CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Exhibit 10.6
CELLCEPT(R) COLLABORATION AND PROMOTION AGREEMENT
This Cellcept(R) COLLABORATION AND PROMOTION AGREEMENT (the "AGREEMENT")
is entered into as of July 18, 2003 (the "EFFECTIVE DATE"), by and among, on the
one hand, Aspreva Pharmaceuticals GmbH, a Swiss corporation having offices at
Xxx Xxxxxxx-Xxxx 00, 0000 Xx Xxxxx-xx-Xxxxx, Xxxxxxxxx, Xxxxxxxxxxx ("ASPREVA"),
a subsidiary of Aspreva Pharmaceuticals Corporation ("ASPREVA CANADA"), and on
the other hand, Xxxxxxxx-Xx Xxxxx Inc., a New Jersey corporation having offices
at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000 and X. Xxxxxxxx-Xx Xxxxx Ltd,
having offices at Xxxxxxxxxxxxxxxxx 000, XX-0000 Xxxxx, Xxxxxxxxxxx
(collectively, "ROCHE"). Both Aspreva and Roche are referred to individually as
a "PARTY" and collectively as the "PARTIES."
WHEREAS, Roche has developed, obtained regulatory approval for and is
manufacturing, promoting, detailing and selling its proprietary drug
mycophenolate mofetil under the brand name CellCept(R) in many countries
throughout the world for the suppression of rejection of transplanted organs,
and has certain related intellectual property rights;
WHEREAS, Aspreva has developed proprietary methods and know-how regarding
the development, marketing, and commercialization of pharmaceutical products for
the treatment of rare diseases;
1.
WHEREAS, Roche and Aspreva wish to collaborate to maximize the expertise
of each in the development, promoting and detailing of Cellcept(R) for the
treatment of autoimmune diseases, on the terms set forth in this Agreement.
NOW THEREFORE, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "ADJUSTED GROSS SALES" shall mean the gross amount invoiced for sales
of the Product in the Territory by Roche, its Affiliates, and their respective
sublicensees, to Third Parties that are not Affiliates or sublicensees of the
selling party (except where such Affiliates or sublicensees are end users), less
the following items, as allocable to the Product (if not previously deducted
from the amount invoiced or separately invoiced) and each as consistently
applied by Roche to its products: (a) the amounts actually allowed as volume or
quantity discounts, (b) rebates (including price reductions, rebates to social
and welfare systems, chargebacks or reserves for chargebacks, cash rebate
incentives, government mandated rebates and similar types of rebates, for
example, Pharmaceutical Price Regulation Scheme, Medicaid), (c) returns and
return reserves, if applicable (including allowances actually given for spoiled,
damaged, out-dated, rejected, or returned Product, withdrawals and recalls); and
(d) taxes, duties or other government tariffs, including value added or sales
taxes, government mandated exceptional taxes and other taxes directly linked to
the gross sales amount (other than income taxes).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
2.
1.2 "AFFILIATE" shall mean (a) an entity that owns directly or indirectly,
a controlling interest in a Party, by stock ownership or otherwise, (b) any
entity in which a Party owns a controlling interest, by stock ownership or
otherwise, or (c) any entity under common control with a Party, directly or
indirectly. For purposes of this paragraph, "controlling interest" and "control"
mean ownership of fifty percent (50%) or more of the voting stock permitted to
vote for the election of the board of directors or any other arrangement
resulting in control of or the right to control the management and the affairs
of the entity or Party in question. [ * ]
1.3 "AI COMMERCIALIZATION" shall mean the Promotion and Detailing of the
Product in the Field in the Territory.
1.4 "AI DEVELOPMENT" shall mean the non-clinical, clinical, and regulatory
development of the Product for use in the Field in the Territory.
1.5 "ASPREVA COMMERCIALIZATION ACTIVITIES" shall have the meaning set
forth in Section 6.2(a).
1.6 "ASPREVA DEVELOPMENT ACTIVITIES" shall have the meaning set forth in
Section 5.2(a).
1.7 "ASPREVA HOUSE MARKS" shall mean the corporate names of Aspreva and
its Affiliates, and their trade names, service marks, domain names, and
associated logos and designs.
1.8 "ASPREVA KNOW-HOW" shall mean all present and future [ * ] knowledge
and information Controlled by Aspreva as of the Effective Date or during the
Term,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
3.
whether or not [ * ], but which [ * ] or when [ * ] upon one [ * ] an ability to
[ * ] the [ * ] in the [ * ], which ability one [ * ] not have [ * ], including
techniques, know-how, inventions, practices, methods, methodologies, knowledge,
skill, experience, data (including pharmacological, toxicological and clinical
test data, analytical data, marketing and market research data and data
contained in any Regulatory Filing) software, algorithms, promotional materials,
assays and biological materials Controlled by Aspreva as of the Effective Date
or during the Term that are [ * ] to the [ * ] of the [ * ].
1.9 "ASPREVA PATENTS" shall mean all Patents owned by Aspreva that claim
an Aspreva Sole Invention.
1.10 "ASPREVA PROMOTIONAL MATERIALS" shall have the meaning set forth in
Section 6.5(b).
1.11 "ASPREVA SALES REPRESENTATIVE" shall mean an employee of Aspreva and
member of Aspreva's sales force engaged in the conduct of Details of the
Product, trained as provided under this Agreement and in accordance with the
Commercialization Plan.
1.12 "ASPREVA SOLE INVENTION" shall have the meaning set forth in
Section 9.1.
1.13 "AUTOIMMUNE INDICATIONS" shall mean all indications that involve
pathogenic consequences produced by autoantibodies or autoreactive lymphocytes
interacting with self epitopes, including but not limited to Alopecia Areata,
Ankylosing
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
4.
Spondylitis, Antiphospholipid Syndrome, Autoimmune Addison's Disease, Autoimmune
Hemolytic Anemia, Autoimmune Hepatitis (chronic, active non-pathogenic),
Behcet's Disease, Bullous Pemphigoid, Cardiomyopathy, Celiac Sprue-Dermatitis,
Chronic Fatigue Immune Dysfunction Syndrome (CFIDS), Chronic Inflammatory
Demyelinating Polyneuropathy, Churg-Strauss Syndrome, Cicatricial Pemphigoid,
CREST Syndrome, Cold Agglutinin Disease, Crohn's Disease, Discoid Lupus,
Essential Mixed Cryoglobulinemia, Fibromyalgia-Fibromyositis, Xxxxxx' Disease,
Guillain-Barre, Hashimoto's Thyroiditis, Idiopathic Pulmonary Fibrosis,
Idiopathic Thrombocytopenia Purpura (ITP), IgA Nephropathy, Insulin-dependent
Diabetes, Juvenile Arthritis, Lichen Planus, Lupus, Meniere's Disease, Mixed
Connective Tissue Disease, Multiple Sclerosis, Myasthenia Gravis, Pemphigus
Vulgaris, Pernicious Anemia, Polyarteritis Nodosa, Polychondritis, Polyglandular
Syndromes, Polymyalgia Rheumatica, Polymyositis and Dermatomyositis, Primary
Agammaglobulinemia, Primary Biliary Cirrhosis, Psoriasis, Raynaud's Phenomenon,
Xxxxxx'x Syndrome, Rheumatic Fever, Rheumatoid Arthritis, Sarcoidosis,
Scleroderma, Xxxxxxx'x Syndrome, Stiff-Man Syndrome, Takayasu Arteritis,
Temporal Arteritis/Giant Cell Arteritis, Ulcerative Colitis, Uveitis,
Vasculitis, Vitiligo, and Xxxxxxx'x Granulomatosis.
It is explicitly understood that Autoimmune Indications does not include
the treatment of patients with autoimmune diseases or conditions for the purpose
of suppressing rejection of transplanted organs, bone marrow, or other tissue.
In other words, any patient for whom the Product is prescribed for use following
transplant of an organ, bone marrow, or other tissue, for so long as so
prescribed, shall not be deemed a patient receiving the Product for Autoimmune
Indications.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
5.
1.14 "AVERAGE UNIT SELLING PRICE" shall be calculated as follows:
AUSP = X / Y,
where AUSP is the Average Unit Selling Price; X is aggregate Adjusted Gross
Sales in the Major Market Countries for a particular year; and Y is the total
milligrams of solid formulation MMF sold in the Major Market Countries for such
year and comprising such Net Sales. The calculations of both X and Y include all
formulations of the Product other than CellCept(R) Intravenous.
1.15 "BASELINE RESIDUAL SALES" shall mean one hundred thirty-four million
(134,000,000) CHF (and pro rata for any part of a year), which amount shall be
subject to adjustment after the Effective Date based on the results of more
accurate bone marrow transplant data, which may have the effect of increasing
Baseline Residual Sales. In any event, Baseline Residual Sales shall not exceed
one hundred seventy-eight million (178,000,000) CHF. During the Term, Baseline
Residual Sales may be adjusted pursuant to Section 8.7. The Parties agree and
acknowledge that, as of the Effective Date, the determination of Baseline
Residual Sales assumes that [ * ] is (or will be prior to the commencement of
the Royalty Term) part of the Territory, and the Parties shall negotiate in good
faith an appropriate reduction in Baseline Residual Sales in the event that [ *
] to be [ * ].
1.16 "COMMERCIALIZATION PLAN" shall have the meaning set forth in
Section 6.1.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6.
1.17 "COMMERCIALLY REASONABLE EFFORTS" shall mean with respect to each
Party, commercially reasonable efforts in accordance with such Party's business,
legal, medical and scientific judgment, and in accordance with the efforts and
resources such Party would use for a product owned by it or to which it has
rights, which is of similar market potential, at a similar stage in its product
life, taking into account the competitiveness of the marketplace, the
proprietary position of the product, the regulatory structure involved, the
profitability of the product and other relevant factors.
1.18 "COMPETITIVE COMPANY" shall mean a pharmaceutical company with a
marketed product, or a product in development for which [ * ] has been obtained
[ * ], having an indication that is [ * ] (a) one or more indications in the
Field in the Territory [ * ]; or (b) any Transplant Indication, either approved
or in development.
1.19 "CONFIDENTIAL INFORMATION" of a Party shall mean all information and
materials (including but not limited to data, results, technical or economic
information, and strategies for development, commercialization, or promotion)
disclosed by such Party to the other Party during the Term.
1.20 "CONTROL" shall mean, with respect to any information or intellectual
property right, possession by a Party of the ability (whether by ownership,
license, or otherwise) to grant access, a license, or a sublicense to such
information or intellectual property right without violating the terms of any
agreement or other arrangement with any Third Party as of the time such Party
would first be required hereunder to grant the other Party such access, license,
or sublicense.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7.
1.21 "DETAIL" OR "DETAILING" shall mean a face-to-face presentation by an
Aspreva Sales Representative, to one or several medical professional(s) having
prescribing authority in the Field, as well as to other individuals or entities
that have significant impact or influence on prescribing decisions in the Field,
as identified in the Commercialization Plan approved by the JC (collectively,
the "TARGET AUDIENCE"), in which the Product is given the [ * ] during the
presentation if other pharmaceutical products are discussed, and where the
principal objective is to emphasize the features and function of the Product. A
discussion of the Product at a conference or convention, where members of the
Target Audience are in attendance, shall not be deemed a Detail.
1.22 "DEFECTIVE PRODUCT" shall have the meaning set forth in Section
7.1(d).
1.23 "DEVELOPMENT PLAN" shall have the meaning set forth in Section 5.1.
1.24 "DRUG SAFETY COMMITTEE" shall mean the committee of representatives
from both Parties responsible for addressing drug safety issues that arise
during AI Development and AI Commercialization, as more fully described in
Section 5.8(b).
1.25 "ESTIMATED INCREMENTAL RESIDUAL SALES" shall be calculated, for a
given calendar quarter, as follows:
EIRS = NS - ( PGTS + BRS ),
where "EIRS" is Estimated Incremental Residual Sales for such quarter; "NS" is
Net Sales for such quarter; "PGTS" is Projected Global Tracked Sales for such
quarter; and "BRS" is Baseline Residual Sales for such quarter.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8.
1.26 "EXISTING PROMOTIONAL MATERIALS" shall have the meaning set forth in
Section 6.5(a).
1.27 "FDA" shall mean the United States Food and Drug Administration, or
any successor organization.
1.28 "FIELD" shall mean the treatment and/or prevention of any Autoimmune
Indication in humans.
1.29 "FINANCE LIAISON" shall mean the individual with expertise in
financial reporting designated by a Party to oversee and facilitate the exchange
of financial, accounting, tax, and other information contemplated under Article
8.
1.30 "FULLY BURDENED MANUFACTURING COST" shall mean [ * ] of Roche's fully
burdened cost of manufacturing (including material, personnel, equipment,
depreciation, energy, workshop, quality control, waste disposal and production
management) for the Product in accordance with Roche's accounting policies
consistently applied, which shall comprise the cost of goods produced as
determined by Roche for each stage of the manufacturing process, whether
conducted by Roche or contracted with a third party, in accordance with
international accounting standards ("IAS") consistently applied by Roche, and
other costs borne by Roche for transport, customs clearance and storage of
product at the request of Aspreva prior to the time of sale (that is, freight,
customs, duty and insurance). As of the Effective Date, Roche is calculating the
Fully Burdened Manufacturing Cost and shall provide to Aspreva in writing the
final determination of such Fully Burdened Manufacturing Cost within ninety (90)
days following the Effective Date. In any event, the Fully Burdened
Manufacturing Cost shall not exceed [ * ] CHF per [ * ] tablets ([ * ] mg each)
of labeled and packaged Product.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
9.
1.31 "GLOBAL TRACKED SALES" shall mean those Net Sales in the Territory
calculated in accordance with the then-applicable Sales Tracking Methodology, as
provided in Section 8.5, to determine which portion of Net Sales in the
Territory resulted from purchases of the Product for use in Transplant
Indications.
1.32 "GMP" shall mean the current Good Manufacturing Practices of the FDA
and any similar practice standards promulgated by governmental or regulatory
agencies with jurisdiction over the manufacture, use, or sale of the Product, as
then in effect.
1.33 "INCREMENTAL RESIDUAL SALES" shall be calculated, for a given time
period, as follows:
IRS = RS - BRS,
where "IRS" is Incremental Residual Sales; "RS" is Residual Sales for such time
period; and "BRS" is Baseline Residual Sales. For calculations of Incremental
Residual Sales for periods other than a single calendar year, Baseline Residual
Sales shall be multiplied by the number of years (or fraction thereof) in the
period prior to subtracting it from Residual Sales for such same time period.
1.34 "INFORMATION COORDINATOR" shall have the meaning set forth in
Section 5.4.
1.35 "INVENTION" shall mean any invention or discovery, whether or not
patentable, made as a result of the activities of a Party or the Parties
pursuant to this Agreement, which invention or discovery relates to the Product
or any use thereof.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10.
1.36 "JC" OR "JOINT COMMITTEE" shall have the meaning set forth in
Section 3.1.
1.37 "MAJOR MARKET COUNTRIES" shall mean the United States, Italy,
Germany, France, United Kingdom, and Spain.
1.38 "NET SALES" shall be calculated, for each accounting period, as
follows:
NS = AGS - ([ * ] x AGS ),
where "NS" is Net Sales; and "AGS" is Adjusted Gross Sales for such time period.
1.39 "OTHER INDICATIONS" shall mean all indications for the Product other
than Autoimmune Indications and Transplant Indications.
1.40 "PATENTS" shall mean (a) unexpired letters patent (including
inventor's certificates) in any country of the Territory that have not been held
invalid or unenforceable by a court of competent jurisdiction from which no
appeal can be taken or has been taken within the required time period, including
without limitation any substitution, extension, term restoration, registration,
confirmation, reissue, re-examination, renewal or any like filing thereof and
(b) pending applications for letters patent in any country of the Territory,
including without limitation any continuation, division or continuation-in-part
thereof and any provisional applications.
1.41 "PRODUCT" shall mean that prescription pharmaceutical product, the
active ingredient of which is MMF (mycophenolate mofetil), and any prescription
pharmaceutical product having as an active ingredient any salt, ester, or
metabolite of
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
11.
MMF, in all forms and formulations for which Roche or its Affiliates Controls a
regulatory approval or Regulatory Filing as of the Effective Date (which
formulations are set forth on Schedule 1.41) or during the Term.
1.42 "PRODUCT SAMPLES" shall mean the complimentary supply of units of the
Product which are distributed to customers for the purpose of Promoting use of
Product for Autoimmune Indications.
1.43 "PROJECTED GLOBAL TRACKED SALES" shall have the meaning set forth in
Section 8.2(a).
1.44 "PROMOTION" or "PROMOTE" shall mean the marketing and advertising of
the Product in the Field in accordance with the Commercialization Plan,
including medical education, information and communication, market development
and medical liaison activities.
1.45 "RECONCILIATION" shall have the meaning set forth in Section 8.4.
1.46 "RECONCILIATION PERIOD" shall have the meaning set forth in
Section 8.4(a).
1.47 "REGULATORY APPROVALS" shall mean any approvals, licenses,
registrations or authorizations (including pricing and reimbursement approvals)
of any Regulatory Authority, whether or not conditional, that are necessary for
the commercial sale of the Product in the Field in a regulatory jurisdiction in
the Territory and obtained as a result of activities under this Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
12.
1.48 "REGULATORY AUTHORITY" shall mean any and all national,
supra-national, regional, state, or local regulatory agency, department, bureau,
commission, council, or other governmental entity, whose approval or
authorization is necessary for, or to whom notice must be given prior to, the
manufacture, distribution, use, or sale of the Product in the Territory or the
designation of the Product as an orphan drug (or equivalent designation) in any
country in the Territory.
1.49 "REGULATORY FILINGS" shall mean all applications, filings, dossiers
and the like submitted to a Regulatory Authority in the Territory for the
purpose of obtaining Regulatory Approval from that Regulatory Authority in the
Territory.
1.50 "RESIDUAL SALES" shall be calculated, for each accounting period, as
follows:
RS = NS - GTS,
where "RS" is Residual Sales; "NS" is Net Sales for such time period; and "GTS"
is Global Tracked Sales for such time period.
