agreement will be treated as a
deduction from Net Sales in the first calendar quarter of sales under this
Agreement.
10.5 Within 45 days following the end of each calendar quarter (and
accompanying any payments made to ABI under this Section 10), APP must supply
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ABI with a report, on behalf of the APP Parties, setting forth in reasonable
detail the calculation of ABI's share of Gross Profits (or Losses). APP must
keep and maintain, and must cause the APP Parties to keep and maintain, detailed
and accurate books and records with regard to Gross Profits (or Losses), Net
Sales, and the calculations for Gross Profits (or Losses) and Net Sales. A
nationally known independent certified public accounting firm selected by ABI
(which must be (A) other than APP's designated certified public accounting firm,
(B) reasonably acceptable to APP, and
(C) bound in confidence not disclose any information except to inform ABI of
discrepancies) will be entitled, for purposes of determining compliance with
this Section 10, to review and audit the books and records of the APP Parties
----------
from time to time, but no more than three times a year as to each such party,
during normal business hours upon reasonable notice to the relevant APP Party
and at ABI's expense. Provided however, if the review or audit shows an
underpayment of more than 10% for the applicable period, the relevant APP Party
will bear the expense. The findings of the accounting firm will be binding on
the Parties.
10.6 At the end of each calendar year, the parties shall "true up" the
Gross Profits (or Losses) applicable to APP manufactured Product sold by the APP
Parties in the Territory as follows:
(A) Within 45 days after the end of each calendar year, APP shall
determine its Actual Costs of manufacturing Product during such calendar
year. The Actual Costs shall be APP's actual direct and indirect costs of
manufacturing Product, including without limitation the materials,
components, facility maintenance and depreciation, utilities, and labor and
overhead, attributable to Production, processing, packaging and quality
control of Product manufactured by APP and sold by it during such calendar
year. The Actual Costs shall include an allowance for the costs of Bad
Batches, as set forth in Section 10.6(B). On the basis of such Actual Costs,
---------------
APP shall calculate its revised Chargeable Price for such calendar year,
which shall be determined by substituting Actual Costs for Standard Costs in
the formula set forth in Section 1.5 (the "Revised Chargeable Price"). If
the aggregate Revised Chargeable Price is less than the aggregate Chargeable
Price originally included in the determination of Gross Profits (or Losses)
for all Product sold during such calendar year, then APP shall remit to ABI
one-half of such difference. If the aggregate Revised Chargeable Price is
greater than the aggregate Chargeable Price originally included in the
determination of Gross Profits (or Losses) for all Product sold during such
calendar year, then ABI shall remit to APP one-half of such difference. APP
shall include such calculations in its accounting report which is due 45
days after the end of each calendar year.
(B) For purposes of determining Actual Costs, APP shall be
permitted to include the costs of actual Bad Batches manufactured by APP
[***]
(C) In addition to, and separate and apart in all respects from the
provisions of Section 10.6(B), the costs of Bad Batches in the first
---------------
seventeen batches manufactured after the Effective Date (excluding pilot or
pilot scale batches), shall be borne equally by the Parties. ABI shall
reimburse APP for 50% of such costs, and APP's share of such costs shall be
omitted from all calculations of Standard Costs and Actual Costs.
(D) As used in this Section 10.6, "Bad Batches" shall mean batches
------------
of Product which are lost in the course of manufacture, or are determined by
APP not to be suitable for release. Notwithstanding the foregoing, Bad
Batches shall not include pilot or pilot scale batches.
11. Sales Achievement Milestone Payments. APP is required to make the
------------------------------------
highest of the following milestone payments that have been achieved but not yet
paid to ABI within 30 days following the end of the calendar year in which the
indicated level of annual Adjusted Net Sales of the Product has been attained or
exceeded by the APP Parties:
Annual Adjusted Net Sales Milestone Payment
------------------------- -----------------
[***] $10 million
[***] $20 million
[***] $30 million
[***] $50 million
For the sake of clarity, each such milestone payment shall be made one time
only, if at all, during the course of this Agreement. If an indicated level of
Adjusted Net Sales is attained in a calendar year but the corresponding
milestone payment has previously been paid, APP shall pay the next lowest level
of unpaid milestone payments, if any. For purposes of this Section 11,
----------
"Adjusted Net Sales" means Net Sales as defined in Section 1.18 but without the
------------
deduction contained in Section 1.18(D).
---------------
12. Further Development of the Product.
----------------------------------
12.1 ABI will diligently pursue development of the Product for the
indications of breast, lung, ovarian and prostate cancers, according to the
objectives established by the Steering Committee. The Steering Committee will
reasonably determine the claims desired, the design, conduct and desired
endpoints of clinical trials, regulatory submissions to be made, timelines,
indications (other than those referred to above) to be studied and petitioned,
and other objectives of development and of lifecycle management efforts (e.g.,
Phase IIIb/IV) (the "Development Issues").
------------------
12.2 All developments will be performed at ABI's sole cost and expense,
but APP must provide to ABI, as requested by ABI (A) up to $2 million of the
Product (based on Chargeable Price) free of charge, [***].
12.3 The steering team will be comprised of three representatives from
each of ABI and APP (the "Steering Committee"), and is required to meet in
------------------
person or by conference call at least once every three months, or more often as
needed. Each Party's representatives must reasonably cooperate in establishing
meeting dates, setting agendas, attending and conducting the meetings, and
working diligently toward, and contributing to, the goals and business of the
Steering Committee and the Development Issues.
