EXHIBIT 10.24
Portions of this exhibit were omitted and filed separately with the Secretary of
the Commission pursuant to an application for confidential treatment filed with
the Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.
Such portions are marked by a series of asterisks.
PRODUCT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Product Development and Commercialization Agreement (the "Agreement") dated
as of the 19th day of November, 1999 (the "Effective Date") is made and entered
into by and between ViroPharma Incorporated, a Delaware corporation having its
principal place of business at 000 Xxxxxxxxx Xxxxxxxxx, Xxxxx, XX 00000
("ViroPharma"), and Battelle Memorial Institute, an Ohio non-profit corporation,
having a principal place of business at 000 Xxxx Xxxxxx, Xxxxxxxx, XX 00000,
through its Battelle Pulmonary Therapeutics Division ("BPTD"). ViroPharma and
BPTD may be referred to herein as a "Party" or, collectively, as "Parties."
BACKGROUND
In consideration of the covenants and promises contained in this Agreement, and
intending to be legally bound, the Parties agree as follows:
1. DEFINITIONS.
As used herein, the following capitalized terms shall have the following
meanings when used in this Agreement, and all terms defined in the singular
shall have the same meanings when used in the plural (and vice versa, as
appropriate), unless otherwise specified:
1.1 "Affiliate" means a corporation, partnership, entity, person, firm,
company, or joint venture, whether de jure or de facto, that controls,
is controlled by or is under the common control with the referenced
Party. For the purposes of this definition the word "control"
(including, with correlative meaning, the terms "controlled by" or "is
under the common control with") means (a) ownership directly or
indirectly of at least fifty percent (50%) of the voting stock of the
applicable entity, or such lesser percentage that is the maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction, or (b) the actual ability to control the management and
operations of the applicable entity.
1.2 "Approval Application" means any application to a Regulatory
Authority, required to be approved by such Regulatory Authority before
marketing the Drug Inhalation System in a particular country, and may
include, without limitation a New Drug Application, Abbreviated New
Drug Application, 510(k) Premarketing Notification, and/or a Premarket
Application, and analogous foreign regulatory filings.
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November 19, 1999 ViroPharms-BPTD Agreement Page 1
1.3 "BPTD Invention" means any Invention that covers the EHD Device, the
Drug Container, or the Drug Vehicle, or any method of making or using
the EHD Device, the Drug Container, or the Drug Vehicle in the Field,
which Invention is made during the Term of this Agreement.
1.4 "BPTD Patent" means any Patent owned or Controlled by BPTD or a BPTD
Affiliate during the term of the Agreement that generically or
specifically claims or covers the manufacture, use, sale, or offer for
sale, import or export of the EHD Device, the Drug Container, or the
Drug Vehicle. Attached hereto as Exhibit A is a list of BPTD Patents
existing as of the Effective Date, which Exhibit A shall be updated by
BPTD on at least a semiannual basis during the term of the Agreement,
provided, however, that unintentional omission of Patents from such
Exhibit A shall not constitute a breach of the Agreement, nor shall it
limit the scope of the defined term "BPTD Patent."
1.5 "BPTD Technology" means all BPTD Patents and BPTD Inventions, and all
Information reasonably necessary for ViroPharma to practice the rights
granted and fulfill the responsibilities imposed in this Agreement,
and all copyrights relating to the Drug Inhalation System, that BPTD
or a BPTD Affiliate owns or Controls during the term of the Agreement.
1.6 "Commercialization Plan" means the plan developed by ViroPharma for
the distribution, marketing and sale of the Drug Inhalation System.
1.7 "cGMPs" means the then current standards for manufacture of
pharmaceuticals and pharmaceutical delivery devices, as set forth in
the United States Federal Food, Drug, and Cosmetic Act and applicable
regulations promulgated thereunder, as amended from time to time, and
such standards of good manufacturing practice as are required by the
European Union and other organizations and governmental agencies in
countries in which the Drug Inhalation System is intended to be sold.
1.8 (a) "Confidential Information" means all secret, confidential or
proprietary information or data, whether provided in written, oral,
graphic, video, computer or other form, provided by one Party (the
"Discloser") to the other Party ("Disclosee") pursuant to this
Agreement or the Confidential Disclosure Agreement between the Parties
dated January 20, 1999, or generated pursuant to this Agreement,
including but not limited to information relating to the Discloser's
existing or proposed research, development efforts, business or
products, the terms of this Agreement and any other materials that
have not been made available by the Discloser to the general public.
(b) Notwithstanding the foregoing Section 1.8(a), Confidential
Information shall not include any information or materials that: (i)
at the time of disclosure by the Discloser to the Disclosee are in, or
after such disclosure become part of, the
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November 19, 1999 ViroPharms-BPTD Agreement Page 2
public domain, through no improper act on the part of the Disclosee
or any of its officers, employees, or agents; (ii) was in the
Disclosee's possession at the time that such information was first
disclosed by the Discloser, as shown by written evidence, and was not
acquired, directly or indirectly, from the Discloser; (iii) the
Disclosee receives from a third party, provided that such information
was not obtained by such third party, directly or indirectly, from
the Discloser; (iv) are required to be disclosed pursuant to valid
law, regulation or court order; or (v) was independently developed by
Disclosee employees having no access to the Confidential Information.
1.9 "Control" means, with respect to a material, Information or
intellectual property right, possession by a Party of the ability to
grant access to or a license or sublicense as provided for herein
under such material, Information or right without violating the terms
of any agreement or other arrangements with any Third Party existing
at the time such Party would be first required hereunder to grant the
other Party such access or license or sublicense.
1.10 "Development Activities" means all activities performed pursuant to
the Development Plan and this Agreement.
1.11 "Development Plan" means the detailed written work plan prepared in
accordance with Section 3.2.1, as such plan may be amended from time
to time.
1.12 "Device Specifications" means the analytical and design
specifications for the EHD Device and the Drug Container, prepared
and modified in accordance with Section 3.2.3(a), and incorporated
into this Agreement by reference.
1.13 "Diligent Efforts" means efforts that are no less than the applicable
efforts that a Party applies to the development, manufacture or
commercialization of its own compounds or products with similar
regulatory requirements and market potential.
1.14 "Drug" means a Small Molecule for use in the Field, and shall
include, without limitation VP 14637.
1.15 "Drug Container" means the container developed or identified for
ViroPharma for the Formulated Drug, all connectors, adapters and
other equipment necessary to permit the attachment of the container
to and incorporation of the container into the EHD Device, all
connectors, adapters and other equipment necessary to permit the
container to be attached to a device to fill the container with
Formulated Drug, and all labels, labeling and packaging for such
container.
1.16 "Drug Inhalation System" means the EHD Device and Packaged Drug
combined and assembled together for use in the Field by a patient
or subject.
1.17 "Drug Master File" or "DMF" means Information and materials, or the
applicable part thereof, submitted to a Regulatory Authority,
providing
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November 19, 1999 ViroPharms-BPTD Agreement Page 3
information on the manufacturing facilities and manufacturing
processes for making a Drug Inhalation System or component thereof,
including, without limitation, activities relating to manufacturing,
processing, formulating, packaging and storage to be conducted by or
under the direction of BPTD or its Affiliates, which Information may
be used to support Regulatory Approval of the Drug Inhalation System
in a country. For purposes of this Agreement, the Drug Master File
shall include, without limitation, chemistry, manufacturing and
control information, as defined in the FDA regulations at 21 CFR
Section 314.50(d).
1.18 "Drug Vehicle" means the combination of all excipients, active, and
inactive ingredients developed for ViroPharma other than the Drug,
with which the Drug is mixed to permit the Pulmonary Delivery of the
Drug via the EHD Device.
1.19 "EHD Device" means the hand-held, single-user, disposable device
developed by BPTD for ViroPharma for the electrohydrodynamic delivery
of Drugs by inhalation, including, without limitation, any removable
mouthpiece or mask for use by patients, and any other equipment or
accessories necessary for a patient to use the device in accordance
with its approved labeling and supplied together with the device, all
of which meet the Specifications.
1.20 "FDA" means the United States Food and Drug Administration, or the
successor thereto.
1.21 "Field" means the treatment and/or prevention of the effect on humans
of respiratory syncytial viruses ("RSV") by Pulmonary Delivery of one
or more Small Molecules not in a formulation or in a combination with
one or more ********** or **********, but not the treatment and/or
prevention of the effect on humans of RSV by Pulmonary Delivery of
one or more ********** or ********** alone or in a formulation or in
a combination with one or more Small Molecules.
1.22 "First Commercial Sale" means, on a country by country basis, the
first sale of the Drug Inhalation System to a Third Party after
Regulatory Approval.
1.23 "Formulated Drug" means the combined, formulated Drug and Drug
Vehicle.
1.24 "Full Royalty Rate Period" for the Drug Inhalation System in any
given country means the period during which ViroPharma's distribution
and/or sale of the Drug Inhalation System in the applicable country,
in the absence of the rights and licenses granted by this Agreement,
would have infringed a BPTD Patent.
1.25 "Information" means information and data of any type whatsoever, in
any tangible or intangible form, including without limitation
inventions, practices, methods, techniques, specifications,
formulations, formulae, knowledge, know-how, skill, experience, trade
secrets, test data including pharmacological,
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November 19, 1999 ViroPharms-BPTD Agreement Page 4
biological, chemical, biochemical, toxicological and clinical test
data, analytical and quality control data, stability data, studies
and procedures, and patent and other legal information or
descriptions.
1.26 "Invention" means any invention, modification, discovery,
improvement, technology, trade secret, chemical or biological
material, assay, method, process, technique, documentation,
scientific and technical data, drawing or other information, whether
patentable or not, relating to a Drug, Drug Vehicle, Formulated Drug,
Drug Container, or EHD Device, or any method of making or using such
Drug, Drug Vehicle, Formulated Drug, Drug Container, or EHD Device in
the Field.
1.27 "Major Markets" means Austria, Belgium, Canada, Denmark, Finland,
France, Germany, Indonesia, Ireland, Italy, Japan, Mexico,
Netherlands, Portugal, Spain, Sweden, the United Kingdom, the United
States.
1.28 "Net Sales" means the total amount invoiced or otherwise charged by
ViroPharma or its Affiliates to customers or Third Party licensees on
account of the sale of the Drug Inhalation System, less the following
deductions: (a) deductions, credits, allowances, and discounts
actually granted for spoiled, damaged, out-dated and returned units
of the Drug Inhalation System (including withdrawals and recalls);
(b) rebates (including Medicaid, managed care rebates and other
similar types of rebates, e.g. chargebacks); (c) freight and
insurance costs for transporting the Drug Inhalation System which are
included in the billed amount; (d) sales, use, excise, value-added
and other direct taxes on the sale of the Drug Inhalation System; (e)
customs duties, surcharges and other governmental charges incurred in
connection with the exportation or importation of the Drug Inhalation
System; (f) trade, cash, and quantity discounts off the invoiced
price and similar promotional discounts or rebates (such as
management fees required by hospital buying groups or granted to
managed care organizations) off the invoiced price, and (g) amounts
reflecting retroactive price adjustments on sale of products, to the
extent not previously deducted from net sales, but only to the extent
such adjustment is not made more than one year after the sale; all of
the foregoing to the extent consistent with the normal practice in
the industry, and provided that any and all of the foregoing are
calculated in accordance with United States generally accepted
accounting principles consistently applied. Included in Net Sales
shall be any disposition of a Drug Inhalation System or component
thereof for value, and if for other than cash, such disposition to be
converted to a cash amount equal to the amount such system or
components are sold to others.
1.29 "Packaged Drug" means Formulated Drug packaged in a finished Drug
Container.
1.30 "Patent" means (a) all patent applications heretofore or hereafter
filed or having legal force in any country; (b) all patents that have
issued or in the future issue
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November 19, 1999 ViroPharms-BPTD Agreement Page 5
therefrom, including without limitation utility, model and design
patents and certificates of invention; and (c) all divisionals,
continuations, continuations-in-part, reissues, renewals, extensions
(including supplemental protection certificates), additions,
registrations or confirmations to or of any such patent applications
and patents.