1.51 "ROCHE BASE PATENTS" shall mean any and all Roche Patents claiming
the composition of matter (i.e., active ingredient) of the Product. For the
purpose of Section 9.3 (but not for the purpose of any other section of this
Agreement), Roche Base Patents shall also include any and all Roche Patents
claiming the use of the Product in the Field.
1.52 "ROCHE COMMERCIALIZATION ACTIVITIES" shall have the meaning set forth
in Section 6.2(b).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
13.
1.53 "ROCHE DEVELOPMENT ACTIVITIES" shall have the meaning set forth in
Section 5.2(b).
1.54 "ROCHE HOUSE MARKS" shall mean the corporate names of Roche and its
Affiliates, their trade names, service marks, domain names, and associated logos
and designs.
1.55 "ROCHE PATENTS" shall mean all Patents owned by or licensed to Roche
as of the Effective Date or during the Term.
1.56 "ROCHE PRODUCT INFORMATION" shall mean, all data, knowledge, and
information Controlled by Roche as of the Effective Date or during the Term and
relating specifically to the testing, development, manufacture, use or sale of
the Product to the extent necessary or useful for development or
commercialization of Product in the Field and in the Territory, including
without limitation toxicological data, pharmacological data, manufacturing data,
clinical test data, formulations, specifications, analytical and quality control
testing data, marketing, cost, sales data, as well as in particular all data
supporting or illustrating use of the Product in the Field and related
Regulatory Filings and correspondence to and from Regulatory Authorities.
1.57 "ROCHE SOPS" shall mean Roche's written internal guidelines for
preparing regulatory filings for the Product, as they may be revised or modified
from time to time by the JC.
1.58 "ROCHE TECHNOLOGY" shall mean the Roche Product Information and the
Roche Patents.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
14.
1.59 "ROCHE TEMPLATES" shall mean written templates used and approved by
Roche for the preparation of regulatory filings for the Product under this
Agreement, as they may be revised or modified from time to time by the JC.
1.60 "ROCHE TRADEMARKS" shall mean CellCept(R) and all other trademarks
used or intended for use by Roche or its Affiliates on the Effective Date or
during the Term in connection with the marketing or sale of the Product, other
than Roche House Marks.
1.61 "ROYALTY TERM" shall have the meaning set forth in Section 8.1.
1.62 "SALES TRACKING METHODOLOGY" shall have the meaning set forth in
Section 8.5.
1.63 "SENIOR MANAGEMENT" shall mean, for Roche, with respect to the
Development Activities, the [ * ] and with respect to the Commercialization
Activities, the [ * ] and, for Aspreva, the [ * ] Any such designees shall be
senior managers of Roche or Aspreva, respectively.
1.64 "SPECIFICATIONS" shall have the meaning set forth in Section 7.1(a).
1.65 "TERM" shall mean the term of this Agreement, as set forth in
Section 14.1.
1.66 "TERRITORY" shall mean all the countries of the world except
Japan, [ * ].
1.67 "THIRD PARTY" shall mean any entity other than a Party or its
Affiliates.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
15.
1.68 "THIRD PARTY DISTRIBUTION AGREEMENTS" shall have the meaning set
forth in Section 2.6(b).
1.69 "TRANSPLANT INDICATIONS" shall mean all indications that involve the
suppression of rejection of transplanted organs, bone marrow, or other tissue.
ARTICLE 2
GRANT OF RIGHTS
2.1 GRANT TO ASPREVA.
(a) DEVELOPMENT LICENSE. Subject to the terms and conditions of this
Agreement, Roche hereby grants to Aspreva the exclusive right and license during
the Term in the Territory, under the Roche Technology, to develop the Product in
the Field, in accordance with the Development Plan, and to import and use the
Product for such purposes.
(b) PROMOTION RIGHT. Subject to the terms and conditions of this
Agreement, Roche hereby grants to Aspreva the exclusive, non-transferable
(subject to Section 16.2) right, during the Term in the Territory to Promote and
Detail the Product in the Field, in accordance with applicable law and the
Commercialization Plan. During the Term and in the Territory, Roche shall not
perform under or enter into any agreements with any Third Party granting rights
to Promote or Detail Product in the Field, except pursuant to Third Party
Distribution Agreements in force as of the Effective Date or which may otherwise
come into force as provided in Section 2.6(b).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
16.
(c) SUBLICENSES. The licenses granted to Aspreva in Sections 2.1(a)
and 2.1(b) are sublicensable without the consent of Roche, but only to Aspreva's
Affiliates.
2.2 ROCHE TRADEMARK LICENSE. Subject to the terms and conditions of this
Agreement, Roche hereby grants to Aspreva and Aspreva's Affiliates, the
non-exclusive right and license to use the Roche Trademarks during the Term in
the Territory, solely in connection with the Promotion, and Detailing of the
Product in the Field in the Territory. Further, Roche covenants not to xxx
Aspreva or its Affiliates or approved subcontractors for infringement of the
Roche House Marks with respect to its or their activities under this Agreement
conducted in accordance with the Development Plan and Commercialization Plan.
2.3 LICENSE GRANTS TO ROCHE.
(a) ASPREVA KNOW-HOW AND HOUSE MARKS. Aspreva hereby grants to
Roche, during the Term and subject to the terms and conditions of this
Agreement, an exclusive license, except as to Aspreva and its Affiliates, to use
and practice the Aspreva Know-How and the Aspreva House Marks solely in the
Field and in the conduct of its obligations under this Agreement, including the
conduct of the Roche Development Activities and the Roche Commercialization
Activities. Accordingly, during the Term, Aspreva shall not enter into any
agreement with any Third Party to develop, Promote or Detail any prescription
pharmaceutical product, the active ingredient of which is MMF (mycophenolate
mofetil), and any prescription pharmaceutical product
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
17.
having as an active ingredient any salt, ester, or metabolite of MMF (other than
any agreement with a subcontractor permitted under Section 2.4).
(b) ASPREVA PATENTS. Subject to the terms and conditions of this
Agreement, Aspreva hereby grants to Roche an exclusive, worldwide license under
any and all Aspreva Patents and Aspreva's interest in any and all Joint Patents
to make, have made, and sell the Product in the Field during the Term; which
such license shall become non-exclusive upon expiration or, in certain
instances, termination of this Agreement, as provided in Article 14.
2.4 THIRD-PARTY PERFORMANCES OF ASPREVA ACTIVITIES.
(a) DEVELOPMENT ACTIVITIES AND COMMERCIALIZATION ACTIVITIES OTHER
THAN PROMOTION AND DETAILING. If set forth in the applicable Development Plan or
Commercialization Plan, Aspreva may subcontract the Aspreva Development
Activities or the Aspreva Commercialization Activities to a Third Party, subject
to the requirements and restrictions of this Section 2.4. Specifically, Aspreva
may subcontract the Aspreva Development Activities to a clinical research
organization approved by the JC. In addition, Aspreva may subcontract certain
Commercialization Activities, except for Promotion and Detailing, to a Third
Party whose primary business is to carry out commercialization activities on
behalf of other parties (e.g., an advertising agency) if such Third Party is
approved by the JC to carry out the subcontracted Commercialization Activities.
(b) PROMOTION AND DETAILING. In the event that Aspreva cannot
Promote or Detail, or desires to use a Third Party to Promote or Detail, in a
country in
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the Territory, it shall so notify Roche in writing. Upon receipt of such notice,
Roche shall inform Aspreva within [ * ] whether Roche desires to perform such
Aspreva Commercialization Activities in such country. If Roche notifies Aspreva
of its interest in performing such Commercialization Activities in such country,
then Roche shall have the [ * ] right to Detail and Promote the Product [ * ] in
such country pursuant to a specific arrangement to be approved by the JC,
including, where permitted by law, allowing Aspreva to do some level of
Promotion activity in such country. Any such country shall nonetheless be deemed
within the Territory and subject to this Agreement, and, in particular, all
Adjusted Gross Sales generated in such countries shall be included in the
calculation of Net Sales. If Roche notifies Aspreva that it does not wish to
perform such Commercialization Activities, or fails to notify Aspreva within
such [ * ] period of its interest in so performing such Commercialization
Activities, then Aspreva shall have the right to engage a Third Party approved
by the JC to perform such activities.
(c) ROCHE REIMBURSEMENT. If Roche performs any Commercialization
Activities pursuant to Section 2.4(b), then for each such country, the Parties
shall [ * ] and [ * ] to the [ * ] remuneration to Roche for the activities
performed by Roche in such country, taking into account the cost [ * ] to
promote and detail pharmaceutical products [ * ] in such country.
2.5 RESTRICTIONS ON ASPREVA. During the Term, Aspreva shall not develop in
the Field any form or formulation of the Product that Roche is not marketing or
developing at the time.
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2.6 TERRITORY; OTHER EXCEPTIONS TO GRANTS.
(a) [ * ]. Roche represents and Aspreva acknowledges that [ * ]
possesses the [ * ] those rights granted under Section 2.1 to Aspreva for the
Territory. [ * ] Accordingly, within ninety (90) days of the Effective Date,
Roche agrees to use its best efforts to [ * ] among [ * ] for the purpose of
informing [ * ] of [ * ] for the [ * ] of the [ * ] and commencing discussions
with [ * ] for its consent to [ * ] for purposes of this Agreement [ * ]. Roche
shall promptly notify Aspreva in writing of the intention of [ * ] to be [ * ]
for purposes of this Agreement. If Roche notifies Aspreva that [ * ] intends to
be [ * ] for all purposes of this Agreement, then thereafter [ * ] for purposes
of this Agreement. If [ * ] does not agree to be [ * ] for purposes of this
Agreement, then Roche shall have a right to use [ * ] that pertains to the
Product in the Field in the Territory, solely to the extent that such use is
necessary for Roche [ * ] to comply with requirements regarding drug safety
required by Regulatory Authorities [ * ]. In any event, the Parties shall amend
this Agreement where and to the extent necessary to effectuate a decision by [ *
] to be [ * ] as the case may be, as [ * ] for the purposes of this Agreement.
(b) ROCHE DISTRIBUTION AGREEMENTS WITH THIRD PARTIES. Schedule
2.6(b) is a list of countries in which Roche, to the best of its knowledge as of
the Effective Date, may be required to use Third Party distributors pursuant to
exclusive or non-exclusive distribution agreements which grant such Third Party
distributors an exclusive or non-exclusive right, as the case may be, to
promote, detail and otherwise market the Product (the "THIRD PARTY DISTRIBUTION
AGREEMENTS"). During the Term and in the Major Market Countries, Roche agrees
that it shall not enter into any
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agreement with any Third Party granting such Third Party the right to detail or
promote or otherwise market the Product in the Field. Notwithstanding the
foregoing sentence, Aspreva understands that one or more of Roche's Affiliates
in certain countries of the Territory outside the Major Market Countries may,
from time to time, grant to Third Parties the right to detail or promote the
Product in the Field in one or more of such countries, to the extent in
accordance with Roche's Affiliates' usual business practices as applied to that
country. In such event, Roche will use commercially reasonable efforts to notify
Aspreva in writing that such additional Third Party rights have been given, and
Schedule 2.6(b) shall be updated to so reflect such country. Notwithstanding the
existence of such Third Party Distribution Agreements, the countries set forth
on Schedule 2.6(b), as may be amended, shall nonetheless be included in the
Territory for purposes of this Agreement. In particular, all Adjusted Gross
Sales generated in such countries shall be included in the calculation of Net
Sales, but all payments owed to such Third Party distributors shall be borne
solely by Roche and Aspreva shall have no obligation hereunder to remunerate
Roche for the cost to Roche of such Third Party distributor performing
activities to promote and detail Product in the Field in such countries. Roche
agrees that, upon request by Aspreva, Roche shall use its reasonable efforts to
facilitate any meetings or communications between Aspreva and any Third Party
distributor described above for the purpose of informing such distributor of
Aspreva's capabilities and strategy with respect to the Product in the Field.
2.7 OTHER INDICATIONS. Roche shall have the right, either itself, or
through one or more Third Parties, to develop and promote the Product for one or
more Other Indications during the Term in the Territory; provided, however, that
Roche shall only
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undertake such activities or grant to such Third Parties such right where it has
first obtained Aspreva's written consent, not to be unreasonably withheld, to
the reasonableness, fairness and accuracy of Roche's method for tracking the
portion of Net Sales during the Term and in the Territory attributed to the use
of the Product for such Other Indication.
ARTICLE 3
COLLABORATION GOVERNANCE
3.1 JOINT COMMITTEE; MINUTES. Within thirty (30) days after the Effective
Date, Aspreva and Roche shall form a Joint Committee ("JC") consisting of [ * ]
representatives from Aspreva and [ * ] representatives from Roche. Each Party
may replace its representatives at any time upon prior written notice to the
other Party. Each Party may invite a reasonable number of additional employees
and/or advisors to attend part or all of the meetings of the JC. Roche shall
have the right to designate the first chairperson of the JC, whose term shall
run until [ * ], and such right shall thereafter alternate between the Parties
on a calendar year basis. The chairperson shall be responsible for providing an
agenda for each meeting at least [ * ] in advance of such meeting. The Party not
chairing the JC shall prepare written draft minutes of all meetings in
reasonable detail and distribute such draft minutes to all members of the JC for
comment and review within [ * ] after the relevant meeting. The members of the
JC shall have [ * ] to provide comments. The Party preparing the minutes shall
incorporate timely received comments and distribute finalized minutes to all
members of the JC within [ * ] of the relevant meeting.
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3.2 SUBCOMMITTEES. The JC shall have the right to establish subcommittees,
which may include but will not be limited to the following: a clinical
manufacture subcommittee, a development subcommittee, a commercialization
subcommittee, and a regulatory subcommittee.
3.3 MEETINGS OF THE JC. During the first [ * ] calendar years of the Term,
the JC shall meet at least once every quarter, unless otherwise decided by the
JC. The chairman of the JC shall have the right to convene any additional
meetings of the JC upon [ * ] written notice to all members of the JC. Meetings
may be held by audio or video conference with the consent of each Party,
provided that at least two (2) meetings per year shall be held in person at
locations to which both Parties have mutually consented. Each Party shall be
responsible for its own expenses for participating in the JC. Meetings of the JC
shall be effective only if at least one representative of each Party is present
or participating.
3.4 RESPONSIBILITIES OF THE JC. The JC shall have the responsibility and
authority to:
(a) oversee all aspects of the development and commercialization of
the Product in the Field;
(b) approve, adopt, comment upon and/or amend or modify the
Development Plan and Commercialization Plan, and all updates or amendments
thereto;
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(c) review, comment upon, and approve the Aspreva Promotional
Materials, and, at Aspreva's request, submit the Aspreva Promotional Materials
to Roche for Roche's approval;
(d) establish subcommittees pursuant to Section 3.2, and address
disputes or disagreements arising in any subcommittee so established;
(e) approve, where appropriate, revised Roche SOPs and Roche
Templates;
(f) create mechanisms for interaction of the Parties with respect to
submission of Regulatory Filings by Roche in the Field;
(g) coordinate efforts of the Parties to assure proper reporting of
all adverse events;
(h) develop standard operating procedures for addressing customer
inquiries and complaints;
(i) implement policies and procedures for providing to Aspreva a
copy of all correspondence and communications with Regulatory Authorities
relating to the Product in the Field in the Territory;
(j) determine the availability, timing, and amount of Product and
placebo to be supplied by Roche to Aspreva for the conduct of the Aspreva
Development Activities, in accordance with Section 7.1, and procedures for
forecasting and ordering same;
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(k) monitor Roche's manufacturing capacity for the Product pursuant
to Section 7.3;
(l) review any New Sales Tracking Data submitted by either Party
pursuant to Section 8.5, and, as it deems appropriate, adopt revisions or
modifications to the Sales Tracking Methodology;
(m) provide a conduit for the transfer of Roche Product Information
and information regarding sales force training meetings from Roche to Aspreva;
(n) approve any arrangement under which Roche Details and Promotes
the Product with Aspreva's assistance, pursuant to Section 2.4;
(o) determine Parties' rights and obligations with respect to Joint
Patents, on a case-by-case basis;
(p) approve clinical research organizations and CSOs pursuant to
Section 2.4;
(q) approve disclosure of Confidential Information to Third Parties;
and
(r) perform such other functions as the Parties may agree in
writing.
3.5 AREAS OUTSIDE THE JC'S AUTHORITY. The JC shall have no authority other
than that expressly set forth in Section 3.4.
3.6 OPERATING PRINCIPLES. The Parties hereby acknowledge and agree that
the deliberations and decision-making of the JC and any subcommittee established
by the JC shall be in accordance with the following operating principles:
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(a) Time is of the essence in addressing the market for the Product
in the Field.
(b) The Parties' mutual objective is to maximize the clinical and
commercial potential of the Product in the Field, consistent with sound and
ethical business and scientific practices.
3.7 DECISIONS.
(a) CONSENSUS; GOOD FAITH. The JC shall decide all matters by
consensus, with each Party having one collective vote. Consistent with Section
3.6, the members of the JC shall act in good faith to cooperate with one another
and to reach agreement with respect to issues to be decided by the JC.
(b) FAILURE TO REACH CONSENSUS. In the event that the members of the
JC cannot come to consensus within [ * ] with respect to any matter over which
the JC has authority and responsibility, the JC shall submit the respective
positions of the Parties with respect to such matter for discussion in good
faith by Senior Management. Until and only if Senior Management is able to
mutually agree upon the resolution to such matter, the Parties shall continue to
operate under the status quo and neither Party shall have the right, without the
consent of the other Party, to implement any changes to the status quo that
would result from resolution of such matter.
ARTICLE 4
JOINT OBLIGATIONS; DILIGENCE
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4.1 NEW INFORMATION. Each Party will promptly inform the other of the
following information relating to the Product: (i) [ * ] by the [ * ] that such
Party [ * ] which relate to the Product [ * ]; and (ii) any [ * ] in [ * ]
affecting the Product in the Field and in the Territory or either Party's
obligations with respect to this Agreement.
4.2 CONDUCT OF PARTIES. Each Party understands and agrees that it is to
their mutual benefit to maximize the clinical and commercial potential of the
Product, and accordingly, that time is of the essence in addressing the market
for the Product in the Field. Each Party shall conduct itself and its activities
hereunder consistent with that understanding, consistent with sound and ethical
business and scientific practices, and in accordance with the Development Plan
and the Commercialization Plan.