12.4 If consensus cannot be reached on one or more Development Issues,
APP's representatives will be entitled to make the final decision with respect
to breast, lung and ovarian indications and ABI's representatives will be
entitled to make the final decision for all other indications.
13. Regulatory Filings/Approvals.
----------------------------
13.1 ABI will be responsible for and required to:
(A) make all filings, and other submissions, to the applicable
governmental agency, department or other body regarding or relating to the
Product; and
(B) obtain all Regulatory Approvals to develop, test, market, and
distribute the Product in the Territory in the manner and for the
indications indicated in this Agreement and determined by the Steering
Committee, except for filings and other submissions required to be made by
APP for the manufacture of the Product as set forth in the Manufacturing
Agreement.
13.2 APP will reasonably cooperate with ABI in its efforts under Section
-------
13.1. All costs and expenses associated with the foregoing with respect to a
----
particular indication will be borne by ABI until ABI obtains FDA approval of the
NDA for such indication. Thereafter, for each indication for which APP makes the
milestone payment under Section 9, although ABI will continue to be responsible
---------
for regulatory filings and the maintenance of such approvals, APP will promptly
reimburse ABI for any further direct costs incurred with respect to the
maintenance of such regulatory approvals for each such indication in the
Territory upon presentation of documentary evidence of these types of payments.
13.3 ABI will use all commercially reasonable efforts to diligently and
aggressively pursue the development of the Product for breast, lung and ovarian
indications.
14. Use of Brand Names.
------------------
14.1 During the term of this Agreement, and as permitted under Section
-------
16.2, and except for those indications for which APP does not make payments
----
under Section 9, APP will have the right to market, distribute, import, export,
---------
offer to sell and sell the Product in the Territory using any brand name
included in an NDA that is approved by the FDA or otherwise established by ABI
for the Product ("ABI Brand Names") and no other party will have such right in
---------------
the Territory. APP shall have such right to the full extent that ABI has the
right to use ABI Brand Names. Any use by APP of ABI Brand Names will be subject
to ABI's comments and may not impair or dilute the value of the names. Except as
provided under Section 16 APP may not sell the Product using any other brand
----------
names.
14.2 As between ABI and APP, ABI will be the sole owner of all ABI Brand
Names and hereby grants APP a royalty-free trademark license for the use of ABI
Brand Names, subject to the other payment provisions in this Agreement.
14.3 In connection with its use of ABI Brand Names, APP must:
(A) credit ABI for ownership of the ABI Brand Names in any
marketing efforts in which it uses any ABI Brand Names;
(B) at its expense, take whatever action may be required under any
Legal Requirement to use any ABI Brand Names in the Territory or refrain
from taking any action that could impair or dilute the value of any ABI
Brand Names; and
(C) reasonably cooperate with ABI in connection with any Action
relating to the use by ABI (or its licensees, including APP) of any ABI
Brand Names that APP is using.
15. No Restriction on Competition. Nothing in this Agreement will be deemed
-----------------------------
to prohibit either Party from developing, making, using, marketing or otherwise
distributing or promoting Products competitive with the Product.
16. Term.
----
16.1 This Agreement will commence on the Effective Date and, except as
provided in this Section 16 and Section 17 will continue until the date of
---------- ----------
expiration of the last patent containing a valid claim that would be infringed
by the use, marketing, sale or distribution of the Product, including in
finished form, but upon the expiration, APP will have a fully-paid, royalty-free
(except as provided in Section 16.4) irrevocable, non-exclusive right to use,
------------
market, sell and distribute the Product in the Territory except for those
indications for which APP does not make payments under Section 9.
---------
16.2 If APP desires to continue to sell Product using ABI Brand Names
after the expiration of such last patent, it may, except for those indications
for which APP does not make payments under Section 9, do so by providing ABI
---------
with six months notice prior to such expiration of APP's desire to extend the
license to ABI Brand Names, as provided in Section 14.1. Except as provided in
------------
Section 16.3, this Agreement will continue for successive one-year terms
------------
thereafter (the "Extension Periods") until APP provides ABI with a minimum of
-----------------
six months notice of APP's intention to terminate.
16.3 If, during the Extension Periods, the APP Parties are selling the
Product under any ABI Brand Name while concurrently selling Product in a generic
form, ABI will have the right to terminate this Agreement upon notice to APP
during any calendar year that Gross Profits for sales of the Product by such
Parties using one or more ABI Brand Names are not at least equal to 50% of Gross
Profits for sales of the Product using ABI Brand Names, in the calendar year
immediately prior to the first Extension Period.
16.4 So long as the APP Parties continue to sell Product under an ABI
Brand Name, APP must pay to ABI the percentage of Gross Profits or consideration
that APP would be obligated to pay to ABI under Section 10 but only for sales of
----------
the Product sold using ABI Brand Names. During an Extension Period, the APP
Parties shall have no payment or royalty obligations to ABI for sales by APP
Parties of Product sold under any name other than an ABI Brand Name.
17. Termination.
-----------
17.1 This Agreement may be terminated:
(A) At any time by mutual agreement of the Parties;
(B) Immediately, by the non-defaulting Party, if the other Party:
(1) commits a material breach or default ("Breach") under this
Agreement, which Breach is not remedied within 60 days after the receipt of
written notice of the Breach by the Party in Breach (except as to the
payment of money by APP, for which the notice period will be 10 days).