1.31 "Pulmonary Delivery" means
a. the administration of any substance by:
i. inhalation through the mouth, or
ii. simultaneous inhalation through the mouth and nose, or
iii. where inhalation through the mouth is not possible or
reasonably practicable due to the patient's condition,
inhalation through the nose,
in each case to the lungs and/or to the trachea (including
necessary incidental non-therapeutic and non-functional [i.e.,
not for diagnosis, prevention or treatment of disease] delivery
to the mouth, nose and throat as a result of such inhalation) for
the purpose of diagnosis, prevention or treatment of disease;
b. the administration of any substance to the lungs, trachea, mouth,
throat or nasal passages by inhalation through the mouth and/or
nose for the treatment, prevention, or diagnosis of all cancers
of the respiratory tract; and
c. where it can be shown by clinical trials that treatment or
prevention of a particular disease by delivery of a substance to
the lungs and/or the trachea in accord with Section 1.31(a) above
is significantly improved by simultaneous delivery of the same
substance to the mouth and/or throat then "Pulmonary Delivery"
will be extended to include delivery under Section 1.31(a) above
together with simultaneous delivery of the same substance to the
mouth and/or throat for the prevention or treatment of that
disease.
For the avoidance of doubt, "Pulmonary Delivery" shall not include:
---
d. any delivery or deposition to the nasal passage or nasal cavities
other than as expressly permitted in Sections 1.31(a-b) above;
and
e. except as provided in Section 1.31(b) above, delivery to the
mouth and/or throat when not done simultaneously with delivery to
the lungs and/or trachea in accordance with Section 1.31(c)
above.
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November 19, 1999 ViroPharms-BPTD Agreement Page 6
1.32 "Pulmonary Surfactant" means
a. More than ********** total, per dose, of one or more of the
following **********; **********, and/or
b. Any amount of ********** or ********** or any derivative thereof
(a fragment or modified form of ********** or ********** or such
fragment) or any molecule specifically developed and
intentionally used to replace ********** or ********** in whole,
or in part, and/or
c. Any amount of ********** or any derivative thereof (a fragment
or modified form of ********** or such fragment) plus (i)
********** conforming to a) above and/or (ii) any molecule
conforming to b) above.
1.33 "Recovery Cost" means the actual costs inclusive of all direct and
reasonable indirect costs of products or services incurred after the
Effective Date, with no xxxx-up for profits, and in the case of
products or services provided by a Third Party, the actual amount
charged by such Third Party, but in no event shall Recovery Costs
include Third Party Payments. Notwithstanding anything in this
Agreement to the contrary, all services and/or property provided by
any Battelle Memorial Institute operating unit, division, or
affiliate other than BPTD shall be sold or billed to ViroPharma or
any other party under this Agreement at ordinary and customary prices
and/or rates, including profits (but not for BPTD).
1.34 "Reduced Royalty Rate Period" for the Drug Inhalation System in a
country means the period beginning on the expiration of the Full
Royalty Rate Period for the Drug Inhalation System in that country,
or if there is no Full Royalty Rate Period in that country, then
beginning on the First Commercial Sale of the Drug Inhalation System
in that country, and ending on the ********** anniversary of the
Effective Date.
1.35 "Regulatory Approval"
1.36 "Regulatory Authority" { shall mean any national (e.g., the United
States Food and Drug Administration), supra-national (e.g., the
European Commission, the Council of the European Union, or the
European Agency for the Evaluation of Medicinal Products), regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity in each country of the
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November 19, 1999 ViroPharms-BPTD Agreement Page 7
world involved in the granting of Regulatory Approval for the Drug
Inhalation System.
1.37 "Retained Rights" means the right of the Third Party identified in
Exhibit B to this Agreement to have granted to it upon request a
paid-up, non-exclusive license to make, keep, use and sell subject
matter disclosed and claimed in those of the BPTD Patents designated
with an asterisk in Exhibit A to this Agreement.
1.38 "Small Molecule" means any chemical entity or compound, but not small
peptides or proteins.
1.39 "Specifications" means the System Specifications and the Device
Specifications.
1.40 "System Specifications" means the analytical, design and performance
specifications for the Drug Inhalation System, prepared and modified
in accordance with Section 3.2.2, and incorporated into this
Agreement by reference.
1.41 "Third Party" means any entity or individual other than BPTD,
ViroPharma, or Affiliates of either.
1.42 "Third Party Payment" means any payment made by BPTD or a BPTD
Affiliate:
a. to any Third Party as a result of BPTD's obtaining or licensing,
before or after the Effective Date, such Third Party's Patents or
technology; or
b. to any Third Party as a result of any defense or settlement of
any Third Party claim or action alleging that the manufacture,
use, sale, offer for sale, importation or exportation of the EHD
Device, the Drug Vehicle or the Drug Container infringes a Third
Party Patent in any country of the world.
1.43 "ViroPhaema Invention" means any Invention that is not a BPTD
Invention, including, without limitation, any Invention that covers
the Drug, or the Formulated Drug, or any method of making or using
the Drug or Formulated Drug in the Field, which Invention is made
during the Term of this Agreement.
1.44 "ViroPharma Patent" means any Patent owned or Controlled by
ViroPharma or a ViroPharma Affiliate during the term of the Agreement
that claims an Invention in the Field or that generically or
specifically claims or covers the manufacture, use, sale, or offer
for sale, import or export of the Drug or Formulated Drug.
1.45 "ViroPharma Technology" means all ViroPharma Patents and ViroPharma
Inventions, and all copyright, trademarks, and Information that
ViroPharma or an Affiliate owns or Controls during the term of the
Agreement.
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November 19, 1999 ViroPharms-BPTD Agreement Page 8
2. LICENSES
2.1 License to ViroPharma.
2.1.1 General. Except as limited by the Retained Rights, BPTD grants
to ViroPharma and its Affiliates the worldwide, royalty-
bearing, exclusive, except as to BPTD and its Affiliates,
sublicensable right and license to use the BPTD Technology to
the extent necessary to perform the activities under this
Agreement in the Field, including, without limitation, making,
using, selling, offering for sale, importing, or exporting the
Drug Inhalation System or any part of the Drug Inhalation
System, or licensing a Third Party to do any of the foregoing.
2.1.2 Post Expiration of Payment Obligation. After the expiration of
the obligation to make payments under Sections 9.1-9.6 of this
Agreement, the licenses under this Section 2.1 shall be fully-
paid, perpetual, irrevocable and royalty-free.
2.2 License to BPTD. ViroPharma grants to BPTD and its Affiliates the
royalty-free, non-sublicensable, non-exclusive, right and license to
use the ViroPharma Technology only to the extent necessary to perform
the activities under this Agreement in the Field, but for no other
purposes.
2.3 Exclusive Relationship.
2.3.1 General. Except as specifically permitted by the terms of this
Agreement and for the purposes of this Agreement, during the
term of this Agreement, without the prior written consent of
ViroPharma, neither BPTD nor any of its Affiliates shall
directly or indirectly use or license a Third Party to use the
BPTD Technology in the Field.
2.3.2 Drug Vehicle Use. Except as specifically permitted by the terms
of this Agreement and for the purposes of this Agreement,
neither BPTD nor any of its Affiliates shall directly or
indirectly use the Drug Vehicle in the Field, or any BPTD
Technology covering the Drug Vehicle in the Field:
a. During the term of this Agreement; and
b. For five years after the term of this Agreement, unless
this Agreement is terminated pursuant to Section 14.2 or
14.3.
2.3.3 Drug Vehicle License. Neither BPTD nor any of its Affiliates
shall directly or indirectly license a Third Party to use the
Drug Vehicle in the Field, or any BPTD Technology covering the
Drug Vehicle in the Field:
a. During the term of this Agreement; and
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November 19, 1999 ViroPharms-BPTD Agreement Page 9
b. For five years after the term of this Agreement, unless
this Agreement is terminated pursuant to Section 14.2 or
14.3.
2.3.4 ********** or ********** Used with Small Molecules. Without the
prior written consent of ViroPharma, BPTD and its Affiliates
shall not directly or indirectly use or license a Third Party
to use the BPTD Technology for the Pulmonary Delivery of one or
more Small Molecules in a formulation or in a combination with
one or more ********** or ********** for the treatment and/or
prevention of the effect on humans of RSV where any Small
Molecule in such formulation or combination is active as a
single agent for the treatment and/or prevention of the effect
on humans of RSV.
2.4 Right of Reference. BPTD and its Affiliates grant ViroPharma, its
Affiliates and designees a "Right of Reference," as that term is
defined in 21 C.F.R. (S) 314.3(b), to any data developed under this
Agreement or under the Master Services Agreement between the Parties
dated April 12, 1999, and BPTD and/or its Affiliates shall provide a
signed statement to this effect, if requested by ViroPharma, in
accordance with 21 C.F.R. (S) 314.50(g)(3).
3. PRODUCT DEVELOPMENT.
3.1 General.
3.1.1 Compliance with Laws. The Parties shall perform all activities
under this Agreement, including, without limitation,
Development Activities, in compliance with all federal, state
and local laws, regulations and ordinances, and with any
applicable professional standards. Neither Party shall take
legal action against the other Party for damages for a non-
material breach of this Section 3.1.1.
3.1.2 Diligence. The Parties will use Diligent Efforts in performing
Development Activities.
3.1.3 Terms for Performing Development Activities. All Development
Activities performed by BPTD shall be performed pursuant to
Section 4 of this Agreement. ViroPharma shall not be liable to
BPTD for the costs of any Development Activities not performed
pursuant to Section 4.
3.2 Development Planning and Development Activities.
3.2.1 Preparation of Development Plan. Within ninety days after the
Effective Date, ViroPharma and BPTD will prepare a mutually
agreeable
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November 19, 1999 ViroPharms-BPTD Agreement Page 10
Development Plan, which shall be attached to this Agreement
as Exhibit C that shall identify in reasonable detail the
activities necessary to:
a. Design and develop an EHD Device appropriate to deliver
the Formulated Drug, in accordance with Device
Specifications;
b. Design and develop a Drug Vehicle that is compatible
with the EHD Device and the Drug;
c. Design and develop a Drug Container or identify a
commercially available Drug Container that can contain
adequate quantities of the Formulated Drug, and that
can be readily incorporated into the EHD Device, in
accordance with Device Specifications for the Drug
Container; and
d. Develop preclinical and clinical data and complete
Approval Applications necessary to obtain Regulatory
Approval for the Drug Inhalation System in countries
throughout the world.
At least semiannually, after reviewing the results of the
development efforts to that time, ViroPharma and BPTD shall
mutually agree on any amendments to the Development Plan to
reflect revised development and/or regulatory activities or
goals. In the event of any failure to agree on the portions
of the Development Plan described in Sections 3.2.1(a)
through(c), BPTD shall have final decision making authority.
In the event of any failure to agree on the portions of the
Development Plan described in Section 3.2.1(d), ViroPharma
shall have final decision making authority.
3.2.2 Drug Inhalation System Specifications. The summary System
Specifications for the Drug Inhalation System setting forth
the planned design, performance and features of the Drug
Inhalation System are to be developed after the Effective
Date and attached to this Agreement as Exhibit D (the
"System Specifications"). The System Specifications may be
altered by ViroPharma, only after BPTD has had a reasonable
opportunity to review and comment on any proposed changes.
3.2.3 EHD Device and Drug Container.
a. EHD Device and Drug Container Specifications.
ViroPharma and BPTD shall collaborate to prepare
summary Device Specifications for the EHD Device and
Drug Container setting forth the planned design,
features and performance of the EHD Device and the Drug
Container consistent with the System Specifications. If
the System Specifications and the Device Specifications
conflict in any material regard, the System
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November 19, 1999 ViroPharma-BPTD Agreement Page 11
Specifications shall govern. At any time during the
term of the Agreement, BPTD may suggest changes to the
design of the EHD Device or the Drug Container. No such
changes shall be implemented except upon the written
approval of ViroPharma.
b. Development Activities. The Parties shall perform
Development Activities on the EHD Device and the Drug
Container in compliance with the Development Plan and
the Specifications. BPTD shall perform Development
Activities pursuant to Article 4, as requested by
ViroPharma. ViroPharma shall not employ Third Parties
to perform Development Activities on the EHD Device and
the Drug Container.
3.2.4 Drug Vehicle Development. The Parties shall perform
Development Activities on the Drug Vehicle in compliance
with the Development Plan and the Specifications. At
ViroPharma's reasonable request, BPTD shall perform
Development Activities pursuant to Article 4.
3.2.5 Costs. Except as expressly set out in this Agreement,
ViroPharma shall pay for all Development Activities under
this Agreement.
