EXHIBIT 10.3
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LICENSE AGREEMENT
THIS LICENSE AGREEMENT is entered into effective as of November 13, 1996
(the "Effective Date") between ALKERMES CONTROLLED THERAPEUTICS, INC., a
Pennsylvania corporation ("Alkermes"), located at 00 Xxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxxxxxx 00000 and GENENTECH, INC., a Delaware corporation ("Genentech"),
located at 000 Xxxxx Xxx Xxxxx Xxxxxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000.
Alkermes possesses certain technology currently known as the ProLease(R)
delivery system, consisting of patents and know-how, that permits PLGA
encapsulation of particular molecules leading to sustained release of such
molecules when injected under the skin.
Genentech wishes to incorporate such technology in formulations of
recombinant human growth hormone for use in human beings and, accordingly,
wishes to obtain a license from Alkermes for such use of the Alkermes
technology.
Therefore, Alkermes and Genentech agree as follows:
1. DEFINITIONS.
1.1 "AFFILIATE" shall mean an entity that, directly or indirectly,
through one or more intermediaries, is controlled by Alkermes or Genentech. As
used herein, the term "control" will mean the direct or indirect ownership of
fifty percent (50%) or more of the stock having the right to vote for directors
thereof or the ability to otherwise control the management of the corporation or
other business entity.
1.2 "ALKERMES KNOWHOW" shall mean any and all proprietary information,
data, test results, safety and efficacy data, knowledge, discoveries,
inventions, materials, specifications, designs, regulatory filings, methods,
processes and techniques which are now or hereafter owned by or in the
possession or control of Alkermes and which Alkermes has the right to transfer
or sublicense and which are related to the encapsulation of proteins in
microspheres utilizing the ProLease(R) delivery system and any improvements
thereto. Alkermes Knowhow does not include any of the foregoing which is
generally ascertainable from publicly available information or which was known
to Genentech prior to disclosure to Genentech by Alkermes, as evidenced by prior
competent proof or which Genentech obtained independently or in collaboration
with another partner and not in violation of any obligation of confidentiality.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
1.3 "ALKERMES PATENTS" shall mean the patents and patent applications
listed on Exhibit A hereto and their foreign counterparts and all patents
(including inventor's certificates) and patent applications containing claims to
the encapsulation of proteins in microspheres and substitutions, extensions,
reissues, renewals, divisions, continuations or continuation-in-parts of any of
the foregoing, which Alkermes presently or hereafter owns or controls, either
solely or jointly with Genentech or a third party, and which Alkermes now has or
hereafter shall have the right to grant sublicenses to. Alkermes shall use its
best efforts to amend Exhibit A by December 31 of each year to include any
Alkermes Patents that have arisen in the period since the Effective Date or
since the last amendment to Exhibit A; provided, however, that if Alkermes does
not so amend Exhibit A by December 31 of any year, Alkermes shall so amend
Exhibit A within thirty (30) days after receipt of a written request from
Genentech to do so.
1.4 "ALKERMES TECHNOLOGY" shall mean the Alkermes Patents and the
Alkermes Knowhow.
1.5 "BLA" shall mean a Biologics License Application as that term is used
in Title 21 of the Code of Federal Regulations.
1.6 "COLLABORATION AGREEMENT" shall mean the Collaborative Development
Agreement between Genentech and Alkermes dated as of January 9, 1995.
1.7 "COMMERCIAL INTRODUCTION" shall mean the date of first commercial
sale of a Licensed Product by Genentech.
1.8 "FULLY BURDENED MANUFACTURING COST" shall mean the sum of: (a) the
cost of goods produced, determined in accordance with generally accepted
accounting principles in the United States as consistently applied by a Party,
including but not limited to direct labor, material and product testing costs of
the Licensed Product, as well as allocable overhead, (b) any intellectual
property acquisition and licensing costs directly allocable to the manufacture,
use or sale of Licensed Products by a Party, as determined in accordance with
generally accepted accounting principles in the United States as consistently
applied by a Party, and (c) any other costs borne by a Party for the transport,
customs clearance, and storage of the Licensed Product (e.g., freight, duties,
insurance and warehousing).
1.9 "FIELD OF USE" shall mean the prevention, treatment, and diagnosis of
any human disease or condition using any Licensed Product.
1.10 "GENENTECH KNOWHOW" shall mean any and all proprietary information,
data, test results, safety and efficacy data, knowledge, discoveries,
inventions, materials, specifications, and designs and other information owned
or controlled by or in the possession of Genentech and which Genentech has the
right to transfer or sublicense which is
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
specifically and only directed at the manufacture of a Licensed Product
(including all research, preclinical, clinical data specific for or a Licensed
Product), but only to the extent derived by Genentech pursuant to or in the
course of research conducted pursuant to the Collaboration Agreement. Genentech
Knowhow does not include any of the foregoing which are generally ascertainable
from publicly available information.
1.11 "GENENTECH PATENTS" shall mean any patents (including inventor's
certificates) and patent applications containing claims to the composition or
use of Licensed Products, as well as substitutions, extensions, reissues,
renewals, divisions, continuations, or continuations-in-part of any of the
foregoing, which Genentech own or control, either solely or jointly with
Alkermes, and as to which Genentech now have or hereafter shall have the right
to grant sublicenses.
1.12 "GENENTECH TECHNOLOGY" shall mean the Genentech Patents and the
Genentech Knowhow.
1.13 "LICENSED PRODUCT(S)" shall mean any pharmaceutical formulation for
use in or for humans which contains human growth hormone or analogues thereof or
contains nucleic acids meant to be incorporated into cells, causing production
of human growth hormone or analogues thereof, and (i) which, but for the license
granted herein, cannot be manufactured, used or sold without infringing a Valid
Claim which is contained in an Alkermes Patent, or (ii) which utilizes or was
made utilizing, contains, is based upon, is derived from, or could not have been
made but for, the Alkermes Technology.
1.14 "MAJOR MARKET COUNTRY" shall include each of the following: Germany,
France, Italy, Japan, the United Kingdom or Spain.
1.15 "NDA" shall mean a New Drug Application as that term is used in Title
21 of the Code of Federal Regulations.
1.16 "NET SALES" shall mean the gross invoiced sales price charged for all
Licensed Products sold or commercially disposed of for value by Genentech, in
arm's length sales to independent third parties after deduction of the following
items, to the extent such items are incurred, provided that such items are
included in the gross price charged and do not exceed reasonable and customary
amounts for each such item in the market in which such sale occurred:
(A) trade, cash and quantity discounts or rebates actually allowed
and taken;
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
(B) credits or allowances given or made for rejection or return of,
and for uncollectible amounts on, a previously sold Licensed Product or for
retroactive price reductions;
(C) any tax or government charge (including any tax such as a value
added or similar tax or government charge other than an income tax) levied on
the sale, transportation or delivery of a Licensed Product and borne by the
seller thereof; and
(D) any charges allowed or prepaid for freight or insurance billed to
the final customer.
