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EXHIBIT 10.1
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
ALTUS PHARMACEUTICALS INC.
AND
GENENTECH, INC.
DATED AS OF DECEMBER 19, 2006
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This COLLABORATION AND LICENSE AGREEMENT (this "Agreement"), dated
as of
December 19, 2006 (the "Execution Date"), is made by and between
Altus
Pharmaceuticals Inc., a Delaware corporation having its principal
office at 125
Sidney Street, Cambridge, Massachusetts, 02139 ("Altus"), and
Genentech, Inc., a
Delaware corporation having its principal office at 1 DNA Way,
South San
Francisco, CA 94080 ("Genentech"). Altus and Genentech may each be
referred to
as a "Party" or together, the "Parties".
WHEREAS, Altus is engaged in the development and commercialization
of
protein therapeutics for patients with chronic gastrointestinal and
metabolic
diseases and is currently developing a drug product candidate,
known as
ALTU-238, for the treatment of patients with growth hormone
disorders; and
WHEREAS, Genentech has significant experience in the development
and
commercialization of drug products, particularly growth hormone
products, and
can make significant contributions to the successful development
and
commercialization of Products (as defined below) in the Licensed
Territory (as
defined below);
NOW, THEREFORE, in consideration of the mutual promises and
agreements
contained herein, and for other good and valuable consideration,
the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as
follows:
ARTICLE I
DEFINITIONS; CONSTRUCTION
1.1 Defined Terms.
1.1.1 "Accounting Standards" means United States Generally
Accepted
Accounting Principles, consistently applied.
1.1.2 "Acquisition" means (a) a merger, reorganization or
consolidation of a Party with a Third Party that results in the
shareholders of
such Party receiving less than fifty percent (50%) of the combined
voting power
of the surviving entity immediately after such merger,
reorganization or
consolidation, (b) a Third Party becoming the direct or beneficial
owner of
fifty percent (50%) or more of the combined voting power of the
outstanding
securities or outstanding share of common stock of such Party, (c)
the
stockholders of a Party have approved of a plan or proposal for the
liquidation
or dissolution of the company, or (d) the sale, lease, exchange or
other
transfer (in one transaction or a series of related transactions)
of all or
substantially all of such Party's assets which relate to this
Agreement to a
Third Party.
1.1.3 "Act" means both the United States Federal Food, Drug,
and
Cosmetic Act, as amended from time to time, and the regulations
promulgated
under the foregoing.
1.1.4 "Adverse Drug Experience" means any of the following: an
"adverse drug experience," a "life-threatening adverse drug
experience," a
"serious adverse drug experience," or an "unexpected adverse drug
experience,"
as those terms are defined at either 21 C.F.R. Section 312.32 or 21
C.F.R.
Section 314.80, or their equivalents under Laws of jurisdictions
outside the
United States.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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1.1.5 "Affiliate" means, with respect to a Party, any other
Person
that directly or indirectly controls, is controlled by or is under
common
control with such Party. For purposes of this definition, "control"
(including,
with correlative meanings, "controlled by", "controlling" and
"under common
control with") means possession, direct or indirect, of (a) the
power to direct
or cause direction of the management and policies of such Party
(whether through
ownership of securities or other ownership interests), or (b)
greater than 50%
of the voting securities (whether directly or pursuant to any
option, warrant or
other similar arrangement) or other comparable equity interests.
Notwithstanding
that Genentech and Roche Holdings Ltd. ("Roche") are Affiliates in
accordance
with the foregoing, for purposes of this Agreement, with respect to
Genentech,
the term "Affiliate" shall not include Roche and its successors, or
any entity
that controls, is controlled by or is under common control with
Roche, in each
case that is not controlled by Genentech. For the avoidance of
doubt, neither of
the Parties shall be deemed to be an "Affiliate" of the other. A
"Controlled
Affiliate" is an Affiliate that is controlled by the applicable
Party.
1.1.6 "Allocable Overhead" means costs incurred by a Party or for
its
accounts that are attributable to a Party's (a) [***] services, (b)
[***] and
[***] (excluding [***] charges for [***] and [***]), (c) [***] and
[***]
functions, (d) [***] costs and (e) [***] costs (to the extent not
directly
charged), which, in each case, are reasonably allocated to company
departments
or functions utilized to support the activities under this
Agreement based on
[***] or [***] or [***] consistently applied by a Party.
1.1.7 "ALTU-238" means any pharmaceutical product containing a
[***],
including [***] ALTU-238.
1.1.8 "Altus Housemark" means the name and logo of Altus, or an
Affiliate of Altus, as identified by Altus to Genentech from time
to time.
1.1.9 "Altus Know-How" means Know-How that (a) is Controlled by
Altus
as of the Effective Date or during the Term and (b) is necessary or
useful to
research, develop, make, use, sell, offer for sale, or import any
Formulation or
Product in the Field; excluding Collaboration Technology.
1.1.10 "Altus Patents" means those Patent Rights that (a) are
Controlled by Altus as of the Effective Date or during the Term and
(b) are
necessary or useful to research, develop, make, use, sell, offer
for sale, or
import any Formulation or Product in the Field, including the
Patent Rights set
forth in Schedule 1.1.10 (which Schedule, shall be updated by Altus
from time to
time); excluding Collaboration Technology.
1.1.11 "Altus Technology" means Altus Patents and Altus
Know-How.
1.1.12 "Approval Application" means the submission to the
relevant
Regulatory Authority of an appropriate application, such as an NDA,
seeking a
Marketing Authorization for a Product.
1.1.13 "Bankruptcy Code" means Title 11 of the United States Code,
as
amended from time to time.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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1.1.14 "Business Day" means a day that is not a Saturday, Sunday
or
public holiday in South San Francisco, California or Cambridge,
Massachusetts.
1.1.15 "Calendar Quarter" means for each Calendar Year, any of
the
three (3) month periods ending March 31, June 30, September 30, and
December 31;
provided, that the first Calendar Quarter for the first Calendar
Year shall
extend from the Effective Date to the end of the calendar quarter
in which the
Effective Date falls.
1.1.16 "Calendar Year" means, for the first Calendar Year, the
period
commencing on the Effective Date and ending on December 31 of the
calendar year
during which the Effective Date occurs, and each successive period
beginning on
January 1 and ending twelve (12) consecutive calendar months later
on December
31.
1.1.17 "Collaboration Know-How" means all Know-How first conceived,
or
otherwise first created, in furtherance of and as a direct result
of activities
under this Agreement (including under the Development Plan or
Commercialization
Plan): (i) which activities were [***] the [***] of the [***] or
[***], or were
[***], either in whole or in any part, by [***] as [***] or other
[***] or [***]
by [***] under this Agreement, including under Section [***], [***]
or [***] or
use any [***] in support of such activities under this Agreement,
which Know-How
was conceived or created [***] by [***] and/or its respective
employees,
contractors or consultants or [***] by [***] and/or its respective
employees,
contractors or consultants [***] and [***] and/or their respective
employees,
contractors or consultants on the other hand; (ii) which Know-How
was conceived
or created jointly by the Parties and/or their employees,
contractors or
consultants; or (iii) which Know-How was conceived or created [***]
by [***]
and/or its respective employees, contractors or consultants,
excluding any
Know-How [***] to the [***] of a [***]. Collaboration Know-How
shall exclude
Collaboration Patents.
1.1.18 "Collaboration Patents" means all Patent Rights which
claim
Collaboration Know-How.
1.1.19 "Collaboration Technology" means Collaboration Know-How
and
Collaboration Patents.
1.1.20 "Commercially Reasonable Efforts" means the carrying out
of
obligations under this Agreement using those efforts and resources
as would be
expended on, or committed to, a development or commercialization
program of
[***] and [***], at a [***] in development or product life, [***]
and [***], and
[***] of the [***] or to be [***], taking into account the
following factors to
the extent reasonable and relevant: issues of [***] the Product,
[***] Third
Party products, the [***] or other [***] of the Product and/or
Third Party
products, the [***] involved and the [***], and [***] and
[***].
1.1.21 "Competing Product" means a pharmaceutical product
containing
[***], other than a Product, that is being or has been developed
[***] or [***].
1.1.22 "Complexed" means any association of a [***] with [***],
including a [***] of a [***] and a [***], or other association.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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1.1.23 "Compound" means synthetic, natural or recombinant human
growth
hormone or any of its active fragments, analogues derivatives or
other variants.
1.1.24 "Confidential Information" means all confidential or
proprietary information, materials or data (including Know-How),
whether
provided in written, oral, graphic, video, computer, or other form,
provided or
transmitted by or on behalf of one Party (the "Disclosing Party")
to the other
Party (the "Receiving Party"), including information relating to
the Disclosing
Party's existing or proposed research, development efforts, Patent
Rights,
Know-How, business, finances (including all financial information
subject to
review under or prepared by accountants pursuant to Section 9.15 or
provided
pursuant to Section 9.21) or products (including Product training
materials
contemplated by Section 7.5.2, the Development Plan and the
Commercialization
Plan), and the existence of and terms of this Agreement.
Notwithstanding the
foregoing sentence, Confidential Information shall not include any
information,
materials or data that the Receiving Party can demonstrate:
(a) were already known to the Receiving Party (other than under
an
obligation of confidentiality) at the time of disclosure by the
Disclosing
Party;
(b) were generally available to the public or otherwise part of
the
public domain at the time of disclosure by the Disclosing
Party;
(c) became generally available to the public or otherwise part of
the
public domain after disclosure or development, as the case may be,
other than
through any act or omission of the Receiving Party in breach of the
Receiving
Party's confidentiality obligations to the Disclosing Party;
(d) were disclosed to the Receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no
obligation to the
Disclosing Party not to disclose such information to others;
(e) were independently discovered or developed, as the case may be,
by
or on behalf of the Receiving Party by Persons without the use of
or reliance on
the Disclosing Party's Confidential Information; or
(f) released from the restrictions set forth in this Agreement by
the
express prior written consent of the Disclosing Party.
1.1.25 "Consumer Price Index" or "CPI" means the Consumer Price
Index
- Urban Wage Earners and Clerical Workers, U.S., All Items, 1982-84
= 100,
published by the United States Department of Labor, Bureau of Labor
Statistics
(or its successor equivalent index).