3.2.6 Master Services Agreement. As reasonably requested by
ViroPharma, BPTD shall perform the activities described in
the document entitled "ViroPharma Project: Preformulation
and EHD Aerosol Feasibility Study of VP 14637" attached to
the Master Services Agreement between the Parties dated
April 12, 1999, in accordance with the terms of such Master
Services Agreement. If the performance of activities under
the Master Services Agreement conflicts with, or is made
impractical by, this Agreement, such activities shall be
performed pursuant to this Agreement. If any provisions of
the Master Services Agreement are in conflict with the
provisions of this Agreement, this Agreement shall control.
3.3 Clinical Testing of Inhalation System. ViroPharma or its designees
shall be responsible for designing, performing and funding clinical
studies necessary to obtain Regulatory Approval for the Drug
Inhalation System.
3.4 Development Product Supply. ViroPharma or its designees shall supply,
at its own cost, adequate amounts of Drug, Formulated Drug and placebo
for the performance of Development Activities under this Section 3.
BPTD shall supply, at ViroPharma's expense (to be charged to
ViroPharma at BPTD's Recovery Cost), adequate numbers of Drug
Inhalation System units for the performance of Development Activities
under this Article 3, consistent with Article 5.
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November 19, 1999 ViroPharma-BPTD Agreement Page 12
3.5 Approval Applications.
3.5.1 Generally. ViroPharma, by itself, or through its Affiliates
or sublicensees will use Diligent Efforts to prepare,
assemble and submit in its own name and at its own expense
all Approval Applications and DMFs for the Drug Inhalation
System in countries of the world consistent with the
Commercialization Plan. ViroPharma will own any such
Approval Applications, DMFs and Regulatory Approvals.
3.5.2 Assistance by BPTD. BPTD and its Affiliates shall provide to
ViroPharma for inclusion in Approval Applications or DMFs
any necessary information or materials regarding the EHD
Device and/or the Drug Container and shall employ Diligent
Efforts to provide any reasonably necessary assistance to
ViroPharma in obtaining Regulatory Approval or in submitting
DMFs at ViroPharma's cost. Upon ViroPharma's reasonable
request, BPTD and/or BPTD's Affiliates shall attend and
participate in meetings regarding the Drug Inhalation
System, including meetings with Regulatory Authorities.
3.5.3 Filings by BPTD. If the laws or regulations of any country
require that BPTD, or a BPTD Affiliate rather than
ViroPharma, file any part of any Approval Application, DMF
or part thereof, BPTD, or such BPTD Affiliate, shall file
the Approval Application, DMF or part thereof at
ViroPharma's expense and shall, consistent with the laws and
regulations of the country, transfer such Approval
Application, DMF, Regulatory Approval, or part thereof, to
ViroPharma, or hold and maintain the same on ViroPharma's
behalf.
4. PERFORMANCE OF DEVELOPMENT ACTIVITIES BY BPTD.
4.1 Work Orders. BPTD shall perform Development Activities as agreed to by
the Parties, consistent with the Development Plan from time to time.
The specific details of each assignment in respect of the Development
Activities will be separately negotiated and contracted for in
writing, and shall be set forth in a work order in substantially the
form attached hereto as Exhibit E each to be sequentially numbered and
to be subject to all of the terms and conditions set forth in this
Agreement, and incorporated into this Agreement by reference (each, a
"Work Order").
4.2 Protocols. Unless otherwise indicated on the applicable Work Order,
BPTD shall prepare protocols describing the Development Activities for
ViroPharma's review and approval prior to initiating such Development
Activities. BPTD shall make such changes to such protocol that are
reasonably requested by ViroPharma and agreed to by BPTD, such
agreement not to be withheld or delayed unreasonably
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November 19, 1999 ViroPharma-BPTD Agreement Page 13
(as so modified, the "Protocol"). BPTD shall perform the Development
Activities in accordance with the applicable Protocol.
4.3 Deliverables. BPTD shall deliver to ViroPharma the deliverables
described or referred to on the applicable Work Order (each, a
"Deliverable"). The Development Activities described in a particular
Work Order shall be deemed to have been completed upon BPTD's
completing such Development Activities in accordance with the Work
Order terms and with the terms of this Agreement.
4.4 Inspection; Project Materials. Upon reasonable advance notice to BPTD,
and at reasonable times during normal business hours, ViroPharma shall
be permitted to send certain of its employees or designees to BPTD's
facilities to consult with BPTD's employees and consultants engaged in
the activities contemplated by a Work Order, to observe BPTD in the
performance of its duties hereunder, and to inspect and take copies of
any of the results of the Development Activities. BPTD shall make
BPTD's employees and consultants and such results available to
ViroPharma for such purposes. During such visits, ViroPharma shall
comply with BPTD policy regarding security, as such policy shall be in
force from time to time.
4.5 Reports. BPTD shall maintain accurate and complete records of all
Development Activities it performs and all results of any trials,
studies and other investigations conducted by or on behalf of
ViroPharma hereunder. Unless otherwise indicated on the applicable
Work Order, BPTD shall prepare and deliver to ViroPharma a final
written Report for each Work Order, in such detail as agreed to by the
Parties. BPTD shall provide ViroPharma with summary data describing
the interim results of the Development Activities, and copies of all
materials generated in connection with the activities contemplated by
this Agreement, upon ViroPharma's request and at ViroPharma's cost,
provided that ViroPharma is not then in default of its obligations
under this Agreement.
4.6 Fees. Except as expressly agreed to in advance by ViroPharma: (a) in
no event shall the price to ViroPharma for any Deliverable exceed the
"Maximum Fee" listed opposite such Deliverable on such Work Order; (b)
in no event shall the aggregate amount due for any Work Order exceed
the "Total Fee" set forth on such Work Order; and (c) in no event
shall Development Activities be billed at more than BPTD's Recovery
Cost. The Maximum Fee and Total Fee are to be negotiated for the work
orders on a case-by-case basis. Unless otherwise agreed to by
ViroPharma in a Work Order, BPTD shall be solely responsible for
expenses incurred by it in the performance of the Development
Activities.
4.7 Invoices. BPTD shall generate invoices in accordance with the mutually
agreed upon payment schedule described in the applicable Work Order
(the "Payment Schedule"). All invoices that are not disputed by
ViroPharma in good faith shall be payable within thirty days after
ViroPharma's receipt. ViroPharma will pay interest of 1% per month on
balances due for late payment.
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November 19, 1999 ViroPharma-BPTD Agreement Page 14
5. CLINICAL SUPPLY MANUFACTURING.
5.1 General. BPTD agrees to itself, or through its Affiliates, (a) supply
ViroPharma's clinical testing requirements of the EHD Device, (b)
install Packaged Drug supplied by ViroPharma to BPTD into such EHD
Devices, and (c) ship labeled and packaged investigational Drug
Inhalation Systems to clinical trial sites or a clinical trial
distributor identified by ViroPharma. If the Drug Container is not
readily commercially available, BPTD agrees to itself, or through its
Affiliates, (x) supply ViroPharma's clinical testing requirements of
the Drug Container, and (y) ship such Drug Container to ViroPharma or
a designee. BPTD shall perform or cause to be performed all such
activities in accordance with the Specifications and the terms of this
Agreement and in compliance with all applicable federal, state, and
local laws, regulations and ordinances, including, without limitation,
cGMPs. Neither BPTD nor its Affiliates shall alter the manufacturing
processes of clinical supplies under this Section 5.1 without the
prior written approval of ViroPharma, not to be unreasonably withheld
or delayed.
5.2 Manufacturing Facilities, Equipment and Licenses. In manufacturing
clinical supplies pursuant to Section 5.1, BPTD and BPTD's Affiliates
shall:
5.2.1 acquire all equipment and licenses, including, without
limitation, all necessary plant equipment and facilities
licenses, necessary to manufacture investigational EHD
Devices and Drug Containers under this Section 5;
5.2.2 use Diligent Efforts to keep such equipment properly
maintained and to reduce risks of breakdown of critical
machinery;
5.2.3 obtain and maintain all necessary federal, state and local
manufacturing licenses and approvals for the manufacturing
facilities;
5.2.4 maintain all records that are necessary and appropriate to
demonstrate compliance with cGMPs; and
5.2.5 BPTD shall ensure that the manufacturing of investigational
EHD Devices, Drug Containers, or assembly of Drug Inhalation
Systems under Section 5 complies with all applicable
federal, state and local environmental, health and safety
laws and regulations in effect at the time and place of such
manufacture, and all waste, including but not limited to all
hazardous waste, generated in such manufacturing shall be
disposed of in accordance with all applicable federal, state
and local laws and regulations.
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November 19, 1999 ViroPharma-BPTD Agreement Page 15
5.3 Orders.
5.3.1 Placement of an Order. ********** prior to the start of each
clinical trial, ViroPharma will advise BPTD of the estimated
number of Drug Inhalation System units necessary to complete
such clinical trial, the estimated schedule on which the
units will be needed and an order specifying the number of
units needed for the first ********** of the clinical trial.
ViroPharma will place orders for ********** of inventory for
the Drug Inhalation System at a time, ********** in advance
of the required delivery date.
5.3.2 Confirmation of an Order. Within two business days after
receiving a an order under Section 5.3.1, BPTD shall provide
written confirmation of its ability to fill such order as
well as the address to which ViroPharma should ship Packaged
Drug to be used in filling the order. If BPTD believes that
it may be unable to fulfill such order, it shall notify
ViroPharma by telephone and in writing immediately, but in
no case later than two business days after receiving such
order.
5.3.3 Conflicting Terms in Order Forms or Invoices. If any
purchase order, invoice or acknowledgment form used by
either ViroPharma or BPTD contains any provision additional
or contrary to the provisions of this Agreement, such
additional or contrary provision shall have no force or
effect and the terms of this Agreement shall control.
5.4 Shipment of Packaged Drug.
5.4.1. Shipping by ViroPharma. Within two business days after
ViroPharma receives written confirmation of BPTD's ability
to fulfill an order pursuant to Section 5.3.2, ViroPharma
shall ship a number of units of Packaged Drug equal to 102%,
rounded up to the nearest whole number, of the number of
units of Drug Inhalation System requested in the order FOB
the address supplied by BPTD in such written confirmation.
5.4.2. Receipt and Possession by BPTD. ViroPharma shall retain
title and BPTD shall be solely responsible for the risk of
loss of Packaged Drug in the inventory or possession of BPTD
or a BPTD Affiliate which loss is due to the negligence or
intentional misconduct of BPTD or the BPTD Affiliate.
ViroPharma shall be responsible for all losses of Packaged
Drug not described in the preceding sentence. BPTD shall
notify ViroPharma promptly upon the loss of any Packaged
Drug. ViroPharma shall invoice BPTD for the cost of any lost
Packaged Drug, for which BPTD is liable under this Section
5.4.2., which amount BPTD shall pay within thirty days of
its receipt of such invoice.
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November 19, 1999 ViroPharma-BPTD Agreement Page 16
5.5 Completion and Packaging. BPTD will combine the Packaged Drug and the
EHD Device, package and label the Drug Inhalation System for use in
the clinical research program in accordance with the Specifications.
5.6 Inspection of Final Products.
5.6.1 Inspection. BPTD shall inspect finished Drug Inhalation
System units pursuant to the applicable Specifications, all
federal, state, and local laws and regulations, and in
accordance with reasonable industry standards. ViroPharma
shall have the right, at its own cost, to witness or
participate in any and all inspections of finished Drug
Inhalation System units at the site where such inspection
takes place.
5.6.2 Documentation. Within three business days after completing
the inspection of finished Drug Inhalation System units,
BPTD shall forward to ViroPharma:
a. a production report identifying any problems
encountered in the fulfillment of the applicable
Binding Order, the results of the QC analysis, and the
results of any inspection, along with any supporting
data, and
b. a Certificate of Analysis and Conformance ("COA")
specifying that all Drug Inhalation System units
subject to such COA conform with the Specifications.
The COAs will use lot numbers as directed by ViroPharma.
ViroPharma shall be under no obligation to accept any
shipment of BPTD products without an accompanying COA.
5.7 Shipment of Final Products. BPTD, or its Affiliates shall ship the
units of Drug Inhalation Systems in fulfillment of an order FOB the
address specified in such order for delivery by the Delivery Date.