In the event Alkermes is receiving royalties under this Agreement from any
Licensed Product sold in a form containing in addition to simple Licensed
Product, at least one other ingredient which is Therapeutically Active but
excluding diluents, vehicles or specific adjuvants, Net Sales for such
combination Licensed Product will be calculated by multiplying actual Net Sales
of such combination Licensed Product by the fraction A/(A+B) where A is the
invoice price of the Licensed Product if sold separately, and B is the total
invoice price of any other ingredient which is Therapeutically Active in the
combination, if sold separately. If, on a country-by-country basis, the other
ingredient which is Therapeutically Active in the combination is not sold
separately in said country, Net Sales for the purpose of determining royalties
of the combination Licensed Product shall be calculated by multiplying actual
Net Sales of such combination Licensed Product by the fraction A/C where A is
the invoice price of the Licensed Product, if sold separately, and C is the
invoice price of the combination Licensed Product. If, on a country-by-country
basis, neither the Licensed Product nor the other ingredient which is
Therapeutically Active of the combination Licensed Product is sold separately in
said country, Net Sales for the purpose of determining royalties of the
combination Product shall be determined by the Parties in good faith. For
purposes of this Section 1.16, "Therapeutically Active" shall mean biologically
active but shall not include diluents, vehicles or specific adjuvants or any
other ingredient (other than a Licensed Product) which does not have any, or
only incidental, therapeutic properties when present alone.
In general, the Parties agree to negotiate in good faith for an equitable
determination of Net Sales of Licensed Product, on a country-by-country basis,
in the event that Genentech sells Licensed Product in such a manner that gross
sales of the same are not readily identifiable.
1.17 "PARTY" shall mean Genentech or Alkermes and, when used in the
plural, shall mean Genentech and Alkermes.
1.18 "PHASE I/II CLINICAL TRIAL" shall mean studies in humans of the
pharmacokinetics, pharmacodynamics, safety, dose ranging and efficacy of a
Licensed
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
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Product which are designed to generate sufficient data to commence a Phase III
Clinical Trial.
1.19 "PHASE III CLINICAL TRIAL" shall mean as to a specific Licensed
Product, a controlled (or uncontrolled if appropriate) study in humans of the
efficacy and safety of such Licensed Product which is prospectively designed to
demonstrate statistically whether the Licensed Product is effective for use in a
particular indication in a manner sufficient to file a BLA or NDA to obtain
regulatory approval to market that Licensed Product for the indication being
investigated by the Phase III Clinical Trial.
1.20 "REGULATORY APPROVAL" means any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations of any
federal, state or local regulatory agency, department, bureau or other
governmental entity, necessary for the manufacture and sale of a Licensed
Product in a regulatory jurisdiction.
1.21 "TERRITORY" shall mean all of the countries in the world except the
United States.
1.22 "VALID CLAIM" shall mean a subsisting claim of an issued and
unexpired Alkermes Patent (i) that has not been declared invalid, unpatentable
or unenforceable by a decision of a governmental body or court of competent
jurisdiction, (ii) that is unappealable or unappealed within the time allowed
for appeal, (iii) that has not been rendered unenforceable through disclaimer or
otherwise, and (iv) that is not subject to an interference claim.
2. LICENSES AND OPTIONS TO GENENTECH AND ALKERMES.
2.1 GRANT OF LICENSE RIGHT TO GENENTECH.
(A) Alkermes hereby grants to Genentech a coexclusive right and
license along with Alkermes within the United States and within the Field of Use
and an exclusive right and license (even as to Alkermes) within the Territory
and within the Field of Use, under the Alkermes Patents and the Alkermes Knowhow
to perform research and development on, to manufacture and have manufactured,
use, import, offer for sale and sell any Licensed Product containing human
growth hormone. Genentech may not sublicense any of the rights granted in this
Section 2.1. Alkermes hereby agrees not to grant any further licenses to the
rights it retains pursuant to this Section 2.1.
2.2 GRANT OF LICENSE RIGHT TO ALKERMES. Genentech hereby grants to
Alkermes a coexclusive royalty-free right and license along with Genentech
within the United States, under the Genentech Technology to perform research and
development on and to manufacture any Licensed Product pursuant to Section 5
hereof.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
3. PAYMENTS TO ALKERMES.
3.1 MILESTONE PAYMENTS. Genentech shall pay Alkermes the amounts
specified below upon completion of the listed events:
Events Milestone Payment
-------------------------------------------------------------------------------
Fifteen days after the execution of this Agreement $[XXXXXXX]
Upon completion of the first Phase III Clinical Trial of $[XXXXXXX]
the Licensed Product
Filing of the first application for Regulatory Approval $[XXXXXXX]*
from the FDA for the Licensed Product
Receipt of Regulatory Approval from the FDA for the $[XXXXXXX]*
Licensed Product
Receipt of the first Regulatory Approval $[XXXXXXX]*
from one of the Major Market Countries for the
Licensed Product
3.2 ROYALTIES.
(A) ROYALTIES PAYABLE BY GENENTECH. Genentech shall pay royalties to
Alkermes of [XXXXXXXXXXXXXXXXXXX] of Net Sales of Licensed Products sold by
Genentech, in each country in the United States and the Territory.
(B) OFFSETS FOR THIRD PARTY ROYALTIES. The royalties otherwise
payable by Genentech hereunder shall be reduced by [XXXXX] of the amounts that
Genentech must pay to any third party due to manufacture, use, or sale of
Licensed Products and caused by the fact that the Licensed Product incorporates
the Alkermes Technology, on a country-by-country basis; provided, however, that
in no event shall the royalties payable hereunder be reduced by [XXXXXXXXXXX].
(C) MILESTONE CREDITS. [XXXXXXXXXXXXX] of the milestone payments
marked with an asterisk made with respect to the events described in Section 3.1
shall be creditable by Genentech against future royalties to be paid to Alkermes
pursuant to Section 3.2.
(D) ROYALTY REDUCTION. The royalties otherwise payable by Genentech
hereunder shall be reduced to [XXXXXXXXXXXXXXXXXXXX] of Net Sales of Licensed
Products sold by Genentech in the United States, effective automatically if (and
when) Alkermes commences
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
development and commercialization, outside of the scope of the collaboration
with Genentech pursuant to this Agreement, of any pharmaceutical formulation of
human growth hormone using any Alkermes Technology and any human growth hormone
or analogues thereof (or nucleic acids meant to be incorporated into cells,
causing production of human growth hormone or analogues thereof) not within the
Genentech Technology. Any such pharmaceutical formulation is referred to herein
as a "Competing Product". Such development and commercialization shall be
deemed to include commencement of any human clinical trial of any Competing
Product, and Alkermes shall be required to notify Genentech of the commencement
of any such trial not later than the date of enrollment of the first subject in
such trial. However, the automatic royalty reduction herein shall apply even if
Alkermes fails to provide such notice, and if Genentech continues to pay
royalties at the higher rate under Section 3.2(a) for any time period during
which it later learns that Alkermes had commenced development and
commercialization of a Competing Product, Genentech shall be entitled to offset
against any future payments owed under this Agreement the full amount of any
excess royalties paid to Alkermes during such time period that the reduced
royalty rate herein should have applied (plus interest thereon at a rate equal
to [XXXXXXXXXXXXXX] over the prime rate of interest as reported by Bank of
America NT&SA in San Francisco, California from time to time)."
