AMENDED AND RESTATED DEVELOPMENT AND SUPPLY AGREEMENT (Hylenex)
EXHIBIT 99.4
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CONFIDENTIAL TREATMENT REQUESTED: INFORMATION FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED IS OMITTED AND NOTED WITH “***.” AN UNREDACTED VERSION OF THIS
DOCUMENT HAS BEEN SUBMITTED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION.
HAS BEEN REQUESTED IS OMITTED AND NOTED WITH “***.” AN UNREDACTED VERSION OF THIS
DOCUMENT HAS BEEN SUBMITTED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION.
| EXECUTION COPY |
THIS AMENDED AND RESTATED DEVELOPMENT AND SUPPLY AGREEMENT (this “Agreement”) dated as of
February 13, 2007 (the “Restatement Date”), is entered into between ▇▇▇▇▇▇ HEALTHCARE CORPORATION,
a Delaware corporation, with its principal place of business at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, ▇▇▇, and ▇▇▇▇▇▇ HEALTHCARE S.A., a Swiss corporation, with its principal place
of business at ▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (together with its Affiliates,
collectively, “Baxter”), on the one hand, and HALOZYME, INC., a corporation existing under the laws
of the State of California, with its principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ (“Halozyme”), on the other hand.
WHEREAS Halozyme is the owner or exclusive licensee of certain patents, formulations and
know-how related to Standalone Product (as defined below);
WHEREAS Baxter, or one or more of its Affiliates (as defined below) has the expertise and the
manufacturing facility suitable for the Production (as defined below) of Standalone Product;
WHEREAS, Halozyme wishes to have Baxter Produce (as defined below) Standalone Product and
Baxter wishes to Produce Standalone Product for Halozyme for sale and distribution in the
Territory;
WHEREAS, Halozyme and ▇▇▇▇▇▇ Healthcare Corporation previously entered into that certain
Development and Supply Agreement dated as of March 24, 2005 (as amended to date, the “Original
Development Agreement”);
WHEREAS, Halozyme and Baxter desire to amend and restate the Original Development Agreement in
certain respects, on the terms and conditions of this Agreement;
WHEREAS, Halozyme and Baxter are entering into that certain Amended and Restated Exclusive
Distribution Agreement dated as of the Restatement Date (as amended or restated from time to time,
the “Exclusive Distribution Agreement”) for the distribution of Standalone Product.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein
contained, the parties hereby amend the Original Development Agreement, and, for convenience,
restate the Original Development Agreement in its entirety, effective as of the Restatement Date as
follows:
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1. DEFINITIONS.
1.1 “Advisory Committee” shall mean the committee composed of representatives of
Baxter and Halozyme described in Section 2.3 below.
1.2 “Affiliate” shall mean, with respect to a party hereto, any entity that controls
or is controlled by such party, or is under common control with such party. For purposes of this
definition, (a) for purposes of the definition of Baxter, an entity shall be deemed to control
another entity if it owns or controls, directly or indirectly, one hundred percent (100%) (or if
the law of the jurisdiction in which the other entity is organized does not permit foreign
ownership of one hundred percent (100%), the highest percentage permitted by applicable law to be
owned by such entity) of the voting equity of the other entity (or other comparable interest for an
entity other than a corporation), and (b) for all other purposes, an entity shall be deemed to
control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%)
of the voting equity of the other entity (or other comparable interest for an entity other than a
corporation).
1.3 “API” shall mean the bulk form of active compound of PH20 Drug.
1.4 “API Price” shall mean the amount to be paid by Baxter to Halozyme for the API as
set forth on Exhibit A.
1.5 “API Specifications” shall mean the specifications for the API mutually agreed
upon in writing by the parties.
1.6 “Batch” shall mean a specific quantity of Standalone Product comprising a number
of units mutually agreed upon between Halozyme and Baxter, and that (a) is intended to have uniform
character and quality within specified limits, and (b) is produced according to a single
manufacturing order during the same cycle of manufacture.
1.7 “Baxter SOPs” shall mean ▇▇▇▇▇▇’▇ Standard Operating Procedures. Copies of
▇▇▇▇▇▇’▇ Relevant Product Specific Standard Operating Procedures as per Quality Agreement (Section
5.6.2) have been provided by Baxter to Halozyme prior to the Restatement Date. Baxter shall be
responsible at all times to cause the Standalone Product-specific Baxter SOPs to be consistent with
the Standalone Product Master Plan.
1.8 “cGMP” shall mean the principles detailed in the US Current Good Manufacturing
Practices (21 CFR 200, 211 and 600), the “Rules Governing Medicinal Product in The European
Community — Volume IV Good Manufacturing Practice for Medicinal Products,” and/or “Cooperative
Manufacturing Arrangements for Licensed Biologics” FDA-CBER.
1.9 “Components” shall mean all components used by Baxter in Production of Standalone
Product under this Agreement.
1.10 “Confidential Information” shall mean all information and data that (a) is
provided by one party to the other party under this Agreement or the Confidentiality Agreement
signed by Halozyme and Baxter on August 14, 2003 (as amended, the “Confidentiality Agreement”), and
(b) if disclosed in writing or other tangible medium is marked or identified as
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confidential at the
time of disclosure to the recipient, or is acknowledged at the time of disclosure to be
confidential, or otherwise should reasonably be deemed to be confidential. Notwithstanding the
foregoing, Confidential Information of a party shall not include that portion of such information
and data which, and only to the extent, the recipient can establish by written documentation: (i)
is known to the recipient as evidenced by its written records before receipt thereof from the
disclosing party, (ii) is disclosed to the recipient free of confidentiality obligations by a third
person who has the right to make such disclosure, (iii) is or becomes part of the public domain
through no fault of the recipient, or (iv) the recipient can reasonably establish is independently
developed by persons on behalf of recipient without access to or use of the information disclosed
by the disclosing party.
1.11 “DESI Review Indication” shall mean the DESI Review indication “as an adjuvant to
increase the absorption and dispersion of other injected drugs; for hypodermoclysis; as an adjunct
in subcutaneous urography for improving the resorption of radiopaque agents” (as described in 37
Fed. Reg. No. 122, p. 12418 (June 13, 1972)).
1.12 “FDA” shall mean the United States Food and Drug Administration or any successor
entity thereto or any applicable Regulatory Authority as defined in the Standalone Product Master
Plan.
1.13 “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as
may be amended from time to time.
1.14 “Labeling” shall mean all labels and other written, printed, or graphic matter
upon: (i) Standalone Product or any container, carton, or wrapper utilized with Standalone Product
or (ii) any written material accompanying Standalone Product.
1.15 “Master Batch Record” or “MBR” shall mean the formal set of instructions
for Production of Standalone Product, as amended, supplemented or restated from time to time by
mutual written agreement of the parties. The MBR will be developed jointly by Halozyme and Baxter
and approved by both parties, prior to Production of Standalone Product.
1.16 “NDA” shall mean a New Drug Application as defined in the FD&C Act or FDA
Regulations (21 CFR).
1.17 “PH20 Drug” shall mean 150 USP units per container of the active compound,
recombinant human PH20 hyaluronidase (i.e. a truncated form of native human PH20 hyaluronidase
consisting of residues 36-482, inclusive, of the native human PH20 hyaluronidase), in any liquid
injectable or subcutaneously infusible formulation, supplied by Halozyme to Baxter hereunder.
1.18 “Production”, “Produce”, or “Produced” shall mean the filling,
packaging, inspection, labeling, and testing of Standalone Product by Baxter.
1.19 “Quality Agreement” shall mean the Amended and Restated Quality Agreement, in the
form attached as Exhibit B, entered into by Baxter and Halozyme as of the Restatement Date, as
amended, supplemented or restated from time to time in accordance with Section 2.4 or as the
parties otherwise mutually agree in writing.
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1.20 “Regulatory Authority” shall mean those agencies or authorities responsible for
regulation of Standalone Product as described within the Standalone Product Master Plan.
1.21 “Regulatory Plan” shall mean the plan containing regulatory services and support
for the development and maintenance of regulatory submissions and supporting documentation for
Production of the Standalone Product. Such plan will be created, and may be amended, supplemented
or restated from time to time, by mutual written agreement of the parties, and will be shared with
the Advisory Committee.
1.22 “Released Executed Batch Record” shall mean the completed batch record (in the
form of the applicable Master Batch Record) and associated deviation reports, investigation
reports, and Certificates of Analysis (provided in accordance with the Quality Agreement) created
for each Batch of Standalone Product and approved as released to Halozyme under cGMP by ▇▇▇▇▇▇’▇
quality assurance department.
1.23 “Standalone Product” shall mean (a) the PH20 Drug product in the form developed
under the Original Development Agreement, and (b) any other formulation of such PH20 Drug product
that Halozyme develops under this Agreement, in each case of clauses (a) and (b), which product is
promoted, marketed and sold on a standalone basis (i.e., in a separate container, separately
packaged and labeled, and at a separate price), as the sole active pharmaceutical ingredient,
solely for use in the DESI Review Indication.
1.24 “Standalone Product Master Plan” shall mean, collectively, the following:
| • | the Quality Agreement (Exhibit B) | ||
| • | the Standalone Product Specifications; incl. API, Final Standalone Product, Components, Excipient (HSA) as in effect upon the Restatement Date (Exhibit C) | ||
| • | Territories (as per Distribution Agreement) | ||
| • | the API Price (Exhibit A). |
1.25 “Standalone Product Specifications” shall mean those specifications and testing
to be performed for the Standalone Product as set forth in Exhibit C as they exist as of the
Restatement Date, with such changes (a) as the parties mutually agree in writing, and (b) as
required by the FDA.
1.26 “Territory” shall mean all countries of the world.
2. STANDALONE PRODUCT MASTER PLAN.
2.1 Standalone Product Master Plan. The exhibits attached to this Agreement comprise
the Standalone Product Master Plan.