Notwithstanding the foregoing, if the Breach is not curable in 60 days and
the breaching or defaulting party in good faith notifies the other party in
writing prior to the 60 days that it is initiating cure of the Breach, and
initiates cure of such Breach within 60 days after the initial notice and
in good faith continues diligently to attempt to cure the Breach, then
this Agreement shall not be terminated pursuant to this Section
--------
17.1(B)(1). Provided, however, it shall not be a breach of the Agreement if
----------
APP does not make one or more of the milestone payments under Section 9.1
-----------
(A) - (H), but rather, in such instance and subject to Section 9.4, APP
--------- -----------
shall immediately lose all right to use, market, distribute, import, export,
sell and offer to sell the Product for such indication and that indication
for which the payment was not made shall not longer be included within the
license grant to APP. From and after APP's failure to make a milestone
payment, ABI will have the right to use the Technology for the relevant
indication in any manner it deems appropriate, including use within the
Territory.
(2) made a material misrepresentation of any representation or
warranty contained in this Agreement; or
(3) has a permanent or temporary restraining order, preliminary
injunction or other order granted against it by a court or authority
enjoining or restricting the sale of the Product as contemplated hereby in
the Territory. Notwithstanding the foregoing, if any such order results or
would foreseeably result in a decline of 10% or less of units of Product
sold in the Territory as compared to the prior calendar year's sales of
units of Product sold in the Territory, then this Agreement shall not be
terminated pursuant to this Section 17.1(B)(3).
------------------
(C) Following a 60-day period after written notice to cure such
condition, by either ABI or APP if the other Party:
(1) does not pay its debts generally as they become due, or is
unable to pay its debts generally as they become due;
(2) has or has instituted against it any proceeding seeking to
adjudicate it bankrupt or insolvent, or seeking liquidation, winding up,
reorganization, arrangement, adjustment, protection, relief or composition
of it or its debts under any law relating to bankruptcy, insolvency or
reorganization or relief of debtors;
(3) makes a general assignment for the benefit of creditors;
(4) seeks the entry of an order for relief or the appointment of a
receiver, liquidator, sequestrator, trustee, custodian or similar official
for it; or
(5) takes advantage of any other law or procedure for the
protection of creditors.
17.2 Upon the termination of this Agreement by ABI pursuant to Section
-------
17.1, the rights and license granted to APP under this Agreement and
----
APP's obligations under Sections 8, 9, 10 and 11 (except to the extent earned
but not yet paid) will terminate, sublicenses will terminate, and ABI's
obligations to provide Technology or information will cease. The rights and
license to APP under this Agreement, and the sublicenses granted thereunder,
shall survive termination of this Agreement by ABI for any other reason. Except
to the extent that any monies are owned and not yet paid and for the provisions
of Sections 5, 6, 7, 17, 18, 19, 20, 21, 22, 23, 25, 26, 32, and 33, none of the
-------- - - - -- -- -- -- -- -- -- -- --
provisions of this Agreement shall survive termination. Upon the termination by
APP under Sections 17.1(B) or (C), ABI's license to APP Owned Developments shall
-----------------------
also terminate. Upon ABI's termination of this Agreement pursuant to Section
-------
17.1, ABI will have the right to concurrently terminate the Manufacturing
----
Agreement.
17.3 Termination is not the sole remedy under this Agreement, and
whether or not termination is effected, all other remedies remain available to
each Party.
18. Confidentiality.
---------------
18.1 Each Party recognizes that the other Party holds its Proprietary
Information as important. In particular, each Party recognizes that the other
Party's Proprietary Information (and the confidential nature thereof) is
critical to the other Party's business and that neither Party would enter into
this Agreement without assurance that such information and the value thereof
will be protected as provided in this Section 18 and elsewhere in this
----------
Agreement.
18.2 Each Party must, therefore:
(A) Hold the other Party's Proprietary Information in confidence
and take reasonable precautions to protect the Proprietary Information
(including, without limitation, no less than all precautions that it
employs with respect to its own confidential materials);
(B) not divulge (except pursuant to a sublicense expressly
authorized in this Agreement) the other Party's Proprietary Information
or any information derived therefrom to any third person; and
(C) not make any use whatsoever at any time of the other Party's
Proprietary Information except for purposes of and expressly authorized in
this Agreement.
18.3 Any employee given access to any Proprietary Information must have
a legitimate "need to know" and must be bound in writing to maintain the
confidence of information to which it is given access.
18.4 Without granting any right or license, the disclosing Party agrees
that the foregoing restrictions will not apply with respect to information that
the receiving Party is able to demonstrate by competent evidence:
(A) is in or (through no improper action or inaction by the
receiving Party or any Affiliate of the receiving Party or its agents or
employees) enters the public domain (and is readily available without
substantial effort);
(B) was rightfully disclosed to it by another person without
restriction; or
(C) was independently developed by it by persons without access to
such information and without use of any of the disclosing Party's
Proprietary Information.
18.5 Each Party's obligations under this Section 18 will terminate
----------
five years after the date of termination or expiration of this Agreement. The
Parties recognize and acknowledge that prior to the Effective Date of this
Agreement, each Party has received the other Party's Proprietary Information and
each hereby agrees to protect the Proprietary Information to the same extent as
set forth in this Section 18.