3.3 MODE OF PAYMENT OF ROYALTIES. For purposes of determining when a sale
of a Licensed Product occurs, the sale shall be deemed to occur on the earlier
of: (i) the date the Licensed Product is shipped, or (ii) the date of the
invoice to the purchaser of the Licensed Product. All royalty payments shall be
made within ninety (90) days of the end of each calendar quarter in which the
sale was made. Such royalty payments shall be accompanied by a detailed
statement that shall include for each country in which sales of Licensed
Products occurred: the gross sales (if available) and Net Sales in each
country's currency; the applicable royalty rate; the royalties payable in each
country's currency, including an accounting of all deductions taken in the
calculation of Net Sales and a separate accounting for all Combination Products
sold and the formulas used in the calculation of royalties owed thereon; the
applicable exchange rate to convert from each country's currency to U.S.
Dollars; and the royalties payable in U.S. Dollars. Royalty payments shall first
be calculated in the currency in which sales took place and then converted to
United States Dollars at an average of the prices reported by the western
edition of the Wall Street Journal, on the first and the last business day of
the calendar quarter for which such payment is due. All royalty payments
hereunder shall be made to Alkermes in U.S. Dollars by bank wire transfer in
immediately available funds to such account designated by Alkermes. Genentech
shall provide notice at least five (5) days prior to the wire transfer date of
the amount of payment, the nature of the payment (with reference to the
applicable section of this Agreement) and the date of receipt of good funds.
Such notice should be given to the Treasurer of Alkermes at the address set
forth in the Notices and Deliveries Section of this Agreement or such other
address directed by Alkermes. All payments hereunder shall be made free and
clear of any taxes, duties, levies, fees or charges, except for withholding
taxes
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
(to the extent applicable). Genentech shall make any withholding payments due on
behalf of Alkermes and shall promptly provide Alkermes with written
documentation of any such payment sufficient to satisfy any requirements of the
United States Internal Revenue Service related to an application by Alkermes for
a foreign tax credit for such payment. Genentech agrees to take reasonable and
lawful steps as Alkermes may request to minimize the amount of tax to which
payments to Alkermes are subject.
3.4 RESTRICTIONS ON PAYMENT. If by law, regulations or fiscal policy of a
particular country, remittance of royalties in U.S. Dollars is restricted or
forbidden, notice thereof will be promptly given to Alkermes, and payment of the
royalty shall be made by the deposit thereof in local currency to the credit of
Alkermes in a recognized banking institution designated by Alkermes. When in any
country the law or regulations prohibit both the transmittal and deposit of
royalties on sales in such a country, royalty payments shall be suspended for as
long as such prohibition is in effect and as soon as such prohibition ceases to
be in effect, all royalties that Genentech would have been under obligation to
transmit or deposit but for the prohibition, shall forthwith be deposited or
transmitted promptly to the extent allowable. Genentech will first obtain
written agreement from Alkermes before selling a Licensed Product in a country
known to Genentech to restrict or forbid remittance of royalties in U.S.
Dollars.
3.5 RECORDS RETENTION. Genentech agrees to keep for at least three (3)
years, records of all sales of Licensed Products in sufficient detail to permit
Alkermes to confirm the accuracy of Genentech's royalty calculations. At the
request of, upon at least five (5) days' prior written notice, and at the
expense of Alkermes, Genentech shall permit a nationally recognized,
independent, certified public accountant appointed by Alkermes and reasonably
acceptable to Genentech to examine these records solely to the extent necessary
to verify such calculations, provided that such accountant has entered into a
confidentiality agreement with Genentech substantially similar to the
confidentiality provisions of this Agreement, limiting the use and disclosure of
such information to purposes germane to this Section 3.5. Results of any such
examination shall be made available to Alkermes and to Genentech. If such
examination reveals an underpayment of royalties by ten percent (10%) or more,
Genentech shall pay all costs of such examination. In the event such accountant
concludes that additional royalties are owed, the additional royalties shall be
paid within thirty (30) days of the date Alkermes delivers to Genentech the
accountant's written report reflecting such conclusion. This Section 3.5 shall
survive any termination of this Agreement for three (3) years.
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3.6 MILESTONE PAYMENTS FOR CLINICAL DEVELOPMENT AND PROCESS SCALE-UP.
(A) Genentech shall pay Alkermes the amounts specified below if the
listed events are completed on or before the listed dates and Alkermes performs
the clinical development and process scale-up work necessary for the completion
of the particular event.
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx]
(B) If Alkermes performs the Phase I/II and Phase III Clinical Trials
referred to above and completes event number 6 above on or before the listed
date for that event, then in addition to the milestone payment for event number
6, Genentech shall pay Alkermes [xxxxx] of all previous milestone payments to
the extent not previously paid.
3.7 OPTION FOR [xxxxx] For a period of twelve (12) months from the
Effective Date, the Parties will exclusively discuss with each other in good
faith the terms under which Genentech may obtain a license to the Alkermes
ProLease(R) delivery system for the PLGA encapsulation of [xxxxx]. As a
starting point, the Parties agree that the financial terms for such a license
shall be those set forth in Exhibit B of the Collaborative Development Agreement
between the Parties dated January 9, 1995. At the end of such twelve-month
period, if the Parties have not agreed to the major terms of an agreement for
such a license, they may either mutually agree to continue their negotiations or
to end such discussions with no further obligations with respect to such a
license on either Party's part.
4. DEVELOPMENT.
4.1 CLINICAL DEVELOPMENT OF LICENSED PRODUCT BY ALKERMES.
(A) Alkermes shall be solely responsible for and shall use its
commercially reasonable efforts to perform Phase I/II Clinical Trials of
Licensed Product to treat pediatric GHD and make any associated filings with
regulatory agencies. For the purposes of this Agreement, "commercially
reasonable" efforts shall mean those efforts expended by Alkermes on its own
high priority projects. Genentech may determine, in its sole discretion, to have
Alkermes take responsibility for and use its commercially reasonable efforts to
perform Phase III Clinical Trials and make any associated filings with
regulatory agencies for Licensed Product to treat pediatric GHD and/or to
perform clinical trials for other indications. Genentech may also, in its sole
discretion, determine to have Alkermes make filings for Regulatory Approval.