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2.2 Amendment of Standalone Product Master Plan. Except as otherwise set forth in
this Section or Section 2.4, the Standalone Product Master Plan may be amended from time to time,
as the parties’ experience with the Production, testing and use of the Standalone Product warrants,
only upon recommendation of the Advisory Committee and mutual written agreement of Halozyme and
Baxter. At the reasonable request of Halozyme, the parties shall negotiate in good faith
modification(s) to the Standalone Product Specifications to address regulatory concerns raised by
any Regulatory Authority or reasonably raised by Halozyme.
2.3 Advisory Committee.
2.3.1 The Purpose of the Advisory Committee. The purpose of the Advisory Committee
shall be (a) to facilitate the exchange of information between the parties regarding the Standalone
Product, (b) to review and discuss the commercialization plans (including the annual marketing
plans) and the product launch plans for each jurisdiction regarding the Standalone Product, and (c)
to review and discuss priorities for the commercialization of the Standalone Product. Baxter shall
have final decision making authority with respect to the commercialization of the Standalone
Product. For the avoidance of doubt, this authority does not affect ▇▇▇▇▇▇’▇ contractual
obligations under Section 2.2 of the Exclusive Distribution Agreement.
2.3.2 Composition of the Advisory Committee. The Advisory Committee shall consist of
three (3) named representatives of Baxter and three (3) named representatives of Halozyme. Each
party shall appoint its respective representatives to the Advisory Committee from time to time, and
may substitute one or more of its representatives, in its sole discretion, effective upon notice to
the other party of such change but shall use commercially reasonable efforts to maintain stability
of Advisory Committee representation.
2.3.3 Meetings. The Advisory Committee shall meet not less than twice each calendar
year, on such dates and at such times and places as agreed to by Baxter and Halozyme.
2.3.4 Advisory Committee Minutes and Reports. One representative of each party shall
be designated to take minutes of each Advisory Committee meeting. Within fifteen (15) days
following each Advisory Committee meeting during the term of the Agreement, a member of the
Advisory Committee shall prepare and provide to each party reasonably detailed written minutes
which shall summarize the outcome of the meeting, provided that such minutes shall not be finalized
unless they have been expressly approved in writing by each party.
2.4 Quality Agreement. At the reasonable request of either party, the parties shall
negotiate in good faith amendment(s) to the Quality Agreement to address matters specific to the
Production of the Standalone Product to address regulatory concerns raised by any Regulatory
Authority or reasonably raised by either party.
2.5 No Amendment of Agreement. In the event that the terms of the Standalone Product
Master Plan or Quality Agreement are inconsistent with the terms of this Agreement, this Agreement
shall control, unless otherwise explicitly agreed to in writing by the
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parties. The Standalone
Product Master Plan and Quality Agreement shall be incorporated herein by reference and made a part
of this Agreement.
3. DEVELOPMENT AND PRODUCTION OF STANDALONE PRODUCT.
3.1 Development. Pursuant to the Original Distribution Agreement, the parties
conducted the development of the Standalone Product. Following the Restatement Date, Halozyme
shall control the development of any other form or formulation of the Standalone Product, and in
doing so shall consider in good faith the interests of Baxter.
3.2 Production. Pursuant to the terms and conditions of this Agreement, Baxter shall,
in a timely manner, conduct Production of Standalone Product necessary for Halozyme to meet its
obligations under the Exclusive Distribution Agreement and otherwise as necessary to meet market
demand.
3.3 Documentation. Each Batch of Standalone Product shall be Produced by using a copy
of the Master Batch Record. Each copy of the Master Batch Record, known as a “Batch Record” or,
when completed, an “Executed Batch Record,” for such Batch of Standalone Product shall be assigned
a unique batch number. Any deviation from the manufacturing process specified in the Master Batch
Record must be documented in the copy of the Executed Batch Record for that Batch. Baxter shall
provide Halozyme with required supporting documentation in a form reasonably suitable for
Halozyme’s submission to the FDA.
3.4 API.
3.4.1 Prior to the Restatement Date, Baxter has prepared and provided to Halozyme a written
forecast (the “Initial API Forecast”) of its good faith requirements for API for each of the first
eighteen (18) months following the Restatement Date. Not later than one hundred eighty (180) days
prior to the first day of each calendar quarter during the term of this Agreement (commencing with
the calendar quarter beginning July 1, 2007), Baxter shall prepare and provide Halozyme with a
written forecast (together with the Initial API Forecast, each a “Rolling API Forecast”) of its
good faith estimated requirements for API under this Section 3.4 for each of the subsequent six (6)
calendar quarters. Baxter shall not (a) increase or decrease the quantity estimated for the first
quarterly period of each forecast from the quantity estimated for the second quarterly period of
the previous forecast, or (b) increase or decrease the quantity estimated for the second and third
quarterly periods of each forecast by more than twenty five percent (25%) of the quantity estimated
for the third and fourth quarterly periods of the previous forecast, respectively, without the
prior express written consent of Halozyme. The quantities estimated for the fifth and sixth
quarterly periods of each forecast shall be non-binding, and for planning purposes only.
3.4.2 Baxter shall be required to purchase one hundred percent (100%) of the quantity of API
forecasted for the first and second quarterly periods of each Rolling API Forecast.
3.4.3 Halozyme shall be required to supply the quantity of API ordered by Baxter under this
Section 3.4 in any calendar quarter up to one hundred ten percent (110%) of the quantity forecasted
for the first quarterly period of the most recent Rolling API Forecast. If
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▇▇▇▇▇▇’▇ orders in any
calendar quarter exceed one hundred ten percent (110%) of the quantity forecasted for the first
quarterly period of the most recent forecast, Halozyme shall use good faith efforts to supply such
excess. Halozyme shall use commercially reasonable efforts to meet ▇▇▇▇▇▇’▇ delivery requirements
specified in accordance with Section 3.4.4.
3.4.4 Baxter shall make all purchases under this Section 3.4 by submitting firm purchase
orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable
to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required
delivery date therefor, which shall not be less than sixty (60) days after the date of such
purchase order. No additional terms of any such purchase order shall be binding on Halozyme and
are expressly rejected hereby. In the event of a conflict between the terms and conditions of any
purchase order and this Agreement, the terms and conditions of this Agreement shall prevail.
3.4.5 Halozyme shall develop and transfer to Baxter in a timely manner analytical methods and
API Specifications, excipients and final dosage form applicable to the Production of Standalone
Product. Halozyme will be responsible for the manufacture or contract manufacture of the API
meeting cGMP, in compliance with the API Specifications and in a manner suitable for use in the
final dosage form of the Standalone Product. The manufacturing site of the API must allow Baxter
to audit the site as per the Quality Agreement on a periodic basis to be no more than once per
year. In the event any material or API to be supplied by Halozyme is imported into the United
States for delivery to Baxter, then Halozyme shall be the importer of record and such material or
API shall be delivered FCA place of manufacture (Incoterms 2000).
3.4.6 Baxter shall only use the API to Produce Standalone Product under this Agreement, which
Standalone Product shall only be sold by Baxter under and in accordance with the Exclusive
Distribution Agreement.
3.4.7 Halozyme shall sell to Baxter the API at a transfer price equal to its “API Price” as
defined in Exhibit A. Within sixty (60) days following the receipt of an invoice from Halozyme for
the API, unless Baxter properly determines in accordance with the foregoing that such API does not
conform to the API Specifications, Baxter shall pay to Halozyme the applicable API Price. If the
API does not conform to the API Specifications, Baxter shall promptly return such API, at
Halozyme’s cost, and shall not be obligated to pay to Halozyme the API Price therefor. Shipping
shall be FOB destination.
3.4.8 Following the Restatement Date, Halozyme shall be responsible for implementing a
commercially reasonable backup manufacturing strategy for API sufficient to meet ▇▇▇▇▇▇’▇ Rolling
API Forecasts. Halozyme shall review such manufacturing strategy with Baxter at least annually,
and prior to implementing any material changes requiring a CBE-30 or equivalent regulatory filing.
3.5 Delivery Delays. Each party shall use its commercially reasonable efforts to
ensure a steady supply of the API and Standalone Product (as applicable) or to resolve any
associated supply issues with their respective contractors.
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3.6 Material Safety Data Sheet. Halozyme shall provide Baxter a Material Safety Data
Sheet for API delivered to Baxter. Baxter shall immediately notify Halozyme of any unusual health
or environmental occurrence relating to Standalone Product, including, but not limited to any claim
or complaint by any employee of Baxter or any of its Affiliates or third party that the operations
of Baxter pursuant to this Agreement have resulted in any adverse health or safety effect on an
employee or third party. Baxter agrees to advise Halozyme immediately of any safety or toxicity
problems of which it becomes aware regarding the Standalone Product.
3.7 Vendor and Supplier Audit and Certification. Halozyme shall be solely responsible
for certifying and auditing all Standalone Product-related vendors and suppliers of API. All
vendors and suppliers of API shall be subject to Halozyme’s prior written approval.
3.8 Foreign Corrupt Practices Act. Baxter acknowledges that it is not the agent of
Halozyme and represents and warrants that it has not, and covenants that it will not, pay anything
of value to any government employee in connection with the resale of the Standalone Product.
3.9 Storage of API and Standalone Product.
3.9.1 Baxter shall provide, at its expense, appropriate storage for API and Standalone Product
in one or more secure, insured and bonded warehouses with appropriate climate-control for API and
Standalone Product in a manner consistent with operating procedures that Baxter uses for its own
products and consistent with storage conditions as provided in the Quality Agreement, Section 5.11.
Such API and Standalone Product shall be segregated from ▇▇▇▇▇▇’▇ other products per established
cGMP procedures. Following final release of Standalone Product, if the Exclusive Distribution
Agreement is then in effect, unless the parties otherwise mutually agree in writing (where such
Standalone Product is intended for clinical testing or development purposes in accordance with this
Agreement), such Standalone Product shall be transferred to Baxter pursuant to the Exclusive
Distribution Agreement.