4.3 ASSISTANCE. Each Party agrees to provide to the other all reasonable
assistance and take all actions reasonably requested by the other Party that are
necessary to enable the requesting Party to comply with its obligations under
this Agreement or otherwise meet the mutual objectives of the Parties set forth
in Section 4.2 above, or with any applicable law or regulation.
4.4 COMMERCIALLY REASONABLE EFFORTS. Each Party agrees to use Commercially
Reasonable Efforts to carry out those activities for which it is responsible as
set forth in each Development Plan and Commercialization Plan, it being
understood that activities set forth in such Development Plan or
Commercialization Plan with respect to years later than the then-present year
shall be of a less definitive nature than those set forth for the then-present
year.
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4.5 SHARING OF MARKET INFORMATION. Each Party may, at its discretion and
expense, undertake such [ * ] relating to the Product in the Field as it deems
fit, and such [ * ] shall remain the property of the Party undertaking same.
During the Term, each Party shall, to the extent it is capable of doing so, make
such [ * ] specifically relating to the Product in the Field available to the
other Party at [ * ] It is expressly understood that any such [ * ] is different
and distinct from, [ * ] by a Party [ * ] and [ * ].
ARTICLE 5
DEVELOPMENT
5.1 DEVELOPMENT PLAN. All AI Development shall be conducted pursuant to a
Development Plan, which shall set forth the plan for the non-clinical, clinical,
and regulatory development of the Product in the Field and the activities to be
carried out related thereto by Aspreva and Roche (the "DEVELOPMENT PLAN"). The
Parties have agreed upon an initial Development Plan, a copy of which is
attached hereto as Schedule 5.1. No later than [ * ], and on an annual basis
thereafter, Aspreva shall submit to the JC an updated Development Plan, which
the JC shall review and approve on a timely basis. Each updated Development Plan
shall include for the next [ * ] years the succeeding projection of (a) the plan
of development activities and timelines for performing such activities, and (b)
a non-binding forecast of clinical supply of Product to be supplied as provided
under Section 7.1. Once approved by the JC, such updated Development Plan shall
become effective and supercede the previous Development Plan as of the date of
such approval or at such other time decided by the JC. The JC
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shall not approve an updated Development Plan that is inconsistent with or
contradicts the terms of this Agreement without the written consent of both
Parties, and in the event of any inconsistency between the Development Plan and
this Agreement, the terms of this Agreement shall prevail.
5.2 DEVELOPMENT ACTIVITIES.
(a) ASPREVA OBLIGATIONS. As between Aspreva and Roche, Aspreva shall
be responsible for carrying out, as set forth in and in accordance with the
Development Plan, all activities relating to AI Development other than those
limited activities set forth in Section 5.2(b) as "Roche Development Activities"
(the "ASPREVA DEVELOPMENT ACTIVITIES"). Without limiting the foregoing, Aspreva
Development Activities shall include preparation of Regulatory Filings in the
Territory for the Product in the Field and conducting (or having conducted) all
clinical trials (including but not limited to Phase IV studies) for the Product
in the Field. Roche agrees and acknowledges that Aspreva shall not be in breach
of this Agreement solely as a result of failing to meet one or more goals or
objectives set forth in the Development Plan, or for the failure of the Product
in any clinical trial. Aspreva must provide Roche, in a timely manner, with all
safety data that Roche indicates to Aspreva are required to fulfill Roche's
regulatory obligations (as outlined in section 5.2(b)).
(b) ROCHE OBLIGATIONS. As between Aspreva and Roche, Roche shall be
responsible for (i) submitting all Regulatory Filings prepared by Aspreva for
Regulatory Approval and conducting all meetings and discussions with Regulatory
Authorities with respect to the Product in the Field, as further provided in
Sections 5.5
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and 5.6, (ii) processing all safety reports and notifying Aspreva of any Product
withdrawals or recalls, as further described in Sections 5.8 and 5.9; and (iii)
supplying Product to Aspreva for clinical trials, as further described in
Section 7.1 (collectively, the "ROCHE DEVELOPMENT ACTIVITIES").
5.3 DEVELOPMENT COSTS.
(a) ASPREVA COSTS. Aspreva shall bear all costs and expenses
incurred in connection with the Aspreva Development Activities.
(b) ROCHE COSTS. Roche shall bear all costs and expenses incurred in
connection with the Roche Development Activities, except that (i) Aspreva shall
purchase from Roche all Product and placebo supplied by Roche for the conduct of
the Aspreva Development Activities, as set forth in Section 7.1, and (ii)
Aspreva shall pay for all filing fees associated with Regulatory Filings in the
United States, as set forth in Section 5.5(f).
5.4 TRANSFER OF ROCHE PRODUCT INFORMATION. Roche shall identify an
individual (the "INFORMATION COORDINATOR") who will report to the JC and
coordinate and regulate the transfer of Roche Product Information from Roche to
Aspreva. In the event Aspreva desires access to and/or copies of, or has
inquiries with respect to, Roche Product Information, it shall submit a request
to the JC, which shall require that the Information Coordinator promptly make
available to Aspreva any Roche Product Information responsive to such requests
as reasonably necessary or useful for Aspreva to carry out the Aspreva
Development Activities.
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5.5 REGULATORY FILINGS IN THE FIELD.
(a) REGULATORY APPROVAL COUNTRIES; RIGHT OF CROSS-REFERENCE.
Promptly following the Effective Date, Roche shall provide Aspreva with a list
of all countries in the Territory where Roche has obtained one or more approvals
from Regulatory Authorities with respect to the Product in the Territory. In
preparing Regulatory Filings to be submitted in Roche's name, Aspreva shall, as
appropriate, include a cross-reference or cross-references to any Regulatory
Filings Controlled by Roche and related to the Product.
(b) PREPARATION OF REGULATORY FILINGS. Aspreva has the right to
receive copies of the [ * ], which Roche shall provide upon request by Aspreva.
Aspreva shall prepare all Regulatory Filings for the Product in the Field in the
Territory in a form that is consistent with, and in accordance with, the [ * ],
and the Development Plan. The Parties anticipate that as they work together
under this Agreement, the [ * ] may be revised by the JC to facilitate the
timely preparation of Regulatory Filings.
(c) SUBMISSION OF PROPOSED REGULATORY FILINGS TO ROCHE. Aspreva
shall submit to Roche each proposed Regulatory Filing prepared as provided under
Section 5.5(a) for Roche's comments and review. Unless Roche notifies Aspreva in
writing of Roche's proposed modification of a Regulatory Filing prepared by
Aspreva hereunder within [ * ] of Roche's receipt thereof, such Regulatory
Filing shall be deemed approved by Roche as to form and substance and ready for
filing with the relevant Regulatory Authority. If Roche notifies Aspreva that
such proposed Regulatory Filing lacks necessary information, is not in
accordance with the [ * ] or the data is not in
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accordance with the [ * ] or otherwise is not appropriate for filing with the
relevant Regulatory Authority, it shall so notify Aspreva during such [ * ]
period, and the Parties shall confer with respect to any changes or additions
recommended by Roche (the "INITIAL CONFERENCE"). In addition, the JC shall
establish mechanisms or guidelines for the interactions following the Initial
Conference of the Parties with respect to the submission of Regulatory Filings,
including the submission of information as a follow up to any submitted
Regulatory Filing, which mechanisms or guidelines shall be consistent with the
joint obligations of the Parties set forth in Article 4.
(d) SUBMISSION TO REGULATORY AUTHORITIES. Following Roche's approval
of a Regulatory Filing (either by express approval or by failure to reject as
provided above in Section 5.5(c)), Roche agrees to file promptly, in its own
name, such Regulatory Filing with the proper Regulatory Authority so as to meet
the Parties objectives as outlined in Section 4.2. Aspreva, on the other hand,
agrees that, notwithstanding the foregoing, Roche shall not be obligated to file
with the relevant Regulatory Authorities any Regulatory Filing that is not
consistent with the [ * ].
(e) COPIES TO ASPREVA. Roche shall provide to Aspreva copies of all
Regulatory Filings in the Field submitted to Regulatory Authorities in the
Territory within [ * ] days following receipt of filing thereof.
(f) FILING FEES. Roche shall pay for all filing fees associated with
any Regulatory Filings in the Field in the Territory outside the United States,
and Aspreva shall pay for all filing fees associated with any Regulatory Filings
in the Field in the United States.
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5.6 INTERACTIONS WITH REGULATORY AUTHORITIES. To the extent possible,
Roche shall provide to Aspreva reasonable written notice of all meetings and
conference telephone calls with any Regulatory Authority related to the Product
in the Field in the Territory, and Aspreva shall have the right to have [ * ]
attend each such meeting and [ * ] attend each such call, in each case as silent
observers and to the extent permitted by the relevant Regulatory Authority. The
JC shall implement policies and procedures for providing to Aspreva a copy of
all correspondence or communications, other than Regulatory Filings (which are
addressed under Section 5.5(e)), with Regulatory Authorities relating to the
Product in the Field in the Territory. If such correspondence or communication
requires a response, Aspreva shall prepare a draft response, which draft shall
be subject to approval by Roche, and where so approved, filed by Roche. Such
draft will be deemed approved by Roche if Roche fails to provide a written
modification or comments thereto to Aspreva by the earlier of: (i) [ * ]
following Roche's receipt of the response prepared by Aspreva or (ii) [ * ]
prior to any deadline for filing the response.
5.7 OWNERSHIP OF REGULATORY APPROVALS. As between the Parties, Roche shall
own and maintain all Regulatory Filings and all Regulatory Approvals that relate
to the Product in the Field in the Territory.
5.8 DRUG SAFETY.
(a) ADVERSE EVENT REPORTING; SAFETY DATABASE. Roche shall report, at
its expense, to appropriate authorities, in accordance with local requirements,
all adverse events related to use of the Product in the Field in the Territory.
Adverse
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events related to the use of the Product in the Field in the Territory shall be
recorded in a single, centralized database, which shall be held and owned by
Roche. Direct access to the global safety database will not be granted to
Aspreva but Roche will provide, upon request by Aspreva, all reasonable
assistance in responding to safety queries related to the Product in the Field
and in assessing safety issues related to the Product in the Field. Details of
safety reporting activities relating to the Product in the Field will be
addressed in a pharmacovigilance contract, which the Parties shall enter into
after the Effective Date of this Agreement.
(b) SAFETY CRISIS MANAGEMENT. Promptly after the Effective Date of
this Agreement, each Party shall identify, in writing, its representatives who
will serve on the Parties' joint Drug Safety Committee. Each Party may replace
any or all of its representatives to the joint Drug Safety Committee by
providing written notice to the other Party. In the event of an unresolved
dispute between the Parties over a safety issue involving the Product in the
Field which rises to the level of a safety crisis that affects Product labeling
or the conduct of a clinical trial, the Parties will notify both Parties'
representatives on the joint Drug Safety Committee in order to organize a
meeting. The Parties shall in addition exercise their best efforts to provide
the joint Drug Safety Committee with all then-current information regarding the
safety crisis issue prior to the meeting, if possible. The joint Drug Safety
Committee shall agree on the appropriate measures to be taken to address the
relevant safety issue, and which Party is most appropriate to implement such
measures, which such Party or Parties shall fully implement such measures. The
joint Drug Safety Committee shall operate by consensus. If the Drug Safety
Committee is unable to reach a consensus decision with
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respect to any safety crisis issue after thorough discussion and consultation by
Roche's Drug Safety Committee members with Aspreva's Drug Safety Committee
members, then Roche shall have the final say as holder of the regulatory
approval for the Product; provided, however, that Aspreva may veto any
unilateral decision by Roche that would impose on Aspreva costs or expenses that
exceed [ * ]. Schedule 5.8(b) contains the contact information for safety crisis
management for each party.
5.9 PRODUCT WITHDRAWALS AND RECALLS. In the event that (i) Roche
determines that an event, incident, or circumstance has occurred which may
result in the need for a recall or other removal of the Product or any lot or
lots thereof from the market in the Territory; (ii) any Regulatory Authority in
the Territory threatens or initiates any action to remove a Product from the
market in the Field; or (iii) any Regulatory Authority in the Territory requires
distribution of a "Dear Doctor" letter or its equivalent, regarding use of
Product in the Field, Roche shall promptly advise Aspreva in writing with
respect thereto, and shall provide to Aspreva copies of all relevant
correspondence, notices, and the like. Aspreva further agrees, upon reasonable
request by Roche and at Roche's cost and expense, to assist Roche in the conduct
of any such Product recall or withdrawal in the Territory.
ARTICLE 6
COMMERCIALIZATION
6.1 COMMERCIALIZATION PLAN. All AI Commercialization shall be conducted
pursuant to a Commercialization Plan, which shall set forth the plan for the
Detailing and Promotion of the Product in the Field and the activities to be
carried out related
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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thereto (the "COMMERCIALIZATION PLAN"). The Parties have agreed upon a
high-level outline of the Commercialization Plan, a copy of which is attached
hereto as Schedule 6.1. No later than [ * ], and on an annual basis thereafter,
Aspreva shall submit to the JC an updated Commercialization Plan, which the JC
shall review and approve on a timely basis. Each updated Commercialization Plan
shall include for the next [ * ] years the succeeding projection of (a) the plan
for Detailing and Promotion activities for the Product in the Field in the
Territory and timelines for performing such activities, and (ii) a non-binding
forecast of supply of Product Samples in the Territory. Once approved by the JC,
such updated Commercialization Plan shall become effective and supercede the
previous Commercialization Plan as of the date of such approval or at such other
time decided by the JC. The JC shall not approve an updated Commercialization
Plan that is inconsistent with or contradicts the terms of this Agreement
without the written consent of the Parties, and in the event of any
inconsistency between the Commercialization Plan and this Agreement, the terms
of this Agreement shall prevail.
6.2 COMMERCIALIZATION ACTIVITIES.
(a) ASPREVA OBLIGATIONS. Except as otherwise provided herein,
Aspreva shall (i) Promote and Detail the Product in the Field in the Territory
in accordance with the Commercialization Plan and Section 6.4, including the
development of advertising and promotional materials as set forth in Section
6.5; (ii) implement a call center for providing medical information services to
hospitals and/or customers; (iii) establish Phase IV registries for patients
receiving the Product for use in the Field, where required by Regulatory
Authorities as a condition for granting Regulatory Approval in the Field; and
(iv) perform other activities (other than Roche
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Commercialization Activities) not otherwise accounted herein but which are
required by Regulatory Authorities to Promote and Detail the Product in the
Field in the Territory (collectively, the "ASPREVA COMMERCIALIZATION
ACTIVITIES").
(b) ROCHE OBLIGATIONS. Roche shall sell and distribute the Product
in the Territory for all uses, including use in the Field. Related activities
include (i) providing Aspreva with the Existing Promotional Materials and filing
of the Aspreva Promotional Materials with relevant Regulatory Authorities; (ii)
taking orders, booking all sales, distributing Product, and handling invoicing,
inventory, receivables, managing relationships with the trade, returns,
reimbursements, and charge-backs, customer complaints and inquiries; (iii)
making certain sales force training materials available to Aspreva; and (iv)
providing Aspreva with Product Samples for Aspreva's use in carrying out the
Aspreva Commercialization Activities, as set forth in Section 7.2 (collectively,
the "ROCHE COMMERCIALIZATION ACTIVITIES").
6.3 COMMERCIALIZATION COSTS.
(a) ASPREVA COSTS. Aspreva shall bear all costs and expenses
incurred in connection with the Aspreva Commercialization Activities.
(b) ROCHE COSTS. Roche shall bear all costs and expenses incurred in
connection with the Roche Commercialization Activities.
6.4 ASPREVA DETAILING ACTIVITIES.
(a) DETAILING EFFORT. During the Term, and consistent with the
Commercialization Plan and applicable law, Aspreva shall deploy the Aspreva
Sales
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Representatives to Detail Product in the Field in the Territory at such level of
effort (whether in terms of headcount or number of Details) as is set forth in
the Commercialization Plan.
(b) FAILURE TO SUPPLY DETAILS. For each Major Market Country on a
country-by-country basis, during the period commencing [ * ] after obtaining the
first Regulatory Approval of the Product in such Major Market Country and ending
upon expiry of the last-to-expire Roche Base Patent in such Major Market
Country, in the event that Aspreva does not employ at least [ * ] of the number
of aggregate full-time equivalent Aspreva Sales Representatives as is set forth
in the Commercialization Plan for such Major Market Country for the relevant
time period, then Roche shall, upon written notice to Aspreva, have the right to
provide its sales representatives to perform Aspreva's Details of the Product in
such Major Market Country until such time as Aspreva is reasonably able to
demonstrate to Roche that it has hired the requisite Aspreva Sales
Representatives and such Aspreva Sales Representatives are capable of sustaining
such effort. If Roche so provides such sales force, then Aspreva shall reimburse
Roche [ * ] of Roche's costs associated therewith. For the sake of clarity, it
is understood that Roche's right under this Section 6.4(b) to Detail the Product
in a Major Market Country upon Aspreva's failure to employ a sufficient number
of Aspreva Sales Representatives is distinct from Roche's right under Section
2.4(b) to Detail and Promote the Product in the Territory.
6.5 ADVERTISING AND PROMOTIONAL MATERIALS.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(a) EXISTING PROMOTIONAL MATERIALS. At Aspreva's request, Roche
shall, at its sole cost and expense, provide and ship to Aspreva reasonable
quantities of those promotional, sales, marketing, and educational materials for
the Product and all other written communications that describe the features or
benefits of the Product, as such materials or communications then currently
exist (the "EXISTING PROMOTIONAL MATERIALS"). Such Existing Promotional
Materials shall include, by way of example, [ * ] As between Roche and Aspreva,
Roche shall own all right, title, and interest in and to any such Existing
Promotional Materials provided to Aspreva hereunder, including applicable
copyrights and trademarks. Roche hereby grants to Aspreva the right, during the
Term, to use all Existing Promotional Materials in conjunction with Aspreva
Commercialization Activities under this Agreement, and to make derivative works
based thereon as provided in Section 6.5(b), in all cases as provided in the
Commercialization Plan.