1.1.26 "Control" or "Controlled" means the possession by a Party
or
its Controlled Affiliates, as of the Effective Date or during the
term of this
Agreement, of (i) with respect to materials, data or information,
physical
possession or the right to such physical possession of those items
and the right
to provide such materials, data or information to the other Party,
and (ii) with
respect to intellectual property or other intangible rights, rights
(whether by
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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ownership or license other than a licensed granted under this
Agreement)
sufficient to grant the applicable license or sublicense under this
Agreement;
in each case without violating the terms of any agreement with any
Third Party.
1.1.27 "Co-Promote" or "Co-Promotion" means the performing of
sales
calls by Altus or Genentech Sales Representatives to specific
customer targets
and to medical staff associated with those customer targets in the
Co-Promote
Territory under the Product Trademark(s), as more specifically
described and to
the extent permitted by ARTICLE VII. "Co-Promote" when used as a
verb means to
engage in such Co-Promotion.
1.1.28 "Cover", "Covering" or "Covered" means, with respect to
a
Product, that the using, selling, or offering for sale of such
Product would,
but for ownership of, or a license granted under this Agreement to,
the relevant
Patent Rights infringe a Valid Claim of the relevant Patent Rights
in the
country in which the activity occurs.
1.1.29 "Development Costs" means the costs actually incurred by or
on
behalf of a Party, including [***], for [***] of the [***] of a
Product
conducted [***], or by [***] or [***], [***] for the purpose of
[***] for the
purpose of submission to a Governmental Authority to [***]
Marketing
Authorization of a Product. The "Development Costs" shall also
include expenses
for [***] and [***] Costs for [***] of such Product.
1.1.30 "Development Plan" means the plan for the development of,
and
pursuit of Marketing Authorization for, Products in the North
American
Territory.
1.1.31 "Effective Date" means the date, on or after the HSR
Clearance
Date, on which (i) Genentech has received from Altus a certificate,
signed by a
duly authorized officer of Altus, that the representations and
warranties of
Altus set forth in Section 11.2 are true and correct as if made on
and as of
such date, or (ii) Genentech has waived, in writing, the
requirement set forth
in (i) above.
1.1.32 "FDA" means the United States Food and Drug Administration
and
any successor agency thereto.
1.1.33 "Field" means the prevention, treatment or control of
any
disease or condition in humans.
1.1.34 "First Commercial Sale" means the first commercial sale of
a
Product to an end user in a country in the Licensed Territory after
receipt of
Marketing Authorization for such country.
1.1.35 "Formulation" means any composition containing [***].
1.1.36 "FTC" means the United States Federal Trade Commission.
1.1.37 "FTE" means a full-time equivalent person year (consisting
of a
total of [***] hours per year or [***] hours per quarter) of [***]
work.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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1.1.38 "Fully Burdened Manufacturing Costs or "FBMC" means one
hundred
percent (100%) of the costs incurred by the manufacturing Party
that are
attributable to manufacturing of a Product or Compound, including
without
limitation the [***] of goods produced as determined in accordance
with GAAP by
the Party manufacturing or contracting with a Third Party [***] of
the
manufacturing process (i.e., bulk, fill/finish), including [***],
plus [***].
1.1.39 "Genentech Housemark" means the name and logo of Genentech
or
an Affiliate of Genentech as identified by Genentech to Altus from
time to time.
1.1.40 "Genentech Know-How" means Know-How that (a) is Controlled
by
Genentech as of the Effective Date or during the Term and (b) is
necessary to
develop, make, use, sell, offer for sale or import a Product in the
Field;
excluding Collaboration Technology; but excluding any Know-How
related to the
manufacture of a Compound.
1.1.41 "Genentech Patents" means those Patent Rights that (a)
are
Controlled by Genentech as of the Effective Date or during the Term
and (b)
claim a Compound, Formulation or Product (or their manufacture or
use) in the
Field; but excluding Collaboration Technology and any Patent Rights
related to
the manufacture of a Compound.
1.1.42 "Genentech Technology" means Genentech Patents and
Genentech
Know-How.
1.1.43 "Governmental Authority" means any applicable government
authority, court, tribunal, arbitrator, agency, legislative body,
commission or
other instrumentality of (a) any government of any country or
territory, (b) any
state, province, county, city or other political subdivision
thereof or (c) any
supranational body.
1.1.44 "Housemark" means, when used in connection with Altus,
the
Altus Housemark, and, when used in connection with Genentech, the
Genentech
Housemark.
1.1.45 "HSR Act" means the Hart-Scott-Rodino Antitrust
Improvements
Act of 1976, as amended (15 U.S.C. Section 18a), and the rules and
regulations
promulgated thereunder.
1.1.46 "HSR Clearance Date" means the date on which (i) the
Parties
shall have complied with all applicable requirements of the HSR
Act, and (ii)
any applicable waiting period specified in the HSR Act, including
any extensions
thereof, shall have expired or been terminated; provided that (a)
no judicial or
administrative proceeding opposing consummation of all or any part
of this
Agreement shall be pending; (b) no injunction (whether temporary,
preliminary or
permanent) prohibiting consummation of the transactions
contemplated by this
Agreement or any material portion hereof shall be in effect; and
(c) no
requirements or conditions shall have been formally requested or
imposed by the
DOJ or FTC in connection therewith that are not satisfactory to the
Parties.
1.1.47 "Improved Formulations" means any Know-How and Patent
Rights
Controlled by Altus as of the Effective Date or during the Term
that relate to
[***] of [***] or [***] other than [***].
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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1.1.48 "Initial Indications" means (a) [***] and (b) [***].
1.1.49 "Know-How" means any and all technical information,
data,
ideas, test results, inventions, instructions, processes,
knowledge, techniques,
discoveries, formulae, specifications, designs, regulatory filings,
and
biological or other materials (including biological, chemical,
toxicological,
physical and analytical, safety, manufacturing and quality control
data and
information) and other information (whether or not patentable).
Know-How
excludes Patent Rights.
1.1.50 "Laws" means all applicable laws, statutes, rules,
regulations,
orders, judgments, injunctions, ordinances or other pronouncements
having the
binding effect of law of any Governmental Authority in the Licensed
Territory.
1.1.51 "Licensed Territory" means (a) North American Territory,
and
(b) upon exercise of the option set forth in Section 2.1, the
Option Territory.
1.1.52 "Loss" or "Losses" means any and all (a) losses,
liabilities,
damages, fines, penalties, costs or expense (including, without
limitation,
reasonable attorneys' fees and other expenses of litigation).
1.1.53 "Major European Country" means the [***].
1.1.54 "Marketing Authorization" means, with respect to a country,
all
approvals, licenses, registrations and regulatory authorizations
required to
make, store, import, transport, market and sell a Product in such
country as
granted by the relevant Regulatory Authority. For countries where
Regulatory
Authority approval is required for pricing or reimbursement for
Product,
"Marketing Authorization" shall not be deemed to occur until such
pricing or
reimbursement approval is obtained.
1.1.55 "NDA" means a complete "application" or "New Drug
Application"
as defined in 21 C.F.R. 314.3 and containing the content, and in
the format,
required by 21 C.F.R. Part 314, Subpart B, or a corresponding
application with a
regulatory agency in a country other than the United States,
together with all
additions, deletions, and supplements thereto.
1.1.56 "Net Sales" means the gross amounts invoiced by a Party,
its
Affiliates and sublicense licensees for, in the case of Genentech,
sales of
Products, and, in the case of Altus, Termination Products and other
products (in
each case, in final form for end use) "as used in this definition
"products"),
less the following deductions:
(a) trade, quantity and cash discounts or rebates;
(b) refunds, chargebacks and any other allowances that
effectively
reduce the net selling price;
(c) actual product returns, credits and allowances allowed to
customers, credits and allowances for wastage replacement and bad
debts;
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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(d) credits and allowances for [***] and similar programs, to
the
extent such credits and allowances do not exceed one and [***] of
gross amounts
invoiced for products (prior to these deductions (a)-(j));
(e) rebates paid or credited to any Governmental Authority (or
branch
thereof) or to any Third Party payor, administrator or
contractee;
(f) discounts mandated by or granted to meet the requirements of
Law,
including required chargebacks and retroactive price
reductions;
(g) [***], and inventory management fees, discounts or credits;
(h) commissions related to import or distribution of products paid
to
Third Parties (excluding sales personnel, sales representatives and
sales agents
who are employees or consultants of the selling Party, its
Affiliates or their
respective sublicensees);
(i) transportation, freight, data, postage charges and other
charges,
such as insurance, related to the handling or distribution of
products or
services provided in connection with the handling or distribution
of products
(to the extent not paid by a Third Party customer); and
(j) taxes, excises or other governmental charges or duties upon
or
measured by the production, sale, transportation, import, export,
delivery or
use of products.
All of the foregoing elements of Net Sales calculations shall be
determined
on an accrual basis in accordance with Accounting Standards.
The Steering Committee shall determine an [***] following the
deductions
set forth in (a) through (j) above, [***] relating to products.
Sales between or among a Party and its Affiliates, and their
respective
sublicensees, shall be excluded from the computation of Net Sales,
but Net Sales
shall include the first sales to Third Parties by any such
Affiliates or
sublicensees.
Notwithstanding anything else in this Section, the supply or
other
disposition of products as (i) samples, (ii) for use in
non-clinical or clinical
studies, (iii) for use in any tests or studies reasonably necessary
to comply
with any Law, regulation or request by a regulatory or Governmental
Authority or
as is otherwise reasonable and customary in the industry, in each
case shall not
be included within the computation of Net Sales.
In the event a product is sold in combination with, or contains,
one or
more other active ingredients which are not the subject of this
Agreement (as
used in this definition of Net Sales, a "Combination"), then the
gross amount
invoiced for that product shall be calculated by multiplying the
gross amount
invoiced for such Combination by the [***], where [***] is the
gross amount
invoiced for the product sold separately and [***] is the gross
amount invoiced
for the other active ingredient(s) sold separately. In the event
that the other
active ingredient is not
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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sold separately, then the [***] for that product shall be
calculated by
multiplying the gross amount invoiced for the Combination by the
[***], where
[***] is the gross invoice amount for the product, if sold
separately, and [***]
is the gross invoice amount for the Combination. In the event that
no such
separate sales are made, Net Sales for royalty determination shall
be determined
by the Parties in good faith.