----------
18.6 Immediately upon termination or expiration of this Agreement, each
Party will turn over to the other Party all Proprietary Information of the other
Party and all documents or media containing any Proprietary Information and any
and all copies or extracts thereof except insofar as necessary to practice the
license as set forth in Section 16.1.
------------
18.7 Each Party acknowledges and agrees that due to the unique nature
of Proprietary Information, there can be no adequate remedy at law for any
breach of each Party's obligations under this Section 18, that any breach may
----------
result in irreparable harm to the disclosing Party, and therefore, that upon any
breach or any threat of breach, the disclosing Party will be entitled to
appropriate equitable relief (without the posting of any bond) in addition to
whatever remedies it might have at law in connection with any breach or
enforcement of the receiving Party's obligations under this Agreement or the
unauthorized use or release of any Proprietary Information.
19. Patent Matters.
--------------
19.1 ABI will, in a scientifically and commercially reasonable manner,
file and prosecute patent applications and maintain patents in the Territory
relating to the Technology, the ABI Owned Developments and any improvements made
by or on behalf of ABI ("ABI Developments").
----------------
19.2 APP will not attempt to file or prosecute any patent applications
or maintain any patent covering the Technology, the ABI Developments, or the ABI
Owned Developments except: (i) as ABI may, in its sole discretion, approve in
writing; (ii) in the event ABI elects to discontinue or abandon the prosecution
and/or maintenance of any patent or patent application covering the Technology
in the Territory, it shall provide adequate notice to APP and shall give APP the
opportunity to file, continue prosecution of, pay any issuance fee and/or
maintain such patent application and/or patent at APP's own expense.
19.3 APP may take whatever steps it deems necessary to protect and
enforce its rights and interest in APP Owned Developments. ABI will not attempt
to file or prosecute any patent applications or maintain any patent covering the
APP Owned Developments.
19.4 If either Party becomes aware of any Product or activity of any
third party that involves or may involve infringement or other violation of any
patent relating to the Proprietary Information, APP Owned Developments (to the
extent related to the Product), ABI Owned Developments, ABI Developments or
other Proprietary Right in the Territory, that Party must promptly notify the
other Party in writing of the infringement or violation.
19.5 ABI will have the first right, but not the obligation, to file
suit or take other action to prevent the infringement of any patents or
Technology owned by ABI related to the Product in the Territory. If ABI takes
such action, ABI will control any action undertaken by ABI against an infringer,
and ABI may enter into settlements, stipulated judgments or other arrangements
respecting the infringement, at its own expense unless the proposed settlements,
judgments or arrangements would adversely affect APP, in which case, they will
be subject to APP's consent which will not be unreasonably withheld. If ABI
takes such action, ABI will defend, indemnify and hold APP harmless from related
costs and expenses for such claimed infringement. APP will permit an action to
be brought by ABI in APP's name if required by law. APP agrees to provide all
assistance that ABI may reasonably require in any litigation, including
providing written evidence, deposition and trial testimony, for which ABI will
pay APP a reasonable hourly rate of compensation, together with reimbursement
for out-of-pocket costs. Any damages or other recovery from an infringement
action undertaken by ABI pursuant to this Section 19.5 to enforce ABI's
------------
Proprietary Rights relating to the Product sold in the Territory, will be used
first to reimburse ABI's legal costs and expenses incurred in the action and
thereafter any damages or other recovery relating to Products sold by the APP
Parties in the Territory will be shared equally with APP.
19.6 If ABI does not, within 90 days after receipt of notice of a
patent infringement relating to the use of the Product sold by the APP Parties
in the Territory, commence action directed toward restraining or enjoining such
patent infringement, APP may take such legally permissible action as it deems
necessary or appropriate to enforce ABI's patent rights and restrain such
infringement at its own expense unless the actions would adversely affect ABI,
in which case they will be subject to ABI's consent which will not be
unreasonably withheld. If APP takes such action, APP will indemnify, defend and
hold harmless ABI in respect of any such action. Any damages or other recovery
from an infringement action undertaken by APP pursuant to this Section 19.6 to
------------
enforce ABI Proprietary Rights on the Product sold in the Territory, will be
first used to reimburse APP's legal costs and expenses incurred in such action
and thereafter shared equally with ABI; provided if any portion of such damages
or other recovery relate to infringement outside the Territory or Product not
sold by the APP Parties in the Territory, such portion shall be paid 100% to
ABI.
19.7 Each Party must fully cooperate with the other Party bringing any
action, including joining as a Party to the suit, if necessary, and also
including, without limitation, supplying essential documentary evidence and
making essential witnesses then in its employ available.
19.8 If any third party threatens or commences a lawsuit against either
Party alleging the Product in any way infringes or otherwise violates any
Proprietary Rights of such third party, it shall promptly notify the other Party
in writing.
20. Adverse Experience Reporting; Recalls.
-------------------------------------
20.1 Each Party will report to the other Party any information of which
it becomes aware concerning any adverse drug experience in connection with the
use of the Product, including the incidence and the severity thereof. ABI will
provide to APP copies of any reports submitted to the FDA relating to any
adverse drug experiences that ABI determines to be significant.
20.2 If ABI is required to initiate, or otherwise in its discretion
decides to initiate, a recall, withdrawal or field correction (collectively, a
"Recall") of the Product sold by the APP Parties in the Territory, ABI will
------
notify APP and provide a copy of its proposal with respect to such Recall,
including the Recall letter, for APP's review prior to ABI's initiation of the
Recall. If APP independently believes that a Recall of the Product sold by the
APP Parties in the Territory may be necessary or appropriate, it must notify
ABI, and the parties must fully cooperate with each other concerning the
necessity and nature of the Action.