(b) ASPREVA PROMOTIONAL MATERIALS. Aspreva will be responsible for
development of all advertising and promotional materials related to the use of
the Product and all other written communications that describe the features or
benefits of the Product, in each case in the Field and in the Territory (the
"ASPREVA PROMOTIONAL MATERIALS"), in accordance with Roche's style and branding
guidelines, provided that Roche shall have the right to approve such materials
with respect to determination of whether or not messages and methods contained
in such materials meet all requisite medical, legal, and regulatory
requirements, in accordance with the approval process set forth below. As a
general principle, to the extent allowed by applicable law, Aspreva shall have
the right to include the Aspreva House Marks in the Aspreva Promotional
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Materials, subject to branding and implementation guidelines to be agreed upon
by the Parties. The JC shall review, comment upon and approve all Aspreva
Promotional Materials, with all comments and approvals to be made in writing no
later than thirty (30) days following the first meeting of the JC after
submission of the materials to the JC by Aspreva. Following JC approval of the
Aspreva Promotional Materials, Aspreva shall submit (or the JC shall submit at
Aspreva's request) the Aspreva Promotional Materials to Roche for Roche's
approval of all requisite medical, legal, and regulatory requirements, such
approval to be given in a timely fashion. Aspreva shall not use in the conduct
of the Aspreva Commercialization Activities any Aspreva Promotional Materials
that have not been approved by both Roche and the JC.
(c) OWNERSHIP OF ASPREVA PROMOTIONAL MATERIALS. Roche expressly
agrees and acknowledges that the Aspreva Promotional Materials may include,
without limitation, derivative works based on one or more Existing Promotional
Materials. As between Roche and Aspreva, Aspreva shall own all right, title, and
interest in and to any intellectual property appurtenant to the Aspreva
Promotional Materials, including any Aspreva House Marks and copyrights, but
excluding the Roche Trademarks, Roche House Marks and any other intellectual
property of Roche appurtenant to the Existing Promotional Materials.
(d) PROHIBITION ON ASPREVA. Aspreva agrees that it will not develop
or use any promotional materials with respect to pharmaceutical products other
than the Product, either itself or with or through any Third Parties, which
compromise or otherwise misappropriate or infringe upon, or are confusingly
similar to, any trade dress rights or "look and feel" of the Existing
Promotional Materials.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(e) FILING OF MATERIALS WITH REGULATORY AUTHORITIES. Roche shall
timely file with the relevant Regulatory Authority, in accordance with all
applicable laws and regulations, all Aspreva Promotional Materials required to
be filed with such Regulatory Authority with respect to use of the Product in
the Field. Roche shall provide Aspreva with copies of such filings and any
correspondence with Regulatory Authorities pursuant to Section 5.6.
6.6 DISTRIBUTION OF PRODUCT SAMPLES. Aspreva shall, through Aspreva Sales
Representatives, provide Product Samples to medical professionals authorized to
receive such samples, in accordance with the Commercialization Plan. Aspreva
shall notify Roche within [ * ] of learning of any instances of theft or
significant loss, or upon Aspreva having reason to believe there has been a
diversion or falsification of a sample record, or other instance of
non-compliance with any applicable laws regarding Product Samples. Any and all
records, reports or other documentation with respect to Product Samples,
generated from compliance reports, accountability cards and the like produced by
Aspreva shall be maintained by Aspreva for a period of not less than [ * ]
years. Aspreva shall fully cooperate with Roche in the production or delivery of
any such documentation as may be requested or required by the FDA or any other
governmental authority. Aspreva further acknowledges and agrees that Roche shall
cause Aspreva to become designated as an authorized distributor of record with
respect to Product Samples. Aspreva further agrees that it will comply fully
with all Roche policies and procedures relating to sampling practice, to the
extent Roche informs Aspreva thereof.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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6.7 CUSTOMER SERVICES. Roche shall accept and fill all orders for Product
originating from Aspreva's promotional efforts on a non-discriminatory basis
relative to accepting and filling orders originating from its own sales force.
If Aspreva receives any customer order for the Product in the Territory, Aspreva
shall immediately forward such order to Roche by facsimile (or other agreed
method), followed by the original hard copy if the order is placed by hard copy.
6.8 CUSTOMER COMPLAINTS AND INQUIRIES. The Parties intend that customer
complaints and inquiries shall be initially received by Roche, which shall log
the complaint or inquiry [ * ] whether a response [ * ] is most appropriate,
depending upon whether the complaint or inquiry relates to [ * ], all in
accordance with [ * ] to [ * ] by [ * ] set forth in the Commercialization Plan.
Aspreva shall be responsible for responding to complaints and inquiries relating
primarily to the Aspreva Commercialization Activities and Roche shall be
responsible for responding to all other complaints and inquiries; provided,
however, that Roche shall in any event inform Aspreva of any complaint or
inquiry (or issues related thereto) that would materially effect Aspreva's
rights or obligations under this Agreement.
6.9 PRODUCT SELLING PRICES. Roche shall set all Product prices, [ * ],
rebates and similar matters, and shall independently determine the selling price
of the Product in all formulations; provided, however, that Roche shall consider
in good faith any input provided by Aspreva regarding Product pricing,
discounting, and the like in the Field and in the Territory. Roche shall also
determine all credit terms and return policies.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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6.10 SALES FORCE TRAINING. Roche shall, on a country-by-country basis,
provide Aspreva with copies of all current training material, including all
amendments and revisions thereof, used by Roche for the purposes of marketing
and selling Product in that country. Aspreva shall ensure that the Aspreva Sales
Representatives review and understand such materials prior to attending any
meetings described in the following sentence. Roche shall also through the JC,
on a country-by-country basis, advise Aspreva of all meetings in any [ * ] in
which [ * ] purpose of such meeting is the training of the Roche sales force in
[ * ] and shall invite [ * ] of the Aspreva sales force applicable to [ * ] to
attend such meetings.
6.11 CONDUCT OF PROMOTION AND DETAILING. Aspreva shall cause its Sales
Representatives and other employees engaged in the conduct of the Promotion
activities hereunder to comply with Roche's internal prescription pharmaceutical
promotional practice policies and guidelines as and to the extent such are
conveyed to Aspreva.
ARTICLE 7
PRODUCT SUPPLY
7.1 CLINICAL SUPPLY BY ROCHE.
(a) ROCHE OBLIGATIONS. Subject to the terms set forth below, Roche
shall supply to Aspreva all Product and placebo requested by Aspreva for the AI
Development, pursuant to the terms of this Section 7.1. Roche shall not be
obligated to supply (i) any amount of Product or placebo not in accordance with
the Development Plan or (ii) any number of units of placebo in excess of the
units of Product supplied by
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Roche. Roche warrants that all Product supplied hereunder: (i) shall meet all
then-applicable specifications for the Product (the "SPECIFICATIONS"); and (ii)
shall be manufactured in accordance with GMP and any other applicable regulatory
or legal requirements. At the first JC meeting, the Parties shall agree upon
availability and timing of delivery of clinical supplies of the Product
hereunder.
(b) MAXIMUM SUPPLY. Roche shall in no event be obligated to supply
more than (i) [ * ] tablets of Product ([ * ] mg per tablet) and an equivalent
number of placebo during the period commencing with the Effective Date until [ *
], and (ii) thereafter [ * ] tablets of Product ([ * ] per tablet) and an
equivalent number of placebo during each calendar year during the Term, until [
* ]. In any event, Roche's requirements for supply of Product necessary to
fulfill orders for sale shall take precedence over Aspreva's orders for clinical
supplies.
(c) PRICE. Aspreva shall pay to Roche an amount equal to [ * ] for
such clinical supplies of the Product and placebo supplied under this
Section 7.1.
(d) PURCHASE ORDERS. At the first JC meeting, Roche and Aspreva
shall agree upon and set forth in a writing signed by the Parties (i) the amount
of Product and placebo to be supplied by Roche to Aspreva during the period
commencing with the Effective Date until [ * ], and (ii) the procedures for
Aspreva to submit its requirements and Roche to supply such requirements. Such
procedures shall include (i) annual non-binding [ * ] forecasts of Aspreva's
requirements, (ii) firm purchase commitments no less than [ * ] prior to the
time the order must be delivered to Aspreva by Roche, and (iii) procedures for
return and replacement of Product that does not meet
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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the Specifications or is in breach of the warranty set forth in Section 7.1(a)
(collectively, "DEFECTIVE PRODUCT"). Any purchase orders, purchase order
releases, confirmations, acceptances, invoices, and similar documents submitted
by either Party shall be for administrative purposes only and shall not add to
or modify the terms of this Agreement, except for the specification of
quantities or delivery dates.
(e) CLINICAL SUPPLY OF THIRD PARTY MATERIAL. The Parties anticipate
that the Development Plan may require the use of pharmaceuticals manufactured by
Third Parties as controls for the clinical testing of Product in the Field. In
such event, Roche shall, on terms to be discussed, and if agreed in writing,
obtain on Aspreva's behalf and supply to Aspreva such Third Party pharmaceutical
material, and Aspreva shall reimburse Roche its costs in connection therewith.
7.2 SUPPLY OF PRODUCT SAMPLES. Roche shall provide Aspreva with Product
Samples for Aspreva's use in the Aspreva Commercialization Activities at no
charge to Aspreva. Product Samples will be provided in such amounts and in such
configurations as set forth in the Commercialization Plan, but in no event shall
Roche be obligated to provide more than [ * ] (of [ * ] tablets per unit
and [ * ] mg per tablet) per year during the Term.
7.3 COMMERCIAL SUPPLY CAPACITY. On a [ * ] basis, Roche shall provide to
the JC (or to a duly formed subcommittee) forecast data showing expected
worldwide manufacturing capacity and demand for the Product for the subsequent [
* ], and the JC shall decide whether Roche will have adequate manufacturing
capacity to fulfill such demand for Product for such [ * ] period. In the event
that the JC concludes that a
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manufacturing shortfall is reasonably possible, it shall inform the Parties and
the Parties shall [ * ].
ARTICLE 8
ROYALTIES AND ACCOUNTING
8.1 ROYALTY PAYMENTS TO ASPREVA. Beginning with the fifth full quarter
following the quarter in which occurs the dosing of the first patient in
accordance with the Development Plan and continuing each quarter until the end
of the Term (such period, the "ROYALTY TERM"), Roche shall owe to Aspreva a
royalty payment equal to fifty percent (50%) of Incremental Residual Sales for
such quarter, or portion thereof. Such royalty payment obligation shall be based
upon Roche's forecast of sales, as set forth in Section 8.2, followed by a
reconciliation on a yearly basis as provided in Section 8.4.
8.2 SALES FORECAST-BASED PAYMENTS.
(a) PROJECTED GLOBAL TRACKED SALES. At the start of the Royalty Term
and for each calendar year thereafter, Roche shall provide to Aspreva a forecast
of its anticipated Net Sales of the Product attributable to the Transplant
Indications for each quarter of such calendar year (or portion remaining
thereof) using such methodology as Roche otherwise uses in the forecasting of
such Net Sales for its own internal purposes (the "PROJECTED GLOBAL TRACKED
SALES"). Roche shall provide such forecast no more than [ * ] days following the
start of the Royalty Term and no less than [ * ] days prior to the beginning of
each calendar year, as applicable. Thereafter, Roche shall provide to Aspreva
any modifications to the Projected Global Tracked Sales within [ * ] days of any
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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such modification. Each forecast provided by Roche shall be the same forecast
used by Roche at such time for its own internal purposes.
(b) PAYMENT DUE TO ASPREVA. Roche shall, following each calendar
quarter, calculate the Estimated Incremental Residual Sales for such quarter and
shall, until a reconciliation is performed as to such quarter pursuant to
Section 8.4, pay to Aspreva fifty percent (50%) of such Estimated Incremental
Residual Sales for such quarter.
8.3 PAYMENTS AND REPORTS. Roche agrees to pay to Aspreva the quarterly
payment set forth in Section 8.2(b) within forty-five (45) days after the end of
such quarter. Along with such payment, Roche shall submit to Aspreva a report
that includes the following information for such quarter in the Territory:
(a) Projected Global Tracked Sales;
(b) Adjusted Gross Sales and Net Sales for the Product;
(c) Estimated Incremental Residual Sales; and
(d) an enumeration of the payments due to Aspreva under
Section 8.2(b).
8.4 RECONCILIATION.
(a) TIMING; FREQUENCY. Within [ * ] days after the end of each
Reconciliation Period (as defined below) for which Roche provides a Projected
Global Tracked Sales forecast, Roche shall calculate and provide a written
report to Aspreva of
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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the Incremental Residual Sales as compared against Estimated Incremental
Residual Sales for such period, as determined using the Sales Tracking
Methodology according to Section 8.5 (the "RECONCILIATION"). Such Reconciliation
shall be conducted for (i) the period from the start of the Royalty Term until
the first to occur of June 30 or December 31 of such year, (ii) each of the next
three (3) six-month periods thereafter, and (iii) each calendar year period
thereafter (each period, a "RECONCILIATION PERIOD"). Such report shall include a
statement certifying that the Reconciliation was performed in accordance with
the Sales Tracking Methodology and shall also include the following information
for such Reconciliation Period in the Territory:
(i) Projected Global Tracked Sales for the particular
Reconciliation Period;
(ii) Adjusted Gross Sales and Net Sales for the Product for
the particular Reconciliation Period;
(iii) Estimated Incremental Residual Sales for the particular
Reconciliation Period;
(iv) Global Tracked Sales for the Product for the particular
Reconciliation Period, to permit Aspreva to verify the calculation of such
figure under the Sales Tracking Methodology; and
(v) Incremental Residual Sales for the particular
Reconciliation Period.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(b) RECONCILIATION MEETING. Within [ * ] days of receipt of the
Reconciliation, upon written request by Aspreva, the Financial Liaison of Roche
shall meet with the Financial Liaison of Aspreva to go through the information
contained in the Reconciliation, including the calculation of Global Tracked
Sales in accordance with the Sales Tracking Methodology, and address Aspreva's
concerns or questions related thereto (the "RECONCILIATION MEETING").
Notwithstanding the Reconciliation Meeting, Aspreva shall have a period of [ * ]
days after receipt to review, comment upon, or otherwise object in writing or
inquire as to the Reconciliation information provided by Roche pursuant to
Section 8.4(a), it being understood that any such comments or objections shall
be [ * ] the [ * ] of the Sales Tracking Methodology and the Reconciliation
process as described in Section 8.4(a), and not to the [ * ] of the Sales
Tracking Methodology [ * ]. Upon receipt of any such objections or questions,
Roche shall supply to Aspreva such information as Aspreva reasonably requests.
In the event an error is identified, Roche shall [ * ], and shall [ * ]. This
Section 8.4(b) shall not be construed as diminishing Aspreva's rights under
Section 8.13.
(c) PAYMENTS OWED OR DEDUCTIONS ALLOWED. In the event that
Incremental Residual Sales for the Reconciliation Period exceeds the Estimated
Incremental Residual Sales upon which Roche's quarterly payments pursuant to
Section 8.2(b) for the Reconciliation Period were based, Roche shall promptly
pay Aspreva such amount as is necessary to make Aspreva whole, as though the
Estimated Incremental Residual Sales for such Reconciliation Period accurately
reflected Incremental Residual Sales. In the event that Incremental Residual
Sales for the Reconciliation Period are less than the estimated Incremental
Residual Sales upon
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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which Roche's quarterly payments pursuant to Section 8.2(b) for the
Reconciliation Period were based, Roche shall be entitled to deduct such amount
as is necessary, from the next payment due Aspreva under this Article 8, to make
Roche whole, as though Estimated Incremental Residual Sales accurately reflected
Incremental Residual Sales; provided that such deduction shall not exceed [ * ]
of the amounts otherwise payable to Aspreva for such next payment owed Aspreva.
Any deduction otherwise allowed but not taken as a result of such [ * ]
limitation shall be carried forward and applied to payments due Aspreva under
this Article 8 in future quarters, subject in each case to such [ * ]
limitation.
8.5 SALES TRACKING METHODOLOGY.
(a) METHODOLOGY. For the purpose of each Reconciliation and the
determination of actual Global Tracked Sales, Roche shall use a defined
methodology (the "SALES TRACKING METHODOLOGY") to determine which portion of Net
Sales in the Territory resulted from purchases of the Product for use in the
Transplant Indications. Aspreva and Roche agree that the Sales Tracking
Methodology shall initially be such methodology as is described in Schedule 8.5,
subject to modification by the JC pursuant to Section 8.5(b).
(b) MODIFICATIONS TO METHODOLOGY. The JC may elect at any point to
adopt a different or modified Sales Tracking Methodology, which, if the JC so
elects, shall become effective for the Reconciliation Period in which such
election occurs (or for the first Reconciliation Period, if such election occurs
before the start of the Royalty Term), and Schedule 8.5 shall be so amended to
substitute such newly agreed-upon
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Sales Tracking Methodology. If the JC fails to agree on a different Sales
Tracking Methodology proposed by either Party, the Sales Tracking Methodology
then in effect shall continue to be used. Notwithstanding the foregoing, it is
understood and agreed by the Parties that each shall have the right, at its own
expense, to undertake such market research and analysis, including "probes" or
sampling of patient data, physician prescribing habits and the like (the "NEW
SALES TRACKING DATA") or otherwise propose modifications to the Sales Tracking
Methodology at any time during the Term, and to present such data or otherwise
propose modifications to the Sales Tracking Methodology to the JC to enhance the
validity or reliability of the Sales Tracking Methodology. It shall be the JC's
continuing obligation to review any such New Sales Tracking Data in good faith,
with the overriding obligation to ensure fair and accurate compensation to the
Parties under this Agreement by tracking as accurately as reasonably possible,
purchases of the Product in the Transplant Indications, balancing the
desirability of increased accuracy against the costs of obtaining same. In the
event that the JC adopts a new Sales Tracking Methodology that incorporates New
Sales Tracking Data proposed by a Party, such proposing Party bears the burden
of payment of any incremental costs of obtaining such New Sales Tracking Data;
provided, however, that after [ * ], the Parties will share such costs [ * ] to
the extent such costs are then prospective.