Where (A) the consideration for products includes [***]; or (B)
products
are transferred by the selling Party, its Affiliate, or a
respective
sublicensee, in any manner other than an arms-length, invoiced
sale, the Net
Sales applicable to any such transaction shall be the [***] in the
[***] of the
Territory. The fair market value shall be determined, wherever
possible, by
reference to the [***] of the relevant product in [***] in the
[***].
1.1.57 "North American Territory" means the United States of
America
(and its territories and possessions), Canada and Mexico.
1.1.58 "Option Territory" means every territory in the world that
is
not part of the North American Territory.
1.1.59 "Patent Rights" means all patents and patent
applications,
including any continuations, continuations-in-part, divisions,
provisionals, or
any substitute applications, any patent issued with respect to any
such patent
applications, any reissue, reexamination, renewal, or extension
(including any
supplementary protection certificate) of any such patent, and any
confirmation
patent or registration patent or patent of addition based on any
such patent,
and all foreign counterparts of any of the foregoing, or as
applicable portions
thereof or individual claims therein.
1.1.60 "Person" means any individual, partnership, joint
venture,
limited liability company, corporation, firm, trust, association,
unincorporated
organization, Governmental Authority or any other entity not
specifically listed
herein.
1.1.61 "Phase II Clinical Trial" means a human clinical trial in
any
country in the Licensed Territory that would satisfy the
requirements of 21
C.F.R. Section 312.21(b).
1.1.62 "Phase III Clinical Trial" means a human clinical trial in
any
country in the Licensed Territory that would satisfy the
requirements of 21
C.F.R. Section 312.21(c).
1.1.63 "Polycation Collaboration Technology" means that [***],
and
[***] in the event that [***] is [***] pursuant to Section [***],
solely to the
extent that such [***] and, if applicable, [***], claims or relates
directly to
[***].
1.1.64 "Product" means any pharmaceutical product containing a
Formulation, and not any other active pharmaceutical ingredient
that is not a
Compound which active pharmaceutical ingredient is Covered by a
Valid Claim
within the Altus Technology or that uses or embodies Altus
Know-How.
1.1.65 "Product Reversion Package" means, with respect to a
particular
Termination Product: (i) copies of any data and materials
Controlled by
Genentech and made or
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developed in the course of developing such Termination Product
hereunder that
are necessary for the continued development or commercialization of
such
Termination Product (including any information regarding safety,
efficacy,
toxicity, and potential side effects), (ii) all of Genentech's
right, title and
interest in and to any agreements between Genentech and Third
Parties that are
[***], (iii) to the extent [***] as of the effective date of such
termination;
(iv) [***] all regulatory filings and Marketing Authorizations
Controlled by
Genentech and specific to such Termination Product; (v) a right of
reference to
the applicable drug master files, or the equivalent, necessary to
obtain or
maintain Marketing Authorization for such Termination Product; and
(vi) subject
to the terms of Section [***] and any licenses or sublicenses
granted by
Genentech to a Third Party, a non-exclusive, non-sublicensable,
non-transferable
license under the Genentech Technology and Genentech Collaboration
Technology as
necessary to make, have made, use, sell, offer for sale and import
such
Termination Product.
1.1.66 "Product Trademark" means the trademark(s) used by Genentech
in
connection with the distribution, marketing, promotion and sale of
a Product or
accompanying logos, trade dress or indicia of origin, but excluding
Housemarks.
1.1.67 "Regulatory Authority" means the FDA or any other
counterpart
or additional Governmental Authority responsible for granting
applicable
Marketing Authorizations.
1.1.68 "Sales FTE Rate" means the annual rate to be payable at
[***],
increased or decreased by the percentage increase or decrease in
the Consumer
Price Index as of the then most recent December 31 over the level
of the CPI as
of December 31, 2006, and calculation of the rate of payment for
such FTE to be
pro-rated on a daily basis (per annum amount to be divided by [***]
to produce
the rate per whole day consisting of eight hours).
1.1.69 "Sales Representative" means an individual who engages
in
Co-Promotion of Products and who has been trained in accordance
with Section
7.5.3.
1.1.70 "Third Party" means any Person other than Genentech or Altus
or
any Affiliate of either Party.
1.1.71 "Valid Claim" means claim of an issued and unexpired
patent
that has not been revoked or held unenforceable or invalid by a
final decision
of a court or other Governmental Authority of competent
jurisdiction, and that
has not been disclaimed, denied or admitted to be invalid or
unenforceable
through reissue or disclaimer or otherwise.
1.1.72 Other Terms. The definition of each of the following terms
is
set forth in the section of this Agreement indicated below:
<TABLE>
<CAPTION>
Term Section
---- -------
<S> <C>
1974 Convention 16.6
AAA 14.2(a)
AGHD 1.1.48
Agreement Preamble
</TABLE>
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<TABLE>
<CAPTION>
Term Section
---- -------
<S> <C>
Altus Preamble
Altus Co-Promote Opt-Out 7.8.3
Altus Parties 13.1
AMA 7.5.4
AMA Guidelines 7.5.4
Combination 1.1.56
Confidentiality Agreement 15.5
Commercialization Plan 7.3
Controlled Affiliate 1.1.5
Co-Promote Territory 7.2
Decision Period 2.7.2
Disclosing Party 1.1.24
Effective Date Preamble
Exchange 15.6.3
Genentech Preamble
Genentech Collaboration Technology 10.1.3(a)
Genentech Option 2.1.1
Genentech Parties 13.2
HSR Filings 12.7
Indemnified Party 13.3
Indemnifying Party 13.3
Initial Co-Promotion Period 9.12
Joint Collaboration Technology 10.1.3(b)
Joint Other Inventions 10.3
Joint Project Team or JPT 3.1
License 2.2.3
Option Period 2.1.1
Other Inventions 10.3
Outside Patent Counsel 10.5.4
Parties Preamble
Party Preamble
PGHD 1.1.48
PhRMA 7.5.4
PhRMA Code 7.5.4
PHS Act 7.5.4
Prosecution or Prosecute 10.5.1
Quality Agreement 6.3
Recalls 5.5
Receiving Party 1.1.24
Royalties 9.8, 9.9, 12.9
Royalty Report 9.11
Royalty Term 9.8.5
Severed Clause 16.8
Term 12.1
</TABLE>
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<TABLE>
<CAPTION>
Term Section
---- -------
<S> <C>
Termination Date 12.1
Termination Product 12.8.1
Third Party Claims 13.1
</TABLE>
1.2 Captions; Certain Conventions; Construction. All captions
herein are
for convenience only and shall not be interpreted as having any
substantive
meaning. The Schedules and Exhibits to this Agreement are
incorporated herein by
reference and shall be deemed a part of this Agreement. Unless
otherwise
expressly provided herein or the context of this Agreement
otherwise requires,
(a) words of any gender include each other gender, (b) words such
as "herein",
"hereof", and "hereunder" refer to this Agreement as a whole and
not merely to
the particular provision in which such words appear, (c) words
using the
singular shall include the plural, and vice versa, (d) the words
"include,"
"includes" and "including" shall be deemed to be followed by the
phrase "but not
limited to", "without limitation", "inter alia" or words of similar
import, and
(e) references to "ARTICLE," "Section," "subsection", "clause" or
other
subdivision, or to a Schedule or Exhibit, without reference to a
document are to
the specified provision, Schedule or Exhibit of this Agreement. In
the event of
any conflict between the operative terms of this Agreement and any
Schedule or
Exhibit, the operative terms of this Agreement shall prevail. This
Agreement
shall be construed as if the Parties drafted it jointly.
ARTICLE II
GRANT OF RIGHTS; OPTIONS
2.1 Option Territory.
2.1.1 Genentech Option. Genentech shall have the exclusive
option,
until the later of [***] days following the [***] or [***] ("Option
Period"), to
include the Option Territory within the Licensed Territory (the
"Genentech
Option"). The Option Period shall be extended for a period of [***]
upon the
request of Genentech. The Option Period also may be extended upon
agreement of
the Parties.
2.1.2 Option Exercise. In order to exercise the Genentech
Option,
Genentech must provide Altus with written notice thereof at any
time within the
Option Period. Upon Genentech's exercise of the Genentech Option,
the Option
Territory shall become part of the Licensed Territory.
2.2 Grant by Altus.
2.2.1 Exclusive License. Subject to the terms and conditions of,
this
Agreement, Altus hereby grants to Genentech an exclusive right and
license, with
the right to grant sublicenses (subject only to Section 2.2.4)
under the Altus
Technology and Altus's interest in and to the Joint Collaboration
Technology to
(i) make (and have made), use, and import Formulations and Products
in the Field
in the Licensed Territory and (ii) sell and offer for sale Products
in the Field
in the Licensed Territory.
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2.2.2 Non-Exclusive License. As applicable prior to the expiration
of
the Option Period or if Genentech does not exercise the Genentech
Option, Altus
further grants to Genentech a non-exclusive right and license, with
the right to
grant sublicenses (subject only to Section 2.2.4), under the Altus
Technology to
(i) make (and have made, subject to Section 2.2.4) Formulations and
Products in
the Field in the Option Territory, and (ii) to use, and import (but
not sell or
offer for sale) Formulations and Products in the Field in the
Option Territory;
in each case of (i) and (ii) above, solely for the purpose of
developing
Formulations and Products and commercializing Products in the Field
in the
Licensed Territory.
2.2.3 License Defined. The licenses granted under this Section 2.2
are
referred to collectively as the "License".
2.2.4 Sublicensing by Genentech.
(a) The License includes the right by Genentech to grant
sublicenses;
provided that [***]. No consent shall be required from Altus for
any sublicense
granted by Genentech to [***].
(b) Any sublicense granted by Genentech under the License must
be
granted pursuant to a written agreement that contains terms
regarding the
confidentiality and use of Altus Know-How and Altus's Confidential
Information
substantially similar to those contained in this Agreement. In the
event of any
such sublicense, Genentech shall continue to remain primarily
liable for all
liabilities and obligations under this Agreement, including the
payment
obligations set forth in ARTICLE IX.
2.3 Grants by Genentech.
(a) Conduct of Development Plan. Subject to the terms and
conditions
of this Agreement, Genentech hereby grants to Altus a
non-exclusive,
non-transferable, non-sublicenseable right and license under the
(i) Genentech
Technology, (ii) Genentech Collaboration Technology, (iii) Altus
Technology (to
the extent licensed to Genentech pursuant to Section 2.2.1) and
(iv) [***]; in
each case to make and use (but not sell, offer for sale or import)
Products in
the Field in the North American Territory (a) [***] for Altus to
perform those
development activities with respect to a Formulation or Product to
be performed
by Altus pursuant to Section 4.4 and (b) to conduct certain other
activities
[***].