20.3 ABI will be responsible for all Recall activities with respect to
Recall of the Product. APP will reasonably cooperate with ABI in connection with
any Recall. Each Party will maintain complete and accurate Recall records
relating to the Product for any periods that are required by any Legal
Requirement.
20.4 The fees, costs and expenses of any Recall (collectively, the
"Recall Expenses") of the Product will be apportioned between the Parties as
---------------
follows:
(A) Except as provided in Section 20.4(C), ABI will pay all Recall
Expenses related to Recalls of the Product outside the Territory.
(B) Except as provided in Section 20.4(C), the Parties will share
50%/50% all Recall Expenses related to Recalls of the Product sold by the
APP Parties in the Territory.
(C) If the Recall is a Manufacturing Recall as determined by an
independent third party mutually agreed upon, then APP will pay all Recall
Expenses.
(D) In the event of a Recall of the Product outside the Territory as
provided in Section 20.4(A) or for Manufacturing Recalls as provided in
Section 20.4(C), the responsible Party shall promptly reimburse the other
Party for any Recall Expenses the other Party incurred. In the event of a
Recall of the Product in the Territory as provided in Section 20.4(B), each
Party shall submit to the other Party on a quarterly basis an accounting of
its Recall Expenses incurred, and the Party that incurred the lesser amount
shall make a reconciling payment to the other Party for 50% of the
difference.
21. Indemnification; Incidental And Consequential Damages.
-----------------------------------------------------
21.1 APP agrees to indemnify, defend and hold harmless the ABI Parties
from any Damages incurred by or assessed against the ABI Parties resulting from
a third party claim caused or alleged to be caused by:
(A) APP's failure to perform any of its obligations under this
Agreement;
(B) any breach of or inaccuracy in any representations or warranty
made by APP in this Agreement;
(C) any Product Liability Claim arising from the gross negligence,
fraud or intentional misconduct of an APP Party;
(D) a sublicesee's material breach of its sublicense under this
Agreement or related to any gross negligence, fraud or intentional
misconduct on the part of any sublicensee of APP; and
(E) any Product Liability Claim directly resulting from the use of
the Product that, when manufactured by APP, was adulterated or contaminated,
or was otherwise caused by APP's failure to comply with this Agreement
or the Specifications provided for in the Manufacturing Agreement.
21.2 ABI agrees to indemnify, defend and hold harmless the APP Parties
from any Damages incurred by or assessed against the APP Parties resulting from
a third party claim caused or alleged to be caused by:
(A) ABI's failure to perform any of its obligations under this
Agreement;
(B) any breach of or inaccuracy in any representations or warranty
made by ABI in this Agreement;
(C) any Product Liability Claim arising from the gross negligence,
fraud or intentional misconduct of ABI Parties;
(D) any Product Liability Claim directly resulting from the use
and/or sale of the Product outside the Territory, except for those
covered in Section 21.1(C) or Section 21.1(E);
--------------- ---------------
(E) any Product Liability Claim directly resulting from the use
and/or sale of the Product inside the Territory, when sold by ABI
Parties for indications other than those licensed to APP, except for those
covered in Section 21.1(C) or Section 21.1(E).
--------------- ---------------
21.3 Except with respect to the APP Owned Developments or ABI Owned
Developments, ABI further indemnifies APP for any proceedings instituted by or
on behalf of a third party based upon a claim that the manufacture, use or sale
of the Product infringes a patent or any other proprietary right of that third
party. Such indemnification obligation shall be limited as follows:
(A) to the extent such proceeding or settlement thereof results in a
future royalty to be paid by APP, ABI's indemnity obligation shall be
satisfied by having such royalty payment be a deduction from Net Sales; and
(B) to the extent such proceeding or settlement thereof results in a
payment obligation other than as provided in Section 21.3(A) above, ABI
---------------
shall indemnify APP only to the extent of fifty percent (50%) of
payments previously made by APP to ABI pursuant to Section 8.1 hereof,
-----------
and any indemnity payments to be made by ABI to APP or on behalf of APP
pursuant to the foregoing shall be limited to fifty percent (50%) of
ABI's operating cash flow, including without limitation, the split of
Gross Profits under this Agreement.
21.4 If any Party entitled to be indemnified pursuant to this Section
-------
21 (an "Indemnified Party") receives notice of the assertion by any Person of
--
any claim or of the commencement by any Person of any Action (any such claim or
Action being referred to herein as an "Indemnifiable Claim") with respect to
-------------------
which another Party hereto (an "Indemnifying Party") is or may be obligated to
------------------
provide indemnification, the Indemnified Party shall promptly notify the
Indemnifying Party in writing (the "Claim Notice"). However, the failure to
------------
provide the notice will not relieve or otherwise affect the obligation of the
Indemnifying Party to provide indemnification under this Agreement, except to
the extent that any Damages directly resulted or were caused by that failure.
