AMENDED AND RESTATED
DEVELOPMENT AND COMMERCIAL SUPPLY AGREEMENT
between
PHARMACIA & UPJOHN CO.
and
MIRAVANT MEDICAL TECHNOLOGIES
June 8, 1998
AMENDED AND RESTATED
DEVELOPMENT AND COMMERCIAL SUPPLY CONTRACT
THIS AGREEMENT, effective as of June 8, 1998 (the "Effective Date"), by and
among PHARMACIA & UPJOHN CO., a Delaware corporation having a place of business
in Clayton, North Carolina ("P&U"); and MIRAVANT MEDICAL TECHNOLOGIES, a
Delaware corporation having its principal place of business in Santa Barbara,
California ("Miravant").
W I T N E S S E T H:
WHEREAS, P&U (successor by merger to Pharmacia, Inc.) and Miravant (f/k/a
PDT, Inc.) entered into a Development and Commercial Supply Agreement as of
August 31, 1994 (the "Original Supply Agreement"), to develop and manufacture a
certain emulsion product;
WHEREAS, the development of this emulsion product is nearly complete and,
in anticipation of entering the commercial manufacturing phase, the parties
desire to make certain amendments to the Original Agreement;
WHEREAS, P&U plans to transfer its production facility in Clayton, N.C.,
and, in anticipation of such transfer, the parties desire to make further
amendments, and the parties have therefore agreed to amend and restate the
Original Agreement in its entirety as set forth below;
NOW, THEREFORE, the parties agree as follows:
SECTION 1. - DEFINITIONS
1.1 Definitions. The terms set forth in Exhibit 1 shall have the indicated
meanings for purposes of this Agreement.
SECTION 2. - DEVELOPMENT WORK
2.1 Description. As part of the Development Work, P&U will, in accordance
with applicable GLP/GMP requirements for injectibles, use commercially
reasonable efforts to: (a) perform such additional formulation work as the
parties shall agree to perform, (b) produce stability lots and supplies of
Emulsions containing the Agent for use in the preclinical and clinical studies,
(c) establish quality assurance, cleaning and manufacturing procedures for the
manufacture of the Emulsions and the Product in accordance with GMP and the
Specifications, (d) perform process scale-up for regulatory filing and
commercial distribution, and (e) obtain such engineering and other services as
may be required to enable P&U to comply with applicable environmental laws in
the manufacture of Emulsions containing the Agent. Miravant (or its Affiliates
or licensees) will conduct all preclinical and clinical studies.
2.2 Efforts of the Parties. Both parties shall use commercially reasonable
efforts in carrying out their roles. The foregoing notwithstanding, the parties
acknowledge that no assurance can be given that the Products can be developed,
or that, if developed, such Products will have commercial utility or that FDA
regulatory approval can be obtained.
2.3 Location. Except as otherwise provided in Section 5.4, all Development
Work to be performed by P&U under this Agreement shall be performed at P&U's
research and development facilities or its plant in Clayton, North Carolina
("Clayton Facility").
2.4 Development Work Data Collection. P&U shall maintain records and retain
samples of all raw materials and Emulsions and the Product, including all
FDA-required records and samples, in accordance with FDA requirements and in
sufficient detail and in good scientific and patent manner as will properly
reflect all work done and results achieved in the performance of the Development
Work. Except to the extent disclosing P&U Technology, all Data produced,
generated or procured by P&U or its employees during the Development Work
(including Development Work done prior to the Effective Date) shall be owned by
and shall be Proprietary Information of Miravant. Upon the reasonable request of
Miravant, (a) Miravant may examine and review such Data at reasonable times, and
(b) P&U shall deliver to Miravant copies of such Data. P&U shall not be required
to retain any Data or samples beyond the later of ***** from the date of
completion of the Development Work or the period for which applicable FDA
regulations require such Data and samples to be retained.
***** Confidential Treatment Requested
2.5 Regulatory Filings; Drug Master File. P&U will provide Miravant, at
Miravant's request, with all chemistry, manufacturing and controls information
required to be submitted in an IND, NDA or amendment or supplement thereto,
except such information described on Exhibit 5 (the "DMF Information") The DMF
Information shall not be submitted to Miravant, but all such information shall
be submitted in a drug master file ("DMF") prepared and promptly submitted by
P&U. In respect to such DMF:
(c) the contents and format shall comply with applicable FDA
requirements, including 21 C.F.R. ss.314.420 (or, if appropriate, the
equivalent government authority in the applicable country);
(d) P&U shall maintain such DMF in a current status at all times, and
Miravant shall be informed of the making of all changes to the DMF in
accordance with applicable FDA regulations and guidelines;
(e) P&U shall authorize Miravant to cross reference any information
contained in such DMF in connection with Miravant's submittal of the IND,
NDA or amendment or supplement thereto for use with Product manufactured by
P&U or under the licenses expressly granted to Miravant hereunder; and
(f) a letter authorizing Miravant to cross-reference the DMF will be
submitted to the FDA on behalf of Miravant by P&U.
All FDA filing or user fees associated with the IND, NDA, DMF or amendments or
supplements thereto shall be borne by Miravant.
2.6 Quality Assurance; Access to P&U Technology.
(a) Product Testing. P&U shall assume responsibility for all quality
assurance testing, including raw material testing, in-process control
testing and final product release testing, in connection with the Emulsions
and the Product in accordance with all applicable FDA regulations. Miravant
shall have the right to also have an independent, qualified laboratory
perform such testing periodically when Miravant deems it necessary to do
so. Subject to appropriate confidentiality undertakings, P&U agrees to
disclose to such third party such analytical methods and product
specifications as may be required to conduct such testing.
(b) Inspection Rights. To assure satisfaction with the applicable
quality control procedures in connection with the Development Work and
commercial production of the Product, upon reasonable prior notice, and at
reasonable times with a representative of P&U present, P&U shall permit
Miravant or its representatives to periodically review P&U's quality
control procedures and records. To the extent reasonably required to comply
with GLP/GMP requirements or to the extent a review of such records is not
adequate to assure satisfaction with such quality control requirements,
Miravant's regulatory personnel may visit P&U's production facility upon
reasonable prior notice. Such visits shall be conducted in a reasonable
manner and shall be limited to the equipment, records or production area
relating to P&U's performance under this Agreement. In addition to the
foregoing rights, Miravant shall have the right to inspect and audit such
facilities for compliance with GMP requirements. Miravant shall provide P&U
at least five (5) days notice of its intention to conduct such inspection
and audit, and such inspection and audit shall in no way interfere with the
manufacturing, packaging or control of the Product or any other products.
None of the foregoing rights shall apply to the DMF Information, to which
Miravant may have access solely as provided in Section 2.5(d) below.
(c) Site Visit Restrictions. Miravant personnel shall observe all
safety regulations of P&U when on P&U's premises. Miravant acknowledges
that P&U considers that such facility (including its equipment and manner
of use) embodies Proprietary Information, all of which shall be subject to
the provisions of Section 10 below. To the extent any such inspection or
audit cannot be reasonably performed due to the unavoidable observance of
confidential information of any third party which has imposed restrictions
on P&U's disclosure of such information, the parties shall determine in
good faith alternative procedures to assure compliance with GMP
requirements (including using an independent third party).
(d) Access to P&U Technology. Notwithstanding anything to the contrary
in this Agreement, Miravant shall not have access to or the right to use:
(a) any P&U Technology described in subsection (a) of the definition of P&U
Technology (Paragraph 1.20 of Exhibit 1); and (b) except as otherwise
expressly provided in this Agreement, any other P&U Technology. To the
extent Miravant needs to review P&U Emulsion Technology not otherwise
available to it under this Agreement to confirm that an Emulsion or the
Product is manufactured in accordance with all applicable GMP requirements
and Product Specifications, P&U shall disclose such information as is
required to comply with such requirements to an independent third party
consultant selected by Miravant and to which P&U does not reasonably
object. Such consultant shall be directed not to submit any report or other
information to Miravant prior to providing P&U an opportunity to review
such information and expunge any of P&U's Proprietary Information embodying
P&U Technology. P&U shall complete promptly its review of such reports and
other information. To the extent Miravant's chief medical officer
reasonably requires to review any expunged P&U Technology to assure the
safety of an Emulsion or the Product or to assure that an Emulsion or
Product is manufactured in accordance with all applicable GMP requirements
and Product Specifications, and notifies P&U of such requirement, P&U shall
allow only such individual to review the original version of such reports
solely for such purpose.
SECTION 3. - DEVELOPMENT WORK MANAGEMENT
3.1 Project Leaders. The parties designate the following individuals as
their respective Project Leaders:
For P&U: Xxxx Xxxxxxx-Gold
For Miravant: Xxx Xxxxxxxx
The Project Leaders (and their staffs) shall meet at least once each calendar
quarter, or from time to time as agreed by the parties, to exchange scientific
information and progress reports summarizing the Development Work completed, the
results obtained during that quarter and the Development Work expected to be
performed in the next quarter. Either party may change its Project Leader upon
prior notice to the other party.