Within thirty (30) days of the Effective Date, the Parties will establish a
Joint Development Committee ("JDC") to oversee clinical development and
regulatory filings and to carry out plans for clinical development and
regulatory filings
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
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SECURITIES AND EXCHANGE COMMISSION.
communicated to it by Genentech. The JDC will have three representatives
appointed by each of Genentech and Alkermes. Such representatives will have
expertise in any of the areas of clinical development, process sciences,
manufacturing or regulatory affairs. Either Party may replace any or all of its
representatives at any time upon written notice to the other Party. The JDC will
meet at least once each calendar quarter or at such other times as directed by
Genentech. While the Alkermes representatives may comment on any development and
regulatory filing plans, Genentech shall have the final say and shall direct the
process, except that Alkermes shall make the final determination if there is a
disagreement on a matter that would lead to a substantial increase in the total
manpower committed by Alkermes or the scheduling of Alkermes critical facilities
when the scheduling is less than one year in advance. Reimbursement of Alkermes'
expenses for performing its clinical development and regulatory filing
obligations hereunder shall be made as set forth in (b) below. Exhibit B
attached hereto sets forth the anticipated timeline, requirements and estimated
costs for the Phase II and Phase III and any follow-on Clinical Trials and
associated regulatory filings. The JDC shall suggest necessary changes to
Exhibit B to Genentech each year no later than September 30, but Genentech shall
make all final decisions on any changes or additions to Exhibit B.
(B) Genentech will reimburse the costs incurred by Alkermes pursuant
to Section 4.1(a) above at Alkermes' actual cost of performing the obligations
set forth in that section, as determined by Alkermes in accordance with, an FTE
rate agreed upon by the JDC at the beginning of each Alkermes fiscal year, to be
consistently applied throughout the year, plus external costs of performing
clinical trials as agreed upon by the JDC. Alkermes shall submit a reasonably
detailed invoice to Genentech at the end of each quarter during which it incurs
costs under Section 4.1(a) setting forth activities completed and costs for such
activities, which shall be reasonably in accordance with amounts previously
agreed upon by the JDC for such activities. Genentech shall reimburse Alkermes'
costs within thirty (30) days of receiving each invoice.
(C) At any time, if, in Genentech's sole discretion, Genentech
believes that Alkermes is not using its commercially reasonable efforts to
complete or is not capable of completing any of the clinical development tasks
for which Alkermes is given responsibility, Genentech may so notify Alkermes and
complete such task itself. Alkermes shall be reimbursed for work completed up to
the time Alkermes receives notification that Genentech intends to complete such
task and for any remaining non-cancellable obligations.
4.2 SUPPLY OF CLINICAL MATERIAL BY ALKERMES.
(A) Alkermes shall be responsible for, and shall use its commercially
reasonable efforts to, supply all clinical needs and requirements of Licensed
Product. Such Licensed Product shall be produced under GMP and all other
applicable laws and regulations. Attached hereto as Exhibit C is Alkermes'
estimated timeline, requirements, and
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
costs for supplying Licensed Product for the Phase II and Phase III Clinical
Trials containing Licensed Product. Alkermes will provide, and the Parties will
agree upon, additions to Exhibit C for other clinical trials of Licensed
Products.
(B) Genentech shall pay Alkermes at an FTE rate, which will be
consistently applied, to be agreed upon at the beginning of each Alkermes fiscal
year by the JDC for Alkermes' cost of producing and supplying clinical material.
Alkermes shall provide an invoice to Genentech at the end of each quarter in
which it provides Licensed Product for clinical use which sets forth in
reasonable detail the amount of Licensed Product supplied and the calculation of
such cost. Alkermes shall only ship to Genentech and invoice Genentech for
amounts of Licensed Product ordered pursuant to binding purchase orders.
Genentech shall pay such invoices within thirty (30) days of receipt.
4.3 SCALE-UP OF THE MANUFACTURING PROCESS BY ALKERMES.
(A) Alkermes shall be responsible for, and shall use its commercially
reasonable efforts to, scale up the process for producing Licensed Product for
both clinical and (unless Genentech manufactures commercial Licensed Product
pursuant to Section 5) commercial requirements provided that Genentech supplies
sufficient quantities of human growth hormone (at Genentech's expense) to enable
Alkermes to do so. Exhibit C attached hereto sets forth the anticipated
timeline, requirements and costs for scaling-up the manufacturing process for
making Licensed Product for clinical and commercial use to treat pediatric GHD.
Genentech shall not be responsible for any of Alkermes' capital cost of its
facilities except as otherwise set forth in Exhibit C or approved by the JDC for
the facility in which commercial Licensed Product is to be manufactured. The
Parties will prepare and agree upon a separate document setting forth the
anticipated timeline, requirements and costs for scaling-up the manufacturing
process for other applications of the Licensed Product.
(B) Genentech will reimburse the costs incurred by Alkermes pursuant
to Section 4.3(a) above at Alkermes' actual cost of performing the obligations
set forth in that section, as determined by Alkermes in accordance with an FTE
rate established as set forth above as consistently applied by Alkermes.
Alkermes shall submit a reasonably detailed invoice to Genentech at the end of
each quarter during which it incurs costs under Section 4.3(a) setting forth
activities completed and costs for such activities, which shall be reasonably in
accordance with amounts previously agreed upon by the JDC for such activities.
Genentech shall reimburse Alkermes' costs within thirty (30) days of receiving
each invoice.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
5. MANUFACTURE OF LICENSED PRODUCT.
5.1 MANUFACTURE BY ALKERMES. Alkermes shall be responsible for, and shall
use its commercially reasonable efforts to, supply all clinical and commercial
requirements of Licensed Product in either final vial form or bulk form as
agreed upon by the Parties. The provisions governing production of material for
clinical trials are set forth in Section 4.2. The provisions governing the
production of commercial material shall be set forth in a Supply Agreement
entered into by the Parties on or before the completion of the first Phase III
Clinical Trial. The price of supply of commercial material in the Supply
Agreement will be a purchase price per vial (or similar quantity) of [xxxx] of
the gross invoiced sales price per vial (or similar quantity) used in the
calculation of Net Sales less the deductions used in the calculation of Net
Sales. Prior to Commercial Introduction, the purchase price will be based on the
expected gross invoiced sales price and expected deductions upon Commercial
Introduction. If Alkermes supplies only bulk product in this situation,
Genentech shall be entitled to deduct its Fully Burdened Manufacturing Cost of
filling and finishing Licensed Product from the amount otherwise payable to
Alkermes. Genentech will supply the necessary amount of growth hormone free-of-
charge to enable Alkermes to fulfill its supply obligations. Alkermes will
permit Genentech representatives to review periodically Alkermes' quality
control procedures and records, and to visit Alkermes' facilities, upon prior
written notice to Alkermes and at reasonable times for quality assurance
purposes.