21.5 The Indemnifying Party will have 30 days after receipt of the
Claim Notice to undertake, conduct and control, through counsel of its own
choosing and at its expense, the settlement or defense of the claim, and the
Indemnified Party will cooperate with the Indemnifying Party in connection with
the settlement or defense, if:
(A) the Indemnifying Party permits the Indemnified Party to
participate in the settlement or defense through counsel chosen by the
Indemnified Party (subject to the consent of the Indemnifying Party, which
consent shall not be unreasonably withheld);
(B) the fees and expenses of such counsel will not be borne by the
Indemnifying Party; and
(C) the Indemnifying Party does not settle any Indemnifiable Claim
without the Indemnified Party's consent which consent may not be
unreasonably withheld. So long as the Indemnifying Party is vigorously
contesting any Indemnifiable Claim in good faith, the Indemnified Party may
not pay or settle the claim without the Indemnifying Party's consent, which
consent shall not be unreasonably withheld.
21.6 If the Indemnifying Party does not notify the Indemnified Party
within 30 days after receipt of the Claim Notice that it elects to undertake the
defense of the Indemnifiable Claim described in the Claim Notice, the
Indemnified Party has the right to contest, settle or compromise the
Indemnifiable Claim in the exercise of its reasonable discretion. However, the
Indemnified Party must notify the Indemnifying Party of any compromise or
settlement of any such Indemnifiable Claim.
21.7 Notwithstanding anything in this Section 21 to the contrary, APP
----------
is not entitled to assume the defense for any Indemnifiable Claim (and will be
liable for the reasonable fees and expenses incurred by the Indemnified Party in
defending the claim) if the Indemnifiable
Claim seeks an order, injunction or other equitable relief (or other relief for
other than money damages) against ABI or its Affiliates which ABI determines,
after conferring with its counsel, cannot be separated from any related claim
for money damages and which, if successful, would adversely affect the
commercialization of the Product. However, if an equitable relief portion of the
Indemnifiable Claim can be separated from that for money damages, APP may assume
the defense of the portion relating to money damages.
22. Product Liability.
-----------------
22.1 Subject to Section 21, each Party must promptly reimburse the
----------
other Party for 50% of the amount of: (A) the costs of responding to or
defending any Product Liability Claim arising from use or sale of the Product in
the Territory, regardless of the reason for such claim except as expressly set
forth in Sections 21.1(C) or 21.1(E); and (B) any Damages payable by the Party
---------------- -------
following final judgment or settlement of any Product Liability Claim arising
from use or sale of the Product in the Territory regardless of the reason for
such claim except as expressly set forth in Sections 21.1(C) or 21.1(E). For the
---------------- -------
sake of clarity, the 50%/50% sharing ratio for Product Liability Claims arising
from the use or sale of the Product in the Territory (except as provided in
Sections 21.1(C) and 21.1(E) shall include, without limitation, claims based on
---------------- -------
allegations of latent defect, failure to warn, and the establishment of the
Specifications.
22.2 For so long as ABI is conducting clinical trials of the Product or
commercially marketing and selling the Product, it must maintain Product
liability insurance with respect to the Product, with a reputable carrier, in
the amounts set forth in Exhibit B, naming APP and its Affiliates as additional
---------
insureds.
22.3 For so long as APP is commercially marketing and selling the
Product in the Territory, it must maintain Product liability insurance with
respect to the Product, with a reputable carrier, in the amounts set forth in
Exhibit C, naming ABI and its Affiliates as additional insureds.
---------
22.4 Each Party must notify the other Party as promptly as practicable
if a Product Liability Claim under Section 22.1 is commenced or threatened
------------
against any Party. Each Party must cooperate with the other Party in connection
with any such Product Liability Claim that is commenced or threatened against
the other Party.
22.5 If a Product Liability Claim under Section 22.1 is asserted against
------------
both Parties, each Party will have the right to designate counsel to defend
itself in the Product Liability Claim. If a Product Liability Claim under
Section 22.1 is brought against one Party but not the other Party, the named
------------
Party will (subject to Section 22.6) have absolute control of litigation,
------------
except that:
(A) the other Party may appoint counsel to participate in the
defense of the Product Liability Claim if the named Party reasonably
determines that the participation would not adversely affect the
attorney-client privilege; and
(B) if the litigation could reasonably be expected to have an
adverse effect on the development and commercialization of the Product,
the named Party must consult
with the other Party regarding the conduct of the litigation if the
named Party reasonably determines that the cooperation would not adversely
affect the attorney-client privilege.
22.6 Neither Party may agree to a settlement of any Product Liability
Claim under Section 22.1 without the consent of the other Party, which consent
------------
may not be unreasonably withheld or delayed, if the settlement:
(A) would have an adverse effect on the development or
commercialization of the Product; or
(B) would otherwise have a material adverse effect on the other
Party.
23. EXCEPT FOR BODILY INJURY OF A PERSON, NEITHER PARTY WILL BE LIABLE
HEREUNDER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS FROM THE USE OF (OR INABILITY TO
USE) THE TECHNOLOGY, THE DEVELOPMENT OR COMMERCIALIZATION OF THE PRODUCT OR
OTHERWISE IN CONNECTION WITH, OR ARISING OUT OF, THIS AGREEMENT.
24. Independent Contractors. ABI and APP are independent Parties, and
-----------------------
nothing contained herein will be construed to create a joint venture,
partnership or similar relationship. Neither Party is authorized to, nor may it,
make any statements, claims, representations, warranties or otherwise act in any
way so as to incur any liability whatsoever for which the other may become
directly, indirectly or contingently liable.