3.2 Administrative Responsibility. The technical personnel and other
representatives at any time furnished by either party to the other or otherwise
performing services pursuant to this Agreement shall at all times remain the
employees or representatives of the party furnishing such personnel. Except as
otherwise expressly provided in Section 4 below, each party shall be responsible
for and shall pay all salaries, living allowances, insurance coverages,
traveling expenses, any withholding required for tax or other purposes and other
remunerations and expenses to which its own employees or representatives may be
entitled. Notwithstanding the foregoing, such employees or representatives of
either party, while on the property of the other party or its designee, shall be
at all times subject to the reasonable rules and regulations adopted by such
other party with respect to the conduct of its own employees or representatives.
SECTION 4. - DEVELOPMENT WORK COMPENSATION
4.1 Initial Fee. In consideration of P&U's commitment to develop the
Emulsions and the Product in accordance with the terms hereof and the use of
P&U's Technology for the development of the Emulsions and the Product, Miravant
paid P&U an initial fee of $600,000.
4.2 Hourly Rates. P&U shall provide the services required to perform the
Development Work after the Effective Date at the hourly rates set forth in
Exhibit 2 hereto. It is assumed that all standard laboratory equipment and
instrumentation procurement and usage are included in the hourly charge, with
the exception of dedicated equipment used solely for the Development Work as
provided in Section 4.4 herein.
4.3 Travel and Supplies. Subject to its prior written approval for travel
outside the United States, Miravant shall also reimburse P&U for its actual,
reasonable and necessary out-of-pocket travel expenses incurred specifically in
connection with providing the services hereunder (exclusive of commuting
expenses), including, but not limited to, coach air and ground transportation,
reasonable lodging and meals. Miravant shall also reimburse P&U for its
out-of-pocket expenses for courier services, outside reproduction services,
laboratory chemicals (except the Agent which shall be provided by Miravant
pursuant to Section 5.5), other laboratory supplies, and outside analytical or
other testing work, and other purchased items which are not presently available
at the P&U site and which are required to produce Emulsions for the Development
Work (including any replacement items). P&U may, without Miravant's prior
approval, procure any item of laboratory or other equipment with a purchase
price less than ***** without the prior approval by Miravant, which is required
for P&U to perform its obligations hereunder, and is not now available for use
at the facility where the equipment is needed. All equipment purchased pursuant
to this Section 4.3 by P&U shall be owned by P&U.
4.4 Purchased Equipment. P&U shall not acquire any laboratory equipment or
other item with a purchase price greater than ***** without Miravant's prior
consent. Upon receipt of such consent, P&U shall then have the option to
purchase such item itself. All such items purchased by P&U shall be owned by
P&U, and P&U may charge Miravant for the pro rata allocable depreciation on such
equipment based upon five year straight line depreciation. All equipment
purchased pursuant to this Section 4.4 by Miravant shall be owned by Miravant.
Title to and risk of loss of any equipment purchased under this Section 4.4
shall be in P&U if purchased by P&U, and in Miravant if purchased by Miravant.
Miravant may, at its option, furnish P&U the use of any such equipment Miravant
possesses or to which it may have access, in which case Miravant shall retain
title to and risk of loss of such equipment. P&U shall, upon request by
Miravant, plainly xxxx any equipment owned by Miravant which is in P&U's
possession.
***** Confidential Treatment Requested
4.5 Invoicing. During the Development Work after the Effective Date, P&U
shall submit monthly invoices to Miravant which shall include: (a) total hours
expended by each person in a category listed on Exhibit 2 for whom reimbursement
is sought, and (b) itemized list of all reimbursable expenses. Miravant's
payment shall be due thirty (30) days after its receipt of each such invoice,
except for amounts that Miravant reasonably disputes. P&U shall maintain
accurate records of time charges and travel and equipment expenses, and shall
maintain accurate supporting documents to verify all of the foregoing. Such
records and documents shall be available for audit by Miravant during normal
business hours and on reasonable notice, but not later than the end of the
calendar year in which the invoice is rendered.
SECTION 5. - COMMERCIAL SUPPLY
5.1 Purchase and Sale. During the term of this Agreement, (a) Miravant
shall purchase, and P&U shall manufacture and supply, all of Miravant's (and its
Affiliates') worldwide requirements of Emulsions containing the Agent for
commercial use; and (b) to the extent not purchased by Miravant, Miravant shall
cause its licensees to purchase from P&U, and P&U shall manufacture and supply,
all of their worldwide requirements of such Emulsions for commercial use. Except
as set forth in Section 5.2 below, P&U shall not be obligated to supply more
than ***** Units per year of the Product. The Initial Facility will be
configured to produce up to ***** Units per year. P&U's main production line
will be modified to produce the Product in excess of such quantity. P&U shall
not be required to produce the Product for commercial use above such level until
***** further notice from Miravant that its requirements will exceed such level,
plus the amount of time required for internal and FDA validation and approval of
such modified production facility.
5.2 Expanded Capacity.
(a) Miravant's Right to Manufacture. As soon as practicable, Miravant
shall notify P&U in writing when it expects its aggregate annual worldwide
requirements of Product to exceed ***** Units ("Notice to Expand"). P&U
shall then have the right to produce all such additional worldwide
requirements of Product if the parties negotiate mutually acceptable terms
amending this Agreement (including construction time periods and extension
of the term of this Agreement for the construction of a dedicated or
multipurpose production line ("Expanded Production Line")). In no event
shall P&U be obligated to supply Product manufactured in the Expanded
Production Line sooner than ***** after entering into a written agreement
with Miravant to construct the Expanded Production Line, plus the amount of
time required for internal and FDA validation and approval of such
production facility. If the parties fail to agree upon such terms for an
Expanded Production Line, (a) P&U shall continue to produce, and Miravant
shall continue to purchase, Product from P&U up to ***** Units or such
higher quantity as P&U may then commit in writing to provide for so long as
this Agreement shall continue pursuant to Section 13; and (b) Miravant
shall have the right to manufacture (or have manufactured) its requirements
of the Products in excess of the quantity so committed by P&U as provided
in Section 5.2(b) below.
(b) Standby License; Supply of *****. If Miravant elects to
manufacture or have manufactured by a third party Miravant's excess
requirements for the Product as provided in Section 5.2(a) and if then
requested by Miravant, P&U and Miravant shall enter into a separate license
agreement providing Miravant with a non-exclusive license (with a right to
sublicense as provided below) under the P&U Emulsion Technology to
manufacture the Product (the "Standby License Agreement"). The Standby
License Agreement shall provide, among other customary terms and
conditions, the following: (i) the license grant shall continue
indefinitely, subject to termination for breach of such Standby License
Agreement; (ii)***** (iii) Miravant may grant to one or more third parties
(other than an Emulsion Competitor, unless Miravant terminates under
Section 13.2 for a material breach by P&U, in which case there will be no
such restrictions) a sublicense under the P&U Emulsion Technology for the
purpose of producing the Product and supplying it to Miravant and its
Affiliates and licensees. An "Emulsion Competitor" means a third party
which, at the time of entering into the applicable licensing arrangement,
is manufacturing or selling pharmaceutical emulsion products competitive
with those manufactured or sold by P&U or any of its Affiliates. In
addition, P&U shall agree to supply its ***** for use in producing the
Product; provided, that such ***** is then used in the Product. Such
material shall be supplied upon commercially reasonable terms, including a
supply price equal to the amount referred to in Exhibit 4 hereto and P&U
may not terminate such supply agreement, other than for specified causes to
be set forth therein, without providing written notice of at least *****
***** Confidential Treatment Requested
5.3 Packaging. Unless otherwise specified by Miravant, all Product supplied
hereunder shall be in finished dosage form, i.e., packaged, labeled, and
suitable for shipment to end users in accordance with the Packaging
Specifications.
5.4 Manufacturing Location. All Product shall be manufactured at the
Xxxxxxx Facility, except that, at P&U's option, P&U shall have the right to
manufacture and supply such Product from one or more production facilities owned
by P&U or any of its Affiliates on the following conditions:
(a) Such other production facility or facilities shall have been
approved by the FDA (and, if appropriate, the equivalent governmental
authority in the applicable country) for manufacturing the Product;
(b) Miravant shall have access to such facility and related records to
the same extent as it does to the Xxxxxxx Facility; and
(c) The Production Cost will not exceed the Production Cost which
would have applied if such Products were manufactured at the Xxxxxxx
Facility, and there will not be any additional costs for Development Work
as a result of using such other facility.
5.5 Supply of Agent. Within thirty (30) days after submitting any purchase
order for the Product, Miravant shall use its best efforts to deliver at no cost
to P&U, DDP to P&U's manufacturing plant (INCOTERMS 1990), sufficient quantities
of the Agent and other active therapeutic ingredients necessary for P&U to
manufacture the Product thereunder. The Agent shall be shipped in containers
adequate to prevent losses or breakage from all reasonably expected handling
procedures. In the event Miravant is unable to provide the Agent and other
active therapeutic ingredients within any such 30 day period, the "lead time"
period for the manufacture of the Product referred to in Paragraph 5.1 of
Exhibit 2 hereof under the affected purchase order shall be extended for the
period of time P&U is delayed by such inability. Miravant shall retain title to
all Agent and other active therapeutic ingredients supplied to P&U. Except as
provided in Section 7.5 below, P&U shall bear the risk of loss for such Agent
and other active therapeutic ingredients while they are in the care, custody and
control of P&U. Such Agent and other active therapeutic ingredients shall meet
the specifications therefor.