3.9.2 Upon termination of the Exclusive Distribution Agreement, (a) all Standalone Product
that has not yet been transferred to Baxter pursuant to Section 3.9.1 and all API and Components
that are then in Production shall continue in Production to become Standalone Product and
transferred to Baxter solely for distribution under the terms and conditions of the Exclusive
Distribution Agreement that govern distribution of remaining Standalone Product following
termination, and (b) all API that has not yet been put into Production of Standalone Product shall
be returned to Halozyme at an amount equal to the API Price actually paid by Baxter for such API
(if any) and reasonable shipping costs therefor.
3.10 Non-Contravention.
3.10.1 During the term of this Agreement, except as provided for in this Agreement, the
Exclusive Distribution Agreement or as otherwise permitted by written
agreement of the parties in each instance, neither Halozyme nor its Affiliates shall sell,
transfer or otherwise provide, directly or indirectly, to any third party 1500 USP units (or less)
per container of recombinant human PH20 hyaluronidase as the sole active pharmaceutical
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ingredient for the DESI Review Indication in any liquid injectable or subcutaneously infusible formulation,
and/or any lyophilized formulation. To the extent not prohibited by applicable law, Halozyme shall
restrict (through contracts and/or purchase orders, marketing literature, shipping documents, or
similar documents used when a supply, distribution or similar agreement is not in place) its
customers and distributors and require similar restrictions throughout the supply chain, from
selling any product described above. Halozyme shall use commercially reasonable efforts to enforce
such restrictions, including without limitation by (i) notifying such customer or distributor in
writing of such alleged violation, (ii) conducting an investigation of such alleged violation as
Halozyme deems reasonably appropriate under the circumstances, and (iii) suspending shipments of
recombinant human PH20 hyaluronidase to a customer or distributor if Halozyme becomes aware that
such customer or distributor is selling any product described above. Baxter acknowledges and
agrees that Halozyme’s obligations under this Section 3.10.1 do not expand or enlarge the rights
granted to Baxter hereunder, which rights are limited in all respects to the Standalone Product.
3.10.2 During the term of this Agreement, except as provided for in this Agreement, the
Exclusive Distribution Agreement or as otherwise permitted by written agreement of the parties in
each instance, neither Baxter nor any of its Affiliates shall (a) sell, transfer or otherwise
provide, directly or indirectly, to any third party (other than Halozyme and its Affiliates) any
product comprising recombinant human PH20 hyaluronidase, (b) condition the sale or transfer of the
Standalone Product with the sale or transfer of any other product or the use of any service unless
the price for the Standalone Product is separately itemized on the applicable invoice and is the
same price charged by Baxter for the Standalone Product when sold separately, (c) promote, sell or
transfer a product comprising a coformulation of the Standalone Product, or any portion thereof,
with any other product, (d) promote, sell or transfer a product comprising the Standalone Product
kitted with any other product (i.e., in one or more containers or delivery devices, with a single
label, packaged together at a single price), (e) promote, sell or transfer any Standalone Product
for any use other than the DESI Review Indication, or (f) conduct, have conducted or assist or
facilitate the conduct of any study of the Standalone Product that requires the use of more than
requires the administration of more than a single 150 USP unit dose. To the extent not prohibited
by applicable law, Baxter and its Affiliates shall restrict (through contracts and/or purchase
orders, marketing literature, shipping documents, or similar documents used when a supply,
distribution or similar agreement is not in place) its customers and distributors and require
similar restrictions throughout the supply chain, from selling any other product comprising
recombinant human PH20 hyaluronidase or bundling the Standalone Product with any other product.
Baxter and its Affiliates shall use commercially reasonable efforts to enforce such restrictions,
including without limitation by (i) notifying such customer or distributor in writing of such
alleged violation, (ii) conducting an investigation of such alleged violation as Baxter and its
Affiliates deem reasonably appropriate under the circumstances, and (iii) suspending shipments of
Standalone Product to a customer or distributor if Baxter or its Affiliates become aware that such
customer or distributor is violating such restrictions.
3.11 Regulatory Approvals. Halozyme shall be responsible for obtaining required
regulatory approvals to sell Standalone Product in each country in the Territory on a
schedule consistent with prudent business practices in the pharmaceutical industry. Halozyme
shall give Baxter the first opportunity to conduct any necessary pre-approval clinical studies and
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regulatory activities in the European Union, provided that Baxter has the expertise and resources
to do so and is able to do so in a manner that is timely, cost-effective and competitive with third
party contract research organizations. Subject to the foregoing, Halozyme shall have the right, to
contract with any third party to conduct such studies and activities in any country in the
Territory.
3.12 Baxter Clinical Studies. Baxter shall have the right to conduct post-approval
marketing clinical studies of the Standalone Product for use in the DESI Review Indication. Prior
to finalizing the protocol for any clinical study of the Standalone Product, (a) Baxter shall
provide Halozyme with a copy of the reasonably complete draft of such protocol; (b) Halozyme shall
have a reasonable opportunity to review, comment and consult on each such protocol; and (c) the
parties shall meet to discuss Halozyme’s comments, and (d) Baxter shall in good faith consider the
comments of Halozyme.
4. DEVELOPMENT FUNDING.
4.1 Initial Development. The parties acknowledge and agree that Halozyme was
responsible for certain costs incurred by Baxter or Halozyme in order to Produce the registration
stability and validation Batches of the initial Standalone Product under the Original Development
Agreement, up to an aggregate of three million ($3,000,000). Commencing on the Restatement Date,
all Production Costs and Other Costs incurred by Halozyme in connection with this Agreement shall
be funded by Baxter in accordance with this Section 4.
4.2 Production Costs and Other Costs. Baxter shall bear the Production Costs and
Other Costs (as each is defined below), calculated on a fully-burdened basis, as follows:
4.2.1 Baxter shall be responsible for (a) equipment acquired for Production of Standalone
Product, (b) costs for the API at the price defined in Exhibit A, (c) changes to Standalone Product
Specifications or equipment or facility due to regulatory requirements, (d) insurance procured
solely for such Production, (e) taxes owing for such Production, and (f) direct salary and
headcount costs directly related to such Production to the extent not attributable to other
projects but specifically excluding general corporate overhead or headcount, such as legal,
business development or finance services (clauses (a) — (f), collectively, the “Production Costs”).
4.2.2 ▇▇▇▇▇▇ shall be responsible for (a) the reasonable fully-burdened cost to Halozyme to
conduct its research, development, regulatory and related activities for Standalone Product
conducted after the Restatement Date under this Agreement (consistent with the Standalone Product
Master Plan, as amended from time to time), and (b) all other costs (other than Production Costs)
to conduct all other activities (including post-approval activities) regarding the development,
clinical, manufacturing, regulatory, promotion, sales, marketing and distribution of Standalone
Product; provided, however, that ▇▇▇▇▇▇’▇ obligation to pay for the maintenance of marketing
applications for Standalone Product in the Territory shall be limited to the obligation to pay all
out-of-pocket costs paid or payable to applicable governmental
authorities to maintain such marketing applications (clauses (a) — (b) collectively, the
“Other Costs”).
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4.2.3 Within thirty (30) days following the end of each calendar quarter during the term of
this Agreement, Halozyme shall invoice ▇▇▇▇▇▇ for the amount of Production Costs and Other Costs
actually incurred by Halozyme during such calendar quarter, and ▇▇▇▇▇▇ shall within sixty (60) days
of receipt of such invoice, pay to Halozyme such amounts.
4.2.4 The Production Costs and Other Costs shall be calculated in accordance with U.S.
Generally Accepted Accounting Principles (“GAAP”) and standard accounting practices, consistently
applied.
4.3 Formulations. If, during the term of this Agreement, a party believes that a
different formulation of the Standalone Product is required by the applicable Regulatory Authority
of any country within the Territory, then such party may provide written notice to the other party
describing in reasonable detail the requirements of such Regulatory Authority regarding such
formulation. Following the receipt of such written notice, the parties shall meet and consider
such requirements; provided, however, that any proposed changes to this Agreement, the Exclusive
Distribution Agreement, the Quality Agreement or the Standalone Product shall not be binding on
either party unless set forth in a writing that has been duly authorized and executed by both
parties.
4.4 Data.
4.4.1 Except as the parties otherwise mutually agree in writing, all data and information
generated or obtained by ▇▇▇▇▇▇ with respect to the Standalone Product (including without
limitation the results of clinical studies of the Standalone Product, collectively referred to as
“▇▇▇▇▇▇ Data”) shall be the property of ▇▇▇▇▇▇. ▇▇▇▇▇▇ has the unrestricted right to freely
utilize ▇▇▇▇▇▇ Data in any lawful purpose consistent with the rights of the parties under this
Agreement. ▇▇▇▇▇▇ shall provide Halozyme with all results of the ▇▇▇▇▇▇ clinical studies, and
Halozyme shall have the unrestricted right to use such results for any lawful purpose consistent
with the rights of the parties under this Agreement.
4.4.2 Except as the parties otherwise mutually agree in writing, all data and information
generated or obtained by Halozyme with respect to the Standalone Product (including without
limitation the results of clinical studies of the Standalone Product, collectively referred to as
“Halozyme Data”) shall be the property of Halozyme. Halozyme has the unrestricted right to freely
utilize Halozyme Data in any lawful purpose consistent with the rights of the parties under this
Agreement. Halozyme shall provide ▇▇▇▇▇▇ with all results of Halozyme clinical studies resulting
from clinical studies of the Standalone Product, and ▇▇▇▇▇▇ shall have the unrestricted right to
use such results for any lawful purpose consistent with the rights of the parties under this
Agreement.
4.4.3 ▇▇▇▇▇▇ will report to Halozyme any serious adverse events and any adverse events and
product complaints regarding the Standalone Product, consistent with the Quality Agreement.
Halozyme must report to ▇▇▇▇▇▇ any serious adverse events immediately
and any adverse events and product complaints regarding the Standalone Product, in each case
in accordance with the Quality Agreement.
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5. TERM AND TERMINATION.
5.1 Term. This Agreement shall commence on the Restatement Date and will continue,
unless terminated pursuant to this section, as long as the Exclusive Distribution Agreement is in
effect. Upon the expiration or termination of the Exclusive Distribution Agreement, this Agreement
shall immediately terminate.