(b) Co-Promotion. Subject to the terms of this Agreement,
Genentech
hereby grants to Altus a non-exclusive, non-transferable,
non-sublicenseable,
right and license under the (i) Genentech Technology, (ii)
Genentech
Collaboration Technology, (iii) Altus Technology (to the extent
licensed to
Genentech pursuant to Section 2.2.1) and (iv) [***]; in each case
[***] to
Co-Promote Products in the Co-Promote Territory in the Field in
accordance with
the Commercialization Plan and ARTICLE VII, and in accordance with
the
requirements of all applicable Marketing Authorizations.
(c) [***] Technology. Subject to the terms of this Agreement
(including Section 9.9), Genentech hereby grants to Altus a
non-exclusive,
non-transferable right and license under the [***] Technology to
make, use,
sell, offer for sale or import any product that is
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not a Formulation or Product in the Licensed Territory, and any
product outside
of the Licensed Territory. Any sublicense granted by Altus to an
Affiliate or
Third Party under the [***] Technology must be granted pursuant to
a written
agreement. In the event of any such sublicense, Altus shall
continue to remain
primarily liable for all liabilities and obligations under this
Agreement,
including the payment obligations set forth in Section 9.9.
(d) Genentech Housemarks. Subject to the terms of this
Agreement,
Genentech hereby grants to Altus a non-exclusive,
non-transferable,
non-sublicenseable, right and license to use the Genentech
Housemarks and
Product Trademarks solely in connection with Altus's Co-Promotion
of Products in
the Co-Promote Territory in the Field in accordance with the
requirements of the
applicable Marketing Authorizations, and to such limited extent as
set forth in
the Commercialization Plan and ARTICLE VII. All Genentech
Housemarks and Product
Trademarks are and shall remain the sole and exclusive property of
Genentech and
all use thereof and goodwill associated therewith shall inure to
the benefit of
Genentech.
2.4 No Implied Licenses. Except as expressly set forth in this
Agreement,
nothing contained in this Agreement shall be construed as
conferring to either
Genentech or Altus, by implication, estoppel, or otherwise, any
option, license
or right under the Genentech Technology, Altus Technology,
Collaboration
Technology or any other Patent Rights or other intellectual
property rights held
by Genentech or Altus.
2.5 Section 365(n) of the Bankruptcy Code. The rights and licenses
granted
under or pursuant to any Section of this Agreement, including under
Sections 2.2
and 2.3, are rights to "intellectual property" (as defined in
Section 101(35A)
of the Bankruptcy Code). Each Party shall retain and may fully
exercise all of
its rights and elections under the Bankruptcy Code or equivalent
legislation in
any jurisdiction other than the United States. Upon the bankruptcy
of either
Party and the occurrence of the events described in 11 U.S.C.
Sections 365(n)(3)
or 365(n)(4), the other Party shall further be entitled to a
complete duplicate
of, or complete access to, as appropriate, any such intellectual
property, and
such intellectual property, if not already in its possession, shall
be promptly
delivered to such other Party, unless the Party in bankruptcy
elects to
continue, and continues, to perform all of its obligations under
this Agreement.
2.6 Exclusivity. Beginning on the Effective Date and for a period
of [***]
following the Effective Date, Genentech shall not, alone or in
collaboration
with a Third Party or Affiliate, [***] for the Licensed Territory.
Beginning on
the Effective Date and for a period of [***] from the [***],
Genentech shall
not, alone or in collaboration with a Third Party or Affiliate,
[***].
2.7 Right of First Negotiation for [***].
2.7.1 Notification of [***]. From time to time, but in no event
less
than once per year, Altus shall provide Genentech with a report, in
writing, of
all [***]. The report shall be in a form and contain a sufficient
level of
detail to provide Genentech with enough information to evaluate the
nature and
applications of the [***].
2.7.2 [***] Rights. Altus agrees that, prior to licensing,
transferring or otherwise conveying or granting rights to any Third
Party to any
[***], or if so requested by Genentech, the Parties will in good
faith discuss
and negotiate a license to Genentech covering
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[***] for use, development and commercialization. If Altus and
Genentech cannot
agree on the terms and conditions of any such license within [***]
of commencing
such negotiations, then Altus may negotiate the terms and
conditions of a
license covering [***] with a Third Party; provided, however, that
in each case,
prior to licensing [***] to a Third Party, Altus shall be obligated
to offer to
Genentech a license on substantially the same terms and conditions
as negotiated
with the Third Party. If Genentech does not accept such terms and
conditions for
such license [***] of the date of offer by Altus (the "Decision
Period"), then
Altus may enter into the license covering such [***] with the Third
Party;
provided that if Altus does not enter into such license with such
Third Party
[***] shall again be subject to the provisions of this Section
2.7.2.
ARTICLE III
GOVERNANCE; EXCHANGE OF INFORMATION
3.1 Committees. In order to fulfill the objectives of this
Agreement, the
Parties shall establish a "Steering Committee". The members of the
Steering
Committee, as designated in equal numbers by each Party, shall be
appropriate
for the tasks then being undertaken and the stage of development,
in terms of
their seniority, availability, function in their respective
organizations,
training and experience. The Steering Committee shall have two
co-chairpersons,
one designated by each of Altus and Genentech. From time to time,
the Steering
Committee may establish "Joint Project Teams" ("JPTs") to oversee
particular
projects or activities; those JPTs will be constituted as the
Steering Committee
approves. It is the intent of the Parties that the Parties shall
have, through
the Steering Committee or one or more JPTs, a forum for
communication with
respect to the development, commercialization and manufacture of
Products to the
degree both Parties continue to have responsibilities for aspects
of
development, commercialization, and manufacture as dictated by this
Agreement.
3.2 Meetings. The co-chairpersons of the Steering Committee shall
call
meetings at least once per Calendar Quarter or as otherwise
mutually agreed.
Steering Committee meetings may be held in person, by telephone, or
by video
conference call. The location of any in-person Steering Committee
meeting shall
alternate between United States sites selected by each
co-chairperson, unless
otherwise agreed. The decisions of the Steering Committee shall be
by a vote of
the co-chairpersons, each co-chairperson having one vote, and all
decisions
shall be by unanimous consent of the co-chairpersons, except as
provided in
Section 3.4. Additional participants may be invited by any
representative of the
Steering Committee to attend meetings when and where deemed
appropriate by the
co-chairpersons and provided that such additional participants are
bound by
appropriate confidentiality obligations. Each Party's
representatives on the
Steering Committee shall act in good faith to resolve all matters
presented to
them as cooperatively and expeditiously as possible. Each Party
shall be
responsible for expenses incurred by its employees and its members
of the
Steering Committee and any established JPTs in attending or
otherwise
participating in meetings.
3.2.1 Meeting Minutes. The Steering Committee shall record all
decisions made, and otherwise take minutes as appropriate.
Responsibility for
keeping minutes will alternate between the Parties, beginning with
Genentech.
Steering Committee meeting minutes will be sent to each Party's
co-chairperson
for review as soon as practicable after a meeting.
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3.3 Steering Committee Responsibilities. Subject to Section 3.4,
the
Steering Committee shall perform the following functions:
(a) overseeing the development and commercialization, and as set
forth
herein the manufacture, of Products in the North American
Territory;
(b) reviewing the Development Plan and Commercialization Plan;
(c) reviewing and allocating resources and efforts for the
development
of Products for the North American Territory and commercialization
of Products
in the Co-Promote Territory;
(d) performing such other functions referred to in the
Development
Plan and/or Commercialization Plan, or as otherwise specified in
this Agreement
or agreed to by the Parties.
3.4 Decision Making. The Steering Committee and any established JPT
shall
strive to work cooperatively to reach unanimous decisions. If,
despite such
efforts, any JPT established by the Steering Committee is unable to
reach a
decision on any issue within [***], the issue shall be referred for
resolution
to the Steering Committee. If the Steering Committee is unable to
reach a
decision on any issue [***], then [***], provided that in no event
may [***].
3.5 Exchange of Information. Each Party shall, through the
Steering
Committee or appropriate JPT, keep the other Party updated on the
progress of
activities under a Development Plan and/ or Commercialization Plan.
In addition,
as directed by the Steering Committee, the Parties shall set up and
establish a
secure and reliable means of transferring information, such as a
secure server,
as soon as practicable after the Effective Date.
ARTICLE IV
DEVELOPMENT OF PRODUCTS
4.1 General. The Parties intend and agree that the development,
filing for
any Marketing Authorization, and commercialization (subject to
Altus's right to
Co-Promote as set forth in ARTICLE VII) of Products shall be
controlled by
Genentech. Without limiting the generality of the foregoing,
Genentech shall be
responsible for making and have authority to make all decisions,
and undertake
any actions necessary as a result of such decisions, regarding
development
(including additional preclinical and clinical development and
testing), and
preparing and filing NDAs and any other Approval Applications and
Marketing
Authorizations; and shall solely own all data, results and
regulatory
submissions related thereto, including all Approval Applications
and Marketing
Authorizations. Altus shall have, through the Steering Committee or
appropriate
JPT, the opportunity to provide input and suggestions into matters
relating to
the development of Products solely with respect to the North
American Territory,
and Genentech shall reasonably consider such input and
suggestions.
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4.2 Transition of Development Responsibilities to Genentech.
(a) Oversight. Within [***] of the Effective Date, the Steering
Committee, or appropriate JPT, shall meet to discuss the further
development of
Products subsequent to the Effective Date, the transition of
control over such
development to Genentech, and Altus's role in such development.
(b) Committee Responsibilities. The Steering Committee, or
appropriate
JPT, shall facilitate the exchange of information and the
coordination between
the Parties relating to the development of Products for the North
American
Territory, and to serve as a forum for each Party to keep the other
Party
updated with regard to such development, including with respect to
the
commencement and progress of clinical trials, the results of any
clinical
trials, and the strategy for obtaining Marketing Authorizations in
the North
American Territory.