5.6 *****
(a) *****
(b) *****
(c) *****
(d) *****
SECTION 6. - ADDITIONAL TERMS AND CONDITIONS
6.1 Additional Terms. The supply and purchase of the Product shall be
governed by the terms of this Agreement, including the terms and conditions set
forth in Exhibit 3.
6.2 Agreement Governs. The terms and conditions of this Agreement,
including all Exhibits hereto, constitute the entire agreement between the
parties with respect to all purchase orders issued to P&U for the supply of
Product. Acceptance by P&U of Miravant's orders is expressly limited to and
conditioned upon acceptance of these terms and conditions, which may not be
changed or waived except in a writing signed by the parties. Any additional or
inconsistent terms and conditions contained in Miravant's purchase orders or
other documents supplied by Miravant or in acknowledgments or other documents
supplied by P&U are hereby expressly rejected.
SECTION 7. - COMPENSATION
7.1 Supply Price. Subject to adjustment as provided in Section 7.3 below,
the purchase price for each Unit of Product supplied by P&U during any year for
commercial sale ("Supply Price") ***** units annually during the ***** from the
Effective Date without a price limitation, and, thereafter, the Supply Price
***** and ***** . The Production Cost shall be determined in the manner
described in Exhibit 4 hereto.
***** Confidential Treatment Requested
7.2 *****
*****
*****
7.3 Adjustments. If P&U can demonstrate its Production Costs have increased
due to changes in GMP or other legal requirements or manufacturing methods
outside of P&U's control, then the parties will agree on an equitable adjustment
to the Supply Price, and if they fail to agree within ***** , it will be
resolved as provided in Article 14 hereof.
7.4 INTENTIONALLY DELETED.
7.5 Agent Yield. To the extent P&U's consumption of the Agent exceeds the
amount permitted by the yield rate determined as provided below, P&U shall
credit Miravant for the amount of Miravant's actual costs to procure such
excessive consumption of the Agent. After the ***** of commercial production (so
long as at least ***** commercial batches of the Product were produced in P&U's
Initial Facility), the parties shall determine an appropriate yield rate of the
Agent. In making such determination the parties shall apply customary production
standards and take into account all relevant factors, including the actual yield
losses during such commercial production, likely effect of contemplated changes
to the production methods, container size and configuration, and anticipated
production schedules. In no event shall such yield rate exceed the lower limit
of a ***** confidence interval containing the mean of the actual yields during
such commercial production. The parties shall establish reasonable procedures
for measuring the actual yields, calculating Miravant's actual costs to procure
Agent, adjusting such yield rate to account for the effect of changes to the
Specifications, GMP and other legal requirements and other conditions beyond the
reasonable control of P&U. The foregoing procedure, including ***** of
commercial operation, shall be applied each time the production facility is
transferred to a different capacity batch size. All Agent used (including all
production losses not resulting from P&U's gross negligence) during each such
***** period shall be Miravant's responsibility.
7.6 Payment. P&U shall submit invoices upon each shipment for the number of
Units so shipped. Miravant shall pay all invoices, plus all proper taxes,
freight and other transportation charges stated thereon, within thirty (30) days
after its receipt.
***** Confidential Treatment Requested
SECTION 8. - INVENTIONS AND LICENSES
8.1 P&U Technology. P&U shall retain the entire right, title and interest
in all P&U Technology, and except as otherwise provided in Sections 5.2(b) and
13.7, nothing in this Agreement shall give Miravant any ownership or other
rights in or to any P&U Technology.
8.2 Miravant Technology. Miravant shall retain the entire right, title and
interest in all Miravant Technology, and nothing in this Agreement shall give
P&U any ownership rights in or to any Miravant Technology.
8.3 Development Technology. Miravant shall own the entire right, title and
interest in all Development Technology, whether conceived solely by its
employees or consultants or conceived solely by or jointly with employees or
consultants of P&U or its Affiliates and employees or consultants. P&U hereby
assigns and agrees to assign, and shall cause its Affiliates to assign and agree
to assign, to Miravant all right, title and interest in such Development
Technology conceived by employees or consultants of P&U or its Affiliates,
either solely or jointly with others.
8.4 P&U License. Miravant hereby grants and agrees to grant to P&U *****
license to use Miravant's Patents, Know-How and the Development Technology to
manufacture Emulsions and the Product exclusively for Miravant (and its
licensees and Affiliates) and to perform its other obligations hereunder. Such
license shall include the right to grant sublicenses only to P&U Affiliates to
the extent necessary for the performance of this Agreement. Miravant also grants
and agrees to grant to P&U and its Affiliates an ***** (subject to the
confidentiality provisions contained in Section 10 below), worldwide license
(with right to sublicense and assign) to use the Development Technology for the
manufacture, use and sale of any emulsion product suitable for parenteral
nutritional purposes or as a delivery system for compounds other than compounds
for photodynamic therapeutic uses.
8.5 Patent Applications. If a patentable invention embodying Development
Technology is conceived in the course of and within the scope of the Development
Work and reduced to practice during the term hereof or within ***** thereafter,
Miravant shall have the sole right to determine whether to file patent
applications covering the invention and shall bear all expenses incurred in
connection with the prosecution of all applications and the maintaining of all
patents. P&U shall cooperate in the filing and prosecution of any such
applications and patents.
8.6 Patent Infringement.
(a) Miravant Indemnity. Miravant shall defend and indemnify P&U and
its Affiliates from any claims or actions brought against P&U or its
Affiliates alleging that the manufacture, use or sale by or for Miravant or
P&U of the Product or any Emulsion infringes any claim of any United States
or foreign patent or other proprietary right of a third party; provided
that Miravant shall have no obligation to so defend or indemnify to the
extent such infringement results from the use of P&U Technology or
Development Technology invented solely by P&U or its Affiliates, in each
case, other than uses where the presence of the Agent causes the
infringement. P&U shall have the right to advisory counsel in such action
at its own expense. Miravant shall have the right to settle or otherwise
terminate said actions; provided, the settlement does not obligate P&U in
any way.
(b) P&U Indemnity. P&U shall defend and indemnify Miravant and its
Affiliates from any claims or actions brought against Miravant or its
Affiliates alleging that the manufacture, use or sale by or for Miravant or
P&U of the Product or any Emulsion manufactured by P&U infringes any claim
of any United States or foreign patent or other proprietary right of a
third party, to the extent such infringement results only from the use of
P&U Technology or Development Technology invented solely by P&U or its
Affiliates, in each case, other than uses where the presence of the Agent
causes the infringement. Miravant shall have the right to advisory counsel
in such action at its own expense. P&U shall have the right to settle or
otherwise terminate said actions; provided, the settlement does not
obligate Miravant in any way.
SECTION 9. - TRADEMARKS.
9.1 Trademark Selection. Miravant shall have the sole authority to select
and use trademarks for the Product and shall bear all the costs associated with
such selection. Miravant shall defend, indemnify and hold P&U harmless from and
against all claims, demands, liabilities, damages, costs and expenses (including
attorneys' reasonable fees) in respect to the alleged infringement of trademark,
trade name or other similar rights of third parties arising out of the sale and
marketing of Product by or for Miravant.
***** Confidential Treatment Requested
SECTION 10. - CONFIDENTIALITY
10.1 Non-Disclosure. Except as otherwise provided in Section 10.2 below,
during the duration of this Agreement and thereafter: (a) neither party shall
use or disclose to third parties any of the other party's Proprietary
Information, and (b) neither party shall use or disclose to third parties,
except as permitted by, or reasonably necessary to perform its obligations
under, this Agreement, any Development Technology or any Data unless or until it
becomes part of the public domain or is lawfully received by the receiving party
from a third party under no obligation to the disclosing party with respect
thereto, it being expressly understood, however, that Miravant shall be entitled
to file patent applications with respect to any inventions embodied in the
Development Technology and shall be entitled to license the Development
Technology to a third party manufacturer of the Product in accordance with
Section 5.2(b) and 13.7 hereof. Both parties shall take all reasonable steps to
minimize the risk of disclosure of any Proprietary Information of the other,
including without limitation:
(i) limiting access to such information to only those employees and
consultants approved by the other party whose duties require them to
possess same (which consultant approval shall not be unreasonably
withheld);
(ii) requiring such employees and consultants to execute a written
agreement obligating such employees or consultants to maintain the
confidentiality of the information to at least the same extent as his
employer is obligated; copies of such agreements shall be provided to the
other party on request;
(iii) exercising at least the same degree of care that it uses for its
own Proprietary Information; and
(iv) providing proper and secure storage for the Proprietary
Information.
10.2 Permitted Disclosure. Either party may disclose Proprietary
Information of the other pursuant to a lawful request, order or demand of any
governmental agency or judicial authority or, to the extent reasonably necessary
for a party to perform its obligations hereunder, to any Affiliates or
subcontractors; provided, that protective orders or other assurances of
confidentiality are received to the extent reasonably available from such
agency, authority or third party; and provided, further, that the disclosing
party (a) gives the other party notice of the request or order and reasonable
time to object, (b) follows any proper instructions of the other party regarding
such disclosure or objections; and (c) prior notice of any intended disclosure
to such Affiliate or subcontractor which shall have entered into a nondisclosure
agreement substantially equivalent to the terms of this Section 10.
