LICENSE AGREEMENT
This LICENSE AGREEMENT ("Agreement"), effective as of May 17th, 1999,
by and between XXX XXXXX AND COMPANY, an Indiana corporation with its principal
office located at Lilly Corporate Center, Indianapolis, Indiana 46285 ("Lilly"),
and VERSICOR, INC., a Delaware corporation with its principal offices located at
00000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000 and Versicor's Affiliates
(together "Versicor").
RECITALS
1. WHEREAS, Lilly is engaged, among other things, in the business of
discovering, developing, manufacturing and marketing pharmaceutical products for
the treatment and prevention of infectious diseases;
2. WHEREAS, Lilly's research for antifungal agents has resulted in
Lilly owning patents, patent applications and know-how relating to an
echinocandin B analog known as LY303366 (and analogs thereof);
3. WHEREAS, Lilly has been developing intravenous and oral formulations
of LY303366 and generated regulatory filings, pre-clinical and clinical data and
other information related to LY303366;
4. WHEREAS, Lilly is interested in exclusively licensing LY303366 to a
pharmaceutical company capable and desirous of developing and commercializing
both parenteral and enteral pharmaceutical products of LY303366 (and/or analogs,
salts or prodrugs thereof);
5. WHEREAS, Versicor is a specialty pharmaceutical company which
concentrates in the development and commercialization of compounds in the area
of infectious diseases;
6. WHEREAS, Versicor has the capability and expertise to develop and
commercialize both parenteral and enteral pharmaceutical products.
7. WHEREAS, Versicor is interested in exclusively licensing rights to
LY303366 from Lilly for the worldwide development and commercialization of both
the parenteral and enteral products of LY303366 (and/or analogs, salts or
prodrugs thereof); and
8. WHEREAS, subject to the terms and conditions set forth in this
Agreement, Lilly is willing to exclusively license to Versicor and Versicor
desires to exclusively license from Lilly rights related to LY303366 so that
Versicor may be enabled to proceed with the further development and
commercialization of LY303366;
NOW, THEREFORE, the Parties hereto, intending to be legally bound,
hereby agree as follows:
SECTION 1
DEFINITIONS
1.1 DEFINITIONS. For purposes of this Agreement, the following terms
shall have the meanings set forth below:
"AFFILIATES" shall mean, with respect to a Party to this Agreement, any
Persons directly or indirectly controlling, controlled by, or under common
control with, such other Person. For purposes hereof, the term "controlled"
(including the terms "controlled by" and "under common control with"), as used
with respect to any Person, shall mean the direct or indirect ability or power
to direct or cause the direction of management policies of such Person or
otherwise direct the affairs of such Person, whether through ownership of equity
participation, voting securities, beneficial interest, by contract or otherwise.
Affiliate shall specifically exclude third parties to which Versicor has granted
a sublicense pursuant to authority granted by this Agreement where Versicor has
no relationship to the sublicensee other than a licensor-licensee relationship.
"APPLICATION FOR MARKETING AUTHORIZATION" shall mean (a) in the United
States a new drug application filed with the FDA pursuant to 21 U.S.C. Section
357 and 21 C.F.R. Section 314 ("NDA") with respect to the Product and (b) in any
country other than the United States, an equivalent application or set of
applications for marketing approval comparable to an NDA necessary to make and
sell Product commercially in such country.
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f) is independently developed by an employee or agent of the
receiving Party, subsequent to receipt of such information from
the disclosing Party, as demonstrated by contemporaneous written
records.
"CO-PROMOTE" or "CO-PROMOTION" shall mean an arrangement, in one or
more jurisdictions where permitted, in which (i) there is a single registration
holder for the Product; (ii) a single Party responsible for the manufacture of
Product; (iii) a single Party establishing the price of Product; (iv) a single
Party booking sales; (v) a single trademark being used in connection with the
Product; (vi) both Parties promote and market sales of the Product in such
jurisdiction(s); and (vii) either or both names or logos of the Parties appear
on the Product.
"DAMAGES" shall mean any and all costs, losses, claims, liabilities,
fines, penalties, damages and expenses, court costs, and reasonable fees and
disbursements of counsel, consultants and expert witnesses incurred by a Party
hereto (including any interest payments which may be imposed in connection
therewith).
"DATA EXCLUSIVITY PERIOD" shall mean the period, if any, during which
the FDA, or other equivalent regulatory agency in the case of countries other
than the United States, prohibits reference, for purposes of seeking Regulatory
Approval, to clinical and other data contained in the Regulatory Approval
package of Versicor or its sublicensee which is not published or publicly
available outside of the Regulatory Approval package and relates to the Product,
without the consent of the Party holding the NDA or equivalent Regulatory
Approval.
"EFFECTIVE DATE" shall be the date set forth in the first paragraph of
this Agreement.
"EUROPE" shall mean the European Union, including the following
countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland,
Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom and any
other European Union countries at the time of the Effective Date.
"FDA" shall mean the United States Food and Drug Administration, or any
successor thereto.
"FTE" shall mean the equivalent of the scientific work on or directly
related to the
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Product of one scientific person full time for one year (consisting of a total
of forty-seven (47) weeks or one thousand eight hundred eighty (1,880) hours per
year (excluding vacations and holidays).
"GAAP" shall mean generally accepted accounting principles in the
United States, consistently applied.
"HOSPITAL MARKET SECTOR" shall mean that segment of the Product market
in which the Product is administered by a licensed medical professional (i) in a
hospital or critical care setting; and/or (ii) in a facility that is recognized
as a hospital by the American Hospital Association in the United States or
equivalent associations in other countries.
"INDEMNIFIED PARTY" shall have the meaning given in Section 8.2 hereof.
"INDEMNIFYING PARTY" shall have the meaning given in Section 8.2
hereof.
"INTRAVENOUS FORMULATION" shall mean parenteral (ip) formulations of
the Product Which may be administered by injection; referring particularly to
the introduction of substances by means of intravenous, subcutaneous,
intramuscular, or intramedullary injection.
"LICENSED PATENTS" shall mean all (i) patents and patent applications
listed in EXHIBIT A attached hereto; (ii) any international counterparts
thereof; (iii) any divisionals, continuations, continuations-in-part (except as
provided below), refilings, and extensions of any of the foregoing patents and
patent applications; (iv) all substitutions, reissues, renewals, reexaminations,
patents of addition, and inventors' certificates thereof, patent term
extensions, supplementary protection certificates and pediatric data package
exclusivity extensions of the foregoing patents; and (v) all patents issuing
from any of the foregoing. "Licensed Patents" shall also include patents and/or
patent applications which are filed or which issue after the Effective Date to
the extent of any claims that covers the Licensed Technology and does not
include new matter. "Licensed Patents" shall not include any claims in
continuation-in-part patent applications (including all divisionals and
continuations of these continuations-in-part), patents issuing from
continuations-in-part (including all reissues, reexaminations, and extensions of
such patents), and all international counterparts thereof to the extent that
such claims are directed to new matter which is not the subject matter of those
patents and patent applications listed in EXHIBIT A.
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For clarity, the Cal-Tech patent application (08/905359) to the modified ECB
Deacylase enzyme (the "Cal-Tech Patent Application") is intentionally not
included as a Licensed Patent; HOWEVER, Versicor shall have the right, pursuant
to a separate license agreement to be negotiated in good faith between the
Parties, to obtain a sublicense from Lilly to the Cal-Tech Patent Application as
related specifically to the Product.
"LICENSED TECHNOLOGY" shall mean all tangible or intangible know-how,
trade secrets, inventions (whether or not patentable), data, clinical and
preclinical results, analytical reference materials and all confidential and/or
proprietary chemical substances, Biological Materials, assays, and technical
information (collectively, "Technology"), which has been developed or acquired
before the Effective Date (with the right to disclose and sublicense and subject
to the rights of Third Parties as of the Effective Date) by Lilly to the extent
such Technology is reasonably necessary or useful for the development,
manufacture, use, import, offer for sale or sale of the Product. Licensed
Technology does not include Transferred Assets.
"LILLY DEVELOPMENT OPTION" shall mean Lilly's right to elect to assume
exclusive development and commercialization rights and obligations for the Oral
Formulation of the Product after completion of Phase II Clinical Trials by
Versicor, in accordance with Section 2.7.
"NET SALES" shall mean, with respect to the Product, the gross amount
invoiced by Versicor, its Affiliates, and sublicensees to unrelated third
parties for sales of the Product, less:
(a) trade, quantity and cash discounts actually allowed;
(b) discounts, refunds, rebates, chargebacks, retroactive
price adjustments and any other allowances which effectively reduce the net
selling price;
(c) actual product returns, credits and allowances; and
(d) freight, insurance, taxes, customs, duties and other
government charges if separately set forth in the invoiced amount.
Such amounts shall be determined from books and records maintained in
accordance with GAAP. No deductions shall be made for commissions paid to
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individuals, whether they are with independent sales agencies or regularly
employed by Versicor, or sublicensees, and on its payroll, or for the cost of
collections.
"MAJOR MARKET COUNTRY" or "MAJOR MARKET COUNTRIES" shall mean the
United States, Japan, United Kingdom, France, Germany, Italy and/or Spain.
"NORTH AMERICA" or "NORTH AMERICAN" shall mean the United States,
Mexico and/or Canada, and their respective territories, possessions and
commonwealths.
"ORAL FORMULATION" shall mean enteral formulations of the Product which
are administered orally and are absorbed through the intestine or
gastrointestinal tract; referring without limitation to the introduction of
substances by means of controlled time-release preparations, liquid suspensions,
and sublingual administration.
"ORAL FORMULATION DEVELOPMENT PLAN" shall have the meaning described in
Section 6.7 herein.
"OTHER FORMULATIONS" shall mean any means by which the Product is
administered other than by an Oral Formulation and/or Intravenous Formulation,
including, without limitation, the introduction of substances by means of
internasal administration, pulmonary absorption, rectal administration, topical
applications and the like.
"PARTY" or "PARTIES" shall mean either Lilly or Versicor or both.
"PERSON" shall mean a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental authority
or any other entity or organization.
"PHASE II CLINICAL TRIALS" shall mean human clinical trials conducted
in patients anywhere in the world in accordance with good clinical practice to
demonstrate efficacy with the Product in the particular indication tested, as
well as to obtain a preliminary indication of the limit and/or daily dosage
regimen required.
"PHASE III CLINICAL TRIALS" means large scale human clinical trials
conducted in patients anywhere in the world in accordance with good clinical
practice to generate data
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concerning the efficacy and a level of safety in the particular indication
tested sufficient to obtain Approval of the Product.
"PRODUCT" shall mean a finished or semi-finished good containing the
compound LY303366, having the chemical name (1-[(4R,5R)-4,5-Dihydroxy-N(2)-[[4"-
(pentyloxy)[1, 1' :4' 1"-terphenyl]-4-yl]carbonyl]-L-omithine]echinocandin B
(including analogs, salts, and prodrugs thereof), and all dosage strengths and
sizes thereof, that may, pursuant to applicable laws and regulations be
manufactured, marketed and sold upon Regulatory Approval, together with all
expansions and improvements thereon which may be included in any supplement,
modification or addition to the Regulatory Approval.
"PRODUCT DATA PACKAGE" shall include the following information and data
directly related to the Product in the tangible possession or control of Lilly
as of the Effective Date: (a) Regulatory Documents; (b) pre-clinical and
clinical development protocols, data, and reports; (c) manufacturing development
technical reports; (d) toxicology reports; and (e) such other information and
data specifically identified in EXHIBIT C attached hereto. EXHIBIT C shall
represent a complete listing of the information and data included in Product
Data Package, as such term is used in this Agreement.
"PRODUCT INVENTORY" shall mean LY303366, LY303366/Fructose complex,
freeze-dried vials containing LY303366 Intravenous Formulation, related
intermediates and certificates of analyses which Lilly owns or controls as of
the Effective Date, including without limitation Start-Up Inventory, which
inventory is listed in EXHIBIT D attached hereto. Lilly shall file such
amendments with the Regulatory Documents as appropriate to reflect the
manufacturing processes used in manufacturing the Product Inventory.
"REGULATORY APPROVAL" shall mean (a) in the United States, approval by
the FDA of an Application for Marketing Authorization and satisfaction of any
related applicable FDA registration and notification requirements (if any) and
(b) in any country other than the United States, approval by regulatory
authorities having jurisdiction over such country of a single Application or set
of Applications for Marketing Authorization.
"REGULATORY DOCUMENTS" shall mean the (a) United States investigational
new drug application (IND) #51,111, dated July 15, 1996; (b) United States IND
#54,597, dated November 20, 1997; (c) Spain CTA #PEI97-06 dated August 17, 1998;
(d) Canada IND ## 044571, 056065 and 056082, approved September 25, 1996, June
16, 1998, June
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16, 1998, respectively; (e) Japan IND # 10-2469, dated August 3, 1998; and (g)
equivalent filings, authorizations and applications in the countries of France,
United Kingdom CTX 6/350/A #61292; and Xxxxxxx, Xxxxxxx (XXX xxx 000/00),
Xxxxxxx (4013536), Argentina (2345/98) and Brazil; and (h) all amendments and
reports related to the aforementioned documents.