5.2 Termination for Breach. If a party has materially breached this Agreement and
such material breach shall continue for thirty (30) days for a monetary breach, and sixty (60) days
for a non-monetary breach, or such additional time reasonably necessary to cure such non-monetary
breach, provided that the breaching party has commenced a cure within the sixty (60) day period and
is diligently pursuing completion of such cure, such additional period not to exceed one hundred
and twenty (120) days in total after written notice of such breach was provided to the breaching
party by the nonbreaching party, the nonbreaching party shall have the right at its option to
terminate this Agreement effective at the end of such period.
5.3 Termination by ▇▇▇▇▇▇. ▇▇▇▇▇▇ may terminate this Agreement at any time upon one
hundred and eighty (180) days prior written notice to Halozyme.
5.4 Additional Rights and Remedies. Subject to Section 14.1, termination under this
Section 5 shall be in addition to the other rights and remedies of the terminating party.
Termination of this Agreement for any reason shall not relieve any party of any obligations
accruing prior to such termination.
5.5 Survival. Termination, expiration, cancellation or abandonment of this Agreement
through any means or for any reason, except as set forth in Section 5.1, shall be without prejudice
to the rights and remedies of either party with respect to any antecedent breach of any of the
provisions of this Agreement. The provisions of Sections 5, 7, 11, 12, 13, 14, 15, 16 and 17
hereof shall survive expiration or termination of this Agreement.
5.6 Files and Records. Within sixty (60) days following the expiration or termination
of this Agreement, ▇▇▇▇▇▇ shall make available to Halozyme copies of all manufacturing and process
development documents and records relating to Standalone Product, shall store the originals or
electronic copies of such documents and records according to cGMP in a safe and secure facility for
at least two (2) years after the expiration date of the last Batch Produced by ▇▇▇▇▇▇ under this
Agreement, and shall permit the FDA or other Regulatory Authorities access to such documents and
records to the extent requested thereby. For a period of twelve (12) months following expiration
or termination of this Agreement, ▇▇▇▇▇▇ shall make available to Halozyme for review, from
regulatory filings, any non-confidential information contained therein that is reasonably related
to Standalone Product that may be used by Halozyme to support any investigational studies or
commercial marketing of Standalone Product.
6. PRODUCTION OF STANDALONE PRODUCT.
6.1 Production. ▇▇▇▇▇▇ or one or more of its Affiliates shall Produce the Standalone
Product in accordance with the Product Requirements and cGMP applicable to each Territory. Subject
to compliance with reasonable rules and regulations of ▇▇▇▇▇▇ relating to confidentiality, safety
and security, Halozyme shall have the right to access the ▇▇▇▇▇▇ facilities
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CONFIDENTIAL TREATMENT REQUESTED
directly affecting the Production of the Standalone Product, and all applicable records related thereto, to oversee
Production of the Standalone Product in accordance with the Quality Agreement and ▇▇▇▇▇▇’▇ standard
visitation policy. Halozyme shall have the right to monitor each Production run of the Standalone
Product (from Component preparation through final labeling and assembly) in accordance with the
Quality Agreement. Halozyme shall have the right to render technical advice and direction to
▇▇▇▇▇▇ regarding Production of the Standalone Product pursuant to their involvement in the
generation of the Master Batch Record or direct communication with the Project Manager or Technical
Service Representative. ▇▇▇▇▇▇ promptly shall implement all reasonable advice and direction
provided that such advice and direction is not inconsistent with the Standalone Product Master
Plan, ▇▇▇▇▇▇ SOPs, and cGMP. If Halozyme observes or discovers variances from established
standards and methods of Production of Standalone Product, Halozyme shall give written notice
thereof to ▇▇▇▇▇▇, and upon receipt of any such notice, ▇▇▇▇▇▇ promptly shall take all appropriate
remedial or corrective action and give written notice to Halozyme describing in reasonable detail
such actions taken. If ▇▇▇▇▇▇ disagrees with any such advice and direction, the parties shall
discuss in good faith an appropriate resolution.
6.2 Audits. ▇▇▇▇▇▇ will allow representatives from Halozyme to have access to their
manufacturing, warehousing, laboratory premises, records, regulatory filings and communications
(e.g., FDA483s and Establishment Inspection Reports) for audit purposes listed below in Sections
6.2.1 through 6.2.3; provided, however, ▇▇▇▇▇▇ has the obligation to protect the confidential
information of its clients.
6.2.1 ▇▇▇▇▇▇ will permit Halozyme to conduct one preparatory audit of cGMP manufacture of the
Standalone Product for pre-approval inspection for Standalone Product. Follow-up to this audit will
be considered part of the first audit. Subsequent, new audits will be subject to ▇▇▇▇▇▇’▇ customary
charges.
6.2.2 ▇▇▇▇▇▇ will permit Halozyme to conduct audits to address significant Standalone Product
quality or safety problems as discovered through Standalone Product failures or complaints related
to ▇▇▇▇▇▇’▇ manufacturing of the Standalone Product.
6.2.3 ▇▇▇▇▇▇ will permit Halozyme to perform one standard cGMP compliance audits per year.
6.2.4 Subject to the execution of a confidential disclosure agreement among ▇▇▇▇▇▇, Halozyme
and Halozyme’s licensee(s), ▇▇▇▇▇▇ will permit access by Halozyme’s licensees to ▇▇▇▇▇▇’▇ premises
for audit purposes, consistent with the limitations listed in Sections 6.2.1 through 6.2.3.
Halozyme will accompany the licensees during each audit, provided the audit is directly related to
Halozyme’s Standalone Product.
6.3 Audit Closeout. An exit meeting will be held with representatives from ▇▇▇▇▇▇ and
Halozyme to discuss significant audit observations. Halozyme will provide a written report of all
observations within thirty (30) days to ▇▇▇▇▇▇. Within thirty (30) days of the audit report
receipt, ▇▇▇▇▇▇ will provide a written response to all findings that details corrective action to
be implemented. ▇▇▇▇▇▇ will follow up to ensure that all corrective actions are implemented
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CONFIDENTIAL TREATMENT REQUESTED
6.4 Testing. In accordance with the Quality Agreement, ▇▇▇▇▇▇ shall test, or cause to
be tested by third party testing facilities audited by ▇▇▇▇▇▇, in accordance with the Standalone
Product Requirements, each Batch of Standalone Product Produced pursuant to this Agreement before
any release or distribution pursuant to the Exclusive Distribution Agreement. A certificate of
analysis for each Batch of Standalone Product shall set forth the items tested by ▇▇▇▇▇▇,
Standalone Product Specifications, and test results in accordance with the Quality Agreement.
▇▇▇▇▇▇ shall send, or cause to be sent, such certificates along with one (1) copy of the entire
Released Executed Batch Record to Halozyme prior to selling any Standalone Product from such Batch
and within thirty (30) days following the completion of such Batch. As required by the FDA,
Halozyme shall assume responsibility for final release of each lot of Standalone Product prior to
distribution of the applicable lot.
6.5 Permits and Licenses.
6.5.1 Subject to the terms and conditions of this Agreement, Halozyme shall have sole
responsibility for obtaining all permits and licenses necessary or required for the sale, marketing
and commercialization of all Standalone Product. ▇▇▇▇▇▇ shall be responsible to obtain and
maintain all permits and licenses required for it to carry out its regulatory and Production
obligations hereunder. ▇▇▇▇▇▇ shall cooperate with Halozyme by assisting in preparing and filing
any necessary documents to support Halozyme’s applications for permits and licenses.
6.5.2 Notwithstanding anything to the contrary in this Agreement, the parties acknowledge and
agree that nothing in this Agreement gives Halozyme any rights to reference the NDA No. 6-343 for
Wydase.
6.6 Regulatory Requirements. Each party promptly shall notify the other of new
regulatory requirements of which it becomes aware which are relevant to the Production of a
Standalone Product under this Agreement and which are required by the FDA, any other applicable
Regulatory Authority or other applicable laws or governmental regulations, and shall confer with
each other with respect to the best means to comply with such requirements. Notwithstanding
anything to the contrary in this Agreement, each party shall be responsible for its compliance with
all regulatory requirements of the United States and all foreign countries that are applicable to
such party’s facilities and each party’s activities in Production, whether or not a party is aware
of such requirements and has failed to give notice to the other party.
6.7 Regulatory Approvals. Halozyme shall solely own all regulatory filings, approvals
and licenses for the Standalone Product. In accordance with the Standalone Product Master Plan,
and subject to ▇▇▇▇▇▇’▇ funding obligations under Section 4.2, Halozyme shall pursue regulatory
approval of marketing licenses for the Standalone Product, in each case Produced by ▇▇▇▇▇▇ for
Halozyme hereunder. Halozyme will advise ▇▇▇▇▇▇ of document
requirements in support of NDA and similar applications required of foreign governments and
agencies with respect to the Standalone Product, including amendments, license applications,
supplements and maintenance of such. ▇▇▇▇▇▇ will provide documents and assist Halozyme in
preparation of submissions to Regulatory Authorities (both U.S. and foreign) designated by Halozyme
in support of Halozyme’s NDA and similar applications required of foreign governments and licenses
with respect to the Standalone Product. Halozyme will be responsible
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CONFIDENTIAL TREATMENT REQUESTED
for all contacts with the FDA
(and foreign regulatory authorities) and all adverse event reporting and complaint handling for the
Standalone Product in the Territory.
6.8 Regulatory Authority Inspections.
6.8.1 Interaction with Regulatory Authorities. All interaction with Regulatory
Authorities (both written and oral) that directly affects Standalone Product or the Production of
Standalone Product shall be conducted in accordance with the provisions of this Section 6.