10.3 Duties Upon Termination. Except to the extent reasonably necessary for
exercising its rights which survive termination of this Agreement, upon request
by the disclosing party after such termination, the receiving party shall return
all Proprietary Information of the other in its possession and shall make no
further use of such Proprietary Information.
10.4 Disclosure of Agreement. Any public disclosure of this Agreement, the
terms hereof, the transactions contemplated hereby or the results obtained
hereunder (including, without limitation, press releases, advertising,
governmental filings, discussions with lenders, investment bankers, public
officials and the media and other statements made available generally by a party
hereto to the public) will be reviewed and consented to by each party prior to
such disclosure, and neither party hereto shall disclose the terms of this
Agreement to any third party without the prior written consent of the other.
Such consents shall not be untimely or unreasonably withheld by either party
hereto. In addition, if either party is required to make public disclosure of
this Agreement, or of any provision hereof or of the transactions contemplated
hereby pursuant to any law, rule or regulation of any government agency,
including without limitation the United States Securities and Exchange
Commission or any securities exchange on which securities of the disclosing
party are then listed, then in each case, the disclosing party shall endeavor to
obtain confidential treatment of the Agreement and transactions contemplated
hereby to the extent reasonably requested by the other party.
10.5 Technical Publication. No technical paper, abstract, article,
publication, or announcement of advances generated in connection with the
Development Work, whether during the period of performance of this Agreement or
thereafter, shall be made by either party without the written consent of the
other party.
10.6 Injunctive Relief. Both parties acknowledge that either party would
not have an adequate remedy at law for breach of any of the covenants contained
in this Section 10 and hereby consent to the enforcement of same by the
non-breaching party by means of temporary or permanent injunction issued by any
court having jurisdiction thereof and further agrees that it be entitled to
assert any claim it may have for damages resulting from the breach of such
covenants in addition to seeking injunctive or other relief.
SECTION 11. - EXCLUSIVITY
11.1 P&U. P&U agrees that during the term of this Agreement, its services
and activities in developing and manufacturing the Emulsions, the Product or
***** shall be exclusive to and only for Miravant, its licensees and Affiliates.
Notwithstanding the foregoing, P&U may ***** to any third party.
11.2 Miravant. Except as otherwise provided herein, Miravant agrees that
during the term of this Agreement it shall purchase from P&U all of its (and its
Affiliates') worldwide requirements of the Emulsions, and, to the extent not
purchased by Miravant, it shall cause its licensees to purchase from P&U all of
their worldwide requirements of Emulsions.
SECTION 12. - REPRESENTATIONS AND WARRANTIES
Each party hereby warrants and represents as follows:
12.1 It has full power and authority to execute and deliver this Agreement
and to consummate the transactions contemplated herein. This Agreement and the
provisions hereof constitute the valid and legally binding obligations of it and
do not require the consent, approval or authorization of any person, public or
governmental authority or other entity;
12.2 The execution and delivery of this Agreement by it, and the
performance of its obligations hereunder, are not in violation or breach of, and
will not conflict with or constitute a default under, its Certificate of
Incorporation or Bylaws, or any material agreement, contract, commitment or
obligation to which it is a party or by which it is bound, and will not conflict
with or violate any applicable law, rule, regulation, judgment, order or decree
of any governmental agency or court having jurisdiction over it or its assets or
properties; and
12.3 In the case of Miravant only, it represents and warrants that it has
the exclusive right to exploit the Agent for all medical uses, and no rights
thereto have been granted to any third party.
SECTION 13. - TERMINATION.
13.1 Term of Agreement. Unless terminated earlier as provided in Sections
13.2 through 13.5 or 16.2 below, this Agreement shall continue in full force and
effect indefinitely, except that either party may terminate this Agreement upon
or after the tenth anniversary of the first commercial sale of the Products, by
giving written notice of its intent to so terminate at least ***** prior to the
effective date of termination.
13.2 Termination for Cause. Without prejudice to any other rights it may
have hereunder or at law or in equity, either party may terminate this Agreement
immediately by written notice to the other party upon the occurrence of any of
the following:
(a) the other party becomes insolvent, an order for relief is entered
against the other party under any bankruptcy or insolvency laws or laws of
similar import, or fails generally to pay its debts as they become due;
(b) the other party makes an assignment for the benefit of its
creditors or a receiver or custodian is appointed for it, or its business
is placed under attachment, garnishment or other process involving a
significant portion of its business;
(c) the other party fails to maintain operations as a going business
for more than twenty days; or
(d) after sixty days' written notice from the terminating party (which
notice shall state the intent to so terminate), the other party fails to
remedy any material breach of this Agreement.
13.3 Termination by P&U. P&U may terminate this Agreement ***** after
written notice to Miravant if ***** In either of such events, Miravant and P&U
shall meet together within the thirty (30) day notice period to consider the
causes for delay and alternatives to termination of this Agreement.
13.4 Termination by Either Party. Either party may terminate this Agreement
upon written notice at any time if: (a) Miravant permanently abandons the
further development of Emulsions containing the Agent or the Product, (b)
neither party is able to obtain, after expending commercially reasonable efforts
in good faith, a stable viable formulation of Emulsion to submit in an NDA; or
(c) Miravant stops sales of Product at any time.
***** Confidential Treatment Requested
13.5 Right to Withdraw. Miravant may permanently withdraw the Product from
the market because such Product: (a) is subject to a recall not involving only
isolated lots; (b) is recalled or withdrawn in any country in the world; or (c)
is otherwise reasonably believed to have material adverse risks not affecting
only isolated lots. If Miravant so withdraws the Product, it shall then have the
right to terminate this Agreement.
13.6 Rights and Duties Upon Termination. Termination of this Agreement, for
whatever reason, shall not affect any rights or obligations accrued by either
party prior to the effective date of termination including a purchase order for
Product. Without limiting the generality of the foregoing, upon termination of
this Agreement after commencement of manufacturing:
(a) Provided that Miravant provides adequate assurances for payment,
P&U shall sell to Miravant at the Supply Price (Miravant shall then have
the obligation to purchase) P&U's inventory of Product and/or to return to
Miravant its existing inventory of the Agent, in whole or in part, by
notice to Miravant within thirty (30) days following termination.
(b) Upon any termination by Miravant, P&U shall continue to cooperate
with Miravant in respect of all requirements of the FDA and this Agreement
regarding previously produced Product.
(c) Upon any termination, both parties shall immediately cease using
the other party's Proprietary Information, except as permitted by Sections
8.3, 8.4, and 13.7
13.7 Miravant License. In the event of termination of this Agreement: (i)
by either party under Section 13.1, (ii) by Miravant under Section 13.2, or
(iii) by P&U under Section 13.3, and the request of Miravant, P&U shall grant
Miravant a non-exclusive license to practice the P&U Emulsion Technology to
manufacture, or have manufactured by a third party (other than an Emulsion
Competitor), Emulsions (including the Product). Miravant shall pay P&U a royalty
on its Net Sales of Emulsions containing the Agent or the Product for *****
years following termination of this Agreement or for ***** years following the
first commercial sale, whichever is later. The royalty per Unit of Product shall
be equal to the following percentages of the Product:
(a) *****, if terminated by P&U under Section 13.1;
(b) *****, for the ***** following such first commercial sale and
***** for ***** , if terminated by Miravant under Section 13.1 (and no
royalty shall be payable on Net Sales after ***** of such first
commercial sale);
(c) *****, if terminated by Miravant under Section 13.2; and
(d) *****, if terminated by P&U under Section 13.3.
13.8 Miravant's Books and Records. Miravant shall maintain adequate books
and records to verify the calculation and derivation of royalties payable by
Miravant. Such books and records shall be available for inspection and audit by
P&U and its representatives at reasonable times and on reasonable notice, but
not later than the end of the second calendar year after the year in which the
records are generated, for the purpose of verifying reports and payments due
hereunder. In the event such inspection and audit should show an understatement
of the royalties payable by Miravant, Miravant shall promptly pay to P&U any
additional amounts due hereunder, and if such understatement should be more than
five percent (5%) of the royalties for the respective period, Miravant shall
also bear the expenses incurred for said audit.
13.9 Disagreements. In the event of a disagreement which cannot be resolved
in respect of the calculation of the royalties referred to in Section 13.7
herein, the matter shall be submitted for dispute resolution pursuant to Section
14 and at least one neutral arbitrator shall be a certified public accountant.
13.10 Survival. The following Sections survive any termination of this
Agreement: 1, 2.4, 4, 5.2(b), 8, 9, 10, 12, 13.6, 13.7, 13.8, 15, and Paragraphs
2, 3, and 12 of Exhibit 2 and any other provisions which by their terms extend
beyond termination.
***** Confidential Treatment Requested
SECTION 14. - DISPUTE RESOLUTION
14.1 Mediation. If a dispute arises under this Agreement which cannot be
resolved by the personnel directly involved, either party may invoke the dispute
resolution procedure set forth in this Section 14 by giving written notice to
the other party, designating an executive officer with appropriate authority to
be its representative in negotiations relating to the dispute. Upon receipt of
such notice, the other party shall, within ten (10) business days, designate an
executive officer with similar authority to be its representative. The
designated executive officers shall, following whatever investigation each deems
appropriate, promptly enter into discussions concerning the dispute. If the
dispute is not resolved as a result of such discussion within 60 days after the
date of such notice, either party may commence arbitration as provided in
Section 14.2 below.