"REASONABLE DILIGENCE" shall mean commercially reasonable efforts to
develop and obtain Regulatory Approval in the Territory, consistent with
accepted business practices and legal requirements, and comparable to efforts in
the pharmaceutical industry for compounds at an equivalent stage of development
and similar market potential,; PROVIDED, HOWEVER, that prior to the first human
dose for the Oral Formulation, "Reasonable Diligence" with respect to
development of the Oral Formulation shall be deemed satisfied upon the earlier
of (a) administration of the first human dose for the Oral Formulation; or (b)
cumulative out-of-pocket third party expenses by Versicor in connection with
Oral Formulation development pursuant to the Oral Formulation Development Plan
equal to or greater than Five Hundred Thousand Dollars ($500,000) on or before
December 31, 2000 and One Million Dollars ($1,000,000) on or before December
31, 2001.
"REIMBURSABLE DEVELOPMENT EXPENSES" shall mean all internal and
external direct, actual and documented costs incurred by Versicor after the
Effective Date to develop the Oral Formulation of the Product, including,
without limitation, pre-clinical and clinical trial expenses (including, without
limitation, the direct cost of clinical trial materials), reasonable Third Party
costs, Regulatory Approval expenses and fees, and costs associated with
scientific personnel dedicated to development of the Oral Formulation of the
Product, where scientific personnel costs shall be calculated at a rate of Two
Hundred Thousand Dollars ($200,000) per FTE. The purchase of raw materials or
supplies or external Third Party services shall be calculated using actual
direct costs incurred by the Parties for such Third Party goods or services.
"RESERVE INVENTORY" shall mean Product Inventory which is not being
purchased by Versicor as of the Effective Date and which is specifically
identified as Reserve Inventory in EXHIBIT D attached hereto.
"ROW" shall mean all the countries and territories of the world, except
those in North America and Europe.
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"ROYALTY TERM" shall mean, with respect to each country in which
Product is sold the period of time equal to the longer of (i) ten (10) years
from the date of first sale of the Product in such country, (ii) the expiration
of the last-to-expire Licensed Patent listed in EXHIBIT A in such country that
claims such Product, or (iii) the period of time equal to the Data Exclusivity
Period in such country.
"START-UP INVENTORY" shall mean Product Inventory which is being
purchased by Versicor as of the Effective Date of this Agreement and which is
specifically identified as Start-Up Inventory in EXHIBIT D attached hereto.
"TERRITORY" shall mean all the countries and territories of the world.
"TRANSFERRED ASSETS" shall mean the Start-Up Inventory and the Product
Data Package.
"VERSICOR CO-PROMOTION RIGHT" shall have the meaning set forth in
Section 2.7(g).
"VERSICOR IMPROVEMENTS" shall mean any inventions, patentable or not,
information and/or data that are generated, identified and/or discovered by
Versicor during the term of the Agreement, based on use or practice of the
Licensed Patents or Licensed Technology, and are related to the Product,
including, without limitation, pre-clinical studies and clinical trial
information, manufacturing processes, formulations, modes of delivery and/or
data necessary for the manufacture, use or sale of the Product, or peripheral
and/or SAR compounds, pharmaceutical compositions, manufacturing processes,
product configurations and methods of use related to the Licensed Patents.
"VERSICOR RESPONSIBILITIES" shall have the meaning set forth in Section
2.4 hereof.
SECTION 2
GRANT OF LICENSES, TRANSFER OF TRANSFERRED ASSETS AND
ASSUMPTION OF LIABILITIES
2.1 GRANT OF LICENSES. Upon the terms and subject to the conditions of
this Agreement:
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(a) During the term of the Agreement, Lilly hereby grants to
Versicor an exclusive, even as to Lilly (except as expressly reserved by Lilly
herein), license under the Licensed Patents and Licensed Technology to make,
have made, use, sell, offer to sell and import the Product in the Territory.
Lilly shall retain a non-exclusive license under the Licensed Patents and
Licensed Technology to make and use the Product solely for internal research
purposes;
(b) Upon expiration of the Agreement in any country in the
Territory pursuant to Section 4.1, Versicor shall thereafter have a fully
paid-up, perpetual, irrevocable, non-exclusive license to the Licensed
Technology to make, have made, use, sell, offer to sell and import the Product
in such country; and
(c) Versicor hereby grants to Lilly a non-exclusive
royalty-free license, with a right to sublicense only to Affiliates, to make and
use Versicor Improvements in connection with the Licensed Patents and Licensed
Technology solely for internal research purposes.
2.2 TRANSFERRED ASSETS. As of the Effective Date, Lilly hereby assigns,
transfers and conveys to Versicor all of Lilly's right, title and interest in
and to the Transferred Assets and Versicor hereby accepts such assignment,
transfer and conveyance. Within thirty (30) days following the Effective Date,
Lilly shall work with Versicor to transfer possession of the Product Data
Package to Versicor. Lilly shall be responsible for the initial shipment of the
Product Data Package F.O.B. to Versicor or its designee. In the event that
Versicor is unwilling or unable to assume physical possession of the Product
Data Package by the end of the initial thirty (30) day period, Lilly shall be
entitled to charge Versicor a reasonable fee for storage of the Product Data
Package beyond such thirty (30) day period. Except as otherwise provided in
Section 2.9 or 2.10 below, Lilly shall not be obligated to provide any
additional information or assistance to Versicor regarding the Product. Versicor
acknowledges that Lilly makes no representations or warranties with respect to
the Transferred Assets and that it accepts such Transferred Assets "as is."
2.3 PRODUCT INVENTORY.
(a) POSSESSION. Within ninety (90) days of the Effective Date, Versicor
shall arrange, at Versicor's expense, and with reasonable assistance of the
appropriate and necessary Lilly personnel, to take possession and control of all
Product Inventory,
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including Start-Up Inventory and Reserve Inventory. In the event Versicor fails
to take possession of Product Inventory within the ninety (90) day period
referenced above, Versicor shall pay Lilly a storage fee of Two Thousand Dollars
($2,000.00) per day, plus any reasonable costs and expenses incurred by Lilly
(including without limitation the cost of personnel time) in maintaining the
Product Inventory, until the date upon which Versicor takes the required
possession.
(b) MAINTENANCE OF RESERVE INVENTORY. Upon possession, Versicor shall
assume sole responsibility for and shall undertake commercially reasonable
efforts in the maintenance and periodic evaluations required to preserve and
maximize the utility, stability and value of all components of Reserve
Inventory, including, without limitation, timely maintenance and extension of
expiry dates when reasonable and appropriate. Versicor shall maintain the
Reserve Inventory in appropriate and secure storage facilities under appropriate
temperature conditions and controls and shall otherwise manage the Product
Inventory with the same care as Versicor would provide for its own property,
including without limitation proper insurance. Additionally, Versicor shall
provide Lilly with a quarterly report on the status of the Reserve Inventory,
setting forth the information described in EXHIBIT X. Xxxxx shall be entitled to
audit and inventory, at its expense and no more often that once per twelve (12)
month period, the Reserve Inventory at any time during normal business hours.
(c) OWNERSHIP. Versicor shall be the title owner of the Start-Up
Inventory, for which Versicor has agreed to pay Lilly [ * ] in accordance
with Section 3.4 herein. With respect to the Reserve Inventory, Versicor
shall be a bailee for the mutual benefit of Versicor and Lilly, until such
time as Versicor either purchases such Reserve Inventory for itself or Lilly
reclaims possession.
(d) RESERVE INVENTORY OPTION. Versicor shall have the right to
unilaterally purchase and use Reserve Inventory on an as needed, component by
component, and unit by unit basis at any time after the Effective Date and
without prior notice to Lilly, provided that Versicor shall pay Lilly the per
unit/component costs set forth in EXHIBIT D and such payment and a detailed
description of the inventory purchased/used is provided to Lilly within thirty
(30) days of the purchase/use. Except as specifically permitted herein with
respect to purchase or use of Reserve Inventory, Versicor shall have no right to
otherwise deplete, destroy, encumber or transfer the Reserve Inventory without
the prior written consent of Lilly.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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2.4 VERSICOR UNDERTAKING. Except as otherwise provided in this
Agreement, Versicor hereby agrees that, commencing on the Effective Date,
Versicor is responsible for all aspects of the development and commercialization
of the Product in the Territory, including satisfying all obligations, claims,
liabilities, burdens and problems of any nature whatsoever (collectively, the
"Obligations") associated directly or indirectly with Versicor's licensing
and/or practice of the Licensed Patents from and after the Effective Date and
possession, use, ownership and transport of the Transferred Assets and the
Reserve Inventory from and after the Effective Date, as well as those associated
directly or indirectly with the manufacture, development, marketing and sale of
the Products by Versicor or its sublicensees from and after the Effective Date,
including, without limitation, all recalls, all warranty claims and all product
liability claims (without regard to the nature of the causes of action alleged
or theories of recovery asserted) arising in connection with Products On or
after the Effective Date, except for (1) those Obligations with respect to which
Lilly is providing indemnification pursuant to the provisions of Section 8.1 of
this Agreement, and (2) the hereinafter defined Excluded Liabilities, which
items shall remain the responsibility of Lilly as set forth herein. All of the
foregoing is hereinafter collectively referred to as the "Versicor
Responsibilities."
2.5 LIABILITIES NOT ASSUMED BY VERSICOR. Anything herein to the
contrary notwithstanding, Lilly shall be responsible for, and Versicor shall not
be deemed to assume, any of the following (collectively, the "Excluded
Liabilities"):
(a) Any Obligations arising out of a claim of any third party
relating to the Product arising out of or relating to events occurring prior to
the Effective Date; or
(b) Any Obligations arising out of a claim by a government
entity or regulatory body that Lilly has failed to fulfill Lilly's regulatory
obligations under the Regulatory Documents prior to the Effective Date.
2.6 SUBLICENSES. Subject to the terms and conditions herein, the Lilly
Development Option and the provisions in Section 2.8, Versicor shall have the
right to sublicense the licenses granted to it by Lilly. Any sublicenses granted
by Versicor under this Agreement shall provide for termination or assignment to
Lilly, at the option of Lilly, of Versicor's interest therein upon termination
of this Agreement and contain provisions
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which obligate the sublicensee to Versicor to at least the same extent that
Versicor is obligated to Lilly under this Agreement.
2.7 LILLY DEVELOPMENT OPTION: ORAL FORMULATION. Within thirty (30) days
of receiving the final results of the first Phase II Clinical Trial of the Oral
Formulation of the Product, Versicor shall provide to Lilly a written report
summarizing in reasonable detail such results (the "Phase II Report"). Within
sixty (60) days after receipt by Lilly from Versicor of the Phase II Report,
Lilly shall have the right, but not the obligation, to elect by written notice
to Versicor (the "Election") to exercise the Lilly Development Option for the
Oral Formulation. During the sixty (60) day period, Lilly shall have the right
to engage in a reasonable due diligence audit of Versicor's prior development
activities with respect to such Oral Formulation to assess whether Lilly desires
to exercise its Lilly Development Option. In the event Lilly makes the Election,
Lilly's Development Option shall take effect under the following terms and
conditions:
(a) The licenses granted to Versicor by Lilly under Section
2.1 shall automatically terminate with respect to the Oral Formulation of the
Product;
(b) Versicor shall grant, and hereby does grant, to Lilly
an exclusive, worldwide license, with a right to sublicense, to Versicor
Improvements solely to make, use, sell, promote, offer to sell, and import
the Oral Formulation of the Product, except to the extent such rights must be
retained by Versicor in connection with any Versicor Co-Promotion Right which
Versicor may obtain pursuant to subsection (g) below.
(c) Lilly shall pay to Versicor a royalty of [ * ] on Net
Sales of the Oral Formulation in the Territory for the Royalty Term, payment
of which shall be on terms equivalent to those set forth in Sections 3.5,
3.6, 3.7 and 3.8;
(d) Within ninety (90) days of the Election, Lilly shall
(i) reimburse to Versicor [ * ] of the Reimbursable Development Expenses
actually incurred by Versicor as of the date of the Election; (ii) reimburse
to Versicor [ * ] of any Oral Formulation milestone payments actually paid by
Versicor to Lilly pursuant to Section 3.3 of this Agreement; (iii) pay to
Versicor an additional fee of [ * ]; and (iv) reimburse to Versicor [ * ] of
the actual costs and expenses incurred by Versicor in filing,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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prosecuting and/or maintaining the Licensed Patents that relate solely to the
Oral Formulation.
(e) As of the date of the Election, Lilly shall become solely
responsible for the development and commercialization of the Oral Formulation,
including, without limitation, the costs and expenses associated therewith.
Versicor shall have no further financial obligations to Lilly with respect to
the Oral Formulation, including, without limitation, no further obligation to
pay Royalty Payments or milestone payments under Section 3 of this Agreement.
(f) Within sixty (60) days of the Election, Versicor shall
promptly provide and make accessible to Lilly, as requested, all Versicor
Improvements in Versicor's or its agents' possession or control that is
reasonably useful or necessary for Lilly to proceed efficiently and effectively
with the further development and commercialization of the Oral Formulation,
including, without limitation, pre-clinical and clinical data, clinical research
regulatory files and filings, relevant technology and know-how, manufacturing
reports, sponsorship of all Regulatory Documents related to the Oral
Formulation, and relevant patents or patent applications encompassing Versicor
Improvements. Additionally, Versicor shall execute, acknowledge and deliver such
further instruments, and do all such other acts, consistent with the transition
support obligations described in Section 2.9 and 2.10, to enable and facilitate
an effective transition of development and commercialization responsibilities
and activities to Lilly for the Oral Formulation of the Product.