6.8.2 Standalone Product Pre-Approval Inspection. In the case of a Standalone Product
Pre-Approval Inspection by the FDA related to the Standalone Product, the following shall apply:
(a) ▇▇▇▇▇▇ immediately shall inform Halozyme of the notice of such inspection; (b) ▇▇▇▇▇▇ shall
permit a representative of Halozyme to be present at the ▇▇▇▇▇▇ facility that is the subject of
such inspection (not to be present at the inspection or to participate, except to be available on
an as-needed basis as requested by ▇▇▇▇▇▇); (c) ▇▇▇▇▇▇ shall apprise such representative of
Halozyme regarding each daily wrap up session for such inspection and the post-inspection wrap up
session for such inspection; (d) ▇▇▇▇▇▇ promptly shall provide Halozyme with copies of all written
materials, including without limitation copies of any Notice of Inspection (FDA Form 482), other
notice of inspection, notice of violation, other similar notice, or Inspectional Observations (FDA
Form 483, its foreign equivalent and Establishment Inspection Reports) received by ▇▇▇▇▇▇ relating
to such inspection, and (e) ▇▇▇▇▇▇ shall provide Halozyme with advance copies of all proposed
responses to any such inspections, notices or actions, shall permit Halozyme reasonable opportunity
to review and comment within 3 to 5 business days on each such response, shall reasonably consider
Halozyme’s reasonable comments thereon, and shall provide Halozyme with copies of each such
response as submitted. ▇▇▇▇▇▇ shall retain final authority for the content of the responses to the
regulatory authority
6.8.3 Other Product Specific Inspections. In the case of an inspection (other than
the Standalone Product Pre-Approval Inspection) by a Regulatory Authority that directly affects the
Production of Standalone Product, the following shall apply: (a) ▇▇▇▇▇▇ immediately shall inform
Halozyme of the notice of such inspection; (b) ▇▇▇▇▇▇ shall permit a representative of Halozyme to
be present at the ▇▇▇▇▇▇ facility that is the subject of such inspection (not to be present at the
inspection or to participate, except to be available on an as-needed basis as requested by ▇▇▇▇▇▇);
(c) ▇▇▇▇▇▇ shall apprise such representative of Halozyme regarding each daily wrap up session for
such inspection and the post-inspection wrap up session for such inspection; (d) ▇▇▇▇▇▇ promptly
shall provide Halozyme with copies of all written materials, including without limitation copies of
any Notice of Inspection (FDA Form 482), other notice of inspection, notice of violation, other
similar notice, or Inspectional Observations (FDA Form 483, its foreign equivalent and
Establishment Inspection Reports) received by ▇▇▇▇▇▇ relating to such inspection, and (e) ▇▇▇▇▇▇
shall provide Halozyme with advance copies of
all proposed responses that directly affect Production of Standalone Product to any such
inspections, notices or actions, shall permit Halozyme reasonable opportunity to review and comment
on each such response, shall reasonably consider Halozyme’s reasonable comments thereon, and shall
provide Halozyme with copies of each such response as submitted.
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CONFIDENTIAL TREATMENT REQUESTED
6.8.4 Other Inspections. The parties’ respective rights and obligations with respect
to any inspections relating to the Standalone Product, other than those described above, shall be
as set forth in the Quality Agreement.
6.9 Labeling. Labeling development shall be conducted in accordance with ▇▇▇▇▇▇’▇
standard procedures and as mutually agreed upon by the parties per the requirements located in
Exhibit ▇. ▇▇▇▇▇▇ shall promote and market the Standalone Product solely using those trademark(s)
mutually agreed upon in writing by the parties prior to the applicable commercial launch. ▇▇▇▇▇▇
shall include on the packaging, label and all promotional and marketing materials for the
Standalone Product a secondary label, reasonably determined by Halozyme, identifying that Halozyme
technology is included in the Standalone Product.
7. ACCEPTANCE OF STANDALONE PRODUCT.
7.1 Standalone Product Conformity. Within the later of forty-five (45) calendar days
following the date of Halozyme’s receipt of retention samples of the Standalone Product, or fifteen
(15) calendar days following the date of Halozyme’s receipt of the applicable entire Released
Executed Batch Record(s) and related documentation in accordance with the Standalone Product Master
Plan, Halozyme shall have the right to determine whether the Standalone Product conforms to cGMP,
to all other applicable United States laws and regulations and all applicable foreign laws and
regulations, to the applicable Standalone Product Specifications, and to the Quality Agreement
(collectively the “Standalone Product Requirements”). Notwithstanding the foregoing, if Halozyme
has conducted at least one test of the applicable Batch and in good faith has requested in writing,
within the time period specified in this Section 7.1, additional time to perform additional
testing, then such period shall be extended as reasonably necessary for Halozyme, or ▇▇▇▇▇▇ (if
requested by Halozyme), to perform such additional testing.
7.1.1 If (a) the Standalone Product conforms to the Standalone Product Requirements, or (b)
Halozyme fails to notify ▇▇▇▇▇▇ within the time period specified in Section 7.1 that any Standalone
Product does not conform to the Standalone Product Requirements, then Halozyme shall be deemed to
have accepted the same and waived its right to revoke acceptance.
7.1.2 If Halozyme believes the Standalone Product does not conform to the Standalone Product
Requirements, it shall give written notice to ▇▇▇▇▇▇ specifying the manner in which it fails to
meet the Standalone Product Requirements. Guidelines for resolving any disputed claims regarding
conformity are set forth in Section 7.1.3.
7.1.3 If the parties dispute whether the Standalone Product is conforming or non-conforming,
the samples thereof will be submitted to a mutually acceptable laboratory or consultant for
resolution, whose determination of conformity or non-conformity,
and the cause thereof of non-conformity, shall be binding upon the parties. The
non-prevailing party shall bear the costs of such laboratory or consultant.
7.2 Remedy for Non Conforming Standalone Product. In the event ▇▇▇▇▇▇ agrees that any
Standalone Product is non-conforming or the laboratory determines that the
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CONFIDENTIAL TREATMENT REQUESTED
shipment thereof is non-conforming, ▇▇▇▇▇▇ shall destroy all non-conforming quantities and
shall at its option (i) schedule to run a new Batch to replace such non-conforming quantities
within the later of (a) sixty (60) calendar days from the date of determination by the third party
of non-conformity, or (b) (60) days from the receipt of the non-conforming drug substance and
agreement by ▇▇▇▇▇▇ of such non-conformity, or (ii) refund the cost of the non-conforming batch.
Any costs incurred by ▇▇▇▇▇▇ to run a new Batch pursuant to this
Section 7.2 shall not be Production
Costs or Other Costs.
7.3 Non Conforming API. If the Standalone Product is rejected by Halozyme, and the
failure to meet the Standalone Product Requirements is the result of non-conforming API and the
cause of such non-conformity is demonstrated not to be a result of the negligence, omission or
willful misconduct of ▇▇▇▇▇▇ the rejection will be deemed not to be a breach of ▇▇▇▇▇▇’▇ warranties
or obligations under this Agreement. In the event of non-conforming API, Halozyme shall be
responsible for costs reasonably incurred by ▇▇▇▇▇▇ for the rejected quantities.
8. STANDALONE PRODUCT RECALLS.
8.1 Standalone Product Recalls. Each party promptly shall notify the other if any
Batch of Standalone Product is alleged or proven to be the subject of a recall, market withdrawal
or correction. ▇▇▇▇▇▇ shall be responsible, subject to the oversight of Halozyme, for coordinating
any recall, market withdrawal or field correction of Standalone Product, and such recall, market
withdrawal or correction shall be conducted in accordance with the provisions of the Quality
Agreement. ▇▇▇▇▇▇ will provide Halozyme with access to and copies of all consignees and
distribution records for the Standalone Product and will cooperate with Halozyme in the
determination of satisfactory execution of the recall action. Halozyme shall provide ▇▇▇▇▇▇ with a
copy of all documents relating to such recall, market withdrawal or field correction. Halozyme
shall cooperate with ▇▇▇▇▇▇ (including providing ▇▇▇▇▇▇ with all data, information and documents
requested by ▇▇▇▇▇▇) in connection with such recall, market withdrawal or field correction, at
▇▇▇▇▇▇’▇ expense. ▇▇▇▇▇▇ shall bear all costs of such recall, market withdrawal or field
correction; provided, however, that if a recall, market withdrawal or field correction is due
solely to the API not conforming to the API Specifications or caused solely by the negligence,
omission or willful misconduct of Halozyme, or solely by Halozyme’s breach of its warranties or
obligations under this Agreement, Halozyme shall bear all costs of such recall, market withdrawal
or field correction (including but not limited to costs associated with receiving and administering
the recalled Standalone Product and notification of the recall to those persons whom Halozyme deems
appropriate).
8.2
Entire Liability of ▇▇▇▇▇▇. This Section 8 sets forth the entire liability of
▇▇▇▇▇▇ in the event of a recall, market withdrawal, or field correction.
9. FORCE MAJEURE EVENTS.
Any delay in the performance of any of the duties or obligations of either party hereto
(except the payment of money), to the extent caused by an event outside the affected party’s
reasonable control, shall not be considered a breach of this Agreement, and unless provided to the
contrary herein, the time required for performance shall be extended for a period equal to the
period of such delay. Such events shall include without limitation, acts of God; acts of public
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CONFIDENTIAL TREATMENT REQUESTED
enemies; insurrections; riots; injunctions; embargoes; labor disputes, including strikes,
lockouts, job actions, or boycotts; fires; explosions; floods; shortages of material or energy;
delays in the delivery of raw materials; acts or orders of any government or agency thereof or
other unforeseeable causes beyond the reasonable control and without the fault or negligence of the
party so affected. The party so affected shall give prompt written notice to the other party of
such cause and a good faith estimate of the continuing effect of the force majeure condition and
duration of the affected party’s nonperformance, and shall take whatever reasonable steps are
appropriate to relieve the effect of such causes as rapidly as possible. If the period of
nonperformance by ▇▇▇▇▇▇ because of force majeure conditions exceeds one hundred eighty (180)
calendar days, Halozyme may terminate this Agreement by written notice to ▇▇▇▇▇▇. If the period of
nonperformance by Halozyme because of force majeure conditions exceeds one hundred eighty (180)
calendar days, ▇▇▇▇▇▇ may terminate this Agreement by written notice to Halozyme.