4.3 Development Plan.
(a) Initial Development Plan; Modifications. Within [***] of
the
Effective Date, the Steering Committee, or appropriate JPT, shall
meet to discus
the strategy for further development of Products for the North
American
Territory subsequent to the Effective Date, and the implementation
thereof.
Within [***] of the Effective Date, Genentech will create an
initial Development
Plan which will address the further development of Products for the
North
American Territory subsequent to the Effective Date. From time to
time,
Genentech will update the Development Plan as needed to address any
changes in
the plans for development of Products in the North American
Territory, including
in Genentech's reasonable discretion the development of indications
beyond the
Initial Indications.
(b) Altus Review and Comment. Although Genentech shall be
responsible
for the creation and updating of the Development Plan, Altus shall
have, through
the Steering Committee, or appropriate JPT, the opportunity to
comment on the
Development Plan, and [***] with respect to the Development Plan.
Genentech
shall inform Altus between meetings of the Steering Committee, or
appropriate
JPT, of significant changes to the Development Plan.
4.4 Altus Development Activities. Without limiting the generality
of
Section 4.1, the Parties, through the Steering Committee, may agree
that certain
activities related to the development and seeking of Marketing
Authorization of
Products be performed by Altus, provided, however, that no such
activities shall
be allocated to Altus without the prior consent of Altus. Altus
shall perform
all activities allocated to Altus hereunder with Commercially
Reasonable Efforts
and in compliance with all Laws.
4.5 Cooperation. Each Party shall cooperate with and provide
reasonable
support to the other Party in its conduct of any activities in the
development
and seeking of Marketing Authorization of Products for the Licensed
Territory,
including any activities set forth in the Development Plan.
4.6 Transfer of Information and Regulatory Filings. Altus shall
disclose
(and transfer as applicable) to Genentech all Altus Know-How,
including any
preclinical data, clinical data, assays and associated materials,
protocols,
procedures and any other information in Altus's
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possession or control, that is reasonably necessary or useful to
continue or
initiate pre-clinical or clinical development, or in seeking
Marketing
Authorization, of Products. Without limiting the generality of the
foregoing,
upon Genentech's request Altus shall assign to Genentech (i) all
applications
and filings made with any Regulatory Authority with respect to a
Formulation or
Product, including any IND and orphan drug designations, (ii) all
agreements
related to the conduct of any clinical trial with respect to a
Formulation or
Product, and (iii) all agreements related to the manufacture,
supply or
distribution of clinical and/or commercial supplies of a
Formulation or Product.
4.7 Development Costs. Genentech shall be responsible for all
Development
Costs incurred by it in respect of Products following the Effective
Date and
[***], as set forth in Section 9.4, [***] Section [***].
ARTICLE V
REGULATORY MATTERS
5.1 General. As between Genentech and Altus, Genentech shall own
all
Approval Applications and Marketing Authorizations and other
regulatory
authorizations related to the development and commercialization of
Products in
the Licensed Territory. Altus shall assist Genentech, its
Affiliates and any
Genentech sublicensee in the preparation and filing for any
Marketing
Authorization with respect to Products, including by delivering all
information
in Altus's possession (in a complete and accurate form) necessary
or useful to
complete and file any Approval Application for a Product.
5.2 Communication with Governmental Authorities. Genentech (or one
of its
Affiliates or sublicensees) shall be responsible for and act as the
sole point
of contact for communications with Governmental Authorities in
connection with
the development, commercialization, and manufacturing of Products
in the Field
in the Licensed Territory after the end of the communications
relating to those
Phase II Clinical Trials initiated by Altus before the Effective
Date. Following
the Effective Date, Altus shall not initiate, with respect to any
Product, any
meetings or contact with Governmental Authorities in the Licensed
Territory
without Genentech's prior written consent. Any correspondence
directed to Altus
from Governmental Authorities in the Licensed Territory shall
promptly be
forwarded to Genentech for coordination of response.
5.2.1 Certain Obligations.
(a) Genentech shall, through the Steering Committee or
appropriate
JPT, keep Altus apprised of all material regulatory communications
with
Governmental Authorities relating to Products with respect to the
North American
Territory. In addition, Genentech shall (i) provide Altus with a
copy of any
material documents, to the extent related to a Product and the
North American
Territory, submitted to, and material written correspondence with,
Governmental
Authorities, if reasonably possible sufficiently in advance of the
intended
submission dates to enable Altus to review and provide comments to
Genentech
concerning the content thereof and (ii) as soon as reasonably
practicable after
completion of any inspections by any Governmental Authority with
respect to a
Product for the North American Territory, provide
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to Altus a summary of such inspection, the outcome and any
corrective actions,
all to the extent related directly and solely to a Product and the
North
American Territory. Any documents, correspondence, summary or other
information
provided by Genentech to Altus pursuant to this Section shall be
Genentech's
Confidential Information.
(b) To the extent Altus receives any written or oral
communication
from any Governmental Authority relating to a Product, Altus shall
(i) refer
such Governmental Authority to Genentech, and (ii) as soon as
reasonably
practicable, notify Genentech and provide Genentech with a copy of
any written
communication received by Altus or, if applicable, complete and
accurate minutes
of such oral communication.
5.2.2 Participation in Meetings. Altus shall have the right to
have,
[***] representatives observe substantive meetings with the
Governmental
Authorities in the North American Territory pertaining to Products.
Genentech
shall provide Altus with reasonable advance notice of all such
meetings.
Genentech shall have the right to initiate meetings and contact
with
Governmental Authorities independently of Altus, provided that
Altus shall have
the right to observe in such meetings as set forth above.
5.3 Cooperation. Each Party agrees to provide the other Party with
all
reasonable assistance and take all actions reasonably requested
that are
reasonably necessary to enable such Party to comply with any Laws
applicable to
Products in the Licensed Territory, including meeting its reporting
and other
obligations to maintain and update any Marketing Authorizations for
Products in
the Licensed Territory.
5.4 Drug Safety Information. As soon as reasonably necessary, the
Parties
shall enter into a pharmacovigilance and global safety reporting
agreement
reasonably acceptable to both Parties in respect of any Products.
As between
Genentech and Altus, Genentech shall be responsible for maintenance
of the
global safety database and global safety monitoring, except to the
extent
prohibited by Law.
5.5 Recalls. Genentech shall make all decisions with respect to any
recall,
market withdrawals or any other corrective action related to a
Product in the
Licensed Territory (collectively, "Recalls") for safety or any
other reason, and
shall have responsibility for executing such Recalls. Genentech
shall promptly
notify Altus of any decision by Genentech to conduct any Recalls;
provided,
that, if reasonably practicable, such notice shall occur prior to
such action so
as to permit Altus a reasonable opportunity to consult with
Genentech with
respect thereto. Altus will cooperate with Genentech in connection
with any
Recall, including making available to Genentech, upon request, all
of its
pertinent records which Genentech may reasonably request to assist
Genentech in
effecting any Recall.
5.6 Costs. Except as otherwise set forth in this Agreement,
Genentech
shall, following the Effective Date, bear all costs relating to
obtaining,
supporting and maintaining Marketing Authorizations in the Licensed
Territory.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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5.7 Altus Access to Clinical Data.
5.7.1 Initial Indications. In the event that Genentech does not
exercise the Genentech Option, Altus may request, in writing, that
Genentech
provide to Altus access to and the right to use certain clinical
and other data
generated by Genentech following the Effective Date reasonably
necessary to
Altus's pursuit of Marketing Authorizations for Products in the
Initial
Indications outside the North American Territory. [***] following
such written
request from Altus, Genentech shall provide Altus with an invoice
in the amount
of [***] of the [***]. [***] of Altus's written approval of such
invoice, [***],
Genentech shall provide Altus with the requested data and
associated right to
use such data as reasonably necessary for obtaining Marketing
Authorizations for
Products outside the North American Territory. Altus shall provide
Genentech
with written notice of any such submission [***] thereof. Altus
shall [***]
associated with transferring the requested data to Altus.
5.7.2 Other Indications. In the event that Genentech does not
exercise
the Genentech Option, Altus may request, in writing, that Genentech
provide to
Altus access to and the right to use certain clinical and other
data reasonably
necessary for Altus's pursuit of Marketing Authorizations for
Products outside
the North American Territory in indications other than the Initial
Indications.
Following such request, the Parties shall discuss in good faith the
possible
provision of such data to Altus and the compensation due to
Genentech therefor.
5.7.3 Other Data Sharing. In the event that Genentech does not
exercise the Genentech Option, upon the written request of either
Party, the
other Party shall discuss in good faith the possible sharing of
clinical and
other data generated by each Party for their respective territories
with the
goal of enabling a more efficient global development and
commercialization of
Products for both Parties.
5.7.4 Genentech Confidential Information. All clinical and other
data
provided to Altus pursuant to this Section 5.7 shall be the
Confidential
Information of Genentech.
ARTICLE VI
MANUFACTURE AND SUPPLY
6.1 Manufacture and Supply of Clinical Requirements of Product.
Unless
otherwise agreed to by the Steering Committee, Altus shall, subject
to oversight
by the Steering Committee and the terms and conditions of this
Agreement, be
initially responsible for the manufacture and supply of all
quantities of
Products for use in development (including clinical trials) of
Products for use
in the Licensed Territory. Genentech shall be responsible for
reasonably
supporting Altus in such efforts, including supplying, at
Genentech's own
expense, all quantities of Compound reasonably required by Altus to
manufacture
Products for use in development (including clinical development) in
the Licensed
Territory. Genentech's supply of Compound shall be according to a
reasonable
production schedule established by the Steering Committee. The FBMC
of Products
for use in development (including clinical trials) in the Licensed
Territory
shall be deemed a Development Cost for which Genentech shall
reimburse Altus in
accordance with Section 9.4. Altus and Genentech shall cooperate to
transfer to
Genentech, as soon as reasonably practicable following the
Effective Date,
responsibility for the manufacture
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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of Product for use in development. Altus shall use Commercially
Reasonable
Efforts to affect such transfer.
6.2 Manufacture and Supply of Commercial Requirements of Product.
As
between Genentech and Altus, Genentech shall be responsible for the
manufacture
and supply of Products for promotion and sale in the Licensed
Territory, and
bear all costs associated therewith. Altus shall support and
provide all
assistance, including any Altus Know-How, reasonably required by
Genentech to
manufacture Products.