8.6 SAMPLE PAYMENT CALCULATIONS. Schedule 8.6 contains an example of the
calculations of the quarterly payments due under Section 8.1 and the periodic
Reconciliation payments under Section 8.4. The sales figures shown in
Schedule 8.6
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are hypothetical and are presented solely for the purpose of illustrating the
method for calculating the royalty payments under this Agreement.
8.7 ADJUSTMENTS TO BASELINE RESIDUAL SALES.
(a) CHANGES IN AVERAGE UNIT SELLING PRICE. Commencing January 2004,
Roche shall calculate the Average Unit Selling Price and communicate same to
Aspreva in writing. On an annual basis thereafter, Roche shall calculate the
increase or decrease in the Average Unit Selling Price from the prior twelve
month period, and the Parties shall adjust Baseline Residual Sales upward or
downward, as the case may be, by that same percentage. On or before January 31st
of each year, Roche shall provide to Aspreva a report listing (i) such increase
or decrease in the Average Unit Selling Price and (ii) the new Baseline Residual
Sales figure for the then-current year, both calculated pursuant to this Section
8.7(a).
(b) PRODUCT RECALLS AND WITHDRAWALS. In the event that, due to a
Product recall or withdrawal, the Product is no longer sold in such country,
then Baseline Residual Sales shall be adjusted downward to offset the loss of
sales in such country. Such adjustment for such country shall be at that
percentage level set forth in Schedule 8.7(b) opposite the name of such country.
For example, in the event the Product were no longer being sold in Germany,
Baseline Residual Sales would be reduced by [ * ], and would only be subject to
upward adjustment thereafter as provided in Section 8.7(a). [ * ]
(c) TERMINATION BY ASPREVA. In the event that Aspreva terminates
this Agreement with respect to a particular country in the Territory as provided
in
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Section 14.2, then the Territory shall be defined thereafter as excluding such
country for purposes of calculating Net Sales, and Baseline Residual Sales shall
be adjusted downward to offset the loss of sales in such country. Such
adjustment for such country shall be equal to that percentage level set forth in
Schedule 8.7(b) opposite the name of country. For example, in the event the
Product were no longer being sold in Germany, Baseline Residual Sales would be
reduced by [ * ], and would only be subject to upward adjustment thereafter as
provided in Section 8.7(a). [ * ]
8.8 FINANCE LIAISON. No later than thirty (30) days prior to the start of
the Royalty Term, each Party shall designate a Finance Liaison responsible for
overseeing and facilitating the exchange of information contemplated under this
Article 8. Either Party may replace its Finance Liaison at any time upon thirty
(30) days prior written notice to the other Party.
8.9 CURRENCY AND CONVERSION. All payments under this Agreement shall be in
Swiss Francs. For the purpose of computing Net Sales for Product sold in a
currency other than Swiss Francs, Roche shall convert the amount of Net Sales in
foreign currencies as computed in accordance with Roche's then current standard
practices.
8.10 INTEREST. In the event that Roche is late in paying to Aspreva any
amounts due under this Agreement within the applicable time period set forth
herein, such payment shall bear interest at the lesser of [ * ] as reported by
[ * ] (or a successor or similar organization) from time to time.
8.11 TAXES.
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(a) COOPERATION AND COORDINATION. The Parties acknowledge and agree
that it is their mutual objective and intent to minimize, to the extent
feasible, taxes payable with respect to their collaboration efforts under this
Agreement and that they shall use their best efforts to cooperate and coordinate
with each other to achieve such objective.
(b) PAYMENT OF TAX. A Party receiving a payment pursuant to this
Article 8, or deemed to receive a payment as a result of the cross-licensing
arrangement under Article 2, shall pay any and all taxes levied on such payment
or deemed payment. If applicable laws or regulations require that taxes be
deducted and withheld from a payment made pursuant to this Article 8, the
remitting Party shall (i) deduct those taxes from the payment; (ii) pay the
taxes to the proper taxing authority; and (iii) send evidence of the obligation
together with proof of payment to the other Party within sixty (60) days
following that payment.
(c) TAX RESIDENCE CERTIFICATE. A Party (including any party to whom
this Agreement may be assigned as permitted under Section 16.2) receiving a
payment pursuant to this Article 8 shall provide the remitting Party
certification from the revenue authorities of a jurisdiction (a "TAX RESIDENCE
CERTIFICATE") that it is a tax resident of that jurisdiction if such receiving
Party wishes to claim the benefits of an income tax treaty to which that
jurisdiction is a party. Upon the receipt thereof, any deduction and withholding
of taxes shall be made at the appropriate treaty tax rate.
(d) ASSESSMENT. Either Party may, at its own expense, protest any
assessment, proposed assessment, or other claim by any governmental authority
for
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any additional amount of taxes, interest or penalties or seek a refund of such
amounts paid if permitted to do so by law. The Parties shall cooperate with the
other in any protest by providing records and such additional information as may
reasonably be necessary for a Party to pursue such protest.
8.12 BLOCKED CURRENCY. If by reason of law Roche is unable to convert to
Swiss Francs a portion of the amount due by Roche under this Agreement, then
Roche shall notify Aspreva in writing and Aspreva shall have the right to
receive such portion and, upon written request from Aspreva, Roche shall pay to
Aspreva such portion, in the currency of any other country designated by Aspreva
and legally available to Roche.
8.13 ACCOUNTING; AUDITS.
(A) RECORDS. Roche agrees to keep full, clear, and accurate records
for a period of at least three (3) years, or such longer period as may coincide
with Roche's internal records retention policy, setting forth sales of the
Product in the Territory during the Term in sufficient detail to permit Aspreva
to confirm the accuracy of (i) Roche's determination of Global Tracked Sales
pursuant to the Sales Tracking Methodology and (ii) the calculation of royalty
payments and other compensation payable to Aspreva under this Agreement.
(B) AUDIT. Roche further agrees to permit Aspreva to engage Roche's
independent, certified public accountant, on behalf of Aspreva, to examine by
way of an audit conducted in accordance with IAS, such of its books and records
related to the calculations set forth in this Article 8, including all data used
in conducting the Sales Tracking Methodology and in calculating any
Reconciliation, but in any event no more
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than once in any given calendar year. Aspreva shall have a right to request from
the independent certified public accountant full access to review all work
papers and supporting documents pertinent to such audit. If Aspreva reasonably
believes, after reviewing information received from Roche's independent public
accountant, that an additional audit is appropriate to address an apparent
discrepancy with respect to Roche's calculation of Net Sales or other
calculations set forth in this Article 8, Aspreva shall have the right, by an
audit specialty firm acceptable to Roche, employed by Aspreva and at Aspreva's
own expense, to perform such necessary audit procedures.
(C) COSTS OF AUDIT. Aspreva shall bear the cost of any audit under
this Section 8.13, except in the event that the results of the audit reveal an
underpayment of the amounts described in this Article 8 by [ * ] or more over
the period being audited, in which case Roche shall pay all costs of such
examination. In the event that such examination concludes that additional
amounts are owed to Aspreva, Roche shall pay any such additional amounts within
thirty (30) days of the date that Roche receives the written report so
concluding. In the event that such examination concludes that there has been an
overpayment with respect to amounts paid to Aspreva, the excess (after deducting
the cost of the examination) shall be credited to Roche against future payments
required by this Article 8.
ARTICLE 9
PATENTS AND INVENTIONS
9.1 INVENTIONS. As between the Parties, Aspreva shall own any and all
Inventions invented, either solely or jointly with Third Parties, by the
employees or
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agents of Aspreva (the "ASPREVA SOLE INVENTIONS"). Aspreva and Roche shall each
own an undivided equal interest in any Invention invented jointly by the
employees or agents of Aspreva and Roche, with or without Third Parties (the
"JOINT INVENTIONS"), and any Patents that claim such Joint Inventions (the
"JOINT PATENTS"). Aspreva and Roche, as joint owners, shall each have the right
to practice and to grant licenses under such Joint Patents without the other
Party's consent or a duty of accounting, except as otherwise provided in this
Agreement or agreed in writing by the Parties or as required by law. Solely for
the purpose of determining ownership of Inventions under this Section 9.1,
inventorship shall be determined in accordance with United States patent laws.
9.2 PATENT PROSECUTION.
(A) ASPREVA PATENTS. Aspreva shall retain control and ownership
over, and bear all expenses associated with, the filing, prosecution, and
maintenance of any Aspreva Patents. Aspreva shall confer in good faith with
Roche regarding Aspreva's patent strategy, including those countries in the
Territory in which Aspreva intends to file applications for Aspreva Patents.
Roche shall have the right to comment upon Aspreva's strategy and to propose
additional countries in the Territory where it believes Aspreva should seek
Patent protection. The Parties shall determine in good faith how to [ * ] and to
[ * ] associated with the [ * ] of the Aspreva Patents in such additional
countries; provided, however, that [ * ] shall not be obligated to [ * ] in any
country [ * ] or otherwise to incur costs in connection therewith. In the event
Aspreva decides not to file an application for an Aspreva Patent relating to the
Product in the Field in a country where Aspreva had previously agreed to file an
application, Aspreva
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shall promptly notify Roche of such decision and Roche shall have the right to
file, prosecute, and maintain such Aspreva Patent at its sole expense and
discretion. If Aspreva chooses not to file an application for an Aspreva Patent
relating to the Product in the Field and Roche elects to file such patent
application at its own expense, Aspreva shall assign any and all rights that it
may have to such a patent application to Roche (in which case it shall become a
Roche Patent), and Roche shall grant Aspreva a license under such patent
application or Patent issuing therefrom to the extent such a license is
necessary or useful for Aspreva's conduct of activities outside the Field,
including the making, using, selling, offering for sale, or importing of
products outside the Field.
(b) JOINT PATENTS. The JC shall determine the Parties' rights and
obligations with respect to the filing, prosecution, maintenance and enforcement
of Joint Patents and the costs associated therewith, on a case-by-case basis.
9.3 ENFORCEMENT OF PATENT RIGHTS.
(a) NOTICE. If either Party becomes aware of any Third Party
activity in a Major Market Country that infringes a Roche Base Patent, or an
Aspreva Patent in the Field or a Joint Patent in the Field, then that Party
shall give prompt written notice to the other Party within [ * ] days after
gaining knowledge of such infringement or violation.
(b) ROCHE'S PRIMARY RIGHT TO BRING ACTION. Roche shall have the
primary right, but not the obligation, to institute, prosecute or control any
action or proceeding, with respect to such Third Party activity, by counsel of
its own choice. If Roche institutes such an action, Aspreva shall confer with
Roche, and Aspreva shall
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have the right, at its sole option, to pay up to fifty percent (50%) of Roche's
ongoing litigation expenses associated with such action.
(C) ALLOCATION OF RECOVERY. In the event that Aspreva decides to pay
a portion of Roche's litigation expenses as provided in Section 9.3(b), any
damages or monetary awards recovered by Roche shall first be applied to
reimburse each Party an amount equal to the reasonable costs and expenses of
such Party in connection with such litigation, and the balance shall be [ * ] In
the event that Aspreva decides not to pay a portion of Roche's litigation
expenses, any damages or monetary awards recovered shall first be applied to
reimburse Roche an amount equal to its reasonable costs and expenses in
connection with such litigation. Roche and Aspreva shall share that portion of
any remaining damages or monetary award attributable to lost profits, with Roche
receiving [ * ] of such portion and Aspreva receiving [ * ] of such portion. The
Parties shall determine in good faith Aspreva's share, if any, of damages or
monetary awards based on a reasonable royalty or any legal theories other than
lost profits. After deducting the amounts described above, any balance of
damages or monetary awards shall belong to Roche.
(D) ASPREVA'S RIGHT TO BRING ACTION. If Roche fails to bring an
infringement action under the Roche Base Patents, or the Aspreva Patents in the
Field or the Joint Patents in the Field, within a period of [ * ] days after
delivery of the notice set forth in Section 9.3(a), then Aspreva shall have the
right, but not the obligation, to bring and control an action, with respect to
such Third Party activity, by counsel of its own choice. Roche shall have the
right, at its sole option, to pay up to fifty percent (50%) of Aspreva's ongoing
litigation expenses associated with such action. In the
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event that Roche decides to pay a portion of Aspreva's litigation expenses, any
damages or monetary awards recovered shall first be applied to reimburse each
Party an amount equal to the reasonable costs and expenses of such Party in
connection with such litigation, and the balance shall be shared by the Parties
in proportion to the costs and expenses borne by each Party. In the event that
Roche decides not to pay a portion of Aspreva's litigation expenses, any damages
or monetary awards recovered shall first be applied to reimburse Aspreva an
amount equal to its reasonable costs and expenses in connection with such
litigation. Roche and Aspreva shall share that portion of any remaining damages
or monetary award attributable to lost profits, with Aspreva receiving [ * ] of
such portion and Roche receiving [ * ] of such portion. The Parties shall
determine in good xxxxx Xxxxx'x share, if any, of damages or monetary awards
based on a reasonable royalty or any legal theories other than lost profits.
After deducting the amounts described above, any balance of damages or monetary
awards shall belong to Aspreva.
(e) In any event, the Party not bringing an infringement action
under this Section 9.3 shall have the right (at its own expense, which shall not
be reimbursed out of any damages or monetary award recovered) to participate in
such action and to be represented by counsel of its own choice; furthermore, the
Party not bringing such an infringement action agrees to be joined as a party to
the suit, at the request and expense of the Party bringing such action, and to
provide reasonable assistance in any such action, at the requesting Party's
expense.
9.4 ENFORCEMENT OF OTHER GOVERNMENT-CONFERRED RIGHTS. If either Party
becomes aware of any Third Party activity in the Territory that is in violation
of
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government-conferred exclusivity (e.g., an Orphan Drug designation) with respect
to the Product (the "REGULATORY EXCLUSIVITY RIGHTS"), then that Party shall give
prompt written notice to the other Party within [ * ] days after gaining
knowledge of such infringement or violation.
9.5 DEFENSE OF THIRD PARTY CLAIMS. If a claim is brought by a Third Party
against Roche or Aspreva that any activity conducted pursuant to this Agreement
or the use, manufacture, sale, offer for sale, or importation of the Product in
the Field in the Territory infringes the intellectual property rights of such
Third Party, such Party will give prompt written notice to the other Party of
such claim. If such claim is not based solely on the use of the Product in the
Field, then Roche shall defend and hold harmless Aspreva against any such claim
and any resulting suit at its expense and shall indemnify Aspreva against any
resulting judgments and settlements, provided that Roche shall not settle any
claim or suit in a manner that would negatively affect Aspreva without obtaining
Aspreva's prior written consent, which shall not be unreasonably withheld.
Alternatively, if such claim is based solely on the use of the Product in the
Field, then Roche shall be entitled to deduct [ * ] of its reasonable costs of
defense, plus any amounts paid in settlement or adverse judgment, in [ * ] from
Net Sales over [ * ], prior to the calculation of royalty payments owed to
Aspreva under Section 8.2(b); provided, however, that in no quarter shall such
royalty payments be reduced to below [ * ]. Any deduction otherwise allowed but
not taken as a result of insufficient Net Sales shall be carried forward and
applied in [ * ].
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 10
TRADEMARK USAGE AND MAINTENANCE
10.1 OWNERSHIP OF TRADEMARKS.
(a) ROCHE TRADEMARKS. Roche or its Affiliates shall exclusively own
all Roche Trademarks, and shall be responsible for procurement and maintenance
of trademark registrations for such Roche Trademarks and shall bear all expenses
attributable thereto. Except for the license granted in Section 2.2, nothing
herein shall create any ownership rights of Aspreva in and to the Roche
Trademarks. Roche agrees to execute any required documents, to provide upon
request any required records, and otherwise to cooperate fully with Aspreva as
may be necessary to accomplish the recordation of such license in any
jurisdiction that Aspreva seeks such recordation. In such event, the expenses
for recordation will be borne by Aspreva.
(b) ASPREVA HOUSE MARKS. Aspreva shall exclusively own all Aspreva
House Marks, and shall be responsible for procurement and maintenance of
trademark registrations for such Aspreva House Marks and shall bear all expenses
attributable thereto. Except for the license granted in Section 2.3(a), nothing
herein shall create any rights of Roche in and to the Aspreva House Marks.
10.2 USE OF THE TRADEMARKS. Aspreva shall use the Roche Trademarks only in
connection with the developing, Detailing, and Promoting of Products in the
Field in the Territory. It is understood and agreed by Roche that Aspreva shall
have the right to use the Aspreva House Marks in conjunction with the Roche
Trademarks, as provided
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in Section 6.5. Roche shall use the Aspreva House Marks only as provided in
Section 2.3(a).
10.3 HOUSE MARKS. Each Party acknowledges the goodwill and reputation
associated with the other Party's House Marks, and shall use such House Marks in
a manner that maintains and promotes such goodwill and reputation. Each Party
shall take all reasonable precautions and actions to protect the goodwill and
reputation that has inured to the other Party's House Marks, shall refrain from
doing any act that is reasonably likely to impair the reputation of such House
Marks, and shall cooperate fully to protect such House Marks.
10.4 QUALITY CONTROL. As provided in Section 6.5(b), Aspreva shall not use
any Aspreva Promotional Material without review by the JC.
10.5 ACKNOWLEDGEMENT OF OWNERSHIP RIGHTS. Aspreva undertakes to conduct
its activities in such a way so as not to jeopardize or compromise in any way
the Roche Trademarks or rights therein, and Roche undertakes to conduct its
activities in such a way so as not to jeopardize or compromise in any way the
Aspreva House Marks. Each Party shall not use the other Party's Trademarks or
House Marks, as the case may be, as all or part of any corporate name, trade
name, trademark, service xxxx, certification xxxx, collective membership xxxx,
domain name, or any other designation confusingly similar to the other Party's
Trademarks or House Marks in any way that damages the other Party's Trademarks
or House Marks. If Aspreva or its Affiliates challenge or, directly or
indirectly, assert any right, title or interest in or to the Roche House Marks,
the Roche Trademarks, or any registrations or applications for
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registration thereof, or seek to register the Roche House Marks, the Roche
Trademarks, or any trademark confusingly similar thereto in any country for any
goods and services, then Roche shall have the right to give written notice to
Aspreva of such conduct and Aspreva shall immediately cease such conduct. If
Roche or its Affiliates challenge or, directly or indirectly, assert any right,
title or interest in or to the Aspreva House Marks or any registrations or
applications for registration thereof, or seek to register the Aspreva House
Marks or any trademark confusingly similar thereto in any country for any goods
and services, then Aspreva shall have the right to give written notice to Roche
of such conduct and Roche shall immediately cease such conduct.