5.2 MANUFACTURE BY GENENTECH. If in Genentech's reasonable opinion,
Alkermes is unable to manufacture all clinical and commercial quantities of
Licensed Product, Alkermes shall transfer to and fully enable Genentech with the
then most current version of all materials, regulatory filings, know-how,
reagents and expertise necessary for Genentech to undertake the manufacture of
Licensed Products. All transfers of materials and information to Genentech shall
be free of charge to Genentech if the transfer occurs due to a breach of this
Agreement by Alkermes. If the transfer occurs due to any other inability to
perform of Alkermes, Genentech shall reimburse Alkermes for all reasonable costs
of transfer of materials and information. Alkermes shall continue to manufacture
Licensed Product until, in Genentech's reasonable opinion, Genentech is fully
enabled to manufacture. Manufacture of Licensed Product may be done partially by
Alkermes and partially by Genentech in this situation. If that is the case, and
the situation is caused by a breach of this Agreement by Alkermes, the price
otherwise payable by Genentech to Alkermes under the provisions of Section 5.1
shall be reduced to [xxxxxxxx] of the gross invoiced sales price per vial (or
similar quantity) used in the calculation of Net Sales less the deductions used
in the calculation of Net Sales. Otherwise, the price otherwise payable will be
prorated based on the percentage of the total manufacture of Licensed Product
being done by each Party.
6. COMMERCIALIZATION. Genentech agrees to pursue a diligent sales and
marketing effort for a Licensed Product to be sold by Genentech relative to
other products of similar commercial potential that are being sold and marketed
by Genentech. A default by
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Genentech with respect to pursuing a diligent sales and marketing effort for a
Licensed Product in one country shall not constitute a default by Genentech with
respect to any other country.
7. REPRESENTATIONS AND WARRANTIES.
7.1 REPRESENTATIONS AND WARRANTIES OF ALKERMES. Alkermes hereby
represents and warrants that:
(A) the execution and delivery of this Agreement and the performance
of the transactions contemplated hereby have been duly authorized by all
appropriate Alkermes corporate action;
(B) this Agreement is a legal and valid obligation binding upon
Alkermes and enforceable in accordance with its terms. The execution, delivery
and performance of the Agreement by Alkermes does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it is bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over it;
(C) Alkermes has the right to grant the licenses granted in Section
2.1, and has no knowledge of any rights of any third parties that would
interfere with the practice of the Alkermes Technology by Genentech as
contemplated under this License Agreement; and
(D) to the best of its knowledge, Alkermes is not obligated under any
agreement as of the date hereof to pay any third party royalties with respect to
the Alkermes Technology;
7.2 REPRESENTATIONS AND WARRANTIES OF GENENTECH. Genentech represents and
warrants that:
(A) the execution and delivery of this Agreement and the performance
of the transactions contemplated hereby have been duly authorized by all
appropriate Genentech corporate action;
(B) this Agreement is a legal and valid obligation binding upon
Genentech and enforceable in accordance with its terms. The execution, delivery
and performance of the Agreement by Genentech does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it is bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over it;
and
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(C) Genentech has the right to grant the license granted herein.
8. CONFIDENTIALITY.
8.1 DISCLOSED CONFIDENTIAL INFORMATION. In the course of performance of
this Agreement, one Party may disclose to the other or receive written
information from the other relating to the subject matter of this Agreement
which information, if so identified in writing either pursuant to this Section
8.1 or otherwise upon disclosure, shall be considered to be the disclosing
Party's "Disclosed Confidential Information." Each Party agrees that it will
take the same steps to protect the confidentiality of the other Party's
Disclosed Confidential Information as it takes to protect its own proprietary
and confidential information. Each Party shall protect and keep confidential and
shall not use, publish or otherwise disclose to any third party, except as
contemplated by this Agreement or with the other Party's written consent, the
other Party's Disclosed Confidential Information for a period of five (5) years
from the date of termination of this Agreement.
8.2 SHARED CONFIDENTIAL INFORMATION. In the course of performance of this
Agreement, the Parties may jointly develop, invent or discover information,
substances or processes, which shall be considered to the "Shared Confidential
Information" except as otherwise set forth in Section 9.6. Each Party agrees
that it will take the same steps to protect the confidentiality of the Shared
Confidential Information as it takes to protect its own proprietary and
confidential information. Each Party shall protect and keep confidential and
shall not publish or otherwise disclose to any third party, except as
contemplated by this Agreement or with the other Party's written consent, the
Shared Confidential Information for a period of five (5) years from the date of
termination of this Agreement. Each Party may, however, use any Shared
Confidential Information for any purpose; provided that such use shall not be
deemed a license or a grant of any additional right or license other than or in
addition to the right and license granted in Section 2 of this Agreement.
8.3 PERMITTED DISCLOSURE. In addition, each Party shall be entitled to
disclose, under a binder of confidentiality containing provisions as protective
as this Section 8, "Confidential Information," which shall include Disclosed
Confidential Information and Shared Confidential Information, to consultants and
other third parties for any purpose provided for in this Agreement. The Parties
shall consult prior to the submission of any manuscript for publication if the
publication will contain any Confidential Information of the other Party unless
the laws and regulations applicable to the third party submitting such
manuscript prohibit such consultation. Such consultation shall include providing
a copy of the proposed manuscript to the other Party at least sixty (60) days
prior to the proposed date of submission to a publisher, incorporating
appropriate changes proposed by the other Party into the manuscript submission
and deletion of all Confidential Information of which such Party does not agree
to the publication. The foregoing notwithstanding, Confidential Information may
be disclosed as a part of a patent application filed on inventions made under
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this Agreement and during any official proceeding before a court or governmental
agency if reasonably related and necessary to that proceeding. For the purpose
of this Agreement, Confidential Information shall not include such information
that:
(i) was known to the receiving Party at the time of disclosure; or
(ii) was generally available to the public or was otherwise part of
the public domain at the time of disclosure or became generally available to the
public or otherwise part of the public domain after disclosure other than
through any act or omission of the receiving Party in breach of this Agreement;
or
(iii) became known to the receiving Party after disclosure from a
source that had a lawful right to disclose such information to others; or
(iv) was independently developed by the receiving Party where such
independent development can be established by written documentation.
8.4 INTEGRATION. This Section 8 supersedes any confidential disclosure
agreement between the Parties as to the subject matter hereof. Any confidential
information under any such agreement shall be treated as Confidential
Information hereunder.
9. TERM; TERMINATION.
9.1 TERM; TERMINATION AT FULL TERM. This Agreement shall commence as of
the Effective Date and, except as provided in the next sentence or unless sooner
terminated as provided hereunder, shall terminate on a country-by-country basis
on the later of (i) 10 years after Commercial Introduction in that country, or
(ii) the expiration of the last Valid Claim of an Alkermes Patent in that
country. Notwithstanding any termination at the full term of this Agreement,
which shall occur upon termination as described in the preceding sentence in
each country in the Territory, or termination as otherwise provided in this
Section 9, the provisions of Sections 8,10, 11 and 12 will not terminate on said
date but will continue in full effect. Upon termination of the royalty
obligations in any country, Genentech shall thereafter have in perpetuity a
fully paid up, royalty-free exclusive license in that country under the Alkermes
Technology to import, make, have made, use, offer for sale and sell Licensed
Products in the Field of Use without any accounting to Alkermes.