6.3 Quality Agreement. The Parties shall enter into a separate
agreement
governing the roles and responsibilities of the Parties in the
manufacture,
testing, release and storage of Product and/or Compound (the
"Quality
Agreement"). The Parties shall use reasonable efforts to complete
such Quality
Agreement [***] of the Effective Date.
6.4 Manufacture and Supply of Compound for Option Territory. In the
event
that Genentech does not exercise the Genentech Option, Altus may,
[***]
expiration of the Genentech Option, provide Genentech with a
written request for
Genentech to supply Altus with clinical and/or commercial
requirements of
Compound, which as of the date of Altus's written request is
currently
manufactured by Genentech, to use exclusively outside the Licensed
Territory.
Provided that Genentech timely receives such written request,
Genentech shall
supply Altus, under terms mutually agreeable to the Parties, with
clinical
requirements of Compound for a period of no longer than [***]
expiry of the
Genentech Option and commercial requirements for a period of no
longer than
[***] receipt of the first Marketing Authorization for Product
outside the
Licensed Territory. Altus shall reimburse Genentech for such supply
of Compound
at a cost to be negotiated no less than Genentech's [***] and no
more than
Genentech's [***].
ARTICLE VII
COMMERCIALIZATION; CO-PROMOTION
7.1 General. Subject to Altus's right to Co-Promote Products in
the
Co-Promote Territory (as defined in Section 7.2 below) in
accordance with this
ARTICLE VII, Genentech shall be responsible for commercializing
Products in the
Licensed Territory.
7.2 Altus Co-Promotion Option. Subject to the conditions in
Sections 7.4
and 9.12, Altus shall have the option to Co-Promote Products in
each country
within the North American Territory, which option shall be
exercisable with
respect to each country in the North American Territory no later
than [***] the
first Approval Application for a Product is submitted to the
appropriate
Regulatory Authority in the applicable country; provided that Altus
provides
Genentech with written notice of its exercise of such option within
the
foregoing time period, which notice specifically identifies the
countries within
the North American Territory in which Altus elects to Co-Promote
Products (the
"Co-Promote Territory").
7.3 Commercialization Plan. Within [***] the first Approval
Application for
a Product in the Co-Promote Territory is filed, the Steering
Committee, or
appropriate JPT, shall meet to discus the strategy for
commercialization of
Product in the Co-Promote Territory. Within [***] the foregoing
meeting of the
Steering Committee or appropriate JPT, Genentech
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shall submit to the Steering Committee, or appropriate JPT, an
annual plan for
the commercialization of such Product in the Co-Promote Territory
(the
"Commercialization Plan"). Although Genentech shall be responsible
for the
creation of the Commercialization Plan, Altus, through the Steering
Committee,
or appropriate JPT, shall have the opportunity to comment on
the
Commercialization Plan, and Genentech shall reasonably consider
Altus's comments
with respect to the Commercialization Plan. Genentech shall update
the
Commercialization Plan on [***]. Prior to each [***] of the
Commercialization
Plan, the Steering Committee, or appropriate JPT, shall meet to
broadly review
the past year's commercialization of Products in the Co-Promote
Territory and
discuss plans for commercialization of Products in the Co-Promote
Territory in
the upcoming year. Altus shall be kept apprised of the
commercialization
activity by and through the Steering Committee, or appropriate JPT.
In addition,
Genentech shall, as reasonably practicable, inform Altus between
meetings of the
Steering Committee, or appropriate JPT, of significant changes to
the
Commercialization Plan and any material events in the marketing and
sales of
Products in the Co-Promote Territory.
7.4 Co-Promotion Responsibilities. The Parties acknowledge that, as
of the
Effective Date, Genentech is the Party that has established the
infrastructure
and expertise for the marketing and sales of therapeutic drugs, and
that except
as set forth in this ARTICLE VII, Genentech shall have the [***],
and [***], for
the [***] and [***] of [***] and the [***] and [***] of Products,
including
[***], and [***], and the [***] of [***]. Subject to the term and
conditions of
this ARTICLE VII, Section 9.12 and provided that Altus has
established [***],
Altus shall have the right to deploy, in the Co-Promote Territory,
a
Co-Promotion sales force equal to [***] of the total number of
Sales
Representatives for Products, or as otherwise unanimously
determined by the
Steering Committee. The Steering Committee shall [***] and [***]
within the
Co-Promote Territory to [***] in a [***] in view of the [***] of
[***] and
[***].
7.5 Commercialization Efforts. Each Party, to the extent that such
Party is
participating in the Co-Promotion of Products, shall use
Commercially Reasonable
Efforts in marketing Products in accordance with the
Commercialization Plan.
7.5.1 Sales and Distribution. Unless otherwise agreed in
writing,
Genentech shall have the sole responsibility for the following with
respect to
Products:
(a) Booking sales for and distributing Products. If Altus receives
any
orders for Products, it shall refer such orders to Genentech.
(b) Handling all returns of Products. If any Product is returned
to
Altus, it shall promptly be shipped to the facility responsible for
shipment of
such Product in the country in question to the attention of the
"returned goods
department" or another location as may be designated by
Genentech.
(c) Handling all aspects of order processing, invoicing and
collection, distribution, warehousing, inventory and receivables,
and collection
of data of sales to hospitals and other end users (e.g., DDD
data).
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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(d) Handling all other customer service related functions,
including
providing customer medical information.
7.5.2 Marketing and Promotional Materials. All marketing and
promotional materials related to Products shall be prepared by
Genentech.
Genentech shall be entitled to select any Third Party involved in
the
preparation of such materials.
7.5.3 Training Program. Genentech shall develop training
programs
relating to Products for the sales forces of each respective Party
and for any
Third Party engaged in selling or promotion. The Steering
Committee, or
appropriate JPT, may reasonably assign responsibility to itself,
Genentech,
Altus or a Third Party for the preparation of materials for
training programs
and conduct of training. The Parties agree to utilize such training
programs on
an ongoing basis to assure a consistent, focused promotional
strategy. The
initial training shall be carried out at a time which is mutually
acceptable to
the Parties, and which is prior to but reasonably near the date on
which the
first Marketing Authorization in the Co-Promote Territory is
expected. As
additional members are added to the Parties' respective sales
forces, training
will be given to groups of the newly selected members.
7.5.4 Co-Promotion Compliance Responsibilities. Each Party
Co-Promoting a Product shall in all material respects conform its
practices and
procedures relating to such Co-Promotion to the Act, the Public
Health Service
("PHS Act"), the Pharmaceutical Research and Manufacturers of
America ("PhRMA")
Code of Pharmaceutical Marketing Practices (the "PhRMA Code") and
the American
Medical Association ("AMA") Guidelines on Gifts to Physicians from
Industry (the
"AMA Guidelines"), as the same may be amended from time to time,
and the rules
and regulations promulgated under any of the foregoing, and
promptly notify the
other Party of and provide the other Party with a copy of any
material
correspondence or other reports with respect to the Co-Promotion of
a Product
submitted to or received from the FDA (or other Regulatory
Authority), PhRMA or
the AMA relating to the Act, the PHS Act, the PhRMA Code, or the
AMA Guidelines.
7.6 Product Trademarks.
7.6.1 Selection, Prosecution and Maintenance. All Products shall
be
sold under the Product Trademarks selected by Genentech. All
Product Trademarks
shall be owned by Genentech worldwide. Genentech shall control the
preparation,
prosecution and maintenance of applications related to any and all
Product
Trademarks.
7.6.2 Enforcement and Defense. Each Party shall notify the other
Party
promptly upon learning of any actual, alleged or threatened
infringement of a
Product Trademark in the North American Territory, or of any unfair
trade
practices, trade dress imitation, passing off of counterfeit goods,
or like
offenses. Upon learning of such offenses, the Parties shall confer
regarding the
defense of the Product Trademark. The ultimate decision whether and
how to
enforce or defend a Product Trademark will rest solely with
Genentech, and
Genentech shall have the exclusive right to respond to and defend
any such
infringement or offense. Altus shall cooperate, in good faith, with
respect to
all Product Trademark enforcement actions hereunder, including as
necessary or
desirable, being joined as a party to such action. Genentech shall
notify Altus
of all substantive developments with respect to such Product
Trademark
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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enforcement actions in the North American Territory, including, but
not limited
to, all material filings, court papers and other related documents.
Genentech
shall consider the timely, reasonable comments and advice of Altus
with respect
to the strategy employed and submissions made relative to any
Product Trademark
enforcement actions in the North American Territory. Genentech
shall have the
right to control settlement of any claims or actions regarding a
trademark
applicable to a Product; provided, however, that no settlement
shall be entered
into with respect to the North American Territory without the
written consent of
Altus if such settlement would materially and adversely affect any
right or
obligation of Altus under this Agreement.
7.6.3 Costs. All of the costs, expenses and legal fees associated
with
preparing filing, prosecuting, registering and maintaining a
Product Trademark,
as well as any action to maintain, protect or defend a Product
Trademark, and
any recovery, shall be Genentech's.
7.7 Party Name on Licensed Packaging and Labeling. With respect to
each
Product marketed in the Co-Promote Territory and then currently
Co-Promoted by
Altus, to the extent such Product's packaging, labeling or
promotional materials
identifies or otherwise references any of the Parties, both
Genentech and Altus
shall be presented and described with equal prominence and emphasis
as having
joined and participated in the development and Co-Promotion
thereof, as
permitted by Laws.
7.8 Termination of Co-Promotion.
7.8.1 Breach of Agreement. If Altus (i) materially breaches
this
Agreement and fails to cure such breach within [***] written notice
from
Genentech or (ii) fails to cure, within [***] written notice from
Genentech,
circumstances or conditions [***] a material breach, for which
Altus has also
received written notices thereof; Genentech shall have the right to
terminate,
by written notice, Altus's Co-Promotion rights granted under this
Agreement
(including this ARTICLE VII) with respect to all Products.
Termination of
Altus's Co-Promotion rights under this Section 7.8.1 shall be
effective [***]
Genentech's notice of termination and, on such effective date, (i)
all licenses
granted in Section 2.3, except for the license granted under
Section 2.3(c),
shall terminate and (ii) all rights and privileges granted to Altus
under this
ARTICLE VII shall terminate.
7.8.2 [***]. Upon any [***] of this Agreement [***] or [***],
Genentech shall have [***] under this Agreement (including [***])
by written
notice. [***] under this Section 7.8.2 shall be effective on the
[***] and, on
such effective date, (i) [***] and (ii) [***].