14.2 Arbitration. Subject to the terms of Section 14.1 above, any dispute,
controversy or claim arising out of or in connection with this Agreement, or the
breach, termination or invalidity thereof, shall be settled by arbitration in
Raleigh, North Carolina before a panel of three (3) arbitrators in accordance
with the Commercial Arbitration Rules of the American Arbitration Association.
The parties agree that the arbitrators shall have the power to award damages,
injunctive relief and reasonable attorneys' fees and expenses to either party in
such arbitration. The decision reached by such arbitrators in any such
proceeding shall be final and binding upon the parties thereto. The parties
shall, however, in addition to the rights provided in Section 10.6, remain free
to apply to any competent judicial authority for interim or conservatory
measures, even after the transmittal of the file to the aforesaid arbitrators
and even if there are no exceptional circumstances.
SECTION 15. - LIMITATION OF LIABILITY
IN NO EVENT SHALL EITHER PARTY NOR ANY OF ITS RESPECTIVE AFFILIATES BE
LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT,
NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, including, but not limited to, loss
of profits (except for Profit) or revenue, loss of use of any equipment, cost of
capital, down time costs, delays, or claims of customers of any of them or other
third parties for such or other damages.
SECTION 16. - MISCELLANEOUS
16.1 Choice of Law. This Agreement shall be governed and interpreted, and
all rights and obligations of the parties shall be determined, in accordance
with the laws of the State of North Carolina, excluding its conflicts of law
rules.
16.2 Force Majeure.
(a) P&U and Miravant shall not be deemed to be in default nor be
liable for loss, damage, or for delay in performance, when and to the
extent due to causes beyond its reasonable control or from fire, strike,
labor difficulties, act or omission of any governmental authority,
compliance with governmental regulations, noncompliance with GLP/GMP
requirements despite such party's good faith efforts and adherence to
procedures consistent with past practice, insurrection or riot, embargo,
delays or shortages in transportation.
(b) Each party agrees to give the other party prompt written notice of
the occurrence of any such condition, the nature thereof, and the extent to
which the affected party will be unable fully to perform its obligations
hereunder. Each party further agrees to use reasonable efforts to correct
the condition as quickly as possible and to give the other party prompt
written notice when it is again fully able to perform such obligations. In
the event such condition is not corrected within six (6) months from the
original notification under this Section 16.2, the party whose performance
was not affected by the condition may terminate this Agreement.
16.3 Notices. All notices, requests, demands, waivers, consents,
approvals or other communications to any party hereunder shall be in
writing and shall be deemed to have been duly given if delivered personally
to such party or sent to such party by facsimile transmission or by
registered or certified mail, postage prepaid, to its address as shown
below:
Miravant:
Miravant Medical Technologies
0000 Xxxxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
Attention: Xx. Xxxx X. Xxxxxxx
Fax: 000-000-0000
with a copy, in the case of notices expressly provided for in this Agreement,
to:
Xxxxxx X. Xxxx
Xxxx & Xxxxxxx, P.C.
000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
Fax: (000) 000-0000
P&U: Pharmacia &Upjohn Inc.
0000 X.X. 00 Xxxx
Xxxxxxx, XX 00000
Attention:
Fax: 000-000-0000
with copies, in the case of notices expressly provided for in this Agreement,
to:
Xxxxx X. Xxxxxxxxxx, Xx.
Xxxxxx & Xxxx
000 Xxxxxxx Xxxx.
Xxxxxxxx, XX 00000
Fax: (000) 000-0000
or to such other address as the addressee may have specified in notice duly
given to the sender as provided herein. Such notice, request, demand, waiver,
consent, approval or other communications will be deemed to have been given as
of the date so delivered, telegraphed, telexed, or five days after so mailed.
16.4 Severability. In the event that any provision of this Agreement, which
is not a material part of the consideration thereof, shall be found in any
jurisdiction to be illegal or unenforceable in law or equity, such finding shall
in no event invalidate any other provision of this Agreement in that
jurisdiction, and this Agreement shall be deemed amended to the minimum extent
required to comply with the law of such jurisdiction.
16.5 Entire Contract. This instrument states the entire agreement reached
between the parties hereto with respect to the transactions contemplated hereby
and may not be amended or modified except by written instrument duly executed by
the parties hereto. Any and all previous agreements and understandings between
the parties regarding the subject matter hereof, whether written or oral, are
superseded by this Agreement. The failure of either party hereto to enforce at
any time, or for any period of time, any provision of this Agreement shall not
be construed as a waiver of such provision or of the right of such party
thereafter to enforce each and every provision.
16.6 Assignment, Binding Effect. Neither party shall assign this Agreement
or any of their respective rights or obligations hereunder, by operation of law
or otherwise, without the prior written consent of the other party (which shall
not be unreasonably withheld), and any such attempted assignment without such
consent shall be void. Notwithstanding the foregoing, either party shall assign
this Agreement to a third party (and shall then be released from all liabilities
hereunder arising thereafter) without such consent upon thirty (30) days' prior
notice, if such third party (a) acquires (by purchase or merger) all or
substantially all of such party's business and assets or, in the case of P&U,
the production facility at Clayton, N.C., and substantially all of the P&U's
assets relating thereto, (b) assumes all of the obligations of such party
hereunder, and (c) Miravant is provided reasonable assurances of performance of
all obligations hereunder by the successor to P&U, including, without
limitation, protections that include P&U control of analytical methods, a direct
supply arrangement for Emulsions between such assignee and P&U or one or more of
its Affiliates (to the extent P&U or any of its Affiliates then have any rights
under separate agreements with Miravant to sell the Emulsion) and for Emulsion
also to be provided to Miravant and other assurances commensurate with the
release of liability of P&U as set forth above. In no event shall Miravant so
assign this Agreement to a third party which is an Emulsion Competitor at the
time of such assignment. No assignment shall be effective until the assignee
shall have unconditionally assumed in writing all of the assignor's obligations
hereunder and a written notice of such assignment is given to the other party.
When duly assigned in accordance with the foregoing, this Agreement shall be
binding upon and inure to the benefit of P&U, Miravant and their respective
successors and permitted assignees.
16.7 Independent Contractor. Each party shall be and shall endeavor to act
as the independent contractor of the other party. Neither party shall be the
legal agent of the other for any purpose whatsoever and therefore has no right
or authority to make or underwrite any promise, warranty or representation, to
execute any contract or otherwise to assume any obligation or responsibility in
the name of or in behalf of the other party, except to the extent specifically
authorized in writing by the other party. Neither of the parties hereto shall be
bound by or liable to any third persons for any act or for any obligation or
debt incurred by the other toward such third party, except to the extent
specifically agreed to in writing by the party so to be bound.
16.8 Headings. All section headings contained in this Agreement are for
convenience of reference only, do not form a part of this Agreement and shall
not affect in any way the meaning or interpretation of this Agreement.
16.9 Future Modifications. The parties acknowledge that the non-financial
terms hereof relating to the manufacturing of the Product, including delivery,
storage, manufacturing method and quality control, are based on the parties'
current best estimates of expected conditions, which estimates were derived from
laboratory test results and P&U's commercial experience with other fat emulsion
products. After filing the first NDA, the parties shall discuss such
non-financial terms and appropriate changes as may be reasonably required in
view of the actual commercial manufacturing requirements. In no event shall such
adjustments apply to Miravant's compensation obligations.
PHARMACIA & UPJOHN CO.
By: /S/
------------------------------------
Name: _________________________________
Title: _______________________________
MIRAVANT MEDICAL TECHNOLOGIES
By: /S/
------------------------------------
Name: Xxxx X. Xxxxxxx
Title: Chairman of the Board and
Chief Executive Officer
EXHIBIT 1
DEFINED TERMS
1.1 "Act" means the United States Federal Food, Drug & Cosmetic Act (21 U.S.C.
Section 301 et seq.), or any successor act, as the same may be amended from time
to time, and the regulations promulgated thereunder.
1.2 "Affiliate" means any person, firm or corporation which, directly or
indirectly, through one or more intermediaries, controls, is controlled by, or
is under common control with, a party, but only so long as such relationship
exists. "Control" means the legal or beneficial ownership of more than fifty
percent (50%) of the voting or equity interests or the power or right to direct
the management and affairs of the business (including acting as the general
partner of a limited partnership).
1.3 "Agent" means Miravant's tin ethyl etiopurpurin compound suitable for
intravenous administration in a lipid emulsion formulation.
1.4 "Compound" means any photosensitizing agent (other than the Agent), or a
derivative or ***** of such photosensitizing agent or the Agent, which Miravant
has the right to use and which is suitable for intravenous administration in a
lipid emulsion formulation.
1.5 "Data" means all books, records, reports, lab notebooks, charts, graphs,
computations, analyses, recordings, photographs, computer programs and
documentation thereof, computer information storage means and other graphic or
written data generated in the performance of the Development Work, including any
data required to be maintained pursuant to applicable FDA regulations.