(g) Versicor shall have the right, subject to negotiation of a
mutually acceptable agreement between the Parties, to obtain from Lilly a
license to exclusively Co-Promote with Lilly the Oral Formulation in the
Hospital Market Sector (the "Versicor Co-Promotion Right"). Versicor may
exercise the Versicor Co-Promotion Right no later than ninety (90) days prior to
the anticipated completion of Phase III Clinical Trials by providing Lilly with
written notice of its desire to negotiate a Co-Promotion agreement. Upon
exercise of the Versicor Co-Promotion Right, the Parties shall mutually
negotiate in good faith the terms and conditions on a country-by-country basis
under which such Co-Promotion shall occur, which terms and conditions must be
consistent with the applicable terms of this Agreement and market comparables
and must include the following: (1) compensation to Versicor for its
Co-Promotion efforts in the Hospital Market Sector taking into account the
economic burdens assumed by Versicor; (2) a manner of defining
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Versicor Co-Promotion efforts qualifying for compensation from Lilly, taking
into account the form, substance and delivery of such efforts; and (3) agreement
that Versicor's negotiated license to Co-Promote the Oral Formulation shall be
limited exclusively to Versicor, with no right to sublicense or use a third
party or Affiliate sales force without the prior written consent of Lilly. In
the event a Co-Promotion agreement is not fully executed by the Parties on or
before ninety (90) days after completion of the last Phase III Clinical Trial
necessary for preparing the first Application for Marketing Authorization for
the Oral Formulation, the Versicor Co-Promotion Right shall expire. Thereafter,
Versicor shall have a right to match Co-Promotion offers, similar to Lilly's
rights under Section 2.8 below.
2.8 LILLY RIGHT TO FUTURE OPPORTUNITIES. Versicor recognizes that Lilly
has an interest in future royalties and milestone fees for the Product.
Therefore, in addition to Lilly's rights under Section 2.7 above, in the event
that Versicor seeks at any time to license a third party any rights with respect
to Product in the Territory ("License Opportunity"), whether together with or
independent of Versicor, Versicor shall in good faith consider Lilly for such
License Opportunity, subject to arms-length negotiations.
2.9 TRANSITION SUPPORT. Subject to the other provisions of this Section
2.9 and Section 2.10, Lilly shall make available to Versicor the Licensed
Technology, either through access to documents and/or to personnel in possession
of such Licensed Technology. Lilly and Versicor shall establish a joint team of
personnel to coordinate transition of the Licensed Patents, Licensed Technology
and Transferred Assets. Lilly undertakes to work in good faith with Versicor to
complete an effective transition of the Licensed Patents, Licensed Technology
and Transferred Assets to Versicor within six (6) months of the Effective Date
("Transition Period"), subject to the limitations set forth herein. During the
Transition Period, Lilly shall provide, at no cost to Versicor, reasonable
access to appropriate and available personnel for up to two hundred (200) person
hours (during normal business hours) for reasonable regulatory, scientific,
medical, information technology, and patent assistance and consultation related
to the transition of the Licensed Patents, Licensed Technology and Transferred
Assets from Lilly to Versicor, not including Manufacturing Support which is
otherwise covered by Section 2.10 below, and shall execute, acknowledge and
deliver such further instruments as may be necessary to enable and facilitate an
effective transition for the Product. In the event the Parties mutually agree to
extend either the Transition Period or the total man hours of Lilly support,
Versicor shall reimburse Lilly for the cost of such additional time
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or hours at a rate of Three Hundred Dollars ($300.00) per hour for Lilly patent
counsel hours and One Hundred Fifty Dollars ($150.00) per hour for all other
Lilly personnel hours. Notwithstanding the foregoing, all out-of-pocket expenses
or other costs associated with travel and related accommodations for Lilly
personnel involved in transition support shall be paid by Versicor.
Additionally, Lilly shall execute, acknowledge and deliver such further
instruments, and do all such other acts, consistent with the transition support
obligations described in Section 2.9 and 2.10, to enable and facilitate an
effective transition of development and commercialization responsibilities and
activities to Versicor for the Product.
2.10 MANUFACTURING SUPPORT. Upon request by Versicor, Lilly shall
provide, at no cost to Versicor, reasonable access to appropriate and available
manufacturing and information technology personnel for up to three hundred (300)
person hours (during normal business hours) ("Manufacturing Support") for
reasonable manufacturing process technical assistance and consultation that
would enable Versicor and/or a third party manufacturer to reasonably employ the
Licensed Patents and/or Licensed Technology in the manufacture of the Product;
provided, however, that such Manufacturing Support shall be (i) provided over a
time period not exceeding two (2) months in duration, commencing with the first
date of engagement in such Manufacturing Support by Lilly personnel; and (ii)
completed no later than August 31, 2000.
2.11 BIOLOGICAL MATERIALS. In connection with providing manufacturing
support under Section 2.10, Lilly shall transfer all the Biological Materials to
Versicor. Versicor shall not distribute or release the Biological Materials to
others except to further the purposes of this Agreement. All Biological
Materials, provided to Versicor and/or its sublicensee by Lilly under the terms
of this Agreement shall be maintained as a trade secret by Versicor and/or its
sublicensee and shall not be delivered or transmitted to any third party without
the express written consent of Lilly and then only upon enforceable written
assurances to Lilly by Versicor and the third party that the know-how and trade
secret rights in the Biological Materials will not be compromised by the
transaction. Versicor shall protect the Biological Materials at least as well as
it protects its own valuable tangible personal property and shall take measures
to protect the Biological Materials from any claims by third parties including
creditors and trustees in bankruptcy. Versicor's and/or its sublicensee's
obligation to safeguard the trade secret status of the Biological Materials
shall extend in perpetuity beyond the Royalty Term. Upon early termination of
this Agreement (but not expiration under Section 4.1), Versicor shall
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return any remaining Biological Materials to Lilly or otherwise dispose of such
materials as instructed by Lilly.
SECTION 3
PAYMENTS
In consideration of the exclusive license granted herein and the
transfer of ownership of the Transferred Assets, Versicor shall pay the
following amounts to Lilly:
3.1 CASH PAYMENT UPON SIGNING. Within five (5) days of the execution
of this Agreement, in consideration for the Product Data Package, Versicor
shall pay to Lilly the non-refundable sum of [ * ] by Federal Reserve
electronic wire transfer in immediately available funds to an account
designated by Lilly.
3.2 MILESTONE PAYMENTS FOR INTRAVENOUS FORMULATION. Within thirty (30)
days of Versicor and/or its sublicensees achieving a milestone event listed
below with respect to the Intravenous Formulation, Versicor shall pay the below
specified non-refundable fees to Lilly by Federal Reserve electronic wire
transfer in immediately available funds to an account designated by Lilly.
Except as otherwise provided in Section 2.7 such fees shall be non-refundable.
Intravenous Formulation Milestone Fee
--------------------------------- ---
[ * ] [ * ]
Total $51 million
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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3.3 MILESTONE PAYMENTS FOR ORAL FORMULATION. Within thirty (30) days of
achieving a milestone event listed below with respect to the Oral Formulation of
the Product, Versicor shall pay the below specified fee to Lilly by Federal
Reserve electronic wire transfer in immediately available funds to an account
designated by Lilly.
Oral Formulation Milestone Cash
-------------------------- ----
[ * ] [ * ]
Total $79 million
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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3.4 PAYMENT FOR PRODUCT INVENTORY.
(a) START-UP INVENTORY. In consideration for the Start-Up
Inventory, Versicor shall pay Lilly a total of [ * ] by Federal Reserve
electronic wire transfer in immediately available funds to an account
designated by Lilly as follows:
(1) [ * ] on or before the date which is twelve (12)
months after the Effective Date;
(2) [ * ] on or before the date which is twenty-four
(24) months after the Effective Date;
(3) [ * ] on or before the date which is thirty-six
(36) months after the Effective Date;
(b) RESERVE INVENTORY. In the event Versicor elects to
purchase any or all of the Reserve Inventory pursuant to Section
2.3(d), Versicor shall pay Lilly for such inventory pursuant to the
terms set forth in Section 2.3(d), by Federal Reserve
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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electronic wire transfer in immediately available funds to an account
designated by Lilly.
3.5 ROYALTIES.
(a) During the Royalty Term, Versicor shall pay to Lilly
running royalties ("Royalty Payments") for the Product as follows:
(1) [ * ] of Net Sales of all Intravenous Formulations
and Other Formulations (excluding the Oral Formulation) of the Product in
the North America and Europe during a Calendar Year;
(2) [ * ] of Net Sales in ROW of all Intravenous
Formulations and Other Formulations of the Product (excluding the Oral
Formulation); and
(3) [ * ] of Net Sales of the Oral Formulation of the
Product in the Territory during a Calendar Year.
(b) In the event practice or use of the Licensed Patents or
Licensed Technology consistent with the terms of this Agreement results in
(i) an infringement claim by a third party or (ii) a desire on the part of
Versicor to enter into a third party license agreement based on its good
faith opinion that an infringement against such third party's patent(s) may
occur without such a license and notice to and concurrence by Lilly to such
third party license (which concurrence shall not be unreasonably withheld),
Versicor shall be entitled to credit, against royalties otherwise owed to
Lilly under Section 3.5 above, [ * ] of any amount actually paid by Versicor
to such third party for a license under a patent owned or controlled by such
third party; PROVIDED, HOWEVER, that Versicor may only credit against
royalties otherwise due in a Calendar Year such amounts that (i) are directly
attributable to the manufacture or sale of the Product (and not with respect
to any other uses or products); and (ii) that in total for such Calendar Year
do [ * ]. Except as set forth in this subsection (b), Versicor shall be
solely responsible for any royalties or other payments due a third party for
the Product.
(c) Royalty payments shall be made within sixty (60) days
after the end of each Calendar Quarter for which royalties are due. All payments
shall be made in U.S. Dollars and mailed to the attention of Lilly Royalty
Administration, Lilly Corporate Center, Xxxxxxxxxxxx, Xxxxxxx 00000.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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(d) During the term of this Agreement and after the first sale
of the Product, Versicor shall furnish to Lilly on a quarterly basis a written
report covering each Calendar Quarter (each such Calendar Quarter being
sometimes referred to herein as a "reporting period") showing (1) the Net Sales
of Product in each country by Versicor or its Affiliates or sublicensees, and
(2) the Royalty Payments, which shall have accrued under this Section 3.5 in
respect of such sales and the basis for calculating those royalties. With
respect to sales of the Product invoiced in a currency other than U.S. Dollars,
the Net Sales and amounts due to Lilly hereunder shall be expressed in the U.S.
Dollar equivalent calculated on a monthly basis in the currency of the country
of sale and converted to their dollar equivalent using the official rate of
exchange as determined by the European American Bank (or such other bank as may
be regularly relied upon by Versicor with respect to official exchange rates) in
effect on the last business day of the applicable month of the Calendar Quarter
to which the report relates. Versicor will, at Lilly's reasonable request but
not more frequently than once a year, inform Lilly as to the specific exchange
rate translation methodology used for a particular country or countries. Each
quarterly report shall be due thirty (30) days following the close of each
reporting period. Amounts shown to have accrued by each sales report shall be
due and payable on the date such sales report is due.
(e) Versicor shall keep accurate records in sufficient detail
to enable the Royalty Payments due to be determined and verified by the audit
described in Section 3.6 for at least three years following the period in which
such obligation arose. Additionally, if laws or regulations require the
withholding of taxes, the taxes will be deducted by Versicor from the Royalty
Payments and remitted by Versicor to the proper tax authority. Proof of payment
shall be provided to Lilly within ninety (90) days after payment. Versicor will
cooperate in pursuing the refund of such tax, if such refund is appropriate in
Lilly's determination.
3.6 AUDITS. Versicor and its Affiliates and sublicensees shall keep
full and accurate books and records relating to the performance of its payment
obligations required under this Agreement. During the term plus three (3) years
after termination or expiration of this Agreement, Lilly shall have the right,
during regular business hours and upon reasonable advance notice, no more often
than once every twelve (12) months to have such books and records audited so as
to verify the accuracy of the payments made to Lilly. The scope of such audits
shall be restricted to the review of not more than three (3) prior years. Such
information shall be Versicor Confidential Information and, as such, subject
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to confidentiality pursuant to Section 6.3. The cost of such audit shall be
borne by Lilly; however, in the event such audit reveals that the Royalty
Payments to Lilly deviates by five percent (5%) or more from that revealed by
the audit to be actually owed, the cost of the audit shall be borne by Versicor.
Versicor shall include in all sublicenses granted as permitted under Section 2.6
an audit provision substantially similar to the foregoing requiring the
sublicensee to keep full and accurate books and records relating to the Product
and granting Lilly the right to audit the accuracy of the information reported
by the sublicensee in connection therewith on the same terms as apply to an
audit of Versicor's records hereunder.
3.7 LATE PAYMENTS. Any amounts not paid by Versicor when due under this
Agreement shall be subject to interest from and including the date payment is
due through and including the date upon which Lilly has collected immediately
available funds in an account designated by Lilly at a rate equal five percent
(5%) plus the prime rate of interest quoted in the Money Rates section of THE
WALL STREET JOURNAL, calculated daily on the basis of a 360-day year, or similar
reputable data source.