5.8 Invoices. BPTD will invoice ViroPharma for the Recovery Cost of
investigational EHD Devices and Drug Containers upon delivery of the
Drug Inhalation Systems to the carrier identified by ViroPharma. Such
invoices shall reasonably itemize BPTD's Recovery Costs for labor,
materials, supplies, and payments to Third Parties or Affiliates, by
production lot number for the Drug Inhalation System, and shall
contain such other information as may be reasonably requested by
ViroPharma.
5.9 Payments. ViroPharma shall pay any invoice under Section 5.8 within
thirty days of receiving such invoice.
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November 19, 1999 ViroPharma-BPTD Agreement Page 17
6. MANUFACTURING OF COMMERCIAL SUPPLY.
6.1 General. ViroPharma or its designees shall be solely responsible for
contracting for and paying the costs of any commercial supply of the
Drug Inhalation System. ViroPharma may, but is not required to,
contract with BPTD to provide any part of such commercial supply.
6.2 Volume Discounts for EHD Device Component Supply. BPTD shall disclose
to ViroPharma the identity of the supplier for each component of the
EHD Device or the Drug Container purchased from a Third Party for
which BPTD is eligible to receive a volume discount, and will exert
reasonable commercial efforts to cause any such supplier to provide
similar discounts to ViroPharma.
6.3 Consulting and Technology Transfer. If ViroPharma contracts with a
Third Party to manufacture commercial supplies of the EHD Device, Drug
Container, and/or Drug Vehicle (the "Third Party Manufacturer"), then
BPTD shall, at its Recovery Cost for such services:
6.3.1 assist ViroPharma in transferring to the Third Party
Manufacturer all BPTD Technology existing at the time of
transfer which is necessary in the manufacture of the EHD
Device, Drug Container, and/or Drug Vehicle to
Specifications and in compliance with all applicable
federal, state, and local laws and regulations, except that
the first such transfer shall be at BPTD's expense;
6.3.2 assist ViroPharma and the Third Party Manufacturer in
troubleshooting any problems that may arise in manufacturing
the EHD Device, Drug Container, and/or Drug Vehicle;
6.3.3 consult with ViroPharma and its Third Party Manufacturer on
all aspects of manufacturing of the EHD Device, Drug
Container, and/or Drug Vehicle, and any improvements that
can be made to the manufacturing process; and
6.3.4 perform any other consulting, advisory, technology transfer,
problem-solving or other activities reasonably necessary to
assist ViroPharma and its Third Party Manufacturer to
successfully manufacture the EHD Device, Drug Container,
and/or Drug Vehicle.
7. COMMERCIALIZATION AND MARKETING.
7.1 Commercialization Plan. Ninety days before it submits the first
Approval Application for the Drug Inhalation System to any Regulatory
Authority, ViroPharma shall provide to BPTD a copy of its
Commercialization Plan. The Commercialization Plan shall set out the
countries in which ViroPharma intends
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November 19, 1999 ViroPharma-BPTD Agreement Page 18
to seek Regulatory Approval for and launch the Drug Inhalation System
in the next five years. ViroPharma shall update the Commercialization
Plan at least annually and shall provide BPTD with a copy of all
updated Commercialization Plans.
7.2 Diligence. Within ********** of receiving the first Regulatory
Approval for the Drug Inhalation System, ViroPharma shall obtain
Regulatory Approval of the Drug Inhalation System in ********** of the
Major Market countries.
7.2.1 If ViroPharma's failure to obtain such Regulatory Approvals
is not due to reasonably unforeseeable adverse regulatory
actions, or refusal or delay of Regulatory Approval because
of a Regulatory Authority's concerns with the EHD Device,
the Drug Container, or the Drug Vehicle, the license grant
to ViroPharma under this Agreement becomes non-exclusive for
all countries in which ViroPharma has not already obtained
Regulatory Approval or in which approval is not pending.
7.2.2 If ViroPharma's failure to obtain such Regulatory Approvals
is due to reasonably unforeseeable adverse regulatory
actions, then the period for obtaining such Regulatory
Approvals shall be extended by a reasonable period of time,
mutually agreed to by the Parties.
7.2.3 If ViroPharma's failure to obtain such Regulatory Approvals
is due to refusal or delay of Regulatory Approval because of
a Regulatory Authority's concerns with the EHD Device, the
Drug Container, or the Drug Vehicle, then the period for
obtaining such Regulatory Approvals shall be extended for as
long as necessary to resolve such Regulatory Authority's
concerns with the EHD Device, the Drug Container, or the
Drug Vehicle.
7.3 Further Diligence. ViroPharma shall exercise Diligent Efforts to
obtain Regulatory Approval in countries consistent with the
Commercialization Plan.
7.3.1 Countries Declined by ViroPharma. If ViroPharma has not
received Regulatory Approval for the Drug Inhalation System
in a country, and ViroPharma has confirmed to BPTD in
writing that it does not intend to seek Regulatory Approval
for the Drug Inhalation System in such country, and if no
xxxx market or price effects exist as set forth in Section
7.3.3, then upon ninety days prior written notice, BPTD may
grant a non-exclusive license to a Third Party to use the
BPTD Technology, in the Field, in such country.
7.3.2 Countries Requested by BPTD. If ********** after the first
Regulatory Approval, ViroPharma has not submitted an
Approval Application for the Drug Inhalation System in a
country, and if BPTD has received a request from a Third
Party to License the BPTD Technology in the Field in such
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November 19, 1999 ViroPharma-BPTD Agreement Page 19
country, then BPTD may request from ViroPharma, in writing,
the right to make such license.
a. If within ninety days of such request, ViroPharma does
not respond in writing stating that ViroPharma will
submit an Approval Application for the Drug Inhalation
System in such country or that xxxx market or price
effects exist as set forth in Section 7.3.3, then BPTD
may license a Third Party to use the BPTD Technology,
in the Field, in such country.
b. If ViroPharma responds in writing stating that it will
submit an Approval Application for the Drug Inhalation
System in such country, then ViroPharma shall have a
reasonable period of time, mutually agreed to by the
Parties, but in no event less than **********, to
obtain Regulatory Approval in such country, and
ViroPharma will use Diligent Efforts to obtain such
Regulatory Approval. The Parties shall agree to extend
the time for obtaining Regulatory Approval in the event
of reasonably unforeseeable adverse regulatory actions,
or in the event of a refusal or delay of Regulatory
Approval because of a Regulatory Authority's concerns
with the EHD Device, the Drug Container, or the Drug
Vehicle. If ViroPharma fails to obtain Regulatory
Approval in such country in the period agreed to by the
Parties, then upon ninety days prior written notice,
BPTD may grant a non-exclusive license to a Third Party
to use the BPTD Technology, in the Field, in such
country, unless the failure is due to the Regulatory
Authority's concerns with the EHD Device, the Drug
Container, or the Drug Vehicle.
7.3.3 Xxxx Market and Price Effects. Xxxx market or price effects
shall be deemed to exist if it is reasonably expected that
the licensing of the BPTD Technology in the Field to a Third
Party in a country would either:
a. Reduce ********** of the Drug Inhalation System
********** by ********** or more; or
b. Reduce ********** of the Drug Inhalation System by
********** or more.
In the event of a failure of the Parties to agree on the
existence of xxxx market or price effects under this
Section 7.3.3, the Parties shall resolve the matter in
accordance with Section 15.15.
7.4 Marketing Diligence. During the term of this Agreement, ViroPharma
shall use Diligent Efforts to promote the use and sale of the Drug
Inhalation System in each country in which the Drug Inhalation System
has received Regulatory Approval,
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November 19, 1999 ViroPharma-BPTD Agreement Page 20
and ViroPharma shall assure that an adequate sales force is maintained
for the appropriate promotion of the Drug Inhalation System.
7.5 Regulatory Reporting. ViroPharma or its designee shall be responsible
for filing all reports required to be filed in order to maintain any
Regulatory Approvals granted for the Drug Inhalation System in the
world, including, without limitation, adverse drug experience reports.
BPTD and its Affiliates shall cooperate with ViroPharma in preparing
and filing all such reports and, upon ViroPharma's request, provide
ViroPharma with any information in BPTD's or its Affiliates'
possession or Control that ViroPharma reasonably deems to be relevant
to any such reports. If BPTD or a BPTD Affiliate has or receives any
information regarding any adverse drug experience that may be related
to the use of the Drug Inhalation System, BPTD shall provide
ViroPharma with all such information in writing within forty-eight
hours of BPTD's receiving such information.
7.6 Recalls.
7.6.1 Notification. BPTD shall immediately inform ViroPharma
orally of all information in BPTD's possession relating to:
a. any incident relating to a Drug Inhalation System unit
and/or any lot of the Drug Inhalation System that is
the subject of recall, market withdrawal or correction,
or
b. any Drug Inhalation System Units that may require,
whether based on design defect, manufacturing defect,
or otherwise, a recall, field alert, product withdrawal
or field correction arising from any defect in such
units.
7.6.2 Costs of Recall. The costs of any recall shall be borne
consistent with the indemnification in Sections 13.1-2.
7.7 Failure Analysis. BPTD shall, at ViroPharma's expense, assist
ViroPharma or its designees in performing all failure analysis for
recalled, rejected, and out-of-System Specification Drug Inhalation
System units that is required by federal, state, or local laws or
regulations, or that is reasonably requested by ViroPharma. BPTD shall
assist in making all reasonable changes to the Specifications to
reduce failure rates in Drug Inhalation System units.
7.8 Technical Assistance. At ViroPharma's reasonable request and expense,
BPTD shall provide ViroPharma with reasonable technical assistance and
advice for responding to consumer queries regarding the Drug
Inhalation System.
7.9 Patent Marking. ViroPharma shall assure that, consistent with the laws
of the country in which it is distributed, each Drug Inhalation System
unit subject in such country to a BPTD Patent shall be marked in a
conspicuous location with a
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November 19, 1999 ViroPharma-BPTD Agreement Page 21
patent notice adequate to meet the patent notification requirements of
that country.
8. GENERAL REGULATORY MATTERS.
8.1 Inspections. If BPTD or a BPTD Affiliate is inspected by a Regulatory
Authority regarding activities under this Agreement, BPTD or the
Affiliate shall promptly notify ViroPharma. BPTD or the inspected
party shall provide ViroPharma with a written report of any such
inspection, noting with specificity any record or document reviewed by
the regulatory inspector. When a copy of a document or record is
supplied to the inspector on request, that fact will be noted in the
report. BPTD or the BPTD Affiliate shall keep copies of each of these
records or documents in a separate inspection file and, on
ViroPharma's request, will provide ViroPharma with copies of any or
all of these Study Records or documents.
8.2 Regulatory Correspondence. BPTD shall provide ViroPharma with a copy
of all correspondence between BPTD or any Affiliate and a Regulatory
Authority pertaining to the manufacturing of investigational EHD
Devices, Drug Containers, or assembly of Drug Inhalation Systems under
Section 5, including, without limitation, any Form 483s, or similar
notices or observations. BPTD shall provide ViroPharma with a copy of
any proposed response or correspondence to a Regulatory Authority that
relates directly or indirectly to the manufacturing of investigational
EHD Devices, Drug Containers, or assembly of Drug Inhalation Systems
under Section 5 for ViroPharma's approval at least five business days
before the submission of such response or correspondence.
8.3 Audits. At reasonable times and at reasonable intervals, ViroPharma or
a designee may inspect and audit BPTD's, or a BPTD Affiliate's
manufacturing of investigational EHD Devices, Drug Containers, or
assembly of Drug Inhalation Systems under Section 5. BPTD, or the BPTD
Affiliate shall make all documents and records available for review
and copying. BPTD or the BPTD Affiliate shall adopt reasonable
suggestions of ViroPharma or a designee to correct any deficiencies
identified in any site visit or audit.
9. LICENSE FEES AND ROYALTIES.
9.1 Milestone License Fees. In partial consideration for the licenses
granted to ViroPharma under this Agreement, ViroPharma shall pay BPTD
the following amounts in U.S. Dollars within the specified time period
after the occurrence of the specified events:
**********
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November 19, 1999 ViroPharma-BPTD Agreement Page 22
9.2 Royalty Payments on ViroPharma Sales During Full Royalty Rate Period.
During the Full Royalty Rate Period, in partial consideration for the
licenses granted to ViroPharma under this Agreement, ViroPharma shall
pay BPTD the following amounts:
9.2.1 Marginal Rates. For each calendar year, or portion thereof,
in the Full Royalty Rate Period during which ViroPharma or
any of its Affiliates sells the Drug Inhalation System,
ViroPharma shall pay BPTD a royalty on the combined Net
Sales made by ViroPharma and its Affiliate of such Drug
Inhalation System units **********:
**********
9.2.2 Minimum Payments. In no event shall the payment under
Section 9.2.1 for the second or any subsequent full calendar
year during which ViroPharma or an Affiliate sells the Drug
Inhalation System be less than **********.