1.6 "Development Technology" means all Inventions, to the extent embodying the
composition or manufacture of any Emulsion, conceived or reduced to practice by
P&U, Miravant and their respective Affiliates, or any of them, either separately
or jointly with one another, during the course of the performance of the
Development Work.
1.7 "Development Work" means the program of work previously undertaken by P&U on
behalf of Miravant in connection with the development of formulations for
Emulsions suitable for intravenous administration of a photodynamic therapeutic
compound and the additional work described in Section 2.1.
1.8 "Emulsion" means a lipid emulsion suitable for intravenous administration of
the Agent.
1.9 "FDA" means the United States Food and Drug Administration or any successor
agency having the administrative authority to regulate the approval for testing
or marketing of human pharmaceutical or biological therapeutic products in the
United States (or, where appropriate, the equivalent governmental authority in
any foreign country).
1.10 "FDA Approval" means approval by the FDA of Miravant's NDA.
1.11 "GLP" means the applicable current good laboratory practices promulgated
from time to time by the FDA in accordance with the Act, including those set
forth in 21 CFR Part 58.
1.12 "GMP" means the applicable current good manufacturing practices promulgated
from time to time by the FDA in accordance with the Act, including those set
forth in 21 CFR Parts 210 and 211.
1.13 "IND" means an investigational new drug application submitted to the FDA
under 21 CFR 312 for the purpose of conducting clinical investigations of
Emulsions containing the Agent (or the equivalent in any foreign country).
1.14 "Invention" means any invention which may be protectable by patents in the
country in which the invention was made, whether or not patent applications are
filed.
1.14A "Initial Facility" means the small batch production facility at the
Xxxxxxx Facility used for the production of clinical materials of the Emulsion
and which shall be used to produce the initial requirements of the Product, up
to ***** Units.
***** Confidential Treatment Requested
1.15 "Know-How" means all inventions (whether or not patentable), trade secrets,
technical and other information and data, including, without limitation,
formulae; compositions; processes; controls; systems (including QA systems) and
procedures; apparatus; correlations; flow sheets; reports; operating, test and
performance data; and process, mechanical, material and product specifications.
1.16 "NDA" means a New Drug Application or other premarket approval application
to sell the Product, and any supplement or abbreviated application relating
thereto, submitted to the FDA by or on behalf of Miravant (or the equivalent in
any foreign country).
1.17 "Packaging Specifications" means the packaging, labeling and shipping
specifications for the Product determined by Miravant and approved by P&U.
1.18 "Patents" means patents of all countries, including improvement patents,
patents of addition, patents of importation, certificates of invention, utility
model and design patents, and all reissues, renewals and extensions thereof; and
applications for such patents, including original, divisional, continuation and
continuation-in-part applications pending before any patent office.
1.19 "Miravant Technology" means all Patents and Know-How owned or licensed by
Miravant or any of its Affiliates relating to the composition or manufacture of
the Agent and any Compounds, including, to the extent Miravant is permitted to
grant a sublicense to P&U, any Patents or Know-How licensed by Miravant from a
third party.
1.20 "P&U Technology" means all Patents and Know-How (other than Development
Technology) owned or licensed by P&U or any of its Affiliates which: (a) relate
to the composition or manufacture of phospholipid, soybean oil or other
proprietary raw materials; or (b) are used by P&U to manufacture (including to
sterilize) any Emulsion or other emulsion product, including, in each case, to
the extent P&U is permitted to grant a sublicense to Miravant, any Patents or
Know-How licensed by P&U from a third party (the Patents and Know-How described
in subsection (b) are referred to as "P&U Emulsion Technology").
1.21 "Product" means the injectible formulation in final dosage form of the
Agent suspended in an Emulsion described in the Product Specifications.
1.22 "Product Specifications" means the specifications for the Product specified
by Miravant in its NDA and approved by the FDA and P&U, and any modifications or
changes thereto specified by Miravant and approved by the FDA and P&U.
1.23 "Project Leaders" means the individual designated by P&U and the individual
designated by Miravant having the authority, obligations and responsibilities
referenced in Section 3.2 hereto.
1.24 "Proprietary Information" means all Know-How or other confidential or
proprietary information:
(a) relating to the composition, manufacture or use of the Agent, any
Compound, any Emulsion, the Product or P&U's other emulsion products;
(b) designated in writing by either party as confidential, proprietary or
not to be disclosed, whether by letter or by the use of an appropriate
proprietary stamp or legend, prior to or at the time any such Know-How or
confidential or proprietary information is disclosed by one party to the other;
or
(c) which is orally or visually disclosed (including the observation of
process equipment at the Xxxxxxx Facility), or is disclosed in writing without
an appropriate letter, proprietary stamp or legend, and which: (1) would be
apparent to a reasonable person familiar with the pharmaceutical and
biotechnology industries that such information is of a confidential or
proprietary nature, or (2) the disclosing party, within thirty (30) days after
such disclosure, delivers to the recipient a written document or documents
describing such information and referencing the place and date of such oral,
visual or written disclosure and the names of the employees or officers of the
recipient to whom such disclosure was made.
Proprietary Information shall not include any Know-How or other confidential or
proprietary information which:
(A) either before or after the date of the disclosure to the receiving
party becomes published or generally known to the public through no
fault or omission on the part of the receiving party, but such
inapplicability applies only after such information is published or
becomes generally known;
(B) was known or used by the receiving party prior to its date of
disclosure to the receiving party by the disclosing party, as evidenced
by the prior written records of the receiving party;
(C) either before or after the date of the disclosure to the receiving
party is lawfully disclosed to the receiving party by an independent,
unaffiliated third party rightfully in possession of the proprietary
information; or
(D) is independently developed by the receiving party without reference
to or reliance upon any proprietary information of the disclosing
party.
1.25 "Reprocessing" means the performance of any procedures or processes in
connection with the manufacture of the Product not normally required in the
manufacture of the Product which would require a regulatory submission to the
FDA or the initiation of additional stability studies.
1.26 "Specifications" means the Product Specifications and the Packaging
Specifications.
1.27 "Unit" means a container having a volume of ***** of Product (emulsion
containing ***** of emulsion), or such other volumes as the parties may agree
from to time.
1.28 "Other Definitions" The following terms are defined in the indicated
Sections of the Agreement:
Term Section
Xxxxxxx Facility 2.4
DMF 2.5
Initial Facility 2.2
Supply Price 7.1
***** Confidential Treatment Requested
EXHIBIT 2
DEVELOPMENT WORK COMPENSATION
1998
Personnel Hourly Rate
Laboratory Technician $*****
and Junior Scientist
Senior Scientist and $*****
Project Manager
Such rates shall be subject to escalation on *****, and annually thereafter, at
a rate not to exceed the percentage increase for the preceding twelve (12) month
period in the Consumer Price Index for All Urban Consumers (U.S. South Region)
issued by the Bureau of Labor Statistics, or comparable successor index.
***** Confidential Treatment Requested
EXHIBIT 3
TERMS AND CONDITIONS OF SALE
1. Storage Requirements. P&U shall maintain at all times during the term of this
Agreement adequate inventories of all raw materials and packaging components in
a quantity sufficient so that delivery of all Product to the marketplace will be
made in a timely manner. Such storage requirements shall be limited by the
purchase forecasts furnished by Miravant pursuant to Section 5.1 hereof. Unless
the parties otherwise agree, P&U shall not be required to store any finished
Product after completion of the release tests therefor or at other than room
temperature. After successful completion of release testing, P&U has the right
to ship the Product ordered by Miravant to Miravant in a commercially reasonable
manner.
2. Samples. P&U shall retain at all times during the term of this Agreement
samples of each lot of active ingredient and final dosage forms with respect to
the Product for time periods which are in accordance with GMP.
3. Product Recalls. In the event (i) any government authority issues a request,
directive or order that Product be recalled, (ii) a court of competent
jurisdiction orders such a recall or (iii) Miravant reasonably determines after
consultation with P&U that Product should be recalled, the parties shall take
all appropriate corrective actions. Except to the extent such recall is
attributable to P&U's gross negligence or willful misconduct or a breach of
P&U's warranties under Section 11.1 hereof, Miravant shall be responsible for
the cost of notifying end users and costs associated with shipment of any
recalled Product from end users. To the extent such recall is attributable to
P&U's gross negligence or willful misconduct or a breach of P&U's warranties
under Section 11.1 hereof, P&U shall be responsible for the cost of notifying
end users and costs associated with shipment of any recalled Product from end
users. P&U and Miravant shall fully cooperate with one another and provide all
reasonable assistance in conducting any recall under this Section; provided,
that P&U shall have no financial obligation for recall expenses unless any such
recall is attributable to P&U under the above conditions.
4. General Obligations of P&U and Miravant.
4.1 Except as provided in Section 5.5 of the Agreement and Section 8.2
hereof, all other materials required to manufacture, test, package, label and
release the Product shall be supplied by P&U.
4.2 P&U shall manufacture the Product in accordance with, and conduct such
quality assurance and other testing which demonstrates that the Product meets,
the Specifications and GMP. P&U shall not conduct Reprocessing with respect to
the Product without the prior written approval of Miravant. P&U shall not
release or distribute any Product to any third party, or use the Product in any
way not expressly permitted in the Agreement, except with Miravant's prior
written consent.