10. CHANGES IN PRODUCTION.
10.1 Changes to Standalone Product. ▇▇▇▇▇▇ agrees to inform Halozyme within fifteen
(15) calendar days of the result of any regulatory development that directly affects the Production
of a Standalone Product or changes to Standalone Product-specific ▇▇▇▇▇▇ SOPs. ▇▇▇▇▇▇ shall give
written notice to Halozyme of any such changes, and Halozyme and ▇▇▇▇▇▇ will review such
development or changes in accordance with the Quality Agreement; provided, however, that any
changes to the Standalone Product Master Plan shall be made only in
accordance with Section 2.2.
10.2 Standalone Product-Specific Changes. If facility, equipment, process or system
changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other
Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of a
Standalone Product, then Halozyme and ▇▇▇▇▇▇ will review such requirements and agree in writing to
such regulatory changes in accordance with the Quality Agreement.
11. CONFIDENTIALITY.
11.1 Confidentiality. During the term of this Agreement, and for a period of five (5)
years following the expiration or earlier termination hereof, each party shall maintain in
confidence all Confidential Information disclosed by the other party (including all Confidential
Information disclosed under the Confidentiality Agreement), and shall not use, grant the use of or
disclose to any third party the Confidential Information of the other party other than as expressly
permitted hereby, or by the Exclusive Distribution Agreement or the Quality Agreement. Each party
shall notify the other promptly upon discovery of any unauthorized use or disclosure of the other
party’s Confidential Information.
11.2 Permitted Disclosures. Either party may disclose Confidential Information of the
disclosing party (a) on a need-to-know basis, to such party’s directors, officers and employees to
the extent such disclosure is reasonably necessary in connection with such party’s activities as
expressly authorized by this Agreement, and (b) to those Affiliates, agents and consultants who
need to know such information to accomplish the purposes of this Agreement (collectively,
“Permitted Recipients”); provided such Permitted Recipients are bound
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CONFIDENTIAL TREATMENT REQUESTED
to maintain such Confidential Information in confidence to the same extent as set forth in
Section 11.1.
11.3 Terms of Agreement. Neither party shall disclose any terms or conditions of this
Agreement to any third party without the prior consent of the other party; provided, however, that
a party may disclose the terms or conditions of this Agreement, (a) on a need-to-know basis to its
legal and financial advisors to the extent such disclosure is reasonably necessary, and (b) to a
third party in connection with (i) an equity investment in such party, (ii) a merger, consolidation
or similar transaction by such party, or (iii) the sale of all or substantially all of the assets
of such party. Notwithstanding the foregoing, prior to execution of this Agreement, the parties
have agreed upon the substance of information that can be used to describe the terms and conditions
of this transaction, and each party may disclose such information, as modified by mutual written
agreement of the parties, without the consent of the other party.
11.4 Litigation and Governmental Disclosure. Each party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for prosecuting or
defending litigation, complying with applicable governmental regulations or conducting pre-clinical
or clinical trials, provided that if a party is required by law or regulation to make any such
disclosure of the other party’s Confidential Information it will, except where impractical for
necessary disclosures, for example in the event of a medical emergency, give reasonable advance
notice to the other party of such disclosure requirement and will use good faith efforts to assist
such other party to secure a protective order or confidential treatment of such Confidential
Information required to be disclosed.
11.5 Limitation of Disclosure. The parties agree that, except as otherwise may be
required by applicable laws, regulations, rules or orders, including without limitation the rules
and regulations promulgated by the United States Securities and Exchange Commission, and except as
may be authorized in Section 11.5, no information concerning this Agreement and the transactions
contemplated herein shall be made public by either party without the prior written consent of the
other.
11.6 Publicity and SEC Filings. The parties agree that the public announcement of the
execution of this Agreement shall only be by one or more press releases mutually agreed to by the
parties. The failure of a party to return a draft of a press release with its proposed amendments
or modifications to such press release to the other party within five (5) business days of such
party’s receipt of such press release shall be deemed as such party’s approval of such press
release as received by such party. Each party agrees that it shall cooperate fully and in a timely
manner with the other with respect to all disclosures to the Securities and Exchange Commission and
any other governmental or regulatory agencies, including requests for confidential treatment of
Confidential Information of either party included in any such disclosure.
12. INVENTIONS
12.1 Existing Intellectual Property. Except as the parties may otherwise expressly
agree in writing, each party shall continue to own its existing patents, trademarks,
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CONFIDENTIAL TREATMENT REQUESTED
copyrights, trade secrets and other intellectual property, without conferring any interests
therein on the other party. Without limiting the generality of the preceding sentence, and except
as expressly set forth in this Agreement, Halozyme shall retain all right, title and interest
arising under the United States Patent Act, the United States Trademark Act, the United States
Copyright Act and all other applicable laws, rules and regulations in and to Standalone Product,
API, Labeling and Halozyme’s trademarks associated therewith (collectively, “Halozyme’s
Intellectual Property”).
12.2 Individually Owned Inventions.
12.2.1 Except as the parties may otherwise agree in writing, all Inventions (as defined
herein) which are conceived, reduced to practice, or created by a party in the course of performing
its obligations under this Agreement shall be solely owned and subject to use and exploitation by
the inventing party without a duty to account to the other party. For purposes of this Agreement,
“Invention” shall mean information relating to any innovation, improvement, development, discovery,
computer program, device, trade secret, method, know-how, process, technique or the like, whether
or not written or otherwise fixed in any form or medium, regardless of the media on which contained
and whether or not patentable or copyrightable. Baxter hereby grants to Halozyme a royalty-free,
non-exclusive, worldwide license (with the right to grant sublicenses) under all patent rights and
other intellectual property rights specifically describing and claiming Inventions which are
conceived, reduced to practice, or created by Baxter in the course of performing its obligations
under this Agreement and which in each case (i) use or are supported by data and information
derived from the use of recombinant human PH20 hyaluronidase or are derived from the activities
under this Agreement, and (ii) only to the extent they relate to recombinant human PH20
hyaluronidase, its manufacture or use, and expressly excluding any intellectual property rights
that were not conceived, reduced to practice or created by Baxter under this Agreement. Halozyme
shall use commercially reasonable efforts to obtain a similar grantback license from any third
party that enters into a development agreement with Halozyme for rights to make and sell products
comprising recombinant human PH20 hyaluronidase, and if Halozyme is unable to obtain such a
grantback license from any such third party, then Halozyme shall not grant a sublicense to such
third party under the license grant from Baxter under this
Section 12.2.1, and any such sublicense
granted by Halozyme to such third party shall be void.
12.2.2 The party solely owning any Invention shall have the world-wide right to control the
drafting, filing, prosecution and maintenance of patents covering the Invention, including
decisions about the countries in which to file patent applications. Patent costs associated with
the patent activities described in this Section 12.2.2 shall be borne by the sole owner.
12.3 Jointly Owned Inventions. All Inventions which are conceived, reduced to
practice, or created jointly by the parties and/or their respective agents (i.e., employees or
agents who would be or are properly named as co-inventors under the laws of the United States on
any patent application claiming such inventions) in the course of the performance of this Agreement
shall be owned jointly by the parties. Each party shall have full rights, subject to the
provisions of this Agreement, to freely exploit, transfer, license or encumber its rights in any
such jointly-owned Inventions and the patent rights and other intellectual property rights therein
without the
20
CONFIDENTIAL TREATMENT REQUESTED
consent of, or payment or accounting to, the other party. The parties shall share equally in
the cost of mutually agreed patent filings with respect to all such jointly owned Inventions. The
decision to file for patent coverage on jointly owned inventions shall be mutually agreed upon and
the parties shall select a mutually agreeable patent counsel to file and prosecute patent
applications based on such joint Inventions; provided, however, that in the event that one party (a
“Non-Interested Party”) notifies the other in writing that is not interested in rights it may have
in a joint Invention (relative to its corresponding expenses and costs including patent prosecution
and maintenance), the other party (the “Interested Party”) may elect to pursue rights in such a
joint Invention at its own cost and expense (in which case the Non-Interested Party shall assign to
the Interested Party the former’s interests in and to the joint Invention). Each party shall
cooperate with the other party in the filing and prosecution of such jointly owned patent
applications. Such cooperation will include, but not be limited to, furnishing supporting data and
affidavits for the prosecution of patent applications and completing and signing forms needed for
the prosecution, assignment and maintenance of patent applications.
12.4 Disclaimer. Except as otherwise expressly provided herein, nothing contained in
this Agreement shall be construed or interpreted, either expressly or by implication, estoppel or
otherwise, as: (i) a grant, transfer or other conveyance by either party to the other of any right,
title, license or other interest of any kind in any of its Inventions or other intellectual
property, (ii) creating an obligation on the part of either party to make any such grant, transfer
or other conveyance or (iii) requiring either party to participate with the other party in any
cooperative development program or project of any kind or to continue with any such program or
project, except to the extent the other party expressly agrees in writing.
12.5 Confidentiality of IP. IP shall be deemed to be the Confidential Information of
the party owning such IP. The protection of each party’s Confidential Information is described in
Section 11. Any disclosure of information by one party to the other under the provisions of this
Section 12 shall be treated as the disclosing party’s Confidential Information under this Agreement.
It shall be the responsibility of the party preparing a patent application to obtain the written
permission of the other party, which consent can not unreasonably be withheld, to use or disclose
the other party’s Confidential Information in the patent application before the application is
filed and for other disclosures made during the prosecution of the patent application.
12.6 License for Performance of this Agreement. For the avoidance of doubt, Halozyme
hereby grants to Baxter, and its Affiliates, a non-exclusive license under the Halozyme
Intellectual Property, including any grantback rights to the Standalone Product or API that was
obtained from third parties, solely for and to the extent necessary for Baxter or such Affiliate to
perform its obligations under this Agreement, including but not limited to, the manufacture and
handling of Standalone Product under this Agreement.
13. REPRESENTATIONS AND WARRANTIES.
13.1 Mutual Representations. Each party hereby represents and warrants to the other
party that (a) the person executing this Agreement is authorized to execute this Agreement; (b)
this Agreement is legal and valid and the obligations binding upon such party are enforceable by
their terms; and (c) the execution, delivery and performance of this Agreement does not
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CONFIDENTIAL TREATMENT REQUESTED
conflict with any agreement, instrument or understanding, oral or written, to which such party
may be bound, nor violate any law or regulation of any court, governmental body or administrative
or other agency having jurisdiction over it.