9.3 Royalty Payments on ViroPharma Sales During Reduced Royalty Period.
During the Reduced Royalty Rate Period, in partial consideration for
the know-how and trade secret licenses granted to ViroPharma under
this Agreement, ViroPharma shall pay BPTD, for each calendar year, or
portion thereof during which ViroPharma sells the Drug Inhalation
System, a royalty equal to ********** of the Net Sales made by
ViroPharma and its Affiliates of the Drug Inhalation System units.
9.4 Royalty Payments on Sublicensed Sales Outside the U.S.
9.4.1 In partial consideration for the licenses granted to
ViroPharma under this Agreement, for each calendar year, or
portion thereof during which a Third Party sublicensee of
ViroPharma or its Affiliates sells the Drug Inhalation
System outside the U.S. during the Full Royalty Rate Period,
ViroPharma shall pay BPTD an amount equal to **********, and
during the Reduced Royalty Rate Period, ViroPharma shall pay
BPTD an amount equal to ********** of ********** during each
calendar year or portion thereof for such Third Party
sublicensee's sales of, and/or right to sell Drug Inhalation
System units outside the U.S., including **********, but
excluding **********.
9.4.2 In partial consideration for the licenses granted to
ViroPharma under this Agreement, for each calendar year, or
portion thereof during which ViroPharma or its Affiliates
sells the Drug Inhalation System to a sublicensee for
intended sale outside the U.S. during the Full Royalty Rate
Period, ViroPharma shall pay BPTD an amount equal to
********** of
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November 19, 1999 ViroPharma-BPTD Agreement Page 23
Net Sales to such sublicensee, and ********** of Net
Sales to such sublicensee during the Reduced Royalty Rate
Period.
9.5 Royalty Payments on Sublicensed Sales in the U.S. For purposes of
Sections 9.2-9.3, any sale in the U.S. of the Drug Inhalation System
by a Third Party sublicensee of ViroPharma shall be deemed a sale by
ViroPharma.
9.6 Reduction in Royalty Payments for Infringing Competition. If
infringing Competition, as defined below in this Section 9.6, exists
during a given calendar quarter during the Full Royalty Rate Period
for the Drug Inhalation System in a country, the royalty rates used to
calculate the royalties payable to BPTD for sales of the Drug
Inhalation System in such country during such calendar quarter will be
reduced to **********, retroactive to the first date that infringement
is determined to exist by agreement of the Parties, or pursuant to
Section 15.15. Infringing Competition shall be deemed to exist if,
during the applicable calendar quarter, each of the following is true:
9.6.1 one or more Third Parties is selling a pharmaceutical
product for electohydrodynamic inhalation delivery for use
in the Field that infringes a BPTD patent. If the parties
disagree as to whether or not such an infringement exists,
the matter shall be resolved in accordance with the terms of
Section 15.15;
9.6.2 BPTD has not filed suit against such Third Parties for
infringement of a BPTD Patent, and BPTD has not obtained a
discontinuance of such infringement by such Third Parties;
and
9.6.3 the sales of such competing products (measured on a unit
basis) accounts for ********** or more of the combined
market for the Drug Inhalation System and such competing
products in such country.
9.7 Sales Reports. Within forty-five days of the end of each calendar
quarter after the first commercial sale of the Drug Inhalation System
in any country, ViroPharma will provide BPTD with a report listing the
Net Sales of Drug Inhalation System units by country, to the extent
available; identifying whether such sales were made by ViroPharma
and/or an Affiliate, or by a Third Party sublicensee of ViroPharma
and/or an Affiliate and calculating the royalty due on such Net Sales
pursuant to this Section 9.
9.8 Payments.
9.8.1 Timing. The payment obligations under Sections 9.2-9.6 shall
accrue upon the sale of the Drug Inhalation System to a
Third Party purchaser, other than a Third Party Sublicensee
of ViroPharma and/or an Affiliate, by ViroPharma, its
Affiliates or sublicensees. Such a sale shall be deemed to
occur on the date of the invoice for such sale. Payment
obligations under
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November 19, 1999 ViroPharma-BPTD Agreement Page 24
Sections 9.2-9.6 that accrue during a calendar quarter shall
be payable within forty-five days after the end of such
calendar quarter.
9.8.2 Currency. All amounts due under this Agreement shall be
payable in the United States in U.S. Dollars. Net Sales in a
particular country outside the United States shall be
converted from the currency of the sale into U.S. Dollars at
the average daily rates of exchange for the four week period
immediately preceding the last week in such calendar quarter
as reported in the Wall Street Journal or some other source
agreeable to both Parties.
9.9 Records; Audits.
9.9.1 Record Keeping. ViroPharma shall keep, and shall require its
Affiliates and sublicensees to keep complete and accurate
records of all Net Sales, and ViroPharma shall obtain and
keep copies of such records sent by its Affiliates and
sublicensees. BPTD shall keep, and shall require its
Affiliates to keep complete and accurate records of all
costs of the manufacturing of investigational EHD Devices,
Drug Containers or assembly of Drug Inhalation Systems under
Section 5, and BPTD shall obtain and keep copies of such
records sent by its Affiliates.
9.9.2 Audits. Upon thirty days prior written notice from a Party
(the "Auditing Party"), the other Party (the "Audited
Party") shall permit an independent certified public
accounting firm of nationally recognized standing selected
by the Auditing Party and reasonably acceptable to the
Audited Party, to examine, at the Auditing Party's sole
expense, the relevant books and records of the Audited Party
and its Affiliates as may be reasonably necessary to verify
the accuracy of the calculation of sales and royalties under
Sections 9.2-9.6, and Recovery Costs of the manufacture of
investigational EHD Devices, Drug Containers or assembly of
Drug Inhalation Systems under Section 5. An examination by a
Party under this Section 9.9.2 shall occur not more than
once in any calendar year and shall be limited to the
pertinent books and records for any calendar year ending not
more than thirty-six months before the date of the request.
The accounting firm shall be provided access to such books
and records at the Audited Party's facility(ies) where such
books and records are normally kept and such examination
shall be conducted during the Audited Party's normal
business hours. The Audited Party may require the accounting
firm to sign a standard non-disclosure agreement before
providing the accounting firm access to the Audited Party's
facilities or records. Upon completion of the audit, the
accounting firm shall provide both Parties with a written
report disclosing whether the reports submitted by the
Audited Party are correct or incorrect, whether the
royalties under Sections 9.2-9.6, and Recovery Costs of the
manufacture of investigational EHD Devices, Drug Containers,
or assembly of Drug Inhalation Systems under Section 5, are
correct or incorrect, and, in each case, the specific
details
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November 19, 1999 ViroPharma-BPTD Agreement Page 25
concerning any discrepancies. No other information shall be
provided to the Auditing Party.
9.9.3 Underpayments/Overpayments. If the results of the audit
under Section 9.9.2 show that additional royalties were due
to BPTD, ViroPharma shall pay BPTD the additional royalties
together with interest at 1% per month (or the maximum
amount allowed by law, if less) from the day such amounts
were first due until paid, within thirty days of the date
ViroPharma receives the written audit report. If such
underpayment exceeds five percent of the royalties that were
to be distributed to BPTD, ViroPharma also shall reimburse
BPTD for the out-of-pocket expenses incurred in conducting
the audit. If the results of the audit under Section 9.9.2
show that ViroPharma overpaid BPTD for the Recovery Costs of
manufacturing under Section 5, BPTD will refund such
overpayments, together with interest at 1% per month (or the
maximum amount allowed by law, if less) from the day such
amounts were first paid by ViroPharma until reimbursed by
BPTD, within thirty days of the date BPTD receives the
written audit report. If such overpayment exceeds five
percent of the Recovery Costs that were to be paid to BPTD,
BPTD also shall reimburse ViroPharma for the out-of-pocket
expenses incurred in conducting the audit.
9.9.4 Confidentiality. All financial information of a Party which
is subject to review under this Section 9.9 shall be deemed
to be Confidential Information subject to the provisions of
Article 11, and such Confidential Information shall not be
disclosed to any Third Party or used for any purpose other
than verifying payments to be made by one Party to the other
hereunder, provided, however, that such Confidential
Information may be disclosed to Third Parties only to the
extent necessary to enforce a Party's rights under this
Agreement.
10. INTELLECTUAL PROPERTY.
10.1 Pre-existing Technology. ViroPharma shall remain the sole and
exclusive owner of the ViroPharma Patents and all Information,
copyrights, and trademarks owned or Controlled by ViroPharma at the
Effective Date, subject to the rights granted hereunder. BPTD shall
remain the sole and exclusive owner of the BPTD Patents and all
Information, copyrights, and trademarks owned or Controlled by BPTD at
the Effective Date, subject to the rights granted hereunder.
10.2 Inventions. ViroPharma shall own all ViroPharma Inventions and BPTD
shall own all BPTD Inventions, whether such Inventions are made solely
by either Party or jointly by the Parties. BPTD hereby irrevocably
assigns and transfers to ViroPharma, and to the extent that an
executory assignment is not enforceable, BPTD hereby agrees to assign
and transfer to ViroPharma, in writing, from time
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November 19, 1999 ViroPharma-BPTD Agreement Page 26
to time, upon request, any and all right, title and interest that BPTD
may have or may later acquire in the ViroPharma Inventions under
copyright, patent, trade secret and trademark law, in perpetuity or
for the longest period otherwise permitted by law, without the
necessity of further consideration. ViroPharma hereby irrevocably
assigns and transfers to BPTD, and to the extent that an executory
assignment is not enforceable, ViroPharma hereby agrees to assign and
transfer to BPTD, in writing, from time to time, upon request, any and
all right, title and interest that ViroPharma may have or may later
acquire in the BPTD Inventions under copyright, patent, trade secret
and trademark law, in perpetuity or for the longest period otherwise
permitted by law, without the necessity of further consideration.
10.3 Prosecution and Maintenance of Patents; Abandonment.
10.3.1 Primary Responsibility. ViroPharma shall have the sole right
and responsibility to file, prosecute and maintain the
ViroPharma Patents, and to file Patents on ViroPharma
Inventions, and shall bear all expenses associated
therewith. BPTD shall have the sole right and responsibility
to file, prosecute and maintain the BPTD Patents, and to
file Patents on BPTD Inventions, and shall bear all expenses
associated therewith. Each Party will keep the other Party
reasonably apprised of the filing, prosecution and
maintenance status of the Party's respective Patents
referred to in this Section 10.3.1.
10.3.2 Abandonment. BPTD shall use Diligent Efforts to initially
file those BPTD Patents owned by BPTD (or foreign
equivalents thereof) in the countries identified in Exhibit
F to the extent such filing is permitted under the
applicable patent laws. BPTD shall use Diligent Efforts to
prosecute and maintain those BPTD Patents owned by BPTD (or
foreign equivalents thereof) in the countries listed in
Exhibit F in which it has chosen to prosecute and maintain
such Patents to the extent such prosecution is permitted
under the applicable patent laws. If BPTD decides to refrain
from filing, or to abandon prosecution or maintenance of a
particular BPTD Patent whose claims relate generically or
specifically to the Drug Inhalation System in any country,
ViroPharma may request that ViroPharma have the right to
continue such prosecution and/or maintenance, which request
BPTD will reasonably consider, provided that BPTD need not
in any event grant any such request if BPTD has a strategic
reason, with respect to its prosecution strategy for its
Patents, for abandoning such Patent (which reason may not
include simply cost savings). If BPTD grants ViroPharma's
request, ViroPharma may continue the prosecution and
maintenance of such BPTD Patent, at ViroPharma's expense,
provided that ViroPharma keeps BPTD reasonably informed of
the progress of any such prosecution.
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November 19, 1999 ViroPharma-BPTD Agreement Page 27
10.4 Third Party Patent Licenses.
10.4.1 Procedures. If either Party reasonably believes that the
manufacture, use, sale, offering for sale, import, or export
of the Drug Inhalation System may infringe a Patent owned by
a Third Party, then such Party will provide the other Party
all Information in its possession relating to such belief.