7.8.3 Altus Co-Promotion Opt-Out. Altus shall have the right to
elect
to cease its Co-Promotion of Products in the Co-Promote Territory
("Altus
Co-Promote Opt-Out"); provided that Altus provides Genentech with
written notice
of such election. An Altus Co-Promote Opt-Out for which Genentech
received
notice prior to [***] of a particular Calendar Year shall become
effective on
[***] of the following Calendar Year. If notice of an Altus
Co-Promote Opt-Out
is received after [***] of a particular Calendar Year, such Altus
Co-Promote
Opt-Out shall not become effective until [***] the Calendar Year
following the
next Calendar Year, or such other earlier date that Genentech may
determine (of
which date Genentech shall provide Altus notice). On the effective
date of an
Altus Co-Promote Opt-Out (i) all licenses
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granted in Section 2.3, except for the license granted under
Section 2.3(c),
shall terminate and (ii) all rights and privileges granted to Altus
under this
ARTICLE VII shall terminate.
7.8.4 Transitional Assistance. Upon any termination of Altus's
Co-Promotion rights in accordance with this Section 7.8, Altus
covenants and
agrees to cooperate, and cause its employees, contractors and
agents to
cooperate, with Genentech to enable Genentech to transition any
Co-Promotion
activities performed by Altus to Genentech in a timely and orderly
manner.
7.9 Commercial Expenses. Except where otherwise specifically set
forth in
this Agreement, Genentech shall bear all costs and expenses
incurred in
connection with the marketing and sale of Products in the Licensed
Territory;
provided that [***].
7.10 Outsourcing of Co-Promotion Activities. Provided that Altus
is
currently Co-Promoting Products in the Co-Promote Territory, if
Genentech
desires to outsource or contract its Co-Promotion of Products in
the Co-Promote
Territory to a Third Party, Genentech shall discuss in good-faith
with Altus the
possibility of Altus engaging in such Co-Promotion activities on
Genentech's
behalf.
ARTICLE VIII
DILIGENCE OBLIGATIONS
8.1 Commercially Reasonable Efforts by Genentech. Subject to
Altus's
fulfillment of its obligations under this Agreement, Genentech
shall use
Commercially Reasonable Efforts to develop and commercialize at
least one
Product in the United States and, if Genentech exercises the
Genentech Option,
[***]. Activities by Genentech's Affiliates and sublicensees will
be considered
as Genentech's activities under this Agreement for purposes of
determining
whether Genentech has complied with any obligation to use
Commercially
Reasonably Efforts.
8.2 Commercially Reasonable Efforts by Altus. Subject to
Genentech's
fulfillment of its obligations under this Agreement, Altus shall
use
Commercially Reasonable Efforts to execute and perform all
development
(including activities performed by Altus pursuant to Section 4.4)
and
commercialization activities (including the Co-Promotion of
Products as set
forth in ARTICLE VII) reserved for or assigned to Altus under this
Agreement.
8.3 Genentech's Cessation of Development and Commercialization of
Products.
If, [***] of the Effective Date, Genentech, despite the use of
Commercially
Reasonable Efforts as set forth in Section 8.1 [***] ceases all
development and
commercialization of Products in the Licensed Territory, Genentech
agrees, upon
the written request of Altus, [***].
ARTICLE IX
FINANCIAL PROVISIONS
9.1 Program Fee. In consideration of the grant of the License and
its other
rights under this Agreement, Genentech shall pay Altus a
non-creditable,
non-refundable fee of Fifteen Million Dollars (US$15,000,000) [***]
of the
Effective Date.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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REQUESTING
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9.2 Stock Purchase. On the Execution Date, Altus and Genentech will
execute
the "Stock Purchase Agreement" attached hereto as Exhibit A,
pursuant to which
Genentech will purchase, and Altus will sell, subject to the terms,
conditions
and contingencies set forth in the Stock Purchase Agreement,
Fifteen Million
Dollars (US$15,000,000) of Altus common stock.
9.3 Genentech Option Fee. In the event that Genentech exercises
the
Genentech Option in accordance with Section 2.1.1, Genentech shall,
[***] of the
written notice required by Section 2.1.1, pay Altus a [***].
9.4 Development Costs. Genentech shall reimburse Altus for
undisputed
Development Costs actually incurred by Altus following the
Effective Date in
connection with the Development Plan [***].
9.5 Milestone Payments. In consideration of the grant of the
License and
other rights under this Agreement, Genentech shall make the
following payments
[***] of the milestone events listed below:
<TABLE>
<CAPTION>
MILESTONE PAYMENT
MILESTONE EVENT (IN U.S. $ MILLIONS)
--------------- --------------------
<S> <C>
Development Milestones
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***]
</TABLE>
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<TABLE>
<CAPTION>
MILESTONE PAYMENT
MILESTONE EVENT (IN U.S. $ MILLIONS)
--------------- --------------------
<S> <C>
[***] [***]
[***] [***]
[***] [***]
</TABLE>
Genentech shall provide Altus with written notice of the
achievement of each of
the milestone events listed above promptly (and in any event [***])
following
such achievement.
9.6 Option Territory Milestone Payments. Provided that Genentech
exercises
the Genentech Option under Section 2.1.1, Genentech shall make the
following
payments [***] of the milestone events listed below:
<TABLE>
<CAPTION>
MILESTONE PAYMENT
MILESTONE EVENT (IN U.S. $ MILLIONS)
--------------- --------------------
<S> <C>
[***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***]
[***] [***]
[***] [***]
[***] [***]
</TABLE>
Genentech shall provide Altus with written notice of the
achievement of each of
the milestone events listed above promptly (and in any event [***])
following
such achievement.
9.7 Single Milestone Payment. With respect to each set of
milestone
payments to be made under this Agreement, only one set shall ever
be due and
payable, regardless of the number of Products developed, or the
number of
indications pursued or approved or whether a Product is
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discontinued after a milestone payment has been made. Milestone
payments due
under Section 9.5 or 9.6 shall only by due on those Products
Covered by a Valid
Claim within the Altus Patent Rights or Valid Claim of Patent
Rights within
Joint Collaboration Technology, or which uses or embodies Altus
Know-How.
9.8 Royalties. In each Calendar Quarter during the Royalty Term in
which
Genentech records Net Sales of a Product, and subject to and in
accordance with
the terms and conditions of this Agreement, Genentech shall pay
royalties to
Altus at the time it issues each Royalty Report as calculated
according to this
Section 9.8 (such amounts, the "Royalties").
9.8.1 North American Territory Covered by Valid Altus Patent
Claim.
Genentech shall pay Altus Royalties on annual Net Sales of Products
in the North
American Territory Covered by a Valid Claim within the Altus
Patents as follows:
<TABLE>
<CAPTION>
CALENDAR YEAR NET SALES OF PRODUCTS ROYALTY RATE
(IN U.S. $ MILLIONS) AS A PERCENTAGE OF SUCH NET SALES
-----------------------------------
---------------------------------
<S> <C>
Up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] [***]
</TABLE>
For example, if, during a Calendar Year Net Sales of Products
Covered by a Valid
Claim within the Altus Patents were equal to [***], the Royalties
payable by
Genentech under this Section 9.8.1 would be calculated by adding
(a) the royalty
with respect to the first [***] at the first level percentage of
[***], (b) the
royalty with respect to the next [***] at the second level
percentage of [***],
(c) the royalty with respect to the next [***] at the third level
percentage of
[***], (d) the royalty with respect to the next [***] at the fourth
level
percentage of [***] and (e) the royalty with respect to the final
[***] at the
fifth level percentage of [***], for total Royalties of [***].
9.8.2 Option Territory Covered by Valid Altus Patent Claim.
Provided
that Genentech exercises the Genentech Option under Section
2.1.1,Genentech
shall pay Altus Royalties on annual Net Sales of Products in the
Option
Territory Covered by a Valid Claim within the Altus Patents as
follows:
<TABLE>
<CAPTION>
CALENDAR YEAR NET SALES OF PRODUCTS ROYALTY RATE
(IN U.S. $ MILLIONS) AS A PERCENTAGE OF SUCH NET SALES
-----------------------------------
---------------------------------
<S> <C>
Up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] [***]
</TABLE>
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<PAGE>
9.8.3 Licensed Territory Covered by Valid Joint Collaboration
Technology Claim. Genentech shall pay Altus Royalties on annual Net
Sales of
Products in the Licensed Territory Covered by a Valid Claim of a
Patent Right
within the Joint Collaboration Technology as follows:
<TABLE>
<CAPTION>
CALENDAR YEAR NET SALES OF PRODUCTS ROYALTY RATE
(IN U.S. $ MILLIONS) AS A PERCENTAGE OF SUCH NET SALES
-----------------------------------
---------------------------------
<S> <C>
Up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] [***]
</TABLE>
9.8.4 Know-How Royalty. Genentech shall pay Altus Royalties on
annual
Net Sales in the Licensed Territory of Products that use or embody
Altus
Know-How as follows:
<TABLE>
<CAPTION>
CALENDAR YEAR NET SALES OF PRODUCTS ROYALTY RATE
(IN U.S. $ MILLIONS) AS A PERCENTAGE OF SUCH NET SALES
-----------------------------------
---------------------------------
<S> <C>
Up to and including [***] [***]
Above [***] and up to and including [***] [***]
Above [***] [***]
</TABLE>
9.8.5 Royalty Term. Genentech's obligation to pay Altus
Royalties
under (a) Section 9.8.1, 9.8.2, 9.8.3, as applicable, are payable
only during
time periods in which the applicable Product is Covered by a Valid
Claim within
the Altus Patents or Patent Rights within the Joint Collaboration
Technology (as
applicable) in the applicable country, and (b) Section 9.8.4, if
applicable,
shall expire no later than [***] the First Commercial Sale of the
applicable
Product that utilizes or incorporates Altus Know-How in the
applicable country
(as applicable, the "Royalty Term"). [***].
9.8.6 Single Royalty. Notwithstanding anything herein to the
contrary,
with respect to any Product only a single royalty payment shall be
due and
payable, regardless if such Product is Covered by more than one
Valid Claim. In
the event that more than one royalty rate described in this Section
9.8 apply to
a Product, only the highest applicable royalty rate shall
apply.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<PAGE>
9.9 Royalties to Genentech. In each Calendar Quarter in which
Altus, an
Altus Affiliate or permitted sublicensee of Altus records Net Sales
of any
product utilizing any [***] or [***], Altus shall pay royalties to
Genentech at
the time it issues each Royalty Report as calculated according to
this Section
9.9 (such amounts also "Royalties").