10.6 USE OF TRADEMARK DESIGNATIONS. The (TM) designation shall be used in
conjunction with each Roche Trademark or Aspreva House Xxxx within the Territory
until such time as registrations issue, except to the extent such designation is
not common practice in a given country of the Territory. Once registrations
issue, the (R) designation shall be used in connection with the Roche Trademarks
and the Aspreva House Marks, except to the extent such designation is not common
practice in a given country of the Territory. An appropriate statutory notice of
trademark ownership shall be affixed to or imprinted on any material wherever
the Roche House Marks, Roche Trademarks, and Aspreva House Marks are used.
Roche's and Aspreva's respective ownership of such marks shall be identified on
all materials on which they appear. The exact language for identification of
ownership shall be in accordance with branding and implementation guidelines to
be agreed upon by the Parties.
10.7 INFRINGEMENT OF ROCHE TRADEMARKS.
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(a) PROCEDURE. In the event that either Party becomes aware of (i)
actual infringement of a Roche Trademark; (ii) a xxxx or name confusingly
similar to a Roche Trademark; or (iii) any unfair trade practices, trade dress
imitation, passing off, or like offenses, that relate to the Roche Trademarks,
such Party shall promptly so notify the other Party in writing. Roche shall have
the right, but not the obligation, at its sole cost and expense, to initiate,
prosecute, and control an infringement action or file any other appropriate
action or claim related to infringement of the Roche Trademark against any Third
Party. If Roche fails to bring an such infringement action within a period of
ninety (90) days after delivery of the notice set forth above, then Aspreva
shall have the right, but not the obligation, at its sole cost and expense, to
initiate, prosecute, and control an infringement action or file any other
appropriate action or claim related to infringement of the Roche Trademark
against any Third Party. In either event, the Party not bringing any such action
(i) shall have the right (at its own expense) to participate in such action and
to be represented by counsel of its own choice, and (ii) agrees, at the request
and expense of the Party bringing such action, to be joined as a party to the
suit and to provide reasonable assistance in any such action. The Party
controlling such action shall take all reasonable and appropriate steps to
protect, defend, and maintain the Roche Trademarks for use by the Parties and
shall have the right to control settlement of such action; provided, however,
that no settlement shall be entered into without the written consent of the
other Party, not to be unreasonably withheld.
(b) COSTS. Any damages or monetary award recovered shall be applied
first to reimburse the reasonable costs and expenses of the Party bringing such
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action in connection with such litigation, with the balance being allocated to
the Parties in proportion that Party's share of such costs and expenses.
10.8 THIRD PARTY TRADEMARK CLAIMS.
(a) CLAIMS BASED ON USE OF THE ROCHE TRADEMARKS. If a claim is
brought by a Third Party that use of the Roche Trademarks infringes such Third
Party's trademarks, the Party against which the action is brought will give
prompt written notice to the other Party of such claim. Roche shall defend such
claim and any resulting suit at its expense and shall indemnify Aspreva against
any resulting final judgments and settlements, provided that Roche shall not
settle any claim or suit in a manner that would adversely affect Aspreva without
obtaining Aspreva's prior written consent, which shall not be unreasonably
withheld.
(b) CLAIMS BASED ON USE OF EITHER PARTY'S HOUSE MARKS. If a claim is
brought by a Third Party that use of either Party's House Marks infringes such
Third Party's trademarks, the Party against which the action is brought will
give prompt written notice to the other Party of such claim. The Party that owns
the relevant House Marks shall defend such claim and any resulting suit at its
expense and shall indemnify the other Party against any resulting final
judgments and settlements, provided that the defending Party shall not settle
any claim or suit in a manner that would adversely affect the other Party
without obtaining the other Party's prior written consent, which shall not be
unreasonably withheld.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 11
COVENANTS, REPRESENTATIONS, AND WARRANTIES
11.1 MUTUAL COVENANTS. Each Party covenants the following:
(a) That it shall comply and cause its employees to comply, with all
federal, state, provincial, territorial, governmental, and local laws, rules,
and regulations applicable to the development, manufacture, Promotion,
Detailing, and commercialization of the Product by such Party pursuant to the
Development Plan, Commercialization Plan, and this Agreement, including without
limitation, with respect to the United States, the Prescription Drug Marketing
Act ("PDMA"), the Federal Food, Drug and Cosmetics Act of 1938, as amended, the
Health Insurance Portability and Accountability Act ("HIPAA"), the Federal
Anti-Kickback Statute, and any applicable FDA regulations relating to sampling
practices.
(b) That it shall disclose promptly, without delay, to the other
Party all information in its Control, and as to which it becomes aware,
concerning side effects, injury, toxicity, or sensitivity reaction and incidents
or severity thereof with respect to the Product.
11.2 ROCHE COVENANTS. Roche covenants, on behalf of itself and its
Affiliates, that:
(a) It shall not, nor shall its Affiliates, during the Term, pledge
or otherwise convey any security interest in any [ * ] or sell or transfer any [
* ], except as expressly provided for herein, and except that Roche shall have
the right to transfer
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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same to any Affiliate of Roche, or in connection with a merger or acquisition of
or by Roche, or in connection with a sale of assets of Roche to which this
Agreement relates, provided any such transfer shall be at all times subject to
the terms and conditions of this Agreement.
(b) It or its Affiliates shall maintain the [ * ] within the
Territory in the [ * ] during the Term.
11.3 ASPREVA COVENANT. Aspreva covenants, on behalf of itself and its
Affiliates, that it or its Affiliates will use its or their best efforts over
the thirty-six (36) months following the Effective Date to raise adequate
capital to finance the first three (3) clinical trial programs in the Field as
set forth in the Development Plan.
11.4 REPRESENTATIONS AND WARRANTIES OF THE PARTIES.
(a) Roche and Aspreva each represents and warrants to the other
that, as of the Effective Date: (i) it is duly organized, validly existing, and
in good standing under the laws of its jurisdiction of incorporation, (ii) it
has the authority and right to enter into this Agreement and to perform its
obligations hereunder, (iii) this Agreement is a legal and valid obligation
binding upon it and is enforceable in accordance with its terms, subject to
applicable limitations on such enforcement based on bankruptcy laws and other
debtors' rights, and (iv) its execution, delivery and performance of this
Agreement will not conflict in any material fashion with the terms of any other
agreement or instrument to which it is or becomes a party or by which it is or
becomes bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having authority over it.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(b) Roche and Aspreva each represents and warrants to the other, as
of the Effective Date, that neither its name nor the name of any of its
employees or consultants who will be undertaking any activities related to this
Agreement or the Product are listed on the debarment list maintained by the FDA
pursuant to 21 U.S.C. Sections. 335(a) and sections. 335(b) and published on the
internet at the following address (or any successor address):
xxxx://xxx.xxx.xxx/xxx/xxxxxxxxxx_xxx/xxxxx/xxxxxxx.xxx.
11.5 REPRESENTATIONS AND WARRANTIES OF ROCHE. Roche hereby represents and
warrants to Aspreva that, as of the Effective Date:
(a) It has not withheld any information related to the Product,
including but not limited to clinical data, Regulatory Filings, and regulatory
communications, that would be reasonably determined to be material to Aspreva's
decision to enter into this Agreement;
(b) There are no [ * ] (or the equivalent in countries outside the
United States) pending with respect to the Product in the Major Market
Countries;
(c) Other than [ * ], neither Roche nor any of its Affiliates has
granted any licenses to, or otherwise authorized, any person or entity under [ *
] to [ * ] the [ * ] in the [ * ];
(d) To the best of Roche's knowledge, Roche or its Affiliates [ * ]
all right, title and interest in and to [ * ], such [ * ] are not owned or
co-owned by any other Party, and neither Roche nor its Affiliates have pledged
or otherwise conveyed any security interest in such [ * ].
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(e) In the Major Market Countries, there is no [ * ] or, to Roche's
knowledge, [ * ] that [ * ] the Product [ * ] of any Third Party;
(f) It has sufficient capacity for the manufacture and supply of the
Product in the Territory to meet the demand to be created by the efforts of
Aspreva under this Agreement in accordance with the Development Plan and the
Commercialization Plan, based on Aspreva's projections of such demand, as
communicated to Roche as of the Effective Date; and
(g) Schedule 2.6(c) is [ * ] a listing of all countries [ * ]
wherein [ * ] any [ * ] the right to [ * ] the Product.
11.6 PERFORMANCE BY AFFILIATES. The Parties recognize that each may
perform some or all of its obligations under this Agreement through one or more
Affiliates, provided, however, that (i) Roche shall remain responsible and be
guarantor of the performance by its Affiliates; and (ii) Aspreva Canada shall
remain responsible and be guarantor of the performance of Aspreva and its or
Aspreva's Affiliates. Roche and Aspreva Canada shall each cause its Affiliates,
and Aspreva Canada shall cause Aspreva and its or Aspreva's Affiliates, to
comply with the provisions of this Agreement in connection with such
performance.
ARTICLE 12
CONFIDENTIALITY
12.1 TREATMENT OF CONFIDENTIAL INFORMATION. Except as provided below, the
Parties agree that during the Term, and for a period of [ * ] years thereafter,
each Party
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(the "RECEIVING PARTY") shall (i) maintain in confidence Confidential
Information of the other Party (the "DISCLOSING PARTY") to the same extent and
with the same degree of care as the Receiving Party maintains its own
proprietary industrial information of similar kind and value (but at a minimum
each Party shall use commercially reasonable efforts), (ii) not disclose such
Confidential Information to any Third Party without prior written consent of the
Disclosing Party, except for disclosures made in confidence to any Third Party
that are explicitly permitted by the Commercialization Plan or Development Plan
or approved by the JC, and (iii) not use such Confidential Information for any
purpose except those permitted by this Agreement.
12.2 EXCEPTIONS. Notwithstanding the foregoing, the Receiving Party shall
have no such confidentiality obligations with respect to any portion of the
Confidential Information of the Disclosing Party that:
(a) at the time of disclosure by the Disclosing Party to the
Receiving Party, was generally available to the public, or after such
disclosure, becomes generally available to the public through no fault
attributable to the Receiving Party; or
(b) was known to the Receiving Party, without obligation to keep it
confidential, prior to when it was received from the Disclosing Party; or
(c) is subsequently disclosed to the Receiving Party, without
obligation to keep it confidential, by a Third Party lawfully in possession
thereof and having the right to so disclose; or
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(d) as demonstrated by the Receiving Party by competent written
proof, has been independently developed by employees of the Receiving Party who
do not have access to or knowledge of such Confidential Information.
12.3 AUTHORIZED DISCLOSURES. Nothing in this Agreement shall prohibit the
Receiving Party from disclosing Confidential Information of the other Party, as
well as the terms and conditions of this Agreement:
(a) to the Receiving Party's Affiliates, employees, agents,
consultants, sublicensees, potential collaborators, advisors, clinical
investigators, and contract manufacturers, if any, but only on a need-to-know
basis for purposes provided for in this Agreement, provided such disclosure
occurs pursuant to a written confidentiality agreement containing provisions at
least as protective as those of this Article 12;
(b) to professional advisors bound by a duty of confidentiality;
(c) in cases where Aspreva is the Receiving Party, to Aspreva's
investors and potential investors, acquirers, or merger candidates; or
(d) to the extent required by court order, law, or regulation,
provided that the Receiving Party provides the other Party prior written notice
of the required disclosure and takes reasonable steps to limit such disclosure
to the minimum required amount and to obtain, or cooperate with the other Party
in obtaining, a protective order or other similar order requiring that such
Confidential Information be used only for the purposes required by such court
order, law, or regulation.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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12.4 PUBLICITY. All publicity, press releases, and other public
announcements relating to this Agreement or the performance hereunder other than
publications described in Section 12.5 shall be reviewed in advance by, and
subject to the approval of, both Parties (which approval shall not be
unreasonably withheld); provided, however, that any disclosure which it believes
in good faith is required by law or any listing or securities trading agreement
concerning its publicly traded securities, based upon advice of the disclosing
Party's counsel, may be made without the prior consent of the other Party,
although the other Party shall be given prompt notice of any such legally
required disclosure and to the extent practicable the disclosing Party shall
provide the other Party an opportunity to comment on the proposed disclosure.
12.5 PUBLICATION.
(a) Each Party agrees that it shall not publish or present to the
public the results of non-clinical scientific studies or clinical trials related
to the Product in the Field without the opportunity for prior review by the
other Party. If a Party (the "PUBLISHING PARTY") wishes to publish or to present
to the public such results, then it shall provide the other Party (the
"NON-PUBLISHING PARTY") the opportunity to review any of the Publishing Party's
proposed abstracts, manuscripts or presentations (including verbal
presentations) which relate to any Product at least thirty (30) days prior to
its intended submission for publication and agrees, upon request, not to submit
any such abstract or manuscript for publication until the other Party is given a
reasonable period of time to secure patent protection for any material in such
publication which it believes to be patentable. Both Parties understand that a
reasonable commercial strategy may require delay of publication of information
or filing of patent applications.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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The Parties agree to review and consider delay of publication and filing of
patent applications under certain circumstances. Neither Party shall have the
right to publish or present to the public Confidential Information of the other
Party, except as permitted under Sections 12.2 and 12.3. Nothing contained in
this Section 12.5 shall prohibit the inclusion of information necessary for a
patent application, except for Confidential Information of the non-filing Party,
provided the non-filing Party is given a reasonable opportunity to review the
information to be included prior to submission of such patent application.
(b) It is understood that a Detail of the Product in the Field in
the Territory shall not be considered to be publication or presentation to the
public and shall therefore not be subject to the requirements of Section
12.5(a).
12.6 TERMINATION OF PRIOR AGREEMENTS. This Agreement supersedes all
non-disclosure agreements entered into by the Parties prior to the Effective
Date. All information exchanged between the Parties under such nondisclosure
agreements prior to the Effective Date shall be deemed Confidential Information
and shall be subject to the terms of this Article 12.
ARTICLE 13
INDEMNIFICATION
13.1 INDEMNIFICATION BY ASPREVA. Unless otherwise provided herein, Aspreva
agrees to indemnify, hold harmless and defend Roche and its directors, officers,
employees and agents (the "ROCHE INDEMNITEES") from and against any and all
Third Party suits, claims, actions, demands, liabilities, losses, and/or
expenses (including
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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reasonable attorneys fees and legal expenses) (collectively, "CLAIMS") resulting
or alleged to result from, directly or indirectly, any of the following (each,
an "ASPREVA ASSUMED LIABILITY"):
(a) a breach by Aspreva of a representation, warranty, or covenant
of this Agreement;
(b) any statement or representation attributable to Aspreva, its
Affiliates, or their respective officers, directors, employees, agents,
sublicensees or subcontractors (the "ASPREVA PARTIES") that is inconsistent with
or contrary to the Product labeling or any Existing Promotional Materials or
Aspreva Promotional Materials;
(c) any violation of applicable law or regulation by an action,
policy, or practice of the Aspreva Parties in the performance of Aspreva's
obligations under this Agreement except when the action, policy, or practice
found to be in violation was the direct result of approval by Roche of any
Aspreva Promotional Materials or such action, policy, or practice was a
procedure of or established by Roche;
(d) any negligence or willful misconduct of the Aspreva Parties in
connection with their performance of Aspreva's obligations under this Agreement.
Such indemnity shall not apply if Roche fails to comply with the indemnification
procedures set forth in Section 13.3 or to the extent it is shown that the Claim
was the result of any Roche Assumed Liability (as defined below).
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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13.2 INDEMNIFICATION BY ROCHE. Unless otherwise provided herein, Roche
shall indemnify, hold harmless and defend Aspreva and its directors, officers,
employees and agents (the "ASPREVA INDEMNITEES") from and against any and all
Claims resulting or alleged to result to result from, directly or indirectly,
any of the following (each, a "ROCHE ASSUMED LIABILITY"):
(a) a breach of a representation, warranty, or covenant of this
Agreement by Roche;
(b) any statement or representation attributable to Roche, its
Affiliates, or their respective officers, directors, employees, agents,
sublicensees or subcontractors (the "ROCHE PARTIES") that is inconsistent with
or contrary to the Product labeling or Existing Marketing Materials;
(c) Third Party personal injury or death, possibility of injury or
death, or economic loss with respect to Product (other than an Advertising Claim
in the Field);
(d) any violation of applicable law or regulation by the Roche
Parties in the performance of Roche's obligations under this Agreement,
including, without limitation, with regard to Roche's obligations pertaining to
adverse event reporting and recalls of the Product;
(e) any negligence or willful misconduct of the Roche Parties;
(f) terms and conditions with respect to the sale of Product in the
Territory;
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(g) failure of the Product to comply with Specifications or Roche's
warranty under Section 7.1;
(h) violation or infringement of any right granted by a Roche Party
to a Third Party Distributor, or breach of any obligation undertaken by a Roche
Party with respect to a Third Party Distributor; or
(i) infringement of Third Party patent rights through the
manufacture, sale, advertising, and/or importation of the Product, if such
Claims are not based solely on use of the Product in the Field. Such indemnity
shall not apply if Aspreva fails to comply with the indemnification procedures
set forth in Section 13.3 or to the extent it is shown that the Claim was the
result of any Aspreva Assumed Liability.