Promptly thereafter, the Parties shall meet to discuss in
good faith the appropriate steps to take to address such
possible infringement, which may include, without
limitation:
a. negotiating and entering into a license agreement with
such Third Party that grants the Parties the right to
continue making, importing, using, selling and/or
offering for sale the Drug Inhalation System,
b. modifying the Drug Inhalation System so that the
Parties believe it no longer infringes, or
c. proceeding without any change based on a reasonable
analysis that the Drug Inhalation System does not
infringe and/or such Patent is not valid or
enforceable.
10.4.2 Costs of License. If the Parties decide to obtain a license
pursuant to Section 10.4.1(a), then ViroPharma shall be
solely responsible for the payment of all consideration for
such license if the Drug is the basis for the infringement,
BPTD shall be solely responsible for the payment of all
consideration for such license if the EHD Device, the Drug
Vehicle, or the Drug Container is the basis for the
infringement, and the Parties shall share equally the
responsibility for payment of all consideration for such
license if the Formulated Drug is the basis for the
infringement. If the EHD Device, the Drug Vehicle, the
Formulated Drug, or the Drug Container is the basis for the
infringement, and if the Parties do not agree that
proceeding under Section 10.4.1(c) is prudent and BPTD is
unwilling or unable to make the modifications described in
Section 10.4.1(b), and BPTD elects not to enter into a
license agreement with such third party pursuant to Section
10.4.1(a), then ViroPharma may enter into such agreement,
and all amounts paid by ViroPharma thereunder, or half of
such amounts if the basis for infringement is the Formulated
Drug, shall be creditable against amounts payable to BPTD
under this Agreement.
10.4.3 Cost of Royalties. If the Parties agree to obtain a license
pursuant to Section 10.4.1(a) for the manufacture, import,
use, sale or offering for sale of the Drug Inhalation
System, or if the Parties are required to pay royalties or
other consideration to a Third Party to settle or otherwise
resolve a Patent infringement suit alleging Patent
infringement by the Drug Inhalation System:
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November 19, 1999 ViroPharma-BPTD Agreement Page 28
a. all royalties based on the manufacture, import, use,
sale, or offer for sale of the EHD Device, the Drug
Vehicle, or the Drug Container shall be paid by BPTD;
b. all royalties based on the manufacture, import, use,
sale, or offer for sale of the Drug shall be paid by
ViroPharma;
c. each Party shall pay half of all royalties based on the
manufacture, import, use, sale, or offer for sale of
the Formulated Drug.
10.5 Defense of Third Party Patent Claims.
10.5.1 Third Party Claims Regarding BPTD Products.
ViroPharma shall promptly notify BPTD in writing
of any action against ViroPharma based on alleged
infringement of a Third Party's Patent by the EHD
Device, the Drug Vehicle, or the Drug Container.
BPTD shall defend any claim or action by a Third
Party against ViroPharma and/or BPTD based on a
claim that the EHD Device, the Drug Vehicle, or
the Drug Container infringes a Patent that is
owned or controlled by such Third Party.
ViroPharma shall give BPTD control of the defense
thereof (and any negotiations for settlement or
compromise thereof) and will cooperate fully in
the defense thereof. BPTD shall not settle or
compromise any such claim or action without
ViroPharma's prior written consent, if such
settlement or compromise would impose on
ViroPharma any obligation to pay or incur any
costs or expenses. If BPTD does not undertake the
defense of an action against ViroPharma hereunder
within fifteen days of notice to BPTD of such
claim, then ViroPharma shall have the full right
to defend itself, using counsel of its own
choosing, against such claim, including any
negotiations for settlement or compromise thereof,
and BPTD shall reimburse ViroPharma for all
reasonable costs and expenses of such defense.
10.5.2 Third Party Claims Regarding ViroPharma Products.
BPTD shall promptly notify ViroPharma in writing
of any action against BPTD based on alleged
infringement of a Third Party's Patent by the Drug
or Formulated Drug. ViroPharma shall defend any
claim or action by a Third Party against
ViroPharma and/or BPTD based on a claim that the
Drug or Formulated Drug infringes a Patent that is
owned or controlled by such Third Party. BPTD
shall give ViroPharma control of the defense
thereof (and any negotiations for settlement or
compromise thereof) and will cooperate fully in
the defense thereof. ViroPharma shall not settle
or compromise any such claim or action without
BPTD's prior written consent, if such settlement
or compromise would impose on BPTD any obligation
to pay or incur any costs or expenses. If
ViroPharma does not undertake the defense of an
action against BPTD hereunder within fifteen
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November 19, 1999 ViroPharma-BPTD Agreement Page 29
days of notice to ViroPharma of such claim, then
BPTD shall have the full right to defend itself,
using counsel of its own choosing, against such
claim, including any negotiations for settlement
or compromise thereof, and ViroPharma shall
reimburse BPTD for all reasonable costs and
expenses of such defense.
10.6 Enforcement of Patent Rights. If any BPTD Patent or ViroPharma
Patent is infringed by a Third Party in any country, the Party to
this Agreement first having knowledge of such infringement shall
promptly notify the other in writing. The notice shall set forth
the facts of that infringement in reasonable detail. BPTD shall
have the primary right, but not the obligation, to institute,
prosecute, and control any action or proceeding with respect to
such infringement of a BPTD Patent by counsel of its own choice
and at its expense, and ViroPharma shall have the primary right,
but not the obligation, to institute, prosecute, and control any
action or proceeding with respect to such infringement of a
ViroPharma Patent by counsel of its own choice and at its
expense.
10.7 Patent Certifications. Each Party shall immediately give written
notice to the other of any certification of which it becomes
aware filed pursuant to 21 U.S.C. (S) 355(b)(2)(A), or (S)
355(j)(2)(A)(vii) (or any amendment or successor statute thereto)
claiming that any Patent covering the Drug Inhalation System is
invalid or that infringement will not arise from the manufacture,
use or sale of the Drug Inhalation System by a Third Party.
10.8 Trademarks and Tradenames Generally. ViroPharma will select and
own the trademarks or tradenames to be used by ViroPharma for the
Drug Inhalation System. Neither Party nor its Affiliates shall
adopt, use, or register any acronym, trademark, tradename,
service xxxx or other marketing name that is the same as or
confusingly similar to any acronym, trademark, tradename, service
xxxx or other marketing name used by the other Party or its
Affiliates except to the extent such adoption, use or
registration was in process prior to the Effective Date.
11. EXCHANGE OF INFORMATION, CONFIDENTIALITY AND PUBLICATION.
11.1 Exchange Of Information. Promptly after the Effective Date, BPTD
shall disclose and supply to ViroPharma all Information relating
to the EHD Device, the Drug Vehicle, the Formulated Drug and the
Drug Container, to the extent known to and legally disclosable by
BPTD, that is necessary to enable ViroPharma to fully carry out
all of its rights and obligations under this Agreement.
Thereafter, during the term of the Agreement, BPTD shall promptly
disclose and supply to ViroPharma any further Information meeting
the foregoing requirements that may have become known to BPTD
during such time. For clarification, the foregoing obligation
shall not require BPTD to disclose proprietary Information except
as reasonably required to implement the licenses granted to
ViroPharma.
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November 19, 1999 ViroPharma-BPTD Agreement Page 30
11.2 Confidentiality. Except as otherwise provided in this Article 11,
during the term of this Agreement and for a period of five years
thereafter, each Party shall maintain in confidence and shall use only
for purposes of this Agreement all Confidential Information disclosed
by the other Party under the Agreement, except as may be otherwise
provided herein. Notwithstanding the foregoing, a Party may disclose
the other Party's Confidential Information to those of its Affiliates,
Permitted Sublicensees (as defined in Section 11.3), directors,
officers, employees, agents, consultants and clinical investigators
that have a need to know such Information in order to achieve the
purposes of this Agreement, provided that such Party obtains prior
agreement from such disclosees to hold in confidence and not make use
of such Confidential Information for any purpose other than those
permitted by this Agreement. Each Party will promptly notify the other
upon discovery of any unauthorized use or disclosure of the
Confidential Information. Any breech of this obligation of
Confidentiality by an Affiliate, Permitted Sublicensee, director,
officer, employee, agent, consultant or clinical investigator of a
Party shall be deemed a breech by that Party.
11.3 Authorized Disclosure. Each Party may disclose Confidential
Information of the other Party to Third Parties solely to the extent
such disclosure is reasonably necessary in filing or prosecuting
patent applications, prosecuting or defending litigation, applying for
and obtaining Regulatory Approvals or complying with applicable laws,
governmental regulations or court orders, provided that such Party
will give reasonable advance notice to the other Party of such
disclosure requirement and shall give the other Party sufficient
opportunity to object to such disclosure or to secure confidential
treatment of such Confidential Information required to be disclosed to
the extent that such is available. Either Party may disclose (subject
to the confidentiality restrictions contained herein) Confidential
Information to Third Parties to the extent necessary to perform its
obligations or exercise its rights under this Agreement, provided such
Third Parties execute confidentiality agreements containing terms no
less strict than those contained herein (a "Permitted Sublicensee").
Further, nothing in this Article 11 shall be construed as preventing
or in any way inhibiting either Party from complying with statutory
and regulatory requirements governing the development, manufacture,
use and sale or other distribution of the Drug Inhalation System in
any manner consistent with the terms of this Agreement, provided that
any such compliance that requires disclosing to regulatory authorities
confidential or other information received from the other Party may be
made only if such Party provides reasonable advance notice of such
disclosure to the other Party and makes reasonable efforts to obtain
confidential treatment of such confidential information if requested
by the other Party to the extent that such is available.
11.4 Publication. BPTD shall not submit for written or oral publication any
manuscript, abstract or the like which includes data or other
information relating directly or indirectly to the Drug Inhalation
System or any part of it without first obtaining the prior written
consent of ViroPharma, which consent shall not be
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November 19, 1999 ViroPharma-BPTD Agreement Page 31
unreasonably withheld. ViroPharma shall not submit for written or oral
publication any manuscript, abstract or the like which includes data
or other information relating directly or indirectly to the EHD
Device, Vehicle or Drug Container without first obtaining the prior
written consent of BPTD, which consent shall not be unreasonably
withheld. The Parties agree to review and comment within thirty
working days on any such draft publication. Each Party shall use its
Diligent Efforts to bind the clinical investigators and other agents
it utilizes for the Development of the Drug Inhalation System to a
provision similar to this Section, provided that it is understood that
a Party's inability to bind a clinical investigator to such a similar
provision shall not prohibit such party from utilizing such clinical
investigator. The contribution of each Party shall be noted in all
publications or presentations by acknowledgment or coauthorship,
whichever is appropriate.
11.5 Confidentiality Issues In Bankruptcy. In the event that a court
or other legal or administrative tribunal, directly or through an
appointed master, trustee or receiver, assumes partial or complete
control over the assets of a Party to this Agreement based on the
insolvency or bankruptcy of such Party, the bankrupt or insolvent
Party shall promptly notify the court or other tribunal: (a) that
Confidential Information received from the other Party under this
Agreement remains the property of the other Party and (b) of the
confidentiality obligations under this Agreement with respect to such
information. In addition, the bankrupt or insolvent Party shall, to
the extent permitted by law, take all steps necessary or desirable to
maintain the confidentiality of the other Party's Confidential
Information and to seek to ensure that the court, other tribunal or
appointee maintains such information in confidence in accordance with
the terms of this Agreement.
12. REPRESENTATIONS & WARRANTIES.
12.1 Representations and Warranties of the Parties. Each of ViroPharma and
BPTD represents and warrants to the other that:
12.1.1 It is duly organized and validly existing and in good
standing under the laws of its organization or formation, and
has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof.
12.1.2 It is duly authorized to execute and deliver this Agreement
and to perform its obligations hereunder.
12.1.3 This Agreement is a legal and valid obligation binding upon
it and enforceable in accordance with its terms, except to
the extent limited by applicable bankruptcy and creditor's
rights laws. The execution, delivery and performance of this
Agreement by it does not conflict with any
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November 19, 1999 ViroPharma-BPTD Agreement Page 32
agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate
any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction
over it.
12.1.4 It has obtained all necessary consents, approvals and
authorizations of all governmental authorities and other
entities and persons required to be obtained by it in
connection with entry into this Agreement.