9.2 UNILATERAL TERMINATION. Genentech shall have the right following
thirty (30) days written notice to Alkermes to terminate this Agreement at any
time for any reason except for material breach by Alkermes, which shall be
governed by Section 9.3 hereof. In the event that a Licensed Product has
received Regulatory Approval and Alkermes is manufacturing such Licensed Product
for commercial sale, Genentech may so terminate this Agreement only after
providing six (6) months written notice. In any event, Alkermes shall
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be reimbursed for any non-cancellable obligations it has incurred for which
Genentech would otherwise be obligated to pay if this Agreement had not been
terminated. If Genentech terminates this Agreement pursuant to this Section 9.2,
all rights granted hereunder by Alkermes to Genentech shall immediately revert
to Alkermes, neither Party shall have any further obligation to the other
hereunder except to the extent otherwise accrued under this Agreement, and no
amounts paid by Genentech to Alkermes hereunder shall be refunded. If
manufacturing technology has been transferred to Genentech by Alkermes other
than by reason of a material breach by Alkermes, then Genentech shall transfer
all such technology back to Alkermes, at Alkermes' expense. Genentech shall be
entitled to a complete refund of its [XXXX] milestone payment for mutual signing
of the Agreement pursuant to Section 3.1, and its [XXXX] milestone payment
pursuant to Section 3.6(a) (Event. no. 1), effective immediately in the event
Genentech provides written notice to Alkermes requesting such refund not later
than thirty (30) days after the Effective Date, based on the results of
Genentech's review, in its sole determination, of patents relating to the
Alkermes Technology, and Genentech has given written notice of termination of
this Agreement under this Section 9.2 at the same time. Genentech shall not be
entitled to any such refund if its written notice to Alkermes is not provided
within the deadline specified herein. Alkermes agrees to pay the full amount of
such refund to Genentech within five (5) days of receipt of such timely notice
from Genentech (if any).
9.3 BREACH. Failure by either Party to comply with any of the material
obligations contained in this Agreement shall entitle the other Party (the "Non-
Defaulting Party") to give to the Party (the "Defaulting Party") in default
written notice specifying the nature of the default and requiring it to make
good such default. If such default is not cured within ninety (90) days after
the receipt of such notice, the Non-Defaulting Party shall be entitled, without
prejudice to any of its other rights conferred on it by this Agreement, in
addition to any other remedies available to it by law or in equity, immediately
to terminate this Agreement by giving written notice to the Defaulting Party.
With respect to either party, a default with respect to its obligations in one
country shall not constitute a default with respect to its obligations in any
other country. The termination of this Agreement by Alkermes under this Section
9.3 shall terminate all rights granted to it hereunder. The right of a Party to
terminate this Agreement, as hereinafter provided, shall not be affected in any
way by its waiver or failure to take action with respect to any previous
default. Upon any termination by Genentech under this Section 9.3, the Parties
shall have the rights and obligations set forth in Section 9.7.
9.4 INSOLVENCY OR BANKRUPTCY. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement, by
written notice to the other Party in the event the other Party shall have become
insolvent or bankrupt, or shall have made an assignment for the benefit of its
creditors, or there shall have been appointed a trustee or receiver of the other
Party or for all or a substantial part of its property, or any case or
proceeding shall have been commenced or other action taken by or against the
other
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Party in bankruptcy or seeking reorganization, liquidation, dissolution,
winding-up, arrangement, composition or readjustment of its debts or any other
relief under any bankruptcy, insolvency, reorganization or other similar act or
law of any jurisdiction now or hereafter in effect, or there shall have been
issued a warrant of attachment, execution, distraint or similar process against
any substantial part of the property of the other Party, and any such event
shall have continued for sixty (60) days undismissed, unbonded and undischarged.
9.5 ACCRUED RIGHTS. Termination, relinquishment or expiration of this
Agreement for any reason shall be without prejudice to any rights which shall
have accrued to the benefit of either Party prior to such termination or
expiration. Such termination, relinquishment or expiration shall not relieve
either Party from obligations which are expressly indicated to survive
termination or expiration of this Agreement.
9.6 OWNERSHIP OF CLINICAL DATA. All data produced as a result of clinical
trials conducted under this Agreement shall be owned by Genentech, except to the
extent in conflict with the requirements of any regulatory agency from which the
Parties have received, will apply to receive or have applied to receive
Regulatory Approval, and such ownership shall survive any expiration or
termination of this Agreement. Genentech shall be named as the applicant in any
regulatory submission to be made hereunder and shall be the holder of all
Regulatory Approvals. Alkermes may use such data for any purpose contemplated
by this Agreement. Such data shall be considered Disclosed Confidential
Information.
9.7 RIGHTS AND OBLIGATIONS UPON TERMINATION. In the event of termination
by Genentech for a material breach by Alkermes or upon expiration of this
Agreement, if Alkermes was previously manufacturing Licensed Product for
Genentech, Alkermes shall remain responsible for its supply obligations
hereunder until Alkermes has fully transferred and enabled Genentech or its
designee to perform all of Alkermes' supply obligations. Such transfer shall
include making its personnel and other resources reasonably available to
Genentech as necessary to effect an orderly transition of manufacture of
Licensed Product, with the costs of providing such personnel and resources to be
borne by Genentech, in the event of expiration, and by Alkermes, in the event of
termination by Genentech for material breach. Such transfer will take place, at
Genentech's option, at any time after expiration in any of the Major Market
Countries or the U.S. until expiration in the last country, in the event of
transfer due to expiration. In addition, Genentech shall thereafter have an
exclusive license in all countries after termination by Genentech for a material
breach by Alkermes for which it shall pay a [XXXX] royalty on Net Sales if
Alkermes had previously completed a Phase I/II Clinical Trial.
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10. PATENT RIGHTS.
10.1 SOLE INVENTIONS. The Parties recognize that either Party may
independently and separately make inventions during the course of this Agreement
relating to human growth hormone, delivery systems for human growth hormone,
PLGA encapsulation of proteins or otherwise related to the scope of this
Agreement but not as a result of activities performed pursuant to this
Agreement. Each Party shall retain title to inventions and knowhow, whether or
not patentable, made or owned solely by it or on its behalf which do not arise
out of the activities performed by it or on its behalf under this Agreement
("Sole Knowhow"). In such event, the Party making the invention shall be the
sole owner of that invention and of any patent applications and patents thereon
(including inventor's certificates) and shall be solely responsible for the
filing, prosecution and maintenance of all such patent application and patents.
Except as provided in this Agreement, neither Party shall have any right to use
or license knowhow to which the other Party has sole title.