13.3 PROCEDURE. In the event of a claim by a Third Party against a Party
entitled to indemnification under this Agreement ("INDEMNIFIED PARTY"), the
Indemnified Party shall promptly notify the other Party ("INDEMNIFYING PARTY")
in writing of the claim and the Indemnifying Party shall undertake and solely
manage and control, at its sole expense, the defense of the claim and its
settlement. The Indemnified Party shall cooperate with the Indemnifying Party,
including, as requested by the Indemnifying Party and at the Indemnifying
Party's cost, entering into a joint defense agreement. The Indemnified Party
may, at its option and expense, be represented in any such action or proceeding
by counsel of its choice. The Indemnifying Party shall not be liable for any
litigation costs or expenses incurred by the Indemnified Party without the
Indemnifying Party's written consent. The Indemnifying Party shall not settle
any such
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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claim unless such settlement fully and unconditionally releases the Indemnified
Party from all liability relating thereto, unless the Indemnified Party
otherwise agrees in writing.
13.4 ADVERTISING CLAIMS IN THE FIELD. Roche and Aspreva shall each be
jointly responsible for any Third Party economic loss, incurred by Roche or
Aspreva, with respect to Product labeling or marketing material ("ADVERTISING
CLAIM") with respect to the use of the Product in the Field. Any Advertising
Claim amounts paid by Roche shall be deducted from Net Sales in [ * ] commencing
with the [ * ] in which such loss was incurred prior to calculation of royalty
payments owed to Aspreva under this Agreement; provided, however, that in no [ *
] shall such royalty payments be reduced to below [ * ]. Any deduction otherwise
allowed but not taken as a result of insufficient Net Sales shall be carried
forward and applied in future [ * ] Where such Advertising Claim amount was paid
by Aspreva, Roche shall reimburse Aspreva [ * ] of such Advertising Claim within
thirty (30) days of written notice thereof by Aspreva.
13.5 INSURANCE. Each party shall procure and maintain insurance, including
product liability insurance, adequate to cover its obligations hereunder and
which are consistent with normal business practices of prudent corporations
similarly situated at all times during which the Product is being clinically
tested with human subjects or commercially distributed or sold. The Parties
acknowledge and agree that such insurance shall not be construed to create a
limit of either Party's liability with respect to its indemnification
obligations under this Article 13. Each Party shall provide the other with
written evidence of such insurance upon request. Each Party shall provide the
other with written notice at least thirty (30) days prior to the cancellation,
non-renewal or
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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material change in such insurance or self-insurance which materially adversely
affects the rights of the other Party hereunder.
ARTICLE 14
TERM AND TERMINATION
14.1 TERM. Unless earlier terminated in accordance with the terms of this
Article 14, the term of this Agreement shall begin on the Effective Date and
will expire December 31, 2017. Upon expiration of this Agreement:
(a) Roche shall pay Aspreva a sunset royalty for the years 2018,
2019, and 2020 equal to a percentage of Net Sales, if any, in the Territory in
each of these years. Such percentage shall be calculated according to the
following table:
YEAR ROYALTY PERCENTAGE
---- ------------------
2018 [ * ]
2019 [ * ]
2020 [ * ]
where [ * ] is total [ * ] for the period [ * ], inclusive, and [ * ] is [ * ]
for the same period. Any royalty payments due to Aspreva under this Section 14.1
for a particular year shall be due and payable by [ * ] of the subsequent year.
(b) Roche shall continue to have the right to use all aspects of the
Aspreva Promotional Materials other than the Aspreva House Marks, solely in
connection with the commercialization of the Product in the Field in the
Territory, subject to payment of the amounts owed under Section 14.1(a).
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(c) Roche shall retain a fully paid, non-exclusive license to use
and practice the Aspreva Know-How, solely in connection with the development or
commercialization of the Product in the Field. Such license shall terminate, on
a country-by-country basis, at such time that Roche ceases selling the Product
in each such country.
(d) The license granted Roche in Section 2.3(b) shall remain in
effect, but shall convert to a fully paid, non-exclusive license.
14.2 UNILATERAL TERMINATION BY ASPREVA. Aspreva shall have the right to
terminate this Agreement, on a country-by-country basis, at any time during the
Term, upon six (6) months notice to Roche. Upon termination by Aspreva pursuant
to this Section 14.2 with respect to a country in the Territory:
(a) Aspreva shall use Commercially Reasonable Efforts to return to
Roche all Product Samples, Existing Promotional Materials, and Aspreva
Promotional Materials then in Aspreva's Control that are specific to such
country.
(b) Baseline Residual Sales shall be adjusted downward and the
Territory shall be redefined to exclude such country, pursuant to Section
8.7(c).
(c) In such country, Roche shall continue to have the right to use
all aspects of the Aspreva Promotional Materials other than the Aspreva House
Marks, solely in connection with the commercialization of the Product in the
Field.
(d) Roche shall retain a fully paid, exclusive, except as to Aspreva
and its Affiliates, license to use and practice the Aspreva Know-How, solely in
connection
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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with the development or commercialization of the Product in the Field in such
country. Such license shall terminate at such time that Roche ceases selling the
Product in such country.
(e) In such country, the license granted Roche in Section 2.3(b)
shall remain in effect, but shall convert to a fully paid, non-exclusive
license.
(f) Aspreva shall continue to conduct or wind-down, as appropriate,
any then-existing clinical trials at its cost.
14.3 TERMINATION BASED ON SALES. In the event at any time after December
31, 2011, cumulative Residual Sales in the Territory over [ * ] are less than
Baseline Residual Sales, either Party shall have the right thereafter to
terminate this Agreement in its entirety upon ninety (90) days written notice to
other Party. For the sake of clarity, the Parties intend that termination under
this Section will be based entirely on Residual Sales calculated by applying the
Sales Tracking Methodology to actual sales of the Product, not on projected or
forecasted sales. Upon termination of this Agreement pursuant to this Section
14.3:
(a) Aspreva shall use Commercially Reasonable Efforts to return to
Roche all Product Samples, Existing Promotional Materials, and Aspreva
Promotional Materials then in Aspreva's Control.
(b) Roche shall retain a fully paid, exclusive, except as to Aspreva
and its Affiliates, license to use and practice the Aspreva Know-How, solely in
connection with the development or commercialization of the Product in the
Field. Such license
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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shall terminate, on a country-by-country basis, at such time that Roche ceases
selling the Product in each such country.
(c) The license granted Roche in Section 2.3(b) shall remain in
effect, but shall convert to a fully paid, non-exclusive license.
14.4 TERMINATION UPON CESSATION OF SALE OF THE PRODUCT. Either Party may
terminate this Agreement, on a country-by-country basis, at any time upon sixty
(60) days written notice to the other Party if the Product is (i) withdrawn from
the market in such country by Roche for safety reasons or (ii) recalled by Roche
for a period of [ * ] (and not reasonably expected to be reintroduced) in such
country. Upon termination of this Agreement pursuant to this Section 14.4:
(a) Aspreva shall use Commercially Reasonable Efforts to return to
Roche all Product Samples, Existing Promotional Materials, and Aspreva
Promotional Materials then in Aspreva's Control that are specific to such
country; and
(b) Baseline Residual Sales shall be adjusted downward pursuant to
Section 8.7(b).
14.5 MATERIAL BREACH.
(a) If either Party believes that the other is in material breach of
this Agreement (including without limitation any material breach of a
representation or warranty made in this Agreement), then the non-breaching Party
may deliver notice of such breach to the other Party. In such notice the
non-breaching Party shall identify the actions or conduct that such Party would
consider to be an acceptable cure of such
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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breach. For all breaches other than a failure to make a payment set forth in
Article 8, the allegedly breaching Party shall have ninety (90) days to either
cure such breach or, if cure cannot be reasonably effected within such ninety
(90) day period, to deliver to the other Party a plan for curing such breach
which is reasonably sufficient to effect a cure. Such a plan shall set forth a
program for achieving cure as rapidly as practicable. Following delivery of such
plan, the breaching Party shall use commercially reasonable efforts to carry out
the plan and cure the breach. For any breach arising from a failure to make a
payment set forth in Article 8, the allegedly breaching Party shall have ten
(10) days to cure such breach.
(b) If the Party receiving notice of breach fails to cure such
breach within the 90-day period or 10-day period (as applicable), or the Party
providing the notice reasonably determines that the proposed corrective plan or
the actions being taken to carry it out is not commercially practicable, the
Party originally delivering the notice may seek such remedies as are available
to such Party at law or in equity in accordance with the dispute resolution
provisions in Article 15.
(c) In the event that, as permitted by Section 16.2, the Agreement
either (i) is assigned to a Third Party or (ii) a Third Party becomes a
successor in interest to Aspreva as a result of merger or acquisition with or by
Aspreva or Aspreva Canada (in each case, a "SUCCESSOR ENTITY"), then Section
14.5(b) shall be automatically amended to provide Roche with the right, in
addition to any other remedies, to terminate this Agreement if such Successor
Entity fails to cure a material breach following notice thereof by Roche
according to Section 14.5(a), or if Roche reasonably determines that the
corrective plan, if any, proposed by such Successor
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Entity under Section 14.5(a) or the actions being taken to carry out such plan
are not commercially practicable. Such termination will be effective upon
expiration of the notice period provided in Section 14.5(a) or thirty (30) days
following Roche's written notice to such Successor Entity of a determination
regarding such commercial impracticability, as the case may be. In the event of
such termination: (i) the Successor Entity shall use Commercially Reasonable
Efforts to return to Roche all Product Samples, Existing Promotional Materials,
and Aspreva Promotional Materials then in the Successor Entity's Control; (ii)
Roche shall retain a fully paid, exclusive, except as to Aspreva and its
Affiliates, license to use and practice the Aspreva Know-How solely in
connection with the development or commercialization of the Product in the
Field, which such license shall terminate, on a country-by-country basis, at
such time that Roche ceases selling the Product in each such country; and (iii)
the license granted Roche in Section 2.3(b) shall remain in effect, but shall
convert to a fully paid, non-exclusive license.
(d) Notwithstanding Section 14.5(a), in the event that Aspreva
materially breaches its covenant under Section 11.3, then Roche shall have the
right to terminate this Agreement upon ninety (90) days advance written notice
to Aspreva if Aspreva fails to cure such breach within such ninety (90) day
period. In the event of such termination: (i) Aspreva shall use Commercially
Reasonable Efforts to return to Roche all Product Samples, Existing Promotional
Materials, and Aspreva Promotional Materials then in Aspreva's Control; (ii)
Roche shall retain a fully paid, non-exclusive license to use and practice the
Aspreva Know-How solely in connection with the development or commercialization
of the Product in the Field, which such license shall
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
84.
terminate, on a country-by-country basis, at such time that Roche ceases selling
the Product in each such country; and (iii) the license granted Roche in Section
2.3(b) shall remain in effect, but shall convert to a fully paid, non-exclusive
license.
14.6 SURVIVAL; ACCRUED RIGHTS. The rights and obligations of the Parties
under the following provisions of this Agreement shall survive expiration or any
termination of this Agreement: Sections 6.5(d), 8.13, 9.1, 9.2(a) (solely with
respect to assignments made or licenses granted pursuant thereto), 10.1, 14.6,
16.3, 16.5 and 16.6, and Articles 12, 13, and 15. In addition, the rights and
obligations specifically enumerated or referenced under 14.1, 14.2, 14.3, 14.4,
14.5(c), and 14.5(d) shall also survive as applicable to the events of
expiration or termination set forth in such Sections. Following any expiration
or termination of this Agreement, each Party shall, at the other Parties'
request, reasonably cooperate with the other Party with respect to the filing
and prosecution of any Joint Patent invented during the Term or any Aspreva
Patent invented during the Term (including any Aspreva Patent assigned to Roche
pursuant to Section 9.2(a)). In any event, expiration or termination of this
Agreement shall not relieve the Parties of any liability which accrued hereunder
prior to the effective date of such expiration or termination nor preclude
either Party from pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement nor prejudice
either Party's right to obtain performance of any obligation.
ARTICLE 15
DISPUTE RESOLUTION
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
85.
15.1 DISPUTES. Unless otherwise set forth in this Agreement, in the event
of a dispute arising under this Agreement between the Parties, the Parties shall
refer such dispute to the respective Senior Management, and such Senior
Management shall attempt in good faith to resolve such dispute.
15.2 ARBITRATION. If the Parties are unable resolve a given dispute
pursuant to Section 15.1 within [ * ] days of referring such dispute to the
Senior Management, either Party may have the given dispute settled by binding
arbitration in the manner described below:
(a) ARBITRATION REQUEST. If a Party intends to begin an arbitration
to resolve a dispute arising under this Agreement, such Party shall provide
written notice (the "ARBITRATION REQUEST") to the other Party of such intention
and the issues for resolution. From the date of the Arbitration Request and
until such time as the dispute has become finally settled, the running of the
time periods as to which Party must cure a breach of this Agreement becomes
suspended as to the subject matter of the dispute.
(b) ADDITIONAL ISSUES. Within [ * ] business days after the receipt
of the Arbitration Request, the other Party may, by written notice, add
additional issues for resolution.
(c) NO ARBITRATION OF PATENT/CONFIDENTIALITY ISSUES. Unless
otherwise agreed by the Parties, disputes relating to patents and
non-disclosure, non-use and maintenance of Confidential Information shall not be
subject to arbitration, and shall be submitted to a court of competent
jurisdiction.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
86.
(d) ARBITRATION PROCEDURE. Discovery shall be under the U.S. Federal
Rules of Civil Procedure then in effect in the District Court for the [ * ]. The
Arbitration shall be held in [ * ] under the rules of the American Arbitration
Association ("AAA"). The arbitration shall be conducted by [ * ] arbitrators who
are knowledgeable in the subject matter at issue in the dispute. [ * ] The
arbitrators may proceed to an award, notwithstanding the failure of either Party
to participate in the proceedings. The arbitrators shall, within [ * ] calendar
days after the conclusion of the arbitration hearing, issue a written award and
statement of decision describing the essential findings and conclusions on which
the award is based, including the calculation of any damages awarded. The
arbitrators shall be authorized to award compensatory damages, but shall NOT be
authorized to award non-economic damages or punitive damages, or to reform,
modify or materially change this Agreement or any other agreements contemplated
hereunder. The arbitrators also shall be authorized to grant any temporary,
preliminary or permanent equitable remedy or relief the arbitrators deem just
and equitable and within the scope of this Agreement, including, without
limitation, an injunction or order for specific performance. The award of the
arbitrators shall be the sole and exclusive remedy of the Parties. Judgment on
the award rendered by the arbitrators may be enforced in any court having
competent jurisdiction thereof, subject only to revocation on grounds of fraud
or clear bias on the part of the arbitrators. Notwithstanding anything contained
in this Section 15.2 to the contrary, each Party shall have the right to
institute judicial proceedings against the other Party or anyone acting by,
through or under such other Party, in order to enforce the instituting Party's
rights hereunder through specific performance, injunction or similar equitable
relief.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
87.
(e) COSTS; SATISFACTION. Each Party shall bear its own attorneys'
fees, costs, and disbursements arising out of the arbitration, and shall pay an
equal share of the fees and costs of the arbitrators; provided, however, that
the arbitrators shall be authorized to determine whether a Party is the
prevailing Party, and if so, to award to that prevailing Party reimbursement for
its reasonable attorneys' fees, costs and disbursements (including, for example,
expert witness fees and expenses, photocopy charges and travel expenses), and/or
the fees and costs of the arbitrators. Absent the filing of an application to
correct or vacate the arbitration award as permitted by applicable law, each
Party shall fully perform and satisfy the arbitration award within [ * ] days of
the service of the award.
15.3 WAIVER. By agreeing to this binding arbitration provision, the
Parties understand that they are waiving certain rights and protections which
may otherwise be available if a dispute between the Parties were determined by
litigation in court, including, without limitation, the right to seek or obtain
certain types of damages precluded by this provision, the right to a jury trial,
certain rights of appeal, and a right to invoke formal rules of procedure and
evidence.
ARTICLE 16
MISCELLANEOUS
16.1 POSSIBLE AMENDMENT OF AGREEMENT. In order to address certain
corporate finance and taxation objectives of either Party, at the request of
either Party within one hundred eighty (180) days after the Effective Date,
Roche and Aspreva shall discuss in good faith any amendment and restatement of
this Agreement proposed by a
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
88.
Party in order to achieve such objectives. In no event shall any such amendment
or restatement in order to achieve such objectives disadvantage either Party
with respect to the financial arrangement of this Agreement.
16.2 ASSIGNMENT.
(a) ROCHE ASSIGNMENT. Roche may not assign this Agreement or any
rights or obligations hereunder without the prior written consent of Aspreva,
such consent not to be unreasonably withheld, and any attempted assignment
without such consent shall be null and void. Notwithstanding the foregoing,
Roche may assign this Agreement to any of its Affiliates, or in connection with
a merger or acquisition of or by Roche, or a sale of Roche's assets to which
this Agreement relates. This Agreement shall be binding upon and, subject to the
other terms of this Section 16.2, inure to the benefit of the Roche's successors
and permitted assigns.
(b) ASPREVA ASSIGNMENT. Aspreva may not assign this Agreement or any
rights or obligations hereunder without the prior written consent of Roche, and
any attempted assignment without such consent shall be null and void.
Notwithstanding the foregoing, Aspreva may assign this Agreement to any of its
Affiliates, or in connection with a merger or acquisition of or by Aspreva, or a
sale of Aspreva's assets to which this Agreement relates, provided that such
assignment is not to a Competitive Company; and provided further that Aspreva
provides Roche with reasonable prior notice, under the circumstances then
existing, of such merger, acquisition, or sale of Aspreva's assets. This
Agreement shall be binding upon and, subject to the other terms of this Section
16.2, inure to the benefit of Aspreva's successors and permitted assigns.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
89.
16.3 BANKRUPTCY. All rights and licenses granted under or pursuant to this
Agreement by Roche or Aspreva are, and will otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
"intellectual property" as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that the Parties, as licensees of such rights under this
Agreement, will retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code. The Parties further agree that, in the event of
the commencement of a bankruptcy proceeding by or against either Party under the
U.S. Bankruptcy Code, the Party hereto that is not a party to such proceeding
will be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in their possession, will be
promptly delivered to them (a) upon any such commencement of a bankruptcy
proceeding upon their written request therefor, unless the Party subject to such
proceeding elects to continue to perform all of its obligations under this
Agreement, or (b) if not delivered under (a) above, following the rejection of
this Agreement by or on behalf of the Party subject to such proceeding upon
written request therefor by the non-subject Party.