3.8 NO EXCUSE. Versicor shall not be excused from or relieved of its
obligations to pay the amounts actually owed as described in this Section 3 by
any claimed or actual event of force majeure, commercial or other
impracticability or impossibility, or frustration of essential purpose, except
to the extent otherwise provided in this Agreement.
SECTION 4
TERM OF AGREEMENT
4.1 TERM. The term of this Agreement shall begin upon the Effective
Date and, unless sooner terminated as hereinafter provided, shall continue in
full force and effect on a country-by-country basis until Versicor, its
Affiliates and sublicensees have no remaining royalty obligations in a country
as set forth in Section 3.5.
SECTION 5
REPRESENTATIONS AND WARRANTIES
5.1 CORPORATE EXISTENCE AND POWER. As of the Effective Date, each Party
represents and warrants to the other that it (a) is a corporation duly
organized, validly existing and in good standing under the laws of the state in
which it is incorporated, and
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(b) has full corporate power and authority and the legal right to own and
operate its property and assets and to carry on its business as it is now being
conducted and is contemplated in this Agreement, including, without limitation,
the right to grant the licenses granted hereunder.
5.2 AUTHORITY. As of the Effective Date, each Party represents and
warrants to the other that it (a) has the corporate power and authority and the
legal right to enter into this Agreement and perform its obligations hereunder;
(b) has taken all necessary corporate action on its part required to authorize
the execution and delivery of the Agreement and the performance of its
obligations hereunder; and (c) the Agreement has been duly executed and
delivered on behalf of such Party, and constitutes a legal, valid and binding
obligation of such Party and is enforceable against it in accordance with its
terms.
5.3 ABSENCE OF LITIGATION. As of the Effective Date, Lilly represents
and warrants to Versicor that it is not aware of any pending or threatened
litigation (and has not received any communication relating thereto) which
alleges that Lilly's activities, with respect to the Product or the Licensed
Technology or otherwise related to this Agreement, have infringed or
misappropriated, or that by conducting the activities as contemplated herein by
Versicor would infringe or misappropriate, any of the intellectual property
rights of any other person. To the best Lilly's knowledge, there is no material
unauthorized use, infringement or misappropriation of any of its intellectual
property rights licensed hereunder.
5.4 NO APPROVALS OR CONSENTS. Except as otherwise described in this
Agreement, each Party represents and warrants to the other that all necessary
consents, approvals and authorizations of all governmental authorities and other
persons or entities required to be obtained by such Party in connection with
entry into this Agreement have been obtained.
5.5 PATENTS; PRIOR ART. Except as Lilly has otherwise advised Versicor
in writing prior to the Effective Date, Lilly represents and warrants to
Versicor that as of the Effective Date, (a) to the best of its knowledge, it has
sufficient legal and/or beneficial title and ownership under its intellectual
property rights necessary for it to fulfill its obligations under this
Agreement; (b) it has granted Versicor a license to all patents and patent
applications (with the exception of the "Cal-Tech Patent Application" defined in
the
-24-
Licensed Patent definition) which Lilly owns or controls in connection with the
Product as of the Effective Date; and (c) to the best of its knowledge, there is
no material unauthorized use, infringement or misappropriation of any of its
intellectual property rights by third parties relevant to the Product or other
rights granted under this Agreement. As used herein, "intellectual property
rights" shall mean all patent rights, copyrights, trademarks, trade secrets, and
confidential and/or proprietary chemical substances, Biological Materials,
technical information, data and assays necessary or useful to make, use or sell
the Product.
5.6 NO CONFLICT. Each Party represents and warrants to the other that
the execution and delivery of the Agreement by such Party and the performance of
such Party's obligations hereunder (a) do not conflict with or violate any
requirement of applicable law or regulation or any provision of articles of
incorporation or bylaws of such Party in any material way, and (b) do not
conflict with, violate or breach or constitute a default or require any consent
under, any contractual obligation or court or administrative order by which such
Party is bound.
5.7 REGULATORY DOCUMENTS. Lilly represents and warrants to Versicor
that: (a) Lilly has furnished Versicor with access to a complete copy of the
United States Regulatory Documents for the Product, including all material
amendments and supplements thereto; (b) Lilly is and was, at all times prior to
the Effective Date, the lawful holder of all rights under the Regulatory
Documents; (c) to the best of Lilly's knowledge, Lilly has complied in all
material respects with all applicable laws and regulations in connection with
the preparation and submission to the relevant regulatory authorities of the
Regulatory Documents; (d) the Regulatory Documents have been approved by, and
nothing has come to the attention of Lilly which has, or reasonably should have,
led Lilly to believe that the Regulatory Documents are not in good standing with
relevant regulatory authorities; (e) Lilly has filed with the relevant
regulatory authorities all required notices, supplemental applications and
annual or other reports, including adverse experience reports, with respect to
the Regulatory Documents which are material; and (f) there is no pending or
overtly threatened action by relevant regulatory authorities which will have a
material adverse effect on the Regulatory Documents. Except for the
representations contained in this Section 5.7, upon which Versicor is relying
(which Lilly hereby acknowledges), Versicor has had a reasonable opportunity to
review and evaluate the Regulatory Documents and Versicor is relying solely upon
its own judgment and experience in connection therewith.
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5.8 NO DEBARMENT. Each Party represents and warrants to the other that
it will comply at all times with the provisions of the Generic Drug Enforcement
Act of 1992 and will upon request certify in writing to the other that neither
it, its employees, nor any person has provided services to such Party in
connection with the Product have been debarred under the provisions of such Act.
5.9 NO THIRD PARTY INFRINGEMENT. To the best of Lilly's knowledge,
there is no patent issued to a Third Party as of the Effective Date that would
be infringed by the manufacture, use or sale of Product.
5.10 IMPLIED WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION
5, LILLY MAKES NO REPRESENTATION OR WARRANTY AS TO THE LICENSED PATENTS OR THE
TRANSFERRED ASSETS, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND LILLY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR
STATUTORY WARRANTIES. Without limiting the foregoing, Versicor acknowledges that
it has not and is not relying upon any implied warranty of merchantability,
fitness for a particular purpose or otherwise, or upon any representation or
warranty whatsoever as to the prospects (financial, regulatory or otherwise), or
the validity or likelihood of success, of the Product after the date of this
Agreement.
5.11 NO PRIOR LICENSES. Lilly represents and warrants to Versicor that
prior to the Effective Date Lilly has not granted any licenses or
covenants-not-to-xxx to Third Parties with respect to the Licensed Patents or
Licensed Technology.
SECTION 6
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES
6.1 GOVERNMENTAL FILINGS. Lilly and Versicor each agree to prepare and
file whatever filings, requests or applications are required to be filed with
any governmental authority in connection with this Agreement and to cooperate
with one another as reasonably necessary to accomplish the foregoing. Without
limiting the generality of the foregoing, prior to the assignment, transfer and
conveyance by Lilly to Versicor of the Transferred Assets pursuant to Section
2.2, Lilly shall have submitted to the relevant regulatory authorities the
information required of a former owner of regulatory filings with
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respect to the Product, and Versicor shall submit to the relevant regulatory
authorities the information required of a new owner of regulatory filings with
respect to the Product.
6.2 COMPLIANCE WITH LAW. Versicor shall comply with all federal, state
and local laws and regulations related to Versicor's manufacture, development,
marketing and selling of the Product. Without limiting the generality of the
foregoing sentence, Versicor shall not promote the Product in any manner in
conflict with any applicable laws or regulations.
6.3 CONFIDENTIALITY. Except as provided elsewhere in this Agreement,
Lilly and Versicor each agree to maintain Confidential Information in confidence
and not use, transfer or disclose such Confidential Information to a third party
without the prior written approval of the other Party, except as is contemplated
by this Agreement, or as is required to be disclosed to recover Damages for a
breach of this Agreement, or as is required to comply with any order of a court
or any applicable rule, regulation, or law of any jurisdiction. In the event
that a Party is required by judicial or administrative process to disclose
Confidential Information of the other Party (except with respect to disclosures
to tax authorities), it shall promptly notify the other Party and allow the
other Party a reasonable time to oppose such process. For disclosures to tax
authorities, no prior notification to the other Party shall be required. The
foregoing obligations shall remain in force until ten (10) years following
termination of this Agreement by either Party, except with respect to trade
secrets for which such obligations shall continue in perpetuity.
(a) Both Lilly and Versicor shall protect Confidential Information by
using the same degree of care, but not less than a reasonable degree of
care, to prevent the unauthorized disclosure or use of Confidential
Information, as that Party uses to protect its own confidential
information of like nature.
(b) Any provision of this Agreement to the contrary notwithstanding,
both Lilly and Versicor are entitled to disclose Confidential
Information to the extent reasonably necessary for the purposes of this
Agreement, to their respective Affiliates and their consultants,
outside contractors and clinical investigators on the condition that
such entities agree to be bound by this Agreement with respect to
nondisclosure and/or non-use of such information.
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6.4 PUBLICITY AND DISCLOSURE OF AGREEMENT. Within ten (10) days of the
Effective Date, the Parties shall agree in good faith on a form of press release
which Versicor may release after June 6, 1999. The Parties agree that no future
publicity release or announcement concerning the transactions contemplated
hereby shall be issued without the advance written consent of the other Party to
the extent such release or announcement includes statements concerning terms of
this Agreement and/or explicitly includes either Parties' trademark(s) or
name(s), except to the extent such release or announcement may be required by
law. For releases or announcements required by law, the Party making the release
or announcement shall, before making any such release or announcement, afford
the other Party a reasonable opportunity to review and comment. Any copy of this
to be filed with the Securities and Exchange Commission shall be redacted to the
reasonable satisfaction of both Parties; provided, however, in the event that
the Securities and Exchange Commission objects to the redaction of any portion
of the Agreement after the initial submission, the filing Party shall inform the
other Party of the objections and shall in good faith respond to the objections
in an effort to limit the disclosure required by the Securities and Exchange
Agreement, but in any event the filing Party shall be free to include any
portions of the Agreement it deems necessary to respond to the objections in any
future filings. Further, Versicor shall have the right to disclose the Agreement
in confidence to existing or prospective investors or acquirers and investment
bankers and related financial service providers.
6.5 USE OF NAMES, LOGOS OR SYMBOLS. No Party hereto shall use the name,
trademarks, logos, physical likeness, employee names or owner symbol of the
other Party hereto for any purpose, including, without limitation, in connection
with any private or public securities placements, without the prior written
consent of the affected Party, such consent not to be unreasonably withheld or
delayed so long as such use of name is limited to objective statements of fact,
rather than for endorsement purposes. Nothing contained herein shall be
construed as granting either Party any rights or license to use any of the other
Party's trademarks or tradenames without separate, express written permission of
the owner of such trademark or tradename.
6.6 EXPENSES. Lilly and Versicor shall each bear their own direct and
indirect expenses incurred in connection with the negotiation and preparation of
this Agreement and, except as set forth in this Agreement, the performance of
the obligations contemplated hereby.
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6.7 EFFORTS. Versicor shall use Reasonable Diligence to develop and
obtain Regulatory Approval in the Territory for both the Intravenous and Oral
Formulations of the Product. On or before January 1,2000, Versicor shall
prepare and submit to Lilly a detailed plan for development of the Oral
Formulation, setting forth a description of the efforts Versicor intends to
make in connection with its Reasonable Diligence obligations for the Oral
Formulation, which plan shall include at least one animal study ("Oral
Formulation Development Plan"). Versicor shall provide Lilly with a
reasonable opportunity to review and comment on the Oral Formulation
Development Plan. Except as otherwise provided in Section 2.7, Versicor shall
be solely responsible for all development efforts and costs associated with
developing and obtaining Regulatory Approval of both the Intravenous and Oral
Formulations of the Product. Lilly and Versicor each hereby agree to use all
reasonable efforts to take, or cause to be taken, all actions and to do, or
cause to be done, all things necessary or proper to make effective the
transactions contemplated by this Agreement, including such actions as may be
reasonably necessary to obtain approvals and consents of governmental Persons
and other Persons (including, without limitation, all applicable drug listing
and notifications to the relevant regulatory authorities identifying Versicor
as a licensee of the Product); PROVIDED that no Party shall be required in
connection with such activities to (1) make any payments (other than as
expressly required pursuant to this Agreement), or (2) assume any other
material obligation not otherwise required to be assumed by this Agreement.
In the event Versicor or its sublicensees fail to undertake Reasonable
Diligence in developing and/or obtaining Regulatory Approval of the
Intravenous Formulation and/or the Oral Formulation of the Product in a
particular country in the Territory, such failure shall be considered a
material default of this Agreement for which Lilly shall be entitled to
terminate this Agreement under Section 9.1 (b) solely with respect to such
particular country and only as to the affected formulation (I.E., IV or oral)
(but may not terminate the entire Agreement under Section 9.1 (d) for any
such default), PROVIDED THAT Versicor (or its sublicensee) does not cure such
failure within sixty (60) days of written notice from Lilly specifying its
belief that such failure has occurred and the reasons therefor. However,
Lilly shall not be entitled to exercise the foregoing termination rights if
Versicor reasonably disputes Lilly's contention that Versicor has failed in
such Reasonable Diligence until after the Parties have first pursued dispute
resolution discussions and procedures as required under Section 10.14 with
respect to such dispute. In the event of an uncured default by Versicor of
its obligations to use Reasonable Diligence for the Oral Formulation prior to
first human dose on an Oral Formulation, Lilly shall be entitled to terminate
Versicor's license under Section 2.1 (a) in the Territory only with respect
to the Oral Formulation, after first
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pursuing dispute resolution discussions and procedures as required under Section
10.14 (if Versicor disputes Lilly's claim that Versicor defaulted on such
obligation), and Versicor shall, and hereby does, grant to Lilly the license
described in Section 2. l(c) with respect to such Oral Formulation.