10.2 JOINT PATENTS. All inventions conceived or first reduced to practice
hereunder shall be jointly owned by Genentech and Alkermes. In addition, in the
event that it is determined, in accordance with applicable law, that both: (i)
employees or agents of Genentech or any other persons obliged to assign such
invention to Genentech, and (ii) employees or agents of Alkermes or any other
persons obliged to assign such invention to Alkermes, are joint inventors of an
invention, the Parties shall jointly own patents, inventor's certificates and
applications therefor covering such invention. With respect to any joint
invention or jointly-owned invention, Genentech shall prosecute all such patents
relating to Genentech Technology and Alkermes shall prosecute all such patents
relating to the Alkermes Technology. The party having such obligation to
prosecute will be referred to herein as the "Controlling Party". The
Controlling Party shall have the right (but not the obligation) to undertake
such filings, prosecutions and maintenance at its sole expense, provided that:
(a) the Controlling Party notifies the non-Controlling Party within one (1)
month after the filing of any patent application by the Controlling Party; (b)
the Controlling Party provides the non-Controlling Party promptly with copies of
all communications received from or filed in patent office(s) with respect to
such filings; and (c) the Controlling Party provides the non-Controlling Party,
a reasonable time prior to taking or failing to take any action that would
substantially affect the scope or validity of rights under any patent
applications or patents (including but not limited to substantially narrowing or
canceling any claim without reserving the right to file a continuing or
divisional application (which shall not be unreasonably delayed), abandoning any
patent or not filing or perfecting the filing of any patent application), with
notice of such proposed action or inaction so that the non-Controlling Party has
a reasonable opportunity to review and make comments. In the event that the
Controlling Party breaches the foregoing obligations regarding updating and
consultation and such breach is not cured within thirty (30) days of a written
notice from the non-Controlling Party to the Controlling Party describing such
breach, or in the event that the Controlling Party fails to undertake the filing
of a patent application (or continuing or divisional
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application) within ninety (90) days of being designated as the Controlling
Party with respect to such patent application, the non-Controlling Party may
undertake such filing, prosecution and maintenance at its sole expense, in which
case such patent application and subsequently issued patent thereon shall be
owned solely by the non-Controlling Party. Notwithstanding the foregoing, the
Parties shall assist each other to the maximum extent reasonable in securing
intellectual property rights resulting from activities conducted hereunder. As
to enforcement of jointly-owned patents, including actions against an infringer,
the Parties shall consult with each other in good faith as to the best manner in
which to proceed. The Parties agree as a basic principle that in the case of
such actions against infringers, the expenses incurred and damages awarded shall
be for the account of the Party or Parties which take such actions to the extent
of their financial participation therein. Either Party may withdraw from or
abandon any jointly-owned patent or patent application, on reasonable prior
notice to the other providing a free-of-charge option to assume the prosecution
and/or maintenance thereof.
10.3 INFRINGEMENT CLAIMS RELATING TO GENENTECH TECHNOLOGY. Genentech
shall defend, at its sole cost and expense, any legal proceedings brought
against it or Alkermes claiming that Alkermes' manufacture of any Licensed
Product under this Agreement constitutes an infringement of third party patent
rights arising out of the use of Genentech Knowhow or the practice of Genentech
Patents, except to the extent that any such proceedings shall arise from the
gross negligence or willful misconduct of Alkermes and shall indemnify and hold
Alkermes harmless from any damages or expenses incurred or awarded as the result
of any settlement related thereto agreed to by Genentech or judgment against
Alkermes, provided that Alkermes gives Genentech written notice of any such
claim or the institution of any suit or suits against it within 30 days after
Alkermes has knowledge of any such claim or suit or suits, that Alkermes assist
Genentech, at Genentech's expense, in the investigation of, preparation for and
defense of any such claim or suit or suits, and that Alkermes not compromise or
settle any such claim or suit or suits without Genentech's written consent.
Alkermes' failure to notify Genentech of such claim or suit or suits within 30
days shall not obviate its right to receive indemnification hereunder so long as
such failure does not materially prejudice the defense of such claim or suit or
suits. Genentech shall promptly notify Alkermes in writing of the institution of
any suit by a third party against Genentech for patent infringement involving
the manufacture, use, sale, distribution or marketing of Licensed Product
arising out of the activities carried out pursuant to this Agreement.
10.4 INFRINGEMENT CLAIMS RELATING TO THE ALKERMES TECHNOLOGY. Alkermes
shall defend, at its sole cost and expense, any legal proceedings brought
against it or Genentech claiming that Alkermes' manufacture of any Licensed
Product or Genentech's manufacture, use, sale, distribution or marketing of
Licensed Product hereunder constitutes an infringement of third party patent
rights arising out of the use of Alkermes Knowhow or the practice of Alkermes
Patents, except to the extent that any such proceedings shall arise
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from the gross negligence or willful misconduct of Genentech, and shall
indemnify and hold Genentech harmless from any damages or expenses incurred or
awarded as the result of any settlement related thereto agreed to by Alkermes or
judgment against Genentech, provided that Genentech gives Alkermes written
notice of any such claim or the institution of any suit or suits against it
within 30 days after Genentech has knowledge of any such claim or suit or suits,
that Genentech assist Alkermes, at Alkermes' expense, in the investigation of,
preparation for and defense of any such claim or suit or suits, and that
Genentech not compromise or settle any such claim or suit or suits without
Alkermes' written consent. Genentech's failure to notify Alkermes of such claim
or suit or suits within 30 days shall not obviate its right to receive
indemnification hereunder so long as such failure does not materially prejudice
the defense of such claim or suit or suits. Alkermes shall promptly notify
Genentech in writing of the institution of any suit by a third party against
Alkermes for patent infringement involving the manufacture, use, sale,
distribution or marketing of Licensed Product arising out of the activities
carried out pursuant to this Agreement.
10.5 SURVIVAL. This Section 10 shall survive the termination or
expiration of this Agreement.
11. INDEMNIFICATION.
(A) Genentech hereby agrees to save, defend and hold Alkermes and its
agents and employees harmless from and against any and all suits, claims,
actions, demands, liabilities, expenses and/or loss, including reasonable legal
expense and attorneys' fees ("Losses") except for patent claims handled under
Section 10, resulting directly from the marketing, packaging, testing, labeling,
manufacture, use, or sale of Licensed Products in the United States and the
Territory by Genentech, except to the extent such Losses result from the
negligence or willful misconduct of Alkermes.
(B) Alkermes hereby agrees to save, defend and hold Genentech and its
agents and employees harmless from and against any and all Losses except for
patent claims handled under Section 10, resulting directly from the manufacture
of Licensed Products by Alkermes, except to the extent such Losses result from
the negligence or willful misconduct of Genentech.
(C) In the event that one Party is seeking indemnification under this
Section 11 (the "Indemnified Party"), it shall inform the other Party (the
"Indemnifying Party") of a claim as soon as reasonably practicable after the
Indemnified Party receives notice of the claim, shall permit the Indemnifying
Party to assume direction and control of the defense of the claim (including the
right to settle the claim solely for monetary consideration), and shall
cooperate as requested (at the expense of the Indemnifying Party) in the defense
of the claim.