25. Assignment.
----------
25.1 The rights and obligations of the Parties under this Agreement may
not be assigned or transferred in any manner, including, without limitation, by
operation of law, sale of stock or sale of assets, without the prior written
approval, which shall not be unreasonably withheld, of the other Party (and any
attempt to do so will be void) except that:
(A) rights to payment of money may be assigned without such
approval, and
(B) a Party has the right to assign this Agreement to its lenders as
collateral security under a credit facility and following acceleration of
that credit facility, it's lender has the right to assign this Agreement to
a third party reasonably satisfactory to the other Party. Despite the
foregoing, in no event shall ABI be obligated to consent to an assignment to
a Competitor.
25.2 Notwithstanding anything to the contrary in Section 25.1, if:
------------
(A) any Party:
(1) merges or consolidates with any other corporation,
partnership or other business entity, or
(2) all or substantially all of such Party's business or assets
are transferred in any manner to any other corporation, partnership
or other business entity; or
(B) any other Person acquires the power, directly or indirectly, to
direct or cause the direction of management and the policies of such Party
(a "Change of Control");
-----------------
such event will be deemed an approved assignment for purposes of this
Agreement if the conditions set forth in this Section 25.3 are satisfied.
------------
25.3 Following a Change of Control, such successor to such Party will
succeed to, and be subject to, all rights, interests, duties and obligations of,
and will thereafter be deemed for all purposes to be the applicable Party under
this Agreement. The successor to be approved under this Section 25.3 will be
------------
require to:
(A) have the experience, facilities, capabilities, and financial
resources equal to or greater than such Party; and
(B) expressly acknowledge, in a written instrument delivered to the
other Party in a form reasonably acceptable to the Parties:
(1) the succession to all duties and obligations of the Party
under this Agreement, and
(2) the existence of the requirements set forth in this Section
-------
25.
--
25.4 Despite the foregoing, for the purposes of this Agreement, an IPO
will not be considered a Change of Control.
25.5 If APP's successor does not meet the following requirements in
Section 25.5(A) and 25.5(B) in each calendar year after a Change of Control
--------------- -------
occurs, ABI may, at its sole option, convert the exclusive license to a
non-exclusive license or terminate this Agreement:
(A) spend on marketing and sales at least the same amounts that the
APP Parties (other than those which have continuing agreements with such
a successor) and its Affiliates and permitted assignees spent on marketing
and sales in the calendar year prior to the Change of Control; and
(B) achieve revenues that are greater than or equal to 90% of the
greater of:
(1) the revenues of the APP Parties (other than those which have
continuing agreements with such a successor) in the calendar year
prior to the Change of Control; or
(2) the average of the revenues of the APP Parties (other than
those which have continuing agreements with such a successor) for
the immediately preceding three calendar years.
25.6 In the event a Change of Control, the foregoing amounts in Section
-------
25.5 shall be prorated for the portion of the calendar year subsequent to the
----
Change of Control.
25.7 If the successor entity fails to achieve the sales level required
in Section 25.5, such successor shall be entitled to make a supplemental payment
------------
to ABI (within 45 days after the end of each calendar year) of an amount equal
to: (A) the difference between its actual revenues from the Product and the
revenues required by Section 25.5, multiplied by (B) one-half (1/2) of its Gross
------------
Profits from Product sales as a percentage of such actual revenues. Such
payment, if made, shall prevent ABI from exercising any other remedy under
Section 25.5 with respect to the calendar year for which such payment is made.
------------
26. Notices. Any and all notices given pursuant to this Agreement must
-------
be in writing, and will be deemed to have been properly given when delivered
personally or sent by facsimile, air courier, or post, to the respective address
shown below or such other address as shall be specified by the Party(ies)
pursuant to written notice given in accordance with this Section 26. Any notice
----------
will be effective upon receipt, which will be deemed to occur one business day
after the facsimile is send, two business days the notice is sent by air
courier, and five calendar days after the notice is delivered to the US Postal
Service, properly marked and stamped for first class mail, return receipt
requested. Any and all notices must be sent:
If to ABI to:
American BioScience, Inc.
0000 Xxxxxxxx Xxxxxxxxx
Xxxxx Xxxxxx, Xxxxxxxxxx 00000
Attention: Chief Executive Officer
Facsimile: 310/998-8553
With a copy to:
[
Attention:
Facsimile: ]
If to APP to:
American Pharmaceutical Partners, Inc.
00000 Xxxxxxxx Xxxxxxxxx
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Operating Officer
Facsimile: 310/470-4222
With a copy to:
American Pharmaceutical Partners, Inc.
0000 Xxxxxxxxx Xxxxx
Xxxxxxxxxx, Xxxxxxxx 00000
Attention: General Counsel
Facsimile: 847/413-2670
27. Force Majeure.
-------------
27.1 The obligations of a Party hereunder will be suspended during the
time and to the extent that such Party is prevented from complying with its
obligations due to any event or circumstances beyond the reasonable control
and without the fault or negligence of the affected Party (which
circumstance is referred to as "Force Majeure"), including but not limited
-------------
to inevitable accidents, perils of navigation, floods, fire, storms,
earthquakes, lockouts, explosion, hostilities, war (whether declared or
undeclared), acts of terrorism, civil disturbances, order or acts of any
government, whether de jure or de facto or any official purporting to act
under authority of any such government (other than as to Regulatory
Approval), illegality arising from domestic or foreign laws or regulations,
insurrections, quarantine or custom restrictions (other than due to the
action or inaction of the Party claiming a Force Majeure), damage in
factories or warehouses, strikes, lockouts, or other labor difficulty of the
Parties, inability to obtain paclitaxel active pharmaceutical ingredient or
other components and raw materials, lack of conveyance, breakdown of
machinery or instruments or other disturbances of the Parties or their
suppliers or acts of God or other similar event beyond the reasonable
control of, as the case may be, ABI or APP that results in hindrance of the
performance by the Party of its obligations under this Agreement.