6.8 COOPERATION. If either Party shall become engaged in or participate
in any investigation, claim, litigation, interference or other proceeding with
any third party, including any proceeding before a relevant regulatory
authority, relating in any way to the Product or any of the Licensed Patents the
other Party shall cooperate in all reasonable respects with such Party in
connection therewith, including, without limitation, using its reasonable
efforts to make available to the other Party such party's employees who may be
helpful with respect to such investigation, claim, litigation, interference or
other proceeding, provided that, for purposes of this provision, reasonable
efforts to make available any employee shall be deemed to mean providing a Party
with reasonable access to any such employee at no cost for a period of time not
to exceed 24 hours (e.g., three 8-hour business days). Thereafter, any such
employee shall be made available for such time and upon such terms and
conditions (including, but not limited to, compensation) as the Parties may
mutually agree.
6.9 CONFLICTING RIGHTS. Lilly shall not grant any right to any third
party relating to the Licensed Patents or Licensed Technology that would violate
the terms of or conflict with the rights granted to Versicor pursuant to this
Agreement.
6.10 MANUFACTURING. After the Effective Date, Versicor shall be solely
responsible for the manufacture of the Product, including without limitation for
clinical trials and commercialization. In the event Lilly exercises the Lilly
Development Option, Lilly shall assume manufacturing responsibilities for the
Oral Formulation.
6.11 DEEMED BREACH OF COVENANT. Neither Lilly nor Versicor shall be
deemed to be in breach of any covenant contained in this Section 6 if such
Party's deemed breach is the result of any action or inaction on the part of the
other Party.
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SECTION 7
INTELLECTUAL PROPERTY MANAGEMENT
7.1 PATENT PROSECUTION AND MAINTENANCE. Except to the extent otherwise
agreed by the Parties pursuant to subsection (f) and Section 7.3 below, Versicor
shall be responsible for the preparation, filing, prosecution and maintenance of
the Licensed Patents including all payment obligations and shall on an ongoing
basis promptly furnish copies of all related documents to Lilly within thirty
(30) days of receipt or deposition.
a) Versicor shall, subject to the prior approval of Lilly (not
to be unreasonably withheld), select registered patent attorneys or
patent agents to provide services for preparing, filing, prosecuting
and maintaining the Licensed Patents on behalf of Versicor and Lilly.
Versicor shall directly pay such attorneys or agents and provide Lilly
copies of each invoice associated with such services, as well as
documentation that such invoices have been paid.
b) Lilly shall provide appropriate powers of attorney and
other documents necessary to undertake such actions to the patent
attorneys or patent agents providing such services.
c) Versicor and its attorneys or agents shall consult with
Lilly in all aspects of the preparation, filing, prosecution and
maintenance of the Licensed Patents and shall provide Lilly sufficient
opportunity to comment on any document that Versicor intends to file or
to cause to be filed with the relevant intellectual property or patent
office.
d) Each Party shall promptly inform the other as to all
matters that come to its attention that may affect the preparation,
filing, prosecution, or maintenance of the Licensed Patents and permit
each other to provide comments and suggestions with respect to such
activities, which comments and suggestions shall be reasonably
considered by the other Party.
e) Upon receipt of approval to market Product in a country of
a Territory, Lilly shall provide assistance to Versicor in obtaining
patent extensions, supplementary protection certificates, and the like
for the Licensed Patents to the
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extent the laws of the country provide it. It is understood that
Versicor is responsible for promptly notifying Lilly of receipt of
Regulatory Approval. Versicor shall provide Lilly with at least sixty
(60) days prior written notice before surrendering or abandoning any
Licensed Patent in any country of the Territory.
f) Except with respect to those patents and patent
applications listed on List A-1 ("core patents and patent applications")
in EXHIBIT A that are filed in a country in the Major Market Countries,
upon ninety (90) days written notice to Lilly, Versicor may elect to
surrender its rights under any particular Licensed Patent in any country
in the Territory and owe no payment or other obligation under this
section for patent-related expenses incurred in that country as to such
Licensed Patent as of the effective date of such written notice. To the
extent that Lilly desires to continue maintenance and/or prosecution of
such Licensed Patents in such countries which Versicor has elected to
surrender rights, Versicor shall cooperate fully with Lilly, its
attorneys, and agents in assuming such responsibilities and provide
Lilly with complete copies of any and all documents or other materials
that Xxxxx xxxxx necessary to undertake such responsibilities.
7.2 RIGHT TO RECLAIM PATENT MANAGEMENT RESPONSIBILITIES. In the event
that Lilly exercises the Lilly Development Option, Lilly may provide Versicor
with written notice that Lilly wishes to assume control as of a certain date of
the preparation, filing, prosecution and maintenance of any or all patent
applications and patents ("Selected Patents") included in the Licensed Patents.
a) If Lilly elects to assume responsibilities for Selected
Patents, Versicor agrees to cooperate fully with Lilly, its attorneys,
and agents in the preparation, filing, prosecution and maintenance
related to the Selected Patents and, upon request, to provide Lilly
with complete copies of any and all documents or other materials that
Xxxxx xxxxx necessary to undertake such responsibilities. Lilly shall
assume responsibility for all costs associated with the Selected
Patents, including costs associated with transferring patent
prosecution responsibilities to an attorney or agent of Lilly's choice,
as of the date specified by Lilly in its election notice.
b) Lilly and its attorneys or agents shall consult with
Versicor in all aspects of the preparation, filing, prosecution and
maintenance of the Selected
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Patents and shall provide Versicor sufficient opportunity to comment on
any document related thereto that Lilly intends to file or to cause to
be filed with the relevant intellectual property or patent office.
c) Each Party shall promptly inform the other as to all
matters that come to its attention that may affect the preparation,
filing, prosecution, or maintenance of the Selected Patents and permit
each other to provide comments and suggestions with respect to such
activities, which comments and suggestions shall be reasonably
considered by the other Party.
d) Lilly shall provide ninety (90) days prior written notice
to Versicor prior to any abandonment or surrender of rights by Lilly
related to any or all of the Selected Patents, and Versicor shall have
the right to notify Lilly of its election as of a certain date during
such ninety (90) day period to resume responsibilities for such
Selected Patents. If Versicor elects to resume responsibility of any or
all of such Selected Patents, Lilly shall cooperate fully with
Versicor, its attorneys, and agents in assuming the responsibilities of
such related patent applications and patents and to provide Versicor
with complete copies of any and all documents or other materials that
Versicor deems necessary to undertake such responsibilities. Versicor
shall assume responsibility for all costs associated with the Selected
Patents for which it elects to resume responsibility under this
subsection (d), including costs associated with transferring patent
prosecution responsibilities to an attorney or agent of Versicor's
choice, as of the date specified by Versicor in its election notice.
7.3 INFRINGEMENT AND MISAPPROPRIATION.
(a) NOTICE. Each Party shall promptly notify the other in
writing of any alleged infringement or misappropriation by third parties of any
Licensed Patent or Licensed Technology and provide any information available to
that Party relating to such alleged infringement or misappropriation.
(b) ENFORCEMENT OF LICENSED PATENTS. Versicor shall have the
primary right, but not the obligation, to take action in its own name to secure
the cessation of any infringement or misappropriation or to enter suit against
the infringer. Any such action will be at Versicor's expense, employing counsel
of its own choosing. If Versicor elects
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not to exercise its right to prosecute or take other appropriate action in
connection with an infringement or misappropriation of the Licensed Patents or
fails to take any such action within sixty (60) days of first receiving of such
infringement or misappropriation, Lilly may do so at its own expense,
controlling such action. In the event of any infringement or misappropriation
suit against a third party brought by either Party pursuant to this Section, the
Party so proceeding shall pay to the other Party all of its costs and expenses
(but not attorney's fees) in connection with such action and such other Party
shall join in and reasonably cooperate with respect to such action to the extent
necessary to initiate and maintain it (e.g., by providing relevant documents,
witnesses and testimony, etc.).
(c) ALLOCATION OF DAMAGES OR OTHER MONETARY AWARDS. If
Versicor brings action, any Damages or other monetary awards recovered by
Versicor shall be applied proportionately first to defray the unreimbursed costs
and expenses (including reasonable attorneys' fees) incurred by either or both
Parties in the action. If any balance remains, Versicor shall second pay to
Lilly an amount equal to the royalty that Lilly would otherwise be entitled to
under this Agreement if such remaining balance was treated as Net Sales. If any
balance remains after payment to Lilly, such balance shall be the property of
Versicor. If Versicor fails to bring action and Lilly brings action, any Damages
or other monetary awards recovered by Lilly shall be applied first to defray the
costs and expenses (including reasonable attorneys' fees) incurred in the action
by either or both of the Parties. If any balance remains, Lilly shall second
retain as its own property an amount equal to the royalty that Lilly would
otherwise be entitled to under this Agreement if such remaining balance was
treated as Net Sales. If any balance remains, such balance shall be the property
of Versicor.
(d) SETTLEMENT PROCEDURES. No settlement, consent judgment or
other voluntary final disposition of a suit being prosecuted by a Party under
this Section 7.3 may be entered into without the consent of the other Party if
such settlement, consent judgment or other voluntary final disposition would
alter, derogate or diminish such other Party's rights under the Agreement or
otherwise materially adversely affect such other Party, which consent shall not
be unreasonably withheld or delayed.
SECTION 8
INDEMNIFICATION
8.1 INDEMNIFICATION.
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(a) Lilly shall indemnify, defend and hold Versicor (and its
directors, officers, employees, and Affiliates) harmless from and against any
and all Damages incurred or suffered by Versicor (and its directors,
officers, employees, and Affiliates) (excluding incidental or consequential
Damages suffered or incurred by Versicor directly (as opposed to incidental
or consequential Damages suffered or incurred by third parties who are, in
turn, seeking the same from Versicor, which shall be covered by the indemnity
set forth herein)) as a consequence of third party claims or actions based
upon:
(1) any breach of any representation or warranty made by
Lilly in this Agreement;
(2) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of Lilly contained in this Agreement;
(3) any Excluded Liabilities.
(b) Versicor shall indemnify, defend and hold Lilly (and its
directors, officers, employees, and Affiliates) harmless from and against any
and all Damages incurred or suffered by Lilly (and its directors, officers,
employees, and Affiliates) (excluding incidental or consequential Damages
suffered or incurred by Lilly directly (as opposed to incidental or
consequential Damages suffered or incurred by third parties who are, in turn,
seeking the same from Lilly, which shall be covered by the indemnity set
forth herein)) as a consequence of third party claims or actions based on:
(1) any breach of any representation or warranty made by
Versicor in this Agreement;
(2) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of Versicor contained in this Agreement;
(3) and the Versicor Responsibilities, including; any action
or inaction by Versicor (and its agents, directors, officers, employees,
Affiliates and sublicensees) related to the making, using, selling, offering to
sell, or importing of the Product or Transferred Assets after the Effective
Date, except to the extent such action or inaction is caused by the misconduct
or negligence of Lilly.
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8.2 NOTICE AND OPPORTUNITY TO DEFEND. Promptly after receipt by a Party
hereto of notice of any claim which could give rise to a right to
indemnification pursuant to Section 8.1, such Party (the "Indemnified Party")
shall give the other Party (the "Indemnifying Party") written notice describing
the claim in reasonable detail. The failure of an Indemnified Party to give
notice in the manner provided herein shall not relieve the Indemnifying Party of
its obligations under this Section, except to the extent that such failure to
give notice materially prejudices the Indemnifying Party's ability to defend
such claim. The Indemnifying Party shall have the right, at its option, either
to compromise or defend, at its own expense and by its own counsel, any such
matter involving the asserted liability of the Party seeking such
indemnification, except as provided below. The Indemnifying Party shall promptly
(and in any event not less than twenty (20) days after receipt of the
Indemnified Party's original notice) notify the Indemnified Party in writing of
its intention to either compromise or defend such matter, and the Indemnified
Party agrees to cooperate fully with the Indemnifying Party and its counsel in
the compromise or defense against any such asserted liability. All reasonable
costs and expenses incurred in connection with such cooperation shall be borne
by the Indemnifying Party. If the Indemnifying Party elects in writing not to
compromise or defend the asserted liability, fails to notify the Indemnified
Party of its election to compromise or defend as herein provided, fails to admit
its obligation to indemnify under this Agreement with respect to the claim
following a written request of the Indemnified Party (except in the case where
the Indemnifying Party denies, on reasonable grounds, that it has such an
obligation (which dispute shall be resolved under Section 10.14)), or, if in the
reasonable opinion of counsel to the Indemnified Party, the claim could result
in the Indemnified Party becoming subject to injunctive relief or relief other
than the payment of money Damages that could materially adversely affect the
ongoing business of the Indemnified Party in any manner, the Indemnified Party
shall have the right, at its option, to pay, compromise or defend such asserted
liability by its own counsel and its reasonable costs and expenses shall be
included as part of the indemnification obligation of the Indemnifying Party
hereunder; provided, however, in the event the Indemnifying Party intends to
compromise or settle a claim under this Section 8.2, the Indemnifying Party
shall provide at least ten (10) business days prior written notice to the
Indemnified Party describing the proposed compromise or settlement in order that
the Indemnified Party may comment and/or object. Notwithstanding the foregoing,
neither the Indemnifying Party nor the Indemnified Party may settle or
compromise any claim under this Section 8.2 over the written objection of the
other Party if such settlement or compromise could reasonably result in a
material adverse effect on the other Party or otherwise alter, diminish or
derogate the other Party's
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rights under this Agreement. In any event, the Indemnified Party and the
Indemnifying Party may participate, at their own expense, in the defense of such
asserted liability. If the Indemnifying Party defends any claim, the Indemnified
Party shall make available to the Indemnifying Party any books, records or other
documents within its control that are necessary or appropriate for such defense.