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(D) This Section 11 shall survive termination or expiration of this
Agreement.
12. MISCELLANEOUS PROVISIONS.
12.1 NO PARTNERSHIP. Nothing in this Agreement is intended or shall be
deemed to constitute a partnership, agency, distributorship, employer-employee
or joint venture relationship between the Parties. No Party shall incur any
debts or make any commitments for the other, except to the extent, if at all,
specifically provided herein.
12.2 ASSIGNMENTS. Neither Party shall assign any of its rights or
obligations hereunder except: (i) as incident to the merger, consolidation,
reorganization or acquisition of stock or assets affecting substantially all of
the assets or voting control of the assigning Party; (ii) to any wholly-owned
subsidiary if the assigning Party remains liable and responsible for the
performance and observance of all of the subsidiary's duties and obligations
hereunder; or (iii) with the consent of the other Party. This Agreement shall
be binding upon the successors and permitted assigns of the Parties, and the
name of a Party appearing herein shall be deemed to include the names of such
Party's successor's and permitted assigns to the extent necessary to carry out
the intent of this Agreement. Any assignment not in accordance with this
Section 12.2 shall be void.
12.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
12.4 NO TRADEMARK RIGHTS. Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner the names
"Alkermes" or "Genentech" or any other trade name or trademark of Alkermes or
Genentech in connection with the performance of this Agreement.
12.5 PUBLIC ANNOUNCEMENTS. Except as may otherwise be required by law or
regulation, neither Party shall make any public announcement concerning this
Agreement or the subject matter hereof without the prior consent of the other
Party unless the nature of the information has been previously approved for
disclosure. If the nature of the information has been approved, this Section
12.5 will no longer apply to that information.
12.6 ADVERSE EVENT REPORTS. In order to comply with adverse event
reporting regulations of the FDA (as provided in Title 21 of the Code of Federal
Regulations) and other international regulatory agencies, each of Genentech and
Alkermes acknowledge that once the Parties hereunder are selling and/or
clinically testing in humans any Licensed Product they must report promptly to
each other the occurrence of adverse events regarding such products for timely
reporting to the FDA and other reporting agencies. The specific
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terms of the adverse event data exchange between the appropriate parties shall
be set forth in a separate agreement and identify the departments responsible
for safety surveillance at each entity. The appropriate parties, which shall be
designated within three weeks of the Effective Date, shall begin negotiating
such agreement no less six months after the Effective Date.
12.7 ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement
constitutes and contains the entire understanding and agreement of the Parties
and cancels and supersedes any and all prior negotiations, correspondence,
understandings and agreements, whether verbal or written, between the Parties
respecting the subject matter hereof. No waiver, modification or amendment of
any provision of this Agreement shall be valid or effective unless made in
writing and signed by a duly authorized officer of each of the Parties.
12.8 SEVERABILITY. In the event any one or more of the provisions of this
Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement or either of the parties to be invalid, illegal
or unenforceable, such provision or provisions shall be validly reformed to as
nearly as possible approximate the intent of the Parties and, if unreformable,
shall be divisible and deleted in such jurisdiction; elsewhere, this Agreement
shall not be affected so long as the Parties are still able to realize the
principal benefits bargained for in this Agreement.
12.9 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
12.10 APPLICABLE LAW. This Agreement shall be governed by and interpreted
in accordance with the laws of the State or California applicable to contracts
entered into and to be performed entirely within the State of California.
12.11 NOTICES AND DELIVERIES. Any notice, requests, delivery, approval or
consent required or permitted to be given under this Agreement shall be in
writing and shall be deemed to have been sufficiently given if delivered in
person, transmitted by telecopy with a confirming copy sent by overnight
courier, overnight courier, or registered mail to the Party to whom it is
directed at its address shown below or such other address as such party shall
have last given by notice to the other Party. Any such notice, requests,
delivery, approval or consent shall be deemed received on the date of telecopy
or hand delivery, one business day after deposit with an overnight courier, or 3
days after deposit of the registered mail with the U. S. postal service.
22
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
If to Alkermes, addressed to:
Alkermes Controlled Therapeutics, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: President
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
If to Genentech, addressed to:
Genentech, Inc.
000 Xxxxx Xxx Xxxxx Xxxxxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
Attention: Corporate Secretary
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
12.12 PREVAILING PARTY. In the event of any dispute which results in a
suit or other legal proceeding to construe or enforce any provision of this
Agreement or because of an alleged breach, default or misrepresentation in
connection with any of the provisions of this Agreement, the parties agree that
the prevailing party or parties (in addition to all other amounts and relief to
which such party or parties may be entitled) shall be entitled to recover
reasonable attorney's fees and other costs incurred in any action or proceeding.
12.13 COUNTERPARTS. This Agreement may be executed simultaneously in two
or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
12.14 SURVIVAL. The representations, warranties, covenants and agreements
made herein shall survive any investigation made by a Party and shall be able to
be relied fully on by the Parties.
23
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their respective duly authorized officers as of the day and year first above
written, each copy of which shall for all purposes be deemed to be an original.
ALKERMES CONTROLLED THERAPEUTICS, INC. GENENTECH, INC.
BY: /s/ Xxxxxxx X. Xxxxxxx BY: /s/ Xxxxxxxx X. Drien
----------------------------- ------------------------------
TITLE: Vice President TITLE: Vice President
24
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT A: "ALKERMES PATENTS"
------------------------------
1. "Very Low Temperature Casting of Controlled Release Microspheres" US Patent
No. 5,019,400; issued May 28, 1991
2. "Process for Producing Small Particles of Biologically Active Molecules"
U.S.S.N. 07/345,684; filed May 1, 1989
3. "Production Scale Method of Forming Microparticles" U.S.S.N. 08/443,726;
filed May 18, 1995
4. "Controlled Release Growth Hormone Containing Microspheres" U.S.S.N.
07/984,323; filed December 2, 1992
5. "Composition for Sustained Release of Human Growth Hormone" U.S.S.N.
08/473,544 and 08/477,725; filed June 7, 1995
6. "Modulated Release from Biocompatible Polymers" U.S.S.N. 08/237,057; filed
May 3, 1994
7. "Method for Fabricating Polymer-Based Controlled Release Devices" U.S.S.N.
08/649,128; filed May 14, 1996
8. "Device for the Sustained Release of Aggregation-Stabilized, Biologically
Active Agent" U.S.S.N. 08/521,744 and 60/003,079; filed June 7, 1995
9. "Compositions and Methods for Controlling Release from Microparticles with
a Hydrophobic Material" U.S.S.N. not yet assigned; filed August 21, 1996
A-1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT B: PROLEASE(R) - HGH CLINICAL PLAN
-------------------------------------------
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx]
B-1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT C: PROLEASE-HGH DEVELOPMENT AND MANUFACTURING PLAN
-----------------------------------------------------------
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx]
C-1