13.2 Baxter Warranty. Baxter represents and warrants that, as of the time of delivery
by Baxter of Standalone Product to a distributor, end-user or other third party in accordance with
this Agreement and the Exclusive Distribution Agreement, all Standalone Product Produced under this
Agreement, (a) conforms to the Specifications, (b) has been Produced in accordance with cGMP, all
applicable laws and regulations and in accordance with the applicable Certificates of Analysis
(provided in accordance with the Quality Agreement) accompanying each Batch of Standalone Product,
and (c) is not adulterated or misbranded within the meaning of the FD&C Act; provided, however,
that the foregoing warranty will not extend to the API or any Halozyme supplied components or
labeling. Baxter represents and warrants that it has obtained (or will obtain prior to Producing
Standalone Product), and will remain in compliance with during the term of this Agreement, all
permits, licenses and other authorizations (the “Permits”) which are required under federal, state
and local laws, rules and regulations applicable to the Production of Standalone Product ;
provided, however, Baxter shall have no obligation to obtain Permits relating to the sale,
marketing, distribution or use of API or Standalone Product or with respect to the Labeling of
Standalone Product. Baxter represents that to the best of its knowledge (i) no Baxter employees
performing services on behalf of Baxter under this Agreement have been debarred under Section 306
of the FD&C Act, and (ii) no persons (other than Baxter employees) performing services on behalf
of Baxter under this Agreement have been debarred under Section 306 of the FD&C Act.
13.3 Baxter Disclaimer of Warranties. Except for those warranties set forth in
Sections 13.1 and 13.2 of this Agreement, Baxter makes no warranties, written, oral, express or implied,
with respect to Standalone Product or the development and Production of Standalone Product. ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY
BAXTER. NO WARRANTIES OF BAXTER MAY BE CHANGED BY ANY REPRESENTATIVES OF BAXTER. Halozyme accepts
the Production of the Standalone Product subject to the terms hereof.
13.4 Halozyme Warranties. Halozyme warrants that it has the right to give Baxter any
information provided by Halozyme hereunder, and that Baxter has the right to use such information
for the Production of Standalone Product. Halozyme further warrants that the API provided to
Baxter hereunder (1) conforms to the API Specifications, (2) has been produced in accordance with
cGMP and all applicable laws and regulations relating to the API and in accordance with the
applicable Certificates of Analysis (provided in accordance with the Quality Agreement)
accompanying each Lot of API and (3) is not adulterated or misbranded within the meaning of the
FD&C Act. Halozyme further warrants that to its knowledge, upon reasonable inquiry, Halozyme is
not aware of, nor has any third party asserted against Halozyme any claim, notice, or concern
regarding the potential infringement of such third party’s proprietary rights as a result of the
manufacture, use, offer to sell, sale, importation or distribution of the Standalone Product.
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CONFIDENTIAL TREATMENT REQUESTED
13.5
Disclaimer of Warranties. Except for those warranties set
forth in Section 14.1 and
13.4 of this Agreement, Halozyme makes no warranties, written, oral, express or implied, with respect
to API or Standalone Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT HEREBY ARE DISCLAIMED BY HALOZYME. NO WARRANTIES OF HALOZYME MAY BE CHANGED BY ANY
REPRESENTATIVES OF HALOZYME. Baxter accepts API subject to the terms hereof.
14. LIMITATION OF LIABILITY; WAIVER OF SUBROGATION.
14.1 Limitation of Liability. UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE FOR
LOSS OF USE OR PROFITS OR OTHER COLLATERAL, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES,
INCLUDING BUT NOT LIMITED TO THE COST OF A RECALL IN CONNECTION WITH OR BY REASON OF THE PRODUCTION
AND DELIVERY OF STANDALONE PRODUCT UNDER THIS AGREEMENT OR OTHERWISE IN CONNECTION WITH THIS
AGREEMENT, EXCEPT AS SET FORTH IN SECTION 7 AND 15, WHETHER SUCH CLAIMS ARE FOUNDED IN TORT OR
CONTRACT. Without limiting the generality of the foregoing and notwithstanding anything to the
contrary herein, the only liability of Baxter for any cost of cover claims (i) shall exist in the
event of a breach hereof by Baxter due to its willful misconduct resulting in a failure to Produce
conforming Standalone Product; and (ii) shall not include any costs or expenses associated with
qualifying of another supplier or delays if one has not been so qualified by Halozyme.
14.2 Waiver of Subrogation. All Components and equipment used by Baxter in the
Production of Standalone Product, other than those Components and equipment that are specifically
stated in this Agreement to be owned by Halozyme (collectively, “Baxter Property”), shall at all
times remain the property of Baxter and Baxter assumes risk of loss for the Baxter Property.
Baxter hereby waives any and all rights of recovery against Halozyme and its Affiliates, and
against any of their respective directors, officers, employees, agents or representatives, for any
loss or damage to Baxter Property to the extent the loss or damage is covered or could be covered
by insurance (whether or not such insurance is described in this Agreement). Halozyme assumes all
risk of loss for all API supplied by Halozyme (collectively “Halozyme Property”) until such
Halozyme Property is received by Baxter or its Affiliates; and Halozyme hereby waives any and all
rights of recovery against Baxter and its Affiliates for any such loss or damage to the Halozyme
Property to the extent that the loss or damage is covered by or could be covered by insurance
(whether or not such insurance is described in this Agreement).
15. INDEMNIFICATION.
15.1 Halozyme Indemnification. Halozyme shall indemnify, defend and hold harmless
Baxter and its Affiliates and any of their respective directors officers, employees, authorized
subcontractors and agents (collectively the Baxter “Indemnified Parties”) from and against any and
all liabilities, obligations, penalties, judgments, disbursements of any kind and nature, losses,
damages, costs and expenses (including, without limitation, reasonable attorney’s fees and costs)
incurred as a result of any claims, demands, actions or other proceedings by
23
CONFIDENTIAL TREATMENT REQUESTED
unaffiliated third parties against an Indemnified Party to the extent arising out of property
damage or personal injury (including without limitation death) of third parties (collectively
“Claims”), resulting from (a) Halozyme’s negligence, omission or willful misconduct, (b) Halozyme’s
breach of its representations or obligations under this Agreement or the Exclusive Distribution
Agreement, (c) the execution, delivery and performance of this Agreement or the Exclusive
Distribution Agreement by Halozyme conflicting with any other agreement of Halozyme relating to the
production and supply of API, (d) Halozyme’s use of the results of Baxter clinical studies of the
Standalone Product or (e) any claim that the use of API by Baxter in accordance with this
Agreement, violates the patent, trademark, copyright or other proprietary rights of any third
party, except to the extent any of the foregoing (a) — (e) is caused solely or principally by the
negligence, omission or willful misconduct of the Baxter Indemnified Parties or solely by the
breach by Baxter of its representations or obligations under this Agreement.
15.2 Baxter Indemnification. Baxter shall indemnify, defend and hold harmless
Halozyme and its Affiliates and any of their respective directors, officers, employees, authorized
subcontractors and agents from and against any and all Claims to the extent resulting from (a)
▇▇▇▇▇▇’▇ negligence, omission or willful misconduct, (b) ▇▇▇▇▇▇’▇ breach of its representations or
obligations under this Agreement or the Exclusive Distribution Agreement, (c) the execution,
delivery and performance of this Agreement or the Exclusive Distribution Agreement by Baxter
conflicting with any other agreement of Baxter relating to the Production and supply of Standalone
Product, (d) ▇▇▇▇▇▇’▇ use of the results of Halozyme clinical studies of the Standalone Product,
(e) any claim that the Production of Standalone Product by Baxter in accordance with this
Agreement, violates the patent, trademark, copyright or other proprietary rights of any third
party, except to the extent that such claim is related to the API or the manufacture thereof, or
(f) any claim that ▇▇▇▇▇▇’▇ promotion, marketing or distribution of Standalone Product under the
Exclusive Distribution Agreement violates the patent, trademark, copyright or other proprietary
rights of any third party, except to the extent that such claim is related to the API or the
manufacture thereof, or otherwise violates applicable laws or regulations or rights of any third
party; except to the extent any of the foregoing (a) — (f) is caused solely by the negligence,
omission or willful misconduct of the Halozyme Indemnified Parties or solely or principally by the
breach by Halozyme of its representations or obligations under this Agreement.
15.3 Indemnitee Obligations. A party (the “Indemnitee”) which intends to claim
indemnification under this Section 15 shall promptly notify the other party (the “Indemnitor”) in
writing of any claim, demand, action, or other proceeding in respect of which the Indemnitee
intends to claim such indemnification; provided, however, that failure to provide such notice
within a reasonable period of time shall not relieve the Indemnitor of any of its obligations
hereunder except to the extent the Indemnitor is prejudiced by such failure. The Indemnitee shall
permit, and shall cause its Affiliates, and their respective directors, officers, employees,
subcontractors and agents to permit, the Indemnitor, at its discretion, to settle any such action,
claim or other matter, and the Indemnitee agrees to the complete control of such defense or
settlement by the Indemnitor. Notwithstanding the foregoing, the Indemnitor shall not enter into
any settlement that would adversely affect the Indemnitee’s rights hereunder, or impose any
obligations on the Indemnitee in addition to those set forth herein, in order for it to exercise
such rights, without Indemnitee’s prior written consent, which shall not be unreasonably
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CONFIDENTIAL TREATMENT REQUESTED
withheld or delayed. No such action, claim or other matter shall be settled without the prior
written consent of the Indemnitor, which shall not be unreasonably withheld or delayed. The
Indemnitee, its Affiliates, and their respective directors, officers, employees, subcontractors and
agents shall reasonably cooperate with the Indemnitor and its legal representatives in the
investigation and defense of any claim, demand, action, or other proceeding covered by the
indemnification obligations of this Section 15. The Indemnitee shall have the right, but not the
obligation, to be represented in such defense by counsel of its own selection and at its own
expense.