Notwithstanding anything to the contrary in this Section 8.2, (1) the Party
conducting the defense of a claim shall (A) keep the other Party informed on a
reasonable and timely basis as to the status of the defense of such claim (but
only to the extent such other Party is not participating jointly in the defense
of such claim), and (B) conduct the defense of such claim in a prudent manner,
and (2) the Indemnifying Party shall not cease to defend any claim (except
pursuant to a permitted settlement or compromise thereof) without the prior
written consent of the Indemnified Party (which consent shall not be
unreasonably withheld).
8.3 INDEMNIFICATION PAYMENT OBLIGATION. No Indemnifying Party will have
any obligations under Sections 8.1(a) or 8.1(b) until the cumulative aggregate
amount of Damages incurred or suffered by the Indemnified Party (or which likely
would be incurred or suffered if the relevant claim were successful) which the
Indemnifying Party is otherwise subject to under this Agreement exceeds
$100,000, at which time the entire cumulative aggregate amount of such Damages
shall be covered. The provisions of this Section 8.3 shall not limit or
otherwise affect the obligations of any Indemnifying Party under any other
Section of this Agreement.
8.4 INDEMNIFICATION PAYMENT ADJUSTMENTS. The amount of any Damages for
which indemnification is provided under this Section 8 shall be reduced to take
account of any net tax benefit and shall be increased to take account of any net
tax detriment arising from the incurrence or payment of any such Damages or from
the receipt of any such indemnification payment and shall be reduced by the
insurance proceeds received and any other amount recovered, if any, by the
Indemnified Party with respect to any Damages; provided, however, that an
Indemnified Party shall not be subject to an obligation to pursue an insurance
claim relating to any Damages for which indemnification is sought hereunder. If
any Indemnified Party shall have received any payment pursuant to this Section 8
with respect to any Damages and shall subsequently have received insurance
proceeds or other amounts with respect to such Damages, then such Indemnified
Party shall pay to the Indemnifying Party an amount equal to the difference (if
any) between (1) the sum of the amount of those insurance proceeds or other
amounts received and the amount of the payment by such Indemnifying Party
pursuant to this Section 8 with respect
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to such Damages and (2) the amount necessary to fully and completely indemnify
and hold harmless such Indemnified Party from and against such Damages;
PROVIDED, HOWEVER, in no event will such Indemnified Party have any obligation
pursuant to this sentence to pay to such Indemnifying Party an amount greater
than the amount of the payment by such Indemnifying Party pursuant to this
Section 8 with respect to such Damages.
8.5 INDEMNIFICATION PAYMENT. Upon the final determination of liability
and the amount of the indemnification payment under this Section 8, the
appropriate Party shall pay to the other in immediately available funds, within
thirty (30) business days after such determination, the amount of any claim for
indemnification made hereunder.
8.6 SURVIVAL. The provisions of this Section 8 shall survive any
termination of this Agreement with respect to actions of the Parties during the
term of this Agreement. Each Indemnified Party's rights under this Section 8
shall not be deemed to have been waived or otherwise affected by such
Indemnified Party's waiver of the breach of any representation, warranty,
agreement or covenant contained in or made pursuant this Agreement, unless such
waiver expressly and in writing also waives any or all of the Indemnified
Party's right under this Section 8.
SECTION 9
TERMINATION
9.1 TERMINATION. Anything herein to the contrary notwithstanding, this
Agreement may be terminated as follows:
(a) VERSICOR VOLUNTARY TERMINATION. Versicor may terminate
this Agreement at any time by giving ninety (90) days written notice of its
intention to terminate.
(b) LILLY TERMINATION FOR CAUSE. Lilly may terminate this
Agreement solely with respect to a particular country and as to the applicable
formulation (I.E., IV or oral) for Versicor's uncured breach of its obligations
of Reasonable Diligence in such country with respect to such formulation of the
Product as provided in Section 6.7.
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(c) TERMINATION FOR BANKRUPTCY. If either Versicor or
Lilly (1) makes a general assignment for the benefit of creditors; (2) files
an insolvency petition in bankruptcy; (3) petitions for or acquiesces in the
appointment of any receiver, trustee or similar officer to liquidate or
conserve its business or any substantial part of its assets; (4) commences
under the laws of any jurisdiction any proceeding involving its insolvency,
bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or
any other similar proceeding for the release of financially distressed
debtors; or (5) becomes a Party to any proceeding or action of the type
described above in (3) or (4) and such proceeding or action remains
undismissed or unstayed for a period of more than sixty (60) days, then the
other Party may by written notice terminate this Agreement in its entirety
with immediate effect.
(d) TERMINATION FOR DEFAULT.
(1) Versicor and Lilly each shall have the right (except as
otherwise provided in Section 6.7) to terminate this Agreement with respect
to the Product for default upon the other Party's uncured failure to comply
in any material respect with the terms and conditions of this Agreement. At
least sixty (60) days prior to any such termination for default, the Party
seeking to so terminate shall give the other written notice of its intention
to terminate this Agreement in accordance with the provisions of this Section
9.1(d), which notice shall set forth the default(s) which form the basis for
such termination. If the defaulting Party fails to correct such default(s)
within sixty (60) days after receipt of notification, or if the same cannot
reasonably be corrected or remedied within sixty (60) days, then if the
defaulting Party has not commenced curing said default(s) within said sixty
(60) days and is not diligently pursuing completion of same, then such Party
immediately may terminate this Agreement with respect to such Product.
(2) This Section 9.1 (d) shall not be an exclusive remedy
and shall not be in lieu of any other remedies available to a Party hereto for
any default hereunder on the part of the other Party.
(e) RIGHTS UPON TERMINATION.
(1) LILLY RIGHTS UPON TERMINATION. In the event of
termination of the entire Agreement by Lilly under Sections 9.1(b) or 9.1(d)
or termination by
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Versicor under Section 9.1(a), payment by Versicor to Lilly of all amounts
actually earned and accrued by Lilly but remaining unpaid as of the effective
date of such termination shall be immediately accelerated and all such amounts
shall be immediately due and payable by Versicor to Lilly on the date of
termination. Additionally, the license granted by Lilly to Versicor shall
immediately terminate and the ownership of the Product Data Package shall
immediately revert back to Lilly with no further notice required on Lilly's
behalf. Consequently, notwithstanding anything else contained in this Agreement
to the contrary, (A) Lilly shall have the right, directly or indirectly, to
make, use, sell, offer to sell and import the Product in the Territory and (B)
Versicor shall have no further rights in the Product whatsoever.
(2) VERSICOR RIGHTS UPON TERMINATION UPON DEFAULT BY LILLY.
In the event of termination of this Agreement by Versicor under Section 9.1(d),
Versicor shall (A) have no further obligation to make any payments under
Sections 3.2 and 3.3 of the Agreement as of the effective date of the
termination, and (B) retain all of the rights under the licenses granted by
Lilly to Versicor hereunder with respect to the Product.
(3) ASSISTANCE FOLLOWING TERMINATION. In the event of
termination of this Agreement pursuant to Section 9.1(b), 9.1(c) or 9.1(d)
and if Lilly so requests, Versicor shall provide reasonable assistance to
Lilly for a period of ninety (90) days following the date of notice of
termination. Additionally, Versicor shall (and shall cause any subcontractors
under contract with Versicor) grant to Lilly an exclusive license (but solely
in the country or countries where such termination occurred) to all Versicor
Improvements related to Product, including but not limited to, all applicable
regulatory files and filings related to the Product and any patents or patent
applications encompassing Versicor Improvements, solely to develop, make,
have made, use, sell, offer to sell and import the Product in such countries.
(f) CONTINUING OBLIGATIONS. Except as otherwise provided
above, termination of this Agreement for any reason shall not relieve the
Parties of any obligation accruing prior thereto and shall be without
prejudice to the rights and remedies of either Party with respect to any
antecedent breach of the provisions of this Agreement. Without limiting the
generality of the foregoing, no termination of this Agreement, whether by
lapse of time or otherwise, shall serve to terminate the obligations of the
Parties hereto under Sections 2.1(b), 3.4, 3.5 (only in the event Versicor
terminates under Section 9.1(d)), 3.6, 3.7, 6.3, 6.4, 6.5, 7.1 (only in the
event Versicor terminates under Section
-40-
9.1(d), 7.2 (only in the event Versicor terminates under Section 9.1(d)), all
of Section 8, subsections 9.1, 9.2, all of Section 10 and such other Sections
as by their nature should survive, and such obligations shall survive any
such termination.
9.2 BIOLOGICAL MATERIAL. Upon termination of this Agreement, whether by
Lilly or Versicor, Versicor shall cease all use of any Biological Materials and
shall, upon request, return or destroy (at Lilly's option) all Biological
Materials under its control or in its possession within sixty (60) days and
provide a written warranty by an Officer of Versicor that the Biological
Materials have been returned or destroyed.
SECTION 10
MISCELLANEOUS
10.1 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
shall inure to the benefit of the Parties hereto and their respective successors
and assigns. No assignment of this Agreement or Of any rights hereunder shall
relieve the assigning Party of any of its obligations or liability hereunder. In
the event Versicor assigns this Agreement to a third party or a third party
acquires substantially all of the assets or greater than forty percent (40%)
outstanding shares of, or merges with, Versicor ("Change of Control"), as the
case may be, Lilly shall have the right, in its sole discretion, to terminate
the Versicor Co-Promotion Right in Section 2.7(g). Notwithstanding the
foregoing, Lilly may assign its rights and obligations under this Agreement to
an Affiliate.
10.2 NOTICES. All notices or other communications required or permitted
to be given hereunder shall be in writing and shall be deemed to have been duly
given if delivered by hand, facsimile and confirmed in writing or mailed first
class, postage prepaid, by registered or certified mail, return receipt
requested (mailed notices shall be deemed to have been given three (3) days
after mailing; notices sent by facsimile and confirmed in writing shall be
deemed given on the date sent) as follows:
If to Lilly, as follows:
Xxx Xxxxx and Company
Lilly Xxxxxxxxx Xxxxxx
Xxxxxxxxxxxx, Xxxxxxx 00000
Facsimile: (000) 000-0000
Attn: General Counsel
If to Versicor, as follows:
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Versicor Inc.
Xxx Xxxxxxxxx Xxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
Facsimile: (000) 000-0000
Attn: Chief Executive Officer
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 10.2 by any Party hereto to the other
Party.
10.3 WAIVER; REMEDIES. Any term or provision of this Agreement may be
waived at any time by the Party entitled to the benefit thereof by a written
instrument executed by such Party. No delay on the part of Lilly or Versicor in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of either Lilly or Versicor of any
right, power or privilege hereunder operate as a waiver of any other right,
power or privilege hereunder nor shall any single or partial exercise of any
right, power or privilege hereunder preclude any other or further exercise
thereof or the exercise of any other right, power or privilege hereunder. The
indemnification provided in Section 8 shall be the sole remedy available for any
Damages arising out of or in connection with this Agreement except for any
rights or remedies which the Parties hereto may otherwise have in equity.
10.4 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter hereof and supersedes all
prior communications, agreements or understandings, written or oral, of the
Parties relating thereto.
10.5 AMENDMENT. This Agreement may be modified or amended only by
written agreement of the Parties hereto.
10.6 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute a single instrument.
10.7 GOVERNING LAW. This Agreement shall be governed and construed in
accordance with the laws of the State of Indiana, excluding any choice of law
rules that may direct the application of the law of another state.
-42-
10.8 CAPTIONS. All section titles or captions contained in this
Agreement, in any Exhibit referred to herein and the table of contents, if any,
to this Agreement are for convenience only, shall not be deemed a part of this
Agreement and shall not affect the meaning or interpretation of this Agreement.
10.9 NO THIRD PARTY RIGHTS OR OBLIGATIONS. No provision of this
Agreement shall be deemed or construed in any way to result in the creation of
any rights or obligation in any Person not a Party to this Agreement.
10.10 SEVERABILITY. If any provision of this Agreement is found or
declared to be invalid or unenforceable by any court or other competent
authority having jurisdiction, such finding or declaration shall not invalidate
any other provision hereof, and this Agreement shall thereafter continue in full
force and effect.
10.11 ATTACHMENTS. All Exhibits and other attachments to this Agreement
are by this reference incorporated herein and made a part of this Agreement.
10.12 DISCLAIMER OF AGENCY. This Agreement shall not constitute any
Party the legal representative or agent of another, nor shall any Party have the
right or authority to assume, create, or incur any third party liability or
obligation of any kind, express or implied, against or in the name of or on
behalf of another except as expressly set forth in this Agreement.
10.13 INTERPRETATION. This Agreement has been jointly prepared by the
Parties and their respective legal counsel and shall not be strictly construed
against either Party.