16.4 NON-WAIVER. The waiver by either of the Parties of any breach of any
provision hereof by the other Party shall not be construed to be a waiver of any
succeeding breach of such provision or a waiver of the provision itself.
16.5 GOVERNING LAW. This Agreement shall be construed and interpreted in
accordance with the laws of the State of New York, without regard to any
conflicts of law principles that would provide for the application of the laws
of another jurisdiction.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
90.
16.6 SEVERABILITY. If and to the extent that any court or tribunal of
competent jurisdiction holds any of the terms or provisions of this Agreement,
or the application thereof to any circumstances, to be invalid or unenforceable
in a final nonappealable order, the Parties shall use their best efforts to
reform the portions of this Agreement declared invalid to realize the intent of
the Parties as fully as practical, and the remainder of this Agreement and the
application of such invalid term or provision to circumstances other than those
as to which it is held invalid or unenforceable shall not be affected thereby,
and each of the remaining terms and provisions of this Agreement shall remain
valid and enforceable to the fullest extent of the law.
16.7 NOTICE. Any notice to be given to a Party under or in connection with
this Agreement shall be in writing and shall be (i) personally delivered, (ii)
delivered by a nationally recognized overnight courier or (iii) delivered by
certified mail, postage prepaid, return receipt requested to the party at the
address set forth below for such party:
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
91.
To Roche: To Aspreva:
X. Xxxxxxxx-Xx Xxxxx Ltd Xxxxxxx Xxxxxxxx
Grenzacherstrasse 124 Chairman & CEO
CH-4070 Aspreva Pharmaceuticals Corp.
Basel, Switzerland 0000 Xxxxxxx Xx. #0000
Attn: Corporate Law Xxxxxxxx, XX X0X 0X0
Xxxxxx
With a copy to: with a copy to:
Xxxxxxxx-Xx Xxxxx Inc. Xxxxxxx Xxxxxx, Esq.
000 Xxxxxxxxx Xxxxxx Xxxxxx Godward LLP
Nutley, New Jersey 07110 Five Palo Alto Square
Attn: Corporate Secretary 0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
or to such other address as to which the Party has given written notice thereof.
Such notices shall be deemed given upon receipt.
16.8 HEADINGS. The headings appearing herein have been inserted solely for
the convenience of the Parties hereto and shall not affect the construction,
meaning or interpretation of this Agreement or any of its terms and conditions.
16.9 NO IMPLIED LICENSES. Except as expressly provided herein, no right or
license under any patent application, issued patent, trademark, know-how or
other proprietary information is granted or shall be granted by implication.
16.10 FORCE MAJEURE. No failure or omission by the Parties hereto in the
performance of any obligation of this Agreement shall be deemed a breach of this
Agreement nor shall it create any liability if the same shall arise from any
cause or causes beyond the reasonable control of the affected Party, including,
but not limited to, the following, which for purposes of this Agreement shall be
regarded as beyond the control of the Party in question: acts of nature; acts or
omissions of any government;
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
92.
any rules, regulations, or orders issued by any governmental authority or by any
officer, department, agency or instrumentality thereof; fire; storm; flood;
earthquake; accident; war; rebellion; insurrection; riot; invasion; strikes; and
lockouts or the like; provided that the Party so affected shall use its best
efforts to avoid or remove such causes or nonperformance and shall continue
performance hereunder with the utmost dispatch whenever such causes are removed.
16.11 ENTIRE AGREEMENT. This Agreement, including the schedules hereto,
constitutes the entire understanding between the Parties with respect to the
subject matter contained herein and supersedes any and all prior agreements,
understandings and arrangements whether oral or written between the Parties
relating to the subject matter hereof. This Agreement will control in the event
of any conflict between this Agreement and the Development Plan or between this
Agreement and the Commercialization Plan.
16.12 AMENDMENTS. No amendment, change, modification or alteration of the
terms and conditions of this Agreement shall be binding upon either Party unless
in writing and signed by the Party to be charged.
16.13 INDEPENDENT CONTRACTORS. It is understood that both Parties hereto
are independent contractors and engage in the operation of their own respective
businesses, and neither Party hereto is to be considered the agent or partner of
the other Party for any purpose whatsoever, except as otherwise expressly
provided in this Agreement. Neither Party has any authority to enter into any
contracts or assume any obligations for the other Party or make any warranties
or representations on behalf of
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
93.
the other Party. Furthermore, nothing in this Agreement shall be construed as
creating a partnership or joint venture among the Parties.
16.14 SCHEDULES. All schedules to this Agreement are part of this
Agreement.
16.15 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.
16.16 COUNTERPARTS. This Agreement may be executed in counterparts, each
of which shall be deemed an original and both of which together shall constitute
one and the same instrument.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
94.
IN WITNESS WHEREOF, the parties hereto have caused this Collaboration
Agreement to be executed by their duly authorized officers as of the date first
above written.
ASPREVA PHARMACEUTICALS GMBH X. XXXXXXXX-XX XXXXX LTD
By: /s/ Xxxxxxx Xxxxxxxx By: /s/ B. Bolzon
------------------------- ------------------------------------
Name: Xxxxxxx Xxxxxxxx Name: Xxxxxxx Xxxxxx, Ph.D.
---------------------- -----------------------------------
Title: CEO Title: Executive Vice President, Business
--------------------- Development, Licensing & Alliances
----------------------------------
By: /s/ Xxxxxx Xxxxxxxxx
-------------------------------------
Name: Xxxxxx Xxxxxxxxx, Ph.D.
-----------------------------------
Title: Vice President Licensing
----------------------------------
Approved as to form by Law Dept.:
/s/ PT
-----------------------------------------
XXXXXXXX-XX XXXXX INC.
By: /s/ Xxxxxx X. Xxxxx
-------------------------------------
Name: Xxxxxx X. Xxxxx
-----------------------------------
Title: Vice President Global Head of
Business Development
----------------------------------
For the limited purpose set forth in Section 11.6:
ASPREVA PHARMACEUTICALS CORP.,
a Canadian corporation
By:/s/ Xxxx Xxxx
--------------------------
Name: Xxxx Xxxx
Title: President
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
95.
SCHEDULE 1.41
FORMULATIONS FOR PRODUCT SAMPLES
1. CellCept(R) (mycophenolate mofetil capsules) 250 mg
NDC Number Size
----------------- ------------------------------------
NDC 0004-0259-01 Bottle of 100
NDC 0000-0000-00 Package containing 12 bottles of 120
NDC 0000-0000-00 Bottle of 500
2. CellCept(R) (mycophenolate mofetil tablets) 500 mg
NDC Number Size
---------------- -------------
NDC 0000-0000-00 Bottle of 100
NDC 0000-0000-00 Bottle of 500
3. CellCept(R) Oral Suspension (mycophenolate mofetil for oral suspension) 250
mg
NDC Number Size
---------------- --------------------------------------------
NDC 0000-0000-00 225 mL bottle with bottle adapter and 2 oral
dispensers
4. CellCept(R) Intravenous (mycophenolate mofetil hydrochloride for injection)
NDC Number
NDC 0000-0000-00
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1
SCHEDULE 2.6(b)
THIRD PARTY DISTRIBUTION COUNTRIES
[ * ]
SCHEDULE 5.1
DEVELOPMENT PLAN
[ * ]
SCHEDULE 5.8(b)
CONTACT INFORMATION FOR CRISES MANAGEMENT
FOR ROCHE: [ * ]
Xxxxxxxx-Xx Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000-0000 XXX
Tel: [ * ]
Fax: [ * ]
E-mail: [ * ]
FOR ASPREVA:
[ * ]
Aspreva Pharmaceuticals Corporation
#1201, 0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX X0X 0X0 Xxxxxx
Tel: [ * ]
SCHEDULE 6.1
COMMERCIALIZATION PLAN
[ * ]
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1
SCHEDULE 8.5
SALES TRACKING METHODOLOGY
[ * ]
SCHEDULE 8.6
SAMPLE ROYALTY CALCULATIONS
[ * ]
2
SCHEDULE 8.7(b)
COUNTRY-BY-COUNTRY SALES PERCENTAGES
% OF
TOTAL
COUNTRY 2002
------- -----
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1
TABLE OF CONTENTS
PAGE
ARTICLE 1 DEFINITIONS............................................ 2
1.1 "Adjusted Gross Sales".................................... 2
1.2 "Affiliate"............................................... 3
1.3 "AI Commercialization".................................... 3
1.4 "AI Development".......................................... 3
1.5 "Aspreva Commercialization Activities".................... 3
1.6 "Aspreva Development Activities".......................... 4
1.7 "Aspreva House Marks"..................................... 4
1.8 "Aspreva Know-How"........................................ 4
1.9 "Aspreva Patents"......................................... 4
1.10 "Aspreva Promotional Materials"........................... 4
1.11 "Aspreva Sales Representative"............................ 5
1.12 "Aspreva Sole Invention".................................. 5
1.13 "Autoimmune Indications".................................. 5
1.14 "Average Unit Selling Price".............................. 6
1.15 "Baseline Residual Sales"................................. 6
1.16 "Commercialization Plan".................................. 7
1.17 "Commercially Reasonable Efforts"......................... 7
1.18 "Competitive Company"..................................... 7
1.19 "Confidential Information"................................ 8
1.20 "Control"................................................. 8
1.21 "Detail" or "Detailing"................................... 8
1.22 "Defective Product"....................................... 9
1.23 "Development Plan"........................................ 9
1.24 "Drug Safety Committee"................................... 9
1.25 "Estimated Incremental Residual Sales".................... 9
1.26 "Existing Promotional Materials".......................... 9
1.27 "FDA"..................................................... 9
1.28 "Field"................................................... 9
1.29 "Finance Liaison"......................................... 10
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
1.30 "Fully Burdened Manufacturing Cost"...................... 10
1.31 "Global Tracked Sales"................................... 10
1.32 "GMP".................................................... 11
1.33 "Incremental Residual Sales"............................. 11
1.34 "Information Coordinator"................................ 11
1.35 "Invention".............................................. 11
1.36 "JC" or "Joint Committee" .............................. 11
1.37 "Major Market Countries"................................ 11
1.38 "Net Sales".............................................. 12
1.39 "Other Indications"...................................... 12
1.40 "Patents"................................................ 12
1.41 "Product"................................................ 12
1.42 "Product Samples"........................................ 13
1.43 "Projected Global Tracked Sales"......................... 13
1.44 "Promotion" or "Promote"................................. 13
1.45 "Reconciliation"......................................... 13
1.46 "Reconciliation Period".................................. 13
1.47 "Regulatory Approvals"................................... 13
1.48 "Regulatory Authority"................................... 13
1.49 "Regulatory Filings"..................................... 14
1.50 "Residual Sales"......................................... 14
1.51 "Roche Base Patents"..................................... 14
1.52 "Roche Commercialization Activities"..................... 14
1.53 "Roche Development Activities"........................... 14
1.54 "Roche House Marks"...................................... 15
1.55 "Roche Patents".......................................... 15
1.56 "Roche Product Information".............................. 15
1.57 "Roche SOPs"............................................. 15
1.58 "Roche Technology"....................................... 15
1.59 "Roche Templates"........................................ 16
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
1.60 "Roche Trademarks"....................................... 16
1.61 "Royalty Term"........................................... 16
1.62 "Sales Tracking Methodology"............................. 16
1.63 "Senior Management"...................................... 16
1.64 "Specifications"......................................... 16
1.65 "Term"................................................... 16
1.66 "Territory".............................................. 17
1.67 "Third Party"............................................ 17
1.68 "Third Party Distribution Agreements".................... 17
1.69 "Transplant Indications"................................. 17
ARTICLE 2 GRANT OF RIGHTS....................................... 17
2.1 Grant to Aspreva......................................... 17
2.2 Roche Trademark License.................................. 18
2.3 License Grants to Roche.................................. 18
2.4 Third-Party Performances of Aspreva Activities........... 19
2.5 Restrictions on Aspreva.................................. 21
2.6 Territory; Other Exceptions to Grants.................... 21
2.7 Other Indications........................................ 23
ARTICLE 3 COLLABORATION GOVERNANCE.............................. 24
3.1 Joint Committee; Minutes................................. 24
3.2 Subcommittees............................................ 24
3.3 Meetings of the JC....................................... 25
3.4 Responsibilities of the JC............................... 25
3.5 Areas Outside the JC's Authority......................... 27
3.6 Operating Principles..................................... 27
3.7 Decisions................................................ 28
ARTICLE 4 JOINT OBLIGATIONS; DILIGENCE.......................... 28
4.1 New Information.......................................... 28
4.2 Conduct of Parties....................................... 29
4.3 Assistance............................................... 29
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
4.4 Commercially Reasonable Efforts.......................... 29
4.5 Sharing of Market Information............................ 30
ARTICLE 5 DEVELOPMENT........................................... 30
5.1 Development Plan......................................... 30
5.2 Development Activities................................... 31
5.3 Development Costs........................................ 32
5.4 Transfer of Roche Product Information.................... 32
5.5 Regulatory Filings in the Field.......................... 33
5.6 Interactions with Regulatory Authorities................. 35
5.7 Ownership of Regulatory Approvals........................ 36
5.8 Drug Safety.............................................. 36
5.9 Product Withdrawals and Recalls.......................... 38
ARTICLE 6 COMMERCIALIZATION..................................... 38
6.1 Commercialization Plan................................... 38
6.2 Commercialization Activities............................. 39
6.3 Commercialization Costs.................................. 40
6.4 Aspreva Detailing Activities............................. 40
6.5 Advertising and Promotional Materials.................... 41
6.6 Distribution of Product Samples.......................... 44
6.7 Customer Services........................................ 45
6.8 Customer Complaints and Inquiries........................ 45
6.9 Product Selling Prices................................... 45
6.10 Sales Force Training..................................... 46
6.11 Conduct Of Promotion and Detailing....................... 46
ARTICLE 7 PRODUCT SUPPLY........................................ 47
7.1 Clinical Supply by Roche................................. 47
7.2 Supply of Product Samples................................ 49
7.3 Commercial Supply Capacity............................... 49
ARTICLE 8 ROYALTIES AND ACCOUNTING.............................. 49
8.1 Royalty Payments to Aspreva.............................. 49
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
8.2 Sales Forecast-Based Payments............................ 50
8.3 Payments and Reports..................................... 51
8.4 Reconciliation........................................... 51
8.5 Sales Tracking Methodology............................... 54
8.6 Sample Payment Calculations.............................. 55
8.7 Adjustments to Baseline Residual Sales................... 56
8.8 Finance Liaison.......................................... 57
8.9 Currency and Conversion.................................. 57
8.10 Interest................................................. 58
8.11 Taxes.................................................... 58
8.12 Blocked Currency......................................... 59
8.13 Accounting; Audits....................................... 59
ARTICLE 9 PATENTS AND INVENTIONS................................ 61
9.1 Inventions............................................... 61
9.2 Patent Prosecution....................................... 61
9.3 Enforcement of Patent Rights............................. 63
9.4 Enforcement of Other Government-Conferred Rights......... 65
9.5 Defense of Third Party Claims............................ 66
ARTICLE 10 TRADEMARK USAGE AND MAINTENANCE....................... 67
10.1 Ownership of Trademarks.................................. 67
10.2 Use of the Trademarks.................................... 67
10.3 House Marks.............................................. 68
10.4 Quality Control.......................................... 68
10.5 Acknowledgement of Ownership Rights...................... 68
10.6 Use of Trademark Designations............................ 69
10.7 Infringement of Roche Trademarks......................... 70
10.8 Third Party Trademark Claims............................. 71
ARTICLE 11 COVENANTS, REPRESENTATIONS, AND WARRANTIES............ 72
11.1 Mutual Covenants......................................... 72
11.2 Roche Covenants.......................................... 72
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(CONTINUED)
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11.3 Aspreva Covenant......................................... 73
11.4 Representations and Warranties of the Parties............ 73
11.5 Representations and Warranties of Roche.................. 74
11.6 Performance by Affiliates................................ 76
ARTICLE 12 CONFIDENTIALITY....................................... 76
12.1 Treatment of Confidential Information.................... 76
12.2 Exceptions............................................... 77
12.3 Authorized Disclosures................................... 77
12.4 Publicity................................................ 78
12.5 Publication.............................................. 79
12.6 Termination of Prior Agreements.......................... 80
ARTICLE 13 INDEMNIFICATION....................................... 80
13.1 Indemnification by Aspreva............................... 80
13.2 Indemnification by Roche................................. 81
13.3 Procedure................................................ 83
13.4 Advertising Claims in the Field.......................... 84
13.5 Insurance................................................ 84
ARTICLE 14 TERM AND TERMINATION.................................. 85
14.1 Term..................................................... 85
14.2 Unilateral Termination by Aspreva........................ 86
14.3 Termination Based on Sales............................... 87
14.4 Termination upon Cessation of Sale of the Product........ 88
14.5 Material Breach.......................................... 89
14.6 Survival; Accrued Rights................................. 91
ARTICLE 15 DISPUTE RESOLUTION.................................... 92
15.1 Disputes................................................. 92
15.2 Arbitration.............................................. 92
15.3 Waiver................................................... 95
ARTICLE 16 MISCELLANEOUS......................................... 95
16.1 Possible Amendment of Agreement.......................... 95
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(CONTINUED)
PAGE
16.2 Assignment............................................... 95
16.3 Bankruptcy............................................... 96
16.4 Non-Waiver............................................... 97
16.5 Governing Law............................................ 97
16.6 Severability............................................. 97
16.7 Notice................................................... 98
16.8 Headings................................................. 98
16.9 No Implied Licenses...................................... 99
16.10 Force Majeure............................................ 99
16.11 Entire Agreement......................................... 99
16.12 Amendments............................................... 100
16.13 Independent Contractors.................................. 100
16.14 Schedules................................................ 100
16.15 No Strict Construction................................... 100
16.16 Counterparts............................................. 100
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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CELLCEPT(R) COLLABORATION AND PROMOTION AGREEMENT
ASPREVA PHARMACEUTICALS GMBH
XXXXXXXX-XX XXXXX INC.
X. XXXXXXXX-XX XXXXX LTD
JULY 18, 2003
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