4.3 In the event P&U's manufacturing facility is inspected by
representatives of any federal, state or local regulatory agency in connection
with P&U's manufacture of the Product, P&U shall notify Miravant immediately (by
telephone and, if possible, in writing) upon learning of such inspection, and
shall supply Miravant with copies of any correspondence or portions of
correspondence which relate to the Product. Miravant may send representatives to
the manufacturing facility and may participate fully in any portion of such
inspection relating to the Product (and shall do so, at P&U's request). In the
event P&U receives any regulatory letter or written comments from any federal,
state or local regulatory agency in connection with its manufacture of the
Product requiring a response or action by P&U, including but not limited to
receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Miravant
promptly will provide P&U with any data or information required by P&U in
preparing any response relating to P&U's manufacture of the Product, and will
cooperate fully with P&U in preparing such response. P&U shall provide Miravant
with a copy of each such response for Miravant's review prior to submission of
the response.
4.4 Miravant shall promptly notify P&U of, and shall provide P&U with
copies of, any correspondence and other documentation received or prepared by
Miravant in connection with any of the following events: (1) receipt of a
regulatory letter from the FDA in connection with the manufacture of the
Product; (2) any recall of the Product; (3) the withdrawal of the Product from
the market; (4) any change in Miravant's formulation of, or manufacturing
process for, the Agent, (5) any change in Miravant's labeling for the Product;
(6) any regulatory comments relating to the manufacture of the Product requiring
a response or action by Miravant.
4.5 Miravant shall maintain complaint files in accordance with GMP
regulations. P&U shall promptly provide to Miravant copies of all complaints
received with respect to the Product as well as responses sent, if any. Miravant
shall promptly provide P&U with copies of any complaints relating to the
manufacture of the Product received by Miravant. Miravant shall have
responsibility for reporting all complaints relating to the Product, including
complaints relating to the manufacture of the Product, to the FDA.
4.6 P&U shall maintain all manufacturing and analytical records, all
records of shipments of the Product from P&U, and all validation data relating
to the Product for the time periods required by applicable laws and regulations
and shall make such data available to the FDA upon Miravant's request or if
required by law.
5. Orders.
5.1 Forecasts. Beginning with the first day of the quarter following the
quarter in which Miravant's NDA for the Product is approved, Miravant shall
provide quarterly its estimated forecast of requirements for the Product for
each of the ***** following the end of the quarter in which such forecast is
submitted (each a "Forecast"). The monthly sales quantities shown in the
Forecast for the ***** shall be considered a firm purchase order. All Forecasts
under this Agreement and updates thereof for any period after the ***** shall be
for the sole purpose of assisting P&U in its planning and will not constitute an
obligation of Miravant to purchase the quantities of Product indicated;
provided, however, that the total quantity of Product ordered by Miravant in any
quarter shall not exceed Miravant's most recent estimated quantity by more than
***** without P&U's prior written consent. Miravant and P&U shall each cooperate
to attempt to meet each others needs in connection with the manufacture and
supply of Product for Miravant's launch and the months following FDA Approval
before the Forecasts are applicable. As soon as practicable, P&U and Miravant
shall agree upon actual delivery times based upon scheduling and production
results determined during the Development Work.
5.2 Purchase Orders. Except to the extent the parties may otherwise agree
with respect to a particular shipment, the Product shall be ordered by Miravant
pursuant to written purchase orders, which shall be sent to P&U with not less
than the number of days "lead time" prior to delivery dates agreed on by the
parties for delivery times based on scheduling and production results determined
during the Development Work, as provided in Section 5.1 above. Subject to
Section 5.1, upon receipt of each purchase order hereunder, P&U shall supply the
Product, in such quantities and within the time period specified in such
purchase order. During the period of time that the Initial Facility is used for
commercial use, P&U may produce up to ***** Units in each production run of up
to ***** duration. Miravant's order requirements shall be subject to such
production limits. When the Initial Facility is modified or another production
line or facility is used to produce larger quantities (as described in Section
5.1 of the Agreement), the parties shall establish other production limits to
allow efficient utilization of such larger facility.
5.3 Emergency Orders. In the event Miravant experiences an emergency
backorder or other emergency situation, Miravant may place one or more purchase
orders for amounts of Product exceeding the amounts P&U would otherwise be
obligated to supply under this Agreement, or specifying a "lead time" of less
than the "lead time" agreed to by the parties pursuant to Section 5.1 hereof.
P&U shall use all reasonable efforts to accommodate such emergency purchase
orders according to their terms; and in the event P&U does supply Product in
accordance with the terms of such an emergency purchase order, any additional
costs incurred and documented by P&U in connection with the filling of such
emergency purchase order shall be reimbursed by Miravant.
6. Shipment. Product shall be shipped in the manner and to the location
specified by Miravant. All Products shall be delivered Ex Works Xxxxxxx Facility
(INCOTERMS 1990), or as otherwise agreed to by the parties.
7. Claims.
7.1 In the event that any of the Product delivered to Miravant by P&U shall
fail to conform with the permissible quantity requirements of any purchase order
or warranties set forth in Section 11.1 hereof, Miravant shall be entitled to
reject such Product by giving written notice to P&U within thirty (30) days
after Miravant's receipt of such Product. Any notice given hereunder shall
specify the manner in which the Product fails to conform to such quantity
requirements or warranties. If it is determined that the nonconformity (i) is
due to damage to the Product caused by (a) Miravant or (b) any carrier, or (ii)
results from the Agent supplied by Miravant, P&U shall have no liability to
Miravant with respect thereto. If such nonconformity is caused in any other
manner, P&U shall credit Miravant's account for the price invoiced for such
nonconforming Products and Miravant's cost for the Agent supplied therefor. If
payment therefor has previously been made by Miravant, P&U shall at Miravant's
option pay Miravant the amount of such credit or offset the amount thereof
against other amounts then due P&U. Except to the extent otherwise specified in
Sections 11.1 and 12.1 hereof, the foregoing remedy constitutes the exclusive
remedy against P&U, and the entire liability of P&U in connection with any
shipment.
7.2 In any case where Miravant expects to make a claim against P&U with
respect to nonconforming Product, Miravant shall not dispose of such Product
without written authorization and instructions of P&U either to dispose of the
Product or to return the Product to P&U.
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8. Packaging.
8.1 Containers. P&U shall supply containers meeting FDA requirements and
Packaging Specifications for each Unit of Product, which Product shall be filled
into these containers and appropriately sterilized and packaged for shipment to
Miravant pursuant to GMP and the Packaging Specifications.
8.2 Labels. Miravant shall supply in a timely manner all necessary labels
(or label copy for procurement of labels by P&U) and package inserts for the
containers for each Unit of Product as well as for the shipping container, which
labels and package inserts shall comply with applicable FDA requirements and
shall be the only labels and package inserts used by P&U for Product. All labels
and labeling produced by P&U, including in terms of packaging layout, design and
color, shall be consistent with artwork supplied or approved by Miravant and P&U
shall comply with Miravant's requirements concerning labels and labeling;
provided, however, that Miravant shall consider in good faith any requests by
P&U as to physical dimensions and specifications relating to the methods of
handling and affixing on containers. In no event shall P&U be responsible for
the content of any label or otherwise liable for any failure to supply adequate
warnings or to comply with the requirements of 21 CFR Part 201 relating to the
content of labels or package inserts.
9. Taxes. The actual amount of sales, use, excise, value-added and similar taxes
levied upon the transfer of Product to Miravant are payable by Miravant. Any
such tax may be contested with any assessing governmental authority so long as
Miravant agrees in advance to indemnify P&U therefor. Property, franchise, and
other business privilege-type taxes are not reimbursable by Miravant, except as
they may be a component of overhead. P&U shall pay any taxes imposed by a
government on the income resulting from the sale of Product or the receipt of
payments from Miravant hereunder, including but not limited to gross income,
adjusted gross income, supplemental net income, gross receipts, excess profits
taxes or other similar taxes.
10. Late Payments. If payments are not made within thirty (30) days after the
date when due, unless contested in good faith, Miravant shall pay, in addition
to the overdue payment, a late charge equal to the lesser of 1-1/2% per month or
the highest applicable rate allowed by law on all such overdue amounts. If, in
the reasonable judgment of P&U, the financial condition of Miravant at any time
does not justify continuation of such terms of payment, P&U may demand full or
partial payment in advance.
11. Product Warranty.
11.1 Product Warranty. P&U warrants that the Product, at the time of
shipment to Miravant, (a) will comply with the Specifications; and (b) will not
be products that have been adulterated within the meaning of the Act, or any
applicable state or local law substantially similar to the Act. Product sold
hereunder shall have been manufactured, packaged, labeled, stored and shipped in
conformity with all applicable GMP requirements and with the Specifications; and
Product sold hereunder shall have been manufactured, packaged and stored in
facilities which are approved by the FDA at the time of such manufacture,
packaging and storage, to the extent such approval is required by law. The
foregoing warranties shall not apply to any Product to the extent the
nonconformity or adulteration results from the Agent or other materials provided
by Miravant or was manufactured, packaged, labeled, stored and shipped in
accordance with practices or other specifications stipulated by Miravant. Title
to all Product sold hereunder shall pass to Miravant as provided herein free and
clear of any security interest, lien or other encumbrance.