12.1.5 No agreement between it and a Third Party in existence as of
the Effective Date would prevent it from performing its
obligations under this Agreement or granting to the other
Party the rights granted hereunder, and it shall not enter
into any such Third Party agreement that would prevent it
from performing its obligations under this Agreement or
granting to the other Party the rights granted hereunder.
12.2 Additional Representation and Warranties of BPTD. BPTD represents and
warrants to ViroPharma that:
12.2.1 To the best of BPTD's knowledge, as of the Effective Date,
the manufacture, use or sale of the EHD Device, the Drug
Vehicle, or the Drug Container will not violate the
intellectual property rights of any Third Party, and BPTD has
no present knowledge from which it reasonably can be inferred
that any BPTD Patent is invalid.
12.2.2 BPTD has no present knowledge of the existence of any pre-
clinical or clinical data or information concerning the EHD
Device, the Drug Vehicle, or the Drug Container that BPTD has
not provided to ViroPharma that suggests that there may exist
quality, toxicity, safety and/or efficacy concerns that may
materially impair the utility and/or safety of the EHD
Device, the Drug Vehicle, or the Drug Container in the Field;
12.2.3 BPTD shall use Diligent Efforts in performing all Development
Activities;
12.2.4 at the time of delivery of any unit of the investigational
Drug Inhalation System, any part of such unit that BPTD or a
BPTD Affiliate manufactured shall conform in all material
respects to the Specifications, and federal, state and local
laws and regulations, and shall be free from material defects
in materials and workmanship;
12.2.5 the term "condition" as used in Section 1.31(a)(iii),
includes but is not limited to infancy and elderly;
12.2.6 BPTD has the full right, power, and authority to grant
ViroPharma all the right, title, and interest in the license
described in Section 2.1.1 for each
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November 19, 1999 ViroPharma-BPTD Agreement Page 33
BPTD Patent included in Exhibit A as such Exhibit A exists on
the Effective Date; and
12.2.7 only those BPTD Patents designated with an asterisk in
Exhibit A as such Exhibit A exists on the Effective Date are
subject to the Retained Rights.
12.3 DISCLAIMER. EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS
CONTAINED IN THIS AGREEMENT, NEITHER VIROPHARMA NOR BPTD MAKES, AND
EACH HEREBY EXPRESSLY DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS,
EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING
WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
12.4 Certain Additional Covenants.
12.4.1 BPTD shall pay all royalties or other sums that BPTD may owe
to any Third Party by virtue of its activities under this
Agreement, and shall perform and observe all of the other
material obligations under all present and future agreements
between BPTD and any Third Party that are in any way related
to BPTD's ability to grant the rights BPTD has granted to
ViroPharma under this Agreement or to BPTD's ability to
perform its obligations to ViroPharma under this Agreement.
If BPTD receives notice from any such Third Party that BPTD
has committed a breach of its obligations under any such
agreement, or if BPTD anticipates such breach, which breach
may give rise to a right by such Third Party to terminate or
materially diminish BPTD's rights to Patents and/or
Information in the Field licensed to BPTD, which Patents
and/or Information are sublicensed to ViroPharma hereunder,
or otherwise to diminish materially BPTD's ability to perform
its obligations to ViroPharma under this Agreement, BPTD
shall immediately notify ViroPharma of such situation, and
BPTD shall promptly cure such breach. However, if BPTD is
unable to cure such breach, BPTD shall, to the extent
possible, permit ViroPharma to cure such breach on BPTD's
behalf.
12.4.2 BPTD agrees that, without the prior written approval of
ViroPharma, BPTD and its Affiliates shall not knowingly
conduct any development work, either themselves or in
conjunction with any other licensees or partners, on the EHD
Device, the Drug Vehicle, the Formulated Drug, the Drug, or
the Drug Container for use in the Field; provided that the
foregoing shall not be interpreted to prevent BPTD or its
Affiliates or other licensees from developing other BPTD
pulmonary drug delivery products for use outside the Field.
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November 19, 1999 ViroPharma-BPTD Agreement Page 34
12.5 Representation by Legal Counsel. Each Party hereto represents
that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the
terms and provisions of this Agreement, the Parties agree
that no presumption shall exist or be implied against the
Party that drafted such terms and provisions.
13. INDEMNIFICATION.
13.1 Indemnification by BPTD. BPTD shall indemnify, defend and
hold ViroPharma, its directors, employees, agents and
representatives (including but not limited to ViroPharma's
Affiliates and sublicensees) harmless from and against all
claims, causes of action, settlement costs (including but not
limited to reasonable attorney's fees and expenses) losses or
liabilities of any kind which (a) arise from or are
attributable to any negligent act or omission or willful
misconduct on the part of BPTD, its directors, employees,
agents or representatives relating to any of its obligations
under this Agreement, including, but not limited to any
breach of a representation or warranty; or (b) arise from or
are attributable to a defect in the EHD Device, the Drug
Container or the Drug Vehicle or in the manufacture of the
EHD Device, the Drug Container or the Drug Vehicle where such
manufacture is under the control of BPTD, and which in either
case are not otherwise attributable to any negligent act or
omission or willful misconduct on the part of ViroPharma, its
directors, employees, agents or representatives (including,
but not limited to ViroPharma's Affiliates).
13.2 Indemnification by ViroPharma. ViroPharma shall indemnify,
defend and hold BPTD, its directors, employees, agents and
representations harmless from and against all claims, causes
of actions, settlement costs (including but not limited to
reasonable attorney's fees and expenses) losses or
liabilities of any kind which: (a) arise from or are
attributable to any negligent act or omission or willful
misconduct on the part of ViroPharma, its directors,
employees, agents or representatives relating to any of its
obligations under this Agreement; or (b) arise from or are
attributable to the labeling, distribution, use, sale,
marketing and promotion of the Drug Inhalation System or
manufacturing of the Drug Inhalation System or its components
where such manufacturing is under the control of ViroPharma,
and which in either case are not otherwise attributable to
any negligent act or omission or willful misconduct on the
part of BPTD, its directors, employees, agents or
representatives (including, but not limited to BPTD's
Affiliates).
13.3 Indemnity Procedure. If a Party seeks indemnification under
Section 13.1 or 13.2, it shall inform the other Party (the
"Indemnifying Party") of a claim as soon as reasonably
practicable after it receives notice of the claim, shall
permit the Indemnifying Party to assume direction and control
of the defense of the claim (including the right to settle
the claim solely for monetary consideration), and, at
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November 19, 1999 ViroPharma-BPTD Agreement Page 35
the Indemnifying Party's expense, shall cooperate as
reasonably requested in the defense of the claim. The
Indemnified Party shall have the right to retain its own
counsel, subject to the approval of any such outside counsel
by the Indemnifying Party, with the fees and expenses to be
paid by the Indemnifying Party if representation of such
Party by the counsel retained by Indemnifying Party would be
inappropriate due to actual or potential differing interests
between such indemnitee and any other party represented by
such counsel in such proceedings. The Indemnifying Party may
not settle such action or claim, or otherwise consent to an
adverse judgment in such action or claim, without the express
written consent of the Indemnified Party if such settlement
or adverse judgment diminishes the rights or interests of the
Indemnified Party.
13.4 LIMITATION OF LIABILITY. IN NO EVENT, NOT WITHSTANDING ANY
PROVISION OF THIS AGREEMENT TO THE CONTRARY, SHALL EITHER
PARTY, ITS DIRECTORS, TRUSTEES, OFFICERS, EMPLOYEES, AGENTS
OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A
CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT
LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT OF THIS
AGREEMENT.
13.5 Insurance. Each Party hereby agrees to maintain, during the
term of this Agreement, insurance with reputable and sound
independent insurers at commercially reasonable levels of
coverage in relation to the type, scope and size of business
it conducts and to all its obligations herein contained and
shall give the other Party an opportunity from time to time
to review the insurance policies so that the other Party may
satisfy itself that such insurance policies are valid, that
the premiums are being paid regularly and that the policies
are kept in full force and effect. Each Party shall, upon the
other Party's reasonable request from time to time, produce
evidence that all insurance premiums have been paid and kept
up to date and are kept in accordance with any local
insurance laws or regulations from time to time in force.
Each Party will, at the request of the other Party, name the
other Party and its Affiliates as additional insureds as
applicable on all liability insurance policies, including,
but not limited to, product liability, products and
clinicians, malicious product tampering and general liability
policies and will obtain for the other Party an endorsement
that such insurance shall not be cancelled without thirty
days prior written notice to the other Party. A Party's
liability to the other is in no way limited to the extent of
the Party's insurance coverage. In the event of duplicate
coverage, the insurance policy of the Party whose fault
causes the need for reimbursement under an insurance policy
shall be primary and the other Party's secondary.
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November 19, 1999 ViroPharma-BPTD Agreement Page 36
14. TERM OF AGREEMENT AND TERMINATION.
14.1 Term. Unless earlier terminated as provided herein, this
Agreement shall expire on the expiration of the last to
expire Reduced Royalty Rate Period for the Drug Inhalation
System.
14.2 Termination for Material Breach. A non defaulting Party shall
have the right to terminate this Agreement after written
notice to the other that the other is in material breach of
this Agreement (the "Defaulting Party"), unless the
Defaulting Party cures the breach before the expiration of
ninety days - thirty days in the case of a delayed payment -
after such written notice.
14.3 Termination by ViroPharma. ViroPharma may terminate this
Agreement at any time effective upon thirty (30) days written
notice to BPTD and payment of any amounts due as of the date
of notice of termination, including direct costs to terminate
commitments and work in process authorized through open Work
Orders that cannot be avoided through reasonable commercial
efforts.
14.4 Termination for Bankruptcy. Either Party may terminate this
Agreement if, at any time, the other Party shall file in any
court or agency pursuant to any statute or regulation of any
state or country, a petition in bankruptcy or insolvency or
for reorganization or for an arrangement or for the
appointment of a receiver or trustee of the Party or of its
assets, or if the other Party proposes a written agreement of
composition or extension of its debts, or if the other Party
shall be served with an involuntary petition against it,
filed in any insolvency proceeding, and such petition shall
not be dismissed within sixty days after the filing thereof,
or if the other Party shall propose or be a party to any
dissolution or liquidation, or if the other Party shall make
an assignment for the benefit of creditors.
14.5 Consequences of Termination. Upon the expiration or any
termination of this Agreement, (i) all licenses under this
Agreement shall be terminated, except as expressly provided
under this Agreement, including, without limitation, Sections
14.8 and 2.1; and (ii) each Party shall destroy and shall not
retain any copies of any Confidential Information provided by
the other Party hereunder, except for one copy to be retained
by legal counsel solely for archival purposes.
Notwithstanding anything in this Agreement to the contrary,
in the event of the termination or expiration of this
Agreement, ViroPharma shall have a continuing right to sell
under this Agreement for a period of ********** days
following termination, such amount of EHD Devices or Drug
Containers remaining in its inventory.
14.6 Accrued Rights, Surviving Obligations. Termination or
expiration of this Agreement shall not affect any rights to
payment or other rights that accrued before the date of
termination or expiration. The terms of the following
Articles and Sections shall survive any termination of this
Agreement: 2.1.2, 2.3.2-2.3.3, 2.4, 3.5.3, 7.5-7.6, 9.9,
10.1, 10.2, 10.5, 10.7, 11, 12, 13, 14.5, 14.6, 14.8.
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November 19, 1999 ViroPharma-BPTD Agreement Page 37
14.7 Financial Status; Rights in Event of Financing Difficulties.
BPTD and ViroPharma agree to keep each other informed as to
its financial condition during the term of this Agreement. If
at any time the financial resources of BPTD or ViroPharma are
not reasonably sufficient to enable it to continue to meet
its obligations hereunder for at least the next six months,
the parties will meet to review and consider steps that might
be taken to ensure that the other party will be able to
perform its obligations under this Agreement.
14.8 Rights In Event of Bankruptcy.
14.8.1 Notwithstanding the bankruptcy of BPTD, or the impairment of
performance by BPTD of its obligations under this Agreement
as a result of bankruptcy or insolvency of BPTD, ViroPharma
shall be entitled to retain the license rights and licenses
granted herein, subject to ViroPharma's performance of all
its obligations under the Agreement and to BPTD's rights to
terminate this Agreement for reasons other than bankruptcy or
insolvency as expressly provided in this Agreement.