27.2 As soon as possible after being affected by a Force Majeure
circumstance, the affected Party must furnish to the other Party all
particulars of the Force Majeure and the manner in which its performance is
prevented or delayed. The Party whose obligations under this Agreement have
been suspended must promptly and diligently pursue appropriate action to
enable it to lift the Force Majeure situation, except that such Party will
not be obligated to settle any strike, lockout or other labor difficulty on
terms contrary to its wishes.
27.3 If any Force Majeure circumstance cannot be removed or overcome
within 120 days (or such other period as the Parties mutually agree) from
the date the Party affected first became affected, then the non-affected
Party may, at the expiration of such period, by notice to the affected Party
terminate this Agreement, and neither Party will be liable to the other for
Damages.
28. Amendment and Waiver. This Agreement (including the Exhibits hereto)
--------------------
may be amended, modified, superseded or canceled, and any other of the terms
or conditions hereof may be modified, only by a written instrument executed
by both Parties or, in the case of a waiver, by the Party waiving
compliance. Failure of either Party at any time or times to require
performance of any provision hereof will in no manner affect the right of
such Party at a later time to enforce the same, and no waiver of any nature,
whether by conduct or otherwise, in any one or more instances, will be
deemed to be or considered as a further or continuing waiver of any
provision of this Agreement.
29. Severability. If any one or more of the agreements, provisions or
------------
terms contained herein are declared invalid, illegal or unenforceable in any
respect, the validity of the remaining agreements, provisions or terms contained
herein will not be affected, prejudiced or invalidated thereby.
30. Entire Agreement. This Agreement, the Security Agreement noted in
----------------
Section 8.2 and all Exhibits hereto, contain the entire agreement between the
-----------
Parties, and supersedes any prior agreements between them, with respect to the
subject matter hereof.
31. Section Headings; Recitals. The section headings contained in this
--------------------------
Agreement are for reference purposes only and do not affect in any way the
meaning or interpretation of this Agreement. The recitals are hereby
incorporated into this Agreement by reference.
32. Governing Law. This Agreement shall be governed by and construed and
-------------
enforced in accordance with the substantive law (without regard to conflicts of
law provisions) of the State of California.
33. Arbitration; Equitable Relief.
-----------------------------
33.1 Except in the case of a Party seeking equitable relief
hereunder, any and all disputes or controversies, whether of law or fact and of
any kind and nature whatsoever, arising out of or relating to this Agreement,
will be decided by binding arbitration in accordance with Title 9 of the United
States Code and the Commercial Arbitration Rules of the American Arbitration
Association ("AAA"). For claims under $1,000,000, the arbitration will be held
---
before a single arbitrator. If the Parties are unable to agree on an arbitrator,
the arbitration will be held before an arbitrator selected by AAA. For claims
over $1,000,000, the arbitration will be held before a three-member panel of
arbitrators. If the Parties are unable to agree on a three-member panel of
arbitrators, the arbitration will be held before a three-member panel of
arbitrators selected by the AAA. Arbitration shall take place in Los Angeles
County, State of California, or such other location as may be agreed by the
Parties. Claims with respect to injunctive relief or specific performance will
be resolved by a court of law in accordance with Section 33.2. APP irrevocably
------------
consents and submits to personal jurisdiction in the State of California for any
arbitration contemplated by this Section 33.1. The decision of the arbitrators
------------
will be binding upon the Parties hereto and all parties claiming under and
through them, and judgment will be entered by any court of competent
jurisdiction. The fees and expenses of the arbitrator will be paid equally by
the Parties.
33.2 With respect to actions for injunctive relief and specific
performance, the Parties submit to the jurisdiction of any state or federal
court sitting in Los Angeles County in any Action arising out or respecting this
Agreement and agree that all claims in respect of such Action shall be heard and
determined in any such court. The Parties waive any defense of inconvenient
forum to the maintenance of any Action and waive any bond, surety or other
security that may be required of any other party with respect to the Action. The
Parties agree that a final judgment in any Action brought under this Section
-------
33.2 will be conclusive. Either Party may seek injunctive relief if any
----
provision of this Agreement is not performed in accordance with its terms and
for which such Party would not have an adequate remedy for money damages. Any
such remedy will be in addition to any other remedy that may be available at law
or equity.
34. Counterparts. This Agreement may be executed in separate
------------
counterparts, each of which will be deemed to be an original, but which together
will constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first above written.
AMERICAN BIOSCIENCE, INC.,
a California corporation
By: /s/ Xxxxxxx Soon-Shiong
-----------------------
Xxxxxxx Soon-Shiong
President
AMERICAN PHARMACEUTICAL PARTNERS, INC.,
a California corporation
By: /s/ Xxxxxxx X. Xxxxxx
---------------------
Xxxxxxx X. Xxxxxx
Chief Operating Officer
EXHIBIT A
ABI Patents
-----------
[***]
EXHIBIT B
ABI Insurance
-------------
$25,000,000 per incident and in the aggregate
EXHIBIT C
APP Insurance
-------------
$25,000,000 per incident and in the aggregate