10.14 DISPUTE RESOLUTION. In the event of any dispute relating to this
Agreement, prior to instituting any lawsuit, arbitration or other dispute
resolution process on account of such dispute, the Parties shall attempt in good
faith to settle such dispute first by negotiation and consultation between
themselves, including referral of such dispute to the Chief Executive Officer of
Versicor and Group Vice President of Lilly Research Laboratories. In the event
said executives are unable to resolve such dispute or agree upon a mechanism to
resolve such dispute within sixty (60) days of the first written request for
dispute resolution under this Section 10.14, the Parties shall then consider
other forms of alternative dispute resolution as a means of resolving any such
dispute. Thereafter, either Party shall be free to institute litigation and seek
such remedies as may be available.
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Notwithstanding anything in this Agreement to the contrary, either Party shall
be entitled to institute litigation immediately if the same shall be necessary
to prevent irreparable harm to either Party.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed and delivered on the day and year first above written.
XXX XXXXX AND COMPANY VERSICOR, INC.
By: /s/ August X. Xxxxxxxx By: /s/ Xxxxxx X. Xxxxxx III
--------------------------------- ------------------------------
August X. Xxxxxxxx, M.D Xxxxxx X. Xxxxxx III
Executive Vice President President and CEO
Versicor/License Agreement
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EXHIBIT A
LIST A-1 ("CORE PATENTS AND PATENT APPLICATIONS")
PENDING U.S. APPLICATIONS
-----------------------------------------------------------------------------------------------------
TITLE U.S. FILING DATE FIRST NAMED INVENTOR
APPLICATION #
-----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal Agents 08/449056 5/24/1995 Xxxxxxxxx, Xxxxxxxxx X.
and Process for
Preparation Thereof
-----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 09/291900 4/14/1999 Xxxxxxxxx, Xxxxxxxxx X.
Agents and Process for
Preparation Thereof
-----------------------------------------------------------------------------------------------------
Echinocandin/Carbo- 60/122692 3/3/1999 Xxxxx, Xxxxx X.
hydrate Complexes
-----------------------------------------------------------------------------------------------------
Echinocandin 60/122623 3/3/1999 Xxxxxx, Xxxxxxxxx
Pharmaceutical
Formulations Containing
Micelle-Forming
Surfactants
-----------------------------------------------------------------------------------------------------
Processes for Making 60/122693 3/3/1999 Xxxxxxx, Xxxx X.
Pharmaceutical Oral ECB
Formulations and
Compositions
-----------------------------------------------------------------------------------------------------
Formation and Anion-Exchange of 60/123073 3/3/1999 Xxxxxx, Xxxxx X.
Crystalline
Echinocandin Ammonium
Salts
-----------------------------------------------------------------------------------------------------
1
EXHIBIT A
LIST A-2 ("NON-CORE PATENTS AND PATENT APPLICATIONS")
ISSUED PATENTS
-----------------------------------------------------------------------------------------------------------
DATE OF
TITLE PATENT # ISSUANCE FIRST NAMED INVENTOR
-----------------------------------------------------------------------------------------------------------
Derivatives of S31794/F-1 US 4,287,120 9/1/1981 Xxxxxx, Xxxxxxx X.
Nucleus
-----------------------------------------------------------------------------------------------------------
Method of Producing the A- US 4,288,549 9/8/1981 Xxxxx, XxXxxxx X.
00000 Antibiotics
-----------------------------------------------------------------------------------------------------------
Derivatives of A-30912B US 5,293,488 10/6/1981 Xxxxxx, Xxxxxx
Nucleus
-----------------------------------------------------------------------------------------------------------
Derivatives of A-30912A US 4,293,489 10/6/1981 Xxxxxx, Xxxxxx
Nucleus
-----------------------------------------------------------------------------------------------------------
A-30912B Nucleus & US 4,299,763 11/10/1981 Xxxxxx, Xxxxxxx X.
Deacylation Process
-----------------------------------------------------------------------------------------------------------
Derivatives of A-30912D Nucleus US 4,320,053 3/16/1982 Xxxxxx, Xxxxxxx X.
-----------------------------------------------------------------------------------------------------------
Derivatives of A-30912B US 4,322,338 3/10/1982 Xxxxxx, Xxxxxxx X.
Nucleus
-----------------------------------------------------------------------------------------------------------
Process for Purifying US 5,573,936 11/12/1996 Xxxxxxxx, Xxxx X.
Echinocandin B Deacylase
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal US 5,629,289 5/13/1997 Xxxxxxxxx, Xxxxxxx X.
Agents
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal US 5,652,213 7/29/1997 Xxxxxxx, Xxxxx X.
Agents
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal US 5,629,290 5/13/1997 Xxxxxxxxxx, Xxxx X.
Agents
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal US 5,786,325 7/28/1998 Xxxxxxxx, Xxxxx X.
Agents and Methods of
Making and Using
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal Agents US 5,693,611 12/2/1997 Xxxxx, Xxxxx X.
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal Agents US 5,618,787 4/8/1997 Xxxxxxx, Xxxxx X.
-----------------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal US 5,646,111 7/8/1997 Xxxxxxxx, Xxxxx X.
Agents
-----------------------------------------------------------------------------------------------------------
Method For Treating Pneumocysits South African Patent 11/25/1992 Current, Xxxxxxx X.
91-1447
-----------------------------------------------------------------------------------------------------------
2
EXHIBIT A
LIST A-2 (CONTINUED)
PENDING U.S. APPLICATIONS
----------------------------------------------------------------------------------------------------
TITLE U.S. FILING DATE FIRST NAMED INVENTOR
APPLICATION #
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 08/032228 3/17/1993 Xxxxxxxxx, Xxxxxxxxx X.
Agents and Process for
Preparation Thereof
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 08/873480 6/12/1997 Xxxxxxxxx, Xxxxxxxxx X.
Agents and Process for
Preparation Thereof .
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 09/129062 8/4/1998 Xxxxxxx, Xxxx X., Xx
Agents
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 09/245572 2/5/1999 Xxxxxxx, Xxxxx X.
Agents
----------------------------------------------------------------------------------------------------
Echinocandin Binding 09/217272 12/21/1998 Ma, Xxxxxx
Domain of 1,3-Bta-Glucan
Synthase
----------------------------------------------------------------------------------------------------
Reversible Boronate 60/098267 8/28/1998 Xxxxx, Xxxxx X.
Complexes of 1,2-C/S Diol
Cyclic Peptides
----------------------------------------------------------------------------------------------------
Ring Modified Cyclic Peptide 60/097228 8/20/1998 Xxxxxxxx, Xxxxx X.
Analogs
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal Agent 60/112434 12/16/1998 Xxxxxxxxx, Xxxxxxx X.
----------------------------------------------------------------------------------------------------
Cyclic Peptide Antifungal 60/112433 12/16/1998 Xxxxxxxxx, Xxxxxxx X.
Agents
----------------------------------------------------------------------------------------------------
Purification of 60/111524 12/9/1998 Xxxxxx, Xxxxxx X.
Echinocandin Cyclopeptide
Compounds
----------------------------------------------------------------------------------------------------
Photochemical Process for 60/105936 10/28/1998 Xxxxxxxxx, Xxxxxxx X.
Making 1-Deoxy-2-Keto
Derivatives
----------------------------------------------------------------------------------------------------
3
EXHIBIT C - PRODUCT DATA PACKAGE
REGULATORY
1. United States investigational new drug application (IND) #51,111, dated
July 15, 1996;
2. United States IND #54,597, dated November 20, 1997;
3. Spain CTA #PEI97-06 dated August 17, 1998;
4. Canada IND ##044571, 056065 and 056082, approved September 25, 1996, June
16, 1998, June 16, 1998, respectively;
5. Japan IND # 10-2469, dated August 3, 1998;
6. Equivalent filings, authorizations and/or applications in the countries of
France, United Kingdom CTX 6/350/A #61292; Xxxxx, Xxxxxxx, Xxxxxxx (XXX xxx
000/00), Xxxxxxx (4013536), Argentina (2345/98)and Brazil;
7. All amendments and reports related to the aforementioned documents.
8. Annual Reports with the FDA;
9. Existing correspondence with relevant regulatory authorities;
10. Serious Adverse Event reports
MEDICAL
11. Investigator's files, clinical trial AS400 system data, final study
reports(1) clinical investigator brochures, and protocols (each to the
extent of Lilly's existing rights) from the following clinical studies:
XBAA-Single dose safety and PK study (oral)
XBAB-Multiple dose safety and PK (oral)
XBAE-Single dose safety and PK (IV)
XBAU-Multiple dose safety and PK (IV)
XBAC-Phase II study of LY (oral) vs. fluconazole in the therapy of OPC.
XBAW-Phase I comparative study of safety PK in HIV-infected and uninfected
volunteers (oral).
XBAI-Phase II open label study of LY (oral) in the treatment of OPC.
XBAF-Phase II pilot efficacy study of LY in treatment of candida
esophagitis.
XBAG-Phase II/III study of LY (IV) vs. fluconazole in the treatment of
candidemia and systemic candidiasis in non-neutropenic patients.
12. Toxicology Reports
13. Pharmacokinetics reports
--------
(1) Final study reports for XBAI, XBAF, and XBAG are currently being prepared
and will not be completed and made available to Versicor in approximately
July/August, 1999.
PRECLINICAL
14. Protocols and data for LY303366 and control compounds from preclinical
studies listed in Attachment I hereto.
CM&C
15. 290 grams of reference standard lot 185EM6 (reevaluation date July 2000).
16. Process development technical reports
17. Formulation development technical reports
18. Analytical development technical reports
19. Pilot plant campaign summaries
20. Certificate of Analysis for API and drug product in Start-Up Inventory
21. Batch release data for API and drug product (contained in IND)
22. Analytical methods for API and drug product(contained in IND)
23. Existing stability information (contained in IND)
ATTACHMENT I - EXHIBIT C
----------------------------------------------------------------------------------------------------
Title of Study (All Contain 303366 Studies) Notebook
----------------------------------------------------------------------------------------------------
Linoleic Acid and Cremaphor Formulation (From Xxxxx Xxxxxx--Oral H97-5QX-56
Emulsion Formulation)
----------------------------------------------------------------------------------------------------
Oral Bioavailability of 303366 in Rats at Various Time Intervals H97-5QX-91-98
----------------------------------------------------------------------------------------------------
Oral Bioavailability of ECB Analogs at Various Time Intervals H97-5QX-99-130
----------------------------------------------------------------------------------------------------
Renal Recovery of Aspergillus From Mice Treated With LY295337, ECB H97-5QX-134-143
Analogs, Fluconazole or Fungizone
----------------------------------------------------------------------------------------------------
Renal Recovery OF ASPERGILLUS FUMIGATUS From Mice Treated With ECB H97-5QX-152-160
Finalists and Controls (IP and Oral)
----------------------------------------------------------------------------------------------------
Oral Bioavailability of 280949 and 303366 in Rats H97-5QX-170-173
----------------------------------------------------------------------------------------------------
IN VITRO Resistance Development of LY303366, Fluconazole & H97-LPU-3-4
Amphotericin B
----------------------------------------------------------------------------------------------------
IN VITRO Susceptibility of Clinical Isolates of CANDIDA ALBICANS to H97-LPU-9-22
LY303366 and Ampho B in Antibiotic 3 or RPMI & MOPs Using a Microbroth
Dilution, Assay
---------------------------------------------------------------------------------------------------
LY303366 Fungicidal Activity vs. CANDIDA spp. H97-LPU-23-26
----------------------------------------------------------------------------------------------------
Efficacy of LY303366 versus Murine systemic Candidiasis When Treated IP H97-LPU-38-41
(4,24,48); (6,24,48); or (24,48,72) Hr Post-Infection
----------------------------------------------------------------------------------------------------
IN VIVO Antifungal Efficacies of LY303366 & Amphotericin B Against a H97-LPU-47-52
Disseminated C. ALBICANS Infection in ICR Mice (Xxxxx Recovery)
----------------------------------------------------------------------------------------------------
Efficacy of LY303366 Versus Murine Systemic Candidiasis When Treated IV H97-LPU-53-56
(4,24,48); (6,24,48) or (24,48,72) Hr Post-Infection
----------------------------------------------------------------------------------------------------
Oral Pharyngeal Candidiasis in Rats H97-LPU-91-93
----------------------------------------------------------------------------------------------------
Target Oragan Recovey of Candida albicans From Mice Treated With H97-LPU-133-142
LY303366, Amphotercin B or Fluconazole
----------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------
Pharmacokinetic Study of 303366 and 307853 H97-CKX-28-29
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA ALBICANS From Mice Treated With ECB Finalists H97-CKX-3l-39
and Controls
----------------------------------------------------------------------------------------------------
Pharmacokinetic Study of 303366 Prodrug 25 mg/kg Orally in H2O or H97-CKX-45-50
Cremophro/Linoleic Acid and 303366 25 mg/kg Orally in Cremophor/Linoleic
Acid in Rat Plasma
----------------------------------------------------------------------------------------------------
Pharmacokinetic Study of 303366 Prodrug 5.0 mg/kg IV in H20 and 303366 H97-CKX-51-52
5.0 mg/kg IV in 33% PEG 300 and 0.05 M Phosphate Buffer, pH 7.0
in Rat Plasma
----------------------------------------------------------------------------------------------------
Chemotherapy of Rat Vaginal Candidiasis (Miconazole, Fluconazole, H97-CKX-72-78
LY303366)
----------------------------------------------------------------------------------------------------
Monoclonal Antibody Plus Candida albicans A26 and LY303366 H97-CKX-79-82
----------------------------------------------------------------------------------------------------
Checkerboard Synergism Assay H97-CKX-83-84
----------------------------------------------------------------------------------------------------
Submission of Plasma From Rats Treated Orally Via Gavage With 303366 H97-CKX-85-86
and Acacia w/wo Ethanol for HPLC Analysis
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA ALBICANS From Mice Treated with ECB Finalists H97-CKX-87-93
(329960,333006,303366, 311725) and Controls
----------------------------------------------------------------------------------------------------
Renal Recovery OF CANDIDA spp. (C. GLABRATA, C. PARAPSILOSIS, C. H97-CKX-98-107
TROPICALIS) From Mice Treated with ECB Finalists (329960, 333006,
303366, 311725) and Controls
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA ALBICANS From Mice Treated With ECB Finalists H97-CKX-108-115
and Controls for 10 Days-Cidal Activity Determination
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA spp. (C. GLABRATA, C. PARAPSILOSIS, C. H97-CKX-116-123
TROPICALIS) From Mice Treated With ECB Finalists (329960, 333006,
303366, 311725) and Controls
----------------------------------------------------------------------------------------------------
Chemotherapy of Rat Vaginal Candidiasis (LY303366, Fluconazole PO and H97-CKX-124-134
Clotrimazole, Miconazole Topically)
----------------------------------------------------------------------------------------------------
LY303366 Parenteral (IV) Formulations Comparison Study in Rats H97-CKX-135-141
----------------------------------------------------------------------------------------------------
Agar Dilution Assay of Candida spp. Isolates Versus ECB Analogs H97-CKX-142-149
----------------------------------------------------------------------------------------------------
Effect of Delaying Initial Treatment on the ED50 of 303366 in H97-CKX-150-151
Immunocompromised Mice Infected With CANDIDA ALBICANS A26
----------------------------------------------------------------------------------------------------
ATTACHMENT I - EXHIBIT C
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA spp. (C. GLABRATA. C. TROPICALIS. C. H97-CKX-152-158
PARAPSILOSIS) From Mice Treated With ECB Prodrugs and Parents
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA spp. (C. GLABRATA. C. TROPICALIS. C. H97-CKX-159-175
PARAPSILOSIS) From Mice at Various Time Intervals (Days 4,7,10)
----------------------------------------------------------------------------------------------------
IN VITRO Activity of LY303366, Amphotericin B and Azoles Versus Azole H97-CKX-177-181
Resistant CANDIDA ALBICANS Isolates
----------------------------------------------------------------------------------------------------
Antifungal Activity of LY303366 Against CANDIDA ALBICANS by H97-CKX-182-183
Agar Dilution Assay
----------------------------------------------------------------------------------------------------
Chemotherapy of HISTOPLAMSA CAPSULATUM ATCC 26032-24 (LY303366, LY295337 H97-CKX-184
& Fungizone)
----------------------------------------------------------------------------------------------------
Comparison of the IN VITRO Activities of LY303366 and other Antifungal H97-CKX-185-189
Agents Against CANDIDA spp.