9.9.1 [***]. Altus shall pay Genentech a royalty of [***] of
annual
Net Sales of products, the making, using, selling, offering for
sale, or import
of which would infringe a Valid Claim of a Patent Right within the
[***].
9.9.2 [***]. Altus shall pay Genentech a royalty of [***] of
annual
Net Sales of products, the making, using, selling, offering for
sale, or import
of which would infringe a Valid Claim of a Patent Right within the
[***].
9.9.3 Single Royalty. In the event that more than one royalty
rate
described in this Section 9.9 apply to a product, only the highest
applicable
royalty rate shall apply.
9.10 Deductions from Payments.
9.10.1 Generally. If in Genentech's [***] it is necessary or
reasonable [***] in order for Genentech, its Affiliates, or a
sublicensee [***]
herein, or Genentech, its Affiliates, or a sublicensee [***] any
Third Party
(including in connection with [***]) any [***] in connection with
the
manufacture, use, sale, offer for sale or import of a Product,
Genentech shall
have the right to set [***] of any [***] to such [***] (other than
amounts
[***]), including [***], against any royalty payment payable to
Altus hereunder;
provided that as a result of such offset the royalties otherwise
payable to
Altus (i) pursuant to Sections 9.8.1 or 9.8.2 shall not be reduced
below [***]
of applicable Net Sales and (ii) pursuant to Section 9.8.3 or 9.8.4
shall not be
reduced by greater than [***] of the royalties otherwise payable to
Altus under
such Sections.
9.10.2 Exceptions.
(a) [***].
(b) [***].
9.10.3 [***].
9.10.4 Rights are Cumulative. The rights of offset set forth in
this
Section 9.10 shall be in addition to, and not in lieu of, any other
rights or
claims either Party may have under this Agreement or otherwise.
9.11 Reporting of Net Sales. Within [***] after the end of each
Calendar
Quarter in which a Royalty is required to be paid, the paying Party
shall submit
to the other Party a written report (each a "Royalty Report")
setting forth for
such Calendar Quarter the following information: (i) total Net
Sales of all
Products sold in the Licensed Territory during such Calendar
Quarter, (ii) Net
Sales on a country-by-country basis, (iii) the exchange rate used
to convert Net
Sales from the currency in which they are earned to United States
dollars; and
(iv) the total royalty payments due. Within [***] after the end of
each Calendar
Quarter in which a
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<PAGE>
Royalty is required to be paid, the paying Party shall submit to
the other Party
an informal written report setting forth for such Calendar Quarter
its unaudited
estimate of the foregoing information.
9.12 Altus Co-Promotion Costs. Commencing on the date of Altus's
exercise
of its Co-Promotion option as set forth in Section 7.2, and for a
period of
[***] after the First Commercial Sale of a Product in the
Co-Promote Territory
(the "Initial Co-Promotion Period"), Genentech shall reimburse
Altus for the
[***] Altus Sales Representatives, [***], that are dedicated by
Altus to the
Co-Promotion of Products in the Co-Promote Territory within [***]
the receipt by
Genentech of an invoice for such and a supporting report detailing
the names of
each Altus Sales Representative and [***] for the completed
Calendar Quarter.
The invoice amount shall be computed at the [***] multiplied by the
number of
[***] reported by Altus as Sales Representatives during the invoice
period, up
to the maximum number of Altus Sales Representatives determined
pursuant to
Section 7.4. Altus shall provide Genentech with any such invoice
within [***]
the end of each Calendar Quarter. Altus may elect to continue to
Co-Promote
Products in the Co-Promote Territory beyond the Initial
Co-Promotion Period at
entirely its own cost and expense, such election to be made by
Altus in writing
no later than [***] prior to expiry of the Initial Co-Promotion
Period. In the
event that Altus elects to continue to Co-Promote Products in the
Co-Promote
Territory beyond the Initial Co-Promotion Period, the Parties may
discuss
financial consideration due to Altus for its continued Co-Promotion
of Products
in the Co-Promote beyond the Initial Co-Promotion Period; provided
that any such
financial consideration shall be subject to approval of the
Steering Committee.
9.13 Commercial Expenses. If Genentech requests Altus's assistance
with
commercialization activities in the Licensed Territory beyond the
Co-Promotion
activities set forth in ARTICLE VII, and Altus agrees to provide
such
assistance, Genentech shall pay Altus for those costs and expenses
incurred by
Altus and approved in advance in writing by Genentech [***] the
receipt by
Genentech of an invoice for such expenses. Altus shall only provide
Genentech
with any such invoice [***] the end of each Calendar Quarter.
9.14 Books and Records; Audit Rights. Each Party shall keep and
maintain
(in conformity with the Accounting Standards), for a period of
[***] following
the end of a Calendar Year, complete and accurate records to enable
Royalties,
Development Costs, and reimbursement for Altus Sales
Representatives to be
determined. Each Party shall have the right, once per Calendar Year
and not more
frequently than once with respect to records covering any specific
period of
time, at its own expense, to have an independent, certified public
accounting
firm, acceptable to the other Party review any such records in the
location(s)
where such records are maintained by such Party upon reasonable
notice (which
shall be no less than [***] prior written notice) and during
regular business
hours for the sole purpose of verifying the basis and accuracy of
payments of
Royalties or the calculation of Development Costs or reimbursement
for Altus
Sales Representatives within the [***] as of the date of the
request for review.
Prior to any review, the independent certified public accounting
firm shall have
entered into a written agreement with the Party whose records are
subject to
review limiting the use of such records to verification of the
accuracy of
payments due under this Agreement and prohibiting the disclosure of
any
information contained in such records to a Third Party for any
purpose and to
the other Party for a purpose other than as set forth in this
Section 9.14. The
report of such accounting
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<PAGE>
firm shall be limited to a certificate stating whether any report
made or
payment submitted by Genentech, or invoice of Development Costs or
reimbursement
for Altus Sales Representatives by Altus, during such period is
accurate or
inaccurate and the actual amounts of Royalties due for such period,
or actual
Development Costs or appropriate reimbursement to Altus for the
costs of its
Sales Representatives. The Party whose records are being reviewed
shall receive
a copy of each such report of the independent certified public
accountant prior
to such report being provided to the other Party. After review of
the certified
public accounting firm's report, each Party shall promptly pay any
uncontested,
understated amounts due to the other Party. In the event of a
dispute regarding
such amounts, one finance representative of each Party shall meet
and attempt in
good faith to resolve any such dispute. Any overpayment made by a
Party shall be
promptly refunded or fully creditable against amounts payable in
subsequent
payment periods, at such Party's election. Any review or audit by
an independent
certified public accounting firm under this Section 9.14 is to be
made at the
expense of the Party requesting such review or audit, except that
if the results
of the review reveal that a Party has underpaid or overstated by
[***] for the
period under review, then the reasonable audit fees shall be paid
by the Party
whose records were reviewed.
9.15 Confidentiality. The Parties agree that all information
provided in a
Royalty Report, all records kept by a Party under Section 9.14, and
any
information provided by the independent certified public accounting
firm to a
Party are Confidential Information of the Party whose records were
reviewed
pursuant to Section 9.14.
9.16 Payment Type. All payments due under this Agreement shall be
paid in
immediately available funds by wire transfer to a United States
based account to
be identified by the payee.
9.17 Taxes. Each Party shall comply with Laws regarding filing
and
reporting for income tax purposes. Neither Party shall treat their
relationship
under this Agreement as a pass through entity for tax purposes. All
payments
made under this Agreement shall be free and clear of any and all
taxes, duties,
levies, fees or other charges, except for withholding taxes. Each
Party shall be
entitled to deduct from its payments to the other Party under this
Agreement the
amount of any withholding taxes required to be withheld, to the
extent paid to
the appropriate Governmental Authority on behalf of the other Party
(and not
refunded or reimbursed). Each Party shall deliver to the other
Party, upon
request, proof of payment of all such withholding taxes. Each Party
shall
provide reasonable assistance to the other Party in seeking any
benefits
available to such Party with respect to government tax withholdings
by any
relevant Law or double tax treaty.
9.18 Currency Denomination. With respect to amounts invoiced in
United
States Dollars, all corresponding Royalties shall be expressed in
United States
Dollars. With respect to amounts invoiced in a currency other than
United States
Dollars, all corresponding Royalties shall be expressed both in the
currency in
which the amount was invoiced and in the United States Dollar
equivalent. The
United States Dollar equivalent shall be calculated using the
conversion rate
reported by Reuters Ltd. on for the last day of the Calendar
Quarter for which
such payment is being determined.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.
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<PAGE>
9.19 Blocked Payments. If by reason of Laws in any country in the
Licensed
Territory or Option Territory, the prompt remittance of milestone
payments,
Royalties or other payments to a Party under this Agreement is
prevented, the
paying Party shall promptly notify the other Party. During any such
period
described above, milestone payments, Royalties or other payments
shall continue
to accrue, and shall continue to be reported, until such time
payment can be
made through any lawful means or methods that may be available as
the Parties
shall reasonably determine.
9.20 Late Payments. Each Party shall pay interest to the other
Party on the
aggregate amount of any payment that is not paid on or before the
date such
payment is due from the date due at [***] on the last Business Day
of the
applicable Calendar Quarter prior to the date on which such payment
is due, plus
[***], calculated on the basis of a 360-day year.
9.21 Rights Regarding Consolidation of Financial Data. With a view
toward
compliance with the currently in effect Accounting Standards, if,
at any time
during the term of this Agreement, compliance with any term or
condition of this
Agreement would, [***], require Genentech to consolidate Altus
within
Genentech's financial statements, then upon Genentech's request,
Altus shall
provide to Genentech (a) Altus's unaudited quarterly consolidated
financial
statements, prepared in accordance with Accounting Standards (i.e.,
balance
sheet, income statement and statement of cash flows) [***] after
the end of each
Calendar Quarter, and (b) subject to the obligations under ARTICLE
XV, Altus's
[***] results for a given Calendar Quarter, based on its [***]
estimates, no
earlier tha
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