14.8.2 All rights and licenses granted under or pursuant to this
Agreement are, for all purposes of Section 365(n) of Title 11
of the United States Code ("Title 11"), licenses of rights to
"intellectual property" as defined in Title 11. Each Party
agrees that the other Party, as licensee of such rights under
this Agreement shall retain and may fully exercise all of its
rights and elections under Title 11. Each Party shall during
the Term of this Agreement create and maintain current copies
or, if not amenable to copying, detailed descriptions or
other appropriate embodiments, to the extent feasible, of all
such intellectual property. If a case is commenced by or
against a Party under Title 11 (the "Affected Party"), the
Affected Party (in any capacity, including debtor-in-
possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall:
a. as the other Party may elect in a written request,
immediately upon such request:
i. perform all of the obligations provided in this
Agreement to be performed by the Affected Party
including, where applicable and without limitation,
providing to the other Party portions of such
intellectual property (including embodiments
thereof) held by the Affected Party and such
successors and assigns or otherwise available to
them; or
ii. provide to the other Party all such intellectual
property (including all embodiments thereof) held
by the Affected Party and such successors and
assigns or otherwise available to them; and
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November 19, 1999 ViroPharma-BPTD Agreement Page 38
b. not interfere with the rights of the other Party under
this Agreement, or any agreement supplemental hereto, to
such intellectual property (including such embodiments),
including any right to obtain such intellectual property
(or such embodiments) from another entity.
14.8.3 If a Title 11 case is commenced by or against the Affected
Party, and this Agreement is rejected as provided in Title
11, and the other Party elects to retain its rights hereunder
as provided in Title 11, then the Affected Party (in any
capacity, including debtor-in-possession) and its successors
and assigns (including, without limitation, a Title 11
Trustee) shall provide to the other Party all such
intellectual property (including all embodiments thereof)
held by the Affected Party and such successors and assigns,
or otherwise available to them, immediately upon the other
Party's written request. Whenever the Affected Party or any
of its successors or assigns provides to the other Party any
of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this Section 13.8, the other
Party shall have the right to perform the obligations of the
Affected Party hereunder with respect to such intellectual
property, but neither such provision nor such performance by
the other Party shall release the Affected Party from any
such obligation or liability for failing to perform it.
14.8.4 All rights, powers and remedies of the other Party provided
herein are in addition to and not in substitution for any and
all other rights, powers and remedies now or hereafter
existing at law or in equity (including, without limitation,
Title 11) in the event of the commencement of a Title 11 case
by or against the Affected Party. The other Party, in
addition to the rights, power and remedies expressly provided
herein, shall be entitled to exercise all other such rights
and powers and resort to all other such remedies as may now
or hereafter exist at law or in equity (including, without
limitation, Title 11) in such event. The Parties agree that
they intend the foregoing rights to extend to the maximum
extent permitted by law, including, without limitation, for
purposes of Title 11:
a. the right of access to any intellectual property
(including all embodiments thereof) of the Affected
Party, or any third party with whom the Affected Party
contracts to perform an obligation of the Affected Party
under this Agreement, and, in the case of the Third
Party, which is necessary for the development,
registration, manufacture and marketing of Drug
Inhalation Systems; and
b. the right to contract directly with any Third Party
described in 14.8.4(a) to complete the contracted work.
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November 19, 1999 ViroPharma-BPTD Agreement Page 39
15. MISCELLANEOUS.
15.1 Press Releases; Disclosure of Agreement. No public announcement
or other disclosure to Third Parties concerning the terms of
this Agreement shall be made, either directly or indirectly, by
either Party to this Agreement, except as may be legally
required or as may be required by the terms of that certain
license agreement between Battelle Memorial Institute and
Electrosols, Ltd. dated March 29, 1999, and as may be required
for recording purposes, without first obtaining the written
approval of the other Party and agreement upon the nature and
text of such announcement or disclosure. The Party desiring to
make any such public announcement or other disclosure shall
inform the other Party of the proposed announcement or
disclosure in reasonably sufficient time prior to public
release, and shall provide the other Party with a written copy
thereof, in order to allow such other Party to comment upon
such announcement or disclosure. Each Party agrees that it
shall cooperate fully with the other with respect to all
disclosures regarding this Agreement to the Securities Exchange
Commission and any other governmental or regulatory agencies,
including requests for confidential treatment of proprietary
information of either Party included in any such disclosure.
15.2 Recordation. Subject to compliance with all confidentiality
obligations of ViroPharma under this Agreement, ViroPharma
shall have the right, at any time, to record or register this
Agreement in appropriate governmental or regulatory offices
anywhere in the world, and BPTD shall provide reasonable
assistance to ViroPharma in effecting such recording or
registration, provided that ViroPharma shall take appropriate
measures available to protect the confidentiality of the terms
of the Agreement.
15.3 Entire Agreement; Amendment. This Agreement, and the existing
Confidentiality Agreements between the Parties related to the
subject matter of this Agreement, sets forth the terms of the
collaboration agreement between the Parties hereto and, except
as otherwise set forth herein, supersedes and terminates all
prior representations, agreements and understandings between
the Parties regarding the subject matter hereof. Any
modification of this Agreement shall be effective only when in
writing and signed by the Parties, and specifically stating
that it is an amendment to this Agreement.
15.4 Assignment. This Agreement and the licenses and rights herein
granted shall be binding upon and inure to the benefit of the
successors in interest of the respective Parties. Neither Party
may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the
other Party, which consent shall not be unreasonably withheld,
except that a Party may make such an assignment without the
other Party's consent to Affiliates or to a successor to all or
substantially all of the related business assets of such Party
relating to this Agreement, whether by way of a merger, sale of
stock, sale of assets or other similar transaction.
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November 19, 1999 ViroPharma-BPTD Agreement Page 40
15.5 Notices. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this
Agreement and shall be effective on receipt, as evidenced in writing,
when given by registered airmail or overnight courier and addressed,
unless otherwise specified in writing, to the addresses of the
Parties described below:
For BPTD: Battelle Pulmonary Therapeutics Division
Attention: Xxxxxx Xxxxxxxx
000 Xxxx Xxxxxx
Xxxxxxxx, Xxxx 00000-0000
FAX (000) 000-0000
With a copy to: Xxxxxx X. Xxxx (same address)
FAX (000) 000-0000
For ViroPharma: ViroPharma Incorporated
000 Xxxxxxxxx Xxxxxxxxx
Xxxxx, XX 00000
FAX: (000) 000-0000
Attention: Xxxxxxx Xxxxxx, Ph.D.
With a copy to: ViroPharma Incorporated
000 Xxxxxxxxx Xxxxxxxxx
Xxxxx, XX 00000
FAX: (000) 000-0000
Attention: General Counsel
15.6 Severability. If any Article or part thereof of this Agreement is
declared invalid by any court of competent jurisdiction, or any
government or other agency having jurisdiction over either BPTD or
ViroPharma deems any Article or part thereof to be contrary to any
anti-trust or competition laws then such declaration shall not affect
the remainder of the Article or other Articles. To the extent
possible the Parties shall revise such invalidated Article or part
thereof in a manner that will render such provision valid without
impairing the Parties' original intent. In the event a Party's rights
are materially affected as a result of a change in this Agreement
under this Paragraph, the Parties will renegotiate the terms and
conditions of this Agreement to resolve any inequities.
15.7 Force Majeure. Except as otherwise provided herein, no Party shall be
in breach of this Agreement, or liable to the other Party, for any
delay or failure of performance to the extent such delay or failure
is caused by circumstances beyond its reasonable control and that by
the exercise of Diligent Efforts it is unable to
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 41
prevent, provided that the party claiming excuse uses its Diligent
Efforts to overcome the same.
15.8 Expenses. Except as otherwise provided in the Agreement, all expenses
incurred by ViroPharma in connection with its obligations under this
Agreement will be borne solely by ViroPharma and all expenses
incurred by BPTD in connection with its obligations under this
Agreement will be borne solely by BPTD. Each Party will be
responsible for appointing its own employees, agents and
representatives, who will be compensated by such Party. Each Party
will be responsible for paying any finder's or broker's fee owed to a
Third Party that such Party incurs based directly or indirectly on
negotiating and entering this Agreement, and shall indemnify the
other Party against any obligation to pay such fee.
15.9 Non-Waiver. The failure of a Party in any one or more instances to
insist upon strict performance of any of the terms and conditions of
this Agreement shall not be construed as a waiver or relinquishment,
to any extent, of the right to assert or rely upon any such terms or
conditions on any future occasion.
15.10 Disclaimer of Agency; Relationship of the Parties. This Agreement
shall not render either Party the legal representative or agent of
the other, nor shall either Party have the right or authority to
assume, create, or incur any Third Party liability or obligation of
any kind, express or implied, against or in the name of or on behalf
of another except as expressly set forth in this Agreement. The
relationship between BPTD and ViroPharma under this Agreement is that
of independent contractors. BPTD and ViroPharma are not joint
venturers, partners, principal and agent, master and servant,
employer or employee, and have no relationship other than as
independent contracting Parties. Neither Party shall have any
responsibility for the hiring, firing, compensation or employee
benefits of the other Party's employees.
15.11 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as
may be necessary or appropriate in order to carry out the purposes
and intent of the Agreement.
15.12 Governing Law. This Agreement will be governed by and interpreted in
accordance with the laws of the Commonwealth of Pennsylvania, without
regard to the choice of law doctrines of Pennsylvania or any other
jurisdiction.
15.13 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which
shall constitute together the same document.
15.14 Debarment. Each Party certifies that none of its directors, officers,
employees, consultants or agents, nor any of its Affiliates'
directors, officers, employees, consultants or agents have been
debarred, nor have they been engaged in any acts
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 42
that could serve as the basis for debarment under the Generic Drug
Enforcement Act.
15.15 Dispute Resolution. In the event the parties cannot resolve any
controversy or claim arising out of or relating to this Agreement or
the breach thereof, such controversy or claim shall be settled by a
sole neutral through a binding, non-reviewable and non-appealable
alternative dispute resolution process in accordance with the then
existing Non-Administered Arbitration Rules of the CPR Institute for
Dispute Resolution, 000 Xxxxxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000-
3122. The neutral's award may be entered in any court having final
jurisdiction.
IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as of
the date first above written.
BATTELLE MEMORIAL INSTITUTE- VIROPHARMA INCORPORATED
COLUMBUS OPERATIONS
By: /s/ Xxxxxx X. Xxxxxxxx By: /s/ Xxxxxx X. Xxxx
Name: Xxxxxx X. Xxxxxxxx Name: Xxxxxx X. Xxxx
Its: Senior Vice President Its: President, CEO & Chairman
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 43
EXHIBIT A
BPTD Patents/Applications
**********
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 44
EXHIBIT B
The Third Party referred to in Section 1.37 of this Agreement is ********** and
its successors in interest.
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 45
EXHIBIT C
Development Plan
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 46
EXHIBIT D
System Specifications
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 47
EXHIBIT E
Form of Work Order
WORK ORDER
This Work Order is entered into this ____ day of ______________, 1999
between BPTD and ViroPharma and is subject to all of the terms and conditions
set forth in that certain Product Development and Commercialization Agreement
dated November 19, 1999, between the BPTD and ViroPharma (the "PDC Agreement").
In the event of any conflict between the terms of this Work Order and the PDC
Agreement, the terms of this Work Order shall control.
1. Description of Services.
-----------------------
2. Deliverables; Fees; Delivery Dates.
----------------------------------
Maximum Fee
Description of Deliverables for Deliverable Delivery Date
--------------------------- --------------- -------------
TOTAL MAXIMUM FEE
3. Payment Schedule.
----------------
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 48
The PDC Agreement shall remain in full force and effect, subject only to
the express terms of this Work Order, and the parties hereto hereby ratify and
confirm the provisions of the PDC Agreement, as may be so modified by this Work
Order. The parties have executed this Work Order as of the latest of the dates
set forth below.
VIROPHARMA INCORPORATED BATTELLE MEMORIAL INSTITUTE
By:_______________________________ By:________________________________
Name, Title:______________________ Name, Title:_______________________
Date:_____________________________ Date:______________________________
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 49
EXHIBIT F
Countries in Which BPTD Shall File, Prosecute
and Maintain BPTD Patents Pursuant to Section 10.3.2
----------------------------------------------------
**********
________________________________________________________________________________
November 19, 1999 ViroPharma-BPTD Agreement Page 50