----------------------------------------------------------------------------------------------------
Oral Pharmacokinetci Mouse Study 303366 in Acacia H97-CKX-190-192
----------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------
Comparison of the IN VITRO Activities of LY303366 and other Antifungal H97-JBN-1-7
Agents (303366, Fluconazole, Amphotericin B) Against CANDIDA spp.
(C. KRUSEI, C. ALBICANS, C. PARAPSILOSIS, C. GLABRATA, C. TROPICALIS)
----------------------------------------------------------------------------------------------------
Renal Recovery of CANDIDA spp. (10(5) or 10(6)) From Mice H97-JBN-8-24
(x-ray or non x-ray) Treated with 303366 and Controls
----------------------------------------------------------------------------------------------------
Effect of Delaying Initial Treatment on the ED(50) of LY303366 in H97-JBN-25-27
Immunocompromised Mice Infected With CANDIDA ALBICANS A26
----------------------------------------------------------------------------------------------------
Antimicrobial Susceptibilities of CANDIDA ALBICANS Isolates (107) to H97-JBN-31-42
LY303366 and Amphotericin B in an Agar Dilution Assay
----------------------------------------------------------------------------------------------------
Growth Inhibition of C. ALBICANS by LY303366 in Antibiotic 3-Growth H97-JBN-43-46
Curve
----------------------------------------------------------------------------------------------------
Effect of Delaying Initial Treatment on the ED(50) of LY303366 in H97-JBN-49-50
Immunocompromised Mice Infected with CANDIDA ALBICANS A26
----------------------------------------------------------------------------------------------------
Effect of Delaying Initial Treatment on the ED(50) of LY303366 in H97-JBN-51
Immunocompromised Mice Infected with CANDIDA ALBICANS A26
----------------------------------------------------------------------------------------------------
Pharmacokinetic Study of LY303366 Administered Orally via Gavage in H97-JBN-55-57
ICR Mice
----------------------------------------------------------------------------------------------------
Notes for the Preparation of the Dose solution of 085R94-LY303366 H97-JBN-74
and (14)C-LY303366
----------------------------------------------------------------------------------------------------
Antifungal Susceptibility Testing of Filamentous Fungal Dermatophytes H97-JBN-75-78
Versus LY303366
----------------------------------------------------------------------------------------------------
Chemotherapy of Rat Vaginal Candidiasis (LY303366 and Fluconazole PO) H97-JBN-79-87
----------------------------------------------------------------------------------------------------
Email Message discussing lack of PO activity in vaginal model possibly H97-JBN-87 bottom of page
predicting failure versus esophygeal candidiasis when
LY303366 administered orally
----------------------------------------------------------------------------------------------------
Susceptibility of CANDIDA spp. Grown on Sabourauds Agar by the Agar H97-JBN-88-97
Dilutlion Test LY303366 and Ampho B
----------------------------------------------------------------------------------------------------
IN VITRO Resistance Development vs. C. ALBICANS for LY303366 and H97-JBN-98
Fluconazole
----------------------------------------------------------------------------------------------------
Gastrointestinal Candidiasis--LY303366 and Fluconazole H97-JBN-99-106
----------------------------------------------------------------------------------------------------
Renal Recovery of C. ALBICANS From Mice Treated IV with LY303366 in an H97-JBN-107-113
Bio-Pharm Formulation, PEG or Cyclodextran for 7 Day Post-Infection
----------------------------------------------------------------------------------------------------
IN VITRO Antifungal Testing of 303366, Fluconazole and Amphotericin B H97-JBN-116
----------------------------------------------------------------------------------------------------
Chemotherapy of HISTOPLASMA CAPSULATUM and BLASTOMYCES DERMATITIDIS vs. H97-JBN-121
ECB Analogs (303366)
----------------------------------------------------------------------------------------------------
Gastrointestinal Candidiasis (303366 and Fluconazole) H97-JBN- 143-152
----------------------------------------------------------------------------------------------------
Various Broth and Methods for MIC Determination of 303366, Fluconazole H97-JBN-165-173
and Ampho B
----------------------------------------------------------------------------------------------------
Oral Pharyngeal Candidiasis in Rats Procedure H97-JBN- 174-175
----------------------------------------------------------------------------------------------------
Efficacy of a Microemulsion Formulation of LY303366 vs. Murine H97-JBN-185-186
Candidiasis When Treated IV at 4,24 & 48 hr Post-Infection
----------------------------------------------------------------------------------------------------
Recovery of C. ALBICANS From Kidney and Liver Homogenates of Mice H97-JBN- 187-192
Treated IP With LY303366 (4,24); (4,24,48); or (4,24,72) hr
Post-Infection
----------------------------------------------------------------------------------------------------
ATTACHMENT I - EXHIBIT C
Anti-pneumocystis Activity of 280949 and LY303366 Study
----------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------
PC Cyst-Reduction Model (4 days therapy) oral dose LY303366 in rats PT9211
(280949 included in study as a positive control drug).
----------------------------------------------------------------------------------------------------
Oral Prophylaxis of PCP with LY303366 PT9212
----------------------------------------------------------------------------------------------------
Oral Prophylaxis of PCP with LY303366 and 280949 PT9301
----------------------------------------------------------------------------------------------------
Oral Prophylaxis of PCP with 303366 and Oral dose ranging Cyst Reduction PT9302
Study of PCP with LY303366: IV and oral single dose vs. IV/Oral combined
therapy
----------------------------------------------------------------------------------------------------
Parenteral Prophylaxis of PCP with 1,2 and 3 x weekly dosing of LY303366 PT9303
----------------------------------------------------------------------------------------------------
Parenteral Prophylaxis of PCP with 1 x weekly dosing of LY303366 PT9304
----------------------------------------------------------------------------------------------------
Cyst-Reduction Study-single IV dose vs. 4 days oral therapy of PCP PT9401
LY303366
----------------------------------------------------------------------------------------------------
Oral Therapy of PCP with LY303366 PT9402
----------------------------------------------------------------------------------------------------
Oral Prophylaxis of PCP: once a week VS. QD dosing LY303366 PT9403
----------------------------------------------------------------------------------------------------
Oral Cyst Reduction Study comparing 303366 Biopharm formulation with PT9503
LY303388 in 17.5% PEG
----------------------------------------------------------------------------------------------------
303366 Only Study Locations
ECB SAR DATABASE
ECB SAR data is included in a FileMaker Pro database. This database contains
records for approximately 604 analogs. The majority of MIC, ED(50) and glucan
synthase data can be found here. This information can be provided on a CD due
to its large size (7.7 MB). The following information can be found in this
database:
1. Serial numbers
2. Lot numbers
3. Structure drawings
4. ClogP values
5. MIC's for CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, ASPERGILLUS FUMIGATUS,
CRYPTOCOCCUS NEOFORMANS, HISTOPLASMA CAPSULATUM in Antibiotic 3,
Sabouaruads and/or RPMI & MOPS broths.
6. Glucan synthase % inhibition + control values for CANDIDA ALBICANS and
ASPERGILLUS FUMIGATUS.
7. Murine candidiasis ED(50) values (IP and/or PO)
8. Murine cryptococcosis ED(50) values (IP and/or PO)
9. Murine aspergillosis ED(50) values (IP and/or PO)
10. PNEUMOCYSITIS CARINII IN VIVO evaluation
11. Pharmacokinetic data (plasma levels following IV or PO dosing)
EXHIBIT D
START UP INVENTORY
-------------------------------------- --------------- --------------- --------------- -----------------
NAME QUANTITY UOM UNIT COST TOTAL COST
-------------------------------------- --------------- --------------- --------------- -----------------
ECB Nucleus HCI [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
Terphenyl Acid [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
HOBT [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB fructose complex API [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB vials for injection 25 mg [ * ] Vials [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB vials for injection 35 mg [ * ] Vials [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
Grand Total: [ * ]
RESERVE INVENTORY
-------------------------------------- --------------- --------------- --------------- -----------------
NAME QUANTITY UOM UNIT COST TOTAL COST
-------------------------------------- --------------- --------------- --------------- -----------------
ECB Nucleus HCI [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
Terphenyl Acid [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
HOBT [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB fructose complex API [ * ] Kg [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB vials for injection 25 mg [ * ] Vials [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
ECB vials for injection 35 mg [ * ] Vials [ * ] [ * ]
-------------------------------------- --------------- --------------- --------------- -----------------
Grand Total: [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
EXHIBIT E
QUARTERLY REPORTING OF RESERVE INVENTORY STATUS
Date of Report:
Period of Time Covered by this Report:
PART 1: INVENTORY USED
-------------------------------- --------------- ------------ ---------------- ------------------
NAME AMOUNT USED UOM UNIT COST TOTAL COST OWED
SINCE LAST (FROM EXHIBIT TO LILLY
REPORT D)
-------------------------------- --------------- ------------ ---------------- ------------------
ECB Nucleus HCI Kg [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
Terphenyl Acid Kg [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
HOBT Kg [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
ECB fructose complex API Kg [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
ECB vials for injection 25 mg Vials [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
ECB vials for injection 35 mg Vials [ * ]
-------------------------------- --------------- ------------ ---------------- ------------------
Grand Total:
PART 2: INVENTORY REMAINING IN RESERVE STATUS
-------------------------------- ------------ ------------- ------------ ------------------------
NAME AMOUNT UOM UNIT COST COMMENTS
-------------------------------- ------------ ------------- ------------ ------------------------
ECB Nucleus HCI Kg
-------------------------------- ------------ ------------- ------------ ------------------------
Terphenyl Acid Kg
-------------------------------- ------------ ------------- ------------ ------------------------
HOBT Kg
-------------------------------- ------------ ------------- ------------ ------------------------
ECB fructose complex API Kg
-------------------------------- ------------ ------------- ------------ ------------------------
ECB vials for injection 25 mg Vials
-------------------------------- ------------ ------------- ------------ ------------------------
ECB vials for injection 35 mg Vials
-------------------------------- ------------ ------------- ------------ ------------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
EXHIBIT F- BIOLOGIC MATERIAL
STRAIN QUANTITY
ASPERGILLUS NIDULANS E00382-02-73 70 straws
ASPERGILLUS NIDULANS E00560-03-57 10 straws
STREPTOMYCES LIVIDANS PSHP150-2 80 straws