11.2 Remedy. Should any failure to conform with the foregoing warranties
appear prior to the expiration date of the Product, and if given prompt written
notice by Miravant, P&U shall correct such nonconformity by, at its option, (1)
replacing promptly the nonconforming Product or (2) refunding promptly the
payments by Miravant for such nonconforming Product.
11.3 Exclusive Warranties and Remedies.
(a) No Other Warranties. Except as expressly provided for in Section
11.1, P&U makes no representations or warranties of any nature whatsoever
with respect to the Product, any Emulsions or other materials supplied
hereunder by it to Miravant or its licensees or Affiliates, and ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED
BY PHARMACIA AND ITS AFFILIATES AND THEIR SUBCONTRACTORS.
(b) Exclusive Remedy. Except as otherwise expressly provided in
Section 12.1, correction of nonconformities in the manner and for the
period of time provided in Section 11.2 shall be the exclusive remedy and
shall constitute fulfillment of all obligations to Miravant, its Affiliates
and other purchasers of Product directly or indirectly from P&U, its
Affiliates and their subcontractors (including any liability for direct,
indirect, special, incidental or consequential damages), whether in
warranty, contract, negligence, tort, strict liability, or otherwise with
respect to any nonconformance of or defect or deficiency in the Product or
other materials supplied hereunder by P&U or its Affiliates.
12. Indemnification.
12.1 Indemnification by P&U. Subject to Miravant's compliance with its
obligations set forth in Section 12.4 below, P&U agrees to indemnify, defend and
hold Miravant and its Affiliates, their shareholders, directors, officers,
employees and agents harmless from and against any and all losses, damages,
liabilities, claims, demands, judgments, settlements, costs and expenses
(including, without limitation, reasonable attorneys' fees and other costs of
defense) (collectively "Losses") attributable to, or arising out of, any claim,
lawsuit or other action by a third party for personal injury or property damage
to the extent caused by a breach of any P&U warranty or representation hereunder
or the gross negligence or willful misconduct of P&U in the manufacture of the
Product or any Emulsion.
12.2 Indemnification by Miravant. Subject to P&U's compliance with its
obligations set forth in Section 12.4 below, Miravant agrees to indemnify,
defend and hold P&U and its Affiliates, their shareholders, directors, officers,
employees and agents harmless from and against any and all Losses attributable
to, or arising out of (a) any claim, lawsuit or other action by a third party
for personal injury or property damage, arising out of or connected with the use
or sale of the Product or an Emulsion (except for Losses caused by P&U's gross
negligence or willful misconduct in the manufacture of the Product or Emulsion),
(b) Miravant's negligence or willful misconduct, or (c) breach of any Miravant
representation or warranty hereunder.
12.3 Employees. Except as otherwise provided in Section 12.1 or 12.2, each
party shall indemnify and hold the other party harmless, and hereby forever
releases and discharges the other party, from and against all claims, demands,
liabilities, damages and expenses (including reasonable attorney's fees) arising
out of personal injury (including death) or property damage incurred or suffered
by the indemnifying party, its Affiliates, contractors or their employees
(regular or contract) arising out of or in connection with the work performed
hereunder, except to the extent caused by the sole negligence of such other
party, its employees or agents.
12.4 Notice and Assistance. A party (the "indemnitee") which intends to
claim indemnification under this Section 12 shall promptly notify the other
party (the "indemnitor") in writing of any action, claim or other matter in
respect of which the indemnitee or any of its employees or agents intend to
claim such indemnification. The indemnitee shall permit, and shall cause its
employees and agents to permit, the indemnitor, at its discretion, to settle any
such action, claim or other matter and agrees to the complete control of such
defense or settlement by the indemnitor; provided, however, that such settlement
does not adversely affect the indemnitee's rights hereunder or impose any
obligations on the indemnitee in addition to those set forth herein in order for
it to exercise such rights. No such action, claim or other matter shall be
settled without the prior written consent of the indemnitor and the indemnitor
shall not be responsible for any legal fees or other costs incurred other than
as provided herein.
12.5 Unenforceability. The foregoing indemnity obligations of this Section
12 shall not be deemed to extend to any type of claim, act or omission by P&U or
Miravant for which the indemnity obligation would be void, unenforceable or
otherwise not permitted by applicable law, and if any are deemed to so extend,
it shall be interpreted and restricted to the extent to which it is permitted by
applicable law.
13. Compliance with Law.
13.1 Scope. P&U and Miravant shall comply with all applicable federal,
state and local laws, regulations and executive orders insofar as applicable to
the performance of their respective obligations hereunder. Notwithstanding the
foregoing, Miravant shall be solely responsible for compliance with all
applicable regulatory requirements relating to the registration, advertising,
sale, adverse reaction reporting and other activities concerning the Product,
including, but not limited to, compliance with applicable FDA and other
regulatory authorities' requirements; provided, that P&U shall comply with
applicable GLP/GMP requirements as provided in Section 2.1 of the Agreement and
Section 12.1 hereof.
13.2 Assistance by Miravant. Miravant and P&U shall furnish each other
reasonable assistance for compliance with Section 13.1 above to the extent such
compliance involves the composition, toxicity, safety and other chemical or
physical characteristics of the Agent or any Emulsion, including, but not
limited to, furnishing to the extent reasonably available to it, the technical
data required by all environmental, health, safety and fire laws.
14. Insurance.
14.1 Scope. Both parties shall maintain insurance during the term of this
Agreement with policy limits and coverage as are customary in the respective
party's business and reasonably adequate to cover all perils customarily
protected against in performing their respective obligations hereunder or while
visiting any facility in connection with this Agreement. Subject to reasonable
self-insurance limits, such insurance shall include the following minimum
coverage and policy limits: (a) Workers' Compensation in accordance with all
applicable statutory requirements; (b) Employer's Liability in an amount not
less than *****; (c) Comprehensive General Liability, including Independent
Contractor's Liability, Contractual Liability and Products - Completed
Operations Liability, as well as coverage on all equipment (other than motor
vehicles licensed for highway use) owned, hired or used in performance of this
Agreement in an amount not less than ***** combined single limit; and (d)
Automobile Liability, covering all motor vehicles owned, hired or used, in an
amount not less than ***** bodily injury and property damage combined single
limit each occurrence; provided, that the limit of the insurance referred to in
clause (c) may be ***** prior to commencing *****. In the event such insurance
or the specified limits thereof are not commercially available at reasonable
premiums, the parties shall discuss alternate forms of protection and shall not
withhold consent to any reasonable alternative.
14.2 Evidence of Insurance. Both parties shall furnish the other party
certificates of insurance evidencing the foregoing coverage, which certificates
shall provide: (a) that the insurer will provide thirty days' written notice
prior to any cancellation; and (b) without limiting either party's indemnity
obligations hereunder, that the other party shall be named as an additional
insured for the original insured's acts or omissions.
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EXHIBIT 4
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(b) Accounting Standards and Procedures.
(1) Except as otherwise stated herein, the Production Cost shall be
determined in accordance with generally accepted cost accounting
principles applied on a consistent basis in the country of
manufacture. *****, the parties shall determine the variance between
the aggregate of the actual Production Cost and the aggregate
Production Cost paid by Miravant for Product purchased during such
year. If such variance is positive, Miravant shall pay such amount
within thirty days of receipt of invoice; and if such variance is
negative, P&U shall issue Miravant a credit. Production Cost for the
succeeding ***** shall be based on the actual Production Cost *****
with appropriate standard cost adjustments for Miravant's purchase
forecasts, planned manufacturing efficiencies, and expected cost
variations in raw materials, labor and overhead.
(2) Any method of allocating a particular cost under this Agreement shall
be consistent with the method of allocating that cost for any other
product manufactured at that same location. For any materials which
are purchased by P&U for both its own products and for Product, except
with respect to emulsifier and other materials manufactured by P&U or
any of its Affiliates, the cost to Miravant shall not be more than for
P&U's own products.
(3) As used herein, "cost" for purchased materials or services means the
actual amount paid therefor including the benefit of any price
reductions, payment or terms discounts, or other reimbursements, such
as volume discounts, which may be applicable to such purchases by any
arrangement with the supplier.
(4) In no event shall reimbursement for costs or overhead be duplicated in
any manner.
(5) Overhead shall be allocated in a manner consistent with similar
Xxxxxxx Facility products and in accordance with generally accepted
cost accounting methods applied on a consistent basis.
(c) Books and Records. P&U shall maintain adequate books and records to verify
the calculation and derivation of Production Cost. Such books and records
shall be available for inspection and audit by Miravant and its
representatives at reasonable times and on reasonable notice, but not later
than the end of the second calendar year after the year in which the
records are generated, for the purpose of verifying reports and payments
due hereunder. In the event such inspection and audit should show an
variance with the Production Cost actually paid by Miravant, such variance
shall be paid promptly by payments by P&U or Miravant, as the case many be,
and if such variance should be more than five percent (5%) of the aggregate
Production Costs paid during the respective period, P&U shall also bear the
expenses incurred for said audit.
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EXHIBIT 5
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