16. INSURANCE.
16.1 Baxter Insurance. Baxter shall procure and maintain, during the Term of this
Agreement Commercial General Liability Insurance, including, Product Liability. The Successor
Insurance shall cover amounts not less than three million dollars combined single limit. Baxter
retains the right to insure or self insure in any combination at its sole discretion the above
coverages.
16.2 Halozyme Insurance. Halozyme shall maintain general liability insurance during
the term of this Agreement adequately covering Halozyme’s obligations under this Agreement. Not
more than once in any twelve (12) month period, Halozyme shall provide to Baxter evidence of such
insurance, upon ▇▇▇▇▇▇’▇ written request. Notwithstanding the foregoing, once there is a
commercial sale of Standalone Product under the Exclusive Distribution Agreement, Halozyme shall
maintain, at a minimum, during the term of this Agreement and for a period of three (3) years from
the expiration or earlier termination of this Agreement, (a) commercial general liability insurance
with a combined single limit for bodily injury of not less than five million U.S. Dollars
($5,000,000) each occurrence and five million U.S. Dollars ($5,000,000) in the aggregate, and (b)
products liability/completed operations coverage with a per claim limit of not less than five
million U.S. Dollars ($5,000,000) for the first year of this Agreement, five million U.S. Dollars
($5,000,000) for the second year of this Agreement, and five million U.S. Dollars ($5,000,000) for
the remaining term of this Agreement. With respect to the policy under clause (b), such policy
shall show Baxter as an additional insured and loss payee, and provide that Baxter will be given
thirty (30) days advance written notice of the termination or cancellation thereof.
17. GENERAL PROVISIONS.
17.1 Notices. All notices hereunder shall be delivered by facsimile (confirmed by
overnight delivery), or by overnight delivery with a reputable overnight delivery service, to the
following address of the respective parties:
| If to Halozyme: | Halozyme, Inc. | |||
| ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇ | ||||
| ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ | ||||
| Attn: President and Chief Executive Officer | ||||
| Fax: (▇▇▇) ▇▇▇-▇▇▇▇ | ||||
| Phone: (▇▇▇) ▇▇▇-▇▇▇▇ |
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CONFIDENTIAL TREATMENT REQUESTED
| with a copy to: | ▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇ LLP | |||
| ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ | ||||
| ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ | ||||
| Attention: ▇▇▇▇ ▇. ▇▇▇▇▇▇ | ||||
| Fax: (▇▇▇) ▇▇▇-▇▇▇▇ | ||||
| Phone: (▇▇▇) ▇▇▇-▇▇▇▇ | ||||
| If to Baxter: | ▇▇▇▇▇▇ Healthcare Corporation | |||
| ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ | ||||
| ▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ | ||||
| Attn: General Manager | ||||
| Fax: (▇▇▇) ▇▇▇-▇▇▇▇ | ||||
| Phone: (▇▇▇) ▇▇▇-▇▇▇▇ | ||||
| With a copy to: | ▇▇▇▇▇▇ Healthcare Corporation | |||
| ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ | ||||
| ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ | ||||
| Attn: General Counsel | ||||
| Fax: ▇▇▇-▇▇▇-▇▇▇▇ | ||||
| Phone: ▇▇▇-▇▇▇-▇▇▇▇ | ||||
| And to: | ▇▇▇▇▇▇ Healthcare SA | |||
| ▇▇▇▇▇▇▇▇▇▇▇▇ ▇ | ||||
| ▇▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ | ||||
| ▇▇▇▇▇▇▇▇▇▇▇ | ||||
| Attn: Corporate Counsel | ||||
| Fax: ▇▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇ | ||||
| Phone: ▇▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇ |
Notices shall be effective on the day of receipt. A party may change its address listed above
by notice to the other party given in accordance with this
Section 17.1.
17.2 Entire Agreement. The parties hereto acknowledge that this Agreement, together
with the Stock Purchase Agreement dated as of the Restatement Date, between Halozyme Therapeutics,
Inc., a Nevada corporation, and ▇▇▇▇▇▇ International Inc., a Delaware corporation (as amended or
restated from time to time), the Quality Agreement and the Exclusive Distribution Agreement sets
forth the entire agreement and understanding of the parties and supersedes all prior written or
oral agreements or understandings, including the Original Development Agreement, with respect to
the subject matter hereof. No modification of any of the terms of this Agreement, or any
amendments thereto, shall be deemed to be valid unless in writing and signed by an authorized agent
or representative of both parties hereto. No course of dealing or usage of trade shall be used to
modify the terms and conditions herein.
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CONFIDENTIAL TREATMENT REQUESTED
17.3 Waiver. None of the provisions of this Agreement (including the Exhibits hereto)
shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by
authorized agents of such party. The failure of a party to insist upon strict conformance to any
of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or
by law shall not be deemed a waiver of any rights of any party hereto.
17.4 Obligations to Third Parties. Each party warrants and represents that this
Agreement does not conflict with any contractual obligations, expressed or implied, undertaken with
any third party.
17.5 Assignment. Neither party shall assign this Agreement or any part hereof or any
interest herein to any non-affiliated third party (or use any subcontractor) without the written
approval of the other party; provided, however, that either party may assign this Agreement without
such consent to an Affiliate or in the case of a merger, consolidation, change in control or sale
of all or substantially all of the assets of the party seeking such assignment or transfer and such
transaction relates to the business covered by this Agreement and the resulting entity assumes all
of the obligations under this Agreement. No assignment shall be valid unless the permitted
assignee(s) assumes all obligations of its assignor under this Agreement. No assignment shall
relieve any party of responsibility for the performance of its obligations hereunder. Any
purported assignment in violation of this Section 17.5 shall be void.
17.6 Independent Contractor. Baxter and Halozyme are acting under this Agreement as
independent contractors and neither shall be considered an agent of, or joint venturer with, the
other. Unless otherwise provided herein to the contrary, each party shall furnish all expertise,
labor, supervision, machining and equipment necessary for the performance of its obligations
hereunder and shall obtain and maintain all building and other permits and licenses required by
public authorities.
17.7 Governing Law. In any action brought regarding the validity, construction and
enforcement of this Agreement, it shall be governed in all respects by the laws of the State of New
Jersey, without regard to the principles of conflicts of laws, and shall not be governed by the
United Nations Convention on Contracts for the International Sale of Goods. The courts of the
State of California shall have jurisdiction over the parties hereto in all matters arising
hereunder and the parties hereto agree that the venue will be a state or federal court in
California.
17.8 Severability. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof, and this Agreement shall be
interpreted and construed as if such term or provision, to the extent the same shall have been held
to be invalid, illegal or unenforceable, had never been contained herein.
17.9 Headings, Interpretation. The headings used in this Agreement are for
convenience only and are not part of this Agreement.
17.10 Baxter Entities. Each of ▇▇▇▇▇▇ Healthcare Corporation and ▇▇▇▇▇▇ Healthcare
S.A. (a) represents and warrants that all Affiliates within the definition of Baxter shall be bound
by the terms and conditions of this Agreement as if each were an original signatory to
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CONFIDENTIAL TREATMENT REQUESTED
this Agreement, and (b) shall be jointly and severally liable for all acts and omissions of
any Baxter entity in connection with this Agreement. Any act or omission of, or notice to, any
Baxter entity shall constitute the act or omission of, or notice to, each Baxter entity.
17.11 Counterparts. The Agreement may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one and the same
instrument.
IN WITNESS WHEREOF, the parties hereto have each caused this Amended and Restated Development
and Supply Agreement to be executed by their duly-authorized representatives as of the Restatement
Date above written.
HALOZYME, INC. |
||||
| By: | /s/ ▇▇▇▇▇▇▇▇ ▇▇▇ | |||
| Name: | ▇▇▇▇▇▇▇▇ ▇▇▇ | |||
| Title: | President and Chief Executive Officer | |||
▇▇▇▇▇▇ HEALTHCARE CORPORATION |
||||
| By: | /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇ | |||
| Name: | ▇▇▇▇▇ ▇▇▇▇▇▇▇ | |||
| Title: | President | |||
▇▇▇▇▇▇ HEALTHCARE S.A. |
||||
| By: | /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ | |||
| Name: | ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ | |||
| Title: | Vice President of Finance | |||
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT A
API Price
The API Price shall be equal to *** percent (***%) of Halozyme’s fully-burdened manufacturing
costs, storing, shipping, insurance and associated handling costs for the API; provided, however,
in no event shall the API Price exceed *** dollars ($***) per 150 USP units (for the liquid
injectable formulation supplied by Halozyme as of the Restatement Date).
| *** | Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. |
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
Quality Agreement
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EXHIBIT C
Standalone Product Specifications
HYLENEX COMPOSITION
| INGREDIENT | UNIT FORMULA (mg/mL) | |
rHuPH20 |
150 U/mL | |
Sodium Chloride |
8.5 | |
Dibasic Sodium Phosphate |
1.4 | |
Albumin, Human |
1.0 | |
Edetate Disodium |
0.9 | |
Calcium Chloride |
0.3 | |
Sodium Hydroxide |
Added for pH adjustment |
HYLENEX SPECIFICATIONS
| ATTRIBUTE | SPECIFICATION | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
| *** | ||
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
| *** | Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. |
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CONFIDENTIAL TREATMENT REQUESTED
RECOMBINANT HUMAN HYALURONIDASE (rHuPH20) SPECIFICATIONS
| TEST | ACCEPTANCE CRITERIA | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
| *** | ||
| *** | ||
*** |
*** | |
| *** | ||
| *** | ||
| *** | ||
*** |
*** | |
| *** | ||
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** | |
*** |
*** |
| *** | Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. |
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EXHIBIT ▇
▇▇▇▇▇▇ Requirements for Standalone Product Packaging Development
| 1. | Halozyme will provide current approved labeling content that should be used for ▇▇▇▇▇▇ artwork. | |
| 2. | ▇▇▇▇▇▇ will determine cap colors. | |
| 3. | Halozyme will provide the official manufacturer address. |
33